Page 13 - 09 EMA

ndication

administration of Grastofil is indicated to increase neutrophil counts and
o reduce the incidence and duration of infection-related events.
Grastofil is indicated for the treatment of persistent neutropenia (ANC
ess 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.
Rheumatoid arthritis
nflectra, 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
diseasemodifying antirheumatic drugs (DMARDs), including
methotrexate, has been inadequate;

 adult patients with severe, active and progressive disease not
previously treated with methotrexate or other DMARDs.

n these patient populations, a reduction in the rate of the progression of
oint damage, as measured by Xray, has been demonstrated.
Adult Crohns disease
nflectra is indicated for:

 treatment of moderately to severely active Crohns disease, in
adult patients who have not responded despite a full and
adequate course of therapy with a corticosteroid and / or an
immunosuppressant; or who are intolerant to or have medical
contraindications for such therapies;

 treatment of fistulising, active Crohns disease, in adult patients
who have not responded despite a full and adequate course of
therapy with conventional treatment (including antibiotics,
drainage and immunosuppressive therapy).

Paediatric Crohns disease
nflectra is indicated for treatment of severe, active Crohns disease in
hildren and adolescents agedsix to 17years, who have not responded to

-7-