REPAGLINIDE TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
02-08-2019

Viambatanisho vya kazi:

REPAGLINIDE

Inapatikana kutoka:

PRO DOC LIMITEE

ATC kanuni:

A10BX02

INN (Jina la Kimataifa):

REPAGLINIDE

Kipimo:

1MG

Dawa fomu:

TABLET

Tungo:

REPAGLINIDE 1MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

MEGLITINIDES

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2016-12-16

Tabia za bidhaa

                                _ 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
................................................
                                
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