NAT-GRANISETRON TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

GRANISETRON (GRANISETRON HYDROCHLORIDE)

Beschikbaar vanaf:

NATCO PHARMA (CANADA) INC

ATC-code:

A04AA02

INN (Algemene Internationale Benaming):

GRANISETRON

Dosering:

1MG

farmaceutische vorm:

TABLET

Samenstelling:

GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG

Toedieningsweg:

ORAL

Eenheden in pakket:

2/10

Prescription-type:

Prescription

Therapeutisch gebied:

5-HT3 RECEPTOR ANTAGONISTS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2016-02-19

Productkenmerken

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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
_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
................................................................................................
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
.....................................