GNH USA

Europe — EMA

Haemate P

Haemate P is a prescription injectable solution 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 injectable solution containing human coagulation factor VIII and von Willebrand factor. It is supplied as a sterile intravenous preparation used to replace deficient clotting proteins in patients with bleeding disorders. The product is manufactured for the European market and is classified as a coagulation factor concentrate. Haemate P is administered under medical supervision to support normal clot formation and platelet adhesion.

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

Haemate P is indicated for the management of several inherited bleeding disorders where factor VIII and von Willebrand factor are deficient or dysfunctional.

- Treatment of acute bleeding episodes in patients with hemophilia A. - Routine prophylaxis to prevent spontaneous bleeds in hemophilia A. - Management of von Willebrand disease types 1, 2, and 3, including on‑demand therapy for bleeding. - Surgical or invasive procedure support to maintain hemostasis in affected individuals. - Use in combination with other hemostatic agents when clinically appropriate.

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: - Injection site pain or erythema. - Headache. - Fever or chills. - Nausea or vomiting. - Transient increase in liver enzymes.

Serious: - Development of inhibitors (antibodies) to factor VIII. - Anaphylactic or severe allergic reactions. - Thromboembolic events. - Hemolysis. - Disseminated intravascular coagulation (DIC).

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

Before initiating Haemate P therapy, clinicians should evaluate several safety considerations.

- Assess patient history for previous inhibitors to factor VIII. - Monitor for signs of allergic reactions during and after infusion. - Evaluate liver and renal function prior to treatment. - Use caution in patients with a history of thrombosis or cardiovascular disease. - Adjust dose in pediatric patients and those with low body weight. - Avoid use in individuals with known hypersensitivity to any component of the product. - Ensure proper storage and handling to maintain product stability.

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.

Avoid: - Concurrent use of other factor concentrates without medical supervision. - High‑dose aspirin or non‑steroidal anti‑inflammatory drugs (NSAIDs) that increase bleeding risk. - Antifibrinolytic agents unless specifically indicated.

Use with caution: - Immunosuppressive therapies that may alter inhibitor development. - Warfarin or other anticoagulants; monitor coagulation parameters closely. - Desmopressin (DDAVP) when combined with Haemate P for von Willebrand disease.

Frequently asked questions

What is the active ingredient in 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 given as an intravenous injection under the supervision of a healthcare professional.
Which bleeding disorders are treated with Haemate P?+
Haemate P is used for hemophilia A and von Willebrand disease types 1, 2, and 3.
Can Haemate P be used for surgical prophylaxis?+
Yes, Haemate P may be administered before surgery or invasive procedures to help maintain hemostasis in patients with factor deficiencies.
What are common side effects of Haemate P?+
Common side effects include injection site pain, headache, fever or chills, nausea, and temporary elevation of liver enzymes.
What serious adverse reactions should be monitored with Haemate P?+
Serious reactions can include development of factor VIII inhibitors, severe allergic responses, thromboembolic events, hemolysis, and disseminated intravascular coagulation.
Should patients be screened for inhibitors before starting Haemate P?+
Yes, a history of inhibitors to factor VIII should be evaluated, and testing may be performed before initiating therapy.
Is Haemate P safe to use with other clotting factor concentrates?+
Concurrent use of other factor concentrates should be avoided unless specifically directed by a physician.
How does Haemate P differ from other factor VIII products?+
Haemate P combines both factor VIII and von Willebrand factor in a single preparation, providing dual activity for patients who need both proteins.
What monitoring is required during Haemate P infusion?+
Patients should be observed for signs of allergic reactions, and coagulation parameters may be checked to assess treatment effectiveness.
Can Haemate P be used in children?+
Haemate P may be used in pediatric patients, but dosing adjustments and careful monitoring are required.
What storage conditions are recommended for Haemate P?+
Haemate P should be stored according to the manufacturer’s instructions, typically refrigerated and protected from light until use.
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 S.A.
Origin
EU

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