IDAMYCIN - CAP 5MG CAPSULE

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

IDARUBICIN HYDROCHLORIDE

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

L01DB06

INN (International Name):

IDARUBICIN

Dosering :

5MG

Legemiddelform:

CAPSULE

Sammensetning:

IDARUBICIN HYDROCHLORIDE 5MG

Administreringsrute:

ORAL

Enheter i pakken:

1

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2006-08-02

Preparatomtale

PRODUCT MONOGRAPH
Pr
IDAMYCIN
*
,
idarubicin hydrochloride for injection, House Std.
5 mg and 10 mg vials
and
idarubicin hydrochloride capsules
5 mg, 10 mg and 25 mg
Pr
IDAMYCIN
*
PFS
idarubicin hydrochloride injection
1 mg/mL (5 mL, 10 mL and 20 mL vials)
Antineoplastic Agent
Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
*TM Pharmacia & Upjohn S.P.A
Pfizer Canada Inc., licensee
©
Pfizer Canada Inc., 2006
Date of Revision:
July 4, 2006
Submission Control No: 100257
_ _
_IDAMYCIN – Product Monograph _
_Page 2 of 32_
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS..................................................................................................10
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND
ADMINISTRATION..............................................................................11
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND
STABILITY..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
..........................................