ZYM-PIOGLITAZONE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
09-01-2013
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Aktiva substanser:
PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)
Tillgänglig från:
ZYMCAN PHARMACEUTICALS INC
ATC-kod:
A10BG03
INN (International namn):
PIOGLITAZONE
Dos:
15MG
Läkemedelsform:
TABLET
Sammansättning:
PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 15MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
THIAZOLIDINEDIONES
Produktsammanfattning:
Active ingredient group (AIG) number: 0141541001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2014-06-16
Produktens egenskaper
PRODUCT MONOGRAPH
PR
ZYM-PIOGLITAZONE
(Pioglitazone Hydrochloride)
15 mg, 30 mg, 45 mg Tablets
Anti-Diabetic Agent
ZYMCAN PHARMACEUTICALS INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
January 9, 2013
Submission Control No: 161132
_ _
_Zym-PIOGLITAZONE Product Monograph _
_Page 2 of 42_
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
.......................................................................................13
OVERDOSAGE
...........................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
....................................................................14
STORAGE AND STABILITY
...................................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................20
PART II: SCIENTIFIC
INFORMATION............................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................21
CLINICAL TRIALS
...................................................................................................
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