JAMP GRANISETRON TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

GRANISETRON (GRANISETRON HYDROCHLORIDE)

Disponibil de la:

JAMP PHARMA CORPORATION

Codul ATC:

A04AA02

INN (nume internaţional):

GRANISETRON

Dozare:

1MG

Forma farmaceutică:

TABLET

Compoziție:

GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

5-HT3 RECEPTOR ANTAGONISTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-02-02

Caracteristicilor produsului

PRODUCT MONOGRAPH
Pr
JAMP Granisetron
Granisetron Hydrochloride Tablets
1 mg granisetron (as granisetron hydrochloride)
Manufacturer Standard
Antiemetic
(5-HT
3
receptor antagonist)
Jamp Pharma Corporation
1310 rue Nobel
Boucherville, Québec
Canada J4B 5H3
Submission Control No.: 234371
DATE OF REVISION:
January 13, 2020
JAMP Granisetron
Page 2 of 25
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
........................................................................................................
14
DETAILED PHARMACOLOGY
..........