Thallium (201Tl) chloride Curium Netherlands
ItalyTable of Contents
Package leaflet: Information for the patient
Thallium (Tl) chloride Curium Netherlands 37 MBq/ml
injection solution
thallium (Tl) chloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, consult the nuclear medicine physician supervising the procedure.
If you experience any side effects, including those not listed in this leaflet, inform the nuclear medicine physician. See section 4.
Contents of this leaflet:
- What Tallium (Tl) chloride Curium Netherlands is and what it is used for
- What you need to know before using Tallium (Tl) chloride Curium Netherlands
- How to use Tallium (Tl) chloride Curium Netherlands
- Possible side effects
- How to store Tallium (Tl) chloride Curium Netherlands
- Contents of the pack and other information
1. What Tallio (Tl) cloruro Curium Netherlands is and what it is used for
This medicinal product is a radiopharmaceutical for diagnostic use only.
This medicine contains thallium (Tl) chloride, a radioactive substance which, after injection,
accumulates in certain organs such as the heart.
The radioactive substance can be detected from outside the body using special machines that produce an image called a scan, showing the distribution of radioactivity within the organ and the body. This provides the physician with valuable information about the function of that organ.
Tallio (Tl) cloruro Curium Netherlands is used to perform scans:
- of the heart muscle and blood circulation in the heart, to examine heart diseases
- of the leg muscles, to assess blood flow in the muscles in a condition where arteries in the limbs are narrowed (peripheral vascular disorder)
- of the parathyroid gland
- of certain tumours known to take up thallium, such as brain or thyroid tumours and metastases.
The use of Tallio (Tl) cloruro Curium Netherlands involves exposure to low levels of radioactivity.
Your treating physician and the nuclear medicine physician have determined that the clinical benefit you will obtain from the procedure with this radiopharmaceutical outweighs the radiation-related risk.
2. What you need to know before using Tallium (Tl) Chloride Curium Netherlands
Tallium (Tl) Chloride Curium Netherlands must not be used
- if you are allergic to thallium chloride or to any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant
- if you are breastfeeding
- if you are under 18 years of age
Warnings and precautions
Speak to the nuclear medicine physician before being administered Tallium (Tl) Chloride Curium Netherlands if you have
impaired renal or hepatic function.
Before being administered Tallium (Tl) Chloride Curium Netherlands you must
drink plenty of water prior to the start of the examination, in order to urinate as frequently as possible during the first
hours following the study.
fast for at least 4 hours.
Children and adolescents
Tallium (Tl) Chloride Curium Netherlands must not be used in children under 18
years of age.
Other medicines and Tallium (Tl) Chloride Curium Netherlands
Inform the nuclear medicine physician if you are taking, have recently taken, or might take
any other medicines, as they may interfere with the examination or the interpretation of images. The
nuclear medicine physician will inform you whether it is necessary to discontinue certain medications
before the procedure and for how long.
Examples include:
- certain products containing methylxanthines, such as some medicines for the treatment of migraine, and theophylline (a medicine used for the treatment of asthma and other respiratory diseases)
- dipyridamole: a medicine that reduces blood clotting
- certain medicines known as beta-blockers. These are used to treat high blood pressure, heart diseases or other conditions, and contain active substances whose names end in "olol"
- certain medicines known as nitrates, for the treatment of chest pain due to narrowing of the blood vessels of the heart, irregular heartbeat, or high blood pressure
- certain medicines known as calcium antagonists, for the treatment of high blood pressure and certain heart conditions
- certain medicines containing digitalis, such as digoxin, for the treatment of heart failure.
Tallium (Tl) Chloride Curium Netherlands with beverages
Depending on the type of examination, you may need to avoid caffeine-containing beverages for
at least 12 hours before the procedure. Your physician will inform you if this is necessary in your case.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, have missed a menstrual period, or are breastfeeding,
consult your nuclear medicine physician before administration of Tallium (Tl) Chloride Curium Netherlands.
If you have any doubts, it is important to consult the nuclear medicine physician supervising the
procedure.
If you are pregnant
The nuclear medicine physician will not administer this product during pregnancy, due to the risk of harm to the fetus.
If you are breastfeeding
Inform your physician if you are breastfeeding, as he or she may decide to postpone the examination until after
breastfeeding has ended. If this is not possible, the physician will ask you to interrupt breastfeeding for
2 days and discard the expressed milk until your body is completely free of radioactivity.
Ask your nuclear medicine physician when you can resume breastfeeding.
Driving and using machines
It is unlikely that Tallium (Tl) Chloride Curium Netherlands will affect your ability to drive
or operate machinery.
Tallium (Tl) Chloride Curium Netherlands contains sodium
This medicine contains 3.5 mg of sodium (a main component of table salt) per ml.
This corresponds to 0.18% of the maximum daily dietary intake recommended for an adult.
3. How to use Thallium (Tl) Chloride Curium Netherlands
There are very strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.
Thallium (Tl) Chloride Curium Netherlands will be used only in special, controlled areas. This
medicinal product will be handled and administered exclusively by healthcare personnel trained and
qualified to use it safely. These personnel will take all necessary precautions for the safe use of this
medicinal product and will keep you informed about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of Thallium (Tl)
Chloride Curium Netherlands to be used in your case. This will be the minimum amount necessary to obtain
the required diagnostic information.
The usually recommended administered activity in adults ranges from 50 to 110 MBq (megabecquerels are
the units used to express radioactivity).
Administration of Thallium (Tl) Chloride Curium Netherlands and procedure performance
Thallium (Tl) Chloride Curium Netherlands is administered by intravenous injection.
A single injection is usually sufficient to perform the examination requested by the physician, although
sometimes a second injection may be required.
Other tests, such as exercise or the administration of other medicinal products, may be part of the procedure.
Duration of the procedure
The nuclear medicine physician will inform you about the expected duration of the procedure.
After administration of Thallium (Tl) Chloride Curium Netherlands you should
- urinate frequently to eliminate the product from your body.
The nuclear medicine physician will inform you if special precautions are necessary after receiving the
medicinal product. For any questions, please consult your nuclear medicine physician.
If you are given more Thallium (Tl) Chloride Curium Netherlands than you should have received
Overdose is unlikely, as you will receive only a precisely controlled dose of Thallium (Tl) Chloride,
administered under the supervision of the nuclear medicine physician. However, in the event of an overdose,
appropriate treatment will be provided. The nuclear medicine physician may advise you to drink large amounts
of water and to urinate frequently to help remove residual radioactivity from your body.
If you have any further questions about the use of Thallium (Tl) Chloride Curium Netherlands, please consult
the nuclear medicine physician supervising the procedure.
4. Possible side effects
Like all medicines, this medicinal product can cause side effects, although not everyone experiences them.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- allergic reactions with symptoms such as
- laryngospasm
- throat inflammation
- swelling at various sites, for example of the face, larynx, or tongue
- breathing difficulties
- skin redness, rash, pustules, itching, urticaria, skin pain
- hypersensitivity
- facial pain
- eye inflammation causing eye itching, tearing, or redness
- disturbance of tear flow
- hot flushes
- increased sweating
- cough
In case of an allergic reaction, appropriate treatment will be provided.
- fainting, or symptoms such as
- dizziness
- slow heartbeat
- hypotension
- chills
- headache
- pallor
- reactions at the injection site, such as local swelling, pain, redness, or other reactions at the injection site
- in cases where the injection was not administered intravenously, local tissue damage (necrosis) has been reported.
- nausea and vomiting.
This radiopharmaceutical will emit low levels of ionizing radiation, which entails a very low risk of cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your nuclear medicine physician. You may also report side effects directly via the national reporting system at the following address: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Thallium (Tl) chloride Curium Netherlands
It is not your responsibility to store this medicinal product. This medicinal product is stored under
the responsibility of the specialist in appropriate locations. Storage of radiopharmaceuticals must comply
with national regulations concerning radioactive materials.
The following information is intended exclusively for the specialist.
Do not store above 25°C.
For storage conditions after first opening of the medicinal product, see the SmPC (section 6.3).
Thallium (Tl) chloride Curium Netherlands must not be used after the expiry date stated on the label.
6. Package contents and other information
What Tallium (Tl) chloride Curium Netherlands contains
- The active substance is: Tl-201 as thallium chloride. Each ml contains 37 MBq of thallium (Tl) chloride at the date and time of calibration.
The other components are: sodium chloride, water for injections, and sodium hydroxide or hydrochloric acid for pH adjustment.
Description of the appearance of Tallium (Tl) chloride Curium Netherlands and package contents
Tallium (Tl) chloride Curium Netherlands is a clear, colourless solution. It is supplied in a 10 ml glass vial sealed with a bromobutyl rubber stopper and an aluminium crimp cap. The vial is provided shielded with lead.
1 vial contains between 1.7 ml and 10 ml, corresponding to 63 MBq–370 MBq at the date and time of calibration.
Marketing Authorisation Holder and Manufacturer
Curium Netherlands B.V.
Westerduinweg 3
1755 LE Petten
The Netherlands
Further information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency www.aifa.gov.it
The following information is intended exclusively for physicians or healthcare professionals:
*The complete Product Characteristics Summary (SmPC) of Tallium (Tl) chloride Curium Netherlands injection is supplied as a separate document inside the product packaging, aimed at providing healthcare personnel with additional scientific and practical information on the administration and use of this radiopharmaceutical.