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ONDANSETRON 2 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Package leaflet: Information for the user
Ondansetron 2 mg/ml Solution for Injection or Infusion
Ondansetron
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, 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.
The name of the medicinal product is Ondansetron 2mg/ml Solution for Injection or Infusion but will be
referred to as Ondansetron Injection throughout the package leaflet
What is in this leaflet:
1. What Ondansetron Injection is and what it is used for
2. What you need to know before you use Ondansetron Injection
3. How to use Ondansetron Injection
4. Possible side effects
5. How to store Ondansetron Injection
6. Contents of the pack and other information
1. What Ondansetron Injection is and what it is used for
Ondansetron Injection contains the active ingredient ondansetron, which belongs to a group of medicines
called anti-emetics.
Ondansetron Injection is used for
• Preventing nausea (feel sick) and vomiting (be sick) caused by
o chemotherapy for cancer in adults and in children aged ≥6 months.
o radiotherapy for cancer in adults
• Preventing and treatment of nausea and vomiting after surgery in adults and in children aged ≥ 1 month.
Ask your doctor, nurse or pharmacist if you would like any further explanation about this uses.
2. What you need to know before you use Ondansetron Injection
Do not use Ondansetron Injection:
- If you are allergic to Ondansetron or any of the other ingredients of this medicine (listed in section 6)or to
any similar medicines e.g. granisetron or dolasetron.
- If you are taking Apomorphine (medicine used to treat Parkinson’s disease)
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ondansetron Injection
- if you have a blockage in your gut or suffer from severe constipation Ondansetron can make these
conditions worse.
- if you have liver problems
- if you have ever had problem with your heart or are taking medicines used to treat heart problems
- if you have an uneven heart beat (arrhythmias)
- if you are having surgery to remove your tonsils, because treatment with ondansetron may hide symptoms

of internal bleeding
- if you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium
- if your child is being treated & he / she is less than 2 years old, with liver damage.
Always inform the laboratory during tests of blood and urine that you are being treated with ondansetron.
If any of the above statements are applicable to you, please tell your doctor before having the injection.
Other medicines and Ondansetron injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
natural supplements or vitamins or minerals.
You must tell your doctor that you are using Ondansetron, if he/she starts treating you with the following
medicine:
• Phenytoin (used to treat epilepsy & heart arrhythmias)
• Carbamazepine (used to treat epilepsy & neuralgic pain)
• Rifampicin (an antibiotic)
• 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 (used to treat pain following surgery)
• Apomorphine (medicine used to treat Parkinson’s disease)
• Medicines that affect the heart (such as haloperidol or methadone)
• Cancer medicines (especially anthracyclines and trastuzumab).
The effect of ondansetron may be weakened if you are taking phenytoin, carbamazepine or rifampicin. The
painkilling effect of Tramadol may be weakened if you are taking ondansetron.
Contact your doctor. It may be necessary to adjust the dose.
Ondansetron injection with food and drink
You may use ondansetron injection independently of food and drink
Pregnancy, breast-feeding and fertility:
Pregnancy:
Because of insufficient experience the use of ondansetron injection in pregnancy is not recommended. If you
are pregnant, especially during the first third of your pregnancy, you should use ondansetron only, if your
treating physician has performed a careful benefit/risk assessment.
Breast –Feeding:
The ondansetron in Ondansetron Injection may pass into mothers' milk. Therefore mothers receiving
ondansetron injection should not breast-feed their baby
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines:
Ondansetron injection will not affect your ability to drive or operate machinery.
Important information about some of the ingredients in this medicine
This medicinal product contains 2.5 mmol (or 57.9 mg) sodium per maximum daily dose of 32 mg. To be
taken into consideration by patients on a controlled sodium diet.
3. How to use Ondansetron Injection
Ondansetron Injection is normally given by a nurse or doctor. The dose you have been prescribed will
depend on the treatment you are having.
To prevent nausea and vomiting from chemotherapy or radiotherapy

Adults
On the day of chemotherapy or radiotherapy the usual adult dose is 8 m g given by an injection into your
vein or muscle, just before your treatment, and another 8 mg twelve hours later.
On the following days
• the usual adult intravenous dose does not exceed 8 mg.
• oral dosing can commence twelve hours later and may be continued 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 Injection. Your doctor will decide this.
To prevent nausea and vomiting from chemotherapy
Children aged over 6 months and adolescents
The doctor will decide the dose.
On the day of chemotherapy
• 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; the usual dose is a 4 mg.
To prevent nausea and vomiting after an operation
• The usual dose for adults is 4 mg given by an injection into your vein or muscle. This will be given just
before your operation.
• For children aged over 1 month and adolescents, the doctor will decide the dose. The maximum dose is 4
mg given as an injection into the vein. This will be given just before the operation.
To treat nausea and vomiting after an operation
• The usual adult dose is 4 mg given by an injection into your vein or muscle.
• For children aged over 1 month and adolescents, the doctor will decide the dose. A single dose of
ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose 0.1
mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.
Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg.
If you received more Ondansetron Injection than you should
Little is known at present about over dosage with ondansetron. In a few patients, the following effects were
seen after overdosage: disturbances of vision, severe constipation, lowered blood pressure and loss of
consciousness. In all cases the symptoms disappeared completely. There is no particular antidote to
ondansetron. For that reason, if overdose is suspected, only the symptoms should be treated. Tell your doctor
or nurse if any of these symptoms occur.
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
These are rare, but allergic (hypersensitivity) reactions can produce a skin rash- red spots or lumps under
your skin (hives) anywhere on your body and itching as well as more serious symptoms such as swelling of
the hands, feet, ankles, face, eyelids, lips, mouth and/or throat. This can lead to difficulty swallowing and
breathing.
Heart rhythm disorders

These are uncommon but can produce palpitations (an unpleasant sensation of an irregular and/or forceful
beating of the heart) or a very slow heart beat. There may also be chest pain or chest tightness and sudden
wheezing or collapse.
These serious side-effects can be life-threatening, therefore TELL YOUR DOCTOR OR NURSE
IMMEDIATELY IF YOU EXPERIENCE ANY OF THE SYMPTOMS ABOVE.
Less serious side-effects:
Headache

Very common
More than 1 in 10 patients



Common
More than 1 in 100, but less
than 1 in 10, patients





Uncommon
More than 1 in 1,000, but less
than 1 in 100 patients








Seizures (fits or convulsions)
Unusual body movements or shaking
Uneven heart beat
Chest pain
Low blood pressure, which can make you feel faint or dizzy
Hiccups

Rare
More than 1 in 10,000 patients,
but less than 1 in 1,000 patients





Feeling dizzy or light headed
Poor vision or temporary loss of eyesight
Disturbance in heart rhythm (sometimes causing a sudden loss of
consciousness)

Very rare
Less than 1 in 10,0000 patients,
including isolated reports



Temporary loss of vision, usually lasting less than 20 minutes, mostly
in patients receiving cisplatin chemotherapy.

Sensations of flushing or warmth
Constipation
Changes to liver function test results (if you have Ondansetron
injection with a medicine called cisplatin, otherwise this side effect is
uncommon)
• Irritation and redness at the site of injection

If you are going to have any blood tests or liver function test, this medicine may affect the results, so inform
your doctor. If you feel unwell or have any unusual discomfort you do not understand, tell your doctor as
soon as possible.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed
in this leaflet.
5. How to store Ondansetron Injection
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 ampoule or carton after EXP. The
expiry date refers to last day of that month.
This medicinal product does not require any special temperature storage conditions.
Keep ampoules in the outer carton in order to protect from light
Do not use this medicine if you notice container is damaged or particles / crystals are visible.
Do not throw away any medicine 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 Further information

What Ondansetron Injection contains:
The active ingredient in Ondansetron Injection is ondansetron (as hydrochloride dihydrate).
Each ml of solution for injection or infusion contains 2 mg ondansetron (as ondansetron hydrochloride
dihydrate)
Each ampoule of 2ml contains 4mg of ondansetron (as ondansetron hydrochloride dihydrate).
Each ampoule of 4ml contains 8mg of ondansetron (as ondansetron hydrochloride dihydrate).
The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide and/or
hydrochloric acid for pH adjustment and water for Injections
What Ondansetron solution for Injection or Infusion looks like and contents of the pack:
Ondansetron Injection is a clear colourless solution for injection or infusion filled in clear/amber glass
ampoule.
Ondansetron Injection 2 mg/ml is available in pack containing 5 X 2 ml and 5 X 4 ml ampoules and also
available in 10 X 2 ml and 10 X 4 ml ampoules.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow HA1 4HF, UK
This medicinal product is authorized in the Member States of the EEA under the following names:
Name of the
Name of the medicinal product
member state
United
Ondansetron 2mg/ml Solution for Injection or Infusion
Kingdom
Austria
Ondansetron Accord 2 mg/ml Lösung zur Injektion oder Infusion
Ondansetron Accord Healthcare 2 mg/ml solution pour injection ou
Belgium
perfusion/ oplossing voor injectie of infusie/ Lösung zur Injektion oder
Infusion
Cyprus
Ondansetron Accord 2 mg/ml ενέσιμο διάλυμα ή διάλυμα για έγχυση
Czech
Ondansetron Accord 2 mg/ml injekční roztok nebo infuzi
Republic
Denmark
Ondansetron Accord 2 mg/ml injektions og infusionsvæske, opløsning
Germany
Ondansetron Accord 2 mg/ml Lösung zur Injektion oder Infusion
Estonia
Ondansetron Accord 2 mg/ml
Greece
Ondansetron Accord 2 mg/ml ενέσιμο διάλυμα ή διάλυμα για έγχυση
Ondansetron Accord Healthcare 2 mg/ml para inyección o infusión
Spain
EFG
Ondansetron Accord 2 mg/ ml injektio- tai infuusioneste/ Lösning för
Finland
injektion och infusion
Hungary
Ondansetron Accord 2 mg/ml oldatos injekció vagy infúzió
Ireland
Ondansetron 2 mg/ml Solution for Injection or Infusion
Ondansetrone Accord Healthcare 2mg/ml Soluzione per Iniezione o
Italy
Infusione
Latvia
Ondansetron Accord 2 mg/ml šķīdums injekcijām vai infūzijām
Malta
Ondansetron 2 mg/ml Solution for Injection or Infusion
Norway
Ondansetron Accord 2 mg/ml oppløsning til injeksjon og infusjon
Poland
Ondansetron Accord 2 mg/ml
Portugal
Ondansetrom Accord
Sweden
Ondansetron Accord 2 mg/ml Lösning för injektion och infusion
Slovenia
Ondansetron Accord 2 mg/ml raztopina za injiciranje ali infundiranje

Name of the
member state
Slovak
Republic
Bulgaria
The
Netherlands
Lithuania

Name of the medicinal product
Ondansetron Accord 2 mg/ml injekčný alebo infúzny roztok
Ondansetron Accord 2 mg/ml Solution for Injection or Infusion
Ondansetron Accord 2 mg/ml oplossing voor injectie of infusie
Ondansetron Accord 2 mg/ml injekcinis/infuzinis tirpalas

The leaflet was last approved in 08/2012.

The following information is intended for medical or healthcare professionals only
Instructions for use:
For intravenous injection or intramuscular injection or intravenous infusion after dilution.
Prescribers intending to use ondansetron in the prevention of delayed nausea and vomiting associated with
chemotherapy or radiotherapy in adults, adolescents or children should take into consideration current
practice and appropriate guidelines.
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 in the range of 8-32 mg a day and selected as shown below.
Emetogenic chemotherapy and radiotherapy:
For patient receiving Emetogenic chemotherapy and radiotherapy, ondansetron can be given either by
intravenous or intramuscular or other routes of administration. However this product is for injection or
infusion only.
For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron 8 m g should be
administered as a slow intravenous or intramuscular injection or as a short-time intravenous infusion over 15
immediately before treatment, followed by 8 mg orally twelve hourly.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron
associated with dexamethasone should be continued for up t o 5 da ys after a course of treatment.
Ondansetron treatment with other dosage forms than intravenous should be continued for up to 5 days after a
course of treatment.
Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemotherapy, e.g.. high-dose
cisplatin, ondansetron can be given either by intravenous or intramuscular administration. Ondansetron has
been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy:
• A single dose of 8 mg by slow intravenous or intramuscular injection immediately before chemotherapy.
• A dose of 8 m g by slow intravenous or intramuscular injection or as a short-time intravenous infusion
over 15 minutes immediately before chemotherapy, followed by two further intravenous or intramuscular
doses of 8 mg two to four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.
• A single dose of 16mg of ondansetron may only be given by intravenous infusion diluted in 50-100 ml
of saline (0.9% w/v) or other compatible infusion fluid and over not less than 15 m inutes immediately
before chemotherapy.
The selection of dose regimen should be determined by the severity of the emetogenic challenge.
A single dose greater than 16mg 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).
The efficacy of ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a
single intravenous dose of dexamethasone sodium phosphate, 20 mg administered prior to chemotherapy.
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.
Paediatric Population:
CINV in children aged ≥ 6 months and adolescents
The dose for CINV can be calculated based on body surface area (BSA) or weight – see below.
Dosing by BSA:

Ondansetron Injection 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 t o 5 da ys (see SPC for dosing tables). The total daily dose must not exceed
adult dose of 32 mg.
Dosing by bodyweight:
Weight-based dosing results in higher total daily doses compared to BSA-based dosing. Ondansetron
Injection should be administered immediately before chemotherapy as a single intravenous dose of 0.15
mg/kg. The intravenous dose must not exceed 8 m g. Two further intravenous doses may be given in 4hourly intervals. The total daily dose must not exceed adult dose of 32 mg. Oral dosing can commence
twelve hours later and may be continued for up to 5 days (see SPC for further details).
Ondansetron Injection should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible
infusion fluid (see section 6.6) and infused intravenously over not less than 15 minutes.
There are no d ata from controlled clinical trials on the use of Ondansetron Injection in the prevention of
delayed or prolonged CINV. There are no data from controlled clinical trials on t he use of Ondansetron
Injection for radiotherapy-induced nausea and vomiting in children.
Post-operative nausea and vomiting (PONV):
Adults: For the prevention of PONV ondansetron can be administered orally or by intravenous or
intramuscular injection.
Ondansetron may be administered as a single dose of 4 mg given by intramuscular or slow intravenous
injection at induction of anaesthesia.
For treatment of established PONV a single dose of 4 m g given by intramuscular or slow intravenous
injection is recommended.
Children (aged over 1 month and adolescents)
Oral formulation:
No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment
of post-operative nausea and vomiting; slow i.v. injection is recommended for this purpose.
Injection:
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. 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 t o a maximum of 4mg. There are no data on t he use of Ondansetron Injection in the
treatment of PONV in children below 2 years of age.
Elderly: There is limited experience in the use of ondansetron in the prevention and treatment of PONV in
the elderly, however ondansetron is well tolerated in patients over 65 years receiving chemotherapy.
Please refer also to “Special Populations”.
Special populations
Patients with renal impairment: No alteration of daily dosage or frequency of dosing, or route of
administration is 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.
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 is required.
Incompatibilities:
The solution must not be sterilised in an autoclave.
Ondansetron Injection should only be admixed with those infusion solutions, which are recommended:
Sodium Chloride Intravenous Infusion BP 0.9%w/v
Glucose Intravenous Infusion BP 5%w/v
Mannitol Intravenous Infusion BP 10%w/v
Ringers Intravenous Infusion
Potassium Chloride 0.3%w/v and Sodium Chloride 0.9%w/v Intravenous Infusion BP
Potassium Chloride 0.3%w/v and Glucose 5%w/v Intravenous Infusion BP
The stability of Ondansetron Injection after dilution with the recommended infusion fluids have been
demonstrated in concentrations 0.016 mg/ml and 0.64 mg/ml.
Use only clear and colourless solutions.
The diluted solutions should be stored protected from light.
Shelf-life and storage
Unopened
3 years
This medicinal product does not require any special temperature storage conditions.
Keep ampoules in the outer carton in order to protect from light.
Injection
After first opening the medicinal product should be used immediately.
Infusion
After dilution with recommended diluents chemical and physical in-use stability has been demonstrated for
7 days at 25°C and 2-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse 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 dilution has taken place in controlled and validated aseptic
conditions.

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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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