STORVAS

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
29-11-2017

Aktivna sestavina:

atorvastatin calcium, Quantity: 41.44 mg (Equivalent: atorvastatin, Qty 40 mg)

Dostopno od:

Sun Pharma ANZ Pty Ltd

INN (mednarodno ime):

Atorvastatin calcium

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: colloidal anhydrous silica; croscarmellose sodium; lactose; hyprolose; butylated hydroxyanisole; sodium lauryl sulfate; butylated hydroxytoluene; microcrystalline cellulose; sodium carbonate; magnesium stearate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

Pot uporabe:

Oral

Enote v paketu:

100 tablets per pack, 28 tablets per pack, 30 tablets per pack

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see Clinical Trials, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Povzetek izdelek:

Visual Identification: White to off-white, film-coated, oval tablets debossed with "AT4" on one side and plain on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status dovoljenje:

Licence status A

Datum dovoljenje:

2011-08-22

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