Ország: Kanada
Nyelv: angol
Forrás: Health Canada
DICLOFENAC SODIUM
PHARMA STULLN INC.
S01BC03
DICLOFENAC
0.1%
SOLUTION
DICLOFENAC SODIUM 0.1%
OPHTHALMIC
0.3MLX10 X20 X50
Prescription
ANTIALLERGIC AGENTS
Active ingredient group (AIG) number: 0114417004; AHFS:
APPROVED
2018-06-19
_Diclofenac Sodium Ophthalmic Solution _ _Page 1 of 26 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr DICLOFENAC Diclofenac Sodium Ophthalmic Solution Ophthalmic solution, 0.1% w/v for Topical use Anti-inflammatory agents, non-steroids Pharma Stulln Inc 6500 Transcanada Highway, Suite 400 Pointe-Claire Quebec H9R0A5 Date of Initial Authorization: JUN 19, 2018 Date of Revision: November 16, 2023 Submission Control Number: 275190 _Diclofenac Sodium Ophthalmic Solution _ _ _ _Page 3 of 26 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 11/2023 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 11/2023 SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................................................................ 3 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................................................................... 5 1 INDICATIONS .................................................................................................................................................................. 5 1.1 P EDIATRICS ....................................................................................................................................................................... 5 1.2 G ERIATRICS ....................................................................................................................................................................... 5 2 CONTRAINDICATIONS ..................................................................................................................................................... 5 4 DOSAGE AND ADMINISTRATION .................................................................................................................................... 5 4.2 R ECOMMENDED D OSE AND D OSAGE A DJUSTM Olvassa el a teljes dokumentumot