DORZOLAMIDE SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Dostępny od:

MICRO LABS LIMITED

Kod ATC:

S01EC03

INN (International Nazwa):

DORZOLAMIDE

Dawkowanie:

2%

Forma farmaceutyczna:

SOLUTION

Skład:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

Droga podania:

OPHTHALMIC

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2022-06-24

Charakterystyka produktu

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