PATIENT INFORMATION LEAFLET

PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING

FIBROGAMMIN® P

What does Fibrogammin P contain?

Fibrogammin P is a freeze-dried powder that contains 250 units of human plasma coagulation factor XIII.

It also contains human albumin, glucose and sodium chloride, and must be dissolved in the Water for Injections supplied before it is injected.

This medicinal product contains a maximum of 24 mg glucose per 250 U vial, which corresponds to a maximum of 360 mg when the maximum dose of 50U/kg is given to a patient with 75 kg bodyweight.

This should be taken into account in patients with diabetes mellitus.

This medicinal product contains a maximum of 17 mg sodium per 250 U vial, which corresponds to a maximum of 255 mg when the maximum dose of 50U/kg is given to a patient with 75 kg bodyweight.

To be taken into consideration by patients on a controlled sodium diet.

The product is presented in a 6 ml injection vial with one ampoule of 4 ml water for injections. The ampoule and vial will appear partly empty but this is normal and does not mean that there is the wrong amount of powder or solution.

Why have I been prescribed Fibrogammin P by my doctor?

Fibrogammin P has been prescribed to stop or prevent bleeding that you might get because of a lack of factor XIII in your blood, a condition that you have had from birth. Fibrogammin P also helps slow healing wounds to heal more quickly.

Factor XIII is needed to join together strands of fibrin in the final stages of blood clotting. This forms a stable blood clot and hence stops bleeding. If factor XIII is lacking, a soft clot that is easily dissolved forms and bleeding can easily re-start or not be stopped as quickly as normal. This is why the right amount of factor XIII in the blood is needed to heal wounds and repair damage to tissues.

Before you take Fibrogammin P.

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 that those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include 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 infection.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), 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).

It is strongly recommended that every time you receive a dose of Fibrogammin P, the name and batch number of the product are recorded in order to maintain a record of the batches used. Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly receive human plasma-derived products.

When should I not receive Fibrogammin P?

Do not use Fibrogammin P if you are allergic to any of the ingredients. If you are unsure about this then you should ask your doctor before taking this product. Usually if you are allergic to Fibrogammin P it will show up the first time that you use it. Possibly you may feel sick, dizzy or feel a tightness in your chest, or you may develop a rash.

How much Fibrogammin P should I use or be given?

Your doctor will calculate your dose depending on need.

If you are bleeding it will be about 10 - 20 units (up to a maximum of 50 units) for every kilogram that you weigh every day until the bleeding stops.

To prevent bleeding it will be about 10 units for every kilogram that you weigh at approximately 4-week intervals.

If you need an operation, you will need about 35 units for every kilogram that you weigh before the operation and then as required until the wound has healed.

Your doctor will monitor your condition and adjust the dose according to your needs and any test that may be done.

How is Fibrogammin P administered?

Fibrogammin P will normally be given to you by injection into a vein by your doctor or nurse. The dried powder is completely dissolved with the diluent supplied, which has been previously warmed to body temperature. Aseptic precautions should be taken in dissolving the powder and drawing up the dose so as not to introduce germs. The solution is usually very slightly cloudy but should not contain particles.

Once the powder is dissolved the solution should be used within 8 hours. If not used immediately after reconstitution it should be kept in a refrigerator at +2 to + 8 °C for a maximum of 8 hours.

Fibrogammin P should be injected or infused slowly. Any solution not used must be thrown away.

What side effects may I experience?

In very rare cases you may experience a rise in your temperature. This may be a sign that you have suffered an allergic reaction to Fibrogammin P. Let your doctor know if you feel uncomfortable during the injection. You may also experience a rash, hives, difficulty in breathing or a fall in blood pressure (this may make you feel faint or dizzy). Your doctor may choose to stop your treatment. A very small number of patients who are being treated with Fibrogammin P develop substances in their blood, which block its effect.

If you already have a blood clot it may be made more stable and favour blockage of a blood vessel.

If you experience a rise in temperature, or if your treatment becomes less effective, or if you experience any other undesirable effect tell your doctor immediately.

How should Fibrogammin P be stored?

Store in its outer carton at +2 to +8 °C in a refrigerator. Do not freeze. When kept in this way Fibrogammin P will keep until the expiry date shown on the label. Do not use after this expiry date.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Remember this medicine is for you and only your doctor can prescribe it for you. It should not be given to others as it may harm them, even if their symptoms are the same as yours.