TIMOLOL MALEATE-EX SOLUTION (EXTENDED RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TIMOLOL (TIMOLOL MALEATE)

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

S01ED01

INN (Διεθνής Όνομα):

TIMOLOL

Δοσολογία:

0.5%

Φαρμακοτεχνική μορφή:

SOLUTION (EXTENDED RELEASE)

Σύνθεση:

TIMOLOL (TIMOLOL MALEATE) 0.5%

Οδός χορήγησης:

OPHTHALMIC

Μονάδες σε πακέτο:

5ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

BETA-ADRENERGIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2006-09-05

Αρχείο Π.Χ.Π.

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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
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
................................................................................................
5
4.2 Recommended Dose and Dosage Adjust