APO-TRAVOPROST Z SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-04-2019
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Active ingredient:
TRAVOPROST
Available from:
APOTEX INC
ATC code:
S01EE04
INN (International Name):
TRAVOPROST
Dosage:
0.004%
Pharmaceutical form:
SOLUTION
Composition:
TRAVOPROST 0.004%
Administration route:
OPHTHALMIC
Units in package:
2.5ML/5ML
Prescription type:
Prescription
Therapeutic area:
PROSTAGLANDIN ANALOGS
Product summary:
Active ingredient group (AIG) number: 0145801001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-08-13
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-TRAVOPROST Z
TRAVOPROST OPHTHALMIC SOLUTION, USP
0.004% W/V
ELEVATED INTRAOCULAR PRESSURE THERAPY
PROSTAGLANDIN F
2Α ANALOGUE
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
APRIL 29, 2019
TORONTO ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 227007
Page 2 of 27
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
CL
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