Country: Canada
Language: English
Source: Health Canada
GEMCITABINE (GEMCITABINE HYDROCHLORIDE)
HOSPIRA HEALTHCARE ULC
L01BC05
GEMCITABINE
1G
POWDER FOR SOLUTION
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 1G
INTRAVENOUS
25ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0133122003; AHFS:
CANCELLED POST MARKET
2014-08-01
_Gemcitabine for Injection, USP Product Monograph _ _Page 1 of 55_ PRODUCT MONOGRAPH PR GEMCITABINE FOR INJECTION, USP 200 mg, 1 g and 2 g gemcitabine (gemcitabine hydrochloride) per vial Sterile THERAPEUTIC CLASSIFICATION Antineoplastic Agent Hospira Healthcare Corporation 1111 Dr.-Frederik-Philips, Suite 600 Montreal, QC H4M 2X6 Date of Revision: August 29, 2014 Control No: 177248 _ _ _Gemcitabine for Injection, USP Product Monograph _ _Page 2 of 55_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................8 DRUG INTERACTIONS ..................................................................................................21 DOSAGE AND ADMINISTRATION ..............................................................................21 OVERDOSAGE ................................................................................................................25 ACTION AND CLINICAL PHARMACOLOGY ............................................................25 STORAGE AND STABILITY ..........................................................................................27 SPECIAL HANDLING INSTRUCTIONS .......................................................................27 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................27 PART II: SCIENTIFIC INFORMATION ................................................................................28 PHARMACEUTICAL INFORMATION .................. Read the complete document