JAMP-KETOTIFEN SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

KETOTIFEN (KETOTIFEN FUMARATE)

Disponible des:

JAMP PHARMA CORPORATION

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:

100

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:

2019-06-27

Fitxa tècnica

_Page 1 of 11_
PRODUCT MONOGRAPH
Pr
JAMP-KETOTIFEN
Ketotifen Fumarate Ophthalmic Solution
(0.25 mg
/
mL as ketotifen)
Anti-allergy Agent
Jamp Pharma Corporation
1310, rue Nobel
Boucherville, Quebec
J4B 5H3
Date of Preparation:
June 17, 2019
Submission Control No: 212300
_Page 2 of 11_
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
...............................................................5
STORAGE AND STABILITY
............................................................................................5
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 5
PART II: SCIENTIFIC INFORMATION
..................................................................................6
PHARMACEUTICAL INFORMATION
...........................................................................
6
DETAILED PHARMACOLOGY
.......................................................................................7
TOXICOLOGY
.................................................................................