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Active substance(s): INDIUM-111

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DRN 4901

Package leaflet: Information for the user

Indium In111 Chloride
radiophamaceutical precursor
Active substance: 111In as indium chloride
Read all of this leaflet carefully before this medicine mixed with another component is administered to you because it contains important
information for you.
- 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. See section 4.
What is in this leaflet:
1. What Indium In111 chloride is and what it is used for
2. What you need to know before Indium In111 chloride is used
3. How Indium In111 chloride is used
4. Possible side effects
5. How to store Indium In111 chloride
6. Contents of the pack and other information


Other medicines and Indium In111 chloride

What Indium In111 chloride is and what it is
used for

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
Further information regarding medicines which can influence or be
influenced by Indium In111 is provided in the package leaflet of the other

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.

Pregnancy and breast-feeding

This medicine is for diagnostic use only.

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.


Wht 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.

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.


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
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.

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.

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Method of use

The method of use depends on the substance with which it is

If more Indium In111 chloride is administered than
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


Marketing Authorisation Holder and

• Marketing Authorisation Holder
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, The Netherlands
PL 12288/0004
• Manufacturer
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, The Netherlands

This leaflet was last approved in

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


How to store Indium In111 chloride


Contents of the pack and otherinformation

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.

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)

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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.