Patient leaflet - PALONOSETRON 250 MICROGRAMS SOLUTION FOR INJECTION
Palonosetron 250 micrograms solution for injection
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.
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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.
The name of your medicine is Palonosetron 250 micrograms solution for injection; in the rest of the leaflet it will be called “Palonosetron”.
What is in this leaflet
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1. What Palonosetron is and what it is used for
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2. What you need to know before you use Palonosteron
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3. How to use Palonosteron
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4. Possible side effects
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5. How to store Palonosteron
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6. Contents of the pack and other information
1.what palonosetron is and what it is used for
Palonosetron belongs to a group of medicines known as serotonin (5HT3) antagonists.
These have the ability to block the action of the chemical serotonin, which can cause nausea and vomiting.
Palonosetron is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adults, adolescents and children over one month of age.
2.what you need to know before you use palonosetron
Do not use Palonosetron:
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– if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Palonosetron:
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– If you have acute bowel obstruction or a history of repeated constipation.
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– If you are using Palonosetron in addition to other medicines that may induce an abnormal heart rhythmsuch as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone.
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– If you have a personal or family history of alterations in heart rhythm (QT prolongation).
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– If you have other heart problems.
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– If you have an imbalance of certain minerals in your blood such as potassium and magnesium which has not been treated.
It is not recommended to use Palonosetron in the days following chemotherapy unless you are receiving another chemotherapy cycle.
Other medicines and Palonosetron
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:
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– SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/ or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
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– SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Pregnancy and breast-feeding
If you are pregnant or think you might be, your doctor will not administer Palonosetron to you unless it is clearly necessary.
It is not known whether Palonosetron will cause any harmful effects when used during pregnancy.
It is not known if Palonosetron is found in breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Palonosetron may cause dizziness or tiredness. If affected, do not drive or use any tools or machines.
Palonosetron contains sodium
This medicinal product contains 0.04 mmol (or 0.91 mg) sodium per ml. Maximum dose for children contains 1.19 mmol (or 27.3 mg) sodium. To be taken into consideration for patients on a controlled sodium diet.
3.how to use palonosetron
A doctor or nurse will normally inject Palonosetron about 30 minutes before the start of chemotherapy.
Adults
The recommended dose of Palonosetron is 250 micrograms given as a rapid injection into a vein.
Children and Adolescents (aged 1 month to 17 years)
The doctor will decide the dose, depending on bodyweight, however the maximum dose is 1500 micrograms.
Palonosetron Fresenius Kabi will be given as a slow infusion into a vein.
If you have any further questions on the use of this medicine, ask your doctor.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects and their frequencies are listed below:
Adults
Common (may affect up to 1 in 10 people):
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– headache,
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– dizziness,
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– constipation and diarrhoea.
Uncommon (may affect upto 1 in 100 people): – high or low blood pressure, – abnormal heart rate or lack of blood flow to the heart,
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– change in the colour of the vein and/or veins becoming larger,
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– abnormally high or low levels of potassium in the blood,
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– high levels of sugar in the blood or sugar in the urine,
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– low levels of calcium in the blood,
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– high levels of the pigment bilirubin in the blood,
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– high levels of certain liver enzymes,
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– elevated moods or feelings of anxiousness, – sleepiness or trouble sleeping, – decrease or loss of appetite,
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– weakness, tiredness, fever or flu like symptoms,
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– numbness, burning, prickling or tingling sensations on the skin,
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– itchy skin rash,
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– impaired vision or eye irritation,
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– motion sickness,
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– ringing in the ear,
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– hiccups, flatulence, dry mouth or indigestion,
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– abdominal (stomach) pain,
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– difficulty urinating,
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– joint pain,
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– electrocardiogram abnormalities (QT prolongation).
Very rare (may affect up to 1 in 10,000 people): – Allergic reactions to Palonosetron (the signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, you could also notice an itchy, lumpy rash (hives)), burning or pain at the site of injection.
Children and Adolescents:
Common (may affect up to 1 in 10 people):
- headache
- Uncommon (may affect upto 1 in 100 people): dizziness
- jerky body movements
- abnormal heart rate
- coughing or shortness of breath
The following information is intended for healthcare professionals only:
Posology and method of administration
Adults
250 micrograms palonosetron administered as a single intravenous bolus approximately 30 minutes before start of chemotherapy. Palonosetron should be injected over 30 seconds.
Elderly people
No dose adjustment is necessary for the elderly.
Children and Adolescents (aged 1 month to 17 years):
20 micrograms/kg (the maximum total dose should not exceed 1500 micrograms) palonosetron administered as a single 15 minute intravenous infusion beginning approximately 30 minutes before the start of chemotherapy.
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
M080048/01 UK
- 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 For UK – via the Yellow Card Scheme at: yellowcard
For Ireland – HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971; Fax: +353 1 6762517; Website: ; E-mail:. By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store palonosetron
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. The expiry date refers to the last day of that month.
Do not use this medicine if the solution is not clear or has visible particles.
This medicine does not require any special storage conditions.
Single use only, any unused solution should be disposed of.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.contents of the pack and other information
What Palonosetron contains
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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 (E421), disodium edetate dihydrate, sodium citrate dihydrate (E331), citric acid anhydrous (E330) and water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).
What Palonosetron looks like and contents of the pack
Palonosetron solution for injection is a clear, colorless solution and is supplied in single use glass vials closed with halobutyl rubber stopper and sealed with aluminium – plastic tear-off cap.
Pack sizes:
1 or 10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
For UK
Fresenius Kabi Limited
Cestrian Court,
Eastgate Way,
Manor Park,
Runcorn,
Cheshire, WA71NT UK
For IRL
Fresenius Kabi Deutschland GmbH Else-Kroener Strasse 1,
Bad Homburg v.d.H. 61352,
Germany
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
This medicinal product is authorised in the Member States of the EEAunderthe following names:
| Name of the Member State | Name of the medicinal product |
| Belgium | Palonosetron Fresenius Kabi 250 microgram oplossing voor injectie, solution injectable, Injektionslosung |
| Czech Republic | Palonosetron Fresenius Kabi 250 mikrogramu injekcni roztok |
| Denmark | Palonosetron Fresenius Kabi |
| Finland | Palonosetron Fresenius Kabi 250 mikrog injektioneste, liuos |
| France | PALONOSETRON FRESENIUS KABI 250 microgrammes/ 5 ml, solution injectable |
| Germany | Palonosetron Fresenius Kabi 250 Mikrogramm Injektionslosung |
| Ireland | Palonosetron 250 micrograms solution for injection |
| Italy | Palonosetron Fresenius Kabi |
| Luxembourg | Palonosetron Fresenius Kabi 250 Mikrogramm Injektionslosung |
| Malta | Palonosetron 250 micrograms solution for injection |
| Norway | Palonosetron Fresenius Kabi |
| Poland | Palonosetron Fresenius Kabi |
| Portugal | Palonossetrom Fresenius Kabi |
| Romania | Palonosetron Fresenius Kabi 250 micrograme solutie injectabila |
| Slovak Republic | Palonosetron Fresenius Kabi 250 mikrogramov injekcny roztok |
| Slovenia | Palonosetron Fresenius Kabi 250 mikrogramov raztopina za injiciranje |
| Spain | Palonosetron Fresenius Kabi 250 microgramos Solucion inyectable |
| Sweden | Palonosetron Fresenius Kabi 250 mikrog injektionsvatska, losning |
| The Netherlands | Palonosetron Fresenius Kabi 250 microgram, oplossing voor injectie |
| United Kingdom | Palonosetron 250 micrograms solution for injection |
This leaflet was last revised in July 2018.
V002
IJk FRESENIUS III KABI
Special precautions for storage
This medicinal product does not require any special storage conditions.
Special precautions for disposal
Single use only, any unused solution should be discarded.
Any unused product or waste material should be disposed of in accordance with local requirements.