PHL-ROSIGLITAZONE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE)

Tersedia dari:

PHARMEL INC

Kode ATC:

A10BG02

INN (Nama Internasional):

ROSIGLITAZONE

Dosis:

2MG

Bentuk farmasi:

TABLET

Komposisi:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 2MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

THIAZOLIDINEDIONES

Ringkasan produk:

Active ingredient group (AIG) number: 0138802002; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2017-09-12

Karakteristik produk

PRODUCT MONOGRAPH
PR
PHL-ROSIGLITAZONE
Rosiglitazone (as Rosiglitazone Maleate)
2 mg, 4 mg and 8 mg Tablets
Professed Standard
Antidiabetic Agent
Insulin Resistance Reducing Agent
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
DATE OF PREPARATION:
November 25, 2011
_ _
Submission Control No: 120553, 151179_ _
_ _
_ _
_phl-ROSIGLITAZONE Product Monograph_
_Page 2 of 48 _
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
............................................................................................................................................
9
DRUG
INTERACTIONS...........................................................................................................................................
14
DOSAGE AND
ADMINISTRATION.......................................................................................................................
16
OVERDOSAGE.........................................................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................................................
18
STORAGE AND STABILITY
..........................................................................................................