PMS-GLIMEPIRIDE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

GLIMEPIRIDE

Tersedia dari:

PHARMASCIENCE INC

Kode ATC:

A10BB12

INN (Nama Internasional):

GLIMEPIRIDE

Dosis:

4MG

Bentuk farmasi:

TABLET

Komposisi:

GLIMEPIRIDE 4MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

SULFONYLUREAS

Ringkasan produk:

Active ingredient group (AIG) number: 0146247003; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2016-10-28

Karakteristik produk

PRODUCT MONOGRAPH
PR
PMS-GLIMEPIRIDE
Glimepiride Tablets, House Standard
1 mg, 2 mg and 4 mg
Oral Hypoglycemic (Sulfonylurea)
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
February 12, 2014
www.pharmascience.com
Submission Control No: 167575
_pms-GLIMEPIRIDE 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
....................................................................................................
8
DRUG
INTERACTIONS
..................................................................................................
11
DOSAGE
AND
ADMINISTRATION
..............................................................................
14
OVERDOSAGE
................................................................................................................
16
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................. 17
STORAGE
AND
STABILITY
..........................................................................................
20
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING .............................................. 21
PART II: SCIENTIFIC INFORMATION
...................................................................................
22
PHARMACEUTICAL
INFORMATION
..........................................................................
22
CLINICAL
TRIALS
..........................................................................................................
23
DETAILED