Nota Informativa Importante su Velcade® (bortezomib) (16/01/2012)
L’Agenzia Italiana del Farmaco rende disponibile on line nuove ed importanti informazioni di sicurezza sul medicinale Velcade® (bortezomib).
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L’Agenzia Italiana del Farmaco rende disponibile on line nuove ed importanti informazioni di sicurezza sul medicinale Velcade® (bortezomib).
New Boxed Warning and Contraindication highlighting these risks added to product labeling.
Failure of therapy could result in the potential for harm or death of a ventilator-dependent patient.
Particulate matter in injections can be harmful when introduced into the bloodstream.
A packaging problem may result in a pill, tablet or caplet getting mixed in with a different prescription.
Consumers are asked to either destroy or return unused product identified in the recall to Novartis.
Adverse consequences may include hypoxia, hypotension, bradycardia, cardiac arrest, organ damage, acute respiratory distress syndrome (ARDS), neurological deficits, or death.
Ventilator may stop ventilating and result in life-threatening injury or death.
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