MOXIFLOXACIN TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
21-09-2021
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Aktivna sestavina:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Dostopno od:
SANIS HEALTH INC
Koda artikla:
J01MA14
INN (mednarodno ime):
MOXIFLOXACIN
Odmerek:
400MG
Farmacevtska oblika:
TABLET
Sestava:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Pot uporabe:
ORAL
Enote v paketu:
15G/50G
Tip zastaranja:
Prescription
Terapevtsko območje:
QUINOLONES
Povzetek izdelek:
Active ingredient group (AIG) number: 0142242001; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2021-09-23
Lastnosti izdelka
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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