Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
Atorvastatin Calcium 86.80mg eqv Atorvastatin
VIATRIS PRIVATE LIMITED
C10AA05
80 mg
TABLET, FILM COATED
Atorvastatin Calcium 86.80mg eqv Atorvastatin 80 mg
ORAL
Prescription Only
Viatris Pharmaceuticals LLC
ACTIVE
2007-06-22
LIP-SIN-0413/1 Date of Last Revision: March 2014 Page 1 of 22 ETURION ® TABLETS ATORVASTATIN CALCIUM 1. TRADE NAME(S) OF THE MEDICINAL PRODUCT Eturion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: atorvastatin. The tablets for oral administration contain atorvastatin calcium equivalent to 10, 20, 40, or 80 mg atorvastatin. 3. PHARMACEUTICAL FORM Tablets: 10 mg, 20 mg, 40 mg, 80 mg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, or combined (mixed) hyperlipidemia (Fredrickson Types IIa and IIb), elevated serum triglyceride levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other non-pharmacological measures is inadequate. Atorvastatin also raises HDL-cholesterol and lowers the LDL/HDL and total cholesterol/HDL ratios. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. _Prevention of Cardiovascular Disease_ Eturion is indicated to reduce the risk of myocardial infarction in adult hypertensive patients without clinically evident coronary heart disease, but with at least three additional risk factors for coronary heart disease such as age 55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on ECG, microalbuminia or proteinuria, ratio of plasma total cholesterol to HDL-cholesterol Perskaitykite visą dokumentą
Page 1 of 28 ETURION ® TABLETS ATORVASTATIN CALCIUM 1. NAME OF THE MEDICINAL PRODUCT Eturion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: atorvastatin. The tablets for oral administration contain atorvastatin calcium equivalent to 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin. 3. PHARMACEUTICAL FORM Tablets: 10 mg, 20 mg, 40 mg, 80 mg. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and triglycerides (TG) in adults, adolescents and children aged 10 years or older with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, or combined (mixed) hyperlipidemia (Fredrickson Types IIa and IIb), elevated serum TG levels (Fredrickson Type IV), and for patients with dysbetalipoproteinemia (Fredrickson Type III) when response to diet and other non-pharmacological measures is inadequate. Atorvastatin also raises high density lipoprotein cholesterol (HDL-C) and lowers the LDL/HDL and total-C/HDL ratios. Atorvastatin is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. _Prevention of Cardiovascular Disease_ Eturion is indicated to reduce the risk of myocardial infarction (MI) in adult hypertensive patients without clinically evident coronary heart disease (CHD), but with at least three additional risk factors for CHD such as age ≥55 years, male sex, smoking, left ventricular hypertrophy, other specified abnormalities on Page 2 of 28 electrocardiogram (ECG), microalbuminuria or proteinuria, ratio of plasma total-C to HDL-C ≥6, or premature family history of CHD. In adults with type 2 diabetes and without clinically evident CHD, but with multiple risk factors for CHD such as retinopathy, albuminuria, smoking or hypertension, Eturion is indicated to: • Redu Perskaitykite visą dokumentą