Aloxi
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
19-07-2018
Charakterystyka produktu
(SPC)
19-07-2018
Sprawozdanie z oceny publicznego
(PAR)
09-04-2015
Składnik aktywny:
palonosetron hydrochloride
Dostępny od:
Helsinn Birex Pharmaceuticals Ltd.
Kod ATC:
A04AA05
INN (International Nazwa):
palonosetron
Grupa terapeutyczna:
Antiemetics and antinauseants, , Serotonin (5HT3) antagonists
Dziedzina terapeutyczna:
Vomiting; Cancer
Wskazania:
Aloxi is indicated in adults for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy,the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.Aloxi is indicated in paediatric patients 1 month of age and older for:the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Podsumowanie produktu:
Revision: 22
Status autoryzacji:
Authorised
Data autoryzacji:
2005-03-22
Ulotka dla pacjenta
36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALOXI 250 MICROGRAMS SOLUTION FOR INJECTION
Palonosetron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 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 or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Aloxi is and what it is used for
2.
What you need to know before you are given Aloxi
3.
How you are given Aloxi
4.
Possible side effects
5.
How to store Aloxi
6.
Contents of the pack and other information
1.
WHAT ALOXI IS AND WHAT IT IS USED FOR
Aloxi contains the active substance palonosetron. This belongs to a
group of medicines called
‘serotonin (5HT
3
) antagonists’.
Aloxi 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 ARE GIVEN ALOXI
DO NOT TAKE ALOXI IF:
•
you are allergic to palonosetron or any of the other ingredients of
this medicine (listed in
section 6).
You will not be given Aloxi if any of the above apply to you. If you
are not sure, talk to your doctor
or nurse before you are given this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given Aloxi if:
•
you have a blocked bowel or have had repeated constipation in the past
•
you have had heart problems or heart problems run in your family, such
as changes in your heart
beat (‘QT prolongation’)
•
you have an imbalance of certain minerals in your blood which has not
been treated - such as
potassium and magnesium.
If any of t
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aloxi 250 micrograms solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms palonosetron (as
hydrochloride).
Each vial of 5 ml of solution contains 250 micrograms palonosetron (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aloxi is indicated in adults for:
•
the prevention of acute nausea and vomiting associated with highly
emetogenic cancer
chemotherapy,
•
the prevention of nausea and vomiting associated with moderately
emetogenic cancer
chemotherapy.
Aloxi is indicated in paediatric patients 1 month of age and older
for:
•
the prevention of acute nausea and vomiting associated with highly
emetogenic cancer
chemotherapy and prevention of nausea and vomiting associated with
moderately emetogenic
cancer chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Aloxi should be used only before chemotherapy administration. This
medicinal product should be
administered by a healthcare professional under appropriate medical
supervision.
Posology
_Adults _
250 micrograms palonosetron administered as a single intravenous bolus
approximately 30 minutes
before the start of chemotherapy. Aloxi should be injected over 30
seconds.
The efficacy of Aloxi in the prevention of nausea and vomiting induced
by highly emetogenic
chemotherapy may be enhanced by the addition of a corticosteroid
administered prior to
chemotherapy.
_Elderly people _
No dose adjustment is necessary for the elderly.
_ _
3
_ _
_Paediatric population _
_ _
_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.
The safety and efficacy of Aloxi in children aged le
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