APO-CLOPIDOGREL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CLOPIDOGREL (CLOPIDOGREL BISULFATE)

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

B01AC04

INN (Διεθνής Όνομα):

CLOPIDOGREL

Δοσολογία:

300MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

CLOPIDOGREL (CLOPIDOGREL BISULFATE) 300MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PLATELET AGGREGATION INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0134440002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-01-04

Αρχείο Π.Χ.Π.

_APO-CLOPIDOGREL (clopidogrel tablets) Product Monograph _
_Page 1 of 65 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-CLOPIDOGREL
Clopidogrel Tablets
Tablets, 75 mg and 300 mg Clopidogrel, as clopidogrel bisulfate, Oral
USP
Platelet Aggregation Inhibitor
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JAN 04, 2013
Date of Revision:
JUN 19, 2023
Submission Control Number: 271440
_APO-CLOPIDOGREL (clopidogrel tablets) Product Monograph _
_Page 2 of 65 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
07/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS.....................................................................................................................4
1.1
Pediatrics
....................................................................................................................4
1.2
Geriatrics
....................................................................................................................4
2
CONTRAINDICATIONS
.....................................................................................................5
4
DOSAGE AND ADMINISTRATION
.....................................................................................5
4.2
Recommended Dose and Dosage Adjustment
..............................................................5
4.4
Administration
............................................................................................................6
4.5
Missed
Dose...............................