FrancophonIA/ELRC3.0 huggingface dataset:
English: A mean change from baseline of 8.22 µmol/L (range -26.5 to 51.2 µmol/L) was observed after 48 weeks treatment.
Croatian: Nakon 48 tjedana liječenja primijećena je srednja vrijednost promjene od 8,22 µmol/l (raspon od -26,5 do 51,2 µmol/l) u odnosu na početnu vrijednost.
English: Rilpivirine demonstrated limited in vitro activity against HIV-2 with IC50 values ranging from 2,510 to 10,830 nM.
Croatian: Rilpivirin je pokazao ograničenu aktivnost in vitro protiv HIV-2, uz vrijednosti IC50 u rasponu od 2510 do 10 830 nM.
English: Limited data is available in patients with hepatitis C co-infection.
Croatian: Dostupni su ograničeni podaci o primjeni u bolesnika s istodobnom infekcijom virusom hepatitisa C.
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.
Croatian: Iako je ukupna koncentracija dolutegravira u plazmi bila podjednaka, u ispitanika s umjerenim oštećenjem jetrene funkcije izloženost nevezanom dolutegraviru bila je 1,5 do 2 puta veća nego u zdravih ispitanika.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET ViiV Healthcare BV
English: Dexamethasone/ Rilpivirine (systemic, except for single dose use)
Croatian: deksametazon / dolutegravir deksametazon / rilpivirin (sistemski, osim kod primjene samo jedne doze)
English: Rilpivirine ↔ AUC ↓ 5%
Croatian: rilpivirin ↔ AUC ↓ 5%
English: Dolutegravir is primarily metabolized through glucuronidation via UGT1A1 with a minor CYP3A component.
Croatian: Dolutegravir se prvenstveno metabolizira glukuronidacijom putem UGT1A1, a manjim dijelom posredstvom CYP3A.
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Juluca with metformin, to maintain glycaemic control.
Croatian: Potrebno je razmotriti prilagodbu doze metformina kod započinjanja ili prekidanja istodobne primjene lijeka Juluca i metformina, da bi se održala kontrola glikemije.
English: At supra-therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 5.1).
Croatian: Primjena rilpivirina u dozama većima od terapijskih (75 mg i 300 mg jedanput na dan) povezana je s produljenjem QTc intervala na elektrokardiogramu (EKG) (vidjeti dijelove 4.5 i 5.1).
English: In a Week 96 pooled analyses of virologic failures with baseline viral load ≤100,000 copies/mL and resistance to rilpivirine (n = 5), subjects had cross-resistance to efavirenz (n = 3), etravirine (n = 4), and nevirapine (n = 1).
Croatian: Prema analizama objedinjenih podataka o bolesnicima s virološkim neuspjehom koji su na početku ispitivanja imali virusno opterećenje ≤ 100 000 kopija/ml i rezistenciju na rilpivirin (n = 5), provedenima u 96. tjednu, ispitanici su imali križnu rezistenciju na efavirenz (n = 3), etravirin (n = 4) i nevirapin (n = 1).
English: As dolutegravir and rilpivirine are highly bound to plasma proteins, dialysis is unlikely to result in significant removal of the active substances.
Croatian: Budući da se dolutegravir i rilpivirin u velikoj mjeri vežu za proteine u plazmi, nije vjerojatno da će se te djelatne tvari značajno ukloniti dijalizom.
English: Neither Juluca nor the combination dolutegravir and rilpivirine as single entities have been studied in children.
Croatian: Ni Juluca ni kombinacija dolutegravira i rilpivirina kao zasebnih lijekova nisu se ispitivali u djece.
English: No clinically important pharmacokinetic differences of dolutegravir or rilpivirine due to race have been identified.
Croatian: Nisu utvrđene klinički važne razlike u farmakokinetici dolutegravira ili rilpivirina povezane s rasom.
English: No dose adjustment of oral contraceptives is required when co-administered with Juluca.
Croatian: Nije potrebno prilagođavati dozu oralnih kontraceptiva pri njihovoj istodobnoj primjeni s lijekom Juluca.
English: Steadystate administration of rilpivirine 75 mg once daily and 300 mg once daily resulted in a mean Cmax approximately 2.6-fold and 6.7-fold, respectively, higher than the mean steady-state Cmax observed with the recommended 25 mg once daily dose of rilpivirine (see section 4.4).
Croatian: Primjena rilpivirina u dozi od 75 mg jedanput na dan i 300 mg jedanput na dan u stanju dinamičke ravnoteže dovela je do srednje vrijednosti Cmax koja je bila približno 2,6 puta odnosno 6,7 puta veća od srednje vrijednosti Cmax u stanju dinamičke ravnoteže opažene kod primjene preporučene doze rilpivirina od 25 mg jedanput na dan (vidjeti dio 4.4).
English: increase).
Croatian: vrijednosti).
English: In this analysis, the resistance-associated mutations (RAMs) associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y, and F227C.
Croatian: U toj su analizi utvrđene sljedeće mutacije povezane s rezistencijom na NNRTI-je koje su se razvile u najmanje 2 bolesnika liječena rilpivirinom koja su doživjela virološki neuspjeh: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y i F227C.
English: From the week 48 to the week 96 analysis, 24 (3.5%) and 14 (2.1%) additional virologic failures occurred in the rilpivirine and efavirenz arm, respectively.
Croatian: Između analize u 48. tjednu i one u 96. tjednu zabilježena su dodatna 24 (3,5%) slučaja virološkog neuspjeha u skupini liječenoj rilpivirinom i 14 (2,1%) u onoj liječenoj efavirenzom.
English: How to take Juluca
Croatian: Kako uzimati lijek Juluca
English: Lower exposures of dolutegravir and rilpivirine were observed during pregnancy.
Croatian: Primijećena je manja izloženost dolutegraviru i rilpivirinu tijekom trudnoće.
English: Azole anti-fungals Ketoconazole/ Dolutegravir Ketoconazole/ Rilpivirine1,2
Croatian: Azolni antifungici ketokonazol / dolutegravir ketokonazol / rilpivirin1,2
English: Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
Croatian: U mokraći je rilpivirin u nepromijenjenu obliku pronađen samo u tragovima (< 1% doze).
English: Gastrointestinal disorders very common nausea increased pancreatic amylase diarrhoea common abdominal pain vomiting flatulence increased lipase abdominal discomfort upper abdominal pain dry mouth
Croatian: Poremećaji probavnog sustava vrlo često mučnina povišene vrijednosti gušteračne amilaze proljev često bol u abdomenu povraćanje flatulencija povišene vrijednosti lipaze nelagoda u abdomenu bol u gornjem dijelu abdomena suha usta
English: It is unknown whether dolutegravir or rilpivirine are excreted in human milk.
Croatian: Nije poznato izlučuju li se dolutegravir ili rilpivirin u majčino mlijeko.
English: Metabolic inducers may significantly decrease dolutegravir/rilpivirine plasma concentrations, resulting in loss of therapeutic effect.
Croatian: Metabolički induktori mogu značajno smanjiti koncentracije dolutegravira/rilpivirina u plazmi i tako dovesti do gubitka terapijskog učinka.
English: Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption due to gastric pH increase).
Croatian: Očekuju se značajna smanjenja koncentracija rilpivirina u plazmi (smanjena apsorpcija zbog povećanja želučane pH
English: When Juluca is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day should be taken at the same time with Juluca, for the duration of the rifabutin co-administration (a separate formulation of rilpivirine is available for this dose adjustment, see section 4.2).
Croatian: tijekom cijelog razdoblja liječenja rifabutinom potrebno je istodobno s lijekom Juluca uzimati dodatnu tabletu rilpivirina od 25 mg (za tu prilagodbu doze dostupna je zasebna formulacija rilpivirina, vidjeti dio 4.2).
English: Juluca 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, facial oedema, eosinophilia, angioedema).
Croatian: Primjena lijeka Juluca 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,
English: No treatment emergent resistanceassociated substitutions were observed for the other three subjects who experienced confirmed virologic failure.
Croatian: U ostala tri ispitanika koja su doživjela potvrđen virološki neuspjeh nisu opažene supstitucije povezane s rezistencijom koje se javljaju tijekom liječenja.
English: A dose adjustment of metformin should be considered when starting and stopping co-administration of Juluca with metformin, to maintain glycaemic control (see section 4.5).
Croatian: Potrebno je razmotriti prilagodbu doze metformina kod započinjanja ili prekidanja istodobne primjene lijeka Juluca i metformina, da bi se održala kontrola glikemije (vidjeti dio 4.5).
English: Rilpivirine is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1.
Croatian: Rilpivirin je diarilpirimidinski nenukleozidni inhibitor reverzne transkriptaze (engl. non-nucleoside reverse transcriptase inhibitor, NNRTI) virusa HIV-1.
English: The pharmacokinetics of rilpivirine in 36 antiretroviral treatment-naïve HIV-1 infected adolescent subjects (12 to <18 years of age) receiving rilpivirine 25 mg once daily were comparable to those in treatment-naïve HIV-1 infected adults receiving rilpivirine 25 mg once daily.
Croatian: Farmakokinetika rilpivirina u 36 adolescentnih ispitanika (od 12 do < 18 godina) s HIV-1 infekcijom prethodno neliječenih antiretroviroticima koji su primali 25 mg rilpivirina jedanput na dan bila je usporediva s onom u prethodno neliječenih odraslih ispitanika s HIV-1 infekcijom koji su primali rilpivirin u dozi od 25 mg jedanput na dan.
English: The effect of Juluca on human pregnancy is unknown.
Croatian: Nije poznat učinak lijeka Juluca na trudnoću u ljudi.
English: In a DEXA substudy mean bone mineral density (BMD) increased from Baseline to Week 48 in subjects who switched to dolutegravir plus rilpivirine (1.34% total hip and 1.46% lumbar spine) compared with those who continued on treatment with a TDF-containing antiretroviral regimen (0.05% total hip and 0.15% lumbar spine.
Croatian: U podispitivanju u kojem se provodila apsorpciometrija s pomoću rendgenskih zraka dviju različitih energija (engl. dual-energy X-ray absorptiometry, DEXA), srednja vrijednost mineralne gustoće kostiju (engl. bone mineral density, BMD) povećala se od početka ispitivanja do 48. tjedna u ispitanika koji su prešli na dolutegravir plus rilpivirin (1,34% za cijeli kuk te 1,46% za lumbalnu kralježnicu) u odnosu na ispitanike koji su nastavili liječenje antiretrovirusnim režimom koji je uključivao tenofovirdizoproksilfumarat (0,05% za cijeli kuk te 0,15% za lumbalnu kralježnicu).
English: Each pack consists of one bottle containing 30 film-coated tablets and a desiccant.
Croatian: Jedno pakiranje sadrži jednu bocu s 30 filmom obloženih tableta i sredstvom za sušenje.
English: • abnormal dreams
Croatian: • poremećaji spavanja • neuobičajeni snovi
English: Each bottle contains 30 film-coated tablets and a desiccant to reduce moisture.
Croatian: Jedna boca sadrži 30 filmom obloženih tableta i sredstvo za sušenje koje smanjuje količinu vlage.
English: The IC50 for dolutegravir against various laboratory strains using PBMC was 0.5 nM, and when using MT-4 cells it ranged from 0.7-2 nM.
Croatian: IC50 dolutegravira protiv različitih laboratorijskih sojeva u mononuklearnim stanicama periferne krvi iznosio je 0,5 nM, a na MT-4 stanicama kretao se u rasponu od 0,7 do 2 nM.
English: No pharmacokinetic data are available for the combination of dolutegravir and rilpivirine in pregnancy.
Croatian: Nema dostupnih podataka o farmakokinetici kombinacije dolutegravira i rilpivirina u trudnoći.
English: Juluca should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
Croatian: Potreban je oprez kad se Juluca primjenjuje istodobno s lijekovima za koje se zna da nose rizik od torsade de pointes.
English: If you vomit more than 4 hours after taking Juluca you do not need to take another tablet until your next scheduled dose.
Croatian: Ako povratite više od 4 sata nakon uzimanja lijeka Juluca, ne morate uzeti još jednu tabletu do sljedeće doze prema rasporedu.
English: The absorption of dolutegravir is reduced by certain anti-acid medicinal products (see Table 1).
Croatian: Određeni antacidi smanjuju apsorpciju dolutegravira (vidjeti Tablicu 1).
English: Juluca can make you dizzy, tired or drowsy or and have other side effects that make you less alert.
Croatian: Juluca može uzrokovati omaglicu, umor, omamljenost ili druge nuspojave koje mogu utjecati na Vašu pozornost.
English: Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Croatian: Dolutegravir nije bio mutagen ni klastogen u in vitro testovima provedenima na bakterijskim stanicama i kultiviranim stanicama sisavaca niti u in vivo mikronukleusnom testu provedenom na glodavcima.
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.56 times the 50 mg human clinical exposure based on AUC).
Croatian: U kunića je toksičnost za majku (smanjen unos hrane, slabo izlučivanje/izostanak fecesa/mokraće, suprimiran prirast tjelesne težine) primijećena pri primjeni doze od 1000 mg/kg (izloženost 0,56 puta veća od kliničke izloženosti pri primjeni doze od 50 mg u ljudi, što je utvrđeno na temelju AUC-a).
English: H2-receptor antagonists should be taken well separated in time from the administration of Juluca (minimum 4 hours after or 12 hours before)
Croatian: H2-receptora treba uzeti sa značajnim vremenskim odmakom u odnosu na primjenu lijeka Juluca (najmanje 4 sata nakon ili 12 sati prije).
English: However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate hepatic impairment.
Croatian: Međutim, ne može se isključiti mogućnost da je kod umjerenog oštećenja jetrene funkcije značajno povećana izloženost farmakološki aktivnom, nevezanom rilpivirinu.
English: Don't stop taking Juluca without advice from your doctor Take Juluca for as long as your doctor recommends.
Croatian: Nemojte prestati uzimati lijek Juluca bez prethodnog savjetovanja sa svojim liječnikom.
English: Each pack of 30 film-coated tablets contains a desiccant.
Croatian: Svako pakiranje s 30 filmom obloženih tableta sadrži sredstvo za sušenje.
English: Juluca contains lactose
Croatian: Juluca sadrži laktozu
English: No clinical data are available in patients with hepatitis B co-infection.
Croatian: Nema dostupnih kliničkih podataka o primjeni u bolesnika s istodobnom infekcijom virusom hepatitisa B.
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 granična vrijednost (FC u odnosu na virus divljeg tipa) nije utvrđena;
English: Antacids and supplements Antacids (e.g., aluminium magnesium hydroxide, and/or calcium carbonate)/
Croatian: Antacidi i dodaci prehrani antacidi (npr. aluminijev i magnezijev hidroksid i/ili kalcijev karbonat) / dolutegravir1
English: In vitro, dolutegravir inhibited the renal uptake transporters, organic anion transporters (OAT)1 and OAT3.
Croatian: In vitro je dolutegravir inhibirao bubrežne prijenosnike za unos tvari te prijenosnike organskih aniona 1 i 3 (engl. organic anion transporters, OAT1 i OAT3).
English: No specific symptoms or signs have been identified following acute overdose with dolutegravir or rilpivirine apart from those listed as adverse reactions.
Croatian: Nakon akutnog predoziranja dolutegravirom ili rilpivirinom nisu primijećeni nikakvi specifični simptomi ni znakovi, osim onih navedenih među nuspojavama.
English: Co-administration of Juluca with systemic dexamethasone is contraindicated (except as a single dose) see section 4.3.
Croatian: Istodobna primjena lijeka Juluca i sistemskog deksametazona je kontraindicirana (osim kad se primjenjuje samo jedna doza), vidjeti dio 4.3.
English: Oral contraceptives Ethinyl estradiol (EE)1 and Norelgestromin (NGMN)1 / Dolutegravir
Croatian: Oralni kontraceptivi etinilestradiol (EE)1 i norelgestromin (NGMN)1 / dolutegravir etinilestradiol (EE)1 i noretindron1 / rilpivirin dolutegravir ↔ EE ↔
English: In patients with severe renal impairment or end-stage renal disease, Juluca should be used with caution, as rilpivirine plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Croatian: Lijek Juluca treba primjenjivati uz oprez u bolesnika s teškim oštećenjem bubrežne funkcije ili onih u terminalnoj fazi bubrežne bolesti jer se koncentracije rilpivirina u plazmi mogu povećati zbog promjena u apsorpciji, distribuciji i/ili metabolizmu lijeka uzrokovanih bubrežnom disfunkcijom.
English: Population pharmacokinetic analyses from studies with the individual components revealed that gender had no clinically relevant effect on the pharmacokinetics of dolutegravir or rilpivirine.
Croatian: Populacijske farmakokinetičke analize podataka iz ispitivanja pojedinačnih sastavnica pokazale su da spol nije imao klinički značajnog učinka na farmakokinetiku dolutegravira ni rilpivirina.
English: Combinations of multiple substitutions T66K/L74M, E92Q/N155H, G140C/Q148R, G140S/Q148H, R or K, Q148R/N155H, T97A/G140S/Q148, and substitutions at
Croatian: Kombinacije većeg broja supstitucija T66K/L74M, E92Q/N155H, G140C/Q148R, G140S/Q148H, R ili K, Q148R/N155H, T97A/G140S/Q148 te supstitucije na položajima E138/G140/Q148 smanjile su osjetljivost na dolutegravir više od 2 puta (raspon od 2,5 puta do 21 puta u odnosu na referentnu vrijednost).
English: The pooled primary analysis demonstrated that dolutegravir plus rilpivirine is non-inferior to CAR, with 95% of subjects in both arms achieving the primary endpoint of <50 copies/mL plasma HIV-1 RNA at Week 48 based on the Snapshot algorithm (Table 3).
Croatian: Primarna analiza objedinjenih podataka pokazala je da je kombinacija dolutegravir plus rilpivirin neinferiorna dotadašnjem kombiniranom antiretrovirusnom režimu, pa je 95% ispitanika u obje skupine postiglo primarnu mjeru ishoda - plazmatsku koncentraciju HIV-1 RNK < 50 kopija/ml u 48. tjednu prema algoritmu za globalnu snimku distribuiranog sustava (Tablica 3).
English: Taking Juluca in fasted condition or with only a protein-rich nutritional drink may result in decreased plasma concentrations of rilpivirine, which could potentially reduce the therapeutic effect of Juluca.
Croatian: Uzimanje lijeka Juluca natašte ili samo s napitkom bogatim proteinima može smanjiti koncentracije rilpivirina u plazmi, što bi moglo smanjiti terapijski učinak lijeka Juluca.
English: Population pharmacokinetic analysis indicated that hepatitis C virus co-infection had no clinically relevant effect on the exposure to dolutegravir or rilpivirine.
Croatian: Populacijska farmakokinetička analiza pokazala je da istodobna infekcija virusom hepatitisa C nije imala klinički značajnog utjecaja na izloženost dolutegraviru ili rilpivirinu.
English: In patients with severe renal impairment or end-stage renal disease, the combination of Juluca with a strong CYP3A inhibitor should only be used if the benefit outweighs the risk.
Croatian: U bolesnika s teškim oštećenjem bubrežne funkcije ili onih u terminalnoj fazi bubrežne bolesti, kombinaciju lijeka Juluca i snažnog inhibitora CYP3A treba primjenjivati samo ako korist nadmašuje rizik.
English: If a patient vomits within 4 hours of taking Juluca, another Juluca tablet should be taken with a meal.
Croatian: Ako bolesnik povrati unutar 4 sata od uzimanja lijeka Juluca, treba uzeti još jednu tabletu lijeka Juluca uz obrok.
English: Rilpivirine AUC(0-∞) was increased by 57% and 72% and Cmax by 89% and 117%, with moderate and high fat meals respectively, compared to fasted conditions.
Croatian: Kod primjene uz obrok s umjerenim i visokim udjelom masnoća AUC(0-∞) rilpivirina povećao se za 57%, odnosno 72%, a Cmax za 89%, odnosno 117% u odnosu na primjenu natašte.
English: 300 mg once daily
Croatian: 50 mg jedanput na dan.
English: Rifampicin/ Rilpivirine1,2
Croatian: rifampicin / rilpivirin1,2
English: Juluca 50 mg/25 mg film-coated tablets dolutegravir/rilpivirine
Croatian: Juluca 50 mg/25 mg filmom obložene tablete dolutegravir/rilpivirin
English: What Juluca contains - The active substances are dolutegravir and rilpivirine.
Croatian: Sadržaj pakiranja i druge informacije Što Juluca sadrži - Djelatne tvari su dolutegravir i rilpivirin.
English: * compared to 25 mg once daily rilpivirine alone
Croatian: * u usporedbi s primjenom samo rilpivirina u dozi od 25 mg jedanput na dan
English: Population pharmacokinetic analysis using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir or rilpivirine exposures.
Croatian: Populacijska farmakokinetička analiza na temelju podataka prikupljenih u odraslih osoba s HIV-1 infekcijom pokazala je da dob nije imala klinički značajnog utjecaja na izloženost dolutegraviru ili rilpivirinu.
English: Seven hundred and five raltegravir resistant isolates from raltegravir experienced patients were analysed for susceptibility to dolutegravir.
Croatian: Osjetljivost na dolutegravir analizirala se u 705 izolata rezistentnih na raltegravir prikupljenih u bolesnika koji su prethodno primali raltegravir.
English: GI intolerance in monkeys occurred at 30 times the human mg/kg equivalent dose (based on a 50 kg human), and 11 times the human mg/m2 equivalent dose for a clinical dose of 50 mg.
Croatian: Gastrointestinalna nepodnošljivost u majmuna javljala se nakon primjene doza koje su bile 30 puta veće od ekvivalentne doze u ljudi izražene u mg/kg (određeno na temelju osobe tjelesne težine 50 kg) te 11 puta veće od ekvivalentne doze u ljudi izražene u mg/m2 za kliničku dozu od 50 mg.
English: Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious.
Croatian: U nekih osoba koje uzimaju lijekove za liječenje HIV infekcije mogu se razviti i neka druga stanja,
English: *** The results of the pooled analysis are in line with those of the individual studies, for which differences in proportions meeting the primary endpoint of <50 copies/mL plasma HIV-1 RNA at Week 48 (based on the Snapshot algorithm) for DTG+RPV versus CAR were -0.6 (95% CI: -4.3; 3.0) for SWORD-1 and 0.2 (95% CI: -3.9; 4.2) for SWORD-2 with a preset noninferiority margin of -10%.
Croatian: Prilagođena razlika (95% CI) od -0,6 (-1,7; *** Rezultati analize objedinjenih podataka u skladu su s onima iz pojedinačnih ispitivanja, u kojima je razlika u udjelu ispitanika koji su postigli primarnu mjeru ishoda - plazmatsku koncentraciju HIV-1 RNK < 50 kopija/ml u 48. tjednu (prema snapshot algoritmu) - uz DTG + RPV u odnosu na dotadašnji kombinirani antiretrovirusni režim iznosila -0,6 (95% CI: -4,3; 3,0) u ispitivanju SWORD-1 odnosno 0,2 (95% CI: -3,9; 4,2) u ispitivanju SWORD-2, uz unaprijed određenu graničnu vrijednost neinferiornosti od -10%.
English: AUC ↓ 9% Cmin NA
Croatian: AUC ↓ 9% Cmin NP
English: Juluca is bioequivalent to a dolutegravir 50 mg tablet and a rilpivirine 25 mg tablet administered together with a meal.
Croatian: Juluca je bioekvivalentna tableti dolutegravira od 50 mg i tableti rilpivirina od 25 mg primijenjenima zajedno uz obrok.
English: Juluca should be used with caution in patients with moderate hepatic impairment.
Croatian: Lijek Juluca treba primjenjivati uz oprez u bolesnika s umjerenim oštećenjem jetrene funkcije.