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 concentrate containing human coagulation factor VIII and von Willebrand factor. It is supplied as a sterile solution for intravenous infusion. The product is marketed in the European Union and is classified as a factor VIII/VWF concentrate used to replace deficient clotting proteins. It is indicated for patients with hemophilia A or von Willebrand disease who require prophylactic or on‑demand treatment to achieve hemostasis.

Manufacturer / TM Owner

Csl Behring Gmbh

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Indications & Clinical Uses

Haemate P is used to manage bleeding disorders that involve deficiency of factor VIII, von Willebrand factor, or both.

  • Prophylactic replacement therapy in patients with severe hemophilia A to prevent spontaneous joint and muscle bleeds.
  • On‑demand treatment of acute bleeding episodes in hemophilia A.
  • Management of bleeding episodes and surgical prophylaxis in patients with von Willebrand disease types 1, 2, and 3.
  • Peri‑operative hemostatic coverage for surgical or invasive procedures in individuals with combined factor VIII and VWF deficiency.
  • Supportive therapy in patients undergoing major trauma when factor levels are low.

Side Effects

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

Common

  • Mild headache or fatigue, typically transient and not requiring specific treatment.
  • Low-grade fever or chills occurring shortly after infusion, usually resolving within 24 hours.
  • Local infusion site reactions such as erythema, mild pain, or swelling at the catheter site.

Serious

  • Development of inhibitors (neutralizing antibodies) to factor VIII, which can reduce treatment efficacy and may require alternative therapies.
  • Severe allergic reactions, including urticaria, bronchospasm, or anaphylaxis, necessitating immediate medical intervention.
  • Thromboembolic events such as deep‑vein thrombosis or pulmonary embolism, particularly in patients with pre‑existing risk factors.

Precautions & Warnings

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

  • Test for factor VIII inhibitors before initiating therapy and periodically during treatment.
  • Assess for a history of allergic reactions to plasma‑derived products.
  • Use caution in patients with a history of thrombosis or cardiovascular disease.
  • Monitor for signs of infection, especially if the product is administered via a central line.
  • Adjust dosage in patients with renal or hepatic impairment as recommended by clinical guidelines.
  • Avoid use in patients with known hypersensitivity to any component of the formulation.

Avoid Interactions

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

Avoid

  • Concomitant use of other factor concentrates or bypassing agents without specialist guidance, as this may increase thrombotic risk.
  • Administration with high‑dose aspirin or non‑steroidal anti‑inflammatory drugs (NSAIDs) that impair platelet function.

Use with caution

  • Antifibrinolytic agents such as tranexamic acid, which can augment clot stability when used together.
  • Immunosuppressive therapies that may alter inhibitor development.
  • Vaccinations administered shortly before or after infusion, which could affect immune response.
  • Heparin or low‑molecular‑weight heparin, requiring careful monitoring of anticoagulation parameters.

Frequently Asked Questions

Haemate P is a prescription intravenous concentrate that contains human coagulation factor VIII and von Willebrand factor, used to replace deficient clotting proteins.

Haemate P is administered by intravenous infusion under the supervision of a healthcare professional.

Haemate P is indicated for hemophilia A and von Willebrand disease, including prophylaxis and treatment of bleeding episodes.

Yes, Haemate P can be used as regular prophylactic replacement therapy to prevent spontaneous bleeds in patients with severe hemophilia A.

Common side effects include mild headache or fatigue, low‑grade fever or chills, and local infusion‑site reactions such as erythema or mild pain.

Serious reactions include development of factor VIII inhibitors, severe allergic responses (including anaphylaxis), and thromboembolic events like deep‑vein thrombosis.

Inhibitor testing is recommended before starting therapy and periodically thereafter, as advised by the treating hematologist.

Haemate P should not be used in patients with known hypersensitivity to any of its components or to other plasma‑derived products.

Concurrent use of other factor concentrates or bypassing agents without specialist guidance and high‑dose aspirin or NSAIDs should be avoided.

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

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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