IDAMYCIN POWDER -5MG/VIAL POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

IDARUBICIN HYDROCHLORIDE

Disponible depuis:

PFIZER CANADA ULC

Code ATC:

L01DB06

DCI (Dénomination commune internationale):

IDARUBICIN

Dosage:

5MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

IDARUBICIN HYDROCHLORIDE 5MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

1VIAL

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0122755002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2014-03-21

Résumé des caractéristiques du produit

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