GNH USA

Europe — EMA

Haemate P

Haemate P is an IV concentrate of human 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 intravenous solution containing human coagulation factor VIII and human von Willebrand factor. It is supplied as a sterile concentrate for intravenous infusion. The product is used in the European market to replace deficient clotting factors in patients with hemophilia A or von Willebrand disease. Its formulation provides both factor VIII and von Willebrand activity in a single preparation for treatment.

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 deficiency.

- Treatment of acute bleeding episodes in patients with hemophilia A. - Routine prophylaxis to prevent spontaneous bleeds in hemophilia A. - Management of bleeding and surgical prophylaxis in von Willebrand disease of any type. - Replacement therapy during major surgery or invasive procedures in patients lacking factor VIII or von Willebrand factor. - Supportive 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?

Adverse reactions reported with Haemate P vary in frequency and severity.

Common: - Headache, fever, chills, or infusion‑related reactions such as erythema at the site. - Nausea, vomiting, or abdominal discomfort. - Transient elevations in liver enzymes. - Mild allergic symptoms like rash or itching.

Serious: - Development of inhibitors (antibodies) against factor VIII, reducing efficacy. - Severe allergic reactions including anaphylaxis. - Thrombotic events such as deep vein thrombosis. - Renal impairment or hemolysis in rare cases.

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

Clinicians should consider several precautions when prescribing Haemate P to ensure safe use.

- Screen for pre‑existing factor VIII inhibitors before initiating therapy. - Monitor inhibitor titres regularly during long‑term treatment. - Use caution in patients with a history of allergic reactions to plasma‑derived products. - Adjust dose in individuals with renal or hepatic impairment. - Avoid rapid infusion rates to reduce risk of infusion‑related reactions. - Observe for signs of thrombosis, especially in patients receiving concurrent pro‑coagulant agents.

What does Human Coagulation Factor Viii, Human Von Willebrand Factor interact with?

Haemate P may interact with other medications that affect coagulation or immune response.

Avoid: - Concomitant use of other factor concentrates without medical supervision. - High‑dose aspirin or non‑steroidal anti‑inflammatory drugs that increase bleeding risk.

Use with caution: - Immunosuppressive agents that may alter inhibitor development. - Antifibrinolytic agents (e.g., tranexamic acid) when used together, requiring dose adjustment. - Other intravenous products administered through the same line without proper flushing.

Frequently asked questions

What is the mechanism of action of Haemate P?+
Haemate P provides both factor VIII and von Willebrand factor, restoring platelet adhesion and the intrinsic coagulation cascade to achieve hemostasis in patients with deficiencies.
For which types of von Willebrand disease is Haemate P used?+
Haemate P is indicated for all types of von Willebrand disease, including type 1, type 2 (subtypes), and type 3, when replacement of von Willebrand factor is required.
Can Haemate P be used for surgical prophylaxis?+
Yes, Haemate P can be administered before major surgery or invasive procedures to prevent peri‑operative bleeding in patients lacking factor VIII or von Willebrand factor.
How is Haemate P administered?+
Haemate P is supplied as an intravenous solution and is given by slow intravenous infusion under medical supervision.
What monitoring is recommended during Haemate P therapy?+
Patients should be monitored for inhibitor development, liver function tests, and signs of allergic or thrombotic reactions throughout treatment.
Is Haemate P suitable for pediatric patients?+
Haemate P may be used in children with hemophilia A or von Willebrand disease, but dosing and monitoring should be individualized by a pediatric hematologist.
What are common infusion‑related side effects of Haemate P?+
Common side effects include headache, fever, chills, mild rash or itching, nausea, and transient elevations in liver enzymes.
What serious adverse events require immediate medical attention?+
Serious events include development of factor VIII inhibitors, severe allergic reactions such as anaphylaxis, and thrombotic complications like deep vein thrombosis.
Can Haemate P be combined with antifibrinolytic agents?+
Antifibrinolytic agents such as tranexamic acid can be used with Haemate P, but dose adjustments and careful monitoring are advised.
What precautions are needed for patients with renal impairment?+
Dose adjustments and close monitoring of renal function are recommended for patients with moderate to severe renal impairment receiving Haemate P.
Is Haemate P a plasma‑derived product?+
Yes, Haemate P is derived from human plasma and contains purified factor VIII and von Willebrand factor.
What regulatory status does Haemate P have in the EU?+
Haemate P is a prescription‑only medication authorized for use in the European Union for the treatment of hemophilia A and von Willebrand disease.
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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