Nivestim

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

filgrastim

Saatavilla:

Pfizer Europe MA EEIG 

ATC-koodi:

L03AA02

INN (Kansainvälinen yleisnimi):

filgrastim

Terapeuttinen ryhmä:

Immunostimulants,

Terapeuttinen alue:

Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer

Käyttöaiheet:

Filgrastim 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 filgrastim are similar in adults and children receiving cytotoxic chemotherapy.Filgrastim 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 filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Filgrastim is indicated for the treatment of persistent neutropenia (ANC ≤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.

Tuoteyhteenveto:

Revision: 27

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-06-07

Pakkausseloste

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIVESTIM 12 MU/0.2 ML SOLUTION FOR INJECTION/INFUSION
NIVESTIM 30 MU/0.5 ML SOLUTION FOR INJECTION/INFUSION
NIVESTIM 48 MU/0.5 ML SOLUTION FOR INJECTION/INFUSION
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, nurse or
pharmacist.
-
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 Nivestim is and what it is used for
2.
What you need to know before you use Nivestim
3.
How to use
Nivestim
4.
Possible side effects
5.
How to store Nivestim
6.
Contents of the pack and other information
1.
WHAT NIVESTIM IS AND WHAT IT IS USED FOR
Nivestim 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. Nivestim 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. Nivestim stimulates the bone
marrow to produce new white cells
quickly.
Nivestim 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;
-
before high-dose chemotherapy to make the bone marrow produce more
stem cells which can be
collected and given back to you after your treatment. These can be
taken

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Nivestim 12 MU/0.2 ml solution for injection/infusion
Nivestim 30 MU/0.5 ml solution for injection/infusion
Nivestim 48 MU/0.5 ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nivestim 12 MU/0.2 ml solution for injection/infusion
Each ml of solution for injection or infusion contains 60 million
units [MU] (600 micrograms [mcg])
of filgrastim*.
Each pre-filled syringe contains 12 million units (MU) (120 micrograms
[mcg]) of filgrastim in 0.2 ml
(0.6 mg/ml).
Nivestim 30 MU/0.5 ml solution for injection/infusion
Each ml of solution for injection or infusion contains 60 million
units [MU] (600 micrograms [mcg])
of filgrastim*.
Each pre-filled syringe contains 30 million units (MU) (300 micrograms
[mcg]) of filgrastim in 0.5 ml
(0.6 mg/ml).
Nivestim 48 MU/0.5 ml solution for injection/infusion
Each ml of solution for injection or infusion contains 96 million
units [MU] (960 micrograms [mcg])
of filgrastim*.
Each pre-filled syringe contains 48 million units (MU) (480 micrograms
[mcg]) of filgrastim in 0.5 ml
(0.96 mg/ml).
*recombinant methionyl granulocyte colony-stimulating factor

G-CSF

produced in
_Escherichia coli_
(BL21)
_ _
by recombinant DNA technology.
Excipient with known effect
Each ml of solution contains 50 mg of sorbitol (E420) (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion (injection/infusion).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Filgrastim 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 prolo