FrancophonIA/ELRC3.0 huggingface dataset:
English: Dolutegravir is an OCT2 and MATE1 inhibitor; however, lamivudine concentrations were similar with or without co-administration of dolutegravir based on a cross study analysis, indicating that dolutegravir has no relevant effect on lamivudine exposure in vivo.
Croatian: OCT2 i MATE1; međutim, analiza podataka iz različitih ispitivanja pokazala je da su koncentracije lamivudina bile slične i uz istodobnu primjenu dolutegravira i bez njega, što ukazuje na to da dolutegravir nema značajnog učinka na izloženost lamivudinu in vivo.
English: HIV-1 RNA <50 copies/mL Treatment Difference† (95% confidence intervals) Virologic non response
Croatian: HIV-1 RNK < 50 kopija/ml prema početnim kovarijatama n/N (%)
English: Group O isolates from antiviral naïve patients tested for lamivudine activity were highly sensitive.
Croatian: Izolati skupine O prikupljeni u bolesnika koji prethodno nisu primali antivirusnu terapiju pokazali su se vrlo osjetljivima na aktivnost lamivudina.
English: Dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45% Daclatasvir ↔
Croatian: daklatazvir / dolutegravir dolutegravir ↔ AUC ↑ 33% Cmax ↑ 29% Cτ ↑ 45% daklatazvir ↔
English: Administration of a single Dovato tablet with a high fat meal increased dolutegravir AUC(0-∞) and Cmax by 33% and 21%, respectively, and decreased the lamivudine Cmax by 30% compared to fasted conditions.
Croatian: Nakon primjene jedne tablete lijeka Dovato uz obrok s visokim udjelom masnoća AUC(0-∞) i Cmax dolutegravira povećali su se za 33% odnosno 21%, dok se Cmax lamivudina smanjio za 30% u odnosu na primjenu natašte.
English: • supplements or multivitamins containing calcium, iron or magnesium.
Croatian: • dodatke prehrani ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij.
English: Baseline CD4+ (cells/ mm3)
Croatian: CD4+ na početku liječenja (stanice/mm3)
English: In vivo, a 10-14% decrease of creatinine clearance (secretory fraction is dependent on OCT2 and MATE-1 transport) was observed in patients.
Croatian: In vivo je u bolesnika primijećeno smanjenje klirensa kreatinina (udio koji se izlučuje ovisi o prijenosnicima OCT2 i MATE-1) za 10 - 14%.
English: Metabolic parameters Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Croatian: Metabolički parametri Tijekom antiretrovirusne terapije može doći do povećanja tjelesne težine te povišenja razine lipida i glukoze u krvi (vidjeti dio 4.4).
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
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 infekcije.
English: Lamivudine is predominately cleared by renal excretion of unchanged lamivudine.
Croatian: Lamivudin se pretežno uklanja izlučivanjem kroz bubrege u nepromijenjenu obliku.
English: Concomitant use of Dovato with cladribine is not recommended (see section 4.4).
Croatian: Istodobna primjena lijeka Dovato i kladribina se ne preporučuje (vidjeti dio 4.4).
English: • if they are overweight.
Croatian: • ako su pretile
English: Dolutegravir ↑ AUC ↑ 62% Cmax ↑ 34% Cτ ↑ 121%
Croatian: atazanavir + ritonavir / dolutegravir dolutegravir ↑ AUC ↑ 62% Cmax ↑ 34% Cτ ↑ 121%
English: GI intolerance in monkeys occurred at 30 times the human mg/kg equivalent dose (based on 50 kg human), and 11 times the human mg/m2 equivalent dose for a total daily clinical dose of 50 mg.
Croatian: Gastrointestinalna nepodnošljivost u majmuna javljala se nakon primjene doza koje su bile 30 puta veće od ekvivalentne doze u ljudi izražene u mg/kg (određeno na temelju osobe tjelesne težine od 50 kg) te 11 puta veće od ekvivalentne doze u ljudi izražene u mg/m2 za ukupnu dnevnu kliničku dozu od 50 mg.
English: In rabbits, maternal toxicity (decreased food consumption, scant/no faeces/urine, suppressed body weight gain) was observed at 1000 mg/kg (0.55 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
Croatian: U kunića je toksičnost za majku (smanjen unos hrane, slabo izlučivanje/izostanak fecesa/mokraće, suprimiran prirast tjelesne težine) primijećena kod primjene doze od 1000 mg/kg (izloženost 0,55 puta veća od kliničke izloženosti u ljudi kod primjene doze od 50 mg, što je utvrđeno na temelju AUC-a nakon primjene jednokratne doze natašte).
English: Dovato should be prescribed by physicians experienced in the management of HIV infection.
Croatian: 4.2 Doziranje i način primjene Dovato moraju propisati liječnici s iskustvom u liječenju HIV infekcije.
English: Dolutegravir ↑ AUC ↑ 91% Cmax ↑ 50% Cτ ↑ 180%
Croatian: Inhibitori proteaze atazanavir / dolutegravir dolutegravir ↑ AUC ↑ 91% Cmax ↑ 50% Cτ ↑ 180%
English: People taking combination therapy for HIV may get other side effects.
Croatian: U osoba koje primaju kombiniranu terapiju za HIV infekciju mogu se javiti i druge nuspojave.
English: Interactions between dolutegravir, lamivudine and co-administered medical products are listed in Table 1
Croatian: Interakcije između dolutegravira, lamivudina i istodobno primijenjenih lijekova navedene su u
English: Virologic Outcomes of Randomised Treatment at Week 48 (Snapshot algorithm) GEMINI-1 and GEMINI-2 Pooled Data*
Croatian: Tablica 3: Virološki ishodi randomiziranog liječenja u 48. tjednu (algoritam za globalnu snimku distribuiranog sustava [snapshot algoritam]) Objedinjeni podaci iz ispitivanja GEMINI-1 i GEMINI-2* DTG + 3TC N = 716
English: In vitro, dolutegravir inhibited the renal uptake organic anion transporters (OAT)1 and OAT3.
Croatian: In vitro je dolutegravir inhibirao bubrežne prijenosnike za unos organskih aniona 1 i 3 (engl. organic anion transporters, OAT1 i OAT3).
English: Dolutegravir was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Croatian: Dolutegravir nije bio mutagen ni klastogen u in vitro testovima provedenima na bakterijskim stanicama i kultiviranim stanicama sisavaca, kao ni u in vivo mikronukleusnom testu provedenom na glodavcima.
English: Signs of osteonecrosis include:
Croatian: Znakovi osteonekroze uključuju: • ukočenost zglobova
English: België/Belgique/Belgien ViiV Healthcare sprl/bvba Tél/Tel: + 32 (0) 10 85 65 00
Croatian: ViiV Healthcare sprl/bvba Tél/Tel: + 32 (0) 10 85 65 00
English: Dovato can make you dizzy, and have other side effects that make you less alert.
Croatian: Dovato može uzrokovati omaglicu i druge nuspojave koje mogu utjecati na Vašu razinu pozornosti.
English: Tabulated summary of adverse reactions to Dovato based on clinical study and postmarketing experience with Dovato and its individual components Frequency
Croatian: Tablica 2: Tablični sažetak nuspojava lijeka Dovato na temelju iskustva iz kliničkih ispitivanja lijeka Dovato i njegovih pojedinačnih sastavnica i nakon njihova stavljanja u promet
English: There are limited pharmacokinetic data on subjects with hepatitis B co-infection (see section 4.4).
Croatian: Podaci o primjeni u ispitanika s istodobnom infekcijom virusom hepatitisa B su ograničeni (vidjeti dio 4.4).
English: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Croatian: GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
English: If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron or magnesium 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: Ako Dovato ne uzimate s hranom, nemojte uzeti dodatak prehrani ili multivitaminski pripravak koji sadrži kalcij, željezo ili magnezij unutar 6 sati prije primjene lijeka Dovato ni najmanje 2 sata nakon njegove primjene (pogledajte i dio 3. „Kako uzimati Dovato”).
English: If you do not take Dovato with food, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Dovato, or for at least 2 hours after you take it.
Croatian: Ako Dovato ne uzimate s hranom, nemojte uzeti neki dodatak prehrani ili multivitaminski pripravak koji sadrži kalcij, željezo ili magnezij unutar 6 sati prije primjene lijeka Dovato ni najmanje 2 sata nakon njegove primjene.
English: Interaction not studied containing products, since both lamivudine (in Dovato) and emtricitabine are cytidine analogues (i.e. risk for intracellular interactions, (see section 4.4).
Croatian: Dovato u kombinaciji s lijekovima koji sadrže emtricitabin jer su i lamivudin (sastojak lijeka Dovato) i emtricitabin citidinski analozi pa postoji rizik od unutarstaničnih interakcija (vidjeti dio 4.4).
English: The mean IC50 against lab-strains of HIV-2 (LAV2 and EHO) ranged from 0.16 to 0.51 µM for lamivudine.
Croatian: Srednja vrijednost IC50 lamivudina protiv laboratorijskih sojeva HIV-2 (LAV2 i EHO) kretala se u rasponu od 0,16 do 0,51 µM.
English: Dolutegravir ↔ Sofosbuvir ↔ Velpatasvir↔
Croatian: sofosbuvir / velpatasvir / dolutegravir dolutegravir ↔ sofosbuvir ↔ velpatasvir ↔
English: Antacids, to treat indigestion and heartburn, can stop Dovato being absorbed into your body and make it less effective.
Croatian: Antacidi, lijekovi za probavne smetnje i žgaravicu, mogu spriječiti apsorpciju (ulazak) lijeka Dovato u tijelo i tako umanjiti njegovu djelotvornost.
English: For patients receiving lamivudine 300 mg once daily, the terminal intracellular half-life of lamivudine-TP was 16 to 19 hours.
Croatian: U bolesnika koji su primali lamivudin u dozi od 300 mg jedanput na dan, terminalni unutarstanični poluvijek lamivudintrifosfata iznosio je
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Croatian: Pokazalo se da nukleozidni i nukleotidni analozi uzrokuju različite stupnjeve mitohondrijskog oštećenja in vitro i in vivo.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ViiV Healthcare BV
Croatian: ViiV Healthcare BV
English: Don't stop taking Dovato without advice from your doctor Take Dovato for as long as your doctor recommends.
Croatian: Nemojte prestati uzimati Dovato bez prethodnog savjetovanja sa svojim liječnikom.
English: Rare acute hepatic failure1
Croatian: akutno zatajenje jetre1
English: Baseline Plasma Viral Load (copies/mL)
Croatian: Virusno opterećenje u plazmi na početku liječenja (kopija/ml)
English: If you get any symptoms of infection or if you notice any of the symptoms above:
Croatian: Ako dobijete bilo koji simptom infekcije ili ako primijetite neki od gore navedenih simptoma: → Odmah obavijestite svog liječnika.
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
English: Common side effects that may show up in blood tests are:
Croatian: Česte nuspojave koje se mogu vidjeti u nalazima krvnih pretraga:
English: In fed state, the changes in exposure following intake together with calcium or iron supplements were modified by the food effect, resulting in an exposure similar to that obtained with dolutegravir administered in the fasted state.
Croatian: Kada su se uzimali na pun želudac, učinak hrane modificirao je promjene izloženosti dolutegraviru do kojih dolazi nakon istodobnog uzimanja nadomjestaka kalcija ili željeza pa je izloženost bila slična onoj koja se postiže kada se dolutegravir primjenjuje natašte.
English: In the pooled GEMINI studies a mean change from baseline of 10.3 µmol/L (range: -36.3 µmol/L to 55.7 µmol/L) was observed after 48 weeks of treatment.
Croatian: Na temelju objedinjenih podataka iz ispitivanja u sklopu programa GEMINI, nakon 48 tjedana liječenja opažena je srednja vrijednost promjene od 10,3 µmol/l (raspon od -36,3 µmol/l do 55,7 µmol/l) u odnosu na početne vrijednosti.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove.
English: Binding of dolutegravir to plasma proteins is independent of dolutegravir concentration.
Croatian: Vezanje dolutegravira za proteine u plazmi neovisno je o koncentraciji dolutegravira.
English: Lamivudine monotherapy is generally not considered an adequate treatment for hepatitis B, since the risk for hepatitis B resistance development is high.
Croatian: Zbog visokog rizika od razvoja rezistencije virusa hepatitisa B na liječenje, monoterapija lamivudinom obično se ne smatra prikladnim liječenjem za hepatitis B.
English: It is unknown whether dolutegravir is excreted in human milk.
Croatian: Nije poznato izlučuje li se dolutegravir u majčino mlijeko.
English: • anxiety
Croatian: • omamljenost
English: Metabolism and nutrition disorders: Very rare:
Croatian: Poremećaji metabolizma i prehrane:
English: Lamivudine is also substrate of the hepatic uptake transporter OCT1.
Croatian: Lamivudin je i supstrat jetrenih prijenosnika za unos tvari OCT1.
English: Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (induction of UGT1A1 and CYP3A enzymes)
Croatian: Antimikobakterijski lijekovi rifampicin / dolutegravir dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓ 72% (indukcija enzima UGT1A1 i CYP3A)
English: If Dovato is administered under fasting conditions, supplements or multivitamins containing calcium, iron or magnesium are recommended to be taken 2 hours after or 6 hours before Dovato (see section 4.5).
Croatian: preporučuje se dodatke prehrani ili multivitaminske pripravke koji sadrže kalcij, željezo ili magnezij uzeti 2 sata nakon ili 6 sati prije lijeka Dovato (vidjeti dio 4.5).
English: Effect of dolutegravir: NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
Croatian: Učinak dolutegravira: NGMN ↔ AUC ↓ 2% Cmax ↓ 11%
English: Dolutegravir is also a substrate of UGT1A3, UGT1A9, CYP3A4, P-glycoprotein (P-gp), and breast cancer resistance protein (BCRP).
Croatian: Dolutegravir se uglavnom eliminira metabolizmom u kojem posreduje uridin difosfat glukuronoziltransferaza (UGT) 1A1. Dolutegravir je i supstrat za UGT1A3, UGT1A9, enzim 3A4 citokroma P450 (CYP3A4), P-glikoprotein (P-gp) i protein rezistencije raka dojke (engl. breast cancer resistance protein, BCRP).
English: Population pharmacokinetic analysis of dolutegravir using data in HIV-1 infected adults showed that there was no clinically relevant effect of age on dolutegravir exposure.
Croatian: Populacijska farmakokinetička analiza dolutegravira na temelju podataka prikupljenih u odraslih osoba s HIV-1 infekcijom pokazala je da dob nije imala klinički značajnog utjecaja na izloženost dolutegraviru.
English: Iron supplements/Dolutegravir (fasted intake)
Croatian: nadomjesci željeza / dolutegravir (kada se uzima natašte)
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 (0.55 times the 50 mg human clinical exposure, based on AUC following single dose in the fasted state).
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 ni teratogenost (izloženost 0,55 puta veća od kliničke izloženosti u ljudi kod primjene doze od 50 mg, što je utvrđeno na temelju AUC-a nakon primjene jednokratne doze natašte).
English: If Dovato is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of both liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Croatian: preporučuje se periodičko praćenje nalaza testova jetrene funkcije i biljega replikacije HBV-a jer prekid primjene lamivudina može dovesti do akutne egzacerbacije hepatitisa.
English: Drug Interactions Medicinal products by therapeutic areas
Croatian: Tablica 1: Interakcije s drugim lijekovima Lijekovi prema terapijskim područjima
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: These may affect up to 1 in 10,000 people:
Croatian: Mogu se javiti u do 1 na 10 000 osoba:
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5-10%).
Croatian: Budući da se lamivudin u maloj mjeri metabolizira u jetri (5 - 10%), mala je vjerojatnost metaboličkih interakcija između lamivudina i drugih lijekova.
English: The IC50 for dolutegravir in various lab-strains using PBMC was 0.5 nM, and when using MT-4 cells it ranged from 0.7-2 nM.
Croatian: IC50 dolutegravira protiv različitih laboratorijskih sojeva u mononuklearnim stanicama periferne krvi iznosio je 0,5 nM, dok se u MT-4 stanicama kretao u rasponu od 0,7 do 2 nM.
English: Population PK analyses using pooled pharmacokinetic data from clinical studies where dolutegravir or lamivudine was administered to adults in combination with other ARVs revealed no clinically relevant effect of gender on the exposure of dolutegravir or lamivudine.
Croatian: Populacijske farmakokinetičke analize objedinjenih farmakokinetičkih podataka iz kliničkih ispitivanja u kojima su se dolutegravir ili lamivudin primjenjivali u kombinaciji s drugim antiretrovirusnim lijekovima u odraslih osoba pokazale su da spol nije imao klinički značajnog učinka na izloženost dolutegraviru ni lamivudinu.
English: Immune system disorders: Uncommon:
Croatian: Poremećaji imunološkog sustava: Manje često:
English: rhabdomyolysis
Croatian: rabdomioliza
English: Dolutegravir did not change daclatasvir plasma concentration.
Croatian: Dolutegravir nije promijenio koncentraciju daklatazvira u plazmi.
English: There are no data available on the effects of the combination of dolutegravir and lamivudine in animals.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Nema dostupnih podataka o učincima kombinacije dolutegravira i lamivudina u životinja.
English: In vitro, lamivudine did not inhibit or induce CYP enzymes (such as CYP3A4, CYP2C9 or CYP2D6) and demonstrated no or weak inhibition of OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 or MATE2-K. Lamivudine is therefore not expected to affect the plasma concentrations of medicinal products that are substrates of these enzymes or transporters.
Croatian: In vitro dolutegravir nije bio supstrat ljudskih prijenosnika OATP 1B1, OATP 1B3 ni OCT 1. In vitro lamivudin nije inhibirao ni inducirao CYP enzime (kao što su CYP3A4, CYP2C9 ili CYP2D6) te nije inhibirao ili je slabo inhibirao OATP1B1, OAT1B3, OCT3, BCRP, P-gp, MATE1 ili
English: No data are available in patients with severe hepatic impairment (Child-Pugh grade C); therefore Dovato should be used with caution in these patients (see section 5.2).
Croatian: Nema dostupnih podataka o bolesnicima s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C), pa u tih bolesnika
English: In reproductive toxicity studies in animals, dolutegravir and lamivudine were shown to cross the placenta.
Croatian: Ispitivanja reproduktivne toksičnosti Ispitivanja reproduktivne toksičnosti na životinjama pokazala su da dolutegravir i lamivudin prolaze kroz posteljicu.
English: Calcium supplements/Dolutegravir (fasted intake)
Croatian: nadomjesci kalcija / dolutegravir (kada se uzima natašte)
English: Dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% Boceprevir ↔ (historical controls)
Croatian: Druge antivirusne djelatne tvari boceprevir / dolutegravir dolutegravir ↔ AUC ↑ 7% Cmax ↑ 5% Cτ ↑ 8% boceprevir ↔ (kontrole iz prethodnih ispitivanja)
English: At week 48, dolutegravir plus lamivudine was non-inferior to dolutegravir plus tenofovir disoproxil/emtricitabine FDC in GEMINI-1 and GEMINI-2 studies.
Croatian: U 48. tjednu ispitivanja GEMINI-1 i GEMINI-2 kombinacija dolutegravira i lamivudina bila je neinferiorna kombinaciji dolutegravira i fiksnih doza tenofovirdizoproksila/emtricitabina.
English: The apparent volume of distribution of dolutegravir (Vd/F) is 17-20 L. Intravenous studies with lamivudine showed that the mean apparent volume of distribution is 1.3 L/kg.
Croatian: U ispitivanjima intravenske primjene utvrđeno je da srednja vrijednost prividnog volumena distribucije lamivudina iznosi 1,3 l/kg.
English: This combination may increase the risk for lactic acidosis in patients with moderate renal impairment (stage 3a creatinine clearance 45- 59 mL/min) and a cautious approach is recommended.
Croatian: Ta kombinacija može povećati rizik od laktacidoze u bolesnika s umjerenim oštećenjem bubrežne funkcije (stadij 3a, klirens kreatinina:
English: Dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% Rilpivirine ↔
Croatian: rilpivirin / dolutegravir dolutegravir ↔ AUC ↑ 12% Cmax ↑ 13% Cτ ↑ 22% rilpivirin ↔
English: : + 33 (0)1 39 17 69 69 Infomed@viivhealthcare.com
Croatian: ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 69 69 Infomed@viivhealthcare.com
English: Table 1:
Croatian: (vidjeti Tablicu 1).
English: Dolutegravir ↓ (Not studied, a similar reduction in exposure as observed with efavirenz is expected, due to induction)
Croatian: nevirapin / dolutegravir dolutegravir ↓ (Interakcija se nije ispitivala; zbog indukcije se očekuje smanjenje izloženosti slično onome opaženome kod primjene efavirenza.)
English: † Based on CMH-stratified analysis adjusting for the following baseline 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: † Na temelju analize stratificirane Cochran-Mantel-Haenszelovom metodom i prilagođene za sljedeće početne stratifikacijske faktore: plazmatsku koncentraciju HIV-1 RNK (≤ 100 000 kopija/ml naspram
English: No drug interaction studies have been conducted using Dovato.
Croatian: Nisu provedena ispitivanja interakcija između lijeka Dovato i drugih lijekova.
English: Dolutegravir ↔ No dosage adjustment necessary.
Croatian: Inhibitori protonske pumpe omeprazol dolutegravir ↔ Nije potrebno prilagođavati dozu.
English: Dolutegravir ↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected).
Croatian: Biljni lijekovi gospina trava / dolutegravir dolutegravir ↓ (Interakcija se nije ispitivala; očekuje se smanjenje koncentracija zbog indukcije enzima UGT1A1 i CYP3A te smanjenje izloženosti slično onome opaženome kod primjene karbamazepina.)
English: nausea, diarrhoea
Croatian: mučnina, proljev
English: • if you have a kidney problem.
Croatian: • ako imate bubrežnih tegoba
English: Renal impairment Pharmacokinetic data have been obtained for dolutegravir and lamivudine separately.
Croatian: Prikupljeni su farmakokinetički podaci za dolutegravir i lamivudin kao zasebne djelatne tvari.
English: Daclatasvir did not change dolutegravir plasma concentration to a clinically relevant extent.
Croatian: Daklatazvir nije doveo do klinički značajne promjene koncentracije dolutegravira u plazmi.
English: Studies in patients with renal impairment show lamivudine elimination is affected by renal dysfunction.
Croatian: Ispitivanja u bolesnika s oštećenjem bubrežne funkcije pokazuju da bubrežna disfunkcija utječe na eliminaciju lamivudina.
English: The combination of Dovato with cladribine is not recommended (see section 4.5).
Croatian: Ne preporučuje se primjena lijeka Dovato u kombinaciji s kladribinom (vidjeti dio 4.5).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1370/002
Croatian: EU/1/19/1370/001 EU/1/19/1370/002
English: Dovato should not be taken with any other medicinal product containing dolutegravir or lamivudine, except where a dose adjustment of dolutegravir is indicated due to drug-drug interactions (see section 4.5).
Croatian: Dovato se ne smije uzimati ni s jednim drugim lijekom koji sadrži dolutegravir ili lamivudin, osim u slučajevima kada je zbog interakcija s drugim lijekovima potrebno prilagoditi dozu dolutegravira