Biograstim

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

filgrastim

Διαθέσιμο από:

AbZ-Pharma GmbH

Φαρμακολογική κατηγορία (ATC):

L03AA02

INN (Διεθνής Όνομα):

filgrastim

Θεραπευτική ομάδα:

Colony stimulating factors

Θεραπευτική περιοχή:

Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer

Θεραπευτικές ενδείξεις:

Biograstim 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.Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).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 Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Biograstim 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.

Περίληψη προϊόντος:

Revision: 8

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2008-09-15

Φύλλο οδηγιών χρήσης

56
B. PACKAGE LEAFLET
Medicinal product no longer authorised
57
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIOGRASTIM 30 MIU/0.5 ML SOLUTION FOR INJECTION OR INFUSION
BIOGRASTIM 48 MIU/0.8 ML SOLUTION FOR INJECTION OR 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, 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 Biograstim is and what it is used for
2.
What you need to know before you use Biograstim
3.
How to use Biograstim
4.
Possible side effects
5.
How to store Biograstim
6.
Contents of the pack and other information
7.
Information for injecting yourself
8.
The following information is intended for healthcare professionals
only
1.
WHAT BIOGRASTIM
IS AND WHAT IT IS USED FOR
WHAT BIOGRASTIM IS
Biograstim contains the active substance filgrastim. Filgrastim is a
protein produced by biotechnology
in bacteria called
_Escherichia coli_
. It belongs to a group of proteins called cytokines and is very
similar to a natural protein (granulocyte-colony stimulating factor
[G-CSF]) produced by your own
body. Filgrastim stimulates the bone marrow (the tissue where new
blood cells are made) to produce
more blood cells, especially certain types of white cells. White cells
are important as they help your
body fight infection.
WHAT BIOGRASTIM IS USED FOR
Your doctor has prescribed Biograstim for you to help your body make
more white blood cells. Your
doctor will tell you why you are being treated with Biograstim.
Biograstim is useful in several
different conditions, which are:
-
chemotherapy;
-
bone marrow transplantation;
-

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Biograstim 30 MIU/0.5 mL solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution for injection or infusion contains 60 million
international units [MIU] (600 µg)
of filgrastim.
Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5
mL solution for injection or
infusion.
Filgrastim (recombinant methionyl human granulocyte-colony stimulating
factor) is produced in
_Escherichia coli_
K802 by recombinant DNA technology.
_Excipient with known effect _
Each mL of solution contains 50 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Biograstim 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.
Biograstim is indicated for the mobilisation of peripheral blood
progenitor cells (PBPC).
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 Biograstim is indicated to increase neutrophil
counts and to reduce the
incidence and duration of infection-related events.
Biograstim is indicated for the treatment of persistent neutropenia
(ANC less than or equal to
1.0 x 10
9
/L) in patients with advanced HIV infection, in or