Europe — EMA
Haemate P
Haemate P is an IV replacement therapy containing human factor VIII and von Willebrand factor for hemophilia A and von Willebrand disease.
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What is Human Coagulation Factor Viii, Human Von Willebrand Factor?
Haemate P is a prescription medication that contains human coagulation factor VIII and human von Willebrand factor. It is supplied as an intravenous solution; the specific strength is not disclosed. The product is used to replace deficient clotting proteins in patients with hemophilia A or von Willebrand disease, helping to restore normal blood clotting. It is marketed in the European Union and requires administration by a healthcare professional.
What is Human Coagulation Factor Viii, Human Von Willebrand Factor used for?
Haemate P is indicated for the management of bleeding disorders that involve deficiency of factor VIII and von Willebrand factor.
- Treatment of acute bleeding episodes in patients with hemophilia A. - Routine prophylaxis to prevent spontaneous bleeds in hemophilia A. - Management of bleeding episodes in von Willebrand disease types 1, 2, and 3. - Perioperative control of hemostasis for surgical or dental procedures in affected individuals.
What are the side effects of Human Coagulation Factor Viii, Human Von Willebrand Factor?
Adverse reactions reported with Haemate P vary in frequency and severity.
Common: - Headache. - Fever. - Nausea or vomiting. - Injection site reactions such as redness or swelling.
Serious: - Development of inhibitors (antibodies) against factor VIII. - Allergic reactions including anaphylaxis. - Thromboembolic events. - Renal dysfunction.
What precautions apply to Human Coagulation Factor Viii, Human Von Willebrand Factor?
Clinicians should consider several precautions when prescribing Haemate P to ensure safe use.
- Assess inhibitor status before initiating therapy. - Monitor for signs of allergic reactions during and after infusion. - Use caution in patients with a history of thrombosis. - Adjust dose in individuals with renal impairment. - Avoid use in patients with known hypersensitivity to any component of the product. - Ensure proper storage conditions to maintain product stability.
What does Human Coagulation Factor Viii, Human Von Willebrand Factor interact with?
Haemate P may interact with other medications that affect coagulation or immune response.
Avoid: - Concomitant use of other factor VIII concentrates without medical supervision. - Administration of pro‑thrombotic agents such as activated protein C. Use with caution: - Antifibrinolytic agents (e.g., tranexamic acid) may increase clot stability. - Immunosuppressive drugs that could alter inhibitor development. - Certain antibiotics (e.g., beta‑lactams) that may provoke hypersensitivity. - Vaccines administered shortly before or after infusion.
Frequently asked questions
What is the mechanism of action of Haemate P?+
For which types of von Willebrand disease is Haemate P used?+
How is Haemate P administered?+
Can Haemate P be used for prophylactic treatment in hemophilia A?+
What are common side effects of Haemate P?+
What serious adverse reactions should patients be aware of?+
How should clinicians monitor for inhibitors when using Haemate P?+
Is dose adjustment required for patients with renal impairment?+
Can Haemate P be given together with antifibrinolytic agents?+
What storage conditions are recommended for Haemate P?+
Is Haemate P available outside the European Union?+
How often is Haemate P typically administered for acute bleeds?+
Product details
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