Ezetimibe Sandoz

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Ezetimibe 10mg;  

제공처:

Sandoz New Zealand Limited

INN (International Name):

Ezetimibe 10 mg

복용량:

10 mg

약제 형태:

Tablet

구성:

Active: Ezetimibe 10mg   Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate

처방전 유형:

Prescription

Manufactured by:

MSN Laboratories Private Limited

치료 징후:

Ezetimibe Sandoz administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG) and to increase high-density lipoprotein cholesterol (HDL-C) in adult and adolescent (10 to 17 years of age) patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.

제품 요약:

Package - Contents - Shelf Life: Blister pack, Alu-Alu enclosed in a secondary cardboard carton - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture

승인 날짜:

2014-05-30

환자 정보 전단

CONSUMER MEDICINE INFORMATION
EZETIMIBE SANDOZ
®
_Ezetimibe _10 mg tablet
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Ezetimibe Sandoz. 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 Ezetimibe
Sandoz 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.
You should also read any information provided with other medicines you
are currently taking.
WHAT EZETIMIBE SANDOZ IS USED FOR
•
Ezetimibe Sandoz is a cholesterol-lowering medicine.
•
Ezetimibe Sandoz is for adults and adolescents (10 to 17 years of age)
whose cholesterol levels
are too high and when diet alone cannot lower these levels adequately.
•
Ezetimibe Sandoz reduces elevated total-cholesterol, LDL (bad)
cholesterol and triglycerides
and increases HDL (good) cholesterol.
•
Ezetimibe Sandoz may be taken with other cholesterol-lowering
medicines known as statins or
alone, in addition to diet.
CHOLESTEROL
Some of the reasons cholesterol is needed by the body include;
building cell walls, making bile
acids (which help to digest food) and certain hormones. However, too
much cholesterol can be a
problem.
Your body makes cholesterol, but it also comes from food.
Normally the body balances the cholesterol it makes with the
cholesterol it gets from food. This
means if more cholesterol comes from food, less is made by the body.
However, if you eat a diet
high in fat, your body may not keep this balance and your cholesterol
levels rise.
High cholesterol is more likely to occur with certain diseases or if
you have a family history of high
cholesterol.
When you have high levels of cholesterol, it may 'stick' to the inside
of your blood vessels instead
of being carried to the parts of the body where it is needed. Over
time, th

제품 특성 요약

NEW ZEALAND DATA SHEET
240129-ezetimibe-sandoz-ds-v1.0
Page 1 of 22
1 PRODUCT NAME
EZETIMIBE SANDOZ 10 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg ezetimibe.
Contains Lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ezetimibe Sandoz 10 mg is a white to almost white, oval tablet (7.4 mm
x 4.1 mm) with
debossing “10” on one side and “EZT” on the other side.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PRIMARY HYPERCHOLESTEROLAEMIA
Ezetimibe Sandoz, administered with an HMG-CoA reductase inhibitor
(statin) or alone, is
indicated as adjunctive therapy to diet for the reduction of elevated
total cholesterol (total-C),
low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B),
and triglycerides
(TG) and to increase high-density lipoprotein cholesterol (HDL-C) in
adult and adolescent
(10 to 17 years of age) patients with primary (heterozygous familial
and non-familial)
hypercholesterolaemia.
HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)
Ezetimibe Sandoz, administered with a statin, is indicated for the
reduction of elevated total-
C and LDL-C levels in adult and adolescent (10 to 17 years of age)
patients with HoFH.
Patients may also receive adjunctive treatments (e.g., LDL apheresis).
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 Sandoz.
The recommended dose of Ezetimibe Sandoz is 10 mg once daily, used
alone or with a statin.
Ezetimibe Sandoz can be administered at any time of the day, with or
without food.
USE IN RENAL IMPAIRMENT/CHRONIC KIDNEY DISEASE
Monotherapy
In patients with renal impairment, no dosage adjustment of Ezetimibe
Sandoz is necessary
(see Section 5.2_, Characteristics in Patients [Special Populations]).
_
NEW ZEALAND DATA SHEET
240129-ezetimibe-sandoz-ds-v1.0
Page 2 of 22
Combination Therapy with Simvastatin
In patients with mild renal impairment (estimated GFR ≥60
mL/min/1.73 m
2
), no do