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Haemate

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

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

Haemate is a prescription‑only hemostatic agent that contains human coagulation factor VIII and human von Willebrand factor. It is supplied as an injectable solution for intravenous administration; the specific strength is not publicly disclosed. 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, supporting normal blood clot formation effectively and physiologically.

Manufacturer / TM Owner

Csl Behring Gmbh

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Indications & Clinical Uses

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

  • Treatment of acute bleeding episodes in patients with hemophilia A.
  • Perioperative prophylaxis to prevent surgical bleeding in hemophilia A.
  • Management of mucosal or gastrointestinal bleeding in von Willebrand disease.
  • Long‑term prophylactic therapy to reduce the frequency of spontaneous bleeds in severe hemophilia A.
  • Replacement therapy for patients with combined factor VIII and von Willebrand factor deficiency.

Side Effects

Adverse reactions reported with Haemate vary in frequency and severity; they are categorized as common or serious.

Common

  • Mild headache or fatigue.
  • Transient fever, chills, or rigors.
  • Local infusion site reactions such as erythema, swelling, or pain.
  • Nausea or vomiting.

Serious

  • Development of inhibitors (antibodies) against factor VIII.
  • Anaphylactic or severe allergic reactions, including urticaria.
  • Thromboembolic events such as deep‑vein thrombosis or pulmonary embolism.
  • Renal impairment or hemolysis.

Precautions & Warnings

Before initiating Haemate therapy, clinicians should evaluate patient history and monitor specific parameters to minimize risk.

  • Assess for prior inhibitors to factor VIII or allergic reactions to plasma‑derived products.
  • Perform baseline coagulation studies and periodic factor activity levels during treatment.
  • Use caution in patients with a history of thrombosis or cardiovascular disease.
  • Monitor for signs of infection, especially viral transmission, as the product is derived from human plasma.
  • Adjust dosing in patients with renal or hepatic impairment as recommended by clinical guidelines.
  • Educate patients on proper infusion techniques and the importance of reporting adverse symptoms promptly.

Avoid Interactions

Haemate may interact with other medications that affect hemostasis or immune response; awareness of these interactions helps ensure safe use.

Avoid

  • Concomitant use of other factor concentrates or bypassing agents without specialist guidance.
  • Administration of pro‑thrombotic agents such as activated protein C or high‑dose estrogen therapy.

Use with caution

  • Antifibrinolytic agents (e.g., tranexamic acid) may augment hemostatic effect and require dose adjustment.
  • Immunosuppressive drugs can alter inhibitor development risk and should be monitored.
  • Vaccinations, particularly live vaccines, should be timed appropriately around infusion sessions.
  • Renal‑clearing medications such as aminoglycosides may affect drug clearance and need monitoring.

Frequently Asked Questions

Haemate supplies exogenous human factor VIII and von Willebrand factor, which replace the deficient clotting proteins, enabling the intrinsic coagulation pathway to generate thrombin and form a stable fibrin clot.

Haemate is provided as a sterile solution for injection and is administered intravenously under the supervision of a healthcare professional.

Yes, Haemate contains both factor VIII and von Willebrand factor, making it suitable for treating bleeding episodes in patients with hemophilia A, von Willebrand disease, or combined deficiencies.

Clinicians typically monitor factor activity levels, inhibitor development, complete blood counts, and signs of allergic reactions or thrombosis throughout treatment.

Haemate is a plasma‑derived product that undergoes viral inactivation and purification processes to ensure safety.

The product should be stored in a refrigerator (2‑8 °C) and protected from light; it must not be frozen.

Yes, Haemate can be administered before surgery to provide prophylactic coverage and reduce intra‑operative bleeding in patients with hemophilia A.

A mild fever is a common reaction; patients should inform their healthcare provider, who may assess the need for antipyretics or further evaluation.

Haemate is contraindicated in patients with known hypersensitivity to any component of the product or a history of severe allergic reactions to plasma‑derived clotting factors.

Haemate is plasma‑derived and contains both factor VIII and von Willebrand factor, whereas recombinant products contain only factor VIII and are produced using cell‑culture technology.

Administration should be performed by trained medical personnel familiar with intravenous infusion techniques and the management of potential infusion‑related reactions.

Haemate may be prescribed for children with hemophilia A or von Willebrand disease, but dosing and monitoring should follow pediatric guidelines established by the treating specialist.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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