EZETIMIBE/SIMVASTATIN MSD 10 mg/80 mg ezetimibe 10 mg and simvastatin 80 mg tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

ezetimibe, Quantity: 10 mg; simvastatin, Quantity: 80 mg

Disponible desde:

ORGANON PHARMA PTY LTD

Designación común internacional (DCI):

Ezetimibe,Simvastatin

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: magnesium stearate; butylated hydroxyanisole; lactose monohydrate; hypromellose; microcrystalline cellulose; croscarmellose sodium; propyl gallate; citric acid monohydrate

Vía de administración:

Oral

Unidades en paquete:

30 tablets, 10 tablets, 5 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Adults (greater than or equal to 18 years),Prevention of cardiovascular disease,EZETIMIBE/SIMVASTATIN MSD is indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin 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 Section 5.1 Pharmacodynamic Properties, Clinical trials).,Primary hypercholesterolaemia,EZETIMIBE/SIMVASTATIN MSD is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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/SIMVASTATIN MSD is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,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/SIMVASTATIN MSD is indicated as 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/SIMVASTATIN MSD is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Resumen del producto:

Visual Identification: White to off-white, capsule shaped, biconvex compressed tablet with "315" marked on the tablet; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2015-11-25