AGGRASTAT®*(50 micrograms/ml) solution for infusion
AGGRASTAT®*(250 micrograms/ml) concentrate for solution for infusion
* in the following document the abbreviated terms detailed below are used.
• Aggrastat means Aggrastat solution for infusion or Aggrastat concentrate for solution for infusion.
• Aggrastat Solution will be used when referring to Aggrastat solution for infusion i.e. the 250 ml bag.
• Aggrastat Concentrate will be used when referring to Aggrastat concentrate for solution for infusion i.e. the 50 ml vial.
Aggrastat Solution:
1 ml of solution for infusion contains 56 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 50 micrograms tirofiban.
Aggrastat Concentrate:
1 ml of concentrate for solution for infusion contains 281 micrograms of tirofiban hydrochloride monohydrate which is equivalent to 250 micrograms tirofiban.
For the full list of excipients, see section 6.1.
Aggrastat Solution: solution for infusion (250 ml bag).
A clear, colourless solution.
Aggrastat Concentrate: concentrate for solution for infusion (50 ml vial).
A clear, colourless concentrated solution.
Aggrastat is indicated for the prevention of early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) 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 percutaneous coronary intervention (PCI). Aggrastat is also indicated for the reduction of major cardiovascular events in patients with acute myocardial infarction (STEMI) intended for primary PCI (see sections 4.2 and 5.1).
Aggrastat is intended for use with acetylsalicylic acid (ASA) and unfractionated heparin.
This product is for hospital use only, by specialist physicians experienced in the management of acute coronary syndromes.
Aggrastat Concentrate must be diluted before use.
Aggrastat should be administered with unfractionated heparin and oral antiplatelet therapy, including ASA.
Posology
In patients who are managed with an early invasive strategy for NSTE-ACS but not planned to undergo angiography for at least 4 hours and up to 48 hours after diagnosis, Aggrastat is given intravenously at an initial infusion rate of 0.4 microgram/kg/min for 30 minutes. At the end of the initial infusion, Aggrastat should be continued at a maintenance infusion rate of 0.1 microgram/kg/min. Aggrastat should be given with unfractionated heparin (usually an intravenous bolus of 50-60 units [U]/kg simultaneously with the start of Aggrastat therapy, then approximately 1,000 U per hour, titrated on the basis of the activated thromboplastin time [APTT], which should be about twice the normal value) and oral antiplatelet therapy, including but not limited to ASA (see section 5.1), u
