Ondansetron B. Braun

Package leaflet: Information for the patient

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

Generic medicine
Please read all of this leaflet carefully before you start 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell 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 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 B. Braun 2 mg/ml belongs to a group of medicines called antiemetics, used to treat nausea or feeling unwell. Certain medical treatments for cancer (chemotherapy) or radiotherapy may make you feel sick (nausea) or cause you to vomit. You may also experience nausea or vomiting after surgery.
Ondansetron B. Braun 2 mg/ml can help reduce these effects in adults and children from the age of 6 months:

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

2. What you should know before taking Ondansetron B. Braun 2 mg/ml

Ondansetron B. Braun 2 mg/ml must not be administered (please 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 apomorphine (a medicine used to treat Parkinson's disease). Warnings and precautions
  Talk to your doctor or pharmacist before taking this medicine. Special caution will be taken with this medicine:

• If you are allergic to other medicines used to treat nausea or motion sickness, because you may develop an allergy to this medicine.

• If you have intestinal obstruction or suffer from severe constipation. Ondansetron may worsen the obstruction or constipation.

• If you have taken medicines that are harmful to the heart.

• If you have ever had heart problems.

• If you have disturbances in blood electrolyte levels, such as potassium, sodium, or magnesium.

• If you have an irregular heartbeat (arrhythmia).

• If you have undergone tonsillectomy surgery.

• If your liver function is impaired. If your child is taking this medicine and is also receiving 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 medicines.
In particular, it is important that your doctor knows if you are taking:

• certain medicines used to treat epilepsy (e.g. phenytoin, carbamazepine);
• an antibiotic called rifampicin;
• a strong painkiller called tramadol;
• medicines used to treat depression (such as fluoxetine, sertraline, duloxetine, venlafaxine);
• apomorphine (a medicine used to treat Parkinson's disease), because a marked drop 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 breastfeeding Due to insufficient experience, the use of ondansetron during pregnancy is not recommended. Ondansetron is excreted in animal milk. Therefore, mothers receiving ondansetron must not breastfeed. If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Driving and using machines Ondansetron does not affect or affects negligibly the ability to drive or operate machinery. Ondansetron B. Braun 2 mg/ml contains sodium This 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 on a controlled sodium diet.

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

Method of administration
Ondansetron B. Braun 2 mg/ml is administered as an intravenous or intramuscular injection (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
Your 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 (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
Your doctor will determine the dose individually.

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

Patients with renal impairment or reduced sparteine/debrisoquine metabolism:
No adjustment of daily dosage, frequency, or route of administration is required.

Elderly patients
Aged 65–74 years: the same dosing regimen as for adults may be followed.
Over 74 years of age: specific dosage requirements must be observed. Your doctor is aware of these requirements and will administer, where possible, a lower initial dose of this medicine compared to younger patients. Furthermore, you will receive this medicine only after dilution in another solution.

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

What to do in case of overdose of Ondansetron B. Braun 2 mg/ml
Since this medicine will be administered by a doctor or nurse, it is unlikely that you or your child will receive an excessive dose. If you think that you or your child has received too much or has missed a dose, inform your doctor or nurse.

Currently, information available regarding ondansetron overdose is limited. In most patients, symptoms were similar to those already reported in patients receiving the recommended doses of this medicine (see section “Possible side effects”). After overdose, the following effects have been observed: visual disturbances, severe constipation, low blood pressure, and unconsciousness. In all cases, these events resolved completely.

This medicine may alter heart rhythm, especially if you have received an overdose. In such cases, your doctor will monitor your heart rate more closely.

There is no specific antidote for ondansetron; therefore, if overdose is suspected, only the symptoms should 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 will experience them.
The following side effects can be serious. If you experience any of the following side effects, inform your doctor immediately, as he/she may need to stop administration of this medicine:
Uncommon (may affect up to 1 in 100 people):

• Chest pain, irregular heartbeat (arrhythmia, which may be life-threatening in individual cases), and slow heartbeat (bradycardia).
  Rare (may affect up to 1 in 1,000 people):

• Immediate allergic reactions, including life-threatening allergic reactions (anaphylaxis). These reactions may include swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in breathing or swallowing. In addition, rash, itching, or 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 intravenous injection site
  Uncommon (may affect up to 1 in 100 people):

• Movement disorders causing involuntary movements, for example spasmodic eye movements, abnormal muscle contractions which may lead to twisting or jerking movements of the body, seizures (e.g. epileptic spasms).

• Hypotension (low blood pressure).

• Hiccups.

• Asymptomatic increases in liver function parameters. These reactions have been observed particularly in patients undergoing anti-tumour therapy with cisplatin.
  Rare (may affect up to 1 in 1,000 people):

• Dizziness during rapid intravenous administration.

• Transient changes in the electrocardiogram (instrumental measurement of the electrical processes occurring normally during heartbeat), especially after intravenous administration of ondansetron (QTc prolongation, including Torsades de Pointes).

• Transient visual disturbances (e.g. blurred vision) during rapid intravenous administration.

• Hypersensitivity reactions around the injection site (e.g. skin rash, hives, itching) may occur, which may sometimes extend along the vein into which the drug is administered.
  Very rare (may affect up to 1 in 10,000 people):

• Depression.

• Transient blindness has been reported in individual cases in patients receiving chemotherapeutic agents, including cisplatin. Most reported cases resolved within 20 minutes.
  Reporting of side effects
  If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
  You may also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) 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 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.
Polyethylene (LDPE) vials: do not store above 25°C.
Glass vials: this medicine does not require any special storage conditions.
Do not dispose of any medicine 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 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 contents of the pack
Ondansetron B. Braun 2 mg/ml is a clear, 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 Responsible Person 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 under the following names:

The following information is intended exclusively for healthcare professionals:

QT interval prolongation
Rare cases, mainly associated with intravenous administration of ondansetron, have reported transient ECG changes, including QT interval prolongation. Additionally, cases of torsade de pointes have been reported in patients receiving ondansetron. Caution is advised in patients who have or may develop QTc interval prolongation. Such conditions include patients with electrolyte abnormalities, congenital long QT syndrome, or those taking other medicinal products known to prolong the QT interval. Therefore, caution should be exercised in patients with cardiac rhythm or conduction disorders, in patients treated with antiarrhythmic agents or beta-adrenergic blocking agents, and in patients with significant electrolyte disturbances.

Serotonin syndrome
Post-marketing reports have described cases of serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular abnormalities) following concomitant use of ondansetron and other serotonergic medicinal products (including selective serotonin reuptake inhibitors [SSRI] and serotonin-norepinephrine reuptake inhibitors [SNRI]). If concomitant treatment with ondansetron and other serotonergic medicinal products is clinically warranted, appropriate patient monitoring is recommended.

Patient information leaflet

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

Please read this leaflet carefully before this medicine is administered to you, because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effect, including those not listed in this leaflet, please consult 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 receiving Ondansetron B. Braun
3. How to receive Ondansetron B. Braun
4. Possible side effects
5. How to store Ondansetron B. Braun
6. Package contents and other information

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

Ondansetron B. Braun belongs to a group of medicines called antiemetics, used to treat nausea or sickness.
Some medical treatments with medicines for cancer (chemotherapy) or radiotherapy may make you feel sick (nausea) or cause you to be sick (vomiting). You may also feel sick (nausea) or vomit after surgery. Ondansetron B. Braun can help reduce these effects in adults.
Additionally, Ondansetron B. Braun may be used in children,

• from the age of 6 months: to treat nausea and vomiting following cancer therapy
• from the age of 1 month: to prevent and treat nausea and vomiting after surgery.

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

Do not use Ondansetron B. Braun:

• if you are allergic to ondansetron or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking apomorphine (a medicine used to treat Parkinson's disease). Warnings and precautions Talk to your doctor or pharmacist before taking this medicine. Be especially careful with this medicine:
• If you are allergic to other medicines used to treat nausea or vomiting: you may develop an allergic reaction to this medicine.
• If you have intestinal obstruction or suffer from severe constipation. Ondansetron may worsen the obstruction or constipation.
• If you are taking medicines that affect the heart.
• If you have ever had heart problems.
• If you have imbalances in blood electrolyte levels, such as potassium, sodium, or magnesium.
• If you have an irregular heartbeat (arrhythmia).
• If you have recently undergone tonsillectomy.
• If your liver function is impaired. If your child is taking this medicine and is also receiving anticancer medicines that affect the liver, the doctor will monitor your child's liver function.

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

• certain medicines used to treat epilepsy (e.g. phenytoin, carbamazepine);
• an antibiotic called rifampicin;
• a strong painkiller called tramadol;
• medicines used to treat depression (such as fluoxetine, sertraline, duloxetine, venlafaxine);
• apomorphine (a medicine used to treat Parkinson's disease), because marked drop 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 breastfeeding Due to insufficient experience, the use of ondansetron during pregnancy is not recommended. It has been shown that ondansetron is excreted in animal milk. Therefore, mothers receiving ondansetron should NOT breastfeed. If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Driving and operating machinery Ondansetron does not affect or affects negligibly the ability to drive vehicles or operate machinery. Ondansetron B. Braun contains sodium This 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 maximum daily dose of 32 mg. This should be taken into consideration in patients on a low-sodium diet.

3. How to take Ondansetron B. Braun

Dosage
Your 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
Your doctor will determine the dose individually.

Dosage adjustment
Patients with hepatic impairment:
For patients with liver problems, the dose should be adjusted to a maximum daily dose of 8 mg of ondansetron.
Patients with renal impairment or reduced sparteine/debrisoquine metabolism:
No adjustment of daily dosage, frequency, or route of administration is required.
Elderly patients
65–74 years of age: the same dosing regimen as for adults may be followed.

74 years of age: specific dosage requirements must be observed. Your doctor is aware of these requirements and will administer, where possible, a lower initial dose of this medicine compared to that given to younger patients.

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

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

If you receive more Ondansetron B. Braun than you should
Since Ondansetron B. Braun is administered by a doctor or nurse, 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 if you have missed a dose, inform your doctor or nurse immediately.
Currently, information regarding overdose is limited. In most patients, symptoms were similar to those already reported in patients who have taken the recommended doses of this medicine (see section “Possible side effects”). The following effects have been observed after overdose: visual disturbances, severe constipation, low blood pressure, and unconsciousness.
In all cases, these events resolved completely.
This medicine may alter heart rhythm, especially if you have received an overdose. In such cases, your doctor will monitor your heartbeat more closely.
There is no specific antidote for ondansetron; therefore, if overdose is suspected, only the symptoms should 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 will get them.
The following side effects can be serious. If you experience any of the following side effects, inform your doctor immediately; the doctor may need to stop administration of this medicine:
Uncommon (may affect up to 1 in 100 people):

• Chest pain, irregular heartbeat (arrhythmia, which may be fatal in individual cases), and slow heartbeat (bradycardia).
  Rare (may affect up to 1 in 1,000 people):

• Immediate allergic reactions, including life-threatening allergic reactions (anaphylaxis). These reactions may include swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty breathing or swallowing. In addition, skin rash, itching, or 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 intravenous injection site

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

• Movement disorders causing involuntary movements, for example spasmodic eye movements, abnormal muscle contractions which may lead to twisting or jerking body movements, seizures (e.g. epileptic spasms).

• Hypotension (low blood pressure).

• Hiccups.

• Asymptomatic increases in liver function. These reactions have been observed particularly in patients undergoing antitumour therapy, for example with cisplatin.

• Hypersensitivity reactions around the injection site (e.g. rash, urticaria, itching) may occur.
  Rare (may affect up to 1 in 1,000 people):

• Dizziness during rapid intravenous administration.

• Transient changes in the electrocardiogram (instrumental measurement of the electrical processes occurring normally during heartbeat), especially after intravenous administration of ondansetron (QTc 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 people):

• Depression.

• Transient blindness has been reported in individual cases in patients receiving chemotherapeutic agents, including cisplatin. Most reported cases resolved within 20 minutes.
  Reporting of side effects
  If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the following 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 stated on the vial label and on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Keep the vial in the outer packaging to protect the medicine from light.
Do not dispose of any medicine via 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 contains

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

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

• The excipients are sodium chloride, sodium 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 clear, 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
Pack sizes:
Ondansetron B. Braun 0.08 mg/ml: 10 x 100 ml
Ondansetron B. Braun 0.16 mg/ml: 10 x 50 ml

Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
Austria: Ondansetron B. Braun 0.16 mg/ml Infusionslösung
Belgium: Ondansetron B. Braun 0.08 mg/ml, oplossing voor infusie
Ondansetron B. Braun 0.16 mg/ml, oplossing voor infusie
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 perfusión
Ondansetron B. Braun 0.16 mg/ml solución para perfusión
Sweden: Ondansetron B. Braun 0.08 mg/ml infuusioneste, liuos
Ondansetron B. Braun 0.16 mg/ml infuusioneste, liuos

The following information is intended exclusively for healthcare professionals:

QT interval prolongation
Rare cases, mainly associated with intravenous administration of ondansetron, have reported transient ECG changes, including QT interval prolongation. Additionally, cases of torsade de pointes have been reported in patients receiving ondansetron. Caution is advised in patients with known risk factors for QTc prolongation or who may develop QTc prolongation. These conditions include patients with electrolyte abnormalities, congenital long QT syndrome, or those taking other medicinal products known to prolong the QT interval. Therefore, caution should be exercised in patients with cardiac conduction or rhythm disorders, patients treated with antiarrhythmic agents or beta-adrenergic blocking agents, and patients with significant electrolyte disturbances.

Serotonin syndrome
Post-marketing reports have described patients experiencing serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular abnormalities) following 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 warranted, appropriate patient monitoring is recommended.

Compatibility with other medicinal products:
The following drugs may be administered simultaneously with Ondansetron B. Braun via a Y-site infusion line. In general, compatibility has been demonstrated for up to 1 hour; however, the manufacturer's recommendations for the co-administered drug should be taken into account.

Cisplatin: concentrations up to 0.48 mg/ml (e.g., 240 mg in 500 ml).
Carboplatin: concentrations ranging from 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 ranging from 0.14 mg/ml to 0.25 mg/ml (e.g., from 72 mg in 500 ml to 250 mg in 1 liter).
Ceftazidime: compatibility has been demonstrated for 2,000 mg reconstituted with 20 ml of 0.9% NaCl and for 2,000 mg reconstituted with 0.9% NaCl 10 ml of water for injections.
Cyclophosphamide: compatibility has been demonstrated for 1,000 mg reconstituted with 50 ml of 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 sodium phosphate dexamethasone and ondansetron has been demonstrated when administered via the same infusion set, resulting in concentrations of 32 micrograms – 2.5 mg/ml for sodium phosphate dexamethasone and 8 micrograms – 0.75 mg/ml for ondansetron.

For complete information on this medicinal product, refer to the Summary of Product Characteristics.