APO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
27-12-2019

Virkt innihaldsefni:

GLICLAZIDE

Fáanlegur frá:

APOTEX INC

ATC númer:

A10BB09

INN (Alþjóðlegt nafn):

GLICLAZIDE

Skammtar:

30MG

Lyfjaform:

TABLET (EXTENDED-RELEASE)

Samsetning:

GLICLAZIDE 30MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

SULFONYLUREAS

Vörulýsing:

Active ingredient group (AIG) number: 0119934002; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2008-06-04

Vara einkenni

                                PRODUCT MONOGRAPH
Pr
APO-GLICLAZIDE MR
GLICLAZIDE
MODIFIED-RELEASE TABLETS
30 MG
MODIFIED-RELEASE BREAKABLE TABLETS
60 MG
Hypoglycemic sulfonylurea - Oral antidiabetic agent
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
December 27, 2019
TORONTO ONTARIO
M9L 1T9
CONTROL NO: 233440
Page 2 of 43
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
.................................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................................
3
CONTRAINDICATIONS
............................................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................................
4
ADVERSE REACTIONS
............................................................................................................................
8
DRUG INTERACTIONS
..........................................................................................................................
12
DOSAGE AND ADMINISTRATION
......................................................................................................
15
OVERDOSAGE
.........................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................................
17
STORAGE AND STABILITY
..................................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
20
PART II: SCI
                                
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