JAMP-DORZOLAMIDE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Available from:

JAMP PHARMA CORPORATION

ATC code:

S01EC03

INN (International Name):

DORZOLAMIDE

Dosage:

2%

Pharmaceutical form:

SOLUTION

Composition:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

CARBONIC ANHYDRASE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2019-01-18

Summary of Product characteristics

_JAMP-Dorzolamide (dorzolamide hydrochloride) _
_Page 1 of 28 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-DORZOLAMIDE
Dorzolamide Eye Drops
Solution, 2% w/v dorzolamide (as dorzolamide hydrochloride),
Ophthalmic
BP
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, QC
J4B 5H3, Canada
Date of Initial Authorization:
MAR 21, 2016
Date of Revision:
OCT 27, 2023
Submission Control Number: 279907
_JAMP-Dorzolamide (dorzolamide hydrochloride) _
_Page 2 of 28 _
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
......................................................... 5
4.4
Administration
........................................................................................................