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Ondansetron 0.16 Mg/Ml Solution For Infusion

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondansetron 0.16 mg/ml Solution for Infusion

Read all of this leaflet carefully before you are given 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, pharmacist or nurse.

-    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.

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 is given

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 is a clear solution, containing the active ingredient ondansetron (as ondansetron hydrochloride dihydrate), which is an anti-emetics (prevents nausea [feeling sick] and vomiting).

Ondansetron is used for:

-    preventing and treating nausea and vomiting caused by chemotherapy (in adults and children) or radiotherapy for cancer (adults only) .

-    preventing and treating nausea and vomiting after surgery .

Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.

2.    What you need to know before you are given Ondansetron You should NOT be given Ondansetron:

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

-    if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in Section 6).

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Ondansetron:

-    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 liver problems

-    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 applies to you, talk to your doctor, nurse or pharmacist before having Ondansetron.

Other medicines and Ondansetron

Tell your doctor, nurse 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:

-    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 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.

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

Pregnancy and breast-feeding:

It is not known if Ondansetron is safe during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine.

Do not breast-feed if you are given 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 up to 31.3 mmol (or 720 mg) of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

3. How Ondansetron is given

Ondansetron is normally given by a nurse or doctor as intravenous infusion. 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:

-    the recommended adult dose is 8 mg given by an injection into your vein, just before your treatment, and another 8 mg twelve hours later. 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 recommended 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. 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 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 twelve hours later, as 4 mg ondansetron tablet or 5 ml (4 mg) ondansetron 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.

To prevent and treat nausea and vomiting after an operation

Adult:

-    The recommended dose for adults is 4 mg given by a slow injection into your vein. For prevention this will be given just before your operation.

Children:

-    For children aged over 1 month and adolescents, your doctor will decide the dose. The maximum dose is 4 mg given as an injection into the vein. For prevention, this will be given just before the operation.

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 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 are given more Ondansetron than you should

Your doctor or nurse will give you or your child Ondansetron 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 tell your doctor or nurse.

If you miss a dose of Ondansetron

If you think you or your child have missed a dose, please tell your doctor or nurse.

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

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:

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 Ondansetron 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 movements or    shaking.

Rare: may affect up to 1 in 1,000    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 10,000 people

•    poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.

Reporting of side effects

If you get any side effects, talk to your doctor 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 bag after EXP. The expiry date refers to the last day of that month.

Your doctor, pharmacist or nurse knows how to store Ondansetron properly.

Store Ondansetron in the original aluminium overpouch in order to protect from light. Do not freeze.

After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 20±5°C temperature and normal indoor illumination, thus no protection from normal indoor light is necessary while infusion takes place.

From the 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 8°C, unless opening has taken place in controlled and validated aseptic conditions.

Do not use this medicine if you notice any discolouration or particles in the solution. Do not use if container is damaged.

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 to protect the environment.

6. Contents of the pack and other information What Ondansetron contains

-    The active ingredient is ondansetron (as ondansetron hydrochloride dihydrate). Each ml of solution contains 0.16 mg ondansetron (as ondansetron hydrochloride dihydrate).

50 ml Ondansetron solution for infusion contains 8 mg of ondansetron (as ondansetron hydrochloride dihydrate).

100 ml Ondansetron solution for infusion contains 16 mg of ondansetron (as ondansetron hydrochloride dihydrate).

200 ml Ondansetron solution for infusion contains 32 mg of ondansetron (as ondansetron hydrochloride dihydrate).

-    The other ingredients are citric acid (E330), sodium citrate (E331), sodium chloride and water for injections.

What Ondansetron looks like and contents of the pack

Ondansetron is a clear, colourless solution, free from visible particles. It comes in a plastic infusion bag fitted with one infusion port closed with a rubber stopper and snap cap. The infusion bags are contained in an aluminium overpouch.

Pack sizes: 50 ml solution in multipacks containing 5, 10 or 30 bags 100 ml solution in multipacks containing 5, 10 or 30 bags 200 ml solution in multipacks containing 5 or 10 bags Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom Manufacturer

Teva Pharmaceutical Works Private Limited Company Tancsics Mihaly ut 82.

H-2100 Godollo,

Hungary

Pharmachemie B.V

Swensweg 5, 2031 GA Haarlem

The Netherlands

This leaflet was last revised in 03/2016 PL 00289/1465

The following information is intended for healthcare professionals only:

Instructions for use, handling and disposal:

How to prepare and administer Ondansetron

For single use only. Remove overpouch only when ready to use, then check for minute leaks by squeezing the bag firmly. If the bag leaks, do not use as sterility may be impaired. The solution should be visually inspected prior to use and only clear solutions, without particles should be used.

Ondansetron solution for infusion is compatible with Sodium chloride 9 mg/ml (0.9%) solution for injection.

Compatibility with other drugs: Ondansetron may be administered by intravenous infusion at 1 mg/hour, e.g. from an infusion bag or syringe pump. The following drugs may be administered via the Y-site of the ondansetron 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. 5-Fluorouracil: Concentrations up to 0.8 mg/ml (e.g. 2.4 g in 3 litres or 400 mg in 500 ml) administered at a rate of at least 20 ml per hour (500 ml per 24 hours). Higher concentrations of 5-fluorouracil may cause precipitation of ondansetron. The 5-fluorouracil infusion may contain up to 0.045% w/v magnesium chloride in addition to other excipients shown to be compatible.

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 litre), administered over thirty minutes to one hour.

Ceftazidime: Doses in the range 250 mg to 2000 mg reconstituted with Water for Injections as recommended by the manufacturer (e.g. 2.5 ml for 250 mg and 10 ml for 2 g ceftazidime) and given as an intravenous bolus injection over approximately five minutes.

Cyclophosphamide: Doses in the range 100 mg to 1 g, reconstituted with Water for Injections, 5 ml per 100 mg cyclophosphamide, as recommended by the manufacturer and given as an intravenous bolus injection over approximately five minutes.

Doxorubicin: Doses in the range 10-100 mg reconstituted with Water for Injections, 5 ml per 10 mg doxorubicin, as recommended by the manufacturer and given as an intravenous bolus injection over approximately 5 minutes.

Dexamethasone: Dexamethasone sodium phosphate 20 mg may be administered as a slow intravenous injection over 2-5 minutes via the Y-site of an infusion set delivering 8 or 16 mg of Ondansetron over approximately 15 minutes. Compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated supporting administration of these drugs through the same giving set resulting in concentrations in line of 32 microgram - 2.5 mg/ml for dexamethasone sodium phosphate and 8 microgram -1 mg/ml for ondansetron.

How to store Ondansetron Shelf life before opening: 3 years

Store Ondansetron in the original aluminium overpouch in order to protect from light. Do not freeze.

After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 20±5°C temperature and normal indoor illumination, thus no protection from normal indoor light is necessary while infusion takes place.

From the 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 8°C, unless opening has taken place in controlled and validated aseptic conditions.

Disposal of Ondansetron

Any unused product or waste material should be disposed of in accordance with local requirements.