দেশ: সিঙ্গাপুর
ভাষা: ইংরেজি
সূত্র: HSA (Health Sciences Authority)
ROSUVASTATIN CALCIUM 10.4 mg EQV ROSUVASTATIN
ASTRAZENECA SINGAPORE PTE LTD
C10AA07
TABLET, FILM COATED
ROSUVASTATIN CALCIUM 10.4 mg EQV ROSUVASTATIN 10 mg
ORAL
Prescription Only
IPR Pharmaceuticals, Inc (manufacturing)
ACTIVE
2015-05-15
1 VIVACOR (rosuvastatin) 1. NAME OF PHARMACEUTICAL PRODUCTS VIVACOR TM 5 mg, 10 mg, 20 mg Film-Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg, 10 mg or 20 mg of rosuvastatin as rosuvastatin calcium. 3. PHARMACEUTICAL FORM 5 mg film-coated tablet - round, biconvex 7 mm, yellow coloured. 10 mg film-coated tablet - round, biconvex, 7 mm, pink coloured. _ _ 20 mg film-coated tablet - round, biconvex, 9 mm, pink coloured. _ _ Tablets are impressed with ‘ZD4522’ and the tablet strength. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VIVACOR is indicated for patients with primary hypercholesterolaemia and mixed dyslipidaemia (including Fredrickson Type IIa, IIb; and heterozygous familial hypercholesterolaemia) as an adjunct to diet when response to diet and exercise is inadequate. VIVACOR is indicated to treat patients with primary dysbetalipoproteinaemia (Fredrickson Type III hyper lipoproteinaemia) as an adjunct to diet when response to diet and exercise is inadequate. VIVACOR reduces elevated LDL-cholesterol, total cholesterol and triglycerides and increases HDL-cholesterol, thereby enabling most patients to achieve relevant treatment guidelines. VIVACOR also lowers ApoB, nonHDL-C, VLDL-C, VLDL-TG, the LDL- C/HDL-C, total C/HDL-C, nonHDL-C/HDL-C, ApoB/ApoA-I ratios and increases ApoA-I. VIVACOR is also indicated in patients with homozygous familial hypercholesterolaemia, either alone or as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis). Primary prevention of cardiovascular disease: VIVACOR is indicated in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, VIVACOR is indicated to: • reduce the risk of stroke • reduce সম্পূর্ণ নথি পড়ুন