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 plasma‑derived concentrate containing human coagulation factor VIII and von Willebrand factor, supplied for intravenous administration. It is classified as a factor VIII/von Willebrand factor concentrate and is prescribed in the European Union for patients with bleeding disorders. The product provides exogenous clotting proteins to support hemostasis in individuals with hemophilia A or von Willebrand disease and is used under medical supervision.

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 factor deficiencies.

  • Treatment of acute bleeding in hemophilia A patients.
  • Prevention of bleeding during surgical or dental procedures in hemophilia A.
  • Management of bleeding episodes in von Willebrand disease types 1 and 3.
  • Long‑term prophylaxis to reduce frequency of spontaneous bleeds in severe hemophilia A.
  • Replacement therapy in patients with combined factor VIII and von Willebrand factor deficiency.
  • Support of hemostasis in patients undergoing major trauma when factor levels are low.

Side Effects

Adverse reactions to Haemate P have been reported, ranging from mild infusion‑related events to rare serious complications.

Common

  • Headache or mild fever.
  • Transient nausea or vomiting.
  • Localized infusion site reactions such as erythema or swelling.
  • Mild arthralgia or joint discomfort.
  • Fatigue or malaise.

Serious

  • Development of inhibitors (antibodies) against factor VIII.
  • Anaphylactic or severe allergic reactions.
  • Transmission of infectious agents (theoretical risk despite viral inactivation).
  • Thrombotic events (rare).

Precautions & Warnings

Clinicians should consider several precautionary measures before prescribing Haemate P to ensure patient safety and optimal therapeutic outcomes.

  • Assess baseline factor VIII activity and von Willebrand factor levels.
  • Screen for history of inhibitors or allergic reactions to plasma‑derived products.
  • Evaluate for active infections or recent vaccinations.
  • Use caution in patients with cardiovascular disease due to potential thrombotic risk.
  • Monitor for signs of inhibitor development during treatment.
  • Adjust dosing in patients with renal or hepatic impairment as needed.

Avoid Interactions

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

Avoid

  • Concurrent use of other factor concentrates without medical supervision.
  • Administration with high‑dose aspirin or non‑steroidal anti‑inflammatory drugs (NSAIDs) that increase bleeding risk.
  • Use with investigational gene‑therapy agents targeting factor VIII without specialist oversight.
  • Combination with desmopressin (DDAVP) in von Willebrand disease without dose adjustment.

Use with caution

  • Concomitant anticoagulants such as warfarin or direct oral anticoagulants; monitor coagulation parameters closely.
  • Immunosuppressive therapies that may alter inhibitor formation; observe for reduced efficacy.
  • Vaccinations administered shortly before or after infusion; consider timing to minimize immune reactions.
  • Use with heparin; monitor activated partial thromboplastin time (aPTT).

Frequently Asked Questions

Haemate P is a plasma‑derived concentrate that provides human factor VIII and von Willebrand factor to replace deficient clotting proteins and restore normal hemostasis.

It is prescribed for individuals diagnosed with hemophilia A or von Willebrand disease who require factor replacement for bleeding control or surgical prophylaxis.

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

Common adverse events include headache, mild fever, nausea, localized infusion site reactions, joint discomfort, and fatigue.

Yes, a serious but infrequent risk is the formation of antibodies (inhibitors) against factor VIII, which can reduce treatment efficacy.

Haemate P is often used for peri‑operative prophylaxis to maintain adequate clotting factor levels during surgical procedures.

The product should be stored according to the manufacturer’s instructions, typically refrigerated between 2 °C and 8 °C, and protected from light.

Interactions may occur with other clotting factor concentrates, high‑dose NSAIDs, anticoagulants, and certain immunosuppressive or gene‑therapy agents.

Patients are usually monitored for factor activity levels, signs of inhibitor development, and any adverse reactions during and after infusion.

The safety of Haemate P in pregnancy has not been fully established; treatment decisions should be made by a specialist after risk‑benefit assessment.

Haemate P is derived from human plasma and contains both factor VIII and von Willebrand factor, whereas recombinant products are manufactured using cell culture and may contain only factor VIII.

Von Willebrand factor stabilizes factor VIII in circulation and mediates platelet adhesion to damaged vascular surfaces, enhancing clot formation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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