FrancophonIA/ELRC3.0 huggingface dataset:
English: The treatment difference (raltegravir- efavirenz) was 4.2 % with an associated 95 % CI of (-1.9, 10.3) establishing that raltegravir is non-inferior to efavirenz (p-value for non-inferiority < 0.001).
Croatian: Razlika u odgovoru na liječenje (raltegravir-efavirenz) iznosila je 4,2% uz pripadajući 95%-tni CI od (-1,9; 10,3), što pokazuje da raltegravir nije inferioran efavirenzu (p-vrijednost za neinferiornost < 0,001).
English: When concomitant administration of DUTREBIS is warranted, patients should be monitored clinically.
Croatian: Kada je neophodna istodobna primjena lijeka DUTREBIS, potreban je klinički nadzor bolesnika.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis carinii pneumonia.
Croatian: Značajni primjeri su retinitis izazvan citomegalovirusom, generalizirane i/ili fokalne infekcije mikobakterijama i pneumonija izazvana s Pneumocystis carinii.
English: Co-administration of zidovudine with lamivudine results in a 13 % increase in zidovudine exposure and a 28 % increase in peak plasma levels.
Croatian: Istodobna primjena zidovudina s lamivudinom dovodi do 13% veće izloženosti zidovudinu i porasta vršnih vrijednosti u plazmi za 28%.
English: Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking raltegravir, in most cases concomitantly with other medicinal products associated with these reactions.
Croatian: Teške kožne reakcije koje mogu ugroziti život ili imati smrtni ishod prijavljene su u bolesnika koji uzimaju raltegravir, u većini slučajeva istodobno s drugim lijekovima čija je primjena povezana s tim reakcijama.
English: Any child exposed in utero to nucleoside and nucleotide reverse transcriptase inhibitors, even HIV-negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Croatian: Svako dijete koje je bilo izloženo nukleozidnim i nukleotidnim inhibitorima reverzne transkriptaze in utero, uključujući HIV-negativnu djecu, potrebno je pratiti klinički i laboratorijskim pretragama, a u slučaju relevantnih znakova ili simptoma pomno ispitati mogućnost disfunkcije mitohondrija.
English: Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdose, although this has not been studied.
Croatian: Budući da se lamivudin može ukloniti dijalizom, predoziranje se može liječiti kontinuiranom hemodijalizom, premda to nije ispitivano.
English: At Week 240, the treatment difference (raltegravir - efavirenz) was 9.5 % with an associated 95 % CI of (1.7, 17.3).
Croatian: U 240. tjednu razlika u odgovoru na liječenje (raltegravir-efavirenz) iznosila je 9,5% , uz pripadajući 95%-tni CI od (1,7; 17,3).
English: Less potent UGT1A1 inhibitors (e.g., indinavir, saquinavir) may also increase plasma levels of raltegravir, but to a lesser extent compared with atazanavir.
Croatian: Manje potentni inhibitori UGT1A1 (npr. indinavir, sakvinavir) mogu također povisiti koncentraciju raltegravira u plazmi, no u manjoj mjeri nego atazanavir.
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Croatian: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU Velika Britanija
English: Mutations conferring resistance to raltegravir generally also confer resistance to the integrase strand transfer inhibitor elvitegravir.
Croatian: Mutacije koje uzrokuju rezistenciju na raltegravir obično uzrokuju i rezistenciju na inhibitor prijenosa lanca integraze elvitegravir.
English: In addition, caution should also be used when co-administering DUTREBIS with other strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1.
Croatian: Osim toga, potreban je oprez kod istodobne primjene lijeka DUTREBIS s drugim snažnim induktorima uridin difosfat glukuronoziltransferaze (UGT) 1A1.
English: Talk to your doctor immediately if you develop a rash.
Croatian: Odmah se javite liječniku ako dobijete osip.
English: In the second study (n=16), the median cerebrospinal fluid concentration was 3 % (range 1 to 61 %) of the corresponding plasma concentration.
Croatian: U drugom je ispitivanju (n=16) medijan koncentracije u cerebrospinalnoj tekućini iznosio 3% (raspon od 1 do 61%) odgovarajuće koncentracije u plazmi.
English: Non-completer is failure imputation: patients who discontinued prematurely are imputed as failure thereafter.
Croatian: "Prerani prekid = neuspjelo liječenje": bolesnici koji su prerano prekinuli liječenje od toga se trenutka smatraju neuspješno liječenima.
English: Overall, considerable variability was observed in the pharmacokinetics of raltegravir.
Croatian: Općenito, opažena je značajna varijabilnost u farmakokinetici raltegravira.
English: If DUTREBIS is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may result in an acute exacerbation of hepatitis.
Croatian: Ako se u bolesnika s istodobnom infekcijom virusom hepatitisa B obustavi liječenje lijekom DUTREBIS, preporučuje se periodičko praćenje testova funkcije jetre i biljega replikacije HBV-a jer prekid primjene lamivudina može dovesti do akutne egzacerbacije hepatitisa.
English: The pharmacokinetic properties, use in special populations and drug-drug interactions for each of the individual components (lamivudine and raltegravir) are applicable to
Croatian: Farmakokinetička svojstva, primjena u posebnim populacijama te interakcije između lijekova za svaku pojedinačnu komponentu (lamivudin i raltegravir) odnose se i na
English: Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy.
Croatian: Dokazi iz kliničkih ispitivanja pokazuju da lamivudin u kombinaciji sa zidovudinom odgađa pojavu izolata rezistentnih na zidovudin u osoba koje prethodno nisu primale antiretrovirusnu terapiju.
English: Raltegravir 400 mg twice daily (N = 281)
Croatian: Raltegravir 400 mg dvaput na dan (N=281)
English: In a comparison of 30 subjects receiving raltegravir with *28/*28 genotype to 27 subjects with wild-type genotype, the geometric mean ratio (90 % CI) of AUC was 1.41 (0.96, 2.09) and the geometric mean ratio of C12 hr was 1.91 (1.43, 2.55).
Croatian: Usporedba ispitanika koji su primali raltegravir i od kojih je 30 imalo genotip *28/*28, a 27 genotip divljeg tipa pokazala je da geometrijska srednja vrijednost omjera (90% CI) AUC-a iznosi 1,41 (0,96; 2,09), a geometrijska srednja vrijednost omjera C12h 1,91 (1,43; 2,55).
English: The safety profile observed in patients who used atazanavir and / or tenofovir was generally similar to the safety profile of patients who did not use these agents.
Croatian: Sigurnosni profil lijeka opažen u bolesnika koji su primali atazanavir i/ili tenofovir bio je općenito sličan onomu u bolesnika koji nisu uzimali ove lijekove.
English: Additionally, renal insufficiency was evaluated in the composite pharmacokinetic analysis.
Croatian: Osim toga, insuficijencija bubrega je ocijenjena i u objedinjenoj farmakokinetičkoj analizi.
English: An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40 % increase in lamivudine exposure at therapeutic doses.
Croatian: Interakcija s trimetoprimom, sastojkom kotrimoksazola, uzrokuje 40%-tni porast izloženosti lamivudinu pri terapijskim dozama.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipasemia).
Croatian: Glavne prijavljene nuspojave su hematološki poremećaji (anemija, neutropenija) i metabolički poremećaji (hiperlaktatemija, hiperlipazemija).
English: With respect to the primary efficacy endpoint, the proportion (%) of patients achieving HIV RNA < 50 copies/ml at Week 48 was 241/280 (86.1 %) in the group receiving raltegravir and 230/281 (81.9 %) in the group receiving efavirenz.
Croatian: Što se tiče primarnog ishoda djelotvornosti, udio (%) bolesnika u kojih je u 48. tjednu postignuta koncentracija < 50 HIV-RNK kopija/ml iznosio je 241/280 (86,1%) u skupini koja je primala raltegravir i 230/281 (81,9%) u skupini koja je primala efavirenz.
English: In rats, at a maternal dose of 600 mg/kg/day, mean active substance concentrations in milk were approximately 3-fold greater than in maternal plasma.
Croatian: U štakorica je pri primjeni doze od 600 mg/kg/dan u majke, srednja vrijednost koncentracije djelatne tvari u mlijeku bila oko 3 puta veća nego u plazmi majke štakorice.
English: In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness).
Croatian: Podaci iz ispitivanja in vitro upućuju na to da nastavak primjene lamivudina u sklopu antiretrovirusnog režima liječenja, unatoč razvoju M184V, može osigurati rezidualnu antiretrovirusnu aktivnost (najvjerojatnije putem smanjene virulentnosti).
English: ≤ 200 cells/mm
Croatian: ≤ 200 stanica/mm
English: Although in vitro studies indicated that raltegravir is not an inhibitor of the UDP glucuronosyltransferases (UGTs) 1A1 and 2B7, one clinical study has suggested that some inhibition of UGT1A1 may occur in vivo based on effects observed on bilirubin glucuronidation.
Croatian: Premda su istraživanja in vitro pokazala da raltegravir nije inhibitor UDP glukuronoziltransferaza (UGT) 1A1 i 2B7, jedno je kliničko ispitivanje pokazalo mogućnost određenog stupnja inhibicije UGT1A1 in vivo s obzirom na učinke opažene na glukoronidaciju bilirubina.
English: • increased appetite; diabetes; high sugar levels in the blood; excessive thirst; severe weight loss; body fat disorder
Croatian: • pojačan tek; šećerna bolest; visoka razina šećera u krvi; prekomjerna žeđ; značajan gubitak tjelesne težine; poremećaj masnog tkiva
English: The dosing regimen of the lamivudine component of DUTREBIS in the paediatric population is the same as the dosing regimen of the individual component (EPIVIR).
Croatian: Režim doziranja lamivudina kao komponente lijeka DUTREBIS u pedijatrijskoj populaciji isti je kao režim doziranja kod samostalne primjene (EPIVIR).
English: No effect on fertility was seen in male and female rats at doses of raltegravir up to 600 mg/kg/day which resulted in 3-fold exposure above the exposure at the recommended human dose.
Croatian: Nisu opaženi učinci na plodnost mužjaka ni ženki štakora pri dozama raltegravira do 600 mg/kg/dan kojima je postignuta 3 puta veća izloženost od izloženosti preporučene doze za ljude.
English: This variant arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Croatian: Ta je varijanta prisutna in vitro kao i u bolesnika s HIV-1 infekcijom koji primaju antiretrovirusnu terapiju koja uključuje lamivudin.
English: In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, triacetin, yellow iron oxide, Indigo Carmine (E132) Aluminium Lake, and titanium dioxide.
Croatian: Osim toga, film ovojnica sadrži sljedeće pomoćne tvari: hipromelozu, laktozu hidrat, triacetin, žuti željezov oksid, boju Indigo Carmine (E132) Aluminium Lake i titanijev dioksid.
English: • The other ingredients are: hypromellose (2910), croscarmellose sodium, lactose monohydrate, silicon dioxide (colloidal), magnesium stearate, and microcrystalline cellulose.
Croatian: • Drugi sastojci su: hipromeloza (2910), umrežena karmelozanatrij, laktoza hidrat, silicijev dioksid (koloidni), magnezijev stearat i mikrokristalična celuloza.
English: Results 48 week and 96 week analyses
Croatian: Rezultati analiza 48. i 96. tjedna
English: Rifampicin reduces plasma levels of raltegravir; the impact on the efficacy of raltegravir is unknown.
Croatian: Rifampicin snižava koncentraciju raltegravira u plazmi; utjecaj na djelotvornost raltegravira nije poznat.
English: In general the safety profile of raltegravir in patients with hepatitis B and/or hepatitis C virus co-infection was similar to that in patients without hepatitis B and/or hepatitis C virus co-infection, although the rates of AST and ALT abnormalities were somewhat higher in the subgroup with hepatitis B and/or hepatitis C virus co-infection for both treatment groups.
Croatian: Sigurnosni profil raltegravira općenito je bio sličan u bolesnika istodobno inficiranih virusom hepatitisa B i/ili hepatitisa C i u onih koji nisu bili istodobno inficirani virusom hepatitisa B i/ili hepatitisa C, premda su u obje terapijske skupine odstupanja vrijednosti AST-a i ALT-a bila nešto viša u podskupini bolesnika s istodobnom infekcijom virusom hepatitisa B i/ili hepatitisa C.
English: Lamivudine is eliminated mainly by active renal secretion via the organic cationic transport system.
Croatian: Lamivudin se uglavnom eliminira aktivnom bubrežnom sekrecijom uz pomoć sustava organskih kationskih prijenosnika.
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Croatian: Mutanti M184V pokazuju značajno smanjenu osjetljivost na lamivudin i smanjeni kapacitet replikacije virusa in vitro.
English: The pharmacokinetic properties of lamivudine have been determined in a small group of HIV-1-infected adults with impaired renal function.
Croatian: Farmakokinetička svojstva lamivudina određena su u maloj skupini odraslih osoba s HIV-1 infekcijom i oštećenom funkcijom bubrega.
English: The adverse reactions seen in clinical studies and in post-marketing experience are listed below by body system, organ class and absolute frequency.
Croatian: Nuspojave primijećene u kliničkim ispitivanjima i nakon stavljanja lijekova u promet navedene su prema klasifikaciji organskih sustava i apsolutnoj učestalosti.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to CART.
Croatian: Iako se smatra da ima više uzroka (uključujući primjenu kortikosteroida, konzumiranje alkohola, jaku imunosupresiju, povišen indeks tjelesne mase), slučajevi osteonekroze prijavljeni su posebice u bolesnika s uznapredovalom HIV bolešću i/ili u bolesnika izloženih dugotrajnoj kombiniranoj antiretrovirusnoj terapiji (CART).
English: An open-label, single-dose, randomized, two-period crossover study assessed the effect of a high fat meal on DUTREBIS administered to 20 healthy male and female subjects.
Croatian: U otvorenom, randomiziranom, ukriženom ispitivanju primjene jedne doze, provedenom u dva razdoblja, ocjenjivao se utjecaj obroka s visokim udjelom masti na DUTREBIS u 20 zdravih ispitanika i ispitanica.
English: This is because DUTREBIS might interact with other medicines.
Croatian: Razlog tome je mogućnost međudjelovanja lijeka DUTREBIS s drugim lijekovima.
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Croatian: Rezistencija virusa HIV-l na lamivudin uključuje promjenu aminokiseline M184V u blizini aktivnog mjesta virusne reverzne transkriptaze (RT).
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Croatian: Prijavljeni su slučajevi osteonekroze, osobito u bolesnika s opće prihvaćenim faktorima rizika, uznapredovalom HIV bolešću ili onih izloženih dugotrajnoj kombiniranoj antiretrovirusnoj terapiji.
English: As DUTREBIS contains lamivudine and raltegravir, any interactions that have been identified with these agents individually, may occur with DUTREBIS.
Croatian: Budući da DUTREBIS sadrži lamivudin i raltegravir, bilo koja interakcija utvrđena za svaki od tih lijekova pojedinačno može se javiti i pri primjeni lijeka DUTREBIS.
English: Tmax was not significantly affected by renal function.
Croatian: Funkcija bubrega nije značajno utjecala na tmax.
English: DUTREBIS should not be used when co-administered with rifampicin.
Croatian: DUTREBIS se ne bi smio primjenjivati istodobno s rifampicinom.
English: DUTREBIS should not be used during pregnancy.
Croatian: DUTREBIS se ne smije primjenjivati u trudnoći.
English: • antacids containing aluminium and/or magnesium - used for heartburn.
Croatian: • antacide koji sadrže aluminij i/ili magnezij - koriste se za liječenje žgaravice.
English: Lamivudine was not mutagenic in bacterial tests but, like many nucleoside analogues, showed activity in an in vitro cytogenetic assay and the mouse lymphoma assay.
Croatian: Lamivudin se u bakterijskim testovima nije pokazao mutagenim, ali je kao i mnogi drugi analozi nukleozida pokazao aktivnost u citogenetskom testu in vitro te u testu na mišjem limfomu.
English: Lamivudine has not been specifically investigated in HIV patients co-infected with HBV.
Croatian: Lamivudin nije posebno ispitivan u bolesnika koji su istodobno inficirani HIV-om i HBV-om.
English: In faeces, only raltegravir was present, most of which is likely to be derived from hydrolysis of raltegravir-glucuronide secreted in bile as observed in preclinical species.
Croatian: U fecesu je prisutan samo raltegravir, a njegov je veći dio vjerojatno nastao hidrolizom raltegravir-glukuronida izlučenog u žuči, kao što je opaženo u nekliničkim istraživanjima na životinjama.
English: Less potent inducers (e.g., efavirenz, nevirapine, etravirine, rifabutin, glucocorticoids, St. John's wort, pioglitazone) may be used with DUTREBIS.
Croatian: Manje potentni induktori (npr. efavirenz, nevirapin, etravirin, rifabutin, glukokortikoidi, gospina trava, pioglitazon) mogu se primjenjivati s lijekom DUTREBIS.
English: For analysis by prognostic factors, virologic failures were carried forward for percent < 400 and 50 copies/ml.
Croatian: Za analizu prema prognostičkim faktorima, neuspjeli virološki odgovori preneseni su za postotak < 400 i 50 kopija/ml.
English: Patients co-infected with hepatitis B and/or hepatitis C virus In Phase III studies with raltegravir, treatment-experienced patients (N = 114/699 or 16 %; HBV=6 %, HCV=9 %, HBV+HCV=1 %) and treatment-naïve patients (N = 34/563 or 6 %; HBV=4 %, HCV=2 %, HBV+HCV=0.2 %) with chronic (but not acute) active hepatitis B and/or hepatitis C co-infection were permitted to enrol provided that baseline liver function tests did not exceed 5 times the upper limit of normal.
Croatian: Bolesnici koji su istodobno inficirani virusom hepatitisa B i/ili hepatitisa C U kliničkim ispitivanjima raltegravira faze III bilo je dopušteno uključiti prethodno liječene bolesnike (N=114/699 ili 16%; HBV=6%, HCV=9%, HBV+HCV=1%) i bolesnike koji do tada nisu bili liječeni (N=34/563 ili 6%, HBV=4%, HCV=2%, HBV+HCV=0,2%) koji su istodobno imali kronični (ali ne akutni) aktivni hepatitis B i/ili hepatitis C, uz uvjet da rezultati testova funkcije jetre na početku ispitivanja nisu bili više od 5 puta iznad gornje granice normalnih vrijednosti.
English: 156 cells/mm
Croatian: 156 stanica/mm
English: The following adverse reactions have been reported during therapy for HIV disease with lamivudine and/or raltegravir (alone or in combination with other ART).
Croatian: Sljedeće su nuspojave prijavljene tijekom liječenja HIV bolesti lamivudinom i/ili raltegravirom (sami ili u kombinaciji s drugim antiretrovirusnim terapijama).
English: As demonstrated in healthy volunteers administered single oral doses of raltegravir in the fasted state, raltegravir AUC and Cmax increase dose proportionally over the dose range 100 mg to 1,600 mg.
Croatian: Kako je pokazano u zdravih dobrovoljaca koji su primili jednokratnu peroralnu dozu raltegravira natašte, AUC i Cmax raltegravira povećavaju se proporcionalno dozi u rasponu doza od 100 mg do 1600 mg.
English: The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue-DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Croatian: Ispitivanje je pokazalo da je u fetusa koji su bili izloženi kombinaciji lijekova in utero došlo do opsežnije ugradnje DNK analoga nukleozida u više fetalnih organa te do većeg skraćivanja telomera nego u onih koji su bili izloženi samo zidovudinu.
English: • Raltegravir belongs to a group of medicines called HIV integrase strand transfer inhibitors
Croatian: • Raltegravir pripada skupini lijekova koji se zovu inhibitori prijenosa lanca HIV integraze.
English: For analysis by prognostic factors, virologic failures were carried forward for percent < 50 and 400 copies/ml.
Croatian: Za analizu prema prognostičkim faktorima, neuspjeli virološki odgovori preneseni su za postotak < 50 i 400 kopija/ml.
English: • medicines containing raltegravair or emtricitabine - used to treat HIV.
Croatian: • lijekove koji sadrže raltegravir ili emtricitabin - koriste se za liječenje HIV-a.
English: DUTREBIS 150 mg/300 mg film-coated tablets
Croatian: DUTREBIS 150 mg/300 mg filmom obložene tablete
English: The clinical relevance of these findings is not established.
Croatian: Klinički značaj navedenog nalaza nije utvrđen.
English: See a doctor immediately, if you notice any of the side effects above.
Croatian: Odmah se javite liječniku ako primijetite neku od gore navedenih nuspojava.
English: Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness).
Croatian: Rani simptomi (simptomatska hiperlaktatemija) uključuju benigne probavne simptome (mučninu, povraćanje i bol u abdomenu), nespecifičnu malaksalost, gubitak teka, gubitak tjelesne težine, respiratorne simptome (ubrzano i/ili duboko disanje) ili neurološke simptome (uključujući motoričku slabost).
English: In both studies at Week 24, suppression of HIV RNA to less than 50 copies/ml was maintained in 84.4 % of the raltegravir group versus 90.6 % of the lopinavir (+) ritonavir group, (Non-completers = Failure).
Croatian: U oba je ispitivanja supresija HIV-RNK u 24. tjednu održana na manje od 50 kopija/ml u 84,4% bolesnika u skupini koja je primala raltegravir naspram 90,6% bolesnika u skupini koja je primala lopinavir (+) ritonavir ("prerani prekid = neuspjelo liječenje").
English: Considerable inter- and intra-individual variability was observed in the pharmacokinetics of raltegravir.
Croatian: Opažene su značajne interindividualne i intraindividualne razlike u farmakokinetici raltegravira.
English: Raltegravir is an integrase strand transfer inhibitor active against the Human Immunodeficiency Virus
Croatian: Raltegravir je inhibitor prijenosa lanca integraze, aktivan protiv virusa humane imunodeficijencije
English: *The adverse reaction data was collected based on each individual component of DUTREBIS.
Croatian: *Podaci o nuspojavama prikupljeni su na temelju svake od pojedinačnih komponenti lijeka DUTREBIS.
English: Мерк Шарп и Доум България ЕООД Тел.
Croatian: Мерк Шарп и Доум България ЕООД
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz /raltegravir (raltegravir 400 mg Single Dose)
Croatian: Nenukleozidni inhibitori reverzne transkriptaze (NNRTI) efavirenz/raltegravir (raltegravir jednokratna doza od 400 mg)
English: The clinical significance of these findings is
Croatian: Klinički značaj ovih nalaza