Europe — EMA
Haemate P
Haemate P is an IV concentrate of 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 P is a prescription intravenous solution containing human coagulation factor VIII and human von Willebrand factor. It is supplied as a sterile concentrate for intravenous infusion. The product is used in the European market to replace deficient clotting factors in patients with hemophilia A or von Willebrand disease. Its formulation provides both factor VIII and von Willebrand activity in a single preparation for treatment.
What is Human Coagulation Factor Viii, Human Von Willebrand Factor used for?
Haemate P is indicated for the management of bleeding disorders related to factor VIII deficiency.
- Treatment of acute bleeding episodes in patients with hemophilia A. - Routine prophylaxis to prevent spontaneous bleeds in hemophilia A. - Management of bleeding and surgical prophylaxis in von Willebrand disease of any type. - Replacement therapy during major surgery or invasive procedures in patients lacking factor VIII or von Willebrand factor. - Supportive therapy in 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 P vary in frequency and severity.
Common: - Headache, fever, chills, or infusion‑related reactions such as erythema at the site. - Nausea, vomiting, or abdominal discomfort. - Transient elevations in liver enzymes. - Mild allergic symptoms like rash or itching.
Serious: - Development of inhibitors (antibodies) against factor VIII, reducing efficacy. - Severe allergic reactions including anaphylaxis. - Thrombotic events such as deep vein thrombosis. - Renal impairment or hemolysis in rare cases.
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.
- Screen for pre‑existing factor VIII inhibitors before initiating therapy. - Monitor inhibitor titres regularly during long‑term treatment. - Use caution in patients with a history of allergic reactions to plasma‑derived products. - Adjust dose in individuals with renal or hepatic impairment. - Avoid rapid infusion rates to reduce risk of infusion‑related reactions. - Observe for signs of thrombosis, especially in patients receiving concurrent pro‑coagulant agents.
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 concentrates without medical supervision. - High‑dose aspirin or non‑steroidal anti‑inflammatory drugs that increase bleeding risk.
Use with caution: - Immunosuppressive agents that may alter inhibitor development. - Antifibrinolytic agents (e.g., tranexamic acid) when used together, requiring dose adjustment. - Other intravenous products administered through the same line without proper flushing.
Frequently asked questions
What is the mechanism of action of Haemate P?+
For which types of von Willebrand disease is Haemate P used?+
Can Haemate P be used for surgical prophylaxis?+
How is Haemate P administered?+
What monitoring is recommended during Haemate P therapy?+
Is Haemate P suitable for pediatric patients?+
What are common infusion‑related side effects of Haemate P?+
What serious adverse events require immediate medical attention?+
Can Haemate P be combined with antifibrinolytic agents?+
What precautions are needed for patients with renal impairment?+
Is Haemate P a plasma‑derived product?+
What regulatory status does Haemate P have in the EU?+
Product details
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