ZOFRAN 8/4 Mg/Ml Solution for Inj/Inf

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

ONDANSETRON HYDROCHLORIDE

Disponibbli minn:

Novartis Pharmaceuticals UK Ltd

Kodiċi ATC:

A04AA01

INN (Isem Internazzjonali):

ONDANSETRON HYDROCHLORIDE

Dożaġġ:

8/4 Mg/Ml

Għamla farmaċewtika:

Solution for Inj/Inf

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

Serotonin (5HT3) antagonists

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2016-01-22

Fuljett ta 'informazzjoni

 
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�

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zofran 8mg/4ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2mg ondansetron as hydrochloride dihydrate,(8mg/4ml)
For a full list of excipients, see sections 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless solutions.
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.
The recommended intravenous or intramuscular dose of Zofran is 8mg
administered immediately before treatment.
_Highly emetogenic chemotherapy:_
For patients receiving highly emetogenic chemotherapy, a maximum
initial ondansetron dose of 16 mg IV infused over
15 minutes may be used. A single IV dose greater than 16 mg should not
be given due to dose dependent incre