SANDOZ TIMOLOL SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TIMOLOL (TIMOLOL MALEATE)

זמין מ:

SANDOZ CANADA INCORPORATED

קוד ATC:

S01ED01

INN (שם בינלאומי):

TIMOLOL

כמות:

0.5%

טופס פרצבטיות:

SOLUTION

הרכב:

TIMOLOL (TIMOLOL MALEATE) 0.5%

מסלול נתינה (של תרופות):

OPHTHALMIC

יחידות באריזה:

5ML/10ML

סוג מרשם:

Prescription

איזור תרפויטי:

BETA-ADRENERGIC AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

1999-10-07

מאפייני מוצר

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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
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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
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5
4.5 Missed Dose