Zofran 4mg/2ml Solution for Injection or Infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Ondansetron hydrochloride dihydrate

Tilgængelig fra:

Rowex Ltd

ATC-kode:

A04AA; A04AA01

INN (International Name):

Ondansetron hydrochloride dihydrate

Lægemiddelform:

Solution for injection/infusion

Terapeutisk område:

Serotonin (5HT3) antagonists; ondansetron

Autorisation status:

Marketed

Autorisation dato:

1990-06-27

Indlægsseddel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFRAN® 4 MG/2 ML (OR 8 MG/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 or radiotherapy
for cancer in adults
•
preventing and treating nausea and vomiting after surgery in adults
•
preventing nausea and vomiting caused by chemotherapy for cancer in
children and adolescents
aged from 6 months to 17 years
•
preventing and treating nausea and vomiting after surgery in children
and adolescents aged 1
month to 17 years
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these uses.
Zofran injection should start to work soon after having the injection.
You must talk to a doctor if you
do not feel better or if you feel worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU HAVE ZOFRAN SOLUTION FOR INJECTION OR
INFUSION
DO NOT HAVE ZOFRAN INJECTION IF:
•
if y

Produktets egenskaber

Health Products Regulatory Authority
23 February 2023
CRN00DC7H
Page 1 of 13
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