CRITICAL CARE

Fibryga

CRITICAL CARE

Fibryga

Fibryga® is indicated for treatment of bleeding and perioperative prophylaxis in patients with congenital hypo or afibrinogenaemia with bleeding tendency. It can also be used as a complementary therapy to manage uncontrolled severe haemorrhage in patients with acquired hypofibrinogenaemia during surgical intervention.

Fibryga: Human Fibrinogen Concentrate

Fast and Accurate Control

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.1,2

Fibryga® is presented in vials containing 1g of fibrinogen as lyophilised powder for reconstitution with 50 mL sterile water for injection (WFI). After reconstitution, the solution provides approximately 20 mg/mL of human fibrinogen. For intravenous administration via infusion or injection.

References
  1. Schulz P et al. Biochemical characterisation, stability and pathogen safety of a new fibrinogen concentrate (Fibryga®). Biologicals https://doi.org/10.1016/j.biologicals.2017.12.003.
  2. Ross C et al. Pharmacokinetics, clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenital fibrinogen deficiency. J Thromb5. Haemost 2018; 16(2):253-261.

Key Features & Benefits

Fast and reliable reconstitution with a convenient transfer device (octajet®) for prompt treatment initiation3-5
High quality and purity with low levels of activation markers to ensure a fully functional fibrinogen replacement1

Sufficient presence of FXIII to allow γ-γ crosslinking and clot stabilization2
State-of-the-art in pathogen safeguarding with the implementation of a dual inactivation/elimination step for major protection against enveloped and non-enveloped virus and prions3
Up to 24 hours post reconstitution stability at 25°C3-5
References
  1. Peyvandi F et al. Rare coagulation defi ciencies. Haemophilia 2002;8:308-21.
  2. Nascimento B et al. Cryoprecipitate therapy. Br J Anaesth 2014;113:922-34.
  3. O’Shaughnessy DF et al. Guidelines for the use of fresh frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol 2004;126:11-28.

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