SANDOZ GLIMEPIRIDE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
08-03-2017
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Aktiv ingrediens:
GLIMEPIRIDE
Tilgjengelig fra:
SANDOZ CANADA INCORPORATED
ATC-kode:
A10BB12
INN (International Name):
GLIMEPIRIDE
Dosering :
3MG
Legemiddelform:
TABLET
Sammensetning:
GLIMEPIRIDE 3MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
SULFONYLUREAS
Produkt oppsummering:
Active ingredient group (AIG) number: 0146247004; AHFS:
Autorisasjon status:
CANCELLED PRE MARKET
Autorisasjon dato:
2019-08-01
Preparatomtale
_Sandoz Glimepiride _
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PRODUCT MONOGRAPH
PR
SANDOZ GLIMEPIRIDE
Glimepiride Tablets
1 mg, 2 mg, 3 mg and 4 mg
Oral Hypoglycemic (Sulfonylurea)
Sandoz Canada Inc.
Date of Revision:
145 Jules-Léger
March 1, 2017
Boucherville, Quebec
J4B 7K8
Submission Control No: 202815
_Sandoz Glimepiride _
_ Page 2 of 48 _
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
.........................................................................................................
11
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.................................................................................
22
CLINICAL TRIALS
.................................................................
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