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

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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"

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Como devo usar este medicamento?

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BPI 03/11/06 + MS 31.08.07 l

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Quais os males que este medicamento pode causar?

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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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^2/"*=,"=,"%",+(%0%6,+",=?'E,$"@%&'<';%@%"/*"+/=?$%$"='&%'="@,"E'/0%12/9"

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

+%'="0,?$%="&/"!Jv"+Y=9"O"?%+%&C/"@%"0,=2/"&2/"%<,?/*"='6&'<';%?'E%+,&?,"/="$,=*0?%@/=9"O="

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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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BPI 03/11/06 + MS 31.08.07 !!

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3/&?/="#3"w"5B5!-9"

* 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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"

Indicações

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"

Contra-indicações

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Modo de usar e cuidados de conservação depois de aberto

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BPI 03/11/06 + MS 31.08.07 !l

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"

Posologia

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BPI 03/11/06 + MS 31.08.07 !e

Insuficiência hepática"

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Pacientes idosos (com 65 anos ou mais)

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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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/3,$%$"+KM*'&%="%?H"M*,",==,="@'=?D$('/="E'=*%'="?,+3/$K$'/="@'+'&*%+9"

"

Gravidez e lactação

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Lactação

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"

Interações medicamentosas

^2/"</$%+"$,%0')%@/=",=?*@/="@,"'&?,$%12/"</$+%09"

Incompatibilidades

^%"%*=Y&;'%"@,",=?*@/="@," '&;/+3%?'('0'@%@,=B" ,=?,"3$/@*?/"&2/"@,E," =,$"+'=?*$%@/" ;/+"

/*?$/=9"

"

Reações adversas

\+" ?/?%0" @,"!9AJA"3%;',&?,=" </$%+" '&;0*F@/=",+" ?$Y=",=?*@/="@," <%=," VVV9"\+" ?/?%0" @,"fer"

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#TNUV^N-"</'"'&;0*F@/9"ll5"3%;',&?,="</$%+"?$%?%@/=";/+"%"@/=,"$,;/+,&@%@%"@,"5Be"+69"

BPI 03/11/06 + MS 31.08.07 !p

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"

Distúrbios do Sistema Nervoso

Comum:" ;,<%0H'%9"

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Distúrbios Oculares

Muito Comum:" C,+/$$%6'%";/&4*&?'E%0B"@/$"&/"/0C/B"+/=;%="E/0%&?,=B"C,+/$$%6'%"

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BPI 03/11/06 + MS 31.08.07 !f

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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

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