ACTOS TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
18-01-2018
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Aktiv ingrediens:
PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)
Tilgjengelig fra:
TAKEDA CANADA INC
ATC-kode:
A10BG03
INN (International Name):
PIOGLITAZONE
Dosering :
30MG
Legemiddelform:
TABLET
Sammensetning:
PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 30MG
Administreringsrute:
ORAL
Enheter i pakken:
90
Resept typen:
Prescription
Terapeutisk område:
THIAZOLIDINEDIONES
Produkt oppsummering:
Active ingredient group (AIG) number: 0141541002; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2018-03-30
Preparatomtale
_ _
_ACTOS_
®
_ Product Monograph _
_Page 1 of 45_
PRODUCT MONOGRAPH
PR
ACTOS
®
(pioglitazone hydrochloride)
15, 30, 45 mg Tablets USP
Anti-Diabetic Agent
Takeda Canada Inc.
Oakville, Ontario L6H 0J8
DATE OF REVISION:
January 18, 2018
Submission Control No.: 203486
_ _
_ACTOS_
®
_ Product Monograph _
_Page 2 of 45_
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
.......................................................................................................
8
DRUG INTERACTIONS
.....................................................................................................
13
DOSAGE AND ADMINISTRATION
.................................................................................
15
OVERDOSAGE
....................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 16
STORAGE AND STABILITY
.............................................................................................
22
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
...........................................................................
24
CLINICAL TRIALS
.............................................................................................................
25
DETAILED PHAR
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