APO-TRAVOPROST SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

TRAVOPROST

Dostupné z:

APOTEX INC

ATC kód:

S01EE04

INN (Medzinárodný Name):

TRAVOPROST

Dávkovanie:

0.003%

Forma lieku:

SOLUTION

Zloženie:

TRAVOPROST 0.003%

Spôsob podávania:

OPHTHALMIC

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

PROSTAGLANDIN ANALOGS

Prehľad produktov:

Active ingredient group (AIG) number: 0145801002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2020-06-01

Súhrn charakteristických

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Page 1 of 36
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-TRAVOPROST
TRAVOPROST OPHTHALMIC SOLUTION USP
0.003% W/V
ELEVATED INTRAOCULAR PRESSURE
THE
R
A
PY
PROSTAGLANDIN F
2Α
ANALOGUE
APOTEX INC.
150 SIGNET DRIVE
TORONTO ONTARIO
M9L 1T9
DATE OF PREPARATION:
JUNE 24, 2019
SUBMISSION CONTROL NO.: 206622
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Page 2 of 36
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFOR
M
ATION
.....................................................................
3
SUMMARY PRODUCT INFORMATION
......................................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................................
3
CONTRAINDICATIONS...............................................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................................
4
ADVERSE REACTIONS
..............................................................................................................
6
DRUG
INTERACTIONS...............................................................................................................
8
DOSAGE AND
ADMINISTRATION..............................................................................................
9
OVERDOSAGE
.........................................................................................................................
10
ACTION AND CLINICAL
PHARMACOLOGY.............................................................................
10
STORAGE AND STABILITY
......................................................................................................
12
SPECIAL HANDLING INSTRUCTIONS
.....................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................................ 13
PART II: SCIENTIFIC INFORMATION
....................................................