JAMP-LATANOPROST/TIMOLOL SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TIMOLOL (TIMOLOL MALEATE); LATANOPROST

זמין מ:

JAMP PHARMA CORPORATION

קוד ATC:

S01ED51

INN (שם בינלאומי):

TIMOLOL, COMBINATIONS

כמות:

5MG; 50MCG

טופס פרצבטיות:

SOLUTION

הרכב:

TIMOLOL (TIMOLOL MALEATE) 5MG; LATANOPROST 50MCG

מסלול נתינה (של תרופות):

OPHTHALMIC

יחידות באריזה:

2.5ML

סוג מרשם:

Prescription

איזור תרפויטי:

BETA-ADRENERGIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0248501001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2016-04-11

מאפייני מוצר

JAMP-LATANOPROST/TIMOLOL Page 1 of 39
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-LATANOPROST/TIMOLOL
Latanoprost and timolol ophthalmic solution
Solution, latanoprost 50 mcg /mL and timolol 5 mg / mL as timolol
maleate, Ophthalmic
Prostaglandin F
2α
Analogue and Beta-adrenergic Receptor Blocker
Submission
Control
Number:
280402
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
APR 11, 2016
Date of
Revision:
NOV 15, 2023
JAMP-LATANOPROST/TIMOLOL Page 2 of 39
RECENT MAJOR LABEL CHANGES
NONE AT THE TIME OF MOST RECENT AUTHORIZATION
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
................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
..........................................................................................