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INDIUM (IN111) DTPA INJECTION

Active substance(s): INDIUM IN 111 CALCIUM PENTETATE / INDIUM IN 111 CALCIUM PENTETATE

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ORN 4916

Indium (In111) OTPA Injection United Kingdom & Northern Ireland

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Indium In111 OTPA
solution for injection

Active substances: Indium (In111) pentetate and calcium trisodium pentetate
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 Indium In111 DTPA is and what it is used for
2. Before you use Indium In111 DTPA
3. How to use Indium In111 DTPA
4. Possible side effects
5. How to store Indium In111 DTPA
6. Further information

1.

What Indium In111 OTPA is and what it
is used for

This medicine is for diagnostic use only.
Indium In111 DTPA is used through a scan to examine:
• the brain and spinal cord
- obstruction in the flow of cerebrospinal fluid, which is the fluid that
envelops the brain and spinal cord
- differentiation between normal pressure associated with hydrocephalus
and other forms of hydrocephalus
• leakage of cerebrospinal fluid from the nose or ears.
This medicine contains a radioactive substance which when injected, collects
in certain organs such as, the brain.

Pregnancy and breast·feeding
• Pregnancy
Tell your doctor if you are pregnant or think you could be. Your
doctor will only administer Indium In111 DTPA 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 2 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
Indium In111 DTPA is unlikely to impair the ability to drive and
operate machinery .

The radioactive substance can be photographed from ~Giutside 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.
How to use Indium In111 OTPA

3.

2.

Before you use Indium In111 OTPA

Do not use Indium In111 DTPA
if you have
• a tendency to bleed
• increased pressure in your head, which is not associated with
hydrocephalus

Take special care with Indium In111 DTPA
This medicine does involve treatment with radioactivity. Your doctor
will only give you this medicine if the benefit outweighs the risk.

Indium In111 DTPA 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 DTPA amount to be used.
The dose administered depends on the procedure.
The lowest dose possible will be used to produce adequate X-ray
images.

The usual dose is:
Approximate dose for adults is:
• 9.25 -18.5 MBq injected into the skull or spine
MBq is the unit used to measure radioactivity, and defines the
activi ty of a quantity of radioactive material.

Indium In111 DTPA is given in one single dose by specialists, who will
take responsibility for any necessary precautions.

Children under 18 years

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.

One injection is usually sufficient.

Using other medicines

The amount and duration of the scans usually depends on the type of
procedure.

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescri ption.

Drink and uiinate as much as possible before and after treatment. This will prevent active substance gathering in the bladder.

Lower doses are used for children.

Method of use

There are no medicines known which influence or are influenced by
Indium In111 DTPA.

04916006BYS08a 115 CON 4916 United Kingdom SPC 17102012/17 CON 4916 United Kingdom PIL 17102012

DRN 4916

Indium (In111) DTPA Injection United Kingdom & Northern Ireland

If you use more Indium In111 DTPA 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.
Drinking as much as possible will help remove the radioactive substance
more quickly.
If you have any further questions on the use of this product, ask your
doctor.

4.

Possible side effects

Like all medicines, Indium In111 DTPA can cause side effects, although not
everybody gets them.
In the majority of cases the side effects are mild.
Frequency unknown, from the data available
• headache and symptoms associated with irritation from linings which
cover the brain or spinal cord
Usually they improve within 48 hours.
• meningitis
• fever
• drooping of the eyelid or corner of the mouth
• ringing or buzzing in the ears
• 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 Indium In111 OTPA

Do not use Indium In111 DTPA after the expiry date stated on the label.
Hospital staff will ensure correct storage temperature, between 1525°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 Indium In111 DTPA contains
• The active substances are Indium (In111) pentetate and calcium
trisodium pentetate.
One millilitre of Indium In111 DTPA contains 37 MBq.
• The other ingredients are: sodium chloride, disodium phosphate
dodecahydrate, water for injections.

What Indium In111 OTPA looks like and contents of the pack
Indium In111 DTPA is packaged in type 1 Ph.Eur glass vials closed with a
butyl rubber stopper and sealed with an aluminium crimp cap. It is supplied
in one vial containing 0.5 or 1 ml.

Marketing Authorisation Holder and Manufacturer
• Marketing Authorisation Holder

Mallinckrodt UK Commercial Ltd.
4500 Parkway
Whiteley
Fareham
Hampshire P015 ?NY
United Kingdom
Tel : +44(0)1329224477, Fax: +44(0)1329224442
PL 4174410004
• Manufacturer
Mallinckrodt Medical BY, Westerduinweg 3
1755 LE Petten, The Netherlands

This leaflet was last approved in 10/2012.
04916006BYSOBa / 15 CON 4916 United Kingdom SPC 17102012/17 CON 4916 United Kingdom PIL 1710201 2

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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.

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