TEVA-REPAGLINIDE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

REPAGLINIDE

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

A10BX02

INN (International Adı):

REPAGLINIDE

Doz:

1MG

Farmasötik formu:

TABLET

Kompozisyon:

REPAGLINIDE 1MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

MEGLITINIDES

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2021-07-29

Ürün özellikleri

PRODUCT MONOGRAPH
PR
TEVA-REPAGLINIDE
(repaglinide)
0.5 mg, 1 mg and 2 mg tablets
Teva Standard
Oral Antidiabetic Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
March 31, 2011
Toronto, Ontario
M1B 2K9
Control # 133231
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
INDICATIONS AND CLINICAL
USE.......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND
PRECAUTIONS...........................................................................
4
ADVERSE
REACTIONS.............................................................................................
7
DRUG INTERACTIONS
...........................................................................................
10
DOSAGE AND
ADMINISTRATION.......................................................................
14
OVERDOSAGE
.........................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 15
STORAGE AND
STABILITY...................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL
INFORMATION...................................................................
20
CLINICAL
TRIALS.................................................................................................
201
DETAILED
PHARMACOLOGY..............................................................................
24
TOXICOLOGY
..........................................................................................................
27
REFERENCES
.....................................................................................