Europe — EMA
Haemate
Haemate is a prescription injectable containing human factor VIII and von Willebrand factor for hemophilia A and von Willebrand disease treatment.
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What is 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.
What is Human Coagulation Factor Viii, Human Von Willebrand Factor used for?
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.
What are the side effects of Human Coagulation Factor Viii, Human Von Willebrand Factor?
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.
What precautions apply to Human Coagulation Factor Viii, Human Von Willebrand Factor?
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.
What does Human Coagulation Factor Viii, Human Von Willebrand Factor interact with?
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
What is the mechanism of action of Haemate in hemophilia A?+
How is Haemate administered to patients?+
Can Haemate be used for both hemophilia A and von Willebrand disease?+
What monitoring is required during Haemate therapy?+
Is Haemate derived from human plasma?+
What are the storage conditions for Haemate?+
Can Haemate be used in surgical prophylaxis?+
What should a patient do if they develop a fever after infusion?+
Are there any contraindications for Haemate?+
How does Haemate differ from recombinant factor VIII products?+
Is special training required for healthcare providers to administer Haemate?+
Can Haemate be used in pediatric patients?+
Product details
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