FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with telbivudine should be discontinued when metabolic/lactic acidosis of unknown aetiology occurs.
Slovenian: Zdravljenje s telbivudinom je treba prekiniti, če pride do metabolične acidoze/laktacidoze iz neznanega vzroka.
English: Physicians considering concomitant treatment with other agents associated with myopathy should weigh carefully the potential benefits and risks and should monitor patients for any signs or symptoms suggestive of myopathy.
Slovenian: Pri odločanju za sočasno uporabo drugih zdravil, ki so povezana z miopatijo, morajo zdravniki skrbno pretehtati možne koristi in tveganja ter spremljati bolnike glede kakršnihkoli znakov ali simptomov, ki bi kazali na možnost miopatije.
English: Clinical and virological efficacy endpoints were evaluated separately in the HBeAg-positive and HBeAg-negative patient populations.
Slovenian: Klinične cilje opazovanja in tiste glede virološke učinkovitosti so ocenjevali ločeno po skupinah HBeAg-pozitivnih in HBeAg-negativnih bolnikov.
English: Studies in pregnant rats and rabbits showed that telbivudine crosses the placenta.
Slovenian: V študijah na brejih podganah in kuncih se je pokazalo, da telbivudin prehaja skozi placento.
English: Your doctor or pharmacist needs to know about other medicines because some medicines could affect your kidneys and because Sebivo mainly leaves the body via the kidneys in the urine.
Slovenian: Zdravniku ali farmacevtu morate povedati, če jemljete druga zdravila, ker lahko nekatera zdravila vplivajo na ledvice, zdravilo Sebivo pa se iz telesa izloča večinoma preko ledvic z urinom.
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).
Slovenian: V toksikološki študiji na mladih podganah so podgane zdravili od 14. do 70. dne po porodu in jih parili s podganami, ki so bile tretirane enako (parjenja s sorojenci pri tem ni bilo).
English: Outcome for key efficacy end points at 104 weeks based on week 24 results Therapeutic response n/N (%)
Slovenian: Izid glavnih ciljev opazovanja glede učinkovitosti po 104 tednih glede na rezultate po 24. tednu terapevtski odziv n/N (%)
English: Exacerbations of hepatitis B after discontinuation of treatment Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued antihepatitis B therapy including telbivudine (see section 4.4).
Slovenian: Poslabšanja hepatitisa B po zaključku zdravljenja Poročali so o hudih akutnih poslabšanjih hepatitisa B pri bolnikih, ki so prekinili zdravljenje hepatitisa B (vključno z zdravljenjem s telbivudinom) (glejte poglavje 4.4).
English: See section 5.1 for details of the study and specific patient characteristics on which this indication is based.
Slovenian: Glede podrobnosti študije in posebnih značilnosti bolnikov, na katerih temelji ta indikacija, glejte poglavje 5.1.
English: Drink the solution or administer it to the patient immediately.
Slovenian: Raztopino takoj popijte oziroma jo takoj ponudite bolniku.
English: The safety and efficacy of Sebivo in the paediatric population have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Sebivo pri pediatrični populaciji še nista bili dokazani.
English: Most grade 3 or 4 CK elevations were asymptomatic and transient.
Slovenian: Zvišanja CK stopnje 3 ali 4 so bila večinoma brez simptomov in prehodna.
English: What you need to know before you take Sebivo
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Sebivo
English: Study NV-02B-015
Slovenian: Študija NV-02B-015
English: ALT elevation > 2x baseline and > 10x ULN
Slovenian: zvišanje ALT >2 x izhodiščna vrednost in >10 x ULN
English: Sebivo is used to treat adults with chronic hepatitis B. Starting treatment with Sebivo should only be considered when it is not possible or appropriate to use an alternative medicine to which the hepatitis B virus is less likely to develop resistance.
Slovenian: Sebivo se uporablja za zdravljenje odraslih s kroničnim hepatitisom B. O začetku zdravljenja z zdravilom Sebivo velja razmisliti samo v primeru, da ni mogoče ali ni primerno uporabiti drugega zdravila, pri katerem je verjetnost za razvoj rezistence (odpornosti) virusa hepatitisa B manjša.
English: Therefore, hepatic function should be monitored at regular intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Slovenian: Zato je treba delovanje jeter nadzorovati tako klinično kot z laboratorijskimi testi na rednih kontrolnih pregledih vsaj 6 mesecev po prekinitvi zdravljenja hepatitisa B.
English: It can be taken with or without food.
Slovenian: Lahko jo jemljete s hrano ali brez nje.
English: No definitive conclusion could be drawn regarding the effects of telbivudine on the pharmacokinetics of pegylated interferon due to high interindividual variability of pegylated interferon alfa-2a concentrations.
Slovenian: O vplivu telbivudina na farmakokinetične lastnosti pegiliranega interferona ni mogoče podati dokončnih zaključkov zaradi velike interindividualne variabilnosti koncentracij pegiliranega interferona alfa-2a.
English: In assays relating to mitochondrial structure, function and DNA content, telbivudine lacked appreciable toxic effect at concentrations up to at 10 M and did not increase lactic acid production in vitro.
Slovenian: Pri poskusih, povezanih s strukturo in delovanjem mitohondrijev ter vsebnostjo DNA v njih, telbivudin ni pokazal znatnega toksičnega učinka v koncentracijah do 10 mol/l in ni povečal tvorbe mlečne kisline in vitro.
English: The telbivudine area under the plasma concentration-time curve (AUC0-∞) was 28.0  8.5 gh/ml (mean  SD).
Slovenian: Površina pod krivuljo časovne razporeditve koncentracije telbivudina v plazmi (AUC0-∞) je bila 28,0  8,5 gh/ml (povprečje  SD).
English: Clinical experience
Slovenian: Klinične izkušnje
English: However the ovarian and uterine parameters of those females mating successfully were unaffected.
Slovenian: Vendar vplivala na parametre jajčnikov in maternice tistih samic, ki so se uspešno parile, ni bilo.
English: Even if you take Sebivo, you may still infect others with hepatitis B virus (HBV) through sexual contact or exposure to contaminated blood or other body fluids.
Slovenian: Kljub temu da jemljete zdravilo Sebivo, lahko druge okužite z virusom hepatitisa B (HBV) s spolnimi stiki ali preko okužene krvi ali drugih telesnih tekočin.
English: These patients should be closely monitored for clinical, biochemical and virological parameters associated with hepatitis B during treatment and after treatment is discontinued.
Slovenian: Pri teh bolnikih je treba med zdravljenjem in po prekinitvi zdravljenja skrbno spremljati klinične, biokemične in virološke parametre, ki so povezani s hepatitisom B.
English: Simultaneously press down (2a) and turn the child resistant cap (2b) to the left to open the bottle.
Slovenian: Steklenico odprete tako, da za otroke varno zaporko hkrati pritisnete navzdol (2a) in zavrtite v levo stran (2b).
English: The tablet can be taken with or without food.
Slovenian: Tableto lahko zaužijete s hrano ali brez nje.
English: Limited clinical data (less than 300 pregnancy outcomes) after exposure to telbivudine during the first trimester of pregnancy indicate no malformative toxicity and a large amount of data (more than 1000 pregnancy outcomes) after exposure during the second and third trimesters indicate no foetal/neonatal toxicity.
Slovenian: Omejeno število kliničnih podatkov (manj kot 300 izpostavljenih nosečnosti) o izpostavljenosti telbivudinu v prvem trimesečju ne kaže na toksičnost telbivudina v smislu povzročanja malformacij, večje število podatkov (več kot 1.000 izpostavljenih nosečnosti) o izpostavljenosti v drugem in tretjem trimesečju pa ne kaže, da bi bil telbivudin lahko toksičen za plod/novorojenca.
English: Cross-resistance has been observed among HBV nucleoside analogues (see section 4.4).
Slovenian: Opazili so, da med nukleozidnimi analogi HBV obstaja navzkrižna rezistenca (glejte poglavje 4.4).
English: Overall, clinical results at week 104 in telbivudine-treated patients were consistent with those at week 52, demonstrating durability of efficacy responses for telbivudine-treated patients with continued treatment.
Slovenian: Skupno so se klinični rezultati po 104 tednih pri bolnikih, ki so prejemali telbivudin, ujemali z rezultati po 52 tednih, kar kaže na trajnost odziva glede učinkovitosti pri bolnikih, ki so neprekinjeno prejemali telbivudin.
English: By contrast, telbivudine-5'-triphosphate at concentrations up to 100 M did not inhibit cellular DNA polymerases , , or .
Slovenian: Nasprotno pa telbivudin-5'-trifosfat v koncentracijah do 100 mol/l ni zaviral celičnih DNA polimeraz ,  ali .
English: For both HBeAg-positive and HBeAg-negative patients, week 24 HBV DNA results were a predictor of long-term favourable outcomes.
Slovenian: Tako za HBeAg-pozitivne kot za HBeAg-negativne bolnike so rezultati HBV DNA po 24 tednih napovedovali dolgoročno ugoden izid.
English: ALT normalisation rates (78% vs 70%) continued to be higher by week 104.
Slovenian: Delež bolnikov z normalizacijo ALT (78% v primerjavi s 70%) je bil tudi po koncu 104. tedna višji.
English: After reaching peak concentration, plasma disposition of telbivudine declined in a bi-exponential manner with a terminal elimination half-life (t1/2) of 41.8 ± 11.8 hours.
Slovenian: Po doseženi najvišji koncentraciji je upadala razpoložljivost telbivudina v plazmi bieksponentno s končnim razpolovnim časom izločanja (t1/2) 41,8 ± 11,8 ur.
English: Other special populations
Slovenian: Druge posebne skupine
English: Periodic monitoring of hepatic function is recommended during treatment (see section 4.4).
Slovenian: V času zdravljenja je priporočljivo redno spremljanje delovanja jeter (glejte poglavje 4.4).
English: 28 film-coated tablets 98 film-coated tablets
Slovenian: filmsko obložena tableta 28 filmsko obloženih tablet 98 filmsko obloženih tablet
English: Do not pour it back into the bottle as this could cause contamination.
Slovenian: Ne zlivajte je nazaj v steklenico, ker bi lahko onesnažili raztopino v steklenici.
English: Telbivudine is not recommended to be used with lamivudine because in a phase II study, the treatment response observed with combination therapy of telbivudine and lamivudine was lower than with telbivudine alone.
Slovenian: Uporaba telbivudina skupaj z lamivudinom ni priporočljiva, saj so v študiji faze II opažali slabši odziv na zdravljenje s kombinacijo telbivudina in lamivudina v primerjavi z zdravljenjem samo s telbivudinom.
English: Other medicines and Sebivo
Slovenian: Druga zdravila in zdravilo Sebivo
English: Women should not breastfeed if they are taking Sebivo.
Slovenian: Ženske, ki jemljejo Sebivo, ne smejo dojiti.
English: Nonetheless, there have also been reports of severe - and sometimes fatal - post-treatment disease exacerbations.
Slovenian: Vendar pa so poročali tudi o hudih poslabšanjih po zaključku zdravljenja, v nekaterih primerih s smrtnim izidom.
English: Literature shows that exposure to telbivudine in the second and/or third trimester of pregnancy has been shown to reduce the risk of HBV transmission from mother to infant if telbivudine is given in addition to Hepatitis B immune globulin and Hepatitis B vaccine.
Slovenian: Iz literature je razvidno, da izpostavljenost telbivudinu v drugem in/ali tretjem trimesečju nosečnosti zmanjšuje tveganje za prenos virusa hepatitisa B z matere na plod, če mati prejema telbivudin poleg imunoglobulina proti hepatitisu B in cepiva proti hepatitisu B.
English: The effectiveness of dosing interval adjustment has not been clinically evaluated.
Slovenian: Učinkovitosti prilagajanja intervalov med odmerki niso klinično ocenili.
English: Rinse the cup and syringe with clean water.
Slovenian: Odmerno posodico in brizgo sperite s čisto vodo.
English: Regardless of baseline characteristics, the majority of patients taking Sebivo showed histological, virological, biochemical, and serological responses to treatment.
Slovenian: Pri večini bolnikov, ki so jemali Sebivo, je ne glede na izhodiščne značilnosti prišlo do histološkega, virološkega, biokemičnega in serološkega odziva na zdravljenje.
English: Hepatitis B is caused by infection with the hepatitis B virus, which multiplies in the liver and causes liver damage.
Slovenian: Hepatitis B povzroči okužba z virusom hepatitisa B, ki se razmnožuje v jetrih in jih poškoduje.
English: In adult rats, fertility was reduced when both male and female rats were treated with telbivudine at doses of 500 or 1000 mg/kg/day (lower fertility index compared to concurrent controls).
Slovenian: Pri odraslih podganah se je plodnost zmanjšala, če so tako samci kot samice prejemali telbivudin v odmerkih 500 ali 1000 mg/kg/dan (indeks plodnosti je bil nižji kot pri ustreznih kontrolah).
English: Therefore, virological response should be closely monitored in patients with increased dosage interval (see sections 4.2 and 5.2).
Slovenian: Zato je treba pri bolnikih s podaljšanimi intervali med odmerki pazljivo spremljati virološki odziv (glejte poglavji 4.2 in 5.2).
English: The most common adverse reactions were grade 3 or 4 blood creatine kinase elevations (6.8%), fatigue (4.4%), headache (3.0%) and nausea (2.6%).
Slovenian: Najbolj pogosti neželeni učinki so bili zvišanje koncentracije kreatin kinaze v krvi stopnje 3 ali 4 (6,8%), utrujenost (4,4%), glavobol (3,0%) in navzea (2,6%).
English: There are currently no efficacy and safety data for other antiviral combinations with telbivudine.
Slovenian: O učinkovitosti in varnosti drugih kombinacij protivirusnih zdravil s telbivudinom zaenkrat ni podatkov.
English: The risk of hepatic decompensation - and of a subsequent exacerbation of hepatitis - may be elevated in patients with cirrhosis.
Slovenian: Tveganje za odpoved jeter - in poslabšanje hepatitisa kot posledico odpovedi jeter - je lahko pri bolnikih s cirozo večje.
English: Overall, ALT flares occurred more frequently in HBeAg-positive patients than in HBeAg-negative patients.
Slovenian: Do poslabšanja z zvišanjem ALT je prišlo pogosteje pri HBeAg-pozitivnih bolnikih kot pri HBeAgnegativnih.
English: HBeAg-negative (n = 446)
Slovenian: HBeAg-negativni (n = 446)
English: Clinical resistance
Slovenian: Klinična rezistenca
English: Continue taking Sebivo every day for as long as your doctor tells you.
Slovenian: Zdravilo Sebivo jemljite vsak dan in nadaljujte, dokler vam tako svetuje zdravnik.
English: Swallow the entire contents of the dosing cup immediately.
Slovenian: Takoj popijte celotno vsebino odmerne posodice.
English: HBeAg-negative patients: The mean age of patients was 43 years, 79% were male, 65% were Asian, 23% were Caucasian, and 11% had previously received alfa-interferon therapy.
Slovenian: HBeAg-negativni bolniki: Povprečna starost bolnikov je bila 43 let, 79% je bilo moških, 65% je bilo Azijcev, 23% belcev, 11% jih je že prej prejemalo interferon alfa.
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Slovenian: Vrednosti ALT in HBV DNA v serumu je treba po prekinitvi zdravljenja redno spremljati, da bi zaznali morebiten pozen virološki relaps.
English: Cases of myopathy and myalgia have been reported with telbivudine use several weeks to months after starting therapy (see section 4.8).
Slovenian: Poročali so o primerih miopatije in bolečin v mišicah ob uporabi telbivudina, do katerih je prišlo več tednov do več mesecev po začetku zdravljenja (glejte poglavje 4.8).
English: For full instructions on how to take Sebivo, see section “Instructions for use” at the end of this leaflet.
Slovenian: Za podrobna navodila glede načina jemanja zdravila Sebivo glejte poglavje “Navodila za jemanje zdravila” na koncu tega navodila za uporabo.
English: Patients should be advised that treatment with Sebivo has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
Slovenian: Bolnike je treba opozoriti, da zdravljenje z zdravilom Sebivo ni pokazalo učinkov na zmanjševanje tveganja za prenos virusa hepatitisa B s spolnimi stiki ali z okuženo krvjo ali krvnimi pripravki.
English: Telbivudine was not active against HIV in vitro.
Slovenian: Telbivudin ni deloval proti humanemu virusu imunske pomanjkljivosti (HIV) in vitro.
English: N/A = not applicable * Virological breakthrough: “1 log above nadir” definition assessed at week 104
Slovenian: NP = podatek smiselno ni potreben * virološki preboj: opredeljen kot “1 log nad najnižjo vrednostjo”, ocenjen po 104 tednih
English: Moreover, the benefit of the combination of telbivudine with interferon alfa (pegylated or standard) is not currently established.
Slovenian: Razen tega tudi koristi zdravljenja s kombinacijo telbivudina in interferona alfa (pegiliranega ali standardnega) zaenkrat niso dokazane.
English: If you cannot measure the prescribed amount precisely using the dosing cup alone, you should use the oral syringe.
Slovenian: Če predpisane količine ne morete natančno odmeriti samo z odmerno posodico, uporabite brizgo za peroralno dajanje zdravila.
English: The difference in populations is due to patient discontinuation from the study and missing HBV DNA assessment at week 52.
Slovenian: Velikost skupin se razlikuje zaradi prekinitve sodelovanja nekaterih bolnikov v študiji in manjkajočih izvidov HBV DNA po 52. tednu.
English: Do not use this medicine if the pack is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če je ovojnina poškodovana ali opazite, da je bila že odprta.
English: The antiviral activity of telbivudine is specific to the hepatitis B virus and related hepadnaviruses.
Slovenian: Protivirusno delovanje telbivudina je specifično za virus hepatitisa B in sorodne hepadnaviruse.
English: Following initiation of antiviral treatment, serum ALT may rise in some patients while serum levels of HBV DNA fall (see section 4.8).
Slovenian: Po začetku protivirusnega zdravljenja se lahko pri nekaterih bolnikih ALT v serumu zviša, vrednosti HBV DNA v serumu pa znižajo (glejte poglavje 4.8).
English: The no observed adverse effect level (NOAEL) for effects on fertility or mating parameters amounted to 250 mg/kg/day, which provided exposure levels 2.5 to 2.8 times higher than those achieved in humans with normal renal function at the therapeutic dose.
Slovenian: Raven, pri kateri niso opažali nobenega vpliva na plodnost ali parametre parjenja (no observed adverse effect level - NOAEL), je znašala 250 mg/kg/dan, kar pomeni ravni izpostavljenosti, ki so 2,5-2,8-krat višje od izpostavljenosti pri ljudeh z normalno ledvično funkcijo pri uporabi terapevtskih odmerkov.
English: In general, caution must be exercised when prescribing Sebivo to older patients in view of the greater frequency of decreased renal function due to concomitant disease or concomitant use of other medicinal products.
Slovenian: Na splošno je pri predpisovanju zdravila Sebivo starejšim ljudem potrebna previdnost, predvsem zaradi večje pogostnosti zmanjšanega delovanja ledvic zaradi spremljajočih bolezni ali sočasne uporabe drugih zdravil.
English: A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Slovenian: V kliničnem preskušanju s kombinacijo telbivudina 600 mg dnevno in subkutano aplikacijo pegiliranega interferona alfa-2a 180 mikrogramov enkrat na teden se je pokazalo, da je ta kombinacija povezana s povečanim tveganjem za razvoj periferne nevropatije.
English: Oral syringe for measuring out doses that cannot be precisely measured using the cup.
Slovenian: Brizga za peroralno dajanje za merjenje odmerkov, ki jih ne morete natančno odmeriti z odmerno posodico.
English: If use of the oral solution is not possible, Sebivo film-coated tablets could be used as an alternative and dosing should be adjusted by increasing the time interval between doses, as detailed in Table 1.
Slovenian: Če bolnik ne more uporabljati peroralne raztopine, lahko kot drugo možnost uporablja filmsko obložene tablete Sebivo, odmerjanje pa je treba prilagoditi s podaljšanjem intervala med odmerki, kot je prikazano v preglednici 1.
English: It is not known whether telbivudine is excreted in human milk.
Slovenian: Ni znano, ali se telbivudin izloča v materino mleko pri človeku.
English: In rabbits doses of telbivudine providing exposure levels of 37 times those observed in humans at the therapeutic dose (600 mg) were associated with an increased incidence of abortion and early delivery.
Slovenian: Odmerki telbivudina, pri katerih je sistemska izpostavljenost 37-krat večja od izpostavljenosti pri ljudeh, ki prejemajo terapevtske odmerke (600 mg), so bili pri kuncih povezani s povečano incidenco splava in prezgodnje skotitve.
English: Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
Slovenian: O začetku zdravljenja z zdravilom Sebivo velja razmisliti samo v primeru, da drugo protivirusno zdravilo z višjim genetskim pragom za rezistenco za posameznega bolnika ni na voljo ali ni primerno.
English: During the treatment with Sebivo: - Sebivo can cause persistent unexplained muscle weakness or muscle pain (myopathy).
Slovenian: V času jemanja zdravila Sebivo: - Zdravilo Sebivo lahko povzroča trdovratno nepojasnjeno šibkost mišic ali bolečine v mišicah (miopatijo).
English: Most CK elevations were asymptomatic and CK values typically decreased by the next visit on continued treatment.
Slovenian: Zvišanje CK je potekalo večinoma brez simptomov, vrednosti CK pa so se ob nadaljevanju zdravljenja praviloma znižale do naslednjega kontrolnega obiska.
English: The safety and efficacy of telbivudine in liver transplant recipients are unknown.
Slovenian: Varnost in učinkovitost telbivudina pri bolnikih s presajenimi jetri nista znani.
English: For patients with detectable HBV DNA after 24 weeks of therapy, treatment modification should be considered.
Slovenian: Pri bolnikih, ki imajo po 24 tednih zdravljenja merljive vrednosti HBV DNA, je treba razmisliti o spremembi zdravljenja.
English: Some side effects could be serious: - Persistent muscle weakness or muscle pain - Numbness, tingling, pain and/or burning sensation in the arms and/or legs If you experience any of these, call your doctor immediately.
Slovenian: Nekateri neželeni učinki so lahko resni: - trdovratna šibkost mišic ali bolečina v mišicah - odrevenelost, mravljinčenje, bolečina in/ali pekoč občutek v rokah in/ali nogah Če pride do katerega od navedenih učinkov, takoj pokličite svojega zdravnika.
English: Since telbivudine is eliminated primarily by renal excretion, co-administration of Sebivo with substances that affect renal function (such as aminoglycosides, loop diuretics, platinum compounds, vancomycin, amphotericin B) may affect plasma concentrations of telbivudine and/or the coadministered substance.
Slovenian: Ker se telbivudin izloča večinoma preko ledvic, lahko sočasna uporaba zdravila Sebivo s snovmi, ki vplivajo na delovanje ledvic (kot so aminoglikozidi, diuretiki Henlejeve zanke, pripravki s platino, vankomicin in amfotericin B), vpliva na plazemske koncentracije telbivudina in/ali sočasno uporabljanih zdravil.
English: Sebivo may reduce the risk of passing your hepatitis B virus on to your unborn baby if taken in combination with Hepatitis B immune globulin and Hepatitis B vaccine.
Slovenian: Zdravilo Sebivo lahko zmanjša tveganje za prenos virusa hepatitisa B na vašega nerojenega otroka, če ga jemljete v kombinaciji z imunoglobulinom proti hepatitisu B in s cepivom proti hepatitisu B.
English: Selected virological, biochemical and serological outcome measures are shown in Table 5 and histological response in Table 6.
Slovenian: V preglednici 5 so prikazana izbrana virološka, biokemična in serološka merila izida, v preglednici 6 pa so prikazani histološki odzivi.