GNH USA

Europe — EMA

Haemate P

Haemate P is a prescription IV solution containing factor VIII and von Willebrand factor for hemophilia A and von Willebrand disease treatment.

Human Coagulation Factor Viii, Human Von Willebrand Factor

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What is Human Coagulation Factor Viii, Human Von Willebrand Factor?

Haemate P is a prescription solution for injection that contains human coagulation factor VIII and human von Willebrand factor. It is supplied as a sterile liquid concentrate without a specified strength, intended for intravenous administration. The product is used in the European market to replace deficient clotting factors in patients with hemophilia A or von Willebrand disease, helping to support normal blood clot formation.

What is Human Coagulation Factor Viii, Human Von Willebrand Factor used for?

Haemate P is indicated for the management of bleeding episodes and perioperative prophylaxis in patients with specific clotting disorders. It is used under medical supervision to replace missing clotting proteins.

- Treatment of acute bleeding episodes in hemophilia A patients. - Surgical or invasive procedure prophylaxis for hemophilia A. - Management of bleeding in von Willebrand disease types 1, 2, and 3. - Long‑term prophylaxis to reduce frequency of spontaneous bleeds in severe hemophilia A. - Adjunct therapy when other factor concentrates are unavailable or contraindicated.

What are the side effects of Human Coagulation Factor Viii, Human Von Willebrand Factor?

Side effects of Haemate P may vary in frequency and severity. Patients should be monitored for any adverse reactions during and after infusion.

Common: - Headache or mild dizziness. - Fever or chills. - Injection site pain, redness, or swelling. - Nausea or mild gastrointestinal discomfort. - Transient increase in blood pressure.

Serious: - Development of inhibitors (antibodies) against factor VIII. - Allergic reactions including rash, urticaria, or anaphylaxis. - Thromboembolic events such as deep vein thrombosis. - Hemolysis or renal impairment. - Severe hypotension or shock.

What precautions apply to Human Coagulation Factor Viii, Human Von Willebrand Factor?

Healthcare providers should assess individual risk factors before initiating Haemate P therapy. Monitoring and patient education are essential.

- Screen for a history of inhibitors to factor VIII before treatment. - Use caution in patients with cardiovascular disease or a history of thrombosis. - Monitor for signs of allergic reactions during infusion. - Adjust dosing in patients with renal or hepatic impairment as clinically indicated. - Ensure proper aseptic technique to prevent contamination. - Educate patients on recognizing symptoms of inhibitor development and thrombosis.

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. Review patient medication lists carefully.

Avoid: - Concurrent use of pro‑coagulant agents (e.g., activated prothrombin complex concentrates) without specialist guidance. - High‑dose aspirin or non‑steroidal anti‑inflammatory drugs (NSAIDs) that increase bleeding risk.

Use with caution: - Immunosuppressive therapies that may alter inhibitor formation. - Antifibrinolytic agents (e.g., tranexamic acid) when combined with factor replacement. - Other plasma‑derived products that could increase viral transmission risk. - Vaccinations administered shortly before or after infusion.

Frequently asked questions

What is the active composition of Haemate P?+
Haemate P contains human coagulation factor VIII and human von Willebrand factor as its active ingredients.
How is Haemate P administered to patients?+
Haemate P is supplied as a sterile solution for intravenous injection and is administered under medical supervision.
Which conditions are treated with Haemate P?+
Haemate P is used to treat hemophilia A and various types of von Willebrand disease, including managing bleeding episodes and surgical prophylaxis.
Can Haemate P be used for long‑term prophylaxis in hemophilia A?+
Yes, Haemate P may be prescribed for long‑term prophylaxis to reduce the frequency of spontaneous bleeds in patients with severe hemophilia A.
What are common side effects of Haemate P?+
Common side effects include headache, fever, injection‑site reactions, mild nausea, and transient blood pressure changes.
What serious adverse reactions should be monitored?+
Serious reactions can include development of inhibitors to factor VIII, allergic reactions such as anaphylaxis, thromboembolic events, and severe hypotension.
Should patients be screened for inhibitors before using Haemate P?+
Yes, screening for existing factor VIII inhibitors is recommended before initiating therapy with Haemate P.
Are there any medications that should be avoided with Haemate P?+
Pro‑coagulant agents and high‑dose aspirin or NSAIDs should generally be avoided unless directed by a specialist.
Is Haemate P safe for patients with a history of thrombosis?+
Patients with a history of thrombosis should be monitored closely, and the use of Haemate P should be evaluated by a healthcare professional.
Can Haemate P be used together with antifibrinolytic drugs?+
Antifibrinolytic agents such as tranexamic acid can be used with caution alongside Haemate P, following specialist advice.
What monitoring is required during Haemate P infusion?+
Patients should be observed for signs of allergic reactions, inhibitor development, and changes in vital signs during and after infusion.
Is Haemate P available over the counter?+
No, Haemate P is a prescription‑only medication and must be prescribed by a qualified healthcare provider.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Human Coagulation Factor Viii, Human Von Willebrand Factor
Route
Intravenous Use
Manufacturer
Csl Behring Gmbh
Origin
EU

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