GNH USA

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.

Human Von Willebrand Factor

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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?+
Haemate P is a plasma‑derived concentrate of human von Willebrand factor that is administered intravenously to replace deficient von Willebrand factor, supporting platelet adhesion and stabilizing factor VIII.
For which types of von Willebrand disease is Haemate P approved?+
Haemate P is approved for all types of von Willebrand disease, including type 1, type 2 (sub‑types), and type 3.
How is Haemate P administered to patients?+
Haemate P is supplied as a sterile solution for injection and is given by intravenous infusion under medical supervision.
Can Haemate P be used to prevent bleeding during surgery?+
Yes, Haemate P may be used perioperatively to control or prevent bleeding in patients with von Willebrand disease undergoing surgical or invasive procedures.
What are the common side effects of Haemate P infusion?+
Common side effects include headache, nausea or vomiting, fever or chills, and mild infusion‑site reactions such as redness or swelling.
Are there any serious risks associated with Haemate P treatment?+
Serious risks, although rare, can include allergic reactions (including anaphylaxis), thromboembolic events, development of inhibitors to von Willebrand factor, and severe hypotension.
How should clinicians monitor patients receiving Haemate P?+
Patients should be monitored for signs of allergic reaction, thrombosis, vital signs during infusion, and laboratory parameters such as factor VIII activity and inhibitor development.
Is Haemate P safe for use during pregnancy?+
The safety of Haemate P in pregnancy has not been established; it should be used only if the potential benefit justifies the potential risk to the fetus.
What should be done if a patient experiences an allergic reaction to Haemate P?+
Infusion should be stopped immediately, and appropriate medical treatment such as antihistamines, corticosteroids, or epinephrine should be administered as needed.
Can Haemate P be combined with antifibrinolytic agents?+
Antifibrinolytic agents like tranexamic acid may be used together with Haemate P, but clinicians should monitor for enhanced hemostatic effect.
How does Haemate P differ from recombinant von Willebrand factor products?+
Haemate P is derived from human plasma, whereas recombinant products are produced using genetically engineered cell lines; both provide von Willebrand factor but differ in source and potential immunogenicity.
What are the recommended storage conditions for Haemate P?+
Haemate P should be stored in a refrigerator (2‑8 °C) and protected from light; do not freeze. Once prepared for infusion, it should be used within the time frame specified by the manufacturer.
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 Von Willebrand Factor
Route
Intravenous Use
Manufacturer
Csl Behring E.P.E.
Origin
EU

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