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Za virološko suprimirane bolnike ni podatkov o prehodu z zdravil iz druge protiretrovirusne skupine na zdravilo CELSENTRI.
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There are no data regarding the switch from a medicinal product of a different antiretroviral class to CELSENTRI in virologically suppressed patients.
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Last Update: 2012-04-11 |
eg 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
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Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
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Last Update: 2012-04-11 |
ur 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
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Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
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Last Update: 2012-04-11 |
ur 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
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ori response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
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Last Update: 2012-04-11 |
Pričakujemo lahko, da je pri bolnikih z virološko supresijo klinični pomen tega znižanja omejen (glejte poglavje 5. 1).
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In virologically suppressed patients, the clinical relevance of this reduction can be expected to be limited (see section 5.1).
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Last Update: 2012-04-11 |
Da bi odkrili kakršnokoli pozno virološko ponovitev bolezni je treba po prekinitvi zdravljenja redno nadzorovati ravni serumske ALT in HBV DNA.
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Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
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Last Update: 2012-04-11 |
Poleg zgoraj navedenega je prisotno tudi tveganje hitrega pojava odpornosti proti nenukleozidnim zaviralcem reverzne transkriptaze, če je zdravljenje virološko neuspešno.
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In addition to the data presented above, there exists a risk of rapid emergence of resistance to NNRTIs in case of virological failure.
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Last Update: 2012-04-11 |
Kombinacija sakvinavirja in ritonavirja je imela boljšo virološko aktivnost kot kombinacija indinavirja in ritonavirja, prekinitev predpisanega zdravljenja so upoštevali kot pomanjkanje virološkega odziva.
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18 exhibited a superior virological activity compared with the indinavir and ritonavir arm when switch from the assigned treatment was counted as virological failure.
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Last Update: 2012-04-11 |
Podatki učinkovitosti po 48 tednih iz študije AI266073, v kateri so zdravilo Atripla dajali bolnikom z virološko supresijo, ki so prejemali kombinirano protiretrovirusno zdravljenje
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48-week efficacy data from study AI266073 in which Atripla was administered to virologically suppressed patients on combination antiretroviral therapy
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Last Update: 2012-04-11 |
Ob sočasni uporabi teh zdravil svetujemo previdnost in temeljito klinično in virološko nadziranje, saj je učinek kombinacije amprenavirja in ritonavirja na delavirdin težko napovedati.
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28 close clinical and virological monitoring should be performed since it is difficult to predict the effect of the combination of amprenavir and ritonavir on delavirdine.
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Last Update: 2012-04-11 |
Pri bolnikih, ki niso dosegli virološkega odziva do 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
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Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive
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Last Update: 2012-04-11 |
Pri bolnikih, ki niso dosegli virološkega odziva do 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
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Patients who fail to achieve virological response at 6 months are highly unlikely to become sustained virological responders (negative predictive value 96%).
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Last Update: 2012-04-11 |
Pri bolnikih, ki niso dosegli virološkega odziva do 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
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Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
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Last Update: 2012-04-11 |
Indicirano je za zdravljenje okužbe z virusom humane imunske pomanjkljivosti- 1 (HIV- 1) pri odraslih z virološko supresijo (HIV- 1 RNA < 50 kopij/ ml) pri obstoječem kombiniranem protiretrovirusnem zdravljenju, ki ga prejemajo več kot tri mesece.
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It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of < 50 copies/ ml on their current combination antiretroviral therapy for more than three months.
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Last Update: 2012-04-11 |
8 V teh kliničnih študijah so imeli bolniki aktivno virološko replikacijo (HBV DNA ≥ 100. 000 kopij/ ml) in povišane vrednosti ALT (≥ 1, 2 krat zgornja referenčna vrednost (ULN, Upper Limit of Normal)).
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In these clinical studies patients had active viral replication (HBV DNA ≥ 100,000 copies/ ml) and elevated ALT levels (≥ 1.2 x Upper Limit of Normal (ULN)).
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Last Update: 2012-04-11 |
V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCV- RNA pod spodnjo mejo detekcije), tudi kasneje niso postali virološko odzivni (HCV- RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
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During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) did not become sustained virologic responders (HCV- RNA below lower limit of detection six months after withdrawal of treatment).
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Last Update: 2012-04-11 |
3 V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCV - RNA pod spodnjo mejo detekcije), tudi kasneje postali virološko odzivni (HCV- RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
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During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
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Last Update: 2012-04-11 |
V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCV - RNA pod spodnjo mejo detekcije), tudi kasneje niso postali virološko odzivni (HCV- RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
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During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
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Last Update: 2012-04-11 |
V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCV - RNA pod spodnjo mejo detekcije), tudi kasneje niso postali virološko odzivni (HCV- RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
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RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
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Last Update: 2012-04-11 |
Na podlagi izsledkov teh preskušanj lahko ugotovimo, da zdravilo INTELENCE ni priporočljivo za uporabo v kombinaciji z N( t) RTI samo pri tistih bolnikih, pri katerih je bilo protivirusno zdravljenje s shemo z NNRTI in N( t) RTI virološko neuspešno.
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Based on these trial results, INTELENCE is not recommended for use in combination with N(t)RTIs only in patients who have experienced virological failure on an NNRTI- and N(t)RTI-containing regimen.
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Last Update: 2012-04-11 |
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