SPC changes
Fludara
Fludara (fludarabine phosphate) Oral is now additionally indicated for
first-line treatment of B-cell chronic lymphocytic leukaemia in patients
with insufficient bone marrrow reserves (see SPC) (Schering Health Care).
The summaries of product characteristics for Fludara and Fludara Oral
now state that, in rare cases, the occurrence of myelodysplastic syndrome
has been described in patients treated with Fludara and that the majority
of these patients received prior, concomitant or subsequent treatment
with alkylating agents or irradiation. See SPCs.
Gemzar
Gemzar (gemcitabine hydrochloride) 200mg and 1g powder for solution for
infusion is now addionally indicated in combination with paclitaxel
for the treatment of patients with metastatic breast cancer who have
relapsed following adjuvant/neoadjuvant chemotherapy (Lilly). The dose
for this indication is paclitaxel 175mg/m2 administered on day one
over three hours as an intravenous infusion, followed by gemcitabine
1,250mg/m2 as a
30-60 minute intravenous infusion on days one and eight of each
21-day cycle. Dose reduction with each cycle or within a cycle may be
applied based on the amount of toxicity experienced by the patient. See
SPC.
Zometa
The summary of product characteristics for Zometa (zoledronic acid) concentrate
for solution for infusion now states that osteonecrosis has been reported
in patients with cancer receiving treatment regimens including bisphosphonates
(Novartis). It also now states that a dental examination with appropriate
preventive dentistry should be considered before treatment with bisphosphonates
in patients with concomitant risk factors and that patients should
avoid invasive dental procedures if possible during treatment. See
SPC.
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