SPC changes
Accessing SPCs
The summaries of product characteristics and patient
information leaflets for medicines licensed in the UK are available online |
Etopophos
New information about the in-use stability of Etopophos (etoposide phosphate;
Bristol-Myers Squibb) injection has been added to the product’s
summary of product characteristics.
Rapamune
Hypophosphataemia and hyperglycaemia have been included as very common
undesirable effects (>=1/10) in the summary of product characteristics
for Rapamune (sirolimus; Wyeth).
The SPC also now states that there
have been “reports of fluid accumulation, including peripheral
oedema, lymphoedema, and pericardial effusions (including haemodynamically
significant effusions in children and adults), in patients receiving
Rapamune”. Telzir
The therapeutic indication for Telzir (fosamprenavir; GlaxoSmithKline)
has been expanded to include treatment of children and adolescents
(aged 6 to 17 years) with HIV-1, used in combination with low-dose
ritonavir.
The summaries of product characteristics for Telzir have
been updated to include dosing information for this age group.
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