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 intravenous medication that contains human coagulation factor VIII and human von Willebrand factor. It is supplied as a sterile solution for infusion, with the specific strength determined by the manufacturer. The product is classified as a hemostatic agent and is clinically used in the European market to replace deficient clotting proteins in patients with hemophilia A or von Willebrand disease.

Manufacturer / TM Owner

Csl Behring Gmbh

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Indications & Clinical Uses

Haemate P is indicated for the management of bleeding disorders that involve deficiency of factor VIII and von Willebrand factor.

  • Treatment of acute bleeding episodes in patients with hemophilia A.
  • Prophylactic replacement therapy to prevent spontaneous bleeds in hemophilia A.
  • Management of bleeding episodes in patients with von Willebrand disease types 1, 2, and 3.
  • Perioperative hemostatic support for surgical or dental procedures in individuals with these clotting factor deficiencies.
  • Use in combination with other clotting factor concentrates when indicated by a specialist.

Side Effects

Potential adverse reactions to Haemate P have been reported, ranging from mild to severe.

Common

  • Headache or mild fever.
  • Nausea, vomiting, or abdominal discomfort.
  • Local infusion site reactions such as redness or swelling.
  • Transient increase in blood pressure during infusion.
  • Mild joint pain or swelling.

Serious

  • Development of inhibitors (antibodies) against factor VIII or von Willebrand factor.
  • Allergic reactions including rash, urticaria, or anaphylaxis.
  • Thromboembolic events such as deep vein thrombosis or pulmonary embolism.

Precautions & Warnings

When prescribing Haemate P, clinicians should consider several precautionary measures to ensure safe use.

  • Assess for a history of inhibitors to factor VIII before initiating therapy.
  • Monitor for signs of allergic reactions during and after infusion.
  • Evaluate cardiovascular status, especially in patients with a history of thrombosis.
  • Use caution in patients with renal or hepatic impairment, adjusting dosing as needed.
  • Conduct regular laboratory testing to verify factor levels and treatment efficacy.
  • Avoid use in patients with known hypersensitivity to any component of the product.

Avoid Interactions

Haemate P may interact with other medications, influencing clotting balance or immune response.

Avoid

  • Concomitant use of other factor VIII concentrates without specialist guidance.
  • Administration of high‑dose pro‑coagulant agents that could increase thrombosis risk.

Use with caution

  • Antifibrinolytic agents (e.g., tranexamic acid) may enhance hemostatic effect and require monitoring.
  • Immunosuppressive drugs could affect inhibitor development.
  • Certain antibiotics (e.g., beta‑lactams) have been associated with hypersensitivity reactions in some patients.
  • Vaccines administered shortly before or after infusion may alter immune response.

Frequently Asked Questions

Haemate P replaces deficient human factor VIII and von Willebrand factor, restoring normal clot formation in patients with hemophilia A or von Willebrand disease.

Haemate P is given as an intravenous infusion under the supervision of a healthcare professional.

Yes, Haemate P can be used as a prophylactic replacement therapy to reduce the frequency of spontaneous bleeding episodes in hemophilia A.

Haemate P is marketed in the European Union; its regulatory status in the United States may differ and should be confirmed with local authorities.

Patients typically undergo regular laboratory testing to measure factor VIII and von Willebrand factor activity levels and to detect possible inhibitor development.

Common side effects include headache, mild fever, nausea, local infusion site reactions, transient blood pressure changes, and mild joint discomfort.

Serious reactions such as development of inhibitors, severe allergic responses (including anaphylaxis), or signs of thrombosis require prompt medical attention.

Caution is advised; clinicians should evaluate cardiovascular risk and may avoid or closely monitor use in patients with a known history of thrombotic events.

Antifibrinolytic agents like tranexamic acid can be used together with Haemate P, but the combination should be managed carefully to avoid excessive clotting.

Haemate P should be stored according to the manufacturer’s instructions, typically refrigerated, and protected from light until it is prepared for infusion.

Yes, some patients may develop inhibitors (antibodies) against factor VIII or von Willebrand factor, which can reduce the effectiveness of the therapy.

The dosing schedule for surgical prophylaxis is individualized; a specialist determines the timing and amount based on the type of procedure and patient’s factor levels.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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