AJ-IDARUBICIN SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

IDARUBICIN HYDROCHLORIDE

Mevcut itibaren:

AGILA JAMP CANADA INC

ATC kodu:

L01DB06

INN (International Adı):

IDARUBICIN

Doz:

1MG

Farmasötik formu:

SOLUTION

Kompozisyon:

IDARUBICIN HYDROCHLORIDE 1MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0122755004; AHFS:

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2015-11-03

Ürün özellikleri

1
PRODUCT MONOGRAPH
PR
AJ-IDARUBICIN
IDARUBICIN HYDROCHLORIDE INJECTION
PROFESSED
1 MG/ML
[5 ML, 10 ML AND 20 ML VIALS]
Antineoplastic Agent
Sterile Solution
Agila Jamp Canada Inc.
1380 – 203 Newton
Boucherville, Québec
Canada
J4B 5H2
DATE OF PREPARATION: September 12, 2013
Submission Control No: 167520
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE
REACTIONS....................................................................................................9
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND
STABILITY..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL
INFORMATION..........................................................................17
CLINICAL TRIALS
.............................................................................