Clopi-Denk 75 tablets film-coated

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

clopidogrel (clopidogrel besylate)

Disponible depuis:

Artesan Pharma GmbH & Co. KG

Code ATC:

B01AC04

DCI (Dénomination commune internationale):

clopidogrel (clopidogrel besylate)

Dosage:

75mg

forme pharmaceutique:

tablets film-coated

Unités en paquet:

(30/3x10/) in blister

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2019-12-20

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clopi-Denk 75
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: clopidogrel.
Each film-coated tablet contains 75 mg of clopidogrel (as besylate).
Excipients with known effect: each film-coated tablet contains 2.6 mg
of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex, film-coated tablet.
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.
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.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS AND ELDERLY
Clopidogrel should be given as a single daily dose of 75 mg.
In patients suffering from acute coronary syndrome:

Non-ST segment elevation acute coronary syndrome (unstable angina or
non-Q-wave
myocardial infarction): clopidogrel treatment should be initiated with
a single 300