MOXIFLOXACIN TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
19-02-2021
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Inapatikana kutoka:
PRO DOC LIMITEE
ATC kanuni:
J01MA14
INN (Jina la Kimataifa):
MOXIFLOXACIN
Kipimo:
400MG
Dawa fomu:
TABLET
Tungo:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
30
Dawa ya aina:
Prescription
Eneo la matibabu:
QUINOLONES
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0142242001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2017-04-12
Tabia za bidhaa
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
........................................................................................
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