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 coagulation factor concentrate that combines human coagulation factor VIII and human von Willebrand factor. It is supplied as a sterile powder for solution for intravenous injection. The product is manufactured for the European market and is used to replace deficient clotting proteins in patients with hemophilia A or von Willebrand disease, helping to restore normal hemostasis. The formulation is designed for infusion and is stored according to guidelines.

Manufacturer / TM Owner

Csl Behring Gmbh

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Indications & Clinical Uses

Haemate P is indicated for the management of bleeding episodes and peri‑operative prophylaxis in patients with specific clotting disorders.

  • Treatment of acute bleeding in hemophilia A patients with factor VIII deficiency.
  • Prevention of bleeding during surgical or dental procedures in hemophilia A.
  • Management of bleeding episodes in von Willebrand disease types 1, 2, and 3.
  • Long‑term prophylactic therapy to reduce frequency of spontaneous joint bleeds in severe hemophilia A.
  • Supportive therapy in patients undergoing major trauma or invasive diagnostics when factor levels are low.

Side Effects

Adverse reactions reported with Haemate P reflect the typical safety profile of plasma‑derived clotting factor concentrates.

Common

  • Mild infusion‑site reactions such as erythema, warmth, or tenderness.
  • Transient headache or low‑grade fever.
  • Nausea or mild abdominal discomfort.
  • Temporary elevation of liver enzymes without clinical significance.

Serious

  • Development of inhibitors (antibodies) against factor VIII, reducing treatment efficacy.
  • Allergic reactions ranging from urticaria to anaphylaxis.
  • Thromboembolic events, particularly in patients with pre‑existing risk factors.
  • Transmission of viral infections, although modern manufacturing greatly reduces this risk.

Precautions & Warnings

Before prescribing Haemate P, clinicians should evaluate patient history and laboratory data to minimize risks associated with plasma‑derived products.

  • Assess for prior development of factor VIII inhibitors.
  • Review history of allergic reactions to blood products.
  • Evaluate for active thrombotic disease or high risk of thrombosis.
  • Monitor liver function tests periodically during long‑term therapy.
  • Use caution in patients with hepatitis or HIV infection.
  • Ensure appropriate dosing based on body weight and factor activity levels.
  • Store and reconstitute according to manufacturer instructions to maintain product integrity.

Avoid Interactions

Haemate P may interact with other agents that affect hemostasis or immune response, requiring careful management.

Avoid

  • Concomitant use of pro‑coagulant agents such as activated factor VII or prothrombin complex concentrates unless clinically indicated.
  • Administration with high‑dose aspirin or non‑steroidal anti‑inflammatory drugs (NSAIDs) that increase bleeding risk.
  • Simultaneous infusion with large volumes of crystalloid solutions may dilute clotting factors and reduce efficacy.

Use with caution

  • Concurrent immunosuppressive therapy may alter inhibitor development risk.
  • Use with other plasma‑derived products may increase cumulative viral exposure.
  • Combination with antifibrinolytic agents (e.g., tranexamic acid) should be monitored for synergistic clotting effects.

Frequently Asked Questions

Haemate P provides the missing human coagulation factor VIII and von Willebrand factor, restoring the intrinsic coagulation pathway and platelet adhesion to achieve hemostasis.

Haemate P is indicated for the treatment of bleeding episodes in von Willebrand disease types 1, 2, and 3.

Yes, Haemate P may be administered before surgical or dental procedures to prevent peri‑operative bleeding in patients with hemophilia A.

Yes, Haemate P is manufactured from human plasma and undergoes viral inactivation steps to ensure safety.

The product is supplied as a powder for solution for injection and is given intravenously under medical supervision.

Clinicians should monitor factor activity levels, inhibitor development, and liver function tests, especially during long‑term use.

Haemate P should be stored according to the manufacturer’s instructions, typically refrigerated, and protected from light until reconstitution.

Patients with known factor VIII inhibitors require individualized assessment; Haemate P may be less effective in such cases.

Common adverse events include mild infusion‑site reactions, transient headache, low‑grade fever, nausea, and temporary liver enzyme elevations.

When used together, antifibrinolytics such as tranexamic acid may increase clot stability; clinicians should monitor for excessive clotting.

Haemate P is marketed in the European Union; regulatory status in other regions should be confirmed with local health authorities.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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