DOXORUBICIN HYDROCHLORIDE INJECTION SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DOXORUBICIN HYDROCHLORIDE

Доступно од:

NOVOPHARM LIMITED

АТЦ код:

L01DB01

INN (Међународно име):

DOXORUBICIN

Дозирање:

2MG

Фармацеутски облик:

SOLUTION

Састав:

DOXORUBICIN HYDROCHLORIDE 2MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

100ML

Тип рецептора:

Prescription

Терапеутска област:

ANTINEOPLASTIC AGENTS

Резиме производа:

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

Статус ауторизације:

DORMANT

Датум одобрења:

2017-08-25

Карактеристике производа

PRODUCT MONOGRAPH
Pr
DOXORUBICIN HYDROCHLORIDE INJECTION, USP
doxorubicin hydrochloride injection
2 mg/mL
10 mg (5 mL), 20 mg (10 mL), 50 mg (25 mL)
and 200 mg (100 mL) Vials
ANTINEOPLASTIC AGENT
Novopharm Limited
30 Novopharm Court
Date of Revision:
Scarborough, Ontario
July 18, 2008
M1B 2K9
Submission Control No: 122001
2
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................................................................................
10
OVERDOSAGE
..................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 14
STORAGE AND
STABILITY............................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 16
PART II: SCIENTIFIC
INFORMATION....................................................................................
17
PHARMACEUTICAL
INFORMATION............................................................................
17
CLINICAL
TRIALS..............