Page 21 - 09 EMA
P. 21
ndication
oncomitant human chorionic gonadotropin (hCG) therapy.
n adult men
Ovaleap in association with a luteinising hormone (LH) preparation is
ecommended for the stimulation of follicular development in women
with severe LH and FSH deficiency. In clinical trials these patients were
defined by an endogenous serum LH level 1.2 IU/L.
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
xception 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
ransplantation 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).
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 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
educe the risk of bacterial infections when other options to manage
neutropenia are inappropriate.
Rheumatoid arthritis
Remsima, in combination with methotrexate, is indicated for the
eduction of signs and symptoms as well as the improvement in physical
unction in:
adult patients with active disease when the response to
- 11 -
oncomitant human chorionic gonadotropin (hCG) therapy.
n adult men
Ovaleap in association with a luteinising hormone (LH) preparation is
ecommended for the stimulation of follicular development in women
with severe LH and FSH deficiency. In clinical trials these patients were
defined by an endogenous serum LH level 1.2 IU/L.
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
xception 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
ransplantation 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).
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 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
educe the risk of bacterial infections when other options to manage
neutropenia are inappropriate.
Rheumatoid arthritis
Remsima, in combination with methotrexate, is indicated for the
eduction of signs and symptoms as well as the improvement in physical
unction in:
adult patients with active disease when the response to
- 11 -