TARO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

GLICLAZIDE

Διαθέσιμο από:

SUN PHARMA CANADA INC

Φαρμακολογική κατηγορία (ATC):

A10BB09

INN (Διεθνής Όνομα):

GLICLAZIDE

Δοσολογία:

60MG

Φαρμακοτεχνική μορφή:

TABLET (EXTENDED-RELEASE)

Σύνθεση:

GLICLAZIDE 60MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

SULFONYLUREAS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0119934003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2015-04-02

Αρχείο Π.Χ.Π.

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_TARO-GLICLAZIDE MR (Gliclazide) Tablets - Product Monograph _
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_Page 1 of 44 _
PRODUCT MONOGRAPH
PR
TARO-GLICLAZIDE MR
GLICLAZIDE
MODIFIED-RELEASE TABLETS
30 MG
MODIFIED-RELEASE BREAKABLE TABLETS
60 MG
Hypoglycemic sulfonylurea - Oral antidiabetic agent
Sun Pharma Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision:
March 11, 2020
Submission Control No.: 236213
_Pr_
_TARO-GLICLAZIDE MR (Gliclazide) Tablets - Product Monograph _
_ _
_Page 2 of 44 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
.................................................................................................
3
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
.................................................................................................
8
DRUG INTERACTIONS
...............................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................
16
OVERDOSAGE
..............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 18
STORAGE AND STABILITY
.......................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 22
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
...................