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ONDEMET 2MG/ML INJECTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondemet® 2 mg/ml Injection
(Ondansetron 2mg/ml Solution for Injection and Infusion)

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 will be used
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 belongs to a group of drugs called antiemetics. Ondansetron inhibits the effect of the
neuron-transmitter serotonin in the brain. Serotonin
causes nausea and vomiting.
Ondansetron is used for
• preventing and treating nausea and vomiting induced
by cytotoxic chemotherapy (CINV) and radiotherapy
(adults and children aged ≥ 6 months)
• preventing and treating nausea and vomiting in patients
following an operation (PONV) (in adults and children
aged ≥ 1 month)
Your doctor may have prescribed ondansetron for another
use. Always follow your doctor’s advice.
2. What you need to know before you are given
Ondansetron
You should not be given Ondansetron:
• if you are allergic to ondansetron or any of the other
ingredients of this medicine (listed in section 6)
• if you are taking apomorphine (used to treat
Parkinson’s disease)
• if you have previously experienced allergy to other
drugs belonging to the group of serotonin antagonists
(e.g. granisetron, dolasetron). If this is the case it is
possible that you are also allergic to Ondansetron
Warnings and precautions
Talk to your doctor or nurse before taking Ondansetron
• if you have a blockage of your intestines or
constipation, as you will need to be closely monitored
by your doctor
• if you are going to have or recently had your tonsils
removed, as treatment with Ondansetron may hide
symptoms of internal bleeding
• if you have heart problems (with arrhythmias or
conduction disorders) and are being treated with other
medicines such as anaesthetics, anti-arrhythmics or
beta-blockers at the same time
• if you need to pay attention to your sodium intake.
However, Ondansetron has a low sodium content (less
than 1 mmol per ampoule)
• if it is for children below the age of 6 months or with a
body surface of less than 0.6 m2

• if you have liver problems
• if children or adolescents receive ondansetron together
with drugs, that may have a harmful effect on the liver.
Careful monitoring of the liver function is recommended
• if you have problems with the levels of salts in your
blood, such as potassium and magnesium.
Always tell the laboratory if you are having blood or urine
tests, that you are being treated with Ondansetron.
Other medicines and Ondansetron
Ondansetron may have an effect on other drugs or other
drugs may have an effect on Ondansetron.
Tell your doctor or nurse if you are taking or have recently
taken or might take any other medicines.
You must tell your doctor that you are being given
Ondansetron, if he/she starts treating you with any of the
following medicine:
• Drugs for epilepsy (phenytoin, carbamazepine)
• Antibiotics and antifungal medicines (e.g. rifampicin,
erythromycin or ketoconazole)
• Pain relieving medicine (tramadol)
• Medicines inducing heart damage (e.g. anthracyclines
or trastuzumab)
• Anti-arrhythmic medicines used to treat an uneven
heart beat (e.g. amiodarone)
• Drugs which may result in QT prolongation (heart
rhythm disorder)
• Beta-blocker medicines used to treat certain heart or
eye problems, anxiety or prevent migraines (e.g.
atenolol or timolol)
• Serotonergic drugs (medicines of the type SSRI or
SNRI used in the treatment of depressions)
• Apomorphine (used to treat Parkinson’s disease).
Contact your doctor. It may be necessary to adjust the dose.
Using Ondansetron with food and drink
Ondansetron may be given independently of food and drink.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
Pregnancy:
Use in pregnancy has not been established and is not
recommended.
If it is absolutely necessary that ondansetron be given,
caution should be exercised when prescribing to pregnant
women especially in the first trimester. Your doctor should
evaluate the risk/benefit balance.
Breast-feeding:
Do not take Ondansetron if you are breast-feeding,
because it is excreted into the milk.
Driving and using machines
Ondansetron does not affect the ability to use any tools or
machines or the ability to drive safely in traffic.
Ondemet contains sodium
The solution for injection contains less than 1 mmol
sodium (23 mg) per ampoule, i.e. essentially ‘sodium- free’.
3. How Ondansetron will be used
Always use this medicine exactly as your doctor or nurse
has told you. Check with your doctor or nurse if you are
not sure.

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The following information is intended for medical or healthcare
professionals only.
Ondemet 2mg/ml Injection (Ondansetron)
Please read this information carefully before using Ondemet 2mg/ml
Injection. Further information is contained in the Summary of
Product Characteristics.
Instructions for use and handling
For injection:
For single use only. Any unused solution should be discarded.
The solution is to be visually inspected prior to use (also after dilution).
Only clear solutions practically free from particles should be used.
For infusion:
May be diluted with solution for infusion containing: Sodium chloride 9
mg/ml (0.9%), Glucose 50 mg/ml (5 %), Mannitol 100 mg/ml (10 %),
Potassium chloride 3 mg/ml (0.3%) + Sodium chloride 9 mg/ml (0.9 %) and
Potassium chloride 3 mg/ml (0.3%) + Glucose 50 mg/ml (5 %) as well as
Ringer’s solution for infusion.
Should not be mixed with other pharmaceutical products.
From a microbiological point of view, unless the method of opening/
reconstitution/dilution precludes the risk of microbial contamination, the
product should be used immediately. If not used immediately, in-use storage
times and conditions are the responsibility of the user, and these should, if
dilution has not been performed controlled and under validated aseptic
conditions, normally not exceed 24 hours at 2-8°C.
Posology and method of administration
For intravenous injection or after dilution for intravenous infusion.
Chemotherapy and radiotherapy induced nausea and vomiting
Adults
The emetogenic potential of cancer treatment varies according to the
doses and combinations of chemotherapy and radiotherapy regimens
used. The route of administration and dose of ondansetron should be
flexible and selected as shown below.
Emetogenic chemotherapy and radiotherapy:
For patients receiving emetogenic chemotherapy or radiotherapy
ondansetron can be given either by oral or intravenous administration.

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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 or
pharmacist or nurse.
• 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

Highly emetogenic chemotherapy:
Either 8 mg as a slow intravenous bolus injection or as a short-term
infusion lasting 15 minutes immediately before chemotherapy. If this initial
dose has insufficient effect it can be supplemented by either 8 mg
(intravenous bolus or 15 minutes' infusion) every 4th hour, at most twice,
or continuous infusion of 1 mg/hour for 24 hours.
A single intravenous dose of 16mg diluted in 50-100ml of saline or other
compatible infusion fluid and infused over not less than 15 minutes
immediately before chemotherapy. A single dose greater than 16 mg must
not be given due to dose dependent increase of QT-prolongation risk (see
sections 4.4, 4.8 and 5.1 of the SPC).
After 24 hours treatment is changed to the oral route.
The effect of Ondemet may be enhanced by the simultaneous
administration of 20 mg dexamethasone intravenously or an equally potent
dose of other glucocorticoids for intravenous use.
Paediatric Population
Chemotherapy-induced nausea and vomiting in children aged ≥ 6
months and adolescents:
The dose for chemotherapy-induced nausea and vomiting can be
calculated based on body surface area (BSA) or weight – see below.
Weight-based dosing results in higher total daily doses compared to
BSA-based dosing - see sections 4.4 and 5.1 of the SPC.
There are no data from controlled clinical trials on the use of
Ondansetron in the prevention of chemotherapy-induced delayed or
prolonged nausea and vomiting. There are no data from controlled
clinical trials on the use of Ondansetron for radiotherapy-induced nausea
and vomiting in children.
Dosing by BSA:
Ondansetron should be administered immediately before chemotherapy
as a single intravenous dose of 5 mg/m2. The intravenous dose must not
exceed 8 mg.
Oral dosing can commence twelve hours later and may be continued for
up to 5 days - see Table 1 below.
The total daily dose must not exceed adult dose of 32 mg.
Table 1: BSA-based dosing for Chemotherapy - Children aged ≥ 6
months and adolescents

For most patients receiving emetogenic chemotherapy or radiotherapy,
ondansetron should initially be administered intravenously immediately
before treatment, followed by 8 mg orally twelve hourly.

BSA

For oral administration: 8 mg 1-2 hours before treatment, followed by 8 mg
12 hours later.

> 0.6 m2

To protect against delayed or prolonged emesis after the first 24 hours,
oral treatment with ondansetron should be continued for up to 5 days after
a course of treatment. The recommended dose for oral administration is
8 mg twice daily.

< 0.6 m

Day 1 a,b
2

Days 2-6b

5 mg/m i.v
2 mg syrup after 12 hours

2 mg syrup or tablet every
12 hours

5 mg/m2 i.v.
4 mg syrup or tablet after 12 hours

4 mg syrup or tablet every
12 hours

2

a The intravenous dose must not exceed 8mg.
b The total daily dose must not exceed adult dose of 32 mg.

Continued overleaf...

Adults
Your doctor or hospital may give you ondansetron as an
injection, an infusion (drip) or tablets. The dose is
individual to each patient.
Paediatric population
CINV in children aged ≥ 6 months and adolescents:
Ondansetron injection should be mixed with 5% dextrose
or 0.9% sodium chloride or other compatible infusion fluid
and infused into a vein over not less than 15 minutes.
Ondansetron should be administered immediately before
chemotherapy as a single dose of 5 mg/m2 or 0.15 mg/kg
given into a vein. Oral dosing can commence 12 hours
later and may be continued for up to 5 days. The
maximum daily dose is 32 mg.
PONV in children aged ≥ 1 month and adolescents:
For prevention of PONV in paediatric patients having
surgery performed under general anaesthesia, a single
dose of ondansetron may be given by slow injection into a
vein (not less than 30 seconds) at a dose of 0.1mg/kg up
to a maximum of 4mg either before or after the
anaesthesia.
For the treatment of PONV in paediatric patients having
surgery performed under general anaesthesia, a single
dose of ondansetron may be given by slow injection into a
vein (not less than 30 seconds) at a dose of 0.1mg/kg up
to a maximum of 4mg.
There are no data on the use of ondansetron in the
treatment of PONV in children below 2 years of age.
If you receive more Ondansetron than you should
Contact your doctor or the hospital if you receive more
Ondansetron than you should and you feel uncomfortable.
The symptoms of overdose are disturbances of vision,
severe constipation, low blood pressure and disturbances
in heart beat rhythm.
4. Possible side effects
Like all medicines, Ondansetron can cause side effects,
although not everybody gets them.
Serious, rare side effects (occur in between 1 and 10
of 10,000 patients treated).
Tell your doctor or nurse immediately if you
experience any of the following:
• Swollen tongue and throat
• Difficulty breathing
• Collapse
Very common side effects (occur in more than 1 in 10
patients treated):
• Headache.
Common side effects (occur in between 1 and 10 of
100 patients treated):
• A sensation of reddening and warmth
• Constipation
• Hypersensitivity reactions at the injection site (local
swelling, pain, redness, tissue hardening).
Uncommon side effects (occur in between 1 and 10 of
1,000 patients treated):
• Hiccups
• Low blood pressure
• Irregular heart beats, heart pain and slow pulse
• Seizures
• Involuntary movements
• Changes in liver function
• Upward rolling of the eye.
Rare side effects (occur in between 1 and 10 of 10,000
patients treated):
• Dizziness during injection
• Temporary blurred vision
• Abnormally rapid heart rhythm called “Torsade de
Pointes”.

Very rare side effects (occur in less than 1 of 10,000
patients treated):
• Temporary blindness. Most of these blindness cases
were resolved within 20 minutes.
If any of these side effects occur, immediately seek
medical attention.
Other less severe side effects may occur rarely or very
rarely. If you need more information on these side effects
ask your doctor or nurse for advice.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the internet at www.mhra.gov.uk/yellowcard or call
Freephone 0808 100 3352. By reporting side effects you
can help provide more information on the safety of this
medicine.
5. How to store Ondansetron
• Keep out of the sight and reach of children.
• Do not use Ondansetron after the expiry date which is
stated on the ampoule and the carton (EXP).
• Unopened ampoules do not require any special storage
conditions.
• After opening/dilution/reconstitution: Shelf life is
24 hours stored in a refrigerator (2-8°C).
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
protect the environment.
6. Contents of the pack and other information
What Ondansetron contains
The active substance in 1 ml solution for injection is 2 mg
ondansetron as ondansetron hydrochloride dihydrate. Each
2 ml ampoule contains 4 mg ondansetron as ondansetron
hydrochloride dihydrate. Each 4 ml ampoule contains 8 mg
ondansetron as ondansetron hydrochloride dihydrate.
The other ingredients are Sodium chloride (0.15 mmol
Na+/ml); Citric acid monohydrate; Sodium citrate
(0.0026mmol Na+/ml); Water for injections.
What Ondansetron looks like and contents of the pack
Ondemet 2mg/ml Injection is a clear liquid in brown glass
ampoules.
Every ampoule contains 2 ml or 4 ml solution. They are
marketed in packs of 5 ampoules or 5 x 5 ampoules
respectively. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Alliance Pharmaceuticals Limited, Avonbridge House, Bath
Road, Chippenham, Wiltshire, SN15 2BB, UK.
Manufacturer
Pharmathen S.A., 6, Dervenakion str., 15351 Pallini,
Attikis, Greece
This medicinal product is authorised in the Member
States of the EEA under the following names:
• Denmark, Ondansetron Pharmathen inj. væske, 2mg/ml.
• Greece, Trondamet solution for injection.
• Germany, Sigondan 2mg/ml Injektionslosung.
• Ireland, Ondansetron 2mg/ml Solution for injection and
infusion.
This leaflet was last revised in July 2013
Ondemet is a registered trademark in the United Kingdom
of Alliance Pharmaceuticals Limited.
Alliance and associated devices are registered trademarks
of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2013

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Dosing by bodyweight:
Weight-based dosing results in higher total daily doses compared to
BSA-based dosing (see sections 4.4 and 5.1 of the SPC).
Ondansetron should be administered immediately before chemotherapy
as a single intravenous dose of 0.15 mg/kg. The intravenous dose must
not exceed 8 mg.
Two further intravenous doses may be given in 4-hourly intervals. The
total daily dose must not exceed adult dose of 32 mg.

Paediatric population
Post-operative nausea and vomiting in children aged ≥ 1 month and
adolescents
For prevention of PONV in paediatric patients having surgery performed
under general anaesthesia, a single dose of ondansetron may be
administered by slow intravenous injection (not less than 30 seconds) at
a dose of 0.1mg/kg up to a maximum of 4mg either prior to, at or after
induction of anaesthesia.

Oral dosing can commence twelve hours later and may be continued for
up to 5 days (see Table 2 below).

For the treatment of PONV after surgery in paediatric patients having
surgery performed under general anaesthesia, a single dose of
ondansetron may be administered by slow intravenous injection (not less
than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4mg.

Table 2: Weight-based dosing for Chemotherapy - Children aged
≥ 6 months and adolescents

There are no data on the use of ondansetron in the treatment of postoperative nausea and vomiting in children under 2 years of age.

Weight

Day 1 a,b

Days 2-6b

≤10 kg

Up to 3 doses of 0.15 mg/kg at 4-hourly
intervals

2 mg syrup or tablet every
12 hours

> 10 kg

Up to 3 doses of 0.15 mg/kg at 4-hourly
intervals

4 mg syrup or tablet every
12 hours

a The intravenous dose must not exceed 8mg.
b The total daily dose must not exceed adult dose of 32 mg.

Elderly
Ondansetron is well tolerated by patients over 65 years and no alteration
of dosage, dosing frequency or route of administration are required.
Patients with renal impairment
No alteration of daily dosage or frequency of dosing, or route of
administration are required.
Patients with hepatic impairment
Clearance of Ondansetron is significantly reduced and serum half life
significantly prolonged in subjects with moderate or severe impairment of
hepatic function. In such patients a total daily dose of 8 mg should not be
exceeded and therefore parenteral or oral administration is
recommended.
Patients with poor sparteine / debrisoquine metabolism
The elimination half-life of ondansetron is not altered in subjects
classified as poor metabolisers of sparteine and debrisoquine.
Consequently, in such patients repeat dosing will give drug exposure
levels no different from those of the general population. No alteration of
daily dosage or frequency of dosing are required.
Post-operative nausea and vomiting (PONV)
Adults
For the prevention of PONV ondansetron can be administered orally or
by intravenous injection.
Ondansetron may be administered as a single dose of 4mg given by
intramuscular or slow intravenous injection at induction of anaesthesia.
For the treatment of established PONV a single dose of 4mg given by
intramuscular or slow intravenous injection is recommended.

Elderly
There is limited experience in the use of ondansetron in the prevention
and treatment of post-operative nausea and vomiting (PONV) in the
elderly, however ondansetron is well tolerated in patients over 65 years
receiving chemotherapy.
Patients with renal impairment
No alteration of daily dosage or frequency of dosing, or route of
administration are required.
Patients with hepatic impairment
Clearance of ondansetron is significantly reduced and serum half life
significantly prolonged in subjects with moderate or severe impairment of
hepatic function. In such patients a total daily dose of 8 mg should not be
exceeded and therefore parenteral or oral administration is
recommended.
Patients with poor sparteine / debrisoquine metabolism
The elimination half-life of ondansetron is not altered in subjects classified as
poor metabolisers of sparteine and debrisoquine. Consequently in such
patients, repeat dosing will give medicinal product exposure levels no
different from those of the general population. No alteration of daily dosage
or frequency of dosing are required.

Expand Transcript

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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