MOXIFLOXACIN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
21-09-2021
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Aktiv ingrediens:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Tilgjengelig fra:
SANIS HEALTH INC
ATC-kode:
J01MA14
INN (International Name):
MOXIFLOXACIN
Dosering :
400MG
Legemiddelform:
TABLET
Sammensetning:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Administreringsrute:
ORAL
Enheter i pakken:
15G/50G
Resept typen:
Prescription
Terapeutisk område:
QUINOLONES
Produkt oppsummering:
Active ingredient group (AIG) number: 0142242001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2021-09-23
Preparatomtale
Page 1 of 66
PRODUCT MONOGRAPH
PR
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin
(as moxifloxacin
hydrochloride)
House Standard
Antibacterial Agent
SANIS HEALTH INC.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
September 21, 2021
SUBMISSION CONTROL NO:
249928
Page 2 of 66
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
........................................................................
3
CONTRAINDICATIONS
............................................................................................
5
WARNINGS AND PRECAUTIONS
............................................................................
6
ADVERSE
REACTIONS............................................................................................14
DRUG INTERACTIONS
............................................................................................18
DOSAGE AND ADMINISTRATION
.........................................................................20
OVERDOSAGE
.........................................................................................................21
ACTION AND CLINICAL
PHARMACOLOGY.........................................................22
STORAGE AND STABILITY
....................................................................................29
SPECIAL HANDLING INSTRUCTIONS
...................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................29
PART II: SCIENTIFIC INFORMATION
..........................................................................
30
PHARMACEUTICAL INFORMATION
.....................................................................30
CLINICAL TRIALS
...................................................................................................31
DETAILED
PHARMACOLOGY..........................
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