EZETIMIBE GH ezetimibe 10 mg tablet bottle (HDPE bottle with molecular sieve sachet)

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

ezetimibe, Quantity: 10 mg

Disponible desde:

Lupin Australia Pty Limited

Designación común internacional (DCI):

Ezetimibe

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: crospovidone; povidone; lactose monohydrate; sodium lauryl sulfate; stearic acid; colloidal anhydrous silica

Vía de administración:

Oral

Unidades en paquete:

HDPE bottle with molecular sieve sachet, pack of 30 tablet

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Adults (greater than or equal to 18 Years),Primary Hypercholesterolaemia,Ezetimibe GH administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,Homozygous Familial Hypercholesterolaemia (HoFH),Ezetimibe GH, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).,Homozygous Sitosterolaemia (Phytosterolaemia) Ezetimibe GH is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia. Prevention of Cardiovascular Disease,Ezetimibe GH is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) 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).,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 GH co-administered with simvastatin (doses up to 40 mg) is indicated as an 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 GH co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with HoFH. Patients may also receive adjunctive treatments (eg. LDL apheresis).

Resumen del producto:

Visual Identification: White to off white, capsule shaped, flat faced, beveled edge tablet, debossed with E on one side and 10 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Licence status A

Fecha de autorización:

2016-07-04

Ficha técnica

AUSTRALIAN PRODUCT INFORMATION – EZETIMIBE GH
(EZETIMIBE) UNCOATED TABLET
1
NAME OF THE MEDICINE
Ezetimibe.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Ezetimibe GH contains 10 mg ezetimibe.
List of excipients with known effect: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ezetimibe GH 10 mg: White to off-white, capsule shaped, flat faced,
bevelled edge tablet, debossed with
“
E
”
on one side and
“
10
”
on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS (
≥
18 YEARS)
Primary Hypercholesterolaemia
Ezetimibe GH administered alone, or with an HMG-CoA reductase
inhibitor (statin), is indicated as
adjunctive
therapy
to
diet
in
patients
with
primary
(heterozygous
familial
and
non-familial)
hypercholesterolaemia.
Homozygous Familial Hypercholesterolaemia (HoFH)
Ezetimibe GH, administered with a statin, is indicated for patients
with HoFH. Patients may also receive
adjunctive treatments (eg. LDL apheresis).
Homozygous Sitosterolaemia (Phytosterolaemia)
Ezetimibe GH is indicated for the reduction of elevated sitosterol and
campesterol levels in patients with
homozygous familial sitosterolaemia.
Prevention of Cardiovascular Disease
Ezetimibe GH is indicated for administration in combination with the
maximum tolerated dose of a statin
with proven cardiovascular benefit in patients with coronary heart
disease (CHD) and a history of acute
coronary syndrome (ACS) in need of additional lowering of LDL-C in the
expectation of a modest further
Ezetimibe GH v4.0
Page 2 of 28
(ezetimibe) uncoated tablet
reduction in the risk of cardiovascular events following at least one
year of therapy (see SECTION 5.1
PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS).
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 GH co-administered with simvastatin (doses up to 40 mg) is
indicated