natgillin/translations-raw huggingface dataset:
In Study SC-I, abatacept was given subcutaneously to patients after a single loading dose of intravenous abatacept and then every week thereafter.
V študiji SC-I so bolniki abatacept prejeli subkutano po enkratnem začetnem intravenskem odmerku abatacepta, nato pa so ga prejemali enkrat na teden.
In study SC-I, ACR responses were assessed at
V študiji SC-I so odziv ACR ovrednotili po 5 letih.
In Study SC-I, the goal was to demonstrate non-inferiority of the efficacy and comparability of the safety of abatacept subcutaneous relative to intravenous administration in subjects with moderate to severely active RA and experiencing inadequate response to MTX.
SC-I je bil dokazati neinferiorno učinkovitost in primerljivo varnost subkutane uporabe abatacepta v primerjavi z intravensko uporabo pri bolnikih z zmernim do hudo aktivnim revmatoidnim artritisom in nezadostnim odzivom na MTX.
In study SC-I, the mean decrease in HAQ-DI from baseline to week 24 was 0.6 on both the subcutaneous and intravenous arms.
V študiji SC-I je bilo povprečno zmanjšanje po HAQ-DI od izhodišča do 24. tedna 0,6 v subkutani in intravenski skupini.
In study SC-II, at week 24 there was ACR20 of 60.9%, ACR50 of 39.8% and ACR70 of 19.7% for patients treated with tocilizumab subcutaneous every other week versus placebo ACR20 of 31.5%, ACR50 of 12.3% and ACR70 of 5.0%.
V študiji SC-II je bil ACR 20 60,9 %, ACR 50 39,8 % in ACR 70 19,7 % za bolnike, zdravljene s tocilizumabom subkutano vsak drug teden v primerjavi s placebom ACR 20 31,5 %, ACR 50 12,3 % in ACR 70 5,0 %.
In study SC-II, mean decrease in HAQ-DI from baseline to week 24 was significantly greater for patients treated with tocilizumab subcutaneous every other week (0.4) versus placebo (0.3).
V študiji SC-II je bilo povprečno zmanjšanje po HAQ-DI od izhodišča do 24. tedna značilno večje pri bolnikih, zdravljenih s tocilizumabom subkutano vsak drugi teden (0,4) v primerjavi s placebom (0,3).
In Study SC-II, structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde-modified Total Sharp Score (mTSS) and its components.
V študiji SC-II so strukturne poškodbe sklepa vrednotili radiološko in jih izrazili kot spremembo od izhodišča na osnovi skupne Sharpove ocene, modificirane po van der Heijdeu (mTSS; “van der Heijde-modified Total Sharp Score”), in njenih komponent.
In study SC-III, abatacept SC was evaluated in combination with methotrexate, or as abatacept monotherapy, and compared to MTX monotherapy in induction of remission following 12 months of treatment, and the possible maintenance of drug-free remission after complete drug withdrawal, in adult MTX-naive patients with highly active early rheumatoid arthritis (mean DAS28-CRP of 5.4; mean symptom duration less than 6.7 months) with poor prognostic factors for rapidly progressive disease (e.g. anti- citrullinated protein antibodies [ACPA+], as measured by anti-CCP2 assay, and/or RF+, baseline joint erosions).
V študiji SC-III so vrednotili subkutano (s.c.) uporabo abatacepta v kombinaciji z metotreksatom (MTX) ali abatacepta v monoterapiji v primerjavi z uporabo MTX v monoterapiji pri indukciji remisije po 12- mesečnem zdravljenju ter morebitno ohranitev remisije v času brez uporabe zdravila po popolni odtegnitvi zdravila, in sicer pri odraslih bolnikih, ki se predhodno še niso zdravili z MTX, z močno aktivnim zgodnjim revmatoidnim artritisom (povprečna vrednost DAS28-CRP 5,4; povprečna vrednost trajanja simptomov manj kot 6,7 meseca) s slabimi prognostičnimi dejavniki za hitro napredovanje bolezni (npr. protitelesa proti citruliranemu proteinu [ACPA+], izmerjena z anti-CCP2 testom, in/ali RF+, izhodiščne erozije sklepa).
In Study SC-III, similar immunogenicity rates were seen in patients on treatment for the abatacept+MTX, and abatacept monotherapy groups (2.9% (3/103) and 5.0% (5/101), respectively) during the double-blind 12 month period.
V študiji SC-III so med dvojno slepim 12-mesečnim obdobjem zdravljenja pri bolnikih, ki so se zdravili z abataceptom+MTX, in bolnikih, ki so se zdravili z abataceptom v monoterapiji, poročali o podobnih deležih imunogenosti (2,9 % (3/103) in 5,0 % (5/101)).
In Study SC-III, structural joint damage was assessed by MRI.
V študiji SC-III so strukturne poškodbe sklepa ocenili z magnetnoresonančnim slikanjem (MRI).
In study TAX 316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
V študiji TAX316 so še trajajoče periferne edeme zabeležili pri 19 od 119 bolnic s perifernimi edemi v kraku s TAC in pri 4 od 23 bolnic s perifernimi edemi v kraku FAC.
In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
V študiji TAX316 se je kongestivno srčno popuščanje pojavilo 26 (3,5 %) bolnicam v kraku s TAC in 17 bolnicam (2,3 %) v kraku s FAC.
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients and 645 of 736 FAC patients.
V študiji TAX316 je alopecija trajala še naprej v obdobju spremljanja po koncu kemoterapije pri 687 od 744 bolnic, ki so prejemale TAC, in 645 od 736 bolnic, ki so prejemale FAC.
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients and 645 of 736FAC patients.
V študiji TAX316 je alopecija trajala še naprej v obdobju spremljanja po koncu kemoterapije pri 687 od 744 bolnic, ki so prejemale TAC, in 645 od 736 bolnic, ki so prejemale FAC.
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 TAC patients and 645 FAC patients.
V študiji TAX316 je alopecija trajala v obdobju spremljanja po koncu kemoterapije pri 687 bolnicah, ki so prejemale TAC, in 645 bolnicah, ki so prejemale FAC.
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 TAC patients and 645 FAC patients.
V študiji TAX316 je alopecija trajala še naprej v obdobju spremljanja po koncu kemoterapije pri 687 od 744 bolnic, ki so prejemale TAC, in pri 645 od 736 bolnic, ki so prejemale FAC.
In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
V študiji TAX316 so še trajajoče periferne edeme zabeleţili pri 19 od 119 bolnic s perifernimi edemi v kraku s TAC in pri 4 od 23 bolnic s perifernimi edemi v kraku FAC.
In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
V študiji TAX316 so še trajajoče periferne edeme zabeležili pri 19 od 119 bolnic s perifernimi edemi v kraku s TAC in pri 4 od 23 bolnic s perifernimi edemi v kraku FAC.
In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in theTAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
V študiji TAX316 so še trajajoče periferne edeme zabeležili pri 19 od 119 bolnic s perifernimi edemi v kraku s TAC in pri 4 od 23 bolnic s perifernimi edemi v kraku FAC.
In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
V študiji TAX316 so še trajajoče periferne edeme zabeležili pri 19 od 119 bolnic s perifernimi edemi v kraku s TAC in pri 4 od 23 bolnic s perifernimi edemi v kraku FAC.
In study TAX316, peripheral oedema was observed to be ongoing in19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
V študiji TAX316 so še trajajoče periferne edeme zabeležili pri 19 od 119 bolnic s perifernimi edemi v kraku s TAC in pri 4 od 23 bolnic s perifernimi edemi v kraku FAC.
In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
V študiji UC-II je zdravljenje z adalimumabom pripeljalo do izboljšanja rezultatov Vprašalnika o vnetni bolezni črevesa (IBDQ – Inflammatory Bowel Disease Questionaire).
In Study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Trudexa and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Trudexa monotherapy at week 52 and responses were sustained at week 104 (see Table 4).
V študiji V pri bolnikih z zgodnim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija s Trudexo in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija s Trudexo, odzivi pa so se ohranili do 104. tedna (glejte tabelo 4).
In Study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Trudexa/methotrexate combination therapy versus methotrexate monotherapy and Trudexa monotherapy at week 52, which was maintained through week 104.
V študiji V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji s Trudexo in metotreksatom po 52 tednih izboljšala bolj (p < 0,001) kot ob monoterapiji z metotreksatom ali ob monoterapiji s Trudexo ; to se je ohranilo do 104. tedna.
In study V59P13E1, the persistence of immune responses against serogroups A, C, W135 and Y was assessed at 21 months, 3 years and 5 years post primary vaccination among subjects aged 11-18 years at the time of vaccination.
V študiji V59P13E1 so ocenjevali obstojnost imunskega odziva proti seroskupinam A, C, W135 in Y po 21 mesecih, 3 letih in 5 letih po osnovnem cepljenju pri osebah, ki so bile v času cepljenja stare 11 do 18 let.
In Study VI, the mean change in TSS at 12 months was significantly lower in patients treated with abatacept plus methotrexate compared to those treated with methotrexate plus placebo.
V študiji VI je bila povprečna sprememba vrednosti TSS po 12 mesecih signifikantno manjša pri bolnikih, ki so se zdravili z abataceptom in metotreksatom, kot pri bolnikih, ki so prejemali metotreksat in placebo.
In study WV16241, the primary efficacy endpoints were ALT normalisation and HBV- DNA below 2 x 104 copies/ml.
V študiji WV16241 sta bila primarna cilja raziskave normalizacija ALT in število HBV DNA pod 2 x 104 kopij/ml.
In Study-05A, 1,055 patients on hemodialysis (N=968) or peritoneal dialysis (N=87) with serum phosphorus ≥1.94 mmol/L following a 2-4 week phosphate binder washout period, were randomized and treated with either Velphoro, at a starting dose of 1,000 mg/day (N=707), or active-control (sevelamer carbonate, N=348) for 24 weeks.
V študiji­05A so 1.055 bolnikov na hemodializi (N = 968) ali peritonealni dializi (N = 87) s fosforjem v serumu ≥ 1,94 mmol/l, ki je sledila 2­ do 4­tedenskemu obdobju brez fosfatnih vezalcev, naključno porazdelili in jih 24 tednov zdravili z zdravilom Velphoro z začetnim odmerkom 1.000 mg/dan (N = 707) ali s kontrolo z zdravilno učinkovino (sevelamerijev karbonat, N = 348).
In sub-group analysis of overall survival, a benefit consistent with the overall population was observed in patients <65 years old and ≥65 years old who received the ZALTRAP/FOLFIRI regimen.
V analizi podskupin glede celokupnega preživetja je bila korist, skladna s tisto za splošno populacijo, ugotovljena med prejemniki sheme ZALTRAP/FOLFIRI tako med bolniki, starimi < 65 let, kot med starimi ≥ 65 let.
In subchronic continuous intrathecal infusion studies in rats and dogs, behavioural effects were seen at doses ≥ 8-fold the maximum recommended clinical intrathecal infusion dose of 21.6 μg/day (on a mg/kg basis).
V študijah, kjer so bile uporabljene subkronične kontinuirane intratekalne infuzije na psih in podganah, so bili učinki na obnašanje opaženi pri odmerkih, ki so  8-krat presegali največji priporočeni klinični intratekalni infuzijski odmerek 21,6 µg/dan (preračunano na mg/kg).
In subgroup analyses, for subjects in the 60 mg treatment group who were dose reduced to 30 mg in the ENGAGE AF-TIMI 48 study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 104 (3.05% per year) of edoxaban 30 mg dose reduced subjects and 166 (4.85% per year) of warfarin dose reduced subjects had a major bleeding event [HR (95% CI): 0.63 (0.50, 0.81)].
V analizah podskupin za preiskovance v skupini, zdravljeni s 60 mg, ki so imeli v študiji ENGAGE AF-TIMI 48 odmerek zmanjšan na 30 mg zaradi telesne mase ≤ 60 kg, zmerne okvare ledvic ali sočasne uporabe inhibitorjev P-gp, so imeli 104 (3,05 % na leto) preiskovanci, zdravljeni z zmanjšanim odmerkom edoksabana 30 mg, in 166 (4,85 % na leto) preiskovancev z zmanjšanim odmerkom varfarina velik krvavitveni dogodek [HR (95 % CI): 0,63 (0,50, 0,81)].
In subgroup analyses, for subjects who were dose reduced to 30 mg in the Hokusai-VTE study for body weight ≤ 60 kg, moderate renal impairment, or concomitant use of P-gp inhibitors, 58 (7.9%) of edoxaban 30 mg dose reduced subjects and 92 (12.8%) of warfarin subjects had a major bleeding or CRNM event [HR (95%): 0.62 (0.44, 0.86)].
V analizi podskupin preiskovancev, ki so imeli v študiji Hokusai-VTE odmerek zmanjšan na 30 mg zaradi telesne mase ≤ 60 kg, zmerne okvare ledvic ali sočasne uporabe inhibitorjev P-gp, je imelo 58 (7,9 %) preiskovancev, ki so prejemali zmanjšan odmerek edoksabana 30 mg, in 92 (12,8 %) preiskovancev, ki so prejemali varfarin, veliko krvavitev ali CRNM dogodek [HR (95 %): 0,62 (0,44; 0,86)].
In subjects 60 years of age or older who were receiving chronic/maintenance systemic corticosteroid therapy at a daily dose equivalent of 5 to 20 mg of prednisone for at least 2 weeks prior to enrollment, and 6 weeks or more following vaccination, the safety profile was generally comparable to that seen in the Adverse Event Monitoring Substudy of the SPS (see sections 4.3 and 5.1).
Pri osebah, starih 60 let ali več, ki so vsaj 2 tedna pred vključitvijo in 6 tednov ali več po cepljenju prejemale kronično/vzdrževalno zdravljenje s sistemskimi kortikosteroidi v dnevnem odmerku, enakovrednem 5 do 20 mg prednizona, je bil varnostni profil na splošno podoben kot v podštudiji spremljanja neželenih učinkov študije SPS (glejte poglavji 4.3 in 5.1).
In subjects > 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (58.0%), muscle aches (19.7%), fatigue (13.5%), headache (12.4%) and joint pain (10.3%).
Pri odraslih, starejših od 64 let, so bili najpogostejši neželeni učinki po cepljenju bolečina na mestu injiciranja (58,0 %), bolečine v mišicah ( 19,7 %), utrujenost (13,5 %), glavobol (12,4 %) in bolečine v sklepih (10,3 %).
In subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin, the most commonly reported adverse reactions (greater than 20% of subjects) were fatigue and nausea.
Pri preiskovancih, ki so prejemali zdravili Exviera in ombitasvir/paritaprevir/ritonavir z ribavirinom, sta bila najpogosteje opisana neželena učinka (pri več kot 20 % preiskovancev) utrujenost in navzea.
In subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
Pri preiskovancih, ki so prejemali zdravilo Exviera in ombitasvir/paritaprevir/ritonavir brez ribavirina, so bili neželeni učinki, ki so običajno povezani z ribavirinom (npr. navzea, insomnia, anemija), manj pogosti in noben preiskovanec (0/588) ni trajno prekinil zdravljenja zaradi neželenih učinkov.
In subjects taking vardenafil 10 mg orodispersible tablets with a high fat meal no effect on vardenafil AUC and tmax was observed, while vardenafil Cmax was reduced by 35% in the fed condition.
Pri bolnikih, ki so jemali orodisperzibilne tablete po 10 mg vardenafila hkrati z obrokom, ki vsebuje veliko maščob niso opazili vpliva na AUC in tmax vardenafila, medtem ko je bila Cmax zmanjšana za 35 % v stanju sitosti.
In subjects treated with boceprevir who did not achieve SVR and with post-baseline samples analyzed for RAVs, interferon responsiveness was associated with detection of fewer RAVs, with 31% of these subjects having post-baseline RAVs compared to 69% of subjects with < 1-log10 decline in viral load at Treatment Week 4.
Pri preiskovancih, zdravljenih z boceprevirjem, ki niso dosegli SVR in so imeli opravljeno analizo RAV v vzorcih po začetku zdravljenja, je bila odzivnost na interferon povezana z odkritjem manj RAV: po začetku zdravljenja je imelo RAV 31 % teh preiskovancev v primerjavi z 69 % tistih, ki so imeli 4. teden zdravljenja < 1-log10 zmanjšanje virusnega bremena.
In subjects treated with Humira with no radiographic progression from baseline to Week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Pri 84% preiskovancev, ki so dobivali zdravilo Humira in od izhodišča do 48. tedna niso imeli rentgenografsko vidnega napredovanja (n = 102), se takšno napredovanje tudi do 144. tedna zdravljenja ni pojavilo.
In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
pri osebah, ki po cepljenju ne kažejo imunskega odziva (brez merljive količine protiteles proti virusu hepatitisa B), in pri osebah, pri katerih je obvezno stalno preprečevanje zaradi stalnega tveganja okužbe z virusom hepatitisa B.
In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 IU to adults and 8 IU/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/ml.
Pri osebah, ki po cepljenju niso imele imunskega odziva (brez merljive količine protiteles proti virusu hepatitisa B), in pri osebah, pri katerih je obvezno stalno preprečevanje, upoštevajte dajanje 500 i.e. za odrasle in 8 i.e./kg za otroke vsaka dva meseca; za najmanjši zaščitni titer protiteles lahko štejeta 10 mi.e./ml.
In subjects who received the recommended regimen, 97% achieved SVR overall (among which 181 subjects with compensated cirrhosis achieved 97% SVR), while 0.5% experienced virologic breakthrough and 1.2% experienced post-treatment relapse.
Od preiskovancev, ki so prejeli priporočeno shemo, jih je SVR skupno doseglo 97 % (med temi je 181 preiskovancev s kompenzirano cirozo doseglo 97 % SVR), medtem ko se je pri 0,5 % pojavil virološki preboj, pri 1,2 % pa recidiv po zdravljenju.
In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Med preiskovanci, ki so imeli izhodiščno ugodne vse tri laboratorijske vrednosti (AFP < 20 ng/ml, trombocite ≥ 90 x 109/l in albumin ≥ 35 g/l), so bili deleži recidiva, pri zdravljenih 12 tednov in zdravljenih 24 tednov, podobni.
In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Pri preiskovancih, ki so imeli izhodiščno ugodne vse tri laboratorijske vrednosti (AFP < 20 ng/ml, trombocite ≥ 90 x 109/l in albumin ≥ 35 g/l), so bili deleži recidiva podobni pri tistih, ki so bili zdravljeni 12 tednov, in pri tistih, ki so bili zdravljeni 24 tednov.
In subjects with end-stage renal disease (ESRD) (CrCl < 10 ml/min) requiring haemodialysis, a dose of 16.5 mg tenofovir disoproxil following completion of haemodialysis is predicted to limit tenofovir systemic accumulation to exposures approximately 2-fold compared to those observed in patients with normal renal function receiving tenofovir disoproxil (as fumarate) 245 mg film-coated tablets.
Pri osebah z ledvičnim obolenjem v končni fazi (ESRD, end stage renal disease) (CLCR < 10 ml/min), ki so potrebovali hemodializo, se predvideva, da odmerek 16,5 mg dizoproksiltenofovirata po končani hemodializi omeji sistemsko kopičenje tenofovirja do izpostavljenosti, ki so približno 2-kratne v primerjavi s tistimi, opaženimi pri bolnikih z normalno ledvično funkcijo, ki so prejemali dizoproksiltenofovirat (v obliki dizoproksiltenofovirijevega fumarata) 245 mg filmsko obložene tablete.
In subjects with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 (19%) μg·h/ml of emtricitabine, and over 48 hours to 42,857 (29%) ng·h/ml of tenofovir.
Pri posameznikih z ledvičnim obolenjem v končni fazi (ESRD-end-stage renal disease), ki so potrebovali hemodializo, se je med dializami izpostavljenost zdravilu znatno povišala v obdobju 72 ur na 53 (19%) μg h/ml emtricitabina in v obdobju 48 ur na 42.857 (29%) ng h/ml tenofovirja.
In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).
Pri preiskovancih s končno odpovedjo ledvic je hemodializa učinkovito odstranila vareniklin (glejte poglavje 4.2).
In subjects with giant cell tumour of bone who received 120 mg every 4 weeks with a loading dose on days 8 and 15, steady- state levels were achieved within the first month of treatment.
Pri preiskovancih z gigantocelularnim kostnim tumorjem, ki so dobivali 120 mg na 4 tedne in polnilni odmerek 8. in 15. dan, je bila koncentracija v stanju dinamičnega ravnovesja dosežena v prvem mesecu zdravljenja.
In subjects with HAMA, there may be a greater chance of hypersensitivity reactions and diminished efficacy in imaging.
Pri osebah s HAMA lahko obstaja večja verjetnost za nastanek preobčutljivostnih reakcij in zmanjšano učinkovitost slikanja.
In subjects with mild (creatinine clearance calculated by the Cockcroft-Gault formula 60-90 ml/min), moderate (creatinine clearance 30-60 ml/min) and severe renal impairment (creatinine clearance 15- 30 ml/min) AUC was increased by 46%, 51% and 87%, respectively.
Med preiskovanci z blago (očistek kreatinina, izračunan po Cockcroft-Gaultovi formuli 60–90 ml/min), zmerno (očistek kreatinina 30–60 ml/min) in hudo okvaro ledvic (očistek kreatinina 15–30 ml/min) je bila AUC zvišana za 46 %, 51% in 87 %.
In subjects with mild (creatinine clearance  50 - < 80 mL/min) and moderate (creatinine clearance
Pri osebah z blago (očistek kreatinina  50–< 80 ml/min) in zmerno (očistek kreatinina  30
In subjects with moderate hepatic impairment (Child-Pugh score of 7-9), a reduced dose of fosamprenavir 450 mg twice daily with a reduced dosing frequency of ritonavir 100 mg once daily is predicted to deliver similar plasma amprenavir Cmax and AUC(0-12), but approximately 35 % lower plasma total amprenavir C12 values and approximately 88 % higher plasma unbound amprenavir C12 values than achieved in subjects with normal hepatic function receiving the standard fosamprenavir with ritonavir 700 mg / 100 mg twice daily regimen.
Pri osebah z zmerno jetrno okvaro (ocena po Child-Pugh-u 7-9) se predvideva, da bo nižji odmerek fosamprenavirja 450 mg dvakrat na dan v kombinaciji z manjšo pogostnostjo odmerjanja ritonavirja v odmerku 100 mg enkrat na dan zagotovil podobne plazemske vrednosti Cmax in AUC(0-12) amprenavirja, vendar pa približno 35 % nižje vrednosti C12 skupnega amprenavirja v plazmi in približno 88 % višje vrednosti C12 nevezanega amprenavirja v plazi kot pri osebah z normalnim delovanjem jeter pri standardnem režimu odmerjanja fosamprenavirja v kombinaciji z ritonavirjem 700 mg/100 mg dvakrat na dan.