Palonosetron Fresenius Kabi 250mcgs Solution for Injection in pre-filled syringe

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

PALONOSETRON HYDROCHLORIDE

متاح من:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC رمز:

A04AA05

INN (الاسم الدولي):

PALONOSETRON HYDROCHLORIDE 50 µg/ml

الشكل الصيدلاني:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

تركيب:

PALONOSETRON HYDROCHLORIDE 50 µg/ml

نوع الوصفة الطبية :

POM

المجال العلاجي:

ANTIEMETICS AND ANTINAUSEANTS

الوضع إذن:

Authorised

تاريخ الترخيص:

2019-02-19

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PALONOSETRON FRESENIUS KABI 250 MICROGRAMS SOLUTION FOR INJECTION IN
PRE-FILLED SYRINGE
palonosetron
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, 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.
THE NAME OF YOUR MEDICINE IS PALONOSETRON FRESENIUS KABI 250
MICROGRAMS SOLUTION FOR
INJECTION IN PRE-FILLED SYRINGE; 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 Palonosetron
3.
How to use Palonosetron
4.
Possible side effects
5.
How to store Palonosetron
6.
Contents of the pack and other information
1.
WHAT PALONOSETRON IS AND WHAT IT IS USED FOR
Palonosetron contains the active substance palonosetron. This belongs
to a group of medicines
called ‘serotonin (5HT
3
) antagonists’.
Palonosetron is used in adults 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 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).
You will not be given Palonosetron 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 using Palonosetron 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 fami

خصائص المنتج

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Palonosetron Fresenius Kabi 250 micrograms solution for injection in
pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms palonosetron (as
hydrochloride).
Each pre-filled syringe of 5 ml of solution contains 250 micrograms
palonosetron (as hydrochloride).
Excipient with known effect
This medicinal product contains 0.2 mmol sodium per pre-filled
syringe.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe
Clear, colourless solution, free from visible particles.
pH
4.7 – 5.3
Osmolality
270 – 330 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Palonosetron 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Palonosetron 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 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 people _
No dose adjustment is necessary for the elderly.
_Paediatric population _
Palonosetron in pre-filled syringe is not recommended for use in
children and adolescents. For this
population Palonosetron in glass vials can be used.
_Hepatic impairment _
No dose adjustment is necessary for patients with impaired hepatic
function.
Page 2 of 12
_Renal impairment _
No dose adjustment is necessary for pat