PMS-ROSIGLITAZONE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
27-06-2016
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Aktiv ingrediens:
ROSIGLITAZONE (ROSIGLITAZONE MALEATE)
Tilgjengelig fra:
PHARMASCIENCE INC
ATC-kode:
A10BG02
INN (International Name):
ROSIGLITAZONE
Dosering :
8MG
Legemiddelform:
TABLET
Sammensetning:
ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 8MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
THIAZOLIDINEDIONES
Produkt oppsummering:
Active ingredient group (AIG) number: 0138802004; AHFS:
Autorisasjon status:
CANCELLED PRE MARKET
Autorisasjon dato:
2017-08-03
Preparatomtale
PRODUCT MONOGRAPH
PR
PMS-ROSIGLITAZONE
Rosiglitazone (as Rosiglitazone Maleate)
2 mg, 4 mg and 8 mg Tablets
Professed Standard
Antidiabetic Agent
Insulin Resistance Reducing Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
June 20, 2016
_ _
Submission Control No: 195686_ _
_ _
_ _
_pms-ROSIGLITAZONE Product Monograph _
_Page 2 of 53_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................................
3
SUMMARY PRODUCT INFORMATION
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3
INDICATIONS AND CLINICAL USE
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3
CONTRAINDICATIONS
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4
WARNINGS AND PRECAUTIONS
........................................................................................................................
4
ADVERSE REACTIONS
.......................................................................................................................................
10
DRUG INTERACTIONS
........................................................................................................................................
15
DOSAGE AND ADMINISTRATION
....................................................................................................................
18
OVERDOSAGE
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19
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................................
19
STORAGE AND STABILITY
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