JAMP-TIMOLOL SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TIMOLOL (TIMOLOL MALEATE)

זמין מ:

JAMP PHARMA CORPORATION

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

סוג מרשם:

Prescription

איזור תרפויטי:

BETA-ADRENERGIC AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2015-10-22

מאפייני מוצר

_ JAMP-Timolol_
_ _
_(Timolol Maleate Ophthalmic Solution)_
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_Page 1 of 25_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-Timolol
Timolol Maleate Ophthalmic Solution
Sterile Solution, 0.5% w/v timolol (as timolol maleate), Ophthalmic
Manufacturer’s Standard
Elevated Intraocular Pressure Therapy
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Initial Authorization:
October 22, 2015
Date of Revision:
April 11, 2023
Submission Control Number: 271239
_ JAMP-Timolol_
_ _
_(Timolol Maleate Ophthalmic Solution)_
_ _
_Page 2 of 25_
_ _
RECENT MAJOR LABEL CHANGES
Not applicable.
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
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
4.5
Missed Dose
....................................................................