SPC changes
Abilify
The summary of product characteristics for Abilify (aripiprazole; Bristol-Myers
Squibb and Otsuka) has been updated to include additional information
on cerebrovascular events, diabetes and overdose. The shelf life is now
three years. See SPC.
Nyogel
The summary of product characteristics for Nyogel (timolol maleate; Novartis)
has been updated. It now states that the product should generally not
be used in combination with amiodarone, calcium antagonists or beta-blockers
and that beta-blockers may increase the risk of rebound hypertension.
The sections on interactions, undesirable effects, pregnancy and lactation
and overdose have also been updated. See SPC.
Staril
The summary of product characteristics for Staril (fosinopril; Bristol-Myers
Squibb) now states that the use of Staril in children and adolescents
is not recommended. See SPC.
Zometa
The summary of product characteristics for Zometa (zoledronic acid; Novartis)
now includes a dose reduction for patients with mild to moderate renal
impairment (creatinine clearance 30–60ml/min). The SPC also states
that among the rare cases of osteonecrosis reported in patients treated
with biphosphonates, many had signs of local infection, including osteomyelitis.
See SPC.
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