Ratiograstim

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

filgrastim

Beschikbaar vanaf:

Ratiopharm GmbH

ATC-code:

L03AA02

INN (Algemene Internationale Benaming):

filgrastim

Therapeutische categorie:

Immunostimulants,

Therapeutisch gebied:

Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer

therapeutische indicaties:

Ratiograstim 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.Ratiograstim 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 Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Ratiograstim 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.

Product samenvatting:

Revision: 16

Autorisatie-status:

Authorised

Autorisatie datum:

2008-09-15

Bijsluiter

42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
RATIOGRASTIM 30 MIU/0.5 ML SOLUTION FOR INJECTION/INFUSION
RATIOGRASTIM 48 MIU/0.8 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, 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 Ratiograstim is and what it is used for
2.
What you need to know before you use Ratiograstim
3.
How to use Ratiograstim
4.
Possible side effects
5.
How to store Ratiograstim
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 RATIOGRASTIM
IS AND WHAT IT IS USED FOR
WHAT RATIOGRASTIM IS
Ratiograstim is a white blood cell growth factor (granulocyte
colony-stimulating factor) and belong 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. Ratiograstim works by
encouraging the bone marrow to produce more white blood cells.
WHAT RATIOGRASTIM IS USED FOR
A reduction in the number of white blood cells (neutropenia) can occur
for several reasons and makes
your body less able to fight infection. Ratiograstim stimulates the
bone marrow to produce new white
cells quickly.
Ratiograstim 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 hig

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ratiograstim 30 MIU/0.5 mL solution for injection/infusion
Ratiograstim 48 MIU/0.8 mL solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution for injection/infusion contains 60 million
international units [MIU] (600 µg) of
filgrastim.
Ratiograstim 30 MIU/0.5 mL solution for injection/infusion
Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5
mL solution for
injection/infusion.
Ratiograstim 48 MIU/0.8 mL solution for injection/infusion
Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8
mL solution for
injection/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/infusion
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ratiograstim 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.
Ratiograstim 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 Ratiograstim is indicated to increase
neut