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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT    w hameln

Ondansetron 2 mg/ml Solution for Injection

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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of the medicinal product is Ondansetron 2 mg/ml Solution for Injection but will be referred to as Ondansetron 2 mg/ml throughout the leaflet.

In this leaflet:

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

2.    Before Ondansetron 2 mg/ml is given to you

3.    How Ondansetron 2 mg/ml is given

4.    Possible side effects

5.    How to store Ondansetron 2 mg/ml

6.    Further information

1.    what ondansetron 2 mg/ml is and what it is USED for

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 or be sick. Also after surgical treatment you can feel sick or be sick. Ondansetron 2 mg/ml may help to reduce these effects.

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 have cardiac problems.

-    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, carbamazepine, rifampicin or tramadol, anthracylines (cancer medicine) including medicines obtained without a prescription.

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

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

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 a single dose of 4 mg ondansetron is usually given.

Children aged over 6 months and adolescents The doctor will decide the dose. In cases of chemotherapy or radiotherapy the usual dose in children and adolescents is 4 mg.

Children aged over 1 month and adolescents The doctor will decide the dose. For treatment of postoperative nausea and vomiting a maximum dose of 4 mg is given into a vein.

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.

4.    POSSIBLE SIDE EFFEOTS

Like all medicines, Ondansetron 2 mg/ml can cause side effects, although not everybody gets them.

The frequency of side effects is classified into the following categories:

-----x-----------------------------------------------------------------

The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR:

Ondansetron 2 mg/ml Solution for Injection

It is important that you read the entire contents of this guide prior to the preparation of this medicinal product.

Therapeutic indications

Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of postoperative nausea and vomiting (PONV).

Paediatric Population:

Ondansetron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged >6 months, and for the prevention and treatment of PONV in children aged >1 month.

For full prescribing information please consult the Summary of Product Characteristics (SmPC).

Prescribers intending to use ondansetron in the prevention of delayed nausea and vomiting associated with chemotherapy

or radiotherapy in adults, adolescents or children should take into consideration current practice and appropriate guidelines.

Administration

Ondansetron is administered by intravenous injection or by intravenous infusion after dilution.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those detailed below (see Dilution).

Shelf life

Unopened:

3 years Injection:

After first opening the medicinal product should be used immediately.

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, who were sensitive to 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

(ECG) predominantly after intravenous application of ondansetron.

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.

Ophthalmic 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 including cisplatin. Most reported cases resolved within 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)

-----x---------------------------------------------------

Infusion:

Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C with the solutions detailed below (see Dilution).

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

The diluted solutions should be stored protected from light.

The solution is to be visually inspected prior to use. Only clear solution practically free from particles should be used.

Any unused product or waste material should be disposed of in accordance with local requirements.

Dilution

Ondansetron 2 mg/ml may be diluted with the following solutions for infusion

-    Sodium chloride 9 mg/ml (0.9% w/v) solution

-    Glucose 50 mg/ml (5% w/v) solution

-    Mannitol 100 mg/ml (10% w/v) solution

-    Ringer’s lactate solution

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 becomes 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 in colourless glass ampoules containing 2 ml or 4 ml of solution for injection.

Pack sizes: 5 and 10 ampoules Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

hameln pharma plus gmbh

Langes Feld 13, 31789 Hameln, Germany

Distributor:

hameln pharmaceuticals ltd,

Gloucester, United Kingdom Manufacturer

hameln pharmaceuticals gmbh Langes Feld 13, 31789 Hameln, Germany hameln rds a.s.

Horna 36, 900 01 Modra, Slovak Republic HBM Pharma s.r.o

Sklabinska 30, 03680 Martin, Slovak Republic

This medicinal product is authorised in the Member States of

the EEA under the following names:

46173/23/13

The diluted solutions should be stored protected from light. Note:

The solution for injection must not be sterilized in an autoclave! Special precautions for storage

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

For storage conditions of the diluted medicinal product, see above.

46173/23/13

#

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT    w hameln

Ondansetron 2 mg/ml Solution for Injection

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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of the medicinal product is Ondansetron 2 mg/ml Solution for Injection but will be referred to as Ondansetron 2 mg/ml throughout the leaflet.

In this leaflet:

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

2.    Before Ondansetron 2 mg/ml is given to you

3.    How Ondansetron 2 mg/ml is given

4.    Possible side effects

5.    How to store Ondansetron 2 mg/ml

6.    Further information

1.    what ondansetron 2 mg/ml is and what it is USED for

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 or be sick. Also after surgical treatment you can feel sick or be sick. Ondansetron 2 mg/ml may help to reduce these effects.

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 have cardiac problems.

-    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, carbamazepine, rifampicin or tramadol, anthracylines (cancer medicine) including medicines obtained without a prescription.

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

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

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 a single dose of 4 mg ondansetron is usually given.

Children aged over 6 months and adolescents The doctor will decide the dose. In cases of chemotherapy or radiotherapy the usual dose in children and adolescents is 4 mg.

Children aged over 1 month and adolescents The doctor will decide the dose. For treatment of postoperative nausea and vomiting a maximum dose of 4 mg is given into a vein.

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.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Ondansetron 2 mg/ml can cause side effects, although not everybody gets them.

The frequency of side effects is classified into the following categories:

-----X-----------------------------------------------------------------

The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR:

Ondansetron 2 mg/ml Solution for Injection

It is important that you read the entire contents of this guide prior to the preparation of this medicinal product.

Therapeutic indications

Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of postoperative nausea and vomiting (PONV).

Paediatric Population:

Ondansetron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged >6 months, and for the prevention and treatment of PONV in children aged >1 month.

For full prescribing information please consult the Summary of Product Characteristics (SmPC).

Prescribers intending to use ondansetron in the prevention of delayed nausea and vomiting associated with chemotherapy

or radiotherapy in adults, adolescents or children should take into consideration current practice and appropriate guidelines.

Administration

Ondansetron is administered by intravenous injection or by intravenous infusion after dilution.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those detailed below (see Dilution).

Shelf life

Unopened:

3 years Injection:

After first opening the medicinal product should be used immediately.

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, who were sensitive to 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

(ECG) predominantly after intravenous application of ondansetron.

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.

Ophthalmic 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 including cisplatin. Most reported cases resolved within 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 becomes 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 in colourless glass ampoules containing 2 ml or 4 ml of solution for injection.

Pack sizes: 5 and 10 ampoules Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

hameln pharma plus gmbh

Langes Feld 13, 31789 Hameln, Germany

Distributor:

hameln pharmaceuticals ltd,

Gloucester, United Kingdom Manufacturer

hameln pharmaceuticals gmbh Langes Feld 13, 31789 Hameln, Germany hameln rds a.s.

Horna 36, 900 01 Modra, Slovak Republic

HBM Pharma s.r.o

Sklabinska 30, 03680 Martin, Slovak Republic

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

56727/23/13

■x.

Infusion:

Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C with the solutions detailed below (see Dilution).

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

The diluted solutions should be stored protected from light. The solution is to be visually inspected prior to use. Only clear solution practically free from particles should be used.

Any unused product or waste material should be disposed of in accordance with local requirements.

Dilution

Ondansetron 2 mg/ml may be diluted with the following solutions for infusion

-    Sodium chloride 9 mg/ml (0.9% w/v) solution

-    Glucose 50 mg/ml (5% w/v) solution

-    Mannitol 100 mg/ml (10% w/v) solution

-    Ringer's lactate solution