Clopidol tablets film-coated

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

clopidogrel (clopidogrel bisulfate)

Disponible desde:

A LAB PHARMACEUTICALS LLC

Código ATC:

B01AC04

Designación común internacional (DCI):

clopidogrel (clopidogrel bisulfate)

Dosis:

75mg

formulario farmacéutico:

tablets film-coated

Unidades en paquete:

(20/2x10/) in blister

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2022-09-23

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
CLOPIDOL
CLOPIDOGREL BISULFATE 75 MG FILM-COATED TABLETS
1. NAME OF THE MEDICINAL PRODUCT
CLOPIDOL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains
_Active substance_: clopidogrel (as clopidogrel bisulfate) 75 mg
_Excipients:_
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Light brown, circular, slightly biconvex film-coated tablets, plain on
both sides.
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:
- 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 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, including stroke.
For further information, please refer to section 5.1.
1
Age, Blood pressure, Clinical feature