M-MOXIFLOXACIN TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
21-09-2022
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Aktivna sestavina:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Dostopno od:
MANTRA PHARMA INC
Koda artikla:
J01MA14
INN (mednarodno ime):
MOXIFLOXACIN
Odmerek:
400MG
Farmacevtska oblika:
TABLET
Sestava:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Pot uporabe:
ORAL
Enote v paketu:
100
Tip zastaranja:
Prescription
Terapevtsko območje:
QUINOLONES
Povzetek izdelek:
Active ingredient group (AIG) number: 0142242001; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2018-02-05
Lastnosti izdelka
M-Moxifloxacin Product Monograph _Page 1 of 72_
PRODUCT MONOGRAPH
PR
M-MOXIFLOXACIN
Moxifloxacin tablets
400 mg
(as moxifloxacin hydrochloride)
Manufacturer’s Standard
Antibacterial Agent
Mantra Pharma Inc.
9150 Leduc boulevard, suite 201
Brossard, Quebec
Canada J4Y 0E3
Submission Control No.: 266794
Date of Revision:
SEP
21, 2022
M-Moxifloxacin Product Monograph _Page 2 of 72_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
15
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
........................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
24
STORAGE AND STABILITY
.................................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 31
PART II : SCIENTIFIC INFORMATION
.................................................................................
32
PHARMACEUTICAL
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