KYTRIL TABLETS 1MG

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

GRANISETRON (GRANISETRON HYDROCHLORIDE)

Dostupné s:

HOFFMANN-LA ROCHE LIMITED

ATC kód:

A04AA02

INN (Mezinárodní Name):

GRANISETRON

Dávkování:

1MG

Léková forma:

TABLET

Složení:

GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG

Podání:

ORAL

Jednotky v balení:

2/10

Druh předpisu:

Prescription

Terapeutické oblasti:

5-HT3 RECEPTOR ANTAGONISTS

Přehled produktů:

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

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2015-11-06

Charakteristika produktu

_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