SANDOZ TIMOLOL SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TIMOLOL (TIMOLOL MALEATE)

Disponível em:

SANDOZ CANADA INCORPORATED

Código ATC:

S01ED01

DCI (Denominação Comum Internacional):

TIMOLOL

Dosagem:

0.5%

Forma farmacêutica:

SOLUTION

Composição:

TIMOLOL (TIMOLOL MALEATE) 0.5%

Via de administração:

OPHTHALMIC

Unidades em pacote:

5ML/10ML

Tipo de prescrição:

Prescription

Área terapêutica:

BETA-ADRENERGIC AGENTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

1999-10-07

Características técnicas

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_Sandoz Timolol _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SANDOZ TIMOLOL
Timolol Maleate Ophthalmic Solution
Solution, 0.25%, 0.5% w/v timolol (as timolol maleate), ophthalmic
USP
Antiglaucoma Preparations and Miotics
Sandoz Canada Inc.
110 rue de Lauzon,
Boucherville, QC,
J4B 1E6
Date of Initial Authorization:
AUG 22, 2005
Date of Revision:
MAR 07, 2024
Submission Control Number:
283616
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_Sandoz timolol _
_Page 2 of 25_
RECENT MAJOR LABEL CHANGES
6
Dosage Forms, Strengths, Composition and Packaging
03/2024
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
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4
4.2 Recommended Dose and Dosage Adjustment
............................................................ 5
4.4 Administration
.............................................................................................................
5
4.5 Missed Dose