TEVA-LATANOPROST SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LATANOPROST

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

S01EE01

INN (Nama Internasional):

LATANOPROST

Dosis:

50MCG

Bentuk farmasi:

SOLUTION

Komposisi:

LATANOPROST 50MCG

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

5ML

Jenis Resep:

Prescription

Area terapi:

PROSTAGLANDIN ANALOGS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2011-08-25

Karakteristik produk

_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
............................