KYTRIL TABLETS 1MG

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

GRANISETRON (GRANISETRON HYDROCHLORIDE)

Saatavilla:

HOFFMANN-LA ROCHE LIMITED

ATC-koodi:

A04AA02

INN (Kansainvälinen yleisnimi):

GRANISETRON

Annos:

1MG

Lääkemuoto:

TABLET

Koostumus:

GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG

Antoreitti:

ORAL

Kpl paketissa:

2/10

Prescription tyyppi:

Prescription

Terapeuttinen alue:

5-HT3 RECEPTOR ANTAGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0123183001; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2015-11-06

Valmisteyhteenveto

_Page 1 of 27 _
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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 _
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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