MYLAN-MOXIFLOXACIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
17-11-2016
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Aktiv bestanddel:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Tilgængelig fra:
MYLAN PHARMACEUTICALS ULC
ATC-kode:
J01MA14
INN (International Name):
MOXIFLOXACIN
Dosering:
400MG
Lægemiddelform:
TABLET
Sammensætning:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
QUINOLONES
Produkt oversigt:
Active ingredient group (AIG) number: 0142242001; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2017-01-11
Produktets egenskaber
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_Page 1 of 61_
PRODUCT MONOGRAPH
Pr
MYLAN-MOXIFLOXACIN
Moxifloxacin Hydrochloride Tablets
400 mg Moxifloxacin (as Moxifloxacin Hydrochloride)
Antibacterial Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
November 15, 2016
Submission Control No: 199712
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_Page 2 of 61_
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
.................................................................................................
12
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 28
PART II: SCIENTIFIC INFORMATION
..............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
.........................................................................................................
31
DETAILED PHARMACOLOGY
....................................................................................
40
MICROBIOLOGY
.......................................................
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