PMS-ROSIGLITAZONE-METFORMIN TABLET
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
24-03-2014
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Trimite cerere.
Trimite cerere.
Ingredient activ:
ROSIGLITAZONE (ROSIGLITAZONE MALEATE); METFORMIN HYDROCHLORIDE
Disponibil de la:
PHARMASCIENCE INC
Codul ATC:
A10BD03
INN (nume internaţional):
METFORMIN AND ROSIGLITAZONE
Dozare:
4MG; 1000MG
Forma farmaceutică:
TABLET
Compoziție:
ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 4MG; METFORMIN HYDROCHLORIDE 1000MG
Calea de administrare:
ORAL
Unități în pachet:
100
Tip de prescriptie medicala:
Prescription
Zonă Terapeutică:
BIGUANIDES
Rezumat produs:
Active ingredient group (AIG) number: 0248901005; AHFS:
Statutul autorizaţiei:
CANCELLED PRE MARKET
Data de autorizare:
2017-08-03
Caracteristicilor produsului
PRODUCT MONOGRAPH
PR
PMS-ROSIGLITAZONE-METFORMIN
rosiglitazone maleate/metformin hydrochloride
1 mg/500 mg Tablets
1 mg rosiglitazone (as rosiglitazone maleate) and 500 mg metformin
hydrochloride
2 mg/500 mg Tablets
2 mg rosiglitazone (as rosiglitazone maleate) and 500 mg metformin
hydrochloride
4 mg/500 mg Tablets
4 mg rosiglitazone (as rosiglitazone maleate) and 500 mg metformin
hydrochloride
2 mg/1000 mg Tablets
2 mg rosiglitazone (as rosiglitazone maleate) and 1000 mg metformin
hydrochloride
4 mg/1000 mg Tablets
4 mg rosiglitazone (as rosiglitazone maleate) and 1000 mg metformin
hydrochloride
Antidiabetic Agent
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave. suite 100
July 12, 2013
Montreal, Canada
H4P 2T4
Submission Control No. 166029
_ _
_pms-ROSIGLITAZONE-METFORMIN Product Monograph _
_Page 2 of 56_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
14
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
22
OVERDOSAGE
................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 24
STORAGE AND STABILITY
..........................................................................
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