NAT-GRANISETRON TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-02-2016
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Active ingredient:
GRANISETRON (GRANISETRON HYDROCHLORIDE)
Available from:
NATCO PHARMA (CANADA) INC
ATC code:
A04AA02
INN (International Name):
GRANISETRON
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG
Administration route:
ORAL
Units in package:
2/10
Prescription type:
Prescription
Therapeutic area:
5-HT3 RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0123183001; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-02-19
Summary of Product characteristics
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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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