TIMOLOL MALEATE-EX SOLUTION (EXTENDED RELEASE)

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

TIMOLOL (TIMOLOL MALEATE)

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

S01ED01

INN (Међународно име):

TIMOLOL

Дозирање:

0.5%

Фармацеутски облик:

SOLUTION (EXTENDED RELEASE)

Састав:

TIMOLOL (TIMOLOL MALEATE) 0.5%

Пут администрације:

OPHTHALMIC

Јединице у пакету:

5ML

Тип рецептора:

Prescription

Терапеутска област:

BETA-ADRENERGIC AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0131275002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2006-09-05

Карактеристике производа

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_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
_ _
_ _
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_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