Nota Informativa Importante su epoetina (29/09/2017)
L'Agenzia Italiana del Farmaco rende disponibili nuove avvertenze riguardanti gravi
reazioni avverse cutanee in pazienti trattati con epoetine.
Italiano
L'Agenzia Italiana del Farmaco rende disponibili nuove avvertenze riguardanti gravi
reazioni avverse cutanee in pazienti trattati con epoetine.
L’EMA annuncia la prima audizione pubblica nell’ambito della revisione
di sicurezza dei farmaci contenenti valproato nelle donne e nelle ragazze in
gravidanza e durante l’età fertile, condotta dal Comitato per la Valutazione
dei Rischi in Farmacovigilanza dell’EMA (Pharmacovigilance Risk Assessment
Committee, PRAC).
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.
Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label.
Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may interact with nitrates and may cause a significant drop in blood pressure that may be life threatening.
Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants.
UPDATED 09/19/2017 Updating after extensive review of data and information.
Tue, 19 Sep 2017 00:00:00 -0400
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