Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Ezetimibe 10mg;
Viatris Limited
Ezetimibe 10 mg
10 mg
Tablet
Active: Ezetimibe 10mg Excipient: Croscarmellose sodium Crospovidone Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Purified water Sodium laurilsulfate
Blister pack, PVC-ACLAR/aluminium-VMCH heat seal lacquer, 30 tablets
Prescription
Prescription
Mylan Laboratories Limited
Administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG) and to increase high-density lipoprotein cholesterol (HDL-C) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Aluminium -VMCH heat seal lacquer - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC-ACLAR/aluminium-VMCH heat seal lacquer - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVdC/Aluminium -VMCH heat seal lacquer - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC-ACLAR/aluminium-VMCH heat seal lacquer - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP cap, induction seal liner and absorbent cotton - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with PP cap, induction seal liner and absorbent cotton - 500 tablets - 36 months from date of manufacture stored at or below 25°C
2010-05-20
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION EZEMIBE _EZETIMIBE TABLET 10 MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Ezemibe. This leaflet answers some common questions about Ezemibe. 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 taking Ezemibe against the benefits they expect it will have for you. 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 EZEMIBE IS USED FOR Ezemibe helps to lower cholesterol levels in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. Ezemibe is used to treat: • Primary hypercholesterolemia • Homozygous familial hypercholesterolemia (HoFH) Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol. LDL cholesterol is often called 'bad' cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build- up can lead to narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke. HDL cholesterol is often called 'good' cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease. This medicine belongs to a group of medicines called selective cholesterol-absorption inhibitors. _HOW EZEMIBE WORKS_ Ezemibe contains the active ingredient ezetimibe. It may be taken alone, or with other cholesterol-lowering medicines known as statins. Ezemibe works by decreasing the absorption of cholesterol in the small intestine. Statins lower cholesterol in a different way – they work in th Đọc toàn bộ tài liệu
Page 1 of 27 NEW ZEALAND DATA SHEET EZEMIBE 1. PRODUCT NAME Ezemibe, 10 mg, tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe. Excipient(s) with known effect: lactose monohydrate. Allergen Declaration: Contains lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off-white, capsule shaped bevelled edge tablet debossed with “M” on one side and “EE 1” on other side. The tablet cannot be halved. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ PRIMARY HYPERCHOLESTEROLEMIA Ezemibe, administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG) and to increase high-density lipoprotein cholesterol (HDL-C) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolemia. HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH) Ezemibe, administered with a statin, is indicated for the reduction of elevated total-C and LDL-C levels in adult and adolescent (10 to 17 years of age) patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis). _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezemibe. The recommended dose of Ezemibe is 10 mg once daily, used alone or with a statin. Ezemibe can be administered at any time of the day, with or without food. Do not halve the tablet. Page 2 of 27 SPECIAL POPULATIONS _USE IN RENAL IMPAIRMENT/CHRONIC KIDNEY DISEASE_ MONOTHERAPY In patients with renal impairment, no dosage adjustment of Ezemibe is necessary (see section 5.2). COMBINATION THERAPY WITH SIMVASTATIN In patients with mild renal impairment (estimated GFR ≥ 60 mL/min/1.73 m 2 ), no dosage adjustment of Ezemibe or simvastatin is necessary. I Đọc toàn bộ tài liệu