APROTININ Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Aprotinin 10,000 KIU/ml Injection BP.
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. For a full ...
Pharmaceutical form
Solution for Injection.
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 ...
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 1 ml (10,000 KIU) ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Patients with a positive aprotinin-specific IgG antibody test are at an increased risk of anaphylactic reaction ...
Special warnings and precautions for use
Aprotinin should not be used when CABG surgery is combined with another cardiovascular surgery because the benefit risk balance of aprotinin in other cardiovascular procedures has not been established. ...
Interaction with other medicinal products and other forms of interaction
Aprotinin has a dose-dependent inhibitory effect on the action of thrombolytic agents, e.g. streptokinase, urokinase, alteplase (r-tPA). Renal dysfunction could be triggered by aprotinin, particularly ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies in pregnant women. Animal studies did not provide any evidence of teratogenic or other embryotoxic effects of aprotinin. Aprotinin should be ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile The safety of aprotinin has been evaluated in more than forty five phase II and phase III studies including more than 3800 patients exposed to aprotinin. In total, about 11% ...
Overdose
There is no specific antidote.
Pharmacodynamic properties
Pharmacotherapeutic group: Antihemorrhagics, proteinase inhibitors ATC code: B02AB01 Aprotinin is a broad-spectrum protease inhibitor which has antifibrinolytic properties. By forming reversible stoichiometric ...
Pharmacokinetic properties
After intravenous injection, rapid distribution of aprotinin occurs into the total extracellular space, leading to an initial decrease in plasma aprotinin concentration with a half-life of 0.3-0.7 h. At ...
Preclinical safety data
Acute toxicity In rats, guinea-pigs, rabbits and dogs, high doses >150,000 KIU/kg) injected quickly caused a blood pressure reduction of varying magnitude, which rapidly subsided. Reproduction toxicity ...
List of excipients
Sodium chloride Water for injections
Incompatibilities
Aprotinin is incompatible with antibiotics such as tetracyclines which react with proteins, corticosteroids, heparin and nutrient solutions containing amino acids or fat emulsions. The addition of aprotinin ...
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store at room temperature (not more than 25°C); protect from light.
Nature and contents of container
Clear glass vials of 50ml.
Special precautions for disposal and other handling
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 ...
Marketing authorization holder
Nordic Group B.V., Siriusdreef 22, 2132 WT Hoofddorp, the Netherlands
Marketing authorization number(s)
PL40621/0020
Date of first authorization / renewal of the authorization
1<sup>st</sup> April 2003
Date of revision of the text
02/2018
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