RIVA-DORZOLAMIDE/TIMOLOL SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Prieinama:

LABORATOIRE RIVA INC.

ATC kodas:

S01ED51

INN (Tarptautinis Pavadinimas):

TIMOLOL, COMBINATIONS

Dozė:

20MG; 5MG

Vaisto forma:

SOLUTION

Sudėtis:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG; TIMOLOL (TIMOLOL MALEATE) 5MG

Vartojimo būdas:

OPHTHALMIC

Vienetai pakuotėje:

10ML

Recepto tipas:

Prescription

Gydymo sritis:

BETA-ADRENERGIC AGENTS

Produkto santrauka:

Active ingredient group (AIG) number: 0237301001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2015-07-02

Prekės savybės

_RIVA-DORZOLAMIDE/TIMOLOL (dorzolamide hydrochloride and timolol
maleate) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA-DORZOLAMIDE/TIMOLOL
Dorzolamide and Timolol Ophthalmic Solution
Solution, 20 mg/mL dorzolamide hydrochloride and 5 mg/mL timolol
maleate, Ophthalmic
BP
Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No.: 273934
Date of Initial Authorization:
JUL
02, 2015
Date of Revision:
APR 21, 2023
_RIVA-DORZOLAMIDE/TIMOLOL (dorzolamide hydrochloride and timolol
maleate) _
_Page 2 of 32_
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
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...............................