PRALECT 40 pravastatin sodium 40mg tablet bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

pravastatin sodium, Quantity: 40 mg

Disponible desde:

Arrotex Pharmaceuticals Pty Ltd

Designación común internacional (DCI):

pravastatin sodium

formulario farmacéutico:

Tablet, uncoated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

30

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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).

Resumen del producto:

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

Estado de Autorización:

Registered

Fecha de autorización:

2012-10-24