Grastofil
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
31-08-2023
Charakterystyka produktu
(SPC)
31-08-2023
Sprawozdanie z oceny publicznego
(PAR)
12-11-2018
Składnik aktywny:
filgrastim
Dostępny od:
Accord Healthcare S.L.U.
Kod ATC:
L03AA02
INN (International Nazwa):
filgrastim
Grupa terapeutyczna:
Immunostimulants,
Dziedzina terapeutyczna:
Neutropenia
Wskazania:
Grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.The safety and efficacy of Grastofil are similar in adults and children receiving cytotoxic chemotherapy.Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Podsumowanie produktu:
Revision: 14
Status autoryzacji:
Authorised
Data autoryzacji:
2013-10-17
Ulotka dla pacjenta
49
B. PACKAGE LEAFLET
50
PACKAGE LEAFLET: INFORMATION FOR THE USER
GRASTOFIL 30 MU/0.5 ML SOLUTION FOR INJECTION/INFUSION IN PRE-FILLED
SYRINGE
filgrastim
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Grastofil is and what it is used for
2.
What you need to know before you use Grastofil
3.
How to use Grastofil
4.
Possible side effects
5.
How to store Grastofil
6.
Contents of the pack and other information
1.
WHAT GRASTOFIL IS AND WHAT IT IS USED FOR
Grastofil contains the active substance filgrastim. Grastofil is a
white blood cell growth factor
(granulocyte colony stimulating factor) and belongs to a group of
medicines called cytokines. Growth
factors are proteins that are produced naturally in the body but they
can also be made using
biotechnology for use as a medicine. Grastofil works by encouraging
the bone marrow to produce
more white blood cells.
A reduction in the number of white blood cells (neutropenia) can occur
for several reasons and makes
your body less able to fight infection. Filgrastim stimulates the bone
marrow to produce new white
cells quickly.
Grastofil can be used:
to increase the number of white blood cells after treatment with
chemotherapy to help prevent
infections;
to increase the number of white blood cells after a bone marrow
transplant to help prevent
infections;
to increase the number of white blood cells if you suffer from severe
chronic neutropenia to help
prevent infections;
in patients with advanced HIV infection which will
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Grastofil 30 MU/0.5 ml solution for injection/infusion in pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 30 million units (MU)/300 micrograms
of filgrastim in 0.5ml
(0.6 mg/ml) solution for injection/infusion.
Filgrastim is a recombinant methionyl human granulocyte-colony
stimulating factor produced in
_Escherichia coli _
(BL21) by recombinant DNA technology.
Excipient with known effect:
Each ml of solution contains 50 mg of sorbitol (E420).
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution.
4.
CLINCAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Grastofil is indicated for the reduction in the duration of
neutropenia and the incidence of febrile
neutropenia in patients treated with established cytotoxic
chemotherapy for malignancy (with the
exception of chronic myeloid leukaemia and myelodysplastic syndromes)
and for the reduction in the
duration of neutropenia in patients undergoing myeloablative therapy
followed by bone marrow
transplantation considered to be at increased risk of prolonged severe
neutropenia.
The safety and efficacy of Grastofil are similar in adults and
children receiving cytotoxic
chemotherapy.
Grastofil is indicated for the mobilisation of peripheral blood
progenitor cells (PBPCs).
In patients, children or adults with severe congenital, cyclic, or
idiopathic neutropenia with an absolute
neutrophil count (ANC) of ≤ 0.5 x 10
9
/L, and a history of severe or recurrent infections, long term
administration of Grastofil is indicated to increase neutrophil counts
and to reduce the incidence and
duration of infection-related events.
Grastofil is indicated f
or the treatment of persistent neutropenia (ANC less than or equal to
1.0 x
10
9
/L) in patients with advanced HIV infection, in order to reduce the
risk of bacterial infections
when other options to manage neutropenia are inappropriate.
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