Europe — EMA
Haemate P
Haemate P is a plasma‑derived von Willebrand factor concentrate for IV use, indicated for treating and preventing bleeding in von Willebrand disease.
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What is Human Von Willebrand Factor?
Haemate P is a plasma‑derived human von Willebrand factor concentrate supplied as a solution for injection for intravenous use. It contains purified human von Willebrand factor and is marketed in the European Union as a hemostatic agent. The product is designed to replace deficient von Willebrand factor in patients with von Willebrand disease or related bleeding disorders and may be used under medical supervision for acute treatment or prophylaxis.
What is Human Von Willebrand Factor used for?
Haemate P is indicated for the management of bleeding associated with von Willebrand disease and related conditions.
- Treatment of all types of von Willebrand disease (type 1, 2, and 3) to control acute bleeding episodes. - Prophylactic administration to prevent recurrent bleeding in patients with von Willebrand disease. - Management of surgical or invasive procedure‑related bleeding in patients with von Willebrand disease. - Treatment of hemophilia A patients who have low von Willebrand factor levels and require factor VIII stabilization. - Use in pediatric and adult patients under the direction of a hematology specialist.
What are the side effects of Human Von Willebrand Factor?
Adverse reactions to Haemate P have been reported, ranging from mild infusion‑related events to rare serious complications.
Common: - Headache - Nausea or vomiting - Fever or chills - Mild infusion site reactions such as erythema or swelling
Serious: - Allergic reactions including urticaria, angioedema, or anaphylaxis - Thromboembolic events such as deep‑vein thrombosis or pulmonary embolism - Development of inhibitors to von Willebrand factor - Hemolytic reactions or severe hypotension
What precautions apply to Human Von Willebrand Factor?
When prescribing Haemate P, clinicians should consider several safety precautions to minimize risk.
- Assess patient history for previous allergic reactions to plasma‑derived products. - Monitor for signs of thrombosis, especially in patients with cardiovascular risk factors. - Use caution in patients with liver disease or impaired renal function. - Evaluate for the presence of inhibitors to von Willebrand factor before initiating therapy. - Ensure appropriate dosing and infusion rate to reduce infusion‑related reactions. - Pregnant or breastfeeding patients should be managed only if the potential benefit outweighs uncertain risks.
What does Human Von Willebrand Factor interact with?
Haemate P may interact with other medications; awareness of potential interactions helps ensure safe use.
Avoid: - Concomitant use of other plasma‑derived clotting factor concentrates unless specifically indicated. - Administration with high‑dose aspirin or other non‑steroidal anti‑inflammatory drugs that increase bleeding risk.
Use with caution: - Antifibrinolytic agents such as tranexamic acid, which may enhance hemostatic effect. - Hormonal contraceptives or hormone replacement therapy that may affect clotting balance. - Heparin or low‑molecular‑weight heparin, requiring close monitoring of coagulation parameters.
Frequently asked questions
What is Haemate P and how does it work?+
For which types of von Willebrand disease is Haemate P approved?+
How is Haemate P administered to patients?+
Can Haemate P be used to prevent bleeding during surgery?+
What are the common side effects of Haemate P infusion?+
Are there any serious risks associated with Haemate P treatment?+
How should clinicians monitor patients receiving Haemate P?+
Is Haemate P safe for use during pregnancy?+
What should be done if a patient experiences an allergic reaction to Haemate P?+
Can Haemate P be combined with antifibrinolytic agents?+
How does Haemate P differ from recombinant von Willebrand factor products?+
What are the recommended storage conditions for Haemate P?+
Product details
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