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

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

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

Beschikbaar vanaf:

ORGANON PHARMA PTY LTD

INN (Algemene Internationale Benaming):

atorvastatin calcium trihydrate,Ezetimibe

farmaceutische vorm:

Tablet, multilayer

Samenstelling:

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

Toedieningsweg:

Oral

Eenheden in pakket:

30, 10

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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).

Product samenvatting:

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

Autorisatie-status:

Licence status A

Autorisatie datum:

2015-02-04