AURO-ROSUVASTATIN 10 rosuvastatin (as calcium) 10 mg tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

rosuvastatin calcium, Quantity: 10.395 mg

Commercializzato da:

Arrotex Pharmaceuticals Pty Ltd

INN (Nome Internazionale):

Rosuvastatin calcium

Forma farmaceutica:

Tablet, film coated

Composizione:

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

Via di somministrazione:

Oral

Confezione:

30, 7, 28

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Visual Identification: Pink coloured, round shaped, biconvex film-coated tablets, debossed with J on one side and 54 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

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2013-05-03