Ondavell injection contains a medicine called Ondansetron. This belongs to a group of medicines called anti-emetics.

Ondavell 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 these uses

-  If you are taking apomorphine (used to treat Parkinson’s disease)

-  If you are allergic (hypersensitive) to Ondansetron or any of the other ingredients in Ondavell injection (listed in section 6).

If you are not sure, talk to your doctor, nurse or pharmacist before Ondavell injection is given to you.

Warning and Precautions

Talk to your doctor or pharmacist before you receive Ondavell injection if:

-  you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles)

-  you have an uneven heart beat (arrhythmias)

-  you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron

-  you have liver problems

-  you have a blockage in your gut

-  you have problems with the level 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 Ondavell injection.

Other medicines and Ondavell Injection

Tell your doctor, nurse or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines. This is because Ondavell Injection can affect the way some medicines work.

Also some other medicines can affect the way Ondavell injection works.

In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines.

-  Apomorphine (used to treat Parkinson’s disease) because a profound drop in blood pressure and loss of consciousness has been reported when ondansetron was administered with apomorphine

-  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 heartbeat.

-  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 Ondavell injection.

Ondavell injection should not be given in the same syringe or infusion (drip) as any other medication.

Pregnancy and breast-feeding

Only use during the first trimester of pregnancy after discussion with your doctor of the potential benefits and risks to you and your unborn baby of the different treatment options. This is because Ondavell Injection can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth). If you are already pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before having Ondavell Injection. If you are a woman of childbearing potential you may be advised to use effective contraception.

Do not breast-feed if you have Ondavell Injection. This is because small amounts pass into the mother’s milk.

Important information about some of the ingredients of Ondavell injection

This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially “sodium-free”. 1 mL Ondavell injection contains 3.56 mg or 0.155 mmol sodium.

Ondavell 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 in adults

On the day of chemotherapy or radiotherapy:

- a single dose should not be more than 16 mg.

-  the usual adult dose is 8 mg given by a slow injection into your vein over at least 30 seconds or muscle just before your treatment,

-  possibly another two 8 mg doses given by injection into your vein over at least 30 seconds or muscle four hours apart, depending on the strength of your chemotherapy or radiotherapy.

On the following days your medicine will usually be given by mouth, e.g. as tablet:

-  the usual adult dose is one 8 mg tablet taken twice a day 12 hours apart

-  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 Ondavell. Your doctor will decide this.

Older people

If you are over 65 years of age, your doctor will adjust your dose as required.

All intravenous doses should be diluted in 50 to 100 ml of saline solution or other compatible infusion solution and infused over at least 15 minutes.

-  In patients 65 to 74 years of age: The dose for adults can be followed. The single dose into your vein must not exceed 16 mg.

-  In patients 75 years of age or older: The single dose into your vein must not exceed 8 mg.

Use in children and adolescents (aged 6 months to 17 years)

To prevent nausea and vomiting from chemotherapy only

The doctor will decide the dose depending on the child’s size (body surface area) or weight.

a.  The intravenous dose must not exceed 8 mg

b.  The total dose over 24 hours must not exceed adult dose 32 mg. On the day of chemotherapy

-  the first dose is given by an slow injection into the vein (in not less than 30 seconds), just before your child’s treatment. Possibly another two 8 mg doses can be given by injection into vein over at least 30 seconds four hours apart.

-  After chemotherapy, 12 hours after the initial injection, your child’s medicine will usually be given by mouth as tablet or 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

Patients with kidney problems

No change of daily dosage, frequency of dosing or route of administration is required.

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

Ondavell injection should start to work soon after having the injection. If you continue to be sick or feel sick, tell your doctor or nurse.

Method of administration

This medicinal product is for intravenous or intramuscular injection or for intravenous infusion after dilution.

If you have more Ondavell injection than you should

Your doctor or nurse will give you or your child Ondavell 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.

Like all medicines, Ondavell 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

Myocardial ischemia Signs include:

-  Sudden chest pain or

-  Chest tightness

Other side effects include:

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 Ondavell 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)

-  Hiccups

-  Low blood pressure, which can make you feel faint or dizzy

-  Uneven heart beat

-  Chest pain

-  fits

-  Unusual body movement or shaking

-  Eye movement disorder

Rare (may affect up to 1 in 1000 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 10000 people)

-  Poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.

Not Known (frequency cannot be estimated from the available data)

-  Obstruction

Reporting of Side Effect

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effect listed in this leaflet.

-  Keep out of the sight and reach of children

-  Do not use Ondavell injection after the expiry date which is stated on the ampoule label

and carton after ‘Exp’. The expiry date refers to the last day of that month.

-  Store Ondavell Injection below 30°C. Protect from light.

-  When Ondavell injection is diluted in intravenous fluids.

-  It must be stored at 2-8°C for not more than 24 hours.

-  It does not need to be protected from light during infusion.

•  Do not throw away 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