FrancophonIA/ELRC3.0 huggingface dataset:
English: If your doctor instructs you to take Baraclude on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Slovenian: Če vam je zdravnik naročil, da morate jemati zdravilo Baraclude na prazen želodec, to pomeni vsaj 2 uri po obroku in vsaj 2 uri pred naslednjim obrokom.
English: Patients treated with Baraclude have reported the following side effects: common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Baraclude, so poročali o naslednjih neželenih učinkih: pogosti (pri več kot 1 od 100 bolnikov): glavobol, insomnija (nespečnost), utrujenost (močna oslabelost), omotica, somnolenca (zaspanost), bruhanje, driska, slabost, dispepsija (prebavne motnje) in povečane vrednosti jetrnih encimov v krvi.
English: For appropriate dosing in the paediatric population, Baraclude oral solution or Baraclude 0.5 mg filmcoated tablets are available.
Slovenian: Za ustrezno odmerjanje pri pediatrični populaciji je zdravilo Baraclude na voljo v obliki peroralne raztopine ali 0,5 mg filmsko obloženih tablet.
English: Hepatobiliary disorders common: increased transaminases
Slovenian: pogosti: povečane vrednosti transaminaz
English: Each 1 mg film-coated tablet contains 241 mg lactose.
Slovenian: Vsaka 1 mg filmsko obložena tableta vsebuje 241 mg laktoze.
English: d ≥ 1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
Slovenian: ≥ 1 log10 povečanje nad najnižjo vrednostjo HBV DNA, določene s PCR, potrjeno z zaporednimi meritvami ali ob koncu časovnega okvira.
English: Also contains: maltitol, preservatives E216, E218.
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi: maltitol, konzervansa E216 in E218.
English: In studies in patients with compensated liver disease, histological improvement was defined as a ≥ 2point decrease in Knodell necro-inflammatory score from baseline with no worsening of the Knodell fibrosis score.
Slovenian: V študijah pri bolnikih s kompenzirano boleznijo jeter, je bilo izboljšanje histološke slike definirano kot zmanjšanje stopnje vnetja in nekroze po Knodell-u ("Knodell necro-inflammatory score") za 2 ali več točk od izhodiščne vrednosti in brez poslabšanja stopnje fibroze po Knodell-u ("Knodell Fibrosis Score").
English: A reduction of the daily dose using Baraclude oral solution, as detailed in the table, is recommended.
Slovenian: Pri zmanjšanju dnevnega odmerka priporočamo uporabo Baraclude peroralne raztopine, kot je prikazano v preglednici.
English: There are limited data on patients co-infected with HIV who have low CD4 cell counts (< 200 cells/mm3).
Slovenian: Podatki pri bolnikih s sočasno okužbo z virusom HIV z nizkim številom CD4 celic (< 200 celic/mm3) so omejeni.
English: Tablet core: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline and povidone.
Slovenian: Jedro tablete: krospovidon, laktoza monohidrat, magnezijev stearat, mikrokristalna celuloza in povidon.
English: Titanium dioxide Hypromellose Macrogol 400
Slovenian: Obloga tablete: titanov dioksid hipromeloza makrogol 400
English: At least 32.6 kgb
Slovenian: 9,5 ml vsaj 32,6 kgb
English: The film-coated tablets (tablets) are pink and triangular-shaped.
Slovenian: Filmsko obložene tablete (tablete) so rožnate barve in trikotne oblike.
English: You should not breast-feed during treatment with Baraclude.
Slovenian: Med zdravljenjem z zdravilom Baraclude ne smete dojiti.
English: Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n
Slovenian: Neodzivnost na lamivudin HBeAg pozitivni (študija 026) ETV 1,0 mg enkrat na dan
English: Baraclude must not be used during pregnancy unless specifically directed by your doctor.
Slovenian: Zdravila Baraclude med nosečnostjo ne smete uporabljati brez izrecnega navodila zdravnika.
English: Baraclude can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Slovenian: Zdravilo Baraclude se lahko uporablja pri otrocih z okvaro jeter, ki še delujejo normalno (kompenzirana bolezen jeter).
English: High-density polyethylene (HDPE) bottle with child resistant polypropylene closure containing 30 film-coated tablets.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko, ki vsebujejo 30 filmsko obloženih tablet.
English: What Baraclude looks like and contents of the pack
Slovenian: Izgled zdravila Baraclude in vsebina pakiranja
English: Do not use this medicine after the expiry date which is stated on the bottle, blister or carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki, pretisnem omotu ali škatli poleg oznake “EXP”.
English: Each carton includes a measuring spoon (polypropylene) with markings from 0.5 ml up to 10 ml
Slovenian: Vsaka škatlica vsebuje merilno žličko (polipropilen), ki ima oznake od 0,5 ml do 10 ml.
English: Liver transplant recipients: the safety and efficacy of entecavir 1 mg once daily were assessed in a single-arm study in 65 patients who received a liver transplant for complications of chronic HBV infection and had HBV DNA <172 IU/ml (approximately 1000 copies/ml) at the time of transplant.
Slovenian: Bolniki s presajenimi jetri: Varnost in učinkovitost entekavirja v odmerku 1 mg enkrat na dan so vrednotili v eno-skupinski študiji pri 65 bolnikih s presajenimi jetri, pri katerih so presaditev opravili zaradi zapletov kronične okužbe z virusom HBV in so imeli v času presaditve vrednost HBV DNA < 172 i.e./ml (približno 1.000 kopij/ml).
English: However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following.
Slovenian: Če ste se predhodno zdravili z učinkovino lamivudin, morate upoštevati naslednje.
English: It is recommended that the dosing spoon be rinsed with water after each daily dose.
Slovenian: Priporočamo, da bolnik po vsakem zaužitju dnevnega odmerka merilno žličko splakne z vodo.
English: Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Slovenian: Zdravilo Baraclude je indicirano za zdravljenje kronične okužbe z virusom hepatitisa B (HBV) (glejte poglavje 5.1) pri odraslih: s kompenzirano boleznijo jeter in dokazano aktivno replikacijo virusa, persistentno povečanimi vrednostmi serumske alanin-aminotransferaze (ALT) in histološko dokazanim aktivnim vnetjem in/ali fibrozo.
English: Excipients with known effect Each 0.5 mg film-coated tablet contains 120.5 mg lactose.
Slovenian: Pomožne snovi z znanim učinkom Vsaka 0,5 mg filmsko obložena tableta vsebuje 120,5 mg laktoze.
English: Year 1 Year 2 Year 3a Year 4a Year 5a
Slovenian: 1. leto 2. leto 3. letoa 4. letoa 5. letoa
English: Baraclude should not be used for children below 2 years of age or weighing less than 10 kg.
Slovenian: Zdravila Baraclude se ne sme uporabljati pri otrocih, mlajših od 2 let, ali otrocih s telesno maso, manjšo od 10 kg.
English: Parahydroxybenzoates: Baraclude oral solution contains the preservatives methylhydroxybenzoate and propylhydroxybenzoate, that may cause allergic reactions (possibly delayed).
Slovenian: Parahidroksibenzoati: Baraclude peroralna raztopina vsebuje konzervansa metilparahidroksibenzoat in propilparahidroksibenzoat, ki lahko povzročita alergijske reakcije (ki so lahko zapoznele).
English: Genotypic evaluations were performed for all patients with available samples who had virologic breakthrough through Week 96 or HBV DNA ≥ 50 IU/ml at Week 48 or
Slovenian: Genotipska vrednotenja so bila izvedena pri vseh bolnikih z razpoložljivimi vzorci, pri katerih je do 96. tedna prišlo do povečanja virusnega bremena (“virologic breakthrough”), ali so imeli v 48. tednu ali 96. tednu vrednost HBV DNA ≥ 50 i.e./ml.
English: Assessment of adverse reactions is based on experience from postmarketing surveillance and four clinical studies in which 1,720 patients with chronic hepatitis B infection and compensated liver disease received double-blind treatment with entecavir (n = 862) or lamivudine (n = 858) for up to 107 weeks (see section 5.1).
Slovenian: Neželeni učinki so bili ocenjeni na podlagi podatkov iz spremljanja zdravila po prihodu na trg in štirih kliničnih študij, v katerih je 1.720 bolnikov s kroničnim hepatitisom B in kompenzirano boleznijo jeter med dvojno slepim zdravljenjem, ki je trajalo do 107 tednov, prejemalo entekavir (n = 862) ali lamivudin (n = 858) (glejte poglavje 5.1).
English: Lamivudine-refractory patients (i.e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose in adults is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before and more than 2 hours after a meal) (see section 5.2).
Slovenian: Bolniki, neodzivni na lamivudin (to je z dokazano viremijo med zdravljenjem z lamivudinom ali prisotnostjo mutacij, povezanih z odpornostjo na lamivudin [LVDr]) (glejte poglavji 4.4 in 5.1): Priporočeni odmerek za odrasle je 1 mg enkrat na dan. Bolniki morajo priporočeni odmerek jemati na prazen želodec (več kot 2 uri pred in več kot 2 uri po obroku) (glejte poglavje 5.2).
English: Women of childbearing potential: given that the potential risks to the developing foetus are unknown, women of childbearing potential should use effective contraception.
Slovenian: Ženske v rodni dobi: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo, saj možna tveganja za razvoj ploda niso znana.
English: 2 years After opening, the solution can be used up to the expiry date on the bottle.
Slovenian: Po odprtju se raztopino lahko uporablja do datuma izteka roka uporabnosti, ki je naveden na plastenki.
English: Baraclude 0.5 mg film-coated tablets Blister packs: EU/1/06/343/003
Slovenian: Baraclude 0,5 mg filmsko obložene tablete Pakiranje v pretisnih omotih: EU/1/06/343/003
English: DNA < 8 log10 IU/ml Baseline HBV DNA ≥ 8 log10 IU/ml aNC=F (noncompleter=failure) * Patients randomized to placebo who did not have HBe- seroconversion by Week 48 rolled over to open-label entecavir for the second year of the study; therefore randomized comparison data are available only through Week 48.
Slovenian: Izhodiščna HBV DNA < 8 log10 i.e./ml Izhodiščna HBV DNA ≥ 8 log10 i.e./ml a NC=F (bolnik, pri katerem študija ni bila dokončana = neuspešno zdravljenje) * Bolniki, randomizirani na placebo, ki niso dosegli serokonverzije Hbe do 48. tedna, so v drugem letu študije prešli na odprto zdravljenje z entekavirjem, zato so randomizirani primerjalni podatki na voljo le do 48. tedna.
English: Breast-feeding should be discontinued during treatment with Baraclude.
Slovenian: Med zdravljenjem z zdravilom Baraclude je treba prenehati z dojenjem.
English: Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and iron oxide red.
Slovenian: Obloga tablete: hipromeloza, makrogol 400, titanov dioksid (E171) in rdeči železov oksid.
English: Baraclude tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Slovenian: Baraclude tablete uporabljamo tudi za zdravljenje kronične (dolgotrajne) okužbe s HBV pri otrocih in mladostnikih, starih od 2 leti do manj kot 18 let.
English: For adults the recommended dose is either 0.5 mg (10 ml) or 1 mg (20 ml) once daily orally (by mouth).
Slovenian: Priporočeni odmerek za odrasle je bodisi 0,5 mg (10 ml) bodisi 1 mg (20 ml) enkrat na dan peroralno (skozi usta).
English: For children and adolescents (from 2 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight.
Slovenian: Za otroke in mladostnike (stare od 2 leti do manj kot 18 let), bo pravilen odmerek določil zdravnik na osnovi telesne mase otroka.
English: - emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd
Slovenian: Skupna verjetnost: - pojava genotipske ETVrc - genotipske ETVrc s povečanjem virusnega bremenad
English: This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).
Slovenian: Zdravilo vsebuje metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216), ki lahko povzročita alergijske reakcije (ki so lahko zapoznele).
English: Experience in patients co-infected with HIV: the safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudine-containing HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4).
Slovenian: Izkušnje pri bolnikih s sočasno okužbo s HIV: Pri omejenem številu bolnikov s sočasno okužbo s HIV in HBV, ki so se med protiretrovirusnem zdravljenju po režimu HAART ("highly active antiretroviral therapy") zdravili tudi z lamivudinom, je bil varnostni profil entekavirja podoben kot pri bolnikih, okuženih le s HBV (glejte poglavje 4.4).
English: Baraclude contains lactose
Slovenian: Zdravilo Baraclude vsebuje laktozo
English: Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml oral solution.
Slovenian: Baraclude 0,05 mg/ml peroralna raztopina je na voljo v plastenki, ki vsebuje 210 ml peroralne raztopine.
English: What you need to know before you take BARACLUDE Do not take Baraclude if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Baraclude če ste alergični na entekavir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: EU/1/06/343/001 Baraclude 1 mg film-coated tablets Blister packs: EU/1/06/343/004 EU/1/06/343/007
Slovenian: EU/1/06/343/001 Baraclude 1 mg filmsko obložene tablete Pakiranje v pretisnih omotih: EU/1/06/343/004 EU/1/06/343/007
English: It has not been demonstrated that Baraclude is safe to use during pregnancy.
Slovenian: Varnost uporabe zdravila Baraclude med nosečnostjo ni dokazana.
English: Patients had stable controlled HIV (HIV RNA < 400 copies/ml) with recurrence of HBV viraemia on a lamivudine-containing HAART regimen.
Slovenian: Bolniki so imeli stabilno nadzorovano breme HIV (HIV RNA < 400 kopij/ml) s ponovitvijo HBV viremije pri HAART režimu zdravljenja, ki je vključeval lamivudin.
English: It is not known whether entecavir, the active ingredient in Baraclude, is excreted in human breast milk.
Slovenian: Ni znano, če se entekavir (učinkovina zdravila Baraclude) izloča v materino mleko.
English: Recommended Once Daily Dose of Oral Solution
Slovenian: Priporočeni odmerek peroralne raztopine enkrat na dan
English: Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433).
Slovenian: Obloga tablete: hipromeloza, makrogol 400, titanov dioksid (E171) in polisorbat 80 (E433).
English: Baraclude oral solution is also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Slovenian: Baraclude peroralno raztopino uporabljamo tudi za zdravljenje kronične (dolgotrajne) okužbe s HBV pri otrocih in mladostnikih, starih od 2 leti do manj kot 18 let.
English: Breast-feeding: it is unknown whether entecavir is excreted in human milk.
Slovenian: Dojenje:Ni znano, ali se entekavir izloča v materino mleko.
English: Baraclude should be taken orally.
Slovenian: Zdravilo Baraclude mora bolnik jemati peroralno.
English: High baseline Knodell necroinflammatory scores (> 10) were associated with greater histological improvement in nucleoside-naive patients.
Slovenian: Visoke izhodiščne vrednosti stopnje vnetja in nekroze po Knodell-u (> 10) so bile pri bolnikih, ki se še niso zdravili z nukleozidi, povezane z večjim izboljšanjem histološke slike.
English: Nucleoside Naive HBeAg Positive (study 022)
Slovenian: Brez predhodnega zdravljenja z nukleozidi HBeAg pozitivni (študija 022)
English: Relative to the adverse reactions noted in section b. Tabulated list of adverse reactions, one additional adverse reaction [decrease in blood bicarbonate (2%)] was observed in entecavir-treated patients through week 48.
Slovenian: Poleg neželenih učinkov, ki so navedeni v poglavju b. Tabelarični seznam neželenih učinkov, so pri bolnikih, ki so se 48 tednov zdravili z entekavirjem, poročali še o enem dodatnem neželenem učinku [zmanjšanje vrednosti bikarbonata v krvi (2%)].
English: OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI (PLASTENKE IN PRETISNI OMOTI) IN BESEDILO NA NALEPKI PLASTENKE
English: At baseline, patients had a mean CTP score of 8.59 and 26% of patients were CTP class C. The mean baseline Model for End Stage Liver Disease (MELD) score was 16.23.
Slovenian: V izhodišču je srednja vrednost ocene po CTP lestvici znašala 8,59, 26% bolnikov pa je po tej isti lestvici spadalo v skupino C. Srednja vrednost ocene po MELD (“Model for End Stage Liver Disease”) točkovanju je v izhodišču znašala 16,23.
English: The other ingredients are: citric acid anhydrous, maltitol (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), orange flavour (acacia and natural flavours), sodium citrate, sodium hydroxide, hydrochloric acid and purified water.
Slovenian: Pomožne snovi so: brezvodna citronska kislina, maltitol (E965), metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), aroma pomaranče (akacija in naravne arome), natrijev citrat, natrijev hidroksid, klorovodikova kislina in prečiščena voda.
English: Also, lamivudine-refractory patients who achieved HBV DNA <104 log10 copies/ml by PCR at Week 24 had a lower rate of resistance than those who did not (5-year cumulative probability 17.6% [n=50] versus 60.5% [n=135], respectively).
Slovenian: Pri bolnikih, neodzivnih na lamivudin, ki so v 24. tednu po metodi PCR imeli vrednost HBV DNA <104 log10 kopij/ml je bil delež odpornosti nižji kot pri bolnikih, pri katerih ta vrednost ni bila dosežena (5-letna skupna verjetnost 17,6% [n=50] v primerjavi s 60,5% [n=135]).
English: *p value vs lamivudine < 0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint.
Slovenian: *p vrednost v primerjavi z lamivudinom < 0,05 a bolniki z ovrednoteno histološko sliko v izhodišču (stopnja vnetja in nekroze po Knodell-u v izhodišču ≥ 2) b primarni opazovani dogodek.
English: Patients with decompensated liver disease: a higher rate of serious hepatic adverse events (regardless of causality) has been observed in patients with decompensated liver disease, in particular in those with Child-Turcotte-Pugh (CTP) class C disease, compared with rates in patients with compensated liver function.
Slovenian: Bolniki z dekompenzirano boleznijo jeter: V primerjavi z bolniki s kompenziranim delovanjem jeter so pri bolnikih z dekompenzirano boleznijo jeter opazili večji odstotek resnih jetrnih neželenih dogodkov (ne glede na vzrok), še posebej pri bolnikih, ki so po Child-Turcotte-Pugh-ovi (CTP) lestvici spadali v skupino C. Pri bolnikih z dekompenzirano boleznijo jeter je večje lahko tudi tveganje za pojav laktacidoze in specifičnih neželenih učinkov na ledvicah, na primer hepatorenalnega sindroma.
English: Paediatric population: the steady-state pharmacokinetics of entecavir were evaluated (study 028) in 24 nucleoside naïve and 19 lamivudine-experienced HBeAg-positive paediatric subjects from 2 to < 18 years of age with compensated liver disease.
Slovenian: Pediatrična populacija: Farmakokinetiko entekavirja v stanju dinamičnega ravnovesja so vrednotili (študija 028) pri 24 z nukleozidi predhodno še nezdravljenimi in 19 z lamivudinom predhodno zdravljenimi HBeAg pozitivnimi pediatričnimi bolniki, starih od 2 do < 18 let, s kompenzirano boleznijo jeter.
English: Baraclude 1 mg film-coated tablets Each tablet contains 1 mg entecavir (as monohydrate).
Slovenian: Baraclude 1 mg filmsko obložene tablete Vsaka tableta vsebuje 1 mg entekavirja (v obliki monohidrata).
English: Baraclude contains maltitol, methylhydroxybenzoate (E218), propylhydroxybenzoate (E216) and sodium
Slovenian: Zdravilo Baraclude vsebuje maltitol, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216) in natrij
English: *p value vs lamivudine < 0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
Slovenian: *p vrednost v primerjavi z lamivudinom < 0,05 a bolniki z ovrednoteno histološko sliko v izhodišču (stopnja vnetja in nekroze po Knodell-u v izhodišču ≥ 2) b primarni opazovani dogodek c Roche Cobas Amplicor PCR test (LLOQ = 300 kopij/ml)
English: 210 ml oral solution in a HDPE bottles with child-resistant closures (polypropylene).
Slovenian: 210 ml peroralne raztopine v plastenkah iz polietilena visoke gostote (HDPE) z za otroke varnimi zaporkami (polipropilen).
English: Baraclude is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to < 18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Slovenian: Zdravilo Baraclude je indicirano tudi za zdravljenje kronične okužbe s HBV pri z nukleozidi predhodno še nezdravljenih pediatričnih bolnikih, starih od 2 do < 18 let, ki imajo kompenzirano bolezen jeter in znake aktivne replikacije virusa ter persistentno povečane vrednosti serumske ALT ali histološke znake zmernega do hudega vnetja in/ali fibroze.
English: Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a Year 4 a
Slovenian: Genotipska odpornost proti entekavirju tekom 5 let v študijah pri bolnikih, neodzivnih na lamivudin 1. leto 2. leto 3. letoa
English: Lamivudine-refractory:
Slovenian: Neodzivnost na lamivudin:
English: 10.0 ml a Body weight should be rounded to the nearest 0.1 kg. b Children with body weight at least 32.6 kg should receive 10.0 ml (0.5 mg) of oral solution or one 0.5 mg tablet once daily.
Slovenian: 10,0 ml a Telesno maso je treba zaokrožiti na najbližji 0,1 kg. b Otroci s telesno maso vsaj 32,6 kg morajo jemati 10,0 ml (0,5 mg) peroralne raztopine ali eno 0,5 mg tableto enkrat na dan.
English: b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58 (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 času zdravljenja v 24. tednu 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: N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Slovenian: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: Therefore, entecavir should not be used in this setting due to the potential for development of HIV resistance (see section
Slovenian: V takšnih okoliščinah se entekavirja zaradi možnega razvoja odpornosti virusa HIV torej ne sme uporabljati (glejte poglavje 4.4).
English: Paediatric population: A lower rate of virologic response (HBV DNA < 50 IU/ml) was observed in paediatric patients with baseline HBV DNA ≥ 8.0 log10 IU/ml (see section 5.1).
Slovenian: Pediatrična populacija: Pri pediatričnih bolnikih, ki so v izhodišču imeli vrednost HBV DNA ≥ 8,0 log10 i.e./ml, so opazili manjši delež virološkega odziva (HBV DNA < 50 i.e./ml) (glejte poglavje 5.1).