GNH USA

Europe — EMA

Haemate P

Haemate P is an EU‑approved injectable solution containing 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 solution for injection that contains human coagulation factor VIII and von Willebrand factor. It is supplied as an intravenous preparation without a specified strength, intended for replacement therapy in patients with deficiencies of these clotting proteins. The product is marketed in the European Union and classified as a coagulation factor replacement used in hemophilia A and von Willebrand disease management.

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

Haemate P is indicated for the management of bleeding disorders that involve deficiency of factor VIII and von Willebrand factor. It is used in both prophylactic and on‑demand settings and may be administered before surgical procedures.

- Treatment of hemophilia A patients with factor VIII deficiency - Management of von Willebrand disease of all types - On‑demand therapy for acute bleeding episodes - Prophylactic replacement to prevent recurrent bleeds - Peri‑operative hemostatic support for surgical interventions - Use in combination with other hemostatic agents when clinically required

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: - Mild headache or dizziness - Low‑grade fever or chills - Injection site erythema or swelling - Transient nausea or abdominal discomfort - Mild hypertension or blood pressure fluctuations

Serious: - Development of inhibitors (antibodies) against factor VIII or von Willebrand factor - Severe allergic reactions, including anaphylaxis - Thromboembolic events such as deep vein thrombosis - Acute hemolytic reactions - Renal impairment or acute kidney injury

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

Before using Haemate P, clinicians should consider several safety aspects to minimize risk.

- Assess patient history for previous inhibitor development or allergic reactions to plasma‑derived products - Perform baseline screening for viral infections (e.g., HIV, hepatitis B/C) as the product is derived from human plasma - Monitor for signs of thrombosis, especially in patients with pre‑existing risk factors - Use caution in patients with renal or hepatic impairment; adjust monitoring accordingly - Ensure proper aseptic technique to avoid contamination during intravenous administration - Educate patients on recognizing early symptoms of inhibitor formation or hypersensitivity

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, which may increase thrombotic risk - High‑dose antifibrinolytic agents combined with factor replacement without careful monitoring - Immunosuppressive therapies that could mask inhibitor development

Use with caution: - Anticoagulants (e.g., warfarin, direct oral anticoagulants) – monitor coagulation parameters closely - Desmopressin (DDAVP) – may augment von Willebrand factor levels, requiring dose adjustments - Non‑steroidal anti‑inflammatory drugs (NSAIDs) – increase bleeding risk, monitor gastrointestinal status - Vaccinations – observe for potential immune reactions that could affect inhibitor formation

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 components.
For which conditions is Haemate P prescribed?+
It is prescribed for hemophilia A and for all types of von Willebrand disease to replace deficient clotting proteins.
How is Haemate P administered?+
Haemate P is given as an intravenous solution for injection, typically by a healthcare professional.
Can Haemate P be used for surgical prophylaxis?+
Yes, it may be administered before surgical procedures to provide hemostatic support in patients with factor deficiencies.
What are common side effects of Haemate P?+
Common side effects include mild headache, low‑grade fever, injection‑site redness, transient nausea, and mild hypertension.
What serious adverse reactions should be monitored?+
Serious reactions can include development of inhibitors, severe allergic responses such as anaphylaxis, thromboembolic events, and acute kidney injury.
Is there a risk of viral transmission with Haemate P?+
Haemate P is derived from human plasma and undergoes viral inactivation steps, but screening for viral infections is still recommended before use.
Should patients be tested for inhibitors before receiving Haemate P?+
Patients with a history of inhibitor development should be evaluated for current inhibitor levels prior to treatment.
How should Haemate P be stored?+
The product should be stored according to the manufacturer’s instructions, typically refrigerated and protected from light, and used before the expiration date.
Can Haemate P be used together with antifibrinolytic agents?+
Concurrent use is possible but should be done under medical supervision to avoid excessive clotting risk.
What monitoring is required during Haemate P therapy?+
Regular assessment of coagulation parameters, inhibitor testing, and observation for signs of allergic reactions or thrombosis are recommended.
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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