aprotinin + calcium chloride dihydrate + human fibrinogen + human thrombin: clinical use

Prescribing considerations

• Hospital use only by surgeons trained in its preparation and application
• Apply epilesionally as a thin layer to visible, appropriately dried subcutaneous surfaces
• Document the product name and batch number for traceability
• Record previous exposure to aprotinin-containing products because repeat exposure may increase anaphylaxis risk
• Human plasma-derived components undergo donor screening and pathogen-reduction measures, but transmission risk cannot be eliminated

Contraindications and cautions

• Hypersensitivity to any active substance or excipient
• Intravascular application
• Spray application during endoscopic procedures
• Use alone for massive or brisk arterial or venous bleeding
• Use as a replacement for skin sutures intended to close surgical wounds

Monitoring

• During spray application, monitor blood pressure, pulse, oxygen saturation and end-tidal carbon dioxide for evidence of air or gas embolism
• Observe for immediate hypersensitivity or anaphylaxis and ensure emergency treatment is available
• Assess solution appearance and integrity before use
• Monitor graft adherence, wound healing and local complications after surgery

Clinical pharmacology

A topical fibrin adhesion system: thrombin converts fibrinogen to fibrin; factor XIII and calcium support cross-linking, while aprotinin inhibits fibrinolysis. The resulting sealant is degraded through fibrinolysis and phagocytosis.

Formulation and product differences

• Deep-frozen, two-component solution in a single-use double-chamber pre-filled syringe
• One chamber contains human fibrinogen with synthetic aprotinin; the other contains human thrombin with calcium chloride dihydrate
• Contains human albumin in both components and polysorbate 80 in the sealer protein component
• Must be fully thawed and warmed according to the product instructions; do not microwave, refreeze or refrigerate after thawing has begun