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6 tilfælde af aktiv tuberkulose inklusive miliær tuberkulose og tuberkulose med ekstrapulmonal placering har været rapporteret hos patienter behandlet med remicade.
cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra pulmonary location have been reported in patients treated with remicade.
det bør bemærkes, at i størstedelen af disse tilfælde var der tale om tuberkulose med ekstrapulmonal placering i form af enten lokal eller dissemineret sygdom.
it should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease.
blandt patienterne med ekstrapulmonal sygdom havde 2 ud af 8 patienter, der også havde verificeret, sandsynlig eller mulig cns-inddragning, gunstigt respons.
among patients with extrapulmonary disease, 2 of 8 patients who also had definite, probable, or possible cns involvement had a favourable response.
tilfælde af tuberkulose, undertiden dødelige, inklusive miliær tuberkulose og tuberkulose med ekstrapulmonal placering har været rapporteret (se pkt.4. 4) .
cases of tuberculosis, sometimes fatal, including miliary tuberculosis and tuberculosis with extrapulmonary location have been reported (see section 4.4) .
ekstrapulmonal tuberkulose (f.eks. i centralnervesystemet, knogler) infektioner, der skyldes andre arter af mykobakterier end mycobacterium tuberculosis latent infektion med mycobacterium tuberculosis.
extra-pulmonary tuberculosis (e.g. central nervous system, bone) infections due to mycobacterial species other than mycobacterium tuberculosis latent infection with mycobacterium tuberculosis
13 i kontrollerede og åbne forsøg med humira blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra- pulmonær tuberkulose) og invasive opportunistiske infektioner (f. eks. dissemineret eller ekstrapulmonal histoplasmose, blastomykose, kokcidioimykose, pneumocytis, candidiasis, aspergillose og listeriose).
in controlled and open label studies with humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e. g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).