NAT-GRANISETRON TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
22-02-2016
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Aktiva substanser:
GRANISETRON (GRANISETRON HYDROCHLORIDE)
Tillgänglig från:
NATCO PHARMA (CANADA) INC
ATC-kod:
A04AA02
INN (International namn):
GRANISETRON
Dos:
1MG
Läkemedelsform:
TABLET
Sammansättning:
GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG
Administreringssätt:
ORAL
Enheter i paketet:
2/10
Receptbelagda typ:
Prescription
Terapiområde:
5-HT3 RECEPTOR ANTAGONISTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0123183001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2016-02-19
Produktens egenskaper
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PRODUCT MONOGRAPH
Pr
NAT-GRANISETRON
Granisetron Hydrochloride Tablets, USP
1 mg granisetron (as granisetron hydrochloride)
Antiemetic
(5-HT
3
receptor antagonist)
Natco Pharma (Canada) Inc.
Date of Preparation:
2550 Argentia Road, Suite 116
FEBRUARY 19, 2016
Mississauga, Ontario
L5N 5R1
Control No.: 169676
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL
USE...........................................................................
3
CONTRAINDICATIONS
................................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
................................................................................................
6
DRUG INTERACTIONS
.................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
9
OVERDOSAGE
.............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 10
STORAGE AND STABILITY
......................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 13
PART II: SCIENTIFIC INFORMATION
.............................................................................
14
PHARMACEUTICAL INFORMATION
......................................................................
14
CLINICAL
TRIALS.......................................................................................................
15
DETAILED PHARMACOLOGY
.....................................
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