PMS-EPIRUBICIN SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

EPIRUBICIN HYDROCHLORIDE

Disponible depuis:

PHARMASCIENCE INC

Code ATC:

L01DB03

DCI (Dénomination commune internationale):

EPIRUBICIN

Dosage:

2MG

forme pharmaceutique:

SOLUTION

Composition:

EPIRUBICIN HYDROCHLORIDE 2MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

5/25/100ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0116901002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2014-02-06

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
PMS-EPIRUBICIN
epirubicin hydrochloride injection
PRESERVATIVE-FREE SOLUTION
2 mg/mL
Professed Standard
ANTINEOPLASTIC AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Date of Revision:
February 15, 2017
Submission Control No.: 201970
_ _
_pms-EPIRUBICIN Product Monograph _
_Page 2 of 41_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
CLINICAL TRIALS
..................