FrancophonIA/ELRC3.0 huggingface dataset:
English: Telbivudine is eliminated primarily by renal excretion, therefore dose interval adjustment is recommended in patients with creatinine clearance < 50 ml/min, including patients on haemodialysis.
Slovenian: Telbivudin se večinoma izloča preko ledvic, zato je pri bolnikih z očistkom kreatinina <50 ml/min, vključno s tistimi na hemodializi, priporočljivo prilagoditi intervale med odmerki.
English: Peripheral neuropathy has been uncommonly reported in telbivudine-treated patients.
Slovenian: O periferni nevropatiji so občasno poročali pri bolnikih, ki so prejemali telbivudin.
English: When secondary to other conditions, some cases were also associated with pancreatitis, liver failure/hepatic steatosis and renal failure.
Slovenian: Kadar je bila laktacidoza sekundarni pojav, je bila v nekaj primerih povezana tudi s pankreatitisom, odpovedjo/steatozo jeter ali ledvično odpovedjo.
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.
Slovenian: Izhodiščni dejavniki, ki so bili povezani z razvojem genotipske rezistence na zdravilo, so vključevali: zdravljenje z lamivudinom, višjo izhodiščno koncentracijo HBV DNA, nižjo izhodiščno koncentracijo ALT v serumu in povečano telesno maso/ITM.
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).
Slovenian: Pripadnost beli rasi je bila povezana s slabšim odzivom na zdravljenje pri obeh protivirusnih zdravilih, uporabljenih v študiji NV-02B-007 (GLOBE); vendar pa je bila skupina bolnikov bele rase v tej študiji majhna (n = 98).
English: Incorporation of telbivudine-5'-triphosphate into viral DNA causes DNA chain termination, resulting in inhibition of HBV replication.
Slovenian: Zaradi vgraditve telbivudin-5'-trifosfata v virusno DNA, se zaključi sinteza DNA verige, kar zavre replikacijo virusa hepatitisa B.
English: Remove the dosing cup.
Slovenian: Odstranite odmerno posodico.
English: In the overall ITT population the cumulative resistance rates at year 4 for HBeAg-positive and HBeAg-negative patients, was 40.8% (131/321) and 18.9% (37/196), respectively.
Slovenian: V celotni populaciji ITT sta bila kumulativna deleža rezistence po 4 letih pri HBeAg-pozitivnih bolnikih 40,8% (131/321), pri HBeAg-negativnih pa 18,9% (37/196).
English: In vitro, telbivudine was not active against the HBV strains containing rtM204V/rtL180M or rtM204I mutations (see section 5.1).
Slovenian: In vitro telbivudin ni bil učinkovit proti sevu HBV z mutacijama rtM204V/rtL180M ali rtM204I (glejte poglavje 5.1).
English: A maximum tolerated dose of telbivudine has not been determined.
Slovenian: Največji še prenosljiv odmerek telbivudina ni ugotovljen.
English: No metabolites of telbivudine were detected following administration of
Slovenian: Pri ljudeh niso odkrili presnovkov telbivudina po aplikaciji
English: If you are on a controlled sodium diet, ask your doctor for advice.
Slovenian: Če se držite diete z omejenim vnosom natrija, se posvetujte z zdravnikom.
English: Push the plunger carefully and slowly to remove the air until a droplet of solution appears.
Slovenian: Počasi in previdno potiskajte bat, da boste iztisnili zrak, dokler se ne pojavi kapljica raztopine.
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).
Slovenian: Pri virusu hepatitisa B z zapisom za substitucijo rtN236T ali rtA181V, povezano z rezistenco na adefovir, je prišlo do približno 0,3- oziroma 4-kratne spremembe občutljivost za telbivudin v celični kulturi (glejte poglavje 4.4).
English: Swallow it whole with some water.
Slovenian: Pogoltnite celo tableto z malo vode.
English: Table 5 Virological, biochemical and serological endpoints at week 52 in NV-02B-007 (GLOBE) study
Slovenian: Preglednica 5 Virološki, biokemični in serološki cilji opazovanja po 52. tednu v študiji NV02B-007 (GLOBE)
English: Close the bottle by screwing the cap back on tightly.
Slovenian: Steklenico zaprete tako, da nanjo spet čvrsto privijete zaporko.
English: Muscle symptoms may progress and become serious, sometimes leading to muscle breakdown
Slovenian: Mišični simptomi se lahko poslabšajo in postanjo resni, v nekaterih primerih pride celo do razgradnje mišic (rabdomiolize), ta pa lahko povzroči okvaro ledvic.
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).
Slovenian: Študija CLDT600ACN04E1 - vpliv zdravljenja na histološko zgradbo jeter V študiji CLDT600ACN04E1 so pri 57 bolnikih vrednotili razpoložljivo biopsijo jeter ob izhodišču in po povprečno 260,8 tednih zdravljenja glede sprememb v histološki zgradbi jeter (38 bolnikov je bilo HBeAg-pozitivnih in 19 HBeAg-negativnih).
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.
Slovenian: 300-mililitrska steklenica iz rjavega stekla z za otroke varno zaporko, vključno s polietilensko zapiralno ploščico, z varnostnim obročem in s polipropilensko odmerno posodico z vtisnjenimi merilnimi oznakami od 5 do 30 ml v korakih po 5 ml ter s polipropilensko brizgo za peroralno dajanje z merilnimi oznakami od 1 do 10 ml v korakih po 0,5 ml.
English: The steady-state pharmacokinetics of telbivudine were unaltered following multiple dose administration in combination with lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, ciclosporin or pegylated interferon alfa-2a.
Slovenian: V stanju dinamičnega ravnovesja se farmakokinetične lastnosti telbivudina niso spremenile po večkratnem odmerjanju v kombinaciji z lamivudinom, adefovir, dipivoksilom, tenofovirdizoproksil fumaratom, ciklosporinom ali pegiliranim interferonom alfa-2a.
English: Sebivo is to be taken orally, with or without food.
Slovenian: Način uporabe Zdravilo Sebivo je treba jemati peroralno, s hrano ali brez nje.
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.
Slovenian: Parametri odzivnosti v času zdravljenja, ki so jih ocenjevali po 24 tednih in so napovedovali pojavljanje virusov z rezistenco na zdravilo po 104 tednih, so bili: HBV DNA >300 kopij/ml in zvišanje koncentracije ALT v serumu.
English: At week 24, 203 HBeAg-positive (44%) and 177 HBeAg-negative (80%) telbivudine-treated subjects achieved undetectable HBV DNA levels.
Slovenian: Po 24 tednih so 203 HBeAg-pozitivni bolniki (44%) in 177 HBeAg-negativnih (80%) bolnikov, zdravljenih s telbivudinom, doseglo nemerljivo koncentracijo HBV DNA.
English: Sebivo oral solution contains approximately 47 mg sodium per 600 mg dose (30 ml), which should be taken into consideration by patients on a controlled sodium diet.
Slovenian: Peroralna raztopina Sebivo vsebuje približno 47 mg natrija na 600-miligramski odmerek (30 ml), kar je treba upoštevati pri bolnikih, ki se držijo diete z omejenim vnosom soli.
English: Approximately 42% of the dose is recovered in the urine over 7 days following a single 600 mg oral dose of telbivudine.
Slovenian: Po enkratnem peroralnem odmerku 600 mg so prestregli v 7 dneh v urinu približno 42% odmerka telbivudina.
English: Patients with cirrhosis with decompensation
Slovenian: Bolniki s cirozo z dekompenzacijo
English: Holding the cup at eye level, carefully and slowly pour the solution from the bottle into the cup until it comes to about halfway between the 5 ml and 10 ml marks.
Slovenian: Odmerno posodico držite v višini oči in počasi ter previdno nalivajte predpisano količino raztopine iz steklenice v odmerno posodico, dokler gladina raztopine ne doseže približno sredine med merilnima oznakama za 5 ml in 10 ml.
English: HBV DNA should be monitored every 6 months to assure continued response.
Slovenian: Za zagotavljanje nadaljnjega odziva je treba meriti vrednosti HBV DNA vsakih 6 mesecev.
English: UNIQUE IDENTIFIER - 2D BARCODE [folding box only]
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA [samo na škatli]
English: C-telbivudine in humans.
Slovenian: C-telbivudina.
English: Preparing a 6 ml dose of medicine using the oral syringe
Slovenian: Pripravljanje 6-mililitrskega odmerka z uporabo brizge za peroralno dajanje zdravila
English: Patients with undetectable HBV DNA at week 24 had better outcomes at 156 and 208 weeks (Table 8).
Slovenian: Bolniki, pri katerih je bila po 24 tednih zdravljenja koncentracija HBV DNA nemerljiva, so po 156 oziroma 208 tednih zdravljenja izkazovali boljše izide (preglednica 8).
English: HBeAg-positive n = 440 and 446, HBeAg-negative n = 203 and 207, for telbivudine and lamivudine groups, respectively.
Slovenian: HBeAg-pozitivni n = 440 za telbivudin in n = 446 za lamivudin, HBeAg-negativni n = 203 za telbivudin in n = 207 za lamivudin.
English: Telbivudine should be administered after haemodialysis.
Slovenian: Telbivudin je treba aplicirati po končanem postopku hemodialize.
English: ALT normalisation n/N (%)
Slovenian: normalizacija ALT n/N (%)
English: Before pouring any solution into the cup, please check the position of the 5 and 10 ml marks to avoid any potential waste or spillage.
Slovenian: Preden v odmerno posodico nalijete raztopino, preglejte, kje so vtisnjene merilne oznake za 5 ml in 10 ml, da vam ne bo treba zdravila odlivati oziroma zavreči.
English: 300 copies/ml to < 3 log10 copies/ml
Slovenian: 300 kopij/ml do <3 log10 kopij/ml
English: Studies NV-02B-007 (GLOBE) and CLDT600A2303 - cumulative genotypic resistance rates The original analysis for cumulative genotypic resistance at week 104 and 208 was based on the ITT population and included all patients who continued treatment until 4 years, regardless of HBV DNA levels.
Slovenian: Študiji NV-02B-007 (GLOBE) in CLDT600A2303 - kumulativni deleži genotipske rezistence Prvotna analiza kumulativnih deležev genotipske rezistence po 104 oziroma 208 tednih je temeljila na podatkih populacije ITT (populacije z namenom zdravljenja) in je vključevala podatke vseh bolnikov, ki so nadaljevali zdravljenje skupno 4 leta, ne glede na koncentracijo HBV DNA.
English: At week 48 among HBeAg-positive and HBeAg-negative patients, 5% (23/458) and 2% (5/222), respectively, had virological rebound with detectable HBV resistance mutations.
Slovenian: Po 48 tednih je pri 5% (23/458) HBeAg-pozitivnih bolnikov in pri 2% (5/222) HBeAg-negativnih bolnikov prišlo do virološkega povratnega odziva z merljivo vrednostjo mutacij za rezistenco HBV.
English: If you experience muscle pain, severe and persistent stomach pain with nausea and vomiting, severe and persistent trouble breathing, tiredness or abdominal discomfort while taking Sebivo, call your doctor immediately.
Slovenian: Nemudoma obvestite zdravnika, če opazite bolečine v mišicah, hude in trdovratne bolečine v želodcu s slabostjo in bruhanjem, hude in trdovratne težave z dihanjem, utrujenost ali neprijeten občutek v trebuhu v času jemanja zdravila Sebivo.
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.
Slovenian: Telbivudin zavira sintezo tako prve verige virusa hepatitisa B (EC50 = 0,4-1,3 mol/l) kot tudi druge verige (EC50 = 0,12-0,24 mol/l) in kaže večjo nagnjenost k zaviranju sinteze druge verige.
English: Telbivudine-treated patients who achieved undetectable HBV DNA by PCR by week 24 had the highest rates of HBV DNA undetectability and HBeAg seroconversion (in HBeAg-positive patients), and the lowest overall rates of virological breakthrough at week 104.
Slovenian: Bolniki, ki so prejemali telbivudin in so po 24 tednih dosegli nemerljive vrednosti HBV DNA pri testu PCR, so po 104 tednih dosegli najvišja deleža nemerljivosti HBV DNA in HBeAg serokonverzije (pri HBeAg-pozitivnih bolnikih) ter najnižji skupni delež virološkega preboja.
English: - Uncommonly Sebivo can induce numbness, tingling, pain and/or burning sensations in the arms and/or legs (peripheral neuropathy).
Slovenian: - Občasno lahko zdravilo Sebivo povzroči odrevenelost, mravljinčenje, bolečino in/ali pekoč občutek v rokah in/ali nogah (periferno nevropatijo).
English: Excipient with known effect: A 600 mg dose (30 ml) of oral solution contains approximately 47 mg sodium.
Slovenian: Pomožna snov z znanim učinkom: 600-miligramski odmerek (30 ml) peroralne raztopine vsebuje približno 47 mg natrija.
English: colloidal anhydrous; magnesium stearate; hypromellose; titanium dioxide (E171); talc;
Slovenian: brezvodni koloidni silicijev dioksid, magnezijev stearat, hipromeloza, titanov dioksid (E171),
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.
Slovenian: Če ste vzeli večji odmerek zdravila Sebivo, kot bi smeli Če ste vzeli preveč zdravila Sebivo ali če kdo drug pomotoma vzame vaše tablete, takoj poiščite pomoč pri vašem zdravniku ali v bolnišnici.
English: Assessment of adverse reactions is mainly based on two studies, NV-02B-007 (GLOBE) and NV-02B015, in which 1,699 patients with chronic hepatitis B received double-blind treatment with telbivudine 600 mg/day (n = 847) or lamivudine (n = 852) for 104 weeks.
Slovenian: Ocena neželenih učinkov temelji večinoma na dveh študijah: NV-02B-007 (GLOBE) in NV-02B-015, v katerih je 1.699 bolnikov s kroničnim hepatitisom B prejemalo dvojno slepo zdravljenje s telbivudinom v odmerku 600 mg/dan (n = 847) ali z lamivudinom (n = 852) 104 tedne.
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).
Slovenian: Ker je poglavitna pot izločanja preko ledvic, je treba bolnikom z zmerno do hudo okvaro delovanja ledvic in tistim, ki so na hemodializi, prilagoditi intervale med odmerki (glejte poglavje 4.2).
English: In HBeAg-positive patients, telbivudine was superior to lamivudine in therapeutic response (75.3% vs 67.0% responders; p = 0.0047).
Slovenian: Pri HBeAg-pozitivnih bolnikih se je telbivudin glede odzivov na zdravljenje izkazal bolje kot lamivudin (75,3% bolnikov z odzivom v primerjavi s 67,0% ob lamivudinu; p = 0,0047).
English: There are no data on telbivudine treatment in patients with established adefovir-resistant hepatitis B virus single mutations of rtN236T or A181V.
Slovenian: O zdravljenju s telbivudinom pri bolnikih z virusom hepatitisa B z enojno mutacijo rtN236T ali A181V, ki je rezistenten na adefovir ni podatkov.
English: Adults The recommended dose of Sebivo is 30 ml, providing a dose equivalent to 600 mg, once daily.
Slovenian: Odrasli Priporočeni odmerek zdravila Sebivo je 30 ml, kar je enakovredno odmerku 600 mg, enkrat na dan.
English: - However, if it is within 4 hours before your next dose, skip the dose you missed and take the next one at the usual time.
Slovenian: - Če je do naslednjega odmerka le še 4 ure ali manj, preskočite odmerek, ki ste ga pozabili vzeti,
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Sebivo 20 mg/ml [folding box only]
Slovenian: Sebivo 20 mg/ml [samo na škatli]
English: Sebivo oral solution contains approximately 47 mg of sodium per 600 mg dose (30 ml).
Slovenian: Peroralna raztopina Sebivo vsebuje približno 47 mg natrija na 600-miligramski odmerek (30 ml).
English: Cases of rhabdomyolysis have been reported during post-marketing use of telbivudine (see section 4.8).
Slovenian: V obdobju trženja telbivudina so poročali o primerih rabdomiolize (glejte poglavje 4.8).
English: Slowly and carefully pour the solution from the bottle into the dosing cup until it reaches the prescribed amount.
Slovenian: Počasi in previdno nalivajte raztopino iz steklenice v odmerno posodico, dokler ne odmerite predpisane količine.
English: Table 6 Histological improvement and change in Ishak Fibrosis Score at week 52 in NV-02B007 (GLOBE) study
Slovenian: Preglednica 6 Izboljšanje histološke slike in sprememba stopnje fibroze po Ishaku (Ishak Fibrosis Score) po 52. tednu v študiji NV-02B-007 (GLOBE)
English: HBeAg seroconversion n/N (%)
Slovenian: HBeAg serokonverzija n/N (%)
English: When considering patients with viral breakthrough by 104 weeks in NV-02B-007 (GLOBE), the rate of resistance was lower in patients with HBV DNA < 300 copies/ml at week 24 than in patients with HBV DNA ≥ 300 copies/ml at week 24.
Slovenian: V okviru bolnikov z virusnim prebojem do konca 104. tedna v študiji NV-02B-007 (GLOBE) je bila rezistenca manj pogosta pri bolnikih, ki so imeli po 24 tednih HBV DNA <300 kopij/ml, kot pri bolnikih, ki so imeli po 24 tednih HBV DNA ≥300 kopij/ml.
English: Virological breakthrough* n/N (%)
Slovenian: virološki preboj* n/N (%)
English: The single- and multiple-dose pharmacokinetics of telbivudine were evaluated in healthy subjects and in patients with chronic hepatitis B. The pharmacokinetics of telbivudine were not evaluated with the recommended dose of 600 mg in patients with chronic hepatitis B. However telbivudine pharmacokinetics are similar between both populations.
Slovenian: Farmakokinetične lastnosti telbivudina po enkratnem odmerku in po večkratnem odmerjanju so ocenjevali pri zdravih osebah in pri bolnikih s kroničnim hepatitisom B. Farmakokinetičnih lastnosti telbivudina v priporočenem odmerku 600 mg pri bolnikih s kroničnim hepatitisom B niso ocenjevali.
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.
Slovenian: Odmerno posodico držite v višini oči in počasi ter previdno nalivajte predpisano količino raztopine iz steklenice v odmerno posodico, dokler gladina raztopine ne doseže vrha ustrezne merilne oznake.
English: In cell-based assays, lamivudine-resistant HBV strains containing either the rtM204I mutation or the rtL180M/rtM204V double mutation had ≥ 1,000-fold reduced susceptibility to telbivudine.
Slovenian: Pri testiranju na celični ravni so bili sevi virusa hepatitisa B z rezistenco na lamivudin, ki so vsebovali mutacijo rtM204I ali dvojno mutacijo rtL180M/rtM204V, ≥1.000-krat manj občutljivi za telbivudin.
English: Results of these studies indicate that no dosage adjustment is necessary for patients with hepatic impairment (see section 4.2).
Slovenian: Na podlagi rezultatov teh študij pri bolnikih z okvaro jeter ni treba prilagajati odmerjanja (glejte poglavje 4.2).
English: Do not chew, split or crush it.
Slovenian: Tablete ne žvečite, ne lomite in ne drobite.
English: Moreover, in the subgroup of patients with baseline ALT levels ≥ 2x ULN (320), a significantly higher proportion of telbivudine patients than lamivudine patients achieved HBeAg seroconversions at week 104 (36% vs 28%, respectively).
Slovenian: Razen tega je v podskupini bolnikov, ki so imeli ob vključitvi ALT ≥2x ULN (n = 320), dosegel HBeAg serokonverzijo po 104 tednih bistveno večji delež bolnikov s telbivudinom (36%) v primerjavi z bolniki z lamivudinom
English: HBeAg-positive < 300 copies/ml
Slovenian: HBeAg-pozitivni <300 kopij/ml
English: Push the plunger slowly and carefully until the solution reaches the 6 ml mark.
Slovenian: Počasi in previdno potiskajte bat, dokler količina raztopine ne doseže oznake 6 ml.
English: No evidence of impaired fertility was seen in other studies when either male or female rats were treated at doses up to 2000 mg/kg/day and mated with untreated rats (systemic exposure levels approximately 6-14 times higher than those achieved in humans).
Slovenian: V drugih študijah, v katerih so odmerke do 2000 mg/kg/dan dajali bodisi samcem ali samicam in jih nato parili z netretiranimi živalmi, ni bilo nobenih znakov zmanjšane plodnosti (ravni sistemske izpostavljenost so bile pri tem približno 6-14-krat višje kot pri ljudeh).
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.
Slovenian: Izmed teh HBeAg-pozitivnih bolnikov jih je do konca 52. tedna 95% ohranilo HBV DNA pod mejo merljivosti, 39% jih je doseglo HBeAg serokonverzijo, 90% normalizacijo ALT, po koncu 48. tedna pa se je pri 0,5% teh bolnikov pokazala rezistenca.
English: No evidence of a direct toxic effect of telbivudine was seen in standard tests of reproduction toxicology.
Slovenian: Pri običajnih testih toksičnosti za sposobnost razmnoževanja ni bilo nobenih znakov za neposreden toksičen učinek telbivudina.
English: Genotypic analysis of 50 HBV isolates from telbivudine-treated patients at week 208 (CLDT600A2303) revealed a similar resistance profile as reported at week 104.
Slovenian: Genotipska analiza 50 izolatov HBV, ki so jih v študiji CLDT600A2303 po 208 tednih odvzeli bolnikom, zdravljenim s telbivudinom, je pokazala podoben vzorec rezistence kot po 104 tednih.
English: Adults The recommended dose of Sebivo is 600 mg (one tablet) once daily.
Slovenian: Odrasli Priporočeni odmerek zdravila Sebivo je 600 mg (ena tableta) enkrat na dan.
English: Talk to your doctor before taking Sebivo: - if you have or have had any kidney problems.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Sebivo se posvetujte z zdravnikom: - če imate ali ste že imeli težave z ledvicami.
English: The combination of telbivudine with any interferon alfacontaining product is contraindicated (see section 4.3).
Slovenian: Uporaba kombinacije telbivudina s katerimkoli zdravilom, ki vsebuje interferon alfa, je kontraindicirana (glejte poglavje 4.3).
English: Table 8 Efficacy analysis in pooled data from NV-02B-007 (GLOBE), NV-02B-015 and CLDT600A2303 studies
Slovenian: Preglednica 8 Analiza učinkovitosti na podlagi podatkov, združenih iz študij NV-02B-007 (GLOBE), NV-02B-015 in CLDT600A2303
English: HBeAg-negative < 300 copies/ml
Slovenian: HBeAg-negativni <300 kopij/ml
English: Out of the 680 telbivudine-treated patients initially included in the pivotal study NV-02B-007 (GLOBE), 517 (76%) enrolled into study CLDT600A2303 for continued telbivudine treatment for up to 208 weeks.
Slovenian: Izmed 680 bolnikov, ki so prejemali telbivudin in so bili najprej vključeni v ključno študijo NV-02B-007 (GLOBE), so jih 517 (76%) vključili v študijo CLDT600A2303, da bi nadaljevali zdravljenje s telbivudinom v trajanju do 208 tednov.
English: The overall safety profile from the pooled analysis up to 104 and 208 weeks was similar.
Slovenian: V celoti so bile varnostne lastnosti zdravila po rezultatih združene analize podobne pri trajanju zdravljenja do 104 tedne in pri trajanju zdravljenja do 208 tednov.
English: Telbivudine monotherapy is not an option for patients with established lamivudine-resistant hepatitis B virus infection.
Slovenian: Zdravljenje s telbivudinom v monoterapiji ni ustrezno pri bolnikih z okužbo z virusom hepatitisa B z ugotovljeno rezistenco na lamivudin.
English: The adverse effects on fertility were greater in a separate study in juvenile animals when both sexes received telbivudine (see section 5.3).
Slovenian: V študijah o vplivu na sposobnost razmnoževanja odraslih podgan se je plodnost nekoliko zmanjšala, če so telbivudin dajali samcem in samicam.V ločeni študiji na mladih živalih, v katerih so telbivudin prav tako prejemale živali obeh spolov, so bili neželeni učinki na plodnost večji (glejte poglavje 5.3).