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SODIUM IODIDE (123I) INJECTION 37 MBQ/ML SOLUTION FOR INJECTION

Active substance(s): SODIUM IODIDE I 123

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• Tolbutamide (used for people with diabetes to lower blood sugar
levels).
• Thiopental (used as a general anaesthetic).
• Medicines given in hospital for x-rays or scans (intravenous
contrast media).
• Vitamins.
If you are not sure if any of the above apply to you, talk to your doctor
or nurse before having Sodium Iodide Injection.

•TheOne
single
injection.
scan
is usually
taken 3 to 6 hours after the injection.
The scan is usually taken 3 to 6 hours after the injection.
4. Possible side effects
4. Possible side effects
Like all medicines, Sodium Iodide Injection can cause side effects,
Like
all medicines,
Sodium
Iodide
Injection can cause side effects,
although
not everybody
gets
them.
although not everybody gets them.
Allergic reactions
Allergic
reactions
If you have
an allergic reaction when you are in hospital or a clinic
If
you
have
an
allergic
reaction
youstraight
are in hospital
or asigns
clinicmay
having the scan,
tell the
doctor when
or nurse
away. The
having
include:the scan, tell the doctor or nurse straight away. The signs may
include:
• skin rash or itching or flushing
•• skin
rashof
orthe
itching
swelling
faceor flushing
•• swelling
the face
difficultyof
breathing.
• difficulty breathing.
If any of the side effects above happen after you leave the hospital or
If
any of
the
side effects
above
youcasualty
leave the
hospital or
clinic,
you
should
go or be
takenhappen
straightafter
to the
department
clinic,
should
go or be taken straight to the casualty department
of youryou
nearest
hospital.
of your nearest hospital.
If any of the side effects gets serious, of if you notice any side effects
If
any
of the
sideleaflet,
effectsplease
gets serious,
ofdoctor
if you notice
any side effects
not
listed
in this
tell your
or nurse.
not listed in this leaflet, please tell your doctor or nurse.

Pregnancy and breast-feeding
You must tell your doctor if you are pregnant or think you might be
pregnant. Your doctor will only use this product if it is considered that
the benefit outweighs the risk.

Taking other medicines
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Iodide (123I) Injection 37 MBq/ml solution for injection
(called Sodium Iodide Injection in this leaflet)

5. How to store Sodium Iodide Injection
5. How to store Sodium Iodide Injection
Sodium Iodide Injection is kept out of the reach and sight of children.
Sodium Iodide Injection is kept out of the reach and sight of children.
The product label includes the correct storage conditions and the
The
product
label
the correct
conditions
and
the is
expiry
date for
theincludes
batch. Hospital
staffstorage
will ensure
that the
product
expiry
date
for
the
batch.
Hospital
staff
will
ensure
that
the
product
stored and
and disposed
disposed of
of correctly
correctly and
and not
not used
used after
after the
the expiry
expiry date
date is
stored
stated
on
the label.
label.
stated
the
6.6
Specialon
precautions
for disposal and other handling

Sodium [123I]iodide
Read all of this leaflet carefully before you are given Sodium
Iodide Injection
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.

Normal safety precautions for handling radioactive materials should be observed. After use, all materials
associated with the preparation and administration of radiopharmaceuticals, including any unused product
and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance
with the conditions specified by the local competent authority. Contaminated material must be disposed of as
radioactive waste via an authorised route.

6. Further
Further information
information
6.
What Sodium
Sodium Iodide
Iodide Injection
Injection contains
contains
What
7. MARKETING AUTHORISATION HOLDER
123I]iodide. Each ml of Sodium
•• GE
The
active
ingredient
is
sodium
The
activeLimited
ingredient is sodium [[123
I]iodide. Each ml of Sodium
Healthcare
123
Amersham
Place
123
Iodide
(
I)
Injection
contains
37
MBq
(Megabecquerel –– the
the unit
unit in
in
Iodide
( I) Injection contains 37 MBq (Megabecquerel
Little
Chalfont
123
123
I]iodide
at
a
fixed
which
radioactivity
is
measured)
of
sodium
[
Buckinghamshire
HP7 9NA
which radioactivity
is measured) of sodium [ I]iodide at a fixed
United Kingdom
time.
time.
8.
AUTHORISATION
NUMBER
The other
other
ingredients
are acetic
acetic acid,
acid, sodium
sodium hydroxide,
hydroxide, sodium
sodium
•• MARKETING
The
ingredients
are
UK: PL 00221/0138
thiosulphate,
sodium
bicarbonate,
sodium
chloride
and
water
for
thiosulphate, sodium bicarbonate, sodium chloride and water for
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
injections.
injections.
Date of first authorisation

Date of last renewal

01 December
23 May
2003
WhatUK
Sodium
Iodide1998
Injection looks
looks
like
and contents
contents of
of the
the pack
pack
What
Sodium
Iodide
Injection
like
and
Sodium
Iodide
Injection
is supplied
supplied as
as a
a single
single glass
glass vial
vial containing
containing a
a
10.
DATE OFIodide
REVISION OF
THE TEXT is
Sodium
Injection
XX/XXXX for injection.
solution
solution for injection.
11. DOSIMETRY

Marketing
Authorisation
Holder
Depending onAuthorisation
the production procedure
of iodine -123, impurities like iodine-125 and/or iodine-124 may be
Marketing
Holder
present as longer life contaminants increasing the radiation dosimetry to the different organs. The ICRP
GEmodel
Healthcare
Limited
GE
Healthcare
Limited
refers to intravenous
administration.
Amersham
Place
For this product
the Effective Dose Equivalent resulting from an administered activity of 14.8 MBq will be
Amersham
Place
2.2 mSv. This Effective Dose Equivalent is dependent on the uptake in the thyroid glands.
Little
Chalfont
Little
Chalfont
The Effective (whole body) Dose Equivalent is calculated from the six standard organs (gonads, breast, red
Buckinghamshire
marrow, lungs, thyroid and bone surfaces) and five additional organs with the highest absorbed dose
Buckinghamshire
(marked with *).
HP7
9NA
HP7
9NA
The table below shows the dosimetry as calculated according to the Publication 53 of the ICRP (International
United
Kingdom
Commission
on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals, Pergamon
United
Kingdom

Thyroid blocked, uptake 55%
Organ
Adrenals
Bladder wall
Bone surfaces
Breast
GI-tract:
* Stomach wall
* Small intest
* ULI wall
LLI wall

Press 1987).

Manufacturer
Manufacturer
Thyroid blocked, uptake 0%
GE Healthcare
Healthcare B.V.
B.V.
GE
Organ
Absorbed dose per unit activity administered (mGy/MBq)
Den
Dolech
2
Adult
15 year
10 year
5 year
1 year
Den Dolech 2
Adrenals
8.7E-03
1.4E-02
2.1E-02
3.9E-02
5612
AZ Eindhoven
Eindhoven 7.0E-03
5612
AZ
* Bladder wall
9.0E-02
1.1E-01
1.6E-01
2.4E-01
4.5E-01
TheBone
Netherlands
surfaces
8.1E-03
9.7E-03
1.5E-02
2.4E-02
4.6E-02
The
Netherlands
Breast
GI-tract:
Stomach wall
* Small intest
* ULI wall
* LLI wall

5.6E-03

5.6E-03

8.1E-03

1.4E-02
This leaflet
leaflet was
was last
last 6.9E-03
approved8.5E-03
in 05/2011
XX/XXXX
This
approved
in
8.5E-03
1.0E-02
1.6E-02
8.0E-03

9.7E-03
Marketing Authorisation
Authorisation
Marketing
UK:* Kidneys
PL 00221/0138
00221/0138 1.1E-02
UK:
PL
Liver
Lungs
Ovaries
Pancreas

6.7E-03
6.1E-03
9.8E-03
7.6E-03

1.3E-02

2.5E-02

3.7E-02
4.6E-02
4.3E-02
5.4E-02
5.1E-02
3.7E-02
3.5E-02
5.3E-02
4.1E-02

9.9E-03
1.2E-02

1.5E-02
1.9E-02

2.1E-02
2.5E-02
2.4E-02
2.9E-02

1.4E-02
8.2E-03
7.8E-03
1.2E-02
9.1E-03

2.0E-02
1.3E-02
1.2E-02
1.9E-02
1.4E-02

2.9E-02
2.0E-02
1.9E-02
3.0E-02
2.2E-02

3.
3.

Thyroid blocked, uptake 15%
Organ
Adrenals
* Bladder wall
Bone surfaces
Breast
GI-tract:
* Stomach wall
* Small intest
* ULI wall
LLI wall
Kidneys
Liver
Lungs
Ovaries
* Pancreas

1.2E-01
9.1E-02
2.9E-02
2.0E-02

2.0E-01
1.4E-01
4.4E-02
3.0E-02

3.9E-01
2.7E-01
7.6E-02
5.5E-02

Kidneys
Liver
Lungs
Ovaries
* Pancreas

9.1E-03
6.4E-03
7.2E-03
1.1E-02
1.4E-02

1.1E-02
7.9E-03
9.7E-03
1.5E-02
1.6E-02

1.6E-02
1.3E-02
1.6E-02
2.3E-02
2.5E-02

2.4E-02
2.2E-02
2.6E-02
3.6E-02
3.6E-02

4.1E-02
4.1E-02
4.8E-02
6.4E-02
6.3E-02

Red marrow
* Spleen
Testes
Thyroid
Uterus

1.1E-02
9.7E-03
4.6E-03
7.0E+00
1.2E-02

1.5E-02
1.1E-02
6.2E-03
1.1E+01
1.6E-02

2.1E-02
1.7E-02
1.0E-02
1.7E+01
2.6E-02

3.0E-02
2.6E-02
1.6E-02
3.6E+01
4.0E-02

5.2E-02
4.6E-02
3.2E-02
6.8E+01
7.2E-02

Other tissue

9.2E-03

1.2E-02

1.9E-02

3.1E-02

5.8E-02

Effective Dose
Equivalent (mSv/MBq)

2.3E-01

3.5E-01

5.3E-01

1.1E+00

2.1E+00

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
This radiopharmaceutical may be received, used and administered only by authorised persons in designated
clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or
appropriate licences of the local competent official organisations (see section 6.6).
The administration of radiopharmaceuticals creates risks for other persons from external radiation or
contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with
national regulations must therefore be taken.
Thyroid blocked, uptake 55%
Organ
Adrenals
Bladder wall
Bone surfaces
Breast
GI-tract:
* Stomach wall
* Small intest
* ULI wall
LLI wall

Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
6.5E-03
8.5E-03
1.4E-02
2.1E-02
3.9E-02
4.3E-02
5.3E-02
7.9E-02
1.2E-01
2.2E-01
8.6E-03
1.2E-02
1.8E-02
2.8E-02
5.1E-02
5.6E-03
5.6E-03
9.5E-03
1.7E-02
3.1E-02
6.8E-02
4.2E-02
1.8E-02
9.8E-03

8.5E-02
5.4E-02
1.9E-02
1.3E-02

1.2E-01
9.1E-02
2.9E-02
2.0E-02

2.0E-01
1.4E-01
4.4E-02
3.0E-02

3.9E-01
2.7E-01
7.6E-02
5.5E-02

9.1E-03
6.4E-03
7.2E-03
1.1E-02
1.4E-02

1.1E-02
7.9E-03
9.7E-03
1.5E-02
1.6E-02

1.6E-02
1.3E-02
1.6E-02
2.3E-02
2.5E-02

2.4E-02
2.2E-02
2.6E-02
3.6E-02
3.6E-02

4.1E-02
4.1E-02
4.8E-02
6.4E-02
6.3E-02

Solution for intravenous injection, ready to use.

PACKAGE LEAFLET: INFORMATION FOR HEALTHCARE PROFESSIONAL

Aseptic conditions must be observed during withdrawal of a patient dose from the vial, including microbial
decontamination of the rubber stopper with a suitable disinfectant before removal of a dose. This product is
not preserved. After removal of a dose from the vial, store at 2°C-8°C and use within one working day.

1.

13. OTHER INFORMATION

NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium [123I]iodide, 37 MBq/ml at reference date and hour.
At calibration time, the radionuclidic purity is at least 99.9% and the main radionuclidic impurities (iodine-125
and tellurium-121) occur for less than 0.05%.
Iodine-123 is a cyclotron product with a physical half-life of 13.2 hours. Iodine-123 decays emitting pure
gamma radiation with predominant energies of 159 keV and 27 keV.

8.5E-02
5.4E-02
1.9E-02
1.4E-02

1.2E-01
9.1E-02
2.9E-02
2.2E-02

2.0E-01
1.4E-01
4.5E-02
3.3E-02

3.8E-01
2.7E-01
7.7E-02
6.0E-02

Red marrow
* Spleen
Testes
Thyroid
Uterus

1.1E-02
9.7E-03
4.6E-03
7.0E+00
1.2E-02

1.5E-02
1.1E-02
6.2E-03
1.1E+01
1.6E-02

2.1E-02
1.7E-02
1.0E-02
1.7E+01
2.6E-02

3.0E-02
2.6E-02
1.6E-02
3.6E+01
4.0E-02

5.2E-02
4.6E-02
3.2E-02
6.8E+01
7.2E-02

1.0E-02
6.2E-03
5.7E-03
1.2E-02
1.4E-02

1.3E-02
7.6E-03
7.2E-03
1.6E-02
1.6E-02

1.8E-02
1.3E-02
1.1E-02
2.5E-02
2.4E-02

2.7E-02
2.1E-02
1.8E-02
3.8E-02
3.5E-02

4.6E-02
3.8E-02
3.4E-02
6.8E-02
6.1E-02

Other tissue

9.2E-03

1.2E-02

1.9E-02

3.1E-02

5.8E-02

Sodium Iodide (123I) Injection is used as a diagnostic agent in the functional or morphological study
of the thyroid gland by means of:

Effective Dose
Equivalent (mSv/MBq)

2.3E-01

3.5E-01

5.3E-01

1.1E+00

2.1E+00



scintigraphy



radioactive iodine uptake test

1.7E-02
1.7E-02
1.2E-02
4.5E+00
3.1E-02

2.5E-02
2.5E-02
2.0E-02
9.8E+00
4.9E-02

4.3E-02
4.4E-02
3.8E-02
1.9E+01
8.6E-02

Other tissue

6.8E-03

8.5E-03

1.3E-02

2.1E-02

3.9E-02

Effective Dose
Equivalent (mSv/MBq)

7.5E-02

1.1E-01

1.7E-01

3.5E-01

6.5E-01

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent
with approximately 0.6% at calibration time and 4% at expiration time.
Thyroid blocked, uptake 35%
Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
6.5E-03
8.4E-03
1.3E-02
2.1E-02
3.8E-02
6.0E-02
7.4E-02
1.1E-01
1.6E-01
3.0E-01
7.9E-03
1.1E-02
1.6E-02
2.5E-02
4.6E-02
5.2E-03
5.2E-03
8.5E-03
1.5E-02
2.7E-02
6.8E-02
4.2E-02
1.8E-02
1.0E-02

8.5E-02
5.4E-02
1.9E-02
1.4E-02

1.2E-01
9.0E-02
2.9E-02
2.1E-02

2.0E-01
1.4E-01
4.5E-02
3.2E-02

3.8E-01
2.7E-01
7.6E-02
5.8E-02

Kidneys
Liver
Lungs
Ovaries
* Pancreas

9.1E-03
6.3E-03
6.5E-03
1.1E-02
1.4E-02

1.1E-02
7.8E-03
8.6E-03
1.5E-02
1.6E-02

1.6E-02
1.3E-02
1.4E-02
2.4E-02
2.4E-02

2.4E-02
2.1E-02
2.2E-02
3.7E-02
3.6E-02

4.1E-02
4.0E-02
4.2E-02
6.6E-02
6.2E-02

Red marrow
* Spleen
Testes
Thyroid
Uterus

1.0E-02
9.6E-03
5.0E-03
4.5E+00
1.4E-02

1.3E-02
1.1E-02
6.8E-03
7.0E+00
1.7E-02

1.9E-02
1.7E-02
1.1E-02
1.1E+01
2.9E-02

2.8E-02
2.5E-02
1.8E-02
2.3E+01
4.4E-02

4.8E-02
4.5E-02
3.5E-02
4.3E+01
7.9E-02

Other tissue

8.0E-03

1.0E-02

1.6E-02

2.6E-02

4.9E-02

Effective Dose
Equivalent (mSv/MBq)

1.5E-01

2.3E-01

3.5E-01

7.4E-01

1.4E+00

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent
with approximately 0.6% at calibration time and 4% at expiration time.

The content of the vial may be used for one or more administrations until time of expiry.
3.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications
This medicinal product is for diagnostic use only.

The 24 hours uptake data are generally used in calculating the therapeutic dose.
4.2 Posology and method of administration
The recommended activity for an adult patient (70 kg) is between 3.7 and 14.8 MBq.

If the administration is found necessary the breast-feeding should be interrupted for 1.5 - 3 days following the
administration of iodine-123 that contains iodine-125 and/or iodine-124 as radio contaminant. Expressed
milk should be discarded.

4.8 Undesirable effects
The frequencies of undesirable effects are defined as follows:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
<1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Immune system disorders
Not known: Hypersensitivity

Determination of the rate of thyroid iodine-123 uptake should be carried out in accordance with well
established standard procedures.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary
defect. As the effective dose is 2.2 mSv when the maximal recommended activity of 14.8 MBq is administered
these adverse events are expected to occur with a low probability.

The activities for children may be calculated from the recommended range of adult activities and adjusted
according to the following equation:

The administration of radiopharmaceuticals creates risks for other persons from external radiation or
contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with
national regulations must therefore be taken.

Activity child (MBq) =

Solution for intravenous injection, ready to use.

activity adult (MBq) x body weight (kg)
70 (kg)

In young children the activity of 14.8 MBq should be used in the equation to calculate the activity for children
in order to obtain images of sufficient quality.

DEU

Sodium Iodide (123I) Injection must be given as an intravenous injection; as a routine check, the activity in the
injection should be measured immediately prior to administration. Imaging is performed 3-6 hours after
administration.

GBR

The instructions for preparation of radiopharmaceuticals are given in section 12.

GE HealthcareGE Healthcare

4.3 Contra-indications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
Individual benefit/risk justification:
For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered
should in every case be as low as reasonably achievable to obtain the required diagnostic information.

Sodium Iodide (123I) Injection
37 MBq/ml solution for injection
Sodium [123I]iodide

GE and the GE Monogram are trademarks of General Electric Company

Paediatric Population:
Paediatric population, see section 4.2.

4.5 Interaction with other medicinal products and other forms of interaction
The uptake of [123I] iodide maybe decreased by recent administration of iodinated contrast materials, by
intake of stable iodine in any form, or by thyroid, antithyroid, and certain other drugs.
Accordingly, the patient should be questioned carefully regarding diet, previous medication, and
procedures involving radiographic contrast media. Relevant medication including the ones mentioned
below should be withheld prior to the administration of sodium [123I] iodide.

1

7

3

6

D_FGBRTP.02

2

4

The frequencies of undesirable effects are defined as follows:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
<1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

This medicinal product contains less than 1mmol sodium
92 mg) per dose, i.e. essentially ‘sodium –free’.
23
Immune system disorders
Not known: Hypersensitivity

to ionising radiation
is linked
with cancer
3. Exposure
How Sodium
Iodide
Injection
isinduction
givenand a potential for development of hereditary

defect. As the effective dose is 2.2 mSv when the maximal recommended activity of 14.8 MBq is administered
these adverse events are expected to occur with a low probability.

Sodium Iodide Injection will be given to you by a specially trained and
qualified person.
• Sodium Iodide Injection will always be used in a hospital or clinic.
• They will tell you anything you need to know for its safe use.
5.
PHARMACOLOGICAL
PROPERTIESon the dose that is best for you.
Your
doctor will decide
4.9 Overdose
In the event of the administration of an overdose of [123I] iodide, the absorbed dose to the patient should be
reduced where possible by increasing the elimination of the radionuclide from the body by diuresis and
frequent voiding of urine. A blocking agent such as potassium perchlorate should be used to minimise
irradiation to the thyroid

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, thyroid, sodium iodide (123I), ATC
code: V09FX02.

The usual dose is:
• One
single injection.
At doses used in diagnostic investigations, sodium iodide has not been observed to exert any
effects. taken 3 to 6 hours after the injection.
Thepharmacodynamic
scan is usually

5.2 Pharmacokinetic properties
Intravenously administered iodide is taken by the thyroid. About 20% of the available radioactivity enters the
thyroid in one pass of the blood volume. Normal thyroid clearance of blood iodide is 20-50 ml/min with an
increase to 100 ml/min in thyroid deficiency.

4. Possible side effects

Peak levels of iodide occur in thyroid gland within a few hours so that diagnostic imaging can take place from
Like
all medicines, Sodium Iodide Injection can cause side effects,
one hour after dosing.
although
not
everybody
gets
The half-time
of iodide
elimination from
the them.
thyroid is estimated at 80 days so that the physical half-life of
iodine-123 of 13 hours governs the temporal opportunity for imaging.

Allergic
reactions
Without considering
the thyroid uptake, the iodide leaves the body stream chiefly by urinary excretion (3775%), while faecal excretion is low (about 1%).
If you have an allergic reaction when you are in hospital or a clinic
5.3
Preclinical
data tell the doctor or nurse straight away. The signs may
having
thesafety
scan,
Known toxic effects of relatively high doses of sodium iodide are not relevant to this use of iodine-123 to
image the thyroid for diagnostic purposes.
include:
No data are available from animal models about toxicity with repeated dose administration or about
• skin
rash or itching or flushing
reproduction toxicity.
Injection
has not been investigated for mutagenicity and carcinogenic/oncogenic
Sodium Iodideof
(123I)the
• swelling
face
potential.
• difficulty breathing.
6.

Active substances: Withdrawal period prior to administration of sodium [123I]iodide
Antithyroid agents (e.g. carbimazole, methimazole, propyluracil), perchlorate: 1 week.
Salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, anticoagulants, antihistamines,
antiparasitics, penicillins, sulfonamides tolbutamide, thiopental: 1 week.
Phenylbutazone: 1-2 weeks.
Expectorants and vitamins: 2 weeks.
Natural or synthetic thyroid preparations (levothyroxine sodium, liothyronine sodium): 1-3 weeks.
Amiodoarone, benzodiazepines, lithium: approx. 4 weeks.
Iodine-containing preparations for topical use: 1-9 months.
Intravenous contrast agents: 1-2 months
Iodine containing contrast agent: up to 1 year.
4.6 Pregnancy and lactation
Women of childbearing potential:
When it is necessary to administer radioactive medicinal product to women of childbearing potential,
information should always be sought about pregnancy. Any woman who has missed a period should be
assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has
missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there
are any) should be offered to the patient.
Pregnancy:
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only
imperative investigations should be carried out during pregnancy, when the likely benefit exceeds the risk
incurred by the mother and foetus.
Breast-feeding:
Before administering a radioactive medicinal product to a mother who is breast-feeding consideration should
be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-

PHARMACEUTICAL PARTICULARS

If any of the side effects above happen after you leave the hospital or
clinic, you should go or be taken straight to the casualty department
of your nearest hospital.

6.1 List of excipients
Acetic acid
Sodium hydroxide
Sodium thiosulphate
Sodium bicarbonate
Sodium chloride
Water for injections

If any of the side effects gets serious, of if you notice any side effects
notIncompatibilities
listed in this leaflet, please tell your doctor or nurse.
6.2
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.

6.3 Shelf life

be used up to 36 hours post calibration time indicated on the label.
5. Can
How
to store Sodium Iodide Injection
Once opened, store in a refrigerator (2°C-8°C) and use within one working day.

Sodium Iodide Injection is kept out of the reach and sight of children.

6.4 Special precautions for storage
Store below 25°C. Do not freeze.

storage conditions
the opened medicinal
product, see
section 6.3.conditions and the
TheForproduct
labelofincludes
the correct
storage
Store
either
in
original
lead
container
or
in
equivalent
shielding.
expiry date for the batch. Hospital staff will ensure that the product is
Storage should take place in accordance with national regulations for radioactive materials.

6.5 Nature and contents of container
10 ml medicinal glass vial, closed with a Teflon coated rubber stopper and sealed with an aluminium cap.
Each vial is enclosed in a lead container of appropriate thickness.
Pack size: 18.5 to 370 MBq.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Normal safety precautions for handling radioactive materials should be observed. After use, all materials
associated with the preparation and administration of radiopharmaceuticals, including any unused product
and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance
with the conditions specified by the local competent authority. Contaminated material must be disposed of as
radioactive waste via an authorised route.
7.

MARKETING AUTHORISATION HOLDER
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
UK: PL 00221/0138

9.

DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Date of first authorisation
01 December 1998

UK

Date of last renewal
23 May 2003

10. DATE OF REVISION OF THE TEXT
XX/XXXX
11. DOSIMETRY
Depending on the production procedure of iodine -123, impurities like iodine-125 and/or iodine-124 may be
present as longer life contaminants increasing the radiation dosimetry to the different organs. The ICRP
model refers to intravenous administration.

5.

The Effective (whole body) Dose Equivalent is calculated from the six standard organs (gonads, breast, red
marrow, lungs, thyroid and bone surfaces) and five additional organs with the highest absorbed dose
(marked with *).

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, thyroid, sodium iodide (123I), ATC
code: V09FX02.
At doses used in diagnostic investigations, sodium iodide has not been observed to exert any
pharmacodynamic effects.
5.2 Pharmacokinetic properties
Intravenously administered iodide is taken by the thyroid. About 20% of the available radioactivity enters the
thyroid in one pass of the blood volume. Normal thyroid clearance of blood iodide is 20-50 ml/min with an
increase to 100 ml/min in thyroid deficiency.
Peak levels of iodide occur in thyroid gland within a few hours so that diagnostic imaging can take place from
one hour after dosing.
The half-time of iodide elimination from the thyroid is estimated at 80 days so that the physical half-life of
iodine-123 of 13 hours governs the temporal opportunity for imaging.

General warnings:
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated
clinical settings. Their receipt, storages, use, transfer and diposal are subject to the regulations and/or
appropriate licences of the competent official organisation/
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and
pharmaceutical quality requirements.Appropriate aseptic precautions should be taken.

1

feeding and toinformation
what is the most appropriate
of radiopharmaceutical
has been made, bearing in mind
Important
aboutchoice
Sodium
Iodide Injection
the secretion activity in breast milk.
When Sodium Iodide Injection is used you are exposed to
If the administration is found necessary the breast-feeding should be interrupted for 1.5 - 3 days following the
radioactivity.
administration of iodine-123 that contains iodine-125 and/or iodine-124 as radio contaminant. Expressed
should be discarded.
• milk
Your
doctor will always consider the possible risks and benefits
4.7 Effects
on ability
drivegiven
and usethe
machines
before
you toare
medicine.
No studies on the effects on the ability to drive and use machines have been performed.
Ask your doctor if you have any questions.
4.8 Undesirable effects

4.9 Overdose
In the event of the administration of an overdose of [123I] iodide, the absorbed dose to the patient should be
reduced where possible by increasing the elimination of the radionuclide from the body by diuresis and
frequent voiding of urine. A blocking agent such as potassium perchlorate should be used to minimise
irradiation to the thyroid

Without considering the thyroid uptake, the iodide leaves the body stream chiefly by urinary excretion (3775%), while faecal excretion is low (about 1%).
5.3 Preclinical safety data
Known toxic effects of relatively high doses of sodium iodide are not relevant to this use of iodine-123 to
image the thyroid for diagnostic purposes.

Specific warnings:
This meidicnal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

GE Healthcare B.V.
P.O. Box 746
NL-5600 AS Eindhoven
T +31(0)40 299 1000
F +31(0)40 299 1299

Driving and using machines
Ask your doctor if you can drive or use machines after you have been
given Sodium Iodide Injection.

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.

The lower activity (3.7 MBq) is recommended for uptake studies and the higher doses (11.1 - 14.8 MBq) for
thyroid scintigraphy. However for each individual case, the dose is decided by the specialist concerned.

This radiopharmaceutical may be received, used and administered only by authorised persons in designated
clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or
appropriate licences of the local competent official organisations (see section 6.6).

Manufacturer
GE Healthcare B.V.
Den Dolech 2
5612 AZ Eindhoven
The Netherlands

Breast-feeding:
Before administering a radioactive medicinal product to a mother who is breast-feeding consideration should
be given as to whether the investigation could be reasonably delayed until the mother has ceased breastfeeding and to what is the most appropriate choice of radiopharmaceutical has been made, bearing in mind
the secretion activity in breast milk.

PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

13. OTHER INFORMATION

Pregnancy:
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only
imperative investigations should be carried out during pregnancy, when the likely benefit exceeds the risk
incurred by the mother and foetus.

For a full list of excipients, see section 6.1.

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent
with approximately 0.6% at calibration time and 4% at expiration time.

Aseptic conditions must be observed during withdrawal of a patient dose from the vial, including microbial
decontamination of the rubber stopper with a suitable disinfectant before removal of a dose. This product is
not preserved. After removal of a dose from the vial, store at 2°C-8°C and use within one working day.

4.6 Pregnancy and lactation
Women of childbearing potential:
When it is necessary to administer radioactive medicinal product to women of childbearing potential,
information should always be sought about pregnancy. Any woman who has missed a period should be
assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has
missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there
are any) should be offered to the patient.

This medicinal product contains:
Sodium: 3.99 mg/ml. This needs to be taken into consideration for patients on a controlled sodium diet.

6.8E-02
4.3E-02
1.8E-02
1.1E-02

1.2E-02
1.1E-02
7.2E-03
3.0E+00
1.9E-02

Amiodoarone, benzodiazepines, lithium: approx. 4 weeks.
Iodine-containing preparations for topical use: 1-9 months.
Intravenous contrast agents: 1-2 months
Iodine containing contrast agent: up to 1 year.

Sodium Iodide (123I) Injection 37 MBq/ml solution for injection
2.

Manufacturer
GE Healthcare B.V.
Den Dolech 2
5612 AZ Eindhoven
The Netherlands

Your doctor will let you know when you can start breast-feeding
again.

Expectorants and vitamins: 2 weeks.

• express
(remove)
milk
and throw
thesodium):
milk.1-3 weeks.
Natural or synthetic
thyroidbreast
preparations
(levothyroxine
sodium,away
liothyronine

Kidneys
Liver
Lungs
Ovaries
* Pancreas

9.4E-03
9.5E-03
5.3E-03
1.9E+00
1.5E-02

Adrenals
* Bladder wall
Bone surfaces
Breast
GI-tract:
* Stomach wall
* Small intest
* ULI wall
LLI wall

8.5E-02
5.4E-02
1.9E-02
1.3E-02

Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
6.3E-03
8.3E-03
1.3E-02
2.0E-02
3.7E-02
7.6E-02
9.5E-02
1.4E-01
2.1E-01
3.8E-01
7.1E-03
9.1E-03
1.4E-02
2.2E-02
4.1E-02
4.7E-03
4.7E-03
7.3E-03
1.2E-02
2.3E-02

Red marrow
Spleen
Testes
Thyroid
Uterus

Organ

6.8E-02
4.2E-02
1.8E-02
9.8E-03

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent
with approximately 0.6% at calibration time and 4% at expiration time.

AC
CK
KA
A G EE LL EE A
A FF LL EE TT :: II N
N FF O
OR
RM
MA
A TT II O
ON
N FF O
OR
R H
H EE A
A LL TT H
HC
CA
AR
R EE PP R
RO
O FF EE SS SS II O
ON
NA
A LL
PP A
RedGmarrow
9.4E-03
1.1E-02
1.7E-02
2.6E-02
4.7E-02
Spleen
7.0E-03
8.3E-03
1.3E-02
2.0E-02
3.7E-02
1. NAME
NAME
OF THE
THE MEDICINAL
MEDICINAL PRODUCT
PRODUCT
Testes
6.9E-03
9.4E-03
1.5E-02
2.5E-02
4.8E-02
1.
OF
123I) Injection 37
ThyroidIodide (123
5.1E-03
7.7E-03
2.0E-02
3.7E-02
Sodium
MBq/ml solution
solution
for injection
injection 1.2E-02
Sodium Iodide ( I) Injection 37
MBq/ml
for
Uterus
1.4E-02
1.7E-02
2.8E-02
4.3E-02
7.6E-02
2. QUALITATIVE
QUALITATIVE AND
AND QUANTITATIVE
QUANTITATIVE COMPOSITION
COMPOSITION
2.
123I]iodide, 37 MBq/ml
Other tissue
7.7E-03
1.9E-02
3.5E-02
Sodium
at reference
reference date
date
and hour.
hour. 1.2E-02
Sodium
[[123I]iodide,
37 MBq/ml6.4E-03
at
and

At calibration
calibration time,
time, the
the radionuclidic
radionuclidic purity
purity is
is at
at least
least 99.9%
99.9% and
and the
the main
main radionuclidic
radionuclidic impurities
impurities (iodine-125
(iodine-125
At
Effective
Dose occur
1.3E-02
2.4E-02
3.7E-02
6.7E-02
and
tellurium-121)
for less
less
than 0.05%.
0.05%. 1.6E-02
and
tellurium-121)
occur
for
than
Equivalent (mSv/MBq)
Iodine-123 is
is aa cyclotron
cyclotron product
product with
with aa physical
physical half-life
half-life of
of 13.2
13.2 hours.
hours. Iodine-123
Iodine-123 decays
decays emitting
emitting pure
pure
Iodine-123
Incomplete
blockage:
gamma radiation
radiation
with predominant
predominant energies
energies of
of 159
159 keV
keV and
and 27
27 keV.
keV.
gamma
with
Effective Dose Equivalent (mSv/MBq) at small uptake in the thyroid
This medicinal
medicinal product
product contains:
contains:
This
uptake:3.990.5%
1.6E-02
2.0E-02
9.6E-02
Sodium:
mg/ml. This
This needs
needs
to be
be taken
taken into
into
consideration3.1E-02
for patients
patients on
on 5.2E-02
controlled sodium
sodium
diet.
Sodium:
3.99 mg/ml.
to
consideration
for
aa controlled
diet.
uptake:
1.0%
1.9E-02
2.5E-02
3.8E-02
6.7E-02
1.3E-01
For
a
full
list
of
excipients,
see
section
6.1.
For
a
full
list
of
excipients,
see
section
6.1.
uptake:
2.0%
2.5E-02
3.4E-02
5.2E-02
9.9E-02
1.8E-01
The content
content of
of the
the vial
vial may
may be
be used
used for
for one
one or
or more
more administrations
administrations until
until time
time of
of expiry.
expiry.
The
Effect
of radionuclidic
impurities:
PHARMACEUTICAL
FORM
PHARMACEUTICAL
FORM
The
radionuclidic impurities
(iodine-125 and tellurium-121) increase the Effective Dose Equivalent with
Solution for
for injection
injection
Solution
approximately
0.5% at calibration time and 3% at expiration time
Clear, colourless
colourless solution.
solution.
Clear,

Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
6.5E-03
8.5E-03
1.4E-02
2.1E-02
3.9E-02
4.3E-02
5.3E-02
7.9E-02
1.2E-01
2.2E-01
8.6E-03
1.2E-02
1.8E-02
2.8E-02
5.1E-02
5.6E-03
5.6E-03
9.5E-03
1.7E-02
3.1E-02

In
this and
leaflet:
stored
disposed of correctly and not used after the expiry date
1.
What
Sodium
Iodide Injection is and what it is used for
stated on the label.
2. Before you are given Sodium Iodide Injection
3. How Sodium Iodide Injection is given
6. Further information
4. Possible side effects
What
Injection
contains
5. HowSodium
to storeIodide
Sodium
Iodide Injection
information
•6. Further
The active
ingredient is sodium [123I]iodide. Each ml of Sodium
Iodide (123I) Injection contains 37 MBq (Megabecquerel – the unit in
123is
1. What
Iodide
and
what[it
used for
which Sodium
radioactivity
is Injection
measured)isof
sodium
I]iodide
at a fixed
time.
This medicine is for diagnostic use only. It is used only to help identify
•illness.
The other ingredients are acetic acid, sodium hydroxide, sodium
thiosulphate, sodium bicarbonate, sodium chloride and water for
Sodium
Iodide Injection is a ‘radiopharmaceutical’ medicine. It is given
injections.
before a scan and helps a special camera see inside a part of your
What
body. Sodium Iodide Injection looks like and contents of the pack
Sodium Iodide Injection is supplied as a single glass vial containing a
• It contains an active ingredient called ‘sodium iodide’.
solution for injection.
• Once injected it can be seen from outside your body by a special
camera used
in the scan.
Marketing
Authorisation
Holder
Healthcare
•GEThe
scan canLimited
help your doctor see the thyroid gland and how well
Amersham
Place
it is working.
Little Chalfont
Buckinghamshire
2. Before you are given Sodium Iodide Injection
HP7 9NA
You should
not be given Sodium Iodide Injection:
United
Kingdom
• If you are allergic (hypersensitive) to the active ingredient or any
Manufacturer
other ingredient. (Listed in Section 6).
GE
B.V. Iodide Injection if the above applies to you. If you
Do Healthcare
not have Sodium
Den
Dolech
are not
sure2talk to your doctor or nurse.
5612 AZ Eindhoven
Take special care with Sodium Iodide Injection
The Netherlands
Check with your doctor or nurse before having Sodium Iodide
Injection:
This leaflet was last approved in XX/XXXX
• If you are pregnant or think you might be pregnant.
•Marketing
If you areAuthorisation
on a low sodium diet.
UK: PL 00221/0138

Please
yourmedicines
doctor or nurse if you are taking or have recently
Takingtell
other
taken any other medicines, including medicines obtained without a
Please tell your doctor or nurse if you are taking or have recently
prescription. This includes herbal medicines. This is because some
taken any other medicines, including medicines obtained without a
medicines can affect the way Sodium Iodide Injection works.
prescription. This includes herbal medicines. This is because some
Before yourcan
scan
tell your
doctor
or nurse
if you
are taking
any of the
medicines
affect
the way
Sodium
Iodide
Injection
works.
types of medicine below. This is because they may affect the results
Before
of youryour
scan:scan tell your doctor or nurse if you are taking any of the
types of medicine below. This is because they may affect the results
•of your
Anti-inflammatory
medicines, such as phenylbutazone.
scan:
•• Antithyroid
medicines,
such assuch
propylthiouracil
or thiamazole.
Anti-inflammatory
medicines,
as phenylbutazone.
•• Expectorants,
such as certain
medicines or
(used
to loosen
Antithyroid medicines,
such ascough
propylthiouracil
thiamazole.
mucus from the respiratory tract).
• Expectorants, such as certain cough medicines (used to loosen
• Salicylates,
as aspirin (used
mucus fromsuch
the respiratory
tract).to treat pain or heart disease).
4.
CLINICAL
PARTICULARS
•• Steroids,
such
as as
hydrocortisone,
dexamathasone.
Salicylates,
such
aspirin (used toprednisolone
treat pain ororheart
disease).
4.1
Therapeutic
indications
•• This
Medicines
used
to
treat
thyroid
disorders,
such
as
levothyroxine
medicinal
product
is
for
diagnostic
use
only.
Steroids, such
as hydrocortisone, prednisolone or dexamathasone.
Sodium
Iodide
I) Injection is used assodium.
a diagnostic agent in the functional or morphological study
sodium
or(123liothyronine
• of
Medicines
used
to treat
thyroid disorders, such as levothyroxine
the thyroid gland
by means
of:
• Medicines
beforesodium.
some types of scan, such as perchlorate.
•sodium
scintigraphy
or taken
liothyronine
radioactive iodine
uptake infections,
test
•• •Medicines
to
treat
Medicines
taken
before
somesuch
typesasofantiparasitics,
scan, such as penicillins,
perchlorate.
The 24 hours uptake data are generally used in calculating the therapeutic dose.
sulfonamides.
•4.2 Posology
Medicines
to treat infections, such as antiparasitics, penicillins,
and method of administration
• Amiodarone,
and antiarrythmic agents (used to treat an irregular
The
recommended
activity for an adult patient (70 kg) is between 3.7 and 14.8 MBq.
sulfonamides.
heartbeat).
lower activity (3.7 MBq) is recommended for uptake studies and the higher doses (11.1 - 14.8 MBq) for
• The
Amiodarone,
and antiarrythmic
agents
an concerned.
irregular
thyroid
scintigraphy. However
for each individual case,
the dose (used
is decidedto
by treat
the specialist
• Lithium
(used to treat
certain conditions
such as
depression
or
heartbeat).
Determination
of the rate of thyroid iodine-123 uptake should be carried out in accordance with well
mental standard
problems.
established
procedures.
• Lithium
(used
to treat certain
conditions
such
as
depression
or
activities nitroprusside
for children may be calculated
the recommended
rangeblood
of adult activities
and adjusted
• The
Sodium
(used from
to treat
very high
pressure).
according
the following equation:
mentaltoproblems.
(used to test how the liver is working).
• Sulfobromophthalein sodium
activity adult (MBq) x body weight (kg)
• Sodium
nitroprusside
(used
to treat very
high blood pressure).
Activity
child
(MBq)
=
70 (kg)
•• Sulfobromophthalein
Topical iodides (used to
clean (used
the skin
before
surgery).
sodium
to
test
how
the liver
is working).
In young children the activity of 14.8 MBq should be used in the equation
to calculate
the activity
for children
•• inAnticoagulants
to
thin
the
blood).
order to obtain images (used
of sufficient
quality.
Topical iodides
(used
to
clean
the
skin
before
surgery).
must be
given as an
intravenous
injection; as a routine
check, the activity in the
Iodide (123I) Injection
•• Sodium
Antihistamines
(used
to
or
prevent
reactions).
Anticoagulants
(used
to treat
thin
the
blood). allergic
injection
should be measured
immediately
prior
to administration.
Imaging is performed 3-6 hours after
•• administration.
Tolbutamide
(used
fortopeople
with
diabetes
to lower
blood sugar
Antihistamines
(used
treat or
prevent
allergic
reactions).
The instructions for preparation of radiopharmaceuticals are given in section 12.
levels).
• Contra-indications
Tolbutamide (used for people with diabetes to lower blood sugar
4.3
• Hypersensitivity
Thiopental
a general
the activeas
substance
or to anyanaesthetic).
of the excipients.
levels). to(used
•4.4
Medicines
given
in
hospital
for
x-rays or scans (intravenous
warnings (used
and precautions
for use
• Special
Thiopental
as a general
anaesthetic).
Individual
benefit/risk
justification:
contrast
media).
each patient, given
the radiation
exposure must
be justifiable
thescans
likely benefit.
The activity administered
• For
Medicines
in hospital
for
x-raysbyor
(intravenous
should
in
every
case be as low as reasonably achievable to obtain the required diagnostic information.
• Vitamins.
contrast media).
If you
arePopulation:
not sure if any of the above apply to you, talk to your doctor
Paediatric
• Paediatric
Vitamins.
population, see section 4.2.
or nurse before having Sodium Iodide Injection.
If you
are not sure if any of the above apply to you, talk to your doctor
General warnings:
Radiopharmaceuticals
should be received,
usedIodide
and administered
only by authorised persons in designated
or
nurse before
Sodium
Injection.
Pregnancy
and having
breast-feeding
clinical settings. Their receipt, storages, use, transfer and diposal are subject to the regulations and/or
licences
of thedoctor
competentifofficial
Youappropriate
must tell
your
youorganisation/
are pregnant or think you might be
Pregnancy and breast-feeding
pregnant.
Your doctor
only
use
this
product
it is considered
that
bewill
prepared
by the
user
in a manner
whichif
satisfies
both radiation safety
YouRadiopharmaceuticals
must tellquality
yourshould
doctor
if you
are
pregnant
or think
you might beand
requirements.Appropriate
thepharmaceutical
benefit outweighs
the risk. aseptic precautions should be taken.
pregnant. Your doctor will only use this product if it is considered that
Specific warnings:
theThis
benefit
risk.
meidicnaloutweighs
product contains the
less than
1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
Do
not
breast-feed
if
you
are
Iodide Injection.
4.5 Interaction with other medicinal productsgiven
and otherSodium
forms of interaction
123I] iodide maybe decreased by recent administration of iodinated contrast materials, by
The
uptake
of
[
This is because small amounts of ‘radioactivity’ may pass into the
of stable iodine in any
form, or
by thyroid,
antithyroid,
andIodide
certain other
drugs.
Do intake
not breast-feed
if you
are
given
Sodium
Injection.
mother’s milk. If you are breast-feeding, your doctor may wait until
ThisAccordingly,
is because
small
amounts
of
‘radioactivity’
may
intoand
the
the patientbreast-feeding
should be questioned carefully
regarding
diet,Sodium
previouspass
medication,
youprocedures
have finished
before
using
Iodide
involving
radiographic
contrast
media.
Relevant
medication
including
the
ones
mentioned
mother’s milk. If you are breast-feeding, your
doctor may wait until
Injection.
If itbeiswithheld
not possible
to wait your
doctor
will ask you to:
below should
prior to the administration
of sodium
[123I] iodide.
you have finished breast-feeding before using Sodium Iodide
•Injection.
stop
breast-feeding
for 1.5
3 days,
Active substances:
period
prior
to
administration
of sodiumwill
[123I]iodide
If it is Withdrawal
not possible
toto
wait
your and
doctor
ask you to:
Antithyroid agents (e.g. carbimazole, methimazole, propyluracil), perchlorate: 1 week.
•• use
formula
feed
for
your
child,
and
Salicylates,
steroids,
sodium
nitroprusside,
sodium
sulfobromophthalein,
anticoagulants,
antihistamines,
stop breast-feeding for 1.5 to 3 days, and
antiparasitics,
penicillins, sulfonamides
tolbutamide,
thiopental:
1 week. the milk.
•• express
(remove)
breast
milk
and
throw
away
Phenylbutazone:
weeks.for your child, and
use
formula1-2feed

Do not breast-feed if you are given Sodium Iodide Injection.
This is because small amounts of ‘radioactivity’ may pass into the
mother’s milk. If you are breast-feeding, your doctor may wait until
you have finished breast-feeding before using Sodium Iodide
Injection. If it is not possible to wait your doctor will ask you to:
• stop breast-feeding for 1.5 to 3 days, and
• use formula feed for your child, and
• express (remove) breast milk and throw away the milk.

No data are available from animal models about toxicity with repeated dose administration or about
reproduction toxicity.
Sodium Iodide (123I) Injection has not been investigated for mutagenicity and carcinogenic/oncogenic
potential.
6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Acetic acid
Sodium hydroxide
Sodium thiosulphate
Sodium bicarbonate
Sodium chloride
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
6.3 Shelf life
Can be used up to 36 hours post calibration time indicated on the label.
Once opened, store in a refrigerator (2°C-8°C) and use within one working day.
6.4 Special precautions for storage
Store below 25°C. Do not freeze.
For storage conditions of the opened medicinal product, see section 6.3.
Store either in original lead container or in equivalent shielding.
Storage should take place in accordance with national regulations for radioactive materials.
6.5 Nature and contents of container
10 ml medicinal glass vial, closed with a Teflon coated rubber stopper and sealed with an aluminium cap.
Each vial is enclosed in a lead container of appropriate thickness.
Pack size: 18.5 to 370 MBq.
Not all pack sizes may be marketed.

For this product the Effective Dose Equivalent resulting from an administered activity of 14.8 MBq will be
2.2 mSv. This Effective Dose Equivalent is dependent on the uptake in the thyroid glands.

The table below shows the dosimetry as calculated according to the Publication 53 of the ICRP (International
Commission on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals, Pergamon
Press 1987).
Thyroid blocked, uptake 0%
Organ
Adrenals
* Bladder wall
Bone surfaces
Breast
GI-tract:
Stomach wall
* Small intest
* ULI wall
* LLI wall

Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
7.0E-03
8.7E-03
1.4E-02
2.1E-02
3.9E-02
9.0E-02
1.1E-01
1.6E-01
2.4E-01
4.5E-01
8.1E-03
9.7E-03
1.5E-02
2.4E-02
4.6E-02
5.6E-03
5.6E-03
8.1E-03
1.3E-02
2.5E-02
6.9E-03
8.5E-03
8.0E-03
9.7E-03

8.5E-03
1.0E-02
9.9E-03
1.2E-02

1.4E-02
1.6E-02
1.5E-02
1.9E-02

2.1E-02
2.5E-02
2.4E-02
2.9E-02

3.7E-02
4.6E-02
4.3E-02
5.4E-02

1.1E-02
6.7E-03
6.1E-03
9.8E-03
7.6E-03

1.4E-02
8.2E-03
7.8E-03
1.2E-02
9.1E-03

2.0E-02
1.3E-02
1.2E-02
1.9E-02
1.4E-02

2.9E-02
2.0E-02
1.9E-02
3.0E-02
2.2E-02

5.1E-02
3.7E-02
3.5E-02
5.3E-02
4.1E-02

Red marrow
Spleen
Testes
Thyroid
Uterus

9.4E-03
7.0E-03
6.9E-03
5.1E-03
1.4E-02

1.1E-02
8.3E-03
9.4E-03
7.7E-03
1.7E-02

1.7E-02
1.3E-02
1.5E-02
1.2E-02
2.8E-02

2.6E-02
2.0E-02
2.5E-02
2.0E-02
4.3E-02

4.7E-02
3.7E-02
4.8E-02
3.7E-02
7.6E-02

Other tissue

6.4E-03

7.7E-03

1.2E-02

1.9E-02

3.5E-02

Effective Dose
Equivalent (mSv/MBq)

1.3E-02

1.6E-02

2.4E-02

3.7E-02

6.7E-02

5.2E-02
6.7E-02
9.9E-02

9.6E-02
1.3E-01
1.8E-01

* Kidneys
Liver
Lungs
Ovaries
Pancreas

Incomplete blockage:
Effective Dose Equivalent (mSv/MBq) at small uptake in the thyroid
uptake:
uptake:
uptake:

0.5%
1.0%
2.0%

1.6E-02
1.9E-02
2.5E-02

2.0E-02
2.5E-02
3.4E-02

3.1E-02
3.8E-02
5.2E-02

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with
approximately 0.5% at calibration time and 3% at expiration time

• One single injection.
•TheOne
single
injection.
scan
is usually
taken 3 to 6 hours after the injection.
The scan is usually taken 3 to 6 hours after the injection.

• Tolbutamide (used for people with diabetes to lower blood sugar
levels).
• Thiopental (used as a general anaesthetic).
• Medicines given in hospital for x-rays or scans (intravenous
contrast media).
• Vitamins.
If you are not sure if any of the above apply to you, talk to your doctor
or nurse before having Sodium Iodide Injection.

4. Possible side effects
4. Possible side effects
Like all medicines, Sodium Iodide Injection can cause side effects,
Like
all medicines,
Sodium
Iodide
Injection can cause side effects,
although
not everybody
gets
them.
although not everybody gets them.
Allergic reactions
Allergic
reactions
If you have
an allergic reaction when you are in hospital or a clinic
If
you have
an allergic
reaction
youstraight
are in hospital
or asigns
clinicmay
having
the scan,
tell the
doctor when
or nurse
away. The
having
the
scan,
tell
the
doctor
or
nurse
straight
away.
The
signs
may
include:
•include:
skin rash or itching or flushing
•• skin
rashof
orthe
itching
swelling
faceor flushing
•• swelling
the face
difficultyof
breathing.
• difficulty breathing.
If any of the side effects above happen after you leave the hospital or
If
any of
the
side effects
above
youcasualty
leave the
hospital or
clinic,
you
should
go or be
takenhappen
straightafter
to the
department
clinic,
should
go or be taken straight to the casualty department
of youryou
nearest
hospital.
of your nearest hospital.
If any of the side effects gets serious, of if you notice any side effects
If
any
of the
sideleaflet,
effectsplease
gets serious,
ofdoctor
if you notice
any side effects
not
listed
in this
tell your
or nurse.
not listed in this leaflet, please tell your doctor or nurse.

Pregnancy and breast-feeding
You must tell your doctor if you are pregnant or think you might be
pregnant. Your doctor will only use this product if it is considered that
the benefit outweighs the risk.

Taking other medicines
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Iodide (123I) Injection 37 MBq/ml solution for injection
(called Sodium Iodide Injection in this leaflet)

5. How to store Sodium Iodide Injection
5. How to store Sodium Iodide Injection
Sodium Iodide Injection is kept out of the reach and sight of children.
Sodium Iodide Injection is kept out of the reach and sight of children.
The product label includes the correct storage conditions and the
The
product
label
the correct
conditions
and
the is
expiry
date for
theincludes
batch. Hospital
staffstorage
will ensure
that the
product
expiry
for the batch.
Hospital
staff
ensure
product
stored date
and disposed
disposed
of correctly
correctly
and
notwill
used
afterthat
the the
expiry
date is
stored
and
of
and
not
used
after
the
expiry
date
stated
on
the label.
label.
stated
the
6.6
Specialon
precautions
for disposal and other handling

Sodium [123I]iodide
Read all of this leaflet carefully before you are given Sodium
Iodide Injection
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.

Normal safety precautions for handling radioactive materials should be observed. After use, all materials
associated with the preparation and administration of radiopharmaceuticals, including any unused product
and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance
with the conditions specified by the local competent authority. Contaminated material must be disposed of as
radioactive waste via an authorised route.

6. Further
Further information
information
6.
What Sodium
Sodium Iodide
Iodide Injection
Injection contains
contains
What
7. MARKETING AUTHORISATION HOLDER
123I]iodide. Each ml of Sodium
The
activeLimited
ingredient is
is sodium
sodium [[123
•• GE
The
active
ingredient
I]iodide. Each ml of Sodium
Healthcare
123I) Injection contains 37 MBq (Megabecquerel – the unit in
Amersham
123
Iodide ((Place
Iodide
I)
Injection
contains
37
MBq
(Megabecquerel – the unit in
Little Chalfont
123I]iodide at a fixed
which
radioactivity
is
measured)
of
sodium
Buckinghamshire
HP7
9NA
which radioactivity is measured) of sodium [[123
I]iodide at a fixed
United Kingdom
time.
time.
8.
AUTHORISATION
NUMBER
The other
other
ingredients
are acetic
acetic acid,
acid, sodium
sodium hydroxide,
hydroxide, sodium
sodium
•• MARKETING
The
ingredients
are
UK: PL 00221/0138
thiosulphate, sodium
sodium bicarbonate,
bicarbonate, sodium
sodium chloride
chloride and
and water
water for
for
thiosulphate,
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
injections.
injections.Date of first authorisation
Date of last renewal
UK
01 December
1998
23 May
2003
What
Sodium
Iodide
Injection
looks
like
and contents
contents of
of the
the pack
pack
What Sodium Iodide Injection looks like
and
Sodium
Iodide
Injection
is
supplied
as
a
single
glass
vial
containing
a
10.
DATE OFIodide
REVISION OF
THE TEXT is supplied as a single glass vial containing a
Sodium
Injection
XX/XXXX
solution for
for injection.
injection.
solution
11. DOSIMETRY

Marketing
Authorisation
Holder
Depending onAuthorisation
the production procedure
of iodine -123, impurities like iodine-125 and/or iodine-124 may be
Marketing
Holder
present as longer life contaminants increasing the radiation dosimetry to the different organs. The ICRP
GE
Healthcare
Limited
GEmodel
Healthcare
Limited
refers to intravenous
administration.
Amersham
Place
For this product
the Effective Dose Equivalent resulting from an administered activity of 14.8 MBq will be
Amersham
Place
2.2 mSv. This Effective Dose Equivalent is dependent on the uptake in the thyroid glands.
Little
Chalfont
Little
Chalfont
The Effective (whole body) Dose Equivalent is calculated from the six standard organs (gonads, breast, red
Buckinghamshire
marrow, lungs, thyroid and bone surfaces) and five additional organs with the highest absorbed dose
Buckinghamshire
(marked with *).
HP7
9NA
HP7
9NA
The table below shows the dosimetry as calculated according to the Publication 53 of the ICRP (International
United
Kingdom
Commission
on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals, Pergamon
United
Kingdom

Thyroid blocked, uptake 55%
Organ
Adrenals
Bladder wall
Bone surfaces
Breast
GI-tract:
* Stomach wall
* Small intest
* ULI wall
LLI wall

Press 1987).

Manufacturer
Manufacturer
Thyroid blocked, uptake 0%
GE Healthcare
Healthcare B.V.
B.V.
GE
Organ
Absorbed dose per unit activity administered (mGy/MBq)
Den Dolech
Dolech 22
Adult
15 year
10 year
5 year
1 year
Den
Adrenals
7.0E-03
8.7E-03
1.4E-02
2.1E-02
3.9E-02
5612
AZ
Eindhoven
5612
AZ Eindhoven
* Bladder
wall
9.0E-02
1.1E-01
1.6E-01
2.4E-01
4.5E-01
TheBone
Netherlands
surfaces
8.1E-03
9.7E-03
1.5E-02
2.4E-02
4.6E-02
The
Netherlands
Breast
GI-tract:
Stomach wall
* Small intest
* ULI wall
* LLI wall

5.6E-03

5.6E-03

8.1E-03

1.4E-02
This leaflet
leaflet was
was last
last 6.9E-03
approved8.5E-03
in XX/XXXX
XX/XXXX
This
approved
in
8.5E-03
1.0E-02
1.6E-02
8.0E-03

9.7E-03
Marketing Authorisation
Authorisation
Marketing
UK:* Kidneys
PL 00221/0138
00221/0138 1.1E-02
UK:
PL
Liver
Lungs
Ovaries
Pancreas

6.7E-03
6.1E-03
9.8E-03
7.6E-03

1.3E-02

2.5E-02

3.7E-02
4.6E-02
4.3E-02
5.4E-02
5.1E-02
3.7E-02
3.5E-02
5.3E-02
4.1E-02

9.9E-03
1.2E-02

1.5E-02
1.9E-02

2.1E-02
2.5E-02
2.4E-02
2.9E-02

1.4E-02
8.2E-03
7.8E-03
1.2E-02
9.1E-03

2.0E-02
1.3E-02
1.2E-02
1.9E-02
1.4E-02

2.9E-02
2.0E-02
1.9E-02
3.0E-02
2.2E-02

3.
3.

Effect
of radionuclidic
impurities:
PHARMACEUTICAL
FORM
PHARMACEUTICAL
FORM
The radionuclidic impurities
(iodine-125 and tellurium-121) increase the Effective Dose Equivalent with
Solution
for
injection
Solution for injection
approximately
0.5% at calibration time and 3% at expiration time
Clear,
colourless
solution.
Clear, colourless solution.
Thyroid blocked, uptake 15%
Organ

6.8E-02
4.2E-02
1.8E-02
9.8E-03

8.5E-02
5.4E-02
1.9E-02
1.3E-02

1.2E-01
9.1E-02
2.9E-02
2.0E-02

2.0E-01
1.4E-01
4.4E-02
3.0E-02

3.9E-01
2.7E-01
7.6E-02
5.5E-02

Kidneys
Liver
Lungs
Ovaries
* Pancreas

9.1E-03
6.4E-03
7.2E-03
1.1E-02
1.4E-02

1.1E-02
7.9E-03
9.7E-03
1.5E-02
1.6E-02

1.6E-02
1.3E-02
1.6E-02
2.3E-02
2.5E-02

2.4E-02
2.2E-02
2.6E-02
3.6E-02
3.6E-02

4.1E-02
4.1E-02
4.8E-02
6.4E-02
6.3E-02

Red marrow
* Spleen
Testes
Thyroid
Uterus

1.1E-02
9.7E-03
4.6E-03
7.0E+00
1.2E-02

1.5E-02
1.1E-02
6.2E-03
1.1E+01
1.6E-02

2.1E-02
1.7E-02
1.0E-02
1.7E+01
2.6E-02

3.0E-02
2.6E-02
1.6E-02
3.6E+01
4.0E-02

5.2E-02
4.6E-02
3.2E-02
6.8E+01
7.2E-02

Other tissue

9.2E-03

1.2E-02

1.9E-02

3.1E-02

5.8E-02

Effective Dose
Equivalent (mSv/MBq)

2.3E-01

3.5E-01

5.3E-01

1.1E+00

2.1E+00

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent
with approximately 0.6% at calibration time and 4% at expiration time.

AC
CK
KA
A G EE LL EE A
A FF LL EE TT :: II N
N FF O
OR
RM
MA
A TT II O
ON
N FF O
OR
R H
H EE A
A LL TT H
HC
CA
AR
R EE PP R
RO
O FF EE SS SS II O
ON
NA
A LL
PP A
RedGmarrow
9.4E-03
1.1E-02
1.7E-02
2.6E-02
4.7E-02
Spleen
7.0E-03
8.3E-03
1.3E-02
2.0E-02
3.7E-02
1. NAME
NAME
OF THE
THE MEDICINAL
MEDICINAL PRODUCT
PRODUCT
Testes
6.9E-03
9.4E-03
1.5E-02
2.5E-02
4.8E-02
1.
OF
123 Injection 37
ThyroidIodide (123
5.1E-03
7.7E-03
2.0E-02
3.7E-02
Sodium
MBq/ml solution
solution
for injection
injection 1.2E-02
Sodium
Iodide ( I)I) Injection
37
MBq/ml
for
Uterus
1.4E-02
1.7E-02
2.8E-02
4.3E-02
7.6E-02
2. QUALITATIVE
QUALITATIVE AND
AND QUANTITATIVE
QUANTITATIVE COMPOSITION
COMPOSITION
2.
123I]iodide, 37 MBq/ml
Other tissue
7.7E-03
1.9E-02
3.5E-02
Sodium
at reference
reference date
date
and hour.
hour. 1.2E-02
Sodium
[[123I]iodide,
37 MBq/ml6.4E-03
at
and

At calibration
calibration time,
time, the
the radionuclidic
radionuclidic purity
purity is
is at
at least
least 99.9%
99.9% and
and the
the main
main radionuclidic
radionuclidic impurities
impurities (iodine-125
(iodine-125
At
Effective
Dose occur
1.3E-02
2.4E-02
3.7E-02
6.7E-02
and
tellurium-121)
for less
less
than 0.05%.
0.05%. 1.6E-02
and
tellurium-121)
occur
for
than
Equivalent (mSv/MBq)
Iodine-123 is
is aa cyclotron
cyclotron product
product with
with aa physical
physical half-life
half-life of
of 13.2
13.2 hours.
hours. Iodine-123
Iodine-123 decays
decays emitting
emitting pure
pure
Iodine-123
Incomplete
blockage:
gamma
radiation
with predominant
predominant energies
energies of
of 159
159 keV
keV and
and 27
27 keV.
keV.
gamma radiation
with
Effective Dose Equivalent (mSv/MBq) at small uptake in the thyroid
This medicinal
medicinal product
product contains:
contains:
This
uptake:3.990.5%
1.6E-02
2.0E-02
9.6E-02
Sodium:
mg/ml. This
This needs
needs
to be
be taken
taken into
into
consideration3.1E-02
for patients
patients on
on 5.2E-02
controlled sodium
sodium
diet.
Sodium:
3.99 mg/ml.
to
consideration
for
aa controlled
diet.
uptake:
1.0%
1.9E-02
2.5E-02
3.8E-02
6.7E-02
1.3E-01
For
a
full
list
of
excipients,
see
section
6.1.
For
a full list of excipients, see section 6.1.
uptake:
2.0%
2.5E-02
3.4E-02
5.2E-02
9.9E-02
1.8E-01
The content
content of
of the
the vial
vial may
may be
be used
used for
for one
one or
or more
more administrations
administrations until
until time
time of
of expiry.
expiry.
The

Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
6.5E-03
8.5E-03
1.4E-02
2.1E-02
3.9E-02
4.3E-02
5.3E-02
7.9E-02
1.2E-01
2.2E-01
8.6E-03
1.2E-02
1.8E-02
2.8E-02
5.1E-02
5.6E-03
5.6E-03
9.5E-03
1.7E-02
3.1E-02

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
This radiopharmaceutical may be received, used and administered only by authorised persons in designated
clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or
appropriate licences of the local competent official organisations (see section 6.6).

In
this and
leaflet:
stored
disposed of correctly and not used after the expiry date
1.
WhatonSodium
Iodide Injection is and what it is used for
stated
the label.
2. Before you are given Sodium Iodide Injection
3. How Sodium Iodide Injection is given
6. Further information
4. Possible side effects
What
Injection
contains
5. HowSodium
to storeIodide
Sodium
Iodide Injection
information
•6. Further
The active
ingredient is sodium [123I]iodide. Each ml of Sodium
Iodide (123I) Injection contains 37 MBq (Megabecquerel – the unit in
123is
1. What
Iodide
and
what[it
used for
which Sodium
radioactivity
is Injection
measured)isof
sodium
I]iodide
at a fixed
time.
This
medicine is for diagnostic use only. It is used only to help identify
•illness.
The other ingredients are acetic acid, sodium hydroxide, sodium
thiosulphate, sodium bicarbonate, sodium chloride and water for
Sodium
Iodide Injection is a ‘radiopharmaceutical’ medicine. It is given
injections.
before a scan and helps a special camera see inside a part of your
What
body. Sodium Iodide Injection looks like and contents of the pack
Sodium Iodide Injection is supplied as a single glass vial containing a
• It contains an active ingredient called ‘sodium iodide’.
solution for injection.
• Once injected it can be seen from outside your body by a special
camera used
in the scan.
Marketing
Authorisation
Holder
Healthcare
•GEThe
scan canLimited
help your doctor see the thyroid gland and how well
Amersham
Place
it is working.
Little Chalfont
Buckinghamshire
2. Before you are given Sodium Iodide Injection
HP7 9NA
You should
not be given Sodium Iodide Injection:
United
Kingdom
• If you are allergic (hypersensitive) to the active ingredient or any
Manufacturer
other ingredient. (Listed in Section 6).
GE
B.V. Iodide Injection if the above applies to you. If you
Do Healthcare
not have Sodium
Den
Dolech
2
are not sure talk to your doctor or nurse.
5612 AZ Eindhoven
Take special care with Sodium Iodide Injection
The Netherlands
Check with your doctor or nurse before having Sodium Iodide
Injection:
This leaflet was last approved in XX/XXXX
• If you are pregnant or think you might be pregnant.
•Marketing
If you areAuthorisation
on a low sodium diet.
UK: PL 00221/0138

The administration of radiopharmaceuticals creates risks for other persons from external radiation or
contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with
national regulations must therefore be taken.
Thyroid blocked, uptake 55%
Organ
Adrenals
Bladder wall
Bone surfaces
Breast
GI-tract:
* Stomach wall
* Small intest
* ULI wall
LLI wall

Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
6.5E-03
8.5E-03
1.4E-02
2.1E-02
3.9E-02
4.3E-02
5.3E-02
7.9E-02
1.2E-01
2.2E-01
8.6E-03
1.2E-02
1.8E-02
2.8E-02
5.1E-02
5.6E-03
5.6E-03
9.5E-03
1.7E-02
3.1E-02
6.8E-02
4.2E-02
1.8E-02
9.8E-03

8.5E-02
5.4E-02
1.9E-02
1.3E-02

1.2E-01
9.1E-02
2.9E-02
2.0E-02

2.0E-01
1.4E-01
4.4E-02
3.0E-02

3.9E-01
2.7E-01
7.6E-02
5.5E-02

PACKAGE LEAFLET: INFORMATION FOR HEALTHCARE PROFESSIONAL

Aseptic conditions must be observed during withdrawal of a patient dose from the vial, including microbial
decontamination of the rubber stopper with a suitable disinfectant before removal of a dose. This product is
not preserved. After removal of a dose from the vial, store at 2°C-8°C and use within one working day.

1.

NAME OF THE MEDICINAL PRODUCT
Sodium Iodide (123I) Injection 37 MBq/ml solution for injection

2.

Manufacturer
GE Healthcare B.V.
Den Dolech 2
5612 AZ Eindhoven
The Netherlands

QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium [123I]iodide, 37 MBq/ml at reference date and hour.
At calibration time, the radionuclidic purity is at least 99.9% and the main radionuclidic impurities (iodine-125
and tellurium-121) occur for less than 0.05%.
Iodine-123 is a cyclotron product with a physical half-life of 13.2 hours. Iodine-123 decays emitting pure
gamma radiation with predominant energies of 159 keV and 27 keV.

Kidneys
Liver
Lungs
Ovaries
* Pancreas

9.1E-03
6.4E-03
7.2E-03
1.1E-02
1.4E-02

1.1E-02
7.9E-03
9.7E-03
1.5E-02
1.6E-02

1.6E-02
1.3E-02
1.6E-02
2.3E-02
2.5E-02

2.4E-02
2.2E-02
2.6E-02
3.6E-02
3.6E-02

4.1E-02
4.1E-02
4.8E-02
6.4E-02
6.3E-02

6.8E-02
4.3E-02
1.8E-02
1.1E-02

8.5E-02
5.4E-02
1.9E-02
1.4E-02

1.2E-01
9.1E-02
2.9E-02
2.2E-02

2.0E-01
1.4E-01
4.5E-02
3.3E-02

3.8E-01
2.7E-01
7.7E-02
6.0E-02

Red marrow
* Spleen
Testes
Thyroid
Uterus

1.1E-02
9.7E-03
4.6E-03
7.0E+00
1.2E-02

1.5E-02
1.1E-02
6.2E-03
1.1E+01
1.6E-02

2.1E-02
1.7E-02
1.0E-02
1.7E+01
2.6E-02

3.0E-02
2.6E-02
1.6E-02
3.6E+01
4.0E-02

5.2E-02
4.6E-02
3.2E-02
6.8E+01
7.2E-02

1.0E-02
6.2E-03
5.7E-03
1.2E-02
1.4E-02

1.3E-02
7.6E-03
7.2E-03
1.6E-02
1.6E-02

1.8E-02
1.3E-02
1.1E-02
2.5E-02
2.4E-02

2.7E-02
2.1E-02
1.8E-02
3.8E-02
3.5E-02

4.6E-02
3.8E-02
3.4E-02
6.8E-02
6.1E-02

Other tissue

9.2E-03

1.2E-02

1.9E-02

3.1E-02

5.8E-02

Sodium Iodide (123I) Injection is used as a diagnostic agent in the functional or morphological study
of the thyroid gland by means of:

Effective Dose
Equivalent (mSv/MBq)

2.3E-01

3.5E-01

5.3E-01

1.1E+00

2.1E+00



scintigraphy



radioactive iodine uptake test

Red marrow
Spleen
Testes
Thyroid
Uterus

9.4E-03
9.5E-03
5.3E-03
1.9E+00
1.5E-02

1.2E-02
1.1E-02
7.2E-03
3.0E+00
1.9E-02

1.7E-02
1.7E-02
1.2E-02
4.5E+00
3.1E-02

2.5E-02
2.5E-02
2.0E-02
9.8E+00
4.9E-02

4.3E-02
4.4E-02
3.8E-02
1.9E+01
8.6E-02

Other tissue

6.8E-03

8.5E-03

1.3E-02

2.1E-02

3.9E-02

Effective Dose
Equivalent (mSv/MBq)

7.5E-02

1.1E-01

1.7E-01

3.5E-01

6.5E-01

Kidneys
Liver
Lungs
Ovaries
* Pancreas

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent
with approximately 0.6% at calibration time and 4% at expiration time.
Thyroid blocked, uptake 35%
Organ
Adrenals
* Bladder wall
Bone surfaces
Breast
GI-tract:
* Stomach wall
* Small intest
* ULI wall
LLI wall

Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
6.5E-03
8.4E-03
1.3E-02
2.1E-02
3.8E-02
6.0E-02
7.4E-02
1.1E-01
1.6E-01
3.0E-01
7.9E-03
1.1E-02
1.6E-02
2.5E-02
4.6E-02
5.2E-03
5.2E-03
8.5E-03
1.5E-02
2.7E-02
6.8E-02
4.2E-02
1.8E-02
1.0E-02

8.5E-02
5.4E-02
1.9E-02
1.4E-02

1.2E-01
9.0E-02
2.9E-02
2.1E-02

2.0E-01
1.4E-01
4.5E-02
3.2E-02

3.8E-01
2.7E-01
7.6E-02
5.8E-02

Kidneys
Liver
Lungs
Ovaries
* Pancreas

9.1E-03
6.3E-03
6.5E-03
1.1E-02
1.4E-02

1.1E-02
7.8E-03
8.6E-03
1.5E-02
1.6E-02

1.6E-02
1.3E-02
1.4E-02
2.4E-02
2.4E-02

2.4E-02
2.1E-02
2.2E-02
3.7E-02
3.6E-02

4.1E-02
4.0E-02
4.2E-02
6.6E-02
6.2E-02

Red marrow
* Spleen
Testes
Thyroid
Uterus

1.0E-02
9.6E-03
5.0E-03
4.5E+00
1.4E-02

1.3E-02
1.1E-02
6.8E-03
7.0E+00
1.7E-02

1.9E-02
1.7E-02
1.1E-02
1.1E+01
2.9E-02

2.8E-02
2.5E-02
1.8E-02
2.3E+01
4.4E-02

4.8E-02
4.5E-02
3.5E-02
4.3E+01
7.9E-02

Other tissue

8.0E-03

1.0E-02

1.6E-02

2.6E-02

4.9E-02

Effective Dose
Equivalent (mSv/MBq)

1.5E-01

2.3E-01

3.5E-01

7.4E-01

1.4E+00

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent
with approximately 0.6% at calibration time and 4% at expiration time.

The content of the vial may be used for one or more administrations until time of expiry.
3.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications
This medicinal product is for diagnostic use only.

The 24 hours uptake data are generally used in calculating the therapeutic dose.
4.2 Posology and method of administration
The recommended activity for an adult patient (70 kg) is between 3.7 and 14.8 MBq.

If the administration is found necessary the breast-feeding should be interrupted for 1.5 - 3 days following the
administration of iodine-123 that contains iodine-125 and/or iodine-124 as radio contaminant. Expressed
milk should be discarded.

4.8 Undesirable effects
The frequencies of undesirable effects are defined as follows:
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
<1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Immune system disorders
Not known: Hypersensitivity

Determination of the rate of thyroid iodine-123 uptake should be carried out in accordance with well
established standard procedures.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary
defect. As the effective dose is 2.2 mSv when the maximal recommended activity of 14.8 MBq is administered
these adverse events are expected to occur with a low probability.

The activities for children may be calculated from the recommended range of adult activities and adjusted
according to the following equation:

The administration of radiopharmaceuticals creates risks for other persons from external radiation or
contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with
national regulations must therefore be taken.

Activity child (MBq) =

Solution for intravenous injection, ready to use.

activity adult (MBq) x body weight (kg)
70 (kg)

In young children the activity of 14.8 MBq should be used in the equation to calculate the activity for children
in order to obtain images of sufficient quality.

DEU

Sodium Iodide (123I) Injection must be given as an intravenous injection; as a routine check, the activity in the
injection should be measured immediately prior to administration. Imaging is performed 3-6 hours after
administration.

GBR

The instructions for preparation of radiopharmaceuticals are given in section 12.

GE HealthcareGE Healthcare

4.3 Contra-indications
Hypersensitivity to the active substance or to any of the excipients.
4.4 Special warnings and precautions for use
Individual benefit/risk justification:
For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered
should in every case be as low as reasonably achievable to obtain the required diagnostic information.

Sodium Iodide (123I) Injection
37 MBq/ml solution for injection
Sodium [123I]iodide

GE and the GE Monogram are trademarks of General Electric Company

Paediatric Population:
Paediatric population, see section 4.2.

Accordingly, the patient should be questioned carefully regarding diet, previous medication, and
procedures involving radiographic contrast media. Relevant medication including the ones mentioned
below should be withheld prior to the administration of sodium [123I] iodide.

GE Healthcare B.V.
P.O. Box 746
NL-5600 AS Eindhoven
T +31(0)40 299 1000
F +31(0)40 299 1299

1

1

7

3

6

D_FGBRTP.02

2

4

Active substances: Withdrawal period prior to administration of sodium [123I]iodide
Antithyroid agents (e.g. carbimazole, methimazole, propyluracil), perchlorate: 1 week.
Salicylates, steroids, sodium nitroprusside, sodium sulfobromophthalein, anticoagulants, antihistamines,
antiparasitics, penicillins, sulfonamides tolbutamide, thiopental: 1 week.
Phenylbutazone: 1-2 weeks.
Expectorants and vitamins: 2 weeks.
Natural or synthetic thyroid preparations (levothyroxine sodium, liothyronine sodium): 1-3 weeks.
Amiodoarone, benzodiazepines, lithium: approx. 4 weeks.
Iodine-containing preparations for topical use: 1-9 months.
Intravenous contrast agents: 1-2 months
Iodine containing contrast agent: up to 1 year.
4.6 Pregnancy and lactation
Women of childbearing potential:
When it is necessary to administer radioactive medicinal product to women of childbearing potential,
information should always be sought about pregnancy. Any woman who has missed a period should be
assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has
missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there
are any) should be offered to the patient.
Pregnancy:
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only
imperative investigations should be carried out during pregnancy, when the likely benefit exceeds the risk
incurred by the mother and foetus.
Breast-feeding:
Before administering a radioactive medicinal product to a mother who is breast-feeding consideration should
be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-

feeding and toinformation
what is the most appropriate
of radiopharmaceutical
has been made, bearing in mind
Important
aboutchoice
Sodium
Iodide Injection
the secretion activity in breast milk.
When Sodium Iodide Injection is used you are exposed to
If the administration is found necessary the breast-feeding should be interrupted for 1.5 - 3 days following the
radioactivity.
administration of iodine-123 that contains iodine-125 and/or iodine-124 as radio contaminant. Expressed
should be discarded.
• milk
Your
doctor will always consider the possible risks and benefits
4.7 Effects
on
drivegiven
and usethe
machines
before ability
you toare
medicine.
No studies on the effects on the ability to drive and use machines have been performed.
Ask
your
doctor
if
you
have
any questions.
4.8 Undesirable effects
The frequencies of undesirable effects are defined as follows:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
This
medicinal
contains
less be
than
1mmol
sodium
<1/1,000),
very rare product
(<1/10,000) and
not known (cannot
estimated
from the
available data).
92 mg) per dose, i.e. essentially ‘sodium –free’.
23
Immune system disorders
Not known: Hypersensitivity

to ionising radiation
is linked
with cancer
3. Exposure
How Sodium
Iodide
Injection
isinduction
givenand a potential for development of hereditary

defect. As the effective dose is 2.2 mSv when the maximal recommended activity of 14.8 MBq is administered

these adverse events are expected to occur with a low probability.
Sodium
Iodide Injection will be given to you by a specially trained and
4.9
Overdose
qualified person.
In the event of the administration of an overdose of [123I] iodide, the absorbed dose to the patient should be
where
possible Injection
by increasing the
elimination
of the
the body by diuresis
and
• reduced
Sodium
Iodide
will
always
beradionuclide
used infrom
a hospital
or clinic.
frequent voiding of urine. A blocking agent such as potassium perchlorate should be used to minimise
• irradiation
They will
tell
you anything you need to know for its safe use.
to the
thyroid
5.
PHARMACOLOGICAL
PROPERTIESon the dose that is best for you.
Your
doctor will decide
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, thyroid, sodium iodide (123I), ATC
code: V09FX02.

The usual dose is:
• One
single injection.
At doses used in diagnostic investigations, sodium iodide has not been observed to exert any
pharmacodynamic
effects. taken 3 to 6 hours after the injection.
The scan is usually

5.2 Pharmacokinetic properties
Intravenously administered iodide is taken by the thyroid. About 20% of the available radioactivity enters the
thyroid in one pass of the blood volume. Normal thyroid clearance of blood iodide is 20-50 ml/min with an
increase to 100 ml/min in thyroid deficiency.

4. Possible side effects

Peak levels of iodide occur in thyroid gland within a few hours so that diagnostic imaging can take place from
Like
all medicines, Sodium Iodide Injection can cause side effects,
one hour after dosing.
although
not
everybody
gets
The half-time
of iodide
elimination from
the them.
thyroid is estimated at 80 days so that the physical half-life of
iodine-123 of 13 hours governs the temporal opportunity for imaging.

Allergic
reactions
Without considering
the thyroid uptake, the iodide leaves the body stream chiefly by urinary excretion (3775%), while faecal excretion is low (about 1%).
If you
have an allergic reaction when you are in hospital or a clinic
5.3
Preclinical
data tell the doctor or nurse straight away. The signs may
having
thesafety
scan,
Known toxic effects of relatively high doses of sodium iodide are not relevant to this use of iodine-123 to
image the thyroid for diagnostic purposes.
include:
No data are available from animal models about toxicity with repeated dose administration or about
• skin
rash or itching or flushing
reproduction toxicity.
Injection
has not been investigated for mutagenicity and carcinogenic/oncogenic
Sodium Iodideof
(123I)the
• swelling
face
potential.
• difficulty breathing.
6.

PHARMACEUTICAL PARTICULARS

If any of the side effects above happen after you leave the hospital or
clinic, you should go or be taken straight to the casualty department
of your nearest hospital.

6.1 List of excipients
Acetic acid
Sodium hydroxide
Sodium thiosulphate
Sodium bicarbonate
Sodium chloride
Water for injections

If any of the side effects gets serious, of if you notice any side effects
notIncompatibilities
listed in this leaflet, please tell your doctor or nurse.
6.2
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.

6.3 Shelf life
Can be used up to 36 hours post calibration time indicated on the label.

5. Once
Howopened,
to store
Sodium Iodide Injection
store in a refrigerator (2°C-8°C) and use within one working day.
Sodium Iodide Injection is kept out of the reach and sight of children.

6.4 Special precautions for storage
Store below 25°C. Do not freeze.

storage conditions
the opened medicinal
product, see
section 6.3.conditions and the
TheForproduct
labelofincludes
the correct
storage
Store either
leadbatch.
container or
in equivalentstaff
shielding.
expiry
datein original
for the
Hospital
will ensure that the product is
Storage should take place in accordance with national regulations for radioactive materials.

6.5 Nature and contents of container
10 ml medicinal glass vial, closed with a Teflon coated rubber stopper and sealed with an aluminium cap.
Each vial is enclosed in a lead container of appropriate thickness.
Pack size: 18.5 to 370 MBq.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Normal safety precautions for handling radioactive materials should be observed. After use, all materials
associated with the preparation and administration of radiopharmaceuticals, including any unused product
and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance
with the conditions specified by the local competent authority. Contaminated material must be disposed of as
radioactive waste via an authorised route.
7.

MARKETING AUTHORISATION HOLDER
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
UK: PL 00221/0138

9.

DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Date of first authorisation
01 December 1998

UK

Date of last renewal
23 May 2003

10. DATE OF REVISION OF THE TEXT
XX/XXXX
11. DOSIMETRY
Depending on the production procedure of iodine -123, impurities like iodine-125 and/or iodine-124 may be
present as longer life contaminants increasing the radiation dosimetry to the different organs. The ICRP
model refers to intravenous administration.

5.

The Effective (whole body) Dose Equivalent is calculated from the six standard organs (gonads, breast, red
marrow, lungs, thyroid and bone surfaces) and five additional organs with the highest absorbed dose
(marked with *).

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic radiopharmaceuticals, thyroid, sodium iodide (123I), ATC
code: V09FX02.
At doses used in diagnostic investigations, sodium iodide has not been observed to exert any
pharmacodynamic effects.
5.2 Pharmacokinetic properties
Intravenously administered iodide is taken by the thyroid. About 20% of the available radioactivity enters the
thyroid in one pass of the blood volume. Normal thyroid clearance of blood iodide is 20-50 ml/min with an
increase to 100 ml/min in thyroid deficiency.
Peak levels of iodide occur in thyroid gland within a few hours so that diagnostic imaging can take place from
one hour after dosing.
The half-time of iodide elimination from the thyroid is estimated at 80 days so that the physical half-life of
iodine-123 of 13 hours governs the temporal opportunity for imaging.
Without considering the thyroid uptake, the iodide leaves the body stream chiefly by urinary excretion (3775%), while faecal excretion is low (about 1%).
5.3 Preclinical safety data
Known toxic effects of relatively high doses of sodium iodide are not relevant to this use of iodine-123 to
image the thyroid for diagnostic purposes.

Specific warnings:
This meidicnal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
4.5 Interaction with other medicinal products and other forms of interaction
The uptake of [123I] iodide maybe decreased by recent administration of iodinated contrast materials, by
intake of stable iodine in any form, or by thyroid, antithyroid, and certain other drugs.

Driving and using machines
Ask your doctor if you can drive or use machines after you have been
given Sodium Iodide Injection.

4.9 Overdose
In the event of the administration of an overdose of [123I] iodide, the absorbed dose to the patient should be
reduced where possible by increasing the elimination of the radionuclide from the body by diuresis and
frequent voiding of urine. A blocking agent such as potassium perchlorate should be used to minimise
irradiation to the thyroid

General warnings:
Radiopharmaceuticals should be received, used and administered only by authorised persons in designated
clinical settings. Their receipt, storages, use, transfer and diposal are subject to the regulations and/or
appropriate licences of the competent official organisation/
Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and
pharmaceutical quality requirements.Appropriate aseptic precautions should be taken.

Your doctor will let you know when you can start breast-feeding
again.

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.

The lower activity (3.7 MBq) is recommended for uptake studies and the higher doses (11.1 - 14.8 MBq) for
thyroid scintigraphy. However for each individual case, the dose is decided by the specialist concerned.

This radiopharmaceutical may be received, used and administered only by authorised persons in designated
clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or
appropriate licences of the local competent official organisations (see section 6.6).

Manufacturer
GE Healthcare B.V.
Den Dolech 2
5612 AZ Eindhoven
The Netherlands

Breast-feeding:
Before administering a radioactive medicinal product to a mother who is breast-feeding consideration should
be given as to whether the investigation could be reasonably delayed until the mother has ceased breastfeeding and to what is the most appropriate choice of radiopharmaceutical has been made, bearing in mind
the secretion activity in breast milk.

PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

13. OTHER INFORMATION

Pregnancy:
Radionuclide procedures carried out on pregnant women also involve radiation doses to the foetus. Only
imperative investigations should be carried out during pregnancy, when the likely benefit exceeds the risk
incurred by the mother and foetus.

For a full list of excipients, see section 6.1.

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent
with approximately 0.6% at calibration time and 4% at expiration time.

Aseptic conditions must be observed during withdrawal of a patient dose from the vial, including microbial
decontamination of the rubber stopper with a suitable disinfectant before removal of a dose. This product is
not preserved. After removal of a dose from the vial, store at 2°C-8°C and use within one working day.

4.6 Pregnancy and lactation
Women of childbearing potential:
When it is necessary to administer radioactive medicinal product to women of childbearing potential,
information should always be sought about pregnancy. Any woman who has missed a period should be
assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has
missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there
are any) should be offered to the patient.

This medicinal product contains:
Sodium: 3.99 mg/ml. This needs to be taken into consideration for patients on a controlled sodium diet.

Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
6.3E-03
8.3E-03
1.3E-02
2.0E-02
3.7E-02
7.6E-02
9.5E-02
1.4E-01
2.1E-01
3.8E-01
7.1E-03
9.1E-03
1.4E-02
2.2E-02
4.1E-02
4.7E-03
4.7E-03
7.3E-03
1.2E-02
2.3E-02

Adrenals
* Bladder wall
Bone surfaces
Breast
GI-tract:
* Stomach wall
* Small intest
* ULI wall
LLI wall

Expectorants and vitamins: 2 weeks.
Natural or synthetic thyroid preparations (levothyroxine sodium, liothyronine sodium): 1-3 weeks.
Amiodoarone, benzodiazepines, lithium: approx. 4 weeks.
Iodine-containing preparations for topical use: 1-9 months.
Intravenous contrast agents: 1-2 months
Iodine containing contrast agent: up to 1 year.

• express (remove) breast milk and throw away the milk.

Solution for intravenous injection, ready to use.

13. OTHER INFORMATION

Please
yourmedicines
doctor or nurse if you are taking or have recently
Takingtell
other
taken any other medicines, including medicines obtained without a
Please tell your doctor or nurse if you are taking or have recently
prescription. This includes herbal medicines. This is because some
taken any other medicines, including medicines obtained without a
medicines can affect the way Sodium Iodide Injection works.
prescription. This includes herbal medicines. This is because some
Before yourcan
scan
tell your
doctor
or nurse
if you
are taking
any of the
medicines
affect
the way
Sodium
Iodide
Injection
works.
types of medicine below. This is because they may affect the results
Before
of youryour
scan:scan tell your doctor or nurse if you are taking any of the
types of medicine below. This is because they may affect the results
•of your
Anti-inflammatory
medicines, such as phenylbutazone.
scan:
•• Antithyroid
medicines,
such assuch
propylthiouracil
or thiamazole.
Anti-inflammatory
medicines,
as phenylbutazone.
•• Expectorants,
such as certain
medicines or
(used
to loosen
Antithyroid medicines,
such ascough
propylthiouracil
thiamazole.
mucus from the respiratory tract).
• Expectorants, such as certain cough medicines (used to loosen
• Salicylates,
as aspirin (used
mucus fromsuch
the respiratory
tract).to treat pain or heart disease).
4.
CLINICAL
PARTICULARS
•• Steroids,
such
as as
hydrocortisone,
dexamathasone.
Salicylates,
such
aspirin (used toprednisolone
treat pain ororheart
disease).
4.1
Therapeutic
indications
•• This
Medicines
used
to
treat
thyroid
disorders,
such
as
levothyroxine
medicinal
product
is
for
diagnostic
use
only.
Steroids, such
as hydrocortisone, prednisolone or dexamathasone.
Sodium
Iodide
I) Injection is used assodium.
a diagnostic agent in the functional or morphological study
sodium
or(123liothyronine
• of
Medicines
used
to treat
thyroid disorders, such as levothyroxine
the thyroid gland
by means
of:
• Medicines
beforesodium.
some types of scan, such as perchlorate.
•sodium
scintigraphy
or taken
liothyronine
radioactive iodine
uptake infections,
test
•• •Medicines
to
treat
such
antiparasitics,
Medicines
taken
before
some
typesasof
scan,
such
as penicillins,
perchlorate.
The
24
hours
uptake
data
are
generally
used
in
calculating
the
therapeutic
dose.
sulfonamides.
•4.2 Posology
Medicines
to treat infections, such as antiparasitics, penicillins,
and method of administration
• Amiodarone,
and antiarrythmic agents (used to treat an irregular
The
recommended activity for an adult patient (70 kg) is between 3.7 and 14.8 MBq.
sulfonamides.
heartbeat).
lower activity (3.7 MBq) is recommended for uptake studies and the higher doses (11.1 - 14.8 MBq) for
• The
Amiodarone,
and antiarrythmic
agents
an concerned.
irregular
scintigraphy. However
for each individual case,
the dose (used
is decidedto
by treat
the specialist
• thyroid
Lithium
(used
to
treat
certain
conditions
such
as
depression
or
heartbeat).
Determination
of the rate of thyroid iodine-123 uptake should be carried out in accordance with well
mental standard
problems.
established
procedures.
• Lithium
(used
tomay
treat
certain
conditions
such
as
depression
or
The
activities
for
children
be calculated
from
the recommended
rangeblood
of adult activities
and adjusted
• Sodium
nitroprusside
(used
to
treat
very
high
pressure).
according
the following equation:
mentaltoproblems.
(used to test how the liver is working).
• Sulfobromophthalein sodium
activity adult (MBq) x body weight (kg)
• Sodium
nitroprusside
(used
to treat very
high blood pressure).
Activity
child
(MBq)
=
70 (kg)
Topical iodides (used to
clean (used
the skin
before
surgery).
sodium
to
test
how
the liver
is working).
•• InSulfobromophthalein
young children the activity of 14.8 MBq should be used in the equation
to calculate
the activity
for children
•• inAnticoagulants
to
thin
the
blood).
order to obtain images (used
of sufficient
quality.
Topical iodides
(used
to
clean
the
skin
before
surgery).
must be
given as an
intravenous
injection; as a routine
check, the activity in the
Iodide (123I) Injection
•• Sodium
Antihistamines
(used
to
or
prevent
reactions).
Anticoagulants
(used
to treat
thin
the
blood). allergic
injection
should be measured
immediately
prior
to administration.
Imaging is performed 3-6 hours after
•• administration.
Tolbutamide
(used
fortopeople
with
diabetes
to lower
blood sugar
Antihistamines
(used
treat or
prevent
allergic
reactions).
The instructions for preparation of radiopharmaceuticals are given in section 12.
levels).
• Contra-indications
Tolbutamide (used for people with diabetes to lower blood sugar
4.3
• Hypersensitivity
Thiopental
a general
the activeas
substance
or to anyanaesthetic).
of the excipients.
levels). to(used
•• Special
Medicines
given
in
hospital
for
x-rays or scans (intravenous
4.4
warnings
and
precautions
for
use
Thiopental
(used
as a general anaesthetic).
Individual
benefit/risk
justification:
contrast
media).
each patient, given
the radiation
exposure must
be justifiable
thescans
likely benefit.
The activity administered
• For
Medicines
in hospital
for
x-raysbyor
(intravenous
in every case be as low as reasonably achievable to obtain the required diagnostic information.
• should
Vitamins.
contrast media).
If you
arePopulation:
not sure if any of the above apply to you, talk to your doctor
Paediatric
• Paediatric
Vitamins.
population, see section 4.2.
or nurse before
having Sodium Iodide Injection.
If you
are not sure if any of the above apply to you, talk to your doctor
General warnings:
Radiopharmaceuticals
should be received,
usedIodide
and administered
only by authorised persons in designated
or
nurse before
Sodium
Injection.
Pregnancy
and having
breast-feeding
clinical settings. Their receipt, storages, use, transfer and diposal are subject to the regulations and/or
licences
of thedoctor
competentifofficial
Youappropriate
must tell
your
youorganisation/
are pregnant or think you might be
Pregnancy and breast-feeding
pregnant.
Your
doctor
will
only
use
this
product
it is considered
that
be prepared by the user
in a manner
whichif
satisfies
both radiation safety
YouRadiopharmaceuticals
must tellquality
yourshould
doctor
if you are
pregnant
or
think
you might beand
pharmaceutical
requirements.Appropriate
aseptic
precautions
should
be
taken.
the benefit outweighs the risk.
pregnant. Your doctor will only use this product if it is considered that
Specific warnings:
theThis
benefit
risk.
meidicnaloutweighs
product contains the
less than
1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
DoInteraction
not breast-feed
if you
are given
Iodide Injection.
4.5
with other medicinal
products
and otherSodium
forms of interaction
of [123I] iodide
maybe
decreased of
by recent
administration ofmay
iodinated
contrast
materials,
ThisTheisuptake
because
small
amounts
‘radioactivity’
pass
into
the by
of stable iodine in any
form, or
by thyroid,
antithyroid,
andIodide
certain other
drugs.
Do intake
not breast-feed
if you
are
given
Sodium
Injection.
mother’s milk. If you are breast-feeding, your doctor may wait until
This is because
small
amounts
ofcarefully
‘radioactivity’
may pass
intoand
the
the patient
should
be questioned
regarding
diet,Sodium
previous
medication,
youAccordingly,
have finished
breast-feeding
before
using
Iodide
procedures
involving
radiographic
contrast media. Relevantyour
medication
including
the ones
mentioned
mother’s
milk.
If you
are breast-feeding,
doctor
may
wait
until
Injection.
If itbeiswithheld
not possible
to wait your
doctor
will ask you to:
below should
prior to the administration
of sodium
[123I] iodide.
you have finished breast-feeding before using Sodium Iodide
•Injection.
stop
breast-feeding
for 1.5
3 days,
Active substances:
period
prior
to
administration
of sodiumwill
[123I]iodide
If it is Withdrawal
not possible
toto
wait
your and
doctor
ask you to:
Antithyroid agents (e.g. carbimazole, methimazole, propyluracil), perchlorate: 1 week.
•• use
formula
feed
for
your
child,
and
Salicylates,
steroids, sodium nitroprusside,
sodium
sulfobromophthalein,
anticoagulants, antihistamines,
stop
breast-feeding
for 1.5 to
3 days,
and
antiparasitics,
penicillins, sulfonamides
tolbutamide,
thiopental:
1 week. the milk.
•• express
(remove)
breast
milk
and
throw
away
Phenylbutazone:
weeks.for your child, and
use
formula1-2feed

Do not breast-feed if you are given Sodium Iodide Injection.
This is because small amounts of ‘radioactivity’ may pass into the
mother’s milk. If you are breast-feeding, your doctor may wait until
you have finished breast-feeding before using Sodium Iodide
Injection. If it is not possible to wait your doctor will ask you to:
• stop breast-feeding for 1.5 to 3 days, and
• use formula feed for your child, and
• express (remove) breast milk and throw away the milk.

No data are available from animal models about toxicity with repeated dose administration or about
reproduction toxicity.
Sodium Iodide (123I) Injection has not been investigated for mutagenicity and carcinogenic/oncogenic
potential.
6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Acetic acid
Sodium hydroxide
Sodium thiosulphate
Sodium bicarbonate
Sodium chloride
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
6.3 Shelf life
Can be used up to 36 hours post calibration time indicated on the label.
Once opened, store in a refrigerator (2°C-8°C) and use within one working day.
6.4 Special precautions for storage
Store below 25°C. Do not freeze.
For storage conditions of the opened medicinal product, see section 6.3.
Store either in original lead container or in equivalent shielding.
Storage should take place in accordance with national regulations for radioactive materials.
6.5 Nature and contents of container
10 ml medicinal glass vial, closed with a Teflon coated rubber stopper and sealed with an aluminium cap.
Each vial is enclosed in a lead container of appropriate thickness.
Pack size: 18.5 to 370 MBq.
Not all pack sizes may be marketed.

For this product the Effective Dose Equivalent resulting from an administered activity of 14.8 MBq will be
2.2 mSv. This Effective Dose Equivalent is dependent on the uptake in the thyroid glands.

The table below shows the dosimetry as calculated according to the Publication 53 of the ICRP (International
Commission on Radiological Protection, Radiation Dose to Patients from Radiopharmaceuticals, Pergamon
Press 1987).
Thyroid blocked, uptake 0%
Organ
Adrenals
* Bladder wall
Bone surfaces
Breast
GI-tract:
Stomach wall
* Small intest
* ULI wall
* LLI wall

Absorbed dose per unit activity administered (mGy/MBq)
Adult
15 year
10 year
5 year
1 year
7.0E-03
8.7E-03
1.4E-02
2.1E-02
3.9E-02
9.0E-02
1.1E-01
1.6E-01
2.4E-01
4.5E-01
8.1E-03
9.7E-03
1.5E-02
2.4E-02
4.6E-02
5.6E-03
5.6E-03
8.1E-03
1.3E-02
2.5E-02
6.9E-03
8.5E-03
8.0E-03
9.7E-03

8.5E-03
1.0E-02
9.9E-03
1.2E-02

1.4E-02
1.6E-02
1.5E-02
1.9E-02

2.1E-02
2.5E-02
2.4E-02
2.9E-02

3.7E-02
4.6E-02
4.3E-02
5.4E-02

1.1E-02
6.7E-03
6.1E-03
9.8E-03
7.6E-03

1.4E-02
8.2E-03
7.8E-03
1.2E-02
9.1E-03

2.0E-02
1.3E-02
1.2E-02
1.9E-02
1.4E-02

2.9E-02
2.0E-02
1.9E-02
3.0E-02
2.2E-02

5.1E-02
3.7E-02
3.5E-02
5.3E-02
4.1E-02

Red marrow
Spleen
Testes
Thyroid
Uterus

9.4E-03
7.0E-03
6.9E-03
5.1E-03
1.4E-02

1.1E-02
8.3E-03
9.4E-03
7.7E-03
1.7E-02

1.7E-02
1.3E-02
1.5E-02
1.2E-02
2.8E-02

2.6E-02
2.0E-02
2.5E-02
2.0E-02
4.3E-02

4.7E-02
3.7E-02
4.8E-02
3.7E-02
7.6E-02

Other tissue

6.4E-03

7.7E-03

1.2E-02

1.9E-02

3.5E-02

Effective Dose
Equivalent (mSv/MBq)

1.3E-02

1.6E-02

2.4E-02

3.7E-02

6.7E-02

5.2E-02
6.7E-02
9.9E-02

9.6E-02
1.3E-01
1.8E-01

* Kidneys
Liver
Lungs
Ovaries
Pancreas

Incomplete blockage:
Effective Dose Equivalent (mSv/MBq) at small uptake in the thyroid
uptake:
uptake:
uptake:

0.5%
1.0%
2.0%

1.6E-02
1.9E-02
2.5E-02

2.0E-02
2.5E-02
3.4E-02

3.1E-02
3.8E-02
5.2E-02

Effect of radionuclidic impurities:
The radionuclidic impurities (iodine-125 and tellurium-121) increase the Effective Dose Equivalent with
approximately 0.5% at calibration time and 3% at expiration time

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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