IDAMYCIN - CAP 25MG CAPSULE

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

IDARUBICIN HYDROCHLORIDE

Beschikbaar vanaf:

PFIZER CANADA ULC

ATC-code:

L01DB06

INN (Algemene Internationale Benaming):

IDARUBICIN

Dosering:

25MG

farmaceutische vorm:

CAPSULE

Samenstelling:

IDARUBICIN HYDROCHLORIDE 25MG

Toedieningsweg:

ORAL

Eenheden in pakket:

1

Prescription-type:

Prescription

Therapeutisch gebied:

ANTINEOPLASTIC AGENTS

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2006-08-02

Productkenmerken

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