PHARMORUBICIN PFS SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

EPIRUBICIN HYDROCHLORIDE

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

L01DB03

INN (nume internaţional):

EPIRUBICIN

Dozare:

2MG

Forma farmaceutică:

SOLUTION

Compoziție:

EPIRUBICIN HYDROCHLORIDE 2MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

5ML/25ML/100ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTINEOPLASTIC AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2003-09-05

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
PHARMORUBICIN PFS
epirubicin hydrochloride injection
2 mg/mL
Professed Standard
ANTINEOPLASTIC AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Date of Revision:
April 10, 2017
Submission Control No.: 203222
_ _
_PHARMORUBICIN PFS Product Monograph _
_Page 2 of 42_
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
.......................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
..........................................