Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE); FLUOCINOLONE ACETONIDE
MEDEXUS PHARMACEUTICALS INC.
S02CA05
FLUOCINOLONE ACETONIDE AND ANTIINFECTIVES
0.3%; 0.025%
SOLUTION
CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 0.3%; FLUOCINOLONE ACETONIDE 0.025%
OTIC
0.25ML
Prescription
ANTIBACTERIALS
Active ingredient group (AIG) number: 0258670001; AHFS:
APPROVED
2016-12-08
_Page 1 of 28_ _OTIXAL™ Product Monograph_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr OTIXAL TM Ciprofloxacin and Fluocinolone acetonide Otic Solution 0.3% w/v ciprofloxacin (as ciprofloxacin hydrochloride) and 0.025% w/v fluocinolone acetonide Antibacterial - Corticosteroid Medexus Inc. 35 Nixon Road, Unit 1 Bolton, Ontario L7E 1K1 Submission Control No.: 270667 Date of Preparation: JAN 23, 2023 _ _ _OTIXAL™ Product Monograph _ _Page 2 of 28 _ 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 ....................................................................................................8 DOSAGE AND ADMINISTRATION ................................................................................8 OVERDOSAGE ..................................................................................................................9 ACTION AND CLINICAL PHARMACOLOGY ..............................................................9 STORAGE AND STABILITY ..........................................................................................10 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................10 PART II: SCIENTIFIC INFORMATION ...............................................................................11 PHARMACEUTICAL INFORMATION ..........................................................................11 CLINICAL TRIALS ........... Prečítajte si celý dokument