Page 11 - 09 EMA
P. 11
ndication
or 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
imilar in adults and children receiving cytotoxic chemotherapy.
Mobilisation of peripheral blood progenitor cells (PBPCs).
n 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
f filgrastim is indicated to increase neutrophil counts and to reduce the
ncidence and duration of infection-related events.
Treatment of persistent neutropenia (ANC 0.5 x 109/l), and a history of
evere or recurrent infections, long-term administration of filgrastim is
ndicated to increase neutrophil counts and to reduce the incidence and
duration of infection-related events.
n patients with advanced HIV infection, in order to reduce the risk of
bacterial infections when other therapeutic options are inappropriate.
Grastofil is indicated for the reduction in the duration of neutropenia
and the incidence of febrile neutropenia in patients treated with
stablished cytotoxic chemotherapy for malignancy (with the exception
f chronic myeloid leukaemia and myelodysplastic syndromes) and for
he reduction in the duration of neutropenia in patients undergoing
myeloablative therapy followed by bone marrow transplantation
onsidered to be at increased risk of prolonged severe neutropenia.
The safety and efficacy of Grastofil are similar in adults and children
eceiving cytotoxic chemotherapy.
Grastofil is indicated for the mobilisation of peripheral blood progenitor
ells (PBPCs).
n patients, children or adults with severe congenital, cyclic, or
diopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x
109/L, and a history of severe or recurrent infections, long term
-6-
or 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
imilar in adults and children receiving cytotoxic chemotherapy.
Mobilisation of peripheral blood progenitor cells (PBPCs).
n 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
f filgrastim is indicated to increase neutrophil counts and to reduce the
ncidence and duration of infection-related events.
Treatment of persistent neutropenia (ANC 0.5 x 109/l), and a history of
evere or recurrent infections, long-term administration of filgrastim is
ndicated to increase neutrophil counts and to reduce the incidence and
duration of infection-related events.
n patients with advanced HIV infection, in order to reduce the risk of
bacterial infections when other therapeutic options are inappropriate.
Grastofil is indicated for the reduction in the duration of neutropenia
and the incidence of febrile neutropenia in patients treated with
stablished cytotoxic chemotherapy for malignancy (with the exception
f chronic myeloid leukaemia and myelodysplastic syndromes) and for
he reduction in the duration of neutropenia in patients undergoing
myeloablative therapy followed by bone marrow transplantation
onsidered to be at increased risk of prolonged severe neutropenia.
The safety and efficacy of Grastofil are similar in adults and children
eceiving cytotoxic chemotherapy.
Grastofil is indicated for the mobilisation of peripheral blood progenitor
ells (PBPCs).
n patients, children or adults with severe congenital, cyclic, or
diopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x
109/L, and a history of severe or recurrent infections, long term
-6-
