Haemate P 500 IU FVIII/1200 IU VWF powder and solvent – factor VIII and von Willebrand factor for haemophilia A and von Willebrand disease

Haemate P (often searched as "Heamate P") is a medicine made from human plasma containing two active substances: human coagulation factor VIII and human von Willebrand factor (VWF). One vial contains 500 IU factor VIII and 1200 IU von Willebrand factor; the powder is dissolved in 10 mL water for injections and given into a vein.

The medicine is used to prevent and treat bleeding in haemophilia A (congenital factor VIII deficiency) and in von Willebrand disease when desmopressin alone is not effective enough or is contraindicated. Treatment is started and supervised by a doctor experienced in treating coagulation disorders.

What is Haemate P used for and how is it given?

Key facts about the medicine

What is Haemate P used for?

• Haemophilia A (congenital factor VIII deficiency): prophylaxis and treatment of bleeding; it can also be used in acquired factor VIII deficiency and in patients with antibodies to factor VIII.
• Von Willebrand disease (VWD): prophylaxis and treatment of bleeding, including surgical bleeding, when desmopressin (DDAVP) monotherapy is ineffective or contraindicated.

Because the medicine contains both factors, the doctor determines the dose according to the factor the patient needs – in haemophilia A by the number of factor VIII units, in von Willebrand disease by the number of VWF units.

How is it given and dosed?

The dose depends on body weight, severity of the disease, site and intensity of bleeding or the need for protection during surgery, and is determined by the doctor (with monitoring of factor levels in the blood).

• Haemophilia A – on demand: 1 IU factor VIII per kg body weight raises factor VIII activity by about 2%; required units = body weight (kg) x desired rise (%) x 0.5. Target levels depend on the bleed (e.g. 20–40% for early haemarthrosis, 60–100% for life-threatening bleeding and 80–100% for major surgery).
• Haemophilia A – prophylaxis: in severe haemophilia usually 20–40 IU factor VIII/kg every 2–3 days; younger patients may need shorter intervals or higher doses.
• Von Willebrand disease: usually 40–80 IU VWF:RCof/kg and 20–40 IU FVIII:C/kg to achieve haemostasis; in type 3 sometimes a loading dose of 80 IU VWF:RCof/kg. Before surgery, administration starts 1–2 hours earlier and is repeated every 12–24 hours.
• Administration: the reconstituted solution is given slowly into a vein, at no more than 4 mL per minute, using a disposable plastic syringe (the solution adheres to glass). The vials are warmed to room temperature before mixing, not above 37 °C; do not shake.

If the medicine is prescribed for home use, the doctor or nurse from the haemophilia centre will train you to prepare and give it. Record the name and batch number with every administration.

Special patient groups

• Children: in von Willebrand disease the dose is based on body weight using the same rules as for adults; there are no clinical study data on dosing in children with haemophilia A. In previously untreated children, inhibitors to factor VIII develop very commonly.
• Heart disease: talk to your doctor if you have heart disease or are at risk of it.
• Central venous catheter: local infections, bacteraemia and thrombosis at the catheter site are possible.
• Sodium-controlled diet: one vial contains 26 mg sodium.

Contraindications – when the medicine must not be used

Do not receive Haemate P if you are allergic to human von Willebrand factor, human coagulation factor VIII or any of the excipients. Tell your doctor about any allergies to medicines or food.

Warnings and precautions

• Allergic reactions: early signs are rash, generalised hives, chest tightness and wheezing, low blood pressure and anaphylaxis – stop administration immediately.
• Inhibitors: development of antibodies to factor VIII (haemophilia A) or to VWF (VWD, especially type 3) is monitored by the doctor; an inadequate response requires testing.
• Blood clots in VWD: with risk factors (no perioperative thromboprophylaxis, immobility, obesity, overdose, cancer), early signs of thrombosis are monitored and prophylaxis is given; persistently high FVIII levels increase the risk.
• Viral safety: donor selection, testing and virus inactivation steps are used (effective for HIV, HBV, HCV and HAV), but transmission of infection cannot be completely excluded; measures may be of limited value against parvovirus B19. The doctor may recommend vaccination against hepatitis A and B.
• Large or frequent doses: possible hypervolaemia is monitored, and in blood groups A, B and AB possible intravascular haemolysis.

Interactions with other medicines, food and drink

Interactions with other medicines have not been studied. The medicine must not be mixed with other medicines, diluents or solvents except the water for injections supplied. Tell your doctor about all medicines you take.

Pregnancy and breast-feeding

• Use during pregnancy and breast-feeding only if absolutely necessary.
• Haemophilia A is rare in women, so there is insufficient experience with factor VIII during pregnancy and breast-feeding.
• Von Willebrand disease affects women more often (menstruation, pregnancy, childbirth); based on post-marketing experience, VWF replacement may be recommended for prevention and treatment of acute bleeding, but clinical studies in pregnant and breast-feeding women are not available.

Driving and using machines

According to the leaflet, Haemate P does not affect the ability to drive or use machines.

Possible side effects

Like all medicines, Haemate P can cause side effects, although not everybody gets them.

• Very rare (up to 1 in 10,000): sudden allergic reactions – angioedema, stinging and burning at the infusion site, chills, flushing, hives, headache, rash, low blood pressure, lethargy, nausea, restlessness, fast heartbeat, chest tightness, itching, vomiting, wheezing, in some cases progressing to anaphylactic shock; fever.
• Von Willebrand disease: very rarely blood clots (thrombotic/thromboembolic events) and neutralising antibodies to VWF, which may occur together with anaphylaxis.
• Haemophilia A: in previously untreated children, factor VIII inhibitors very common (more than 1 in 10); in previously treated patients (more than 150 days) uncommon (up to 1 in 100).
• Not known: with large or frequent doses, hypervolaemia and, in blood groups A, B and AB, intravascular haemolysis or a fall in haematocrit.

Overdose, missed dose and stopping treatment

• Overdose: no symptoms of overdose have been reported, but a risk of thrombosis cannot be excluded with extremely high doses.
• Missed dose: give the prescribed dose as soon as you remember, then continue as instructed by your doctor or nurse.
• Stopping treatment: the duration and any change of treatment are decided by the doctor.

Related information

For questions about prophylaxis, home treatment, preparation for surgery and vaccination, contact your doctor and the team at the haemophilia centre where you are treated.

Composition, pack and manufacturer

• Active substances: 500 IU human coagulation factor VIII and 1200 IU human von Willebrand factor per vial.
• Excipients: human albumin; glycine; sodium chloride; sodium citrate; sodium hydroxide or hydrochloric acid (for pH adjustment). Solvent: water for injections, 10 mL.
• Pack: glass powder vial, glass vial with 10 mL solvent (latex-free stoppers) and Mix2Vial 20/20 filter transfer set.
• Marketing authorisation holder: PharmaSwiss d.o.o., Batajnički drum 5A, Belgrade. Manufacturer: CSL Behring GmbH, Emil-von-Behring-Straße 76, Marburg, Germany.

Storage

• Store below 25 °C, do not freeze, in the original package to protect from light.
• Use the reconstituted solution immediately; if not possible, store for no longer than 8 hours at up to 25 °C. Once drawn into a syringe, it must be used immediately.
• Keep out of the sight and reach of children.

Frequently asked questions

Are "Heamate P" and Haemate P the same medicine?

Yes. The correct name is Haemate P (CSL Behring); "Heamate" is a common misspelling. In Serbia the valid authorisation is for the 500 IU FVIII/1200 IU VWF strength.

When is Haemate P used in von Willebrand disease?

To prevent and treat bleeding, including during surgery, when desmopressin (DDAVP) alone is ineffective or contraindicated.

How fast is it given?

Slowly into a vein, at no more than 4 mL per minute, using a plastic syringe. Administration should be stopped if any reaction occurs.

What if the medicine no longer works as before?

This may be a sign of inhibitors (antibodies) to factor VIII or von Willebrand factor. Contact your doctor or haemophilia centre immediately.

Sources

• ALIMS – Summary of Product Characteristics, Haemate® P 500 IU FVIII/1200 IU VWF (SmPC, Serbian)
• ALIMS – Patient leaflet, Haemate® P 500 IU FVIII/1200 IU VWF powder and solvent for solution for injection/infusion (PIL, April 2022, Serbian)

Sources checked on: 25 October 2026.