PHARMORUBICIN PFS SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EPIRUBICIN HYDROCHLORIDE

Available from:

PHARMASCIENCE INC

ATC code:

L01DB03

INN (International Name):

EPIRUBICIN

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

EPIRUBICIN HYDROCHLORIDE 2MG

Administration route:

INTRAVENOUS

Units in package:

5ML/25ML/100ML

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2003-09-05

Summary of Product characteristics

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
..........................................