Ondansetron Kabi 0.16 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ondansetron Kabi 0,08 mg/ml solution for infusion

Ondansetron Kabi 0,16 mg/ml solution for infusion

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

  1. If you have any questions, ask your doctor, nurse or pharmacist.

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

Contents of the leaflet

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

2. What you need to know before being given Ondansetron Kabi

3. How Ondansetron Kabi is administered

4. Possible adverse effects

   1. Storage of Ondansetron Kabi

5. Contents of the pack and other information

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

Ondansetrón belongs to a group of medicines called antiemetics, medicines used to prevent or treat nausea and vomiting. Certain medical treatments with cancer medications (chemotherapy) or radiation therapy may cause nausea and vomiting. You may also experience nausea or vomiting after a surgical procedure. Ondansetrón can help prevent or stop these effects.

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

Do not use Ondansetron Kabi

• If you are allergic to ondansetron, to other selective 5HT3 receptor antagonists (e.g. granisetron, dolasetron), or to any of the other ingredients of this medicine (listed in section 6).
• if you are being treated with apomorphine (a medicine used to treat Parkinson's disease)

Warnings and precautions

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

• if you have previously experienced hypersensitivity to other medicines for nausea or vomiting, such as granisetron or palonosetron.
• if you have intestinal blockage or suffer from severe constipation. This medicine may impair intestinal motility.
• if you have liver impairment.
• if you are undergoing surgery to remove your palatine tonsils located at the back of your nose (adenotonsillar surgery).
• if you have ever had heart problems, including irregular heartbeats (arrhythmias). This medicine causes a dose-dependent prolongation of the QT interval (an electrocardiogram signal indicating delayed repolarization of the heart after a heartbeat, with risk of life-threatening arrhythmias).
• if you have problems with electrolyte levels in your blood, such as potassium, sodium, and magnesium.

Other medicines and Ondansetron Kabi

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

• If you are taking tramadol (a painkiller): ondansetron may reduce the analgesic effect of tramadol.

• If you are taking phenytoin, carbamazepine (antiepileptic medicines), or rifampicin (an antibiotic for tuberculosis): these reduce blood concentrations of ondansetron.

• If you are taking cardiotoxic medicines (anthracyclines (anticancer antibiotics such as doxorubicin, daunorubicin) or trastuzumab, an anticancer medicine, antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (such as amiodarone), and beta-blockers (medicines that slow the heart rate, such as atenolol or timolol): using ondansetron together with other medicines that prolong the QT interval may lead to additional QT prolongation, thereby increasing the risk of arrhythmias.

• If you are taking other serotonergic medicines such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as sertraline or duloxetine (both are antidepressants): cases of serotonin syndrome (e.g. excessive alertness and agitation, increased heart rate and blood pressure, tremors, and involuntary movements) have been reported in patients using ondansetron concomitantly with other serotonergic medicines.

• If you are taking apomorphine (a medicine to treat Parkinson's disease): apomorphine must not be used together with ondansetron, as cases of profound hypotension (low blood pressure) and loss of consciousness have been reported when both medicines are administered together.

Pregnancy and breastfeeding

Ondansetron must 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 cleft palate (openings or splits in the upper lip or the roof of the mouth).

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

If you are a woman of childbearing potential, you are advised to use an effective method of contraception.

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

Driving and using machines

Ondansetron has no effect on the ability to drive or use machines.

Ondansetron Kabi contains sodium

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

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

3. How Ondansetron Kabi is administered

Method of administration

This medicine is given as an intravenous infusion. It is normally administered by a doctor or nurse.

Dosage

Adults (under 75 years of age)

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

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

In the case of chemotherapy or radiotherapy, the usual adult dose is 8–32 mg of ondansetron per day. A single dose higher than 16 mg should not be administered.

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

Children over 6 months of age and adolescents

In the case of chemotherapy, the normal dose is a single intravenous dose of 5 mg/m² (body surface area) or 0.15 mg/kg (body weight) given immediately before chemotherapy. The single intravenous dose must not exceed 8 mg. The total daily dose (given in divided doses) must not exceed the adult dose of 32 mg.

Children over 1 month of age and adolescents

• For the treatment of postoperative nausea and vomiting, the normal dose is 0.1 mg/kg (body weight) up to a maximum of 4 mg.
• For the prevention of postoperative nausea and vomiting, the normal dose is 0.1 mg/kg (body weight) up to a maximum of 4 mg. This dose should be administered just before surgery.

Dosage adjustment

Elderly patients

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

Patients with hepatic impairment

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

Patients with renal impairment or slow metabolism of sparteine/debrisoquine

No adjustment of the daily dose, dosing frequency, or route of administration is required.

Duration of treatment

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

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

If you have been given more Ondansetron Kabi than you should have

Currently, little is known about overdose with ondansetron. Overdose increases the likelihood of experiencing the adverse effects described in section 4. In a limited number of patients, the following effects have been observed after overdose: visual disturbances, severe constipation, low blood pressure, changes in heart rhythm, and fainting. In all cases, symptoms completely resolved.

Since your doctor or nurse administers ondansetron to you or your child, it is unlikely that you or your child will receive too much. If you think that you or your child have received too much, or if a dose has been missed, 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 further questions about using this medicine, ask your doctor or nurse.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Uncommon: may affect up to 1 in 100 people

• Chest pain, irregular heartbeat (arrhythmia, which in individual cases may be fatal), and slow heartbeat (bradycardia)

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

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

Frequency not known: cannot be estimated from the available data

• Myocardial ischaemia. Signs include: sudden chest pain or tightness in the chest.

Other adverse effects include:

Very common: may affect more than 1 in 10 people

• Headache

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

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

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

• Feeling dizzy or faint
• Blurred vision
• Changes in heart rhythm (sometimes leading to sudden loss of consciousness)

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Ondansetron Kabi Storage

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 label of the vial and the outer carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Ondansetrón Kabi

• The active substance is ondansetron.

Ondansetrón Kabi 0.08 mg/ml: 1 ml of infusion solution contains 0.08 mg of ondansetron as ondansetron dihydrochloride dihydrate.

Each 50 ml vial contains 4 mg of ondansetron.

Each 100 ml vial contains 8 mg of ondansetron.

Ondansetrón Kabi 0.16 mg/ml: 1 ml of infusion solution contains 0.16 mg of ondansetron as ondansetron dihydrochloride dihydrate.

Each 50 ml vial contains 8 mg 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 injections.

Presentation of the product and pack contents

Ondansetrón Kabi is a clear, colourless solution in LDPE plastic vials.

Each vial contains:

Ondansetrón Kabi 0.08 mg/ml: 50 ml, 100 ml
Ondansetrón Kabi 0.16 mg/ml: 50 ml

Pack sizes:

Ondansetrón Kabi 0.08 mg/ml: 1, 10, 20, 40
Ondansetrón Kabi 0.16 mg/ml: 1, 10, 20, 40

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.
C/ Marina 16-18
08005 Barcelona
Spain

Manufacturer:

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 Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: March 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

Instructions for use, handling, and disposal

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

Use only clear and colourless solutions.

For single use only.

This medicine must be used immediately after first opening.

Any unused solution and the vial must be properly discarded in accordance with local requirements.

Compatibility with other medicines:

The following drugs may be administered simultaneously with ondansetron through a Y-connector in the ondansetron infusion set. Although compatibility has generally been demonstrated for up to 1 hour, the recommendations provided by the manufacturer of the concomitantly administered drug should be taken into account.

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

5-Fluorouracil: Concentrations up to 0.8 mg/ml (400 mg in 500 ml) administered at a rate of at least 20 ml/hour (500 ml/24 hours). Higher concentrations of 5-fluorouracil may cause precipitation of ondansetron. The 5-fluorouracil solution may contain up to 0.045% w/v magnesium chloride in addition to other compatible excipients.

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

Etoposide: Concentrations up to 0.25 mg/ml (e.g. 250 mg in 1 litre).

Ceftazidime: Compatibility has been demonstrated for 2,000 mg reconstituted with 20 ml of 0.9% sodium chloride (100 mg/ml) and 2,000 mg reconstituted with 10 ml of water for injections (200 mg/ml).

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

Doxorubicin: Concentrations up to 2 mg/ml (e.g. 100 mg in 50 ml).

Dexamethasone: Compatibility between sodium dexamethasone phosphate at concentrations up to 4 mg/ml and ondansetron has been demonstrated, supporting administration of these drugs through the same infusion set.

For complete information on this medicine, consult the Summary of Product Characteristics or the Technical Data Sheet.