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Critical evaluation of the off-label indication and of the risks associated to the use of multi-dose vials on the treatment of age-related macular degeneration BJPS
Barbosa,Bruna Renata Dutra; Barbosa,Sávio Fujita; Tavares,Guilherme Diniz; Chacra,Nádia Araci Bou; Pinto,Terezinha de Jesus Andreoli.
Age-related macular degeneration (AMD) is an ocular inflammatory diseases treated mainly by means of a bevacizumab (Avastin®) or ranibizumab (Lucentis®) intravitreal injection. Among these drugs, only ranibizumab has a specific therapeutic indication for AMD. Considering that, the off-label use on ophthalmic therapy seems to become a rule when it should be an exception. Furthermore, bevacizumab presentation consists of multi-dose vials although it does not contain preservatives in its formula. The current literature review aimed at assessing the risks for the patient related to the use of off-label indication and multi-dose vials on AMD treatment. Considering this, the proposal related to the Brazilian Public Consultation no.10, dated September 12, 2012,...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Age-related macular degeneration/treatment; Ranibizumab/intravitreal injection; Bevacizumab/intravitreal injection; Ophthalmic therapy/off-label use; Off-label indication/patients risks; Multi-dose vials/patients risks.
Ano: 2014 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000100006
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