Generic Name and Formulations:
Human fibrinogen 79mg, human thrombin 699 IU; per 1g; ready-to-use pwd; preservative-free; contains trehalose, calcium chloride.
Indications for RAPLIXA:
Adjunct to hemostasis for mild-to-moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical. Use in conjunction with absorbable gelatin sponge or RaplixaSpray device.
See full labeling. Apply to surface of bleeding tissue only; give directly from vial using absorbable gelatin sponge or RaplixaSpray device (max 2 vials per device). Individualize dose based on size of bleeding area; max total dose 3g per surgery. Max surface area (25cm2 [vial] or 50cm2 [RaplixaSpray]): use 0.5g; (50cm2 [vial] or 100cm2 [RaplixaSpray]): use 1g; (100cm2 [vial] or 200cm2 [RaplixaSpray]): use 2g.
Intravascular use. Severe or brisk arterial bleeding. Systemic reactions to human blood products.
For topical use only. Life-threatening thrombosis possible from intravascular application. Monitor BP, pulse, oxygen saturation, end tidal CO2 for signs/symptoms of embolism. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Discontinue immediately if hypersensitivity reactions occur. Pregnancy. Nursing mothers.
Procedural pain, nausea, constipation, pyrexia, hypotension; infection, possible antibody formation.
Single-use vial (0.5g, 1g, 2g)—1
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