Scintimun 1 mg, equipo de reactivos para preparacion radiofarmaceutica

Patient Information Leaflet: Information for the Patient

Scintimun 1 mg, Radiopharmaceutical Preparation Kit

Besilesomab

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or a nuclear medicine specialist who will oversee the procedure.
• If you experience any side effects, consult your nuclear medicine specialist or pharmacist, even if they are not listed in this leaflet. See section 4.

Scintimun is a medication that contains an antibody (besilesomab) used to direct itself to specific cells called granulocytes (a type of white blood cell involved in the inflammation process) in your body. Scintimun is used to prepare an injectable radioactive solution of technetium-99m-besilesomab. Technetium-99m is a radioactive element that allows you to see the organs where the besilesomab accumulates using a special camera.

This medication is a radiopharmaceutical for diagnostic use only in adults.

After injection into your vein, your doctor may obtain images (gammagraphies) of your organs that provide more information about the detection of inflammation and/or infection sites. However, Scintimun should not be used for the diagnosis of diabetic foot infections.

The administration of Scintimun involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from this procedure with the radiopharmaceutical outweighs the risk due to radiation.

No use Scintimun:

• If you are allergic to besilesomab, mouse antibodies, or any other antibody, to sodium pertecnetate (99mTc) solution, or to any of the other components of this medication (see section 6).

• If you have a positive result to the mouse antibodies detection test (HAMA test). Consult your doctor if you are unsure.
• If you are pregnant.

Warnings and precautions

Consult your nuclear medicine doctor before starting to use Scintimun:

• If you have been previously administered Scintimun, because Scintimun should only be administered once in a lifetime. If you are unsure if you have received this medication previously, please inform your doctor.

• If a technetium scan has been performed in the last 2 days.
• If you have a tumor-related pathology that involves the secretion of carcinoembryonic antigen (CEA) that could interfere with this investigation.
• If you have any blood disorders.
• If you are breastfeeding (lactation period).

Before Scintimun administration:

To obtain better quality images and to reduce your bladder radiation exposure, you should drink sufficient amounts and empty your bladder before and after the nuclear medicine scan.

Children and adolescents

This product is not recommended for use in patients under 18 years of age.

Use of Scintimun with other medications

Inform your nuclear medicine doctor if you are taking, have taken recently, or may need to take any other medication, including those acquired without a prescription, as they may interfere with the interpretation of the images.

Medications that reduce inflammation and medications that affect blood cell production (such as corticosteroids or antibiotics) may affect the results of your examination.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should inform your nuclear medicine doctor before administering Scintimun if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

In case of doubt, it is essential to consult your nuclear medicine doctor, who will oversee the procedure.

Do not administer Scintimun if you are pregnant.

Nuclear medicine examinations may pose a risk to the embryo.

If you are breastfeeding, you should interrupt breastfeeding for 3 days after your injection and discard the milk expressed during this period. If you wish, you can express and store your milkbeforethe injection. This will protect your baby from the radiation that may be present in your milk.

Your doctor will indicate when you can resume breastfeeding.

Additionally, you should avoid direct contact with your baby during the first 12 hours after the injection.

Driving and operating machines

It is considered unlikely that Scintimun will affect your ability to drive or operate machines.

Scintimun contains sorbitol and sodium

If you have intolerance to any sugar (for example, fructose or sorbitol), inform your doctor before they administer Scintimun.

This medicationcontainsless than 1 mmol of sodium (23 mg) per dose; this is, essentially «sodium-free».

There are strict guidelines for the use, handling, and disposal of radioactive medications. Scintimun will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who will use it safely. These 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 on the amount of technetium (99mTc)-besilesomab to be used in your case, which will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult is 400 to 800 MBq (megabequerel, the unit used to express radioactivity).

Administration of Scintimun and Procedure PerformanceScintimun is administered intravenously.

Single InjectionA single injection into a vein in your arm is sufficient to perform the procedure your doctor needs you to undergo.

Procedure Duration

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

After Scintimun Administration

Since it can emit especially damaging radiation for young children during the first 12 hours after injection, you should avoid direct contact with young children and pregnant women during this time period.

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

If You Have Been Administered More Scintimun Than Necessary

Since the injection is prepared as a single dose by hospital personnel under strictly controlled conditions, it is very unlikely that an overdose will occur. However, in the event of an overdose, you will be asked to drink plenty of water and take laxatives to increase the elimination of the product from your body.

If you have any other questions about the use of this medication, ask the nuclear medicine physician overseeing the procedure.

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

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

It has been observed that approximately 14 out of every 100 patients who receive this injection produce antibodies in their blood that react against the antibody present in Scintimun. This may increase the risk of allergic reactions in the case of repeated administration of Scintimun. Therefore, you should not receive Scintimun again.

In the event of an allergic reaction, you will receive appropriate treatment from your doctor.

The possible adverse effects are listed below in order of frequency:

Very Frequent(may affect more than 1 in 10 people):

Development of human anti-mouse antibodies that react against the antibody present in Scintimun (mouse cell antibody) with a risk of allergic reaction.

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

Low blood pressure.

Uncommon(may affect up to 1 in 100 people).

Allergic reaction, including facial swelling, urticaria.

Rare(may affect up to 1 in 1,000 people):

• Severe allergic reaction that causes difficulty breathing or dizziness.

• Muscle or joint pain.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nuclear medicine specialist who performed the examination, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you cancontribute to providing more information about the safety of this medication.

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

• The active principle is besilesomab (monoclonal antibody against granulocytes obtained from mouse). A vial of Scintimun contains 1 mg of besilesomab.
• The other components are (see section 2 “Scintimun contains sorbitol”)

Scintimun

Dihydrogen phosphate of sodium, anhydrous

Monohydrogen phosphate of disodium, anhydrous

Sorbitol E420

Nitrogen

Scintimun solvent

Tetrasodium salt of 1,1,3,3-propanetetrafosphonic acid, dihydrate (PTP)

Stannous chloride dihydrate

Sodium hydroxide / Hydrochloric acid

Nitrogen

Appearance of the product and contents of the packaging

Scintimun is a kit for radiopharmaceutical preparation.

The Scintimun vial contains a white powder.

The Scintimun solvent vial contains a white powder.

The kit contains one or two multidose vials of Scintimun with one or two vials of solvent.

It is possible that not all packaging sizes are marketed.

Marketing authorization holder and responsible manufacturer

CIS bio international

B.P. 32

F-91192 Gif-sur-Yvette Cedex

France

Last review date of this leaflet: {MM/AAAA}

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

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This information is intended solely for healthcare professionals:

The complete technical datasheet for Scintimun is included as a detachable section at the end of this leaflet 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 technical datasheet.