ONDANSETRON 0.16 mg/ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ondansetron Kabi, 0.08 mg/ml, solution for infusion
3. Ondansetron Kabi, 0.16 mg/ml, solution for infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Ondansetron Kabi and what is it used for
5. Important information before using Ondansetron Kabi
   1. When not to use Ondansetron Kabi:
   2. Warnings and precautions
   3. Ondansetron Kabi and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Ondansetron Kabi contains sodium
6. How to use Ondansetron Kabi
   1. Method of administration
   2. Dosage
   3. Dose adjustment
   4. Duration of treatment
   5. Using more than the recommended dose of Ondansetron Kabi
7. Possible side effects
   1. In case of the following side effects, the patient should immediately inform their doctor or nurse:
   2. Other side effects include:
   3. Reporting side effects
8. How to store Ondansetron Kabi
9. Contents of the packaging and other information
   1. What Ondansetron Kabi contains
   2. What Ondansetron Kabi looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------
   7. Information intended for healthcare professionals only:

Leaflet accompanying the packaging: patient information

Ondansetron Kabi, 0.08 mg/ml, solution for infusion

Ondansetron Kabi, 0.16 mg/ml, solution for infusion

Ondansetron

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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Keep this leaflet, so you can read it again if you need to.
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If you have any doubts, consult your doctor, nurse, or pharmacist.
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If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ondansetron Kabi and what is it 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 packaging and other information

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

Ondansetron Kabi belongs to a group of medicines called antiemetics. Some types of chemotherapy or radiotherapy can cause nausea and vomiting. Nausea and vomiting can 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 other serotonin 5-HT3 receptor antagonists (e.g., granisetron, dolasetron) or any of the other ingredients of this medicine (listed in section 6);
­ if the patient is receiving apomorphine (a medicine used for Parkinson's disease).

Warnings and precautions

Before starting treatment with Ondansetron Kabi, the patient should discuss it with their doctor, nurse, or pharmacist if:
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the patient has had an allergy to other anti-nausea and vomiting medicines, such as granisetron or palonosetron;
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the patient has intestinal obstruction or severe constipation. This medicine may inhibit intestinal peristalsis;
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the patient has liver function disorders;
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the patient has undergone tonsillectomy;
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the patient has had heart rhythm disorders, including irregular heartbeat (arrhythmia). This medicine can cause dose-dependent prolongation of the QT interval (a fragment of the ECG that indicates delayed repolarization of the heart with a risk of life-threatening arrhythmias);
­ the patient has electrolyte imbalances in the blood, such as potassium, sodium, and magnesium.

Ondansetron Kabi and other medicines

The patient should inform their doctor, nurse, or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

• If the patient is taking tramadol (a pain reliever): ondansetron may reduce the pain-relieving effect of tramadol.
• In patients treated with phenytoin, carbamazepine (a medicine used for epilepsy), or rifampicin (an antibiotic used for 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), antiarrhythmic medicines (such as amiodarone), and beta-blockers (medicines that slow the heart rate, such as atenolol or timolol): the use of ondansetron with other medicines that prolong the QT interval may lead to additional prolongation of the QT interval, increasing the risk of 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 cases of serotonin syndrome (e.g., excessive alertness and agitation, increased heart rate and blood pressure, tremors, and hyperreflexia) in patients taking ondansetron with other serotonergic medicines.
• If the patient is taking apomorphine (a medicine used for Parkinson's disease): apomorphine should not be used with ondansetron, as cases of hypotension (low blood pressure) and loss of consciousness have been reported when both medicines are used together.

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 palate.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Women of childbearing age may be advised to use effective contraception.
Ondansetron passes into breast milk. Therefore, mothers taking ondansetron should not breastfeed.

Driving and using machines

Ondansetron does not affect the ability to drive or use machines.

Ondansetron Kabi contains sodium

This medicine contains 357 mg of sodium (the main component of common salt) in each 100 ml bottle.
This corresponds to 17.9% of the maximum recommended daily intake of sodium in the diet for adults.
This medicine contains 178.5 mg of sodium (the main component of common salt) in each 50 ml bottle.
This corresponds to 8.9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ondansetron Kabi

Method of administration

Ondansetron Kabi is administered by intravenous infusion. The medicine is usually administered by a doctor or nurse.

Dosage

Adults (under 75 years of age)
The doctor will decide on the dose of ondansetron suitable for the patient.
The dose varies depending on the patient's treatment (chemotherapy or surgery) and liver function.
For chemotherapy or radiotherapy, the usual dose of ondansetron is 8 to 32 mg per day. Single doses greater than 16 mg should not be administered.
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/m² body surface area or 0.15 mg/kg body weight is usually administered before treatment. The intravenous dose should not exceed 8 mg of ondansetron. The total daily dose (administered in divided doses) should 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 up to a maximum of 4 mg is usually administered.
• For the prevention of postoperative nausea and vomiting, a dose of 0.1 mg/kg body weight up to a maximum of 4 mg is usually administered. The dose should be administered before surgery.

Dose adjustment

Elderly patients
In the case of chemotherapy, the initial dose in patients aged 75 years or older should not exceed 8 mg.
Patients with liver function disorders
In patients with liver function disorders, the total daily dose should not exceed 8 mg of ondansetron.
Patients with kidney function disorders or metabolism of sparteine and/or debrisoquine
There is no need to adjust the daily dose of the medicine, frequency, or route of administration.

Duration of treatment

The doctor will decide on the duration of ondansetron treatment.
After intravenous administration, ondansetron can be continued in the form of tablets or suppositories for up to 5 days.

Using more than the recommended dose of Ondansetron Kabi

There is limited data on the overdose of ondansetron. Overdose increases the frequency of side effects listed in section 4. In a few patients, the following symptoms have been observed after overdose: vision disturbances, severe constipation, low blood pressure, arrhythmias, and fainting. In all cases, the symptoms completely resolved.
Ondansetron Kabi is administered to an adult or child by a doctor or nurse, so it is unlikely that an adult or child will receive too much of the medicine. If it is suspected that an adult or child has received too much of the medicine or missed a dose, they should inform their doctor or nurse.
There is no specific antidote for ondansetron; therefore, in case of suspected overdose, only symptomatic treatment can be used.
If the patient notices any of the above symptoms, they should inform their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of the following side effects, the patient should immediately inform their doctor or nurse:

Uncommon(may occur in less than 1 in 100 patients):
­ chest pain, irregular heartbeat (arrhythmia, which can be life-threatening in some cases), and slow heartbeat (bradycardia).
Rare(may occur in less than 1 in 1000 patients):
­ immediate allergic reactions, including life-threatening reactions (anaphylaxis). These can be reactions such as: itching rash, swelling of the eyelids, face, lips, and tongue.
Frequency not known(frequency cannot be estimated from the available data):
­ myocardial ischemia.
The symptoms include: sudden chest pain or pressure in the chest.

Other side effects include:

Very common(may occur in more than 1 in 10 patients):
­ headache.
Common(may occur in less than 1 in 10 patients):
­ constipation;
­ feeling of warmth or sudden flushing;
­ irritation and redness at the injection site.
Uncommon(may occur in less than 1 in 100 patients):
­ low blood pressure, which can lead to fainting or dizziness;
­ seizures;
­ abnormal body movements or tremors;
­ hiccups;
­ effects on liver function tests.
Rare(may occur in less than 1 in 1000 patients):
­ dizziness or feeling of emptiness in the head;
­ blurred vision;
­ arrhythmias (sometimes leading to sudden loss of consciousness).
Very rare(may occur in less 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 can develop into large blisters.

Reporting side effects

If side effects occur, including any possible side effects not listed in this leaflet, the patient should consult their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ondansetron Kabi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after: EXP.
The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
Store the bottles in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ondansetron Kabi contains

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The active substance of the medicine is ondansetron.
Ondansetron Kabi, 0.08 mg/ml, solution for infusion:1 ml of the solution for infusion contains 0.08 mg of ondansetron in the form of ondansetron hydrochloride 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 the solution for infusion contains 0.16 mg of ondansetron in the form of ondansetron hydrochloride dihydrate.
Each 50 ml bottle contains 8 mg of ondansetron.
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The 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 packaging

Ondansetron Kabi is a clear, colorless solution available in LDPE (KabiPac) bottles, in a cardboard 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 authorization 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
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Instructions for use, storage, and disposal:
Store the bottles in the outer packaging to protect from light.
Use only clear and colorless solution.
For single use only.
The medicinal product should be used immediately after opening.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Compatibility with other medicinal products:
The following medicinal products can be administered simultaneously with Ondansetron Kabi using a three-way set for ondansetron administration. Compatibility has been demonstrated for up to one hour, but the recommendations for the co-administered medicinal product specified by the manufacturer 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 mg/hour (500 ml/24 hours). Higher concentrations of 5-fluorouracil may cause ondansetron to precipitate. The infusion of 5-fluorouracil may contain up to 0.045% w/v magnesium chloride in addition to other excipients listed as compatible.
Carboplatin:concentrations up to 10 mg/ml (e.g., 1000 mg in 100 ml).
Etoposide: concentrations in the range of up to 0.25 mg/ml (e.g., 250 mg in 1 liter).
Ceftazidime:compatibility has been demonstrated for 2000 mg reconstituted in 20 ml NaCl 0.9% (100 mg/ml) and 2000 mg reconstituted in 10 ml water for injections (200 mg/ml).
Cyclophosphamide:compatibility has been demonstrated for 1000 mg reconstituted in 50 ml NaCl 0.9% (20 mg/ml).
Doxorubicin:concentrations up to 2 mg/ml (e.g., 100 mg in 50 ml).
Dexamethasone:compatibility has been demonstrated between dexamethasone sodium phosphate and ondansetron at concentrations up to 4 mg/ml, administered through the same infusion set.
To obtain full information about the medicinal product, refer to the Summary of Product Characteristics.