MOXIFLOXACIN TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
19-02-2021
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Fáanlegur frá:
PRO DOC LIMITEE
ATC númer:
J01MA14
INN (Alþjóðlegt nafn):
MOXIFLOXACIN
Skammtar:
400MG
Lyfjaform:
TABLET
Samsetning:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30
Gerð lyfseðils:
Prescription
Lækningarsvæði:
QUINOLONES
Vörulýsing:
Active ingredient group (AIG) number: 0142242001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2017-04-12
Vara einkenni
Page 1 of 67
PRODUCT MONOGRAPH
PR
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin (as moxifloxacin hydrochloride)
House Standard
Antibacterial Agent
PRO DOC LTÉE
2925 boul. Industriel
Laval, Québec
H7L 3W9
Date of Revision:
February 19, 2021.
SUBMISSION CONTROL NO:
248826
Page 2 of 67
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
...............................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 22
STORAGE AND STABILITY
.........................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 30
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.........................................................................
31
CLINICAL TRIALS
........................................................................................
Lestu allt skjalið
