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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

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

Disponible depuis:

ORGANON PHARMA PTY LTD

DCI (Dénomination commune internationale):

Ezetimibe,Simvastatin

forme pharmaceutique:

Tablet, uncoated

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

30 tablets, 10 tablets, 5 tablets

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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).

Descriptif du produit:

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

Statut de autorisation:

Licence status A

Date de l'autorisation:

2015-11-25