Ondansetron kabi

Package leaflet: Information for the patient

Ondansetron Kabi, 0.08 mg/ml, solution for infusion
Ondansetron Kabi, 0.16 mg/ml, solution for infusion
Ondansetronum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
­ Keep this leaflet for future reference.
­ If you have any questions, please consult your doctor, nurse, or pharmacist.
­ If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Ondansetron Kabi is and what it is used for
2. Important information before using Ondansetron Kabi
3. How to use Ondansetron Kabi
4. Possible side effects
5. How to store Ondansetron Kabi
6. Contents of the pack and other information

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

Ondansetron Kabi belongs to a group of medicines called antiemetics. Certain types of anticancer drug treatments (chemotherapy) or radiotherapy may cause nausea and vomiting. Nausea and vomiting may also occur after surgery. Ondansetron Kabi helps prevent and reduce these symptoms.

2. Important information before using Ondansetron Kabi

When not to use Ondansetron Kabi: ­ if the patient is allergic to ondansetron or to any other medicine in the group of serotonin 5-HT(_3) receptor antagonists (e.g. granisetron, dolasetron), or to any of the other ingredients of this medicine (listed in section 6); ­ if the patient is receiving apomorphine (a medicine used in Parkinson's disease).

Warnings and precautions

Before starting treatment with Ondansetron Kabi, discuss with your doctor, nurse or pharmacist if: ­ the patient has had an allergic reaction to other anti-nausea and anti-vomiting medicines, such as granisetron or palonosetron; ­ the patient has intestinal obstruction or severe constipation. This medicine may inhibit intestinal peristalsis; ­ the patient has liver function disorders; ­ the patient has undergone tonsillectomy; ­ the patient has ever had heart problems, including irregular heartbeat (arrhythmias). This medicine causes dose-dependent QT interval prolongation (a segment on ECG indicating delayed cardiac repolarization, with risk of life-threatening arrhythmias); ­ the patient has electrolyte imbalances in the blood, such as potassium, sodium or magnesium.

Ondansetron Kabi and other medicines

Tell your doctor, nurse or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

• If the patient is taking tramadol (a painkiller): ondansetron may reduce the analgesic effect of tramadol.
• In patients treated with phenytoin, carbamazepine (a medicine used in epilepsy) or rifampicin (an antibiotic used to treat tuberculosis): the blood concentration of ondansetron may be reduced.
• If the patient is taking cardiotoxic medicines (e.g. anthracyclines (anticancer antibiotics such as doxorubicin, daunorubicin) or trastuzumab – an anticancer medicine), antibiotics (such as erythromycin), antifungal medicines (such as ketoconazole), antiarrhythmics (such as amiodarone) and beta-blockers (medicines that reduce heart rate, such as atenolol or timolol): using ondansetron together with other medicines that prolong the QT interval may lead to additional QT prolongation, thus increasing the risk of cardiac arrhythmias.
• If the patient is taking other serotonergic medicines, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), such as sertraline or duloxetine (antidepressants): there have been reports of serotonin syndrome (e.g. excessive alertness and agitation, increased heart rate and elevated blood pressure, tremor and hyperreflexia) in patients following concomitant use of ondansetron with other serotonergic medicines.
• If the patient is taking apomorphine (a medicine used in the treatment of Parkinson's disease): apomorphine must not be used together with ondansetron, as cases of hypotension (low blood pressure) and loss of consciousness have been reported when both medicines were used simultaneously.

Pregnancy and breastfeeding

Ondansetron Kabi should not be used during the first trimester of pregnancy. This is because Ondansetron Kabi may slightly increase the risk of cleft lip and/or cleft palate [a split or opening in the upper lip and/or palate].

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Women of childbearing potential may be advised to use effective contraception.

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

Driving and operating machinery

Ondansetron does not affect the ability to drive or operate machinery.

Ondansetron Kabi contains sodium

This medicine contains 357 mg of sodium (the main component of table salt) in each 100 ml bottle. This corresponds to 17.9% of the maximum recommended daily dietary intake of sodium for adults.

This medicine contains 178.5 mg of sodium (the main component of table salt) in each 50 ml bottle. This corresponds to 8.9% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Ondansetron Kabi

Method of administration
Ondansetron Kabi is administered as an intravenous infusion. The medicine is usually given by a doctor or nurse.
Dosage
Adults (under 75 years of age)
The doctor will decide the appropriate dose of ondansetron for the patient.
The dose varies depending on the patient's treatment (chemotherapy or surgical procedure)
and liver function.
For chemotherapy or radiotherapy, the usual daily dose of ondansetron is between
8 and 32 mg. Single doses must not exceed 16 mg.
For the treatment of postoperative nausea and vomiting, a single dose of 4 mg
of ondansetron is usually used. For the prevention of postoperative nausea and vomiting, a single dose of 4 mg of ondansetron is usually used.
Children aged 6 months and older and adolescents
For chemotherapy, a single intravenous dose of 5 mg/m^2 body surface area
or 0.15 mg/kg body weight is usually given immediately before treatment. The intravenous dose must not
exceed 8 mg of ondansetron. The total daily dose (given in divided doses) must not
exceed the adult dose of 32 mg.
Children aged 1 month and older and adolescents

• For the treatment of postoperative nausea and vomiting, a dose of 0.1 mg/kg body weight is usually given, up to a maximum dose of 4 mg.
• For the prevention of postoperative nausea and vomiting, a dose of 0.1 mg/kg body weight is usually given, up to a maximum dose of 4 mg. The dose should be administered immediately before surgery.

Dose adjustment
Elderly patients
For chemotherapy, the initial dose in patients aged 75 years or older should not exceed 8 mg.
Patients with impaired liver function
In patients with impaired liver function, the total daily dose should not exceed 8 mg of ondansetron.
Patients with impaired kidney function or impaired metabolism of sparteine and (or) debrisoquine
There is no need to adjust the daily dose, frequency, or route of administration.
Duration of treatment
The doctor will decide how long ondansetron should be used.
After intravenous administration, ondansetron may be continued in the form of tablets or rectal suppositories for up to 5 days.
Use of a higher than recommended dose of Ondansetron Kabi
There is limited data on ondansetron overdose. Overdose increases the frequency of occurrence of adverse reactions listed in section 4. In several patients, the following symptoms have been observed after overdose: visual disturbances, severe constipation, low blood pressure, heart rhythm disorders, and fainting. In all cases, symptoms completely resolved.
Ondansetron Kabi is administered to adult or pediatric patients by a doctor or nurse, so it is unlikely that a patient would receive too high a dose. If it is suspected that an adult or child has received too high a dose or a dose has been missed, inform the doctor or nurse immediately.
There is no specific antidote for ondansetron; therefore, in case of suspected overdose, only symptomatic treatment can be used.
If a patient experiences any of the symptoms listed above, they should inform their doctor.
If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, inform your doctor or nurse immediately:
Not very common (may occur in fewer than 1 in 100 patients):
­ chest pain, irregular heartbeat (arrhythmia, which in some cases may be dangerous), and slow heartbeat (bradycardia).
Rare (may occur in fewer than 1 in 1,000 patients):
­ immediate allergic reactions, including life-threatening reactions (anaphylaxis). These may include: itchy rash, swelling of the eyelids, face, lips, mouth, and tongue.
Frequency unknown (frequency cannot be determined from available data):
­ myocardial ischaemia.
Symptoms include: sudden chest pain or chest tightness.
Other adverse reactions include:
Very common (may occur in more than 1 in 10 patients):
­ headache.
Common (may occur in fewer than 1 in 10 patients):
­ constipation;
­ feeling of warmth or sudden flushing;
­ irritation and redness at the site of administration.
Not very common (may occur in fewer than 1 in 100 patients):
­ low blood pressure, which may lead to fainting or dizziness;
­ seizures;
­ unusual body movements or tremors;
­ hiccups;
­ effects on liver function test results.
Rare (may occur in fewer than 1 in 1,000 patients):
­ dizziness or feeling faint;
­ blurred vision;
­ heart rhythm disorders (sometimes leading to sudden loss of consciousness).
Very rare (may occur in fewer than 1 in 10,000 patients):
­ temporary loss of vision (usually lasting no longer than 20 minutes);
­ skin rash, e.g. red spots or lumps under the skin (urticaria), occurring all over the body, which may develop into large blisters.
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Ondansetron Kabi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton following: EXP.
The expiry date refers to the last day of the stated month.
No special temperature storage requirements for this medicine.
Store vials in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Ondansetron Kabi contains
­ The active substance is ondansetron.
Ondansetron Kabi, 0.08 mg/ml, solution for infusion: 1 ml of infusion solution contains
0.08 mg of ondansetron as ondansetron dihydrochloride dihydrate.
Each 50 ml bottle contains 4 mg of ondansetron.
Each 100 ml bottle contains 8 mg of ondansetron.
Ondansetron Kabi, 0.16 mg/ml, solution for infusion: 1 ml of infusion solution contains
0.16 mg of ondansetron as ondansetron dihydrochloride dihydrate.
Each 50 ml bottle contains 8 mg of ondansetron.
­ Other ingredients are: sodium chloride, sodium citrate, citric acid monohydrate, hydrochloric acid
(for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What Ondansetron Kabi looks like and contents of the pack
Ondansetron Kabi is a clear, colourless solution available in LDPE bottles (KabiPac), packed in a carton box.
Each bottle contains:
Ondansetron Kabi, 0.08 mg/ml: 50 ml, 100 ml
Ondansetron Kabi, 0.16 mg/ml: 50 ml

Pack sizes:
Ondansetron Kabi, 0.08 mg/ml: 1, 10, 20, 40 bottles.
Ondansetron Kabi, 0.16 mg/ml: 1, 10, 20, 40 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
Else-Kroener-Strasse 1
61352 Bad Homburg v.d.Hoehe
Germany

Manufacturer
Fresenius Kabi Polska Sp. z o.o.
ul. Henryka Sienkiewicza 25
99-300 Kutno
Poland

For further information, contact the representative of the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Information intended exclusively for medical professionals:

Instructions for use, storage, and disposal:
Store vials in the outer packaging to protect from light.
Use only clear and colourless solutions.
For single use only.
The medicinal product should be used immediately after first opening.
Any unused portions or waste material should be disposed of in accordance with local regulations.

Compatibility with other medicinal products:
The following medicinal products may be administered simultaneously with Ondansetron Kabi using a Y-site administration set. Compatibility has generally been demonstrated for up to one hour; however, the manufacturer's recommendations regarding the co-administered medicinal product should also 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 mg/hour (500 ml/24 hours). Higher concentrations of 5-fluorouracil may cause precipitation of ondansetron. The 5-fluorouracil infusion may contain up to 0.045% w/v magnesium chloride in addition to other excipients shown to be compatible.
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 2000 mg reconstituted in 20 ml of 0.9% NaCl (100 mg/ml) and 2000 mg reconstituted in 10 ml of Water for Injections (200 mg/ml).
Cyclophosphamide: compatibility has been demonstrated for 1000 mg reconstituted in 50 ml of 0.9% NaCl (20 mg/ml).
Doxorubicin: concentrations up to 2 mg/ml (e.g. 100 mg in 50 ml).
Dexamethasone: compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated at concentrations up to 4 mg/ml when administered through the same infusion line.

For complete information on the medicinal product, refer to the Summary of Product Characteristics.