AURO-MOXIFLOXACIN TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
10-03-2020
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:
AURO PHARMA INC
ATC númer:
J01MA14
INN (Alþjóðlegt nafn):
MOXIFLOXACIN
Skammtar:
400MG
Lyfjaform:
TABLET
Samsetning:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100/1000
Gerð lyfseðils:
Prescription
Lækningarsvæði:
QUINOLONES
Vörulýsing:
Active ingredient group (AIG) number: 0142242001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2015-11-04
Vara einkenni
Page 1 of 66
PRODUCT MONOGRAPH
PR
AURO-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin (as moxifloxacin hydrochloride)
House Standard
Antibacterial Agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
CANADA
Date of Revision:
March 10, 2020
SUBMISSION CONTROL NO:
236492
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
.......................................................
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