DORZOLAMIDE PF SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Tersedia dari:

MICRO LABS LIMITED

Kode ATC:

S01EC03

INN (Nama Internasional):

DORZOLAMIDE

Dosis:

2%

Bentuk farmasi:

SOLUTION

Komposisi:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0128558001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2023-10-31

Karakteristik produk

_DORZOLAMIDE PF (Dorzolamide Hydrochloride Ophthalmic Solution) _
_Page 1 of 29 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE PF
Dorzolamide Hydrochloride Ophthalmic Solution
(Preservative-Free)
Solution, 2% weight/volume Dorzolamide (as Dorzolamide hydrochloride),
Ophthalmic
House Standard
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
Manufactured by:
Micro Labs Limited
Bangalore– 560001
INDIA
Date of Initial Authorization:
October 5, 2023
Canadian Importer/Distributor:
13187811 Canada Inc.
Mississauga, ON L4Z 1S1
Submission Control Number: 255546
_DORZOLAMIDE PF (Dorzolamide Hydrochloride Ophthalmic Solution) _
_Page 2 of 29 _
RECENT MAJOR LABEL CHANGES
Not applicable.
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
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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
..................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................