MINT-LATANOPROST/TIMOLOL SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TIMOLOL (TIMOLOL MALEATE); LATANOPROST

Disponível em:

MINT PHARMACEUTICALS INC

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:

5ML

Tipo de prescrição:

Prescription

Área terapêutica:

BETA-ADRENERGIC AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0248501002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2015-08-11

Características técnicas

PRODUCT MONOGRAPH
PR
MINT-LATANOPROST/TIMOLOL
Latanoprost and timolol ophthalmic solution, 50 µg/mL/5 mg/mL (as
timolol maleate)
Elevated Intraocular Pressure Therapy
Prostaglandin F
2α
Analogue and Beta-adrenergic Receptor Blocker
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit 1
Mississauga, Ontario
Canada L5T 1J6
Control No. 176298
Date of Preparation:
10 August 2015
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE...............................................................................3
CONTRAINDICATIONS....................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE
REACTIONS....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSE
......................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
.............................................................14
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................16
PHARMACEUTICAL INFORMATION
..........................................................................16
CLINICAL TRIALS
.....................................................................................................