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805/12613376/0313

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

B. Braun Melsungen AG ■ 34209 Melsungen, Germany

Ondansetron 2 mg/ml Solution for injection or infusion

Read all of this leaflet carefully before this medicine is given to you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.WHAT ONDANSETRON 2 MG/ML IS AND WHAT IT IS USED FOR

Ondansetron 2 mg/ml belongs to a group of medicines called antiemetics, drugs against feeling sick or being sick. Some medical treatment with medicines for treatment of cancer (chemotherapy) or radiotherapy can make you feel sick (nausea) or be sick (vomiting). Also after surgical treatment you can feel sick (nausea) or be sick (vomiting). Ondansetron 2 mg/ml may help to reduce these effects in adults and

in 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 or treat nausea and vomiting after surgery.

2. BEFORE ONDANSETRON 2 MG/ML IS GIvEN TO YOU

Ondansetron 2 mg/ml must not be given (please tell your doctor)

-    if you are allergic (hypersensitive) to ondansetron, any of the other ingredients of Ondansetron 2 mg/ml or to medicinal products from the same class (e.g. granisetron or dolasetron).

Take special care with Ondansetron 2 mg/ml and tell your doctor

-    if you are hypersensitive to other medicines against feeling sick or being sick.

-    if you have a blockage in your gut or suffer from severe constipation. Ondansetron can enhance the blockage or constipation.

-    if you received medicines that affect your heart.

-    if you ever had heart problems.

-    you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.

-    you have an uneven heart beat (arrhythmias)

-    if you are having your tonsils out.

-    if your liver is not working as well as it should.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, such as phenytoin, carbamazepin, rifampicin or tramadol, including medicines obtained without a prescription and medicines that affect your heart rhythm or affect your heart (e.g. anthrycyclines).

If you are taking tramadol (painkiller): ondansetron may reduce the analgesic effect of tramadol

If you are taking phenytoin, carbamazepine (anti-epileptics) or rifampicin (antibiotic): the ondansetron blood concentrations are decreased.

Pregnancy and breast-feeding

Because of insufficient experience the use of ondansetron during pregnancy is not recommended. Ondansetron passes into mother's milk. Therefore mothers receiving ondansetron should NOT breastfeed.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines

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

Important information about some of the ingredients of Ondansetron 2 mg/ml

This medicinal product contains 2.3 mmol (53.5 mg) sodium per maximum daily dose of 32 mg. To be taken into consideration by patients on a controlled sodium diet.

3. HOW ONDANSETRON 2 MG/ML IS GIvEN

Method of administration

Ondansetron 2 mg/ml is given as intravenous injection (into a vein) or, after dilution, as intravenous infusion (for a longer time). It will usually be given by a doctor or a nurse.

Dosage

Your doctor will decide on the correct dose of ondansetron therapy for you.

The dose varies depending on your medicinal treatment (chemotherapy or surgery), on your liver function and on whether it is given by injection or infusion.

In case of chemotherapy or radiotherapy the usual dose in adults is 8 - 32 mg ondansetron a day. For treatment of post-operative nausea and vomiting usually a single dose of 4 mg ondansetron is given.

Children aged over 1 month and adolescents The doctor will decide the dose.

Dosage adjustment

Patients with hepatic impairment:

In patients having hepatic problems the dose has to be adjusted to a maximum daily dose of 8 mg ondansetron.

Elderly as well as patients with renal impairment or poor sparteine/ debrisoquine metabolism:

No alteration of daily dosage or frequency of dosing or route of administration is required.

Duration of treatment

Your doctor will decide on the duration of ondansetron therapy for you.

After intravenous administration of Ondansetron 2 mg/ml the therapy may be continued with other dosage forms.

If you received more Ondansetron 2 mg/ml than you should

Little is known at present about overdosage with ondansetron. In a few patients, the following effects were observed after overdose: visual disturbances, severe constipation, low blood pressure and unconsciousness. In all cases, the symptoms disappeared completely. There is no specific antidote to ondansetron; for that reason, if overdose is suspected, only the symptoms should be treated.

Tell your doctor if any of these symptoms occur.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Serious side effects Immune system disorders

Rare:    Immediate allergic (hypersensitivity) reactions (reaction

in which the body reacts with an exaggerated immune response to a foreign agent), including life-threatening allergic reaction. These reactions may be: swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing. Additionally rash or itching and hives.

Altered hypersensitivity reactions were also observed in patients, which were sensitive towards medicinal products from the same class.

Cardiac disorders

Uncommon: Chest pain, cardiac arrhythmias (changes in the way your heart beats) and bradycardia (slow heart rate). Chest pain and cardiac arrhythmias may be fatal in individual cases.

Inform your doctor immediately if you experience any symptoms suggestive of an allergic reaction.

Less serious side effects Cardiac disorders

Rare:    Transitory changes in the electrocardiogram (instrumen

tal control of electronic processes normally taking place when the heart beats) predominantly after intravenous application of ondansetron (QTc prolongation including Torsade de Pointes).

Nervous system disorders Very Common: Headache

Uncommon: Involuntary movement disorders, e.g. spasmodic movement of eyeballs, abnormal muscle contractions that may cause twisting or jerking movements of the body, seizures (e.g. epileptic spasms).

Rare:    Dizziness during rapid intravenous administration.

Very rare:    Depression.

Eye disorders

Rare:    Transient visual disturbances (e.g. blurred vision) during

rapid intravenous administration.

Very rare: In individual cases transitory blindness was reported in patients receiving chemotherapeutic agents included cisplatin. Most of reported cases were resolved in 20 minutes.

Vascular disorders:

Common:    Sensations of flushing or warmth.

Uncommon: Hypotension (low blood pressure).

Respiratory, thorax and mediastinum disorders Uncommon: Hiccups.

Gastrointestinal disorders

Common:    Ondansetron is known to increase the large bowel tran

sit time and may cause constipation in some patients. Hepato-biliary disorders

Uncommon: Asymptomatic increases of liver function. These reactions were particularly observed in patients under chemotherapy with cisplatin.

Skin and subcutaneous tissue disorders

Uncommon: Hypersensitivity reactions around the injection site (e.g.

rash, urticaria, itching) may occur, sometimes extending along the drug administration vein.

General disorders and administration site conditions Common:    Local reactions at the I.V. injection site.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE ONDANSETRON 2 MG/ML

Keep out of the reach and sight of children.

Ondansetron 2 mg/ml must not be given after the expiry date, which is stated on the ampoule label and carton. The expiry date refers to the last day of that month.

Keep the ampoules in the outer carton, in order to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Ondansetron 2 mg/ml contains

The active substance is ondansetron.

Each ampoule with 2 ml contains 4 mg ondansetron.

Each ampoule with 4 ml contains 8 mg ondansetron.

Each millilitre contains 2 mg ondansetron as ondansetron hydrochloride dihydrate.

The other ingredients are sodium chloride, sodium citrate dihydrate, citric acid monohydrate and water for injections.

What Ondansetron 2 mg/ml looks like and contents of the pack

Ondansetron 2 mg/ml is a clear and colourless solution.

It is available in

•    colourless glass ampoules containing 2 ml or 4 ml solution for injection.

Pack sizes: 5 and 10 ampoules.

•    plastic ampoules containing 4 ml solution for injection.

Pack size: 20 ampoules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen,

Germany postal address:

34209 Melsungen Germany

BBRAUN

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Ondansetron B. Braun 2 mg/ml, Injektionslosung
Belgium	Ondansetron B. Braun 2 mg/ml oplossing voor injectie
Czech Republic	Ondansetron B. Braun 2 mg/ml Injekcrn roztok
Germany	Ondansetron B. Braun 2 mg/ml, Injektionslosung
Denmark	Ondansetron B. Braun 2 mg/ml injektionsv^ske, opl0sning
Greece	Ondansetron B. Braun 2 mg/ml eveoi^o 5iaXu|ja
Spain	Ondansetron B. Braun 2 mg/ml solucion inyectable EFG
Finland	Ondansetron B. Braun 2 mg/ml injektioneste, liuos
Italy	Ondansetron B. Braun 2 mg/ml soluzione iniettabile o per infusione
Luxembourg	Ondansetron B. Braun 2 mg/ml, Injektionslosung
The Netherlands	Ondansetron B. Braun 2 mg/ml, oplossing voor injectie
Poland	Ondansetron B. Braun 2 mg/ml roztwor do wstrzykiwan
Portugal	Ondansetrom B. Braun 2 mg/ml solugao injectavel
Sweden	Ondansetron B. Braun 2 mg/ml injektionsvatska, losning
Slovak Republic	Ondansetron B. Braun 2 mg/ml injekcny roztok
United Kingdom	Ondansetron 2 mg/ml Solution for injection or infusion

This leaflet was last approved in February 2013

The following information is only intended for health-care professionals:

Rarely and predominantly with intravenous Ondansetron, transient ECG changes including QT interval prolongation have been reported. In addition, cases of Torsade de Pointes have been reported in patients using ondansetron. Caution is advised in patients who have or may develop prolongation of QTc. These conditions include patients with electrolyte abnormalities, with congenital long QT syndrome, or patients taking other medicinal products that lead to QT prolongation. Therefore, caution should be exercised in patients with cardiac rhythm or conduction disturbances, in patients treated with anti-arrhythmic agents or beta-adrenergic blocking agents and in patients with significant electrolyte disturbances.

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

B. Braun Melsungen AG, 34209 Melsungen, Germany

Ondansetron 2 mg/ml Solution for injection or infusion

Ondansetron 2 mg/ml belongs to a group of medicines called anti-emetics, drugs against feeling sick or being sick. Some medical treatment with medicines for treatment of cancer (chemotherapy) or radiotherapy can make you feel sick (nausea) or be sick (vomiting). Also after surgical treatment you can feel sick (nausea) or be sick (vomiting). Ondansetron 2 mg/ml may help to reduce these effects in adults and in 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 or treat nausea and vomiting after surgery.

2. BEFORE ONDANSETRON 2 MG/ML IS GIvEN TO YOU

Ondansetron 2 mg/ml must not be given (please tell your doctor)

-    if you are allergic (hypersensitive) to ondansetron, any of the other ingredients of Ondansetron 2 mg/ml or to medicinal products from the same class (e.g. granisetron or dolasetron).

Take special care with Ondansetron 2 mg/ml and tell your doctor

-    if you are hypersensitive to other medicines against feeling sick or being sick.

-    if you have a blockage in your gut or suffer from severe constipation. Ondansetron can enhance the blockage or constipation.

-    if you received medicines that affect your heart.

-    if you ever had heart problems.

-    you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.

-    you have an uneven heart beat (arrhythmias)

-    if you are having your tonsils out.

-    if your liver is not working as well as it should.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, such as phenytoin, carbamazepin, rifampicin or tramadol, including medicines obtained without a prescription and medicines that affect your heart rhythm or affect your heart (e.g. anthrycyclines).

If you are taking tramadol (painkiller): ondansetron may reduce the analgesic effect of tramadol

If you are taking phenytoin, carbamazepine (anti-epileptics) or rifampicin (antibiotic): the ondansetron blood concentrations are decreased.

Pregnancy and breast-feeding

Because of insufficient experience the use of ondansetron during pregnancy is not recommended. Ondansetron passes into mother's milk. Therefore mothers receiving ondansetron should NOT breastfeed.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Important information about some of the ingredients of Ondansetron 2 mg/ml

This medicinal product contains 2.3 mmol (53.5 mg) sodium per maximum daily dose of 32 mg. To be taken into consideration by patients on a controlled sodium diet.

3. HOW ONDANSETRON 2 MG/ML IS GIvEN

Method of administration

Ondansetron 2 mg/ml is given as intravenous injection (into a vein) or, after dilution, as intravenous infusion (for a longer time). It will usually be given by a doctor or a nurse.

Dosage

Your doctor will decide on the correct dose of ondansetron therapy for you.

The dose varies depending on your medicinal treatment (chemotherapy or surgery), on your liver function and on whether it is given by injection or infusion.

In case of chemotherapy or radiotherapy the usual dose in adults is 8 - 32 mg ondansetron a day. For treatment of post-operative nausea and vomiting usually a single dose of 4 mg ondansetron is given.

Children aged over 1 month and adolescents The doctor will decide the dose.

Dosage adjustment

Patients with hepatic impairment:

In patients having hepatic problems the dose has to be adjusted to a maximum daily dose of 8 mg ondansetron.

Elderly as well as patients with renal impairment or poor sparteine/ debrisoquine metabolism:

No alteration of daily dosage or frequency of dosing or route of administration is required.

Duration of treatment

Your doctor will decide on the duration of ondansetron therapy for you.

After intravenous administration of Ondansetron 2 mg/ml the therapy may be continued with other dosage forms.

If you received more Ondansetron 2 mg/ml than you should

Little is known at present about overdosage with ondansetron. In a few patients, the following effects were observed after overdose: visual disturbances, severe constipation, low blood pressure and unconsciousness. In all cases, the symptoms disappeared completely.

There is no specific antidote to ondansetron; for that reason, if overdose is suspected, only the symptoms should be treated.

Tell your doctor if any of these symptoms occur.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Serious side effects Immune system disorders

Rare:    Immediate allergic (hypersensitivity) reactions (reac

tion in which the body reacts with an exaggerated immune response to a foreign agent), including life-threatening allergic reaction. These reactions may be: swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing. Additionally rash or itching and hives. Altered hypersensitivity reactions were also observed in patients, which were sensitive towards medicinal products from the same class.

Cardiac disorders

Uncommon: Chest pain, cardiac arrhythmias (changes in the way your heart beats) and bradycardia (slow heart rate). Chest pain and cardiac arrhythmias may be fatal in individual cases.

Inform your doctor immediately if you experience any symptoms suggestive of an allergic reaction.

Less serious side effects Cardiac disorders

Rare:    Transitory changes in the electrocardiogram (instru

mental control of electronic processes normally taking place when the heart beats) predominantly after intravenous application of ondansetron (QTc prolongation including Torsade de Pointes).

Nervous system disorders Very Common:Headache

Uncommon: Involuntary movement disorders, e.g. spasmodic movement of eyeballs, abnormal muscle contractions that may cause twisting or jerking movements of the body, seizures (e.g. epileptic spasms).

Rare:    Dizziness during rapid intravenous administration.

Very rare:    Depression.

Eye disorders

Rare:    Transient visual disturbances (e.g. blurred vision) du

ring rapid intravenous administration.

Very rare:    In individual cases transitory blindness was reported

in patients receiving chemotherapeutic agents included cisplatin. Most of reported cases were resolved in 20 minutes.

Vascular disorders:

Common:    Sensations of flushing or warmth.

Uncommon: Hypotension (low blood pressure).

Respiratory, thorax and mediastinum disorders Uncommon: Hiccups.

Gastrointestinal disorders

Common:    Ondansetron is known to increase the large bowel

transit time and may cause constipation in some patients.

Hepato-biliary disorders

Uncommon: Asymptomatic increases of liver function. These reactions were particularly observed in patients under chemotherapy with cisplatin.

Skin and subcutaneous tissue disorders

Uncommon: Hypersensitivity reactions around the injection site (e.g.

rash, urticaria, itching) may occur, sometimes extending along the drug administration vein.

General disorders and administration site conditions Common:    Local reactions at the I.V. injection site.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE ONDANSETRON 2 MG/ML

Keep out of the reach and sight of children.

Ondansetron 2 mg/ml must not be given after the expiry date, which is stated on the ampoule label and carton. The expiry date refers to the last day of that month.

Keep the ampoules in the outer carton, in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Ondansetron 2 mg/ml contains

The active substance is ondansetron.

Each ampoule with 2 ml contains 4 mg ondansetron.

Each ampoule with 4 ml contains 8 mg ondansetron.

Each millilitre contains 2 mg ondansetron as ondansetron hydrochloride dihydrate.

The other ingredients are sodium chloride, sodium citrate dihydrate, citric acid monohydrate and water for injections.

What Ondansetron 2 mg/ml looks like and contents of the pack

Ondansetron 2 mg/ml is a clear and colourless solution.

It is available in

•    colourless glass ampoules containing 2 ml or 4 ml solution for injection.

Pack sizes: 5 and 10 ampoules.

•    plastic ampoules containing 4 ml solution for injection.

Pack size: 20 ampoules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen,

Germany postal address:

34209 Melsungen Germany

llllllllll    llllllllll

805/12608484/0313    PACKAGE LEAFLET:

INFORMATION FOR THE PATIENT

Ondansetron 2 mg/ml

Solution for injection or infusion

BIBRAUN

B. Braun Melsungen AG

34209 Melsungen Germany

llllllllll

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria	Ondansetron B. Braun 2 mg/ml, Injektions-losung
Belgium	Ondansetron B. Braun 2 mg/ml oplossing voor injectie
Czech Republic	Ondansetron B. Braun 2 mg/ml Injekcrn roztok
Germany	Ondansetron B. Braun 2 mg/ml, Injektions-losung
Denmark	Ondansetron B. Braun 2 mg/ml injektions-v^ske, opl0sning
Greece	Ondansetron B. Braun 2 mg/ml eveoi^o 5iaAu|ja
Spain	Ondansetron B. Braun 2 mg/ml solucion inyectable EFG
Finland	Ondansetron B. Braun 2 mg/ml injektioneste, liuos
Italy	Ondansetron B. Braun 2 mg/ml soluzione iniettabile o per infusione
Luxembourg	Ondansetron B. Braun 2 mg/ml, Injektions-losung
The Netherlands	Ondansetron B. Braun 2 mg/ml, oplossing voor injectie
Poland	Ondansetron B. Braun 2 mg/ml roztwor do wstrzykiwan
Portugal	Ondansetrom B. Braun 2 mg/ml solugao in-jectavel
Sweden	Ondansetron B. Braun 2 mg/ml injektions-vatska, losning
Slovak Republic	Ondansetron B. Braun 2 mg/ml injekcny roztok
United Kingdom	Ondansetron 2 mg/ml Solution for injection or infusion

This leaflet was last approved in February 2013

The following information is only intended for health-care professionals:

Rarely and predominantly with intravenous Ondansetron, transient ECG changes including QT interval prolongation have been reported. In addition, cases of Torsade de Pointes have been reported in patients using ondansetron. Caution is advised in patients who have or may develop prolongation of QTc. These conditions include patients with electrolyte abnormalities, with congenital long QT syndrome, or patients taking other medicinal products that lead to QT prolongation. Therefore, caution should be exercised in patients with cardiac rhythm or conduction disturbances, in patients treated with anti-arrhythmic agents or beta-adrenergic blocking agents and in patients with significant electrolyte disturbances.