ZOFRAN 4/2 Mg/Ml Solution for Inj/Inf

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

ONDANSETRON HYDROCHLORIDE

Commercializzato da:

Novartis Pharmaceuticals UK Ltd

Codice ATC:

A04AA01

INN (Nome Internazionale):

ONDANSETRON HYDROCHLORIDE

Dosaggio:

4/2 Mg/Ml

Forma farmaceutica:

Solution for Inj/Inf

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Serotonin (5HT3) antagonists

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2016-01-22

Foglio illustrativo

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
ZOFRAN® 4 MG/2 ML (OR 8MG/4 ML) 
SOLUTION FOR INJECTION OR INFUSION  
ONDANSETRON (AS HYDROCHLORIDE DIHYDRATE) 

READ  ALL  OF  THIS  LEAFLET  CAREFULLY  BEFORE  YOU  START  TAKING  THIS  MEDICINE  BECAUSE  IT 
CONTAINS IMPORTANT INFORMATION FOR YOU. 

  Keep this leaflet. You may need to read it again. 

  If  you  have  any  further  questions  about  your  illness  or  your  medicine,  ask  your  doctor, 
nurse or pharmacist. 

  If  you  get  any  side  effects,  talk  to  your  doctor,  nurse  or  pharmacist.  This  includes  any 
possible side effects not listed in this leaflet.  

WHAT IS IN THIS LEAFLET: 
1 
What Zofran Solution for Injection or Infusion is and what it is used for 
2 
What you need to know before
you have Zofran Solution for Injection or Infusion  
3 
How to have Zofran Solution for Injection or Infusion   
4 
Possible side effects 
5 
How to store Zofran Solution for Injection or Infusion 
6  
Contents of the pack and other information 

1  
WHAT ZOFRAN SOLUTION FOR INJECTION OR INFUSION IS AND WHAT IT IS USED 
FOR  

Zofran  Solution  for  Injection  or  Infusion 
(called  ‘Zofran  injection’  in  this  leaflet)  contains  a 
medicine  called  ondansetron  (as  hydrochloride  dihydrate).  This  belongs  to  a  group  of 
medicines called anti-emetics.  

Zofran injection is used for: 

  preventing  nausea  and  vomiting  caused  by  chemotherapy  
[http://www.netdoctor.co.uk/medicines/effect/cancer.shtml]or  radiotherapy  for  cancer  
[http://www.netdoctor.co.uk/cancer/index.shtml]in 
ADULTS 

  preventing and treating nausea and vomiting after surgery in ADULTS  

  preventing  nausea  and  vomiting  caused�

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 4mg/2ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2mg ondansetron as hydrochloride dihydrate.(4mg/2ml)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
Zofran Solution for Injection or Infusion is indicated for the
management of nausea and vomiting induced by cytotoxic
chemotherapy and radiotherapy. Zofran Solution for Injection or
Infusion is also indicated for the prevention and
treatment of post-operative nausea and vomiting.
PAEDIATRIC POPULATION
Zofran Solution for Injection or Infusion is indicated for the
management of nausea and vomiting induced by cytotoxic
chemotherapy in children and adolescents aged from 6 months to 17
years.
IV Zofran injection is indicated for the prevention or treatment of
post-operative nausea and vomiting in children and
adolescents aged from 1 month to 17 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Zofran is also available for oral and rectal use to allow the route of
administration and dosing to be flexible.
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND
RINV)
The emetogenic potential of cancer treatment varies according to the
doses and combinations of chemotherapy and
radiotherapy regimens used. The selection of dose regimen should be
determined by the severity of the emetogenic
challenge.
_CINV AND RINV IN ADULTS:-_
The dose range of Zofran Solution for Injection or Infusion is 8 to 32
mg a day and selected as shown below.
_Emetogenic Chemotherapy and Radiotherapy:_
For most patients receiving emetogenic chemotherapy or radiotherapy,
Zofran 8mg should be administered as a slow
intravenous injection (in not less than 30 seconds) or intramuscular
injection, immediately before treatment, followed
by 8mg orally twelve hourly.
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