APO-MOXIFLOXACIN TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
31-08-2020
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:
APOTEX INC
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:
15G/50G
Dawa ya aina:
Prescription
Eneo la matibabu:
QUINOLONES
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0142242001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2016-01-07
Tabia za bidhaa
Page 1 of 66
PRODUCT MONOGRAPH
PR
APO-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin (as moxifloxacin hydrochloride)
House Standard
Antibacterial Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
CANADA
Date of Revision:
August 31, 2020
SUBMISSION CONTROL NO: 240946
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 .......................................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................
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