Filgrastim ratiopharm
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
20-07-2011
Summary of Product characteristics
(SPC)
20-07-2011
Public Assessment Report
(PAR)
20-07-2011
Active ingredient:
filgrastim
Available from:
Ratiopharm GmbH
ATC code:
L03AA02
INN (International Name):
filgrastim
Therapeutic group:
Immunostimulants,
Therapeutic area:
Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Therapeutic indications:
Filgrastim ratiopharm 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 ratiopharm 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 Filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Filgrastim ratiopharm 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.
Product summary:
Revision: 1
Authorization status:
Withdrawn
Authorization date:
2008-09-15
Patient Information leaflet
55
B. PACKAGE LEAFLET
Medicinal product no longer authorised
56
PACKAGE LEAFLET: INFORMATION FOR THE USER
FILGRASTIM RATIOPHARM 30 MIU/0.5 ML SOLUTION FOR INJECTION OR INFUSION
FILGRASTIM RATIOPHARM 48 MIU/0.8 ML SOLUTION FOR INJECTION OR INFUSION
Filgrastim
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Filgrastim ratiopharm is and what it is used for
2.
Before you use Filgrastim ratiopharm
3.
How to use Filgrastim ratiopharm
4.
Possible side effects
5.
How to store Filgrastim ratiopharm
6.
Further information
1.
WHAT FILGRASTIM RATIOPHARM
IS AND WHAT IT IS USED FOR
WHAT FILGRASTIM RATIOPHARM IS
Filgrastim ratiopharm 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 FILGRASTIM RATIOPHARM IS USED FOR
Your doctor has prescribed Filgrastim ratiopharm for you to help your
body make more white blood
cells. Your doctor will tell you why you are being treated with
Filgrastim ratiopharm. Filgrastim
ratiopharm is useful in several different conditions which are:
-
chemotherapy,
-
bone marrow transplantation,
-
severe chronic neutropenia,
-
neutropenia in patients with HIV infection,
-
peripheral blood stem cell m
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Filgrastim ratiopharm 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: Each ml of solution contains 50 mg of sorbitol.
For a 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
Filgrastim ratiopharm 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 ratiopharm 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 Filgrastim ratiopharm is indicated to increase
neutrophil counts and to reduce
the incidence and duration of infection-related events.
Filgrastim ratiopharm is indicated for the treatment of persistent
neutropenia (ANC less than or equal
to 1.0 x 10
9
/l) in patients w
Read the complete document
