SANDOZ GLYBURIDE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

GLYBURIDE

Dostępny od:

SANDOZ CANADA INCORPORATED

Kod ATC:

A10BB01

INN (International Nazwa):

GLIBENCLAMIDE

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

GLYBURIDE 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SULFONYLUREAS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2017-08-01

Charakterystyka produktu

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_Sandoz Glyburide _
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PRODUCT MONOGRAPH
PR
SANDOZ GLYBURIDE
Glyburide
Manufacturer’s Standard
2.5 mg and 5 mg Tablets
Oral Hypoglycemic - Sulfonylurea
Sandoz Canada Inc. Date of Revision:
145 Jules-Léger
May 11, 2017
Boucherville, Quebec
J4B 7K8
Submission Control No.: 204488
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_Sandoz Glyburide _
_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
.........................................................................................................
19
DETAILED PHARMACOLOGY
...............