Patient leaflet - Indium (In111) Chloride
1. What Indium In111 chloride is and what
it is used for
This medicine is for diagnostic use only.
Indium In111 chloride is used through a scan to examine different parts of your body, depending on the other non-radioactive component used. Your doctor will explain the purpose of use.
This medicine contains a radioactive substance which when mixed with the other component and administered, collects in certain organs.
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. What you need to know b Indium In111
chloride is used
Do not use Indium In111 chloride
if you are
allergic to indium chloride or any of the other ingredients
(listed in section 6).
Further information regarding when this medicine should not be used, is provided in the package leaflet of the other component.
Warnings and Precautions
This medicine does involve treatment with radioactivity. Your doctor will only give you this medicine if the benefit outweighs the risk.
Indium In111 chloride 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.
Other medicines and Indium In111 chloride
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Further information regarding medicines which can influence or be influenced by Indium In111 is provided in the package leaflet of the other component.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice.
Pregnancy and women of childbearing potential
Your doctor will only administer Indium In111 chloride during pregnancy or when you might be pregnant if it is absolutely necessary, as it could harm the unborn child.
Breast-feeding
He/she may delay treatment until breast-feeding is finished. He/she may also ask you to stop breast-feeding until the radioactivity is no longer in your body.
Driving and using machines
It is not investigated whether Indium In111 chloride impairs the ability to drive and operate machinery.
3. How Indium In111 chloride is used
Indium In111 chloride 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 Indium In111 chloride amount to be used. The dose administered depends on the medicine with which it is combined. The lowest dose possible will be used to produce adequate X-ray images
Children and adolescents
Lower doses may be used for children according to their weight, body surface area or age.
Method of use
The method of use depends on the substance with which it is combined.
If more Indium In111 chloride is administered than 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.
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4. Possible side effects
Like all medicines, Indium In111 chloride can cause side effects, although not everybody gets them.
This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.
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 Indium In111 chloride
Do not use Indium In111 chloride after the expiry date stated on the label. Hospital staff will ensure correct storage temperature, below25°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. Contents of the pack and
otherinformation
What Indium In111 chloride contains
The active substance is 111In as indium chloride
One millilitre of Indium In111 chloride contains 370 MBq.
- The other ingredients are : hydrochloric acid, water for injections.
What Indium In111 chloride looks like and contents of the pack
Indium In111 chloride is packaged in type 1 Ph.Eur glass vials closed with a butyl rubber stopper and sealed with an aluminium crimp cap.
Pack sizes:
- 111 MBq (0.3 ml)
- 185 MBq (0,5ml)
- 370 MBq (1.0 ml)
- 555 MBq (1.5 ml)
- 740 MBq (2.0 ml)
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Curium Netherlands B.V., Westerduinweg 3
1755 LE Petten, The Netherlands
PL 12288/0004
Manufacturer
Curium Netherlands B.V., Westerduinweg 3
1755 LE Petten, The Netherlands