APO-EZETIMIBE ezetimibe 10mg tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

ezetimibe, Quantity: 10 mg

Доступна с:

Arrotex Pharmaceuticals Pty Ltd

ИНН (Международная Имя):

Ezetimibe

Фармацевтическая форма:

Tablet, uncoated

состав:

Excipient Ingredients: lactose monohydrate; carmellose sodium; povidone; sodium lauryl sulfate; polysorbate 80; magnesium stearate

Администрация маршрут:

Oral

Штук в упаковке:

10 tablets in blister pack, 30 tablets in blister pack, 7 tablets in blister pack

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Adults (greater than or equal to18 Years),Primary Hypercholesterolaemia,Ezetimibe 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, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).,Homozygous Sitosterolaemia (Phytosterolaemia),Ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,Prevention of Cardiovascular Disease,Ezetimibe 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 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 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)

Обзор продуктов:

Visual Identification: White to off white, capsule shaped, flat faced with beveled edge, uncoated tablets, debossed with 10 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2016-10-05

тонкая брошюра

APO-EZETIMIBE
1
APO-EZETIMIBE
_Ezetimibe _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 this medicine
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 THIS MEDICINE IS
USED FOR
APO-Ezetimibe is used to lower
cholesterol levels. It is used in people
whose cholesterol levels are too high
and when diet alone cannot lower
these levels adequately.
Ezetimibe 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),
Ezetimibe 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, which 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 EZETIMIBE WORKS
Ezetimibe reduces elevated total-
cholesterol by reducing LDL (bad)
cholesterol and triglycerides, and
increasing HDL (good) c

Характеристики продукта

1
AUSTRALIAN PRODUCT INFORMATION – APO-EZETIMIBE TABLETS
(EZETIMIBE)
1 NAME OF THE MEDICINE
Ezetimibe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of ezetimibe for oral administration contains 10mg
ezetimibe.
For the full list of excipients, see section 6.1 List of Excipients.
Excipients with Known Effect: Lactose monohydrate.
3 PHARMACEUTICAL FORM
10 MG TABLETS:
White to off white, capsule shaped, flat faced with beveled edge,
uncoated tablets, debossed with
10 on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS (≥ 18 YEARS)
PRIMARY HYPERCHOLESTEROLAEMIA
Ezetimibe 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, administered with a statin, is indicated for 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 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 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)
2
4.2
DOSE AND METHOD OF ADMINISTRATION
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during
treatment with ezetimibe.
Use in Patients with Primary Hyper