Страна: Канада
мова: англійська
Джерело: Health Canada
GRANISETRON (GRANISETRON HYDROCHLORIDE)
HOFFMANN-LA ROCHE LIMITED
A04AA02
GRANISETRON
1MG
TABLET
GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG
ORAL
2/10
Prescription
5-HT3 RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0123183001; AHFS:
CANCELLED POST MARKET
2015-11-06
_Page 1 of 27 _ _ _ _ _ PRODUCT MONOGRAPH Pr KYTRIL ® granisetron hydrochloride tablets 1 mg granisetron as hydrochloride MANUFACTURE STANDARD Antiemetic (5-HT 3 receptor antagonist) Hoffmann-La Roche Limited Date of Revision: 7070 Mississauga Road June 6, 2014 Mississauga, Ontario L5N 5M8 www.rochecanada.com ©Copyright 2001 – 2014 by Hoffmann-La Roche Limited. Control No. 172914 ®KYTRIL is a registered trade-mark of F. Hoffmann-La Roche AG, used under license. _Page 2 of 27 _ _ _ _ _ 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 ....................................................................................................6 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION ..............................................................................10 OVERDOSAGE ................................................................................................................11 ACTION AND CLINICAL PHARMACOLOGY ............................................................11 STORAGE AND STABILITY ..........................................................................................14 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................14 PART II: SCIENTIFIC INFORMATION ...............................................................................15 PHARMACEUTICAL INFORMATION ..........................................................................15 CLINICA Прочитайте повний документ