EPIRUBICIN HYDROCHLORIDE INJECTION SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

EPIRUBICIN HYDROCHLORIDE

Dostupné z:

OMEGA LABORATORIES LIMITED

ATC kód:

L01DB03

INN (Medzinárodný Name):

EPIRUBICIN

Dávkovanie:

2MG

Forma lieku:

SOLUTION

Zloženie:

EPIRUBICIN HYDROCHLORIDE 2MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

5/25/100ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2013-07-23

Súhrn charakteristických

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
.................................................