FrancophonIA/ELRC3.0 huggingface dataset:
English: In lactating rats that received a single oral dose of 50 mg/kg at 10 days postpartum, dolutegravir was detected in milk at concentrations typically higher than blood.
Croatian: U štakorica u laktaciji koje su primile jednu peroralnu dozu od 50 mg/kg 10 dana postpartalno, dolutegravir je pronađen u mlijeku u koncentracijama koje su obično bile veće od onih u krvi.
English: In Phase I studies in healthy subjects, between-subject CVb% for AUC and Cmax ranged from ~20 to 40% and Cτ from 30 to 65% across studies.
Croatian: U ispitivanjima faze I u zdravih ispitanika, interindividualna vrijednost CVb% za AUC i Cmax kretala se u rasponu od ~20 do 40%, a za Cτ od 30 do 65% u svim ispitivanjima.
English: Based on this data, dolutegravir is not expected to affect the pharmacokinetics of medicinal products that are substrates of major enzymes or transporters (see section 4.5).
Croatian: Na temelju ovih podataka, ne očekuje se da će dolutegravir utjecati na farmakokinetiku lijekova koji su supstrati za glavne enzime ili prijenosnike (vidjeti dio 4.5).
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Croatian: Prijavljeni su i autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa); međutim, prijavljeno vrijeme do njihove pojave je različito pa se ti događaji mogu javiti i mjesecima nakon uvođenja liječenja (vidjeti dio 4.4).
English: Metformin is eliminated renally and, therefore, it is of importance to monitor renal function when co-treated with dolutegravir.
Croatian: Metformin se izlučuje putem bubrega, stoga je važno nadzirati bubrežnu funkciju kada se istodobno primjenjuje s dolutegravirom.
English: In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
Croatian: In vivo dolutegravir nije imao učinak na midazolam, probni supstrat za CYP3A4.
English: The effect of severe hepatic impairment on the pharmacokinetics of Tivicay has not been studied.
Croatian: Utjecaj teškog oštećenja jetrene funkcije na farmakokinetiku lijeka Tivicay nije ispitivan.
English: The proportion of subjects with HIV RNA <50 copies/mL was 96/126 (76%) for No Q148 mutations, 22/41 (54%) for Q148+1 and 5/19 (26%) for Q148+≥2 secondary mutations.
Croatian: Udio ispitanika s HIV RNK <50 kopija/ml bio je 96/126 (76%) za ispitanike bez Q148 mutacije, 22/41 (54%) za Q148+1 i 5/19 (26%) za Q148+≥2 sekundarne mutacije.
English: The response was lower when the Q148-mutation was present at baseline, and in particular in the presence of ≥2 secondary mutations, Table 8.
Croatian: Odgovor je bio niži kada je mutacija Q148 bila prisutna na početku ispitivanja, osobito ako su uz nju bile prisutne i ≥ 2 sekundarne mutacije; Tablica 8.
English: AUC in semen was 7% and 17% in rectal tissue of those in corresponding plasma at steady state.
Croatian: AUC je u sjemenu iznosio 7%, a u rektalnome tkivu 17% odgovarajuće vrijednosti u plazmi u stanju dinamičke ravnoteže.
English: Thirty-two percent of the total oral dose is excreted in the urine, represented by ether glucuronide of dolutegravir (18.9% of total dose), N-dealkylation metabolite (3.6% of total dose), and a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose).
Croatian: Trideset i dva posto ukupne peroralne doze izlučuje se u mokraću u obliku eter-glukuronida dolutegravira (18,9% ukupne doze), metabolita dobivenog N-dealkilacijom (3,6% ukupne doze) i metabolita koji nastaje oksidacijom na benzilnom atomu ugljika (3,0% ukupne doze).
English: In a combined analysis of VIKING-3 and VIKING-4 (n=186, VO population), the proportion of subjects with HIV RNA <50 copies/mL at Week 48 was 123/186 (66%).
Croatian: U združenoj analizi ispitivanja VIKING-3 i VIKING-4 (n=186, populacija s virološkim ishodom (VO)), udio ispitanika s HIV RNK <50 kopija/ml u 48. tjednu bio je 123/186 (66%).
English: G118R lowers the susceptibility to dolutegravir in site directed mutants (FC 10), but was not detected in patients receiving dolutegravir in the Phase III program.
Croatian: Mutacija G118R smanjuje osjetljivost izolata s ciljanom mutagenezom (engl. site directed mutants) na dolutegravir (FC 10), ali nije pronađena u bolesnika koji su primali dolutegravir u programu ispitivanja faze III.
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).
Croatian: U ispitivanju SINGLE, medijan vremena do virusne supresije bio je kraći u bolesnika liječenih dolutegravirom (28 naspram 84 dana [p<0,0001; analiza je bila unaprijed određena i prilagođena za multiplicitet]).
English: 20 to less than 30
Croatian: 20 do manje od 30
English: The pharmacokinetics of dolutegravir following single dose oral administration to Japanese subjects appear similar to observed parameters in Western (US) subjects.
Croatian: Farmakokinetika dolutegravira nakon peroralne primjene jedne doze u ispitanika japanskoga podrijetla čini se sličnom parametrima primijećenima u ispitanika sa zapada (SAD).
English: In serial passage with strain NL432, starting with site directed mutants harbouring N155H or E92Q, no further selection of resistance was seen (FC unchanged around 1).
Croatian: U serijskoj pasaži sa sojem NL432, koja je započela s izolatima s ciljanom mutagenezom i mutacijom N155H ili E92Q, nije primijećena daljnja selekcija rezistencije (FC od približno 1 ostao je nepromijenjen).
English: In the presence of integrase class resistance, Tivicay should preferably be taken with food to enhance exposure (particularly in patients with Q148 mutations) (see section 5.2).
Croatian: U slučaju rezistencije na skupinu inhibitora integraze, Tivicay je poželjno uzimati s hranom radi pospješivanja izloženosti (osobito u bolesnika s mutacijama Q148) (vidjeti dio 5.2).
English: No dose adjustment of oral contraceptives is necessary when co-administered with dolutegravir.
Croatian: Nije potrebno prilagođavati dozu oralnih kontraceptiva pri njihovoj istodobnoj primjeni s dolutegravirom.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, biphosphonates, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported in patients with advanced HIV-disease and/or long-term exposure to CART.
Croatian: Iako se smatra da postoji više uzroka (uključujući primjenu kortikosteroida, bifosfonate, konzumiranje alkohola, jaku imunosupresiju, viši indeks tjelesne mase), slučajevi osteonekroze prijavljeni su u bolesnika s uznapredovalom HIV bolešću i/ili u bolesnika dugotrajno izloženih kombiniranoj antiretrovirusnoj terapiji.
English: Common Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) elevations Common Creatine phosphokinase (CPK) elevations
Croatian: Pretrage često povišene vrijednosti alanin aminotransferaze (ALT) i/ili aspartat aminotransferaze (AST)
English: The exposure to dolutegravir was decreased by approximately 40% in subjects with severe renal impairment.
Croatian: Izloženost dolutegraviru smanjila se za približno 40% u ispitanika s teškim oštećenjem bubrežne funkcije.
English: • difficulty breathing In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
Croatian: Kako postaje snažniji, imunološki sustav u rijetkim slučajevima može napadati i zdravo tkivo u tijelu (autoimuni poremećaji).
English: There are limited data available on the use of dolutegravir in patients aged 65 years and over.
Croatian: Malobrojni su podaci o primjeni dolutegravira u bolesnika u dobi od 65 ili više godina.
English: Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.
Croatian: Dolutegravir se nakon peroralne primjene brzo apsorbira, pri čemu se medijan Tmax postiže 2 do 3 sata nakon primjene doze u obliku tablete.
English: The bottle contains a desiccant to reduce moisture.
Croatian: Boca sadrži sredstvo za sušenje koje smanjuje količinu vlage.
English: Overall, the safety profile in patients co-infected with hepatitis B and/or C was similar to that observed in patients without hepatitis B or C co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or C co-infection for all treatment groups.
Croatian: Sveukupno je sigurnosni profil u bolesnika s istodobnom infekcijom hepatitisom B i/ili C bio sličan onomu primijećenom u bolesnika koji nisu imali istodobnu infekciju hepatitisom B ili C, premda su u svim liječenim skupinama stope odstupanja u vrijednostima AST-a i ALT-a bile nešto više u podskupini bolesnika s istodobnom infekcijom hepatitisom B i/ili C.
English: It should not be taken as five 10 mg tablets.
Croatian: Ne smije se primijeniti kao pet tableta od 10 mg.
English: EXPIRY DATE EXP {MM/YYYY}
Croatian: EXP {MM/GGGG}
English: There is currently limited experience with overdosage in dolutegravir.
Croatian: Trenutno iskustvo s predoziranjem dolutegravirom je ograničeno.
English: • St. John's wort (Hypericum perforatum), a herbal remedy to treat depression
Croatian: • gospinu travu (Hypericum perforatum), biljni lijek za liječenje depresije.
English: • If you are taking certain other medicines, the dose is one 50 mg tablet twice a day.
Croatian: • Ako uzimate i neke druge lijekove, doza je jedna tableta od 50 mg dvaput na dan.
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).
Croatian: U meta-analizi farmakogenomskih uzoraka prikupljenih u kliničkim ispitivanjima u zdravih dobrovoljaca, ispitanici s UGT1A1 (n=7) genotipovima i slabim metabolizmom dolutegravira imali su 32% niži klirens dolutegravira i 46% viši AUC u usporedbi s ispitanicima s genotipovima povezanima s normalnim metabolizmom putem UGT1A1 (n=41).
English: The decision to use dolutegravir for such patients should be informed by the integrase resistance pattern (see section 5.1).
Croatian: Odluku o primjeni dolutegravira u tih bolesnika treba temeljiti po uzorku rezistencije integraze (vidjeti dio 5.1).
English: Warnings and precautions Look out for important symptoms
Croatian: Pripazite na važne simptome
English: PK/PD modelling using pooled data from clinical studies in integrase resistant patients suggest that increasing the dose from 50 mg twice daily to 100 mg twice daily may increase the effectiveness of dolutegravir in patients with integrase resistance and limited treatment options due to advanced multi class resistance.
Croatian: Farmakokinetičko/farmakodinamičko modeliranje, koje koristi združene podatke iz kliničkih ispitivanja u bolesnika rezistentnih na inhibitore integraze, sugerira da povišenje doze s 50 mg dvaput na dan na 100 mg dvaput na dan može povećati učinkovitost dolutegravira u bolesnika s rezistencijom na inhibitore integraze i ograničenim mogućnostima liječenja zbog uznapredovale rezistencije na više skupina lijekova.
English: The between-subject PK variability of dolutegravir was higher in HIV-infected subjects than healthy subjects.
Croatian: Interindividualna farmakokinetička varijabilnost dolutegravira bila je veća u ispitanika s HIV infekcijom nego u zdravih ispitanika.
English: Some medicines can affect how Tivicay works, or make it more likely that you will have side effects.
Croatian: Neki lijekovi mogu utjecati na način djelovanja lijeka Tivicay ili povećati vjerojatnost pojave nuspojava.
English: • The usual dose is one 50 mg tablet once a day.
Croatian: • Uobičajena doza je jedna tableta od 50 mg jedanput na dan.
English: Q148+1 secondary mutationb
Croatian: Q148+1 sekundarna mutacijab
English: When mutations listed as secondary integrase inhibitor associated mutations (for raltegravir/elvitegravir) are added to these primary mutations in experiments with site directed mutants, dolutegravir susceptibility is still unchanged (FC <2 vs wild type virus), except in the case of Q148-mutations, where a FC of 5-10 or higher is seen with combinations of certain secondary mutations.
Croatian: Kada se u pokusima na izolatima s ciljanom mutagenezom primarnim mutacijama dodaju mutacije navedene kao sekundarne mutacije povezane s inhibitorima integraze (raltegravirom/elvitegravirom), osjetljivost na dolutegravir ostaje nepromijenjena (FC < 2 u odnosu na virus divljeg tipa), osim u slučaju mutacija Q148, gdje je u kombinacijama s određenim sekundarnim mutacijama zabilježen FC od 5-10 ili više.
English: In the presence of documented resistance that includes Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I, modelling suggests that an increased dose may be considered for patients with limited treatment options (less than 2 active agents) due to advanced multi class resistance (see section 5.2).
Croatian: U slučaju dokumentirane rezistencije koja uključuje Q148 + ≥2 sekundarne mutacije G140A/C/S, E138A/K/T, L74I, modeliranje upućuje da se može razmotriti povišenje doze u bolesnika s ograničenim mogućnostima liječenja (manje od 2 aktivna lijeka) zbog uznapredovale rezistencije na više skupina lijekova (vidjeti dio 5.2).
English: - The other ingredients are mannitol (E421), microcrystalline cellulose, povidone (K29/32), sodium starch glycolate, sodium stearyl fumarate, polyvinyl alcohol-partially hydrolyzed, titanium dioxide (E171), macrogol, talc and for 25 and 50 mg tablets, iron oxide yellow (E172).
Croatian: Drugi sastojci su manitol (E421), mikrokristalična celuloza, povidon (K29/32), natrijev škroboglikolat, natrijev stearilfumarat, djelomično hidroliziran poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk i za 25 mg i 50 mg tablete, žuti željezov oksid (E172).
English: Co-administration of dolutegravir and other medicinal products that inhibit these enzymes may increase dolutegravir plasma concentration (see Table 2).
Croatian: Istodobna primjena dolutegravira i drugih lijekova koji inhibiraju spomenute enzime može povećati koncentracije dolutegravira u plazmi (vidjeti Tablicu 2).
English: Dolutegravir and dofetilide co-administration is contraindicated due to potential life-threatening toxicity caused by high dofetilide concentration (see section 4.3).
Croatian: Istodobna primjena dolutegravira i dofetilida je kontraindicirana zbog moguće po život opasne toksičnosti uzrokovane visokom koncentracijom dofetilida (vidjeti dio 4.3).
English: The most severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4).
Croatian: Sažetak sigurnosnog profila Najteža nuspojava, primijećena u samo jednog bolesnika, bila je reakcija preosjetljivosti, koja je uključivala osip i teške jetrene nuspojave (vidjeti dio 4.4).
English: 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: NRTI, 75% ≥1 NNRTI, and 71% ≥2 PI major mutations; 62% had non-R5 virus.
Croatian: je imalo ≥2 NRTI, 73% ≥1 NNRTI, i 67% ≥2 IP značajne mutacije; 83% imalo je virus koji nije bio R5.
English: Tivicay contains the active ingredient dolutegravir.
Croatian: Tivicay sadrži djelatnu tvar dolutegravir.
English: Sixteen of 30 subjects (53%) harboured Q148 virus at baseline.
Croatian: Šesnaest od 30 ispitanika (53%) imalo je virus s mutacijom Q148 na početku ispitivanja.
English: Q148 +≥2 secondary mutations 3
Croatian: Q148 + ≥ 2 sekundarne mutacije3
English: Etravirine without boosted protease inhibitors decreased plasma dolutegravir concentration.
Croatian: Etravirin bez pojačanih inhibitora proteaze smanjuje koncentraciju dolutegravira u plazmi.
English: HIV-1 RNA <50 copies/mL at 24 weeks, n (%) HIV-1 RNA <50 copies/mL at 48 weeks, n (%) HIV-1 RNA <400 copies/mL at 24 weeks, n (%) HIV-1 RNA <400 copies/mL at 48 weeks, n (%) Virologic non response
Croatian: HIV-1 RNK < 50 kopija/ml u 24. tjednu, n (%) HIV-1 RNK < 50 kopija/ml u 48. tjednu, n (%) HIV-1 RNK < 400 kopija/ml u 24. tjednu, n (%) HIV-1 RNK < 400 kopija/ml u 48. tjednu, n (%) Izostanak virološkog odgovora Broj CD4 + stanica
English: Although these simulated results have not been confirmed in clinical trials, this high dose may be considered in the presence of the Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I in patients with overall limited treatment options due to advanced multi class resistance.
Croatian: Iako ovi simulirani rezultati nisu potvrđeni u kliničkim ispitivanjima, ova viša doza može se razmotriti u prisustvu Q148 + ≥2 sekundarne mutacije: G140A/C/S, E138A/K/T, L74I u bolesnika sa sveukupno ograničenim terapijskim mogućnostima zbog uznapredovale rezistencije na više skupina lijekova.
English: In patients with moderate renal impairment a dose adjustment of metformin should be considered when coadministered with dolutegravir, because of the increased risk for lactic acidosis in patients with moderate renal impairment due to increased metformin concentration (section 4.4).
Croatian: U bolesnika s umjerenim oštećenjem bubrežne funkcije mora se razmotriti prilagodba doze metformina kad se istodobno primjenjuje s dolutegravirom, zbog povišenog rizika pojave laktacidoze u bolesnika s umjerenim oštećenjem bubrežne funkcije uslijed povišene koncentracije metformina (vidjeti dio 4.4).
English: These mutations were not selected in patients treated with dolutegravir in the clinical studies.
Croatian: Spomenute mutacije nisu izdvojene u bolesnika koji su u kliničkim ispitivanjima primali dolutegravir.
English: No dose adjustment is necessary.
Croatian: Nije potrebno prilagođavati dozu.
English: In patients without a primary mutation detected at baseline (N=60) (i.e. RAL/EVG not part of current failing therapy) there was a 1.63 log10 reduction in viral load at day 8.
Croatian: U bolesnika u kojih na početku ispitivanja nije pronađena primarna mutacija (N=60) (tj. RAL/EVG nije bio dio trenutne neuspješne terapije) zabilježeno je smanjenje virusnog opterećenja za 1,63 log10
English: Week 48 outcomes (including outcomes by key baseline covariates) for SAILING are shown in Table 6.
Croatian: Ishodi nakon 48 tjedana (uključujući ishode prema ključnim kovarijatama s početka ispitivanja) za ispitivanje SAILING prikazani su u Tablici 6.
English: 25 mg once daily
Croatian: 25 mg jedanput na dan
English: The VIKING-4 study examined dolutegravir (plus optimized background therapy) in subjects with primary genotypic resistance to INIs at Screening in 30 subjects.
Croatian: U ispitivanju VIKING-4 istraživao se dolutegravir (uz optimiziranu osnovnu terapiju) u ispitanika s primarnom genotipskom rezistencijom na inhibitore integraze (INI) kod probira u 30 ispitanika.
English: The effect by the Q148-mutations (H/R/K) was also verified in passage experiments with site directed mutants.
Croatian: Q148 (H/R/K) potvrđen je i u pokusima pasaže na izolatima s ciljanom mutagenezom.
English: Table 1 Paediatric dose recommendations Body weight (kg)
Croatian: Tablica 1 Preporuke za doziranje u pedijatrijskoj populaciji Tjelesna težina (kg)
English: Animal studies indicate no effects of dolutegravir on male or female fertility (see section 5.3).
Croatian: Istraživanja na životinjama nisu pokazala da dolutegravir utječe na plodnost mužjaka ili ženki (vidjeti dio 5.3).
English: A study of the pharmacokinetics of dolutegravir was performed in subjects with severe renal impairment (CLcr <30 mL/min) and matched healthy controls.
Croatian: Ispitivanje farmakokinetike dolutegravira provedeno je u ispitanika s teškim oštećenjem bubrežne funkcije (CLcr < 30 ml/min), a rezultati su bili u skladu s rezultatima zdravih kontrolnih ispitanika.
English: A single dose of 50 mg of dolutegravir was administered to 8 subjects with moderate hepatic impairment (Child-Pugh class B) and to 8 matched healthy adult controls.
Croatian: Jedna doza dolutegravira od 50 mg primijenjena je u 8 ispitanika s umjerenim oštećenjem jetrene funkcije (Child-Pugh stadij B) te u 8 kontrolnih zdravih odraslih ispitanika.
English: No dosage adjustment is required in patients with mild, moderate or severe (CrCl <30 mL/min, not on dialysis) renal impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim, umjerenim ili teškim (CrCl < 30 ml/min, bolesnik nije na dijalizi) oštećenjem bubrežne funkcije.
English: The 50 mg dose should be taken as a single 50 mg tablet.
Croatian: Dozu od 50 mg potrebno je primijeniti kao jednu tabletu od 50 mg.
English: In vitro, dolutegravir was not a substrate of human OATP 1B1, OATP 1B3 or OCT 1.
Croatian: In vitro, dolutegravir nije bio supstrat ljudskih prijenosnika OATP 1B1, OATP 1B3 ili OCT 1. Eliminacija
English: Based on the lack of effect on the in vivo pharmacokinetics of the OAT substrate tenofovir, in vivo inhibition of OAT1 is unlikely.
Croatian: Budući da dolutegravir ne utječe in vivo na farmakokinetiku tenofovira, supstrata za OAT prijenosnike, nije vjerojatna inhibicija OAT1 in vivo.
English: The safety and efficacy of dolutegravir in children aged less than 6 years or weighing less than 15 kg have not yet been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost dolutegravira u djece mlađe od 6 godina ili tjelesne težine manje od 15 kg nisu još ustanovljene.
English: Dolutegravir is present in cerebrospinal fluid (CSF).
Croatian: Dolutegravir je pronađen u cerebrospinalnoj tekućini.
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 niti klastogen u in vitro testovima provedenima na bakterijskim stanicama i kultiviranim stanicama sisavaca niti u in vivo mikronukleusnom testu provedenom na glodavcima.
English: The primary endpoint and other week 48 outcomes (including outcomes by key baseline covariates) for SPRING-2 and SINGLE are shown in Table 4.
Croatian: Primarna mjera ishoda i ostali ishodi nakon 48 tjedana (uključujući ishode prema ključnim kovarijatama s početka ispitivanja) za ispitivanja SPRING-2 i SINGLE prikazani su u Tablici 4.
English: In SPRING-2, dolutegravir was still noninferior to raltegravir (viral suppression in 81% vs 76% of patients), and with a median change in CD4 count of 276 vs 264 cells/mm3, respectively.
Croatian: U ispitivanju SPRING-2, dolutegravir je i dalje bio neinferioran u odnosu na raltegravir (virusna supresija postignuta je u 81% naspram 76% bolesnika), uz medijan promjene broja CD4 stanica od 276 stanica/mm3 (dolutegravir) naspram 264 stanica/mm3 (raltegravir).
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Tivicay Lijek čuvajte izvan pogleda i dohvata djece.
English: AUC in cervicovaginal fluid, cervical tissue and vaginal tissue were 6-10% of those in corresponding plasma at steady state.
Croatian: cervikalnom tkivu i vaginalnom tkivu iznosio je 6-10% odgovarajuće vrijednosti u plazmi u stanju dinamičke ravnoteže.
English: Magnesium/ aluminium-containing antacid should be taken well separated in time from the administration of dolutegravir (minimum 2 hours after or 6 hours before).
Croatian: Antacid koji sadrži magnezij/aluminij treba uzeti sa značajnim vremenskim odmakom u odnosu na primjenu dolutegravira (najmanje 2 sata nakon ili 6 sati prije uzimanja dolutegravira).
English: The adverse reactions considered at least possibly related to dolutegravir are listed by body system, organ class and absolute frequency.
Croatian: Nuspojave za koje se smatra da bi mogle biti povezane s liječenjem dolutegravirom navedene su prema organskim sustavima i apsolutnoj učestalosti.