Thallous (Tl201) Chloride Injection 37mbq/Ml Solution For Injection
DRN 8103 Thallous Chloride (TI-201) Injection United Kingdom Page 1 of 2
Package leaflet: Information for the user
Thallous chloride TI201
solution for injection
Active substance: 201TI 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 TI201 is and what it is used for
2. Before you use Thallous chloride TI201
3. How to use Thallous chloride TI201
4. Possible side effects
5. How to store Thallous chloride TI201
6. Further information
IWhat Thallous chloride TI201 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 TI201
Do not use Thallous chloride TI201
if you are
« allergic (hypersensitive) to thallous chloride or any of the other ingredients
» pregnant or breast-feeding
Take special care with Thallous chloride TI201
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 TI201 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.
Using other medicines
Please tell your doctor or pharmacist if you are faking 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.
Pregnancy and breast-feeding
• Pregnancy
Do not take Thallous chloride T1201 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Thallous chloride TI201 is unlikely to impair the ability to drive and operate machinery.
3. How to use Thallous chloride TI201
Thallous chloride TI201 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 TI201 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 TI201 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.
If you have any further questions on the use of this product, ask your doctor.
(J0 Further information
What Thallous chloride TI201 contains
• The active substance is 201TI 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 TI201 looks like and contents of the pack
Thallous chloride TI201 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
Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands
PL 12288/0016
• Manufacturer
Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands
This leaflet was last approved in 11/2014.
4 Possible side effects
Like all medicines, Thallous chloride TI201 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 TI201
Do not use Thallous chloride TI201 after the expiry date stated on the label.
Hospital staff will ensure correct storage temperature, between 15-25°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.
08103006BYS08a.docx /22 CON 8103 United Kingdom SPC 24102014/ 18 CON 8103 United Kingdom PIL 24102014