Страна: Канада
Язык: английский
Источник: Health Canada
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
MANTRA PHARMA INC
J01MA14
MOXIFLOXACIN
400MG
TABLET
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
ORAL
100
Prescription
QUINOLONES
Active ingredient group (AIG) number: 0142242001; AHFS:
APPROVED
2018-02-05
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 Прочитать полный документ