Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aprotinin
Nordic Pharma Ltd
B02AB01
Aprotinin
10000Kallikrein inactivator unit/1ml
Solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02110000; GTIN: 5015919121840
OBJECT 1 APROTININ 10,000 KIU/ML INJECTION BP Summary of Product Characteristics Updated 08-Mar-2017 | Nordic Pharma Limited 1. Name of the medicinal product Aprotinin 10,000 KIU/ml Injection BP 2. Qualitative and quantitative composition Each 50ml vial contains aprotinin solution corresponding to 500,000 Kallikrein Inactivator Units, KIU (= 277.8 European Pharmacopoeia, E.P. units) aprotinin in 0.9% sodium chloride solution. Each 100ml vial contains aprotinin solution corresponding to 1.000,000 Kallikrein Inactivator Units, KIU (= 555.6 European Pharmacopoeia, E.P. units) aprotinin in 0.9% sodium chloride solution.For a full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection 4. Clinical particulars 4.1 Therapeutic indications 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). 4.2 Posology and method of administration An appropriate aprotinin-specific IgG antibody test may be considered before administration of aprotinin (see section 4.3). Adult: Owing to the risk of allergic/anaphylactic reactions, a 1ml (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 1ml 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 Läs hela dokumentet