FrancophonIA/ELRC3.0 huggingface dataset:
English: VO Population (HIV-1 RNA <50 c/mL, Snapshot algorithm)
Slovenian: populacija VO (HIV-1 RNA < 50 kopij/ml, »snapshot« algoritem)
English: The PK variability of dolutegravir is low to moderate.
Slovenian: Farmakokinetična variabilnost dolutegravirja je majhna do zmerna.
English: Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
Slovenian: nevirapin dolutegravir ↓ (Ni raziskano; zaradi indukcije se pričakuje podobno zmanjšanje izpostavljenosti kot pri efavirenzu)
English: Dolutegravir is highly bound (>99%) to human plasma proteins based on in vitro data.
Slovenian: Na podlagi podatkov in vitro je dolutegravir v veliki meri (> 99 %) vezan na humane plazemske beljakovine.
English: Increases in serum creatinine occurred within the first week of treatment with dolutegravir and remained stable through 48 weeks.
Slovenian: Spremembe v izvidih laboratorijskih biokemijskih preiskav Zvišane vrednosti serumskega kreatinina so se pojavile v prvem tednu zdravljenja z dolutegravirjem in ostale nespremenjene skozi 48 tednov.
English: Through 48 weeks in the GEMINI-1 and GEMINI-2 studies, no cases of emergent resistance to the integrase- or NRTI-class were seen in either the DTG+3TC or comparator DTG+ TDF/FTC arms.
Slovenian: Po 48 tednih v študijah GEMINI-1 in GEMINI-2 niso opazili razvoja primarne odpornosti proti skupini integraz ali NRTI niti pri DTG+3TC niti v primerjalnih študijah DTG+ TDF/FTC.
English: • phenytoin and phenobarbital, to treat epilepsy
Slovenian: • fenitoin in fenobarbital za zdravljenje epilepsije
English: The use of Tivicay in children under 6 or weighing less than 15 kg has not yet been studied.
Slovenian: Uporaba zdravila Tivicay pri otrocih, mlajših od 6 let ali s telesno maso manj kot 15 kg, še ni raziskana.
English: The VIKING-4 study examined dolutegravir (plus optimized background therapy) in subjects with primary genotypic resistance to INIs at Screening in 30 subjects.
Slovenian: Študija VIKING-4 je proučevala dolutegravir (ob optimiziranem osnovnem zdravljenju) pri preiskovancih s primarno genotipsko odpornostjo na zaviralce integraze (integrase inhibitors - INI) ob presejanju pri 30 preiskovancih.
English: In SINGLE, the median time to viral suppression was shorter in the dolutegravir treated patients (28 vs 84 days, (p<0.0001, analysis pre-specified and adjusted for multiplicity).
Slovenian: V študiji SINGLE je bil mediani čas do supresije virusov krajši pri bolnikih, zdravljenih z dolutegravirjem (28 v primerjavi s 84 dnevi, p < 0,0001; vnaprej specificirana analiza s korekcijo za večkratne primerjave).
English: If you take too many tablets of Tivicay, contact your doctor or pharmacist for advice.
Slovenian: Če ste vzeli preveč tablet zdravila Tivicay, se posvetujte z zdravnikom ali farmacevtom.
English: Common Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) elevations Common Creatine phosphokinase (CPK) elevations
Slovenian: Preiskave pogosti zvišane vrednosti alanin-aminotransferaze (ALT) in/ali aspartat-aminotransferaze (AST)
English: Subjects were stratified by age, receiving Tivicay (70 mg, as 35 mg twice daily, n=1; 50 mg once daily, n=5; 35 mg once daily, n=6; 25 mg once daily, n= 8; and 20 mg once daily, n=3) plus OBR.
Slovenian: Preiskovanci, ki so prejemali zdravilo Tivicay, so bili razdeljeni glede na starost (70 mg [po 35 mg dvakrat na dan], n = 1; 50 mg enkrat na dan, n = 5; 35 mg enkrat na dan, n = 6; 25 mg enkrat na dan, n = 8; in 20 mg enkrat na dan, n = 3) plus OBR.
English: In a meta-analysis using pharmacogenomics samples collected in clinical studies in healthy subjects, subjects with UGT1A1 (n=7) genotypes conferring poor dolutegravir metabolism had a 32% lower clearance of dolutegravir and 46% higher AUC compared with subjects with genotypes associated with normal metabolism via UGT1A1 (n=41).
Slovenian: V metaanalizi farmakogenomskih vzorcev iz kliničnih študij zdravih preiskovancev so imele osebe z genotipi UGT1A1 (n = 7), ki povzročajo počasno presnovo dolutegravirja, 32 % manjši očistek dolutegravirja in 46 % večjo AUC kot osebe z genotipi, ki so povezani z normalno presnovo z UGT1A1 (n = 41).
English: Table 6 Response in SAILING at 48 Weeks (Snapshot algorithm, <50 copies/mL) Dolutegravir 50 mg Once Daily + BR N=354§
Slovenian: Preglednica 6: Odziv v študiji SAILING po 48 tednih (»snapshot« algoritem, < 50 kopij/ml) Dolutegravir 50 mg enkrat na dan + BR N=354§
English: • calcium supplements, iron supplements and multivitamins.
Slovenian: • kalcijevi dodatki, železovi dodatki ali multivitaminski pripravki.
English: At week 48, 12/30 (40%) subjects had HIV-1 RNA <50 copies/mL (ITT-E, Snapshot algorithm).
Slovenian: Po 48 tednih je imelo 12/30 (40 %) preiskovancev HIV-1 RNA < 50 kopij/ml (ITT-E, algoritem Snapshot).
English: In patients with prior failed therapies, but naïve to the integrase class (SAILING study), integrase inhibitor substitutions were observed in 4/354 patients (follow-up 48 weeks) treated with dolutegravir, which was given in combination with an investigator selected background regimen (BR).
Slovenian: Pri bolnikih s predhodno neuspešnimi terapijami, ki pa še niso bili zdravljeni z zdravili iz skupine zaviralcev integraze (študija SAILING), so substitucije zaviralcev integraz opazili pri 4/354 bolnikih (spremljanje 48 tednov), zdravljenih z dolutegravirjem v kombinaciji z osnovno shemo (BR), ki jo je izbral raziskovalec.
English: • St. John's wort (Hypericum perforatum), a herbal remedy to treat depression
Slovenian: • šentjanževka (Hypericum perforatum), zeliščni pripravek za zdravljenje depresije
English: Therefore, the 50 mg once daily dose should not be given as five 10 mg tablets (see section 5.2).
Slovenian: Odmerka 50 mg enkrat na dan, se ne sme dati kot pet tablet po 10 mg (glejte poglavje 5.2).
English: be administered twice daily.
Slovenian: tako da ga namesto enkrat na dan uporabimo dvakrat na dan.
English: The bottle contains a desiccant to reduce moisture.
Slovenian: Vsebnik vsebuje sušilno sredstvo za zmanjšanje vlage.
English: What Tivicay contains - The active substance is dolutegravir.
Slovenian: Kaj vsebuje zdravilo Tivicay - Učinkovina je dolutegravir.
English: Very common Nausea Very common Diarrhoea Common Vomiting Common Flatulence Common Upper abdominal pain Common Abdominal pain Common Abdominal discomfort
Slovenian: Bolezni prebavil zelo pogosti navzea zelo pogosti driska pogosti bruhanje pogosti napenjanje in vetrovi pogosti bolečine v zgornjem delu trebuhu pogosti bolečine v trebuhu pogosti nelagodje v trebuhu
English: DTG 50 mg BID N=88* n Mean (SD) Plasma HIV-1 RNA log10 c/mL
Slovenian: DTG 50 mg dvakrat na dan N=88* n Srednja vrednost (SD) plazemske HIV-1 RNA log10 kopij/ml
English: Statistically fewer subjects failed therapy with treatment-emergent integrase resistance on Tivicay (4/354, 1%) than on raltegravir (17/361, 5%) (p=0.003) (refer to section ‘Resistance in vivo' above for details).
Slovenian: V skupini, ki je prejemala zdravilo Tivicay, je bilo statistično manj oseb, pri katerih je bila terapija neuspešna zaradi med zdravljenjem nastale odpornosti na zaviralce integraze (4/354, 1%), kot v skupini, ki je prejemala raltegravir (17/361, 5%) (p=0,003) (za podrobnosti glejte poglavje »Odpornost in vivo« zgoraj).
English: Dolutegravir is eliminated mainly through metabolism by UGT1A1.
Slovenian: Dolutegravir se izloča predvsem s presnovo preko UGT1A1.
English: In previously untreated patients receiving dolutegravir + 2 NRTIs in Phase IIb and Phase III, no development of resistance to the integrase class, or to the NRTI class was seen (n=1118 follow-up of 48-96 weeks).
Slovenian: Pri predhodno nezdravljenih bolnikih, ki so prejemali dolutegravir + 2 NRTI v študijah faze IIb in faze III niso opazili odpornosti na zdravila iz skupine zaviralcev integraze ali NRTI (n=1118, spremljanje 48-96 tednov).
English: Sixteen of 30 subjects (53%) harboured Q148 virus at baseline.
Slovenian: 30 preiskovancev (53 %) je imelo izhodiščno virus Q148.
English: Calcium supplements, iron supplements or multivitamins should be taken well separated in time from the administration of dolutegravir (minimum 2 hours after or 6 hours before).
Slovenian: Kalcijeve dodatke, železove dodatke ali multivitaminske pripravke je treba vzeti s precejšnjim časovnim zamikom (minimalno 2 uri po ali 6 ur pred aplikacijo dolutegravirja).
English: In the presence of integrase class-resistance (VIKING-3 study) the following mutations were selected in 32 patients with protocol defined virological failure (PDVF) through Week 24 and with paired genotypes (all treated with dolutegravir 50 mg twice daily + optimized background agents): L74L/M (n=1), E92Q (n=2), T97A (n=9), E138K/A/T (n=8), G140S (n=2), Y143H (n=1), S147G (n=1), Q148H/K/R (n=4), and N155H (n=1) and E157E/Q (n=1).
Slovenian: Pri odpornosti na zdravila iz skupine zaviralcev integraze (študija VIKING-3) so pri 32 bolnikih s po protokolu opredeljenim virološkim neuspehom (PDVF) po 24 tednih in s parnimi genotipi (vsi so bili zdravljeni s 50 mg dolutegravirja dvakrat na dan + optimizirano osnovno shemo) izbrali naslednje mutacije: L74L/M (n = 1), E92Q (n = 2), T97A (n = 9), E138K/A/T (n = 8), G140S (n = 2), Y143H (n = 1), S147G (n = 1), Q148H/K/R (n = 4), N155H (n = 1) in E157E/Q (n = 1).
English: It should not be taken as five 10 mg tablets.
Slovenian: Ne sme se ga vzeti kot pet tablet po 10 mg.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution, however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Slovenian: Poročali so, da se med imunsko reaktivacijo lahko pojavijo tudi avtoimunske bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis); čas do njihovega nastanka je spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja.
English: Mean change from baseline in HIV RNA at day 8 (primary endpoint) was -1.4log10 copies/mL (95% CI -1.3 - -1.5log10, p<0.001).
Slovenian: Srednja vrednost spremembe od izhodiščne vrednosti HIV RNA na 8. dan (primarni cilj) je bila -1.4 log10 kopij/ml (95% CI - 1.3 - -1.5 log10, p < 0,001).
English: The overall response rate through 24 weeks of therapy, 69% (126/183), was generally sustained through 48 weeks with 116/183 (63%) of patients with HIV-1 RNA <50c/mL (ITT-E, Snapshot algorithm).
Slovenian: Celotni delež odziva v 24 tednih zdravljenja, 69 % (126/183), se je na splošno ohranil do 48. tedna in 116/183 (63 %) bolnikov je imelo HIV-1 RNA < 50 kopij/ml (ITT-E, »snapshot«
English: The adjusted difference in proportion and 95% CI were 7.1% (0.9, 13.2), p=0.025.
Slovenian: Korigirana razlika deležev je bila 7,1 % (95 % IZ: 0,9, 13,2; p = 0,025).
English: Dolutegravir ↑ AUC ↑ 91% Cmax ↑ 50% Cτ ↑ 180%
Slovenian: Zaviralci proteaze atazanavir dolutegravir ↑ AUC ↑ 91% Cmax ↑ 50% Cτ ↑ 180%
English: In patients infected with HIV-1 without resistance to the integrase class, the recommended dose of dolutegravir in children (6 to less than 12 years of age and weighing at least 15 kg) is determined according to the weight of the child.
Slovenian: Pri bolnikih, okuženih z virusom HIV-1, brez odpornosti na zdravila iz skupine zaviralcev integraze, je treba priporočeni odmerek dolutegravirja za otroke (stare od 6 do manj kot 12 let, ki tehtajo vsaj 15 kg) določiti glede na otrokovo telesno maso.
English: → Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Tivicay.
Slovenian: → Posvetujte se z zdravnikom o jemanju kalcijevih dodatkov, železovih dodatkov ali multivitaminskih pripravkov skupaj z zdravilom Tivicay.
English: In vitro, dolutegravir inhibited the renal organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter (MATE) 1.
Slovenian: In vitro je dolutegravir zaviral organski kationski prenašalec 2 (OCT2) v ledvicah in prenašalec za ekstruzijo več zdravil in toksinov MATE-1.
English: At week 48, dolutegravir was non-inferior to raltegravir in the SPRING-2 study, and in the SINGLE study dolutegravir + ABC/3TC was superior to efavirenz/TDF/FTC (p=0.003), table 4 above.
Slovenian: Po 48 tednih je bil dolutegravir v študiji SPRING-2 neinferioren raltegravirju, v študiji SINGLE pa je bila kombinacija dolutegravir + ABC/3TC superiorna kombinaciji efavirenz/TDF/FTC (p = 0,003), preglednica
English: Dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45% Daclatasvir ↔
Slovenian: daklatasvir dolutegravir ↔ AUC ↑ 33 % Cmax ↑ 29 % Cτ ↑ 45 % daklatasvir ↔
English: In SPRING-2, four patients in the RAL-arm failed with major NRTI mutations and one with raltegravir resistance; in SINGLE, six patients in the EFV/TDF/FTC-arm failed with mutations associated with NNRTI resistance, and one developed a major NRTI mutation.
Slovenian: V študiji SPRING-2 zdravljenje ni bilo uspešno pri štirih bolnikih v skupini RAL zaradi pomembnih mutacij NRTI in pri enem zaradi odpornosti proti raltegravirju; v študiji SINGLE zdravljenje ni bilo uspešno pri šestih bolnikih v skupini z EFV/TDF/FTC zaradi mutacij, povezanih z odpornostjo proti NNRTI, pri enem pa se je pojavila pomembna mutacija NRTI.
English: No dosage adjustment is required in patients with mild, moderate or severe (CrCl <30 mL/min, not on dialysis) renal impairment.
Slovenian: Okvara ledvic Pri bolnikih z blago, zmerno ali hudo okvaro ledvic (CrCl < 30 ml/min, ki niso na dializi) prilagajanje odmerka ni potrebno.
English: How to take Tivicay
Slovenian: Kako jemati zdravilo Tivicay
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 21 and 0.82 times the 50 mg twice daily human clinical exposure based on AUC, respectively.
Slovenian: Primarni učinek dolutegravirja je bil pri podganah in opicah gastrointestinalna intoleranca ali draženje, in sicer z odmerki, pri katerih je bila sistemska izpostavljenost približno 21- oziroma 0,82-krat tolikšna kot klinična izpostavljenost pri človeku med uporabo 50 mg dvakrat na dan na podlagi AUC.
English: Patients infected with HIV-1 with resistance to the integrase class (documented or clinically suspected) The recommended dose of dolutegravir is 50 mg (one tablet) twice daily.
Slovenian: Bolniki, okuženi z virusom HIV-1, z odpornostjo na zdravila iz skupine zaviralcev integraze (dokumentirano ali klinično domnevne) Priporočeni odmerek dolutegravirja je 50 mg (ena tableta) dvakrat na dan.
English: In vivo, dolutegravir may increase plasma concentrations of medicinal products in which excretion is dependent upon OCT2 or MATE-1 (e.g. dofetilide, metformin) (see Table 2 and section 4.3).
Slovenian: In vivo lahko dolutegravir zviša plazemske koncentracije zdravil, katerih izločanje je odvisno od OCT2 ali MATE-1 (npr. dofetilid, metformin) (glejte
English: Effect of dolutegravir on the pharmacokinetics of other agents
Slovenian: Učinki dolutegravirja na farmakokinetiko drugih zdravil
English: Particular diligence should be applied in initiating or maintaining effective hepatitis B therapy (referring to treatment guidelines) when starting dolutegravir-based therapy in hepatitis B co-infected patients (see section 4.8).
Slovenian: Posebna skrb je potrebna pri uvajanju ali vzdrževanju učinkovitega zdravljenja hepatitisa B (glede na smernice zdravljenja), kadar se začenja s terapijo na osnovi dolutegravirja pri bolnikih,
English: Azole anti-fungal agents Ketoconazole Fluconazole Itraconazole Posaconazole Voriconazole
Slovenian: Azolni antimikotiki ketokonazol flukonazol itrakonazol posakonazol vorikonazol dolutegravir ↔ (Ni raziskano)
English: In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
Slovenian: Dolutegravir in vivo ne vpliva na midazolam, testni substrat za CYP3A4.
English: As neural tube defects occur within the first 4 weeks of foetal development (at which time the neural tubes are sealed) this potential risk would concern women exposed to dolutegravir at the time of conception and in early pregnancy.
Slovenian: Ker pride do okvare nevralne cevi v prvih štirih tednih razvoja ploda (ko se nevralne cevi zaprejo), se to morebitno tveganje nanaša na ženske,
English: Of these four, two subjects had a unique R263K integrase substitution, with a maximum FC of 1.93, one subject had a polymorphic V151V/I integrase substitution, with maximum FC of 0.92, and one subject had pre-existing integrase mutations and is assumed to have been integrase experienced or infected with integrase resistant virus by transmission.
Slovenian: ena oseba je imela polimorfno substitucijo integraze V151V/I z maksimalno vrednostjo FC 0,92, ena oseba pa je imela že obstoječe mutacije integraze in se predpostavlja, da je predhodno že dobivala zdravila iz skupine zaviralcev integraze ali je bila preko prenosa okužena z virusom, odpornim na integrazo.
English: CD4+ Cell Count
Slovenian: Število celic CD4+
English: Following oral administration of tablet formulations, in general, dolutegravir exhibited nonlinear pharmacokinetics with less than dose-proportional increases in plasma exposure from 2 to 100 mg; however increase in dolutegravir exposure appears dose proportional from 25 mg to 50 mg for the tablet formulation.
Slovenian: Po peroralni uporabi tablet je bila farmakokinetika dolutegravirja na splošno nelinearna; pri plazemski izpostavljenosti od 2 do 100 mg je bilo povečanje manj kot sorazmerno odmerku, toda povečanje izpostavljenosti dolutegravirju ob povečanju odmerka s 25 mg na 50 mg v obliki tablet je po vsem sodeč sorazmerno odmerku.
English: The unbound fraction of dolutegravir in plasma is increased at low levels of serum albumin (<35 g/L) as seen in subjects with moderate hepatic impairment.
Slovenian: Delež nevezanega dolutegravirja v plazmi se poveča v primeru nizke koncentracije albumina v serumu (< 35 g/l),
English: NRTI, 75% ≥1 NNRTI, and 71% ≥2 PI major mutations; 62% had non-R5 virus.
Slovenian: na ≥ 1 NNRTI in 71% na ≥ 2 PI; 62% pa je imelo ne-R5 virus.
English: → See a doctor straight away.
Slovenian: → Nemudoma se posvetujte z zdravnikom.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Slovenian: combination antiretroviral therapy) hudo imunsko pomanjkljivost, se lahko pojavi vnetna reakcija na asimptomatske ali rezidualne oportunistične patogene ter povzroči resna klinična stanja ali poslabšanje simptomov.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM ViiV Healthcare BV
English: R263K was reported from two ART experienced, INI naive individual patients with subtypes B and C in the clinical program, but without effects on dolutegravir susceptibility in vitro.
Slovenian: V kliničnem programu so pri dveh posameznih bolnikih s podtipom B in podtipom C, ki so že prejemali ART, ne pa tudi INI, poročali o R263K, vendar brez vpliva na občutljivost za dolutegravir in vitro.
English: Virologic suppression (HIV-1 RNA <50 copies/mL) in the dolutegravir plus lamivudine group was non-inferior to the dolutegravir plus TDF/FTC group at 48 weeks, as shown in Table 5.
Slovenian: Virološka supresija (HIV-1 RNA < 50 kopij/mL) je bila v skupini, ki je prejemala dolutegravir in lamivudin, neinferiorna v primerjavi s skupino, ki je prejemala dolutegravir in TDF/FTC po 48 tednih, kot je prikazano v Preglednici 5.
English: In SINGLE, dolutegravir + ABC/3TC was still superior to EFV/TDF/FTC (viral suppression in 80% vs 72%, treatment difference 8.0% (2.3, 13.8), p=0.006, and with an adjusted mean change in CD4 count of 325 vs 281 cells/ mm3, respectively.
Slovenian: V študiji SINGLE je bila kombinacija dolutegravir + ABC/3TC še vedno superiorna kombinaciji EFV/TDF/FTC (supresija virusov pri 80 % v primerjavi z 72 %, razlika med zdravljenjema 8,0 % (2,3, 13,8), p = 0,006, in prilagojeno povprečno spremembo števila celic CD4 je bila 325 v primerjavi z 281 celic/mm3.
English: The absorption of dolutegravir is reduced by certain anti-acid agents (see Table 2).
Slovenian: Določena antacidna zdravila zmanjšujejo absorpcijo dolutegravirja (glejte Preglednico 2).
English: In SINGLE, 833 subjects were randomized and received at least one dose of either dolutegravir 50 mg once daily with fixed-dose abacavir-lamivudine (DTG + ABC/3TC) or fixed-dose efavirenz-tenofoviremtricitabine (EFV/TDF/FTC).
Slovenian: V študiji SINGLE je bilo randomiziranih 833 oseb, ki so prejeli najmanj en odmerek dolutegravirja 50 mg enkrat na dan z ustaljenim odmerkom abakavir-lamivudin (DTG + ABC/3TC) ali ustaljenim odmerkom efavirenz-tenofovir-emetricitabin (EFV/TDF/FTC).
English: Table 4 Response in SPRING-2 and SINGLE at 48 Weeks (Snapshot algorithm, <50 copies/mL) SPRING-2
Slovenian: Preglednica 4: Odziv v študijah SPRING-2 in SINGLE po 48 tednih (»snapshot« algoritem, <50 kopij/ml)
English: GI intolerance in monkeys occurred at 15 times the human mg/kg equivalent dose (based on a 50 kg human), and 5 times the human mg/m2 equivalent dose for a clinical dose of 50 mg twice daily.
Slovenian: GI se je pri opicah pojavila pri 15-kratniku ustreznega odmerka (v mg/kg) pri človeku (glede na človeka z maso 50 kg) ter pri 5-kratniku ustreznega odmerka (v mg/m2) pri človeku za klinični odmerek 50 mg dvakrat na dan.
English: Polymorphisms in drug metabolising enzymes
Slovenian: Polimorfizmi encimov za presnovo zdravil
English: Mannitol (E421) Microcrystalline cellulose Povidone (K29/32) Sodium starch glycolate Sodium stearyl fumarate
Slovenian: Jedro tablete: manitol (E421) mikrokristalna celuloza povidon (K29/32) natrijev karboksimetilškrob natrijev stearilfumarat
English: While the total dolutegravir concentration in plasma was similar, a 1.5- to 2-fold increase in unbound exposure to dolutegravir was observed in subjects with moderate hepatic impairment compared to healthy controls.
Slovenian: Med tem, ko je bila skupna koncentracija dolutegravirja v plazmi podobna, so v primerjavi z zdravimi kontrolnimi osebami pri preiskovancih z zmerno okvaro jeter opazili 1,5 - 2-kratno povečanje izpostavljenosti nevezanemu dolutegravirju.
English: In a randomized, dose-ranging trial, HIV-1-infected subjects treated with dolutegravir monotherapy (ING111521) demonstrated rapid and dose-dependent antiviral activity, with mean decline in HIV-1 RNA of 2.5 log10 at day 11 for 50 mg dose.
Slovenian: V randomiziranem preskušanju razpona odmerkov je bilo pri preiskovancih, okuženih s HIV-1, ki so prejemali monoterapijo z dolutegravirjem (ING111521), dokazano hitro in od odmerka odvisno protivirusno delovanje; povprečno zmanjšanje HIV-1 RNA je bilo pri odmerku 50 mg 11. dan 2,5 log10.
English: In the presence of integrase class resistance alternative combinations that do not include fosamprenavir/ritonavir should be considered.
Slovenian: Če je odpornost na zdravila iz skupine zaviralcev integraze prisotna, je treba razmisliti o uporabi alternativne kombinacije, ki ne vključuje fosamprenavirja/ritonavirja.
English: In vitro, dolutegravir inhibited the renal uptake transporters, organic anion transporters (OAT1) and OAT3.
Slovenian: In vitro je dolutegravir zaviral organske anionske prenašalce privzema v ledvicah, (OAT1) in OAT3.
English: All factors that decrease dolutegravir exposure should be avoided in the presence of integrase class resistance.
Slovenian: Vsem dejavnikom, ki vplivajo na manjšo izpostavljenost dolutegravirja, se je treba pri prisotni odpornosti na zdravila iz skupine zaviralcev integraze izogibati.
English: HIV-1 RNA <50 copies/mL Adjusted treatment difference‡
Slovenian: HIV-1 RNA < 50 kopij/ml Prilagojena razlika v zdravljenju‡