SPC changes
Aprovel
The summary of product characteristics for Aprovel (irbesartan; Bristol-Myers
Squibb/sanofi-aventis) has been updated. It now states that Aprovel is
not recommended for use in children and adolescents due to insufficient
safety and efficacy data. The SPC also now lists rare hypersensitivity
reactions, such as rash, urticaria and angioedema, and hyperkalaemia,
headache, tinnitus and dysgeusia as undesirable effects. See SPC.
Campto
The summary of product characteristics for Campto (irinotecan; Pfizer)
has been updated. It now includes an additional indication in combination
with cetuximab for the treatment of patients with epidermal growth
factor receptor-expressing metastatic colorectal cancer after failure
of irinotecan-including cytotoxic therapy. Information relating to
this indication has been added to the pharmacodynamic properties section
of the SPC. The SPC also now states that rare cases of symptomatic
or asymptomatic pancreatitis have been associated with irinotecan therapy.
See SPC.
Remicade
The summary of product characteristics for Remicade (infliximab; Schering-Plough)
has been updated. It now states that, for the treatment of psoriatic
arthritis, Remicade can be administered alone to patients who show
intolerance to methotrexate or for whom methotrexate is contraindicated.
Information about opportunistic infections and Pneumocystis carinii pneumonia and hepatosplenic T-cell lymphoma has also been added to
the special warnings and special precautions for use and undesirable
effects sections of the SPC. See SPC.
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