TEVA-LATANOPROST SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LATANOPROST

Dostopno od:

TEVA CANADA LIMITED

Koda artikla:

S01EE01

INN (mednarodno ime):

LATANOPROST

Odmerek:

50MCG

Farmacevtska oblika:

SOLUTION

Sestava:

LATANOPROST 50MCG

Pot uporabe:

OPHTHALMIC

Enote v paketu:

5ML

Tip zastaranja:

Prescription

Terapevtsko območje:

PROSTAGLANDIN ANALOGS

Povzetek izdelek:

Active ingredient group (AIG) number: 0132916001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2011-08-25

Lastnosti izdelka

_TEVA-LATANOPROST (Latanoprost Ophthalmic Solution) _
_Page 1 of 32_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-LATANOPROST
Latanoprost Ophthalmic Solution
Solution, 50 mcg/mL, Ophthalmic
Prostaglandin F
2α
analogue
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
SEP 24, 2012
Toronto, Ontario
M1B 2K9
Date of Revision:
MAR 20, 2024
Submission Control Number: 279755
_TEVA-LATANOPROST (Latanoprost Ophthalmic Solution) _
_Page 2 of 32_
_ _
RECENT MAJOR LABEL CHANGES
None at the time of most recent authorization
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
4.1
Dosing Considerations
..........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
...................................................... 4
4.4
Administration
.....................................................................................................
5
4.5
Missed Dose
............................