PHL-ROSIGLITAZONE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
29-07-2013
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Aktiv ingrediens:
ROSIGLITAZONE (ROSIGLITAZONE MALEATE)
Tilgjengelig fra:
PHARMEL INC
ATC-kode:
A10BG02
INN (International Name):
ROSIGLITAZONE
Dosering :
4MG
Legemiddelform:
TABLET
Sammensetning:
ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 4MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
THIAZOLIDINEDIONES
Produkt oppsummering:
Active ingredient group (AIG) number: 0138802003; AHFS:
Autorisasjon status:
CANCELLED PRE MARKET
Autorisasjon dato:
2017-09-12
Preparatomtale
PRODUCT MONOGRAPH
PR
PHL-ROSIGLITAZONE
Rosiglitazone (as Rosiglitazone Maleate)
2 mg, 4 mg and 8 mg Tablets
Professed Standard
Antidiabetic Agent
Insulin Resistance Reducing Agent
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
DATE OF PREPARATION:
November 25, 2011
_ _
Submission Control No: 120553, 151179_ _
_ _
_ _
_phl-ROSIGLITAZONE Product Monograph_
_Page 2 of 48 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.......................................................................................
3
SUMMARY PRODUCT
INFORMATION.................................................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................................................
3
CONTRAINDICATIONS............................................................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................................................
4
ADVERSE REACTIONS
............................................................................................................................................
9
DRUG
INTERACTIONS...........................................................................................................................................
14
DOSAGE AND
ADMINISTRATION.......................................................................................................................
16
OVERDOSAGE.........................................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................................................
18
STORAGE AND STABILITY
..........................................................................................................
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