natgillin/translations-raw huggingface dataset:
Each 25 mg tablet contains 2 mg sodium. 
Jedna tableta od 25 mg sadrži 2 mg natrija.
The adjusted difference in proportion and 95% CI were 7.1% (0.9, 13.2), p=0.025. 
Prilagođena razlika u udjelu uz 95% CI iznosila je 7,1% (0,9; 13,2),
In a juvenile toxicity study in rats, dolutegravir administration resulted in two preweanling deaths at 75 mg/kg/day. 
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.
Dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28% LPV ↔ RTV ↔ 
lopinavir/ritonavir + etravirin dolutegravir ↔ AUC ↑ 11% Cmax ↑ 7% Cτ ↑ 28% LPV ↔ RTV ↔
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. 
Y143R/H/C, E92Q i T66I) ne utječu na osjetljivost na dolutegravir in vitro.
It is unknown whether dolutegravir is excreted in human milk. 
Nije poznato izlučuje li se dolutegravir u majčino mlijeko u ljudi.
Alternative combinations that do not include these metabolic inducers should be used where possible in INIresistant patients. 
Kad je to moguće, potrebno je primijeniti zamjenske kombinacije koje ne uključuju navedene metaboličke induktore u bolesnika rezistentnih na inhibitore integraze.
Each tablet contains dolutegravir sodium equivalent to 10 mg, 25 mg or 50 mg dolutegravir. 
Jedna tableta sadrži 10 mg, 25 mg ili 50 mg dolutegravira u obliku dolutegravirnatrija.
Tivicay can make you dizzy and have other side effects that make you less alert. 
Tivicay može uzrokovati omaglicu i druge nuspojave koje mogu utjecati na Vašu sposobnost reagiranja.
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. 
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.
Seven hundred and five raltegravir resistant isolates from raltegravir experienced patients were analyzed for susceptibility to dolutegravir. 
Osjetljivost na dolutegravir analizirana je u 705 izolata rezistentnih na raltegravir prikupljenih u bolesnika koji su prethodno primali raltegravir.
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%. 
Prilagođena razlika iznosila je -2,6% (95% CI: -6,7; 1,5) za GEMINI-1 i -0,7% (95%
5 years 
nakon 8 dana.
Dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75% 
efavirenz dolutegravir ↓ AUC ↓ 57% Cmax ↓ 39% Cτ ↓ 75%
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. 
< 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.
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. 
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.
Dolutegravir 50 mg Once Daily + 2 NRTI N=411 
Dolutegravir 50 mg jedanput na dan + 2 NRTI N=411
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). 
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
In paediatric patients the weight-based once daily dose should be administered twice daily. 
U pedijatrijskih bolesnika dnevna doza temeljena na tjelesnoj težini koja se inače primjenjuje jednom dnevno treba se primijeniti dvaput dnevno.
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. 
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.
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). 
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).
Each 50 mg tablet contains 4 mg sodium. 
Jedna tableta od 50 mg sadrži 4 mg natrija.
Dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% Rilpivirine ↔ 
rilpivirin dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% rilpivirin ↔
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). 
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).
Don't stop taking Tivicay without advice from your doctor Take Tivicay for as long as your doctor recommends. 
Nemojte prestati uzimati Tivicay bez prethodnog savjetovanja sa svojim liječnikom.
In the presence of integrase class resistance alternative combinations that do not include nevirapine should be considered (see section 4.4). 
U slučaju rezistencije na skupinu inhibitora integraze, treba razmotriti druge kombinacije koje ne uključuju nevirapin (vidjeti dio 4.4).
Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls) 
Ostali antivirotici boceprevir dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% boceprevir ↔ (kontrole iz prethodnih ispitivanja)
Virologic suppression (HIV-1 RNA <50 copies/mL) in the dolutegravir group (90%) was superior to the DRV/r group (83%) at 48 weeks. 
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%).
Skin and subcutaneous tissue disorders 
Poremećaji kože i potkožnog tkiva često osip često svrbež
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). 
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).
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). 
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).
HIV-1 RNA <50 copies/mL Treatment Difference* 
HIV-1 RNK < 50 kopija/ml
Atazanavir ↔ Ritonavir ↔ (inhibition of UGT1A1 and CYP3A enzymes) 
atazanavir ↔ ritonavir ↔ (inhibicija enzima UGT1A1 i CYP3A)
Primary mutation other than Q148H/K/R2 
Bez primarne mutacije integraze1 Primarna mutacija osim Q148H/K/R2 Q148 + 1 sekundarna mutacija3
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). 
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).
In the presence of integrase class resistance alternative combinations that do not include efavirenz should be considered (see section 4.4). 
U slučaju rezistencije na skupinu inhibitora integraze, treba razmotriti druge kombinacije koje ne uključuju efavirenz (vidjeti dio 4.4).
In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children and adolescents. 
U slučaju rezistencije na inhibitore integraze, nema dovoljno podataka za preporuku doze dolutegravira u djece i adolescenata.
§ 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. 
*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.
CD4+ Cell Count 
CD4+ na početku liječenja
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. 
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.
Dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36% DRV ↔ RTV ↔ 
darunavir/ritonavir + etravirin dolutegravir ↓ AUC ↓ 25% Cmax ↓ 12% Cτ ↓ 36% DRV ↔ RTV ↔
Atazanavir/ritonavir Dolutegravir ↑ AUC ↑ 62% 
atazanavir /ritonavir dolutegravir ↑ AUC ↑ 62% Cmax ↑ 34% Cτ ↑ 121%
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). 
dvostruko slijepim aktivno kontroliranim ispitivanjima SPRING-2 (ING113086) i SINGLE (ING114467).
• stomach pain (abdominal pain) 
• bol u trbuhu (bol u abdomenu)
In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in adolescents. 
U slučaju rezistencije na inhibitore integraze, nema dovoljno podataka za preporuku doze dolutegravira u adolescenata.
DTG 50 mg BID N=88* n Mean (SD) Plasma HIV-1 RNA log10 c/mL 
n Srednja vrijednost (SD) HIV-1 RNK u plazmi log10 kopija/ml
• headache 
• glavobolju
Tivicay 25 mg and 50 mg film-coated tablets 
Tivicay 25 mg i 50 mg filmom obložene tablete
INFORMATION IN BRAILLE tivicay 10 mg 
tivicay 10 mg
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. 
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
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (Complex binding to polyvalent ions) 
nadomjesci željeza dolutegravir ↓ AUC ↓ 54% Cmax ↓ 57% C24 ↓ 56% (stvaranje kompleksa s polivalentnim ionima)
Calcium supplements Dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (Complex binding to polyvalent ions) 
nadomjesci kalcija dolutegravir ↓ AUC ↓ 39% Cmax ↓ 37% C24 ↓ 39% (stvaranje kompleksa s polivalentnim ionima)
Dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6% 
lopinavir/ritonavir dolutegravir ↔ AUC ↓ 4% Cmax ↔ 0% C24 ↓ 6%
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. 
Iako je ukupna koncentracija dolutegravira u plazmi bila podjednaka, u ispitanika s umjerenim oštećenjem jetre izloženost nevezanom dolutegraviru bila
Dolutegravir ↔ Methadone ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1% 
Analgetici metadon dolutegravir ↔ metadon ↔ AUC ↓ 2% Cmax ↔ 0% Cτ ↓ 1%
In the presence of integrase inhibitor resistance, there are insufficient data to recommend a dose for dolutegravir in children. 
U slučaju rezistencije na inhibitore integraze, nema dovoljno podataka za preporuku doze dolutegravira u djece.
Iron oxide yellow (E172) (for 25 mg and 50 mg tablets) 
Ovojnica tablete poli(vinilni alkohol), djelomično hidroliziran titanijev dioksid (E171) makrogol talk željezov oksid, žuti (E172) (za 25 mg i 50 mg tablete)
Monitoring of liver biochemistries is recommended in patients with hepatitis B and/or C co-infection. 
U bolesnika s istodobnom infekcijom hepatitisom B i/ili C preporučuje se praćenje biokemijskih parametara jetre.
Patients with prior treatment failure that included an integrase inhibitor (and integrase class resistance) In the multicentre, open-label, single arm VIKING-3 study (ING112574), HIV-1 infected, ART-experienced adults with virological failure and current or historical evidence of raltegravir and/or elvitegravir resistance received Tivicay 50 mg twice daily with the current failing background regimen for 7 days but with optimised background ART from Day 8. 
U multicentričnom, otvorenom ispitivanju VIKING-3 (ING112574) s jednom skupinom, odrasli bolesnici s HIV-1 infekcijom koji su prethodno liječeni antiretroviroticima i imali virološki neuspjeh i dokaze trenutno ili ranije postojeće rezistencije na raltegravir i/ili elvitegravir, primali su Tivicay u dozi od 50 mg dvaput na dan, prvih 7 dana u kombinaciji s trenutnim neuspješnim osnovnim režimom liječenja, a od 8. dana nadalje s optimiziranom osnovnom antiretrovirusnom terapijom.
Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of race on the exposure of dolutegravir. 
Populacijska farmakokinetička analiza objedinjenih podataka iz ispitivanja faze IIb i faze III u odraslih bolesnika nije ukazala na klinički značajan učinak rase na izloženost dolutegraviru.
In FLAMINGO (ING114915), an open-label, randomised and active-controlled study, 484 HIV-1 infected antiretroviral naïve adults received one dose of either dolutegravir 50 mg once daily (n=242) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (n=242), both administered with either ABC/3TC or TDF/FTC. 
odrasle osobe s HIV-1 infekcijom koje prethodno nisu bile liječene antiretrovirusnim lijekovima primile su jednu dozu dolutegravira od 50 mg jedanput na dan (n=242) ili darunavir/ritonavir (DVR/r) u dozi od 800 mg/100 mg jedanput na dan (n=242); oba su se režima primjenjivala uz ABC/3TC ili
Population PK analyses using pooled pharmacokinetic data from Phase IIb and Phase III adult trials revealed no clinically relevant effect of gender on the exposure of dolutegravir. 
Populacijska farmakokinetička analiza objedinjenih podataka iz ispitivanja faze IIb i faze III u odraslih bolesnika nije ukazala na klinički značajan učinak spola na izloženost dolutegraviru.
† Includes subjects who changed BR to new class or changed BR not permitted per protocol or due to lack of efficacy prior to Week 48 (for SPRING-2 only), subjects who discontinued prior to Week 48 for lack or loss of efficacy and subjects who are ≥50 copies in the 48 week window. 
† Uključuje ispitanike koji su prije 48. tjedna prešli s osnovnog režima liječenja na novu skupinu lijekova ili su promijenili osnovni režim liječenja jer nije bio dopušten prema protokolu ili nije bio dovoljno djelotvoran (samo u ispitivanju SPRING-2), ispitanike koji su prekinuli liječenje prije
The clinical status of the patient and the adverse reaction profile of dolutegravir should be borne in mind when considering the patient's ability to drive or operate machinery. 
Kada se razmatra bolesnikova sposobnost upravljanja vozilima ili rada sa strojevima, treba imati na umu kliničko stanje bolesnika i profil nuspojava dolutegravira.
Do not remove the desiccant. 
Ne uklanjati sredstvo za sušenje.
Median baseline CD4+ was 140 cells/mm3, median duration of prior ART was 14 years, and 56% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 79% had ≥2 
Medijan vrijednosti CD4+ stanica na početku ispitivanja iznosio je 140 stanica/mm3, medijan trajanja prethodne antiretrovirusne terapije iznosio je 14 godina, a 56% bolesnika imalo je HIV infekciju kategorije C prema CDC klasifikaciji.
HIV-1 RNA <50 copies/mL by baseline covariates 
HIV-1 RNK < 50 kopija/ml prema početnim kovarijatama
The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 21 and 0.82 times the 50 mg twice daily human clinical exposure based on AUC, respectively. 
Primarni učinak dolutegravira bile su gastrointestinalna nepodnošljivost ili iritacija u štakora odnosno majmuna pri dozama koje su izazvale sistemsku izloženost približno 21 odnosno
In vitro, dolutegravir did not induce CYP1A2, CYP2B6 or CYP3A4. 
In vitro dolutegravir nije inducirao CYP1A2,
Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets dolutegravir 
Tivicay 10 mg filmom obložene tablete Tivicay 25 mg filmom obložene tablete Tivicay 50 mg filmom obložene tablete
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with these metabolic inducers. 
Preporučena doza dolutegravira u odraslih je 50 mg dvaput na dan kad se istodobno primjenjuje s navedenim metaboličkim induktorima.
≤100,000 cps/mL 
≤ 50 000 kopija/ml > 50 000 kopija/ml
Tivicay is one 50 mg tablet, twice a day. 
Preporučena doza dolutegravira je 50 mg (jedna tableta) dvaput na dan.
Dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (Complex binding to polyvalent ions) 
multivitaminski pripravci dolutegravir ↓ AUC ↓ 33% Cmax ↓ 35% C24 ↓ 32% (stvaranje kompleksa s polivalentnim ionima)
At baseline, median patient age was 49 years, 20% were female, 58% non-white, and 23% had hepatitis B and/or C co-infection. 
Na početku liječenja, medijan dobi bolesnika iznosio je 49 godina, 20% ispitanika bile su žene, 58% ispitanika nisu bili bijelci, i 23% je istodobno imalo infekciju hepatitisom B i/ili C.
No dose adjustment is necessary of either agent. 
Nije potrebno prilagođavati dozu niti jednoga od ovih dvaju lijekova.
→ Talk to your doctor for further advice on taking calcium supplements, iron supplements or multivitamins with Tivicay. 
Za dodatne savjete o uzimanju nadomjestaka kalcija, nadomjestaka željeza ili multivitaminskih pripravaka zajedno s lijekom Tivicay, razgovarajte sa svojim liječnikom.
The study enrolled 183 patients, 133 with INI-resistance at Screening and 50 with only historical evidence of resistance (and not at Screening). 
U ispitivanje je uključeno 183 bolesnika, od kojih je pri probiru njih 133 imalo rezistenciju na inhibitore integraze,
The apparent oral clearance (CL/F) is approximately 1L/hr in HIV-infected patients based on a population pharmacokinetic analysis. 
Na temelju populacijske farmakokinetičke analize, prividni klirens nakon peroralne primjene (CL/F) u bolesnika s HIV infekcijom iznosi približno 1 l/h.
In SINGLE, dolutegravir + ABC/3TC was still superior to EFV/TDF/FTC (viral suppression in 80% vs 72%, treatment difference 8.0% (2.3, 13.8), p=0.006, and with an adjusted mean change in CD4 count of 325 vs 281 cells/ mm3, respectively. 
U ispitivanju SINGLE, kombinacija dolutegravir + ABC/3TC i dalje je bila superiorna u odnosu na EFV/TDF/FTC (virusna supresija postignuta je u 80% naspram 72% bolesnika), uz razliku između liječenja od 8,0% (2,3; 13,8),
Interaction Geometric mean change 
Promjena geometrijske srednje vrijednosti (%)
INFORMATION IN BRAILLE tivicay 50 mg 
tivicay 50 mg
At baseline, median patient age was 48 years, 23% were female, 29% non-white, and 20% had hepatitis B and/or C co-infection. 
Na početku je ispitivanja medijan dobi bolesnika iznosio 48 godina, 23% bolesnika bile su žene, 29% bolesnika nije bilo bijele rase, a 20% bolesnika imalo je istodobnu infekciju hepatitisom B i/ili C.
How to store Tivicay 
Moguće nuspojave Kako čuvati Tivicay
Do not give this medicine to children under 6 years of age, weighing less than 15 kg or with HIV infection that is resistant to other medicines similar to Tivicay. 
Ovaj lijek se ne smije davati djeci mlađoj od 6 godina, djeci tjelesne težine manje od 15 kg ni djeci s
• difficulty moving. 
• otežano disanje
Dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% Tenofovir ↔ 
Nukleozidni inhibitori reverzne transkriptaze tenofovir dolutegravir ↔ AUC ↑ 1% Cmax ↓ 3% Cτ ↓ 8% tenofovir ↔
INFORMATION IN BRAILLE tivicay 25 mg 
tivicay 25 mg
• dizziness 
• mučnina.
ANNEX III LABELLING AND PACKAGE LEAFLET 
Tablica 3 Nuspojave
At baseline, in the pooled analysis, median patient age was 33 years, 15% were female, 32% non-white, 6% had hepatitis C co-infection and 9% were CDC Stage 3. 
Na temelju analize objedinjenih podataka, na početku je ispitivanja medijan dobi bolesnika iznosio 33 godine, 15% ispitanika bile su žene, 32% ispitanika nisu bili bijelci, 6% ih je imalo istodobnu infekciju hepatitisom C, a 9% ispitanika imalo je HIV infekciju stadija 3 prema CDC klasifikaciji.
• joint pain, stiffness and bone problems You need to know about important signs and symptoms to look out for while you're taking Tivicay. 
Morate znati na koje važne znakove i simptome treba pripaziti tijekom liječenja lijekom Tivicay.
Liver biochemistry elevations consistent with immune reconstitution syndrome were observed in some hepatitis B and/or C co-infected patients at the start of dolutegravir therapy. 
U nekih bolesnika s istodobnom infekcijom hepatitisom B i/ili C, u skladu sa sindromom imunološke rekonstitucije, primijećena su povišenja biokemijskih pokazatelja jetrene funkcije na početku liječenja dolutegravirom.
If you notice any of these symptoms: → Tell your doctor. 
Ako primijetite bilo koji od navedenih simptoma:
Tivicay should not be used in children and adolescents with HIV infection that is resistant to other medicines similar to Tivicay. 
HIV infekcijom otpornom na druge lijekove slične lijeku Tivicay.
If the next dose is due within 4 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. 
bolesnik ne smije uzeti propuštenu dozu, nego samo nastaviti s primjenom prema uobičajenom rasporedu.