FibCLOT 1.5 g. Powder and solvent for solution for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

It is a medicine which belongs to the class of antihaemorrhagics. The active substance is human fibrinogen, a protein which is naturally present in the body. The role of this protein is to ensure normal coagulation of the blood and to prevent that bleeding lasts too long.

It is used in all age groups to compensate for the lack of human fibrinogen and, thus, prevent and treat bleeding (haemorrhages) in patients with congenital fibrinogen deficiency.

Congenital fibrinogen deficiency is a hereditary disease characterised by a level less than the normal value or an absence of a protein called fibrinogen. This lack may lead to prolonged bleedings.

If you are allergic to the active substance (human fibrinogen) or any of the other ingredients of this medicine (listed in section 6. "Contents of the pack and other information").

Please inform your doctor if your are allergic to any medicine.

Talk to your doctor, pharmacist or nurse before using FibCLOT.

Traceability

It is strongly recommended that every time you receive a dose of this medicine, the name and batch number of the medicine are recorded in order to maintain a record of the batches used.

Risk of blood clots

With high dose or repeating dosing, this medicine may increase the risk of blood clots in blood vessels.

As a consequence, your doctor should evaluate the benefits of this medicine against the risk of blood clots, particularly:

• If you have had a heart attack (history of coronary heart disease or myocardial infarction).
• If you have a liver disease.
• If you have just had surgery
• If you will be having surgery soon
• In newborn infants (neonates).
• If you are more likely to have blood clots than normal.

Your doctor may also ask you to perform additional tests in order to monitor this risk.

Risk of allergies

Your doctor will inform you of the warning signs of an allergic reaction/serious allergic reaction (anaphylactic reaction) (see section 4. "Possible side effects"). If one of these effects does occur, this medicine should be stopped immediately.

Virus safety

This medicine is manufactured from human plasma (the liquid part of blood).

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include:

• careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
• the testing of each donation and pools of plasma for the signs of virus infections,
• the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.

Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV or AIDS virus), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.

The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).

Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived products.

Risk of antibodies

In the case of replacement therapy with coagulation factors in other congenital deficiencies, antibody reactions have been observed, but there is currently no data with fibrinogen.

Warnings and precautions listed above also apply to children and adolescents.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

No interactions between this treatment and other medicines have been observed to date. However, it should not be mixed with any other products and/or medicinal products.

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. This product should only be used during pregnancy and breast-feeding on the advice of your doctor.
• If you discover that you are pregnant during treatment, consult with your doctor as only he/she can determine whether you need to continue the treatment.

This medicine has no influence on the ability to drive and use machines.

This medicine contains up to 3 mmol (or 69 mg) sodium (main component of cooking/table salt) in each vial. This is equivalent to 3.45% of the recommended maximum daily dietary intake of sodium for an adult.

This should be taken into consideration if you are on a low salt diet.

The appropriate dose and frequency will be determined by your doctor and will depend on the following:

• your body weight,
• the severity of your disorder,
• the location and extent of bleeding, or the nature of your surgery,
• your health condition,

Your doctor will recommend that you undergo blood tests during treatment to control your fibrinogen level.

Based on the results of these tests, your doctor may decide to adapt the dose and frequency of your injections.

Your doctor will determine how often injections must be administered.

Your doctor will adapt the number of injections based on the severity of your bleeding and the efficacy of the treatment.

Information on frequency and duration of treatment for various situations is shown at the end of this leaflet in the section reserved for health professionals.

This medicine should be injected into the veins. The use of an infusion set equipped with a 15 μm filter, as the one supplied within the packaging, is mandatory.

If you have further questions on use of this product, ask your doctor, pharmacist or nurse.

To avoid risk of overdose, your doctor will perform regular blood tests to control your fibrinogen level.

In case of overdose, a risk of abnormal formation of clots in the blood cannot be excluded.

Frequency, type and severity of side effects are similar in adult and paediatric patients (from birth to less than 18 years of age) except for allergic/anaphylactic type reactions that occurred more commonly in paediatric population.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is human fibrinogen (1.5 g per vial). After reconstitution with 100 mL of water for injections FibCLOT contains 15 mg/mL of human fibrinogen.

The other ingredients are arginine hydrochloride, isoleucine, lysine hydrochloride, glycine, sodium citrate dihydrate and the solvent (water for injections).

This medicine is presented as a powder accompanied by solvent for solution for injections in glass vials, a transfer system and an infusion set equipped with a 15 μm filter.

The reconstituted solution should be almost colourless, slightly opalescent (having a pearl-like shine).