IDAMYCIN - CAP 25MG CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IDARUBICIN HYDROCHLORIDE

Available from:

PFIZER CANADA ULC

ATC code:

L01DB06

INN (International Name):

IDARUBICIN

Dosage:

25MG

Pharmaceutical form:

CAPSULE

Composition:

IDARUBICIN HYDROCHLORIDE 25MG

Administration route:

ORAL

Units in package:

1

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0122755003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2006-08-02

Summary of Product characteristics

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