EPIRUBICIN HYDROCHLORIDE INJECTION SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

EPIRUBICIN HYDROCHLORIDE

Saadav alates:

PHARMACEUTICAL PARTNERS OF CANADA INC

ATC kood:

L01DB03

INN (Rahvusvaheline Nimetus):

EPIRUBICIN

Annus:

2MG

Ravimvorm:

SOLUTION

Koostis:

EPIRUBICIN HYDROCHLORIDE 2MG

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

5/25/75/100ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

ANTINEOPLASTIC AGENTS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED PRE MARKET

Loa andmise kuupäev:

2017-08-17

Toote omadused

_PPC Product Monograph – Epirubicin Hydrochloride Injection _
_Page 1 of 39 _
PRODUCT MONOGRAPH
PR
EPIRUBICIN HYDROCHLORIDE INJECTION
(Epirubicin hydrochloride, PPC standard)
Solution for Intravenous Injection, 2 mg/mL
STERILE
Antineoplastic agent
Pharmaceutical Partners of Canada Inc.
Richmond Hill, ON L4B 3P6
Canada
Control # 115701
Date of Preparation:
February 20, 2009
_PPC Product Monograph – Epirubicin Hydrochloride Injection _
_Page 2 of 39 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL
USE.....................................................................................
4
CONTRAINDICATIONS
..........................................................................................................
4
WARNING AND
PRECAUTIONS...........................................................................................
5
ADVERSE
REACTIONS...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND
ADMINISTRATION.....................................................................................
13
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND
STABILITY.................................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...................................