ZIENT ezetimibe 10mg tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

ezetimibe, Quantity: 10 mg

Предлага се от:

ORGANON PHARMA PTY LTD

INN (Международно Name):

Ezetimibe

Лекарствена форма:

Tablet

Композиция:

Excipient Ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; povidone

Начин на приложение:

Oral

Броя в опаковка:

30 Tablets, 5 Tablets, 10 Tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Adults (greater than or equal to 18 Years) Primary Hypercholesterolaemia: - ZIENT 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): - ZIENT, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis). Homozygous Sitosterolaemia (Phytosterolaemia): - ZIENT is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,,Prevention of Cardiovascular Disease ZIENT 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 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): - ZIENT 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): -ZIENT 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 (e.g. LDL apheresis)

Каталог на резюме:

Visual Identification: White to off-white, capsule-shaped tablet debossed with "414" on one side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2015-12-22

Листовка

ZIENT
®
_Ezetimibe_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ZIENT. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ZIENT
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZIENT IS USED
FOR
ZIENT helps to lower cholesterol
levels. It is used in people whose
cholesterol levels are too high and
when diet alone cannot lower these
levels adequately.
ZIENT may be taken alone or with
other cholesterol-lowering medicines
known as HMG-CoA reductase
inhibitors (or statins), in addition to
diet.
In people who have high levels of
plant sterols in their blood (which
doctors call sitosterolaemia), ZIENT
helps to lower these levels.
_CHOLESTEROL_
Cholesterol is one of several fatty
substances found in the bloodstream.
Your total cholesterol is made up
mainly of LDL and HDL cholesterol.
LDL cholesterol is often called 'bad'
cholesterol because it can build up in
the walls of your arteries forming
plaque. Eventually this plaque build-
up can lead to a narrowing of the
arteries.
This narrowing can slow or block
blood flow to vital organs such as the
heart and brain. This blocking of
blood flow can result in a heart attack
or stroke.
HDL cholesterol is often called
'good' cholesterol because it helps
keep the bad cholesterol from
building up in the arteries and
protects against heart disease.
_TRIGLYCERIDES_
Triglycerides are another form of fat
in your blood that may increase your
risk for heart disease.
_HOW ZIENT WORKS_
ZIENT reduces elevated total-
cholesterol, LDL (bad) cholesterol
and triglycerides and increases HDL
(good) cholesterol.
ZIENT works by decreasing the
absorption of cholesterol in the small
intestine. Statins lower cholesterol in
a diff

Данни за продукта

1 of 27
AUSTRALIAN PRODUCT INFORMATION
ZIENT

(EZETIMIBE)
TABLETS
1
NAME OF THE MEDICINE
Ezetimibe
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of ZIENT for oral administration contains 10 mg ezetimibe.
List of excipients with known effect:
-
lactose (as monohydrate)
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ZIENT (ezetimibe) – 10 mg, white to off-white capsule shaped
tablets, debossed with “414”
on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ADULTS (≥ 18 YEARS) _
_PRIMARY HYPERCHOLESTEROLAEMIA _
ZIENT 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)_
ZIENT, administered with a statin, is indicated for patients with
HoFH. Patients may also
receive adjunctive treatments (e.g., LDL apheresis).
_HOMOZYGOUS SITOSTEROLAEMIA (PHYTOSTEROLAEMIA)_
ZIENT is indicated for the reduction of elevated sitosterol and
campesterol levels in patients
with homozygous familial sitosterolaemia.
_PREVENTION OF CARDIOVASCULAR DISEASE _
ZIENT, 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).
2 of 27
_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) _
ZIENT 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
familia