国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Prasugrel hydrochloride 5.49mg
Eli Lilly and Company (NZ) Limited
Prasugrel hydrochloride 5.49 mg
5 mg
Film coated tablet
Active: Prasugrel hydrochloride 5.49mg Excipient: Croscarmellose sodium Glycerol Hypromellose Iron oxide yellow Lactose Magnesium stearate Mannitol Microcrystalline cellulose Purified talc Titanium dioxide
Blister pack, PVC (not marketed), 6 tablets
Prescription
Prescription
Ube Industries Limited
EFFIENT, co-administered with aspirin, is indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (UA), non ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI)) who are to undergo percutaneous coronary intervention (PCI).
Package - Contents - Shelf Life: Blister pack, PVC - 6 tablets - 2 years from date of manufacture stored at or below 30°C. Store in original container - Blister pack, PVC - 28 tablets - 2 years from date of manufacture stored at or below 30°C. Store in original container
2008-08-22
EFFIENT ® CMI_v5.0 1 EFFIENT ® EF'-FEE-ENT _Prasugrel hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Effient. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.lilly.com.au. The updated leaflet may contain important information about this medicine and its use that you should be aware of. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking this medicine against the benefits they expect it will have for you. ALWAYS FOLLOW THE INSTRUCTIONS THAT YOUR DOCTOR OR PHARMACIST GIVE YOU ABOUT EFFIENT. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EFFIENT IS USED FOR Effient is used to prevent blood cells from clotting. It contains the active ingredient, prasugrel. It is used by people who have had a PCI (percutaneous coronary intervention) because of unstable angina or a heart attack. PCI is a procedure where a balloon- tipped tube is used to open a blocked artery, with or without a stent being placed in the artery. Effient belongs to the group of medicines called antiplatelet agents. It works by reducing the ability of blood cells to clot. By preventing blood cells from clumping, it reduces 阅读完整的文件
NEW ZEALAND DATA SHEET vA13_30apr19 SUPERSEDES: vA12_25mar19 Page 1 of 26 1. EFFIENT ® EFFIENT 5 mg film coated tablets EFFIENT 10 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is prasugrel hydrochloride. Each beige 10 mg tablet is manufactured with 10.98 mg prasugrel hydrochloride, equivalent to 10 mg of prasugrel and each yellow 5 mg tablet with 5.49 mg prasugrel hydrochloride, equivalent to 5 mg of prasugrel. For the full list of excipients, see 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Prasugrel is available for oral administration as a 5 mg or 10 mg double-arrow shaped, film- coated, not scored tablet, debossed on each side. EFFIENT 10 mg tablets are beige, double-arrow shaped, not scored and debossed with “10 MG” on one side and with “4759” on the other side. EFFIENT 5 mg tablets are yellow, double-arrow shaped, not scored and debossed with “5 MG” on one side and “4760” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EFFIENT, co-administered with aspirin, is indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (UA), non ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI)) who are to undergo percutaneous coronary intervention (PCI). 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL USE IN ADULTS (≥ 18 YEARS) EFFIENT should be initiated with a single 60 mg loading dose (LD) and then continued at a 10 mg once daily dose maintenance dose (MD). In NSTEMI patients, the loading dose should generally be given at the time of PCI (see 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). Patients taking prasugrel should also take aspirin (75 mg to 325 mg) daily. EFFIENT may be taken with or without food (see 5 PHARMACOLOGICAL PROPERTIES). vA13_30apr19 SUPERSEDES:vA12_25mar19 Page 2 of 26 USE IN ELDERLY 阅读完整的文件