국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
fluvastatin sodium, Quantity: 84.24 mg (Equivalent: fluvastatin, Qty 80 mg)
Novartis Pharmaceuticals Australia Pty Ltd
Tablet, modified release
Excipient Ingredients: hypromellose; hyprolose; potassium bicarbonate; magnesium stearate; povidone; microcrystalline cellulose; titanium dioxide; macrogol 8000; iron oxide yellow
Oral
7 tablets, 28 tablets
(S4) Prescription Only Medicine
Hypercholesterolaemia: Prior to initiating therapy with fluvastatin for treating hypercholesterolaemia, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Adults: As an adjunct to diet in the treatment of hypercholesterolaemia. Heterozygous familial hypercholesterolaemia in paediatric patients: As an adjunct to diet in adolescent boys and in adolescent girls who are at least one year post-menstruation, 10-16 years of age, with heterozygous familial hypercholesterolaemia whose response to dietary restriction has not been adequate and in whom the following findings are present: 1. LDL-C remains greater than or equal to 4.9 mmol/L (190 mg/dL) or 2. LDL-C remains greater than or equal to 4.1 mmol/L (160 mg/dL) and: there is a positive family history of premature cardiovascular disease - or two or more other cardiovascular disease risk factors are present. Secondary Prevention of Cardiac Events: For the prevention of major adverse cardiac events in adult patients with coronary heart disease who have undergone successful coronary transcatheter therapy.
Visual Identification: YELLOW, ROUND, SLIGHTLY BICONVEX WITH BEVELLED EDGES APPROX. 10MM IN DIAMETER. DEBOSSED WITH "LE" ON ONE SIDE, "NVR" ON THE OTHER.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2002-09-17
LESCOL XL ® _fluvastatin sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Lescol XL. 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 listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Lescol XL against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LESCOL XL IS USED FOR Lescol XL is used to lower the amount of cholesterol made by the body. Everyone has cholesterol in their blood. It is a type of fat needed by the body for many things, such as building cells, making bile acids (which help to digest food) and making some hormones. However, having too much cholesterol in the blood can contribute to the development of heart disease. Cholesterol is present in many foods and is also made by your body. If your body does not balance the amount of cholesterol it makes with the amount of cholesterol you eat, then your cholesterol becomes too high. High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol. Lescol XL does not reduce the cholesterol that comes from fat in food. Therefore, you also need to follow a low fat diet, control your weight and exercise regularly. Lescol XL can also be used to help prevent further serious cardiac problems in people with heart disease who have already had cardiac catheterisation 전체 문서 읽기
1 AUSTRALIAN PRODUCT INFORMATION – LESCOL ® XL (FLUVASTATIN SODIUM) TABLETS 1 NAME OF THE MEDICINE fluvastatin sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fluvastatin sodium is a white to pale yellow powder, odourless or weak odour only. Fluvastatin sodium is a racemic mixture of the two enantiomers of which the 3R,5S form possesses more than 30 times the activity of the 3S,5R form. Each prolonged release tablet contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Prolonged release tablets. Yellow, round, slightly biconvex, film-coated tablet, marked "LE" on one side and "NVR" on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS HYPERCHOLESTEROLAEMIA Prior to initiating therapy with fluvastatin for treating hypercholesterolemia, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. ADULTS: • As an adjunct to diet in the treatment of hypercholesterolaemia. HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN PAEDIATRIC PATIENTS: • As an adjunct to diet in adolescent boys and in adolescent girls who are at least one year post-menstruation, 10 -16 years of age, with heterozygous familial hypercholesterolaemia whose response to dietary restriction has not been adequate and in whom the following findings are present: 1. LDL-C remains ≥ 4.9 mmol/L (190 mg/dL) or 2. LDL-C remains ≥ 4.1 mmol/L (160 mg/dL) and: 2 • there is a positive family history of premature cardiovascular disease or • two or more other cardiovascular disease risk factors are present. SECONDARY PREVENTION OF CARDIAC EVENTS: • For the prevention of major adverse cardiac events in adult patients with coronary heart disease who have undergone successful coronary transcatheter therapy. 4.2 D OSE AND METHOD OF ADMINISTRATION Prior to ini 전체 문서 읽기