FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl > 15 but < 30 mL/min) in studies of tenofovir alafenamide.
Slovenian: Klinično pomembnih razlik v farmakokinetiki tenofoviralafenamida ali tenofovirja med zdravimi osebami in bolniki s hudo okvaro ledvic (ocenjen CrCl > 15, a < 30 ml/min) v študijah tenofoviralafenamida niso opazili.
English: The mean age was 38 years, 64% were male, 82% were Asian, 17% were White and < 1% (5 subjects) were Black.
Slovenian: Povprečna starost je bila 38 let, 64 % je bilo moških, 82 % je bilo Azijcev, 17 % je bilo belcev in
English: HBV DNA < 29 IU/mL Treatment differenceb
Slovenian: HBV DNA < 29 i.e./ml Razlika v zdravljenjub
English: In patients with severe hepatic impairment, total plasma concentrations of tenofovir alafenamide and tenofovir are lower than those seen in subjects with normal hepatic function.
Slovenian: Jetrna okvara Pri bolnikih s hudo okvaro jeter so bile skupne koncentracije tenofoviralafenamida in tenofovirja v plazmi manjše kot pri osebah z normalnim delovanjem jeter.
English: Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172).
Slovenian: Polivinilalkohol (E1203), titanov dioksid (E171), makrogol (E1521), smukec (E553b), rumen železov oksid (E172).
English: Following oral administration of Vemlidy under fasted conditions in adult patients with chronic hepatitis B, peak plasma concentrations of tenofovir alafenamide were observed approximately 0.48 hours post-dose.
Slovenian: Po peroralnem dajanju zdravila Vemlidy na tešče odraslim bolnikom s kroničnim hepatitisom B je bila najvišja koncentracija tenofoviralafenamida v plazmi opažena približno 0,48 ur po odmerku.
English: • If it is more than 18 hours after you usually take Vemlidy, then do not take the missed dose.
Slovenian: • Če je minilo več kot 18 ur od takrat, ko običajno vzamete zdravilo Vemlidy, ne vzemite izpuščenega odmerka.
English: Tenofovir alafenamide and tenofovir have a median plasma half-life of 0.51 and 32.37 hours, respectively.
Slovenian: Tenofoviralafenamid ima mediani razpolovni čas v plazmi 0,51 ur, tenofovir pa 32,37 ur.
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Slovenian: Tenofoviralafenamid in vitro ni zaviralec CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali CYP2D6.
English: Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Slovenian: Presnova je glavna pot izločanja tenofoviralafenamida pri ljudeh in znaša > 80 % peroralnega odmerka.
English: In patients who remained on blinded treatment beyond Week 96, mean percentage change in BMD in each group at Week 120 was similar to that at Week 96.
Slovenian: Pri bolnikih, ki so nadaljevali s slepim zdravljenjem po 96. tednu, je bila povprečna sprememba v odstotkih BMD pri vsaki skupini v 120. tednu podobna kot v 96. tednu.
English: • herbal remedies used to treat depression and anxiety, containing: St. John's wort (Hypericum perforatum)
Slovenian: • pripravke rastlinskega izvora, ki se uporabljajo za zdravljenje depresije in tesnobe, ki vsebujejo: šentjanževko (Hypericum perforatum),
English: Oxcarbazepine Phenobarbital
Slovenian: okskarbazepin fenobarbital
English: It is not known whether tenofovir can be removed by peritoneal dialysis.
Slovenian: ali se lahko tenofovir odstrani s peritonealno dializo.
English: Medicinal products that are P-gp inducers (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital or St. John's wort) are expected to decrease plasma concentrations of tenofovir alafenamide, which may lead to loss of therapeutic effect of Vemlidy.
Slovenian: Za zdravila, ki so induktorji P-gp (npr. rifampicin, rifabutin, karbamazepin, fenobarbital ali šentjanževka), se pričakuje, da bodo zmanjšala koncentracije tenofoviralafenamida v plazmi, kar lahko povzroči izgubo terapevtskega učinka zdravila Vemlidy.
English: ↔ Tenofovir alafenamide ↔ Raltegravir
Slovenian: ↔ tenofoviralafenamid ↔ raltegravir
English: Tenofovir alafenamide exposures are dose proportional over the dose range of 8 to 125 mg.
Slovenian: Izpostavljenosti tenofoviralafenamidu so sorazmerne z odmerkom v razponu odmerka od 8 mg do
English: Vemlidy has not been tested in children aged less than 12 years old or weighing less than 35 kg.
Slovenian: Zdravila Vemlidy niso testirali pri otrocih, starih manj kot 12 let ali s telesno maso manj kot 35 kg.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of tenofovir alafenamide.
Slovenian: Minimalna infiltracija histiocitov je bila prisotna v očesu psov pri izpostavljenosti tenofoviralafenamidu približno 4-krat in pri tenofovirju 17-krat večja od pričakovane po dajanju tenofoviralafenamida.
English: On days of haemodialysis, Vemlidy should be administered after completion of haemodialysis treatment (see section 5.2).
Slovenian: Ob dneh s hemodializo je treba zdravilo Vemlidy dati po končanju zdravljenja s hemodializo (glejte poglavje 5.2).
English: HIV antibody testing should be offered to all HBV infected patients whose HIV-1 infection status is unknown before initiating therapy with Vemlidy.
Slovenian: Vsem osebam, okuženim s HBV, in z neznanim statusom okužbe s HIV-1, je treba ponuditi testiranje za protitelesa za HIV pred začetkom zdravljenja z zdravilom Vemlidy.
English: Musculoskeletal and connective tissue disorders Common
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: • Do not breast-feed during treatment with Vemlidy.
Slovenian: • Med zdravljenjem z zdravilom Vemlidy ne dojite.
English: The use of Vemlidy is not recommended in patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.2).
Slovenian: Uporaba zdravila Vemlidy ni priporočljiva pri bolnikih s CrCl < 15 ml/min, ki ne prejemajo hemodialize (glejte poglavje 4.2).
English: In patients who remained on blinded treatment beyond Week 96 in Studies 108 and 110, changes from baseline in renal laboratory parameter values in each group at Week 120 were similar to those at Week 96.
Slovenian: Pri bolnikih, ki so nadaljevali s slepim zdravljenjem po 96. tednu v študijah 108 in 110, je bila sprememba laboratorijskih vrednosti ledvičnih parametrov od izhodiščne vrednosti pri vsaki skupini v 120. tednu podobna kot v 96. tednu.
English: Co-administration of such medicinal products with Vemlidy is not recommended.
Slovenian: Sočasno dajanje teh zdravil z zdravilom Vemlidy se ne priporoča.
English: The most frequently reported adverse reactions were headache (12%), nausea (6%), and fatigue (6%).
Slovenian: (12 %), navzea (6 %) in utrujenost (6 %).
English: HBV isolates expressing the rtA181T, rtA181V, or rtN236T single substitutions associated with resistance to adefovir remained susceptible to tenofovir alafenamide; however, the HBV isolate expressing rtA181V plus rtN236T exhibited reduced susceptibility to tenofovir alafenamide (3.7-fold change in EC50).
Slovenian: Izolati HBV, ki izražajo enojne substitucije rtA181T, rtA181V ali rtN236T, povezane z odpornostjo na adefovir, so ostali občutljivi na tenofoviralafenamid; vendar pa so izolati HBV, ki izražajo rtA181V plus rtN236T, kazali zmanjšano občutljivost na tenofoviralafenamid (3,7-kratna sprememba EC50).
English: Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Slovenian: Tenofoviralafenamid je fosfonamidatno predzdravilo tenofovirja (analog 2'-deoksiadenozin monofosfata).
English: Tenofovir alafenamide enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3.
Slovenian: Tenofoviralafenamid vstopa v primarne hepatocite s pasivno difuzijo in s transporterji jetrnega privzema OATP1B1 in OATP1B3.
English: HBV isolates expressing the rtL180M, rtM204V plus rtT184G, rtS202G, or rtM250V substitutions associated with resistance to entecavir remained susceptible to tenofovir alafenamide.
Slovenian: Izolati HBV, ki izražajo substitucije rtL180M, rtM204V plus rtT184G, rtS202G ali rtM250V, povezane z odpornostjo na entekavir, so ostali občutljivi na tenofoviralafenamid.
English: Lactose monohydrate Microcrystalline cellulose (E460(i)) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza (E460(i)) premreženi natrijev karmelozat (E468) magnezijev stearat (E470b)
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women.
Slovenian: Podatkov o uporabi tenofoviralafenamida pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
English: Table 2: Adverse drug reactions identified with tenofovir alafenamide
Slovenian: Preglednica 2: Neželeni učinki zdravila, opredeljeni s tenofoviralafenamidom
English: If you are sick (vomit) less than 1 hour after taking Vemlidy, take another tablet.
Slovenian: Če vam je slabo (bruhate) manj kot 1 uro po uporabi zdravila Vemlidy, vzemite še eno tableto.
English:  If any of these apply to you, talk to your doctor before taking Vemlidy.
Slovenian:  Če kar koli od navedenega velja za vas, se pred jemanjem zdravila Vemlidy posvetujte z zdravnikom.
English: Co-administration of strong inhibitors of P-gp with Vemlidy is not recommended.
Slovenian: Sočasno dajanje močnih zaviralcev P-gp z zdravilom Vemlidy ni priporočljiva.
English: e The population used for serology analysis included only patients with antigen (HBeAg) positive and antibody (HBeAb) negative or missing at baseline.
Slovenian: e Populacija, uporabljena za serološko analizo, je vključevala samo bolnike s pozitivnim antigenom (HBeAg) in negativnim ali manjkajočim protitelesom (HBeAb) ob izhodišču.
English: Tenofovir has activity that is specific to hepatitis B virus and human immunodeficiency virus (HIV-1 and HIV-2).
Slovenian: Tenofovir ima aktivnost, specifično za virus hepatitisa B in za virus človeške imunske pomanjkljivosti
English: d The population used for serology analysis included only patients with antigen (HBeAg) positive and antibody (HBeAb) negative or missing at baseline.
Slovenian: d Populacija, uporabljena za analizo serologije, je vključevala le bolnike, pozitivne za antigen (HBeAg) in negativne ali manjkajoče za protitelesa (HBeAb) ob izhodišču.
English: The antiviral activity of tenofovir alafenamide was assessed in HepG2 cells against a panel of HBV clinical isolates representing genotypes A-H.
Slovenian: Protivirusna aktivnost Protivirusna aktivnost tenofoviralafenamida je bila ocenjena v celicah HepG2 v baterijskem testu kliničnih izolatov HBV, ki predstavljajo genotipe A-H.
English: Therapy should be initiated by a physician experienced in the management of chronic hepatitis B.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje mora začeti zdravnik, ki že ima izkušnje z zdravljenjem kroničnega hepatitisa B.
English: Normalised ALT (Central lab)c Normalised ALT (AASLD)d Serology
Slovenian: Normalizirana ALT (centralni laboratorij)c Normalizirana ALT (AASLD)d
English: Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro.
Slovenian: Tenofoviralafenamid je in vitro substrat OATP1B1 in OATP1B3.
English: Hepatitis B and HIV co-infection
Slovenian: Sočasna okužba s hepatitisom B in HIV
English: Tenofovir alafenamide is primarily hydrolysed to form tenofovir by carboxylesterase 1 in primary hepatocytes.
Slovenian: Tenofoviralafenamid se primarno hidrolizira v tenofovir s pomočjo karboksilesteraze 1 v primarnih hepatocitih.
English: What you need to know before you take Vemlidy Do not take Vemlidy
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vemlidy Ne jemljite zdravila Vemlidy:
English: ↔ Tenofovir alafenamide ↔ Nevirapine
Slovenian: ↔ tenofoviralafenamid ↔ nevirapin
English: At baseline, mean plasma HBV DNA was 7.6 log10 IU/mL, mean serum ALT was 120 U/L, and 7% of patients had a history of cirrhosis.
Slovenian: Ob izhodišču je bila povprečna vrednost HBV DNA v plazmi 7,6 log10 i.e./ml, povprečna vrednost serumske ALT je bila 120 e./l in 7 % bolnikov je imelo cirozo v anamnezi.
English: In Study 110, HBeAg-positive treatment-naïve and treatment-experienced patients with compensated liver function were randomised in a 2:1 ratio to receive Vemlidy (25 mg; N = 581) once daily or tenofovir disoproxil fumarate (300 mg; N = 292) once daily.
Slovenian: V študiji 110 so bili HBeAg-pozitivni, predhodno nezdravljeni in predhodno zdravljeni bolniki s kompenziranim delovanjem jeter randomizirani v razmerju 2 : 1 za prejemanje zdravila Vemlidy (25 mg; N = 581) enkrat na dan ali dizoproksiltenofovirijev fumarat (300 mg; N = 292) enkrat na dan.
English: • Take steps to avoid getting pregnant during treatment with Vemlidy.
Slovenian: • Z ustreznimi ukrepi preprečite zanositev med zdravljenjem z zdravilom Vemlidy.
English: Co-administration of Vemlidy with medicinal products that inhibit P-gp and BCRP may increase plasma concentrations of tenofovir alafenamide.
Slovenian: Sočasno dajanje zdravila Vemlidy z zdravili, ki zavirajo P-gp in BCRP, lahko poveča koncentracije tenofoviralafenamida v plazmi.
English: No dosing recommendations can be given for patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.4).
Slovenian: Za bolnike s CrCl < 15 ml/min, ki ne prejemajo hemodialize, ni mogoče dati priporočil glede odmerka (glejte poglavje 4.4).
English: In Study 108, HBeAg-negative treatment-naïve and treatment-experienced patients with compensated liver function were randomised in a 2:1 ratio to receive Vemlidy (25 mg; N = 285) once daily or tenofovir disoproxil fumarate (300 mg; N = 140) once daily.
Slovenian: V študiji 108 so bili HBeAg-negativni, predhodno nezdravljeni in predhodno zdravljeni bolniki s kompenziranim delovanjem jeter randomizirani v razmerju 2 : 1 za prejemanje zdravila Vemlidy (25 mg; N = 285) enkrat na dan ali dizoproksiltenofovirijev fumarat (300 mg; N = 140) enkrat na dan.
English: Bone toxicity was observed as reduced BMD in rats and dogs at tenofovir exposures at least four times greater than those expected after administration of tenofovir alafenamide.
Slovenian: Toksičen vpliv na kosti so opazili kot zmanjšano mineralno gostoto kosti pri podganah in psih pri izpostavljenostih tenofovirju, ki so bile vsaj štirikrat večje kot izpostavljenost, pričakovana pri dajanju tenofoviralafenamida.
English: No dose adjustment of Vemlidy is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Pri bolnikih z okvarjenim delovanjem jeter ni treba prilagajati odmerka zdravila Vemlidy (glejte poglavji 4.4 in 5.2).
English: h Study conducted with tenofovir alafenamide 40 mg and emtricitabine 200 mg. i Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
Slovenian: i Študija je bila opravljena z dodatnim voksilaprevirjem 100 mg za doseganje izpostavljenosti voksilaprevirju, pričakovane pri bolnikih, okuženih s HCV.
English: No human data on the effect of Vemlidy on fertility are available.
Slovenian: Podatkov o vplivu zdravila Vemlidy na plodnost pri ljudeh ni na voljo.
English: Tenofovir alafenamide is transported by P-gp and breast cancer resistance protein (BCRP).
Slovenian: Zdravila, ki lahko vplivajo na tenofoviralafenamid Tenofoviralafenamid transportirata P-gp in protein, odporen za raka dojke (BCRP, breast cancer resistance protein).
English: What Vemlidy looks like and contents of the pack
Slovenian: Izgled zdravila Vemlidy in vsebina pakiranja
English: HBV isolates expressing the rtV173L, rtL180M, and rtM204V/I substitutions associated with resistance to lamivudine remained susceptible to tenofovir alafenamide (< 2-fold change in EC50).
Slovenian: Izolati HBV, ki izražajo substitucije rtV173L, rtL180M in rtM204V/I, povezane z odpornostjo na lamivudin, so ostali občutljivi na tenofoviralafenamid (< 2-kratna sprememba EC50).
English: Vemlidy tablets are packaged in high density polyethylene (HDPE) bottles and enclosed with a polypropylene continuous-thread, child-resistant cap, lined with an induction-activated aluminium foil liner.
Slovenian: Zdravilo Vemlidy tablete je pakirano v vsebnik iz polietilena visoke gostote (HDPE, high density polyethylene) s polipropilensko, za otroke varno zaporko z neprekinjeno nitko, obloženo z indukcijsko aktivirano aluminijasto folijo.
English: The following adverse drug reactions have been identified with tenofovir alafenamide in patients with chronic hepatitis B (Table 2).
Slovenian: Naslednje neželene reakcije na zdravilo so bile pri bolnikih s kroničnim hepatitisom B opredeljene za tenofoviralafenamid (preglednica 2).
English: No dose adjustment of Vemlidy is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 15 mL/min or in patients with CrCl < 15 mL/min who are receiving haemodialysis.
Slovenian: Pri odraslih ali mladostnikih (starih vsaj 12 let in s telesno maso vsaj 35 kg) z ocenjenim očistkom kreatinina (CrCl) ≥ 15 ml/min ali pri bolnikih s CrCl < 15 ml/min, ki prejemajo hemodializo, odmerka zdravila Vemlidy ni treba prilagajati.
English: Ethinylestradiol (0.025 mg orally, q.d.)
Slovenian: etinilestradiol (0,025 mg peroralno, q.d.)
English: These patients may be at higher risk of experiencing serious hepatic or renal adverse reactions.
Slovenian: Pri teh bolnikih je morda tveganje za resne neželene učinke na jetrih ali ledvicah večje.
English: The majority of cases are self-limited but severe exacerbations, including fatal outcomes, may occur after discontinuation of treatment for hepatitis B. Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of treatment for hepatitis B. If appropriate, resumption of hepatitis B therapy may be warranted.
Slovenian: Delovanje jeter je treba spremljati v rednih intervalih klinično in z laboratorijskimi preiskavami še vsaj 6 mesecev po prekinitvi zdravljenja zaradi hepatitisa B. Če je ustrezno, se lahko zdravljenje hepatitisa B nadaljuje.
English: Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/ 100 mg + 100 mgi orally, q.d.)
Slovenian: sofosbuvir/velpatasvir/voksilaprevir (400 mg/100 mg/ 100 mg + 100 mgi peroralno, q.d.)
English: Steady state Cmax for tenofovir alafenamide and tenofovir were 0.18 and 0.02 µg/mL, respectively.
Slovenian: Vrednost Cmax v stanju dinamičnega ravnovesja je bila za tenofoviralafenamid 0,18 µg•hr/ml, za tenofovir pa 0,02 µg/ml.
English: If the patient vomits more than 1 hour after taking Vemlidy, the patient does not need to take another tablet.
Slovenian: Če bolnik bruha več kot 1 uro po tem, ko je vzel zdravilo Vemlidy, mu ni treba ponovno vzeti tablete.
English: In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate.
Slovenian: In vivo se tenofoviralafenamid v celicah hidrolizira v tenofovir (glavni presnovek), ki se fosforilizira v aktivni presnovek, tenofovir difosfat.
English: If a dose is missed and less than 18 hours have passed from the time it is usually taken, the patient should take Vemlidy as soon as possible and then resume their normal dosing schedule.
Slovenian: Če bolnik izpusti odmerek in je od časa, ko ga običajno vzame, minilo manj kot 18 ur, mora bolnik zdravilo Vemlidy vzeti takoj, ko je možno, nato pa z jemanjem nadaljevati kot običajno.
English: ANTIDEPRESSANTS Sertraline (50 mg orally, s.d.) Tenofovir alafenamidee (10 mg orally, q.d.)
Slovenian: ANTIDEPRESIVI sertralin (50 mg peroralno, s.d.) tenofoviralafenamide (10 mg peroralno, q.d.)
English: • Tell your doctor if you have a history of liver disease.
Slovenian: • Povejte svojemu zdravniku, če imate bolezen jeter v anamnezi.
English: c The population used for analysis of ALT normalisation included only patients with ALT above ULN of the central laboratory range at baseline.
Slovenian: c Populacija, uporabljena za analizo normalizacije ALT, je vključevala le bolnike z ALT nad ULN razpona centralnega laboratorija ob izhodišču.
English: 1 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Slovenian: 1 Neželeni učinek, opredeljen v okviru nadzora za zdravila, ki vsebujejo tenofoviralafenamid, v obdobju trženja zdravil.
English: • Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Slovenian: • Zdravniku takoj povejte, če imate nove ali neobičajne simptome, ko se prenehate zdraviti,
English: How to take Vemlidy Always take this medicine exactly as your doctor has told you.
Slovenian: Kako jemati zdravilo Vemlidy Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
English: Vemlidy 25 mg film-coated tablets.
Slovenian: IME ZDRAVILA Vemlidy 25 mg filmsko obložene tablete
English: Sertraline (50 mg orally, s.d.)
Slovenian: sertralin (50 mg peroralno, s.d.)
English: In the open-label phase of both studies, mean percentage change in BMD from Week 96 to Week 120 in patients who remained on Vemlidy was +0.6% at the lumbar spine and 0% at the total hip, compared to +1.7% at the lumbar spine and +0.6% at the total hip in those who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
Slovenian: V odprti fazi obeh študij je bila povprečna sprememba v odstotkih BMD od 96. tedna do 120. tedna pri bolnikih, ki so nadaljevali zdravljenje z zdravilom Vemlidy, +0,6 % na ledveni hrbtenici in 0 % na celotnem kolku, v primerjavi s +1,7 % na ledveni hrbtenici in +0,6 % na celotnem kolku pri tistih, ki so v 96. tednu z zdravljenja z dizoproksiltenofovirijevim fumaratom prešli na zdravljenje z zdravilom Vemlidy.
English: Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Slovenian: Intracelično se tenofovir nato fosforilizira v farmakološko aktivni presnovek tenofovir difosfat.
English: Vemlidy (N = 581)
Slovenian: (N = 581)
English: Gilead Sciences Ireland UC Тел.
Slovenian: Gilead Sciences Ireland UC
English: Midazolamd (1 mg IV, s.d.)
Slovenian: midazolamd (1 mg i.v., s.d.)
English: c Treatment-naïve subjects received < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue including tenofovir disoproxil fumarate or tenofovir alafenamide.
Slovenian: b Preiskovanci, ki niso bili predhodno zdravljeni, so < 12 tednov prejemali peroralno protivirusno zdravljenje s poljubnim nukleozidom ali nukleotidnim analogom, vključno z dizoproksiltenofovirijevim fumaratom ali tenofoviralafenamidom.
English: Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxic assays.
Slovenian: V običajnih testih genotoksičnosti tenofoviralafenamid ni bil mutagen ali klastogen.
English: Vemlidy should not be co-administered with medicinal products containing tenofovir alafenamide, tenofovir disoproxil fumarate or adefovir dipivoxil.
Slovenian: Zdravila Vemlidy se ne sme dajati skupaj z zdravili, ki vsebujejo tenofoviralafenamid, dizoproksiltenofovirijev fumarat ali adefovirdipivoksilat.
English: • adefovir dipivoxil
Slovenian: • adefovirdipivoksilat
English: (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov)
English: c The population used for analysis of ALT normalisation included only patients with ALT above ULN of the American Association of the Study of Liver Diseases (AASLD) criteria (> 30 U/L males and > 19 U/L females) at baseline.
Slovenian: c Populacija, uporabljena za analizo normalizacije ALT, je vključevala samo bolnike z vrednostjo ALT nad ULN po kriterijih Ameriškega združenja za preučevanje bolezni jeter (AASLD, American Association of the Study of Liver Diseases) (> 30 e./l za moške in > 19 e./l za ženske) ob izhodišču.
English: Midazolamd (2.5 mg orally, s.d.)
Slovenian: midazolamd (2,5 mg peroralno, s.d.)