ONDANSETRON 2 MG/ML SOLUTION FOR INJECTION

Active substance: ONDANSETRON HYDROCHLORIDE DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ondansetron 2 mg/ml Solution for Injection/infusion
ondansetron
The name of your medicine is Ondansetron 2 mg/ml Solution for Injection/Infusion,
which will be called Ondansetron injection or Ondansetron throughout this 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 any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ondansetron injection is and what it is used for
2. Before you are given Ondansetron injection
3. How you are given Ondansetron injection
4. Possible side effects
5. How to store Ondansetron injection
6. Further information
1. What Ondansetron injection is and what it is used for
Ondansetron injection is a clear solution containing the active ingredient ondansetron
(as ondansetron hydrochloride dihydrate), which is an anti-emetic (prevents nausea
[feeling sick] and vomiting).
Ondansetron Injection is used to prevent and treat nausea and vomiting caused by
chemotherapy or radiotherapy and for the prevention and treatment of nausea and
vomiting after surgery.
2. Before you are given Ondansetron injection
You should not be given Ondansetron injection if:
You are hypersensitive to ondansetron or to other selective 5HT3 receptor antagonists
(e.g. granisetron, dolasetron) or to any of the excipients (see list of ingredients in section
6).
Take special care with Ondansetron injection if:
- you have a blockage in your gut or suffer from severe constipation. Ondansetron can
enhance the blockage or constipation
- you have ever had heart problems
- you have an uneven heart beat (arrhythmias)
- you are having your tonsils out

- you have liver problems
- you have undergone surgery to remove tonsils situated at the back of the nose
(adenotonsillar surgery).
Taking other medicines:
You should tell your doctor if you are taking or have taken any of the following
medicines as they may interact with your Ondansetron injection:
- phenytoin, carbamazepine (treatments for epilepsy)
- rifampicin (an antibiotic)
- tramadol (a painkiller)
- beta-blockers (drugs that slow heart rate)
Please tell your doctor or pharmacist if you are taking, or have recently taken, any
other medicines, including medicines obtained without a prescription.
It may still be alright for you to be given Ondansetron injection and your doctor will be
able to decide what is suitable for you.
Pregnancy and lactation
Please tell your doctor if you are pregnant or planning to be pregnant. Ondansetron
passes
into breast milk, therefore nursing mothers should not breast-feed.
Driving and using machines
Ondansetron injection has no effect on your ability to drive or use machines.
Important information about some of the ingredients in Ondansetron injection
This medicinal product contains 2.52 mmol (57.6 mg) sodium per maximum daily dose
of 32 mg. To be taken into consideration by patients on a controlled sodium diet.
3. How you are given Ondansetron injection
Method of administration
Ondansetron injection is given as intravenous injection (into a vein) or, after dilution, as
intravenous infusion (for a longer time). It will usually be given by a doctor or a nurse.
To prevent nausea and vomiting from chemotherapy or radiotherapy
On the day of chemotherapy or radiotherapy
• the usual adult dose is 8 mg given by an injection into your vein, just before your
treatment, and another 8 mg twelve hours later. The usual dose in adults is 8 to 32 mg
ondansetron a day. 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 usual 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 Injection. Your doctor will decide
this.
Children aged over 6 months and adolescents
The usual dose for children is a single intravenous dose of 5 mg/m2 (body area)
immediately before chemotherapy; two further intravenous doses may be given in 4hourly intervals. 4 mg orally twice daily should be continued for up to 5 days after a
course of treatment.
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; the usual
dose is a 4 mg Ondansetron tablet or 5 ml (4 mg) Ondansetron syrup twelve hours later.
On the following days
• one 4 mg tablet or 5 ml (4 mg) syrup twice a day
• this can be given for up to five days.
To prevent nausea and vomiting after an operation
• The usual dose for adults is 4 mg given by an injection into your vein. This will be
given just before your operation.
• For children aged over 6 months and adolescents, the usual dose for children is a dose
of 0.15 mg/kg (body weight). 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.
• For children aged over 6 months and adolescents, the usual dose for children is a dose
of 0.1 mg/kg (body weight). The maximum dose is 4 mg given as an injection into the
vein.
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 injection 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 have been given more Ondansetron injection than you should
Your doctor or nurse will give you Ondansetron injection so it is unlikely that you will
receive too much. If you think you have been given too much or have missed a dose, tell
your doctor or nurse.
If you forget to take Ondansetron injection
If you think you have missed a dose, please tell your doctor or nurse.

If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Ondansetron injection can cause side effects, although not everybody
gets them.
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.
Side effects can be listed according to how often they occur:
Very common:

affects more than 1 user in 10

Common:

affects 1 to 10 users in 100

Uncommon:

affects 1 to 10 users in 1,000

Rare:

affects 1 to 10 users in 10,000

Very rare:

affects less than 1 user in 10,0000

Not known:

frequency cannot be estimated from the available data

The following side effects have been reported:
Very common
- headache
Common
- constipation
- sensation of warmth or flushing
- interference with liver function tests
- irritation and redness at the site of injection
local burning sensation following insertion of suppositories
Uncommon
- low blood pressure, which can make you feel faint or dizzy
- uneven heart beat
- chest pain- fits
- unusual body movements or shaking
- hiccups
Rare
- feeling dizzy or light headed

- blurred vision
- disturbance in heart rhythm (sometimes causing a sudden loss of consciousness).
Very rare
- temporary blindness (most resolved within 20 minutes)
If any of the side effects gets serious, or if you notice any side effect not listed in the
leaflet, please tell your doctor or pharmacist.
5. How to store Ondansetron injection
Keep out of the reach and sight of children.
Your doctor
or pharmacist knows how to store Ondansetron injection.
Do not use Ondansetron Injection after the expiry date, which is stated on the packaging
after “Exp”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage temperature. Keep ampoules
in the outer carton, in order to protect from light.
Shelf life after opening
After first opening the medicinal product should be used immediately.
Shelf life after dilution of the solution
Chemical and physical in-use stability has been demonstrated for 36 hours at 2-8ºC with
the solutions given in section 6.6.
The diluted solutions should be stored protected from light.
From a 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 8ºC, unless dilution
has taken place in controlled and validated aseptic conditions.
Only clear solutions practically free from particles should be used. Do not use if
container is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. Further information
What Ondansetron injection contains:
The active ingredient is ondansetron (as ondansetron hydrochloride
dihydrate).
Each ml of solution for injection contains 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:
citric acid monohydrate, sodium citrate, sodium chloride, water for injections
What Ondansetron injection looks like and contents of the pack
Ondansetron injection is a clear colourless solution for injection/infusion filled in clear
glass ampoule.
2 ml type I clear glass ampoules containing 2 ml of solution: pack size of 5 or 25
ampoules.
5 ml type I clear glass ampoules containing 4 ml of solution: pack size of 5 or 25
ampoules.
Not all pack sizes may be marketed
Marketing Authorization Holder:

Manufacturer:
Pfizer Service Company BVBA
Hoge Wei 10 – B-1930 Zaventem
Belgium
Pfizer PGM
Zone Industrielle 29, route des Industries 37530 POCE-SUR-CISSE
France
This medicinal product is authorized in the Member States of EEA under the
following name:

This Leaflet was last approved in MM/YYYY

Information for Healthcare professionals,
The following information is intended for medical or healthcare professionals only:
1. Administration
Chemotherapy and Radiotherapy:
Adults:
The route of administration and dose of ondansetron should be flexible in the range
of 8- 32mg a day and selected as shown below.

Emetogenic chemotherapy and radiotherapy: Ondansetron can be given either by
rectal, oral (tablets or syrup), or intravenous administration.
For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron
8mg should be administered as a slow intravenous injection immediately before
treatment, followed by 8mg orally twelve hourly.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal
treatment with Ondansetron 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 rectal or
intravenous 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 8mg by slow intravenous injection immediately before
chemotherapy.
A dose of 8mg by slow intravenous injection immediately before chemotherapy,
followed by two further intravenous doses of 8mg two to four hours apart, or by a
constant infusion of 1mg/hour for up to 24 hours.
A single dose of 16 mg diluted in 50-100ml of saline or other compatible infusion
fluid (see Pharmaceutical Precautions) 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 dependant increase of
QT prolongation risk (see sections 4.4, 4.8 and 5.1 of SPC)
The selection of dose regimen should be determined by the severity of the emetogenic
challenge.
The efficacy of ondansetron in highly emetogenic chemotherapy may be enhanced by
the addition of a single intravenous dose of dexamethasone sodium phosphate, 20mg
administered prior to chemotherapy.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal
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.
BSA-based dosing for Chemotherapy - Children aged > 6 months and adolescents
BSA

Day 1 (a,b)

< 0.6 m2

5 mg/m2 i.v. plus 2 mg syrup 2 mg syrup every 12 hrs
after 12 hrs

> 0.6 m2

5 mg/m2 i.v. plus 4 mg syrup or 4 mg syrup or tablet every 12
tablet after 12 hrs
hrs

<

1.2 m2

Days 2-6(b)

a The intravenous dose must not exceed 8mg.
b The total daily dose must not exceed adult dose of 32 mg
For children with a body surface area of greater than 1.2 m2 an initial i.v. dose of 8
mg is administered immediately before chemotherapy, followed by 8 mg orally 12
hours later. 8mg ondansetron, orally twice daily can be continued for up to five days
after a course of treatment.
Weight-based dosing for Chemotherapy - Children aged > 6 months and adolescents
Weight

Day 1 (a,b)

Days 2-6(b)

<10 kg

Up to 3 doses of 0.15 mg/kg 2 mg syrup every 12 hrs
every 4 hrs

> 10 kg

Up to 3 doses of 0.15 mg/kg 4 mg syrup or tablet every 12
every 4 hrs
hrs

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 8mg should not
be exceeded.
Post-Operative Nausea and Vomiting (PONV):
Adults:
For treatment of established PONV a single dose of 4mg given by slow intravenous
injection is recommended.
Paediatric population
PONV in children aged >1 month and adolescents
For prevention and treatment 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.
There are no data on the use of ondansetron 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.
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 8mg should not
be exceeded.
Patients with poor Sparteine/Debrisoquine Metabolism: No alteration of daily
dosage or frequency of dosing is required.
2. Handling Instructions
Compatibility with intravenous fluids: 0.08mg/ml concentration of Ondansetron
with
each diluents at the storage of 2-8 ºC for 36 hours. The solution must not be sterilised
in an autoclave.

The solution is to be visually inspected prior to use (also after dilution). Only clear
solutions practically free from particles should be used. Do not use if container is
damaged.
Any unused product or waste material should be disposed of in accordance with local
requirements.
Ondansetron 2mg/ml Solution for Injection should only be mixed with those infusion
solutions, which are recommended:
Sodium Chloride Intravenous Infusion 0.9%w/v
Glucose Intravenous Infusion 5%w/v
Mannitol Intravenous Infusion 10%w/v
Ringers Intravenous Infusion
Potassium Chloride 0.3%w/v and Sodium Chloride 0.9%w/v Intravenous Infusion
Potassium Chloride 0.3%w/v and Glucose 5%w/v Intravenous Infusion
Dilutions of Ondansetron in the above mentioned diluents have been demonstrated to
be stable in polyvinyl chloride (PVC) infusion bags, Non polyvinyl chloride (NonPVC) infusion bags, Ph. Eur. Type I glass bottles and polyvinyl chloride (PVC)
administration sets.
Dilutions of Ondansetron in sodium chloride 0.9%w/v or in glucose 5%w/v have
been demonstrated to be stable in polypropylene syringes.
Compatibility with other drugs:
Ondansetron 2mg/ml Solution for Injection may be administered by intravenous
infusion at 1mg/hour, e.g. from an infusion bag or syringe pump. The following
drugs may be administered via the Y-site of the Ondansetron 2mg/ml Solution for
Injection 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.
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 litres), administered over thirty minutes to one hour.
Ceftazidime:
Doses in the range 250 mg to 2000 mg reconstituted with Water for Injections BP as

recommended by the manufacturer (e.g. 2.5 ml for 250 mg and 10 ml for 2g
ceftazidime) and given as an intravenous bolus injection over approximately five
minutes.
3. Storage information
Keep ampoules in the outer carton, in order to protect from light.
Shelf life after opening:
After first opening the medicinal product should be used immediately.
Shelf life after dilution of the solution:
Chemical and physical in-use stability has been demonstrated for 36 hours at 2-8ºC.
The diluted solutions should be stored protected from light.
From a 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 8ºC, 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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