Ondansetron b. braun 2 mg/ml injection solution

Ondansetron B. Braun 2 mg/ml solution for injection
(Ondansetronum)
Read the entire leaflet before using this medicine.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor or pharmacist if you need advice or additional information.
• This medicine has been prescribed for a specific individual and must not be passed on to others, as it may harm them even if their symptoms are the same.
• If any adverse reaction worsens or if you experience any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Ondansetron B. Braun 2 mg/ml is and what it is 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. Contents of the pack and other information

1. What Ondansetron B. Braun 2 mg/ml is and what it is used for
Ondansetron belongs to a group of medicines called antiemetics, which prevent nausea and vomiting.
Certain cancer treatments (chemotherapy) or radiotherapy may cause nausea or vomiting. Nausea and
vomiting may also occur in the postoperative period. Ondansetron 2 mg/ml may help reduce these
symptoms in adult patients and in children over 6 months of age:

• in the treatment of nausea and vomiting following anticancer therapy; in children over 1 month of age:
• in the prevention or treatment of postoperative nausea and vomiting.

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

Do not use Ondansetron B. Braun 2 mg/ml solution for injection (inform your doctor)

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

Warnings and precautions
Before starting treatment with this medicine, discuss it with your doctor or pharmacist.
Exercise particular caution and inform your doctor if:

• the patient is allergic to other antiemetic medicines or medicines used to prevent nausea;
• the patient has intestinal obstruction or severe constipation. Ondansetron may worsen obstruction or constipation;
• the patient is taking medicines that affect heart function;
• the patient has heart disease;
• the patient has electrolyte imbalances such as low levels of potassium, sodium, or magnesium;
• the patient has heart rhythm disorders (arrhythmia);
• the patient is undergoing tonsillectomy;
• the patient’s liver is not functioning properly.

When this medicine is used in children who are also receiving 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 medicines you are currently taking, have recently taken, or plan
to take.
In particular, inform your doctor if you are taking any of the following medicines:

• certain antiepileptic medicines (e.g. phenytoin, carbamazepine);
• an antibiotic called rifampicin;
• a strong painkiller called tramadol;
• medicines used to treat depression (such as fluoxetine, sertraline, duloxetine, venlafaxine);
• a medicine used to treat nausea called apomorphine (used in the treatment of Parkinson’s disease), because significant drop 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, ketoconazole);
• beta-blockers (e.g. atenolol, timolol);
• antiarrhythmic medicines (such as amiodarone).

Pregnancy, breastfeeding, and fertility
Do not use Ondansetron B. Braun 2 mg/ml 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 [an opening or
gap in the upper lip and/or palate].
If you are pregnant, suspect 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, therefore mothers taking ondansetron must not breastfeed.
Driving and operating machinery
Ondansetron has no effect or negligible effect on the ability to drive or operate machinery.
Ondansetron B. Braun 2 mg/ml contains sodium
This medicine contains 3.34 mg of sodium (the main component of table salt) in each ml. This corresponds
to 0.2% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Ondansetron B. Braun 2 mg/ml
Method of administration
This medicine is administered 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 administered by a doctor or
nurse.
Dosage
The doctor will individually determine the appropriate dose of ondansetron.
The dose depends on the type of primary treatment (chemotherapy or surgery), liver function, and whether
the medicine is administered as an injection or infusion.
In the case of chemotherapy or radiotherapy, the typical daily dose for adults is 8 to 32 mg of ondansetron.
For the treatment of postoperative nausea and vomiting, a single dose of 4 mg of ondansetron is usually
administered.
Children over 1 month of age and adolescents
The dose will be determined by the doctor.
Dose adjustment
Patients with hepatic impairment
In patients with liver impairment, the maximum dose must not exceed 8 mg of ondansetron per day.
Elderly patients:
65–74 years: no dose adjustment is necessary;

74 years: dosage adjustment is required. The doctor will adjust the dosage regimen to administer a lower
dose than in younger patients. Additionally, this medicine will be diluted with another solution before
administration.
Duration of treatment
The doctor will individually determine the duration of treatment with ondansetron.
After intravenous administration of Ondansetron B. Braun 2 mg/ml, treatment may be continued with other
formulations of the medicine.
Use of a higher than recommended dose of Ondansetron B. Braun 2 mg/ml
Ondansetron 2 mg/ml will be administered to adult patients or children by a doctor or nurse, so it is unlikely
that an adult patient or child will receive an excessive dose. If you believe that an adult patient or child has
received too high a dose or if a dose has been missed, inform the doctor or nurse.
There is limited data on ondansetron overdose. In most cases, symptoms were similar to those observed
in patients receiving normal doses (see section “Possible side effects”). The following adverse effects have
been observed: visual disturbances, severe constipation, hypotension, and loss of consciousness. In all
cases, symptoms resolved completely.
This medicine may affect heart rhythm, particularly in cases of overdose. In such cases, the doctor will
monitor heart function.
There is no specific antidote for ondansetron, therefore symptomatic treatment should be administered
in case of suspected overdose.
Inform your doctor if any of the above symptoms occur.
If in doubt, contact your doctor or pharmacist again.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below may be serious. If any of these occur,
you must immediately inform your doctor, as it may be necessary to discontinue
treatment with this medicine:
Uncommon (may occur in no more than 1 in 100 patients):

• Chest pain, heart rhythm disorders (arrhythmia, which in some cases may lead to death), and slowed heart rate (bradycardia)

Rare (may occur in no more than 1 in 1,000 patients):

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

Frequency of adverse reactions unknown (cannot be estimated 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 no more than 1 in 10 patients):

• Feeling of warmth or flushing
• Constipation
• Local reactions at the site of intravenous injection

Uncommon (may occur in no more than 1 in 100 patients):

• Involuntary motor disturbances, e.g., eye movements, unusual muscle contractions which may cause twisting or bending of the body, seizures (e.g., epileptic seizures)
• Hypotension (low blood pressure)
• Hiccups
• Asymptomatic increase in liver function test results. These reactions have been observed particularly in patients receiving cisplatin chemotherapy.

Rare (may occur in no more than 1 in 1,000 patients):

• Dizziness with rapid intravenous administration
• Transient changes in ECG (electrocardiogram), 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 at the injection site (e.g., rash, urticaria, itching) may occur, sometimes extending along the vein into which the medicine was administered.

Very rare (may occur in no more than 1 in 10,000 patients):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in
this leaflet, you should inform your doctor 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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 outer packaging. The expiry date refers to the last day of the month indicated.
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 instructions for the medicinal product.
Medicines must 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 pack and other information

What Ondansetron B. Braun 2 mg/ml contains
The active substance is ondansetron.
Each 2 ml ampoule contains 4 mg of ondansetron.
Each 4 ml ampoule contains 8 mg of ondansetron.
Each millilitre contains 2 mg of ondansetron as ondansetron dihydrochloride dihydrate.
The other ingredients are sodium chloride, disodium citrate dihydrate, citric acid monohydrate and water for injections.

What Ondansetron B. Braun 2 mg/ml looks like and contents of the pack
Ondansetron B. Braun 2 mg/ml is a clear, colourless solution.
This medicine is supplied:

• in ampoules made of colourless glass containing 2 ml or 4 ml
  • pack contains 5 or 10 ampoules;
• in plastic ampoules containing 4 ml
  • pack contains 20 ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
correspondence address
34209 Melsungen
Germany

This medicinal product is available in the European Union Member States under the following names:

Information intended exclusively for healthcare professionals:

QT interval prolongation
Rarely and usually after intravenous administration of ondansetron, transient ECG changes have been observed, including prolongation of the QT interval. Additionally, cases of torsade de pointes have been reported in patients receiving ondansetron. Caution is recommended in patients with known or suspected QTc interval prolongation. This recommendation applies to patients with electrolyte imbalances, congenital long QT syndrome, and patients taking other medicinal products that can prolong the QT interval. Therefore, caution should be exercised in patients with cardiac arrhythmias, patients receiving antiarrhythmic drugs or beta-adrenolytic agents, and patients with severe electrolyte disturbances.

Serotonin syndrome
During post-marketing surveillance, cases of serotonin syndrome (including mental status changes, autonomic instability, and neuromuscular abnormalities) have been reported in patients receiving ondansetron concomitantly with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI)). If concomitant use of ondansetron and other serotonergic drugs is clinically indicated, patient monitoring is recommended.