bula lucentis clean aprovado em 24.09.07 - · pdf filebpi 0 3 /1 1 /0 6 + ms 3 1 .0 8 .0 7 a g...
TRANSCRIPT
BPI 03/11/06 + MS 31.08.07 !
LucentisTM"
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Forma farmacêutica, via de administração e apresentação
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USO ADULTO"
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Composição"
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INFORMAÇÕES AO PACIENTE
"
Como este medicamento funciona? "
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Por que este medicamento foi indicado?
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Quando não devo usar este medicamento?
Antes de usar Lucentis:
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NÃO USE MEDICAMENTO SEM O CONHECIMENTO DO SEU MÉDICO. PODE SER
PERIGOSO PARA A SUA SAÚDE9"
"
Como devo usar este medicamento?
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Quais os males que este medicamento pode causar?
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Estes efeitos adversos podem afetar 10 ou mais a cada 100 pacientes.
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"
ATENÇÃO: ESTE É UM MEDICAMENTO NOVO E, EMBORA AS PESQUISAS TENHAM
INDICADO EFICÁCIA E SEGURANÇA ACEITÁVEIS PARA COMERCIALIZAÇÃO,
EFEITOS INDESEJÁVEIS E NÃO CONHECIDOS PODEM OCORRER. NESTE CASO,
INFORME SEU MÉDICO.
"
O que fazer se alguém usar uma grande quantidade deste medicamento de uma só
vez?"
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Onde e como devo guardar este medicamento?
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TODO MEDICAMENTO DEVE SER MANTIDO FORA DO ALCANCE DAS CRIANÇAS."
"
BPI 03/11/06 + MS 31.08.07 p
INFORMAÇÕES TÉCNICAS AOS PROFISSIONAIS DE SAÚDE
"
CARACTERÍSTICAS FARMACOLÓGICAS
Farmacodinâmica
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BPI 03/11/06 + MS 31.08.07 f
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Tabela 1
Resultados no mês 12 e mês 24 no estudo FVF2598g (MARINA)
Medida do resultado Mês Injeção simulada
(n = 238)
Lucentis 0,5 mg
(n = 240)
TY="!J" dJt" ret"],$@%"@,"w"!e"0,?$%="&%"%;*'@%@,"E'=*%0"#t-%"
#T%&*?,&12/"@%"E'=2/-" TY="Jl" eAt" r5t"
TY="!J" et" Alt"Q%&C/"@,"!"!e"0,?$%="&%"%;*'@%@,"E'=*%0"#t-%
TY="Jl" lt" AAt"
TY="!J" >"!5Be"#!dBd-" x"pBJ"#!lBl-"N0?,$%12/"+H@'%"&%"%;*'@%@,"E'=*%0"#0,?$%=-"
#S]-%" TY="Jl" >"!lBr"#!fBp-" x"dBd"#!dBe-"%3"w"5B5!"
"
Tabela 2
Resultados no mês 12 no estudo FVF2587g (ANCHOR)
Medida do resultado TFD verteporfina
(n = 143)
Lucentis 0,5 mg
(n = 140)
],$@%"@,"w"!e"0,?$%="&%"%;*'@%@,"E'=*%0"#t-%"
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"
BPI 03/11/06 + MS 31.08.07 r
Figura 1
Alteração média na acuidade visual a partir do início até o mês 24 no estudo
FVF2598g (MARINA) e até o mês 12 no estudo FVF2587g (ANCHOR): população ITT
"
"
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BPI 03/11/06 + MS 31.08.07 !5
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"
Figura 2
Alteração média na acuidade visual a partir do início até o mês 12 no estudo
FVF3192g (PIER): população ITT
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* O procedimento controle de injeção simulada de Lucentis envolve a anestesia do olho de
forma idêntica à injeção intravítrea de Lucentis. A ponta de uma seringa sem agulha é então
pressionada contra a conjuntiva e o êmbolo da seringa sem agulha é empurrado.
"
BPI 03/11/06 + MS 31.08.07 !J
Farmacocinética
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"
Dados de Segurança Pré-Clínica
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BPI 03/11/06 + MS 31.08.07 !l
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Precauções e Advertências
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Efeitos na habilidade de dirigir veículos e/ou operar máquinas
BPI 03/11/06 + MS 31.08.07 !d
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Interações medicamentosas
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BPI 03/11/06 + MS 31.08.07 !p
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Distúrbios do Sistema Nervoso
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Distúrbios Oculares
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BPI 03/11/06 + MS 31.08.07 !f
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BPI 03/11/06 + MS 31.08.07 !r
ATENÇÃO: ESTE É UM NOVO MEDICAMENTO E EMBORA AS PESQUISAS TENHAM
DEMONSTRADO EFICÁCIA E SEGURANÇA ACEITÁVEIS PARA A
COMERCIALIZAÇÃO, EFEITOS INDESEJÁVEIS E NÃO CONHECIDOS PODEM
OCORRER. NESTE CASO, INFORME SEU MÉDICO.
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