Page 9 - 09 EMA
P. 9
ndication
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
afety and efficacy of filgrastim are similar in adults and children
eceiving cytotoxic chemotherapy.
Biograstim is indicated for the mobilisation of peripheral blood
progenitor cells (PBPC).
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
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
nfection, in order to reduce the risk of bacterial infections when other
ptions to manage neutropenia are inappropriate.
Treatment of symptomatic anaemia associated with chronic renal failure
CRF) in adult and paediatric patients:
treatment of anaemia associated with chronic renal failure in
paediatric and adult patients on haemodialysis and adult
patients on peritoneal dialysis;
Treatment of severe anaemia of renal origin accompanied by clinical
ymptoms in adult patients with renal insufficiency not yet undergoing
dialysis.
Treatment of anaemia and reduction of transfusion requirements in
adult patients receiving chemotherapy for solid tumours, malignant
ymphoma or multiple myeloma, and at risk of transfusion as assessed
by the patient's general status (e.g. cardiovascular status, pre-existing
anaemia at the start of chemotherapy).
Reduction in the duration of neutropenia and the incidence of febrile
neutropenia in patients treated with established cytotoxic chemotherapy
-5-
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
afety and efficacy of filgrastim are similar in adults and children
eceiving cytotoxic chemotherapy.
Biograstim is indicated for the mobilisation of peripheral blood
progenitor cells (PBPC).
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
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
nfection, in order to reduce the risk of bacterial infections when other
ptions to manage neutropenia are inappropriate.
Treatment of symptomatic anaemia associated with chronic renal failure
CRF) in adult and paediatric patients:
treatment of anaemia associated with chronic renal failure in
paediatric and adult patients on haemodialysis and adult
patients on peritoneal dialysis;
Treatment of severe anaemia of renal origin accompanied by clinical
ymptoms in adult patients with renal insufficiency not yet undergoing
dialysis.
Treatment of anaemia and reduction of transfusion requirements in
adult patients receiving chemotherapy for solid tumours, malignant
ymphoma or multiple myeloma, and at risk of transfusion as assessed
by the patient's general status (e.g. cardiovascular status, pre-existing
anaemia at the start of chemotherapy).
Reduction in the duration of neutropenia and the incidence of febrile
neutropenia in patients treated with established cytotoxic chemotherapy
-5-
