AJ-IDARUBICIN SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

IDARUBICIN HYDROCHLORIDE

Disponible desde:

AGILA JAMP CANADA INC

Código ATC:

L01DB06

Designación común internacional (DCI):

IDARUBICIN

Dosis:

1MG

formulario farmacéutico:

SOLUTION

Composición:

IDARUBICIN HYDROCHLORIDE 1MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0122755004; AHFS:

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2015-11-03

Ficha técnica

1
PRODUCT MONOGRAPH
PR
AJ-IDARUBICIN
IDARUBICIN HYDROCHLORIDE INJECTION
PROFESSED
1 MG/ML
[5 ML, 10 ML AND 20 ML VIALS]
Antineoplastic Agent
Sterile Solution
Agila Jamp Canada Inc.
1380 – 203 Newton
Boucherville, Québec
Canada
J4B 5H2
DATE OF PREPARATION: September 12, 2013
Submission Control No: 167520
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....................................................................................................9
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND
STABILITY..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL
INFORMATION..........................................................................17
CLINICAL TRIALS
.............................................................................