FrancophonIA/ELRC3.0 huggingface dataset:
English: Changes in Knodell necroinflammatory and Ishak scores were similar for HBeAg-positive and HBeAg-negative patients.
Croatian: Promjene u Knodellovom nekroinflamatornom skoru i Ishak skoru bile su slične u HBeAg-pozitivnih and HBeAg-negativnih bolesnika.
English: Cmax (g/ml) AUC0-∞ (g•h/ml) CLRENAL (ml/min)
Croatian: Cmax (g/ml) AUC0-∞ (g•h/ml) CLBUBREŽNI (ml/min)
English: In the event of an overdose, Sebivo should be discontinued and appropriate general supportive treatment applied as necessary.
Croatian: U slučaju predoziranja, primjenu Sebiva treba prekinuti i po potrebi provesti primjereno opće potporno liječenje.
English: No data are available to support a specific dose recommendation for patients over the age of 65 years (see section 4.4).
Croatian: Nisu dostupni podaci koji bi podržavali specifične preporuke za doziranje u bolesnika iznad 65 godina starosti (vidjeti dio 4.4).
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF11
Croatian: Farmakoterapijska skupina: Antivirotici za sistemsku primjenu, nukleozidni i nukleotidni inhibitori transkriptaze, ATK oznaka: J05AF11
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: If patients test positive for HBV DNA at any time after their initial response, treatment modification should be considered.
Croatian: U slučaju pozitivnog rezultata na HBV DNK u bilo kojem trenutku nakon početnog odgovora, potrebno je razmotriti promjenu liječenja.
English: There were no abnormalities in sperm morphology or function, and the testes and ovaries were histologically unremarkable.
Croatian: Nije bilo poremećaja u morfologiji niti funkciji sperme, a testisi i jajnici su bili bez histoloških promjena.
English: Also contains sodium.
Croatian: Također sadrži natrij.
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.
Croatian: Čak i ako uzimate Sebivo, još uvijek možete zaraziti druge osobe virusom hepatitisa B (HBV) putem spolnog kontakta ili izlaganjem zaraženoj krvi ili drugim tjelesnim tekućinama.
English: If this applies to you, do not take Sebivo.
Croatian: Ako se navedeno odnosi na Vas, nemojte uzimati Sebivo.
English: It is efficiently phosphorylated by cellular kinases to the active triphosphate form, which has an intracellular half-life of 14 hours.
Croatian: Učinkovito se fosforilira staničnim kinazama do aktivnog trifosfatnog oblika, čije unutarstanično poluvrijeme života iznosi 14 sati.
English: Do not take Sebivo if you are using pegylated or standard interferon alfa (see “Do not take Sebivo”), because the combination of these medicines may increase your risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs).
Croatian: Nemojte uzimati Sebivo ukoliko upotrebljavate pegilirani ili standardni interferon alfa (vidjeti dio “Nemojte uzimati Sebivo”), jer kombinacija ovih lijekova može povećati rizik razvoja periferne neuropatije (obamrlost, trnci i/ili osjećaj pečenja u rukama i/ili nogama).
English: Tested doses up to 1,800 mg/day, three times greater than the recommended daily dose, have been well tolerated.
Croatian: Ispitivane doze do 1800 mg/dan, tri puta veće od preporučene dnevne doze, dobro su se podnosile.
English: Rare (may affect up to 1 in 1,000 people) - Excess of lactic acid in the blood (lactic acidosis) - Muscle breakdown (rhabdomyolysis)
Croatian: Rijetko (mogu se javiti u do 1 na 1000 osoba) - višak mliječne kiseline u krvi (laktacidoza) - razgradnja mišića (rabdomioliza)
English: Treatment with telbivudine should be discontinued when metabolic/lactic acidosis of unknown aetiology occurs.
Croatian: Liječenje telbivudinom treba prekinuti pri pojavi metaboličke acidoze/laktacidoze nepoznate etiologije.
English: Take the pack of tablets with you and show it to your doctor.
Croatian: Sa sobom ponesite pakiranje tableta i pokažite ga liječniku.
English: (rhabdomyolysis) which can cause kidney damage.
Croatian: (rabdomioliza) koja može uzrokovati oštećenje bubrega.
English: ALT normalisation rates (78% vs 70%) continued to be higher by week 104.
Croatian: Stope normalizacije vrijednosti ALT-a (78% u odnosu na 70%) bile su veće sve do 104. tjedna.
English: Clinical experience
Croatian: Kliničko iskustvo
English: A trend towards higher rates of HBeAg loss (35% vs 29%) and seroconversion (30% vs 25%) was also observed for telbivudine.
Croatian: Sklonost prema višim stopama nestanka HBeAg (35% u odnosu na 29%) i serokonverziji (30% u odnosu na 25%) su također bili opaženi za telbivudin.
English: The safety and efficacy of Sebivo in the paediatric population have not yet been established.
Croatian: Sigurnost i djelotvornost Sebiva u pedijatrijskoj populaciji nisu još ustanovljene.
English: Remove the dosing cup.
Croatian: Uklonite dozirnu čašu.
English: Normal
Croatian: Normalna
English: Transient reductions in HIV-1 RNA have been reported in a small number of patients after administration of telbivudine in the absence of antiretroviral therapy.
Croatian: Prolazna smanjenja HIV-1 RNK bila su zabilježena u malog broja bolesnika nakon primjene telbivudina bez antiretrovirusne terapije.
English: Conversions at position 80, 180 and polymorphic positions 91, 229 were always detected in sequences that harboured the M204I mutation that confers genotypic resistance.
Croatian: Konverzije na mjestima 80, 180 i polimorfnim mjestima 91, 229 uvijek su otkrivene u sljedovima koji su nosili mutaciju M2041 koja daje genotipsku rezistenciju.
English: Aspartate aminotransferase increased * This adverse reaction was identified through post-marketing surveillance but not observed in controlled clinical trials.
Croatian: Povišenje aspartat aminotransferaze * Ove nuspojave temelje se na izvješćima nakon stavljanja lijeka u promet, ali nisu zabilježene tijekom ispitivanja.
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.
Croatian: Vaš liječnik ili ljekarnik mora znati ako ste uzimali druge lijekove zbog toga što neki lijekovi mogu djelovati na bubrege i zato što se Sebivo iz tijela uglavnom izlučuje putem bubrega u mokraću.
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.
Croatian: Općenito, potreban je oprez pri propisivanju Sebiva starijim bolesnicima, imajući u vidu veću učestalost smanjene funkcije bubrega zbog druge istodobne bolesti ili zbog istodobne primjene drugih lijekova.
English: Clear, colourless to pale yellow solution.
Croatian: Bistra, bezbojna do blijedo žuta otopina.
English: The safety and effectiveness of these dosing adjustment guidelines have not been clinically evaluated.
Croatian: Sigurnost i učinkovitost ovih smjernica za prilagođavanje doziranja nisu klinički procijenjene.
English: This effect was considered to be secondary to maternal toxicity.
Croatian: Ocijenjeno je da je taj učinak bio izazvan toksičnošću za majku.
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.
Croatian: Ako korištenje oralne otopine nije moguće, kao alternativa se mogu koristiti Sebivo filmom obložene tablete, a doziranje se treba prilagoditi produljenjem vremenskog intervala između doza kao što je detaljno opisano u Tablici 1.
English: Telbivudine is eliminated primarily by urinary excretion of unchanged substance.
Croatian: Telbivudin se eliminira prvenstveno izlučivanjem nepromijenjene tvari u mokraću.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to telbivudine in clinical trials (n = 8,914).
Croatian: Kategorija učestalosti procijenjena ja na osnovu statističkih kalkulacija koje se baziraju na ukupnom broju bolesnika izloženih telbivudinu za vrijeme ispitivanja (n = 8914).
English: Clinical results at week 52
Croatian: Klinički rezultati u 52. tjednu
English: Bottle containing the oral solution.
Croatian: Boca koja sadrži oralnu otopinu.
English: How much Sebivo to take
Croatian: Koliko Sebiva uzeti
English: 200 mg (10 ml) once daily 600 mg once every 72 hours
Croatian: 200 mg (10 ml) jedanput na dan 600 mg jedanput svaka 72 sata
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.
Croatian: Sebivo se koristi za liječenje odraslih osoba s kroničnim hepatitisom B. Početak liječenja Sebivom treba razmotriti samo kada nije moguće ili prikladno koristiti neki drugi lijek za koji je manje vjerojatno da će na njega virus hepatitisa B razviti otpornost.
English: - if you suffer from cirrhosis of the liver (a serious condition which causes liver “scarring”).
Croatian: - ako imate cirozu jetre (ozbiljno stanje koje uzrokuje stvaranje “ožiljaka” na jetri).
English: ALT flare:
Croatian: ALT porast:
English: Telbivudine therapy should be discontinued if myopathy is diagnosed.
Croatian: Terapiju telbivudinom treba prekinuti ako se dijagnosticira miopatija.
English: Secondary endpoints included histological response, ALT normalisation, and various measures of antiviral efficacy.
Croatian: Sekundarne mjere ishoda uključivale su histološki odgovor, normalizaciju ALT-a i različite pokazatelje antivirusne djelotvornosti.
English: These patients should be closely monitored for clinical, biochemical and virological parameters associated with hepatitis B during treatment and after treatment is discontinued.
Croatian: U tih bolesnika treba pažljivo pratiti kliničke, biokemijske i virološke pokazatelje povezane s hepatitisom B tijekom liječenja i nakon prekida liječenja.
English: The adverse effects on fertility were greater in a separate study in juvenile animals when both sexes received telbivudine (see section 5.3).
Croatian: Štetni učinci na plodnost su bili veći u odvojenom ispitivanju na mladim životinjama kada su oba spola primala telbivudin (vidjeti dio 5.3).
English: Selected virological, biochemical and serological outcome measures are shown in Table 5 and histological response in Table 6.
Croatian: Odabrane virološke, biokemijske i serološke mjere ishoda prikazani su u Tablici 5., dok je histološki odgovor prikazan u Tablici 6.
English: 120 mg (6 ml) once daily 600 mg once every 96 hours * End stage renal disease ** In case use of the oral solution is not possible
Croatian: 120 mg (6 ml) jedanput na dan 600 mg jedanput svakih 96 sati * Bubrežna bolest u završnom stadiju ** U slučaju kada primjena oralne otopine nije moguća
English: Telbivudine pharmacokinetics are dose proportional over the range of 25 to 1,800 mg.
Croatian: Farmakokinetika telbivudina razmjerna je dozi u rasponu od 25 do 1800 mg.
English: Inter-subject variability (CV%) for measures of systemic exposures (Cmax, AUC) was typically approximately 30%.
Croatian: Varijabilnost među ispitanicima (CV%) s obzirom na pokazatelje sustavne izloženosti (Cmax, AUC) u tipičnom je slučaju iznosila oko 30%.
English: Turn the syringe to the upright position and incline it slightly so that the air bubbles rise to the top.
Croatian: Okrenite štrcaljku prema gore u uspravan položaj i lagano je nagnite kako bi se mjehurići zraka podigli na vrh.
English: There is no information on intentional overdose of telbivudine, but one subject was given an unintentional overdose which was asymptomatic.
Croatian: Ne postoje podaci o namjernom predoziranju telbivudinom, no jedan je ispitanik nenamjerno primio preveliku dozu što je bilo asimptomatično.
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.
Croatian: Stoga funkciju jetre treba provjeravati u pravilnim vremenskim razmacima, uz kliničko i laboratorijsko praćenje tijekom najmanje 6 mjeseci nakon prekida terapije hepatitisa B.
English: It is not known whether the risk of myopathy during treatment with telbivudine is increased with concurrent administration of other medicinal products associated with myopathy (e.g. statins, fibrates, or ciclosporin).
Croatian: Nije poznato da li se tijekom terapije telbivudinom povećava rizik od miopatije ako se istodobno primjenjuju i drugi lijekovi povezani s miopatijom (npr. statini, fibrati ili ciklosporin).
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).
Croatian: Sebivo može dovesti do povišenja mliječne kiseline u krvi (laktacidoza) koje je obično povezano s povećanjem jetre (hepatomegalija).
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.
Croatian: Liječnici koji razmatraju istodobno liječenje drugim lijekovima povezanim s miopatijom moraju pažljivo odvagati moguće koristi i rizike te u bolesnika moraju pratiti pojavu bilo kojega znaka ili simptoma koji ukazuje na miopatiju.
English: Regardless of baseline characteristics, the majority of patients taking Sebivo showed histological, virological, biochemical, and serological responses to treatment.
Croatian: Neovisno o početnim obilježjima, većina bolesnika koja je uzimala Sebivo pokazala je histološke, virološke, biokemijske i serološke odgovore na liječenje.
English: If you experience any of these symptoms during your treatment with Sebivo, call your doctor immediately.
Croatian: Ako osjetite bilo koji od navedenih simptoma tijekom liječenja Sebivom, odmah se javite svom liječniku.
English: In some cases, fatal outcomes were reported when lactic acidosis was secondary to rhabdomyolysis.
Croatian: U nekim slučajevima, zabilježeni su smrtni ishodi kada je laktacidoza bila posljedica rabdomiolize.
English: Talk to your doctor before taking Sebivo: - if you have or have had any kidney problems.
Croatian: Obratite se svom liječniku prije nego uzmete Sebivo: - ako imate ili ste imali probleme s bubrezima.
English: Patients should be advised to report promptly any persistent unexplained muscle aches, pain, tenderness or weakness.
Croatian: Bolesnike treba uputiti da odmah prijave svaku trajnu i neobjašnjivu bol, osjetljivost ili slabost mišića.
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.
Croatian: Nakon postizanja vršne koncentracije, raspoloživost telbivudina u plazmi smanjivala se po bi-eksponencijalnom obrascu, s terminalnim poluvremenom eliminacije (t1/2) od 41,8 ± 11,8 sati.
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.
Croatian: Trenutno nema kliničkih podataka koji ispravno procjenjuju korist i rizik prebacivanja bolesnika liječenih lamivudinom, koji su postigli potpunu supresiju virusa pomoću lamivudina, na liječenje telbivudinom.
English: The risk of hepatic decompensation - and of a subsequent exacerbation of hepatitis - may be elevated in patients with cirrhosis.
Croatian: Rizik od dekompenzacije jetre - i od posljedične egzacerbacije hepatitisa - može biti povećan u bolesnika s cirozom.
English: Such patients should, therefore, be closely monitored.
Croatian: Stoga, te bolesnike treba pažljivo pratiti.
English: It can be taken with or without food.
Croatian: Možete ga uzimati sa ili bez hrane.
English: Sebivo oral solution may be considered for patients who have difficulties swallowing tablets.
Croatian: Sebivo oralna otopina može se koristiti u bolesnika koji imaju problema s gutanjem tableta.
English: FOLDING BOX AND BOTTLE LABEL
Croatian: KUTIJA I NALJEPNICA BOCE
English: Clinical resistance
Croatian: Klinička rezistencija
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.
Croatian: U ispitivanjima povezanima s građom i funkcijom mitohondrija te DNK sadržajem, telbivudin nije iskazao značajniji toksični učinak u koncentracijama do 10 M i nije povećao proizvodnju mliječne kiseline in vitro.
English: Cumulative genotypic resistance rates were also assessed by applying a mathematical model where only patients with undetectable HBV DNA at the beginning of the respective year are considered.
Croatian: Za određivanje kumulativnih stopa genotipske rezistencije također su korištene matematički modeli u koje su uključeni samo bolesnici s nemjerljivom razinom HBV DNK na početku određene godine.
English: Sebivo film-coated tablets are supplied in packs of 28 or 98 tablets.
Croatian: Sebivo filmom obložene tablete dostupne su u pakiranjima od 28 ili 98 tableta.
English: Studies in pregnant rats and rabbits showed that telbivudine crosses the placenta.
Croatian: Ispitivanja u gravidnih ženki štakora i kunića pokazala su da telbivudin prolazi kroz posteljicu.
English: Oral syringe for measuring out doses that cannot be precisely measured using the cup.
Croatian: Štrcaljka za usta za mjerenje doza koje se ne mogu precizno izmjeriti čašom.
English: Peripheral neuropathy, dysgeusia, hypoaesthesia, paresthesia, sciatica
Croatian: Periferna neuropatija, disgeuzija, hipoestezija, parestezija, išijas
English: Following initiation of antiviral treatment, serum ALT may rise in some patients while serum levels of HBV DNA fall (see section 4.8).
Croatian: Nakon uvođenja antivirusnog liječenja, serumski ALT može u nekih bolesnika porasti, dok razine HBV DNK u serumu padaju (vidjeti dio 4.8).
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.
Croatian: Ako osjetite bol u mišićima, tešku i trajnu bol u trbuhu praćenu mučninom i povraćanjem, teško i trajno otežano disanje, umor ili nelagodu u trbuhu dok uzimate Sebivo, odmah se javite svom liječniku.
English: Do not pour it back into the bottle.
Croatian: Ne ulijevajte tekućinu ponovno u bocu.
English: While you are taking Sebivo, make sure you do not run out of Sebivo.
Croatian: Dok uzimate Sebivo pazite da Vam ne ponestane Sebiva.
English: The antiviral activity of telbivudine is specific to the hepatitis B virus and related hepadnaviruses.
Croatian: Antivirusna aktivnost telbivudina specifična je za virus hepatitisa B i srodne hepadnaviruse.
English: Muscular effects
Croatian: Učinci na mišiće
English: Out of these 517 patients 159 patients (HBeAg-positive=135, HBeAg-negative=24) had detectable HBV DNA.
Croatian: Od tih 517 bolesnika, 159 bolesnika (HBeAgpozitivni=135, HBeAg-negativni=24) imalo je mjerljivu razinu HBV DNK.
English: Moreover, the benefit of the combination of telbivudine with interferon alfa (pegylated or standard) is not currently established.
Croatian: Osim toga, korist kombinacije telbivudina i interferona alfa (pegiliranog ili standardnog) trenutno još nije ustanovljena.
English: On average, 4-5 weeks elapsed prior to the occurrence of an exacerbation in patients treated with telbivudine.
Croatian: U prosjeku prođe 4-5 tjedana prije pojave egzacerbacije u bolesnika liječenih telbivudinom.
English: Cases of myopathy and myalgia have been reported with telbivudine use several weeks to months after starting therapy (see section 4.8).
Croatian: Pri primjeni telbivudina zabilježeni su slučajevi miopatije i mialgije nekoliko tjedana do mjeseci nakon početka terapije (vidjeti dio 4.8).
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.
Croatian: Bolesnike treba upozoriti da nije dokazano da se uzimanjem Sebiva smanjuje rizik od prijenosa HBVa drugim osobama spolnim putem ili zaraženom krvi.
English: - Do not breast-feed during treatment with Sebivo.
Croatian: - Nemojte dojiti tijekom liječenja Sebivom.
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.
Croatian: Ukupno gledajući, klinički rezultati u 104. tjednu u bolesnika liječenih telbivudinom su bili u skladu s onima u 52. tjednu, prikazujući postojanost odgovora u pogledu djelotvornosti u bolesnika liječenih telbivudinom koji su nastavili liječenje.
English: Cellulose microcrystalline Povidone
Croatian: Celuloza, mikrokristalična Povidon
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.
Croatian: Uvođenje lijeka Sebivo u terapiju treba razmotriti jedino u slučaju kada primjena drugih antivirusnih lijekova s višom genetskom barijerom na rezistenciju nije dostupna ili primjerena.
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.
Croatian: Ne preporučuje se primjena telbivudina s lamivudinom, jer je u ispitivanju faze II odgovor na terapiju kombinacijom telbivudina i lamivudina bio slabiji od odgovora na terapiju samo telbivudinom.
English: Do not use this medicine if the pack is damaged or shows signs of tampering.
Croatian: Lijek se ne smije upotrijebiti ako primijetite da je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
English: Overall, ALT flares occurred more frequently in HBeAg-positive patients than in HBeAg-negative patients.
Croatian: Sveukupno, porast ALT-a bio je češći u HBeAg-pozitivnih bolesnika nego u HBeAg-negativnih bolesnika.
English: Blood creatine phosphokinase increased, blood alanine aminotransferase increased, blood amylase increased
Croatian: Povišenje kreatin fosfokinaze u krvi, povišenje alanin aminotransferaze u krvi, povišenje amilaze u krvi
English: HBeAg-positive (n = 921)
Croatian: HBeAg-pozitivni (n = 921)
English: Therapy must be initiated by a physician experienced in the management of chronic hepatitis B infection.
Croatian: Terapiju mora započeti liječnik s iskustvom u liječenju kronične infekcije virusom hepatitisa B.
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.
Croatian: Sebivo je indiciran za liječenje kroničnog hepatitisa B u odraslih bolesnika s kompenziranom bolešću jetre i dokazanom replikacijom virusa, trajno povišenim razinama serumske alanin aminotransferaze (ALT) i histološkim dokazom aktivne upale i/ili fibroze.
English: In reproductive toxicology studies in adult animals, fertility was slightly reduced when both male and female rats received telbivudine.
Croatian: U ispitivanjima reproduktivne toksičnosti na odraslim životinjama, plodnost je bila blago smanjena kada su i mužjaci i ženke štakora primali telbivudin.
English: Women should not breastfeed if they are taking Sebivo.
Croatian: Žene koje uzimaju Sebivo ne smiju dojiti.