PATIENT INFORMATION LEAFLET

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

Thallous Chloride (201Tl)

This medication is a radiopharmaceutical for diagnostic use only.

This medication 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 the outside of 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:

• cardiac muscle and blood circulation in the heart, to examine heart diseases
• muscles in the legs, to examine blood flow in the muscles in a certain disease in which the arteries of the extremities are narrowed (peripheral vascular disorder)
• parathyroid gland
• certain tumors that are known to capture thallium, such as brain tumors 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 obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

Talium Chloride (201Tl) Curium Pharma Spain should not be used:

If you

• are allergic to talium chloride (201Tl) or any of the other components of this medication (listed in section 6)
• are pregnant
• are breastfeeding your child
• are under 18 years old

Warnings and precautions

Consult your nuclear doctor before receiving talium chloride (201Tl), if you have reduced renal or hepatic function.

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

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

Children and adolescents

Talium chloride (201Tl) should not be used in children under 18 years old.

Use of Talium Chloride (201Tl) Curium Pharma Spain with other medications:

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

Some medications are responsible for modifying the capture of talium chloride (201Tl) in the heart.

Some examples are:

• products containingmethylxanthinessuch as certain medications for treating migraine andtheophylline(medication for treating asthma and other respiratory diseases)
• dipyridamole: medication for reducing blood coagulation
• medications known asbeta-blockers. These are used to treat high blood pressure, heart disease, or other diseases, and have names of active substances that end in “olol”
• medications known asnitrates, for treating chest pain due to narrowing of the heart's blood vessels, irregular heartbeats, or high blood pressure
• medications known ascalcium channel blockers, for treating high blood pressure and certain heart conditions
• medications containingdigitalis, such asdigoxin, for treating heart failure.

Talium 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 tell you if this is necessary in your case.

Pregnancy, breastfeeding, and fertility

You must inform your nuclear doctor before receiving talium chloride (201Tl) if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breastfeeding. In case of doubt, it is essential to consult your nuclear doctor who will oversee the procedure.

• If you arepregnant

Your nuclear doctorwill notadminister this medication duringpregnancy, as it could harm the fetus.

• If you are inbreastfeeding

Inform your doctor if you are breastfeeding your child, as you maydelay the procedureuntil breastfeeding has ended. If the procedure cannot be postponed, you shouldinterrupt breastfeeding for 2 daysand discard this milk until the radioactivity is no longer in your body.
Please consult your nuclear doctor when you can resume breastfeeding.

Driving and operating machinery

It is considered unlikely that talium chloride (201Tl) will affect your ability to drive or operate machinery.

Talium Chloride (201Tl) contains sodium

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

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

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Chloride of thallium (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. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear physician overseeing the procedure will decide the amount of chloride of thallium (201Tl) 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 (Megabecquerel, the unit used to express radioactivity).

Administration of Chloride of Thallium (201Tl) by Curium Pharma Spain and Procedure Performance

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

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

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

Procedure Duration

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

After Administration of Chloride of Thallium (201Tl), You Must

• Urinate frequently to eliminate the product from your body.

Your nuclear physician will inform you ifyou need to take special precautionsafterreceiving this medication. Consult your nuclear physician if you have any doubts.

If You Have Been Administered More Chloride of Thallium (201Tl) by Curium Pharma Spain Than You Should

A overdose is unlikelybecauseyou will receive a controlled and precise dose of chloride ofthallium (201Tl)from the nuclear physicianwho supervisesthe procedure.However,in the event of an overdose, you will receive the appropriate treatment. The nuclear physician may recommend that you drink plenty of water and urinate frequently to eliminate radioactive residues from your body.

If you have any other doubts about the use of this chloride of thallium (201Tl), ask your nuclear physician who oversees the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects of 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, pruritus, urticaria, skin pain
• Hypersensitivity
• Facial pain
• Eye inflammation, which causes itching, tearing, or redness of the eye
• Alteration of tear flow
• Redness
• Increased sweating
• Coughing

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 intravenously.

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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse 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 adverse effects, you can contribute to providing more information on the safety of this medication.

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

The followinginformation is intended solely for the specialist.

Do not store above 25°C.

For conservation conditions after the first opening of the product, consult the technical data sheet (section 6.3).

Do not use thallous chloride (201Tl) after the expiration date that appears on the label of the packaging.

Composition of Thallium Chloride ( 201 Tl) Curium Pharma Spain

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

Appearance of the product and contents of the packaging

Thallium chloride ( 201 Tl) is a transparent and colorless injectable solution. It is supplied in multi-dose glass vials of 10 ml, sealed with a bromobutyl stopper and an aluminum overcap. The vial is supplied with a lead shielding.

Thallium chloride ( 201 Tl) 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)

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Curium Pharma Spain S.A.

Avenida Doctor Severo Ochoa Nº 29

28100, Alcobendas, Madrid

Responsible for manufacturing:

Curium Netherlands B.V.

Westerduinweg 3

1755 LE Petten

Netherlands

Last review date of this leaflet: October 2022

This information is intended solely for healthcare professionals:

The complete technical datasheet of Thallium Chloride ( 201 Tl) 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 refer to the technical datasheet [the technical datasheet must be included in the box].