Sodium Iodide (I123) injection – patient leaflet, side effects, dosage

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:

1. a)

   medicines to reduce thyroid gland function such as:

   • propylthiouracil, methimazol, carbimazol
   • perchlorate
2. b) salicylates: medicines to reduce pain, fever or inflammation such as acetylsalicylic acid
3. c) cortisone: medicines to reduce inflammation or prevent organ transplant rejection
4. d) sodium nitroprusside: a medicine to reduce high blood pressure, and also used during an operation
5. e)

   sodium sulfobromophtalein: a medicine to test liver function

   1. 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
   2. g) phenylbutazone: a medicine to reduce pain and inflammation
   3. h) medicines to help free the airways of sputum
   4. i) vitamins
   5. j) medicines containing thyroid hormones such as, thyroxine, liothyronine, thyroid extract
   6. k) amiodarone: a medicine to treat heart rhythm disorders
   7. l) benzodiazepines: medicines which calm and initiate sleep or relax muscles
   8. m) lithium: a medicine to treat depression
   9. n) contrast mediums given into the vein to make inner body parts visible
   10. o) iodidecontaining medicines which are used only on a restricted area of the body
   11. p) Iodine containing contrast agent
   12. 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

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.

Reporting of side effects

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine

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 15-25°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

  Curium Netherlands B.V., Westerduinweg 3

  1755 LE Petten, The Netherlands

  PL 12288/0009

• Manufacturer

  Curium Netherlands B.V., Westerduinweg 3

  1755 LE Petten, The Netherlands

This leaflet was last approved in 04/2023