REPAGLINIDE TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

REPAGLINIDE

Beszerezhető a:

PRO DOC LIMITEE

ATC-kód:

A10BX02

INN (nemzetközi neve):

REPAGLINIDE

Adagolás:

1MG

Gyógyszerészeti forma:

TABLET

Összetétel:

REPAGLINIDE 1MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

MEGLITINIDES

Termék összefoglaló:

Active ingredient group (AIG) number: 0137035002; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2016-12-16

Termékjellemzők

_ Repaglinide _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR REPAGLINIDE
(Repaglinide)
0.5 mg, 1 mg and 2 mg tablets
Oral Antidiabetic Agent
Manufacturer's Standard
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Revision:
August 2, 2019
Submission Control No: 230055
_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
...............................................................................................................
18
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
................................................