IDAMYCIN PFS 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:

1MG

forme pharmaceutique:

SOLUTION

Composition:

IDARUBICIN HYDROCHLORIDE 1MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

5ML/10ML/20ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2006-07-06

Résumé des caractéristiques du produit

_IDAMYCIN PFS (idarubicin hydrochloride injection) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
IDAMYCIN
® PFS
®
idarubicin hydrochloride injection
Preservative Free Solution, 1 mg/mL, intravenous injection
Antineoplastic Agent
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, Quebec, H9J 2M5
Date of Initial Authorization:
April 03, 1991
Date of Revision:
March 15, 2022
Submission Control Number: 258501
®
Idamycin is a registered trademark of Pfizer Italia S.r.L.
®
PFS is a registered trademark of Pfizer Inc.
Pfizer Canada ULC, Licensee
©
Pfizer Canada ULC, 2022
_ _
_IDAMYCIN PFS (idarubicin hydrochloride injection) _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Fertility; 7.1.1 Pregnant
Women, Women of childbearing potential / Contraception in
male and females; Patient Medication Information
03/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................5
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.............................................................