Clopidogrel Sandoz Film Coated Tablet 75mg

Страна: Сингапур

Язык: английский

Источник: HSA (Health Sciences Authority)

Активный ингредиент:

Clopidogrel bisulphate 97.875mg eqv Clopidogrel

Доступна с:

SANDOZ SINGAPORE PTE. LTD.

код АТС:

B01AC04

дозировка:

75mg

Фармацевтическая форма:

TABLET, FILM COATED

состав:

Clopidogrel bisulphate 97.875mg eqv Clopidogrel 75mg

Администрация маршрут:

ORAL

Тип рецепта:

Prescription Only

Производитель:

Sandoz Private Limited

Статус Авторизация:

ACTIVE

Дата Авторизация:

2009-12-14

Характеристики продукта

CLOPIDOGREL SANDOZ FILM COATED TABLET 75MG
1.
NAME OF THE MEDICINAL PRODUCT
Clopidogrel Sandoz Film Coated Tablet 75 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
Clopidogrel (as hydrogen sulphate 97.875 mg) 75.00 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink colored, round shaped, engraved with ‘SZ’ 75 on one side and
plain on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_SECONDARY PREVENTION OF ATHEROTHROMBOTIC EVENTS _
Clopidogrel is indicated in:

Adult patients suffering from myocardial infarction (from a few days
until less than 35
days), ischaemic stroke (from 7 days until less than 6 months) or
established
peripheral arterial disease.

Adult patients suffering from acute coronary syndrome:
o
Non-ST segment elevation acute coronary syndrome (unstable angina or
non-
Q-wave myocardial infarction), including patients undergoing a stent
placement following percutaneous coronary intervention, in combination
with
acetylsalicylic acid (ASA).
o
ST segment elevation acute myocardial infarction, in combination with
ASA in
medically treated patients eligible for thrombolytic therapy.
_IN PATIENTS WITH MODERATE TO HIGH-RISK TRANSIENT ISCHEMIC ATTACK
(TIA) OR MINOR _
_ISCHEMIC STROKE (IS) _
Clopidogrel in combination with ASA is indicated in:

Adult patients with moderate to high-risk TIA (ABCD2
1
score
≥
4) or minor IS
(NIHSS
2
≤
3) within 24 hours of either the TIA or IS event.
1
Age, Blood pressure, Clinical features, Duration, and Diabetes
mellitus diagnosis
2
National Institutes of Health Stroke Scale
_PREVENTION OF ATHEROTHROMBOTIC AND THROMBOEMBOLIC EVENTS IN ATRIAL
FIBRILLATION _
In adult patients with atrial fibrillation (AF) who have at least one
risk factor for vascular
events, are not suitable for treatment with Vitamin K antagonists
(VKA) and who have a low
bleeding risk, clopidogrel is indicated in combination with ASA for
the prevention of
atherothrombotic and thromboembolic events, inclu