PLAVIX TABLET 75 mg

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

CLOPIDOGREL HYDROGEN SULPHATE EQV CLOPIDOGREL

Mevcut itibaren:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC kodu:

B01AC-04

Doz:

75 mg

Farmasötik formu:

TABLET, FILM COATED

Kompozisyon:

CLOPIDOGREL HYDROGEN SULPHATE EQV CLOPIDOGREL 75 mg

Uygulama yolu:

ORAL

Reçete türü:

Prescription Only

Tarafından üretildi:

SANOFI WINTHROP INDUSTRIE

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

1998-06-16

Bilgilendirme broşürü

1 

PLAVIX 
®

clopidogrel hydrogen sulphate 
film-coated tablets 

[sanofi logo] 

1. NAME OF THE MEDICINAL PRODUCT 
Plavix 75 mg film-coated tablets 
Plavix 300 mg film-coated tablets  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
PLAVIX 75 MG FILM-COATED TABLETS 
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate). 
Excipients: each tablet contains 3 mg lactose and 3.3
mg hydrogenated castor oil. 

PLAVIX 300 MG FILM-COATED TABLETS  
Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen
sulphate).  
Excipients: each film-coated tablet contains 12 mg of lactose and
13.2 mg of hydrogenated 
castor oil. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 
PLAVIX 75 MG FILM-COATED TABLETS 
Film-coated tablet. 
Pink, round, biconvex, engraved with “75” on one side and
“1171” on the other side. 

PLAVIX 300 MG FILM-COATED TABLETS  
Pink, oblong, engraved with “300” on one side and “1332” on
the other side.  

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 

_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: 
- 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). 
- ST segment elevation acute myocardial infarction, in combination
with ASA in medically 
treated patients eligible for thrombolytic therapy. 

_PREVENTION OF ATHEROTHROMBOTIC AND THROMBOEMBOLIC EVENTS IN
ATRIAL FIBRILLATION _
In adult patients with

Ürün özellikleri

1
SG/PLA75/0622/CCDSv29,30
PLAVIX
®
clopidogrel hydrogen sulphate
film-coated tablets
[
sanofi logo
]
1. NAME OF THE MEDICINAL PRODUCT
Plavix 75 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PLAVIX 75 MG FILM-COATED TABLETS
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate).
Excipients: each tablet contains 3 mg lactose and 3.3 mg hydrogenated
castor oil.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
PLAVIX 75 MG FILM-COATED TABLETS
Film-coated tablet.
Pink, round, biconvex, engraved with “75” on one side and
“1171” on the 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), ischemic stroke (from 7 days until less than 6 months) or
established peripheral
arterial disease.
•
Adult patients suffering from acute coronary syndrome:
- 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).
- 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.
_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
1
Age, Blood pressure, Clinical features, Duration, and Diabetes
mellitus