Europe — EMA
Haemate P
Haemate P is an IV coagulation factor VIII and von Willebrand factor product for hemophilia A and von Willebrand disease treatment in the EU.
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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 von Willebrand factor. It is supplied for intravenous administration and is used to replace deficient clotting proteins in patients with hemophilia A or von Willebrand disease. The product is marketed in the European Union and is classified as a coagulation factor replacement therapy.
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 and von Willebrand factor deficiencies. It is used in both prophylactic and on‑demand treatment settings.
- Treatment of acute bleeding episodes in hemophilia A patients. - Routine prophylaxis to prevent spontaneous bleeds in hemophilia A. - Management of bleeding episodes in von Willebrand disease. - Perioperative hemostatic support for surgical procedures in patients with these disorders. - Replacement 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?
Side effects of Haemate P vary in frequency and severity. Patients should be monitored for any adverse reactions during and after infusion.
Common: - Headache - Fever or chills - Nausea or vomiting - Injection site reactions such as redness or swelling - Mild hypertension - Transient increase in liver enzymes
Serious: - Development of inhibitors (antibodies) against factor VIII - Anaphylactic or severe allergic reactions - Thromboembolic events (blood clots) - Severe hypertension or hypertensive crisis
What precautions apply to Human Coagulation Factor Viii, Human Von Willebrand Factor?
Before using Haemate P, certain precautions should be considered to ensure safe administration.
- Assess for a history of inhibitors to factor VIII or von Willebrand factor. - Monitor for signs of allergic reactions during infusion. - Use caution in patients with cardiovascular disease or a history of thrombosis. - Evaluate liver and renal function prior to initiating therapy. - Adjust dosing in pediatric patients based on weight and clinical response. - Ensure proper aseptic technique to prevent contamination of the intravenous line.
What does Human Coagulation Factor Viii, Human Von Willebrand Factor interact with?
Haemate P may interact with other medications that affect hemostasis or immune response.
Avoid: - Concurrent use of other clotting factor concentrates without medical supervision. - High‑dose aspirin or non‑steroidal anti‑inflammatory drugs (NSAIDs) that increase bleeding risk.
Use with caution: - Antifibrinolytic agents (e.g., tranexamic acid) when combined with factor replacement. - Immunosuppressive therapies that may alter inhibitor development. - Medications that affect blood pressure, such as vasoconstrictors. - Live vaccines, due to potential immune modulation.
Frequently asked questions
What is the mechanism of action of Haemate P?+
How is Haemate P administered?+
Can Haemate P be used for both prophylaxis and on‑demand treatment?+
What monitoring is required during Haemate P therapy?+
Is Haemate P suitable for pediatric patients?+
What are the most common side effects of Haemate P?+
What serious adverse reactions should be reported?+
Can Haemate P be combined with antifibrinolytic agents?+
Are there any contraindications for Haemate P?+
How should Haemate P be stored?+
What should patients do if they miss a scheduled dose?+
Is Haemate P approved for use outside the European Union?+
Product details
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