FrancophonIA/ELRC3.0 huggingface dataset:
English: A small number (total of 98) of Caucasian patients were treated with telbivudine.
Slovenian: S telbivudinom je bilo zdravljeno majhno število (skupno 98) bolnikov bele rase.
English: The safety and effectiveness of these dosing adjustment guidelines have not been clinically evaluated.
Slovenian: Varnost in učinkovitost navedenega prilagajanja odmerjanja nista klinično ocenjeni.
English: Sebivo can cause an excess of lactic acid in the blood (lactic acidosis) which is usually associated with an enlargement of the liver (hepatomegaly).
Slovenian: Zdravilo Sebivo lahko povzroča prevelike količine mlečne kisline v krvi (laktacidozo), ki je običajno povezana s povečanjem jeter (hepatomegalijo).
English: * The population without viral resistance at entry into study CLDT600A2303 consisted of 502 patients (293 HBeAg-positive and 209 HBeAg-negative).
Slovenian: * Populacija bolnikov, pri katerih ob vstopu v študijo CLDT600A2303 niso zaznali virusne rezistence, je štela 502 bolnika (293 HBeAg-pozitivnih in 209 HBeAg-negativnih bolnikov).
English: Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Slovenian: Zdravilo Sebivo je indicirano za zdravljenje kroničnega hepatitisa B pri odraslih bolnikih s kompenzirano jetrno boleznijo in znaki virusne replikacije, stalno zvišanimi koncentracijami alaninaminotransferaze (ALT) in histološko dokazanim aktivnim vnetjem in/ali fibrozo.
English: FOLDING BOX AND BOTTLE LABEL
Slovenian: ŠKATLA IN NALEPKA NA STEKLENICI
English: Turn the syringe to the upright position and incline it slightly so that the air bubbles rise to the top.
Slovenian: Brizgo obrnite pokonci in jo rahlo nagnite, da se bodo zračni mehurčki nabrali pri vrhu.
English: Clear, colourless to pale yellow solution.
Slovenian: peroralna raztopina bistra brezbarvna do bledo rumena raztopina
English: If any of these symptoms are reported, a detailed muscle examination should be performed in order to evaluate muscle function.
Slovenian: Če bolnik opisuje katerega od navedenih simptomov, je treba mišice natančno pregledati in oceniti njihovo delovanje.
English: If peripheral neuropathy is suspected, treatment with telbivudine should be reconsidered (see section 4.8).
Slovenian: V primeru suma na periferno nevropatijo je treba ponovno pretehtati zdravljenje s telbivudinom (glejte poglavje 4.8).
English: Sebivo 20 mg/ml oral solution is supplied as 300 ml of a clear, colourless to pale yellow solution in an brown glass bottle with a child-resistant white polypropylene closure, including a polyethylene sealing disc and a guarantee ring.
Slovenian: Peroralna raztopina Sebivo 20 mg/ml je na voljo v obliki 300 ml bistre brezbarvne do bledo rumene raztopine v steklenici iz rjavega stekla z za otroke varno belo polipropilensko zaporko, vključno s polietilensko zapiralno ploščico in z varnostnim obročem.
English: Study NV-02B-007 (GLOBE)
Slovenian: Študija NV-02B-007 (GLOBE)
English: Telbivudine is not a substrate, inhibitor or inducer of the cytochrome P450 (CYP450) enzyme system.
Slovenian: Telbivudin ni niti substrat niti zaviralec ali induktor encimskega sistema citokroma P450 (CYP450).
English: A reduction of the daily dose using Sebivo oral solution, as detailed in Table 1 below, is recommended.
Slovenian: Priporočeno je znižanje dnevnega odmerka z uporabo peroralne raztopine Sebivo, kot je prikazno spodaj v preglednici 1.
English: Always close the bottle with the cap after use.
Slovenian: Po uporabi steklenico vedno zaprite z zaporko.
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.
Slovenian: • Pri HBeAg-negativnih bolnikih brez ciroze je treba zdravljenje izvajati vsaj do serokonverzije HBsAg ali do dokazanega prenehanja učinka zdravljenja.
English: Such increased risk cannot be excluded for other interferon alfa (pegylated or standard).
Slovenian: Tudi pri drugih interferonih alfa (pegiliranih ali standardnih) takega povečanega tveganja ni mogoče izključiti.
English: Sebivo has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Sebivo ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: White to slightly yellowish, oval film-coated tablet, imprinted with “LDT” on one side.
Slovenian: Bela do rahlo rumenkasta filmsko obložena tableta ovalne oblike, z vtisnjeno oznako “LDT” na eni strani.
English: The incidence of on treatment alanine aminotransferase (ALT) flares in the two treatment arms according to AASLD (American Association for the Study of Liver Diseases) definition (ALT elevation > 2x baseline and > 10x ULN) are further described in Table 3 below.
Slovenian: Incidence poslabšanj z zvišanjem alanin aminotransferaze (ALT) med zdravljenjem v obeh skupinah bolnikov glede na opredelitev Ameriškega združenja za proučevanje bolezni jeter AASLD (American Association for the Study of Liver Diseases) (zvišanje ALT >2x izhodiščna vrednost in >10x ULN) so podrobneje navedene v spodnji preglednici 3.
English: Knodell necroinflammatory score ≤ 3 (no or minimal necroinflammation) was observed in 98.2% (56/57) of patients.
Slovenian: Oceno ≤3 na Knodellovi nekroinflamatorni lestvici (kar pomeni brez nekroinflamatornih lezij oziroma z minimalnimi nekroinflamatornimi lezijami) so opažali pri 98,2% (56/57) bolnikov.
English: Film-coated tablets containing 600 mg telbivudine are bioequivalent to 30 ml telbivudine oral solution (20 mg/ml).
Slovenian: Filmsko obložene tablete, ki vsebujejo 600 mg telbivudina, so bioekvivalentne 30 ml peroralne raztopine telbivudina (20 mg/ml).
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.
Slovenian: HBeAg-pozitivni bolniki: Povprečna starost bolnikov je bila 32 let, 74% je bilo moških, 82% je bilo Azijcev, 12% belcev, 6% jih je že prej prejemalo interferon alfa.
English: Exacerbations of hepatitis have also been reported in patients who have terminated treatment of hepatitis B. Post-treatment ALT flares are normally associated with increases in serum HBV DNA levels, and the majority of such cases have proven to be self-limiting.
Slovenian: O poslabšanjih hepatitisa so poročali tudi pri bolnikih, ki so zaključili zdravljenje hepatitisa B. Poslabšanja z zvišanjem ALT po zaključku zdravljenja so običajno povezana s porastom vrednosti HBV DNA v serumu in so v večini primerov spontano izzvenela.
English: Results from cell-based assays showed that the adefovir resistance-associated substitution A181V had 1.5- to approximately 4-fold reduced susceptibility to telbivudine.
Slovenian: Rezultati preskusov na celični osnovi so pokazali, da je substitucija A181V, povezana z rezistenco na adefovir, 1,5- do približno 4-krat zmanjšala občutljivost za telbivudin.
English: Patients should be advised to report promptly any persistent unexplained muscle aches, pain, tenderness or weakness.
Slovenian: Bolnike je treba opozoriti, da nemudoma sporočijo, če pride do kakršnihkoli trdovratnih nepojasnjenih bolečin v mišicah, povečane občutljivosti mišic ali njihove šibkosti.
English: • The mean Ishak score of 2.2 (SD 1.1) at baseline improved (p < 0.0001) to 0.9 (SD 1.0) with a mean change of -1.3 (SD 1.3).
Slovenian: • Povprečna izhodiščna ocena 2,2 (SD 1,1) na Ishakovi lestvici se je izboljšala na 0,9 (SD 1,0) (p <0,0001), kar pomeni povprečno spremembo ocene za -1,3 (SD 1,3).
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.
Slovenian: Bolniki z ohranjeno HBeAg serokonverzijo so imeli povprečno koncentracijo HBV DNA 3,3 log10 kopij/ml; in 73,7% jih je imelo koncentracijo HBV DNA <4 log10 kopij/ml.
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).
Slovenian: Po mediano 120 tednih brez zdravljenja sta se pri večini HBeAg-pozitivnih bolnikov, ki so prejemali telbivudin, ohranili tako izguba HBeAg (pri 83,3%;25/30) kot HBeAg serokonverzija (pri 79,2%;19/24).
English: • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBeAg seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBsAg seroconversion or there is evidence of loss of efficacy.
Slovenian: • Pri HBeAg-pozitivnih bolnikih brez ciroze je treba zdravljenje izvajati vsaj 6-12 mesecev po potrditvi serokonverzije HBeAg (izguba HBeAg in HBV DNA s pojavom anti-HBe) ali do serokonverzije HBsAg ali do dokazanega prenehanja učinka zdravljenja.
English: Combination of telbivudine with pegylated or standard interferon alfa (see sections 4.4 and 4.5).
Slovenian: Uporaba kombinacije telbivudina s pegiliranim ali standardnim interferonom alfa (glejte poglavji 4.4 in 4.5).
English: Telbivudine-5'-triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'-triphosphate.
Slovenian: Telbivudin-5'-trifosfat zavira DNA polimerazo virusa hepatitisa B (reverzno transkriptazo), tako da tekmuje z naravnim substratom timidin-5'-trifosfatom.
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.
Slovenian: Zdravljenje z zdravilom Sebivo zmanjšuje količino virusov hepatitisa B v telesu tako, da ovira njihovo razmnoževanje, to pa zmanjšuje poškodbo in izboljšuje delovanje jeter.
English: The pharmacokinetics of telbivudine have been studied in patients (without chronic hepatitis B) with various degrees of hepatic impairment and in some patients with decompensated liver disease.
Slovenian: Farmakokinetične lastnosti telbivudina so ocenjevali pri bolnikih (brez kroničnega hepatitisa B) z različnimi stopnjami okvare jeter in pri nekaterih bolnikih z dekompenzirano boleznijo jeter.
English: Preparing a dose of medicine using the dosing cup
Slovenian: Pripravljanje odmerka zdravila z uporabo odmerne posodice
English: The cumulative genotypic rates by week 104 were 25.1% (115/458) for HBeAg-positive patients and 10.8% (24/222) for HBeAg-negative patients.
Slovenian: Kumulativni deleži genotipske rezistence so bili po 104 tednih 25,1% (115/458) pri HBeAgpozitivnih bolnikih in 10,8% (24/222) pri HBeAg-negativnih bolnikih.
English: Cumulative resistance rates at year 4 were 22.3% for HBeAg-positive patients and 16.0% for HBeAgnegative patients in this analysis.
Slovenian: Pri tej analizi so bili kumulativni deleži rezistence v 4. letu 22,3% pri HBeAgpozitivnih bolnikih in 16,0% pri HBeAg-negativnih bolnikih.
English: ALT normalisation HBeAg seroconversion HBeAg loss
Slovenian: HBeAg serokonverzija izguba HBeAg
English: If this applies to you, do not take Sebivo.
Slovenian: Če kaj od navedenega velja za vas, ne jemljite zdravila Sebivo.
English: Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo since your hepatitis B infection may get worse or become very serious after stopping treatment.
Slovenian: Po zaključku zdravljenja z zdravilom Sebivo bo vaš zdravnik redno spremljal vaše zdravstveno stanje in s pomočjo rednih preiskav krvi preverjal stanje vaših jeter, saj se lahko po prekinitvi zdravljenja okužba z virusom hepatitisa B poslabša ali postane zelo resna.
English: - The other ingredients are: benzoic acid, sodium saccharin, passion fruit flavouring, sodium hydroxide, citrc acid anhydrous, water.
Slovenian: - Druge sestavine zdravila so: benzojska kislina, natrijev saharinat, aroma pasijonke, natrijev hidroksid, brezvodna citronska kislina, voda.
English: There are no clinical data on the effects of telbivudine on male or female fertility.
Slovenian: O vplivu telbivudina na moško ali žensko plodnost ni podatkov.
English: There is currently no clinical data to properly assess the benefit and risk of switching to telbivudine for lamivudine-treated patients who achieve complete viral suppression on lamivudine.
Slovenian: Zaenkrat ni kliničnih podatkov, na podlagi katerih bi lahko pri bolnikih, ki z lamivudinom dosegajo popolno virusno supresijo, ustrezno ocenili koristi in tveganja prehoda na zdravljenje s telbivudinom.
English: Telbivudine is not a substrate, inhibitor or inducer of the cytochrome P450 (CYP450) enzyme system (see section 5.2).
Slovenian: Telbivudin ni niti substrat niti zaviralec ali induktor encimskega sistema citokroma P450 (CYP450) (glejte poglavje 5.2).
English: HBeAg-negative patients (n = 209*)
Slovenian: HBeAg-negativni bolniki (n = 209*)
English: What Sebivo contains - The active substance is telbivudine.
Slovenian: Kaj vsebuje zdravilo Sebivo - Učinkovina je telbivudin.
English: The incidence of post-treatment alanine aminotransferase (ALT) flares in the two treatment arms are further described in Table 4 below.
Slovenian: Incidence poslabšanj z zvišanjem alanin aminotransferaze (ALT) po zdravljenju v obeh skupinah bolnikov so podrobneje navedene v spodnji preglednici 4.
English: What Sebivo looks like and contents of the pack
Slovenian: Izgled zdravila Sebivo in vsebina pakiranja
English: HBeAg-positive (n = 921)
Slovenian: HBeAg-pozitivni (n = 921)
English: Patients with cirrhosis without decompensation
Slovenian: Bolniki s cirozo brez dekompenzacije
English: If you stop taking Sebivo
Slovenian: Če ste prenehali jemati zdravilo Sebivo
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.
Slovenian: Po peroralni aplikaciji 600 mg telbivudina v enkratnem odmerku zdravim osebam (n = 42), je bila najvišja koncentracija telbivudina v plazmi (Cmax) 3,2  1,1 g/ml (povprečje  SD), ki se je pojavila 3,0 ure (mediana) po zaužitju odmerka.
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.
Slovenian: Genotipska analiza za analizo primernih 203 vzorčnih parov s koncentracijo HBV DNA ≥1.000 kopij/ml po 104 tednih v študiji (NV-02B-007 (GLOBE)) je pokazala, da je prvenstvena mutacija, povezana z rezistenco na telbivudin, rtM204I pogosto povezana z mutacijama rtL180M in rtL80I/V in manj pogosto z rtV27A, rtL82M, rtV173L, rtT184I in rtA200V.
English: ≥ 3 log10 copies/ml
Slovenian: ≥3 log10 kopij/ml
English: Sebivo has not been investigated in co-infected hepatitis B patients (e.g. patients co-infected with human immunodeficiency virus [HIV], hepatitis C virus [HCV] or hepatitis D virus [HDV]).
Slovenian: Zdravila Sebivo niso raziskovali pri bolnikih, ki so poleg okužbe z virusom hepatitisa B sočasno okuženi še z drugim virusom (npr. pri bolnikih, ki so sočasno okuženi še s humanim virusom imunske pomanjkljivosti [HIV], z virusom hepatitisa C [HCV] ali z virusom hepatitisa D [HDV]).
English: Based on the results shown in Table 9, adjustment of the dose interval for telbivudine is recommended in patients with creatinine clearance of  50 ml/min (see sections 4.2 and
Slovenian: Na podlagi rezultatov, ki so prikazani v preglednici 9, je bolnikom z očistkom kreatitnina < 50 ml/min priporočljivo prilagajati intervale med odmerki telbivudina (glejte poglavji 4.2 in 4.4).
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).
Slovenian: Farmakokinetične lastnosti telbivudina po enkratnem odmerku (200, 400 in 600 mg) so ocenjevali pri bolnikih (brez kroničnega hepatitisa B) z različnimi stopnjami okvare ledvic (glede na očistek kreatinina).
English: Out of these 517 patients 159 patients (HBeAg-positive=135, HBeAg-negative=24) had detectable HBV DNA.
Slovenian: Izmed omenjenih 517 bolnikov je imelo 159 bolnikov (135 HBeAg-pozitivnih in 24 HBeAg-negativnih) merljivo koncentracijo HBV DNA.
English: Immediately swallow the solution direct from the syringe.
Slovenian: Raztopino takoj zaužijte neposredno iz brizge.
English: Therapy must be initiated by a physician experienced in the management of chronic hepatitis B infection.
Slovenian: Zdravljenje sme uvesti samo zdravnik, ki ima izkušnje z zdravljenjem kronične okužbe z virusom hepatitisa B.
English: What Sebivo is and what it is used for What you need to know before you take Sebivo How to take Sebivo
Slovenian: Kaj je zdravilo Sebivo in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Sebivo Kako jemati zdravilo Sebivo Možni neželeni učinki
English: A trend towards higher rates of HBeAg loss (35% vs 29%) and seroconversion (30% vs 25%) was also observed for telbivudine.
Slovenian: Pri telbivudinu so opazili tudi trend večanja deležev izgube HBeAg (35% v primerjavi z 29%) in serokonverzije (30% v primerjavi s 25%).
English: Following dose interval adjustment for creatinine clearance, no additional dose modification is necessary during routine haemodialysis (see section 4.2).
Slovenian: Ob upoštevanju priporočil za prilagajanje intervalov med odmerki glede na očistek kreatinina dodatno spreminjanje odmerkov v času redne hemodialize ni potrebno (glejte poglavje 4.2).
English: - Do not breast-feed during treatment with Sebivo.
Slovenian: - V času zdravljenja z zdravilom Sebivo ne dojite.
English: macrogol.
Slovenian: smukec, makrogol.
English: HBeAg seroconversion and loss assessed only in patients with detectable HBeAg at baseline.
Slovenian: HBeAg serokonverzijo in izgubo so ocenjevali samo pri bolnikih, ki so imeli merljive izhodiščne vrednosti HBeAg.
English: In addition, telbivudine does not alter the pharmacokinetics of lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate or ciclosporin.
Slovenian: Tudi telbivudin ni vplival na farmakokinetične lastnosti lamivudina, adefovira, dipivoksila, tenofovirdizoproksil fumarata ali ciklosporina.
English: Rare post-marketing cases of lactic acidosis have been reported with telbivudine.
Slovenian: V času trženja zdravila so poročali o redkih primerih laktacidoze pri uporabi telbivudina.
English: 1 bottle containing 300 ml oral solution [folding box only] 1 cup + 1 oral syringe [folding box only]
Slovenian: 1 steklenica vsebuje 300 ml peroralne raztopine [samo na škatli] 1 odmerna posodica + 1 brizga za peroralno dajanje [samo na škatli] 300 ml [samo na nalepki na steklenici]
English: Note: If the amount poured into the cup exceeds the required dose, discard the excess in the sink.
Slovenian: Pozor: Če v odmerno posodico nalijete preveč raztopine, presežek zavrzite v odtok.
English: Myopathy, defined as persistent unexplained muscle aches and/or muscle weakness regardless of the degree of increases in creatine kinase (CK) levels, should be considered in any patient with diffuse unexplained myalgias, muscle tenderness, muscle weakness or myositis (defined as myopathy with histological evidence of muscle damage).
Slovenian: Pri vsakem bolniku z difuznimi nepojasnjenimi bolečinami v mišicah, povečano občutljivostjo mišic, njihovo šibkostjo ali miozitisom (ki je opredeljen kot miopatija s histološko potrjeno poškodbo mišic) je treba pomisliti na miopatijo, opredeljeno kot perzistentne nepojasnjene bolečine v mišicah in/ali šibkost mišic ne glede na stopnjo zvišanja vrednosti kreatin kinaze (CK).
English: The long-term safety population consisted of 655 patients including 518 from NV-02B-007 (GLOBE) and 137 from NV02B-015.
Slovenian: Populacijo za oceno varnosti dolgotrajnega zdravljenja je sestavljalo 655 bolnikov, med katerimi je bilo 518 bolnikov iz študije NV-02B-007 (GLOBE) in 137 bolnikov iz študije NV-02B-015.
English: Maintained undetectable HBV DNA (< 300 copies/ml)
Slovenian: ohranjena nemerljiva koncentracija HBV DNA (<300 kopij/ml)
English: Titanium dioxide (E171) Macrogol
Slovenian: Filmska obloga tablete titanov dioksid (E171) makrogol smukec hipromeloza
English: The efficacy and safety results of the NV-02B-007 (GLOBE) study were confirmed in study NV-02B015.
Slovenian: Rezultate glede učinkovitosti in varnosti v študiji NV-02B-007 (GLOBE) so potrdili rezultati študije NV-02B-015.
English: In HBeAg-negative patients, telbivudine was non-inferior to lamivudine (75.2% and 77.2% responders; p = 0.6187).
Slovenian: Pri HBeAgnegativnih bolnikih telbivudin ni bil slabši kot lamivudin (75,2% bolnikov z odzivom v primerjavi s 77,2% ob lamivudinu; p = 0,6187).
English: HBeAg-positive patients (n = 293*)
Slovenian: HBeAg-pozitivni bolniki (n = 293*)
English: Your doctor may order laboratory tests to check your kidneys are working properly before and during treatment.
Slovenian: Vaš zdravnik vas bo napotil na laboratorijske preiskave, s katerimi bo preverjal delovanje vaših ledvic pred zdravljenjem in med njim.
English: There were no abnormalities in sperm morphology or function, and the testes and ovaries were histologically unremarkable.
Slovenian: Do nepravilnosti v zgradbi in delovanju spermijev ni prišlo, prav tako ni prišlo do histoloških sprememb testisov in jajčnikov.
English: There are no adequate efficacy and safety data in patients with decompensated cirrhosis.
Slovenian: O varnosti in učinkovitosti pri bolnikih z dekompenzirano cirozo ni ustreznih podatkov.
English: The pack contains an oral dosing cup made of polypropylene 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.
Slovenian: Pakiranje vsebuje tudi odmerno posodico iz polipropilena z vtisnjenimi merilnimi oznakami od 5 do 30 ml v korakih po 5 ml in polipropilensko brizgo za peroralno dajanje z merilnimi oznakami od 1 do 10 ml v korakih po 0,5 ml.
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.
Slovenian: Rezultati izidov po 104 tednih glede na koncentracijo HBV DNA po 24 tednih tako za HBeAgpozitivne kot za HBeAg-negativne bolnike so prikazani v preglednici 7.
English: Severe acute exacerbations of chronic hepatitis B are relatively frequent, and are characterised by transient elevation of serum ALT.
Slovenian: Huda akutna poslabšanja kroničnega hepatitisa B, za katera je značilno prehodno zvišanje koncentracije ALT v serumu, so razmeroma pogosta.
English: Cumulative HBeAg seroconversion rates in patients with undetectable HBV DNA at week 24 (%)
Slovenian: kumulativna stopnja HBeAg serokonverzije pri bolnikih z nemerljivo koncentracijo HBV po 24 tednih zdravljenja (%)
English: Telbivudine 600 mg film-coated tablet Alternative** dose adjustment with increased dose intervals
Slovenian: telbivudin 20 mg/ml peroralna raztopina prilagajanje dnevnega odmerka telbivudine 600 mg filmsko obložene tablete druga možnost** prilagajanja odmerka s podaljševanjem intervala med odmerki
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).
Slovenian: Varnost in učinkovitost dolgotrajnega zdravljenja (104 tedne) z zdravilom Sebivo so ocenjevali v dveh kontroliranih kliničnih študijah, v katere so vključili 1.699 bolnikov s kroničnim hepatitisom B (v študijah NV-02B-007 (GLOBE) in NV-02B-015).
English: In patients with compensated liver disease, this elevation of serum ALT is generally not accompanied by elevated levels of serum bilirubin or by other signs of hepatic decompensation.
Slovenian: Pri bolnikih s kompenzirano jetrno boleznijo ob zvišanju ALT v serumu večinoma ne pride do zvišanih vrednosti bilirubina v serumu ali do drugih znakov odpovedi jeter.