Label: information for the patient

Thallous chloride (201Tl) CIS bio international 37MBq/ml injectable solution

Thallous chloride (201Tl)

Read this label carefully before this medication is administered to you because it contains important information for you.

• Keep this label, as you may need to read it again
• If you have any questions, consult your nuclear medicine physician who will oversee the procedure.
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this label. See section 4.

1. What is Thallous chloride (201Tl) CIS bio international and what it is used for.

2. What you need to know before starting to use Thallous chloride (201Tl) CIS bio international

3. How to use Thallous chloride (201Tl) CIS bio international

4. Possible adverse effects

5. Storage of Thallous chloride (201Tl) CIS bio international

6. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

When injected, certain organs of the body absorb it quickly. As the product contains a small amount of radioactivity, it can be made visible from the outside of the body using special cameras and a photograph (known as a gamma scan) can be taken. This gamma scan shows how the radioactivity has spread in the organ, which can provide valuable information to the doctor about the shape of that organ and its functioning.

Thallous Chloride (201Tl) CIS bio international is used to obtain an image that examines:

• the heart. These explorations provide information about heart perfusion, cell quality, and cardiac muscle function.
• leg muscles, to examine blood flow in muscles in a certain disease in which the arteries of the limbs are narrowed (peripheral vascular disorder)
• parathyroid glands,
• or certain tumors that are known to capture thallium, such as brain tumors and thyroid tumors and metastases.

The administration of Thallous Chloride (201Tl) CIS bio international involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

Talium Chloride (201Tl) CIS bio international should not be used:

• If you are allergic to Talium Chloride (201Tl) or any of the other components of this medication (including those listed in section 6).
• If you are pregnant.
• If you are breastfeeding.
• If you are under 18 years old.
• If you have some heart exams, you need to do exercises that make your heart work harder. The nuclear medicine specialist will only consider this type of exam if they are sure that the exercise is not dangerous for you.

Warnings and precautions

Consult your nuclear medicine doctor before Talium Chloride (201Tl) CIS bio international is administered to you if you have reduced renal or hepatic function.

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

• Drink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion.
• Be fasting for at least 4 hours if you are going to have a heart exam.

Use of Talium Chloride (201Tl) CIS bio international with other medications

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

Some examples are:

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

Talium Chloride (201Tl) CIS bio international with beverages

Depending on the type of test, it may be necessary to avoid caffeine-containing beverages for at least 12 hours before the procedure. Your doctor will tell you if this is necessary in your case.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your nuclear medicine doctor before this medication is administered.

You must inform the nuclear medicine specialist before the administration of Talium Chloride (201Tl) CIS bio international if there is any possibility that you may be pregnant, if you have a delay or have lost your period, or if you are breastfeeding. In case of doubt, it is essential to consult the nuclear medicine specialist who will supervise the procedure.

• If you are pregnant:

The nuclear medicine doctor will not administer this medication during pregnancy, as it may harm the fetus.

• If you are breastfeeding:

Inform your doctor if you are breastfeeding, as you may need to delay the procedure until breastfeeding has ended. If the procedure cannot be postponed, you should interrupt breastfeeding for 2 days and discard this milk until the radioactivity is no longer in your body.

Please consult your nuclear medicine doctor when you can resume breastfeeding.

Driving and using machines

It is considered unlikely that Talium Chloride (201Tl) CIS bio international will affect your ability to drive or use machines.

Talium Chloride (201Tl) contains sodium

This medication contains 3.3 mg of sodium (main component of table salt/for cooking) in each mL.

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

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Chloride of thallium (201Tl) CIS bio international will be used exclusively in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide the amount of Chloride of thallium (201Tl) CIS bio international to be used in your case.This will be the minimum amount necessary to obtainthe desired information.

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

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

Chloride of thallium (201Tl)CIS bio internationalwill be administered via intravenous injection.

Normally, one injection is sufficient to provide the information your nuclear medicine physician needs, although sometimes a second injection may be required.

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

Procedure duration

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

After administration of Chloride of thallium (201Tl) CIS bio international, you must

• urinate frequentlyto eliminate the product from your body.

Your nuclear medicine physician will inform you if you need to take any special precautions after receiving this medication. Contact the nuclear medicine physician overseeing the procedure if you have any questions.

If you are administered more Chloride of thallium (201Tl) CIS bio international than you should

A overdose is unlikely because Chloride of thallium (201Tl) CIS bio international is administered by a physician under strictly controlled conditions. However, in the event of an overdose, you will receive the appropriate treatment. The nuclear medicine physician may recommend that you drink plenty of water and urinate frequently to eliminate radioactivity from your body.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been described as a consequence of the administration of Thallous Chloride (201Tl) CIS bio international (unknown frequency (cannot be estimated from available data)):

• Allergic reactions with symptoms such as

• Laryngeal spasm
• Throat inflammation
• Swelling in various areas, such as the face, larynx, tongue
• Difficulty breathing
• Redness of the skin, rash, pustules, itching, urticaria, skin pain
• Hypersensitivity
• Pain in the face
• Eye inflammation, which causes itching, tearing, or redness of the eye
• Alteration of tear flow
• Redness
• Increased sweating
• Coughing

• Fainting or experiencing symptoms such as

• Dizziness
• Slow heart rate
• 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.

Thallous Chloride (201Tl) is often used in combination with a cardiac stress test. The cardiac stress test may cause certain cardiac symptoms, such as palpitations, cardiac tracing abnormalities (ECG), irregular heartbeats, chest pain, shortness of breath, and, ultimately, myocardial infarction. Other stress-induced symptoms related to the test are high or low blood pressure, chills, taste disturbances, nausea, vomiting, and general fatigue or discomfort.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not need to be stored by you. This medication will be stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

Composition of Thallous Chloride (201Tl) CIS bio international

• The active principle is thallous chloride (201Tl)

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

• The other components are sodium chloride and water for injection

Appearance of the product and contents of the packaging

Thallous chloride (201Tl) CIS bio international is presented in the form of an injectable solution.

Packaging size: 1 multi-dose vial.

Holder of the marketing authorization and responsible manufacturer:

CIS bio international

BP 32 - 91192 Gif sur Yvette Cedex

France

For more information about this medication, please contact the local representative of the marketing authorization holder:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone: 91 4841989

Last review date of this prospectus: March 2024.

This information is intended solely for healthcare professionals:

The complete technical data sheet of Thallous Chloride (201Tl) CIS bio international is included as a separate document in the packaging of the product, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the technical data sheet [the technical data sheet must be included in the box].