EPIRUBICIN HYDROCHLORIDE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

EPIRUBICIN HYDROCHLORIDE

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

L01DB03

INN (International Name):

EPIRUBICIN

Dosage:

2.0MG

Pharmaceutical form:

SOLUTION

Composition:

EPIRUBICIN HYDROCHLORIDE 2.0MG

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:

2008-12-04

Summary of Product characteristics

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PRODUCT MONOGRAPH
STERILE
PR
EPIRUBICIN HYDROCHLORIDE INJECTION
(Epirubicin Hydrochloride)
2 mg/mL
Mfr. Standard
ANTINEOPLASTIC AGENT
FRESENIUS KABI CANADA LTD.
Date of Revision:
45 Vogell Road, Suite 200
January 9, 2017
Richmond Hill, ON L4B 3P6
Submission Control No.: 201601
_Epirubicin Hydrochloride-PM-Eng-v2.0 _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
......................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
...............