FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: Neuspješan odgovor na liječenje uzrokovan rezistencijom integraze nastale uslijed liječenja zabilježen u statistički manjega broja ispitanika liječenih lijekom Tivicay (4/354, 1%) nego onih liječenih raltegravirom (17/361, 5%) (p=0,003) (za više informacija vidjeti dio „Rezistencija in vivo“ gore).
English: Dolutegravir should not be used with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir or lopinavir/ritonavir in INIresistant patients (see further below in table).
Croatian: Dolutegravir se ne smije primjenjivati s etravirinom ako se istodobno ne primjenjuju atazanavir/ritonavir, darunavir/ritonavir ili lopinavir/ritonavir u bolesnika rezistentnih na inhibitore integraze (vidjeti nastavak tablice).
English: In the rat pre/post-natal development study, decreased body weight of the developing offspring was observed during lactation at a maternally toxic dose (approximately 27 times human exposure at the maximum recommended human dose).
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja na štakorima, opažena je smanjena tjelesna težina mladunčadi u razvoju tijekom laktacije kod primjene doze toksične za majku (izloženost približno 27 puta veća od izloženosti u ljudi pri primjeni maksimalne preporučene doze u ljudi).
English: Dolutegravir is primarily metabolized and eliminated by the liver.
Croatian: Oštećenje jetrene funkcije Dolutegravir se prvenstveno metabolizira i izlučuje kroz jetru.
English: Mean increase in CD4+ T cell (cells/mm3) ‡ Adjusted for baseline stratification factors.
Croatian: Srednje povećanje CD4+ T stanica (stanica/mm3) ‡ Prilagođeno za početne faktore stratifikacije.
English: The PK variability of dolutegravir is low to moderate.
Croatian: Farmakokinetička varijabilnost dolutegravira je niska do umjerena.
English: There are limited data on subjects with hepatitis B co-infection.
Croatian: Podaci o ispitanicima s istodobnom infekcijom hepatitisom B su malobrojni.
English: HDPE (high density polyethylene) bottles closed with child resistant polypropylene screw closures, with a polyethylene faced induction heat seal liner.
Croatian: Boce od polietilena visoke gustoće (HDPE) zatvorene polipropilenskim zatvaračima na navoj sigurnim za djecu i polietilenskom indukcijski zavarenom zaštitnom folijom.
English: At week 48, 12/30 (40%) subjects had HIV-1 RNA <50 copies/mL (ITT-E, Snapshot algorithm).
Croatian: U 48. tjednu 12/30 (40%) ispitanika imalo je HIV-1 RNK <50 kopija/ml (ITT-E, algoritam za globalnu snimku distribuiranog sustava (engl. snapshot algorithm)).
English: Therefore, the 50 mg once daily dose should not be given as five 10 mg tablets.
Croatian: Stoga, doza od 50 mg jedanput na dan se ne smije primijeniti kao pet tableta od 10 mg.
English: Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Croatian: Bubrežni klirens djelatne tvari u nepromijenjenu obliku je sporedan put eliminacije dolutegravira.
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.
Croatian: Tijekom 48 tjedana u ispitivanjima GEMINI-1 i GEMINI-2 nije opažen nijedan slučaj rezistencije na skupinu inhibitora integraze ili NRTI-ja uzrokovane liječenjem u skupini koja je primala DTG + 3TC niti u usporednoj skupini koja je primala DTG + TDF/FTC.
English: Dolutegravir is highly bound (>99%) to human plasma proteins based on in vitro data.
Croatian: Na temelju podataka in vitro, dolutegravir se u visokom stupnju (> 99%) veže za proteine u plazmi ljudi.
English: In the presence of integrase class resistance this combination should be avoided (see section 4.4).
Croatian: U slučaju rezistencije na skupinu inhibitora integraze, ovu kombinaciju treba izbjegavati (vidjeti dio 4.4).
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of dolutegravir with metformin, to maintain glycaemic control.
Croatian: Potrebno je razmotriti prilagodbu doze metformina kod započinjanja ili prekidanja istodobne primjene dolutegravira i metformina, da bi se održala kontrola glikemije.
English: Dofetilide ↑ (Not studied, potential increase via inhibition of OCT2 transporter)
Croatian: Antiaritmici dofetilid dofetilid ↑ (interakcija nije ispitivana; moguće je povećanje koncentracije zbog inhibicije prijenosnika OCT2)
English: Dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45% Daclatasvir ↔
Croatian: daklatazvir dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45% daklatazvir ↔
English: The pharmacokinetics was evaluated in 11 children 6 to 12 years of age and showed that 25 mg once daily in patients weighing at least 20 kg and 35 mg once daily in patients weighing at least 30 kg resulted in dolutegravir exposure comparable to adults.
Croatian: Ocijenjena je farmakokinetika u 11 djece u dobi od 6 do 12 godina i pokazalo se da doza od 25 mg jedanput na dan u bolesnika tjelesne težine od najmanje 20 kg te doza od 35 mg jedanput na dan u bolesnika tjelesne težine od najmanje 30 kg dovode do izloženosti dolutegraviru usporedive s onom u odraslih.
English: In vitro, dolutegravir inhibited the renal organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter (MATE) 1.
Croatian: Dolutegravir je in vitro inhibirao bubrežni prijenosnik organskih kationa 2 (OCT2) i prijenosnik za izlučivanje više lijekova i toksina (engl. multidrug and toxin extrusion transporter, MATE) 1.
English: In the presence of integrase class resistance alternative combinations that do not include fosamprenavir/ritonavir should be considered.
Croatian: U slučaju rezistencije na skupinu inhibitora integraze, treba razmotriti druge kombinacije koje ne uključuju fosamprenavir/ritonavir.
English: Table 5 Response (<50 cps/ml, snapshot) in GEMINI 1 + 2, pooled data.
Croatian: Tablica 5 Odgovori (< 50 kopija/ml, algoritam za globalnu snimku distribuiranog sustava) u ispitivanjima GEMINI 1 + 2 (objedinjeni podaci).
English: Based on data from other CYP3A4 inhibitors, a marked increase is not expected.
Croatian: S obzirom na podatke o drugim inhibitorima CYP3A4,
English: This includes co-administration with medicinal products that reduce dolutegravir exposure (e.g. magnesium/ aluminium-containing antacid, iron and calcium supplements, multivitamins and inducing agents, etravirine (without boosted protease inhibitors), tipranavir/ritonavir, rifampicin, St. John's wort and certain antiepileptic medicinal products) (see section 4.5).
Croatian: To uključuje istodobnu primjenu lijekova koji smanjuju izloženost dolutegraviru (npr. antacid koji sadrži magnezij/aluminij, nadomjesci željeza i kalcija, multivitaminski pripravci i inducirajući lijekovi, etravirin (bez pojačanih inhibitora proteaze), tipranavir/ritonavir,
English: Dolutegravir pharmacokinetics are similar between healthy and HIV-infected subjects.
Croatian: 5.2 Farmakokinetička svojstva Farmakokinetika dolutegravira slična je u zdravih ispitanika i u onih s HIV infekcijom.
English: EFV/TDF/FTC Once Daily N=419
Croatian: EFV/TDF/F TC jedanput na dan N=419
English: Dolutegravir and other suspect medicinal products should be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by raised liver enzymes, fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis,
Croatian: Primjena dolutegravira i drugih suspektnih lijekova mora se odmah prekinuti ako se pojave znakovi ili simptomi reakcija preosjetljivosti (uključujući između ostaloga, težak osip ili osip praćen povišenim vrijednostima jetrenih enzima, vrućicu, opću malaksalost, umor, tupe bolove u mišićima ili zglobovima, mjehuriće, oralne lezije, konjunktivitis, edem lica, eozinofiliju, angioedem).
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).
Croatian: U prethodno neliječenih bolesnika koji su u ispitivanjima faze IIb i faze III primali dolutegravir + 2 nukleozidna inhibitora reverzne transkriptaze (NRTI), nije primijećen razvoj rezistencije na skupinu inhibitora integraze niti na skupinu NRTI-ja (n=1118, praćenje 48-96 tjedana).
English: Very common Nausea Very common Diarrhoea Common Vomiting Common Flatulence Common Upper abdominal pain Common Abdominal pain Common Abdominal discomfort
Croatian: Poremećaji probavnog sustava vrlo često mučnina vrlo često proljev često povraćanje često flatulencija često bol u gornjem dijelu abdomena često bol u abdomenu često nelagoda u abdomenu
English: Calcium supplements, iron supplements or multivitamins Calcium supplements, iron supplements or multivitamins can stop Tivicay being absorbed into your body and make it less effective.
Croatian: Nadomjesci kalcija, nadomjesci željeza ili multivitaminski pripravci mogu spriječiti apsorpciju lijeka Tivicay u tijelo i tako oslabiti njegovu djelotvornost.
English: → Talk to your doctor for further advice on taking acid-lowering medicines with Tivicay.
Croatian: → Obratite se liječniku za dodatne savjete o uzimanju antacida zajedno s lijekom Tivicay.
English: DTG + TDF/FTC (N=717) n/N (%)
Croatian: DTG + TDF/FTC (N=717)
English: In a Phase I/II 48 week multicentre, open-label study (P1093/ING112578), the pharmacokinetic parameters, safety, tolerability and efficacy of Tivicay has been evaluated in combination regimens in HIV-1 infected, treatment-experienced, INI naive children and adolescents (6 to less than 18 years of age).
Croatian: U 48-tjednom multicentričnom, otvorenom ispitivanju faze I/II (P1093/ING112578) ocjenjivali su se farmakokinetički parametri, sigurnost, podnošljivost i djelotvornost lijeka Tivicay u kombiniranim režimima liječenja u djece i adolescenata (u dobi od 6 do manje od 18 godina) s HIV-1 infekcijom koji su prethodno bili liječeni, ali nisu bili izloženi inhibitorima integraze.
English: • if you are allergic to dolutegravir or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na dolutegravir ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.) • ako uzimate lijek koji se zove dofetilid (za liječenje srčanih bolesti).
English: Dolutegravir ↑ AUC ↑ 91% Cmax ↑ 50% Cτ ↑ 180%
Croatian: Inhibitori proteaze atazanavir dolutegravir ↑ AUC ↑ 91% Cmax ↑ 50% Cτ ↑ 180%
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.
Croatian: U uvjetima imunološke rekonstitucije prijavljeni su i autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa); međutim, prijavljeno vrijeme do pojave je različito pa se ti događaji mogu javiti i mjesecima nakon uvođenja liječenja.
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).
Croatian: U bolesnika koji su neuspješno odgovorili na prethodne terapije, ali nisu primali lijekove iz skupine inhibitora integraze (ispitivanje SAILING), supstitucije uzrokovane inhibitorom integraze primijećene su u 4/354 bolesnika (praćenje od 48 tjedana) liječenih dolutegravirom, koji se primjenjivao u kombinaciji s osnovnim režimom liječenja po izboru ispitivača.
English: • palpitations (rapid or irregular heartbeat) or tremor
Croatian: • osjećaj lupanja srca (brzi ili nepravilni otkucaji srca) ili nevoljno drhtanje • hiperaktivnost (prekomjeran nemir i kretanje)
English: At 144 weeks in the openlabel phase of SINGLE, virologic suppression was maintained, the dolutegravir + ABC/3TC arm (71%) was superior to the EFV/TDF/FTC arm (63%), treatment difference was 8.3% (2.0, 14.6).
Croatian: U 144. tjednu otvorene faze ispitivanja SINGLE, virološka supresija bila je održana, dolutegravir + ABC/3TC skupina (71%) bila je superiorna u odnosu na EFV/TDF/FTC skupinu (63%), razlika između liječenja bila je 8,3% (2,0;
English: Changes in laboratory biochemistries
Croatian: Opis odabranih nuspojava Promjene u laboratorijskim nalazima biokemijskih parametara
English: To what extent dolutegravir provides added efficacy in the presence of such integrase class resistance is uncertain (see section 5.2).
Croatian: Nije posve jasno u kojoj mjeri dolutegravir pruža dodatnu djelotvornost u slučaju takve rezistencije na skupinu inhibitora integraze (vidjeti dio 5.2).
English: Uncommon Hypersensitivity (see section 4.4) Uncommon Immune Reconstitution Syndrome (see section 4.4)** Psychiatric disorders Common Insomnia Common Abnormal dreams
Croatian: Poremećaji imunološkog sustava manje često preosjetljivost (vidjeti dio 4.4) manje često sindrom imunološke rekonstitucije (vidjeti dio 4.4)**
English: Baseline with ongoing RAL/EVG
Croatian: RAL/EVG
English: Dolutegravir 50 mg + ABC/3TC Once Daily N=414
Croatian: Dolutegravir 50 mg + ABC/3TC jedanput na dan N=414
English: Antiviral activity in combination with other antiviral agents No antagonistic effects in vitro were seen with dolutegravir and other antiretrovirals tested: stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc and raltegravir.
Croatian: Nisu primijećeni antagonistički učinci in vitro kod primjene dolutegravira i drugih ispitivanih antiretrovirotika: stavudina, abakavira, efavirenza, nevirapina, lopinavira, amprenavira, enfuvirtida,
English: The decision to use dolutegravir in the presence of integrase class resistance should take into account that the activity of dolutegravir is considerably compromised for viral strains harbouring Q148+≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I (see section 5.1).
Croatian: Pri donošenju odluke o primjeni dolutegravira u slučaju rezistencije na skupinu inhibitora integraze, u obzir treba uzeti činjenicu da je djelovanje dolutegravira značajno oslabljeno kod virusnih sojeva koji imaju mutaciju Q148 + ≥ 2 sekundarne mutacije: G140A/C/S, E138A/K/T, L74I (vidjeti dio 5.1).
English: The use of Tivicay in children under 6 or weighing less than 15 kg has not yet been studied.
Croatian: Primjena lijeka Tivicay u djece mlađe od 6 godina ili tjelesne težine manje od 15 kg još nije ispitana.
English: Dolutegravir is primarily metabolized through glucuronidation via UGT1A1 with a minor CYP3A component.
Croatian: Biotransformacija Dolutegravir se prvenstveno metabolizira glukuronidacijom putem UGT1A1, a manjim dijelom posredstvom CYP3A.
English: Patients infected with HIV-1 without documented or clinically suspected resistance to the integrase class The recommended dose of dolutegravir is 50 mg (one tablet) orally once daily.
Croatian: Bolesnici zaraženi virusom HIV-1 bez dokumentirane ili klinički suspektne rezistencije na skupinu inhibitora integraze Preporučena doza dolutegravira je 50 mg (jedna tableta) peroralno jedanput na dan.
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.
Croatian: U 48. tjednu dolutegravir je bio neinferioran u odnosu na raltegravir u ispitivanju SPRING-2, dok je u ispitivanju SINGLE kombinacija dolutegravir + ABC/3TC bila superiorna u odnosu na efavirenz/TDF/FTC (p=0,003), kao što je prikazano u Tablici 4 gore.
English: A mean change from baseline of 9.96 µmol/L was observed after 48 weeks of treatment.
Croatian: Nakon 48 tjedana liječenja primijećena je srednja promjena od 9,96 µmol/l u odnosu na početnu vrijednost.
English: Azole anti-fungal agents Ketoconazole Fluconazole Itraconazole Posaconazole Voriconazole
Croatian: Azolni antifungici ketokonazol flukonazol itrakonazol posakonazol vorikonazol dolutegravir ↔ (interakcija nije ispitivana)
English: 8%b a 22 subjects contributed Week 48 CD4+ cell count data b 21 subjects contributed Week 24 CD4+ cell count data
Croatian: 8%b a podaci o broju CD4+ stanica u 48. tjednu bili su poznati za 22 ispitanika b podaci o broju CD4+ stanica u 24. tjednu bili su poznati za 21 ispitanika
English: 1 Historical or phenotypic evidence of INI resistance only.
Croatian: 1 Prethodno postojeća ili fenotipska rezistencija samo na inhibitore integraze.
English: In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
Croatian: In vivo je u bolesnika primijećeno smanjenje klirensa kreatinina (udio koji se izlučuje ovisi o prijenosnicima OCT2 i MATE-1) za 10-14%.
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).
Croatian: Srednja vrijednost promjene HIV RNK nakon 8 dana u odnosu na početnu vrijednost (primarna mjera ishoda) iznosila je -1,4 log10 kopija/ml (95% CI -1,3 - -1,5 log10, p<0,001).
English: b Confirmed plasma HIV-1 RNA levels to ≥200 cps/mL after prior confirmed suppression to <200 cps/mL.
Croatian: b Potvrđene razine HIV-1 RNK u plazmi od ≥ 200 kopija/ml nakon prethodne potvrđene supresije na
English: By BL HIV-1 RNA
Croatian: Prema početnoj vrijednosti HIV-1 RNK
English: RAL 400 mg Twice Daily + 2 NRTI N=411
Croatian: RAL 400 mg dvaput na dan + 2 NRTI N=411
English: In vitro, dolutegravir inhibited the renal uptake transporters, organic anion transporters (OAT1) and OAT3.
Croatian: In vitro je dolutegravir inhibirao bubrežne prijenosnike za unos tvari te prijenosnike organskih aniona OAT1 i OAT3.
English: Effect of dolutegravir on the pharmacokinetics of other agents
Croatian: Učinak dolutegravira na farmakokinetiku drugih lijekova
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of dolutegravir with metformin, to maintain glycaemic control (see section 4.5).
Croatian: Potrebno je razmotriti prilagodbu doze metformina kod započinjanja ili prekidanja istodobne primjene dolutegravira i metformina, da bi se održala kontrola glikemije (vidjeti dio 4.5).
English: For the comparator arms, the same lack of treatment emergent resistance was also the case for patients treated with darunavir/r in FLAMINGO.
Croatian: Među usporednim je skupinama isti izostanak razvoja rezistencije uzrokovane liječenjem primijećen i u bolesnika liječenih kombinacijom darunavir/r u ispitivanju FLAMINGO.
English: Effect of other agents on the pharmacokinetics of dolutegravir
Croatian: Učinak drugih lijekova na farmakokinetiku dolutegravira
English: The median change in CD4+ T cell count from baseline for VIKING-3 based on observed data was 61 cells/mm3 at Week 24 and 110 cells/mm3 at Week 48.
Croatian: Prikupljeni podaci pokazali su da je u ispitivanju VIKING-3 medijan promjene broja CD4+ T stanica od početne vrijednosti iznosio 61 stanicu/mm3 nakon 24 tjedna te 110 stanica/mm3 nakon 48 tjedana.
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.
Croatian: Ispitanici su bili podijeljeni u skupine prema dobi, i primali su Tivicay (70 mg primijenjeno kao 35 mg dvaput na dan, n=1; 50 mg jedanput na dan, n=5; 35 mg jedanput na dan, n=6; 25 mg jedanput na dan, n=8; te 20 mg jedanput na dan, n=3) u kombinaciji s optimiziranim osnovnim režimom liječenja.
English: Table 4 Response in SPRING-2 and SINGLE at 48 Weeks (Snapshot algorithm, <50 copies/mL) SPRING-2
Croatian: Tablica 4 Odgovori u ispitivanjima SPRING-2 i SINGLE nakon 48 tjedana (algoritam za globalnu snimku distribuiranog sustava [engl. snapshot algorithm], < 50 kopija/ml)
English: Population pharmacokinetic analysis indicated that hepatitis C virus co-infection had no clinically relevant effect on the exposure to dolutegravir.
Croatian: Populacijska farmakokinetička analiza pokazala je da istodobna infekcija virusom hepatitisa C nema klinički značajnog utjecaja na izloženost dolutegraviru.
English: A clinically relevant phenotypic cut-off value (FC vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Croatian: Klinički značajna fenotipska krajnja vrijednost (FC u odnosu na virus divljeg tipa) nije utvrđena;
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.
Croatian: U bolesnika zaraženih virusom HIV-1 bez rezistencije na skupinu inhibitora integraze, preporučena doza dolutegravira u djece (u dobi od 6 do manje od 12 godina i tjelesne težine od najmanje 15 kg)
English: All patients adjusted diff -1.7% (CI95-4.4, 1.1) a
Croatian: Svi bolesnici prilagođena razlika -1,7% (95% CI: -4,4; 1,1) a
English: In previously untreated patients receiving dolutegravir + lamivudine in the GEMINI studies through week 48 (n=716), no development of resistance to the integrase class, or to the NRTI class was seen.
Croatian: U prethodno neliječenih bolesnika koji su u sklopu ispitivanja iz programa GEMINI primali dolutegravir + lamivudin tijekom 48 tjedana (n=716) nije opažen razvoj rezistencije na skupinu inhibitora integraze ni na skupinu NRTI-ja.
English: The absorption of dolutegravir is reduced by certain anti-acid agents (see Table 2).
Croatian: Određeni antacidi smanjuju apsorpciju dolutegravira (vidjeti Tablicu 2).
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.
Croatian: U randomiziranom ispitivanju raspona doza u ispitanika s HIV-1 infekcijom liječenih monoterapijom dolutegravirom (ING111521) primijećeno je brzo i o dozi ovisno antivirusno djelovanje, uz srednje smanjenje HIV-1 RNK za 2,5 log10 nakon 11 dana primjene doze od 50 mg.
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.
Croatian: nisu odgovorila na liječenje te su imala značajne NRTI mutacije, a u jednog se ispitanika razvila rezistencija na raltegravir; u ispitivanju SINGLE, šest ispitanika koji su primali EFV/TDF/FTC nisu odgovorili na liječenje te su imali mutacije povezane s rezistencijom na NNRTI, dok se u jednog ispitanika razvila značajna NRTI mutacija.
English: Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
Croatian: nevirapin dolutegravir ↓ (interakcija nije ispitivana; zbog indukcije se očekuje smanjenje izloženosti slično onome kod primjene efavirenza)
English: Mannitol (E421) Microcrystalline cellulose Povidone (K29/32) Sodium starch glycolate Sodium stearyl fumarate
Croatian: celuloza, mikrokristalična povidon (K29/32) natrijev škroboglikolat natrijev stearilfumarat
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).
Croatian: U ispitivanju SINGLE 833 ispitanika randomizirano je u skupinu koja je primila najmanje jednu dozu dolutegravira od 50 mg jedanput na dan u kombinaciji s fiksnom dozom abakavira-lamivudina (DTG + ABC/3TC) ili fiksnu dozu efavirenza-tenofovira-emtricitabina (EFV/TDF/FTC).
English: Each 10 mg tablet contains 1 mg sodium.
Croatian: Jedna tableta od 10 mg sadrži 1 mg natrija.