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THALLIUM (201T1) CHLORIDE INJECTION

Active substance(s): THALLIUM (201TL) CHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Thallium (201Tl) chloride injection CIS bio international
Reference: TL-201-S-1

Read all of this leaflet carefully before you are given this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or the nuclear
medicine specialist who will perform your examination, or your
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 the nuclear
medicine specialist who has performed your examination, or your
pharmacist.

In this leaflet:
1. What Thallium (201Tl) chloride injection is and what it is used for
2. Before you are given Thallium (201Tl) chloride injection
3. How you will be given Thallium (201Tl) chloride injection
4. Possible side effects
5. How to store Thallium (201Tl) chloride injection
6. Further information

CIS bio international, member of IBA group
P2609pE
02/2012

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1.

WHAT THALLIUM (201Tl) CHLORIDE INJECTION IS AND WHAT
IT IS USED FOR

Thallium (201Tl) chloride injection is a diagnostic radiopharmaceutical
i.e. a radioactive medicine used for diagnostic purposes only.
When injected into a vein of your arm, thallium (201Tl) chloride, the
radioactive element, temporarily collects in a specific part of your body
like heart, muscles, parathyroid glands, brain or thyroid. Because of its
radioactivity, it can be easily detected from outside your body using a
special camera, and pictures, known as scans, can be taken.These
scans give valuable information on either the structure of the organ or
how efficiently processes associated with blood flow through the organ
are being carried out.
In particular, Thallium (201Tl) chloride injection can be used :
x to examine the heart, the leg muscles and the parathyroid gland, or
x to show up brain and thyroid tumours.
Your doctor / nuclear medicine specialist will explain to you what kind of
examination will be performed.

2.

BEFORE YOU ARE GIVEN THALLIUM (201Tl) CHLORIDE
INJECTION

You must not be given Thallium (201Tl) chloride injection:
x
x
x
x

If you are allergic (hypersensitive) to thallium (201Tl) chloride or any
of the other ingredients of Thallium (201Tl) chloride injection (as
listed in section 6).
If you are pregnant or if there is any possibility that you are pregnant
(please see below section “Pregnancy and breast-feeding”).
If you are breast-feeding (please see below section “Pregnancy and
breast-feeding”).
If you are under 18 years old.

Some examinations of heart behaviour involve exercising to make the
heart work harder. Your doctor / nuclear medicine specialist will only
consider this type of test if she/he is certain that the exercise will not be
harmful to you.

2

Take special care with Thallium (201Tl) chloride injection
The use of thallium (201Tl) chloride injection does involve
administration of small amounts of radioactivity. You may need to avoid
close contact with pregnant women or young children for a while,
depending on the dose administered.
Your doctor / nuclear medicine specialist will inform you if you need to
take any special precautions after the use of this product.

Taking other medicines
Please tell your doctor/ nuclear medicine specialist if you are taking,
or have recently taken, any medicines, including medicines obtained
without a prescription.
Some medicines may affect the quality of the results obtained from
thallium (201Tl) chloride examinations. Particular examples are:
x Medicines used to treat heart conditions and high blood pressure
(dipyridamole, adenosine, isoprenaline, dobutamine, nitrates, betablockers, digitalis analogues,…)
x insulin (Medicine used to treat Diabetes Mellitus),
x Medicines used to treat breathing difficulty (methylxanthines (i.e.
theophyllin))

Pregnancy and breast-feeding
You must not be given Thallium (201Tl) chloride injection if you are
pregnant. It must be established that you are not pregnant before the
use of this product.
So you must tell your doctor/ nuclear medicine specialist if you have
missed a period or if there is any chance you may be pregnant.
Investigations in nuclear medicine may involve a risk to the unborn.
Tell your doctor/ nuclear medicine specialist if you are breastfeeding, as you should completely stop this before treatment.
Moreover you may need to avoid close contact with your baby for a
while depending on the dose administered. Your doctor / nuclear
medicine specialist will inform you.

3

Before Thallium (201Tl) chloride administration you should:
- Drink plenty of water and to be well hydrated before the start of the
examination in order to urinate as often as possible during the first
hours after the study.
- Be fasting for at least 4 hours in case of examination of your heart
Driving and using machines
Thallium (201Tl) chloride injection has no effect on your ability to drive
or to operate machinery.
Ask your doctor/ nuclear medicine specialist or pharmacist for
advice before taking any medicine.

3.

HOW YOU WILL BE GIVEN THALLIUM (201Tl) CHLORIDE
INJECTION

The use of Thallium (201Tl) chloride injection involves administration of
small amount of radioactivity. This involves a very small risk and your
doctor / nuclear medicine specialist will not consider carrying out the
examination unless she/he thinks that the benefit of the examination
outweighs the potential risk.
How much Thallium (201Tl) chloride injection is given
Your doctor / nuclear medicine specialist will decide on the amount of
radioactive Thallium (201Tl) chloride injection to be used. This will be
the minimum amount necessary to give a scan clear enough to supply
the required information.
The quantity to be administered usually recommended for an adult
ranges from 52 to 110 MBq (MBq: Megabecquerel is the unit in which
radioactivity is measured).

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*
How Thallium (201Tl) chloride injection is given
Thallium (201Tl) chloride injection will be injected into a vein of your
arm.
Usually one injection is sufficient to provide your doctor with the
information needed although sometimes a second injection may be
required.
The injection may be given either at rest or during the course of a
stress test in which either exercise or the administration of another
medicinal product is used to make your heart work harder.
Scans may be taken at any time from the beginning of the injection,
depending on which images are required. Additional scans, possibly
involving a second injection may be performed between 3 and 24 hours
after the first injection.
If you are given more Thallium (201Tl) chloride injection than you
should be
Since Thallium (201Tl) chloride injection is administered by a doctor
under strictly controlled conditions it is very unlikely that you will be given
too much. However, in the case of an overdose, you will receive the
appropriate treatment (ferric hexacyanoferrate(II)) and you will be asked
to drink plenty of water and to take laxatives to increase the elimination
of the product from your body.
If you have any questions about the administration of this medicine, ask
your doctor / nuclear medicine specialist.

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4.

POSSIBLE SIDE EFFECTS

Like all medicines, Thallium (201Tl) chloride injection can cause side
effects, although not everybody gets them.
The following effects have been described:
x Anaphylactic reactions (rash, itching, laryngospasm, sore throat,
laboured breathing, rash pustular, rash erythematous, over-sensitivity,
pain of skin, facial pain, tongue oedema, face oedema, oedema, eye
inflammation, tear-related disorder, skin redness, hives, flushing,
excessive sweating, cough)
x Fainting (syncope, dizziness, slow heartbeat, hypotension, tremor,
headache, pallor).
x Injection site reaction
x Local skin damage (necrosis) has been reported when the injection
was not in the vein.
Thallium (201TI) chloride is often used in combination with a cardiac
stress-test. The cardiac stress-test may induce some cardiovascular
symptoms such as palpitations, electrocardiograms abnormalities,
irregular heartbeat, chest pain, shortness of breath and ultimately a heart
attack. Other symptoms related to the induced stress are hypertension or
hypotension, chills, distortion of sense of taste, nausea, vomiting and
general fatigue or malaise.
This radiopharmaceutical will deliver amounts of ionising radiation
associated with the least risk of cancer and hereditary abnormalities.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor/ nuclear medicine
specialist or pharmacist.

5.

HOW TO STORE THALLIUM (201Tl) CHLORIDE INJECTION

Because there are strict laws covering the use, handling and disposal of
radioactivity, this product will always be used in a hospital or a similar
setting. It will only be handled and administered by people who are
trained and qualified in the safe handling of radioactive material and
there are no additional precautions which are your responsibility.

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6.

FURTHER INFORMATION

What Thallium (201Tl) chloride injection contains
x
x

The active substance is Thallium (201Tl) chloride.
The other ingredients are sodium chloride and water for injections.

What Thallium (201Tl) chloride injection looks like and contents of
the pack
You will not have to get this medicine or handle the packaging or the vial.
The following data is for your information only.
Thallium (201Tl) chloride injection is a sterile, clear and colourless
solution for injection.
Packsize: A multidose vial can contain from 1 to 10 ml of solution for
injection, corresponding to 37 up to 370 MBq per vial at calibration date.

Marketing Authorisation Holder and Manufacturer
CIS bio international
B.P. 32
91192 Gif-sur-Yvette Cedex
FRANCE

This leaflet was last approved in

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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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