RIVA-NORFLOXACIN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

NORFLOXACIN

متاح من:

LABORATOIRE RIVA INC.

ATC رمز:

J01MA06

INN (الاسم الدولي):

NORFLOXACIN

جرعة:

400MG

الشكل الصيدلاني:

TABLET

تركيب:

NORFLOXACIN 400MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

QUINOLONES

ملخص المنتج:

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

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2013-07-31

خصائص المنتج

_ _
_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
........