JAMP-LATANOPROST/TIMOLOL SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TIMOLOL (TIMOLOL MALEATE); LATANOPROST

Disponível em:

JAMP PHARMA CORPORATION

Código ATC:

S01ED51

DCI (Denominação Comum Internacional):

TIMOLOL, COMBINATIONS

Dosagem:

5MG; 50MCG

Forma farmacêutica:

SOLUTION

Composição:

TIMOLOL (TIMOLOL MALEATE) 5MG; LATANOPROST 50MCG

Via de administração:

OPHTHALMIC

Unidades em pacote:

2.5ML

Tipo de prescrição:

Prescription

Área terapêutica:

BETA-ADRENERGIC AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0248501001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2016-04-11

Características técnicas

JAMP-LATANOPROST/TIMOLOL Page 1 of 39
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-LATANOPROST/TIMOLOL
Latanoprost and timolol ophthalmic solution
Solution, latanoprost 50 mcg /mL and timolol 5 mg / mL as timolol
maleate, Ophthalmic
Prostaglandin F
2α
Analogue and Beta-adrenergic Receptor Blocker
Submission
Control
Number:
280402
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
APR 11, 2016
Date of
Revision:
NOV 15, 2023
JAMP-LATANOPROST/TIMOLOL Page 2 of 39
RECENT MAJOR LABEL CHANGES
NONE AT THE TIME OF MOST RECENT AUTHORIZATION
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
........................................................ 5
4.4
Administration
..........................................................................................