Thallium chloride (201 Tl) Curium Pharma Spain 37 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Thallium chloride (201Tl) Curium Pharma Spain 37 MBq/ml solution for injection

Thallium chloride (201Tl)

Package leaflet contents:

1. What Cloruro de talio (201Tl) Curium Pharma Spain is and what it is used for.
2. What you need to know before using Cloruro de talio (201Tl) Curium Pharma Spain.
3. How to use Cloruro de talio (201Tl) Curium Pharma Spain.
4. Possible side effects.
5. Storage of Cloruro de talio (201Tl) Curium Pharma Spain.
6. Contents of the pack and other information.

1. What Cloruro de talio (201Tl) Curium Pharma Spain is and what it is used for

This medicine is a radiopharmaceutical intended solely for diagnostic use.

This medicine contains thallium chloride (Tl-201), a radioactive substance which, when injected, accumulates in certain organs such as the heart.

The radioactive substance can be imaged from outside the body using special cameras that capture images. This scan shows where the radioactivity is located within the organ and body. This provides the physician with valuable information about how that organ is functioning.

Thallium chloride (201Tl) is used to obtain images for the examination of:

• cardiac muscle and blood circulation in the heart, to assess heart diseases
• leg muscles, to evaluate blood flow in the muscles in a specific condition where arteries in the limbs are narrowed (peripheral vascular disorder)
• parathyroid gland
• certain tumors known to take up thallium, such as brain or thyroid tumors and metastases.

The use of thallium chloride (201Tl) involves exposure to small amounts of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you need to know before using Thallium Chloride (201Tl) Curium Pharma Spain

Thallium Chloride (201Tl) Curium Pharma Spain 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)
• are pregnant
• are breastfeeding your child
• are under 18 years of age

Warnings and precautions

Consult your nuclear medicine physician before being administered thallium chloride (201Tl) if you have reduced kidney or liver function.

Before administration of Thallium Chloride (201Tl) Curium Pharma Spain you must

• drink plenty of water before starting the procedure to ensure frequent urination during the first hours after completion.
• fast for at least 4 hours

Children and adolescents

Thallium chloride (201Tl) must not be used in children under 18 years of age.

Use of Thallium Chloride (201Tl) Curium Pharma Spain 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 medicines may alter the uptake of thallium chloride (201Tl) in the heart.

Examples include:

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

Thallium chloride (201Tl) and beverages

Depending on the type of test, 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

You must inform the nuclear medicine physician before administration of thallium chloride (201Tl) if there is any possibility you may be pregnant, if you have missed a period, or if you are breastfeeding. In case of doubt, it is important to consult your nuclear medicine physician supervising 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 your child, as the procedure may need to be delayed until breastfeeding has ended. If the procedure cannot be postponed, 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) is considered unlikely to affect your ability to drive or operate machinery.

Thallium Chloride (201Tl) contains sodium

This medicine contains 3.5 mg of sodium (the main component of table/cooking salt) per ml.

This corresponds to 0.18% of the maximum daily recommended sodium intake for an adult.

3. How to use Thallium Chloride (201Tl) Curium Pharma Spain

There are strict regulations regarding the handling, use, and disposal of radiopharmaceuticals. Thallium Chloride (201Tl) 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 about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of thallium chloride (201Tl) to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information. The generally recommended administered activity for an adult is 50 to 110 MBq (Megabecquerels, the unit used to express radioactivity).

Administration of Thallium Chloride (201Tl) Curium Pharma Spain and performance of the procedure

Thallium Chloride (201Tl) Curium Pharma Spain is administered by intravenous injection.

A single injection is usually sufficient for the procedure required by your physician, although occasionally a second injection may be necessary.

Other tests, such as physical exercise or administration of additional medications, may be part of the procedure.

Duration of the procedure

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

After administration of thallium chloride (201Tl), you should

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

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medication. Consult your nuclear medicine physician if you have any doubts.

If you have been administered more Thallium Chloride (201Tl) Curium Pharma Spain than you should have

An overdose is unlikely, as you will receive a precisely controlled dose of thallium chloride (201Tl) administered by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided. The nuclear medicine physician may recommend that you drink plenty of fluids and urinate frequently to help eliminate residual radioactivity from your body.

If you have any further questions about the use of this thallium chloride (201Tl), ask your supervising nuclear medicine physician.

4. Possible adverse effects

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

Adverse effects of unknown frequency (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

• Alteration of tear flow

• Redness

• Increased sweating

• Cough

In case of an allergic reaction, you will receive appropriate treatment.

• 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 into the vein.

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 they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: 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) Curium Pharma Spain

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.

The following information is intended for specialists only.

Do not store above 25°C.

For storage conditions after first opening of the medicinal product, refer to the summary of product characteristics (section 6.3).

Do not use thallium chloride (201Tl) after the expiry date stated on the container label.

6. Contents of the pack and other information

Composition of Thallium Chloride (201Tl) Curium Pharma Spain

• The active substance is: thallium chloride (201Tl). Each ml of injectable solution contains 37 MBq at the time and date of calibration.
• The other components are sodium chloride, water for injections, hydrochloric acid or sodium hydroxide for pH adjustment.

Appearance of the medicinal product and contents of the pack

Thallium chloride (201Tl) is a clear, colourless injectable solution. It is supplied in 10 ml multidose glass vials, sealed with a bromobutyl stopper and an aluminium overseal. The vial is supplied with a lead shield.

Thallium chloride (201Tl) is supplied in a vial containing:

• 63 MBq (1.7 ml),
• 85 MBq (2.3 ml),
• 213 MBq (5.8 ml), or
• 370 MBq (10 ml)

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Curium Pharma Spain S. A.

Avenida Doctor Severo Ochoa No. 29

28100, Alcobendas, Madrid

Manufacturer:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

The Netherlands

Date of the most recent revision of this package leaflet: October 2022

This information is intended for healthcare professionals only:

The complete Summary of Product Characteristics for Thallium Chloride (201Tl) Curium Pharma Spain is included as a separate document in the product packaging, to provide 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].