AG-DORZOLAMIDE TIMOLOL SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Disponível em:

ANGITA PHARMA INC.

Código ATC:

S01ED51

DCI (Denominação Comum Internacional):

TIMOLOL, COMBINATIONS

Dosagem:

5MG; 20MG

Forma farmacêutica:

SOLUTION

Composição:

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

Via de administração:

OPHTHALMIC

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2022-05-26

Características técnicas

_AG-Dorzolamide Timolol (dorzolamide hydrochloride and timolol
maleate)_
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-DORZOLAMIDE
TIMOLOL
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
20 mg / mL (Dorzolamide as Dorzolamide Hydrochloride) and
5 mg / mL (Timolol as Timolol Maleate)
Manufacturer’s Standard
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Angita Pharma Inc.
1310 rue Nobel,
Boucherville Quebec,
J4B 5H3, Canada
Date of Initial Approval:
May 25, 2022
Submission Control No.: 263423
_AG-Dorzolamide Timolol (dorzolamide hydrochloride and timolol
maleate)_
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
TABLE OF CONTENTS
..................................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................................
3
1
INDICATIONS
......................................................................................................................................
3
1.1
Pediatrics
.............................................................................................................................
3
1.2
Geriatrics
..............................................................................................................................
3
2
CONTRAINDICATIONS
....................................................................................................................
3
3
DOSAGE AND ADMINISTRATION
................................................................................................
4
3.1
Recommended Dose and Dosage Adjustment
.................................................................
4
3.2
Administration
......................................................................................................................
4
3.3
Missed Dose
.....................................