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ONDANSETRON 8MG/4ML SOLUTION FOR INJECTION

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Hospira
PACKAGE LEAFLET
Read all of this leaflet carefully before you start taking
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your
pharmacist.
- This medicine has been prescribed for you personally and
you should not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
In this leaflet:
1. What Ondansetron Injection is and what it is used for
2. Before you take Ondansetron Injection
3. How to take Ondansetron Injection
4. Possible side effects
5. Storing Ondansetron Injection

Ondansetron
4 mg/2 ml and 8 mg/4 ml
Solution for Injection
The active substance is ondansetron (as hydrochloride dihydrate).
Other ingredients are sodium chloride, citric acid monohydrate, sodium citrate and water for injections.

Pregnancy
Before starting treatment, you must tell your doctor if you
are pregnant or if you intend to become pregnant. Your
doctor will then decide whether you should receive Ondansetron Injection.
Breast-feeding
The ondansetron in Ondansetron Injection may pass into
mother's milk. It is therefore better that mothers receiving
Ondansetron Injection do not breast-feed.
Taking other medicines
Please inform your doctor or pharmacist if you are taking
or have recently taken any other medicines, even those
not prescribed.
This medicinal product contains less than 1 mmol sodium
(23 mg) per ampoule, i.e. essentially 'sodium-free'.
3. How to take Ondansetron Injection
Daily dosage is fixed according to your individual need.
Your doctor will tell you how long your treatment with
Ondansetron Injection will last.
Ondansetron Injection will usually be given by a doctor or
nurse.

Marketing Authorisation Holder
Hospira Enterprises B.V.
Taurusavenue 19-21
2132LS Hoofddorp
The Netherlands

Ondansetron Injection can be prescribed for two reasons:
- to prevent feelings of sickness (nausea) and sickness
(vomiting) or
- to treat nausea and vomiting

Manufacturer
Hikma Farmaceutica (Portugal), Lda.
Estrada do Rio da M6 n.° 8, 8A e 8B - Fervenca
2705-906 Terrugem SNT
Portugal

For patients receiving chemotherapy and/or radiotherapy
that causes nausea and vomiting:
The recommended dose is 8 mg given by intravenous injection (into a vein) or
intramuscular injection (into a muscle), immediately before
chemotherapy
followed by an 8 mg tablet after 12 hours.

1. What Ondansetron Injection is and what it is used for
Ondansetron Injection is a solution for injection, which is
available as colourless glass ampoules containing 4 mg of
ondansetron per 2 ml of solution and 8 mg of ondansetron
per 4 ml of solution. Ondansetron Injection is packed in
carton boxes of 5 ampoules.
The active substance of Ondansetron Injection belongs to
a group of medicines known as antiemetics and antinauseants being used to prevent vomiting and nausea induced by some medical treatments.
2. Before you take Ondansetron Injection

For patients receiving chemotherapy that causes severe
nausea and vomiting any of the following dose schedules
are recommended:
8 mg given by intravenous or intramuscular injection,
immediately before chemotherapy
- 8 mg given by intravenous or intramuscular injection
immediately before chemotherapy, followed by two further intravenous or intramuscular doses of 8 mg 2 to 4
hours apart, or by an intravenous infusion (drip) of 1
mg per hour for up to 24 hours.
- 32 mg given as an intravenous infusion (drip), over not
less than 15 minutes, immediately before chemotherapy.

Do not take Ondansetron Injection
- if you are allergic to ondansetron or any of the other
ingredients

After the initial Ondansetron injection you may be given
tablets or suppositories for up to 5 days to prevent any further nausea and vomiting.

Take special care with Ondansetron Injection
- if you are allergic to other antiemetic medicines
- if you have intestinal obstruction
- if you suffer from severe constipation
- if you have any liver disease

If prescribed for a child, the dose depends on your child's
weight and height, and is given by intravenous injection
immediately before chemotherapy followed by a 4 mg tablet 12 hours later, which can be continued twice a day for
up to 5 days following chemotherapy.

Also tell your doctor if you are taking any of the following
medicines:
- Phenytoin
- Carbamazepine
- Rifampicin
- Tramadol

To prevent nausea and vomiting after an operation:
The usual adult dose is 4 mg given as an intravenous or
intramuscular injection before the operation.
For children aged 2 years and over the dose is 0.1 mg per
kilogram of body weight, up to a maximum of 4 mg, given
as an intravenous injection before the operation.

Hospira
To treat nausea and vomiting after an operation:
The usual adult dose is 4 mg given as an intravenous or
intramuscular injection.
For children aged 2 years and over the dose is 0.1 m g per
kilogram of body weight, up to a maximum of 4 mg, given
as an intravenous injection.
Patients with moderate or severe liver disease:
The total daily dose should not be more than 8 mg.
If you have the impression that the effect of Ondansetron
Injection is too strong or too weak, talk to your doctor.
Ondansetron Injection should start to work soon after having the injection. If you continue to be sick or feel sick, tell
your doctor.
If you think you may have missed a dose or had too much,
let your doctor or nurse know.
4. Possible side effects
Like all medicines, Ondansetron Injection can have side
effects.
Ondansetron Injection is generally well tolerated. However, the following side effects may occur in some patients
during treatment.
If any of the following rare side effects come on soon after
having your injection, tell your doctor immediately:
- sudden chest tightness or wheeziness
- swelling of eyelids, face lips or tongue
- skin rash - red spots or hives (skin lumps)
- collapse
- upward rolling of the eyes
- abnormal muscular stiffness, body movements or
shaking
-fits
- blurring of vision
If you experience any of these symptoms, advise your
doctor as soon as
possible:
- irregular or slow heartbeat
- dizziness or lightheaded feeling
- headache
- flushes of the face
- feeling of warmth in the head or stomach
- Irritation and redness at the site of injection
- upset bowels, constipation
- hiccups
If you have any blood tests to check how your liver is
working, this medicine may affect the results.
If you notice any side effects not mentioned in this leaflet,
please inform your doctor or pharmacist.
5. Storing Ondansetron Injection
Keep out of the reach and sight of children.
Do not store above 30°C. Keep ampoules in the outer carton to protect from light.
Ondansetron Injection should not be used if the ampoule
is damaged or contains particles or is cloudy.
Do not use after the expiry date stated on the carton box.
This leaflet was prepared in May 2006.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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