natgillin/translations-raw huggingface dataset:
discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Baraclude treatment may be. 
vprašajte svojega zdravnika ali vaša jetra delujejo normalno, in če ne, kako lahko nenormalno delovanje jeter vpliva na zdravljenje z zdravilom Baraclude.
do not stop taking Baraclude without your doctor's advice since your hepatitis may worsen after stopping treatment. 
zdravila Baraclude ne smete nehati jemati brez nasveta zdravnika, saj se hepatitis po prekinitvi zdravljenja lahko poslabša.
Healthcare professionals are asked to report any suspected adverse reactions the national reporting system listed in Appendix V. 
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
If you were switched over to Baraclude because the treatment with lamivudine was not successful, you should take Baraclude on an empty stomach once daily. 
V primeru zamenjave zdravljenja, če vam je zdravnik zdravilo Baraclude predpisal zato, ker je bilo predhodno zdravljenje z zdravilom z učinkovino lamivudin neuspešno, morate zdravilo Baraclude jemati enkrat na dan na prazen želodec.
Name and address of the manufacturer responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy 
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italija
Other medicines and Baraclude 
Druga zdravila in zdravilo Baraclude
Patients with rare hereditary problems of fructose intolerance should not take this medicine. 
Bolniki z redko dedno težavo intolerance za fruktozo tega zdravila ne smejo jemati.
Lactose: this medicinal product contains 120.5 mg of lactose in each 0.5 mg daily dose or 241 mg of lactose in each 1 mg daily dose. 
Laktoza: Zdravilo vsebuje 120,5 mg laktoze v vsakem 0,5 mg dnevnem odmerku ali 241 mg laktoze v vsakem 1 mg dnevnem odmerku.
HBV DNA < 50 IU/mL and HBeAg seroconversiona HBV DNA < 50 IU/mLa HBeAg seroconversiona ALT normalizationa 
HBV DNA < 50 i.e./ml in serokonverzija HBeAga HBV DNA < 50 i.e./mla Serokonverzija HBeAga Normalizacija ALTa
Baraclude should not be used during pregnancy unless clearly necessary. 
Zdravila Baraclude ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Substitutions observed in clinical isolates (rtT184A, C, F, G, I, L, M or S; rtS202 C, G or I; and/or rtM250I, L or V) further decreased entecavir susceptibility 16- to 741-fold relative to wild-type virus. 
Substitucije, ki so jih opazili pri kliničnih izolatih (rtT184A, C, F, G, I, L, M ali S; rtS202 C, G ali I; in/ali rtM250I, L ali V), v primerjavi z divjim tipom virusa še dodatno zmanjšajo občutljivost za entekavir za 16- do 741krat.
Severe Managed with CAPD 
Zdravljenje s CAPD
You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced. 
Zdravila Baraclude za zdravljenje okužbe z virusom hepatitisa B ne smete jemati, če sočasno ne jemljete tudi zdravil za zdravljenje okužbe z virusom HIV, saj se v nasprotnem primeru lahko učinkovitost zdravil za zdravljenje okužbe z virusom HIV v prihodnosti zmanjša.
Excipients with known effect 380 mg maltitol/ml 1.5 mg methylhydroxybenzoate/ml 0.18 mg propylhydroxybenzoate/ml 0.3 mg sodium/ml 
Pomožne snovi z znanim učinkom 380 mg maltitola/ml 1,5 mg metilparahidroksibenzoata/ml 0,18 mg propilparahidroksibenzoata/ml 0,3 mg natrija/ml
HBV DNA < 50 IU/mLa 
HBV DNA < 50 i.e./mla
This medicinal product contains maltitol. 
Zdravilo vsebuje maltitol.
Maltitol: Baraclude oral solution contains maltitol. 
Maltitol: Baraclude peroralna raztopina vsebuje maltitol.
Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted. 
To je pomembno, ker se zdravilo Baraclude iz telesa izloča skozi ledvice in vam bo zdravnik morda moral odmerek ali odmerno shemo prilagoditi.
For children and adolescents (from 2 to less than 18 years of age), Baraclude oral solution or Baraclude 0.5 mg tablets are available 
Za otroke in mladostnike (stare od 2 leti do manj kot 18 let), je zdravilo Baraclude na voljo v obliki peroralne raztopine ali 0,5 mg tablet
The recommended once-daily dose in paediatric patients weighing at least 10 kg, is presented in the table below. 
Priporočeno odmerjanje enkrat na dan pri pediatričnih bolnikih s telesno maso vsaj 10 kg je prikazano v spodnji preglednici.
The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBVinfected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV. 
Varnost in učinkovitost entekavirja so vrednotili tudi v aktivno nadzorovanem kliničnem preskušanju, izvedenem pri 191 bolnikih, ki so bili okuženi z virusom HBV in so imeli dekompenzirano bolezen jeter, ter v kliničnem preskušanju pri 68 bolnikih, ki so bili sočasno okuženi z virusom HBV in virusom HIV.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine. 
Bolniki z redkimi dednimi težavami, kot so intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze ali malabsorpcija glukoze/galaktoze tega zdravila ne smejo jemati.
Also contains lactose monohydrate. 
SEZNAM POMOŽNIH SNOVI Vsebuje tudi laktozo monohidrat.
As an alternative, in case the oral solution is not available, the dose can be adjusted by increasing the dosage interval, also shown in the table. 
Če peroralne raztopine ni na voljo, se odmerek alternativno lahko prilagodi tudi s podaljšanjem odmernega intervala, kar je tudi prikazano v preglednici.
Sodium: Each ml of this medicinal product contains 0.015 mmol (or 0.3 mg) sodium. 
Natrij: En ml tega zdravila vsebuje 0,015 mmol (ali 0,3 mg) natrija.
What Baraclude is and what it is used for What you need to know before you take Baraclude How to take Baraclude 
Kaj je zdravilo Baraclude in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Baraclude Kako jemati zdravilo Baraclude Možni neželeni učinki
decompensated liver disease (see section 4.4). 
z dekompenzirano boleznijo jeter (glejte poglavje 4.4).
Mechanism of action: entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours. 
Mehanizem delovanja: Entekavir je nukleozidni analog gvanozina, ki deluje proti polimerazi HBV in se učinkovito fosforilizira v aktivno trifosfatno (TP) obliko, katere znotrajcelični razpolovni čas je 15 ur.
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. 
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.
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. 
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.
For appropriate dosing in the paediatric population, Baraclude oral solution or Baraclude 0.5 mg filmcoated tablets are available. 
Za ustrezno odmerjanje pri pediatrični populaciji je zdravilo Baraclude na voljo v obliki peroralne raztopine ali 0,5 mg filmsko obloženih tablet.
Hepatobiliary disorders common: increased transaminases 
pogosti: povečane vrednosti transaminaz
Each 1 mg film-coated tablet contains 241 mg lactose. 
Vsaka 1 mg filmsko obložena tableta vsebuje 241 mg laktoze.
d ≥ 1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point. 
≥ 1 log10 povečanje nad najnižjo vrednostjo HBV DNA, določene s PCR, potrjeno z zaporednimi meritvami ali ob koncu časovnega okvira.
Also contains: maltitol, preservatives E216, E218. 
SEZNAM POMOŽNIH SNOVI Vsebuje tudi: maltitol, konzervansa E216 in E218.
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. 
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").
A reduction of the daily dose using Baraclude oral solution, as detailed in the table, is recommended. 
Pri zmanjšanju dnevnega odmerka priporočamo uporabo Baraclude peroralne raztopine, kot je prikazano v preglednici.
There are limited data on patients co-infected with HIV who have low CD4 cell counts (< 200 cells/mm3). 
Podatki pri bolnikih s sočasno okužbo z virusom HIV z nizkim številom CD4 celic (< 200 celic/mm3) so omejeni.
Tablet core: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline and povidone. 
Jedro tablete: krospovidon, laktoza monohidrat, magnezijev stearat, mikrokristalna celuloza in povidon.
Titanium dioxide Hypromellose Macrogol 400 
Obloga tablete: titanov dioksid hipromeloza makrogol 400
At least 32.6 kgb 
9,5 ml vsaj 32,6 kgb
The film-coated tablets (tablets) are pink and triangular-shaped. 
Filmsko obložene tablete (tablete) so rožnate barve in trikotne oblike.
You should not breast-feed during treatment with Baraclude. 
Med zdravljenjem z zdravilom Baraclude ne smete dojiti.
Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n 
Neodzivnost na lamivudin HBeAg pozitivni (študija 026) ETV 1,0 mg enkrat na dan
Baraclude must not be used during pregnancy unless specifically directed by your doctor. 
Zdravila Baraclude med nosečnostjo ne smete uporabljati brez izrecnega navodila zdravnika.
Baraclude can be used in children whose liver is damaged but still functions properly (compensated liver disease). 
Zdravilo Baraclude se lahko uporablja pri otrocih z okvaro jeter, ki še delujejo normalno (kompenzirana bolezen jeter).
High-density polyethylene (HDPE) bottle with child resistant polypropylene closure containing 30 film-coated tablets. 
Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko, ki vsebujejo 30 filmsko obloženih tablet.
What Baraclude looks like and contents of the pack 
Izgled zdravila Baraclude in vsebina pakiranja
Do not use this medicine after the expiry date which is stated on the bottle, blister or carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki, pretisnem omotu ali škatli poleg oznake “EXP”.
Each carton includes a measuring spoon (polypropylene) with markings from 0.5 ml up to 10 ml 
Vsaka škatlica vsebuje merilno žličko (polipropilen), ki ima oznake od 0,5 ml do 10 ml.
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. 
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).
However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following. 
Če ste se predhodno zdravili z učinkovino lamivudin, morate upoštevati naslednje.
It is recommended that the dosing spoon be rinsed with water after each daily dose. 
Priporočamo, da bolnik po vsakem zaužitju dnevnega odmerka merilno žličko splakne z vodo.
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. 
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.
Excipients with known effect Each 0.5 mg film-coated tablet contains 120.5 mg lactose. 
Pomožne snovi z znanim učinkom Vsaka 0,5 mg filmsko obložena tableta vsebuje 120,5 mg laktoze.
Year 1 Year 2 Year 3a Year 4a Year 5a 
1. leto 2. leto 3. letoa 4. letoa 5. letoa
Baraclude should not be used for children below 2 years of age or weighing less than 10 kg. 
Zdravila Baraclude se ne sme uporabljati pri otrocih, mlajših od 2 let, ali otrocih s telesno maso, manjšo od 10 kg.
Parahydroxybenzoates: Baraclude oral solution contains the preservatives methylhydroxybenzoate and propylhydroxybenzoate, that may cause allergic reactions (possibly delayed). 
Parahidroksibenzoati: Baraclude peroralna raztopina vsebuje konzervansa metilparahidroksibenzoat in propilparahidroksibenzoat, ki lahko povzročita alergijske reakcije (ki so lahko zapoznele).
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 
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.
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). 
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).
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). 
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).
Women of childbearing potential: given that the potential risks to the developing foetus are unknown, women of childbearing potential should use effective contraception. 
Ženske v rodni dobi: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo, saj možna tveganja za razvoj ploda niso znana.
2 years After opening, the solution can be used up to the expiry date on the bottle. 
Po odprtju se raztopino lahko uporablja do datuma izteka roka uporabnosti, ki je naveden na plastenki.
Baraclude 0.5 mg film-coated tablets Blister packs: EU/1/06/343/003 
Baraclude 0,5 mg filmsko obložene tablete Pakiranje v pretisnih omotih: EU/1/06/343/003
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. 
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.
Breast-feeding should be discontinued during treatment with Baraclude. 
Med zdravljenjem z zdravilom Baraclude je treba prenehati z dojenjem.
Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and iron oxide red. 
Obloga tablete: hipromeloza, makrogol 400, titanov dioksid (E171) in rdeči železov oksid.
Baraclude tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years. 
Baraclude tablete uporabljamo tudi za zdravljenje kronične (dolgotrajne) okužbe s HBV pri otrocih in mladostnikih, starih od 2 leti do manj kot 18 let.
For adults the recommended dose is either 0.5 mg (10 ml) or 1 mg (20 ml) once daily orally (by mouth). 
Priporočeni odmerek za odrasle je bodisi 0,5 mg (10 ml) bodisi 1 mg (20 ml) enkrat na dan peroralno (skozi usta).
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. 
Za otroke in mladostnike (stare od 2 leti do manj kot 18 let), bo pravilen odmerek določil zdravnik na osnovi telesne mase otroka.
- emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd 
Skupna verjetnost: - pojava genotipske ETVrc - genotipske ETVrc s povečanjem virusnega bremenad
This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed). 
Zdravilo vsebuje metilparahidroksibenzoat (E218) in propilparahidroksibenzoat (E216), ki lahko povzročita alergijske reakcije (ki so lahko zapoznele).
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). 
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).
Baraclude contains lactose 
Zdravilo Baraclude vsebuje laktozo
Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml oral solution. 
Baraclude 0,05 mg/ml peroralna raztopina je na voljo v plastenki, ki vsebuje 210 ml peroralne raztopine.
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). 
Ne jemljite zdravila Baraclude če ste alergični na entekavir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
EU/1/06/343/001 Baraclude 1 mg film-coated tablets Blister packs: EU/1/06/343/004 EU/1/06/343/007 
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
It has not been demonstrated that Baraclude is safe to use during pregnancy. 
Varnost uporabe zdravila Baraclude med nosečnostjo ni dokazana.
Patients had stable controlled HIV (HIV RNA < 400 copies/ml) with recurrence of HBV viraemia on a lamivudine-containing HAART regimen. 
Bolniki so imeli stabilno nadzorovano breme HIV (HIV RNA < 400 kopij/ml) s ponovitvijo HBV viremije pri HAART režimu zdravljenja, ki je vključeval lamivudin.
It is not known whether entecavir, the active ingredient in Baraclude, is excreted in human breast milk. 
Ni znano, če se entekavir (učinkovina zdravila Baraclude) izloča v materino mleko.
Recommended Once Daily Dose of Oral Solution 
Priporočeni odmerek peroralne raztopine enkrat na dan
Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433). 
Obloga tablete: hipromeloza, makrogol 400, titanov dioksid (E171) in polisorbat 80 (E433).
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. 
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.
Breast-feeding: it is unknown whether entecavir is excreted in human milk. 
Dojenje:Ni znano, ali se entekavir izloča v materino mleko.
Baraclude should be taken orally. 
Zdravilo Baraclude mora bolnik jemati peroralno.
High baseline Knodell necroinflammatory scores (> 10) were associated with greater histological improvement in nucleoside-naive patients. 
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.
Nucleoside Naive HBeAg Positive (study 022) 
Brez predhodnega zdravljenja z nukleozidi HBeAg pozitivni (študija 022)
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. 
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%)].
OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) AND BOTTLE LABEL TEXT 
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI BESEDILO NA ŠKATLI (PLASTENKE IN PRETISNI OMOTI) IN BESEDILO NA NALEPKI PLASTENKE
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. 
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.
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. 
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.
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). 
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]).