Prospecto: Information for the User

Ondansetrón Aurovitas 2 mg/ml injectable solution and for infusion EFG

Read this prospectus carefully before starting to use this medicine, because it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or nurse, even if they do not appear in this prospectus. See section 4.

1.What is Ondansetrón Aurovitas and how it is used

2.What you need to know before starting to use Ondansetrón Aurovitas

3.How to use Ondansetrón Aurovitas

4.Adverse effects

5.Storage of Ondansetrón Aurovitas

6.Contents of the package and additional information

Ondansetrón Aurovitas contains the active ingredient ondansetrón, which belongs to a group of medicines called antiemetics (prevents nausea and vomiting).

Ondansetrón injectable is used for:

•Preventing nausea and vomiting caused by chemotherapy (in adults and children) or radiation therapy in cancer treatment (only in adults).

•Preventing postoperative nausea and vomiting in adults and children aged 1 month and older.

Consult your doctor, nurse, or pharmacist if you wish to obtain more information about the use of this medication.

No useOndansetrónAurovitas

•If you areallergicto ondansetron or to any of the other components of this medication (listed in section 6).

•If you are taking apomorphine (a medication used to treat Parkinson's disease).

If you are unsure, consult your doctor, nurse or pharmacist before using ondansetron injectable.

Warnings and precautions

Consult your doctoror nursebefore starting to useOndansetrónAurovitas.

•If you have liver problems.

•If you have ever had heart problems (e.g., congestive heart failure, which causes shortness of breath and swelling of the ankles).

•If you have irregular heartbeats (arrhythmias).

•If you are allergic to similar medications to ondansetron, such as granisetron or palonosetron (do not use this medication).

•If you have chronic constipation.

•If you have an intestinal obstruction.

•If you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.

•The prevention of nausea and vomiting with ondansetron may mask a hidden bleeding after a tonsillectomy. Therefore, patients affected should be closely monitored after administration of ondansetron.

If you are in any of these situations, or if you are unsure, consult your doctor, nurse or pharmacist before using ondansetron injectable.

Other medications andOndansetrónAurovitas

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.This includes medications that you can buy without a prescription and herbal remedies. Ondansetron may affect the way some medications work and other medications may affect the way ondansetron works.

In particular, inform your doctor, nurse or pharmacist if you are taking any of the following medications:

•Carbamazepine or phenytoin, used to treat epilepsy.

•Rifampicin, used to treat infections such as tuberculosis.

•Antibiotics such as erythromycin or ketoconazole.

•Antiarrhythmic medications, used to treat irregular heartbeats.

•Beta-blockers, used to treat some heart or eye problems, anxiety or prevent migraines.

•Tramadol, an analgesic.

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

•Cancer medications (especially anthracyclines or trastuzumab).

•Selective serotonin reuptake inhibitors (SSRIs) used to treat depression and/or anxiety, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.

•Serotonin and noradrenaline reuptake inhibitors (SNRIs) used to treat depression and/or anxiety, including venlafaxine, duloxetine.

•You should not use ondansetron if you are taking apomorphine for Parkinson's disease.

If you are in any of these situations, or if you are unsure, consult your doctor, nurse or pharmacist before using ondansetron injectable.

Ondansetron injectable should not be administered in the same syringe or infusion (drip) as other medications.

Pregnancy and breastfeeding

Pregnancy

Ondansetron should not be used during the first trimester of pregnancy. This is becauseondansetronmay slightly increase the risk of a baby being born with a cleft lip and/or palate (openings or clefts in the upper lip or palate). If you are already pregnant, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before usingondansetron. If you are a fertile woman, it is recommended that you use an effective contraceptive method.

Breastfeeding

Do not breastfeed while using ondansetron as small amounts of ondansetron may pass into breast milk. Ask your doctor or midwife for advice.

Fertility

There are no data on the effects of ondansetron on human fertility.

Driving and operating machinery

The influence ofondansetronon the ability to drive and operate machinery is negligible or insignificant.

OndansetrónAurovitas contains sodium

Patients on low-sodium diets should note that this medication contains 57 mg (or 2.5 mmol) of sodium per maximum daily dose of 32 mg.

Follow exactly the administration instructions of this medication as indicated by your doctor, pharmacist or nurse. In case of doubt, consult your doctor, pharmacist or nurse again.

Ondansetrón Aurovitas is usually administered by a nurse or a doctor. The prescribed dose will depend on the treatment you are receiving.

To prevent nausea and vomiting due to chemotherapy or radiation therapy

On the day of chemotherapy or radiation therapy:

•The usual dose in adults is 8 mg, administered via an injection into a vein or a muscle immediately before your treatment, and another 8 mg 12 hours later.

In the following days:

•The usual intravenous dose in adults will not exceed 8 mg.

•It may be administered for a period of up to 5 days.

If it is likely that your chemotherapy or radiation therapy will cause intense nausea and vomiting, you may be given a higher dose of ondansetrón than usual. Your doctor will decide what to do.

To prevent nausea and vomiting due to chemotherapy in children over 6 months and adolescents

Your doctor will decide the dose based on the child's body surface area or weight.

On the day of chemotherapy:

•The first dose is administered as a slow injection into a vein, immediately before the child's treatment. After chemotherapy, the child's medication is usually administered orally. The usual dose is 4 mg.

To prevent nausea and vomiting after surgery

Adults:

•The usual dose in adults is 4 mg, administered via a slow injection into a vein or a muscle injection. This dose will be administered to you immediately before surgery.

Children (over 1 month) and adolescents:

•Your doctor will decide the dose. The maximum dose is 4 mg, administered via a slow injection into a vein. This dose will be administered to you immediately before surgery.

Patients with renal impairment

No dose adjustment is necessary.

Patients with moderate or severe liver disease

The total daily dose should not exceed 8 mg.

If you continue to feel unwell

Ondansetrón injectable should start working quickly after the injection. If you continue to feel unwell, inform your doctor or nurse.

If you are given more Ondansetrón Aurovitas than you should

Your doctor or nurse will administer the ondansetrón injection to you or your child, so it is unlikely that you or your child will receive too much. If you think you or your child have received too much or not received a dose, inform your doctor or nurse. In some patients, the following effects were observed after an overdose: visual disturbances, severe constipation, low blood pressure, heart rhythm disturbances and loss of consciousness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Allergic reactions

If you have an allergic reaction, immediately inform your doctor or a member of the medical staff. The signs may include:

•sudden wheezing and chest pain or tightness.

•swelling of the eyelids, face, lips, mouth, or tongue.

•skin rash - red spots or lumps under the skin (urticaria) anywhere on the 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)

•sensation of heat or hot flushes.

•constipation.

•abnormal liver function test results (if you are given ondansetron injection with a medicine called cisplatin, if not, this side effect is rare).

•irritation and redness at the injection site.

Rare (may affect up to 1 in 100 people)

•seizures.

•unusual body movements or tremors.

•irregular heartbeat.

•chest pain.

•low blood pressure, which may make you feel dizzy or faint.

•hypotension.

•hypersensitivity reactions around the injection site (e.g., skin rash, urticaria, itching), which sometimes extend along the vein in which the drug is administered.

•abnormal blood test results for liver function checks.

Rare (may affect up to 1 in 1,000 people)

•dizziness.

•blurred vision.

•alteration of heart rhythm (which sometimes causes sudden loss of consciousness).

•diarrhea and abdominal pain.

Very rare (may affect up to 1 in 10,000 people)

•poor vision or temporary loss of vision, which usually resolves in 20 minutes.

•depression.

•generalized rash with blisters and peeling of the skin on a large area of the body (toxic epidermal necrolysis).

Frequency not known (cannot be estimated from available data)

•myocardial ischemia.

The signs include:

-sudden chest pain or

-chest tightness

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store the ampoules in the outer packaging to protect them from light.

Do not use this medication if you observe particles or signs of discoloration.

Medications should not be thrown down the drain or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofOndansetrón Aurovitas

-The active ingredient is ondansetrón (as hydrochloride dihydrate). Each ml ofinjectable and infusion solutioncontains 2 mg of ondansetrón (as hydrochloride dihydrate).

Cada ampoule of 2 ml contains 4 mg of ondansetrón (as hydrochloride dihydrate).

Cada ampoule of 4 ml contains 8 mg of ondansetrón (as hydrochloride dihydrate).

-The other components are citric acid monohydrate, sodium citrate, sodium chloride, and water for injection preparations.

Aspect of the product and contents of the package

Clear and colorless solution, without visible particles.

Ondansetrón Aurovitas is a clear and colorless solution conditioned in transparent type I glass ampoules. To facilitate opening, the ampoules may have a cutting point (OPC) or may be scored.

Ondansetrón Aurovitas 2 mg/ml is available in ampoules of 2 ml and 4 ml, conditioned in boxes of 1, 5 or 10 ampoules.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Further information about this medicinal product can be obtained by contacting the local representative of the holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:April 2023

This information is intended solely for healthcare professionals:

Nausea and vomiting induced by chemotherapy and radiotherapy

Adults

The emetogenic potential of cancer treatment varies according to the dose and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of ondansetrón should be flexible in the range of 8-32 mg per day, and should be selected as follows.

Chemotherapy and radiotherapy-induced emesis:In most patients receiving chemotherapy or radiotherapy-induced emesis, 8 mg of ondansetrón should be administered by intravenous injection over at least 30 seconds or intramuscularly, or by other routes of administration,15 minutes before treatment. However, this product is only for administration by injection or infusion.

To protect against delayed or prolonged emesis after the first 24 hours, ondansetrón treatment by oral route should continue for 5 days after a treatment cycle.

Highly emetogenic chemotherapy:For patients receiving highly emetogenic chemotherapy, p. e., high-dose cisplatino, ondansetrón can be administered by intravenous or intramuscular route.

It has been shown that ondansetrón is equally effective in the following dosing regimens in the first 24 hours of chemotherapy:

•A single dose of 8 mg by intravenous injection over at least 30 seconds or by intramuscular injection15 minutes, immediately before chemotherapy.

•A dose of 8 mg by intravenous injection over at least 30 seconds or by intramuscular injection15 minutes, immediately before chemotherapy, followed by two additional intravenous (over at least 30 seconds) or intramuscular doses of 8 mg, spaced 4 hours apart, or by a continuous infusion of 1 mg/hour for 24 hours.

•Doses of more than 8 mg and up to a maximumof 16 mg diluted in 50-100 ml of saline solution or other compatible infusion liquids (see Instructions for use/manipulation) and infused over at least 15 minutes immediately before chemotherapy.

•A single dose of more than 16 mg should not be administered due to the increased risk of dose-dependent prolongation of the QT interval (see sections 4.4, 4.8 and 5.1 of the SmPC).

The selection of the dosing regimen should be determined according to the intensity of the emetogenic treatment.

The efficacy of ondansetrón in highly emetogenic chemotherapy may be enhanced by the administration of a single intravenous dose of 20 mg of sodium phosphate of dexametasona before chemotherapy.

To protect against delayed or prolonged emesis after the first 24 hours, ondansetrón treatment by oral route should continue for 5 days after a treatment cycle.

Pediatric population

Nausea and vomiting induced by chemotherapy in children ≥6 months and adolescents

The dose for chemotherapy-induced nausea and vomiting can be calculated based on body surface area (SC) or weight (see below). In pediatric clinical studiesondansetrón was administered by intravenous infusion diluted in 25 to 50 ml of saline solution or other compatible infusion liquids and administered over at least 15 minutes. The dosing regimen based on weight results in a higher total daily dose than that calculated from SC (see sections 4.4 and 5.1 of the SmPC).

Hydrochloride of ondansetrón should be diluted in dextrose 5% or sodium chloride 0.9% or other compatible infusion liquids (seeInstructions for use/manipulation) and administered by intravenous infusion over at least 15 minutes.

There are no controlled clinical trial data on the use of ondansetrón injectable for the prevention of delayed or prolonged emesis induced by chemotherapy. There are no controlled clinical trial data on the use of ondansetrón injectable for nausea and vomiting induced by radiotherapy in children.

Calculation of doses by body surface area:

Ondansetrón should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m2. The single intravenous dose should not exceed 8 mg. Oral treatment can start 12 hours later and can continue for up to 5 days (see dosing tables in the SmPC). The total daily dose in 24 hours should not exceed the adult dose of 32 mg.

Calculation of doses by weight:

The dosing regimen based on weight results in a higher total daily dose than that calculated from SC. Ondansetrón should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The single intravenous dose should not exceed 8 mg. Two additional intravenous doses of 8 mg can be administered at intervals of 4 hours. Oral treatment can start 12 hours later and can continue for up to 5 days. The total dose in 24 hours (administered in divided doses) should not exceed the adult dose of 32 mg (for more information, see the SmPC).

Geriatric population

In patients aged 65 to 74 yearsthe same dosing regimens as for adults can be followed. All intravenous doses should be diluted in 50-100 ml of saline solution or other compatible infusion liquids (seeInstructions for use/manipulation) and administered by infusion over 15 minutes.

In patients aged 75 years or older, the initial intravenous dose of ondansetrón should not exceed 8 mg. All intravenous doses should be diluted in 50-100 ml of saline solution or other compatible infusion liquids (seeInstructions for use/manipulation) and administered by infusion over 15 minutes. After the initial dose of 8 mg, two additional doses of 8 mg can be administered by infusion over 15 minutes, with a minimum interval of 4 hours between doses (see SmPC).

Nausea and vomiting postoperative (NVPO)

Adults

For the prevention of NVPO, ondansetrón can be administered by oral or intravenous or intramuscular route.

Ondansetrón can be administered as a single dose of 4 mg by intramuscular or intravenous injection over at least 30 seconds at the time of anesthesia induction.

For the treatment of established NVPO, a single dose of 4 mg by intramuscular or intravenous injection over at least 30 seconds is recommended.

Pediatric population

Children (over 1 month and adolescents)

Injection:

For the prevention of NVPO in pediatric patients undergoing surgery with general anesthesia, a single dose of ondansetrón can be administered by intravenous injection over at least 30 seconds at a dose of 0.1 mg/kg up to a maximum of 4 mg before, during or after anesthesia induction. For the treatment of NVPO in pediatric patients after surgery with general anesthesia, a single dose of ondansetrón can be administered by intravenous injection over at least 30 seconds at a dose of 0.1 mg/kg up to a maximum of 4 mg. There are no data on the use of ondansetrón injectable for the treatment of postoperative vomiting in children under 2 years.

Geriatric population

There is limited experience with the use of ondansetrón for the prevention and treatment of NVPO in the elderly, although ondansetrón is well tolerated in patients over 65 years treated with chemotherapy.

For all indications:

Patients with renal insufficiency:No dose adjustment is required.

Patients with hepatic insufficiency:The clearance of ondansetrón is significantly reduced and the serum half-life is significantly prolonged in patients with moderate or severe hepatic insufficiency. In these patients, the total daily dose should not exceed 8 mg.

Patients who are slow metabolizers of sparteine/debrisoquine:The elimination half-life of ondansetrón is not altered in individuals classified as slow metabolizers of sparteine and debrisoquine. Consequently, the exposure to the drug after repeated administration in these patients does not differ from that achieved in the general population. No dose adjustment is required.

Instructions for use/manipulation

The ondansetrón injectable and infusion solution should not be sterilized in an autoclave.

Incompatibilities:

The ondansetrón injectable and infusion solution is physically compatible and chemically stable when mixed with the following infusion solutions in the concentration range of 0.016 mg/ml to 0.64 mg/ml.

•Sodium chloride 0.9% w/v.

•Dextrose 5% w/v.

•Manitol 10% w/v.

•Ringer's solution.

•Potassium chloride 0.3% w/v and sodium chloride 0.9% w/v.

•Potassium chloride 0.3% w/v and dextrose 5% w/v.

Compatibility studies with the above diluents have been performed in polyvinyl chloride infusion bags and equipment and administration sets of polyvinyl chloride. It is also considered that the use of polyethylene infusion bags or type I glass ampoules provides adequate stability. It has been demonstrated that dilutions of ondansetrón injectable and infusion solution in intravenous infusion solutions of sodium chloride 0.9% w/v or dextrose 5% w/v are stable in polypropylene syringes. It is considered that ondansetrón injectable and infusion solution diluted with other compatible infusion liquids would be stable in polypropylene syringes.

Shelf-life and storage conditions:

Unopened:3 years.

Injection:The product should be used immediately after the first opening.

Infusion:Stability has been demonstrated for 7 days at 15-25°C and at

2-8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage conditions in use should not be longer than 24 hours at 2-8°C,unless the dilution has taken place in controlled and validated aseptic conditions.