SPC changes
Glivec
The summary of products characteristics for Glivec (imatinib; Novartis)
has been updated. It now includes the following additional indications:
(integrated with chemotherapy) for adult patients with newly diagnosed
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL);
as monotherapy in adult patients with relapsed or refactory Ph+ ALL;
treatment of adult patients with unresectable dermatofibrosarcoma protuberans
(DFSP); and treatment of adult patients with recurrent or metastatic
DFSP who are not eligible for surgery. For patients with Ph+ ALL, the
recommended dose of Glivec is 600mg/day.
For patients with DFSP, the recommended dose is 800mg/day. See SPC.
NovoRapid
The summary of product characteristics for NovoRapid (insulin aspart;
Novo Nordisk) has been updated. It now states that NovoRapid can be
used in pregnancy. See SPC.
Remicade
The summary of product characteristics for Remicade (infliximab; Schering-Plough)
has been updated to include an additional indication as a second-line
treatment in Crohn’s disease. Remicade is now indicated for the
treatment of severe, active Crohn’s disease in patients who have
not responded despite a full and adequate course of therapy with a
corticosteroid or an immunosuppressant (or who are intolerant to or
have medical contraindications for such therapies). The initial dose
for this indication is 5mg/kg given as an intravenous infusion over
two hours. The maintenance dose is 5mg/kg at two and six weeks, followed
by infusions every eight weeks. It is also now indicated for the treatment
of fistulising, active Crohn’s disease, in patients who have
not responded despite a full and adequate course of therapy with conventional
treatment (including antibiotics, drainage and immunosuppressive therapy).
The initial dose for this indication is 5mg/kg given as an intravenous
infusion over two hours, followed by additional 5mg/kg infusion doses
at two and six weeks after the first infusion. If a patient does
not respond after these three doses, no additional treatment with Remicade
should be given. In responding patients, the strategies for continued
treatment are additional infusions of 5mg/kg every eight weeks. See
SPC.
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