AURO-PRAVASTATIN 40 pravastatin sodium 40mg tablet bottle

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
28-11-2017

有効成分:

pravastatin sodium, Quantity: 40 mg

から入手可能:

Strides Pharma Science Pty Ltd

INN(国際名):

pravastatin sodium

医薬品形態:

Tablet, uncoated

構図:

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

投与経路:

Oral

パッケージ内のユニット:

30

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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).

製品概要:

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

認証ステータス:

Licence status A

承認日:

2012-10-24