Riik: Kanada
keel: inglise
Allikas: Health Canada
IDARUBICIN HYDROCHLORIDE
PFIZER CANADA ULC
L01DB06
IDARUBICIN
10MG
CAPSULE
IDARUBICIN HYDROCHLORIDE 10MG
ORAL
1
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0122755001; AHFS:
CANCELLED POST MARKET
2006-08-02
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 .......................................... Lugege kogu dokumenti