TARO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

GLICLAZIDE

Dostępny od:

SUN PHARMA CANADA INC

Kod ATC:

A10BB09

INN (International Nazwa):

GLICLAZIDE

Dawkowanie:

60MG

Forma farmaceutyczna:

TABLET (EXTENDED-RELEASE)

Skład:

GLICLAZIDE 60MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SULFONYLUREAS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2015-04-02

Charakterystyka produktu

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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
...................