GNH USA

Europe — EMA

Haemate P

Haemate P is an IV replacement therapy containing human factor VIII and von Willebrand factor for hemophilia A and von Willebrand disease.

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 medication that contains human coagulation factor VIII and human von Willebrand factor. It is supplied as an intravenous solution; the specific strength is not disclosed. The product is used to replace deficient clotting proteins in patients with hemophilia A or von Willebrand disease, helping to restore normal blood clotting. It is marketed in the European Union and requires administration by a healthcare professional.

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.

- Treatment of acute bleeding episodes in patients with hemophilia A. - Routine prophylaxis to prevent spontaneous bleeds in hemophilia A. - Management of bleeding episodes in von Willebrand disease types 1, 2, and 3. - Perioperative control of hemostasis for surgical or dental procedures in affected individuals.

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. - Nausea or vomiting. - Injection site reactions such as redness or swelling.

Serious: - Development of inhibitors (antibodies) against factor VIII. - Allergic reactions including anaphylaxis. - Thromboembolic events. - Renal dysfunction.

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.

- Assess inhibitor status before initiating therapy. - Monitor for signs of allergic reactions during and after infusion. - Use caution in patients with a history of thrombosis. - Adjust dose in individuals with renal impairment. - Avoid use in patients with known hypersensitivity to any component of the product. - Ensure proper storage conditions 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 coagulation or immune response.

Avoid: - Concomitant use of other factor VIII concentrates without medical supervision. - Administration of pro‑thrombotic agents such as activated protein C. Use with caution: - Antifibrinolytic agents (e.g., tranexamic acid) may increase clot stability. - Immunosuppressive drugs that could alter inhibitor development. - Certain antibiotics (e.g., beta‑lactams) that may provoke hypersensitivity. - Vaccines administered shortly before or after infusion.

Frequently asked questions

What is the mechanism of action of Haemate P?+
Haemate P supplies the missing human factor VIII and von Willebrand factor, restoring the normal clotting cascade and improving hemostasis in deficient patients.
For which types of von Willebrand disease is Haemate P used?+
Haemate P is used in von Willebrand disease types 1, 2, and 3 where replacement of von Willebrand factor is required.
How is Haemate P administered?+
The product is given by intravenous infusion under the supervision of a qualified healthcare professional.
Can Haemate P be used for prophylactic treatment in hemophilia A?+
Yes, Haemate P may be prescribed on a regular schedule to prevent spontaneous bleeding episodes in hemophilia A patients.
What are common side effects of Haemate P?+
Common adverse events include headache, fever, nausea or vomiting, and mild injection‑site reactions such as redness or swelling.
What serious adverse reactions should patients be aware of?+
Serious reactions can include development of factor VIII inhibitors, severe allergic responses (including anaphylaxis), thromboembolic events, and renal dysfunction.
How should clinicians monitor for inhibitors when using Haemate P?+
Baseline inhibitor testing is recommended before starting therapy, followed by periodic assays to detect new inhibitor formation during treatment.
Is dose adjustment required for patients with renal impairment?+
Dose modification may be necessary for individuals with significant renal dysfunction; clinicians should assess renal function and adjust accordingly.
Can Haemate P be given together with antifibrinolytic agents?+
Antifibrinolytics such as tranexamic acid can be used alongside Haemate P, but they should be administered with caution and under medical guidance.
What storage conditions are recommended for Haemate P?+
The product should be stored according to the manufacturer’s label, typically refrigerated (2‑8 °C) and protected from light until use.
Is Haemate P available outside the European Union?+
Haemate P is primarily marketed in the EU; availability in other regions depends on local regulatory approvals.
How often is Haemate P typically administered for acute bleeds?+
For acute bleeding, Haemate P is usually given as a single intravenous infusion, with repeat dosing based on clinical response and factor levels.
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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