Europe — EMA
Haemate P
Haemate P is a plasma‑derived factor VIII and von Willebrand factor concentrate for hemophilia A and von Willebrand disease, administered intravenously.
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What is Human Coagulation Factor Viii, Human Von Willebrand Factor?
Haemate P is a plasma‑derived concentrate containing human coagulation factor VIII and von Willebrand factor, supplied for intravenous administration. It is classified as a factor VIII/von Willebrand factor concentrate and is prescribed in the European Union for patients with bleeding disorders. The product provides exogenous clotting proteins to support hemostasis in individuals with hemophilia A or von Willebrand disease and is used under medical supervision.
What is Human Coagulation Factor Viii, Human Von Willebrand Factor used for?
Haemate P is indicated for the management of bleeding episodes and peri‑operative prophylaxis in patients with specific clotting factor deficiencies.
- Treatment of acute bleeding in hemophilia A patients. - Prevention of bleeding during surgical or dental procedures in hemophilia A. - Management of bleeding episodes in von Willebrand disease types 1 and 3. - Long‑term prophylaxis to reduce frequency of spontaneous bleeds in severe hemophilia A. - Replacement therapy in patients with combined factor VIII and von Willebrand factor deficiency. - Support of hemostasis in patients undergoing major trauma when factor levels are low.
What are the side effects of Human Coagulation Factor Viii, Human Von Willebrand Factor?
Adverse reactions to Haemate P have been reported, ranging from mild infusion‑related events to rare serious complications.
Common: - Headache or mild fever. - Transient nausea or vomiting. - Localized infusion site reactions such as erythema or swelling. - Mild arthralgia or joint discomfort. - Fatigue or malaise.
Serious: - Development of inhibitors (antibodies) against factor VIII. - Anaphylactic or severe allergic reactions. - Transmission of infectious agents (theoretical risk despite viral inactivation). - Thrombotic events (rare).
What precautions apply to Human Coagulation Factor Viii, Human Von Willebrand Factor?
Clinicians should consider several precautionary measures before prescribing Haemate P to ensure patient safety and optimal therapeutic outcomes.
- Assess baseline factor VIII activity and von Willebrand factor levels. - Screen for history of inhibitors or allergic reactions to plasma‑derived products. - Evaluate for active infections or recent vaccinations. - Use caution in patients with cardiovascular disease due to potential thrombotic risk. - Monitor for signs of inhibitor development during treatment. - Adjust dosing in patients with renal or hepatic impairment as needed.
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, requiring careful management.
Avoid: - Concurrent use of other factor concentrates without medical supervision. - Administration with high‑dose aspirin or non‑steroidal anti‑inflammatory drugs (NSAIDs) that increase bleeding risk. - Use with investigational gene‑therapy agents targeting factor VIII without specialist oversight. - Combination with desmopressin (DDAVP) in von Willebrand disease without dose adjustment.
Use with caution: - Concomitant anticoagulants such as warfarin or direct oral anticoagulants; monitor coagulation parameters closely. - Immunosuppressive therapies that may alter inhibitor formation; observe for reduced efficacy. - Vaccinations administered shortly before or after infusion; consider timing to minimize immune reactions. - Use with heparin; monitor activated partial thromboplastin time (aPTT).
Frequently asked questions
What is Haemate P and how does it work?+
Which patients are eligible for Haemate P therapy?+
How is Haemate P administered?+
What are the common side effects of Haemate P?+
Can Haemate P cause inhibitor development?+
Is Haemate P safe for use during surgery?+
How should Haemate P be stored before use?+
Are there any known drug interactions with Haemate P?+
What monitoring is required while receiving Haemate P?+
Can pregnant women receive Haemate P?+
How does Haemate P differ from recombinant factor VIII products?+
What is the mechanism of action of von Willebrand factor in Haemate P?+
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