Zofran 8mg/4ml Solution for Injection or Infusion

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Ondansetron hydrochloride dihydrate

Pieejams no:

Novartis Ireland Limited

ATĶ kods:

A04AA; A04AA01

SNN (starptautisko nepatentēto nosaukumu):

Ondansetron hydrochloride dihydrate

Deva:

8mg/4 millilitre(s)

Zāļu forma:

Solution for injection/infusion

Receptes veids:

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

Ārstniecības joma:

Serotonin (5HT3) antagonists; ondansetron

Autorizācija statuss:

Marketed

Autorizācija datums:

1990-06-27

Lietošanas instrukcija

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

Produkta apraksts

Health Products Regulatory Authority
15 December 2021
CRN00CN3K
Page 1 of 13
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 sin