Zofran 4mg/2ml Solution for Injection or Infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ONDANSETRON

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

A04AA01

INN (International Name):

ONDANSETRON 2 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

ONDANSETRON 2 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIEMETICS AND ANTINAUSEANTS

Authorization status:

Withdrawn

Authorization date:

2006-04-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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, ask your doctor, nurse or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
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 use 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
•
preventing nausea and vomiting after surgery.
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.
HOW ZOFRAN SOLUTION FOR INJECTION OR INFUSION WORKS
Ondansetron is a 5HT
3
receptor antagonist. It works by inhibiting the 5HT
3
receptors on neurons located
in peripheral and central nervous system of the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU HAVE ZOF

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zofran 4mg/2ml Solution for Injection or Infusion
Zofran 8mg/4ml Solution for Injection or Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2mg ondansetron as hydrochloride dihydrate (4mg/2ml).
Each ml contains 2mg ondansetron as hydrochloride dihydrate (8mg/4ml).
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
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zofran is also available for oral 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.
ADULTS:-
The dose range of Zofran Solution for Injection or Infusion is 8 to 32
mg a day and selected
as shown below.
2
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 16mg must
not be given
due to dose dependent increase of QT-prolongation risk (see sections
4.4, 4.8, 5.1
and 6.6)
.
•
A single dose of 8mg by slow intravenous injection (in not less than
30 seconds) or intramuscular
injection immediately before chemotherapy.
•
A dose of 8mg by slow intravenous injection (in not less than 30
sec