Page 31 - 09 EMA
P. 31
ndication
Reduction in the duration of neutropenia and the incidence of febrile neutropenia
n patients treated with established cytotoxic chemotherapy for malignancy (with
he exception of chronic myeloid leukaemia and myelodysplastic syndromes) and
eduction in the duration of neutropenia in patients undergoing myeloablative
herapy followed by bone-marrow transplantation considered to be at increased
isk 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 (PBPC).
n children and 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
ecurrent infections, long term administration of filgrastim is indicated to
ncrease neutrophil counts and to reduce the incidence and duration of infection-
elated events.
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
herapeutic options are inappropriate.
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Reduction in the duration of neutropenia and the incidence of febrile neutropenia
n patients treated with established cytotoxic chemotherapy for malignancy (with
he exception of chronic myeloid leukaemia and myelodysplastic syndromes) and
eduction in the duration of neutropenia in patients undergoing myeloablative
herapy followed by bone-marrow transplantation considered to be at increased
isk 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 (PBPC).
n children and 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
ecurrent infections, long term administration of filgrastim is indicated to
ncrease neutrophil counts and to reduce the incidence and duration of infection-
elated events.
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
herapeutic options are inappropriate.
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