Beipackzettel - Palonosetron beta 250 Mikrogramm Injektionslösung
[invented name] 250 micrograms solution for injection
Palonosetron
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
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– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What [invented name] is and what it is used for
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2. What you need to know before you use [invented name]
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3. How to use [invented name]
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4. Possible side effects
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5. How to store [invented name]
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6. Contents of the pack and other information
1. What [invented name] is and what it is used for
[Invented name] contains the active substance palonosetron. This belongs to a group of medicines called ‘serotonin (5HT3) antagonists’.
[Invented name] is used in adults, adolescents and children over one month of age to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy.
It works by blocking the action of a chemical called serotonin, which can cause you to feel sick or to vomit.
2. What you need to know before you use [invented name]
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– you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
You will not be given [invented name] if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given this medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using [invented name] if:
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– you have a blocked bowel or have had repeated constipation in the past.
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– you have had heart problems or heart problems run in your family, such as changes in your heart
beat (‘QT prolongation’).
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– you have an imbalance of certain minerals in your blood which has not been treated – such as
potassium and magnesium.
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given [invented name].
Other medicines and [invented name]
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. In particular, tell them if you are taking the following medicines:
Medicines for depression or anxiety
Tell your doctor, pharmacist or nurse if you are taking any medicines for depression or anxiety, including:
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- medicines called SSRIs (‘selective serotonin reuptake inhibitors’) – such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
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- medicines called SNRIs (‘serotonin noradrenaline reuptake inhibitors’) – such as venlafaxine, duloxetine (can lead to the development of serotonin syndrome and should be used with caution).
Medicines that can affect your heart beat
Tell your doctor, pharmacist or nurse if you are taking any medicines that affect your heart beat – this is because they could cause a heart beat problem when taken with [invented name]. This includes: - medicines for heart problems such as amiodarone, nicardipine, quinidine
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- medicines for infections such as moxifloxacin, erythromycin
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- medicines for serious mental health problems such as haloperidol, chlorpromazine, quetiapine, thioridazine
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- a medicine for feeling or being sick (nausea and vomiting) called domperidone.
If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking [invented name]– this is because these medicines could cause a heart beat problem when taken with [invented name].
Pregnancy
If you are pregnant or think you might be pregnant, your doctor will not give you [invented name] unless it is clearly necessary. This is because we do not know if [invented name] may harm the baby.
Ask your doctor, pharmacist or nurse for advice before using this medicine if you are pregnant or think you might be.
Breast-feeding
It is not known if [invented name] is found in breast milk.
Ask your doctor, pharmacist or nurse for advice before using [invended name] if you are breastfeeding.
Driving and using machines
You may feel dizzy or tired after being given this medicine. If this happens, do not drive or use any tools or machines.
[invented name] contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. How to use [invented name]
[Invented name] is normally given by a doctor or nurse.
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- You will be given the medicine about 30 minutes before the start of chemotherapy.
Adults
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- The recommended dose of [invented name] is 250 micrograms.
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- It is given as an injection into a vein.
Children and young people (aged 1 month to 17 years)
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- The doctor will work out the right dose based on bodyweight.
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- The maximum dose is 1500 micrograms.
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- [Invented name] will be given as a drip (a slow infusion into a vein).
It is not recommended you are given [invented name] in the days following chemotherapy unless you are going to have another chemotherapy cycle.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor straight away if you notice any of the following serious side effects:
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- allergic reaction – the signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, an itchy, lumpy rash (hives). This is very rare: may affect up to 1 in 10,000 people.
Tell your doctor straight away if you notice any of the serious side effects listed above.
Other side effects
Tell your doctor if you notice any of the following side effects:
Adults
Common: may affect up to 1 in 10 people
- headache, feeling dizzy,
- constipation, diarrhoea.
Uncommon: may affect up to 1 in 100 people
- change in the colour of the vein and veins becoming larger
- feeling happier than usual or feeling anxious
- feeling sleepy or trouble sleeping
- decrease or loss of appetite
- weakness, feeling tired, fever or flu like symptoms
- numbness, burning, prickling or tingling sensations on the skin
- itchy skin rash
- impaired vision or eye irritation
- motion sickness
- ringing in the ear
- hiccups, passing wind (flatulence), dry mouth or indigestion
- abdominal (stomach) pain
- difficulty passing water (urinating)
- joint pain.
Uncommon side effects shown in tests: may affect up to 1 in 100 people
- high or low blood pressure
- abnormal heart rate or lack of blood flow to the heart
- abnormally high or low levels of potassium in the blood
- high levels of sugar in the blood or sugar in the urine
- low levels of calcium in the blood
- high levels of the pigment bilirubin in the blood
- high levels of certain liver enzymes
- ECG (electrocardiogram) abnormalities (‘QT prolongation’).
Very rare: may affect up to 1 in 10,000 people
- Burning, pain or redness at the injection site
Children and young people
Common: may affect up to 1 in 10 people
- headache.
Uncommon: may affect up to 1 in 100 people
- dizziness
- jerky body movements
- abnormal heart rate
- coughing or shortness of breath
- nosebleed
- itchy skin rash or hives
- fever
- pain at the site of infusion.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V *. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store [invented name]
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- Keep this medicine out of the sight and reach of children.
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- Do not use this medicine after the expiry date which is stated on the vial and carton after ‘EXP’. The expiry date refers to the last day of that month.
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- This medicine does not require any special storage conditions.
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- Single use only, any unused solution should be disposed of.
6. Contents of the pack and other information
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- The active substance is palonosetron (as hydrochloride). Each ml of solution contains 50 micrograms palonosetron. Each vial of 5 ml of solution contains 250 micrograms of palonosetron.
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- The other ingredients are mannitol, sodium acetate trihydrate, water for injection and for pH adjustment: sodiumhydroxide, hydrochloric acid.
What [invented name] looks like and contents of the pack
[Invented name] 250 micrograms solution for injection is a clear, colourless solution.
The product is packed in 5 mL Type-I, tubular glass vial stoppered with 20 mm bromobutyl omniflex coated rubber stoppers and sealed with 20 mm flip-off seal. Each vial contains one dose.
Available in packs of 1 vial containing 5 ml of solution.
Marketing Authorisation Holder and Manufacturer
[to be completed nationally]
This medicine is authorised in the Member States of the European Economic Area under the following names :
[to be completed nationally]
This leaflet was last revised in
[to be completed nationally]
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