GLYBURIDE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

GLYBURIDE

Dostępny od:

SANIS HEALTH INC

Kod ATC:

A10BB01

INN (International Nazwa):

GLIBENCLAMIDE

Dawkowanie:

2.5MG

Forma farmaceutyczna:

TABLET

Skład:

GLYBURIDE 2.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SULFONYLUREAS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0108708002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2015-06-04

Charakterystyka produktu

_ _
_ _
_Page 1 of 26_
PRODUCT MONOGRAPH
PR
GLYBURIDE
Glyburide
2.5 mg and 5 mg Tablets
B.P.
Oral Hypoglycemic - Sulfonylurea
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
September 7, 2017
Submission Control No.: 209042
_ _
_ _
_Page 2 of 26_
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
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
CLINICAL TRIALS
.........................................................................................................
20
DETAILED PHARMACOLOGY
...................................................................