SANDOZ REPAGLINIDE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

REPAGLINIDE

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

A10BX02

INN（国際名）:

REPAGLINIDE

投薬量:

0.5MG

医薬品形態:

TABLET

構図:

REPAGLINIDE 0.5MG

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:

MEGLITINIDES

製品概要:

Active ingredient group (AIG) number: 0137035001; AHFS:

認証ステータス:

APPROVED

承認日:

2010-09-27

製品の特徴

_ _
_Sandoz Repaglinide _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR
SANDOZ REPAGLINIDE
(Repaglinide)
0.5 mg, 1 mg and 2 mg tablets
Oral Antidiabetic Agent
Manufacturer's Standard
Sandoz Canada Inc.
110 de Lauzon
Boucherville, QC
J4B 1E6
Date of Revision:
August 16, 2018
Submission Control No: 218326
_ _
_Sandoz Repaglinide _
_Page 2 of 43_
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
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
23
DETAILED PHARMACOLOGY
....................