País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Tirofiban hydrochloride monohydrate 0.281 mg/mL equivalent to 0.25 mg/mL tirofiban;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Tirofiban hydrochloride monohydrate 0.281 mg/mL (equivalent to 0.25 mg/mL tirofiban)
0.25 mg/mL
Concentrate for infusion
Active: Tirofiban hydrochloride monohydrate 0.281 mg/mL equivalent to 0.25 mg/mL tirofiban Excipient: Citric acid Hydrochloric acid Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection
Vial, glass, 50 mL
Prescription
Prescription
Cadila Healthcare Ltd
Package - Contents - Shelf Life: Vial, glass, - 50 mL - 36 months from date of manufacture stored at or below 30°C
1997-11-18
CONSUMER MEDICINE INFORMATION AGGRASTAT ® I N F [http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22]O R M A T I O N F O R C O N S U M E R S HOME [http://www.pdfcomplete.com/cms/hppl/tabid/108/Default.aspx?r=q8b3uige22] | CONSUMERS | HEALTH PROFESSIONALS | REGULATORY | OTHER | HOT TOPICS | SEARCH _SINGLE DOSE VIAL _ _TIROFIBAN HYDROCHLORIDE _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about AGGRASTAT. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using AGGRASTAT against the benefits they expect it will have for you. If you have any concerns about being given this medicine, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again. WHAT AGGRASTAT IS USED FOR AGGRASTAT, in combination with heparin (another medicine used to prevent blood clots), is used to prevent complications that may occur in people who have unstable angina (a type of chest pain) or are having a heart attack. AGGRASTAT belongs to a group of medicines called platelet aggregation inhibitors. It works by preventing cells in the blood, called platelets, from sticking together to form blood clots. If blood clots are not treated or prevented, they can block blood vessels. This can lead to complications such as angina or heart attacks. BEFORE YOU ARE GIVEN AGGRASTAT _WHEN YOU MUST NOT BE GIVEN IT _ Do not use AGGRASTAT if you have an allergy to AGGRASTAT or any of the ingredients listed at the end of this leaflet. DO NOT USE AGGRASTAT IF YOU HAVE ANY OF THE FOLLOWING MEDICAL CONDITIONS: l bleeding inside your body l a Llegiu el document complet
NAME OF MEDICINE AGGRASTAT _tirofiban hydrochloride _ ® 50mL Vial PRESENTATION Concentrate: (0.25 mg/mL) 50mL glass vial containing 12.5mg of tirofiban (as 14.05mg tirofiban hydrochloride monohydrate) in 50mL of iso-osmotic citrate buffer solution. THERAPEUTIC CLASS AGGRASTAT (tirofiban hydrochloride, MSD), a non-peptide antagonist of the platelet GP IIb/IIIa receptor, is a platelet aggregation inhibitor. INDICATIONS AGGRASTAT, in combination with heparin, is indicated for patients with unstable angina or non-Q-wave myocardial infarction to prevent cardiac ischaemic events. DOSAGE AND ADMINISTRATION THE VIAL OF AGGRASTAT (CONCENTRATE) MUST BE DILUTED PRIOR TO ADMINISTRATION (SEE INSTRUCTIONS FOR USE). _AGGRASTAT is for intravenous use only using sterile equipment. _AGGRASTAT may be co-administered with heparin through the same line. AGGRASTAT is recommended for use with a calibrated infusion device. Care should be taken to avoid a prolonged loading infusion. Care should also be taken in calculating the bolus dose and infusion rates based on patient weight. In clinical studies patients received aspirin, unless contraindicated. UNSTABLE ANGINA PECTORIS OR NON-Q-WAVE MYOCARDIAL INFARCTION: AGGRASTAT should be administered intravenously, in combination with heparin, at the initial infusion rate of 0.4mcg/kg/min for 30 minutes. Upon completion of the initial infusion, AGGRASTAT should be continued at a maintenance infusion rate of 0.1 mcg/kg/min. The table below is provided as a guide to dosage adjustment by weight. Most Patients Severe Renal Insufficiency Patient Weight (kg) 30 Min Loading Infusion Rate (mL/hr) Maintenance Infusion Rate (mL/hr) 30 Min Loading Infusion Rate (mL/hr) Maintenance Infusion Rate (mL/hr) 30-37 16 4 8 2 38-45 20 5 10 Llegiu el document complet