EPIRUBICIN HYDROCHLORIDE INJECTION SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

EPIRUBICIN HYDROCHLORIDE

Disponibbli minn:

OMEGA LABORATORIES LIMITED

Kodiċi ATC:

L01DB03

INN (Isem Internazzjonali):

EPIRUBICIN

Dożaġġ:

2MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

EPIRUBICIN HYDROCHLORIDE 2MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

5/25/100ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2013-07-23

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
PR
E
PIRUBICIN
H
YDROCHLORIDE
I
NJECTION
2 mg/mL
Professed Standard
ANTINEOPLASTIC AGENT
Omega Laboratories Limited
11,177 Hamon Street
Montreal, Quebec
H3M 3E4
SUBMISSION CONTROL NO.: 141753
DATE OF PREPARATION:
July 15, 2013
_ _
IMPORTANT: PLEASE READ
E
PIRUBICIN
H
YDROCHLORIDE
I
NJECTION
Product Monograph
Page
2
of
38
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
..................................................................................................................
9
DRUG INTERACTIONS
................................................................................................................
14
DOSAGE AND ADMINISTRATION
............................................................................................
14
OVERDOSAGE
...............................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
17
STORAGE AND STABILITY
........................................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
......................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................................ 20
PART II: SCIENTIFIC INFORMATION
.................................................