Clopidogrel Sandoz Film Coated Tablet 75mg

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

Thành phần hoạt chất:

Clopidogrel bisulphate 97.875mg eqv Clopidogrel

Sẵn có từ:

SANDOZ SINGAPORE PTE. LTD.

Mã ATC:

B01AC04

Liều dùng:

75mg

Dạng dược phẩm:

TABLET, FILM COATED

Thành phần:

Clopidogrel bisulphate 97.875mg eqv Clopidogrel 75mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

Sandoz Private Limited

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

2009-12-14

Đặc tính sản phẩm

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