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ONDANSETRON 2MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): ONDANSETRON HYDROCHLORIDE DIHYDRATE / ONDANSETRON HYDROCHLORIDE DIHYDRATE / ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Ondansetron
P15XXXXX

Ondansetron
P15XXXXX

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 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 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 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 use Ondansetron
3. How to use Ondansetron
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 Injection contains the active ingredient ondansetron,
which belongs to a group of medicines called anti-emetics.
Ondansetron Injection is used for
• Preventing nausea and vomiting caused by chemotherapy
(in adults and children) or radiotherapy for cancer (adults only)
• Preventing nausea and vomiting after surgery. 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
Do not use Ondansetron:
• 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)
If you are not sure, talk to your doctor, nurse or pharmacist before
having Ondansetron injection.
Warnings and precautions
Talk to your doctor or nurse before using Ondansetron:
- If you have liver problems
- 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 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 apply to you, talk to your
doctor, nurse or pharmacist before having Ondansetron injection.
Other medicines and Ondansetron:
Tell your doctor 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:


The following information is intended for medical or
healthcare professionals only
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 most patients receiving emetogenic chemotherapy and
radiotherapy, ondansetron 8 mg should be administered as a slow
intravenous injection (in not less than 30 seconds) or intramuscular
injection or other routes of administration over 15 minutes
immediately before treatment. However this product is for injection
or infusion only.
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.
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 injection (in not less
than 30 seconds) or intramuscular injection over 15 minutes
immediately before chemotherapy.
• A dose of 8 mg by slow intravenous injection (in not less than
30 seconds) or intramuscular injection over 15 minutes
immediately before chemotherapy, followed by two further
intravenous injection (in not less than 30 seconds) or
intramuscular doses of 8 mg no less than four hours apart,
or by a constant infusion of 1 mg/hour for up to 24 hours.
• Doses of greater than 8 mg and up to a maximum dose of 16 mg
diluted in 50-100 ml of saline or other compatible infusion fluid
(See Instructions for Use/Handling)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 QTprolongation risk (see sections
4.4, 4.8 and 5.1 of the SPC).
The selection of dose regimen should be determined by the
severity of the emetogenic challenge.




carbamazepine or phenytoin used to treat epilepsy.
rifampicin used to treat infections such as tuberculosis (TB)
antibiotics such as erythromycin or ketoconazoleanti-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 injection.
Ondansetron injection should not be given in the same syringe or
infusion (drip) as any other medication.
Pregnancy and breast feeding:
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Pregnancy:
Because of insufficient experience the use of Ondansetron 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:
Do not breast-feed if you have 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 2.5 mmol (or 57.0 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
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist or nurse has told you. Check with your
doctor, pharmacist or nurse if you are not sure. Ondansetron 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
On the day of chemotherapy or radiotherapy
• the usual adult dose is 8 mg 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.
• this may be given for 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
• 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.


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.
In paediatric clinical studies, ondansetron was given by IV infusion
diluted in 25 to 50 ml of saline or other compatible infusion fluid
and infused over not less than 15 minutes. Weight-based dosing
results in higher total daily doses compared to BSA-based dosing –
see sections 4.4 and 5.1
Ondansetron hydrochloride should be diluted in 5% dextrose or 0.9%
sodium chloride or other compatible infusion fluid (see Instructions for
Use/Handling) and infused intravenously over not less than 15 minutes.
There are no data from controlled clinical trials on the use of
ondansetron Injection 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 Injection for
radiotherapy-induced nausea and vomiting in children.
Dosing by BSA:
Ondansetron Injection should be administered immediately before
chemotherapy as a single intravenous dose of 5 mg/m2.The single
intravenous dose must not exceed 8 mg. Oral dosing can commence
twelve hours later and may be continued for up to 5 days (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 single intravenous
dose must not exceed 8 mg. Two further intravenous doses may
be given in 4-hourly intervals. Oral dosing can commence twelve
hours later and may be continued for up to 5 days. The total dose
over 24 hours (given as divided doses) must not exceed adult
dose of 32 mg(see SPC for further details).

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 take more Ondansetron than you should
Your doctor or nurse will give you or your child Ondansetron
injection 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 or
have missed a dose, tell your doctor or nurse.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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.
Other side effects include:
Very common (may affect more than 1 in 10 people)
• Headache
Common (may affect up to 1 in 10 people)
• 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
Uncommon (may affect up to 1 in 100 people)
• Fits
• Unusual body movements or shaking
• Uneven heart beat
• Chest pain
• Low blood pressure, which can make you feel faint or dizzy
• Hiccups
• Hypersensitivity reactions around the administration site
(e.g. skin rash, urticaria, itching) that sometimes extend along
the vien in which drug is administered
Rare (may affect up to 1 in 1,000 people)
• 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 (may affect up to 1 in 10,000 people), including isolated
reports
• Poor vision or temporary loss of eyesight, which usually comes
back within 20 minutes
• Depression

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 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 carton after EXP. The expiry date refers to the 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 any particulate matter or
discoloration.
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 is ondansetron (as hydrochloride
dihydrate).
Each ml solution for injection or infusion contains 2 mg
ondansetron (as ondansetron hydrochloride dihydrate).
Each ampoule of 2 ml contains 4 mg of ondansetron (as ondansetron
hydrochloride dihydrate).
Each ampoule of 4 ml contains 8 mg of ondansetron (as ondansetron
hydrochloride dihydrate).
The other ingredients are Citric acid monohydrate, sodium citrate,
sodium chloride, water for injection.
What Ondansetron looks like and contents of the pack:
Solution for injection or infusion.
Clear and colorless solution free from visible particles.
Ondansetron is a clear colourless solution for injection or
infusion filled in type-I clear glass ampoules. For ease of breaking,
the ampoules may bear a “One-Point cut (OPC)” or may be
“Scored”.
Ondansetron 2 mg/ml is available in fill volumes of 2 ml and 4 ml
ampoules packed in boxes of 1, 5 or 10 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 01/2017.





Elderly
In patients 65 to 74 years of age, the dose schedule for adults can
be followed. All intravenous doses should be diluted in 50-100 ml
of saline or other compatible infusion fluid (see Instructions for
Use/Handling) and infuse over 15 minutes.
In patients 75 years of age or older, the initial intravenous dose
of ondansetron should not exceed 8 mg. All intravenous doses
should be diluted in 50-100 ml of saline or other compatible
infusion fluid (see Instructions for Use/Handling) and infused over
15 minutes. The initial dose of 8 mg may be followed by two
further intravenous doses of 8 mg, infused over 15 minutes and
given no less than four hours apart (see SPC).
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 mg given by
intramuscular or slow intravenous injection is recommended.
Children (aged over 1 month and adolescents)
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 to a maximum
of 4 mg. There are no data on the 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.
For all indications:
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

A/s: 210 x 540 mm

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To prevent nausea and vomiting after an operation
Adult:
• The usual dose for adults is 4 mg given by a slow injection into
your vein or an injection into your muscle. For prevention, this
will be given just before your operation.
Children:
• For children aged over 1 month and adolescents, the doctor will
decide the dose. The maximum dose is 4 mg given as a slow
injection into the vein. For prevention, this will be given just
before the operation.

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.
Ondansetron Injection/infusion should not be autoclaved.
Incompatibilities:
Ondansetron solution for injection/infusion is physically compatible
and chemically stable when mixed with the following solutions for
infusion over the concentration range of 0.016 mg/ml to 0.64 mg/ml.
• 0.9%w/v Sodium Chloride
• 5%w/v Dextrose
• 10%w/v Mannitol
• Ringers solution
• 0.3%w/v Potassium Chloride and 0.9%w/v Sodium Chloride
• 0.3%w/v Potassium Chloride and 5%w/v Dextrose
Compatibility studies with above diluents have been undertaken in
polyvinyl chloride infusion bags and polyvinyl chloride administration
sets. It is considered that adequate stability would also be conferred
by the use of polyethylene infusion bags or Type 1 glass bottles.
Dilutions of Ondansetron solution for injection/infusion in 0.9%w/v
Sodium Chloride Intravenous Infusion or in 5%w/v Dextrose
Intravenous Infusion for infusion have been demonstrated to be
stable in polypropylene syringes. It is considered that Ondansetron
solution for injection/infusion diluted with other compatible infusion
fluids would be stable in polypropylene syringes.
Shelf-life and storage
Unopened: 3 years
Injection: After first opening the medicinal product should be used
immediately.
Infusion: Chemical and physical in-use stability has been
demonstrated for 7 days at 15-25o C and 28o C.
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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Ondansetron 2 mg/ml

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13.01.2017 & 12:42 PM

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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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