Prospecto: information for the patient

Ondansetrón Kabi 0.08 mg/ml infusion solution

Ondansetrón Kabi 0.16 mg/ml infusion solution

Read this prospect carefully before this medicine is administered to you, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• 1. If you have any doubts, consult your doctor, nurse or pharmacist.

-If you experience any adverse effects, consult your doctor, pharmacist or nurse,even if they are not listed in this prospect. See section 4.

1.What Ondansetrón Kabi is and for what it is used

2.What you need to know before Ondansetrón Kabi is administered to you

3.How Ondansetrón Kabi is administered

4.Possible adverse effects

1. Conservation of Ondansetrón Kabi

6.Contents of the package and additional information

Ondansetrón belongs to a group of medicines called anti-emetics, medicines against the feeling of dizziness or against dizziness. Some medical treatments with medicines for cancer treatment (chemotherapy) or radiation therapy may make you feel dizzy (nauseas) or dizzy (vomiting). You may also feel dizzy (nauseas) or dizzy (vomiting) after a surgical treatment. Ondansetrón may help you prevent or stop these effects.

No useOndansetrón Kabi

• If you are allergic to ondansetron, other 5HT3 receptor selective antagonists (e.g. granisetron, dolasetron), or any of the other components of this medication (listed in section6).
• If you are being treated with apomorphine (a medication used to treat Parkinson's disease)

Warnings and precautions

Consult your doctor, nurse or pharmacist before starting to use ondansetron.

• If you have experienced hypersensitivity to other anti-nausea or anti-vomiting medications, such as granisetron or palonosetron.
• If you have a bowel obstruction or severe constipation. This medication may prevent the movement of the small intestine.
• If you have any liver damage.
• If you are to undergo surgery to remove your tonsils located at the back of the nasal passage (adenoidectomy).
• If you have ever had heart problems, including irregular heartbeats (arrhythmias). This medication prolongs the QT interval in a dose-dependent manner (ECG signal of delayed heart repolarization with risk of life-threatening arrhythmias).
• If you have problems with the levels of salts in your blood, such as potassium, sodium, and magnesium.

Other medications and Ondansetrón Kabi

Inform your doctor, nurse or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

• If you are taking tramadol (analgesic): ondansetron may reduce the analgesic effect of tramadol.
• If you are taking phenytoin, carbamazepine (antiepileptic) or rifampicin (antibiotic for tuberculosis): they decrease the blood concentrations of ondansetron.
• If you are taking cardiotoxic medications (anthracyclines (antibiotics against cancer such as doxorubicin, daunorubicin) or trastuzumab, a cancer medication, antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (such as amiodarone) and beta-blockers (medications that slow the heart rate, such as atenolol or timolol)): the use of ondansetron with other medications that prolong the QT interval may lead to additional QT interval prolongation, i.e., increase the risk of arrhythmias.
• If you are taking other serotoninergic medications such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) such as sertraline or duloxetine (both are antidepressants): cases of serotonin syndrome (e.g., excessive state of alertness and agitation, increased heart rate and blood pressure, tremors, and involuntary movements) have been reported in patients taking ondansetron concomitantly with other serotoninergic medications.

• If you are taking apomorphine (medication for Parkinson's disease): apomorphine should not be used with ondansetron, as cases of deep hypotension (low blood pressure) and loss of consciousness have been reported when both medications are administered together.

Pregnancy and lactation

Ondansetron should not be used during the first trimester of pregnancy. This is because ondansetron may slightly increase the risk of a baby being born with cleft lip and/or palate (openings or clefts in the upper lip or palate).

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

If you are a fertile woman, it is recommended that you use an effective contraceptive method.

Ondansetron passes into breast milk. Therefore, mothers receiving ondansetron should not breastfeed.

Driving and operating machinery

Ondansetron has no effect on the ability to drive or operate machinery.

Ondansetrón Kabicontains sodium

This medication contains 357mg of sodium (main component of table salt/for cooking) in each 100ml bottle. This is equivalent to 17.9% of the maximum daily recommended sodium intake for an adult.

This medication contains 178.5mg of sodium (main component of table salt/for cooking) in each 50ml bottle. This is equivalent to 8.9% of the maximum daily recommended sodium intake for an adult.

Administration Form

This medicationis administered as an intravenous infusion. It is usually administered by a doctor or a nurse.

Dose

Adults (under 75 years of age)

Your doctor will decide on the correct dose of ondansetron therapy for you.

The dose depends on your medical treatment (chemotherapy or surgery) and liver function.

In the case of chemotherapy or radiation therapy, the usual dose in adults is 8‑32mg of ondansetron per day. A single dose should not exceed 16 mg.

For the treatment of postoperative nausea and vomiting, a single dose of 4mg of ondansetron is usually administered. For the prevention of postoperative nausea and vomiting, a single dose of 4mg of ondansetron is usually administered.

Children over 6months of age and adolescents

In the case of chemotherapy, the usual dose is a single intravenous dose of 5 mg/m2(body surface area) or 0.15 mg/kg (body weight)immediately before chemotherapy. The single intravenous dose should not exceed 8 mg. The total dose over 24 hours (administered in divided doses) should not exceed the adult dose of 32 mg.

Children over 1month of age and adolescents

• The usual dose for the treatment of postoperative nausea and vomiting is 0.1 mg / kg (body weight) up to a maximum of 4 mg.
• The usual dose for the prevention of postoperative nausea and vomiting is 0.1 mg/kg (body weight) up to a maximum of 4 mg. This dose should be administered just before the procedure.

Dose Adjustment

Older patients

In the case of chemotherapy, the initial doses should not exceed 8 mg in patients 75 years of age or older.

Patients with liver insufficiency

In patients with liver problems, the dose should be adjusted to a maximum daily dose of 8 mg of ondansetron.

Patients with renal insufficiency or slow metabolism of sparteine/debrisoquine

No dose adjustment is required.

Treatment Duration

Your doctor will decide on the duration of your ondansetron treatment.

After intravenous administration of ondansetron, treatment may be continued with ondansetron tablets or suppositories for up to 5 days.

If you have received more Ondansetrón Kabi than you should

Little is currently known about ondansetron overdose. Overdose increases the likelihood of the adverse effects described in section 4. In a limited number of patients, the following effects were observed after an overdose: visual disturbances, severe constipation, low blood pressure, cardiac rhythm disturbances, and dizziness. In all cases, symptoms disappeared completely.

Your doctor or nurse will administerondansetronto you or your child, so it is unlikely that you or your child will receive more than you should. If you think you or your child have been given more or not given a dose, inform your doctor or nurse.

There is no specific antidote for ondansetron; therefore, if an overdose is suspected, only the symptoms should be treated.

Inform your doctor if you experience any of these symptoms.

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

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 ingested.

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

Inform your doctor or nurse immediately if you notice any of the following symptoms:

Uncommon:may affect up to 1 in 100people

• Chest pain, arrhythmic heartbeat (which can be fatal in individual cases) and slow heartbeat (bradycardia)

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

• Immediate allergic reactions, including life-threatening anaphylaxis. These reactions may be: itchy skin rash, swelling of the eyelids, face, lips, mouth, and tongue.

Frequency not known:cannot be estimated from available data

• Myocardial ischemia
  Signs include: sudden chest pain or chest tightness.

Otherside effectsinclude:

Very common:may affect more than 1 in 10people

• Headache

Common:may affect up to 1 in 10people

• Constipation
• Sensations of redness or heat
• Irritation and redness at the site of injection

Uncommon:may affect up to 1 in 100people

• Low blood pressure, which may make you feel weak or dizzy
• Seizures
• Unusual or agitated body movements
• Hiccups
• Interference with liver function tests

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

• Sensation of dizziness or fainting
• Blurred vision
• Alterations in heart rhythm (sometimes causing sudden loss of consciousness)

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

• Transient blindness(which usually resolves in 20minutes)
• Skin rash, e.g. red spots or lumps under the skin (urticaria) anywhere on the body that may transform into large blisters

Reporting of 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 to theSpanish 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 use this medication after the expiration date that appears on the label of the bottle and 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 bottle in the outer packaging to protect it from light.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

Composition of Ondansetron Kabi

• The active ingredient is ondansetron.

Ondansetron Kabi 0.08 mg/ml, 1ml of infusion solution contains 0.08mg of ondansetron as ondansetron hydrochloride dihydrate.

Each vial with 50ml contains 4mg of ondansetron

Each vial with 100ml contains 8mg of ondansetron

Ondansetron Kabi 0.16 mg/ml, 1ml of infusion solution contains 0.16 mg of ondansetron as ondansetron hydrochloride dihydrate.

Each vial with 50ml contains 8mg of ondansetron

• The other components are sodium chloride, sodium citrate, citric acid monohydrate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injection preparations.

Appearance of the product and contents of the package

Ondansetron Kabi is a transparent and colorless solution in LDPE plastic vials.

Each vial contains:

Ondansetron Kabi 0.08 mg/ml: 50 ml, 100 ml

Ondansetron Kabi 0.16 mg/ml: 50 ml

Package sizes:

Ondansetron Kabi 0.08 mg/ml: 1, 10, 20, 40

Ondansetron Kabi 0.16 mg/ml: 1, 10, 20, 40

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Fresenius Kabi España, S.A.U.

C/ Marina 16-18

08005 Barcelona

Spain

Manufacturer responsible:

Fresenius Kabi Polska SP. Z.o.o.

Ul. Henryka Sienkiewicza 25

99-300 Kutno

Poland

This medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Last review date of this leafletMarch 2022

For detailed and updated information on this medicinal product, please consult the Technical Dossier or Summary of Product Characteristics.

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This information is intended solely for healthcare professionals:

Instructions for use, handling, and disposal

Keep the vial in the outer packaging to protect it from light.

Use only transparent and colorless solutions.

For single use only.

This medicinal product should be used immediately after the first opening.

Any unused solution and the vial should be disposed of properly, in accordance with local requirements.

Compatibility with other medicinal products:

The following medicinal products can be administeredat the same time asondansetronthrough the Y-connector of the infusion equipment.Although general compatibility has been demonstrated for up to 1hour, the recommendations provided by the manufacturer for the medicinal product to be administered at the same time should be taken into account.

Cisplatin:Concentrations of up to 0.48mg/ml (e.g. 240mg in 500ml).

5-Fluorouracil:Concentrations of up to 0.8mg/ml (400mg in 500ml) administered at a rate of at least 20 ml/hour (500 ml/24 hours). Concentrations higher than 5-fluorouracil may cause the precipitation of ondansetron. The 5-fluorouracil solution may contain up to 0.045%p/v of magnesium chloride, as well as other compatible excipients.

Carboplatin:Concentrations of up to 10mg/ml (e.g. 1000mg in 100ml

Etoposide:Concentrations of up to0.25 mg/ml (e.g.250 mg in 1 liter).

Ceftazidima:Compatibility has been demonstrated for 2,000mg reconstituted with 20 ml of 0.9% NaCl (100 mg/ml) and 2,000 mg reconstituted with 10 ml of water for injection preparations (200 mg/ml)

Cyclophosphamide:Compatibility has been demonstrated for 1,000mg reconstituted with 50 ml of 0.9% NaCl (20 mg/ml).

Doxorubicin:Concentrations of up to2 mg/ml (e.g.100 mg in 50 ml).

Dexamethasone:Compatibility has been demonstrated between sodium phosphate dexamethasone in concentrations of up to 4 mg/mland ondansetron, supporting the administration of these medicinal products through the same infusion equipment.

For complete information on this medicinal product, please consult the Technical Dossier or Summary of Product Characteristics.