Ondansetron Teva 0,16 mg/ml, oplossing voor infusie

Ondansetron Teva 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 Teva is used for:

• preventing and treating nausea and vomiting caused by chemotherapy or radiotherapy for cancer .
• preventing and treating nausea and vomiting after surgery .

You should NOT be given Ondansetron Teva:

• 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).

Warnings and precautions

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

• you have ever had heart problems
• you have an uneven heart beat (arrhythmias)
• you are allergic to medicines similar to ondansetron, such as granisetron (known as ‘Kytril’)
• you have liver problems
• you have a blockage in your gut or suffer from severe constipation. Ondansetron Teva can enhance the blockage or constipation
• you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium
• you are having your tonsils out
• you have undergone surgery to remove tonsils situated at the back of the nose (adenotonsillar surgery).

Other medicines and Ondansetron Teva

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ondansetron Teva can affect the way some medicines work. Also some other medicines can affect the way Ondansetron Teva works.

It may still be alright for you to be given Ondansetron Teva and your doctor will be able to decide what is suitable for you.

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 (an antibiotic, used to treat infections such as tuberculosis (TB))
• 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).

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Pregnancy and breast-feeding:

It is not known if Ondansetron Teva 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 Teva. This is because small amounts pass into the mother’s milk. Ask your doctor or midwife for advice.

Driving and using machines

Ondansetron Teva has no or negligible influence on the ability to drive and use machines.

Ondansetron Teva contains sodium

This medicinal product contains 31.3 mmol (or 720 mg) of sodium per maximum daily dose of 32 mg. To be taken into consideration by patients on a controlled sodium diet.

Method of administration

Ondansetron Teva is normally given by a nurse or doctor as intravenous infusion (into a vein for a longer time). The dose you have been prescribed will depend on the treatment you are having.

The recommended dose is

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 Teva. Your doctor will decide this.

Children aged over 6 months and adolescents

The doctor will decide the dose required. 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 4-hourly 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 1 month and adolescents, your doctor will decide the dose. 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. 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 1 month and adolescents, your doctor will decide the dose. 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 Teva 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 Teva than you should

Your doctor or nurse will give you Ondansetron Teva so it is unlikely that you will receive too much. If you think you have been given too much tell your doctor or nurse.

If you miss a dose of Ondansetron Teva

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 medicine, ask your doctor, pharmacist or nurse.

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

• a feeling of warmth or flushing
• constipation

• changes to liver function test results (if you have Ondansetron Teva 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.

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

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 Teva properly.

Store Ondansetron Teva 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.

What Ondansetron Teva 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 Teva solution for infusion contains 8 mg of ondansetron (as ondansetron hydrochloride dihydrate).

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

200 ml Ondansetron Teva 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 Teva looks like and contents of the pack

Ondansetron Teva 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.

In het register ingeschreven onder: RVG 111276

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Nederland B.V.

Swensweg 5, 2031 GA Haarlem

Nederland

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82.

H-2100 Gödöllő,

Hungary

Pharmachemie B.V

Swensweg 5, 2031 GA Haarlem

The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

<[To be completed nationally]>

This leaflet was last revised in maart 2013.

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The following information is intended for healthcare professionals only: Instructions for use, handling and disposal:

How to prepare and administer Ondansetron Teva

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

Compatibility with other drugs: Ondansetron Teva 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. 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 Teva 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 Teva

Shelf life before opening: 3 years

Store Ondansetron Teva 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 Teva

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