MOXIFLOXACIN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
21-09-2021
Sommige documenten voor dit product zijn momenteel niet beschikbaar, u kunt een verzoek sturen naar onze klantenservice en we zullen u hiervan op de hoogte stellen zodra we ze kunnen verkrijgen.
Verzend verzoek.
Verzend verzoek.
Werkstoffen:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Beschikbaar vanaf:
SANIS HEALTH INC
ATC-code:
J01MA14
INN (Algemene Internationale Benaming):
MOXIFLOXACIN
Dosering:
400MG
farmaceutische vorm:
TABLET
Samenstelling:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Toedieningsweg:
ORAL
Eenheden in pakket:
15G/50G
Prescription-type:
Prescription
Therapeutisch gebied:
QUINOLONES
Product samenvatting:
Active ingredient group (AIG) number: 0142242001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2021-09-23
Productkenmerken
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..........................
Lees het volledige document
