KETOTIFEN OPHTHALMIC SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

KETOTIFEN (KETOTIFEN FUMARATE)

Disponible des:

STERIMAX INC

Codi ATC:

S01GX08

Designació comuna internacional (DCI):

KETOTIFEN

Dosis:

0.25MG

formulario farmacéutico:

SOLUTION

Composición:

KETOTIFEN (KETOTIFEN FUMARATE) 0.25MG

Vía de administración:

OPHTHALMIC

Unidades en paquete:

5ML

tipo de receta:

Prescription

Área terapéutica:

ANTIALLERGIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0115676003; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2013-01-30

Fitxa tècnica

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_Ketotifen Ophthalmic Solution _
_Page 1 of 13_
PRODUCT MONOGRAPH
Pr
KETOTIFEN OPHTHALMIC SOLUTION
Ketotifen Fumarate Ophthalmic Solution
(0.25 mg/mL as Ketotifen)
Anti-allergy Agent
SteriMax Inc.
1-2735 Matheson Blvd E
Mississauga, ON L4W 4M8
Date of Preparation:
January 28, 2013
Submission Control Number: 153118
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_Ketotifen Ophthalmic Solution _
_Page 2 of 13_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
ADVERSE REACTIONS
...................................................................................................
4
DRUG INTERACTIONS
...................................................................................................
4
DOSAGE AND ADMINISTRATION
...............................................................................
4
OVERDOSAGE
.................................................................................................................
4
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 4
STORAGE AND STABILITY
...........................................................................................
5
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 5
PART II: SCIENTIFIC INFORMATION
................................................................................
7
PHARMACEUTICAL INFORMATION
...........................................................................
7
DETAILED PHARMACOLOGY
......................................................................................
8
TOXICOLOGY
.