Filgrastim Hexal

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

filgrastim

MAH:

Hexal AG

ATC_code:

L03AA02

INN:

filgrastim

therapeutic_group:

Immunostimulants,

therapeutic_area:

Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer

therapeutic_indication:

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 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.Mobilisation of peripheral blood progenitor cells (PBPCs).In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 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.Treatment of persistent neutropenia (ANC ≤ 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.in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.

leaflet_short:

Revision: 24

authorization_status:

Authorised

authorization_date:

2009-02-06

PIL

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
FILGRASTIM HEXAL 30 MU/0.5 ML SOLUTION FOR INJECTION OR INFUSION IN
PRE-FILLED SYRINGE
FILGRASTIM HEXAL 48 MU/0.5 ML SOLUTION FOR INJECTION OR 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 Filgrastim HEXAL is and what it is used for
2.
What you need to know before you use Filgrastim HEXAL
3.
How to use Filgrastim HEXAL
4.
Possible side effects
5.
How to store Filgrastim HEXAL
6.
Contents of the pack and other information
1.
WHAT FILGRASTIM HEXAL IS AND WHAT IT IS USED FOR
Filgrastim HEXAL is a white blood cell growth factor (granulocyte
colony stimulating factor) and
belongs to a group of proteins 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. Filgrastim HEXAL
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 HEXAL stimulates
the bone marrow to produce new
white cells quickly.
Filgrastim HEXAL 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 cel

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Filgrastim HEXAL 30 MU/0.5 mL solution for injection or infusion in
pre-filled syringe
Filgrastim HEXAL 48 MU/0.5 mL solution for injection or infusion in
pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Filgrastim HEXAL 30 MU/0.5 mL solution for injection or infusion in
pre-filled syringe
Each mL of solution contains 60 million units (MU) (equivalent to 600
micrograms [mcg]) filgrastim*.
Each pre-filled syringe contains 30 MU (equivalent to 300 mcg)
filgrastim in 0.5 mL.
Filgrastim HEXAL 48 MU/0.5 mL solution for injection or infusion in
pre-filled syringe
Each mL of solution contains 96 million units (MU) (equivalent to 960
micrograms [mcg]) filgrastim*.
Each pre-filled syringe contains 48 MU (equivalent to 480 mcg)
filgrastim in 0.5 mL.
* recombinant methionylated human granulocyte-colony stimulating
factor (G-CSF) produced in
_E. coli_ by recombinant DNA technology.
Excipient with known effect
Each mL of solution contains 50 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion in pre-filled syringe (injection or
infusion).
Clear, colourless to slightly yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
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 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.
-
Mobilisation of peripheral blood progenitor cells (PBPCs).
-
In patients, children or adults, with severe congenital, cyclic, or
idiopathic neutropenia with an
absolute neutrophil count (A