FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: 24. tjedna te uparenim genotipovima (svi su bili liječeni dolutegravirom u dozi od 50 mg dvaput na dan u kombinaciji s optimiziranim osnovnim režimom liječenja): 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) te N155H
English: Rebound up to week 48 b
Croatian: Ponovni porast virusnog opterećenja do 48. tjednab
English: Treatment emergent integrase resistance typically appeared in patients with a history of the Q148-mutation (baseline or historic).
Croatian: Rezistencija na inhibitore integraze uzrokovana liječenjem obično se javljala u bolesnika s mutacijom Q148 u anamnezi (na početku liječenja ili u prošlosti).
English: The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with etravirine without boosted protease inhibitors.
Croatian: Preporučena doza dolutegravira za odrasle je 50 mg dvaput na dan kad se istodobno primjenjuje s etravirinom bez pojačanih inhibitora proteaze.
English: TIVICAY ~1 mg/kg Once Daily + OBR
Croatian: TIVICAY ~1 mg/kg jedanput na dan + optimiziran osnovni režim liječenja
English: In SPRING-2, 822 adults were randomized and received at least one dose of either dolutegravir 50 mg once daily or raltegravir (RAL) 400 mg twice daily, both administered with either ABC/3TC or TDF/FTC.
Croatian: U ispitivanju SPRING-2 822 odrasle osobe su randomizirane u skupinu koja je primila najmanje jednu dozu dolutegravira od 50 mg jedanput na dan ili raltegravir (RAL) u dozi od 400 mg dvaput na dan; oba lijeka su se primjenjivala uz ABC/3TC ili TDF/FTC.
English: The efficacy of dolutegravir in combination with lamivudine in adults is supported by 48-week primary endpoint data from two identical 148-week, randomised, multicentre, double-blind, non-inferiority studies GEMINI-1 (204861) and GEMINI-2 (205543).
Croatian: 148-tjednih, randomiziranih, multicentričnih, dvostruko slijepih ispitivanja neinferiornosti pod nazivom GEMINI-1 (204861) i GEMINI-2 (205543).
English: Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Croatian: Daklatazvir nije promijenio koncentraciju dolutegravira u plazmi u klinički relevatnoj mjeri.
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).
Croatian: Kada se terapija utemeljena na dolutegraviru započinje u bolesnika s istodobnom infekcijom hepatitisom B, osobitu pozornost treba posvetiti uvođenju ili održavanju djelotvorne terapije za hepatitis B (sukladno smjernicama za liječenje) (vidjeti dio 4.8).
English: Approximately one third of the patients were infected with an HIV non-B subtype; these characteristics were similar between treatment groups.
Croatian: Približno trećina bolesnika bila je zaražena HIV-om koji nije bio podvrste B.
English: The IC50 for dolutegravir in various labstrains using PBMC was 0.5 nM, and when using MT-4 cells it ranged from 0.7-2 nM.
Croatian: IC50 za dolutegravir u različitim laboratorijskim sojevima na mononuklearnim stanicama periferne krvi iznosio je 0,5 nM, a na MT-4 stanicama kretao se u rasponu od 0,7-2 nM. Slične vrijednosti IC50
English: • if they are overweight.
Croatian: • ako su pretili.
English: Treatment-emergent mutations observed were consistent with those observed in the VIKING-3 study.
Croatian: Primijećene mutacije uzrokovane liječenjem bile se u skladu s onima primijećenim u ispitivanju
English: Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. (See also Section 3).
Croatian: Ne smijete uzeti antacid unutar 6 sati prije primjene lijeka Tivicay i još najmanje 2 sata nakon njegove primjene (pogledajte i dio 3.)
English: Tivicay tablets on a weight-band basis (20 mg, 25 mg, 35 mg, 50 mg) in children of at least 6 years of age weighing at least 15 kg provides comparable exposure to that observed in adults (50 mg), with the lowest weight band of 15 to <20 kg corresponding to 20 mg daily.
Croatian: populacijski farmakokinetički modeli i analize simulacija pokazale su da doziranje Tivicay tableta na temelju kategorija tjelesne težine (20 mg, 25 mg, 35 mg, 50 mg) u djece u dobi od najmanje 6 godina i tjelesne težine od najmanje 15 kg dovodi do izloženosti usporedive s onom u odraslih (50 mg), s time da za najnižu kategoriju tjelesne težine od 15 do < 20 kg odgovara doza od 20 mg na dan.
English: Tivicay should be prescribed by physicians experienced in the management of HIV infection.
Croatian: 4.2 Doziranje i način primjene Tivicay moraju propisati liječnici s iskustvom u liječenju HIV infekcije.
English: EU/1/13/892/004 EU/1/13/892/005 EU/1/13/892/006
Croatian: EU/1/13/892/001 EU/1/13/892/002 EU/1/13/892/003 EU/1/13/892/004 EU/1/13/892/005 EU/1/13/892/006
English: Mean change in CD4 count from baseline at Week 48, c/ mm3 a adjusted for BL stratification factors: Plasma HIV-1 RNA (≤100,000 c/mL vs. >100,000 c/mL) and CD4+ cell count (≤200 cells/mm3 vs. >200 cells/mm3).
Croatian: 48. tjedna, stanica/mm3 a Prilagođeno za početne faktore stratifikacije: vrijednost HIV-1 RNK u plazmi (≤ 100 000 kopija/ml naspram > 100 000 kopija/ml) i broj CD4+ stanica (≤ 200 stanica/mm3 naspram > 200 stanica/mm3).
English: Therefore, Tivicay is recommended to be taken with food by patients infected with HIV with integrase class resistance (see section 4.2).
Croatian: Stoga se u bolesnika s HIV infekcijom i rezistencijom na skupinu inhibitora integraze preporučuje primjena lijeka Tivicay zajedno s hranom (vidjeti dio 4.2).
English: 90 film-coated tablets
Croatian: 30 filmom obloženih tableta 90 filmom obloženih tableta
English: Antacids, to treat indigestion and heartburn, can stop Tivicay being absorbed into your body and make it less effective.
Croatian: Antacidi, lijekovi za probavne smetnje i žgaravicu, mogu spriječiti apsorpciju lijeka Tivicay u tijelo i tako umanjiti njegovu učinkovitost.
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.
Croatian: kliničkom je programu mutacija R263K prijavljena u dva bolesnika s podvrstama B i C koji su prethodno primali antiretrovirotike, ali ne i inhibitore integraze, no ona nije utjecala na osjetljivost na dolutegravir in vitro.
English: Serial passage is used to study resistance evolution in vitro.
Croatian: Za ispitivanje razvoja rezistencije in vitro koristi se metoda serijske pasaže.
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.40 times the 50 mg twice daily 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 0,40 puta veća od kliničke izloženosti pri primjeni doze od 50 mg dvaput na dan u ljudi, što je utvrđeno na temelju AUC-a).
English: Dolutegravir ↓
Croatian: - Djelatna tvar je dolutegravir.
English: At 96 weeks, virologic suppression in the dolutegravir group (80%) was superior to the DRV/r group (68%), (adjusted treatment difference [DTG-(DRV+RTV)]: 12.4%; 95% CI: [4.7, 20.2].
Croatian: DRV/r skupinu (68 %) (prilagođena razlika između liječenja [DTG-(DRV+RTV)]: 12,4%; 95% CI:
English: Antacid medicines
Croatian: Ostali lijekovi
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.
Croatian: Gastrointestinalna nepodnošljivost u majmuna javljala se nakon primjene doza koje su bile 15 puta veće od ekvivalentne doze u ljudi izražene u mg/kg (određeno na temelju osobe tjelesne težine 50 kg) te 5 puta veće od ekvivalentne doze u ljudi izražene u mg/m2 za kliničku dozu od 50 mg dvaput na dan.
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.
Croatian: Nakon peroralne primjene lijeka u obliku tablete dolutegravir je u načelu imao nelinearnu farmakokinetiku; izloženost u plazmi povećavala se manje nego proporcionalno dozi kada se ona povećala s 2 na 100 mg; međutim, povećanje izloženosti dolutegraviru čini se proporcionalnim dozi kod primjene tableta u rasponu od
English: Each 25 mg tablet contains 2 mg sodium.
Croatian: Jedna tableta od 25 mg sadrži 2 mg natrija.
English: The adjusted difference in proportion and 95% CI were 7.1% (0.9, 13.2), p=0.025.
Croatian: Prilagođena razlika u udjelu uz 95% CI iznosila je 7,1% (0,9; 13,2),
English: In a juvenile toxicity study in rats, dolutegravir administration resulted in two preweanling deaths at 75 mg/kg/day.
Croatian: U ispitivanju toksičnosti u mladih životinja kod štakora, primjena dolutegravira u dozi od 75 mg/kg na dan uzrokovala je smrt kod dva mladunca prije prestanka sisanja.
English: Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28% LPV ↔ RTV ↔
Croatian: lopinavir/ritonavir + etravirin dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28% LPV ↔ RTV ↔
English: Primary mutations for raltegravir/elvitegravir (Q148H/R/K, N155H, Y143R/H/C, E92Q and T66I) do not affect the in vitro susceptibility of dolutegravir as single mutations.
Croatian: Y143R/H/C, E92Q i T66I) ne utječu na osjetljivost na dolutegravir in vitro.
English: It is unknown whether dolutegravir is excreted in human milk.
Croatian: Nije poznato izlučuje li se dolutegravir u majčino mlijeko u ljudi.
English: Alternative combinations that do not include these metabolic inducers should be used where possible in INIresistant patients.
Croatian: Kad je to moguće, potrebno je primijeniti zamjenske kombinacije koje ne uključuju navedene metaboličke induktore u bolesnika rezistentnih na inhibitore integraze.
English: Each tablet contains dolutegravir sodium equivalent to 10 mg, 25 mg or 50 mg dolutegravir.
Croatian: Jedna tableta sadrži 10 mg, 25 mg ili 50 mg dolutegravira u obliku dolutegravirnatrija.
English: Tivicay can make you dizzy and have other side effects that make you less alert.
Croatian: Tivicay može uzrokovati omaglicu i druge nuspojave koje mogu utjecati na Vašu sposobnost reagiranja.
English: Treatment emergent resistance in previously untreated patients failing therapy Through 96 weeks in SPRING-2 and FLAMINGO and 144 weeks in SINGLE, no cases of treatment emergent primary resistance to the integrase- or NRTI-class were seen in the dolutegravir-containing arms.
Croatian: Tijekom 96 tjedana u ispitivanjima SPRING-2 i ispitivanju FLAMINGO te 144 tjedana u ispitivanju SINGLE, u skupinama koje su primale dolutegravir nisu primijećeni slučajevi primarne rezistencije uzrokovane liječenjem na razred inhibitora integraze niti NRTI-ja.
English: Seven hundred and five raltegravir resistant isolates from raltegravir experienced patients were analyzed for susceptibility to dolutegravir.
Croatian: Osjetljivost na dolutegravir analizirana je u 705 izolata rezistentnih na raltegravir prikupljenih u bolesnika koji su prethodno primali raltegravir.
English: The adjusted difference was -2.6% (95% CI: -6.7; 1.5) for GEMINI-1 and -0.7% (95% CI: -4.3; 2.9) for GEMINI-2 with a prespecified non-inferiority margin of 10%.
Croatian: Prilagođena razlika iznosila je -2,6% (95% CI: -6,7; 1,5) za GEMINI-1 i -0,7% (95%
English: 5 years
Croatian: nakon 8 dana.
English: Dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
Croatian: efavirenz dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
English: The proportion of responders (HIV-1 RNA <50 c/mL) at week 24 was predicted to increase around 4-18% in the subjects with Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I.
Croatian: < 50 kopija/ml) u 24. tjednu povećati za oko 4-18% u ispitanika s Q148 + ≥2 sekundarne mutacije: G140A/C/S, E138A/K/T, L74I.
English: In the double blind, placebo controlled VIKING-4 study (ING116529), 30 HIV-1 infected, ART-experienced adults with primary genotypic resistance to INIs at Screening, were randomised to receive either dolutegravir 50 mg twice daily or placebo with the current failing regimen for 7 days followed by an open label phase with all subjects receiving dolutegravir.
Croatian: U dvostruko slijepom, placebom kontroliranom ispitivanju VIKING-4 (ING116529), 30 odraslih bolesnika s HIV-1 infekcijom koji su prethodno primali antiretrovirusnu terapiju i koji su na probiru imali primarnu genotipsku rezistenciju na inhibitore integraze, randomizirano je za sedmodnevnu primjenu ili dolutegravira u dozi od 50 mg dvaput na dan ili placeba, u kombinaciji s trenutnim neuspješnim režimom liječenja; nakon toga je uslijedila otvorena faza u kojoj su svi ispitanici primali dolutegravir.
English: Dolutegravir 50 mg Once Daily + 2 NRTI N=411
Croatian: Dolutegravir 50 mg jedanput na dan + 2 NRTI N=411
English: The primary endpoint at Day 8 showed that dolutegravir 50 mg twice daily was superior to placebo, with an adjusted mean treatment difference for the change from Baseline in Plasma HIV-1 RNA of -1.2 log10 copies/mL (95% CI -1.5 -0.8log10 copies/mL, p<0.001).
Croatian: Primarna mjera ishoda nakon 8 dana pokazala je da je dolutegravir u dozi od 50 mg dvaput na dan superioran u odnosu na placebo, uz prilagođenu srednju razliku između liječenja s obzirom na promjenu plazmatske koncentracije HIV-1 RNK od -1,2 log10 kopija/ml u odnosu na početnu vrijednost
English: In paediatric patients the weight-based once daily dose should be administered twice daily.
Croatian: U pedijatrijskih bolesnika dnevna doza temeljena na tjelesnoj težini koja se inače primjenjuje jednom dnevno treba se primijeniti dvaput dnevno.
English: Do not take a calcium supplement, iron supplement or multivitamin during the 6 hours before you take Tivicay, or for at least 2 hours after you take it.
Croatian: Ne smijete uzeti nadomjestak kalcija, nadomjestak željeza niti multivitaminski pripravak unutar 6 sati prije primjene lijeka Tivicay i još najmanje 2 sata nakon njegove primjene.
English: Liver chemistry elevations consistent with immune reconstitution syndrome were observed in some subjects with hepatitis B and/or C co-infection at the start of dolutegravir therapy, particularly in those whose anti-hepatitis B therapy was withdrawn (see section 4.4).
Croatian: Na početku liječenja dolutegravirom, u nekih ispitanika s istodobnom infekcijom hepatitisom B i/ili C primijećene su povišene vrijednosti biokemijskih parametara jetre sukladne sindromu imunološke rekonstitucije, osobito u onih bolesnika u kojih je prekinuto liječenje protiv hepatitisa B (vidjeti dio 4.4).
English: Each 50 mg tablet contains 4 mg sodium.
Croatian: Jedna tableta od 50 mg sadrži 4 mg natrija.
English: Dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% Rilpivirine ↔
Croatian: rilpivirin dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% rilpivirin ↔
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).
Croatian: Nadomjeske kalcija, nadomjeske željeza ili multivitaminske pripravke treba uzimati sa značajnim vremenskim odmakom u odnosu na primjenu dolutegravira (najmanje 2 sata nakon ili 6 sati prije uzimanja dolutegravira).
English: Don't stop taking Tivicay without advice from your doctor Take Tivicay for as long as your doctor recommends.
Croatian: Nemojte prestati uzimati Tivicay bez prethodnog savjetovanja sa svojim liječnikom.
English: In the presence of integrase class resistance alternative combinations that do not include nevirapine should be considered (see section 4.4).
Croatian: U slučaju rezistencije na skupinu inhibitora integraze, treba razmotriti druge kombinacije koje ne uključuju nevirapin (vidjeti dio 4.4).
English: Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Croatian: Ostali antivirotici boceprevir dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% boceprevir ↔ (kontrole iz prethodnih ispitivanja)
English: Virologic suppression (HIV-1 RNA <50 copies/mL) in the dolutegravir group (90%) was superior to the DRV/r group (83%) at 48 weeks.
Croatian: U 48. tjednu je virološka supresija (HIV-1 RNK < 50 kopija/ml) postignuta u skupini liječenoj dolutegravirom (90%) bila superiorna u odnosu na onu postignutu u skupini liječenoj kombinacijom DRV/r (83%).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva često osip često svrbež
English: Dolutegravir did not affect male or female fertility in rats at doses up to 1000 mg/kg/day, the highest dose tested (24 times the 50 mg twice daily human clinical exposure based on AUC).
Croatian: Dolutegravir nije utjecao na plodnost mužjaka niti ženki štakora pri dozama do 1000 mg/kg/dan, što je najveća ispitivana doza (izloženost 24 puta veća od kliničke izloženosti pri primjeni doze od 50 mg dvaput na dan u ljudi, što je utvrđeno na temelju AUC-a).
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).
Croatian: 69% (126/183), u načelu se održala do 48. tjedna u 116/183 (63%) bolesnika koji su imali razinu HIV-1 RNK < 50 kopija/ml (ITT-E, algoritam za globalnu snimku distribuiranog sustava).
English: HIV-1 RNA <50 copies/mL Treatment Difference*
Croatian: HIV-1 RNK < 50 kopija/ml
English: Atazanavir ↔ Ritonavir ↔ (inhibition of UGT1A1 and CYP3A enzymes)
Croatian: atazanavir ↔ ritonavir ↔ (inhibicija enzima UGT1A1 i CYP3A)
English: Primary mutation other than Q148H/K/R2
Croatian: Bez primarne mutacije integraze1 Primarna mutacija osim Q148H/K/R2 Q148 + 1 sekundarna mutacija3
English: Oral administration of dolutegravir to pregnant rabbits at doses up to 1000 mg/kg daily from days 6 to 18 of gestation did not elicit developmental toxicity or teratogenicity (0.40 times the 50 mg twice daily human clinical exposure based on AUC).
Croatian: Peroralna primjena dolutegravira u skotnih ženki kunića u dozama do 1000 mg/kg na dan od 6. do 18. dana gestacije nije uzrokovala razvojnu toksičnost niti teratogenost (izloženost 0,40 puta veća od kliničke izloženosti pri primjeni doze od 50 mg dvaput na dan u ljudi, što je utvrđeno na temelju AUC-a).
English: In the presence of integrase class resistance alternative combinations that do not include efavirenz should be considered (see section 4.4).
Croatian: U slučaju rezistencije na skupinu inhibitora integraze, treba razmotriti druge kombinacije koje ne uključuju efavirenz (vidjeti dio 4.4).
English: In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children and adolescents.
Croatian: U slučaju rezistencije na inhibitore integraze, nema dovoljno podataka za preporuku doze dolutegravira u djece i adolescenata.
English: § 4 subjects were excluded from the efficacy analysis due to data integrity at one study site *The Genotypic Susceptibility Score (GSS) was defined as the total number of ARTs in BR to which a subject's viral isolate showed susceptibility at baseline based upon genotypic resistance tests.
Croatian: *Rezultat za genotipsku osjetljivost (Genotypic Susceptibility Score, GSS) definiran je kao ukupan broj antiretrovirotika u osnovnom režimu liječenja na koje je ispitanikov izolat virusa bio osjetljiv na početku ispitivanja, što je utvrđeno na temelju testova genotipske rezistencije.
English: CD4+ Cell Count
Croatian: CD4+ na početku liječenja
English: Bioavailability of dolutegravir depends on meal content: low, moderate, and high fat meals increased dolutegravir AUC(0-∞) by 33%, 41%, and 66%, increased Cmax by 46%, 52%, and 67%, prolonged Tmax to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively.
Croatian: AUC(0-∞) dolutegravira za 33%, 41% odnosno 66%, Cmax za 46%, 52% odnosno 67% te produljili Tmax na 3, 4 odnosno 5 sati u odnosu na Tmax od 2 sata zabilježen kod primjene lijeka natašte.
English: Dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36% DRV ↔ RTV ↔
Croatian: darunavir/ritonavir + etravirin dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36% DRV ↔ RTV ↔
English: Atazanavir/ritonavir Dolutegravir ↑ AUC ↑ 62%
Croatian: atazanavir /ritonavir dolutegravir ↑ AUC ↑ 62% Cmax ↑ 34% Cτ ↑ 121%
English: The efficacy of dolutegravir in HIV-infected, therapy naïve subjects is based on the analyses of 96-week data from two randomized, international, double-blind, active-controlled trials, SPRING-2 (ING113086) and SINGLE (ING114467).
Croatian: dvostruko slijepim aktivno kontroliranim ispitivanjima SPRING-2 (ING113086) i SINGLE (ING114467).
English: • stomach pain (abdominal pain)
Croatian: • bol u trbuhu (bol u abdomenu)
English: In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in adolescents.
Croatian: U slučaju rezistencije na inhibitore integraze, nema dovoljno podataka za preporuku doze dolutegravira u adolescenata.
English: DTG 50 mg BID N=88* n Mean (SD) Plasma HIV-1 RNA log10 c/mL
Croatian: n Srednja vrijednost (SD) HIV-1 RNK u plazmi log10 kopija/ml
English: • headache
Croatian: • glavobolju
English: Tivicay 25 mg and 50 mg film-coated tablets
Croatian: Tivicay 25 mg i 50 mg filmom obložene tablete
English: INFORMATION IN BRAILLE tivicay 10 mg
Croatian: tivicay 10 mg
English: In GEMINI-1 (204861) and GEMINI-2 (205543), identical 148-week, randomised, double-blind studies, 1433 adult HIV-1 infected antiretroviral naïve subjects were randomised to either a two-drug regimen of dolutegravir 50 mg plus lamivudine 300 mg once daily, or to a three-drug regimen of dolutegravir 50 mg once daily with fixed dose TDF/FTC.
Croatian: U dvama identičnim, 148-tjednim, randomiziranim, dvostruko slijepim ispitivanjima GEMINI-1 (204861) i GEMINI-2 (205543), 1433 odrasla ispitanika s HIV-1 infekcijom i prethodno neliječena antiretroviroticima randomizirana su za primanje dvojnog režima liječenja dolutegravirom u dozi od
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions)
Croatian: nadomjesci željeza dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (stvaranje kompleksa s polivalentnim ionima)
English: Calcium supplements Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions)
Croatian: nadomjesci kalcija dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (stvaranje kompleksa s polivalentnim ionima)
English: Dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
Croatian: lopinavir/ritonavir dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
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 jetre izloženost nevezanom dolutegraviru bila
English: Dolutegravir ↔ Methadone ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1%
Croatian: Analgetici metadon dolutegravir ↔ metadon ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1%
English: In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children.
Croatian: U slučaju rezistencije na inhibitore integraze, nema dovoljno podataka za preporuku doze dolutegravira u djece.
English: Iron oxide yellow (E172) (for 25 mg and 50 mg tablets)
Croatian: Ovojnica tablete poli(vinilni alkohol), djelomično hidroliziran titanijev dioksid (E171) makrogol talk željezov oksid, žuti (E172) (za 25 mg i 50 mg tablete)