Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Nordic Group B.V., Siriusdreef 22, 2132 WT Hoofddorp, the Netherlands
Aprotinin is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Aprotinin should only be used after careful consideration of the benefits and risks, and the consideration that alternative treatments are available (see section 4.4 and 5.1).
An appropriate aprotinin-specific IgG antibody test may be considered before administration of aprotinin (see section 4.3).
Owing to the risk of allergic/anaphylactic reactions, a 1 ml (10,000 KIU) test dose should be administered to all patients at least 10 minutes prior to the remainder of the dose. After the uneventful administration of the 1 ml test dose, the therapeutic dose may be given. A H1-antagonist and a H2-antagonist may be administered 15 minutes prior to the test dose of aprotinin. In any case standard emergency treatments for anaphylactic and allergic reactions should be readily available (see section 4.4).
A loading dose of 1-2 million KIU is administered as a slow intravenous injection or infusion over 20-30 minutes after induction of anaesthesia and prior to sternotomy. A further 1-2 million KIU should be added to the pump prime of the heart-lung machine. To avoid physical incompatibility of aprotinin and heparin when adding to the pump prime solution, each agent must be added during recirculation of the pump prime to assure adequate dilution prior to admixture with the other component.
The initial bolus infusion is followed by the administration of a continuous infusion of 250,000-500,000 KIU per hour until the end of the operation.
In general, the total amount of aprotinin administered per treatment course should not exceed 7 million KIU.
The safety and efficacy in children below 18 years of age have not been established.
Available clinical experience suggests that patients with decreased renal function do not require special dose adjustment.
No data are available on dosage recommendations for patients with hepatic dysfunction.
Reported clinical experience has not identified differences in responses in elderly patients.
Aprotinin should be infused using a central venous catheter. The same lumen should not be used for the administration of any other medicinal product. When using a multi-lumen central catheter, a separate catheter is not required.
Aprotinin must be given only to patients in the supine position and must be given slowly (maximum 5-10 ml/min) as an intravenous injection or a short infusion.
There is no specific antidote.
Shelf life: 3 years.
Store at room temperature (not more than 25°C); protect from light.
Clear glass vials of 50ml.
Parenteral drug products should be inspected visually for particulate matter and colour change prior to administration. Any residual solution should not be kept for later use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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