Haemocomplettan P (Human Fibrinogen)

Haemocomplettan P is indicated for clinical situations where fibrinogen replacement is required to achieve hemostasis.

• Congenital fibrinogen deficiency such as afibrinogenemia and hypofibrinogenemia.
• Acquired hypofibrinogenemia resulting from massive hemorrhage, trauma, or major surgery.
• Bleeding episodes in patients with coagulopathies where low fibrinogen contributes to uncontrolled bleeding.
• Cardiopulmonary bypass or liver transplantation procedures with anticipated fibrinogen depletion.
• Situations requiring rapid restoration of plasma fibrinogen levels to support clot formation.

Adverse reactions reported with Haemocomplettan P are generally related to the infusion process or to immune responses to the protein.

Common

• Mild fever or chills occurring during or shortly after infusion.
• Transient hypotension or hypertension.
• Nausea, vomiting, or abdominal discomfort.
• Headache or dizziness.

Serious

• Allergic or anaphylactic reactions, including rash, urticaria, or bronchospasm.
• Thromboembolic events such as deep‑vein thrombosis or pulmonary embolism.
• Disseminated intravascular coagulation (rare).

When prescribing Haemocomplettan P, clinicians should evaluate patient history and monitor specific parameters to minimize risk.

• Assess baseline fibrinogen level and coagulation profile before administration.
• Use caution in patients with a history of thromboembolic disease or cardiovascular disorders.
• Monitor for signs of allergic reaction during and after infusion.
• Adjust dose in patients with renal or hepatic impairment as recommended by the prescribing information.
• Avoid concurrent use with other pro‑coagulant agents unless clinically justified.
• Observe for changes in blood pressure or respiratory status during infusion.
• Document infusion rate and total administered dose for safety tracking.

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

Avoid

• Concurrent administration of other fibrinogen concentrates or cryoprecipitate without clear indication.
• High‑dose anticoagulants such as unfractionated heparin or direct thrombin inhibitors during infusion.

Use with caution

• Antiplatelet agents (e.g., aspirin, clopidogrel) that may alter bleeding risk.
• Factor replacement therapies (e.g., factor VIII, factor IX) in patients with combined deficiencies.
• Immunosuppressive drugs that could mask allergic reactions.
• Vasopressors or inotropes that influence blood pressure during infusion.