Europe — EMA
Haemocomplettan P
Haemocomplettan P is a human fibrinogen concentrate for IV use, indicated for congenital and acquired fibrinogen deficiencies and massive hemorrhage.
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What is Human Fibrinogen?
Haemocomplettan P is a lyophilized powder for solution for injection that contains human fibrinogen as its active ingredient. It is supplied in an unspecified strength and is administered intravenously. The product is classified as a fibrinogen concentrate and is used as a hemostatic agent to replace deficient fibrinogen in the plasma.
What is Human Fibrinogen used for?
Haemocomplettan P is indicated for the replacement of fibrinogen in several clinical situations where low plasma fibrinogen contributes to bleeding risk.
- Congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. - Acquired hypofibrinogenemia associated with liver disease, massive transfusion, or disseminated intravascular coagulation. - Massive hemorrhage where rapid fibrinogen replacement is required. - Surgical or trauma‑related bleeding when fibrinogen levels are below therapeutic thresholds. - Situations where conventional blood components are unavailable or contraindicated.
What are the side effects of Human Fibrinogen?
Side effects of Haemocomplettan P may vary in frequency and severity. Monitoring for any adverse reaction after infusion is recommended.
Common: - Mild fever or chills. - Headache. - Nausea or vomiting. - Transient hypotension. - Local infusion site reactions such as erythema or pain.
Serious: - Allergic or anaphylactic reactions. - Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). - Disseminated intravascular coagulation. - Severe hypotension or shock. - Hemolysis or renal impairment.
What precautions apply to Human Fibrinogen?
Before using Haemocomplettan P, clinicians should assess patient history and current clinical status to mitigate risks.
- Verify baseline fibrinogen level and avoid over‑correction. - Use caution in patients with a history of thrombosis or hypercoagulable states. - Monitor for signs of allergic reaction during and after infusion. - Adjust dose in patients with renal or hepatic impairment as needed. - Ensure compatibility with other intravenous solutions. - Maintain aseptic technique to prevent contamination. - Document infusion details and patient response for pharmacovigilance.
What does Human Fibrinogen interact with?
Haemocomplettan P may interact with other agents that affect coagulation or immune response.
Avoid: - Concurrent use of pro‑coagulant agents (e.g., activated factor VII) without careful monitoring. - High‑dose anticoagulants that could mask fibrinogen deficiency.
Use with caution: - Other plasma‑derived products (e.g., cryoprecipitate, fresh frozen plasma). - Immunomodulatory drugs that may alter allergic response risk. - Medications that affect renal or hepatic function, requiring dose adjustments. - Blood pressure‑lowering agents if hypotension occurs during infusion.
Frequently asked questions
What is the active ingredient in Haemocomplettan P?+
How is Haemocomplettan P administered?+
Which patients may benefit from Haemocomplettan P?+
Can Haemocomplettan P be used during surgery?+
What laboratory test is used to guide Haemocomplettan P dosing?+
What are common side effects of Haemocomplettan P?+
What serious adverse reactions should be monitored?+
Is Haemocomplettan P safe for patients with a history of thrombosis?+
Does Haemocomplettan P interact with anticoagulant medications?+
What precautions are recommended before administering Haemocomplettan P?+
Can Haemocomplettan P be used in pediatric patients?+
Is Haemocomplettan P available over the counter?+
Product details
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