Страна: Канада
Език: английски
Източник: Health Canada
APRACLONIDINE (APRACLONIDINE HYDROCHLORIDE)
ESSENTIAL PHARMA SWITZERLAND GMBH
S01EA03
APRACLONIDINE
1%
SOLUTION
APRACLONIDINE (APRACLONIDINE HYDROCHLORIDE) 1%
OPHTHALMIC
15G/50G
Prescription
EENT DRUGS, MISCELLANEOUS
Active ingredient group (AIG) number: 0122471001; AHFS:
APPROVED
2023-05-19
_IOPIDINE Product Monograph _ _Page 1 of 29_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr IOPIDINE ® Apraclonidine Ophthalmic Solution, USP 0.5% w/v and 1% w/v (as apraclonidine hydrochloride) S01EA03 Ophthalmologicals: Antiglaucoma Preparations and Miotics Essential Pharma Switzerland GmbH Landis + Gyr-Strasse 1 c/o LacMont AG, 6300 Zug, Switzerland www.essentialpharmagroup.com Date of Preparation: MAY 19, 2023 Imported / Distributed by: McKesson Specialized Distribution Inc. 8449 Lawson Road, Unit 102 Milton, ON L9T 9L1 Canada Submission Control No.: 273954 IOPIDINE is a registered trademark _ _ _IOPIDINE Product Monograph _ _Page 2 of 29_ 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 ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................10 DOSAGE AND ADMINISTRATION ..............................................................................11 OVERDOSAGE ................................................................................................................12 ACTION AND CLINICAL PHARMACOLOGY ............................................................12 STORAGE AND STABILITY ..........................................................................................13 DOSAGE FORMS, COMPOSIT Прочетете целия документ