Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
ATORVASTATIN AS CALCIUM
DEXCEL PHARMA TECHNOLOGIES LTD
C10AA05
TABLETS
ATORVASTATIN AS CALCIUM 40 MG
PER OS
Required
DEXCEL LTD, ISRAEL
ATORVASTATIN
ATORVASTATIN
Litorva is indicated as an adjunct to diet for reduction of elevated total cholesterol LDL- cholesterol apolipoprotein B and triglycerides and to increase HDL Cholesterol in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types IIa and IIb of the fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Litorva is also indicated to reduce total-C and LDL -C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. LDL apheresis) or if such treatments are unavailable. Pediatric patients (10-17 years of age) : Atorvastatin is indicated as an adjunct to diet to reduce total -C LDL-C and apo B levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. LDL-C remains >or = 190 mg/dl or 2. LDL-C remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient. Prevention of cardiovascular and/or cerebrovascular event sush as MI or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. In patients with clinically evident coronary heart disease, Litorva is indicated to : Reduce the risk of non-fatal myocardial infarction. Reduce the risk of fatal and non fatal stroke. Reduce the risk for revascularization procedures. Reduce the risk of hospitalization for CHF. Reduce the risk of angina.
2016-01-31
1 Patient package insert according to Pharmacists’ Regulations (Preparations) – 1986 This medicine can be sold with a physician’s prescription only LITORVA ® 10, 20, 40, 80 MG, TABLETS Each tablet contains atorvastatin ( as calcium ) at a dosage of 10, 20, 40, or 80 mg respectively. Inactive ingredients and allergens in the medicine - see section 6 "Additional information" and in section 2 "Important information about some of the ingredients of this medicine". Read this entire leaflet carefully before using this medicine. This leaflet contains concise information about the medicine. If you have any further questions, ask the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if you think that their medical condition is similar. 1. What is the medicine intended for? • To reduce the blood lipid levels ( cholesterol and triglycerides ) and to increase HDL. • To prevent cardiovascular diseases ( e.g., myocardial infarction or stroke ) in patients at high risk for a primary event. • In patients with a coronary heart disease, Litorva reduces the risk of the occurrence of myocardial infarction, stroke, hospitalization due to heart failure, angina pectoris and/or the need for catheterization. Therapeutic group: Statins - HMG-CoA reductase enzyme inhibitors. 2. Before using the medicine Do not use the medicine if: Special warnings regarding the use of the medicine Before the treatment with Litorva, tell the doctor if: • you suffer from unexplained muscle aches or weakness. • you drink more than two glasses of alcohol daily. • you suffer from diabetes. • you suffer from thyroid problems. • you suffer from kidney problems. • you suffered from a stroke. • you are pregnant or are planning to become pregnant. • you are breastfeeding or are planning to breastfeed. Children and adolescents This medicine is usually not intended for children under 10 years of age and girls who have not yet started menstruating. Tests and follow-up Before Olvassa el a teljes dokumentumot