TEVA-REPAGLINIDE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
31-03-2011
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Werkstoffen:
REPAGLINIDE
Beschikbaar vanaf:
TEVA CANADA LIMITED
ATC-code:
A10BX02
INN (Algemene Internationale Benaming):
REPAGLINIDE
Dosering:
2MG
farmaceutische vorm:
TABLET
Samenstelling:
REPAGLINIDE 2MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
MEGLITINIDES
Product samenvatting:
Active ingredient group (AIG) number: 0137035003; AHFS:
Autorisatie-status:
CANCELLED PRE MARKET
Autorisatie datum:
2021-07-29
Productkenmerken
PRODUCT MONOGRAPH
PR
TEVA-REPAGLINIDE
(repaglinide)
0.5 mg, 1 mg and 2 mg tablets
Teva Standard
Oral Antidiabetic Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
March 31, 2011
Toronto, Ontario
M1B 2K9
Control # 133231
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
INDICATIONS AND CLINICAL
USE.......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND
PRECAUTIONS...........................................................................
4
ADVERSE
REACTIONS.............................................................................................
7
DRUG INTERACTIONS
...........................................................................................
10
DOSAGE AND
ADMINISTRATION.......................................................................
14
OVERDOSAGE
.........................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 15
STORAGE AND
STABILITY...................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL
INFORMATION...................................................................
20
CLINICAL
TRIALS.................................................................................................
201
DETAILED
PHARMACOLOGY..............................................................................
24
TOXICOLOGY
..........................................................................................................
27
REFERENCES
.....................................................................................
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