Finished product reference
Aprotinin
Injection · Parenteral · 10000000 IU/1mL · 10 mL
- List code
- 1861
- Pharmacologic class
- Antifibrinolytic; serine protease inhibitor (bovine origin)
What it is and how it works
Aprotinin is a polypeptide that inhibits serine proteases including plasmin, kallikrein and trypsin. By inhibiting fibrinolysis and the contact activation pathway it reduces blood loss and the systemic inflammatory response during cardiopulmonary bypass.
Indications
Prophylactic use to reduce blood loss and transfusion in adult patients at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (coronary artery bypass grafting without other cardiovascular surgery).
Dosage and administration (summary)
Dosing is individualised by the anaesthetist/cardiac surgeon according to protocol, starting with a 1 mL intravenous test dose at least 10 minutes before the loading dose, followed by loading, pump-prime and continuous infusion doses.
Contraindications
Hypersensitivity to aprotinin; positive aprotinin-specific IgG test or exposure to aprotinin within the previous 12 months (increased anaphylaxis risk).
Warnings and precautions
Risk of anaphylactic reactions, highest on re-exposure; a test dose is mandatory and resuscitation facilities must be available. Possible increased risk of renal dysfunction; careful benefit–risk assessment is required. Requires adequate heparinisation, monitored with a method not affected by aprotinin (e.g. kaolin-activated ACT).
Pregnancy
Use only if clearly needed because data are limited.
Storage and supply
Store below 25 °C; do not freeze.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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