AURO-ROSUVASTATIN 5 rosuvastatin (as calcium) 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

rosuvastatin calcium, Quantity: 5.197 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Rosuvastatin calcium

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate; calcium hydrogen phosphate; crospovidone; titanium dioxide; hypromellose; sunset yellow FCF aluminium lake; triacetin; allura red AC aluminium lake; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

28, 7, 30

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 (excluding heterozygous familial hypercholesterolaemia).,Prior to initiating therapy with Rosuvastatin, 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.

Product summary:

Visual Identification: Pink coloured, oval shaped, biconvex film-coated tablets, debossed with J on one side and 53 on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2013-05-03