PRO-GLYBURIDE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

GLYBURIDE

Boleh didapati daripada:

PRO DOC LIMITEE

Kod ATC:

A10BB01

INN (Nama Antarabangsa):

GLIBENCLAMIDE

Dos:

5MG

Borang farmaseutikal:

TABLET

Komposisi:

GLYBURIDE 5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SULFONYLUREAS

Ringkasan produk:

Active ingredient group (AIG) number: 0108708001; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2017-07-04

Ciri produk

_ _
_PRO-GLYBURIDE _ Product Monograph_ _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
PRO-GLYBURIDE
Glyburide
Tablets, 5 mg
Manufacturer’s Standard
Oral Hypoglycaemic Agent
ATC Code: A10BB01
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
DATE OF REVISION:
June 6, 2013
Submission Control No.: 164951
_ _
_PRO-GLYBURIDE _ Product Monograph_ _
_Page 2 of 31_
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
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARM