RIVA-MOXIFLOXACIN
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
26-02-2016
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Disponibil de la:
LABORATOIRE RIVA INC
Codul ATC:
J01MA
Forma farmaceutică:
Tablet
Calea de administrare:
Oral
Tip de prescriptie medicala:
Prescription
Zonă Terapeutică:
FLUOROQUINOLONES
Rezumat produs:
American Hospital Formulary Service (AHFS): 08:12.18 QUINOLONES; Active ingredient group (AIG) number: 0142242001
Statutul autorizaţiei:
Cancelled Pre Market
Data de autorizare:
2016-01-12
Caracteristicilor produsului
PRODUCT MONOGRAPH
PR RIVA-MOXIFLOXACIN
Moxifloxacin Tablets
Moxifloxacin (as moxifloxacin hydrochloride)
400 mg
ANTIBACTERIAL AGENT
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Canada
J7C 3V4
www.labriva.com
Date of Preparation:
January 15, 2016
Control No: 190659
_ _
_RIVA-MOXIFLOXACIN Product Monograph _
_Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
......................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 26
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.........................................................................
27
CLINICAL TRIALS
.................................................
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