ZETEZE ezetimibe/atorvastatin 10mg/40mg tablet blister pack

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

atorvastatin calcium trihydrate, Quantity: 43.4 mg (Equivalent: atorvastatin, Qty 40 mg); ezetimibe, Quantity: 10 mg

Disponibbli minn:

ORGANON PHARMA PTY LTD

INN (Isem Internazzjonali):

atorvastatin calcium trihydrate,Ezetimibe

Għamla farmaċewtika:

Tablet, multilayer

Kompożizzjoni:

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

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

30, 10

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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).

Sommarju tal-prodott:

Visual Identification: Capsule shaped, biconvex, white to off white tablets, with "337" 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

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2015-02-04