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THALLOUS (TL201) CHLORIDE INJECTION 37MBQ/ML SOLUTION FOR INJECTION

Active substance(s): THALLOUS CHLORIDE TL 201 / THALLOUS CHLORIDE TL 201 / THALLOUS CHLORIDE TL 201

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DRN 8103

Package leaflet: Information for the user

Thallous chloride Tl201
solution for injection

Active substance: 201Tl as thallous chloride
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 Thallous chloride Tl201 is and what it is used for
2. Before you use Thallous chloride Tl201
3. How to use Thallous chloride Tl201
4. Possible side effects
5. How to store Thallous chloride Tl201
6. Further information

1.

What Thallous chloride Tl201 is and
what it is used for

This medicine is for diagnostic use only.

Thallous chloride TI201 is used through a scan to examine the:
• heart
• leg muscles
• parathyroid gland
• tumours, particularly in the thyroid and brain
This medicine contains a radioactive substance which when injected, collects
in certain organs such as the heart.
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.

Before you use Thallous chloride Tl201

Using other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
The following medicines can particularly influence the Thallous
chloride TI201 heart examination:
Your doctor may recommend that you stop the following medicines
before treatment:
• dipyridamole, a medicine to reduce blood clotting and treat heart
disease
• adenosine, a medicine to reduce heart beat
• isoprenaline a medicine to treat reduced heart beat
• dobutamine, a medicine to treat heart diseases
• certain medicines to prevent or treat heart attacks known as
nitrate, such as isosorbide dinitrate and mononitrate, nitroglycerin
• medicines to treat different heart diseases, high blood pressure or migraine and with active substance names ending in “olol”
• theophyllin, a medicine to treat asthma
• medicines to treat heart failure, such as digitoxin or digoxin
• insulin, a medicine to lower blood sugar.

Do not use Thallous chloride Tl201

Pregnancy and breast-feeding

Take special care with Thallous chloride Tl201

• Pregnancy
Do not take Thallous chloride Tl201 if you are pregnant. Any
possibility of pregnancy must be ruled out before using this
medicine.
• 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 until the radioactivity is no longer in your
body.

if you are
• allergic (hypersensitive) to thallous chloride or any of the other
ingredients
• pregnant or breast-feeding
This medicine does involve treatment with radioactivity. Your doctor
will only give you this medicine if the benefit outweighs the risk. This
particularly applies to certain heart examinations.
Thallous chloride Tl201 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.

12 CON 8103 United Kingdom PIL 22032012

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Thallous chloride Tl201 is unlikely to impair the ability to drive and
operate machinery.

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3.

How to use Thallous chloride Tl201

Thallous chloride Tl201 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 Thallous chloride Tl201 amount to be
used. The dose administered will depend on the procedure.
The lowest dose possible will be used to produce adequate X-ray
images.

The usual dose is :
Approximate dose for adults and the elderly is:
• 18.5- 110 MBg injected into a vein
MBq is the unit used to measure radioactivity, and defines the activity
of a quantity of radioactive material.
Children under 18 years

Lower doses are used for children according to their body weight.

Method of use

Fasting 4 hours before the injection is recommended. One injection is
usually sufficient.
Scans can be taken during or shortly after the injection. New scans
can be required for heart examinations, 3 to 24 hours after the first
injection.
Drink and urinate as much as possible before and after
treatment. This will prevent active substance gathering in the
bladder.

If you use more Thallous chloride Tl201 than you should

6.

Further information

What Thallous chloride Tl201 contains

• The active substance is 201Tl as thallous chloride.
One millilitre of Thallous chloride TI201 contains 37 MBq thallium-201.
• The other ingredients are: sodium chloride and water for injections.

What Thallous chloride Tl201 looks like and contents of the
pack

Thallous chloride Tl201 is packaged in type 1 Ph.Eur glass vial closed with a
butyl rubber stopper and sealed with an aluminium crimp cap. It is supplied
in one vial containing 1.7, 2.3, 5.8 or 10 ml.

Marketing Authorisation Holder and Manufacturer
• Marketing Authorisation Holder
Covidien (UK) Commercial Ltd.
4500 Parkway
Whiteley
Fareham
Hampshire PO15 7NY
United Kingdom

Tel: +44(0)1329224411, Fax: +44(0)1329224390
PL 32873/0015
• Manufacturer
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, The Netherlands

This leaflet was last approved in 04/2012.

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.

4.

Possible side effects

Like all medicines, Thallous chloride Tl201 can cause side effects, although
not everybody gets them.
Side effects can occur with the following frequencies:
rare, occurs in 1 to 10 per 10,000 users
• allergic reactions
• widening of blood vessels causing reduced blood pressure, fainting
• skin reactions on the injection side
Hospital staff will treat these reactions, if they occur
Frequency unknown, from the data available
• 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 Thallous chloride Tl201

Do not use Thallous chloride Tl201 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.

12 CON 8103 United Kingdom PIL 22032012

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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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