Land: Canada
Taal: Engels
Bron: Health Canada
TIMOLOL (TIMOLOL MALEATE)
SANDOZ CANADA INCORPORATED
S01ED01
TIMOLOL
0.5%
SOLUTION (EXTENDED RELEASE)
TIMOLOL (TIMOLOL MALEATE) 0.5%
OPHTHALMIC
5ML
Prescription
BETA-ADRENERGIC AGENTS
Active ingredient group (AIG) number: 0131275002; AHFS:
APPROVED
2006-09-05
_ _ _ _ _T-LO and TIMOLOL MALEATE-EX_ ( _timolol maleate) _ _Page 1 of 27_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr T-LO Timolol Maleate Ophthalmic Solution Solution, 0.25%, 0.5% w/v timolol (as timolol maleate), ophthalmic USP and Pr TIMOLOL MALEATE-EX Timolol Ophthalmic Gel Forming Solution Solution (Extended-Release), 0.25%, 0.5% w/v timolol (as timolol maleate), ophthalmic Antiglaucoma Preparations and Miotics Sandoz Canada Inc. 110 rue de Lauzon, Boucherville, QC, J4B 1E6 Date of Initial Authorization: SEP 29, 2017 Date of Revision: DEC 21, 2023 Submission Control Number: 273147 _ _ _ _ _ _ _T-LO and TIMOLOL MALEATE-EX_ ( _timolol maleate) _ _Page 2 of 27_ RECENT MAJOR LABEL CHANGES 6 Dosage Forms, Strengths, Composition and Packaging 12/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES ............................................................................................ 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics .................................................................................................................... 4 1.2 Geriatrics .................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations ................................................................................................ 5 4.2 Recommended Dose and Dosage Adjust Lees het volledige document