APO-TRAVOPROST-TIMOLOL PQ SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TIMOLOL (TIMOLOL MALEATE); TRAVOPROST

Available from:

APOTEX INC

ATC code:

S01ED51

INN (International Name):

TIMOLOL, COMBINATIONS

Dosage:

0.5%; 0.004%

Pharmaceutical form:

SOLUTION

Composition:

TIMOLOL (TIMOLOL MALEATE) 0.5%; TRAVOPROST 0.004%

Administration route:

OPHTHALMIC

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0251602001; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-12-30

Summary of Product characteristics

_APO-TRAVOPROST-TIMOLOL PQ Product Monograph _
_Page 1 of 48 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-TRAVOPROST-TIMOLOL PQ
Travoprost and Timolol Ophthalmic Solution
0.004% w/v Travoprost and 0.5% w/v Timolol (as timolol maleate)
with Polyquaternium-1 0.001% as preservative
Elevated Intraocular Pressure Therapy
Prostaglandin F
2α
analogue and beta-adrenergic receptor blocker
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
DEC 30, 2019
Date of Revision:
APR 25, 2023
Submission Control No: 269437
_APO-TRAVOPROST-TIMOLOL PQ Product Monograph _
_ Page 2 of 48 _
RECENT MAJOR LABEL CHANGES
None
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
4.2
Recommended Dose and Dosage Adjustment
......................................................... 4
4.4
Administration
............................................................................................................
5
4.5
Missed Dose
................................