MINT-LATANOPROST/TIMOLOL SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TIMOLOL (TIMOLOL MALEATE); LATANOPROST

Tilgjengelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

S01ED51

INN (International Name):

TIMOLOL, COMBINATIONS

Dosering :

5MG; 50MCG

Legemiddelform:

SOLUTION

Sammensetning:

TIMOLOL (TIMOLOL MALEATE) 5MG; LATANOPROST 50MCG

Administreringsrute:

OPHTHALMIC

Enheter i pakken:

5ML

Resept typen:

Prescription

Terapeutisk område:

BETA-ADRENERGIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2015-08-11

Preparatomtale

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
.....................................................................................................