PMS-GLIMEPIRIDE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
20-02-2014
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Aktívna zložka:
GLIMEPIRIDE
Dostupné z:
PHARMASCIENCE INC
ATC kód:
A10BB12
INN (Medzinárodný Name):
GLIMEPIRIDE
Dávkovanie:
4MG
Forma lieku:
TABLET
Zloženie:
GLIMEPIRIDE 4MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
SULFONYLUREAS
Prehľad produktov:
Active ingredient group (AIG) number: 0146247003; AHFS:
Stav Autorizácia:
CANCELLED PRE MARKET
Dátum Autorizácia:
2016-10-28
Súhrn charakteristických
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
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