PRALECT 40 pravastatin sodium 40mg tablet bottle

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

pravastatin sodium, Quantity: 40 mg

MAH:

Arrotex Pharmaceuticals Pty Ltd

INN:

pravastatin sodium

pharmaceutical_form:

Tablet, uncoated

composition:

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

administration_route:

Oral

units_in_package:

30

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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).

leaflet_short:

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

authorization_status:

Registered

authorization_date:

2012-10-24