Product image of Haemate P (Human Coagulation Factor Viii, Human Von Willebrand Factor) supplied by GNH India

Haemate P

Active Ingredient:
Human Coagulation Factor Viii, Human Von Willebrand Factor
Origin:
EU

Haemate P (Human Coagulation Factor Viii, Human Von Willebrand Factor)

Haemate P is a prescription‑only human coagulation factor VIII/von Willebrand factor concentrate supplied as a sterile solution for injection. It contains recombinant human factor VIII and von Willebrand factor, administered intravenously to replace deficient clotting proteins. The product is marketed in the European Union and is used under medical supervision for patients with hemophilia A or von Willebrand disease and related bleeding disorders through individualized dosing.

Manufacturer / TM Owner

Csl Behring Gmbh

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Indications & Clinical Uses

Haemate P is indicated for the management of bleeding in patients with specific clotting factor deficiencies.

  • Treatment of acute bleeding episodes in hemophilia A patients.
  • Routine prophylaxis to prevent spontaneous bleeds in hemophilia A.
  • Management of bleeding episodes in von Willebrand disease, especially type 3.
  • Surgical or invasive procedure support in patients with factor VIII or von Willebrand factor deficiency.
  • Peri‑operative hemostasis for patients undergoing major surgery.

Side Effects

Adverse reactions reported with Haemate P vary in frequency and severity.

Common

  • Mild headache.
  • Fever or chills.
  • Infusion site erythema or pain.
  • Nausea.
  • Transient hypertension.
  • Fatigue.

Serious

  • Anaphylactic or severe hypersensitivity reactions.
  • Development of inhibitors (antibodies) to factor VIII.
  • Thromboembolic events.
  • Severe hemolysis.
  • Acute renal failure.

Precautions & Warnings

Before initiating therapy with Haemate P, clinicians should consider several safety considerations.

  • Assess for a history of allergic reactions to plasma‑derived products.
  • Screen for inhibitors to factor VIII prior to treatment.
  • Monitor for signs of thrombosis, especially in patients with cardiovascular risk factors.
  • Use caution in patients with renal or hepatic impairment.
  • Avoid use in patients with uncontrolled hypertension.
  • Evaluate pregnancy and lactation status, as safety data are limited.

Avoid Interactions

Haemate P may interact with other medications that affect hemostasis or immune response.

Avoid

  • Concomitant use of other factor concentrates without medical supervision.
  • High‑dose pro‑coagulant agents (e.g., activated prothrombin complex concentrate) that increase thrombosis risk.

Use with caution

  • Antifibrinolytic agents such as tranexamic acid.
  • Immunosuppressive drugs that may alter inhibitor development.
  • Certain antibiotics (e.g., beta‑lactams) that can cause hypersensitivity.

Frequently Asked Questions

Haemate P is a human coagulation factor VIII/von Willebrand factor concentrate administered intravenously. It replaces deficient factor VIII and von Willebrand factor, restoring normal clot formation and platelet adhesion.

Haemate P is prescribed for hemophilia A and von Willebrand disease, particularly type 3, to control bleeding episodes and for surgical prophylaxis.

Haemate P is supplied as a sterile solution for injection and is given by intravenous infusion under medical supervision.

Yes, Haemate P can be used as a regular prophylactic regimen to reduce the frequency of spontaneous bleeding in patients with hemophilia A.

Common side effects include mild headache, fever, chills, infusion site reactions, nausea, transient hypertension, and fatigue.

Serious reactions may include anaphylaxis, development of inhibitors to factor VIII, thromboembolic events, severe hypersensitivity, hemolysis, and acute renal failure.

Yes, screening for factor VIII inhibitors is recommended before initiating therapy to guide dosing and monitor effectiveness.

Haemate P should be avoided in patients with known hypersensitivity to the product or its components and in those with uncontrolled hypertension.

Concurrent use of other factor concentrates without supervision and high‑dose pro‑coagulant agents should be avoided due to increased thrombosis risk.

Antifibrinolytic agents such as tranexamic acid may be used, but they should be administered with caution and under clinical guidance.

Safety data for Haemate P in pregnancy are limited; it should be used only if the potential benefit justifies the potential risk to the fetus.

Haemate P is marketed in the European Union and is available by prescription only.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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