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10.25.2013, 22:21 # 1
The coordination group (CMDh) adopted the recommendations of the Committee carpet cleaners for Risk Evaluation in Farmacovigilncia (PRAC) of the European Medicines Agency (EMA), restrictions on s es in the use of solutions for perfuso containing hydroxyethyl starch (HES), disclosed in the Information Circular N. 226/CD/8.1.7 of 11/10/2013. The CMDh confirmed that these drugs should be used in the treatment of patients with spsis, burns or critic state due to the increased risks of renal injury and mortality. However, for solutions containing HES perfuso can continue to be used in the treatment of hypovolemia carpet cleaners caused by acute blood loss when treatment with the known alternatives (for solutions crystal carpet cleaners perfuso ides) in sufficient. Face overhaul of security now nished, EMA and Infarmed recommend relating s HES solutions containing the following: Professionals Sade - Only can be used in the treatment of hypovolemia due loss Acute blood and when the use of the cristalides is sufficient; - should be used in the lowest effective dose for the shortest carpet cleaners period of time (less than 24) - must be made one monitors the continuous hemodinmica for the perfuso can be stopped once they are Alcanadas appropriate levels; - should be placed an monitorizao renal function; - In cases of administrative Repeated, the parameters of coagulation should be monitored closely; - No data are robust in the long term seguranaa use in patients with lesions or subjected traumticas surgery so that the benefit of the use of HES should be weighed against the absence of long term data and should be considered seguranaa teraputicas other alternatives. Sero performed carpet cleaners additional carpet cleaners studies of use of these solutions in patients with traumticas injuries and elective surgery; carpet cleaners - In should be used in patients with spsis, burns or state cr tico, due to increased risk of renal injury and mortality; - Esto contraindicated in patients with renal insufficiency or dilise and their use should be discontinued at the first sign of kidney injury. It has been reported a greater need for dilise 90 days apsa administration of HES; - Esto contraindicated in patients with severe coagulopathy and its use should be discontinued carpet cleaners at the first sign of coagulopathy. These recommendations are based on a revision of the data available for efficacy and safety, including carpet cleaners latest information of clinicians studies, meta-analyzes and experience p s-commercialization. The position carpet cleaners of the CMDh was adopted by a majority, so the recommendations of the PRAC sero sent European Commission (EC) for a binding decision. The EMA and Infarmed continuaroa monitor and disclose all disponvel information carpet cleaners on this subject. The Governing Council Helder Mota Filipe
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