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ONDANSETRON 0.16 MG/ML SOLUTION FOR INFUSION

Active substance(s): ONDANSETRON HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ondansetron 0.16 mg/ml Solution for Infusion
Read all of this leaflet carefully before you are given 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, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Ondansetron is and what it is used for
2.
What you need to know before you are given Ondansetron
3.
How Ondansetron is given
4.
Possible side effects
5.
How to store Ondansetron
6.
Contents of the pack and other information
1.

What Ondansetron is and what it is used for

Ondansetron is a clear solution, containing the active ingredient ondansetron (as ondansetron hydrochloride
dihydrate), which is an anti-emetics (prevents nausea [feeling sick] and vomiting).
Ondansetron is used for:
preventing and treating nausea and vomiting caused by chemotherapy (in adults and children) or
radiotherapy for cancer (adults only) .
preventing and treating nausea and vomiting after surgery .
Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
2.

What you need to know before you are given Ondansetron

You should NOT be given Ondansetron:
if you are taking apomorphine (used to treat Parkinson’s disease)
if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in Section
6).
If you are not sure, talk to your doctor, nurse or pharmacist before you are given ondansetron.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Ondansetron:
if you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath
and swollen ankles)
if you have an uneven heart beat (arrhythmias)
if you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
if you have liver problems
if you have a blockage in your gut
if you have problems with the levels of salts in your blood, such as potassium, sodium and
magnesium.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having
Ondansetron.

Other medicines and Ondansetron
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines that you buy without a prescription and herbal medicines. This is
because Ondansetron can affect the way some medicines work. Also some other medicines can affect the
way Ondansetron works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
carbamazepine or phenytoin used to treat epilepsy
rifampicin used to treat infections such as tuberculosis (TB)
antibiotics such as erythromycin or ketoconazole
anti-arrhythmic medicines used to treat an uneven heart beat
beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines
tramadol a pain killer
medicines that affect the heart (such as haloperidol or methadone)
cancer medicines (especially anthracyclines and trastuzumab)
SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including
fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or
anxiety including venlafaxine, duloxetine.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having
Ondansetron.
Ondansetron should not be given in the same syringe or infusion (drip) as any other medication.
Pregnancy and breast-feeding:
It is not known if Ondansetron is safe during pregnancy. If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine.
Do not breast-feed if you are given Ondansetron. This is because small amounts pass into the mother’s milk.
Ask your doctor or midwife for advice.
Ondansetron contains sodium
This medicinal product contains up to 31.3 mmol (or 720 mg) of sodium per dose. To be taken into
consideration by patients on a controlled sodium diet.
3.

How Ondansetron is given

Ondansetron is normally given by a nurse or doctor as intravenous infusion. The dose you have been
prescribed will depend on the treatment you are having.
To prevent nausea and vomiting from chemotherapy or radiotherapy in adults
On the day of chemotherapy or radiotherapy:
the recommended adult dose is 8 mg given by an injection into your vein, just before your treatment,
and another 8 mg twelve hours later. After chemotherapy, your medicine will usually be given by
mouth as an 8 mg ondansetron tablet or 10 ml (8 mg) ondansetron syrup.
On the following days:
the recommended adult dose is one 8 mg tablet or 10 ml (8 mg) syrup taken twice a day
this may be given for up to 5 days.
If your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you may be given more
than the usual dose of Ondansetron. Your doctor will decide this.

To prevent nausea and vomiting from chemotherapy in children aged over 6 months and adolescents
The doctor will decide the dose depending on the child’s size (body surface area) or weight. Look at the
label for more information.
On the day of chemotherapy or radiotherapy:
the first dose is given by an injection into the vein, just before your child’s treatment. After
chemotherapy, your child’s medicine will usually be given by mouth twelve hours later, as 4 mg
ondansetron tablet or 5 ml (4 mg) ondansetron syrup.
On the following days:
2.5 ml (2 mg) syrup twice a day for small children and those weighing 10 kg or less
one 4 mg tablet or 5 ml (4 mg) syrup twice a day for larger children and those weighing more
than 10 kg
two 4 mg tablets or 10 ml (8 mg) syrup twice a day for teenagers (or those with a large body
surface area)
these doses can be given for up to five days.
To prevent and treat nausea and vomiting after an operation
Adult:
The recommended dose for adults is 4 mg given by a slow injection into your vein. For prevention
this will be given just before your operation.
Children:
For children aged over 1 month and adolescents, your doctor will decide the dose. The maximum dose
is 4 mg given as an injection into the vein. For prevention, this will be given just before the operation.
Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg.
If you keep feeling or being sick
Ondansetron should start to work soon after having the injection. If you continue to be sick or feel sick, tell
your doctor or nurse.
If you are given more Ondansetron than you should
Your doctor or nurse will give you or your child Ondansetron so it is unlikely that you or your child will
receive too much. If you think you or your child have been given too much tell your doctor or nurse.
If you miss a dose of Ondansetron
If you think you or your child have missed a dose, please tell your doctor or nurse.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
Allergic reactions
If you have an allergic reaction, tell your doctor or a member of the medical staff straight away. The signs
may include:

sudden wheezing and chest pain or chest tightness

swelling of your eyelids, face, lips, mouth or tongue

skin rash - red spots or lumps under your skin (hives) anywhere on your body



collapse.

Other side effects:
Very common: may affect more than 1 in 10 people

headache.
Common: may affect up to 1 in 10 people

a feeling of warmth or flushing

constipation

changes to liver function test results (if you have Ondansetron with a medicine called cisplatin,
otherwise this side effect is uncommon)

irritation and redness at the site of injection.
Uncommon: may affect up to 1 in 100 people

hiccups

low blood pressure, which can make you feel faint or dizzy

uneven heart beat

chest pain

fits

unusual body movements or shaking.
Rare: may affect up to 1 in 1,000 people

feeling dizzy or light headed

blurred vision

disturbance in heart rhythm (sometimes causing a sudden loss of consciousness).
Very rare: may affect up to 1 in 10,000 people

poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Ondansetron

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bag after EXP. The expiry date refers to
the last day of that month.
Your doctor, pharmacist or nurse knows how to store Ondansetron properly.
Store Ondansetron in the original aluminium overpouch in order to protect from light. Do not freeze.
After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 20±5°C
temperature and normal indoor illumination, thus no protection from normal indoor light is necessary while
infusion takes place.
From the microbiological point of view, the product should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the responsibility of the user and would normally not be

longer than 24 hours at 2 to 8°C, unless opening has taken place in controlled and validated aseptic
conditions.
Do not use this medicine if you notice any discolouration or particles in the solution. Do not use if container
is damaged.
Do not throw away any medicines via wastewater (or household waste). Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

What Ondansetron contains
The active ingredient is ondansetron (as ondansetron hydrochloride dihydrate). Each ml of solution
contains 0.16 mg ondansetron (as ondansetron hydrochloride dihydrate).
50 ml Ondansetron solution for infusion contains 8 mg of ondansetron (as ondansetron hydrochloride
dihydrate).
100 ml Ondansetron solution for infusion contains 16 mg of ondansetron (as ondansetron
hydrochloride dihydrate).
200 ml Ondansetron solution for infusion contains 32 mg of ondansetron (as ondansetron
hydrochloride dihydrate).
The other ingredients are citric acid (E330), sodium citrate (E331), sodium chloride and water for
injections.
What Ondansetron looks like and contents of the pack
Ondansetron is a clear, colourless solution, free from visible particles. It comes in a plastic infusion bag
fitted with one infusion port closed with a rubber stopper and snap cap. The infusion bags are contained in
an aluminium overpouch.
Pack sizes: 50 ml solution in multipacks containing 5, 10 or 30 bags
100 ml solution in multipacks containing 5, 10 or 30 bags
200 ml solution in multipacks containing 5 or 10 bags
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer
Teva Pharmaceutical Works Private Limited Company
Táncsics Mihály út 82.
H-2100 Gödöllő,
Hungary
Pharmachemie B.V
Swensweg 5, 2031 GA Haarlem
The Netherlands
This leaflet was last revised in 03/2016
PL 00289/1465
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The following information is intended for healthcare professionals only:
Instructions for use, handling and disposal:
How to prepare and administer Ondansetron
For single use only. Remove overpouch only when ready to use, then check for minute leaks by squeezing
the bag firmly. If the bag leaks, do not use as sterility may be impaired. The solution should be visually
inspected prior to use and only clear solutions, without particles should be used.
Ondansetron solution for infusion is compatible with Sodium chloride 9 mg/ml (0.9%) solution for injection.
Compatibility with other drugs: Ondansetron may be administered by intravenous infusion at 1 mg/hour, e.g.
from an infusion bag or syringe pump. The following drugs may be administered via the Y-site of the
ondansetron giving set for ondansetron concentrations of 16 to 160 micrograms/ml (e.g. 8 mg/500 ml and
8 mg/50 ml respectively);
Cisplatin: Concentrations up to 0.48 mg/ml (e.g. 240 mg in 500 ml) administered over one to eight hours.
5-Fluorouracil: Concentrations up to 0.8 mg/ml (e.g. 2.4 g in 3 litres or 400 mg in 500 ml) administered at a
rate of at least 20 ml per hour (500 ml per 24 hours). Higher concentrations of 5-fluorouracil may cause
precipitation of ondansetron. The 5-fluorouracil infusion may contain up to 0.045% w/v magnesium chloride
in addition to other excipients shown to be compatible.
Carboplatin: Concentrations in the range 0.18 mg/ml to 9.9 mg/ml (e.g. 90 mg in 500 ml to 990 mg in
100 ml), administered over ten minutes to one hour.
Etoposide: Concentrations in the range 0.14 mg/ml to 0.25 mg/ml (e.g. 72 mg in 500 ml to 250 mg in
1 litre), administered over thirty minutes to one hour.
Ceftazidime: Doses in the range 250 mg to 2000 mg reconstituted with Water for Injections as recommended
by the manufacturer (e.g. 2.5 ml for 250 mg and 10 ml for 2 g ceftazidime) and given as an intravenous
bolus injection over approximately five minutes.
Cyclophosphamide: Doses in the range 100 mg to 1 g, reconstituted with Water for Injections, 5 ml per
100 mg cyclophosphamide, as recommended by the manufacturer and given as an intravenous bolus
injection over approximately five minutes.
Doxorubicin: Doses in the range 10-100 mg reconstituted with Water for Injections, 5 ml per 10 mg
doxorubicin, as recommended by the manufacturer and given as an intravenous bolus injection over
approximately 5 minutes.
Dexamethasone: Dexamethasone sodium phosphate 20 mg may be administered as a slow intravenous
injection over 2-5 minutes via the Y-site of an infusion set delivering 8 or 16 mg of Ondansetron over
approximately 15 minutes. Compatibility between dexamethasone sodium phosphate and ondansetron has
been demonstrated supporting administration of these drugs through the same giving set resulting in
concentrations in line of 32 microgram - 2.5 mg/ml for dexamethasone sodium phosphate and 8 microgram –
1 mg/ml for ondansetron.
How to store Ondansetron
Shelf life before opening: 3 years
Store Ondansetron in the original aluminium overpouch in order to protect from light. Do not freeze.
After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 20±5°C
temperature and normal indoor illumination, thus no protection from normal indoor light is necessary while
infusion takes place.
From the microbiological point of view, the product should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the responsibility of the user and would normally not be
longer than 24 hours at 2 to 8°C, unless opening has taken place in controlled and validated aseptic
conditions.
Disposal of Ondansetron
Any unused product or waste material should be disposed of in accordance with local requirements.

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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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