DRN 5375 Sodium Iodide (1-123) Injection United Kingdom Page 1 of 2

Package leaflet: Information for the user

Sodium Iodide 1123

solution for Injection

Active substance: ¹²³l 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 1123 is and what it is used for

2.    Before you use Sodium Iodide 1123

3.    Howto use Sodium Iodide 1123

4.    Possible side effects

5.    How to store Sodium Iodide 1123

6.    Further information

a What Sodium Iodide 1123 is and what it * ■ is used for

This medicine is for diagnostic use only.

Sodium Iodide 1123 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 1123

Do not use Sodium Iodide 1123

• 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 1123

This medicine does involve treatment with radioactivity. Your doctor will only give you this medicine if the benefit outweighs the risk.

Sodium Iodide 1123 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 1123, 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 1123 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 1V₂-3 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 1123 is unlikely to impair the ability to drive and operate machinery.

3, How to use Sodium Iodide 1123

Sodium Iodide 1123 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 1123 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 1123 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 1123 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 1123

Do not use Sodium Iodide 1123 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.

Further information

What Sodium Iodide 1123 contains

•    The active substance is ¹²³l as sodium iodide.

One millilitre of Sodium Iodide 1123 contains 37 MBq iodide-123,

•    The other ingredients are: sodium chloride, sodium hydrogen carbonate and water for injections,

What Sodium Iodide 1123 looks like and contents of the pack

Sodium Iodide 1123 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 Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands

PL 12288/0009

•    Manufacturer

Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands