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SODIUM IODIDE (I123) INJECTION

Active substance(s): SODIUM IODIDE I 123 / SODIUM IODIDE I 123 / SODIUM IODIDE I 123

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Package leaflet: Information for the user

Sodium Iodide I123
solution for Injection

Active substance: 123 I as sodium iodide
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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 pharmacist.
In this leaflet:
1. What Sodium Iodide I123 is and what it is used for
2. Before you use Sodium Iodide I123
3. How to use Sodium Iodide I123
4. Possible side effects
5. How to store Sodium Iodide I123
6. Further information

1.

What Sodium Iodide I123 is and what it
is used for

This medicine is for diagnostic use only.

Sodium Iodide I123 is used for several types of X-ray procedures of the:
• thyroid gland
This medicine contains a radioactive substance which when injected, collects
in certain organs such as the thyroid gland.
The radioactive substance can be photographed from outside the body,
using special cameras which take a scan. This scan shows the distribution of
radioactivity within the organ and body. This also gives the doctor valuable
information about the structure and function of that organ.

2.

Before you use Sodium Iodide I123

Do not use Sodium Iodide I123

• if you are allergic (hypersensitive) to sodium iodide or any of the
other ingredients (for a full list of other ingredients see section 6).

Take special care with Sodium Iodide I123

This medicine does involve treatment with radioactivity. Your doctor
will only give you this medicine if the benefit outweighs the risk.
Sodium Iodide I123 is given in one single dose by specialists, who will
take responsibility for any necessary precautions.
Your doctor will inform you if you need to take any special precautions
after using this medicine. Contact your doctor if you have any
questions.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Your doctor may recommend that you stop the following medicines
before treatment:
a) medicines to reduce thyroid gland function such as:
- propylthiouracil, methimazol, carbimazol
- perchlorate
b) salicylates: medicines to reduce pain, fever or inflammation such
as acetylsalicylic acid
c) cortisone: medicines to reduce inflammation or prevent organ
transplant rejection
d) sodium nitroprusside: a medicine to reduce high blood pressure,
and also used during an operation
e) sodium sulfobromophtalein: a medicine to test liver function
f) certain medicines
- to reduce blood coagulation
- to treat parasitic infestation
- antihistamines: used to treat allergies
- penicillins and sulphonamides: antibiotics
- tolbutamide: a medicine to reduce the blood sugar
- thiopental: used while under anaesthetic to reduce brain
pressure, and also to treat extreme epileptic seizures
g) phenylbutazone: a medicine to reduce pain and inflammation
h) medicines to help free the airways of sputum
i) vitamins
j) medicines containing thyroid hormones such as, thyroxine,
liothyronine, thyroid extract
k) amiodarone: a medicine to treat heart rhythm disorders
l) benzodiazepines: medicines which calm and initiate sleep or relax
muscles
m) lithium: a medicine to treat depression
n) contrast mediums given into the vein to make inner body parts
visible
o) iodidecontaining medicines which are used only on a restricted
area of the body
p) Iodine containing contrast agent
q) oil based contrast mediums containing iodine.
Before using Sodium Iodide I123, stop using the medicines listed
previously as follows:
a-f): 1 week
g): 1-2 weeks
h-i): 2 weeks
j): 2-3 weeks
k-m): 4 weeks
n) 1-2 months
o): 1-9 months
p-q): up to 1 year

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Pregnancy and breast-feeding
• Pregnancy
Tell your doctor if you are pregnant or think you could be. Your
doctor will only administer Sodium Iodide I123 during pregnancy
if it is absolutely necessary, as it could harm the unborn child.
• Breast-feeding
Tell your doctor if you are breast-feeding as he may delay
treatment until breast-feeding is finished. He may also ask you to
stop breast-feeding for 1½-3 days and discard this milk, until the
radioactivity is no longer in your body.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Sodium Iodide I123 is unlikely to impair the ability to drive and
operate machinery.

3.

How to use Sodium Iodide I123

Sodium Iodide I123 will always be used in a hospital or similar setting. It
will only be administered to you by qualified people trained to safe
handle radioactive material.
Your doctor will decide the Sodium Iodide I123 amount to be used.
The dose administered will depend on the procedure you are having.
The lowest dose possible will be used to produce adequate X-ray
images

The usual dose is :

Approximate doses for adults are:
• 3.7-14.8 MBq injected into a vein
MBq is the unit used to measure radioactivity, and defines the activity
of a quantity of radioactive material.

Children under 18 years

Lower doses are used for children.

Method of use

One injection is usually sufficient. X-rays are usually taken 3 to 6
hours after injection.

If you take more Sodium Iodide I123 than you should

It is unlikely that overdose will occur as this medicine is given under control
by a doctor. However, if this happens you will receive appropriate treatment
from your doctor.
If you have any further questions on the use of this product, ask your
doctor.

4.

Possible side effects

Like all medicines, Sodium Iodide I123 can cause side effects, although not
everybody gets them.
Frequency unknown, from the data available
• allergic reactions
Hospital staff will treat these reactions, if they occur.
• cancer, however the risk is very low as low doses are used in this
investigation
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 pharmacist.

5.

How to store Sodium Iodide I123

Do not use Sodium Iodide I123 after the expiry date stated on the label.
Hospital staff will ensure correct storage temperature, between 1525°C as stated on the label. However, if more than one dose is
intended for use, the vial should be stored between 2-8°C after the
first dose is taken.

6.

Further information

What Sodium Iodide I123 contains
• The active substance is 123I as sodium iodide.
One millilitre of Sodium Iodide I123 contains 37 MBq iodide-123.
• The other ingredients are: sodium chloride, sodium hydrogen carbonate
and water for injections.

What Sodium Iodide I123 looks like and contents of the pack

Sodium Iodide I123 is packaged in a glass bottle closed with a rubber
stopper sealed with an aluminium crimp cap. It is supplied in one vial
containing 1, 2, 5 or 10 ml.

Marketing Authorisation Holder and Manufacturer
• Marketing Authorisation Holder
Mallinckrodt UK Commercial Ltd.
4500 Parkway
Whiteley
Fareham
Hampshire PO15 7NY
United Kingdom

Tel: +44(0)1329224477, Fax: +44(0)1329224442
PL 41744/0013
• Manufacturer
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, The Netherlands

This leaflet was last approved in 12/2013

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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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