Ondansetron Kabi 2 mg/ml roztvur do vstzhikivani

Leaflet attached to the packaging: patient information

Ondansetron Kabi 2 mg/ml solution for injection

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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This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 therapy using anticancer drugs (chemotherapy) or radiation therapy may cause nausea and vomiting. Nausea and vomiting can also occur after surgical procedures. 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 another medicine from the group of 5-HT3 receptor antagonists (e.g., granisetron or 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 to use Ondansetron Kabi, discuss it with your doctor or pharmacist if:
­ the patient has had hypersensitivity reactions to other anti-nausea and vomiting medicines (such as granisetron or palonosetron);
­ the patient has intestinal obstruction or severe constipation. Ondansetron may inhibit intestinal peristalsis;
­ the patient has liver function disorders;
­ the patient has undergone tonsillectomy;
­ the patient has had heart rhythm disorders, including irregular heartbeat (arrhythmias). Ondansetron causes dose-dependent prolongation of the QT interval (a fragment of the ECG, indicating 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

Tell your doctor, nurse, or pharmacist about all medicines the patient is 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 pain reliever): ondansetron may reduce the pain-relieving effect of tramadol.
In patients treated with phenytoin, carbamazepine (a medicine used in epilepsy), or rifampicin (an antibiotic used to treat tuberculosis): the concentration of ondansetron in the blood may be reduced.
If the patient is taking cardiotoxic medicines (e.g., anthracyclines, anticancer antibiotics, e.g., doxorubicin, daunorubicin, or trastuzumab - an anticancer medicine), antibiotics (e.g., erythromycin), antifungal medicines (e.g., ketoconazole), antiarrhythmic medicines (e.g., amiodarone), and beta-blockers (medicines that slow down the heart rate, such as atenolol or timolol): using 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., agitation, increased heart rate, and high blood pressure, tremors, and hyperreflexia) following the 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 should not be used with ondansetron, as cases of hypotension (low blood pressure) and loss of consciousness have been reported when both medicines were used concomitantly.

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 [a hole or gap in the upper lip and/or palate]. If the patient is already pregnant, suspects pregnancy, or plans to become pregnant, they should consult their doctor or pharmacist before using Ondansetron Kabi.
If the patient is a woman of childbearing age, it may be recommended to use effective contraception.
Ondansetron passes into human milk. Therefore, it is recommended that mothers taking ondansetron should NOT breastfeed.
Before using the medicine, consult your doctor.

Driving and using machines

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

Ondansetron Kabi contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free".

3. How to use Ondansetron Kabi

Method of administration

Ondansetron Kabi is administered by intravenous injection (into a vein) or, after dilution, by intravenous infusion (over a longer period). 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 surgical treatment), liver function, and method of administration: injection or infusion.
In the case of chemotherapy or radiation therapy, 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
A single intravenous dose of 5 mg/m² of body surface area is usually administered before treatment. The intravenous dose should not exceed 8 mg of ondansetron.
Children aged 1 month and older and adolescents
For the treatment of postoperative nausea and vomiting, a dose of 0.1 mg of ondansetron per kilogram of body weight is usually administered. The maximum dose is 4 mg of ondansetron per injection.
For the prevention of postoperative nausea and vomiting, a dose of 0.1 mg of ondansetron per kilogram of body weight is usually administered. The maximum dose is 4 mg of ondansetron per injection. The dose should be administered immediately before surgery.

Dose adjustment

Elderly patients
In the case of chemotherapy, the initial dose in patients aged 75 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, frequency, or route of administration of the medicine.

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.

Use of a higher than recommended dose of Ondansetron Kabi

There is little data on ondansetron overdose. 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 will be administered to the patient by a doctor or nurse, so it is unlikely that the patient will receive too high a dose.
If it is suspected that the patient has received too high a dose or missed a dose of the medicine, they should tell their doctor or nurse.
There is no specific antidote for ondansetron; therefore, in the event of an overdose, only symptomatic treatment can be used.
If the patient notices any of the above symptoms, they should tell their doctor.

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, tell your doctor or nurse immediately:

Uncommon (may occur in less than 1 in 100 patients):

­ chest pain, slow and irregular heartbeat.

Rare (may occur in less than 1 in 1000 patients):

­ immediate hypersensitivity reactions, such as itching rash, swelling of the eyelids, face, lips, mouth, and tongue.

Frequency not known (frequency cannot be estimated from the available data):

­ myocardial ischemia.
Symptoms include:

sudden chest pain
or
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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 may 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 (hives) occurring all over the body, which may develop into large blisters.

Additional side effects in children and adolescents

Side effects observed in children and adolescents were comparable to those in adults.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell your 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 gather more information on the safety of the medicine.

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 ampoule and carton after: EXP.
The expiry date refers to the last day of that month.
Ampoules should be stored in the outer packaging to protect them 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. Contents of the packaging and other information

What Ondansetron Kabi contains

­ The active substance of the medicine is ondansetron.
One 2 ml ampoule contains 4 mg of ondansetron.
One 4 ml ampoule contains 8 mg of ondansetron.
Each milliliter contains 2 mg of ondansetron, in the form of ondansetron hydrochloride dihydrate.
­ The other ingredients are: sodium chloride, sodium citrate dihydrate, citric acid monohydrate, and water for injections.

What Ondansetron Kabi looks like and what the pack contains

Ondansetron Kabi is a clear, colorless solution in clear glass ampoules containing 2 ml or 4 ml of solution for injection.
The packaging contains: 1, 5, or 10 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder:

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H
Germany

Manufacturer:

Labesfal - Laboratórios Almiro, S.A.
Zona Industrial do Lagedo

• 3465 - 157 Santiago de Besteiros Portugal

For more detailed information, 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Ondansetron Fresenius Kabi 2 mg/ml Injektionslösung/oplossing voor injectie/solution injectable
Czech Republic:
Ondansetron Kabi
Germany:
Ondasetron Kabi 2 mg/ml Injektionslösung
Denmark:
Ondansetron “Fresenius Kabi”, injektionsvæske, opløsning
Greece:
Ondansetron/Kabi 2 mg/ml Evέσιμο διάλυμα
Spain:
Ondansetron Fresenius Kabi 2 mg/ml inyectable
Finland:
Ondansetron Fresenius Kabi 2 mg/ml injektioneste, liuos
Hungary:
Ondansetron Kabi 2 mg/ml oldatos injekció
Ireland:
Ondansetron Kabi 2 mg/ml solution for injection
Italy:
Ondansetron Kabi
Netherlands:
Ondansetron Kabi 2 mg/ml oplossing voor injectie
Norway:
Ondansetron Fresenius Kabi 2 mg/ml injeksjonsvæske, oppløsning
Poland:
Ondansetron Kabi 2 mg/ml solution for injection
Sweden:
Ondansetron Fresenius Kabi 2 mg/ml injektionsvätska, lösning
Slovakia:
ONDANSETRON KABI 2 mg/ml, injekčný roztok
United Kingdom:
Ondansetron Kabi 2 mg/ml solution for injection
Date of last revision of the leaflet:21.02.2022
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Information intended for healthcare professionals only:

Single doses greater than 16 mg should not be administered due to the risk of dose-dependent QT interval prolongation (see sections 4.2, 4.4, 4.8, and 5.1 of the Summary of Product Characteristics).
Use only a clear and colorless solution.
For single use only. Any unused medicine or waste material should be disposed of in accordance with local regulations.
Use immediately after opening the ampoule.
Ondansetron Kabi can be diluted with the following infusion solutions:
sodium chloride 9 mg/ml (0.9% w/v) solution
glucose 50 mg/ml (5% w/v) solution
mannitol 100 mg/ml (10% w/v) solution
Ringer's solution with lactate
Chemical and physical stability of the solution has been demonstrated for 48 hours at 25°C with the above solutions. If the compatibility of the infusion solution is not proven, it should be administered separately.
The diluted solution should be protected from light.