FrancophonIA/ELRC3.0 huggingface dataset:
English: If Dovato is used in patients co-infected with hepatitis B an additional antiviral is therefore generally needed.
Croatian: Stoga, ako se Dovato primjenjuje u bolesnika istodobno zaraženih virusom hepatitisa B, u načelu je potrebno uvesti dodatni antivirusni lijek.
English: No clinically important pharmacokinetic differences between subjects with severe renal impairment (CLcr <30 mL/min) and matching healthy subjects were observed.
Croatian: Nisu primijećene klinički značajne razlike u farmakokinetici između ispitanika s teškim oštećenjem bubrežne funkcije (CLcr <30 ml/min) i njima odgovarajućim kontrolnim zdravim ispitanicima.
English: Each pack consists of one bottle containing 30 filmcoated tablets.
Croatian: Jedno pakiranje sadrži jednu bocu s 30 filmom obloženih tableta.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays low plasma protein binding (less than 36%).
Croatian: Lamivudin pokazuje linearnu farmakokinetiku kod primjene terapijskih doza te se u maloj mjeri veže za proteine u plazmi (manje od 36%).
English: Dovato includes lamivudine, which is active against hepatitis B. Dolutegravir lacks such activity.
Croatian: Dovato sadrži lamivudin, koji djeluje protiv hepatitisa B.
English: • increase in the level of enzymes produced in the muscles (creatine phosphokinase).
Croatian: • povišene vrijednosti enzima koji nastaju u mišićima (kreatin fosfokinaze) Manje česte nuspojave
English: Animal studies indicate no effects of dolutegravir or lamivudine on male or female fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala da dolutegravir ili lamivudin utječu na plodnost mužjaka ili ženki (vidjeti dio 5.3).
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Dovato with metformin, to maintain glycaemic control.
Croatian: Potrebno je razmotriti prilagodbu doze metformina kod započinjanja i prekidanja istodobne primjene lijeka Dovato i metformina, da bi se održala kontrola glikemije.
English: In vivo, dolutegravir did not have an effect on midazolam, a CYP3A4 probe.
Croatian: In vivo dolutegravir nije utjecao na midazolam, probni supstrat za CYP3A4.
English: Cytotoxics Cladribine/Lamivudine
Croatian: Citotoksici kladribin / lamivudin
English: Lamivudine was not mutagenic in bacterial tests, but consistent with other nucleoside analogues, inhibits cellular DNA replication in in vitro mammalian tests such as the mouse lymphoma assay.
Croatian: Lamivudin nije bio mutagen u bakterijskim testovima, ali je poput drugih nukleozidnih analoga inhibirao replikaciju stanične DNK u in vitro testovima provedenima na sisavcima, kao što je test na mišjem limfomu.
English: The IC50 values of lamivudine against HIV-1 subtypes (A-G) ranged from 0.001 to 0.170 µM, against Group O from 0.030 to 0.160 µM and against HIV-2 isolates from 0.002 to 0.120 µM in peripheral blood mononuclear cells.
Croatian: U mononuklearnim stanicama periferne krvi vrijednosti IC50 lamivudina protiv podvrsta HIV-1 (A - G) kretale su se u rasponu od 0,001 do 0,170 µM, dok su se protiv skupine O kretale u rasponu od 0,030 do 0,160 µM, a protiv izolata HIV-2 u rasponu od 0,002 do 0,120 µM.
English: Population pharmacokinetic analysis indicated that hepatitis C virus co-infection had no clinically relevant effect on the exposure to dolutegravir.
Croatian: Populacijska farmakokinetička analiza pokazala je da istodobna infekcija virusom hepatitisa C nije imala klinički značajnog utjecaja na izloženost dolutegraviru.
English: Gender Male Female Race White African-American/African Heritage/Other Age (years)
Croatian: Afroamerikanci / afričko podrijetlo / ostali
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MULTIPACKS ONLY - WITH BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE (SAMO VIŠESTRUKA PAKIRANJA - S PLAVIM OKVIROM)
English: In animal reproductive toxicology studies with dolutegravir, no adverse development outcomes, including neural tube defects, were identified (see section 5.3).
Croatian: U ispitivanjima reproduktivne toksičnosti na životinjama nisu utvrđeni štetni učinci dolutegravira na razvoj, uključujući oštećenje neuralne cijevi (vidjeti dio 5.3).
English: * The results of the pooled analysis are in line with those of the individual studies, for which the primary endpoint (difference in proportion <50 copies/mL plasma HIV-1 RNA at Week 48 based on the Snapshot algorithm for dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil /emtricitabine FDC) was met.
Croatian: * Rezultati analize objedinjenih podataka u skladu su s onima iz pojedinačnih ispitivanja, u kojima je postignuta primarna mjera ishoda (razlika u udjelu ispitanika kojima je prema snapshot algoritmu u 48. tjednu plazmatska koncentracija HIV-1 RNK iznosila < 50 kopija/ml uz dolutegravir plus lamivudin u odnosu na dolutegravir plus kombinacija fiksnih doza tenofovirdizoproksila/emtricitabina).
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, koja mogu biti ozbiljna.
English: Studies with lamivudine show that plasma concentrations (AUC) are increased in patients with renal dysfunction due to decreased clearance.
Croatian: Ispitivanja lamivudina pokazuju da su u bolesnika s bubrežnom disfunkcijom plazmatske koncentracije lijeka (AUC) povećane zbog smanjenog klirensa.
English: This was supported by the pooled analysis, see Table 3.
Croatian: Te je nalaze potvrdila analiza objedinjenih podataka (vidjeti Tablicu 3).
English: You may need extra checkups, including blood tests, while you're taking your medicine.
Croatian: Dok uzimate ovaj lijek, možda će Vam biti potrebni dodatni kontrolni pregledi, uključujući krvne pretrage.
English: Single dose lamivudine oral solution 300 mg. Lamivudine:
Croatian: Jedna doza oralne otopine lamivudina od 300 mg. lamivudin:
English: No dose adjustment is necessary when Dovato is combined with tenofovir, didanosine, stavudine or zidovudine.
Croatian: Dovato primjenjuje u kombinaciji s tenofovirom, didanozinom, stavudinom ili zidovudinom.
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 na in vivo farmakokinetiku tenofovira, supstrata za OAT, nije vjerojatna inhibicija OAT1 in vivo.
English: Some medicines can affect how Dovato works or make it more likely that you will have side effects.
Croatian: Neki lijekovi mogu utjecati na način djelovanja lijeka Dovato ili povećati vjerojatnost pojave nuspojava.
English: The median or mean IC50 values for lamivudine against lab-strains of HIV-1 ranged from 0.007 to 2.3 µM.
Croatian: Medijani ili srednje vrijednosti IC50 lamivudina protiv laboratorijskih sojeva HIV-1 kretali su se u rasponu od 0,007 do 2,3 µM.
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues, these have predominantly concerned treatment with regimens containing zidovudine.
Croatian: Prijavljeni su slučajevi mitohondrijske disfunkcije u HIV negativne dojenčadi koja je in utero i/ili nakon rođenja bila izložena nukleozidnim analozima, a prvenstveno se radilo o terapijskim režimima koji su uključivali zidovudin.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Croatian: U uvjetima imunološke reaktivacije prijavljeni su i autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa); međutim, prijavljeno vrijeme do pojave je različito, pa se ti događaji mogu javiti i mjesecima nakon uvođenja liječenja.
English: The lamivudine AUC(0-∞) was not affected by a high fat meal.
Croatian: Obrok s visokim udjelom masnoća nije utjecao na AUC(0-∞) lamivudina.
English: Luxembourg/Luxemburg ViiV Healthcare sprl/bvba Belgique/Belgien Tél/Tel: + 32 (0) 10 85 65 00
Croatian: ViiV Healthcare sprl/bvba Belgique/Belgien Tél/Tel: + 32 (0) 10 85 65 00
English: Multipacks containing 90 film-coated tablets (3 packs of 30 film-coated tablets) are also available.
Croatian: Dostupna su i višestruka pakiranja koja sadrže 90 filmom obloženih tableta (3 pakiranja s 30 filmom obloženih tableta).
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Croatian: U bolesnika s HIV infekcijom i teškom imunodeficijencijom u trenutku uvođenja kombinirane antiretrovirusne terapije može se razviti upalna reakcija na asimptomatske ili rezidualne oportunističke patogene te uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
English: The adverse reactions from clinical study and post-marketing experience are listed in Table 2 by body system, organ class and absolute frequency.
Croatian: Nuspojave prijavljene u kliničkim ispitivanjima i nakon stavljanja lijeka u promet navedene su u Tablici 2 prema organskim sustavima i apsolutnoj učestalosti.
English: → See a doctor straight away.
Croatian: → Odmah se javite liječniku.
English: Active renal secretion of lamivudine in the urine is mediated through the organic cation transporter (OCT) 2 and multidrug and toxin extrusion transporters (MATE1 and MATE2-K).
Croatian: U aktivnoj bubrežnoj sekreciji lamivudina u mokraću posreduju prijenosnik organskih kationa 2 (engl. organic cation transporter 2, OCT2) i prijenosnici za izlučivanje više lijekova i toksina (engl. multidrug and toxin extrusion transporters) MATE1 i
English: Nervous system disorders: Very common:
Croatian: Poremećaji živčanog sustava: Vrlo često:
English: Polyvalent cationcontaining antacids are recommended to be taken 2 hours after or 6 hours before Dovato (see section 4.5).
Croatian: Preporučuje se antacide koji sadrže polivalentne katione uzeti 2 sata nakon ili 6 sati prije lijeka Dovato (vidjeti dio 4.5).
English: Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Croatian: Budući da se gastrointestinalna nepodnošljivost smatra posljedicom lokalne primjene djelatne tvari, doza sigurna za primjenu (engl. safety cover) može se na primjeren način izraziti u mg/kg ili mg/m2.
English: In a randomized, dose-ranging trial, HIV-1-infected subjects treated with dolutegravir monotherapy (ING111521) demonstrated rapid and dose-dependent antiviral activity, with mean decline in HIV-1 RNA of 2.5 log10 at day 11 for 50 mg dose.
Croatian: U randomiziranom ispitivanju za određivanje raspona doza, koje je provedeno u ispitanika s HIV-1 infekcijom liječenih dolutegravirom u monoterapiji (ING111521), primijećeno je brzo i o dozi ovisno antivirusno djelovanje, uz srednju vrijednost smanjenja koncentracije HIV-1 RNK od 2,5 log10 nakon 11 dana primjene doze od 50 mg.
English: Do not take an antacid during the 6 hours before you take Dovato, or for at least 2 hours after you take it (see also section 3, ‘How to take Dovato')
Croatian: Ne smijete uzeti antacid unutar 6 sati prije primjene lijeka Dovato ni najmanje 2 sata nakon njegove primjene (pogledajte i dio 3. „Kako uzimati Dovato”)
English: There are no data on the effects of dolutegravir or lamivudine on human male or female fertility.
Croatian: Nema podataka o učincima dolutegravira ili lamivudina na plodnost muškaraca ili žena.
English: Subjects were enrolled with a screening plasma HIV-1 RNA of 1000 c/mL to ≤500,000 c/mL.
Croatian: Uključeni su ispitanici pri probiru imali plazmatsku koncentraciju HIV-1 RNK od 1000 do ≤ 500 000 kopija/ml.
English: Symptoms of infection and inflammation
Croatian: Simptomi infekcije i upale
English: Co-administration of Dovato and other medicinal products that inhibit UGT1A1, UGT1A3, UGT1A9, CYP3A4, and/or P-gp may, therefore, increase dolutegravir plasma concentration.
Croatian: UGT1A1, UGT1A3, UGT1A9, CYP3A4 i/ili P-gp može povećati koncentraciju dolutegravira u plazmi.
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: The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to 17 years) showed that dolutegravir 50 mg once daily dosage resulted in dolutegravir exposure comparable to that observed in adults who received dolutegravir 50 mg once daily.
Croatian: Djeca Farmakokinetika dolutegravira u 10 adolescenata (u dobi od 12 do 17 godina) s HIV-1 infekcijom koji su prethodno bili liječeni antiretroviroticima pokazala je da primjena dolutegravira u dozi od 50 mg jedanput na dan dovodi do izloženosti dolutegraviru usporedive s onom primijećenom u odraslih bolesnika koji su primali dolutegravir u dozi od 50 mg jedanput na dan.
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 slična, u ispitanika s umjerenim oštećenjem jetrene funkcije izloženost nevezanom dolutegraviru bila je 1,5 - 2 puta veća nego u kontrolnih zdravih ispitanika.
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD 18. JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Croatian: Za praćenje vrijednosti lipida i glukoze u krvi dane su preporuke u utvrđenim smjernicama za liječenje HIV-a.
English: Blood and lymphatic systems disorders: Uncommon:
Croatian: Poremećaji krvi i limfnog sustava: Manje često:
English: In patients with moderate renal impairment a dose adjustment of metformin should be considered when coadministered with Dovato, 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 treba razmotriti prilagodbu doze metformina kad se primjenjuje istodobno s dolutegravirom, zbog povećanog rizika od laktacidoze kojem su ti bolesnici izloženi uslijed povećane koncentracije metformina (vidjeti dio 4.4).
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 90 (3 packs of 30) tablets
Croatian: Višestruko pakiranje: 90 (3 pakiranja s 30) tableta
English: • The other ingredients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, mannitol (E421), povidone (K29/32), sodium stearyl fumarate, hypromellose (E464), macrogol, titanium dioxide (E171).
Croatian: manitol (E421), povidon (K29/32), natrijev stearilfumarat, hipromeloza (E464), makrogol, titanijev dioksid (E171).
English: Dolutegravir has been associated with an increase in serum creatinine occuring in the first week of treatment when administered with other antiretroviral medicinal products.
Croatian: Promjene u laboratorijskim nalazima biokemijskih parametara Dolutegravir se povezuje s povećanjem koncentracije kreatinina u serumu u prvom tjednu liječenja kada se primjenjuje istodobno s drugim antiretrovirusnim lijekovima.
English: HIV-1 isolates (CRF01_AE, n=12; CRF02_AG, n=12; and Subtype C or CRF_AC, n=13) from 37 untreated patients in Africa and Asia were susceptible to lamivudine (IC50 fold changes < 3.0.
Croatian: Izolati HIV-1 (CRF01_AE, n=12; CRF02_AG, n=12; podvrsta C ili CRF_AC, n=13) prikupljeni u
English: Dovato is not recommended for use in patients with a creatinine clearance < 50 mL/min (see section 5.2).
Croatian: Ne preporučuje se primjena lijeka Dovato u bolesnika s klirensom kreatinina < 50 ml/min (vidjeti dio 5.2).
English: The stated reductions in dolutegravir exposure were observed with the intake of dolutegravir and these supplements during fasted conditions.
Croatian: Navedena smanjenja izloženosti dolutegraviru opažena su kada su se dolutegravir i ti dodaci prehrani uzimali natašte.
English: As hepatic elimination plays a minor role in the clearance of lamivudine, drug interactions due to inhibition of OCT1 are unlikely to be of clinical significance.
Croatian: Budući da eliminacija putem jetre igra malu ulogu u klirensu lamivudina, nije vjerojatno će zbog inhibicije OCT1 doći do klinički značajnih interakcija s drugim lijekovima.
English: neutropenia, anaemia, thrombocytopenia
Croatian: neutropenija, anemija, trombocitopenija
English: No specific symptoms or signs have been identified following acute overdose with dolutegravir or lamivudine, apart from those listed as adverse reactions.
Croatian: Nakon akutnog predoziranja dolutegravirom ili lamivudinom nisu primijećeni nikakvi specifični simptomi ni znakovi, osim onih navedenih u popisu nuspojava.
English: • The active substances are dolutegravir and lamivudine.
Croatian: • Djelatne tvari su dolutegravir i lamivudin.
English: There is no evidence that a dose adjustment of dolutegravir or lamivudine would be required based on the effects of race on PK parameters.
Croatian: Nema dokaza da bi bilo potrebno prilagoditi dozu dolutegravira ili lamivudina na temelju učinaka rase na farmakokinetičke parametre.
English: In vitro, dolutegravir inhibited the renal transporters OCT2 and MATE1.
Croatian: In vitro je dolutegravir inhibirao bubrežne prijenosnike OCT2 i MATE1.
English: Dolutegravir is present in the female and male genital tract.
Croatian: Dolutegravir je pronađen u genitalijama žena i muškaraca.
English: No dosage adjustment necessary.
Croatian: Nije potrebno prilagođavati dozu.
English: Dolutegravir is highly bound (> 99%) to human plasma proteins based on in vitro data.
Croatian: In vitro podaci pokazuju da se dolutegravir u velikoj mjeri (> 99%) veže za proteine u plazmi ljudi.
English: A total of 1433 HIV-1 infected antiretroviral treatment-naïve adult subjects received treatment in the trials.
Croatian: U sklopu tih ispitivanja liječena su ukupno 1433 odrasla ispitanika s HIV-1 infekcijom koja prethodno nisu primala antiretrovirusnu terapiju,
English: • medicines called antacids, to treat indigestion and heartburn.
Croatian: • lijekove koji se zovu antacidi, a koriste se za liječenje probavnih smetnji i žgaravice.
English: The primary effect of dolutegravir was gastrointestinal intolerance or irritation in rats and monkeys at doses that produce systemic exposures approximately 28.5 and 1.1 times the 50 mg human clinical exposure following single dose in the fasted state based on AUC, respectively.
Croatian: Primarni učinak dolutegravira bile su gastrointestinalna nepodnošljivost ili iritacija u štakora odnosno majmuna kod primjene doza koje su izazvale sistemsku izloženost približno 28,5 odnosno 1,1 puta veću od kliničke izloženosti u ljudi kod primjene doze od 50 mg, što je utvrđeno na temelju AUC-a nakon primjene jednokratne doze natašte.
English: For information around in vitro resistance, and cross resistance to other agents of the integrase- and NRTI class, please refer to the SmPCs of dolutegravir and lamivudine.
Croatian: Za informacije o rezistenciji in vitro i križnoj rezistenciji na druge lijekove iz skupina inhibitora integraze i NRTI-ja vidjeti sažetke opisa svojstava lijeka za dolutegravir te lamivudin.
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: i/ili C bio sličan onome opaženome u bolesnika koji nisu imali istodobnu infekciju virusom hepatitisa B ili C, premda su u svim liječenim skupinama stope odstupanja vrijednosti AST-a i ALT-a bile više u podskupini bolesnika s istodobnom infekcijom virusom hepatitisa B i/ili C.
English: Supplements or multivitamins containing calcium, iron or magnesium Supplements or multivitamins containing calcium, iron or magnesium can stop Dovato being absorbed into your body and make it less effective.
Croatian: Dodaci prehrani ili multivitaminski pripravci koji sadrže kalcij, željezo ili magnezij mogu spriječiti apsorpciju lijeka Dovato u tijelo i tako umanjiti njegovu djelotvornost.
English: In 13 treatment-naïve subjects on a stable dolutegravir plus abacavir/lamivudine regimen, dolutegravir concentration in CSF averaged 18 ng/mL (comparable to unbound plasma concentration, and above the IC50).
Croatian: U 13 prethodno neliječenih ispitanika koji su liječeni stabilnim režimom koji je uključivao dolutegravir u kombinaciji s abakavirom/lamivudinom, koncentracije dolutegravira u cerebrospinalnoj tekućini prosječno su iznosile 18 ng/ml (usporedivo s koncentracijama nevezanog lijeka u plazmi te iznad vrijednosti IC50).
English: There is no evidence that a dose adjustment of dolutegravir or lamivudine would be required based on the effects of gender on PK parameters.
Croatian: Nema dokaza da bi bilo potrebno prilagoditi dozu dolutegravira ili lamivudina na temelju učinaka spola na farmakokinetičke parametre.
English: A dose adjustment of metformin should be considered when starting and stopping coadministration of Dovato with metformin, to maintain glycaemic control (see section 4.5).
Croatian: Potrebno je razmotriti prilagodbu doze metformina kod započinjanja i prekidanja istodobne primjene lijeka Dovato i metformina, da bi se održala kontrola glikemije (vidjeti dio 4.5).
English: If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete: → Obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: In the Phase III studies for the dolutegravir single agent, patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN).
Croatian: U ispitivanja faze III u kojima se dolutegravir primjenjivao u monoterapiji mogli su biti uključeni bolesnici s istodobnom infekcijom virusom hepatitisa B i/ili C, pod uvjetom da im biokemijski parametri jetrene funkcije na početku ispitivanja nisu bili više od 5 puta iznad gornje granice normale (GGN).
English: Women of childbearing potential (WOCBP) should undergo pregnancy testing before initiation of Dovato.
Croatian: U žena reproduktivne dobi treba napraviti test na trudnoću prije početka liječenja lijekom Dovato.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INDIVIDUAL PACKS ONLY)
Croatian: VANJSKO PAKIRANJE (SAMO POJEDINAČNA PAKIRANJA)
English: Multipacks containing 90 (3 packs of 30) film-coated tablets.
Croatian: Višestruko pakiranje s 90 (3 pakiranja s 30) filmom obloženih tableta.
English: Data obtained in patients with moderate to severe hepatic impairment show that lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction.
Croatian: Podaci prikupljeni u bolesnika s umjerenim do teškim oštećenjem jetrene funkcije pokazuju da jetrena disfunkcija nema značajnog utjecaja na farmakokinetiku lamivudina.
English: Renal clearance of unchanged active substance is a minor pathway of elimination for dolutegravir.
Croatian: Bubrežni klirens djelatne tvari u nepromijenjenu obliku sporedan je put eliminacije dolutegravira.