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

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

rosuvastatin calcium, Quantity: 10.395 mg

Διαθέσιμο από:

Arrotex Pharmaceuticals Pty Ltd

INN (Διεθνής Όνομα):

Rosuvastatin calcium

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30, 7, 28

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2013-05-03