ONDANSETRON 2 mg /Ml Roztwór Do Wstrzykiwań

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1. Ondansetron B. Braun 2 mg/ml injectable solution or for infusion
   1. What is Ondansetron B. Braun 2 mg/ml and what it is used for
   2. What you need to know before you take Ondansetron B. Braun 2mg/ml
   3. How to take 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
2. Ondansetron B. Braun 0.08 mg/ml solution for infusion, 0.16 mg/ml solution for infusion
   1. What is Ondansetron B. Braun and what is it used for
   2. What you need to know before you take Ondansetron B. Braun
   3. How to take Ondansetron B. Braun
   4. Possible side effects
   5. How to store Ondansetron B. Braun
   6. Contents of the pack and other information

Ondansetron B. Braun 2 mg/ml injectable solution or for infusion

Generic medicine
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ondansetron B. Braun 2 mg/ml is and what it is used for
• 2. What you need to know before you are given Ondansetron B. Braun 2 mg/ml
• 3. How to use Ondansetron B. Braun 2mg/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 is Ondansetron B. Braun 2 mg/ml and what it is used for

Ondansetron B. Braun 2mg/ml belongs to a group of medicines called antiemetics, for the
treatment of nausea or feeling unwell. Some medical treatments with medicines for the treatment of cancer
(chemotherapy) or radiotherapy may give you a feeling of unwellness (nausea) or cause a state of
unwellness (vomiting). You may also feel unwell (nausea) or experience a condition of unwellness (vomiting) after surgery.
Ondansetron B. Braun 2mg/ml may be useful in reducing these effects in adults and children, from 6
months of age:

• to treat nausea and vomiting after cancer therapy in children from one month of age;
• to prevent and treat nausea and vomiting after surgery.

2. What you need to know before you take Ondansetron B. Braun 2mg/ml

Ondansetron B. Braun 2 mg/ml should not be administered (please inform 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 apomorphine (a medicine for the treatment of Parkinson's disease). Warnings and precautionsTalk to your doctor or pharmacist before taking this medicine. Particular caution will be exercised with this medicine :
• If you are allergic to other medicines for the treatment of nausea or feeling unwell because you may develop an allergy to this medicine.
• If you have an intestinal blockage or suffer from severe constipation. Ondansetron may worsen the blockage or constipation.
• If you have taken medicines harmful to the heart.
• If you have ever suffered from heart disorders.
• If you suffer from disorders of salt levels in your blood, such as potassium, sodium and magnesium.
• If you have an irregular heartbeat (arrhythmia).
• If you have undergone tonsil removal surgery.
• If your liver function is not adequate. If your child is taking this medicine and is also taking anticancer medicines that affect the liver, the doctor will monitor your child's liver function.

Other medicines and Ondansetron B. Braun 2 mg/ml
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, it is important that your doctor knows if you are taking,

• some medicines for the treatment of epilepsy (e.g. phenytoin, carbamazepine);
• an antibiotic called rifampicin;
• a strong painkiller called tramadol;
• medicines used to treat a depressed mood (such as fluoxetine, sertraline, duloxetine, venlafaxine);
• apomorphine (a medicine used to treat Parkinson's disease), because significant drops in blood pressure and loss of consciousness have been reported following concomitant administration with this medicine;
• medicines that affect the rhythm or function of the heart, including:
• anticancer medicines such as anthracyclines (e.g. doxorubicin, daunorubicin or trastuzumab),
• antibiotics (e.g. erythromycin, ketoconazole) or
• beta-blockers (e.g. atenolol, timolol);
• antiarrhythmics (such as amiodarone). Pregnancy and breastfeedingDue to insufficient experience in this regard, the use of ondansetron during pregnancy is not recommended. Ondansetron is excreted in the milk of lactating animals. Therefore, mothers receiving ondansetron should NOT breastfeed. If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machinesOndansetron does not alter or alters negligibly the ability to drive vehicles or use machines. Ondansetron B. Braun 2 mg/ml contains sodiumThis medicine contains 2.3 mmol (53.5 mg) of sodium per maximum daily dose of 32 mg. This should be taken into consideration by patients who are on a sodium-controlled diet.

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

Method of administration
Ondansetron B. Braun 2mg/ml is administered as an intravenous or intramuscular injection (into a vein or
muscle) or, after dilution, as an intravenous infusion (for a more prolonged period).
It is usually administered by a doctor or a nurse.

Dosage
The doctor will decide the correct dose of ondansetron therapy suitable for you.
The dose varies depending on the type of medical treatment (chemotherapy or surgery), liver
function and the method of administration by injection or infusion.
In the case of chemotherapy or radiotherapy, the usual dose in adults is 8-32 mg of ondansetron per day.
For the treatment of postoperative nausea and vomiting, a single dose of
4 mg of ondansetron is usually administered.

Use in children over 1 month of age and adolescents
The doctor will decide the dose individually.

Dosage adjustment

Patients with hepatic impairment:
For patients with liver problems, the dose must be adjusted to a maximum daily dose of 8mg of
ondansetron.

Patients with renal impairment or reduced sparteine/debrisochine metabolism:
No change in daily dose, frequency or route of administration is necessary.

Elderly patients
65-74 years of age: the same dosage regimen as for adults can be followed.
> 74 years of age: specific dosage requirements must be respected. The doctor knows these requirements and will
administer, where possible, a smaller amount of the first dose of this medicine compared to that
received by younger patients. In addition, you will only receive this medicine diluted in another
solution.

Duration of treatment
Your doctor will decide the duration of ondansetron therapy suitable for you.
After intravenous administration of ondansetron 2 mg/ml, therapy may be continued with another
dosage form.

What to do in case of overdose of Ondansetron B. Braun 2 mg/ml
Since the doctor or nurse will administer this medicine to you or your child, it is unlikely
that you or your child will receive an excessive dose. If you believe that you or your child has received an
excessive dose or has missed one, inform the doctor or nurse.
Currently, the information available regarding ondansetron overdose is limited. In most patients, the symptoms were similar to those already reported in patients receiving the recommended doses
of this medicine (see section “Possible side effects”). The following effects have been observed after overdose:
visual disturbances, severe constipation, reduced blood pressure and loss of
consciousness. In all cases, these events resolved completely.
This medicine can alter the heart rhythm, especially if you have received an overdose. In this case
the doctor will further monitor the heartbeat.
There is no specific antidote to ondansetron; for this reason, if an overdose is suspected, only the symptoms must
be treated.
Inform your doctor immediately if any of these symptoms occur.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects may be serious. If any of the following side effects occur, tell your doctor immediately, who may need to stop giving you this medicine:
Uncommon (may affect up to 1 in 100 people):

• Chest pain, irregular heartbeat (arrhythmia which can be fatal in individual cases) and slow heartbeat (bradycardia). Rare (may affect up to 1 in 1,000):
• Immediate allergic reactions, including life-threatening allergic reactions (anaphylaxis). These reactions may be: swelling of the hands, feet, ankles, face, lips, mouth or throat, which can cause difficulty breathing or swallowing. Also, rash or itching and hives may occur. Other side effects include:Very common (may affect more than 1 in 10 people):
• Headache Common (may affect up to 1 in 10 people):
• Sensations of flushing or warmth
• Constipation
• Local reactions at the injection site i.v. Uncommon (may affect up to 1 in 100 people):
• Disorders inducing involuntary movements, for example spasmodic movement of the eyeballs, abnormal muscle contractions that can cause twisting or jerking body movements, convulsions (for example epileptic spasms).
• Hypotension (low blood pressure).
• Hiccups.
• Asymptomatic increases in liver function. These reactions have been observed particularly in patients undergoing anticancer therapy with cisplatin. Rare (may affect up to 1 in 1,000):
• Dizziness during rapid intravenous administration.
• Transient changes in the electrocardiogram (instrumental measurement of the electrical processes that normally occur during the heartbeat), especially after intravenous administration of ondansetron (QT prolongation, including Torsades de Pointes).
• Transient visual disturbances (e.g. blurred vision) during rapid intravenous administration.
• Hypersensitivity reactions may occur around the injection site (e.g. rash, hives, itching), which may sometimes extend along the vein into which the drug is administered. Very rare (may affect up to 1 in 10,000):
• Depression.
• In isolated cases, transient blindness has been reported in patients receiving chemotherapeutic agents, including cisplatin. Most reported cases have resolved within 20 minutes. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency, Website: http://www.agenziafarmaco.gov.it/it/responsabili 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label and on the
packaging. The expiry date refers to the last day of that month.
Store the vial in the outer packaging to protect the medicine from light.
Vials in polyethylene (LDPE): do not store at a temperature above 25°C.
Glass vials: this medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ondansetron B. Braun 2 mg/ml contains

• The active ingredient is ondansetron. Each 2 ml vial contains 4 mg of ondansetron. Each 4 ml vial contains 8 mg of ondansetron. Each millilitre contains 2 mg of ondansetron as ondansetron dihydrochloride dihydrate.
• The excipients are sodium chloride, disodium citrate dihydrate, citric acid monohydrate, and water for injections. Description of the appearance of Ondansetron B. Braun 2 mg/ml and package contentsOndansetron B. Braun 2 mg/ml is a transparent and colourless solution. It is available in: colourless glass vials containing 2 ml or 4 ml of injectable solution. Packs: 5 and 10 vials; plastic vials containing 4 ml of injectable solution. Pack: 20 vials. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible for batch release

• B. Braun Melsungen AG Carl Braun Strasse 1, 34212 Melsungen, Germany Postal address:34209 Melsungen Germany

This medicinal product is authorised in the member states of the European Economic Area with the following
names:

The following information is intended exclusively for healthcare professionals:
QT interval prolongation
Changes in the ECG, including QT interval prolongation, have been reported rarely and predominantly in association with intravenous administration of
ondansetron. In addition, cases of torsades de pointes have been reported in patients taking ondansetron. Caution should be exercised in patients who have or may develop QT interval prolongation. These conditions
include patients with electrolyte abnormalities, with congenital long QT syndrome or patients who
are taking other medicines that cause QT interval prolongation. Therefore, caution should be
exercised in patients with rhythm or conduction disorders of the heart, in patients treated with
antiarrhythmic agents or beta-adrenergic blockers, and in patients with significant electrolyte disturbances.
Serotonin syndrome
Post-marketingreports have described patients with serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular abnormalities) following the concomitant use of
ondansetron and other serotonergic medicines (including selective serotonin reuptake inhibitors [SSRIs]) and serotonin-norepinephrine reuptake inhibitors [SNRIs]). If concomitant treatment with ondansetron and other serotonergic medicines is clinically indicated, adequate patient observation is recommended.

Ondansetron B. Braun 0.08 mg/ml solution for infusion, 0.16 mg/ml solution for infusion

Read this leaflet carefully before you are given this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Ondansetron B. Braun is and what it is used for
• 2. What you need to know before you are given Ondansetron B. Braun
• 3. How to administer Ondansetron B. Braun
• 4. Possible side effects
• 5. How to store Ondansetron B. Braun
• 6. Contents of the pack and other information

1. What is Ondansetron B. Braun and what is it used for

Ondansetron B. Braun belongs to a group of medicines called antiemetics, for the treatment of
nausea or feeling unwell. Some medical treatments with medicines for the treatment of cancer (chemotherapy) or
radiotherapy can give you a feeling of unwellness (nausea) or cause a state of unwellness
(vomiting). You may also feel unwell (nausea) or experience a condition of unwellness (vomiting) after surgery. Ondansetron B. Braun can be helpful in reducing these
effects in adults.
In addition, Ondansetron B. Braun can be used in children,

• from 6 months of age: to treat nausea and vomiting after cancer therapy
• from one month of age: to prevent and treat nausea and vomiting after surgery.

2. What you need to know before you take Ondansetron B. Braun

Do not use Ondansetron B. Braun:

• if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• if you are taking apomorphine (a medicine for the treatment of Parkinson's disease). Warnings and precautionsTalk to your doctor or pharmacist before taking this medicine. Pay particular attention with this medicine :
• If you are allergic to other medicines for the treatment of nausea or vomiting: you may develop an allergy to this medicine.
• If you have an intestinal blockage or suffer from severe constipation. Ondansetron may increase the blockage or constipation.
• If you have taken medicines that affect the heart.
• If you have ever suffered from heart disorders.
• If you suffer from disorders in the levels of salts in your blood, such as potassium, sodium and magnesium.
• If you have an irregular heartbeat (arrhythmia).
• If you have undergone tonsil removal surgery.
• If your liver function is not adequate. If your child is taking this medicine and is also taking anticancer medicines that affect the liver, the doctor will monitor your child's liver function.

Other medicines and Ondansetron B. Braun
Tell your doctor if you are taking, have recently taken or might take any other medicines.
In particular, it is important that the doctor knows if you are taking,

• some medicines for the treatment of epilepsy (e.g. phenytoin, carbamazepine);
• an antibiotic called rifampicin;
• a strong painkiller called tramadol;
• medicines used to treat a depressed mood (such as fluoxetine, sertraline, duloxetine, venlafaxine);
• apomorphine (a medicine used to treat Parkinson's disease), because marked drops in blood pressure and loss of consciousness have been reported following concomitant administration with this medicine;
• medicines that affect the rhythm or function of the heart, including:
• anticancer medicines such as anthracyclines (e.g. doxorubicin, daunorubicin or trastuzumab),
• antibiotics (e.g. erythromycin, ketoconazole) or
• beta-blockers (e.g. atenolol, timolol);
• antiarrhythmics (such as amiodarone). Pregnancy and breastfeedingDue to insufficient experience in this regard, the use of ondansetron during pregnancy is not recommended. Ondansetron has been shown to be excreted in the milk of lactating animals. Therefore, mothers receiving ondansetron should NOT breastfeed. If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machinesOndansetron does not alter or alters negligibly the ability to drive vehicles or use machines. Ondansetron B. Braun contains sodiumThis medicine contains
• Ondansetron 0.08 mg/ml: 62.4 mmol (or 1.428 mg) of sodium
• Ondansetron 0.16 mg/ml: 31.2 mmol (or 714 mg) of sodium per a maximum daily dose of 32 mg. To be taken into consideration in people who are on a low-sodium diet.

3. How to take Ondansetron B. Braun

Dosage
The doctor will decide the correct dose of ondansetron therapy suitable for you.
The dose varies depending on the type of medical treatment (chemotherapy or surgery), liver function and the method of administration by injection or infusion.
In the case of chemotherapy or radiotherapy, the usual dose in adults is 8-32 mg of ondansetron per day.
For the treatment of postoperative nausea and vomiting, a single dose of 4 mg of ondansetron is usually administered.

Use in children over 1 month of age and adolescents
The doctor will decide the dose individually.

Dosage adjustment

Patients with hepatic impairment:
For patients with liver problems, the dose must be adjusted to a maximum daily dose of 8 mg of ondansetron.

Patients with renal impairment or reduced sparteine/debrisochine metabolism:
No dosage adjustment is necessary regarding the daily dose, frequency or route of administration.

Elderly patients
65-74 years of age: the same dosage regimen as for adults may be followed.
> 74 years of age: specific dosage requirements must be respected. The doctor knows these requirements and will administer, where possible, a smaller amount of the first dose of this medicine compared to that received by younger patients.

Duration of treatment
Your doctor will decide the duration of ondansetron therapy suitable for you.
After intravenous administration of Ondansetron B. Braun, therapy may be continued with another dosage form.

Route of administration
Ondansetron B. Braun is administered as a short-term intravenous infusion into a vein. It is usually administered by a doctor or nurse.

If you receive more Ondansetron B. Braun than you should
The doctor or nurse will give you or your child Ondansetron B. Braun, so it is unlikely that you or your child will receive too much. If you think that you or your child have received too much or have forgotten a dose, inform the doctor or nurse.
Currently, the information available regarding overdose is limited. In most patients, the symptoms were similar to those already reported in patients who have taken the recommended doses of this medicine (see section “Possible side effects”). After overdose, the following effects have been observed: visual disturbances, severe constipation, reduced blood pressure and loss of consciousness.
In all cases, these events resolved completely.
This medicine can alter the heart rhythm, especially if you have received an overdose. In this case, the doctor will further monitor the heartbeat.
There is no specific antidote to ondansetron; for this reason, if an overdose is suspected, only the symptoms must be treated.
Inform your doctor immediately if any of these symptoms occur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects may be serious. If you experience any of the following side effects,
inform your doctor immediately, who may need to stop the
administration of this medicine:
Uncommon (may affect up to 1 in 100 people):

• Chest pain, irregular heartbeat (arrhythmia which can be fatal in individual cases) and slow heartbeat (bradycardia). Rare (may affect up to 1 in 1,000):
• Immediate allergic reactions, including life-threatening allergic reactions (anaphylaxis). These reactions may be: swelling of the hands, feet, ankles, face, lips, mouth or throat, which can cause difficulty breathing or swallowing. In addition, skin rash or itching and hives may occur. Other side effects include:Very common (may affect more than 1 in 10 people):
• Headache Common (may affect up to 1 in 10 people):
• Sensations of flushing or warmth
• Constipation
• Local reactions at the i.v. injection site

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

• Disorders inducing involuntary movements, for example spasmodic movement of the eyeballs, abnormal muscle contractions that can cause twisting or jerking body movements, convulsions (for example epileptic spasms).
• Hypotension (low blood pressure).
• Hiccups.
• Asymptomatic increases in liver function. These reactions have been observed particularly in patients undergoing cancer therapy, for example with cisplatin.
• Hypersensitivity reactions may occur around the injection site (e.g. rash, hives, itching). Rare (may affect up to 1 in 1,000):
• Dizziness during rapid intravenous administration.
• Transient changes in the electrocardiogram (instrumental measurement of the electrical processes that normally occur during the heartbeat), especially after intravenous administration of ondansetron (QT prolongation, including Torsades de Pointes).
• Transient visual disturbances (e.g. blurred vision) during rapid intravenous administration. Very rare (may affect up to 1 in 10,000):
• Depression.
• In isolated cases, transient blindness has been reported in patients receiving chemotherapeutic agents, including cisplatin. Most reported cases resolved within 20 minutes. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency, Website: http://www.agenziafarmaco.gov.it/it/responsabili By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ondansetron B. Braun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Keep the vial in the outer packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ondansetron B. Braun contains

• The active substance is ondansetron. Ondansetron B. Braun 0.08 mg/ml 1 ml solution for infusion contains 0.08 mg of ondansetron as ondansetron hydrochloride dihydrate. Each vial containing 100 ml contains 8 mg of ondansetron.

Ondansetron B. Braun 0.16 mg/ml
1 ml solution for infusion contains 0.16 mg of ondansetron as ondansetron hydrochloride dihydrate.
Each vial containing 50 ml contains 8 mg of ondansetron.

• The excipients are sodium chloride, disodium citrate dihydrate, citric acid monohydrate and water for injections.

Description of the appearance of Ondansetron B. Braun and contents of the pack
Ondansetron B. Braun is a transparent and colourless solution.
It is available in:
LDPE plastic vials
Each vial contains:
Ondansetron B. Braun 0.08 mg/ml: 100 ml
Ondansetron B. Braun 0.16 mg/ml: 50 ml
Packs:
Ondansetron B. Braun 0.08 mg/ml: 10 x 100 ml
Ondansetron B. Braun 0.16 mg/ml: 10 x 50 ml

Marketing Authorisation Holder

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

Manufacturer responsible for batch release

• B. Braun Medical, S.A. Crta. de Terrassa, 121 0191 Rubí (Barcelona) - Spain

This medicinal product is authorised in the member states of the European Economic Area with the following
denominations:
Austria: Ondansetron B. Braun 0.16 mg/ml Infusionslösung
Belgium : Ondansetron B. Braun 0.08 mg/ml, solution for infusion
Ondansetron B. Braun 0.16 mg/ml, solution for infusion
Bulgaria: Ондансетрон 0.08 mg/ml инфузионен разтвор
Czech Republic: Ondansetron B. Braun 0.16 mg/ml
Finland: Ondansetron B. Braun 0.08 mg/ml infuusioneste, liuos
Ondansetron B. Braun 0.16 mg/ml infuusioneste, liuos
Germany: Ondansetron B. Braun 0,08 mg/ml Infusionslösung
Ondansetron B. Braun 0,16 mg/ml Infusionslösung
Italy: Ondansetron B. Braun
Ondansetron B. Braun
Netherlands: Ondansetron B. Braun 0,08 mg/ml, oplossing voor infusie
Ondansetron B. Braun 0,16 mg/ml, oplossing voor infusie
Poland: Ondansetron B. Braun
Portugal: Ondansetrom B. Braun
Slovakia: Ondansetron B. Braun 0.16 mg/ml
Spain: Ondansetron B. Braun 0.08 mg/ml solución para perfusion
Ondansetron B. Braun 0.16 mg/ml solución para perfusion
Sweden: Ondansetron B. Braun 0.08 mg/ml infuusioneste, liuos
Ondansetron B. Braun 0.16 mg/ml infuusioneste, liuos

The following information is intended for healthcare professionals only:
QT interval prolongation
Transient changes in the ECG, including QT interval prolongation, have been reported rarely and predominantly in relation to intravenous administration of
ondansetron. In addition, cases of torsade de pointes have been reported in patients receiving ondansetron. Caution is advised in patients who present with or may develop a prolongation of the QTc interval. These conditions
include patients with electrolyte imbalances, with congenital long QT syndrome or patients who
are taking other medicinal products that cause QT interval prolongation. Therefore, caution should be
exercised in patients with cardiac rhythm or conduction disorders, in patients treated with
antiarrhythmic agents or beta-blockers and in patients with significant electrolyte disturbances.
Serotonin Syndrome
Post-marketingreports have described patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of
ondansetron and other serotonergic agents (including selective serotonin reuptake inhibitors [SSRIs]) and serotonin-norepinephrine reuptake inhibitors [SNRIs]). If concomitant treatment with ondansetron and other serotonergic agents is clinically indicated, adequate patient observation is recommended.
Compatibility with other medicines:
The following drugs can be administered simultaneously with Ondansetron B. Braun via the
Y-connector of the ondansetron infusion set. In general, compatibility has been demonstrated for up to
1 hour, however, the manufacturer's recommendations for the drug administered simultaneously should be considered.

Cisplatin:concentrations up to 0.48 mg/ml (e.g. 240 mg in 500 ml).

Carboplatin:concentrations in the range of 0.18 mg/ml to 9.9 mg/ml (e.g. from 90 mg in 500 ml to 990 mg
in 100 ml)

Etoposide:concentrations in the range of 0.14 mg/ml to 0.25 mg/ml (e.g. from 72 mg in 500 ml to 250 mg
in 1 litre)

Ceftazidime:compatibility has been demonstrated for 2,000 mg reconstituted with 20 ml of 0.9% NaCl and 2,000 mg
reconstituted with 10 ml of water for injections.

Cyclophosphamide:compatibility has been demonstrated for 1,000 mg reconstituted with 50 ml 0.9% NaCl.

Doxorubicin:concentrations up to 2 mg/ml (e.g. 10 mg in 5 ml or 100 mg in 200 ml).

Dexamethasone: compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated via the
same infusion set resulting in concentrations in the order of 32 micrograms – 2.5 mg/ml for
dexamethasone sodium phosphate and 8 micrograms– 0.75 mg/ml for ondansetron.
For complete information on this medicinal product, please refer to the summary of product characteristics.