RIVA-NORFLOXACIN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

NORFLOXACIN

Dostupné s:

LABORATOIRE RIVA INC.

ATC kód:

J01MA06

INN (Mezinárodní Name):

NORFLOXACIN

Dávkování:

400MG

Léková forma:

TABLET

Složení:

NORFLOXACIN 400MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

QUINOLONES

Přehled produktů:

Active ingredient group (AIG) number: 0116961001; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2013-07-31

Charakteristika produktu

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_RIVA-NORFLOXACIN _
_Page 1 of 45_
PRODUCT MONOGRAPH
RIVA-NORFLOXACIN
Norfloxacin Tablets USP
400 mg
Antibacterial Agent
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Québec
Canada J7C 3V4
Control # : 117732
Date of Preparation:
November 30, 2007
_ _
_Appendix G - Product Monograph Template - Subsequent Entry Product _
_Page 2 of 45_
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...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND
ADMINISTRATION...............................................................................
9
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 10
STORAGE AND
STABILITY.........................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 12
PART II: SCIENTIFIC INFORMATION
.................................................................. 13
PHARMACEUTICAL
INFORMATION.........................................................................
13
CLINICAL
TRIALS.........................................................................................................
14
DETAILED PHARMACOLOGY 15
MICROBIOLOGY
........