EPIRUBICIN HYDROCHLORIDE INJECTION SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

EPIRUBICIN HYDROCHLORIDE

זמין מ:

UMAN PHARMA INC

קוד ATC:

L01DB03

INN (שם בינלאומי):

EPIRUBICIN

כמות:

2MG

טופס פרצבטיות:

SOLUTION

הרכב:

EPIRUBICIN HYDROCHLORIDE 2MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

5ML/25ML/100ML

סוג מרשם:

Prescription

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2009-02-04

מאפייני מוצר

_Epirubicin Hydrochloride Injection Product Monograph _
_Page 1 of 39 _
PRODUCT MONOGRAPH
PR
EPIRUBICIN HYDROCHLORIDE INJECTION
2 mg epirubicin hydrochloride/mL
Sterile
Professed Standard
ANTINEOPLASTIC AGENT
Uman Pharma Inc.
Date of Preparation: January 29, 2009
100, boul. De l’industrie
Date of Revision: -
Candiac, QC, J5R 1J1
Canada
SUBMISSION CONTROL NO.: 127398
_Epirubicin Hydrochloride Injection Product Monograph _
_Page 2 of 39 _
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
.....................................................................................………..9
DRUG INTERACTIONS
..................................................................................………..13
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
........