FrancophonIA/ELRC3.0 huggingface dataset:
English: Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an NRTI and works by interfering with the normal working of enzymes (in HIV reverse transcriptase; in hepatitis B DNA polymerase) that are essential for the viruses to reproduce themselves.
Slovenian: Tenofovir je nukleotidni zaviralec reverzne transkriptaze, ki je splošno znan pod imenom NRTI (nucleotide reverse transcriptase inhibitors), in deluje tako, da vpliva na normalno delovanje encimov (reverzne transkriptaze pri virusu HIV in DNA-polimeraze pri virusu HBV), ki sta bistvena za pomnoževanje virusa.
English: If you forget to take Tenofovir disoproxil Zentiva It is important not to miss a dose of Tenofovir disoproxil Zentiva.
Slovenian: Če ste pozabili vzeti zdravilo Dizoproksiltenofovirat Zentiva Pomembno je, da ne pozabite vzeti nobenega odmerka zdravila Dizoproksiltenofovirat Zentiva.
English: Open date: [outer packaging only]
Slovenian: Datum odprtja: [samo na zunanji ovojnini]
English: • Talk to your doctor before you stop taking Tenofovir disoproxil Zentiva for any reason, particularly if you are experiencing any side effects or you have another illness.
Slovenian: • Preden prenehate jemati zdravilo Dizoproksiltenofovirat Zentiva iz katerega koli razloga, se pogovorite z zdravnikom, še zlasti če imate kakršne koli neželene učinke ali kakšno drugo bolezen.
English: Table 6: Histological response (%) in compensated HBeAg negative and HBeAg positive subjects at week 240 compared to baseline
Slovenian: Preglednica 6: Histološki odziv (%) pri kompenziranih bolnikih, negativnih na HBeAg in pozitivnih na HBeAg v 240. tednu v primerjavi z izhodiščno točko
English: In clinical trials of HBV infected patients, the most frequently occurring adverse reaction to tenofovir disoproxil was nausea (5.4%).
Slovenian: V kliničnih študijah bolnikov, okuženih s HBV, je bil najpogostejši neželeni učinek, ki se je pojavljal pri dizoproksiltenofoviratu, navzea (5,4%).
English: Late-onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Slovenian: Redko so poročali o nekaterih primerih nevroloških motenj, ki nastopijo kasneje (hipertonija, konvulzije, nenormalno obnašanje).
English: Thirty-one of the 32 nucleos(t)ide-experienced patients had prior lamivudine experience.
Slovenian: Enaintrideset od 32 bolnikov, ki so se predhodno že zdravili z nukleoz(t)idi, je imelo predhodne izkušnje z lamivudinom.
English: Exacerbations of hepatitis
Slovenian: Poslabšanja hepatitisa
English: HIV antiviral activity in vitro: The concentration of tenofovir required for 50% inhibition (EC50) of the wild-type laboratory strain HIV-1IIIB is 1 - 6 µmol/l in lymphoid cell lines and 1.1 µmol/l against primary HIV-1 subtype B isolates in PBMCs.
Slovenian: Protivirusna aktivnost proti virusu HIV in vitro: 50% inhibitorna koncentracija (EC50) tenofovirja za divji tip laboratorijskega seva HIV-1IIIB znaša 1-6 μmol/l v limfoidnih celičnih linijah in EC50 za primarne izolate HIV-1 podtipa B je 1,1 μmol/l v PBMC.
English: If concomitant use of tenofovir disoproxil and nephrotoxic agents is unavoidable, renal function should be monitored weekly.
Slovenian: Če je sočasna uporaba dizoproksiltenofovirata in nefrotoksičnega zdravila neizogibna, je potrebno tedensko nadzorovati ledvično funkcijo.
English: Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.
Slovenian: Tenofovir difosfat zavira reverzno transkriptazo virusa HIV-1 in polimerazo virusa HBV z direktno kompeticijo za vezavo z naravnim dezoksiribonukleotidnim substratom in potem, ko je vključen v DNA, povzroči prekinitev njene sinteze.
English: Tenofovir disoproxil Zentiva is a treatment for HIV (Human Immunodeficiency Virus) infection.
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva se uporablja za zdravljenje okužbe s HIV (virus človeške imunske pomanjkljivosti).
English: Results through 48 weeks from two randomised, phase 3 double-blind studies comparing tenofovir disoproxil to adefovir dipivoxil in adult patients with compensated liver disease are presented in Table 3 below.
Slovenian: Rezultati iz 48 tednov dveh randomiziranih dvojno slepih študij 3. faze, v katerih so primerjali dizoproksiltenofovirat in dipivoksiladefovirat pri odraslih bolnikih s kompenzirano jetrno boleznijo, so prikazani v preglednici 3 spodaj.
English: Acute exacerbation of hepatitis has been reported in patients on treatment as well as in patients who have discontinued hepatitis B therapy (see section 4.4).
Slovenian: O akutnem poslabšanju hepatitisa so poročali tako pri bolnikih, ki so se zdravili kot pri bolnikih, ki so prekinili zdravljenje hepatitisa B (glejte poglavje 4.4).
English: After an initial decline of approximately -4.9 ml/min (using Cockcroft-Gault equation) or3.9 ml/min/1.73 m2 (using modification of diet in renal disease [MDRD] equation) after the first 4 weeks of treatment, the rate of annual decline post baseline of renal function reported in tenofovir disoproxil treated patients was -1.41 ml/min per year (using Cockcroft-Gault equation) and -0.74 ml/min/1.73 m2 per year
Slovenian: Po začetnem upadu za približno -4,9 ml/min (z uporabo CockcroftGaultove enačbe) ali -3,9 ml/min/1,73 m2 (z uporabo enačbe za spremembo prehrane pri ledvičnem obolenju [MDRD, modification of diet in renal disease]) po prvih 4 tednih zdravljenja je bila stopnja letnega upada ledvične funkcije glede na izhodišče, o kateri so poročali pri bolnikih, zdravljenih z dizoproksiltenofoviratom, -1,41 ml/min (z uporabo Cockcroft-Gaultove enačbe) in -0,74 ml/min/1,73
English: Concomitant use not recommended
Slovenian: Sočasna uporaba z drugimi zdravili ni priporočena
English: You do not need to take another tablet if you were sick more than 1 hour after taking Tenofovir disoproxil Zentiva.
Slovenian: Še ene tablete vam ni treba vzeti, če je bruhanje nastopilo več kot 1 uro po zaužitju zdravila Dizoproksiltenofovirat Zentiva.
English: As Tenofovir disoproxil Zentiva may cause renal damage monitoring of renal function is recommended (see sections 4.4 and 4.8 Summary of the safety profile).
Slovenian: Ker lahko zdravilo Dizoproksiltenofovirat Zentiva povzroči ledvično poškodbo, se priporoča nadziranje ledvične funkcije (glejte poglavji 4.4 in 4.8 Povzetek varnostnega profila).
English: • That Tenofovir disoproxil Zentiva is not recommended for use in paediatric patients with renal impairment
Slovenian: • da zdravilo Dizoproksiltenofovirat Zentiva ni priporočljivo za uporabo pri pediatričnih bolnike z ledvično okvaro;
English: What you need to know before you take Tenofovir disoproxil Zentiva
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Dizoproksiltenofovirat Zentiva
English: These patients may be at higher risk of experiencing serious hepatic or renal adverse reactions.
Slovenian: Ti bolniki so lahko izpostavljeni višjemu tveganju za resne neželene učinke na jetrih ali ledvicah.
English: Of the 94 patients with cirrhosis at baseline (Ishak fibrosis score 5-6), 26% (24) experienced no change in Ishak fibrosis score and 72% (68) experienced regression of cirrhosis by week 240 with a reduction in Ishak fibrosis score of at least 2 points.
Slovenian: Od 94 bolnikov s cirozo ob izhodiščni točki (stopnja fibroze po Ishak-u: 5 - 6) jih 26% (24) ni doživelo spremembe v stopnji fibroze po Ishak-u in 72% (68) je doživelo nazadovanje ciroze do 240. tedna z zmanjšanjem stopnje fibroze po Ishak-u za vsaj 2 točki.
English: Treatment with tenofovir disoproxil 245 mg was also associated with significantly greater proportions of patients with HBV DNA < 400 copies/ml, when compared to adefovir dipivoxil 10 mg treatment.
Slovenian: Zdravljenje z 245 mg dizoproksiltenofovirata je bilo povezano tudi s pomembno večjim deležem bolnikov z < 400 kopij/ml HBV DNA, v primerjavi z zdravljenjem z 10 mg dipivoksiladefovirata.
English: If a patient misses a dose of Tenofovir disoproxil Zentiva by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Slovenian: Če bolnik izpusti odmerek zdravila Dizoproksiltenofovirat Zentiva za več kot 12 ur in je že skoraj čas za naslednji odmerek, naj bolnik ne nadomesti izpuščenega odmerka in preprosto nadaljuje z jemanjem po običajnem režimu odmerjanja.
English: In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Slovenian: Pri bolnikih s kompenzirano jetrno boleznijo zvišanja ALT v serumu navadno ne spremlja zvišanje koncentracije bilirubina v serumu ali jetrna dekompenzacija.
English: Tenofovir disoproxil Zentiva is suitable for:
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva je primerno za:
English: Experience beyond 48 weeks in study GS-US-174-0108
Slovenian: Izkušnje po 48. tednu v študiji GS-US-174-0108
English: Tenofovir disoproxil Zentiva does not reduce the risk of passing on HBV to others through sexual contact or blood contamination.
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva ne zmanjšuje nevarnosti prenosa virusa HBV na druge s spolnim stikom ali okužbo s krvjo.
English: (11 subjects)
Slovenian: (11 bolnikov)
English: Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine.
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina pri odmerku 400 mg na dan je bila povezana s pomembnim zmanjšanjem števila celic CD4, morda zaradi znotrajcelične interakcije, ki je povečala količino fosforiliranega (to je aktivnega) didanozina.
English: Treatment discontinuation may also be considered after stable virological suppression is achieved (i.e. for at least 3 years) provided serum ALT and HBV DNA levels are followed regularly after treatment discontinuation to detect any late virological relapse.
Slovenian: O prekinitvi zdravljenja je treba razmisliti tudi v primerih, ko je dosežena stabilna virološka supresija (tj. najmanj 3 leta), pri čemer je treba po prekinitvi zdravljenja redno spremljati ravni ALT in HBV DNA v serumu, da se zazna morebitno virološko ponovitev bolezni.
English: The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body system organ class and frequency.
Slovenian: Spodaj so navedeni neželeni učinki, domnevno (vsaj možno) povezani z zdravljenjem, po organskih sistemih in pogostosti.
English: Long-term studies to evaluate the benefit/risk of bitherapy with emtricitabine plus tenofovir disoproxil in HBV monoinfected patients are ongoing.
Slovenian: Dolgoročne študije za ocenitev koristi in tveganj dvojnega zdravljenja z emtricitabinom in dizoproksiltenofoviratom pri bolnikih, okuženih samo s HBV, potekajo.
English: Administration of 245 mg tenofovir disoproxil every 48 hours can be used based on modelling of single-dose pharmacokinetic data in HIV-negative and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies.
Slovenian: Uporabi se lahko odmerek 245 mg dizoproksiltenofovirata vsakih 48 ur, ki temelji na podatkih farmakokinetičnega modeliranja enkratnih odmerkov pri bolnikih, ki so HIV-negativni in niso okuženi z virusom HBV, z različnimi stopnjami ledvične okvare, vključno s končno fazo ledvične bolezni, zaradi katere je potrebna hemodializa, toda v kliničnih študijah ni bil potrjen.
English: - compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1).
Slovenian: - s kompenzirano jetrno boleznijo z dokazano aktivno replikacijo virusov, persistentno zvišano vrednostjo alanin-aminotransferaze (ALT) v serumu in s histološko dokazano aktivnim vnetjem in/ali fibrozo (glejte poglavje 5.1).
English: In adult patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended.
Slovenian: Pri odraslih bolnikih z dekompenzirano jetrno boleznijo ali cirozo prenehanje zdravljenja ni priporočljivo.
English: Interrupting treatment with tenofovir disoproxil should also be considered in case of progressive decline of renal function when no other cause has been identified.
Slovenian: O prekinitvi zdravljenja z dizoproksiltenofoviratom je treba razmisliti tudi v primeru progresivnega upada ledvične funkcije, če ni bil ugotovljen noben drug razlog.
English: HBV antiviral activity in vitro: The in vitro antiviral activity of tenofovir against HBV was assessed in the HepG2 2.2.15 cell line.
Slovenian: Protivirusna aktivnost proti virusu HBV in vitro: Protivirusno aktivnost tenofovirja proti virusu HBV in vitro so ocenili na celični liniji HepG2 2.2.15.
English: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in adult patients with renal impairment treated with Tenofovir disoproxil Zentiva (see sections 4.2, 4.4 and 5.2).
Slovenian: Ker lahko dizoproksiltenofovirat povzroči ledvično toksičnost, se priporoča skrbno nadziranje ledvične funkcije pri odraslih bolnikih z ledvično okvaro, ki se zdravijo z zdravilom Dizoproksiltenofovirat Zentiva (glejte poglavja 4.2, 4.4 in 5.2).
English: Paired baseline and week 240 liver biopsy data were available for 331/489 patients who remained in studies GS-US-174-0102 and GS-US-174-0103 at week 240 (see Table 6 below).
Slovenian: Podatki o biopsiji jeter ob izhodišču in v 240. tednu so na voljo za 331/489 bolnikov, ki so ostali v študijah GS-US-174-0102 in GS-US-174-0103 v 240. tednu (glejte preglednico 6 spodaj).
English: In patients at risk for renal impairment, a more frequent monitoring of renal function is required.
Slovenian: Pri bolnikih s tveganjem za ledvično okvaro je treba delovanje ledvic nadzirati pogosteje.
English: Only five had adefovir-associated resistance mutations at baseline.
Slovenian: Le pet bolnikov je imelo ob izhodišču mutacije, povezane z rezistenco na adefovir.
English: In patients with severe renal impairment (creatinine clearance < 30 ml/min) and in patients who require haemodialysis use of tenofovir disoproxil is not recommended.
Slovenian: Pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) in pri bolnikih, pri katerih je potrebna hemodializa, uporaba dizoproksiltenofovirata ni priporočljiva.
English: Do not stop taking Tenofovir disoproxil Zentiva without your doctor's advice.
Slovenian: Ne prenehajte jemati zdravila Dizoproksiltenofovirat Zentiva, ne da bi se posvetovali z zdravnikom.
English: • HBV infected adolescents aged 12 to less than 18 years who weigh at least 35 kg.
Slovenian: • mladostnike, okužene s HBV, stare 12 do manj kot 18 let, s telesno maso vsaj 35 kg.
English: Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs).
Slovenian: Znotrajcelični razpolovni čas (T½) tenofovir difosfata je 10 ur v aktiviranih celicah ter 50 ur v mirujočih mononuklearnih celicah periferne krvi (PBMC, peripheral blood mononuclear cells).
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactataemia, hyperlipasaemia).
Slovenian: Glavni opisani neželeni učinki so hematološke motnje (anemija, nevtropenija) in presnovne motnje (hiperlaktatemija, hiperlipazemija).
English: INFORMATION IN BRAILLE Tenofovir disoproxil Zentiva [outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Dizoproksiltenofovirat Zentiva [samo na zunanji ovojnini]
English: Tenofovir disoproxil has not been clinically evaluated in patients receiving medicinal products which are secreted by the same renal pathway, including the transport proteins human organic anion transporter (hOAT) 1 and 3 or MRP 4 (e.g. cidofovir, a known nephrotoxic medicinal product).
Slovenian: Uporaba dizoproksiltenofovirata klinično ni bila ovrednotena pri bolnikih, ki so prejemali zdravila, ki se izločajo po isti ledvični metabolni poti, vključno s transportnimi beljakovinami hOAT (human organic anion transporter) 1 in 3 ali MRP 4 (npr. cidofovir, znano nefrotoksično zdravilo).
English: It is recommended that the dosing interval for tenofovir disoproxil 245 mg is modified in adult patients with creatinine clearance < 50 ml/min or in patients who already have ESRD and require dialysis (see section 4.2).
Slovenian: Priporočljivo je prilagoditi interval med odmerki za 245 mg dizoproksiltenofovirata pri odraslih bolnikih z očistkom kreatinina < 50 ml/min in pri bolnikih z ESRD, ki potrebujejo dializo (glejte poglavje 4.2).
English: Therefore, tenofovir disoproxil should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Slovenian: Zato se sme dizoproksiltenofovirat uporabljati samo, če se oceni, da morebitne koristi zdravljenja odtehtajo morebitna tveganja.
English: HIV-1: Approximately one third of patients can be expected to experience adverse reactions following treatment with tenofovir disoproxil in combination with other antiretroviral agents.
Slovenian: HIV-1: Neželeni učinki so za pričakovati pri približno 1/3 bolnikov, zdravljenih z dizoproksiltenofoviratom v kombinaciji z drugimi protiretrovirusnimi zdravili.
English: Subjects must have been naïve to tenofovir disoproxil, but could have received interferon based regimens (> 6 months prior to screening) or any other nontenofovir disoproxil containing oral anti-HBV nucleoside/nucleotide therapy (> 16 weeks prior to screening).
Slovenian: Bolniki so morali biti predhodno še nezdravljeni z dizoproksiltenofoviratom, lahko pa so prejemali režime na osnovi interferona (> 6 mesecev pred presejanjem) ali katero koli drugo peroralno nukleozidno/nukleotidno zdravilo proti virusu HBV, ki ni vsebovalo dizoproksiltenofovirata (> 16 tednov pred presejanjem).
English: Tenofovir disoproxil should not be initiated in paediatric patients with renal impairment and should be discontinued in paediatric patients who develop renal impairment during tenofovir disoproxil therapy.
Slovenian: Zdravljenja z dizoproksiltenofoviratom se ne sme začeti pri pediatričnih bolnikih z ledvično okvaro in ga je treba prekiniti pri pediatričnih bolnikih, pri katerih se po začetku zdravljenja z dizoproksiltenofoviratom razvije ledvična okvara.
English: If a patient misses a dose of Tenofovir disoproxil Zentiva within 12 hours of the time it is usually taken, the patient should take Tenofovir disoproxil Zentiva with food as soon as possible and resume their normal dosing schedule.
Slovenian: Če bolnik izpusti odmerek zdravila Dizoproksiltenofovirat Zentiva v roku 12 ur od časa, ko ga običajno vzame, naj bolnik vzame zdravilo Dizoproksiltenofovirat Zentiva s hrano takoj, ko je mogoče, nato pa nadaljuje s svojim običajnim režimom odmerjanja.
English: Before starting treatment, your doctor may order blood tests to assess your kidney function.
Slovenian: Pred začetkom zdravljenja bo zdravnik morda naredil krvne preiskave, da bo ocenil delovanje ledvic.
English: • Not for HBV infected children under 12 years of age.
Slovenian: • ni za otroke, okužene s HBV, mlajše od 12 let.
English: Among them, sequence data from paired baseline and on treatment HBV isolates were available for 2 of 4 patients.
Slovenian: Med njimi so sekvenčni podatki izolatov ob izhodišču in HBV zdravljenih bolnikih na voljo za 2 od 4 bolnikov.
English: Complete response (%)a
Slovenian: Popolni odziv (%)
English: Do not take Tenofovir disoproxil Zentiva together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
Slovenian: Ne jemljite zdravila Dizoproksiltenofovirat Zentiva skupaj z zdravili, ki vsebujejo dipivoksiladefovirat (zdravilo, ki se uporablja za zdravljenje kroničnega hepatitisa B).
English: In addition, a K70E substitution in HIV-1 reverse transcriptase has been selected by tenofovir and results in low-level reduced susceptibility to tenofovir.
Slovenian: Poleg tega je s tenofovirjem izbrana substitucija K70E reverzne transkriptaze HIV-1 povzročila zmanjšano občutljivost za tenofovir.
English: In HIV Tenofovir disoproxil Zentiva should always be used combined with other medicines to treat HIV infection.
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva je treba vedno uporabljati v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV.
English: There are limited data on the safety and efficacy of tenofovir disoproxil in adult patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min) and long-term safety data has not been evaluated for mild renal impairment (creatinine clearance 50 - 80 ml/min).
Slovenian: Podatki o varnosti in učinkovitosti dizoproksiltenofovirata pri odraslih bolnikih z zmerno in hudo ledvično okvaro (očistek kreatinina < 50 ml/min) so nezadostni, dolgoročni podatki o varnosti pri bolnikih z blago ledvično okvaro (očistek kreatinina 50-80 ml/min) niso bili ovrednoteni.
English: However, patients should be informed that dizziness has been reported during treatment with tenofovir disoproxil.
Slovenian: Vendar je bolnike potrebno opozoriti, da se lahko v času zdravljenja z dizoproksiltenofoviratom pojavi omotičnost.
English: Cumulatively, there were 4 patients who experienced a viremic episode (HBV DNA > 400 copies/ml) at their last time point on tenofovir disoproxil.
Slovenian: Kumulativno so bili 4 bolniki, ki so imeli viremično epizodo (HBV DNA > 400 kopij/ml) ob zadnji časovni točki zdravljeni z dizoproksiltenofoviratom.
English: However, it should be noted that increases of ALT can be part of HBV clearance during therapy with tenofovir, see above Exacerbations of hepatitis.
Slovenian: Vendar pa je treba vedeti, da je lahko zvišanje ALT del očistka virusa HBV med zdravljenjem s tenofovirjem.
English: Eight (2%) tenofovir disoproxil 245 mg (treated patients developed the K65R mutation within the first 48 weeks.
Slovenian: Osem (2%) bolnikov, zdravljenih z 245 mg dizoproksiltenofoviratom, je razvilo K65R mutacijo v teku prvih 48 tednov.
English: Renal clearance has been estimated to be approximately 160 ml/h/kg (approximately 210 ml/min), which is in excess of the glomerular filtration rate.
Slovenian: Ocenjeno je, da znaša skupni očistek približno 230 ml/h/kg (približno 300 ml/min), ledvični očistek je približno 160 ml/h/kg (približno 210 ml/min) kar presega nivo glomerularne filtracije.
English: In both of these studies tenofovir disoproxil was significantly superior to adefovir dipivoxil for the primary efficacy endpoint of complete response (defined as HBV DNA levels < 400 copies/ml and Knodell necroinflammatory score improvement of at least 2 points without worsening in Knodell fibrosis).
Slovenian: V obeh študijah je bil dizoproksiltenofovirat pomembno učinkovitejši od dipivoksiladefovirata v primarnem izidu učinkovitosti študije, popolnemu odzivu (opredeljeni kot ravni HBV DNA < 400 kopij/ml in izboljšanju za vsaj 2 točki na Knodellovi nekroinflamatorni lestvici (Knodell Necroinflammatory Score) brez poslabšanja na Knodellovi fibrozni lestvici (Knodell Fibrosis)).
English: • decreases in potassium in the blood,
Slovenian: • zmanjšanje količine kalija v krvi
English: If no alternative treatment is available, the dosing interval must be adjusted and renal function should be closely monitored (see sections 4.2 and 5.2).
Slovenian: Če alternativne oblike zdravljenja ni na razpolago, je treba interval med odmerki prilagoditi, delovanje ledvic pa skrbno nadzorovati (glejte poglavji 4.2 in 5.2).
English: Tenofovir disoproxil Zentiva is also a treatment for chronic hepatitis B, an infection with HBV (hepatitis B virus).
Slovenian: Zdravilo Dizoproksiltenofovirat Zentiva se uporablja tudi za zdravljenje kroničnega hepatitisa B, okužbe s HBV (virus hepatitisa B).