StrataMR Adjustable Valves and Shunts by Medtronic: Recall - Potential for Under-Drainage of Cerebrospinal Fluid
If left untreated, under-drainage can potentially lead to coma and death.
Italiano
If left untreated, under-drainage can potentially lead to coma and death.
At the end of February 2017, the Italian Agency of Medicines, AIFA, announced on its website (http://www.agenziafarmaco.gov.it/) the launch of a new modality for reporting suspect adverse reactions to drugs and vaccines. Healthcare professionals and citizens in Italy can now report directly from the Internet, using the website www.vigifarmaco.it.
The management of the pharmacological therapy in the elderly patient has become more and more a relevant and critical aspect.1 The physiological aging process is characterised by structural and functional changes that affect all systems and translate in a reduced ability to maintain homeostasis and an increased vulnerability to external attacks.
The Summary of the Product Characteristics (SPC) represents the source of official and legitimate drug information for the healthcare professionals within the European Union. Specific information concerning the use in pregnancy, breastfeeding and fertile age, besides the effects on fertility, are described in a special section of the SPC, whose content is established by the European Commission for the drugs authorised by centralised procedure.1
L'Agenzia europea per i medicinali (EMA) ha
concluso la revisione di Uptravi (selexipag), avviata a seguito del decesso in
Francia di 5 pazienti.
Il Comitato di valutazione dei rischi per la farmacovigilanza (PRAC) dell’EMA conclude la valutazione dei mezzi di contrasto a base di gadolinio utilizzati nelle scansioni corporee e raccomanda azioni regolatorie, tra cui la sospensione per alcune delle autorizzazioni all'immissione in commercio.
Voluntary recall of all lots of sterile products, to the hospital/user level.
Potential for ventilator reset during normal operation, without an accompanying alarm.
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