IDAMYCIN POWDER -10MG/VIAL POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

IDARUBICIN HYDROCHLORIDE

Disponibbli minn:

PFIZER CANADA ULC

Kodiċi ATC:

L01DB06

INN (Isem Internazzjonali):

IDARUBICIN

Dożaġġ:

10MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

IDARUBICIN HYDROCHLORIDE 10MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0122755001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2003-10-06

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
Pr IDAMYCIN
*
,
idarubicin hydrochloride for injection, house std.
5 mg and 10 mg vials
Pr
IDAMYCIN
* PFS
idarubicin hydrochloride injection
1 mg/mL
Antineoplastic Agent
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
* Idamycin is a registered trademark of Pharmacia & Upjohn
S.P.A
PFS is a registered trademark of Pfizer Enterprises SARL
Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc., 2009
Date of Revision:
February 19, 2009
SUBMISSION CONTROL NUMBER: 126207
_ _
_IDAMYCIN – Product Monograph _
_Page 2 of 29_
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
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND
STABILITY..........................................................................................15
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
.............................