Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
JAMP PHARMA CORPORATION
J01MA14
MOXIFLOXACIN
400MG
TABLET
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
ORAL
30
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0142242001; AHFS:
APPROVED
2015-11-04
_JAMP-MOXIFLOXACIN_ _Page 1 of 71_ PRODUCT MONOGRAPH PR JAMP-MOXIFLOXACIN Moxifloxacin Tablets 400 mg (as moxifloxacin hydrochloride) Antibacterial Agent Manufactured by: Date of Revision: Jamp Pharma Corporation September 18, 2020 1310 rue Nobel Boucherville, Québec J4B 5H3 Canada SUBMISSION CONTROL NO: 239203 _JAMP-MOXIFLOXACIN_ _Page 2 of 71_ 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 ........................................................................... 30 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................. 31 PART II: SCIENTIFIC INFORMATION ................................................................................. 32 PHARMACEUTICAL INFORMATION .................................................................... Přečtěte si celý dokument