SANDOZ TRAVOPROST / TIMOLOL PQ SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TRAVOPROST; TIMOLOL (TIMOLOL MALEATE)

זמין מ:

SANDOZ CANADA INCORPORATED

קוד ATC:

S01ED51

INN (שם בינלאומי):

TIMOLOL, COMBINATIONS

כמות:

0.004%; 0.5%

טופס פרצבטיות:

SOLUTION

הרכב:

TRAVOPROST 0.004%; TIMOLOL (TIMOLOL MALEATE) 0.5%

מסלול נתינה (של תרופות):

OPHTHALMIC

יחידות באריזה:

2.5/5ML

סוג מרשם:

Prescription

איזור תרפויטי:

BETA-ADRENERGIC AGENTS

leaflet_short:

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

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2023-10-30

מאפייני מוצר

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ TRAVOPROST / TIMOLOL PQ
travoprost and timolol ophthalmic solution
0.004% w/v and 0.5% w/v (as timolol maleate)
with POLYQUAD
_*_
(polyquaternium-1 0.001%) as preservative
Elevated Intraocular Pressure Therapy
Prostaglandin F
2

analogue and beta-adrenergic receptor blocker
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Quebec
J4B 1E6
Submission Control No: 249263
*POLYQUAD is a registered trademark.
Date of Revision:
May 10, 2021
_Sandoz Travoprost / Timolol PQ _
_Page 2 of 47_
TABLE OF CONTENTS
TABLE OF CONTENTS
.............................................................................................................
2
1
INDICATIONS
.................................................................................................................
3
1.1
Pediatrics
.............................................................................................................
3
1.2
Geriatrics
.............................................................................................................
3
2
CONTRAINDICATIONS
..................................................................................................
3
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
..................................................... 4
4.3
Administration
......................................................................................................
4
4.5
Missed Dose
........................................................................................................
4
5
OVERDOSAGE
...............................................................................................................
4
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 5
7
WARNINGS AND PRECAUTIONS
.................................................................................
6
7.1
Special Populations
...................................