FrancophonIA/ELRC3.0 huggingface dataset:
English: **on haemodialysis days, administer entecavir after haemodialysis.
Slovenian: ** na dan hemodialize bolniki vzamejo entekavir po hemodializi.
English: Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
Slovenian: Izboljšanje stopnje fibroze po Ishak-u ("Ishak fibrosis score")
English: When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months.
Slovenian: Po prekinitvi zdravljenja z zdravilom Baraclude boste še naprej pod zdravniškim nadzorom.
English: whether you have been treated for HBV infection before, and what medicine you received.
Slovenian: Vaš odmerek je odvisen od: morebitnega predhodnega zdravljenja okužbe s HBV in zdravila, s katerim ste se zdravili.
English: Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥ 26 times those in humans.
Slovenian: Pri študijah toksičnosti pri ponavljajočih se odmerkih so pri glodavcih in psih pri izpostavljenosti, ki je bila ≥ 26krat večja od izpostavljenosti človeka, opazili spremembe na modih (degeneracija semenskih cevk).
English: Dose adjustment is recommended for patients with creatinine clearance < 50 ml/min, including those on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Slovenian: Pri bolnikih s kreatininskim očistkom < 50 ml/min, vključno z bolniki, ki se zdravijo s hemodializo ali kontinuirano ambulantno peritonealno dializo (CAPD - "continuous ambulatory peritoneal dialysis"), priporočamo prilagoditev odmerka.
English: Clinical resistance in Adults: patients in clinical trials initially treated with entecavir 0.5 mg (nucleoside-naive) or 1.0 mg (lamivudine-refractory) and with an on-therapy PCR HBV DNA measurement at or after Week 24 were monitored for resistance.
Slovenian: Klinična odpornost pri odraslih: V kliničnih preskušanjih so spremljali odpornost pri bolnikih, ki so se v začetku zdravili z entekavirjem 0,5 mg (bolniki, ki se še niso zdravili z nukleozidi) ali 1 mg (bolniki, neodzivni na lamivudin) in so jim v času zdravljenja v 24. tednu ali kasneje s PCR določili HBV DNA.
English: Outer carton: Baraclude 1 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanja ovojnina: Baraclude 1 mg
English: Lamivudine-resistant strains harboring rtL180M plus rtM204V in combination with amino acid substitution rtA181C conferred 16- to 122-fold reductions in entecavir phenotypic susceptibility.
Slovenian: Pri proti lamivudinu odpornih sevih s prisotnostjo rtL180M in rtM204V v kombinaciji z aminokislinsko substitucijo rtA181C je bila fenotipska občutljivost za entekavir manjša za 16- do 122-krat.
English: The proposed dose modifications are based on extrapolation of limited data, and their safety and effectiveness have not been clinically evaluated.
Slovenian: Predlagane prilagoditve odmerka temeljijo na ekstrapolaciji majhnega števila podatkov.
English: Baraclude 0.5 mg film-coated tablets Each tablet contains 0.5 mg entecavir (as monohydrate).
Slovenian: Baraclude 0,5 mg filmsko obložene tablete Vsaka tableta vsebuje 0,5 mg entekavirja (v obliki monohidrata).
English: Patients with lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients without lamivudine-resistance.
Slovenian: Pri bolnikih s HBV, odpornim na lamivudin, obstaja večje tveganje za nadaljnji razvoj odpornosti na entekavir kot pri bolnikih brez odpornosti na lamivudin.
English: Baraclude 0.5 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Slovenian: Baraclude 0,5 mg filmsko obložene tablete so na voljo v škatlah s 30 x 1 ali 90 x 1 filmsko obloženo tableto (v pretisnih omotih za enkratni odmerek) in v plastenkah s 30 filmsko obloženimi tabletami.
English: Each ml oral solution contains 0.05 mg entecavir (as monohydrate).
Slovenian: Vsak mililiter peroralne raztopine vsebuje 0,05 mg entekavirja (v obliki monohidrata).
English: Blister pack: 30 x 1 film-coated tablet 90 x 1 film-coated tablet
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Pakiranje v pretisnem omotu: 30 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta
English: Bottle packs: do not store above 25°C.
Slovenian: Pakiranje v plastenki: shranjujte pri temperaturi do 25 °C.
English: Baraclude 1 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Slovenian: Baraclude 1 mg filmsko obložene tablete so na voljo v škatlah s 30 x 1 ali 90 x 1 filmsko obloženo tableto (v pretisnih omotih za enkratni odmerek) in v plastenkah s 30 filmsko obloženimi tabletami.
English: For patients with baseline Ishak fibrosis score ≥ 2, 25/43 (58%)
Slovenian: Pri bolnikih z izhodiščnim indeksom fibroze po Ishak-u ≥ 2 so zmanjšanje indeksa fibroze za ≥ 2 točki ugotovili pri 25/43 bolnikov (58%).
English: If your liver disease is very advanced, your doctor will also instruct you to take Baraclude on an empty stomach.
Slovenian: Da jemljite zdravilo Baraclude na prazen želodec, vam bo zdravnik naročil tudi v primeru, ko je bolezen jeter že močno napredovala.
English: At least 32.6 kg
Slovenian: 9,5 ml vsaj 32,6 kg
English: 3 of the 10 patients experienced virologic breakthrough (≥ 1 log10 increase above nadir).
Slovenian: V obdobju 240 tednov se je pri 3 od 10 bolnikov pojavilo povečanje virusnega bremena (≥ 1 log10 povečanje nad najnižjo vrednostjo).
English: There are no recommendations for Baraclude in children less than 2 years of age or weighing less than 10 kg.
Slovenian: Priporočila za uporabo zdravila Baraclude pri otrocih, mlajših od 2 let, ali otrocih s telesno maso, manjšo od 10 kg, niso na voljo.
English: Do not use this medicine after the expiry date which is stated on bottle or carton after EXP. That expiry date refers to the last day of that month.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki ali škatli poleg oznake “EXP”.
English: Paediatric patients with body weight of at least 32.6 kg, should be administered a daily dose of one 0.5 mg tablet or 10 ml (0.5 mg) of the oral solution, with or without food.
Slovenian: Pediatrični bolniki s telesno maso vsaj 32,6 kg morajo jemati eno 0,5 mg tableto ali 10 ml (0,5 mg) peroralne raztopine enkrat na dan skupaj s hrano ali brez nje.
English: At baseline entecavir-treated patients had a median duration of prior lamivudine therapy of 4.8 years and median CD4 count of 494 cells/mm3 (with only 5 subjects having CD4 count < 200 cells/mm3).
Slovenian: Srednja vrednost števila celic CD4 je bila 494 celic/mm3 (le pri 5-ih osebah je bilo število celic CD4 < 200 celic/mm3).
English: Baraclude can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Slovenian: Zdravilo Baraclude se lahko uporablja tako pri bolnikih z okvaro jeter, ki še delujejo normalno (kompenzirana bolezen jeter), kot pri bolnikih z okvaro jeter, ki več ne delujejo normalno (dekompenzirana bolezen jeter).
English: The oral solution should be used for patients with body weight less than 32.6 kg.
Slovenian: Pri bolnikih s telesno maso, manjšo od 32,6 kg, je treba uporabljati peroralno raztopino.
English: - emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd a Results reflect use of a 1-mg dose of entecavir for 147 of 149 patients in Year 3 and all patients in Years 4 and 5 and of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 20 weeks for 130 of 149 patients in Year 3 and for 1 week for 1 of 121 patients in Year 4 in a rollover study.
Slovenian: Rezultati odražajo zdravljenje z 1 mg entekavirja pri 147 od 149 bolnikov v 3. letu in pri vseh bolnikih v 4. in 5. letu ter kombinirano zdravljenje z entekavirjem in lamivudinom (čemur je sledilo dolgotrajno zdravljenje z entekavirjem) z mediano 20 tednov pri 130 od 149 bolnikov v 3. letu ter 1 tedna pri 1 od 121 bolnikov v 4 letu v nadaljnji študiji.
English: Prothrombin time (≤1 X ULN)b a Roche COBAS Amplicor PCR assay (LLOQ = 300 copies/ml).
Slovenian: ALT (≤ 1 krat ULN)b albumina (≥ 1 krat LLN)b bilirubina (≤ 1 krat ULN)b protrombinskega časa (≤ 1 krat ULN)b a Roche COBAS Amplicor PCR test (LLOQ = 300 kopij/ml).
English: For patients originally assigned to entecavir treatment, the reduction in HBV DNA at 48 weeks was -4.20 log10 copies/ml, ALT normalisation had occurred in 37% of patients with abnormal baseline ALT and none achieved HBeAg seroconversion.
Slovenian: Pri bolnikih, ki so od začetka prejemali entekavir, so se vrednosti HBV DNA v 48. tednu zmanjšale za -4,20 log10 kopij/ml, vrednosti ALT pa normalizirale pri 37% bolnikov, ki so imeli nenormalne izhodiščne vrednosti ALT.
English: Baraclude tablets do not contain maltitol and can be taken by patients with fructose intolerance.
Slovenian: Bolniki z intoleranco za fruktozo lahko jemljejo zdravilo Baraclude v obliki tablet, ki ne vsebujejo maltitola.
English: How to take BARACLUDE Not all patients need to take the same dose of Baraclude.
Slovenian: Odmerek zdravila Baraclude ni enak pri vseh bolnikih.
English: Baraclude oral solution comes with a measuring spoon with markings from 0.5 up to 10 milliliters.
Slovenian: Merilna žlička ima oznake od 0,5 do 10 mililitrov.
English: Among lamivudine-refractory patients with baseline HBV DNA < 107 log10 copies/ml, 64% (9/14) achieved HBV DNA < 300 copies/ml at Week 48.
Slovenian: Pri bolnikih, neodzivnih na lamivudin, z izhodiščno vrednostjo HBV DNA <107 log10 kopij/ml je bila v 48. tednu pri 64% (9/14) dosežena vrednost HBV DNA <300 kopij/ml.
English: A lactose-free Baraclude oral solution is available for these individuals.
Slovenian: Za uporabo pri teh bolnikih je na voljo Baraclude peroralna raztopina, ki ne vsebuje laktoze.
English: In HBeAg positive adult patients, treatment should be administered at least until 12 months after achieving HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Slovenian: Pri HBeAg pozitivnih odraslih bolnikih mora zdravljenje trajati še vsaj 12 mesecev po doseženi serokonverziji HBe (izginotje HBeAg in HBV DNA ter pojav protiteles anti-HBe v dveh zaporednih vzorcih seruma, odvzetih z vsaj 3- do 6-mesečnim vmesnim presledkom) ali do serokonverzije HBs, oziroma do izgube učinkovitosti (glejte poglavje 4.4).
English: Bristol-Myers Squibb Kft. Tel.: +36 1 9206 550
Slovenian: Magyarország Bristol-Myers Squibb Kft. Tel.: +36 1 9206 550
English: Nucleoside-naive:
Slovenian: Bolezni živčevja:
English: They are marked with “BMS” on one side and “1612” on the other.
Slovenian: Na eni strani imajo oznako “BMS”, na drugi strani pa “1612”.
English: (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥ 1point decrease in Ishak fibrosis score.
Slovenian: Izboljšanje histološke slike po prejšnji definiciji (glejte zgoraj) je bilo ugotovljeno pri 55/57 bolnikov (96%), zmanjšanje indeksa fibroze po Ishak-u za ≥ 1-točko pa pri 50/57 bolnikov (88%).
English: At end of dosing, among patients who continued treatment beyond 52 weeks (median of 96 weeks), 81% of 243 entecavir-treated and 39% of 164 lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR while ALT normalisation (≤ 1 times ULN) occurred in 79% of entecavirtreated and 68% of lamivudine-treated patients.
Slovenian: Pri zdravljenju, ki je trajalo dlje kot 52 tednov (v povprečju 96 tednov), je ob zaključku zdravljenja 81% od 243 z entekavirjem zdravljenih bolnikov in 39% od 164 z lamivudinom zdravljenih bolnikov imelo HBV DNA < 300 kopij/ml (s PCR), normalne vrednosti ALT (≤ 1 krat ULN) pa 79% z entekavirjem zdravljenih in 68% z lamivudinom zdravljenih bolnikov.
English: (HBV) through sexual contact or body fluids (including blood contamination).
Slovenian: jemanje zdravila Baraclude ne bo preprečilo prenosa okužbe z virusom hepatitisa B (HBV) na druge pri spolnih stikih ali s telesnimi izločki (vključno s krvjo).
English: EU/1/06/343/002 30 film-coated tablets
Slovenian: EU/1/06/343/002 30 filmsko obloženih tablet
English: Year 1 Year 2 Year 3a
Slovenian: 6.3 Rok uporabnosti 2 leti
English: Dosing for nucleoside naive paediatric patients aged 2 to < 18 years
Slovenian: Odmerjanje pri pediatričnih bolnikih, starih od 2 do < 18 let, ki se še niso zdravili z nukleozidi
English: In studies with lamivudine-refractory patients, on treatment ALT elevations > 10 times ULN and > 2 times baseline occurred in 2% of entecavir treated patients vs 11% of lamivudine treated patients.
Slovenian: V študijah pri bolnikih, neodzivnih na lamivudin, so se vrednosti ALT med zdravljenjem povečale za > 10 krat od ULN in > 2 krat od izhodiščnih vrednosti pri 2% bolnikov, ki so se zdravili z entekavirjem in 11% bolnikov, ki so se zdravili z lamivudinom.
English: Baraclude 0.5 mg film-coated tablets Baraclude 1 mg film-coated tablets
Slovenian: Baraclude 0,5 mg filmsko obložene tablete Baraclude 1 mg filmsko obložene tablete
English: They are marked with “BMS” on one side and “1611” on the other.
Slovenian: Na eni strani imajo oznako “BMS”, na drugi strani pa “1611”.
English: Blister packs: do not store above 30°C.
Slovenian: Pakiranje v pretisnem omotu: shranjujte pri temperaturi do 30 °C.
English: Human immunodeficiency virus (HIV)/HBV co-infected patients not receiving concomitant antiretroviral therapy: entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Slovenian: Bolniki s sočasno okužbo z virusoma humane imunske pomanjkljivosti (HIV) in HBV, ki sočasno ne prejemajo protiretrovirusnega zdravljenja: Pri bolnikih s sočasno okužbo z virusoma HIV in HBV, ki se sočasno niso zdravili z učinkovito obliko zdravljenja okužbe z virusom HIV, uporabe entekavirja niso ovrednotili.
English: Each film-coated tablet contains 1 mg entecavir.
Slovenian: Ena filmsko obložena tableta vsebuje 1 mg entekavirja.
English: Baraclude 1 mg tablets entecavir
Slovenian: Baraclude 1 mg tablete entekavir
English: How to store Baraclude
Slovenian: Kako jemati zdravilo BARACLUDE
English: Outer carton: Baraclude 0.05 mg/ml
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanja ovojnina: Baraclude 0,05 mg/ml
English: Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG Plaza 254
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom: Bristol-Myers Squibb Pharma EEIG Plaza 254
English: What BARACLUDE is and what it is used for Baraclude tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus
Slovenian: Baraclude tablete so protivirusno zdravilo, ki ga uporabljamo za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa B (HBV) pri odraslih.
English: Dizziness, fatigue and somnolence are common side effects which may impair the ability to drive and use machines.
Slovenian: Sposobnost vožnje in upravljanja s stroji lahko zmanjšajo omotica, utrujenost in somnolenca, ki so pogosti neželeni učinki.
English: 210 ml oral solution with a measuring spoon.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 210 ml peroralne raztopine z merilno žličko.
English: Laboratory test abnormalities: In clinical studies with nucleoside-naive patients, 5% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times upper limit of normal (ULN) and > 2 times baseline.
Slovenian: Odstopanja od normalnih vrednosti laboratorijskih preiskav: V kliničnih študijah pri bolnikih, ki se še niso zdravili z nukleozidi, so bile pri 5% bolnikov vrednosti ALT > 3 krat večje od izhodiščnih vrednosti, pri < 1% bolnikov pa so bile vrednosti ALT > 2 krat večje od izhodiščnih vrednosti in sočasno povečane tudi vrednosti skupnega bilirubina, ki so bile > 2 krat večje od zgornje meje normalne vrednosti (ULN; “upper limit of normal”) in > 2 krat večje od izhodiščnih vrednosti.
English: Paediatric population: Study 189 is an ongoing study of the efficacy and safety of entecavir among 180 nucleoside-treatment-naïve children and adolescents from 2 to < 18 years of age with HBeAgpositive chronic hepatitis B infection, compensated liver disease, and elevated ALT.
Slovenian: Pediatrična populacija: Študija 189, ki še poteka, je študija učinkovitosti in varnosti entekavirja pri 180 z nukleozidi predhodno še nezdravljenimi otroci in mladostniki, starimi od 2 do < 18 let, s HBeAg pozitivno kronično okužbo z virusom hepatitisa B, kompenzirano boleznijo jeter in povečano vrednostjo ALT. Bolnike so randomizirali (2:1) na slepo zdravljenje z entekavirjem v odmerku 0,015 mg/kg do največ 0,5 mg/dan (N = 120) ali placebo (N = 60).
English: 0.05 mg once daily OR 0.5 mg every 5-7 days
Slovenian: 0,5 mg vsakih 5-7 dni
English: Baseline ALT levels ≥ 2 times ULN and baseline HBV DNA ≤ 9.0 log10 copies/ml were both associated with higher rates of virologic response (Week 48 HBV DNA < 400 copies/ml) in nucleoside-naive HBeAg-positive patients.
Slovenian: Pri HBeAg pozitivnih bolnikih, ki se še niso zdravili z nukleozidi, so bile izhodiščne vrednosti ALT ≥ 2-krat ULN in izhodiščne vrednosti HBV DNA ≤ 9,0 log10 kopij/ml povezane z višjim odstotkom virusnega odziva (HBV DNA < 400 kopij/ml v 48. tednu).
English: The Cmax, AUC(0-24), and Cmin for these subjects was 14.48 ng/ml, 38.58 ng h/ml, and 0.47 ng/ml, respectively.
Slovenian: Pri teh bolnikih je vrednost Cmax znašala 14,48 ng/ml, vrednost AUC (0-24) 38,58 ng h/ml, vrednost Cmin pa 0,47 ng/ml.
English: What BARACLUDE is and what it is used for Baraclude oral solution is an anti-viral medicine, used to treat chronic (long term) hepatitis B
Slovenian: Baraclude peroralna raztopina je protivirusno zdravilo, ki ga uporabljamo za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa B (HBV) pri odraslih.
English: EU/1/06/343/001 30 film-coated tablets
Slovenian: EU/1/06/343/001 30 filmsko obloženih tablet
English: Patients treated and monitored for resistanceb
Slovenian: Bolniki, ki so bili zdravljeni in pri katerih so spremljali razvoj odpornostib
English: Each film-coated tablet contains 0.5 mg entecavir.
Slovenian: Ena filmsko obložena tableta vsebuje 0,5 mg entekavirja.
English: The safety of entecavir in paediatric patients from 2 to < 18 years of age is based on two ongoing clinical trials in subjects with chronic HBV infection; one Phase 2 pharmacokinetic trial (study 028) and one Phase 3 trial (study 189).
Slovenian: Varnost entekavirja pri pediatričnih bolnikih, starih od 2 do < 18 let, temelji na podatkih dveh kliničnih preskušanj, ki še potekata, in sicer enem farmakokinetičnem preskušanju 2. faze (študija 028) in enem preskušanju 3. faze (študija 189) pri bolnikih s kronično okužbo s HBV. Iz teh preskušanj so na voljo podatki o 99-tedenskem (mediana vrednost) trajanju zdravljenja z entekavirjem pri 195 HBeAg pozitivnih bolnikih, ki se predhodno še niso zdravili z nukleozidi.
English: In juvenile rats administered entecavir from postnatal days 4 to 80, a moderately reduced acoustic startle response was noted during the recovery period (postnatal days 110 to 114) but not during the dosing period at AUC values ≥ 92 times those in humans at the 0.5 mg dose or paediatric equivalent dose.
Slovenian: Pri mladih podganah, ki so entekavir prejemale od 4. do 80. dneva po skotitvi, so v obdobju okrevanja (110. do 114. dan po skotitvi) poročali o zmernem zmanjšanju odziva na akustične plašilne dražljaje.
English: OUTER CARTON AND BOTTLE LABEL TEXT
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI IN NALEPKI PLASTENKE
English: Baraclude 0.5 mg tablets entecavir
Slovenian: Baraclude 0,5 mg tablete entekavir
English: Outer carton: Baraclude 0.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Zunanja ovojnina: Baraclude 0,5 mg
English: 0.3 mg once daily OR 0.5 mg every 48 hours
Slovenian: 0,5 mg vsakih 48 ur
English: Baraclude 0.05 mg/ml oral solution entecavir
Slovenian: Baraclude 0,05 mg/ml peroralna raztopina entekavir
English: Baraclude oral solution is designed as a ready-to-use product.
Slovenian: Baraclude peroralna raztopina je že pripravljena za uporabo.
English: Your doctor will monitor you regularly while you are receiving Baraclude.
Slovenian: Med zdravljenjem z zdravilom Baraclude boste pod rednim zdravniškim nadzorom.
English: The film-coated tablets (tablets) are white to off-white and triangular-shaped.
Slovenian: Izgled zdravila Baraclude in vsebina pakiranja Filmsko obložene tablete (tablete) so bele do sivobele barve in trikotne oblike.
English: Baraclude 0.5 mg film-coated tablets
Slovenian: Baraclude 0,5 mg filmsko obložene tablete
English: Each ml of oral solution contains 0.05 mg entecavir.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Vsak ml vsebuje 0,05 mg entekavirja.
English: Marketing Authorisation Holder and Manufacturer
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom:
English: Oral solution Clear, colourless to pale yellow solution
Slovenian: Peroralna raztopina je bistra, brezbarvna do bledorumena raztopina.
English: Baraclude 1 mg film-coated tablets entecavir
Slovenian: Baraclude 1 mg filmsko obložene tablete entekavir
English: (Year 1), after week 58 through week 102 (Year 2), after week 102 through week 156 (Year 3), after week 156 through week 204 (Year 4), or after week 204 through week 252 (Year 5).
Slovenian: Vključuje bolnike z vsaj eno določitvijo HBV DNA s PCR, v 24. tednu zdravljenja ali kasneje do 58. tedna (1. leto), med 58. tednom in 102. tednom (2. leto), med 102. tednom in 156. tednom (3. leto), med 156. tednom in 204. tednom (4. leto) ali med 204. tednom in 252. tednom (5. leto).
English: Crospovidone
Slovenian: Entekavir
English: Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)c
Slovenian: Delež nedokazljivih (<300 kopij/ml)b
English: The oral solution should be used for patients with body weight less than 32.6 kg. Paediatric patients with body weight at least 32.6 kg, should be administered 10 ml (0.5 mg) of the oral solution or one 0.5 mg tablet once daily.
Slovenian: Pediatrični bolniki s telesno maso vsaj 32,6 kg morajo jemati 10 ml (0,5 mg) peroralne raztopine ali eno 0,5 mg tableto enkrat na dan.
English: 30 x 1 film-coated tablet; 3 blister cards of 10 x 1 film-coated tablet each in Alu/Alu perforated unit dose blisters, or
Slovenian: 30 x 1 filmsko obloženo tableto v 3 perforiranih enoodmernih pretisnih omotih (Alu/Alu), ali 90 x 1 filmsko obloženo tableto v 9 perforiranih enoodmernih pretisnih omotih (Alu/Alu).
English: In studies in nucleoside-naive patients, 6% of entecavir-treated patients and 10% of lamivudine-treated patients experienced ALT elevations (> 10 times ULN and > 2 times reference [minimum of baseline or last end-of-dosing measurement]) during post-treatment follow-up.
Slovenian: V študijah pri bolnikih, ki se še niso zdravili z nukleozidi, so se med spremljanjem po zdravljenju vrednosti ALT povečale (za > 10 krat od ULN in > 2 krat od referenčne vrednosti [najmanjše ob izhodišču ali zadnje, izmerjene ob prekinitvi zdravljenja]) pri 6% bolnikov, ki so se zdravili z entekavirjem in 10% bolnikov, ki so se zdravili z lamivudinom.
English: Baraclude 0.05 mg/ml oral solution
Slovenian: IME ZDRAVILA Baraclude 0,05 mg/ml peroralna raztopina
English: 0.15 mg once daily OR 0.5 mg every 72 hours
Slovenian: 0,5 mg vsakih 72 ur
English: Therefore, virological response should be closely monitored.
Slovenian: Ker njihova varnost in učinkovitost nista bili klinično ovrednoteni, je treba virusni odziv skrbno nadzirati.
English: * for doses < 0.5 mg Baraclude oral solution is recommended.
Slovenian: 0,5 mg vsakih 72 ur * za odmerke < 0,5 mg priporočamo uporabo Baraclude peroralne raztopine.