TEVA-REPAGLINIDE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

REPAGLINIDE

Boleh didapati daripada:

TEVA CANADA LIMITED

Kod ATC:

A10BX02

INN (Nama Antarabangsa):

REPAGLINIDE

Dos:

1MG

Borang farmaseutikal:

TABLET

Komposisi:

REPAGLINIDE 1MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MEGLITINIDES

Ringkasan produk:

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

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2021-07-29

Ciri produk

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