PMS-GLIMEPIRIDE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

GLIMEPIRIDE

Mevcut itibaren:

PHARMASCIENCE INC

ATC kodu:

A10BB12

INN (International Adı):

GLIMEPIRIDE

Doz:

4MG

Farmasötik formu:

TABLET

Kompozisyon:

GLIMEPIRIDE 4MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

SULFONYLUREAS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2016-10-28

Ürün özellikleri

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