FrancophonIA/ELRC3.0 huggingface dataset:
English: Not all pack sizes and container types may be marketed.
Slovenian: Na trgu morda ni vseh navedenih pakiranj in vrste vsebnikov.
English: e ETVr occurring in any year; virologic breakthrough in specified year.
Slovenian: Pojav ETVr v kateremkoli letu; povečanje virusnega bremena v določenem letu.
English: Serious adverse events were generally liver-related, with an on-study cumulative frequency of 69%.
Slovenian: Resni neželeni učinki so bili običajno povezani z jetri, njihova kumulativna pogostnost med študijo pa je bila 69odstotna.
English: The on-study cumulative rate of hepatocellular carcinoma (HCC) was 12% (12/102).
Slovenian: Kumulativni delež pojavnosti hepatocelularnega karcinoma (HCC - Hepatocellular Carcinoma) med študijo je znašal 12% (12/102).
English: Lactic acidosis occurs more often in women, particularly if they are very overweight.
Slovenian: Laktacidoza se pogosteje pojavi pri ženskah, še posebej tistih s prekomerno telesno maso.
English: The predictivity of the findings for humans is not known.
Slovenian: Pomen teh ugotovitev za človeka ni znan.
English: Since some paediatric patients may require long-term or even lifetime management of chronic active hepatitis B, consideration should be given to the impact of entecavir on future treatment options.
Slovenian: Ker bodo nekateri pediatrični bolniki morda potrebovali dolgotrajno ali celo doživljenjsko zdravljenje kroničnega aktivnega hepatitisa B, je treba razmisliti o vplivu entekavirja na možnosti bodočega zdravljenja.
English: Patients in response were followed for an additional 24 weeks offtreatment.
Slovenian: Bolnike, pri katerih je bil dosežen odziv, so spremljali še dodatnih 24 tednov po zdravljenju.
English: Given the exposure margin, this finding is considered of unlikely clinical significance.
Slovenian: Glede na mejo izpostavljenosti je malo verjetno, da bi ta ugotovitev bila klinično pomembna.
English: Your doctor will advise you on the dose that is right for you.
Slovenian: Zdravnik vam je predpisal odmerek, ki je primeren za vas.
English: Entecavir Accord belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Slovenian: zdravilo Entecavir Accord spada v skupino zdravil, ki lahko povzročijo laktacidozo (čezmerno kopičenje mlečne kisline v krvi) in povečanje jeter.
English: Empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Slovenian: Jemanje na prazen želodec pomeni vsaj 2 uri po obroku in vsaj 2 uri pred naslednjim obrokom.
English: Treatment beyond 48 weeks: continued treatment with entecavir for a median duration of 96 weeks did not reveal any new safety signals.
Slovenian: Zdravljenje, daljše od 48-tih tednov: pri kontinuiranem zdravljenju z entekavirjem, ki je v povprečju trajalo 96 tednov, se dodatni učinki, povezani z varnostjo, niso pojavili.
English: ALT normalisation (≤ 1 times ULN)
Slovenian: Normalizacija ALT (≤ 1 krat ULN)
English: Based on urinary excretion of unchanged drug, the bioavailability has been estimated to be at least 70%.
Slovenian: Na osnovi izločanja učinkovine v nespremenjeni obliki z urinom je bilo ocenjeno, da je biološka uporabnost vsaj 70-odstotna.
English: What you need to know before you take Entecavir Accord Do not take Entecavir Accord if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Entecavir Accord Ne jemljite zdravila Entecavir Accord če ste alergični na entekavir ali katero koli sestavino tega zdravila Entecavir Accord (navedeno v poglavju 6).
English: General: patients should be advised that therapy with entecavir has not been proven to reduce the risk of transmission of HBV and therefore appropriate precautions should still be taken.
Slovenian: Splošno: Bolnikom je treba pojasniti, da ni dokazov, da bi zdravljenje z entekavirjem zmanjšalo tveganje za prenos HBV na druge in da morajo zato še naprej skrbeti za ustrezne varnostne ukrepe.
English: Entecavir Accord with food and drink
Slovenian: Zdravilo Entecavir Accord skupaj s hrano in pijačo
English: If overdose occurs, the patient must be monitored for evidence of toxicity and given standard supportive treatment as necessary.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika nadzirati glede pojava toksičnosti in po potrebi uvesti standardno podporno zdravljenje.
English: Immune system disorders: rare
Slovenian: Bolezni imunskega sistema: redki
English: Infection by the hepatitis B virus can lead to damage to the liver.
Slovenian: Okužba z virusom hepatitisa B lahko povzroči okvaro jeter.
English: do not stop taking Entecavir Accord without your doctor's advice since your hepatitis may worsen after stopping treatment.
Slovenian: zdravila Entecavir Accord ne smete nehati jemati brez nasveta zdravnika, saj se hepatitis po prekinitvi zdravljenja lahko poslabša.
English: To differentiate between elevations in aminotransferases due to response to treatment and increases potentially related to lactic acidosis, physicians should ensure that changes in ALT are associated with improvements in other laboratory markers of chronic hepatitis B.
Slovenian: Zaradi razlikovanja med povišanjem vrednosti aminotransferaz zaradi odziva na zdravljenje in povišanjem, ki bi lahko bilo povezano z laktacidozo, se morajo zdravniki prepričati, da so spremembe vrednosti ALT povezane z izboljšanjem drugih laboratorijskih označevalcev kroničnega hepatitisa B.
English: In the clinical trials entecavir treatment was discontinued if patients achieved a prespecified response.
Slovenian: Med kliničnimi preskušanji so zdravljenje z entekavirjem prekinili, če je bil pri bolnikih dosežen vnaprej določen odziv.
English: In patients with a suboptimal virological response after 24 weeks of treatment with entecavir, a modification of treatment should be considered (see sections 4.5 and 5.1).
Slovenian: Pri bolnikih s suboptimalnim virološkim odzivom po 24 tednih zdravljenja z entekavirjem je treba razmisliti o spremembi terapevtske sheme (glejte poglavji 4.5 in 5.1).
English: A 4 hour period of haemodialysis removed ≈ 13% of the dose, and 0.3% was removed by CAPD.
Slovenian: urni hemodializi se je odstranilo ≈ 13% odmerka, pri CAPD pa 0,3%.
English: The decision to treat paediatric patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
Slovenian: Pri odločanju o zdravljenju pediatričnih bolnikov je treba skrbno oceniti potrebe posameznega bolnika in upoštevati trenutne smernice za zdravljenje pediatričnih bolnikov, vključno z oceno histoloških podatkov v izhodišču.
English: Gender: AUC was 14% higher in women than in men, due to differences in renal function and weight.
Slovenian: Spol: pri ženskah so bile vrednosti AUC za 14% večje od vrednosti pri moških, kar je posledica razlik v delovanju ledvic in telesni masi.
English: For adults the recommended dose is either 0.5 mg or 1 mg once daily orally (by mouth).
Slovenian: Priporočeni odmerek za odrasle je bodisi 0,5 mg bodisi 1 mg enkrat na dan peroralno (skozi usta).
English: The on-study cumulative death rate was 23% (23/102), and causes of death were generally liver-related, as expected in this population.
Slovenian: Kumulativni delež smrtnih izidov med študijo je bil 23-odstoten (23/102), vzrok smrti pa je bil v tej skupini bolnikov pričakovano običajno povezan z jetri.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: At 24 weeks the reduction in HBV viral load was significantly greater with entecavir (-3.65 vs an increase of 0.11 log10 copies/ml).
Slovenian: V 24. tednu je bilo zmanjšanje virusnega bremena HBV znatno večje pri entekavirju (-3,65 v primerjavi s povečanjem za 0,11 log10 kopij/ml).
English: Biotransformation: entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
Slovenian: Biotransformacija: Entekavir ni substrat, induktor ali zaviralec encimskega sistema CYP450.
English: This finding was not observed in repeat-dose studies in other species, including monkeys administered entecavir daily for 1 year at exposures ≥ 100 times those in humans.
Slovenian: Teh ugotovitev niso zasledili pri študijah s ponavljajočimi se odmerki pri drugih vrstah, vključno z opicami, ki so 1 leto prejemale entekavir dnevno in pri katerih je bila izpostavljenost ≥ 100-kratni izpostavljenosti človeka.
English: HBsAg lossb Normalization of:
Slovenian: Izginotje HBsAgb Normalizacija:e
English: If you miss a dose of Entecavir Accord, take it as soon as possible, and then take your next scheduled dose at its regular time.
Slovenian: Pozabljeni odmerek zdravila Entecavir Accord vzemite takoj, ko je to mogoče, naslednji odmerek pa nato vzemite ob običajnem času.
English: A micronucleus study and a DNA repair study in rats were also negative.
Slovenian: Negativne so bile tudi študije mikronukleusov in popravljanja DNA pri podganah.
English: Cumulative probability of:
Slovenian: Skupna verjetnost za:
English: Take Entecavir Accord as long as your doctor has told you.
Slovenian: Zdravilo Entecavir Accord jemljite tako dolgo, kot vam je predpisal zdravnik.
English: Caution should be exercised when prescribing nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease.
Slovenian: Pri predpisovanju nukleozidnih analogov kateremu koli bolniku (še posebej ženskam s prekomerno telesno maso) s hepatomegalijo, hepatitisom ali z drugimi znanimi dejavniki tveganja za bolezen jeter je potrebna previdnost.
English: d. Paediatric Population
Slovenian: d. Pediatrična populacija
English: If you take more Entecavir Accord than you should
Slovenian: Če ste vzeli večji odmerek zdravila Entecavir Accord, kot bi smeli
English: HIV variants containing the M184V substitution showed loss of susceptibility to entecavir (see section 4.4).
Slovenian: Variante virusa HIV s substitucijo M184V so izgubile občutljivost za entekavir (glejte poglavje 4.4).
English: The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus.
Slovenian: Koristi dolgoročne virološke supresije s kontinuiranim zdravljenjem je treba presojati glede na tveganja, povezana z dolgotrajnim zdravljenjem, vključno s pojavom odpornosti virusa hepatitisa B.
English: Not applicable.
Slovenian: ni primerno ni primerno
English: Results for selected study endpoints at weeks 24 and 48 are shown in the table.
Slovenian: Rezultati izbranih opazovanih dogodkov v študiji v 24. in 48. tednu so prikazani v preglednici.
English: All (10/10) patients with advanced fibrosis or cirrhosis at baseline (Ishak fibrosis score of 4, 5 or 6) had a ≥ 1 point decrease (median decrease from baseline was 1.5 points).
Slovenian: Pri vseh bolnikih (10/10) z napredovalo fibrozo ali cirozo v izhodišču (indeks fibroze po Ishak-u 4, 5 ali 6) se je indeks fibroze zmanjšal za ≥ 1 točko (srednje zmanjšanje vrednosti indeksa za 1,5 točke).
English: Week 96 Week 48
Slovenian: 96. teden 48. teden n
English: Since entecavir is predominantly eliminated by the kidney (see section 5.2), coadministration with medicinal products that reduce renal function or compete for active tubular secretion may increase serum concentrations of either medicinal product.
Slovenian: Ker se entekavir v glavnem izloča preko ledvic (glejte poglavje 5.2), se pri sočasni uporabi katerega koli zdravila, ki zmanjšuje delovanje ledvic ali je kompetitor za aktivno tubulno sekrecijo, lahko povečajo serumske koncentracije obeh zdravil.
English: Adverse reactions considered at least possibly related to treatment with entecavir are listed by body system organ class.
Slovenian: Neželeni učinki, za katere je obstajala vsaj možna povezava z zdravljenjem z entekavirjem, so navedeni glede na organski sistem.
English: Entecavir is not a substrate, an inducer or an inhibitor of cytochrome P450 (CYP450) enzymes (see section 5.2).
Slovenian: Entekavir ni substrat, induktor ali zaviralec encimov citokroma P450 (CYP450) (glejte poglavje 5.2).
English: Cases of lactic acidosis have been reported, often in association with hepatic decompensation, other serious medical conditions or drug exposures (see section 4.4).
Slovenian: Poročali so tudi o primerih laktacidoze, pogosto v povezavi z dekompenzacijo jeter, drugimi resnimi zdravstvenimi stanji ali jemanjem drugih zdravil (glejte poglavje 4.4).
English: Clinical experience: the demonstration of benefit is based on histological, virological, biochemical, and serological responses after 48 weeks of treatment in active-controlled clinical trials of 1,633 adults with chronic hepatitis B infection, evidence of viral replication and compensated liver disease.
Slovenian: Klinične izkušnje: Dokaz koristi temelji na histološkem, virološkem, biokemičnem in serološkem odzivu po 48-tedenskem zdravljenju v aktivno nadzorovanih kliničnih preskušanjih pri 1.633 odraslih s kronično okužbo z virusom hepatitisa B, dokazi replikacije virusa in s kompenzirano boleznijo jeter.
English: Therefore, clinical and laboratory parameters should be closely monitored in this patient population (see also sections 4.8 and 5.1).
Slovenian: Pri tej skupini bolnikov je treba skrbno nadzirati klinične in laboratorijske parametre (glejte tudi poglavji 4.8
English: HAART regimens did not include emtricitabine or tenofovir disoproxil fumarate.
Slovenian: režim ni vključeval emtricitabina ali tenofovir dizoproksil fumarata.
English: If treatment is discontinued without regard to treatment response, the rate of post-treatment ALT flares could be higher.
Slovenian: Če se zdravljenje prekine ne glede na odziv na zdravljenje, je odstotek nihanja vrednosti ALT po zdravljenju lahko večji.
English: Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000).
Slovenian: (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000).
English: Responses for patients with baseline Knodell Fibrosis Scores of 4 (cirrhosis) were comparable to overall responses on all efficacy outcome measures (all patients had compensated liver disease).
Slovenian: Pri bolnikih, ki so imeli v izhodišču stopnjo fibroze po Knodell-u 4 (ciroza), so bili odzivi primerljivi s celotnim odzivom glede na vsa merila učinkovitosti (vsi bolniki so imeli kompenzirano bolezen jeter).
English: The median EC50 value for entecavir against LVDr HBV (rtL180M and rtM204V) was 0.026 µM (range 0.010-0.059 µM).
Slovenian: Srednja vrednost EC50 entekavirja proti LVDr HBV (rtL180M in rtM204V) je bila 0,026 μM (razpon 0,010 - 0,059 μM).
English: It is important that women of childbearing age receiving treatment with Entecavir Accord use an effective method of contraception to avoid becoming pregnant.
Slovenian: Pomembno je, da ženske v rodni dobi med zdravljenjem z zdravilom Entecavir Accord za preprečitev nosečnosti uporabljajo učinkovito metodo kontracepcije.
English: Result for the main efficacy endpoints at Week 48 and Week 96 are presented below.
Slovenian: Rezultati glavnih opazovanih dogodkov učinkovitosti v 48. in 96. tednu so prikazani v nadaljevanju.
English: Renal impairment: the clearance of entecavir decreases with decreasing creatinine clearance (see section 5.2).
Slovenian: Okvara ledvic: Očistek entekavirja se zmanjšuje z zmanjševanjem kreatininskega očistka (glejte poglavje 5.2).
English: Results at 48 weeks are presented in the table.
Slovenian: Rezultati v 48. tednu so predstavljeni v preglednici.
English: If you forget to take Entecavir Accord
Slovenian: Če ste pozabili vzeti zdravilo Entecavir Accord
English: No pharmacokinetic interactions between entecavir and lamivudine, adefovir or tenofovir were observed.
Slovenian: Farmakokinetičnih interakcij med entekavirjem in lamivudinom, adefovirjem ali tenofovirjem niso opazili.
English: Virological response should be frequently monitored in the lamivudine-refractory population and appropriate resistance testing should be performed.
Slovenian: Pri bolnikih, neodzivnih na lamivudin, je treba pogosto nadzirati virološki odziv in po potrebi izvesti ustrezna testiranja odpornosti.
English: In HBV combination assays in cell culture, abacavir, didanosine, lamivudine, stavudine, tenofovir or zidovudine were not antagonistic to the anti-HBV activity of entecavir over a wide range of concentrations.
Slovenian: Pri testih kombinacije proti HBV na celičnih kulturah abakavir, didanozin, lamivudin, stavudin, tenofovir ali zidovudin v širokem razponu koncentracij niso imeli antagonističnega vpliva na delovanje entekavirja proti HBV.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve za predložitev redno posodobljenih poročil o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive
English: decompensated liver disease (see section 4.4)
Slovenian: z dekompenzirano boleznijo jeter (glejte poglavje 4.4).
English: If your doctor instructs you to take Entecavir Accord 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 Entecavir Accord na prazen želodec, to pomeni vsaj 2 uri po obroku in vsaj 2 uri pred naslednjim obrokom.
English: Entecavir Accord should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Entecavir Accord med nosečnostjo ne smete uporabljati, razen če je nujno potrebno.
English: Do not stop Entecavir Accord without your doctor's advice
Slovenian: Zdravila Entecavir Accord ne smete nehati jemati brez nasveta zdravnika
English: The pharmacokinetics of entecavir following a single 1 mg dose in patients (without chronic hepatitis B infection) are shown in the table below:
Slovenian: Farmakokinetika entekavirja po enkratnem 1 mg odmerku pri bolnikih (brez kronične okužbe z virusom hepatitisa B) je prikazana v spodnji preglednici:
English: Co-infection with hepatitis C or D: there are no data on the efficacy of entecavir in patients co-infected with hepatitis C or D virus.
Slovenian: Sočasna okužba z virusom hepatitisa C ali D: Podatki o učinkovitosti entekavirja pri bolnikih s sočasno okužbo z virusom hepatitisa C ali D niso na voljo.
English: AUC was 29% higher in elderly than in young subjects, mainly due to differences in renal function and weight.
Slovenian: Pri starostnikih so bile vrednosti AUC za 29% večje od vrednosti pri mlajših osebah, predvsem zaradi razlik v delovanju ledvic in telesni masi.
English: Your child's doctor will decide the right dose based on your child's weight.
Slovenian: Pravilen odmerek bo določil zdravnik na osnovi telesne mase otroka.
English: You should not take Entecavir Accord 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.
Slovenian: Zdravila Entecavir Accord 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.
English: The observed drug accumulation index is ≈ 2 times with once daily dosing, suggesting an effective accumulation half-life of about 24 hours.
Slovenian: Pri odmerjanju enkrat na dan je bil opažen ≈ 2kraten indeks akumulacije zdravila, kar kaže na približno 24-urno efektivno razpolovno dobo akumulacije.
English: HBeAg Seroconversion
Slovenian: Serokonverzija HBeAg
English: Year 1 Year 2 Year 3a Year 4a Year 5a
Slovenian: 1. leto 2. leto 3. leto a
English: virus (HBV) infection in adults.
Slovenian: (dolgotrajne) okužbe z virusom hepatitisa B (HBV) pri odraslih.
English: These 14 patients had a lower rate of genotypic entecavir resistance (cumulative probability 18.8% through 5 years of follow-up) than the overall study population (see table).
Slovenian: Pri teh 14 bolnikih je bil delež genotipske odpornosti na entekavir manjši (skupna verjetnost 18,8% med 5-letnim spremljanjem) kot v celotni populaciji bolnikov, vključenih v študijo (glejte preglednico).
English: ULN=upper limit of normal, LLN=lower limit of normal.
Slovenian: * p<0,05 ULN=zgornja meja normalne vrednosti, LLN=spodnja meja normalne vrednosti.
English: Resistance and specific precaution for lamivudine-refractory patients: mutations in the HBV polymerase that encode lamivudine-resistance substitutions may lead to the subsequent emergence of secondary substitutions, including those associated with entecavir associated resistance (ETVr).
Slovenian: Odpornost in posebna previdnost pri bolnikih, neodzivnih na lamivudin: Mutacije HBV polimeraze, ki kodirajo substitucije, povezane z odpornostjo na lamivudin, lahko vodijo do kasnejšega pojava sekundarnih substitucij, vključno s tistimi, ki so povezane z odpornostjo na entekavir (ETVr).
English: Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.
Slovenian: V tem primeru vam zdravnik lahko predpiše manjši odmerek ali pa vam svetuje jemanje zdravila manj pogosto kot enkrat na dan. bolezenske prizadetosti jeter.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov izdelovalca (-cev), odgovornega (-ih) za sproščanje serij
English: In clinical studies in patients with compensated liver disease, the most common adverse reactions of any severity with at least a possible relation to entecavir were headache (9%), fatigue (6%), dizziness (4%) and nausea (3%).
Slovenian: V kliničnih študijah pri bolnikih s kompenzirano boleznijo jeter so bili najpogostejši neželeni učinki katere koli resnosti, za katere je obstajala vsaj možna povezava z entekavirjem: glavobol (9%), utrujenost (6%), omotica (4%) in navzea (3%).
English: Resistance is mediated by reduced inhibitor binding to the altered HBV reverse transcriptase, and resistant HBV exhibits reduced replication capacity in cell culture.
Slovenian: Odpornost se razvije zaradi zmanjšane vezave inhibitorjev na spremenjeno reverzno transkriptazo HBV, odporen HBV pa ima tudi zmanjšano sposobnost replikacije v celični kulturi.
English: Year 5 a
Slovenian: 5. leto a
English: uncommon (at least 1 in 1,000 patients): rash, hair loss.
Slovenian: občasni (pri več kot 1 od 1.000 bolnikov): izpuščaj, izpadanje las.
English: In addition, high exposures of entecavir had no relevant adverse effects on γ polymerase or mitochondrial DNA synthesis in HepG2 cells (Ki > 160 µM).
Slovenian: Pri visoki izpostavljenosti entekavir ni imel pomembnih škodljivih vplivov na γ polimerazo ali sintezo mitohondrijske DNA HepG2 celic (Ki > 160 μM).
English: The frequency and nature of adverse events in this study were consistent with those expected in patients who have received a liver transplant and the known safety profile of entecavir.
Slovenian: Neželeni učinki v tej študiji so po pogostnosti in vrsti ustrezali pričakovanim neželenim učinkom pri bolnikih s presajenimi jetri ter znanemu profilu varnosti entekavirja.
English: Patients who met virologic but not serologic or biochemical response criteria continued blinded treatment.
Slovenian: Pri bolnikih, pri katerih so bili izpolnjeni virološki kriteriji odziva, serološki ali biokemični pa ne, se je nadaljevalo slepo zdravljenje.