Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
TIROFIBAN HYDROCHLORIDE MONOHYDRATE
Iroko Cardio (UK) Ltd
0.05mg/ml Mg/Ml
Solution for Infusion
2011-11-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT AGGRASTAT 250 micrograms/ml concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 281 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 250 micrograms tirofiban. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion, 50ml vial A clear, colourless concentrated solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aggrastat is indicated for the prevention of early myocardial infarction in patients presenting with unstable angina or non-Q-wave myocardial infarction with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes. Patients most likely to benefit from Aggrastat treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (see sections 4.2 and 5.1). Aggrastat is intended for use with acetylsalicylic acid and unfractionated heparin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This product is for hospital use only, by specialist physicians experienced in the management of acute coronary syndromes. Aggrastat concentrate for solution for infusion must be diluted before use. In patients who are managed with an early invasive strategy for NSTE-ACS and not planned to undergo angiography for at least 4 hours and up to 48 hours after diagnosis, tirofiban is given intravenously at an initial infusion rate of 0.4 microgram/kg/min for 30 minutes. At the end of the initial infusion, tirofiban should be continued at a maintenance infusion rate of 0.1 microgram/kg/ Olvassa el a teljes dokumentumot