GRANISETRON HYDROCHLORIDE INJECTION SDZ SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

GRANISETRON (GRANISETRON HYDROCHLORIDE)

Disponível em:

SANDOZ CANADA INCORPORATED

Código ATC:

A04AA02

DCI (Denominação Comum Internacional):

GRANISETRON

Dosagem:

1MG

Forma farmacêutica:

SOLUTION

Composição:

GRANISETRON (GRANISETRON HYDROCHLORIDE) 1MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

1ML/3ML

Tipo de prescrição:

Prescription

Área terapêutica:

5-HT3 RECEPTOR ANTAGONISTS

Resumo do produto:

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

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2019-08-01

Características técnicas

_Granisetron Hydrochloride Injection SDZ _
_Page 1 of 25 _
PRODUCT MONOGRAPH
PR
GRANISETRON HYDROCHLORIDE INJECTION SDZ
PRESERVATIVE FREE
Solution for Injection
1 mg/mL granisetron (as granisetron hydrochloride)
1 mL and 3 mL ampoules
Manufacture’s Standard
STERILE
ANTIEMETIC
(5-HT
3 RECEPTOR ANTAGONIST)
Sandoz Canada Inc.
Date of Revision: October 23, 2014
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 177134
_Granisetron Hydrochloride Injection SDZ _
_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
............................................................................................................
8
DOSAGE
AND
ADMINISTRATION
........................................................................................
9
OVERDOSAGE
........................................................................................................................
10
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................
10
STORAGE
AND
STABILITY
..................................................................................................
12
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 13
PART II: SCIENTIFIC INFORMATION
................................................................................
1