APO-TRAVOPROST-TIMOP PQ SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

TRAVOPROST; TIMOLOL (TIMOLOL MALEATE)

Dostupné z:

APOTEX INC

ATC kód:

S01ED51

INN (Medzinárodný Name):

TIMOLOL, COMBINATIONS

Dávkovanie:

0.004%; 0.5%

Forma lieku:

SOLUTION

Zloženie:

TRAVOPROST 0.004%; TIMOLOL (TIMOLOL MALEATE) 0.5%

Spôsob podávania:

OPHTHALMIC

Počet v balení:

2.5ML/5ML

Typ predpisu:

Prescription

Terapeutické oblasti:

BETA-ADRENERGIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2020-03-02

Súhrn charakteristických

_Page_
_APO-TRAVOPROST-TIMOP PQ Product Monograph_
_1 of 49 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-TRAVOPROST-TIMOP 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
Submission
Control No.:
278611
Date of Initial Authorization:
MAR 02, 2020
Date of Revision:
SEP
22, 2023
_APO-TRAVOPROST-TIMOP PQ Product Monograph _
_Page 2 of 49 _
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
.................................................................