Pylclari 1.000 mbq/ml solucion inyectable

Label: Label: information for the patient

Pylclari 1 000 MBq/ml injectable solution

Pylclari 1 500 MBq/ml injectable solution

piflufolastate (18F)

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to use this medicine, because it contains important information for you.

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

This medication is a radiopharmaceutical for diagnostic use only.

Pylclari contains the active ingredient piflufolastat (18F), which contains radioactive fluorine (18F). It is administered so that doctors can perform a special type of examination called positron emission tomography (PET) to detect specific types of cancer cells with a protein called prostate-specific membrane antigen (PSMA). This medication is used in patients:

• with prostate cancer who have a high risk of disease spread to other parts of the body and who are suitable for curative treatment
• who have previously received treatment for prostate cancer and in whom cancer recurrence is suspected based on results from other tests (e.g., prostate-specific antigen, PSA).

The PET examination with Pylclari may help your doctor to locate where the disease is.

You should discuss the results of the test with the doctor who requested the examination.

The use of Pylclari 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 of exposure to radiation.

Pylclari should not be administered to you

If you are allergic to piflufolastat (18F) or any of the other components of this medication (listed in section 6).

Warnings and precautions

You should be especially careful with Pylclari

• if you have kidney problems
• if you are on a low-sodium diet (see section 2 "Pylclari contains sodium").

Before Pylclari administration, you must

Drink plenty of water before starting the examination to urinate as often as possible during the first hours after the examination.

Children and adolescents

This medication is not intended for use in children and adolescents.

Other medications and Pylclari

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, such as hormone therapy to treat your prostate cancer, as they may interfere with the interpretation of images by your doctor.

Pregnancy and breastfeeding

This medication is not intended for use in women.

Driving and operating machinery

It is unlikely that this medication will affect your ability to drive and use machines.

Pylclari contains alcohol (ethanol)

This medication contains up to 900 mg of alcohol per administration, which is equivalent to less than 23 ml of beer or 11 ml of wine. The small amount of alcohol in this medication will have no notable effect.

Pylclari contains sodium

This medication contains up to 35 mg of sodium (main component of cooking/salt) in each dose. This is equivalent to 2% of the maximum recommended daily sodium intake for an adult.

There are strict laws regarding the use, handling, and disposal of radioactive medications. Pylclari should only be used in special controlled areas. Only personnel with the necessary training and experience in its use with adequate safety precautions will be able to handle and administer this product. These individuals will take the necessary precautions to safely use this medication and will keep you informed of their actions.

Dosage

The nuclear medicine specialist overseeing the procedure will decide on the amount of this medication to be used in your case. It will be the minimum amount necessary to obtain the desired information. The recommended average dose is 4 MBq/kg of body weight; this is approximately 280 megabecquerels for an adult weighing 70 kg (MBq, the unit used to express radioactivity).

Administration of Pylclari and procedure performance

• This medication will be administered as a single injection into a vein in your arm.
• A single injection is sufficient to perform the test your doctor needs you to undergo.

Procedure duration

The nuclear medicine specialist will inform you of the usual duration of the procedure.

The examination will typically begin between 90 and 120 minutes after the injection of Pylclari.

After Pylclari administration, you should:

• avoid close contact with young children and pregnant women for 12 hours after the injection
• drink plenty of water to urinate frequently to eliminate the medication from your body.

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

If you have received more Pylclari than you should

Since this product is administered by a doctor in strictly controlled conditions, it is unlikely that you will receive an overdose.

However, in the event of an overdose, you will receive the necessary treatment. The nuclear medicine specialist in charge of the procedure may offer methods to increase diuresis to help you eliminate the medication from your body.

If you have any other questions about the use of Pylclari, ask your nuclear medicine specialist who is overseeing the procedure.

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

Frequent(may affect up to 1 in 10 people):

• Disgeusia (alteration of taste in the mouth),
• Headache.

Infrequent(may affect up to 1 in 100 people):

• Hypersensitivity (allergic reactions),
• Dehydration (when the body loses too much water and other liquids it needs to function normally),
• Confusion about time and space,
• Fatigue,
• Dizziness,
• Increased sensitivity or increased response to pain from stimuli such as light touch or sound,
• Migraine,
• Dizziness (sensation of spinning),
• Muscle weakness,
• Visual field defect,
• Dry skin,
• Rash,
• Pain in the joints,
• Pain in the extremities,
• Urinary discomfort,
• Chest discomfort,
• Rash at the site of administration,
• Abnormal sensation,
• Pain at the site of administration.

Unknown frequency(cannot be estimated from available data):

• Loss of consciousness
• Nausea (discomfort)
• Vomiting

This radiopharmaceutical product emits low levels of ionizing radiation associated with a lower risk of cancer and hereditary anomalies.

Reporting Adverse Effects

If you experience any type of adverse effect, consult a nuclear medicine specialist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by the patient. This medication will be 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 solely for the specialist.

Do not use Pylclari after the expiration date that appears on the label after «CAD».

Composition of Pylclari

• The active principle is piflufolastato (18F). Eachmlof solution contains 1 000 MBq or 1 500 MBq of Pylclari at the date and time of calibration.
• The other components are ethanol, 9 mg/mlof injectable solution of sodium chloride (0.9%) and sodium ascorbate. Please see section 2 "Pylclari contains sodium and ethanol".

Appearance of Pylclari and contents of the container

Pylclari is a transparent and colourless solution presented in a glass vial.

Each multidose vial contains from 0.5 to 10mlof solution, corresponding to 500 to 15 000 MBq at the date and time of calibration.

Marketing Authorization Holder

CURIUM PET FRANCE

3 rue Marie Curie, Biopole Clermont-Limagne

63 360 Saint-Beauzire - France

Manufacturers

Last revision date of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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This information is intended solely for healthcare professionals:

The full technical datasheet for Pylclari is included as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Consult the technical datasheet.