How does it work?

This medicine contains the active ingredient factor VIII, which is a protein that is essential for the process of blood clotting (coagulation). It is found in human plasma and is produced for this medicine by extracting the factor VIII from blood plasma from screened blood donors.

When bleeding occurs the body quickly seals the breaks in blood vessels by forming clots. A series of clotting proteins is involved in this process. Lack of any one of these clotting factors can lead to uncontrolled bleeding or excessive bruising following injury.

Factor VIII is deficient from birth in people with haemophilia A. This deficiency causes the blood to clot very slowly and can result in prolonged bleeding following any injury or wound. People with haemophilia may also bleed spontaneously into muscles and joints.

Factor VIII fraction is given by injection or drip into a vein (infusion) to people with haemophilia to supplement their deficient factor VIII. This is necessary to help the blood clot and stop bleeding following accidents, surgery or spontaneous bleeds. In severe cases it may also be given regularly every few days to prevent bleeding.

What is it used for?

• Prevention and treatment of bleeding in haemophilia A

Warning!

• Allergic reactions are possible to this medicine. If you get symptoms such as tightness of the chest, wheezing, dizziness or nausea these may be early signs of hypersensitivity or a severe allergic reaction called anaphylaxis. If you get an allergic reaction the medicine should be stopped immediately and your doctor consulted. People known to have a tendency to allergies should be pre-treated with medicines such as antihistamines and corticosteroids to prevent an allergic reaction.
• When medicines prepared from human blood or plasma are administered the possibility of transmitting infections from viruses cannot be totally excluded. To reduce the risk of transmission of infective agents, stringent controls are applied to the selection of blood donors and donations. In addition, virus elimination/inactivation procedures are included in the production process. However, it is recommended that people who regularly receive this medicine should have vaccinations against hepatitis A and B.
• Monoclate-P should be stored in a fridge at 2 to 8°C. Do not freeze. It may also be stored at room temperature for up to 6 months before the expiry date, but not at above 25°C. Keep away from light.

Not to be used in

• Allergy to mouse proteins

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine during pregnancy has not been established. Seek medical advice from your doctor.
• The safety of this medicine during breastfeeding has not been established. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Fever (pyrexia)
• Allergic reaction to active ingredient
• An extreme allergic reaction (anaphylaxis)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

There are no known interactions with this medicine.

Other medicines containing the same active ingredients

Medicines containing factor VIII derived from blood donors:

Medicines containing genetically engineered factor VIII: