Palonosetron Accord

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Palonosetron

Saatavilla:

Accord Healthcare S.L.U.

ATC-koodi:

A04AA05

INN (Kansainvälinen yleisnimi):

palonosetron

Terapeuttinen ryhmä:

Antiemetics and antinauseants,

Terapeuttinen alue:

Vomiting; Nausea; Cancer

Käyttöaiheet:

Palonosetron Accord 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 Accord 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: 5

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2016-05-26

Pakkausseloste

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PALONOSETRON ACCORD 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 or
nurse.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Palonosetron Accord is and what it is used for
2.
What you need to know before you are given Palonosetron Accord
3.
How Palonosetron Accord is given
4.
Possible side effects
5.
How to store Palonosetron Accord
6.
Contents of the pack and other information
1.
WHAT PALONOSETRON ACCORD IS AND WHAT IT IS USED FOR
Palonosetron Accord 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 Accord 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 ACCORD
_ _
DO NOT USE PALONOSETRON ACCORD:
-
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
Accord.
-
if you have acute bowel obstruction or a history of repeated
constipation.
-
if you are using palonosetron accord 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 imbala

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Palonosetron Accord 250 micrograms solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms of palonosetron (as
hydrochloride).
Each vial of 5 ml of solution contains 250 micrograms of palonosetron
(as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution, practically free from foreign particles,
pH 3.0 to 3.9, osmlolarity 260-
320 mOsm/l.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Palonosetron Accord 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 Accord 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 Accord 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 Accord should be injected over
30 seconds.
The efficacy of palonosetron 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.
_ _
_Hepatic impairment _
No dose adjustment is necessary for patients with impaired hepatic
function.
_Renal impairment _
No dose adjustment is necessary for patients with impaired