TRASYLOL INJECTION 500,000 KIU/50 ML [SIN07805P]

Product Info

TRASYLOL INJECTION 500,000 KIU/50 ML

[SIN07805P]

INDICATIONS

Aprotinin is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

POSOLOGY AND METHOD OF ADMINISTRATION

Dosage:

An appropriate aprotinin-specific IgG antibody test should be performed in all patients before administration of aprotinin (see "Contraindications").

The following dose regimen is recommended for adult patients:
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 "Warnings and Precautions for use" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In general, the total amount of aprotinin administered per treatment course should not exceed 7 million KIU.

Method of administration:

All intravenous doses of aprotinin should be administered through a central venous line. Do not administer any other drug using the same line.

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.

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.

Patients with renal impairment: Clinical experience so far suggests that patients with decreased renal function do not require special dose adjustment.

Pediatric use: Infants, toddlers, children, and adolescents: efficacy and safety have not been established in this patient population.

Geriatric use: Reported clinical experience has not identified differences in responses in elderly patients.

CONTRAINDICATIONS

Hypersensitivity to aprotinin.

Patients with a positive aprotinin-specific IgG antibody test are at an increased risk of anaphylactic reaction when treated with aprotinin. Therefore, administration of aprotinin is contraindicated in these patients.
In case no aprotinin specific IgG antibody test is possible prior to treatment, administration of aprotinin to patients with a suspected previous exposure during the last 12 months is contraindicated.