EPIRUBICIN HYDROCHLORIDE FOR INJECTION POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

EPIRUBICIN HYDROCHLORIDE

זמין מ:

HOSPIRA HEALTHCARE ULC

קוד ATC:

L01DB03

INN (שם בינלאומי):

EPIRUBICIN

כמות:

50MG

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

EPIRUBICIN HYDROCHLORIDE 50MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

25ML

סוג מרשם:

Prescription

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0116901001; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2019-01-18

מאפייני מוצר

_Epirubicin Hydrochloride for Injection – Product Monograph_
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PRODUCT MONOGRAPH
PR EPIRUBICIN HYDROCHLORIDE FOR INJECTION
50 mg / vial
Sterile
ANTINEOPLASTIC AGENT
Hospira Healthcare Corporation
Date of Preparation: November 14, 2007
1111 Dr. Frenderik Philips, Suite 600
Saint Laurent, QC
H4M 2X6
Submission Control No: 106825
_Epirubicin Hydrochloride for Injection – Product Monograph_
_ 2 of 38_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT
INFORMATION.........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS....................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE.................................................................................................................16
ACTION AND CLINICAL
PHARMACOLOGY.............................................................17
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING
INSTRUCTIONS........................................................................19
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................20
PART II: SCIENTIFIC
INFORMATION................................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
................................................................................