SANDOZ TRAVOPROST SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRAVOPROST

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

S01EE04

INN (International Name):

TRAVOPROST

Dosage:

0.004%

Pharmaceutical form:

SOLUTION

Composition:

TRAVOPROST 0.004%

Administration route:

OPHTHALMIC

Units in package:

2.5/5ML

Prescription type:

Prescription

Therapeutic area:

PROSTAGLANDIN ANALOGS

Product summary:

Active ingredient group (AIG) number: 0145801001; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-10-22

Summary of Product characteristics

_Sandoz Travoprost Product Monograph _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SANDOZ TRAVOPROST
Travoprost Ophthalmic Solution
0.004% w/v
Elevated Intraocular Pressure Therapy
Prostaglandin F
2α
analogue
Sandoz Canada Inc.
110 Rue de Lauzon,
Boucherville, Quebec
J4B 7K8
Date of Revision:
May 7, 2019
Submission Control No.: 226649
_ _
_Sandoz Travoprost Product Monograph _
_Page 2 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................12
PHARMACEUTICAL INFORMATION
..........................................................................12
CLINICAL TRIALS
.......................................................