Thallium chloride (201Tl) CIS Bio International 37 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Thallium chloride (201Tl) CIS bio international 37 MBq/ml solution for injection

Thallium chloride (201Tl)

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your nuclear medicine physician who will supervise the procedure.
• If you get any side effects, talk to your nuclear medicine physician, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

1. What Thallium chloride (201Tl) CIS bio international is and what it is used for
2. What you need to know before being given Thallium chloride (201Tl) CIS bio international
3. How Thallium chloride (201Tl) CIS bio international is used
4. Possible side effects
5. How to store Thallium chloride (201Tl) CIS bio international
6. Contents of the pack and other information

1. What Cloruro de talio (201Tl) CIS bio international is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

When injected, certain organs in the body rapidly absorb it. Because the product contains a small amount of radioactivity, it can be detected from outside the body using special cameras, and images can be taken (a process known as scintigraphy). This scintigraphy shows how the radioactivity has distributed within the organ, providing the doctor with valuable information about the organ's structure and function.

Cloruro de talio (201Tl) CIS bio international is used to obtain images for examining:

• the heart. These scans provide information on heart perfusion, the condition of the cells, and the function of the cardiac muscle.
• leg muscles, to assess blood flow in the muscles in a specific disease where the arteries in the limbs are narrowed (peripheral vascular disorder),
• parathyroid glands,
• or certain tumors known to take up thallium, such as brain and thyroid tumors and metastases.

Administration of Cloruro de talio (201Tl) CIS bio international involves exposure to a small amount of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before using Thallium Chloride (201Tl) CIS bio international

Thallium Chloride (201Tl) CIS bio international must not be used:

• If you are allergic to thallium chloride (201Tl) 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.
• For certain cardiac tests, you may be required to perform physical exercise to increase the workload on your heart. The nuclear medicine specialist will only consider this type of test if they are certain that exercise is not dangerous for you.

Warnings and precautions

Consult your nuclear medicine physician before receiving Thallium Chloride (201Tl) CIS bio international if you have reduced kidney or liver function.

Before administration of Thallium Chloride (201Tl) CIS bio international you must:

• Drink plenty of water before starting the procedure to ensure frequent urination during the first few hours after completion.
• Fast for at least 4 hours if your heart is being examined.

Use of Thallium Chloride (201Tl) CIS bio international with other medicines

Inform your nuclear medicine physician if you are taking or have recently taken any other medicines, as some medicines may interfere with the test or with the interpretation of images. Your nuclear medicine physician will advise you whether you need to stop taking certain medicines before the procedure and for how long.

Some examples include:

• Products containing methylxanthines, such as certain medications used to treat migraine and theophylline (a medication used to treat asthma and other respiratory diseases)
• Dipyridamole: a medication used to reduce blood clotting
• Medications known as beta-blockers. These are used to treat high blood pressure, heart conditions, or other diseases, and have active substance names ending in “olol”
• Medications known as nitrates, used to treat chest pain due to narrowing of the blood vessels of the heart, irregular heartbeats, or high blood pressure
• Medications known as calcium channel blockers, used to treat high blood pressure and certain heart conditions
• Medications containing digitalis, such as digoxin, used to treat heart failure.

Thallium Chloride (201Tl) CIS bio international and beverages

Depending on the type of test, you may need to avoid caffeine-containing drinks for at least 12 hours before the procedure. Your physician will inform you whether this is necessary in your case.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.

You must inform the nuclear medicine specialist before administration of Thallium Chloride (201Tl) CIS bio international if there is any possibility you could be pregnant, if you have missed or delayed your period, or if you are breastfeeding. If in doubt, it is important to consult the nuclear medicine specialist who will supervise the procedure.

• If you are pregnant:

The nuclear medicine physician will not administer this medicine during pregnancy, as it could harm the fetus.

• If you are breastfeeding:

Inform your physician if you are breastfeeding, as the procedure may need to be postponed until breastfeeding has ended. If the procedure cannot be delayed, you must interrupt breastfeeding for 2 days and discard the milk during this time, until radioactivity is no longer present in your body.

Please consult your nuclear medicine physician regarding when you may resume breastfeeding.

Driving and use of machines

Thallium Chloride (201Tl) CIS bio international is considered unlikely to affect your ability to drive or operate machinery.

Thallium Chloride (201Tl) contains sodium

This medicine contains 3.3 mg of sodium (a main component of table/cooking salt) per mL.

This corresponds to 0.17% of the maximum recommended daily intake of sodium for an adult.

3. How to use Thallium Chloride (201Tl) CIS bio international

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Thallium Chloride (201Tl) CIS bio international will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Thallium Chloride (201Tl) CIS bio international to be used in your case. This will be the minimum quantity necessary to obtain the required information.

The generally recommended administered activity for an adult is 50 to 110 MBq (MBq: megabecquerel, a unit used to express radioactivity).

Administration of Thallium Chloride (201Tl) CIS bio international and performance of the procedure

Thallium Chloride (201Tl) CIS bio international is administered by intravenous injection.

Usually, a single injection is sufficient to provide the information needed by your nuclear medicine physician, although sometimes a second injection may be required.

The injection may be given at rest or during physical exercise. You may also be given a medication that makes your heart work harder.

Duration of the procedure

Your nuclear medicine physician will inform you about the usual duration of the procedure.

After administration of Thallium Chloride (201Tl) CIS bio international, you should

• urinate frequently to help eliminate the product from your body.

The nuclear medicine physician supervising the procedure will inform you if you need to take any special precautions after receiving this medication. Contact the supervising nuclear medicine physician if you have any doubts.

If you are administered more Thallium Chloride (201Tl) CIS bio international than you should receive

Overdose is unlikely, as Thallium Chloride (201Tl) CIS bio international is administered by a physician under strictly controlled conditions. However, in the event of an overdose, appropriate treatment will be provided. The nuclear medicine physician may advise you to drink plenty of fluids and to urinate frequently to help eliminate radioactivity from your body.

If you have any further questions about the use of Thallium Chloride (201Tl) CIS bio international, ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported following administration of Thallium chloride (201Tl) CIS bio international (frequency not known (cannot be estimated from available data)):

• Allergic reactions with symptoms such as

• Laryngospasm

• Throat swelling

• Swelling in various areas, such as the face, larynx, or tongue

• Difficulty breathing

• Skin redness, rash, pustules, itching, hives, skin pain

• Hypersensitivity

• Facial pain

• Eye inflammation causing eye itching, tearing, or redness

• Tear flow disturbance

• Redness

• Increased sweating

• Cough

• Fainting or experiencing symptoms such as

• Dizziness

• Slow heartbeat

• Low blood pressure

• Tremors

• Headache

• Pallor

• Reaction at the injection site such as local swelling, pain, redness, or other reactions at the injection site.

• Local tissue damage (necrosis) has been reported in cases where the injection was not administered intravenously.

Thallium chloride (201Tl) is often used in combination with a cardiac stress test. The cardiac stress test may cause certain cardiac symptoms such as palpitations, abnormalities in the heart tracing (ECG), irregular heartbeats, chest pain, difficulty breathing, and ultimately, myocardial infarction. Other stress-induced symptoms include high or low blood pressure, chills, taste disturbances, nausea, vomiting, and fatigue or general malaise.

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Thallium Chloride (201Tl) CIS bio international

You will not have to store this medicine. This medicine is stored under the responsibility of a specialist in suitable facilities. The storage of radiopharmaceuticals will comply with national regulations concerning radioactive materials.

6. Package contents and other information

Composition of Thallium Chloride (201Tl) CIS bio international

• The active substance is thallium chloride (201Tl).

Each mL contains 37 MBq of thallium chloride (201Tl) at the date and time of calibration.

• The other components are sodium chloride and water for injections.

Appearance of the medicinal product and contents of the pack

Thallium Chloride (201Tl) CIS bio international is presented as an injectable solution.

Pack size: 1 multidose vial.

Marketing Authorization Holder and Manufacturer:

CIS bio international
BP 32 - 91192 Gif sur Yvette Cedex
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Curium Pharma Spain, S.A.
Avda. Dr. Severo Ochoa, 29
28100 Alcobendas
Tel.: 91 4841989

Date of the most recent review of this summary: March 2024.

This information is intended for healthcare professionals only:

The full Summary of Product Characteristics for Thallium Chloride (201Tl) CIS bio international is included as a separate document inside the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics [the Summary of Product Characteristics must be included in the package].