País: Canadá
Idioma: inglés
Fuente: Health Canada
GEMCITABINE (GEMCITABINE HYDROCHLORIDE)
AGILA JAMP CANADA INC
L01BC05
GEMCITABINE
2G
POWDER FOR SOLUTION
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) 2G
INTRAVENOUS
100ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0133122004; AHFS:
CANCELLED PRE MARKET
2015-11-03
PRODUCT MONOGRAPH PR AJ-GEMCITABINE GEMCITABINE FOR INJECTION, USP 200 MG, 1 G AND 2 G PER VIAL 38 MG/ML GEMCITABINE (AS GEMCITABINE HYDROCHLORIDE) STERILE LYOPHILIZED POWDER ANTINEOPLASTIC AGENT DATE OF PREPARATION: AGILA JAMP CANADA INC. 1380 – 203 Newton Boucherville, Québec Canada J4B 5H2 July 18, 2013 SUBMISSION CONTROL NUMBER: 165924 AJ-GEMCITABINE Product Monograph 2 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 ........................................................................................................... 7 DRUG INTERACTIONS ......................................................................................................... 20 DOSAGE AND ADMINISTRATION ..................................................................................... 20 OVERDOSAGE ........................................................................................................................ 24 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 24 STORAGE AND STABILITY ................................................................................................. 25 DOSAGE FORMS, COMPOSITION AND PACKAGING..................................................... 26 PART II: SCIENTIFIC INFORMATION ............................................................................... 27 PHARMACEUTICAL INFORMATION ................................................................................. 27 CLINICAL TRIALS ...... Leer el documento completo