Palonosetron Hospira

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

palonosetron hydrochloride

Saatavilla:

Pfizer Europe MA EEIG

ATC-koodi:

A04AA05

INN (Kansainvälinen yleisnimi):

palonosetron

Terapeuttinen ryhmä:

Antiemetics and antinauseants,

Terapeuttinen alue:

Nausea; Vomiting; Cancer

Käyttöaiheet:

Palonosetron Hospira 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.Palonosetron Hospira 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.

Tuoteyhteenveto:

Revision: 4

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2016-04-08

Pakkausseloste

21
B. PACKAGE LEAFLET
Medicinal product no longer authorised
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PALONOSETRON HOSPIRA 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 pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Palonosetron Hospira is and what it is used for
2. What you need to know before you are given Palonosetron Hospira
3. How Palonosetron Hospira is given
4. Possible side effects
5. How to store Palonosetron Hospira
6. Contents of the pack and other information
1.
WHAT PALONOSETRON HOSPIRA IS AND WHAT IT IS USED FOR
Palonosetron Hospira belongs to a group of medicines known as
serotonin (5HT
3
) antagonists.
These have the ability to block the action of the chemical, serotonin,
which can cause nausea and
vomiting.
Palonosetron Hospira 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 ARE GIVEN PALONOSETRON HOSPIRA
YOU MUST NOT BE GIVEN PALONOSETRON HOSPIRA:
•
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 or pharmacist before you are given Palonosetron
Hospira:
•
if you have acute bowel obstruction or a history of repeated
constipation;
•
if you are using Palonosetron Hospira 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);
�

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Palonosetron Hospira250 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
Palonosetron Hospira 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.
Palonosetron Hospira 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
Palonosetron Hospira 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. Palonosetron Hospira should be injected
over 30 seconds.
The efficacy of Palonosetron Hospira 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 population _
No dose adjustment is necessary for the elderly.
Medicinal product no longer authorised
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