Abbreviations
AcFD: acquired fibrinogen deficiency; CI: confidence interval; CFD: congenital fibrinogen deficiency.
References
1. Prufibry®. Summary of Product Characteristics. 2025. (Germany).
Prufibry – Basic Information
Prufibry 1 g powder and solvent for solution for injection/infusion. Active substance: human fibrinogen. Composition: Powder: 1 vial contains nominally 1 g human fibrinogen. After reconstitution with 50 ml solvent, approx. 20 mg/ml human fibrinogen; arginine hydrochloride, polysorbate 80, sodium chloride, sodium citrate dihydrate, trehalose dihydrate. Solvent: water for injections. Therapeutic indications: For the treatment and peri-operative prophylaxis of bleeding in patients with congenital hypo- or afibrinogenaemia with bleeding tendency. As complementary therapy to management of uncontrolled severe haemorrhage in acquired hypofibrinogenaemia caused by surgery or trauma. Contraindications: Hypersensitivity to any of the ingredients. Warnings: 1 vial contains approx. 132.2 mg sodium (equivalent to approx. 6.6% of the recommended maximum daily intake for an adult). 1 vial contains approx. 25.5 mg polysorbate 80. May cause allergic reactions. Undesirable effects: Thromboembolic events (including myocardial infarction, pulmonary embolism), thrombocytopenia, urticaria, pruritus, pyrexia, allergic or anaphylactic-type reactions.
Biotest Pharma GmbH, Landsteinerstr. 5, 63303 Dreieich | Medical prescription. Information as of: October 2025.
January 2026 | PM-ALL-PRY-0020
