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SODIUM IODIDE (I-131) 74 MBQ/ML AND 925 MBQ/ML SOLUTION FOR INJECTION

Active substance(s): SODIUM IODIDE I-131

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Read all of this leaflet carefully
before you receive this medicine.
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Sodium Iodide (131I) Injection

Sodium Iodide (131I) Injection
74 MBq/ml and 925 MBq/ml
solution for injection
Sodium [131I] Iodide
(called Sodium Iodide Injection in this
leaflet)

• 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.
In this leaflet:
1. What Sodium Iodide Injection is
and what it is used for
2. Before you are given Sodium
Iodide Injection
3. How Sodium Iodide Injection is
given
4. Possible side effects
5. How to store Sodium Iodide
Injection
6. Further information

2

1. What Sodium Iodide Injection is
and what it is used for
This medicine is for diagnostic and
therapeutic use. It is used both to
help identify illness and treat illness.
Sodium Iodide Injection is a ‘radiopharmaceutical’ medicine.
• It contains an active ingredient
called ‘sodium iodide’.
• Once injected it can be seen from
outside your body by a special
camera used in the scan.
• The scan can help your doctor
see tumours in the thyroid glands,
and to see how well a tumour is
responding to treatment or if the
tumour has spread to other parts
of the body.

• Some other people are given this
medicine to treat a thyroid
tumour, an overactive thyroid or
to treat goitre (swelling due to an
enlarged thyroid).
Your doctor or nurse will tell you
anything else you need to know
about how Sodium Iodide Injection
works.
The use of Sodium Iodide Injection for
treatment of an illness is often
combined with surgical treatment
and with medicines that inhibit the
thyroid (antithyroidal agents).

3

2. Before you are given Sodium
Iodide Injection
You should not be given Sodium
Iodide Injection:
• If you are allergic (hypersensitive)
to the active ingredient or any
other ingredient (listed in Section
6).
• If you are pregnant or think you
might be pregnant.
• For a scan of benign thyroid
tumours.
Do not have Sodium Iodide Injection
if any of the above apply to you. If
you are not sure talk to your doctor
or nurse.

Take special care with Sodium
Iodide Injection
Check with your doctor or nurse
before having Sodium Iodide Injection:
• If the person who will be given
this medicine is a child or
adolescent.
• If you have missed your last
period.
• If you are breast-feeding.
• If you are on a low sodium diet.
Taking other medicines
Please tell your doctor if you are
taking or have recently taken any
other medicines, including medicines
obtained without a prescription. This
includes herbal medicines. This is
because some medicines can affect

4

the way Sodium Iodide Injection
works.
Before you are given Sodium Iodide
Injection tell your doctor or nurse if
you are taking any of the types of
medicine below.
• Medicines used for an
overactive or underactive
thyroid such as carbimazole,
propylthiouracil, levothyroxine
sodium, sodium liothyronine or
thyroid extract.
• ‘Salicylates’ such as aspirin.
• Steroids such as prednisolone or
methylprednisolone.
• Medicines used to thin the
blood such as warfarin or
heparin.
• Antihistamines such as
chlorpheniramine or cetirizine.

• Medicines used for parasite
infections such as
thiabendazole, rifampicin or
amphotericin B.
• Penicillins.
• Medicines called
‘sulphonamides’ such as
sulphasalazine (used for
rheumatoid arthritis and some
bowel problems), sumitriptan
(used for migraine) or
probenecid (used for gout).
• Medicines called
‘benzodiazepines’, which are
sedatives or are used to help
you sleep, such as temazepam,
nitrazepam or diazepam.
• ‘Expectorants’, used in cough
and cold remedies, such as
guaifenesin.
• Vitamins.

5

• Lithium, used for mental health
problems.
• Tolbutamide, used for diabetics.
• Thiopental, an anaesthetic
used in hospital.
• Phenylbutazone, used for pain
and arthritis.
• Amiodarone, used for an
uneven heart beat.
• Liquids or ointments that
contain iodine.
• Sodium nitroprusside, used in
hospital to lower blood
pressure.
• Sodium sulfobromophthalein,
used in hospital to check how
well your liver is working.
• Perchlorate, a medicine given
before certain types of scan.

• Medicines used in hospital for
x-rays or scans of the
gallbladder.
• Medicines that contain iodine
used in hospitals for x-rays or
scans.
If you are not sure if any of the above
apply to you, talk to your doctor or
nurse before having Sodium Iodide
Injection.

6

Having Sodium Iodide Injection with
food and drink
• Your doctor may recommend a
low iodine diet.
• After been given Sodium Iodide
Injection you may be asked to
drink more liquids.
Pregnancy and breast-feeding
You should not be given Sodium
Iodide Injection if you are pregnant
or think that you may be pregnant.
This is because it may affect the
baby.
You may be told by your doctor not
to become pregnant for at least
6 months after being given Sodium
Iodide Injection.

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

7

Driving and using machines
Ask your doctor if you can drive or
use machines after you have been
given Sodium Iodide Injection.
Important information Sodium
Iodide Injection
When Sodium Iodide Injection is used
you are exposed to radioactivity.
• Your doctor will always consider
the possible risks and benefits
before you are given the
medicine.
Ask your doctor if you have any
questions.
3. How Sodium Iodide Injection is
given
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.
Your doctor will decide the dose that
is best for you.
The usual dose is:
• One single injection before a scan.
Scans may be taken after 4 hrs
and up to 72 hrs after injection.
• The number of doses and length
of treatment will depend on your
condition.
Ask your doctor if you have any
questions.

8

4. Possible side effects
Like all medicines, Sodium Iodide
Injection can cause side effects,
although not everybody gets them.
The side effects will depend on
whether you are being given this
medicine to scan (diagnose) or treat a
condition. Side effects from Sodium
Iodide Injection may occur soon after
receiving the product (early side
effects) or some time after receiving
the product (late side effects). You are
only at risk of the late side effects if
you have been given this product to
treat a condition.
Early side effects
(within hours, days or weeks):
Allergic reactions
If you have an allergic reaction when
you are in hospital or a clinic, tell the

doctor or nurse straightaway. The
signs may include:
• skin rash or itching or flushing
• swelling of the face
• difficulty in breathing.
If any of these side effects happen
after you leave the hospital or clinic
go straight to the casualty of your
nearest hospital.
Other early side effects include
• feeling sick (nausea)
• being sick (vomiting).
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor.
If you are receiving this product as
treatment for a condition you may
also experience the following early

9

side effects that your doctor may
be able to prevent or treat
• diarrhoea
• pain around your stomach area
(abdominal pain)
• swelling (inflammation) of your
thyroid
• swelling of your windpipe
(trachea), which may cause
difficulty in breathing
• swelling of your saliva glands,
which may cause pain, some loss
of taste and a dry mouth.
Occasionally this can be severe,
and cause a permanent loss of
taste and dry mouth. This has
caused some patients to lose
teeth.
• pain, discomfort and swelling in
the thyroid area (your neck).
• if your thyroid is overactive

(hyperthyroidism) your symptoms
may get worse for a short time
after being given Sodium Iodide
Injection. Symptoms could include
increased appetite, palpitations,
feeling restless (anxiety), weight
loss or sweating.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor.
Late side effects
(within weeks, months or years):
• your thyroid may become
underactive (hypothyroidism).
Signs may include feeling tired or
a loss of energy (lethargy), muscle
weakness, cramps, feeling the
cold, a slow heart rate, dry flaky
skin, hair loss, a deep and husky
voice, weight gain.

10

• your parathyroid may become
underactive (hypoparathyroidism).
Signs may include ‘pins and
needles’, weakness, muscle
spasms, muscle twitches or
cramps all over, tingling, vibrating,
burning and numbness, trouble
concentration, feeling dizzy or
irritable, sensitivity to noise,
muscles that stop working
properly (muscle paralysis) or fits
(seizures).
High doses of Sodium Iodide Injection
or repeat treatments within 6 months
of the first treatment may lead to a
reduction in the ability of your bone
marrow to make blood cells. This can
cause bruising and bleeding
problems. In many cases patients

recover fully. Very rarely, in severe
cases, this may cause death.
Patients who have received Sodium
Iodide Injection appear to be more at
risk of developing stomach cancer
and if high doses have been received,
leukaemia. There may also be a small
increase in the risk of developing
bladder and breast cancers.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor.
5. How to store Sodium Iodide
Injection
Sodium Iodide Injection is kept out of
the reach and sight of children.

11

The product label includes the
correct storage conditions and the
expiry date for the batch. Hospital
staff will ensure that the product is
stored and disposed of correctly and
not used after the expiry date stated
on the label.
6. Further Information
What Sodium Iodide Injection
contains
• The active ingredient is sodium [131I]
iodide. Each ml of Sodium Iodide
(131I) Injection contains 74 MBq
(Megabecquerel – the unit in which
radioactivity is measured) or
925 MBq of sodium [131I] iodide at
a fixed time.
• The other ingredients are sodium
thiosulphate, disodium hydrogen
phosphate, sodium dihydrogen

phosphate, sodium chloride and
water for injections.
What Sodium Iodide Injection looks
like and contents of the pack
Sodium Iodide Injection is supplied as
a single clear glass vial containing a
solution for injection.
Marketing Authorisation Holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom
Manufacturer
GE Healthcare Buchler GmbH & Co.
KG
Gieselweg 1
D-38110 Braunschweig
Germany

This leaflet was last approved in
01/02/2010.
Marketing Authorisations
UK: PL 00221/0113

GE and the GE Monogram are
trademarks of General Electric
Company

EVS 220116

PACKAGE LEAFLET:
INFORMATION FOR THE USER

1. Name OF THE MEDICINAL PRODUCT
Sodium Iodide (131I) Injection
74 MBq/ml and 925 MBq/ml
solution for injection

PACKAGE LEAFLET:
INFORMATION FOR THE
HEALTHCARE PROFESSIONAL

Sodium Iodide (131I)
Injection
74 MBq/ml and 925 MBq/ml
solution for injection
Sodium [131I] Iodide
IBS2P/25P

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Iodide (131I) Injection is a clear, colourless
solution containing sodium [131I] iodide:
37-740 MBq/vial (74 MBq/ml) at the activity reference
date
0.925-9.25 GBq/vial (925 MBq/ml) at the activity
reference date
The specific activity of the sodium [131I] iodide is not less
than 222 GBq/mg iodine at the activity reference date.
Iodine-131 is produced by fission of uranium-235 or
by neutron bombardment of stable tellurium in a
nuclear reactor. Iodine-131 has a half-life of 8.02 days.
It decays by emission of gamma radiations of 365 keV
(81.7 %), 637 keV (7.2 %) and 284 keV (6.1 %) and beta
radiations of maximal energy of 606 keV to stable
xenon-131.
This medicinal product contains 5.92 mg/ml sodium.
This needs to be taken into consideration for patients
on a controlled sodium diet.
For a full list of excipients, see section 6.1.

2
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4

CLINICAL PARTICULARS

4.1 Therapeutic Indications
Diagnostic indications
Sodium iodide may be given as a “tracer” dose to study
radioiodine kinetics. An estimation of the thyroid
uptake and effective half-life obtained with a tracer
dose can be used to calculate the activity required for
radioiodine therapy.
In the management of thyroid carcinoma, sodium
iodide is used to identify thyroid remnant and
metastases (after ablation).
Thyroid scanning for benign conditions with sodium
[131I] iodide can be performed but only where
circumstances do not allow for radiopharmaceuticals
with more favourable dosimetry to be used.
Therapeutic indications
Radioiodide thyroid therapy is indicated for:
• treatment of Graves’ disease, toxic multinodular
goitre or autonomous nodules
• treatment of papillary and follicular thyroid
carcinoma including metastatic disease.
Sodium [131I] iodide therapy is often combined with
surgical intervention and with antithyroid medications.

4.2 Posology and method of administration
Diagnostic use
The recommended activities for an adult patient
(70 kg) are as follows:
1. For the thyroid uptake studies: 0.2-3.7 MBq.
2. For post thyroid ablation (for metastases and
thyroid remnant): a maximum dose of 400 MBq.
3. For thyroid imaging: 7.4-11 MBq.
Scans are usually performed at 4 hours, and then
again at 18-24 hours (for scintigraphy also at
72 hours).
The diagnostic activity to be administered to a child
and adolescent should be a fraction of the adult dose
calculated from the body weight/surface area
methods or according to the following equations:
Paediatric dose (MBq) = Adult dose (MBq) x child weight (kg)
70 kg
Paediatric dose (MBq) = Adult dose (MBq) x child surface (m2)
1.73 m2

Correction factors given for guidance are proposed
below:

3
Fraction of adult dose
3 kg
4 kg
6 kg
8 kg
10 kg
12 kg
14 kg
16 kg
18 kg
20 kg

=
=
=
=
=
=
=
=
=
=

0.10
0.14
0.19
0.23
0.27
0.32
0.36
0.40
0.44
0.46

22 kg
24 kg
26 kg
28 kg
30 kg
32 kg
34 kg
36 kg
38 kg
40 kg

=
=
=
=
=
=
=
=
=
=

0.50
0.53
0.56
0.58
0.62
0.65
0.68
0.71
0.73
0.76

42 kg
44 kg
46 kg
48 kg
50 Kg
52-54 kg
56-58 kg
60-62 kg
64-66 kg
68 kg

=
=
=
=
=
=
=
=
=
=

0.78
0.80
0.82
0.85
0.88
0.90
0.92
0.96
0.98
0.99

(Paediatric Task Group, European Association of
Nuclear Medicines (EANM))
Therapeutic use
The activity administered is a matter for clinical
judgement. The therapeutic effect is only achieved
after several months.
• For the treatment of hyperthyroidism
The activity administered is usually in the range of
200-800 MBq but repeated treatment may be
necessary, with cumulative activities of up to 5000 MBq.
The dose required depends on the diagnosis, the size
of the gland, thyroid uptake and iodine clearance.
Patients should be rendered euthyroid medically
whenever possible before giving radioiodine treatment
for hyperthyroidism.

• For thyroid ablation and treatment of metastases
The administered activities following total or sub total
thyroidectomy to ablate remaining thyroid tissue are
in the range of 1850-3700 MBq. It depends on the
remnant size and radioiodine uptake. In subsequent
treatment for metastases, administered activity is in
the range 3700-11100 MBq.
After high doses used, e.g. for the treatment of thyroid
carcinoma, patients should be encouraged to increase
oral fluids to have frequent bladder emptying to
reduce bladder radiation.
The therapeutic activity to be administered to a child
over 10 years and adolescent should be a fraction of the
adult dose, calculated from body weight or surface area.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of
the excipients.
• Pregnancy
• For diagnostic purposes in children under 10 years
of age.
• Thyroid scanning except in the follow-up of
malignant disease or when iodine-123 or
technetium-99m is not available.
4.4 Special warnings and precautions for use
The possibility of hypersensitivity including
anaphylactic / anaphylactoid reactions should always
be considered. Advanced life support facilities should
be readily available.

4
The administration of high dose radioiodine may
result in significant environmental hazard. Suitable
precautions should be taken concerning the activity
eliminated by the patients in order to avoid any
contamination.
The therapeutic administration of sodium [131I] iodide
in patients with significant renal impairment requires
special attention with regards to administered activity.
Sperm banking should be considered for young men
who have extensive disease and therefore may need
high radioiodine therapeutic doses.
Contraception for 6 months (for patients with benign
thyroid conditions) or 12 months (for patients with
thyroid cancer) is recommended for both sexes after
therapeutic administration of sodium [131I] iodide.
For each patient, exposure to ionising radiation must
be justifiable on the basis of likely benefit. The activity
administered must be such that the resulting radiation
dose is as low as reasonable achievable bearing in
mind the need to obtain the intended diagnostic or
therapeutic result.
4.5 Interaction with other medicinal products and
other forms of interaction
A full drug history should be taken and relevant
medication including the ones mentioned below
should be withheld prior to the administration of
sodium [131I] iodide.

Active substances

Withdrawal period
prior to administration
of sodium [131I] iodine.

Antithyroid agents (e.g.
carbimazole, methimazole,
propyluracil), perchlorate

2 – 5 days before until
several days after
administration.

Salicylates, steroids, sodium 1 week.
nitroprusside, sodium
sulfobromophthalein,
anticoagulants, anti–
histamines, antiparasitics,
penicillins, sulphonamides,
tolbutamide, thiopental
Phenylbutazone

1-2 weeks.

Containing iodine
expectorants and vitamins

approx. 2 weeks.

Thyroid hormone
preparations

2-6 weeks.

Amiodarone*, benzodiazepines, lithium

approx. 4 weeks.

Containing iodine
1–9 months.
preparations for topical use
Containing iodine contrast
media

up to 1 year.

* Due to the long half-life of amiodarone, iodine
uptake in the thyroid tissue can be decreased for
several months.

5
4.6 Pregnancy and lactation
Use during pregnancy:
The absorbed dose to the uterus for this agent is likely
to be in the range 11-511 mGy, and the foetal thyroid
gland avidly concentrates iodine during the second
and third trimesters.
Use during lactation:
Breast feeding should be discontinued after sodium
[131I] iodide administration.
For radioprotection reasons following therapeutic
doses, it is recommended to avoid close contact
between mother and child for at least one week.
4.7 Effects on ability to drive or use machines
No studies on the effect on the ability to drive or use
machines have been performed.
4.8 Undesirable Effects
The following undesirable effects are recognised for
sodium [131I] iodide:
Blood and the lymphatic system disorders
Bone marrow depression
Eye disorders
Sicca syndrome, endocrine ophthalmopathy, acquired
dacryostenosis
Gastrointestinal disorders
Nausea, vomiting

Endocrine disorders
Hypothyroidism, aggravated hyperthyroidism,
Basedow’s (Graves’) disease, hyperparathyroidism
Infections and infestations
Sialoadenitis
Neoplasms benign, malignant and unspecified
(including cysts and polyps)
Gastric cancer, leukaemia, bladder and breast cancer
Immune system disorders
Hypersensitivity
Injury, poisoning and procedural complications
Radiation thyroiditis
Reproductive system and breast disorders
Impairment of fertility in man and woman
Congenital, familial and genetic disorders
Congenital thyroid disorders.
4.9 Overdose
High radiation exposure through overdose can be
reduced by means of administration of thyroid blokking agent, such as potassium perchlorate, the use of
emetics and promoting a diuresis with frequent
voiding of urine.

6
5

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: diagnostic
radiopharmaceuticals, thyroid, sodium [131I] iodide,
ATC Code: V09FX03
Pharmacotherapeutic group: therapeutic
radiopharmaceuticals, sodium [131I] iodide,
ATC Code: V10XA01
Iodide, in the amount used for diagnostic and
therapeutic indications, is not known to have any
pharmacological effect. More than 90 % of the
radiation effects result from beta radiation which has
a mean range of 0.5 mm.
5.2 Pharmacokinetic properties
Following injection, about 20 % of blood iodide is
extracted in a single passage through the thyroid
gland. Peak thyroid accumulation occurs within
24 – 48 hours of dosing with about 50 % of the
maximum at 5 hours. This kinetic profile provides the
rationale for the diagnostics procedures at 24 and
72 hours after dosing.
The effective half-life of radioiodine in plasma is in the
order of 12 hours whereas that for radioiodine taken
by the thyroid gland is about 6 days.
5.3 Preclinical safety data
No acute toxicity is expected or observed.

There are no data available on the toxicity of
repeated doses of sodium iodide nor on its effects on
reproduction in animals or its mutagenic or
carcinogenic potential.
6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Sodium thiosulphate, pentahydrate
Sodium dihydrogen phosphate, dihydrate
Disodium hydrogen phosphate, dodecahydrate
Sodium chloride
Sodium hydroxide
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
The shelf-life for this product is 31 days from the
activity reference date stated on the label.
Once opened store in refrigerator (2ºC-8ºC) and use
within 8 hours.
Since the product does not contain an antimicrobial
preservative and is marketed for multidose use, all
doses from a single vial should be taken within a
single working day and the product stored at (2ºC-8ºC)
after removal of the first aliquot.

7
6.4 Special precautions for storage
Store below 25°C. Do not freeze.
Store in original lead container or in equivalent
shielding.
6.5 Nature and contents of container
The product is supplied in a Type 1 neutral, clear 10 ml
glass vial sealed with a PTFE-faced butyl rubber
closure and aluminium overseal.
Each vial is packed within a radiation shielding
container of lead metal and placed within a sealed
metal tin.
Pack size: 74 MBq - pack sizes range from 37 MBq
to 740 MBq
925 MBq - pack sizes range from 925 MBq
to 9250 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
PL 00221/0113
9

DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
Date of First Authorisation: 01/02/2010
10 DATE OF REVISION OF THE TEXT
02/2010

8
11 DOSIMETRY
The ICRP model refers to intravenous administration.
Since absorption of radioiodide is rapid and complete,
this model is applicable in case of oral administration
also but there is a further radiation dose to the stomach
wall in addition to that due to gastric and salivary
excretion. Assuming that the mean residence time in
the stomach is 0.5 hr, the absorbed dose to the
stomach wall increases by about 30 % for iodine-131.
Radiation dose to specific organs, which may not be
the target organ of therapy, can be influenced
significantly by pathophysiological changes induced
by the disease process.
As part of the risk-benefit assessment it is advised that
the effective dose equivalent (EDE) and likely radiation
doses to individual target organ(s) be calculated prior
to administration. The activity might then be adjusted
according to thyroid mass, biological half-life and the
“re-cycling” factor which takes into account the
physiological status of the patient (including iodine
depletion) and the underlying pathology.
The tables below show 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).

Iodide (131I; 8.02 days)
Thyroid blocked, uptake 0%
Organ

Absorbed dose
per unit activity administered (mGy/MBq)
Adult

15 year

10 year

5 year

1 year

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

3.7E-02
6.1E-01
3.2E-02
3.3E-02

4.2E-02
7.5E-01
3.8E-02
3.3E-02

6.7E-02
1.1E+00
6.1E-02
5.2E-02

1.1E-01
1.8E+00
9.7E-02
8.5E-02

2.0E-01
3.4E+00
1.9E-01
1.7E-01

3.4E-02
3.8E-02
3.7E-02
4.3E-02

4.0E-02
4.7E-02
4.5E-02
5.2E-02

6.4E-02
7.5E-02
7.0E-02
8.2E-02

1.0E-01
1.2E-01
1.2E-01
1.3E-01

1.9E-01
2.2E-01
2.3E-01
2.3E-01

Kidneys
Liver
Lungs
Ovaries
Pancreas

6.5E-02
3.3E-02
3.1E-02
4.2E-02
3.5E-02

8.0E-02
4.0E-02
3.8E-02
5.4E-02
4.3E-02

1.2E-01
6.5E-02
6.0E-02
8.4E-02
6.9E-02

1.7E-01
1.0E-01
9.6E-02
1.3E-01
1.1E-01

3.1E-01
2.0E-01
1.9E-01
2.4E-01
2.1E-01

Red marrow
Spleen
Testes
Thyroid
Uterus

3.5E-02
3.4E-02
3.7E-02
2.9E-02
5.4 E-02

4.2E-02
4.0E-02
4.5E-02
3.8E-02
6.7E-02

6.5E-02
6.5E-02
7.5E-02
6.3E-02
1.1E-01

1.0E-01
1.0E-01
1.2E-01
1.0E-01
1.7E-01

1.9E-01
2.0E-01
2.3E-01
2.0E-01
3.0E-01

Other tissue

3.2E-02

3.9E-02

6.2E-02

1.0E-01

1.9E-01

Effective dose
equivalent
(mSv/MBq)

7.2E-02

8.8E-02

1.4E-01

2.1E-01

4.0E-01

Bladder wall contributes to 50.8% of the effective dose equivalent.
Incomplete blockage:
Effective dose equivalent (mSv/MBq) at small uptake in the thyroid.
uptake: 0.5%

3.0E-01

4.5E-01

6.9E-01

1.5E+00

2.8E+00

uptake: 1.0%

5.2E-01

8.1E-01

1.2E+00

2.7E+00

5.3E+00

uptake: 2.0%

9.7E-01

1.5E+00

2.4E+00

5.3E+00

1.0E+01

9
Thyroid uptake 15%

Organ

Thyroid uptake 35%

Absorbed dose
per unit activity administered (mGy/MBq)
Adult

15 year

10 year

5 year

1 year

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

3.6E-02
5.2E-01
4.7E-02
4.3E-02

4.3E-02
6.4E-01
6.7E-02
4.3E-02

7.1E-02
9.8E-01
9.4E-02
8.1E-02

1.1E-01
1.5E+00
1.4E-01
1.3E-01

2.2E-01
2.9E+00
2.4E-01
2.5E-01

4.6E-01
2.8E-01
5.9E-02
4.2E-02

5.8E-01
3.5E-01
6.5E-02
5.3E-02

8.4E-01
6.2E-01
1.0E-01
8.2E-02

1.5E+00
1.0E+00
1.6E-01
1.3E-01

Kidneys
Liver
Lungs
Ovaries
Pancreas

6.0E-02
3.2E-02
5.3E-02
4.3E-02
5.2E-02

7.5E-02
4.1E-02
7.1E-02
5.9E-02
6.2E-02

1.1E-01
6.8E-02
1.2E-01
9.2E-02
1.0E-01

Red marrow
Spleen
Testes
Thyroid
Uterus

5.4E-02
4.2E-02
2.8E-02
2.1E+02
5.4E-02

7.4E-02
5.1E-02
3.5E-02
3.4E+02
6.8E-02

9.9E-02
8.1E-02
5.8E-02
5.1E+02
1.1E-01

Organ

Absorbed dose
per unit activity administered (mGy/MBq)
Adult

15 year

10 year

5 year

1 year

4.2E-02
4.0E-01
7.6E-02
6.7E-02

5.0E-02
5.0E-01
1.2E-01
6.6E-02

8.7E-02
7.6E-01
1.6E-01
1.3E-01

1.4E-01
1.2E+00
2.3E-01
2.2E-01

2.8E-01
2.3E+00
3.5E-01
4.0E-01

2.9E+00
2.0E+00
2.8E-01
2.3E-01

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

4.6E-01
2.8E-01
5.8E-02
4.0E-02

5.9E-01
3.5E-01
6.5E-02
5.1E-02

8.5E-01
6.2E-01
1.0E-01
8.0E-02

1.5E+00
1.0E+00
1.7E-01
1.3E-01

3.0E+00
2.0E+00
3.0E-01
2.4E-01

1.7E-01
1.1E-01
1.9E-01
1.4E-01
1.5E-01

2.9E-01
2.2E-01
3.3E-01
2.6E-01
2.7E-01

Kidneys
Liver
Lungs
Ovaries
Pancreas

5.6E-02
3.7E-02
9.0E-02
4.2E-02
5.4E-02

7.2E-02
4.9E-02
1.2E-01
5.7E-02
6.9E-02

1.1E-01
8.2E-02
2.1E-01
9.0E-02
1.1E-01

1.7E-01
1.4E-01
3.3E-01
1.4E-01
1.8E-01

2.9E-01
2.7E-01
5.6E-01
2.7E-01
3.2E-01

1.4E-01
1.2E-01
9.4E-02
1.1E+03
1.7E-01

2.4E-01
2.3E-01
1.8E-01
2.0E+03
3.1E-01

Red marrow
Spleen
Testes
Thyroid
Uterus

8.6E-02
4.6E-02
2.6E-02
5.0E+02
5.0E-02

1.2E-01
5.9E-02
3.2E-02
7.9E+02
6.3E-02

1.6E-01
9.6E-02
5.4E-02
1.2E+03
1.0E-01

2.2E-01
1.5E-01
8.9E-02
2.6E+03
1.6E-01

3.5E-01
2.8E-01
1.8E-01
4.7E+03
3.0E-01

Other tissue

6.5E-02

8.9E-02

1.4E-01

2.2E-01

4.0E-01

Other tissue

1.1E-01

1.6E-01

2.6E-01

4.1E-01

7.1E-01

Effective dose
equivalent
(mSv/MBq)

6.6E+00

1.0E+01

1.5E+01

3.4E+01

6.2E+01

Effective dose
equivalent
(mSv/MBq)

1.5E+01

2.4E+01

3.6E+01

7.8E+01

1.4E+02

10
Thyroid uptake 55%

Organ

12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS
Absorbed dose
per unit activity administered (mGy/MBq)

Adult

15 year

10 year

5 year

1 year

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

4.9E-02
2.9E-01
1.1E-01
9.1E-02

5.8E-02
3.6E-01
1.7E-01
8.9E-02

1.1E-01
5.4E-01
2.2E-01
1.9E-01

1.7E-01
8.5E-01
3.2E-01
3.1E-01

3.4E-01
1.6E+00
4.8E-01
5.6E-01

4.6E-01
2.8E-01
5.8E-02
3.9E-02

5.9E-01
3.5E-01
6.7E-02
4.9E-02

8.6E-01
6.2E-01
1.1E-01
7.8E-02

1.5E+00
1.0E+00
1.8E-01
1.3E-01

3.0E+00
2.0E+00
3.2E-01
2.4E-01

Kidneys
Liver
Lungs
Ovaries
Pancreas

5.1E-02
4.3E-02
1.3E-01
4.1E-02
5.8E-02

6.8E-02
5.8E-02
1.8E-01
5.6E-02
7.6E-02

1.0E-01
9.7E-02
3.0E-01
9.0E-02
1.3E-01

1.7E-01
1.7E-01
4.8E-01
1.5E-01
2.1E-01

2.9E-01
3.3E-01
8.0E-01
2.7E-01
3.8E-01

Red marrow
Spleen
Testes
Thyroid
Uterus

1.2E-01
5.1E-02
2.6E-02
7.9E+02
4.6E-02

1.8E-01
6.8E-02
3.1E-02
1.2E+03
6.0E-02

2.2E-01
1.1E-01
5.2E-02
1.9E+03
9.9E-02

2.9E-01
1.7E-01
8.7E-02
4.1E+03
1.6E-01

4.6E-01
3.3E-01
1.7E-01
7.4E+03
3.0E-01

Other tissue

1.6E-01

2.4E-01

3.7E-01

5.9E-01

1.0E+00

Effective dose
equivalent
(mSv/MBq)

2.4E+01

3.7E+01

5.6E+01

1.2E+02

2.2E+02

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
organisation (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.
13 OTHER INFORMATION
Manufacturer
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig
Germany

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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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