THALLIUM CHLORIDE (201Tl) CURIUM PHARMA SPAIN 37 MBq/ml INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Thallous Chloride (201Tl) Curium Pharma Spain 37 MBq/ml injectable solution

Thallous Chloride (201Tl)

Contents of the pack:

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

1. What Thallous Chloride (201Tl) Curium Pharma Spain is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.

This medicinal product contains Thallous Chloride (Tl-201), a radioactive substance that, when injected, accumulates in certain organs such as the heart.

The radioactive substance can be photographed from outside the body using special cameras that take images. This examination shows where the radioactivity is located within the organ and the body. This gives the doctor valuable information about how that organ is functioning.

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

• heart muscle and blood circulation in the heart, to examine heart diseases
• muscles of the legs, to examine blood flow in the muscles in a particular disease in which the arteries of the limbs are narrowed (peripheral vascular disorder)
• parathyroid gland
• certain tumors that are known to capture thallium, such as brain or thyroid tumors and metastases.

The use of Thallous Chloride (201Tl) involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will gain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

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

Thallous Chloride (201Tl) Curium Pharma Spain must not be used:

If you

• are allergic to Thallous Chloride (201Tl) or to any of the other components of this medicinal product (listed in section 6)
• are pregnant
• are breast-feeding
• are under 18 years of age

Warnings and precautions

Consult your nuclear medicine doctor before Thallous Chloride (201Tl) is administered to you, if you have reduced kidney or liver function.

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

• drink plenty of water before starting the procedure to urinate very frequently during the first hours after its completion.
• fast for at least 4 hours

Children and adolescents

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

Use of Thallous Chloride (201Tl) Curium Pharma Spain with other medicinal products:

Tell your nuclear medicine doctor if you are taking or have recently taken any other medicinal products, as some medicinal products 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 medicinal products before the procedure and for how long.

Some medicinal products are responsible for modifying the uptake of Thallous Chloride (201Tl) in the heart.

Some examples are:

• products containing methylxanthinessuch as certain medicinal products for treating migraine and theophylline(medicinal product for treating asthma and other respiratory diseases)
• dipyridamole: medicinal product for reducing blood coagulation
• medicinal products known as beta-blockers. These are used to treat high blood pressure, heart diseases or other diseases, and have active substance names that end in “olol”
• medicinal products known as nitrates, for treating chest pain due to narrowing of the heart's blood vessels, irregular heartbeats or high blood pressure
• medicinal products known as calcium channel blockers, for treating high blood pressure and certain heart conditions
• medicinal products containing digitalis, such as digoxin, for treating heart failure.

Thallous Chloride (201Tl) with beverages

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

Pregnancy, breast-feeding and fertility

You must inform the nuclear medicine doctor before administration of Thallous Chloride (201Tl) if there is any possibility that you may be pregnant, if you have a delayed period or if you are breast-feeding. In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure.

• If you are pregnant

The nuclear medicine doctor will notadminister this medicinal product during pregnancy, as it could harm the fetus.

• If you are breast-feeding

Tell your doctor if you are breast-feeding your child, as you may need to delay the procedureuntil breast-feeding has stopped. If the procedure cannot be postponed, you will need to interrupt breast-feeding for 2 daysand discard this milk, until the radioactivity is no longer in your body. Please consult your nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines

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

Thallous Chloride (201Tl) contains sodium

This medicinal product contains 3.5 mg of sodium (main component of table/cooking salt) in each ml.

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

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

There are strict rules on the use, handling and disposal of radiopharmaceuticals. Thallous Chloride (201Tl) will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of Thallous Chloride (201Tl) to be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended amount to administer to an adult is 50 to 110 MBq (Megabecquerel, the unit used to express radioactivity).

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

Thallous Chloride (201Tl) Curium Pharma Spain is administered by injection into a vein.

A single injection is sufficient to perform the procedure that your doctor needs, although in some cases a second injection may be necessary.

Other tests, such as exercise or taking other medicinal products, may be part of the procedure.

Duration of the procedure

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

After administration of Thallous Chloride (201Tl), you must

• urinate frequently to eliminate the product from your body.

Your nuclear medicine doctor will inform you if you need to take special precautions after this medicinal product is administered to you. Consult your nuclear medicine doctor if you have any doubts.

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

Overdose is unlikely because you will receive a precisely controlled dose of Thallous Chloride (201Tl) by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive the appropriate treatment. The nuclear medicine doctor may recommend that you drink plenty of water and urinate frequently to eliminate the remains of radioactivity from your body.

If you have any further questions on the use of this Thallous Chloride (201Tl), ask your nuclear medicine doctor supervising the procedure.

4. Possible side effects

Like all medicinal products, this medicinal product can cause side effects, although not everybody gets them.

Side effects of unknown frequency (cannot be estimated from the available data):

• Allergic reactions with symptoms such as

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

In case of an allergic reaction, you will receive the 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 a vein.

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 side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Thallous Chloride (201Tl) Curium Pharma Spain

You will not need to store this medicinal product. This medicinal product is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist.

Do not store above 25°C.

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

Do not use Thallous Chloride (201Tl) after the expiry date stated on the label of the container.

6. Contents of the pack and further information

Composition of Thallous Chloride (201Tl) Curium Pharma Spain

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

Appearance of the product and contents of the pack

Thallous Chloride (201Tl) is a clear and colorless injectable solution. It is supplied in 10 ml glass multidose vials, sealed with a bromobutyl stopper and with an aluminum overseal. The vial is supplied with a lead shield.

Thallous Chloride (201Tl) is supplied in a vial that contains:

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

Marketing authorisation holder and manufacturer:

Marketing authorisation 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

Netherlands

Date of last revision of this leaflet: October 2022

This information is intended only for healthcare professionals:

The complete summary of product characteristics of Thallous Chloride (201Tl) Curium Pharma Spain is included as a separate document in the product packaging, in order 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 box].