ROSUVASTATIN DR.REDDY'S rosuvastatin (as calcium) 40 mg film-coated tablets blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
19-10-2017

Aktivna sestavina:

rosuvastatin calcium, Quantity: 41.6 mg

Dostopno od:

Dr Reddys Laboratories Australia Pty Ltd

INN (mednarodno ime):

Rosuvastatin calcium

Farmacevtska oblika:

Tablet, film coated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

30 tablets

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 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 s

Povzetek izdelek:

Visual Identification: Pale pink to pink coloured oval shaped film-coated tablets having '40' on one side & symbol like DR. REDDY'S logo on other side of tablet; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2014-04-15