Ondansetron B. Braun 2 mg/ml roztvur do vstzhikivani

PATIENT INFORMATION LEAFLET: USER INFORMATION

Ondansetron B. Braun 2 mg/ml solution for injection

(Ondansetronum)

Read the leaflet carefully before using the medicine.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you need advice or more information.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Table of contents of the leaflet:

• 1. What is Ondansetron B. Braun 2 mg/ml and what is it used for
• 2. Important information before using Ondansetron B. Braun 2 mg/ml
• 3. How to use Ondansetron B. Braun 2 mg/ml
• 4. Possible side effects
• 5. How to store Ondansetron B. Braun 2 mg/ml
• 6. Package contents and other information

1. What is Ondansetron B. Braun 2 mg/ml and what is it used for

Ondansetron belongs to a group of medicines called antiemetics, which prevent nausea or vomiting. Some pharmacological methods of cancer treatment (chemotherapy) or radiotherapy may cause nausea or vomiting. Nausea and vomiting can also occur in the postoperative period. Ondansetron 2 mg/ml can help reduce these symptoms in adult patients and children over 6 months old:

• in the treatment of nausea and vomiting after anticancer treatment; in children over 1 month old:
• in the prevention or treatment of nausea and vomiting after surgery.

2. Important information before using Ondansetron B. Braun 2 mg/ml

Ondansetron B. Braun 2 mg/ml solution for injection should not be used (tell your doctor)

• if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6);
• if you are taking another medicine containing apomorphine (a medicine used to treat Parkinson's disease), see also "Ondansetron 2 mg/ml and other medicines".

Warnings and precautions

Before starting to use this medicine, discuss it with your doctor or pharmacist.

Be particularly careful when using this medicine and inform your doctor if:

• you are allergic to other antiemetic medicines that prevent nausea;
• you have intestinal obstruction or severe constipation. Ondansetron may worsen obstruction or constipation;
• you have taken medicines that affect heart function;
• you have heart disease;
• you have electrolyte imbalance such as potassium, sodium, and magnesium;
• you have heart rhythm disorders (arrhythmia);
• you are going to have your tonsils removed;
• your liver is not working properly.

If this medicine is used in children who are also taking anticancer medicines that may affect liver function, the doctor will monitor the child's liver function.

Ondansetron B. Braun 2 mg/ml and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Particularly, inform your doctor if you are taking any of the following medicines:

• certain medicines used to treat epilepsy (e.g., phenytoin, carbamazepine);
• an antibiotic called rifampicin;
• a strong pain reliever called tramadol;
• medicines used to treat depression (such as fluoxetine, sertraline, duloxetine, venlafaxine);
• a medicine used to treat nausea called apomorphine (a medicine used to treat Parkinson's disease), as significant drops in blood pressure and loss of consciousness have been reported after concomitant administration with this medicine;
• medicines that affect heart rhythm or heart function, such as:
• anticancer medicines (e.g., anthracyclines such as doxorubicin or daunorubicin, or trastuzumab);
• antibiotics (e.g., erythromycin, ketokonazole);
• beta-blockers (e.g., atenolol, timolol);
• antiarrhythmic medicines (such as amiodarone).

Pregnancy, breastfeeding, and fertility

Ondansetron B. Braun 2 mg/ml should not be used during the first trimester of pregnancy. This is because Ondansetron B. Braun 2 mg/ml may slightly increase the risk of cleft lip and/or cleft palate.
If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetron B. Braun 2 mg/ml.
If you are a woman of childbearing age, you may be advised to use effective contraception.
Ondansetron passes into breast milk, so mothers taking ondansetron SHOULD NOT breastfeed.

Driving and using machines

Ondansetron has no or negligible influence on the ability to drive and use machines.

Ondansetron B. Braun 2 mg/ml contains sodium

The medicine contains 3.34 mg of sodium (a major component of common salt) per ml. This corresponds to 0.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ondansetron B. Braun 2 mg/ml

Method of administration

This medicine is given as an intravenous or intramuscular injection (directly into a vein or muscle), or after dilution as an intravenous infusion (over a longer period). It is usually given by a doctor or nurse.

Dosage

Your doctor will decide on the appropriate dose of ondansetron.
The dose depends on the method of primary treatment (chemotherapy or surgery), liver function, and whether the medicine is given as an injection or infusion.
In the case of chemotherapy or radiotherapy, the typical dose for adults is 8 to 32 mg of ondansetron per day. For the treatment of postoperative nausea and vomiting, a single dose of 4 mg of ondansetron is usually given.
Children over 1 month old and adolescents
The dose will be determined by your doctor.

Dose adjustment

Patients with liver failure
In patients with liver failure, the maximum dose should not exceed 8 mg of ondansetron per day
Elderly patients:
65-74 years: no dose adjustment is necessary;
> 74 years: dose adjustment is necessary. Your doctor knows how to adjust the dose and will adjust the dosing schedule to use a smaller dose of this medicine than in younger patients. Additionally, this medicine will be diluted with another solution before administration.

Duration of treatment

Your doctor will decide on the duration of treatment with ondansetron.
After intravenous administration of Ondansetron B. Braun 2 mg/ml, treatment may be continued with other forms of the medicine.

Using more than the recommended dose of Ondansetron B. Braun 2 mg/ml

Ondansetron 2 mg/ml will be given to you by a doctor or nurse, so it is unlikely that you will receive too much of the medicine. If you think you have received too much of the medicine or missed a dose, tell your doctor or nurse.
So far, there is little data on overdosing with ondansetron. In most cases, symptoms were similar to those experienced by patients receiving normal doses (see "Possible side effects"). The following side effects were observed: vision disturbances, severe constipation, low blood pressure, and loss of consciousness. In all cases, symptoms resolved completely.
This medicine may affect heart rhythm, especially in the case of overdose. In such cases, your doctor will monitor your heart function.
There is no specific antidote for ondansetron, so in case of suspected overdose, symptomatic treatment should be used.
Tell your doctor if you experience any of the above symptoms.
In case of doubt, contact your doctor or pharmacist again.

4. Possible side effects

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

The following side effects may be serious. If you experience any of these side effects, tell your doctor immediately, as you may need to stop using this medicine:

Uncommon (may affect up to 1 in 100 people):

• Chest pain, heart rhythm disorders (arrhythmia, which can lead to death) and slow heart rate (bradycardia)

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

• Immediate allergic reactions, including life-threatening reactions (anaphylaxis). These reactions include: swelling of hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing. Additionally, a rash or itching and hives may occur.

Frequency of side effects not known (cannot be estimated from the available data):

• Myocardial ischemia: symptoms include sudden chest pain or pressure in the chest

Other side effects include:

Very common (may affect more than 1 in 10 people);

• Headache

Common (may affect up to 1 in 10 people):

• Feeling of "rush of blood" or heat
• Constipation
• Local reactions at the site of intravenous injection

Uncommon (may affect up to 1 in 100 people):

• Involuntary movement disorders, e.g., eye movements, abnormal muscle contractions that can cause twisting or bending of the body, seizures (e.g., epileptic seizures)
• Low blood pressure (hypotension)
• Hiccup
• Asymptomatic increase in liver function test results. These reactions have been observed especially in patients undergoing chemotherapy with cisplatin.

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

• Dizziness when administered intravenously quickly
• Transient changes in ECG (a test of the electrical activity of the heart), mainly after intravenous administration of ondansetron (prolongation of QTc interval, including torsade de pointes)
• Transient visual disturbances (e.g., blurred vision) during rapid intravenous administration
• Allergic reactions may occur at the injection site (e.g., rash, hives, itching), sometimes extending along the vein into which the medicine was administered.

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

• Depression
• In individual cases, transient blindness has been reported in patients also taking chemotherapeutic agents, including cisplatin. In most reported cases, symptoms resolved within 20 minutes.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ondansetron B. Braun 2 mg/ml

Keep the medicine out of the reach and sight of children.
Do not use after the expiry date stated on the ampoule and packaging. The expiry date refers to the last day of the month stated.
Store the ampoules in the outer packaging to protect from light.
Polyethylene (LDPE) ampoules: Do not store above 25°C.
Glass ampoules: No special storage precautions are required.
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. Package contents and other information

What Ondansetron B. Braun 2 mg/ml contains

The active substance of the medicine is ondansetron.
Each 2 ml ampoule contains 4 mg of ondansetron.
Each 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 B. Braun 2 mg/ml looks like and package contents

Ondansetron B. Braun 2 mg/ml is a clear, colorless solution.
The medicine is supplied:

• in colorless glass ampoules of 2 ml or 4 ml
• packaging contains 5 or 10 ampoules;
• in plastic ampoules of 4 ml
• packaging contains 20 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

address for correspondence
34209 Melsungen
Germany
This medicinal product is authorized in the Member States of the European Union under the following names:

Date of last revision of the leaflet: 2022-04-08

• - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Information intended for healthcare professionals only:

Prolongation of the QT interval
Rarely and usually after intravenous administration of ondansetron, transient changes in ECG have been observed, including prolongation of the QT interval. Additionally, cases of torsade de pointeshave been observed in patients taking ondansetron. Caution is advised in patients with known or suspected prolongation of the QTc interval. This includes patients with electrolyte imbalance, congenital long QT syndrome, and patients taking other medicines that may prolong the QT interval. Therefore, caution is advised in patients with heart rhythm disorders, patients taking antiarrhythmic medicines or beta-blockers, and patients with severe electrolyte imbalance.
Serotonin syndrome
During post-marketing studies in patients with serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular abnormalities) after concomitant administration of ondansetron and other serotonergic medicines (including selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors (SNRIs)). If concomitant use of ondansetron and other serotonergic medicines is clinically indicated, monitoring of the patient's condition is recommended.