DORZOLAMIDE SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Dostupné z:

JAMP PHARMA CORPORATION

ATC kód:

S01EC03

INN (Medzinárodný Name):

DORZOLAMIDE

Dávkovanie:

20MG

Forma lieku:

SOLUTION

Zloženie:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG

Spôsob podávania:

OPHTHALMIC

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

CARBONIC ANHYDRASE INHIBITORS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2021-11-15

Súhrn charakteristických

_Dorzolamide_
_ _
_(dorzolamide hydrochloride) _Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE
Dorzolamide Hydrochloride Ophthalmic Solution, USP
20 mg/mL Dorzolamide (as Dorzolamide Hydrochloride)
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
November 15, 2021
Date of Revision:
October 12, 2023
Submission Control Number: 275514
_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
....................................................................................................................
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
........................................