COPLAVIX

Land: Indonesië

Taal: Indonesisch

Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Werkstoffen:

ACETYLSALICYLIC ACID; CLOPIDOGREL

Beschikbaar vanaf:

AVENTIS PHARMA - Indonesia

INN (Algemene Internationale Benaming):

ACETYLSALICYLIC ACID; CLOPIDOGREL

Dosering:

75/100 MG

farmaceutische vorm:

TABLET SALUT SELAPUT

Eenheden in pakket:

DUS, 3 BLISTER @ 10 TABLET SALUT ENTERIK

Geproduceerd door:

SANOFI-WINTHROP, FRANCE

Autorisatie datum:

2019-04-04

Productkenmerken

RANCANGAN LEAFLET
COPLAVIX

CLOPIDOGREL / ACETYLSALICYLIC ACID(ASA)
COMPOSITION
Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen
sulphate) and 100 mg of
acetylsalicylic acid (ASA).
PHARMACEUTICAL FORM
Enteric Coated Tablet (tablet).
Light pink, oval, slightly biconvex, engraved with «C75» on one side
and «A100» on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
CoPlavix is indicated for the secondary prevention of atherothrombotic
events in adult patients
already taking both clopidogrel and acetylsalicylic acid (ASA).
CoPlavix is a fixed-dose combination
medicinal product for continuation of therapy in:
-
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
-
ST segment elevation acute myocardial infarction in medically treated
patients eligible for
thrombolytic therapy
For futher information please refer to “_Pharmacodynamic
properties_”.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and elderly
CoPlavix should be given as a single daily 75 mg/100 mg dose.
CoPlavix is used following initiation of therapy with clopidogrel and
ASA given separately.
-
In patients with non-ST segment elevation acute coronary syndrome
(unstable angina or non-Q-
wave myocardial infarction): The optimal duration of treatment has not
been formally established.
Clinical trial data support use up to 12 months, and the maximum
benefit was seen at 3 months (see
section 5.1). If the use of CoPlavix is discontinued, patients may
benefit with continuation of one
antiplatelet medicinal product.
-
In patients with ST segment elevation acute myocardial infarction:
Therapy should be started as early
as possible after symptoms start and continued for at least four
weeks. The benefit of the
combination of clopidogrel with ASA beyond four weeks has not been
studied in this setting (see
section 5.1). If the use of CoPlavix is discontinued, patients may
benefit w