Product image of Haemate P (Human Coagulation Factor Viii, Human Von Willebrand Factor) supplied by GNH India

Haemate P

Active Ingredient:
Human Coagulation Factor Viii, Human Von Willebrand Factor
Origin:
EU

Haemate P (Human Coagulation Factor Viii, Human Von Willebrand Factor)

Haemate P is a powder for solution for injection that contains human coagulation factor VIII and human von Willebrand factor. It is supplied as a prescription‑only concentrate without a listed strength, intended for intravenous administration in the European market.

Manufacturer / TM Owner

Csl Behring Gmbh

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Indications & Clinical Uses

Haemate P is indicated for the management of bleeding disorders that involve deficiency of factor VIII and von Willebrand factor. It is used in clinical practice for:

  • Prophylaxis of bleeding episodes in hemophilia A
  • On‑demand treatment of acute bleeds in hemophilia A
  • Surgical support in patients with hemophilia A
  • Treatment of von Willebrand disease types 1, 2 and 3
  • Management of combined factor VIII/VWF deficiency during bleeding crises

Side Effects

Side effects of Haemate P reflect the typical profile of plasma‑derived factor concentrates. They are reported in clinical use and post‑marketing surveillance.

Common

  • Headache
  • Fever or chills
  • Nausea or vomiting
  • Injection site erythema or swelling
  • Mild arthralgia

Serious

  • Allergic reactions including anaphylaxis
  • Development of inhibitors (neutralizing antibodies) to factor VIII or VWF
  • Thromboembolic events
  • Renal dysfunction in rare cases
  • Severe hypertension

Precautions & Warnings

When prescribing or administering Haemate P, clinicians should consider several safety aspects. Important precautions include:

  • Assessing patient history for inhibitors to factor VIII or VWF before use
  • Monitoring for signs of allergic reaction during and after infusion
  • Evaluating renal and hepatic function in patients with pre‑existing disease
  • Using caution in patients with a history of thrombosis or cardiovascular disease
  • Ensuring proper aseptic technique to prevent contamination
  • Adjusting dosage based on individual pharmacokinetic response when available

Avoid Interactions

Haemate P may interact with other agents that affect hemostasis or immune response. Interaction considerations are:

Avoid

  • Concurrent use of pro‑coagulant agents (e.g., activated prothrombin complex concentrates) without specialist guidance
  • High‑dose aspirin or other non‑steroidal anti‑inflammatory drugs that increase bleeding risk

Use with caution

  • Antifibrinolytic drugs such as tranexamic acid (monitor for thrombotic signs)
  • Immunosuppressive therapies that may alter inhibitor development
  • Other plasma‑derived products (potential additive viral risk)
  • Vaccines administered shortly before or after infusion (monitor immune response)

Frequently Asked Questions

Haemate P contains human coagulation factor VIII and human von Willebrand factor as its active components.

It is prescribed for hemophilia A (including prophylaxis, on‑demand treatment, and surgical support) and von Willebrand disease types 1, 2, and 3.

Haemate P is supplied as a powder that is reconstituted and given by intravenous infusion.

Yes, Haemate P is classified as a prescription‑only (Rx) product.

In rare cases, patients may develop neutralizing antibodies (inhibitors) to factor VIII or von Willebrand factor after treatment.

Common side effects include headache, fever or chills, nausea, injection‑site redness or swelling, and mild joint pain.

Serious reactions can include allergic responses such as anaphylaxis, thromboembolic events, severe hypertension, and renal dysfunction.

Antifibrinolytics like tranexamic acid can be used, but patients should be monitored for signs of thrombosis.

There are no absolute contraindications, but caution is advised in patients with known inhibitors, severe allergic history, or active thrombotic disease.

Regular assessment of factor activity levels, inhibitor testing, and observation for infusion reactions are recommended.

Haemate P may be used in children under specialist supervision, with dosing individualized based on pharmacokinetic studies.

After reconstitution, the solution should be used within the time frame specified in the product labeling and stored according to the manufacturer’s instructions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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