fibryga®
Human Fibrinogen Concentrate
Fibryga® is a highly purified and pathogen inactivated human fibrinogen concentrate and an effective and convenient treatment for fibrinogen deficiency.
Fibryga® offers a number of benefits: concentration is standardised; it is stable at room temperature, can be reconstituted within minutes, and has a low infusion volume; there is no need for thawing or cross-matching blood type and it is double pathogen inactivated.
Indication
- Treatment of bleeding and perioperative prophylaxis in patients with congenital hypo or afibrinogenaemia with bleeding tendency.1-3
- Complementary therapy in the treatment of uncontrolled severe haemorrhage in patients with acquired fibrinogen deficiency.4
Presentation
Fibryga® is presented in vials containing 1 g of fibrinogen as lyophilised powder for reconstitution with 50 mL sterile water for injection (WFI).1
After reconstitution, the solution provides approximately 20 mg/mL of human fibrinogen.
For intravenous administration via infusion or injection.
Do not store above 25 °C. Do not freeze. Keep the bottle in the outer carton to protect from light. The shelf life is two years at room temperature.
References
1. Fibryga® - Summary of Product Characteristics (EU)
2. Fibryga® - US PIL
3. Fibryga® - Canada monograph
4. Fibryga® - Summary of Product Characteristics (Switzerland)
Instructions for the reconstitution of fibryga®
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