ONDANSETRON KABI 0.16 mg/ml SOLUTION FOR INFUSION

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

Do not useOndansetron Kabi

• If you are allergic to ondansetron, other selective 5HT3 receptor antagonists (e.g. granisetron, dolasetron) or 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 treatment with ondansetron.

• If you have had an allergic reaction to other medicines for nausea and vomiting, such as granisetron or palonosetron.
• If you have a blockage in your intestine or severe constipation. This medicine may prevent movement of the small intestine.
• If you have liver damage.
• If you are going to have surgery to remove your tonsils (adenoidectomy), which are located at the back of the nose.
• If you have ever had heart problems, including irregular heartbeat (arrhythmias). This medicine can prolong the QT interval in a dose-dependent manner (a signal of late repolarization of the heart after a beat, with a risk of arrhythmias that can be life-threatening).
• If you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.

Other medicines and Ondansetron Kabi

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

• If you are taking tramadol (a painkiller): ondansetron may reduce the pain-relieving effect of tramadol.
• If you are taking phenytoin, carbamazepine (an antiepileptic) or rifampicin (an antibiotic for tuberculosis): these medicines decrease the blood levels 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 down the heart rate, such as atenolol or timolol)): the use of ondansetron with other medicines that prolong the QT interval may lead to a further prolongation of the QT interval, i.e. an increased risk of arrhythmias.
• If you are taking other serotonergic medicines such as selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as sertraline or duloxetine (both are antidepressants): cases of patients with the so-called serotonergic syndrome (e.g. excessive alertness and agitation, increased heart rate and blood pressure, tremors and involuntary movements) have been reported after concomitant use of ondansetron with other serotonergic medicines.

• If you are taking apomorphine (a medicine used to treat Parkinson's disease): apomorphine should not be used 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 breast-feeding

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 a cleft lip and/or cleft palate.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 should not breast-feed.

Driving and using machines

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

Ondansetron Kabicontains sodium

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

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

3. How Ondansetron Kabi is given

Method of administration

This medicineis given as an intravenous infusion. It will usually be given by a doctor or nurse.

Dose

Adults (under 75 years of age)

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

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

In the case of chemotherapy or radiotherapy, the usual dose in adults is 8-32 mg of ondansetron per day. A single dose of more than 16 mg should not be given.

For the treatment of post-operative nausea and vomiting, a single dose of 4 mg of ondansetron is usually given. For the prevention of post-operative nausea and vomiting, a single dose of 4 mg of ondansetron is usually given.

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) immediately before chemotherapy. The single intravenous dose should not exceed 8 mg. The total dose during 24 hours (given in divided doses) should not exceed the adult dose of 32 mg.

Children over 1 month of age and adolescents

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

Dose adjustment

Elderly patients

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

Patients with liver 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 metabolizers of sparteine/debrisoquine

No dose adjustment is required.

Duration of treatment

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

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

If you have received more Ondansetron Kabi than you should

Little is known about overdose with ondansetron. Overdose increases the likelihood of the side 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, changes in heart rhythm and fainting. In all cases, the symptoms disappeared completely.

Your doctor or nurse will give you ondansetron, so it is unlikely that you will be given too much. If you think you have been given too much or have not been given a dose, tell your doctor or nurse.

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

Tell your doctor if you experience any of these symptoms.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 that can be life-threatening in individual cases) 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 can be: itchy skin rash, swelling of the eyelids, face, lips, mouth and tongue.

Frequency not known:cannot be estimated from the available data

• Myocardial ischemia. The signs include: sudden chest pain or tightness.

Otherside effectsinclude:

Very common:may affect more than 1 in 10 people

• Headache

Common:may affect up to 1 in 10 people

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

Uncommon:may affect up to 1 in 100 people

• Low blood pressure, which can make you feel weak or dizzy
• Seizures
• Unusual body movements or agitation
• Hiccups
• Abnormal liver function tests

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

• Feeling dizzy or fainting
• Blurred vision
• Changes in heart rhythm (sometimes causing a sudden loss of consciousness)

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron Kabi

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 carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage 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 no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ondansetron Kabi

• The active ingredient is ondansetron.

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

Each vial with 50 ml contains 4 mg of ondansetron

Each vial with 100 ml contains 8 mg of ondansetron

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

Each vial with 50 ml 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 injectable preparations.

Product Appearance and Container Content

Ondansetron Kabi is a clear 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

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

Date of the last revision of this leafletMarch 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

-----------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Instructions for use, handling, and disposal

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

Use only clear and colorless solutions.

For single use.

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 administered at the same time as ondansetron through the Y-connector of the ondansetron administration equipment. Although in general, compatibility has been demonstrated for up to 1 hour, the recommendations indicated by the manufacturer for the medicinal product to be administered at the same time should be taken into account.

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

5-Fluorouracil:Concentrations of 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 of up to 10 mg/ml (e.g., 1000 mg in 100 ml

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

Ceftazidime:Compatibility has been demonstrated for 2000 mg reconstituted with 20 ml of NaCl 0.9% (100 mg/ml) and 2000 mg reconstituted with 10 ml of water for injectable preparations (200 mg/ml)

Cyclophosphamide:Compatibility has been demonstrated for 1000 mg reconstituted with 50 ml of NaCl 0.9% (20 mg/ml).

Doxorubicin:Concentrations of up to 2 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/ml and ondansetron, which supports the administration of these medicinal products through the same administration equipment.

To see the complete information on this medicinal product, consult the Summary of Product Characteristics or the Package Leaflet.