Factor VIII (Haemate P)

How does it work?

Haemate P injection 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.

Factor VIII exists as part of a complex with another clotting protein called von Willebrand factor. Haemate P contains sufficient amounts of this protein to also be used to treat bleeding in a blood disorder similiar to haemeophilia, called von Willebrand's disease.

What is it used for?

  • Prevention and treatment of bleeding in haemophilia A.
  • Prevention and treatment of bleeding in other diseases involving factor VIII deficiency.
  • Prevention and treatment of bleeding in a blood disorder similiar to haemeophilia called von Willebrand's disease.

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.
  • 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.
  • People being treated with this medicine can sometimes develop antibodies against the factor VIII. These are known as inhibitors and they can stop the medicine working properly. If your bleeding is not being controlled with this medicine you should let your doctor know immediately, as you may have developed an inhibitor and your doctor may want ot carry out tests to confirm this.

Use with caution in

  • Children under six years of age
  • People on a low sodium diet (the product contains sodium).
  • People with an underactive immune system.
  • People with decreased numbers of red blood cells in the bloodstream caused by an increase in their breakdown (haemolytic anaemia).
  • Pregnancy.

Not to be used in

  • Known sensitivity or allergy to any ingredient.

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. It should only be used to treat pregnant women if the potential benefits outweigh any possible risks to the unborn child. Seek medical advice from your doctor.
  • The safety of this medicine during breastfeeding has not been established. It should only be used to treat breastfeeding women if the potential benefits outweigh any possible risks to the nursing infant. 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. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

  • Burning and stinging at the infusion site.
  • Fever (pyrexia).
  • Flushing.
  • Headache.
  • Nausea and vomiting.
  • Restlessness.
  • Increased heart rate.
  • Allergic reactions including rashes, chills, low blood pressure, wheezing, chest tightness, swelling of lips and throat (angiodema).
  • An extreme allergic reaction (anaphylaxis).

The side effects listed above may not include all of the side effects reported by the medicine'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?

This medicine is not known to affect other medicines.

Other medicines containing the same active ingredients

Medicines containing factor VIII derived from blood donors:

Beriate P Hemofil M Monoclate-P
Optivate Replenate

Medicines containing genetically engineered factor VIII:

AdvateHelixate NexgenKogenate Bayer
RecombinateRefacto