FERANT 250 mikrogram Injektionsvätska, lösning

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

palonosetronhydroklorid

Tillgänglig från:

Medochemie Ltd

ATC-kod:

A04AA05

INN (International namn):

palonosetronhydroklorid

Dos:

250 mikrogram

Läkemedelsform:

Injektionsvätska, lösning

Sammansättning:

palonosetronhydroklorid 281 mikrog Aktiv substans; mannitol Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Ampull, 1 st (1 x 5 ml); Ampull, 5 st (5 x 5 ml); Ampull, 10 st (10 x 5 ml)

Bemyndigande status:

Godkänd

Tillstånd datum:

2016-07-14

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
FERANT 250 MICROGRAMS
SOLUTION FOR INJECTION
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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 Ferant is and what it is used for
2.
What you need to know before you use Ferant
3.
How to use Ferant
4.
Possible side effects
5.
How to store Ferant
6.
Contents of the pack and other information
1.
WHAT FERANT IS AND WHAT IT IS USED FOR
Ferant contains the active substance palonosetron. This belongs to a
group of medicines called
serotonin (5HT3) antagonists.
Ferant 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 USE FERANT
DO NOT USE FERANT:
-
If you are allergic to palonosetron or any of the other ingredients of
this medicine (listed in
section 6).
You will not be given Ferant 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 Ferant:
-
If you have a blocked bowel or have had repeated constipation in the
past.
-
If you have had heart problems or heart problems run in your family,
such as changes in your
heart beat (‘QT prolongation’).
-
If you have an imbalance of certain minerals in your blood which has
not been treated - s

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ferant 250 micrograms solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms palonosetron (as
hydrochloride).
Each ampoule of 5 ml of solution contains 250 micrograms palonosetron
(as hydrochloride).
Excipient with known effect: Each ampoule of 5ml solution contains
0.20mmol (4.65mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless solution, with a pH of 4.5 – 6.5.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ferant 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.
Ferant 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
Ferant 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. Ferant should be injected over 30
seconds.
The efficacy of Ferant 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 _
No dose adjustment is necessary for the elderly.
_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 min