FrancophonIA/ELRC3.0 huggingface dataset:
English: Mutations conferring resistance to raltegravir generally also confer resistance to the integrase strand transfer inhibitor elvitegravir.
Slovenian: Mutacije, povezane z odpornostjo na raltegravir, so običajno povezane tudi z odpornostjo na zaviralec prenosa zapisa integraze elvitegravir.
English: Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products metabolised by this system (e.g. PIs) unlikely.
Slovenian: Presnova lamivudina ne vključuje CYP3A, zato medsebojna delovanja z zdravili, ki se presnavljajo s tem sistemom (npr. zaviralci proteaz), niso verjetna.
English: • antacids containing aluminium and/or magnesium - used for heartburn.
Slovenian: • antacide, ki vsebujejo aluminij in/ali magnezij - uporabljajo se pri zgagi.
English: Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Slovenian: Poročali so o nekaterih nevroloških motnjah s poznim nastankom (hipertonija, konvulzije, nenormalno vedenje).
English: DUTREBIS should not be taken with any other medicinal products containing lamivudine, raltegravir or medicinal products containing emtricitabine.
Slovenian: Zdravila DUTREBIS se ne sme uporabljati z nobenim drugim zdravilom, ki vsebuje lamivudin ali raltegravir; prav tako se ga ne sme uporabljati z zdravili, ki vsebujejo emtricitabin.
English: DUTREBIS 150 mg/300 mg film-coated tablets
Slovenian: DUTREBIS 150 mg/300 mg filmsko obložene tablete
English: No human data on the effect of DUTREBIS on fertility are available.
Slovenian: Podatkov o vplivu zdravila DUTREBIS na plodnost pri človeku ni.
English: The comparative bioavailability of DUTREBIS (150 mg lamivudine/300 mg raltegravir) fixed-dose combination tablet was assessed relative to individual components administered concomitantly (150 mg of lamivudine and 400 mg of raltegravir) in 108 healthy subjects.
Slovenian: Biološko uporabnost zdravila DUTREBIS (150 mg lamivudina/300 mg raltegravirja) v tabletah s fiksno kombinacijo odmerkov so ocenili glede na posamezni učinkovini, uporabljeni sočasno (150 mg lamivudina in 400 mg raltegravirja), pri 108 zdravih osebah.
English: • joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty moving.
Slovenian: • togost sklepov, bolečnost in bolečine (zlasti v kolku, kolenu ali rami) in težave z gibljivostjo.
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.
Slovenian: Odprta, randomizirana navzkrižna študija enkratnega odmerka z dvema obdobjema je ocenila vpliv mastnega obroka na zdravilo DUTREBIS pri 20 zdravih preiskovancih in preiskovankah.
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).
Slovenian: Zgodnji simptomi (simptomatska hiperlaktatemija) vključujejo blage prebavne težave (navzejo, bruhanje in bolečine v trebuhu), nespecifično slabo počutje, izgubo apetita, hujšanje, respiratorne simptome (hitro in/ali globoko dihanje) ali nevrološke simptome (vključno z motorično šibkostjo).
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.
Slovenian: Študija je pokazala, da so imeli plodovi, ki so bili in utero izpostavljeni kombinaciji, višjo raven vgradnje nukleozidnih analogov v DNA v številnih organih in znake večjega skrajšanja telomerov kot plodovi, izpostavljeni samo zidovudinu.
English: Plasma HIV-1 RNA (log10 copies/ml), mean [range]
Slovenian: HIV-1 RNA v plazmi (log10 kopij/ml), povprečje [razpon]
English: Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure.
Slovenian: Poročali so tudi o preobčutljivostnih reakcijah, za katere so bili značilni izpuščaj, sistemski znaki in včasih moteno delovanje organov, vključno z odpovedjo jeter.
English: These neoplasia could result from local deposition and/or aspiration of drug on the mucosa of the nose/nasopharynx during oral gavage dosing and subsequent chronic irritation and inflammation; it is likely that they are of limited relevance for the intended clinical use.
Slovenian: Te novotvorbe so lahko posledica lokalnega odlaganja in/ali aspiracije zdravila na sluznici nosu/nazofarinksa med peroralnim dajanjem zdravila po cevki za hranjenje in posledičnega kroničnega draženja in vnetja.
English: Administration of lamivudine at very high dose levels in acute animal studies did not result in any organ toxicity.
Slovenian: Uporaba zelo velikih odmerkov lamivudina v akutnih študijah na živalih ni povzročila toksičnih učinkov na organe.
English: DUTREBIS should not be co-administered with rifampicin due to reduced plasma concentrations of raltegravir (see section 4.5); the impact on the efficacy of raltegravir is unknown.
Slovenian: Zdravila DUTREBIS se ne sme uporabljati sočasno z rifampicinom, ker se koncentracija raltegravirja v plazmi zniža (glejte poglavje 4.5); vpliv tega na učinkovitost raltegravirja ni znan.
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.
Slovenian: Glede primarnega opazovanega dogodka učinkovitosti je bil delež (%) bolnikov, ki so 48. teden dosegli HIV RNA < 50 kopij/ml, v skupini z raltegravirjem 241/280 (86,1 %) in v skupini z efavirenzem 230/281 (81,9 %).
English: • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis; increased levels of sugar and fats (triglycerides and cholesterol) in the blood; resistance to insulin (so if you are diabetic, you may have to change your insulin dose to control your blood sugar).
Slovenian: • zvišana koncentracija mlečne kisline v krvi, ki lahko v redkih primerih povzroči laktacidozo, zvišana koncentracija sladkorja in maščob (trigliceridov in holesterola) v krvi, odpornost na insulin (če imate sladkorno bolezen, boste morda morali spremeniti odmerek insulina za ureditev
English: As the in vitro mutagenic activity of lamivudine could not be confirmed in in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing
Slovenian: Ker testi in vivo niso potrdili mutagenega delovanja lamivudina, ugotovljenega in vitro, sklepajo, da lamivudin ne pomeni genotoksične nevarnosti za bolnike, zdravljene z njim.
English: Mean CD4 cell count (%) increase from baseline
Slovenian: Povprečno povečanje števila celic CD4 (%) od izhodišča
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Slovenian: Poročali so o primerih osteonekroze, predvsem pri bolnikih s splošno znanimi dejavniki tveganja, napredovalo boleznijo HIV ali med dolgotrajnim kombiniranim protiretrovirusnim zdravljenjem.
English: Autoimmune disorders (such as Graves' disease) 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 (see section 4.4).
Slovenian: Poročali so tudi o pojavu avtoimunskih boleznih (kot je Gravesova bolezen) med imunsko reaktivacijo; vendar je čas do njihovega nastanka zelo različen in se lahko pojavijo tudi več mesecev po začetku zdravljenja (glejte poglavje 4.4).
English: Lamivudine in the fixeddose combination tablet was bioequivalent with the lamivudine (single agent) after administration of the individual component.
Slovenian: Lamivudin v tabletah s fiksno kombinacijo odmerkov je bil bioekvivalenten lamivudinu (samostojno zdravilo) po uporabi posamezne učinkovine.
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.
Slovenian: Lamivudin v bakterijskih testih ni bil mutagen, vendar je enako kot številni nukleozidni analogi pokazal aktivnost v citogenetskem preizkusu in vitro in v preizkusu na celicah mišjega limfoma.
English: In rats, tumours (squamous cell carcinoma) of the nose/nasopharynx were identified at 300 and 600 mg/kg/day in females and at 300 mg/kg/day in males.
Slovenian: Pri podganah so tumorje nosu/nazofarinksa (skvamoznocelični karcinom) odkrili pri samicah, ki so dobivale odmerke 300 in 600 mg/kg/dan, in pri samcih, ki so dobivali odmerke 300 mg/kg/dan.
English: Recommendations concerning co-administration with DUTREBIS
Slovenian: Priporočila glede sočasne uporabe z zdravilom DUTREBIS
English: DUTREBIS should not be used during pregnancy.
Slovenian: Zdravila DUTREBIS se med nosečnostjo ne sme uporabljati.
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.
Slovenian: Pri bolnikih, ki so jemali raltegravir, so poročali o hudih, potencialno življenjsko nevarnih kožnih reakcijah in kožnih reakcijah s smrtnim izidom; večinoma so se pojavile med uporabo skupaj z drugimi zdravili, povezanimi s takšnimi reakcijami.
English: • The other ingredients are: hypromellose (2910), croscarmellose sodium, lactose monohydrate, silicon dioxide (colloidal), magnesium stearate, and microcrystalline cellulose.
Slovenian: • Pomožne snovi so: hipromeloza (2910), premreženi natrijev karmelozat, laktoza monohidrat, koloidni silicijev dioksid, magnezijev stearat in mikrokristalna celuloza.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take:
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati:
English: In a drug interaction study with DUTREBIS and etravirine, there was no clinically meaningful drug interaction between raltegravir and etravirine, with respect to raltegravir.
Slovenian: V študiji medsebojnega delovanja zdravila DUTREBIS in etravirina med raltegravirjem in etravirinom ni bilo klinično pomembnega medsebojnega delovanja, kar zadeva raltegravir.
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Slovenian: Mutanti M184V kažejo močno zmanjšano občutljivost na lamivudin in tudi zmanjšano sposobnost razmnoževanja virusa in vitro.
English: This means that you may keep getting infections or other illnesses associated with HIV, if you don't take DUTREBIS as your doctor has instructed you.
Slovenian: To pomeni, da se še vedno lahko pojavijo okužbe ali druge bolezni, povezane z virusom HIV, če zdravila DUTREBIS ne
English: It also lowers the chance that your medicines will stop being able to fight HIV (also called "drug resistance").
Slovenian: možnost, da zdravila proti virusu HIV ne bi pomagala (kar imenujemo tudi "odpornost na
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Slovenian: Zdravljenje mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
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.
Slovenian: V primeru prenehanja uporabe zdravila DUTREBIS pri bolnikih, sočasno okuženih z virusom hepatitisa B, je priporočljivo redno opravljati teste delovanja jeter in označevalce razmnoževanja HBV, kajti odtegnitev lamivudina lahko povzroči
English: • buzzing, hissing, whistling, ringing or other persistent noise in the ears • palpitations; slow heart rate; fast or irregular heart beats
Slovenian: • brenčanje, piskanje, žvižganje, zvonjenje ali drugi nenehni šumi v ušesih • palpitacije, počasno bitje srca, hitro ali neredno bitje srca
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.
Slovenian: Bolniki, sočasno okuženi z virusom hepatitisa B in/ali hepatitisa C Predhodno že zdravljeni bolniki (N = 114/699 ali 16 %; HBV = 6 %, HCV = 9 %, HBV + HCV = 1 %) in predhodno še nezdravljeni bolniki (N = 34/563 ali 6 %; HBV = 4 %, HCV = 2 %, HBV + HCV = 0,2 %) s sočasnim kroničnim (vendar ne akutnim) aktivnim hepatitisom B in/ali hepatitisom C so lahko bili vključeni v študije III. faze z raltegravirjem pod pogojem, da izhodiščne vrednosti testov jetrne funkcije niso presegale 5-kratne zgornje meje normalnih vrednosti.
English: Limited data are available on the consequences of ingestion of acute overdoses in humans.
Slovenian: Podatkov o posledicah zaužitja akutnih prevelikih odmerkov pri človeku je malo.
English: In addition, caution should also be used when co-administering DUTREBIS with other strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1.
Slovenian: Previdnost je potrebna tudi pri sočasni uporabi zdravila DUTREBIS in drugih močnih induktorjev uridin-difosfat-glukuronoziltransferaze (UGT) 1A1.
English: HIV is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
Slovenian: Virus HIV je virus, ki povzroča AIDS (sindrom pridobljene imunske
English: When DUTREBIS is administered, raltegravir is absorbed with a Tmax of approximately 1 hour in the fasted state.
Slovenian: Ob uporabi zdravila DUTREBIS se raltegravir na tešče absorbira s tmax približno 1 uro.
English: Raltegravir400 mg twice daily + OBT (N = 462)
Slovenian: raltegravir 400 mg dvakrat na dan + OBT (N = 462)
English: Depression, including suicidal ideation and behaviours, has been reported with raltegravir, particularly in patients with a pre-existing history of depression or psychiatric illness.
Slovenian: Med uporabo raltegravirja so poročali o depresiji, vključno s samomorilnimi mislimi in obnašanjem, predvsem pri bolnikih, ki so imeli v anamnezi depresijo ali psihiatrično bolezen.
English: Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of zidovudine resistant isolates in individuals with no prior antiretroviral therapy.
Slovenian: Podatki iz kliničnih študij kažejo, da kombinacija lamivudina in zidovudina zakasni pojav izolatov, odpornih na zidovudin, pri posameznikih, ki pred tem še niso prejemali protiretrovirusnega
English: No dosage adjustment required for DUTREBIS or hormonal contraceptives (oestrogen- and/or progesterone-based).
Slovenian: Odmerka zdravila DUTREBIS ali hormonskih kontraceptivov (na podlagi estrogena in/ali
English: Dosing in children less than 6 years of age and those weighting less than 30 kg requires weight based dose adjustments for the individual components of DUTREBIS.
Slovenian: Odmerjanje pri otrocih, mlajših od 6 let, in tistih, ki tehtajo manj kot 30 kg, zahteva prilagoditev odmerkov posameznih učinkovin zdravila DUTREBIS glede na telesno maso.
English: DUTREBIS 150 mg/300 mg film-coated tablets lamivudine/raltegravir
Slovenian: DUTREBIS 150 mg/300 mg filmsko obložene tablete lamivudin/raltegravir
English: DUTREBIS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).
Slovenian: Zdravilo DUTREBIS je v kombinaciji z drugimi protiretrovirusnimi zdravili indicirano za zdravljenje okužbe z virusom humane imunske pomanjkljivosti (HIV-1) pri odraslih, mladostnikih in otrocih, od 6. leta starosti in s telesno maso vsaj 30 kg, trenutno ali v preteklosti brez dokazov o virusni odpornosti na protivirusna zdravila iz skupin zaviralcev prenosa zapisa integraze (InSTI - Integrase Strand Transfer Inhibitor) ali nukleozidnih zaviralcev reverzne transkriptaze (NRTI - Nucleoside Reverse Transcriptase Inhibitor) (glejte poglavja 4.2, 4.4 in 5.1).
English: The pharmacokinetic properties, use in special populations and drug-drug interactions for each of the individual components (lamivudine and raltegravir) are applicable to
Slovenian: Farmakokinetične lastnosti, uporaba v posebnih populacijah in medsebojna delovanja zdravil za vsako od obeh posameznih učinkovin (lamivudin in raltegravir) veljajo tudi za zdravilo DUTREBIS.
English: • Lamivudine belongs to a group of medicines called nucleoside analogue reverse transcriptase
Slovenian: • lamivudin spada v skupino protiretrovirusnih zdravil, imenovanih nukleozidni zaviralci reverzne
English: A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the combination of zidovudine and lamivudine at human-equivalent exposures.
Slovenian: V študiji genotoksičnosti preko placente so pri opicah primerjali zidovudin sam s kombinacijo zidovudina in lamivudina v odmerkih, kakršnim so izpostavljeni ljudje.
English: A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and NRTIs has been hypothesised.
Slovenian: Domnevajo, da obstaja povezava med visceralno lipomatozo in zaviralci proteaz (PI - protease inhibitor) ter lipoatrofijo in NRTI-ji.
English: Because lamivudine is substantially excreted by the kidney and older people are more likely to have decreased renal function, renal function should be monitored.
Slovenian: Ker se lamivudin v veliki meri izloča skozi ledvice in je pri starejših osebah večja verjetnost za zmanjšano delovanje ledvic, je pri teh bolnikih treba spremljati delovanje ledvic.
English: DUTREBIS should not be given in patients with a creatinine clearance of <50 ml/min
Slovenian: Zdravila DUTREBIS ne smejo prejemati bolniki z očistkom kreatinina < 50 ml/min
English: The evidence of efficacy of raltegravir was based on the analyses of 96-week data from two randomised, double-blind, placebo-controlled studies, (BENCHMRK 1 and BENCHMRK 2, Protocols 018 and 019) in antiretroviral treatment-experienced HIV-1 infected adult patients and the analysis of 240-week data from randomised, double-blind, active-control trial, (STARTMRK, Protocol 021) in antiretroviral treatment-naïve HIV-1 infected adult patients.
Slovenian: Dokaz za učinkovitost raltegravirja temelji na analizi 96-tedenskih podatkov dveh randomiziranih, dvojno slepih, s placebom nadzorovanih študij (BENCHMRK 1 in BENCHMRK 2, Protokola 018 in 019) pri odraslih bolnikih, okuženih s HIV-1 in predhodno že zdravljenih s protiretrovirusnimi zdravili, ter na analizi 240-tedenskih podatkov randomiziranega, dvojno slepega, z zdravilno učinkovino nadzorovanega preskušanja (STARTMRK, Protokol 021) pri odraslih bolnikih, okuženih z virusom HIV-1, ki še niso prejemali protiretrovirusnih zdravil.
English: At a therapeutic dose of 300 mg once daily, the mean (CV) steady-state Cmax, Cmin and 24h AUC are 2.0 μg/ml (26 %), 0.04 μg/ml (34 %) and 8.9 μg•h/ml (21 %), respectively.
Slovenian: Med uporabo terapevtskega odmerka 300 mg enkrat na dan je v stanju dinamičnega ravnovesja povprečna (KV) Cmax 2,0 µg/ml (26 %), Cmin 0,04 µg/ml (34 %) in 24-urna AUC 8,9 µg•h/ml (21 %).
English: When used with other medicines, DUTREBIS may:
Slovenian: Pri sočasni uporabi z drugimi zdravili lahko zdravilo DUTREBIS:
English: • Raltegravir belongs to a group of medicines called HIV integrase strand transfer inhibitors
Slovenian: • raltegravir spada v skupino zdravil, imenovanih zaviralci HIV integraze.
English: Cases of pancreatitis have occurred rarely with lamivudine.
Slovenian: V redkih primerih se je med uporabo lamivudina pojavil pankreatitis.
English: • cladribine - used to treat hairy cell leukaemia.
Slovenian: • kladribin - uporablja se za zdravljenje dlakavocelične levkemije
English: The bioavailablity of the raltegravir component of DUTREBIS in the fasted state is approximately 60 %, which is higher than the bioavailability of raltegravir in the raltegravir poloxamer formulation, and accounts for the difference in raltegravir dose.
Slovenian: Biološka uporabnost raltegravirja v zdravilu DUTREBIS na tešče je približno 60 %, kar je več od biološke uporabnosti raltegravirja v obliki raltegravirjevega poloksamera in to je razlog za razliko v odmerku raltegravirja.
English: An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40 % increase in lamivudine exposure at therapeutic doses.
Slovenian: Medsebojno delovanje s trimetoprimom, sestavino kotrimoksazola, v terapevtskih odmerkih poveča izpostavljenost lamivudinu za 40 %.
English: DUTREBIS is not recommended for use in combination with emtricitabine containing products, since both lamivudine (in DUTREBIS) and emtricitabine are cytidine analogues (i.e. risk for intracellular interactions, (see section 4.4).
Slovenian: Uporaba zdravila DUTREBIS v kombinaciji z zdravili, ki vsebujejo emtricitabin, ni priporočljiva, saj sta lamivudin (učinkovina zdravila DUTREBIS) in emtricitabin analoga citidina (npr. tveganje za medcelične interakcije, glejte poglavje 4.4).
English: Raltegravir C12 hr increases dose proportionally over the dose range of 100 to 800 mg and increases slightly less than dose proportionally over the dose range 100 mg to 1,600 mg.
Slovenian: Pri odmerkih v razponu od 100 do 800 mg se vrednost C12ur raltegravirja povečuje sorazmerno z odmerkom, pri odmerkih v razponu od 100 mg do 1.600 mg pa nekoliko manj kot sorazmerno z odmerkom.
English: Following administration of an oral dose of radiolabeled raltegravir, approximately 51 and 32 % of the dose was excreted in faeces and urine, respectively.
Slovenian: Po peroralni uporabi radioaktivno označenega raltegravirja se je približno 51 % odmerka izločilo v blatu in približno 32 % odmerka v urinu.
English: Clinical end-point data indicate that lamivudine in combination with zidovudine, results in a significant reduction in the risk of disease progression and mortality.
Slovenian: Podatki o kliničnih opazovanih dogodkih kažejo, da lamivudin v kombinaciji z zidovudinom pomembno zmanjša tveganje za napredovanje bolezni in
English: Autoimmune disorders (such as Graves' disease) 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.
Slovenian: Poročali so tudi o pojavu avtoimunskih bolezni (kot je Gravesova bolezen) med imunsko reaktivacijo; vendar je čas do njihovega nastanka zelo različen in se lahko pojavijo tudi več mesecev po začetku zdravljenja.
English: Based on data derived from a study in healthy volunteers, at a therapeutic dose of 150 mg twice daily, mean (CV) steady-state Cmax and Cmin of lamivudine in plasma are 1.2 μg/ml (24 %) and 0.09 μg/ml (27 %), respectively.
Slovenian: Na podlagi podatkov študije pri zdravih prostovoljcih je med uporabo terapevtskega odmerka 150 mg dvakrat na dan v stanju dinamičnega ravnovesja povprečna (KV) Cmax lamivudina v plazmi 1,2 µg/ml (24 %) in njegova Cmin 0,09 µg/ml (27 %).
English: The side effects for the two individual medicines contained in DUTREBIS are presented below.
Slovenian: Spodaj so navedeni neželeni učinki obeh posameznih učinkovin, ki ju vsebuje zdravilo DUTREBIS.