ROSUVASTATIN-RL rosuvastatin (as calcium) 5 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

rosuvastatin calcium, Quantity: 5.2 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; crospovidone; meglumine; magnesium stearate; titanium dioxide; indigo carmine aluminium lake; hypromellose; triacetin; allura red AC aluminium lake; quinoline yellow aluminium lake

Administration route:

Oral

Units in package:

7 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,- Prevention of Cardiovascular Events,Rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). Rosuvastatin is indicated to:,? Reduce the risk of nonfatal myocardial infarction,? Reduce the risk of nonfatal stroke,? Reduce the risk of coronary artery revascularisation procedures.,- In patients with hypercholesterolaemia,Rosuvastatin is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia).,Prior to initiating therapy with rosuvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic s

Product summary:

Visual Identification: Pale yellow to yellow coloured round shaped film-coated tablets having '5' on one side & symbol like DR. REDDY'S logo on other side of tablet; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-04-15