국가: 이스라엘
언어: 영어
출처: Ministry of Health
PRAVASTATIN SODIUM
UNIPHARM LTD, ISRAEL
C10AA03
TABLETS
PRAVASTATIN SODIUM 40 MG
PER OS
Required
UNIPHARM LTD, ISRAEL
PRAVASTATIN
Pravastatin is indicated as a component of multiple risk factor intervention in those individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia . Pravastatin should be used in addition to a diet other nonpharmacological measures alone have been inadequate. Primary prevention of coronary events: In hypercholesterolemic patients wihthout clinically evident coronary heart disease pravastatin is indicated to: 1) Reduce the risk of myocardial infarcton. 2) Reduce the risk for revascularization. 3) Reduce the risk of deaths due to cardiovascular causes with no increase in death due to non-cardiovascular causes. Secondary prevention of cardiovascular events: a) Atherosclerosis: In hypercholesterolemic patients with clinically evident coronary artery disease including prior MI pravastatin is indicated to: 1)Slow the progression of coronary atherosclerosis. 2) Reduce the risk of acute coronary events. b) Myocardial infarction: in patients with previous myocardial infarction and normal cholesterol levels. Pravastatin is indicated to: 1) Reduce the risk of recurrent myocardial infarction. 2)Reduce the risk of undergoing myocardial revascularization procedures. 3) Reduce the risk of stroke or transient ischemic attack (TIA). c) Hypercholesterolemia and mixed dyslipidemia: Pravastatin is indicated as an adjunct to diet to reduce elevated Total-C LDL-C and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Type IIa and IIb).
2020-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only PRAVALIP 10; 20; 40 TABLETS COMPOSITION: Each PRAVALIP 10 tablet contains: Pravastatin sodium 10 mg Each PRAVALIP 20 tablet contains: Pravastatin sodium 20 mg Each PRAVALIP 40 tablet contains: Pravastatin sodium 40 mg For the list of inactive ingredients, please see section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. This medicine is not intended for use in children and adolescents under 18 years of age. THERAPEUTIC GROUP: Pravastatin belongs to a group of medicines called “statins”. Statins inhibit the activity of the HMG-CoA reductase enzyme. 1. WHAT IS THE MEDICINE INTENDED FOR? Reduction of cholesterol, LDL-C and triglyceride levels, and increase in HDL-C levels. In hypercholesterolemic patients and with no evidence of coronary disease, pravastatin reduces the risk of myocardial infarction and extends the life expectancy. In patients with atherosclerosis and average )normal( or high cholesterol level, pravastatin reduces the risk of overall mortality and of mortality due to heart diseases, and reduces the risk of heart attack; in hypercholesterolemic patients, pravastatin reduces the risk of angina pectoris. 2. BEFORE USING THE MEDICINE DO NOT USE THE PREPARATION IF: • you are pregnant, planning to become pregnant or are breastfeeding. • you are sensitive )allergic( to pravastatin or to any of the additional ingredients contained in the medicine )listed in section 6(. • you are suffering from active liver disease or from unexplained, persistent elevations in liver function test results. 119108010 03D20 SPECIAL WARNINGS REGARDING USE 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT: TESTOMAX 50 mg TESTOMAX 25 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: TESTOMAX 50 mg: Testosterone 0.05 g per 5 g sachet TESTOMAX 25 mg: Testosterone 0.025 g per 2.5 g sachet For excipients, see 6.1. 3. PHARMACEUTICAL FORM: Gel Clear, transparent colorless gel, . 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Testosterone replacement therapy for males hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. 4.2 POSOLOGY AND ADMINISTRATION ROUTE Cutaneous use _Adults and elderly _ The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily, at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved by 2.5 g of gel steps. The application should be administered by the patient himself, onto clean, dry, healthy skin over the shoulders, or both arms or abdomen. After opening the sachet, the total content must be extracted from the sachet and applied immediately onto the skin. The gel has just to be simply spread on the skin gently as a thin layer. It is not necessary to rub it on the skin. Allow drying for at least 3-5 minutes before dressing. Wash hands with soap and water after applications. Do not apply to the genital areas as the high alcohol content may cause local irritation. Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment with Testomax. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (one week seems reasonable). The dose may be reduced if the plasma testosterone concentrations are raised above the desired level. If the concentrations are low, the dosage may be increased, not exceeding 10 g of gel per 전체 문서 읽기