NOVO-GLIMEPIRIDE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

GLIMEPIRIDE

Dostupné z:

NOVOPHARM LIMITED

ATC kód:

A10BB12

INN (Medzinárodný Name):

GLIMEPIRIDE

Dávkovanie:

1MG

Forma lieku:

TABLET

Zloženie:

GLIMEPIRIDE 1MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

SULFONYLUREAS

Prehľad produktov:

Active ingredient group (AIG) number: 0146247001; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2015-10-26

Súhrn charakteristických

PRODUCT MONOGRAPH
Pr
NOVO-GLIMEPIRIDE
(glimepiride)
Tablets 1 mg, 2 mg and 4 mg
Oral Hypoglycemic (Sulfonylurea)
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 091409
Date of Preparation:
November 22, 2005
2
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL
USE..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND
PRECAUTIONS..................................................................................
4
ADVERSE
REACTIONS....................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
9
DOSAGE AND
ADMINISTRATION..............................................................................
12
OVERDOSAGE
................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 14
STORAGE AND
STABILITY..........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL
INFORMATION..........................................................................
19
CLINICAL
TRIALS..........................................................................................................
19
DETAILED
PHARMACOLOGY.....................................................................................
24
TOXICOLOGY
...