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 solution for injection containing human coagulation factor VIII and von Willebrand factor. It is supplied as a sterile intravenous concentrate, marketed in the European Union, and prescribed for patients with hemophilia A or von Willebrand disease. The product provides replacement of deficient clotting factors to support normal hemostasis and to manage bleeding episodes under medical supervision and according to clinical guidelines.

Manufacturer / TM Owner

Csl Behring Gmbh

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Indications & Clinical Uses

Haemate P is indicated for the treatment and prophylaxis of bleeding in individuals with specific clotting factor deficiencies.

  • Replacement therapy for patients with hemophilia A (factor VIII deficiency).
  • Management of acute bleeding episodes in von Willebrand disease.
  • Surgical or invasive procedure support to prevent peri‑operative hemorrhage in eligible patients.
  • Long‑term prophylactic regimens to reduce frequency of spontaneous bleeds.
  • Use in combination with other hemostatic agents when clinically appropriate.

Side Effects

Adverse reactions reported with Haemate P are generally consistent with other plasma‑derived factor concentrates.

Common

  • Headache or mild fever.
  • Injection site erythema, swelling, or discomfort.
  • Transient increase in liver enzymes.
  • Nausea or mild abdominal discomfort.
  • Fatigue or malaise.

Serious

  • Development of inhibitors (antibodies) against factor VIII.
  • Anaphylactic or severe allergic reactions.
  • Thromboembolic events such as deep‑vein thrombosis.
  • Transmission of infectious agents (viral or prion) despite screening.
  • Severe hypotension or shock following infusion.
  • Renal impairment or hemolysis.

Precautions & Warnings

When prescribing Haemate P, clinicians should consider several precautionary measures to ensure patient safety.

  • Assess for a history of inhibitors to factor VIII before initiating therapy.
  • Evaluate for known hypersensitivity to any component of the product.
  • Monitor for signs of infection or viral transmission, especially in immunocompromised patients.
  • Use the lowest effective dose and adjust based on clinical response and laboratory parameters.
  • Avoid rapid infusion rates that may increase the risk of adverse reactions.
  • Conduct regular screening for thrombotic complications during prolonged treatment.

Avoid Interactions

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

Avoid

  • Concomitant use of high‑dose pro‑coagulant agents (e.g., activated factor VII) without specialist guidance.
  • Simultaneous administration of other plasma‑derived clotting factor concentrates unless clinically indicated.

Use with caution

  • Antifibrinolytic agents such as tranexamic acid, which may increase clot stability.
  • Immunosuppressive drugs that could alter inhibitor development risk.
  • Vaccines administered shortly before or after infusion, to avoid overlapping immune activation.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs) that may exacerbate bleeding tendencies.

Frequently Asked Questions

Haemate P is a sterile intravenous solution that contains human coagulation factor VIII and von Willebrand factor, used to replace deficient clotting proteins in certain bleeding disorders.

Haemate P is given by intravenous infusion under medical supervision, with the dose and infusion rate determined by the patient’s clinical condition and laboratory monitoring.

Haemate P is indicated for the treatment of von Willebrand disease types 1, 2, and 3 when replacement of von Willebrand factor and factor VIII is required to control bleeding.

Yes, Haemate P may be administered before surgery or invasive procedures to provide hemostatic coverage and reduce the risk of peri‑operative bleeding.

Common reactions include headache, mild fever, injection‑site redness or swelling, transient liver enzyme elevation, nausea, abdominal discomfort, and fatigue.

Inhibitor development is monitored by measuring factor VIII activity and performing Bethesda assays if a reduced clinical response is observed.

Patients should be observed for signs of allergic reaction, vital signs should be checked regularly, and laboratory tests such as factor activity levels may be performed to guide dosing.

Haemate P should be used cautiously with antifibrinolytics, immunosuppressants, certain vaccines, and NSAIDs, and should be avoided with other high‑dose pro‑coagulant agents unless specifically indicated.

Clinicians should review the patient’s inhibitor history, assess for hypersensitivity, evaluate infection risk, determine appropriate dosing, and plan for monitoring of hemostatic response and potential adverse events.

Haemate P is derived from human plasma and contains both factor VIII and von Willebrand factor, whereas recombinant products are produced by cell culture and may contain only factor VIII without von Willebrand factor.

Yes, Haemate P is authorized for prescription use within the European Union for the indicated bleeding disorders.

The patient should stop the infusion immediately, seek emergency medical attention, and inform the healthcare provider about the reaction for further evaluation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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