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PALONOSETRON 250 MICROGRAMS SOLUTION FOR INJECTION

Active substance(s): PALONOSETRON HYDROCHLORIDE

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Package leaflet: Information for the user

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.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, ask your
doctor, pharmacist or nurse.
- This medicine has been prescribed for you
only. Do not pass it on to others.
- 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
1. What Palonosetron is and what it is used
for
2. What you need to know before you use
Palonosteron
3. How to use Palonosteron
4. Possible side effects
5. How to store Palonosteron
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:
- 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:
- If you have acute bowel obstruction or a
history of repeated constipation.
- If you are using Palonosetron in addition to
other medicines that may induce an
abnormal heart rhythm such as amiodarone,
nicardipine,
quinidine,
moxifloxacin,
erythromycin, haloperidol, chlorpromazine,
quetiapine, thioridazine, domperidone.
- If you have a personal or family history of
alterations
in
heart
rhythm
(QT
prolongation).
- If you have other heart problems.
- 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:
− SSRIs (selective serotonin reuptake
inhibitors) used to treat depression and/
or anxiety including fluoxetine, paroxetine,
sertraline,
fluvoxamine,
citalopram,
escitalopram;
− 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.

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.

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):
− headache,
− dizziness,
− constipation and diarrhoea.
Uncommon (may affect up to 1 in 100 people):
− high or low blood pressure,
− abnormal heart rate or lack of blood flow to
the heart,
− change in the colour of the vein and/or
veins becoming larger,
− 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,
− elevated moods or feelings of anxiousness,
− sleepiness or trouble sleeping,
− decrease or loss of appetite,
− weakness, tiredness, 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, flatulence, dry mouth or
indigestion,
− abdominal (stomach) pain,
− difficulty urinating,
− joint pain,
− 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 up to 1 in 100 people):
• dizziness
• jerky body movements
• abnormal heart rate
• coughing or shortness of breath

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.

M0xxxxx/xx GB
V001

• 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: www.mhra.gov.uk/
yellowcard
For Ireland - HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2, Tel: +353
1 6764971; Fax: +353 1 6762517; Website:
www.hpra.ie; E-mail: medsafety@hpra.ie. 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
information

the

pack

and

other

What Palonosetron contains
- 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.
- 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
Fresenius Kabi Ltd.
Cestrian Court
Eastgate Way, Manor Park
Runcorn, Cheshire
WA7 1NT
United Kingdom
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria

Finland












Palonosetron
Fresenius Kabi 250
mikrog injektioneste,
liuos

France















PALONOSETRON
FRESENIUS KABI
250 microgrammes/
5 ml, solution
injectable

Germany












Palonosetron
Fresenius Kabi 250
Mikrogramm
Injektionslösung

Ireland









Palonosetron
250 micrograms
solution for injection

Italy





Palonosetron
Fresenius Kabi

Luxembourg












Palonosetron
Fresenius Kabi 250
Mikrogramm
Injektionslösung

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 soluție
injectabilă

Slovak Republic










Palonosetron
Fresenius Kabi 250
mikrogramov
injekčný roztok

Slovenia















Palonosetron
Fresenius Kabi 250
mikrogramov
raztopina za
injiciranje

Spain














Palonosetron
Fresenius Kabi 250
microgramos
Solución inyectable

Sweden















Palonosetron
Fresenius Kabi 250
mikrog

injektionsvätska,
lösning




The Netherlands













Palonosetron
Fresenius Kabi 250
microgram,
oplossing voor
injectie

United Kingdom







Palonosetron
250 micrograms
solution for injection

This leaflet was last revised in April 2016.

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





















Palonosetron
Fresenius Kabi 250
microgram
oplossing voor
injectie, solution
injectable,
Injektionslösung

Czech Republic










Palonosetron
Fresenius Kabi 250
mikrogramů injekční
roztok

Denmark



Palonosetron
Fresenius 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.

V001

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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