CRESTAT rosuvastatin (as calcium) 10 mg tablets blister

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
28-11-2017

Aktivna sestavina:

rosuvastatin calcium, Quantity: 10.4 mg

Dostopno od:

Medis Pharma Pty Ltd

INN (mednarodno ime):

Rosuvastatin calcium

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: lactose monohydrate; polyvinyl alcohol; crospovidone; purified talc; xanthan gum; calcium hydrogen phosphate; titanium dioxide; microcrystalline cellulose; lecithin; magnesium stearate

Pot uporabe:

Oral

Enote v paketu:

7, 30

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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 = 50 years old and women = 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.

Povzetek izdelek:

Visual Identification: White, round, biconvex tablets, debossed with "R9UN 10" on one side and on the other side scored.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Registered

Datum dovoljenje:

2012-05-14