PRALECT 40 pravastatin sodium 40mg tablet bottle

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

pravastatin sodium, Quantity: 40 mg

Commercializzato da:

Arrotex Pharmaceuticals Pty Ltd

INN (Nome Internazionale):

pravastatin sodium

Forma farmaceutica:

Tablet, uncoated

Composizione:

Excipient Ingredients: microcrystalline cellulose; iron oxide yellow; povidone; lactose monohydrate; heavy magnesium oxide; magnesium stearate; croscarmellose sodium

Via di somministrazione:

Oral

Confezione:

30

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

1. As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (eg, poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.,2. Pravastatin is indicated in patients with previous myocardial infarction including those who have normal (4.0 ? 5.5 mmol/L) serum cholesterol levels.,3. Pravastatin is indicated in patients with unstable angina pectoris (see CLINICAL TRIALS).,4. Pravastatin is indicated as an adjunct to diet and lifestyle modification for the treatment of Heterozygous Familial Hypercholesterolaemia in children and adolescent patients aged 8 years and older (see CLINICAL TRIALS).

Dettagli prodotto:

Visual Identification: Yellow, capsule shaped, biconvex, mottled uncoated tablets debossed with 'R' on one side and '40' on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2012-10-24