25 % Injection

The 123 I - mIBG Injection is useful for scintigraphic (a diagnostic test in nuclear medicine) diagnosis of abnormalities in the adrenal medulla (the inner part of an adrenal gland) and the heart muscle as well as for tumours of the neuroendocrine system (e.g. neuroblastoma (a cancer that develops from immature nerve cells) or phaeochromocytoma (rare, usually noncancerous (benign) tumor that develops in an adrenal gland)).

123 I - mIBG Injection should not be administered to you:

• if you are hypersensitive (allergic) to iodine or any of the other ingredients of 123 I - mIBG Injection (listed in section 6).

Warnings and precautions

123 I - mIBG Injection is radioactive and should only be handled and administered by legally authorised personnel. Tell your doctor or health care provider before being given 123 I - mIBG Injection:

• if you are pregnant, as 123 I - mIBG Injection is not recommended for pregnant patients.
• If you are breast feeding your baby since the iodine - 123 in the 123 I - mIBG Injection is excreted in human milk. You will have to substitute breastfeeding with formula feeding.

Other medicines and 123 I - mIBG INJECTION

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Pregnancy and breastfeeding

The safety of 123 I - mIBG Injection in pregnant women has not been established. Since the iodine - 123 in 123 I - mIBG Injection is excreted in breast milk, you should substitute breastfeeding with formula feeding if you are breastfeeding your baby. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before being given this medicine.

Driving and using machines

It is not always possible to predict to what extent 123 I - mIBG Injection may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which 123 I - mIBG Injection affects them.

You will not be expected to give yourself 123 I - mIBG Injection. It will be given to you by a person who is qualified to do so. Between 74 and 370 MBq of the 123 I - mIBG Injection will be administered intravenously before your specific diagnostic examination.

If you take more 123 I - mIBG INJECTION than you should

Since a health care provider will administer 123 I - mIBG Injection, he or she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to take 123 I - mIBG INJECTION

Since a health care provider will administer 123 I - mIBG Injection, it is unlikely that the dose will be missed.

No side - effects are known at normal levels of the diagnostic agent. However, should your general health worsen or if you experience any untoward effects while being given 123 I - mIBG Injection, please inform your doctor or health care provider.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of 123 I - mIBG Injection.

You will not be expected to store 123 I - mIBG Injection yourself. It will be stored by a person who is qualified to do so.