FrancophonIA/ELRC3.0 huggingface dataset:
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 boleznijo jeter teh povečanj serumske ALT na splošno ne spremlja povečanje koncentracij bilirubina v serumu ali jetrna dekompenzacija.
English: As a result, the amounts of Vemlidy or other medicines in your blood may change.
Slovenian: To lahko posledično vpliva na količino zdravila Vemlidy ali drugih zdravil v vaši krvi.
English: The mean age was 46 years, 61% were male, 72% were Asian, 25% were White and 2% (8 subjects) were Black.
Slovenian: Povprečna starost je bila 46 let, 61 % je bilo moških, 72 % je bilo Azijcev, 25 % je bilo belcev in 2 % (8 oseb) je bilo črncev.
English: It is recommended that you do not breast-feed to avoid passing tenofovir alafenamide or tenofovir to the baby through breast milk.
Slovenian: Priporočljivo je, da ne dojite ter tako preprečite prehajanje tenofoviralafenamida ali tenofovirja na dojenčka z materinim mlekom.
English: However, in animal studies it has been shown that tenofovir is secreted into milk.
Slovenian: Vendar pa so študije na živalih pokazale, da se tenofovir izloča v mleko.
English: • Talk to your doctor if you also have HIV.
Slovenian: • Zdravniku povejte tudi, če ste okuženi z virusom HIV.
English: It is not known whether tenofovir alafenamide is an inhibitor of other UGT enzymes.
Slovenian: Ni znano, ali je tenofoviralafenamid zaviralec drugih encimov UGT.
English: The primary efficacy endpoint in both studies was the proportion of patients with plasma HBV DNA levels below 29 IU/mL at Week 48.
Slovenian: Primarni opazovani dogodek učinkovitosti v obeh študijah je bil delež bolnikov z ravnmi HBV DNA v plazmi pod 29 i.e./ml v 48. tednu.
English: At Week 96, viral suppression as well as biochemical and serological responses were maintained with continued tenofovir alafenamide treatment (see Table 5).
Slovenian: V 96. tednu so se virusna supresija ter biokemični in serološki odziv ohranili z nadaljevanjem zdravljenja s tenofoviralafenamidom (glejte preglednico 5).
English: Pharmacotherapeutic group: Antiviral for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors; ATC code: J05AF13.
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, nukleozidni in nukleotidni zaviralci reverzne transkriptaze; oznaka ATC: J05AF13.
English: If you stop taking Vemlidy Do not stop taking Vemlidy without your doctor's advice.
Slovenian: Če ste prenehali jemati zdravilo Vemlidy Ne prenehajte jemati zdravila Vemlidy brez zdravnikovega nasveta.
English: A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3).
Slovenian: Nefrotoksičnost Možnega tveganja nefrotoksičnosti kot posledice kronične izpostavljenosti nizkim ravnem tenofovirja zaradi odmerjanja tenofoviralafenamida ni mogoče izključiti (glejte poglavje 5.3).
English: The use of Vemlidy once daily in patients with CrCl ≥ 15 mL/min but < 30 mL/min and in patients with CrCl < 15 mL/min who are receiving haemodialysis is based on very limited pharmacokinetic data and on modelling and simulation.
Slovenian: Uporaba zdravila Vemlidy enkrat na dan pri bolnikih s CrCl ≥ 15 ml/min, a < 30 ml/min, in pri bolnikih s CrCl < 15 ml/min, ki prejemajo hemodializo, temelji na zelo omejenih farmakokinetičnih podatkih in na modeliranju ter simulaciji.
English: Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
Slovenian: Tenofovir se s hemodializo učinkovito odstrani z ekstrakcijskim razmerjem približno 54 %.
English: Vemlidy does not reduce the risk of passing on hepatitis B to others through sexual contact or blood contamination.
Slovenian: Zdravilo Vemlidy ne zmanjša tveganja za prenos hepatitisa B na druge s spolnim odnosom ali kontaminacijo s krvjo.
English: If you accidentally take more than the recommended dose of Vemlidy you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Slovenian: Če ste pomotoma zaužili odmerek zdravila Vemlidy, višji od priporočenega, obstaja povečano tveganje za pojav možnih neželenih učinkov (glejte poglavje 4, Možni neželeni učinki).
English: This may stop your medicines from working properly, or may make any side effects worse.
Slovenian: Zaradi tega vaša zdravila morda ne bodo pravilno delovala ali pa se bodo neželeni učinki okrepili.
English: Effect of tenofovir alafenamide on other medicinal products
Slovenian: Učinek tenofoviralafenamida na druga zdravila
English: ↔ GS-331007
Slovenian: GS-331007g
English: Before starting treatment and during treatment, your doctor may order blood tests to monitor how your kidneys work.
Slovenian: Pred začetkom zdravljenja in med njim bo morda zdravnik opravil krvne preiskave, s katerimi bo spremljal delovanje vaših ledvic.
English: Vemlidy has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Vemlidy ne vpliva ali ima zanemarljiv vpliv na sposobnost upravljanja vozil in strojev.
English: Drug interaction information for Vemlidy with potential concomitant medicinal products is summarised in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”; twice daily as “b.i.d.”, single dose as “s.d.”, once daily as “q.d.”; and intravenously as “IV”).
Slovenian: Informacije o medsebojnem delovanju zdravil za zdravilo Vemlidy z možnimi sočasnimi zdravili je povzeto spodaj v preglednici 1 (povečanje je označeno kot „↑“, zmanjšanje kot „↓“, brez spremembe kot „↔“; dvakrat na dan kot „b.i.d.“, enkratni odmerek kot „s.d.“, enkrat na dan kot „q.d.“ in intravensko kot „i.v.“).
English: Tell your doctor immediately if you become pregnant.
Slovenian: Zdravnika takoj obvestite, če zanosite.
English: Patients with liver disease, who are treated for hepatitis B with antiviral medicines, have a higher risk of severe and potentially fatal liver complications.
Slovenian: Pri bolnikih z boleznijo jeter, ki se zdravijo zaradi hepatitisa B s protivirusnim zdravilom, je tveganje za hude in potencialno smrtne zaplete jeter večje.
English: You can still infect others when taking this medicine.
Slovenian: Kljub jemanju tega zdravila lahko še vedno okužite druge.
English: In patients who are co-infected with HBV and HIV, Vemlidy should be co-administered with other antiretroviral agents to ensure that the patient receives an appropriate regimen for treatment of HIV (see section 4.5).
Slovenian: Pri bolnikih s sočasno okužbo s HBV in HIV se mora zdravilo Vemlidy dajati skupaj z drugimi protiretrovirusnimi zdravili, da se zagotovi, da bolnik prejema ustrezni režim zdravljenja okužbe s HIV (glejte poglavje 4.5).
English: The mechanism of tumour formation in mice and potential relevance for humans is uncertain.
Slovenian: Mehanizem nastajanja tumorjev pri miših in možen pomen za človeka nista znana.
English: • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or until there is loss of efficacy (see section 4.4).
Slovenian: • Pri HBeAg pozitivnih bolnikih brez ciroze se zdravljenje daje vsaj 6 do 12 mesecev po potrjeni serokonverziji HBe (izguba HBeAg in izguba HBV DNA z zaznavo anti-HBe) ali do serokonverzije HBs ali do izgube učinkovitosti (glejte poglavje 4.4).
English: What Vemlidy is and what it is used for
Slovenian: Kaj je zdravilo Vemlidy in za kaj ga uporabljamo
English: This is an antiviral medicine, known as a nucleotide reverse transcriptase inhibitor (NtRTI).
Slovenian: To je protivirusno zdravilo, znano kot nukleotidni zaviralec reverzne transkriptaze (NtRTI, nucleotide reverse transcriptase inhibitor).
English: A long-term oral carcinogenicity study in mice showed a low incidence of duodenal tumours, considered likely related to high local concentrations in the gastrointestinal tract at the high dose of 600 mg/kg/day.
Slovenian: Dolgotrajna študija peroralne kancerogenosti pri miših je pokazala majhno incidenco tumorjev dvanajsternika, kar je verjetno povezano z velikimi lokalnimi koncentracijami v prebavilih pri visokih odmerkih 600 mg/kg/dan.
English: Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Slovenian: Študije o vplivu na sposobnost razmnoževanja pri podganah in kuncih niso pokazale učinka na parametre parjenja, plodnosti, brejosti in ploda.
English: Vemlidy may interact with other medicines.
Slovenian: Zdravilo Vemlidy lahko medsebojno deluje z drugimi zdravili.
English:  If this applies to you, do not take Vemlidy and tell your doctor immediately.
Slovenian:  Če to velja za vas, ne jemljite zdravila Vemlidy in se takoj posvetujte z zdravnikom.
English: The use of Vemlidy may be considered during pregnancy, if necessary.
Slovenian: Če je potrebno, se lahko pretehta možnost uporabe zdravila Vemlidy med nosečnostjo.
English: • Talk to your doctor before you restart taking Vemlidy tablets.
Slovenian: • Posvetujte se z zdravnikom, preden nadaljujete jemanje tablet zdravila Vemlidy.
English: Central laboratory ULN for ALT are as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males ≥ 69 years; ≤ 34 U/L for females 18 to < 69 years and ≤ 32 U/L for females ≥ 69 years.
Slovenian: ULN centralnega laboratorija za ALT znaša: ≤ 43 e./l za moške, stare od 18 do < 69 let, in ≤ 35 e./l za moške ≥ 69 let; ≤ 34 e./l za ženske, stare od 18 do < 69 let, in ≤ 32 e./l za ženske, stare ≥ 69 let.
English: In patients with advanced liver disease or cirrhosis, treatment discontinuation is not recommended since post-treatment exacerbation of hepatitis may lead to hepatic decompensation.
Slovenian: Pri bolnikih z napredovalo boleznijo jeter ali cirozo se prekinitev zdravljenja ne priporoča, saj lahko poslabšanje hepatitisa po zdravljenju povzroči jetrno dekompenzacijo.
English: The drug interactions described are based on studies conducted with tenofovir alafenamide, or are potential drug interactions that may occur with Vemlidy.
Slovenian: Opisano medsebojno delovanje zdravil temelji na študijah, izvedenih s tenofoviralafenamidom, ali na možnem medsebojnem delovanju zdravil, do katerega lahko pride z zdravilom Vemlidy.
English: Yellow, round, film-coated tablets, 8 mm in diameter, debossed with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Slovenian: Rumena, okrogla, filmsko obložena tableta s premerom 8 mm z oznako „GSI“ na eni strani tablete in „25“ na drugi strani tablete.
English: Contact your doctor or nearest emergency department immediately for advice.
Slovenian: Nemudoma se povežite z zdravnikom ali urgentnim oddelkom bolnišnice.
English: • In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBs seroconversion or until there is evidence of loss of efficacy.
Slovenian: • Pri HbeAg negativnih bolnikih brez ciroze se zdravljenje daje vsaj do serokonverzije HBs ali do znakov izgube učinkovitosti.
English: Diarrhoea, vomiting, nausea, abdominal pain, abdominal distension, flatulence Hepatobiliary disorders
Slovenian: Pogosti driska, bruhanje, navzea, bolečine v trebuhu, abdominalna distenzija, flatulenca
English: Vemlidy met the non-inferiority criteria in achieving HBV DNA less than 29 IU/mL when compared to tenofovir disoproxil fumarate.
Slovenian: Zdravilo Vemlidy je izpolnilo kriterije za neinferiornost pri doseganju HBV DNA manj kot 29 i.e./ml v primerjavi z dizoproksiltenofovirijevim fumaratom.
English: Treatment of overdose with Vemlidy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Slovenian: ki vključujejo spremljanje vitalnih znakov in opazovanje kliničnega stanja bolnika.
English: Assessment of adverse reactions is based on pooled safety data from 2 controlled Phase 3 studies in which 866 HBV infected patients received tenofovir alafenamide 25 mg once daily in a double-blind fashion through Week 96 (median duration of blinded study drug exposure of 104 weeks) and from post-marketing experience.
Slovenian: Ocena neželenih učinkov temelji na združenih podatkih o varnosti iz 2 nadzorovanih študij 3. faze, v katerih je 866 bolnikov, okuženih s HBV, prejemalo tenofoviralafenamid 25 mg enkrat na dan na dvojno slepi način do konca 96. tedna (mediana trajanja izpostavljenosti zdravilu v slepi študiji je bila 104 tedne), ter iz izkušenj v obdobju trženja.
English: Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Slovenian: Pri bolnikih s cirozo je morda tveganje za jetrno dekompenzacijo po poslabšanju hepatitisa večje, zato jih je treba med zdravljenjem skrbno nadzirati.
English: • Wind (flatulence)
Slovenian: • vetrovi (flatulenca)
English: However, tenofovir disoproxil fumarate reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Slovenian: Vendar pa je dizoproksiltenofovirijev fumarat zmanjšal indeks viabilnosti in telesno maso mladičev v peri- in postnatalni študiji toksičnosti pri odmerkih, toksičnih za mater.
English: If you forget to take Vemlidy
Slovenian: Če ste pozabili vzeti zdravilo Vemlidy
English: • antiviral medicines used to treat HIV, such as:
Slovenian: • protivirusna zdravila za zdravljenje okužbe z virusom HIV, kot so:
English: Vemlidy film-coated tablets are yellow, round, printed (or marked) with “GSI” on one side of the tablet and “25” on the other side of the tablet.
Slovenian: Zdravilo Vemlidy filmsko obložene tablete so rumene, okrogle, z natisom (ali oznako) „GSI“ na eni strani tablete in „25“ na drugi strani tablete.
English: No clinically relevant differences in pharmacokinetics according to age or ethnicity have been identified.
Slovenian: Klinično pomembnih farmakokinetičnih razlik glede starosti ali etnične pripadnosti niso opredelili.
English: Patients must be advised that Vemlidy does not prevent the risk of transmission of HBV to others through sexual contact or contamination with blood.
Slovenian: Prenos HBV Bolnike je treba opozoriti, da zdravilo Vemlidy ne preprečuje tveganja za prenos HBV na druge pri spolnem odnosu ali pri kontaminaciji s krvjo.
English: HIV ANTIRETROVIRAL AGENTS - CCR5 RECEPTOR ANTAGONIST Maraviroc
Slovenian: PROTIRETROVIRUSNA ZDRAVILA ZA ZDRAVLJENJE OKUŽBE S HIV - ANTAGONIST RECEPTORJEV CCR5
English: • If it is less than 18 hours after you usually take Vemlidy, take it as soon as you can, and then take your next dose at its regular time.
Slovenian: • Če je minilo manj kot 18 ur od takrat, ko običajno vzamete zdravilo Vemlidy, ga vzemite takoj, ko lahko, nato pa naslednji odmerek vzemite kot običajno.
English: Patients co-infected with HBV and hepatitis C or D virus
Slovenian: Bolniki s sočasno okužbo s HBV in virusom hepatitisa C ali D
English: ANTIFUNGALS Itraconazole Ketoconazole
Slovenian: ANTIMIKOTIKI itrakonazol ketokonazol
English: If you take more Vemlidy than you should
Slovenian: Če ste vzeli večji odmerek zdravila Vemlidy, kot bi smeli
English: Non-clinical studies in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Slovenian: Predklinične študije pri podganah in psih so pokazale, da sta primarna ciljna organa toksičnosti kosti in ledvice.
English: Flares after treatment discontinuation
Slovenian: Izbruhi po prekinitvi zdravljenja
English: In both studies tenofovir alafenamide was associated with smaller changes in renal safety parameters (smaller median reductions in estimated CrCl by Cockcroft-Gault and smaller median percentage increases in urine retinol binding protein to creatinine ratio and urine beta-2-microglobulin to creatinine ratio) compared to tenofovir disoproxil fumarate after 96 weeks of treatment (see also section 4.4).
Slovenian: V obeh študijah je bil tenofoviralafenamid povezan z manjšimi spremembami varnostnih parametrov delovanja ledvic (manjše mediano zmanjšanje ocenjenega CrCl po lestvici Cockcroft-Gault in manjše mediano odstotno povečanje razmerja beljakovin v urinu, ki vežejo retinol, glede na kreatinin in razmerja beta-2-mikroglobulina v urinu glede na kreatinin) v primerjavi z dizoproksiltenofovirijevim fumaratom po 96. tednih zdravljenja (glejte tudi poglavje 4.4).
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Slovenian: Na voljo so naslednje velikosti pakiranja: zunanja škatla, ki vsebuje 1 HDPE vsebnik s 30 filmsko obloženimi tabletami in škatle z 90 (3 HDPE vsebniki po 30) filmsko obloženimi tabletami.
English: d Includes patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy, e.g.
Slovenian: d Vključuje bolnike, ki sodelovanja niso prekinili zaradi neželenih učinkov, smrti ali pomanjkanja ali izgube učinka, temveč zaradi drugih razlogov, npr. zaradi umika soglasja, izgubljenosti za spremljanje itd.
English: Vemlidy comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Slovenian: Zdravilo Vemlidy je na voljo v HDPE vsebnikih s 30 tabletami (s sušilnim sredstvom iz silikagela, ki mora ostati v vsebniku za zaščito tablet).
English: Acute exacerbation of hepatitis has been reported in patients who have discontinued treatment for hepatitis B, usually in association with rising HBV DNA levels in plasma.
Slovenian: Pri bolnikih, ki so se prenehali zdraviti zaradi hepatitisa B, so poročali o akutnem poslabšanju hepatitisa, običajno v povezavi z naraščajočimi vrednostmi DNA HBV v plazmi.
English: The EC50 (50% effective concentration) values for tenofovir alafenamide ranged from 34.7 to 134.4 nM, with an overall mean EC50 of 86.6 nM.
Slovenian: Vrednosti EC50 (srednje efektivna koncentracija) za tenofoviralafenamid so v razponu od 34,7 do 134,4 nM, s splošnim povprečjem EC50 86,6 nM. CC50 (srednja citotoksična koncentracija) v celicah HepG2 je bila > 44.400 nM.
English: • antibiotics used to treat bacterial infections including tuberculosis, containing:
Slovenian: • antibiotike, ki se uporabljajo za zdravljenje bakterijskih okužb, vključno s tuberkulozo,
English: It is important not to miss a dose of Vemlidy.
Slovenian: Pomembno je, da ne pozabite vzeti nobenega odmerka zdravila Vemlidy.
English: It is not known whether tenofovir alafenamide is secreted in human milk.
Slovenian: Ni znano, ali se tenofoviralafenamid izloča v človeško mleko.
English: Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases that include mitochondrial DNA polymerase γ and there is no evidence of mitochondrial toxicity in vitro based on several assays including mitochondrial DNA analyses.
Slovenian: Tenofovir difosfat je šibek zaviralec sesalske DNA-polimeraze, ki vključuje mitohondrijsko DNA-polimerazo γ; znakov mitohondrijske toksičnosti in vitro na podlagi številnih testov, vključno z analizami mitohondrijske DNA, ni.
English: Do not give this medicine to children who are under 12 years old or weigh less than 35 kg.
Slovenian: Otroci in mladostniki Tega zdravila ne dajajte otrokom, starim manj kot 12 let ali s telesno maso manj kot 35 kg.
English: In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by carboxylesterase-1 in hepatocytes; and by cathepsin A in peripheral blood mononuclear cells (PBMCs) and macrophages.
Slovenian: Študije in vitro so pokazale, da se tenofoviralafenamid presnavlja v tenofovir (glavni presnovek) s karboksilesterazo-1 v hepatocitih; in s katepsinom A v perifernih mononuklearnih krvnih celicah (PBMC) in makrofagih.
English: In a pooled analysis of patients receiving Vemlidy, sequence analysis was performed on paired baseline and on-treatment HBV isolates for patients who either experienced virologic breakthrough (2 consecutive visits with HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or 1.0 log10 or greater increase in HBV DNA from nadir) or patients with HBV DNA ≥ 69 IU/mL at Week 96 or at early discontinuation at or after Week 24.
Slovenian: V združeni analizi bolnikov, ki so prejemali zdravilo Vemlidy, so opravili analizo zaporedja na parnih izhodiščnih izolatih in izolatih HBV med zdravljenjem pri bolnikih, ki so imeli povečanje virusnega bremena (2 zaporedna obiska s HBV DNA ≥ 69 i.e./ml po povečanju < 69 i.e./ml ali 1,0 log10 ali več v HBV DNA od najnižje točke), ali bolnikih, ki so imeli HBV DNA ≥ 69 i.e./ml v 96. tednu ali ob predčasni prekinitvi v 24. tednu ali po njem.
English: Tenofovir is renally eliminated from the body by the kidneys by both glomerular filtration and active tubular secretion.
Slovenian: Tenofovir se iz telesa izloča z ledvicami s pomočjo glomerularne filtracije in aktivnega tubularnega izločanja.
English: g The predominant circulating nucleoside metabolite of sofosbuvir.
Slovenian: g Prevladujoči nukleozidni presnovek sofosbuvirja v obtoku.
English: In analyses at Week 48 (N = 20) and Week 96 (N = 72), no amino acid substitutions associated with resistance to Vemlidy were identified in these isolates (genotypic and phenotypic analyses).
Slovenian: V analizah v 48. tednu (N = 20) in 96. tednu (N = 72) v teh izolatih niso identificirali nobenih substitucij aminokislin z odpornostjo na zdravilo Vemlidy
English: Each bottle contains silica gel desiccant and polyester coil.
Slovenian: En vsebnik vsebuje sušilno sredstvo s silikagelom in poliestrsko vato.
English: If you do miss a dose, work out how long since you should have taken it.
Slovenian: določite, koliko časa je minilo od takrat, ko bi ga morali vzeti:
English: Other medicines and Vemlidy Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali, ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: TDF = tenofovir disoproxil fumarate a Missing = failure analysis.
Slovenian: TDF = dizoproksiltenofovirijev fumarat a Manjkajoči = analiza odpovedi.
English: The safety and efficacy of Vemlidy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Vemlidy pri otrocih, mlajših od 12 let ali s telesno maso < 35 kg, še nista bili dokazani.
English: Gilead Sciences Tél: + 33 (0) 1 46 09 41 00
Slovenian: Tél: + 33 (0) 1 46 09 41 00
English: 1.8% (95% CI = -3.6% to 7.2%)
Slovenian: 1,8 % (95-% IZ = -3,6 % do 7,2 %) -3,6 % (95-% IZ = -9,8 % do 2,6 %)
English: Increased ALT
Slovenian: Pogosti povečana ALT
English: When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Slovenian: Po korekciji za vezavo beljakovin so bile koncentracije nevezanega (prostega) tenofoviralafenamida v plazmi pri hudi okvari jeter in normalnem delovanju jeter podobne.
English: There are no safety data on the use of Vemlidy to treat HBV infected patients with CrCl < 30 mL/min.
Slovenian: Podatkov o varnosti uporabe zdravila Vemlidy za zdravljenje bolnikov, okuženih s HBV, s CrCl < 30 ml/min, ni.
English: Because there is a lower tenofovir exposure in rats and mice after tenofovir alafenamide administration compared to tenofovir disoproxil fumarate, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil fumarate.
Slovenian: Zaradi manjše izpostavljenosti tenofovirju pri podganah in miših po dajanju tenofoviralafenamida v primerjavi z dizoproksiltenofovirijevim fumaratom so študije kancerogenosti in peri- ter postnatalne študije pri podganah izvedli samo z dizoproksiltenofovirijevim fumaratom.