AURO-MOXIFLOXACIN TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
10-03-2020
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:
AURO PHARMA 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:
30/100/1000
Dawa ya aina:
Prescription
Eneo la matibabu:
QUINOLONES
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0142242001; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2015-11-04
Tabia za bidhaa
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
.......................................................
Soma hati kamili
