APO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

GLICLAZIDE

Tersedia dari:

APOTEX INC

Kode ATC:

A10BB09

INN (Nama Internasional):

GLICLAZIDE

Dosis:

30MG

Bentuk farmasi:

TABLET (EXTENDED-RELEASE)

Komposisi:

GLICLAZIDE 30MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

SULFONYLUREAS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2008-06-04

Karakteristik produk

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