Maa: Kanada
Kieli: englanti
Lähde: Health Canada
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
JAMP PHARMA CORPORATION
S01AE07
MOXIFLOXACIN
0.5%
SOLUTION
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 0.5%
OPHTHALMIC
3ML
Prescription
ANTIBACTERIALS
Active ingredient group (AIG) number: 0142242003; AHFS:
APPROVED
2018-04-24
_Jamp-Moxifloxacin Product Monograph_ _Page 1 of 27_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr JAMP-MOXIFLOXACIN Moxifloxacin Ophthalmic Solution USP 0.5% w/v moxifloxacin (as hydrochloride) sterile Antibacterial (ophthalmic) JAMP Pharma Corporation 1310 rue Nobel Boucherville, Québec J4B 5H3 Date of Preparation: January 18, 2018 Submission Control No.: 203089 _Jamp-Moxifloxacin Product Monograph_ _Page 2 of 27_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ........................................................................... 3 INDICATIONS AND CLINICAL USE .............................................................................. 3 CONTRAINDICATIONS .................................................................................................... 4 WARNINGS AND PRECAUTIONS .................................................................................. 4 ADVERSE REACTIONS .................................................................................................... 6 DRUG INTERACTIONS .................................................................................................... 7 DOSAGE AND ADMINISTRATION ................................................................................ 8 OVERDOSAGE ................................................................................................................... 8 ACTION AND CLINICAL PHARMACOLOGY ............................................................... 8 STORAGE AND STABILITY ............................................................................................ 9 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................. 10 PART II: SCIENTIFIC INFORMATION ................................................................................. 11 PHARMACEUTICAL INFORMATION .......................................................................... 11 CLINICAL TRIALS ...................... Lue koko asiakirja