Europe — EMA
Haemate
Haemate is an EU‑approved 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 injectable solution containing human coagulation factor VIII and human von Willebrand factor. It is supplied as an intravenous preparation used to replace deficient clotting proteins in patients with hemophilia A or von Willebrand disease. The product is manufactured in the European Union and is indicated for routine prophylaxis, on‑demand treatment of bleeding episodes, and perioperative management.
What is Human Coagulation Factor Viii, Human Von Willebrand Factor used for?
Haemate is used to manage bleeding disorders that involve deficiency of factor VIII and von Willebrand factor.
- Routine prophylaxis in patients with severe hemophilia A to maintain trough factor levels. - Treatment of acute bleeding episodes in hemophilia A. - Management of surgical or invasive procedures in hemophilia A to prevent peri‑operative hemorrhage. - Prevention and control of bleeding in patients with von Willebrand disease, including type 1, 2, and 3. - Support 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 are generally related to the infusion or immune response.
Common: - Mild fever or chills during infusion. - Headache or fatigue. - Nausea or mild abdominal discomfort. - Local site reactions such as redness or swelling.
Serious: - Development of inhibitors (antibodies) against factor VIII. - Anaphylactic or severe allergic reactions. - Thromboembolic events (rare). - Severe hypertension or renal impairment.
What precautions apply to Human Coagulation Factor Viii, Human Von Willebrand Factor?
Healthcare providers should evaluate patient history and monitor for specific risks before and during Haemate therapy.
- Screen for prior inhibitors to factor VIII. - Assess for history of allergic reactions to plasma‑derived products. - Use caution in patients with cardiovascular disease or thrombosis risk. - Monitor renal and hepatic function during long‑term treatment. - Adjust dosing in pediatric or elderly patients as appropriate. - Avoid use in patients with known hypersensitivity to any component of the formulation.
What does Human Coagulation Factor Viii, Human Von Willebrand Factor interact with?
Haemate may interact with other medications that affect hemostasis or immune response.
Avoid: - Concomitant use of other factor concentrates without medical supervision. - Administration of antifibrinolytic agents (e.g., tranexamic acid) in high doses without monitoring.
Use with caution: - Immunosuppressive drugs that may alter inhibitor development. - Vaccines administered shortly before or after infusion. - Concurrent anticoagulants (e.g., warfarin) may require dose adjustment.
Frequently asked questions
What is the active ingredient in Haemate?+
For which conditions is Haemate prescribed?+
How is Haemate administered?+
Can Haemate be used for surgical prophylaxis?+
What are common side effects of Haemate?+
What serious adverse reactions should be monitored with Haemate?+
Should patients be screened for inhibitors before starting Haemate?+
Is it safe to use Haemate with other clotting factor concentrates?+
Can Haemate be given to children?+
What monitoring is required during long‑term Haemate therapy?+
Are there any contraindications for Haemate?+
How should Haemate be stored before use?+
Product details
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