Rosuvastatin-GX rosuvastatin (as calcium) 20 mg tablet blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

rosuvastatin calcium, Quantity: 20.84 mg

MAH:

Medis Pharma Pty Ltd

INN:

Rosuvastatin calcium

pharmaceutical_form:

Tablet, film coated

composition:

Excipient Ingredients: lactose monohydrate; crospovidone; microcrystalline cellulose; magnesium stearate; calcium hydrogen phosphate dihydrate; titanium dioxide; hypromellose; triacetin; macrogol 3350; cochineal

administration_route:

Oral

units_in_package:

30 tablets

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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 syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

leaflet_short:

Visual Identification: Round, pink, biconvex tablet debossed with 'ST 3' on one side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

authorization_status:

Licence status A

authorization_date:

2014-09-19