PMS-ROSIGLITAZONE-METFORMIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE); METFORMIN HYDROCHLORIDE

から入手可能:

PHARMASCIENCE INC

ATCコード:

A10BD03

INN（国際名）:

METFORMIN AND ROSIGLITAZONE

投薬量:

4MG; 1000MG

医薬品形態:

TABLET

構図:

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

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

BIGUANIDES

製品概要:

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

認証ステータス:

CANCELLED PRE MARKET

承認日:

2017-08-03

製品の特徴

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
..........................................................................