EZETIMIBE ASTRON ezetimibe 10mg tablet bottle pack

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)
24-11-2017

有効成分:

ezetimibe, Quantity: 10 mg

から入手可能:

Accord Healthcare Pty Ltd

INN(国際名):

Ezetimibe

医薬品形態:

Tablet, uncoated

構図:

Excipient Ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate

投与経路:

Oral

パッケージ内のユニット:

30 tablets in bottle pack

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Adults (greater than or equal to 18 years),Primary Hypercholesterolaemia Ezetimibe administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,Homozygous Familial Hypercholesterolaemia (HoFH) Ezetimibe, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,Homozygous Sitosterolaemia (Phytosterolaemia) Ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,Children and Adolescents 10-17 Years (pubertal status: boys Tanner Stage II and above and girls who are at least one year post-menarche),Heterozygous Familial Hypercholesterolaemia (HeFH),Ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate: ? Patients not appropriately controlled with a statin or Ezetimibe alone ? Patients already treated with a statin and Ezetimibe,Homozygous Familial Hypercholesterolaemia (HoFH),Ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis)

製品概要:

Visual Identification: White to off white, capsule shaped, flat faced with beveled edge, uncoated tablets, debossed with 10 on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

認証ステータス:

Licence status A

承認日:

2016-10-05