Scintimun - patient leaflet, side effects, dosage

Patient leaflet - Scintimun

B. PACKAGE LEAFLET

Package leaflet: information for the patient

Scintimun 1 mg kit for radiopharmaceutical preparation besilesomab

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or the nuclear medicine specialist who will supervise the procedure.
– If you get any side effects, talk to your nuclear medicine doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Scintimun is and what it is used for
2. What you need to know before you are given Scintimun
3. How Scintimun is given
4. Possible side effects
5 How Scintimun is stored
6. Contents of the pack and other information

1. What Scintimun is and what it is used for

Scintimun is a medicine containing an antibody (besilesomab) used to target specific cells called granulocytes (a type of white blood cells involved in the inflammation process) in your body.

Scintimun is used for the preparation of a radioactive solution for injection of technetium(99mTc)-besilesomab. Technetium(99mTc) is a radioactive element allowing the organs where besilesomab accumulates to be seen using a special camera.

This medicine is a radiopharmaceutical product for diagnostic use only in adults.

After injection into your vein, your doctor can obtain pictures (scans) of your organs that give more information about the detection of sites of inflammation and/or infection. However Scintimun should not be used for the diagnosis of diabetic foot infection.

The use of Scintimun does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweights the risk due to radiation.

2. What you need to know before you are given Scintimun

Scintimun must not be used:

– if you are allergic to besilesomab, to antibody from mouse origin or any other antibodies, or to sodium pertechnetate (99mTc) solution or any of the other ingredients of this medicine listed in section 6.
– if you have a positive response to a test detecting human anti-mouse antibodies (HAMA test). Ask your doctor if you are not sure.
– if you are pregnant.

Warnings and precautions

Talk to the nuclear medicine specialist before using Scintimun:

– if you have previously been administered Scintimun, because you should only be administered Scintimun once in your lifetime. If you are not sure if you have been given this medicine before, please let your doctor know.
– if you have had a scintigraphy with technetium in the last 2 days.
– if you have a tumoral pathology involving a secretion of carcino-embryonic antigen (CEA) which could interfere with this investigation.
– if you have any blood disease.
– if you are breast-feeding.

Before administration of Scintimun

In order to obtain images of best quality and to reduce the radiation exposure of your bladder, you should drink sufficient amounts and empty your bladder prior to and after the scintigraphic examination.

Children and adolescents

This medicine is not recommended for use in patients below 18 years of age because the safety and efficacy of the product have not been established.

Other medicines and Scintimun

Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, since they may interfere with the interpretation of the images.

Medicines reducing inflammation and medicines affecting the production of your blood cells (such as corticosteroids or antibiotics) may affect the results of your examination.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.

You must inform the nuclear medicine doctor before the administration of Scintimun if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding. When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant you must not be given Scintimun.

Investigations in nuclear medicine may involve a risk to the unborn.

If you are breast-feeding you must stop breast-feeding for 3 days after your injection and the expressed milk should be discarded. If you wish, you can express and store your breast milk before your injection. This will protect your child from the radiation that may be present in your breast milk.

Please ask your nuclear medicine doctor when you can resume breast-feeding.

Moreover you must avoid close contact with your child during the first 12 hours after the injection.

Driving and using machines

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

Scintimun contains sorbitol and sodium

If you have an intolerance to some sugars (for example fructose or sorbitol), tell your doctor before you are given Scintimun.

Scintimun contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially ‘sodium- free’.

3. How Scintimun is given

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Scintimun will only be used in special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide on the quantity of technetium(99mTc)- besilesomab to be used in your case. It will be the smallest quantity necessary to get the desired information.

The quantity to be administered usually recommended for an adult ranges from 400 to 800 MBq (megabecquerel, the unit used to express radioactivity).

Administration of Scintimun and conduct of the procedure

Scintimun is administered intravenously.

A single injection into a vein in your arm is sufficient to conduct the test your doctor needs.

Duration of the procedure

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

After administration of Scintimun

Because you could emit radiation especially harmful to young children during the first 12 hours after the injection, you should avoid close contact with young children and pregnant women during this period of time.

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.

If you have been given more Scintimun than you should

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

Should you have any further questions on the use of Scintimun, please ask the nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities.

About 14 out of 100 patients having this injection have been found to produce antibodies in their blood reacting against the antibody present in Scintimun. This may increase the risk of allergic reactions in case of repeated administration of Scintimun. Therefore you should not receive Scintimun a second time.

In case of allergic reaction you will receive appropriate treatment from your doctor.

Possible side effects are listed in the order of their frequency below:

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

Development of human anti-mouse antibodies reacting against the antibody in Scintimun (antibody of the mouse cells) with a risk of allergic reaction

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

Low blood pressure

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

Allergic reaction, including swelling of the face, hives (urticaria)

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

Serious allergic reaction which causes difficulty in breathing or dizziness
Muscle or joint pain

Reporting of side effects

If you get any side effects, talk to your doctor or the specialist in nuclear medicine. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via directly via the national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How Scintimun is stored

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.

6. Contents of the pack and other information

What Scintimun contains

– The active substance is besilesomab (anti-granulocyte monoclonal antibody from mouse origin).

One vial of Scintimun contains 1 mg of besilesomab.

– The other ingredients are (see section 2 “Scintimun contains sorbitol and sodium”):

Scintimun

Sodium dihydrogen phosphate, anhydrous

Disodium monohydrogen phosphate, anhydrous

Sorbitol E420

Under nitrogen atmosphere

Solvent for Scintimun

1, 1, 3, 3-propane tetraphosphonic acid, tetrasodium salt, dihydrate (PTP)

What Scintimun looks like and contents of the pack

Scintimun is a kit for radioactive preparation.

The vial of Scintimun contains a white powder.

The vial of solvent for Scintimun contains a white powder.

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

Not all pack-sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

CIS bio international

B.P. 32

F-91192 Gif-sur-Yvette Cedex

France

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

The following information is intended for healthcare professionals only:

The complete SmPC of Scintimun is provided as a tear-off section at the end of the printed leaflet in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical. Please refer to the SmPC.