TIMOLOL MALEATE-EX SOLUTION (EXTENDED RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

TIMOLOL (TIMOLOL MALEATE)

Dostopno od:

SANDOZ CANADA INCORPORATED

Koda artikla:

S01ED01

INN (mednarodno ime):

TIMOLOL

Odmerek:

0.25%

Farmacevtska oblika:

SOLUTION (EXTENDED RELEASE)

Sestava:

TIMOLOL (TIMOLOL MALEATE) 0.25%

Pot uporabe:

OPHTHALMIC

Enote v paketu:

5ML

Tip zastaranja:

Prescription

Terapevtsko območje:

BETA-ADRENERGIC AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0131275001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2006-09-05

Lastnosti izdelka

_ _
_ _
_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