PMS-TIMOLOL SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TIMOLOL (TIMOLOL MALEATE)

Disponível em:

PHARMASCIENCE INC

Código ATC:

S01ED01

DCI (Denominação Comum Internacional):

TIMOLOL

Dosagem:

0.25%

Forma farmacêutica:

SOLUTION

Composição:

TIMOLOL (TIMOLOL MALEATE) 0.25%

Via de administração:

OPHTHALMIC

Unidades em pacote:

5ML/10ML

Tipo de prescrição:

Prescription

Área terapêutica:

BETA-ADRENERGIC AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0131275001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

1997-10-06

Características técnicas

_pms-TIMOLOL Ophthalmic Solution Product Monograph _
_Page 1 of 21_
PRODUCT MONOGRAPH
PR
PMS-TIMOLOL
TIMOLOL MALEATE OPHTHALMIC SOLUTION USP 0.25% AND 0.5%
STERILE OPHTHALMIC SOLUTION
ELEVATED INTRAOCULAR PRESSURE THERAPY
PHARMASCIENCE INC.
DATE OF PREPARATION:
6111 Royalmount Ave, Suite
#
100
June 18, 2012
Montreal, Quebec
H4P2T4
Submission Control No: 156072
_pms-TIMOLOL Ophthalmic Solution Product Monograph _
_Page 2 of 21_
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
..................................................................................
6
DRUG INTERACTIONS
..................................................................................
8
DOSAGE AND ADMINISTRATION
..............................................................
9
OVERDOSAGE
................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
............................................
10
STORAGE AND STABILITY
..........................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING .............................
11
PART II: SCIENTIFIC INFORMATION
........................................................................
12
PHARMACEUTICAL INFORMATION
..........................................................
12
CLINICAL TRIALS
..........................................................................................
12
DETAILED PHARMACOLOGY
.....................................................................
13
TOXICOLOGY
................................................................