Țară: Noua Zeelandă
Limbă: engleză
Sursă: Medsafe (Medicines Safety Authority)
Pravastatin sodium 40mg;
Viatris Limited
40 mg
Tablet
Active: Pravastatin sodium 40mg Excipient: Croscarmellose sodium Iron oxide yellow Lactose monohydrate Light magnesium oxide Magnesium stearate Microcelac 100 Povidone
Prescription
Pravastatin is indicated: · in hypercholesterolemic patients without clinically evident coronary heart disease, as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. · for the reduction of elevated total and LDL-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other nonpharmacological measures alone have been inadequate. · as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease. · Coronary Artery Disease: In patients with a history of either a myocardial infarction or unstable angina pectoris to reduce the risk for total mortality, CHD death, recurrent coronary event (including myocardial infarction), need for myocardial revascularisation procedures, and need for hospitalisation. · Cerebrovascular Disease: In patients with a history of coronary artery disease (i.e. either a myocardial infarction or unstable angina pectoris) to reduce the risk of stroke or transient ischemic attacks (TIAs). · Cardiac and Renal Transplantation: In patients receiving immunosuppressive therapy to improve survival in cardiac transplant patients and to reduce the risk of acute rejection in kidney transplant patients
Package - Contents - Shelf Life: Blister pack, Al/Al foil - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, Al/Al foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture
2017-01-11
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION PRAVASTATIN VIATRIS _PRAVASTATIN SODIUM TABLETS 20 MG AND 40 MG _ _ _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking PRAVASTATIN VIATRIS. This leaflet answers some common questions about PRAVASTATIN VIATRIS. 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 PRAVASTATIN VIATRIS 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 PRAVASTATIN VIATRIS IS USED FOR PRAVASTATIN VIATRIS is used to: • reduce the risk of heart attacks, reduce the need for treatment related to heart blood vessels and to reduce deaths related to the heart blood vessels in patients with high cholesterol levels who already follow an amended diet • treat high levels of cholesterol where measures to diet and lifestyle changes were not sufficient • reduce the incidences of further heart diseases in male patients less than 75 years of age with pre- existing diseases related to the heart blood vessels when taken in addition to dietary amendments • reduce the incidences of further heart diseases and reduce the need for treatment related to heart blood vessels in patients who have had such problems • reduce transplant rejection and to improve survival rates in heart or kidney transplant patients who are also being given immunosuppressive medicine PRAVASTATIN VIATRIS contains the active ingredient pravastatin sodium. It belongs to a group of medicines called HMG-CoA reductase inhibitors. It works by reducing the cholesterol biosynthesis. Your doctor may have prescribed this medicine for another reason. Cholesterol is a naturally occurring substance in the body necessary for normal growth. However, when you have high levels of cholesterol it ma Citiți documentul complet
Page 1 of 22 NEW ZEALAND DATA SHEET PRAVASTATIN VIATRIS 1. PRODUCT NAME Pravastatin Viatris, 10 mg, 20 mg and 40 mg, tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains either 10 mg, 20 mg or 40 mg of pravastatin sodium. Excipient with known effect: lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 10 mg: Yellow coloured, rounded, rectangular shaped, biconvex uncoated tablet debossed with ‘PDT’ on one side and ‘10’ on the other side. 20 mg: Yellow coloured, rounded, rectangular shaped, biconvex uncoated tablet debossed with ‘PDT’ on one side and ‘20’ on the other side. 40 mg: Yellow coloured, rounded, rectangular shaped, biconvex uncoated tablet debossed with ‘PDT’ on one side and ‘40’ on the other side. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ • In hypercholesterolaemic patients without clinically evident coronary heart disease, Pravastatin Viatris is indicated as an adjunct to diet to reduce the risk of fatal and non-fatal myocardial infarction, need for myocardial revascularisation procedures, and to improve survival by reducing cardiovascular deaths. • Pravastatin Viatris is indicated for the reduction of elevated total and LDL-cholesterol levels in patients with primary hypercholesterolaemia when the response to diet and other non- pharmacological measures alone have been inadequate. • Pravastatin Viatris is indicated as an adjunct to diet to slow the progressive course of atherosclerosis and reduce the incidence of clinical cardiovascular events in hypercholesterolaemic men under 75 years of age with coronary artery disease. • Coronary Artery Disease: In patients with a history of either myocardial infarction or unstable angina pectoris, Pravastatin Viatris is indicated to reduce the risk for total mortality, CHD death, recurrent coronary event (including myocardial infarction), need for myocardial revascularisation procedures, and need for hospitalisation. Page 2 of 22 • Cerebrovascular Disease: Citiți documentul complet