PMS-ROSIGLITAZONE-METFORMIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE); METFORMIN HYDROCHLORIDE

Commercializzato da:

PHARMASCIENCE INC

Codice ATC:

A10BD03

INN (Nome Internazionale):

METFORMIN AND ROSIGLITAZONE

Dosaggio:

4MG; 1000MG

Forma farmaceutica:

TABLET

Composizione:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 4MG; METFORMIN HYDROCHLORIDE 1000MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

BIGUANIDES

Dettagli prodotto:

Active ingredient group (AIG) number: 0248901005; AHFS:

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2017-08-03

Scheda tecnica

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
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_pms-ROSIGLITAZONE-METFORMIN Product Monograph _
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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
..........................................................................