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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 using this medicine because it contains important information for you

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor, pharmacist 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

The name of the medicinal product is Ondansetron 2mg/ml Solution for Injection or Infusion but will be referred to as Ondansetron Injection throughout the package leaflet

Ondansetron Injection contains the active ingredient ondansetron, which belongs to a group of medicines called anti-emetics.

Ondansetron Injection is used for

•    Preventing nausea (feel sick) and vomiting (be sick) caused by

o chemotherapy for cancer in adults and in children aged >6 months. o radiotherapy for cancer in adults

•    Preventing and treatment of nausea and vomiting after surgery in adults and in children aged > 1 month. Ask your doctor, nurse or pharmacist if you would like any further explanation about this uses.

Do not use Ondansetron Injection:

-    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)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Ondansetron Injection

-    if you have a blockage in your gut or suffer from severe constipation Ondansetron can make these conditions worse.

-    if you have liver problems

-    if you have ever had problem with your heart or are taking medicines used to treat heart problems

-    if you have an uneven heart beat (arrhythmias)

-    if you are having surgery to remove your tonsils, because treatment with ondansetron may hide symptoms

of internal bleeding

-    if you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium

-    if your child is being treated & he / she is less than 2 years old, with liver damage.

Always inform the laboratory during tests of blood and urine that you are being treated with ondansetron.

If any of the above statements are applicable to you, please tell your doctor before having the injection.

Other medicines and Ondansetron injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, natural supplements or vitamins or minerals.

You must tell your doctor that you are using Ondansetron, if he/she starts treating you with the following medicine:

•    Phenytoin (used to treat epilepsy & heart arrhythmias)

•    Carbamazepine (used to treat epilepsy & neuralgic pain)

•    Rifampicin (an antibiotic)

•    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 (used to treat pain following surgery)

•    Apomorphine (medicine used to treat Parkinson’s disease)

•    Medicines that affect the heart (such as haloperidol or methadone)

•    Cancer medicines (especially anthracyclines and trastuzumab).

The effect of ondansetron may be weakened if you are taking phenytoin, carbamazepine or rifampicin. The painkilling effect of Tramadol may be weakened if you are taking ondansetron.

Contact your doctor. It may be necessary to adjust the dose.

Ondansetron injection with food and drink

You may use ondansetron injection independently of food and drink

Pregnancy, breast-feeding and fertility:

Pregnancy:

Because of insufficient experience the use of ondansetron injection 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:

The ondansetron in Ondansetron Injection may pass into mothers' milk. Therefore mothers receiving

ondansetron injection should not breast-feed their baby

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

Ondansetron injection will not affect your ability to drive or operate machinery.

Important information about some of the ingredients in this medicine

This medicinal product contains 2.5 mmol (or 57.9 mg) sodium per maximum daily dose of 32 mg. To be taken into consideration by patients on a controlled sodium diet.

Ondansetron 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

Adults

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.

•    oral dosing can commence twelve hours later and may be continued 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 Injection. Your doctor will decide this.

To prevent nausea and vomiting from chemotherapy

Children aged over 6 months and adolescents The doctor will decide the dose.

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.

To prevent nausea and vomiting after an operation

•    The usual dose for adults is 4 mg given by an injection into your vein or muscle. This will be given just before your operation.

•    For children aged over 1 month and adolescents, the doctor will decide the dose. 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 or muscle.

•    For children aged over 1 month and adolescents, the doctor will decide the dose. A single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose 0.1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.

Patients with moderate or severe liver problems The total daily dose should not be more than 8 mg.

If you received more Ondansetron Injection than you should

Little is known at present about over dosage with ondansetron. In a few patients, the following effects were seen after overdosage: disturbances of vision, severe constipation, lowered blood pressure and loss of consciousness. In all cases the symptoms disappeared completely. There is no particular antidote to ondansetron. For that reason, if overdose is suspected, only the symptoms should be treated. Tell your doctor or nurse if any of these symptoms occur.

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.

SERIOUS SIDE-EFFECTS Allergic Reactions

These are rare, but allergic (hypersensitivity) reactions can produce a skin rash- red spots or lumps under your skin (hives) anywhere on your body and itching as well as more serious symptoms such as swelling of the hands, feet, ankles, face, eyelids, lips, mouth and/or throat. This can lead to difficulty swallowing and breathing.

Heart rhythm disorders

These are uncommon but can produce palpitations (an unpleasant sensation of an irregular and/or forceful beating of the heart) or a very slow heart beat. There may also be chest pain or chest tightness and sudden wheezing or collapse.

These serious side-effects can be life-threatening, therefore TELL YOUR DOCTOR OR NURSE IMMEDIATELY IF YOU EXPERIENCE ANY OF THE SYMPTOMS ABOVE.

Less serious side-effects:

Very common More than 1 in 10 patients

Common

More than 1 in 100, but less than 1 in 10, patients

Uncommon

More than 1 in 1,000, but less than 1 in 100 patients

Rare

More than 1 in 10,000 patients, but less than 1 in 1,000 patients

Very rare

Less than 1 in 10,0000 patients, including isolated reports

If you are going to have any blood tests or liver function test, this medicine may affect the results, so inform your doctor. If you feel unwell or have any unusual discomfort you do not understand, tell your doctor as soon as possible.

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 ampoule or carton after EXP. The expiry date refers to 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 container is damaged or particles / crystals are visible.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ondansetron Injection contains:

The active ingredient in Ondansetron Injection is ondansetron (as hydrochloride dihydrate).

Each ml of solution for injection or infusion contains 2 mg ondansetron (as ondansetron hydrochloride dihydrate)

Each ampoule of 2ml contains 4mg of ondansetron (as ondansetron hydrochloride dihydrate).

Each ampoule of 4ml contains 8mg of ondansetron (as ondansetron hydrochloride dihydrate).

The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for Injections

What Ondansetron solution for Injection or Infusion looks like and contents of the pack:

Ondansetron Injection is a clear colourless solution for injection or infusion filled in clear/amber glass ampoule.

Ondansetron Injection 2 mg/ml is available in pack containing 5 X 2 ml and 5 X 4 ml ampoules and also available in 10 X 2 ml and 10 X 4 ml ampoules.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer:

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow HA1 4HF, UK

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

Name of the member state	Name of the medicinal product
United Kingdom	Ondansetron 2mg/ml Solution for Injection or Infusion
Austria	Ondansetron Accord 2 mg/ml Losung zur Injektion oder Infusion
Belgium	Ondansetron Accord Healthcare 2 mg/ml solution pour injection ou perfusion/ oplossing voor injectie of infusie/ Losung zur Injektion oder Infusion
Cyprus	Ondansetron Accord 2 mg/ml svsotM-o StaXup-a f\ StaXup-a yta syyoon
Czech Republic	Ondansetron Accord 2 mg/ml injekcm roztok nebo infuzi
Denmark	Ondansetron Accord 2 mg/ml injektions og infusionsv^ske, opl0sning
Germany	Ondansetron Accord 2 mg/ml Losung zur Injektion oder Infusion
Estonia	Ondansetron Accord 2 mg/ml
Greece	Ondansetron Accord 2 mg/ml svsot^o StaXu^a f\ StaXu^a yta syxoon
Spain	Ondansetron Accord Healthcare 2 mg/ml para inyeccion o infusion EFG
Finland	Ondansetron Accord 2 mg/ ml injektio- tai infuusioneste/ Losning for injektion och infusion
Hungary	Ondansetron Accord 2 mg/ml oldatos injekcio vagy infuzio
Ireland	Ondansetron 2 mg/ml Solution for Injection or Infusion
Italy	Ondansetrone Accord Healthcare 2mg/ml Soluzione per Iniezione o Infusione
Latvia	Ondansetron Accord 2 mg/ml skidums injekcijam vai infuzijam
Malta	Ondansetron 2 mg/ml Solution for Injection or Infusion
Norway	Ondansetron Accord 2 mg/ml oppl0sning til injeksjon og infusjon
Poland	Ondansetron Accord 2 mg/ml
Portugal	Ondansetrom Accord
Sweden	Ondansetron Accord 2 mg/ml Losning for injektion och infusion
Slovenia	Ondansetron Accord 2 mg/ml raztopina za injiciranje ali infundiranje

Name of the member state	Name of the medicinal product
Slovak Republic	Ondansetron Accord 2 mg/ml injekcny alebo infuzny roztok
Bulgaria	Ondansetron Accord 2 mg/ml Solution for Injection or Infusion
The Netherlands	Ondansetron Accord 2 mg/ml oplossing voor injectie of infusie
Lithuania	Ondansetron Accord 2 mg/ml injekcinis/infuzinis tirpalas

The leaflet was last approved in 08/2012.

The following information is intended for medical or healthcare professionals only Instructions for use:

For intravenous injection or intramuscular injection or intravenous infusion after dilution.

Prescribes intending to use ondansetron in the prevention of delayed nausea and vomiting associated with chemotherapy or radiotherapy in adults, adolescents or children should take into consideration current practice and appropriate guidelines.

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 patient receiving Emetogenic chemotherapy and radiotherapy, ondansetron can be given either by intravenous or intramuscular or other routes of administration. However this product is for injection or infusion only.

For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron 8 m g should be administered as a slow intravenous or intramuscular injection or as a short-time intravenous infusion over 15 immediately before treatment, followed by 8 mg orally twelve hourly.

To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with ondansetron associated with dexamethasone should be continued for up to 5 da ys after a course of treatment. Ondansetron treatment with other dosage forms than intravenous 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 or intramuscular injection immediately before chemotherapy.

•    A dose of 8 mg by slow intravenous or intramuscular injection or as a short-time intravenous infusion over 15 minutes immediately before chemotherapy, followed by two further intravenous or intramuscular doses of 8 mg two to four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.

•    A single dose of 16mg of ondansetron may only be given by intravenous infusion diluted in 50-100 ml of saline (0.9% w/v) or other compatible infusion fluid and over not less than 15 minutes immediately before chemotherapy.

The selection of dose regimen should be determined by the severity of the emetogenic challenge.

A single dose greater than 16mg must not be given due to dose dependent increase of QT-prolongation risk (see sections 4.4, 4.8 and 5.1 of the SPC).

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.

Dosing by BSA:

Ondansetron Injection should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m .The 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 intravenous dose must not exceed 8 mg. Two further intravenous doses may be given in 4-hourly intervals. The total daily dose must not exceed adult dose of 32 mg. Oral dosing can commence twelve hours later and may be continued for up to 5 days (see SPC for further details).

Ondansetron Injection should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid (see section 6.6) 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 delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Ondansetron Injection for radiotherapy-induced nausea and vomiting in children.

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)

Oral formulation:

No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow i.v. injection is recommended for this purpose.

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 4mg. 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.

Please refer also to “Special Populations”.

Special populations

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 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.

Incompatibilities:

The solution must not be sterilised in an autoclave.

Ondansetron Injection should only be admixed with those infusion solutions, which are recommended:

Sodium Chloride Intravenous Infusion BP 0.9%w/v

Glucose Intravenous Infusion BP 5%w/v

Mannitol Intravenous Infusion BP 10%w/v

Ringers Intravenous Infusion

Potassium Chloride 0.3%w/v and Sodium Chloride 0.9%w/v Intravenous Infusion BP Potassium Chloride 0.3%w/v and Glucose 5%w/v Intravenous Infusion BP

The stability of Ondansetron Injection after dilution with the recommended infusion fluids have been demonstrated in concentrations 0.016 mg/ml and 0.64 mg/ml.

Use only clear and colourless solutions.

The diluted solutions should be stored protected from light.

Shelf-life and storage

Unopened 3 years

This medicinal product does not require any special temperature storage conditions.

Keep ampoules in the outer carton in order to protect from light.

Injection

After first opening the medicinal product should be used immediately.

Infusion

After dilution with recommended diluents chemical and physical in-use stability has been demonstrated for 7 days at 25°C and 2-8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, inuse 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 dilution has taken place in controlled and validated aseptic conditions.