PRALECT 40 pravastatin sodium 40mg tablet bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

pravastatin sodium, Quantity: 40 mg

Tillgänglig från:

Arrotex Pharmaceuticals Pty Ltd

INN (International namn):

pravastatin sodium

Läkemedelsform:

Tablet, uncoated

Sammansättning:

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

Administreringssätt:

Oral

Enheter i paketet:

30

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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).

Produktsammanfattning:

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

Bemyndigande status:

Registered

Tillstånd datum:

2012-10-24