ZETEZE ezetimibe/atorvastatin 10mg/20mg tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

atorvastatin calcium trihydrate, Quantity: 21.7 mg (Equivalent: atorvastatin, Qty 20 mg); ezetimibe, Quantity: 10 mg

Предлага се от:

ORGANON PHARMA PTY LTD

INN (Международно Name):

atorvastatin calcium trihydrate,Ezetimibe

Лекарствена форма:

Tablet, multilayer

Композиция:

Excipient Ingredients: polysorbate 80; magnesium stearate; povidone; lactose monohydrate; sodium lauryl sulfate; croscarmellose sodium; microcrystalline cellulose; calcium carbonate; hyprolose; silicon dioxide; titanium dioxide; macrogol 8000; hypromellose; purified talc

Начин на приложение:

Oral

Броя в опаковка:

10, 30

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Prevention of Cardiovascular Disease ZETEZE is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see Clinical Trials). Primary Hypercholesterolaemia ZETEZE is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients: - not appropriately controlled with atorvastatin or ezetimibe alone; - or already treated with atorvastatin and ezetimibe Homozygous Familial Hypercholesterolaemia (HoFH) ZETEZE is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).

Каталог на резюме:

Visual Identification: Capsule shaped, biconvex, white to off white tablets, with "333" debossed on one side of the tablet; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2015-02-04