ONDEMET 2mg/ml Injection (Ondansetron 2mg/ml Solution for Injection and Infusion)
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Ondemet Injection is and what it is used for
2. Before you receive Ondemet Injection
3. How Ondemet Injection will be given
4. Possible side effects
5. Storing Ondemet Injection
The name of this medicine is Ondemet 2mg/ml Injection (referred to as Ondemet Injection throughout this leaflet).
Marketing Authorisation Holder:
Manufacturer:
This medicine is manufactured by
What Ondemet Injection is and what it is used for
Ondemet 2mg/ml Injection is a solution for injection or infusion into a vein or injection into a muscle. It contains the active ingredient ondansetron. Each ampoule contains 4mg or 8mg ondansetron (as hydrochloride dihydrate) in a solution containing 2mg/ml of ondansetron. Other ingredients in Ondemet Injection are sodium chloride, citric acid monohydrate, sodium citrate and water for injections. Ondemet Injection is available in 2ml or 4ml glass ampoules. Each pack of Ondemet Injection contains 5 or 25 ampoules.
Ondansetron is one of a group of medicines called anti-emetics. It is used in children over 2 years, adolescents and adults (including the elderly) to treat nausea (feeling sick) and vomiting (being sick) caused by chemotherapy or radiotherapy. It is also used to prevent nausea and vomiting in patients following an operation.
Before you receive Ondemet Injection
Ondemet Injection should NOT be used if:
- You have ever had an allergic reaction to ondansetron or to other similar anti-emetics (e.g. granisetron, dolasetron) or to any of the other ingredients.
Before receiving Ondemet Injection, tell your doctor if:
- You have a sensitivity to medicines similar to Ondemet Injection.
- You have a blockage in your gut
- You have liver problems
- You are due to have surgery to the adenoids or tonsils
- You have a heart problem or are taking medicines used to treat a heart problem
- Your child is being treated and he/she is very small or is younger that 2 years old
Consult your doctor or pharmacist if these statements were applicable to you at any time in the past.
Taking Ondemet Injection with other medicines
Tell your doctor if you are taking any of the following medicines:
- Phenytoin (used to treat epilepsy and heart arrhythmias), Carbamazepine (used to treat epilepsy and neuralgic pain) or Rifampicin (an antibiotic), as these medicines may reduce the effect of ondansetron
- Tramadol (used to treat pain following surgery), as the effect of this medicine may be reduced by ondansetron
Tell your doctor if you are taking any other medicine including those that you have bought.
Pregnancy and breast feeding
It is not recommended that Ondemet Injection be used during pregnancy. If it is absolutely necessary it should be given with caution especially in the first trimester. If you are receiving Ondemet Injection you should not breast-feed your baby.
Driving and using machines
Ondemet Injection is unlikely to affect your ability to drive or operate machinery.
How Ondemet Injection will be given
Your doctor will have decided the correct dose of Ondemet Injection for you.
Treatment of nausea and vomiting in patients receiving chemotherapy or radiotherapy
For patients receiving chemotherapy or radiotherapy ondansetron can be given either orally or by injection or infusion into a vein. For most patients Ondemet Injection is given by injection into a vein immediately before treatment, followed by 8mg orally every 12 hours. The dose of Ondemet Injection will depend on the dose and combination of chemotherapy and radiotherapy given.
Treatment of severe nausea and vomiting in patients receiving chemotherapy
Adults: the usual dose is 8mg given as a slow injection or as a short infusion into a vein, lasting 15 minutes immediately before chemotherapy. If this dose is not enough, either a further 8mg dose can be given every 4th hour (maximum of two doses), or a continuous infusion of 1mg/hour for 24 hours. In some cases the initial dose can be increased to 32mg given as an infusion lasting at least 15 minutes immediately before chemotherapy. After 24 hours treatment is changed to the oral route.The effect of Ondemet Injection may be increased by giving another type of anti-emetic (e.g.dexamethasone) as an injection into a vein at the same time.
Children (aged 2 years and over) and adolescents (under 18 years old): Ondansetron may be given as a slow injection into a vein over 15 minutes immediately before chemotherapy, followed by a 4mg dose taken orally 12 hours later. Oral treatment should be continued for up to 5 days after a course of treatment. The dose given will depend on the size of the child and will be worked out by the doctor.
Ondemet Injection should not be given to children under 2 years or children who are very small.
The elderly (over 65 years): Ondansetron is well tolerated in this patient group and no special dosing instructions are required.
Prevention of nausea and vomiting after an operation
Ondansetron can be given orally or as an injection into a vein.
Adults: 8mg given as a slow injection at the same time as anaesthesia.
Children aged 2 years and over: 0.1mg/kg up to a maximum of 4mg as a slow injection into a vein either before, at or after anaesthesia.
Treatment of established nausea and vomiting in patients after an operation
Adults: For the treatment of established nausea and vomiting following an operation Ondemet Injection given into a vein is recommended. The usual dose is up to 8mg as a slow injection into a vein or into a muscle.
Children (aged 2 years and over) and adolescents (under 18 years): For the prevention and treatment of nausea and vomiting after an operation slow injection into a vein of 0.1 mg/kg (up to a maximum of 4mg) is recommended
The elderly (over 65 years): There is little experience in the use of ondansetron in the prevention and treatment of nausea and vomiting following an operation, however ondansetron is well tolerated in this group of patients receiving chemotherapy.
Patients with moderate or severe liver problems
The total daily dose should not be more than 8mg.
If you have the impression that the effect of Ondemet Injection is too strong or too weak, talk to your doctor.
Possible side effects
Like all medicines, Ondemet Injection may cause side effects.
A few people can be allergic to some medicines. If any of the following happen, stop taking Ondemet Injection and tell your doctor immediately or go to the casualty department of the nearest hospital:
- Severe itching of the skin, rash
- Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulties in swallowing or breathing.
- Collapse
You may have had a serious allergic reaction to Ondemet Injection.
All of these are very serious side effects and are rare. Tell your doctor if you notice any of the following:
Side effects that are very common:
- Headache
Side effects that are common:
- Constipation
- Local burning sensation following insertion of suppositories
- Sensation of flushing and warmth
- Local reaction at the injection site
Side effects that are uncommon:
- Hiccups
- Low blood pressure
- Chest pains or palpitations
- Slowing of the heart rate
- Seizures
- Upward movement of the eyes
- Abnormal body movements or shaking
- An increase in liver function tests (commonly seen in patients receiving chemotherapy with cisplatin)
Side effects that are rare:
- Dizziness (during rapid injection into a vein)
- Muscle cramps
- Visual disturbances e.g. blurred vision (mainly during rapid injection into a vein)
Side effects that are very rare:
- Temporary blindness (mainly during injection into a vein and in patients receiving chemotherapy e.g. cisplatin)
If you do experience side effects these usually disappear after a few days of treatment. If they are troublesome or persistent, or if you have side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Storing Ondemet Injection
There are no special storage instructions. Ondemet Injection should be used immediately. Any unused solution should be discarded. Do not use if the solution is not clear. Keep out of the reach and sight of children.
Use by date:
Do not use Ondemet Injection after the expiry/use before date on the ampoule and carton.
Further information:
This leaflet does not include all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Date of preparation of the leaflet:
January 2006
PIL Ondemet Inj_02 2col 200601312
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