FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no adequate efficacy and safety data in patients with decompensated cirrhosis.
Croatian: Ne postoje podaci o djelotvornosti i sigurnosti u bolesnika s dekompenziranom cirozom.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA [folding box only]
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM [samo na kutiji]
English: In the juvenile toxicology study, rats were treated from day 14 to day 70 post-partum and were mated with rats receiving the same treatment (no sibling mating).
Croatian: U toksikološkom ispitivanju na mladim životinjama, štakori su primali telbivudin od 14. do 70. dana nakon okota i parili su se sa štakorima koji su primali jednako liječenje (braća/sestre se nisu parili).
English: Caucasian ethnicity was associated with lower treatment response to both antiviral agents used in the NV-02B-007 (GLOBE) study; however the Caucasian patient population was very limited (n = 98).
Croatian: Pripadnici bijele rase su bili povezani sa slabijim terapijskim odgovorom na oba antivirotika korištena u ispitivanju NV-02B-007 (GLOBE); no populacija bolesnika bijele rase bila je vrlo ograničena (n = 98).
English: ESRD/ Haemodialysis (n = 6) 200 mg
Croatian: ESRD/ hemodijaliza (n = 6) 200 mg
English: Holding the cup at eye level, carefully and slowly pour the prescribed amount of solution from the bottle into the dosing cup until the solution reaches the top of the appropriate graduation.
Croatian: Držeći čašu u razini očiju, pažljivo i polako ulijte propisanu količinu otopine iz boce u dozirnu čašu dok otopina ne dođe do vrha odgovarajuće graduacije.
English: The long-term safety population consisted of 655 patients including 518 from NV-02B-007 (GLOBE) and 137 from NV02B-015.
Croatian: Populacija obuhvaćena ispitivanjem dugotrajne sigurnosti sastojala se od 655 bolesnika, uključujući 518 iz NV02B-007 (GLOBE) i 137 iz NV-02B-015.
English: The tablet should not be chewed, split or crushed.
Croatian: Tabletu se ne smije žvakati, lomiti ni drobiti.
English: Nervous system disorders Common
Croatian: Poremećaji živčanog sustava Često
English: After a median off-treatment follow-up period of 120 weeks, the majority of HBeAg-positive telbivudine treated-patients showed sustained HBeAg loss (83.3%; 25/30), and sustained HBeAg seroconversion (79.2%; 19/24).
Croatian: Praćenjem bolesnika tijekom medijana trajanja bez liječenja od 120 tjedana uočeno je da većina HBeAg-pozitivnih bolesnika liječenih telbivudinom ima održivi gubitak HBeAg (83,3%; 25/30), i održivu HBeAg serokonverziju (79,2%; 19/24).
English: Treatment with Sebivo reduces the amount of hepatitis B virus in the body by blocking its growth, resulting in less liver damage and improved liver function.
Croatian: Liječenje Sebivom smanjuje količinu virusa hepatitisa B u tijelu zaustavljanjem njihova umnožavanja, čime se smanjuje oštećenje jetre i poboljšava njezina funkcija.
English: Following oral administration of a 600 mg single dose of telbivudine to healthy subjects (n = 42), the peak plasma concentration (Cmax) of telbivudine was 3.2  1.1 g/ml (mean  SD) and occurred at median 3.0 hours post dose.
Croatian: Nakon peroralne primjene jednokratne doze od 600 mg telbivudina u zdravih ispitanika (n = 42), vršna koncentracija telbivudina u plazmi (Cmax) iznosila je 3,2  1,1 g/ml (srednja vrijednost  SD), a medijan vremena njena postizanja iznosio je 3,0 sati nakon primjene doze.
English: What Sebivo contains - The active substance is telbivudine.
Croatian: Što Sebivo sadrži - Djelatna tvar je telbivudin.
English: Remove the water from the dosing cup, wipe it with a clean tissue and place it back on top of the cap.
Croatian: Uklonite vodu iz dozirne čaše, obrišite je čistom maramicom i ponovo je stavite na zatvarač.
English: Telbivudine is an inhibitor of both HBV first strand (EC50 = 0.4-1.3 M) and second strand (EC50 = 0.12-0.24 M) synthesis, and shows a distinct preference for inhibiting second strand production.
Croatian: Telbivudin je inhibitor sinteze i prvog (EC50 = 0,4-1,3 M) i drugog (EC50 = 0,12-0,24 M) lanca HBV-a, te pokazuje izrazitu sklonost za inhibiciju stvaranja drugog lanca.
English: Study NV-02B-007 (GLOBE)
Croatian: Ispitivanje NV-02B-007 (GLOBE)
English: Race There are no significant race-related differences in telbivudine pharmacokinetics.
Croatian: Rasa Ne postoje značajne razlike među rasama u farmakokinetici telbivudina.
English: Your doctor will monitor you regularly while you are receiving Sebivo.
Croatian: Vaš liječnik će Vas redovito pratiti dok uzimate Sebivo.
English: The safety and efficacy of telbivudine in liver transplant recipients are unknown.
Croatian: Sigurnost i djelotvornost telbivudina u bolesnika s presađenom jetrom nisu poznati.
English: Patients with sustained HBeAg seroconversion had a mean HBV DNA of 3.3 log10 copies/ml; and 73.7% had HBV DNA < 4 log10 copies/ml.
Croatian: Bolesnici s održivom HBeAg serokonverzijom imali su prosječnu razinu HBV DNA of 3,3 log10 kopija/ml; a 73,7% imalo je prosječnu razinu HBV DNA <4 log10 kopija/ml.
English: Telbivudine should be administered after haemodialysis.
Croatian: Telbivudin treba primijeniti nakon hemodijalize.
English: HBeAg-positive patients: The mean age of patients was 32 years, 74% were male, 82% were Asian, 12% were Caucasian, and 6% had previously received alfa-interferon therapy.
Croatian: HBeAg-pozitivni bolesnici: Srednja dob bolesnika bila je 32 godine, 74% bili su muškarci, 82% bili su Azijati, 12% bili su bijelci, a 6% ih je ranije primalo terapiju interferonom alfa.
English: Telbivudine-5'-triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'-triphosphate.
Croatian: Telbivudin-5'-trifosfat inhibira HBV DNK polimerazu (reverznu transkriptazu) nadmetanjem s prirodnim supstratom timidin 5'-trifosfatom.
English: Always close the bottle with the cap after use.
Croatian: Nakon uporabe, bocu uvijek zatvorite zatvaračem.
English: • In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBsAg seroconversion or until there is evidence of loss of efficacy.
Croatian: • u HBeAg-negativnih bolesnika koji nemaju cirozu, liječenje treba primjenjivati barem do HBsAg- serokonverzije ili do pojave dokaza o gubitku djelotvornosti.
English: A reduction of the daily dose using Sebivo oral solution, as detailed in Table 1 below, is recommended.
Croatian: Preporučuje se snižavanje dnevne doze korištenjem Sebivo oralne otopine kako je detaljno opisano niže u Tablici
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstva lijeka, dio 4.2.).
English: Fertility was reduced in pairs given ≥ 1000 mg/kg/day as shown by decreases in fertility and mating indices, and reduced conception rate.
Croatian: Plodnost je bila smanjena u parova koji su dobili ≥1000 mg/kg/dan, što se vidjelo kao smanjenje indeksa plodnosti i parenja te smanjenje stope oplodnje.
English: How long to take Sebivo
Croatian: Koliko dugo uzimati Sebivo
English: In HBeAg-negative patients, telbivudine was non-inferior to lamivudine (75.2% and 77.2% responders; p = 0.6187).
Croatian: U HBeAg-negativnih bolesnika, telbivudin nije bio inferiorniji od lamivudina (75,2% odnosno 77,2% bolesnika s odgovorom; p = 0,6187).
English: ≥ 3 log10 copies/ml
Croatian: ≥3 log10 kopija/ml
English: Genotypic analysis of 203 evaluable sample pairs with HBV DNA ≥ 1,000 copies/ml at week 104 (NV-02B-007 (GLOBE)) demonstrated that the primary mutation associated with telbivudine resistance was rtM204I, often associated with mutations rtL180M and rtL80I/V and infrequently with rtV27A, rtL82M, rtV173L, rtT184I and rtA200V.
Croatian: Genotipska analiza 203 parnih uzoraka prikladnih za analizu s HBV DNK ≥1000 kopija/ml u 104. tjednu (NV-02B-007 (GLOBE)) pokazala je da je primarna mutacija povezana s rezistencijom na telbivudin bila rtM204I, koja je često povezana s mutacijama rtL180M i rtL80I/V, a rijetko s rtV27A, rtL82M, rtV173L, rtT184I i rtA200V.
English: Telbivudine was not active against HIV in vitro.
Croatian: Telbivudin nije bio djelotvoran protiv HIV-a in vitro.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici boce.
English: Studies in pregnant rabbits showed early delivery and/or abortion secondary to maternal toxicity.
Croatian: U ispitivanjima u gravidnih ženki kunića primijećen je prijevremeni porođaj i/ili pobačaj uzrokovan toksičnošću za majku.
English: The in vitro antiviral activity of telbivudine was assessed in the HBV-expressing human hepatoma cell line 2.2.15.
Croatian: Antivirusna aktivnost telbivudina in vitro ispitivana je u staničnoj liniji ljudskoga hepatoma 2.2.15. s ekspresijom HBV-a.
English: Outcome results at week 104, based on level of HBV DNA at week 24, for either HBeAg-positive or HBeAg-negative patients are presented in Table 7.
Croatian: Završni rezultati u 104. tjednu, temeljeni na razini HBV DNK u 24. tjednu i za HBeAg-pozitivne i HBeAg-negativne bolesnike, su prikazani u Tablici 7.
English: ALT elevation > 2x baseline and > 10x ULN
Croatian: ALT povišenje >2x početne vrijednosti i >10x GGN
English: The single-dose pharmacokinetics of telbivudine (200, 400 and 600 mg) have been evaluated in patients (without chronic hepatitis B) with various degrees of renal impairment (as assessed by creatinine clearance).
Croatian: Farmakokinetika jednokratne doze telbivudina (200, 400 i 600 mg) ispitivana je u bolesnika (bez kroničnog hepatitisa B) s različitim stupnjevima oštećenja bubrega (procijenjene klirensom kreatinina).
English: 28 film-coated tablets 98 film-coated tablets
Croatian: Filmom obložena tableta 28 filmom obloženih tableta 98 filmom obloženih tableta
English: Telbivudine is not a substrate, inhibitor or inducer of the cytochrome P450 (CYP450) enzyme system.
Croatian: Telbivudin nije supstrat, inhibitor ni induktor enzimskog sustava citokroma P450 (CYP450).
English: Patients with cirrhosis without decompensation
Croatian: Bolesnici s cirozom bez dekompenzacije
English: Film-coated tablets containing 600 mg telbivudine are bioequivalent to 30 ml telbivudine oral solution (20 mg/ml).
Croatian: Filmom obložene tablete koje sadrže 600 mg telbivudina biološki su ekvivalentne oralnoj otopini koja sadrži 30 ml (20 mg/ml) telbivudina.
English: Adjustment of the dose is required in patients with creatinine clearance < 50 ml/min, including those with end-stage renal disease (ESRD) on haemodialysis.
Croatian: Prilagođavanje doze potrebno je u bolesnika s klirensom kreatinina <50 ml/min, uključujući one s bubrežnom bolešću u završnom stadiju (engl.
English: Diarrhoea, blood lipase increased, nausea, abdominal pain
Croatian: Proljev, povišena lipaza u krvi, mučnina, bol u abdomenu
English: Sebivo has minor influence on the ability to drive and use machines.
Croatian: Sebivo malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: If you have taken too much Sebivo, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice straight away.
Croatian: Ako ste uzeli previše Sebiva, ili je tablete slučajno uzeo netko drugi, odmah se javite svom liječniku ili u bolnicu i zatražite savjet.
English: Clinical studies of telbivudine did not include sufficient numbers of patients  65 years of age to determine whether they respond differently from younger subjects.
Croatian: 65 godina starosti da bi se moglo odrediti reagiraju li oni drugačije od mlađih bolesnika.
English: Cross-resistance has been observed among HBV nucleoside analogues (see section 4.4).
Croatian: Među HBV nukleozidnim analozima uočena je križna rezistencija (vidjeti dio 4.4).
English: A vaccine is available to prevent infection with HBV.
Croatian: Za sprječavanje infekcije HBV-om postoji cjepivo.
English: Telbivudine is a synthetic thymidine nucleoside analogue with activity against HBV DNA polymerase.
Croatian: Telbivudin je sintetski analog timidinskog nukleozida s djelovanjem protiv HBV DNK polimeraze.
English: * The population without viral resistance at entry into study CLDT600A2303 consisted of 502 patients (293 HBeAg-positive and 209 HBeAg-negative).
Croatian: * Populacija od 502 bolesnika koji na ulasku u ispitivanje CLDT600A2303 nisu bili rezistentni na virus (293 HBeAg-pozitivni i 209 HBeAg-negativni).
English: Withdraw all the solution from the cup into the syringe.
Croatian: Izvucite svu otopinu iz čaše u štrcaljku.
English: Sebivo contains sodium
Croatian: Sebivo sadrži natrij
English: When secondary to other conditions, some cases were also associated with pancreatitis, liver failure/hepatic steatosis and renal failure.
Croatian: Kada je laktacidoza bila posljedica drugih stanja, neki su slučajevi također bili povezani s pankreatitisom, zatajenjem jetre/steatozom jetre i zatajenjem bubrega.
English: On-treatment response parameters at week 24 that predicted emergence of drug resistant virus by week 104 were HBV DNA > 300 copies/ml and elevation of serum ALT.
Croatian: Parametri odgovora za vrijeme liječenja u 24. tjednu koji su predviđali pojavu virusa rezistentnog na lijek do 104. tjedna bili su HBV DNK >300 kopija/ml i povišenje ALT-a u serumu.
English: 1 bottle containing 300 ml oral solution [folding box only] 1 cup + 1 oral syringe [folding box only]
Croatian: 1 boca s 300 ml oralne otopine [samo na kutiji] 1 čaša + 1 štrcaljka za usta [samo na kutiji] 300 ml [samo na naljepnici boce]
English: As renal excretion is the predominant route of elimination, patients with moderate to severe renal dysfunction and those undergoing haemodialysis require a dose interval adjustment (see section 4.2).
Croatian: Budući da je izlučivanje putem bubrega glavni put eliminacije, bolesnicima s umjerenom do teškom disfunkcijom bubrega kao i onima na hemodijalizi potrebno je prilagoditi interval doziranja (vidjeti dio 4.2).
English: In vitro, telbivudine was not active against the HBV strains containing rtM204V/rtL180M or rtM204I mutations (see section 5.1).
Croatian: In vitro, telbivudin nije bio djelotvoran protiv HBV sojeva s rtM204V/rtL180M ili rtM204I mutacijama (vidjeti dio 5.1).
English: If you have taken too much Sebivo, or if someone else accidentally takes your oral solution, go to your doctor or hospital for advice straight away.
Croatian: Ako ste uzeli previše Sebiva, ili je oralnu otopinu slučajno uzeo netko drugi, odmah se javite svom liječniku ili u bolnicu i zatražite savjet.
English: - Uncommonly Sebivo can induce numbness, tingling, pain and/or burning sensations in the arms and/or legs (peripheral neuropathy).
Croatian: - Povremeno, Sebivo može izazvati obamrlost, trnce, bol i/ili osjećaj pečenja u rukama i/ili nogama (periferna neuropatija).
English: Baseline ALT levels > 2x ULN and baseline HBV DNA < 9 log10 copies/ml were associated with higher rates of HBeAg seroconversion in HBeAg-positive patients.
Croatian: Početne razine ALT-a >2x GGN i početne razine HBV DNK <9 log10 kopija/ml bile su povezane s višim stopama HBeAg serokonverzije u HBeAg-pozitivnih bolesnika.
English: Tell your doctor if you have, or have ever had, any kidney problems.
Croatian: Obavijestite svog liječnika ako imate, ili ste ikada imali problema s bubrezima.
English: PVC/aluminium blisters
Croatian: 6.5 Vrsta i sadržaj spremnika PVC/aluminij blisteri
English: UNIQUE IDENTIFIER - 2D BARCODE [folding box only]
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD [samo na kutiji]
English: One isolated rtM204V mutation and two rtM204I/V/M mutations were reported in telbivudine-treated patients experiencing viral breakthrough up to week 208.
Croatian: Zabilježena je jedna izolirana rtM204V mutacija te dvije rtM204I/V/M mutacije u bolesnika liječenih telbivudinom kod kojih je došlo do virusnog proboja do 208. tjedna.
English: Take the pack with you and show it to the doctor.
Croatian: Sa sobom ponesite pakiranje oralne otopine i pokažite ga liječniku.
English: 600 mg (30 ml) once daily 600 mg once daily 400 mg (20 ml) once daily 600 mg once every 48 hours
Croatian: Alternativno** prilagođavanje doze produljenjem intervala između doza 600 mg (30 ml) jedanput na dan 600 mg jedanput na dan 400 mg (20 ml) jedanput na dan 600 mg jedanput svakih 48 sati
English: If any of these applies to you, tell your doctor before you take Sebivo.
Croatian: Ako se bilo što od navedenog odnosi na Vas, prije uzimanja Sebiva obavijestite svog liječnika.
English: The safety and efficacy of long-term (104 weeks) Sebivo treatment were evaluated in two activecontrolled clinical studies that included 1,699 patients with chronic hepatitis B (NV-02B-007 (GLOBE) and NV-02B-015).
Croatian: Sigurnost i djelotvornost dugotrajnog liječenja Sebivom (104 tjedna) ispitivani su u dva ispitivanja s aktivnom kontrolom koja su uključivala 1699 bolesnika s kroničnim hepatitisom B (NV-02B-007 GLOBE i NV-02B-015).
English: The primary endpoint of therapeutic response was a composite serological endpoint requiring suppression of HBV DNA to < 5 log10 copies/ml in conjunction with either loss of serum HBeAg or ALT normalised.
Croatian: Primarna mjera ishoda terapijskog odgovora bila je kompozitna serološka mjera ishoda koja se sastoji od supresije HBV DNK do <5 log10 kopija/ml u kombinaciji ili s nestankom serumskog HBeAg ili s normalizacijom ALT-a.
English: It is not known whether telbivudine is excreted in human milk.
Croatian: Nije poznato izlučuje li se telbivudin u majčino mlijeko u ljudi.
English: The efficacy and safety results of the NV-02B-007 (GLOBE) study were confirmed in study NV-02B015.
Croatian: Rezultati djelotvornosti i sigurnosti u ispitivanju NV-02B-007 (GLOBE) bili su potvrđeni u ispitivanju NV-02B-015.
English: Slowly and carefully pour the solution from the bottle into the dosing cup until it reaches the prescribed amount.
Croatian: Polako i pažljivo ulijte otopinu iz boce u dozirnu čašu dok niste ulili propisanu količinu.
English: At week 24, 203 HBeAg-positive (44%) and 177 HBeAg-negative (80%) telbivudine-treated subjects achieved undetectable HBV DNA levels.
Croatian: U 24. tjednu, 203 HBeAg-pozitivnih (44%) i 177 HBeAg-negativnih (80%) ispitanika liječenih telbivudinom su postigli HBV DNK razine koje nije moguće otkriti.
English: Gender There are no significant gender-related differences in telbivudine pharmacokinetics.
Croatian: Spol Ne postoje značajne razlike među spolovima u farmakokinetici telbivudina.
English: Cases of rhabdomyolysis have been reported during post-marketing use of telbivudine (see section 4.8).
Croatian: Nakon stavljanja telbivudina u promet zabilježeni su slučajevi rabdomiolize (vidjeti dio 4.8).
English: Patients who achieve HBV DNA levels < 3 log10 copies/ml by week 24 had optimal responses to treatment; conversely patients with HBV DNA levels > 4 log10 copies/ml at 24 weeks had less favourable outcomes at week 52.
Croatian: Bolesnici koji su do 24. tjedna postigli HBV DNK razine <3 log10 kopija/ml imali su optimalan odgovor na liječenje; s druge strane, bolesnici s HBV DNK razinama >4 log10 kopija/ml u 24. tjednu imali su manje povoljne ishode u 52. tjednu.
English: At week 24, 203 HBeAg-positive and 177 HBeAg-negative subjects achieved non-detectable HBV DNA levels.
Croatian: U 24. tjednu, 203 HBeAg-pozitivnih i 177 HBeAg-negativnih ispitanika postiglo je HBV DNK razine koje nije moguće otkriti.
English: Telbivudine is not a substrate, inhibitor or inducer of the cytochrome P450 (CYP450) enzyme system (see section 5.2).
Croatian: Telbivudin nije supstrat, inhibitor ni induktor enzimskog sustava citokroma P450 (CYP450) (vidjeti dio 5.2).
English: Myopathy/myositis, arthralgia, myalgia, pain in the extremities, back pain, muscle spasm, neck pain, flank pain
Croatian: Miopatija/miozitis , artralgija, mijalgija, bol u udovima, bol u leđima, spazam mišića, bol u vratu, bol u boku
English: In HBeAg-positive patients, telbivudine was superior to lamivudine in therapeutic response (75.3% vs 67.0% responders; p = 0.0047).
Croatian: U HBeAg-pozitivnih bolesnika, telbivudin se pokazao superioran lamivudinu u terapijskom odgovoru (75,3% u odnosu na 67,0% bolesnika s odgovorom; p = 0,0047).
English: Of those HBeAg-positive subjects, 95% achieved non-detectable HBV DNA, 39% achieved HBeAg seroconversion, 90% achieved ALT normalisation at week 52 and 0.5% exhibited resistance at week 48.
Croatian: Među tim HBeAg-pozitivnim ispitanicima, 95% postiglo je stanje u kojem nije moguće otkriti HBV DNK, 39% je postiglo HBeAg serokonverziju, 90% je postiglo normalizaciju ALT-a u 52. tjednu, dok se kod 0,5% javila rezistencija u 48. tjednu.
English: Do not chew, split or crush the tablet.
Croatian: Nemojte žvakati, lomiti ni drobiti tabletu.
English: 300 ml brown glass bottle with a child-resistant closure, including a polyethylene sealing disc and a guarantee ring, a polypropylene dosing cup with embossed graduations from 5 to 30 ml in 5 ml increments, and a polypropylene oral syringe with graduations of 1 ml to 10 ml in 0.5 ml increments.
Croatian: 300 ml oralne otopine u smeđoj staklenoj boci sa sigurnosnim zatvaračem za djecu, uključujući polietilenski zatvarač i sigurnosni prsten, polipropilensku dozirnu čašu graduiranu od 5 ml do 30 ml (povećanja od 5 ml) i polipropilensku štrcaljku za usta graduiranu od 1 ml do 10 ml (povećanja od 0,5 ml).
English: Similarly of those HBeAg-negative subjects, 96% achieved non-detectable HBV DNA, 79% achieved ALT normalisation at week 52 and 0% exhibited resistance at week 48.
Croatian: Slično je bilo i s HBeAgnegativnim ispitanicima, 96% postiglo je stanje u kojem nije moguće otkriti HBV DNK, 79% je postiglo normalizaciju ALT-a u 52. tjednu, dok se kod 0% javila rezistencija u 48. tjednu.
English: One ml contains 20 mg telbivudine.
Croatian: Jedan ml sadrži 20 mg telbivudina.
English: Severe (< 30) (n = 6) 200 mg
Croatian: Teško oštećena (<30) (n = 6) 200 mg
English: Study CLDT600ACN04E1 - Impact of treatment on liver histology In study CLDT600ACN04E1, 57 patients with available paired liver biopsies at baseline and after mean treatment of 260.8 weeks were evaluated for changes in liver histology (38 HBeAg-positive and 19 HBeAg-negative patients).
Croatian: Ispitivanje CLDT600ACN04E1 - učinak liječenja na histološki nalaz jetre Ispitivanje CLDT600ACN04E1 uključivalo je 57 bolesnika s dostupnim usporednim biopsijama na početku i nakon prosječnog liječenja tijekom 260,8 tjedana, pri čemu su određene histološke promjene u jetri (38 HBeAg-pozitivni and 19 HBeAg-negativni bolesnici).
English: No evidence of a direct toxic effect of telbivudine was seen in standard tests of reproduction toxicology.
Croatian: U standardnim testovima reproduktivne toksikologije nije uočen dokaz izravnog toksičnog učinka telbivudina.
English: HBeAg-positive n = 440 and 446, HBeAg-negative n = 203 and 207, for telbivudine and lamivudine groups, respectively.
Croatian: HBeAg-pozitivni n = 440 za telbivudin i 446 za lamivudin, HBeAg-negativni n = 203 za telbivudin i 207 za lamivudin.
English: HBV encoding the adefovir resistance-associated substitutions rtN236T or rtA181V had around 0.3- and 4fold change in susceptibility to telbivudine in cell culture, respectively (see section 4.4).
Croatian: HBV koji kodira supstitucije rtN236T odnosno rtA181V povezane s rezistencijom na adefovir pokazao je oko 0,3 odnosno 4 puta promjenu u osjetljivosti na telbivudin u staničnoj kulturi (vidjeti dio 4.4).
English: Therefore, the potential for CYP450-mediated drug interactions involving Sebivo is low.
Croatian: Stoga je mogućnost interakcija Sebiva s drugim lijekovima posredovana CYP450 mala.
English: This may increase the chance of you getting unwanted side effects.
Croatian: Time možete povećati mogućnost nastanka nuspojava.
English: Baseline factors associated with development of genotypic drug resistance included: lamivudine treatment, higher baseline HBV DNA, lower baseline serum ALT, and increased body weight/BMI.
Croatian: Početni čimbenici povezani s razvojem genotipske rezistencije na lijek su uključivali: liječenje lamivudinom, više početne vrijednosti HBV DNK, niže početne vrijednosti ALT-a u serumu te povišena tjelesna težina/indeks tjelesne mase.