DOXORUBICIN HYDROCHLORIDE INJECTION SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DOXORUBICIN HYDROCHLORIDE

Dostępny od:

OMEGA LABORATORIES LIMITED

Kod ATC:

L01DB01

INN (International Nazwa):

DOXORUBICIN

Dawkowanie:

2MG

Forma farmaceutyczna:

SOLUTION

Skład:

DOXORUBICIN HYDROCHLORIDE 2MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

5/25/100ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0110825002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2013-01-30

Charakterystyka produktu

PRODUCT MONOGRAPH
Pr
D
OXORUBICIN
H
YDROCHLORIDE
I
NJECTION
(Doxorubicin Hydrochloride)
2 mg/mL
10 mg (5 mL), 50 mg (25 mL)
and 200 mg (100 mL) Vials
Omega Standard
ANTINEOPLASTIC AGENT
Omega Laboratories Ltd.
11,177 Hamon Street
Montreal, Quebec
H3M 3E4
SUBMISSION CONTROL NO: 140859
Date of Preparation:
January 21, 2013
_D_
_OXORUBICIN _
_H_
_YDROCHLORIDE _
_I_
_NJECTION_
- Product Monograph
Page
2
of
40
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
...............................................................................................
10
DOSAGE AND ADMINISTRATION
...........................................................................
11
OVERDOSAGE
.............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 14
STORAGE AND STABILITY
.......................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
....................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 16
PART II: SCIENTIFIC INFORMATION
..........................................................................
18
PHARMACEUTICAL INFORMATION
.......................................................................
18
CLINICAL TRIALS
........