DORZOLAMIDE 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:

2022-06-24

Karakteristik produk

_DORZOLAMIDE (Dorzolamide Eye Drops)_
_ _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE
Dorzolamide Eye Drops
Sterile Ophthalmic Solution, 2% weight/volume Dorzolamide (as
Dorzolamide hydrochloride),
ophthalmic
BP
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
Manufactured by:
Micro Labs Limited
Bangalore– 560001
INDIA
Canadian Importer/Distributer:
13187811
Canada Inc.
Mississauga, ON L4Z 1S1
Submission Control Number: 248994
Date of Initial Approval:
June 14, 2022
_DORZOLAMIDE (Dorzolamide Eye Drops)_
Page 2 of 24
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 3
1
INDICATIONS.................................................................................................................
3
1.1
Pediatrics
.........................................................................................................
3
1.2
Geriatrics
..........................................................................................................
3
2
CONTRAINDICATIONS
...................................................................................................
3
3
DOSAGE AND ADMINISTRATION
...................................................................................
3
3.1
Recommended Dose and Dosage Adjustment
.................................................... 3
3.2
Missed Dose
.....................................................................................................
4
4
OVERDOSAGE................................................................................................................
4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
................................... 4
6
WARNINGS AND PRECAUTIONS
....................................................................................
5
6.1
Special Populations
...........................................................................................
7
6.1.1
Pregnant Women
......................