natgillin/translations-raw huggingface dataset:
Vemlidy is indicated for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg) (see section 5.1). 
Vemlidy je indiciran za liječenje kroničnog hepatitisa B u odraslih i adolescenata (u dobi od 12 godina i starijih tjelesne težine od najmanje 35 kg) (vidjeti dio 5.1).
21% were treatment-experienced (previous treatment with oral antivirals, including entecavir (N = 41), lamivudine (N = 42), tenofovir disoproxil fumarate (N = 21), or other (N = 18)). 
21% prethodno je bilo liječeno (prethodno liječenje oralnim antivirusnim lijekovima, uključujući entekavir (N = 41), lamivudin (N = 42), tenofovirdizoproksilfumarat (N = 21) ili druge lijekove (N = 18)).
On days of haemodialysis, Vemlidy should be administered after completion of haemodialysis treatment (see section 5.2). 
Na dane kada se provodi hemodijaliza Vemlidy se treba primijeniti nakon dovršetka postupka hemodijalize (vidjeti dio 5.2).
Oxcarbazepine Phenobarbital 
Okskarbazepin Fenobarbital
The efficacy and safety of Vemlidy in patients with chronic hepatitis B are based on 48- and 96-week data from two randomised, double-blind, active-controlled studies, GS-US-320-0108 (“Study 108”) and GS-US-320-0110 (“Study 110”). 
B utemeljene su na podacima za 48 i 96 tjedana dobivenima tijekom dva randomizirana, dvostruko slijepa, aktivno kontrolirana ispitivanja, GS-US-320-0108 („Ispitivanje 108”) i GS-US-320-0110 („Ispitivanje 110”).
Patients co-infected with HBV and hepatitis C or D virus 
Bolesnici s istodobnom infekcijom HBV-om i virusom hepatitisa C ili D
• anticonvulsants used to treat epilepsy, such as: carbamazepine, oxcarbazepine, phenobarbital or phenytoin 
• antikonvulzive koji se koriste za liječenje epilepsije, kao što su: karbamazepin, okskarbazepin, fenobarbital ili fenitoin
Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the HBV reverse transcriptase, which results in DNA chain termination. 
Tenofovirdifosfat inhibira replikaciju HBV-a ugradnjom u virusnu DNK pomoću HBV reverzne transkriptaze, što rezultira prekidom lanca DNK.
If more than 18 hours have passed from the time it is usually taken, the patient should not take the missed dose and should simply resume the normal dosing schedule. 
Ako je prošlo više od 18 sati od uobičajena vremena uzimanja doze, bolesnik ne smije uzeti propuštenu dozu, te jednostavno treba nastaviti uzimati lijek prema uobičajenom rasporedu.
Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide yellow (E172). 
Poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol (E1521), talk (E553b), žuti željezov oksid (E172).
Stopping treatment with Vemlidy may cause your hepatitis B to get worse. 
Prekid liječenja lijekom Vemlidy može uzrokovati pogoršanje hepatitisa B.
Medicinal products that may affect tenofovir alafenamide 
Lijekovi koji mogu utjecati na tenofoviralafenamid
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. 
Tijekom objedinjene analize bolesnika koji su primali Vemlidy provedena je analiza sekvenci na uparenim početnim, i izolatima HBV-a tijekom liječenja u bolesnika u kojih je došlo do virološkog proboja (tijekom 2 uzastopna posjeta HBV DNK ≥ 69 IU/ml nakon što je bio < 69 IU/ml, ili povećanje HBV DNK od 1,0 log10 ili veće u odnosu na najnižu vrijednost) ili u bolesnika u kojih je u 96. tjednu ili prilikom rana prekida u 24. tjednu ili nakon njega utvrđen HBV DNK ≥ 69 IU/ml.
Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir. 
Tenofoviralafenamid se uglavnom eliminira nakon što se metabolizira u tenofovir.
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. 
Budući da je izloženost tenofoviru u štakora i miševa nakon primjene tenofoviralafenamida manja nego nakon primjene tenofovirdizoproksilfumarata, ispitivanja kancerogenosti te perinatalna i postnatalna ispitivanja na štakorima provedena su samo s tenofovirdizoproksilfumaratom.
BOTTLE AND CARTON LABELLING 
OZNAČIVANJE BOCE I KUTIJE
Elderly No dose adjustment of Vemlidy is required in patients aged 65 years and older (see section 5.2). 
Prilagodba doze lijeka Vemlidy nije potrebna u bolesnika u dobi od 65 godina ili starijih (vidjeti dio 5.2).
Flares after treatment discontinuation 
Pogoršanja bolesti nakon prekida liječenja
• herbal remedies used to treat depression and anxiety, containing: St. John's wort (Hypericum perforatum) 
• biljne pripravke koji se koriste za liječenje depresije i anksioznosti, a sadrže: gospinu travu (Hypericum perforatum)
You do not need to take another tablet if you are sick (vomit) more than 1 hour after taking Vemlidy. 
Drugu tabletu ne trebate uzimati ako ste povraćali nakon što je prošlo više od 1 sata od uzimanja lijeka Vemlidy.
ORAL CONTRACEPTIVES Norgestimate (0.180 mg/0.215 mg/ 0.250 mg orally, q.d.) 
Norgestimat (0,180 mg/0,215 mg/0,250 mg peroralno, q.d.)
No dose adjustment of midazolam (administered orally or IV) is required. 
Nije potrebna prilagodba doze midazolama (koji se primjenjuje peroralno ili intravenski).
ANTIFUNGALS Itraconazole Ketoconazole 
Itrakonazol Ketokonazol
When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar. 
Nakon korekcije koja je uzela u obzir vezanje za proteine, koncentracije nevezanog (slobodnog) tenofoviralafenamida u plazmi pri teškom oštećenju funkcije jetre bile su slične onima pri normalnoj funkciji jetre.
HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum) 
Gospina trava (Hypericum perforatum)
Serology HBeAg loss / seroconversiond 
Serologija gubitak/serokonverzija HBeAge
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. 
U bolesnika s kompenziranom bolešću jetre povećanja ALT-a u serumu obično nisu popraćena povećanjem koncentracija bilirubina u serumu ili dekompenzacijom jetre.
Vemlidy contains lactose 
Vemlidy sadrži laktozu
Medicinal product by therapeutic areas 
Lijek prema terapijskim područjima
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b) Iron oxide yellow (E172) 
Film ovojnica poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol (E1521) talk (E553b) žuti željezov oksid (E172)
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. 
Toksičnost za kosti utvrđena je kao smanjeni BMD u štakora i pasa pri izloženostima tenofoviru koja su najmanje četiri puta veća od onih očekivanih nakon primjene tenofoviralafenamida.
There are no data on the safety and efficacy of Vemlidy in patients co-infected with hepatitis C or D virus. 
Ne postoje podaci o sigurnosti i djelotvornosti upotrebe lijeka Vemlidy u bolesnika s istodobnom infekcijom virusom hepatitisa C ili D.
↔ Tenofovir alafenamide ↔ Raltegravir 
↔ Tenofoviralafenamid ↔ Raltegravir
Tenofovir alafenamide is a phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue). 
Tenofoviralafenamid je fosforoamidatni prolijek tenofovira (analog 2'-deoksiadenozin monofosfata).
If you stop taking Vemlidy Do not stop taking Vemlidy without your doctor's advice. 
Nemojte prestati uzimati Vemlidy bez savjetovanja s liječnikom.
• Tell your doctor if you have a history of liver disease. 
• Obavijestite liječnika ako u anamnezi imate bolest jetre.
No additional adverse reactions to Vemlidy were identified from Week 96 through Week 120 in the double-blind phase and in the subset of subjects receiving open-label Vemlidy treatment (see section 5.1). 
Od 96. do 120. tjedna nisu ustanovljene nikakve dodatne nuspojave lijeka Vemlidy u dvostruko slijepoj fazi niti u podskupini ispitanika koji su otvoreno primali terapiju lijekom Vemlidy (vidjeti dio 5.1).
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. 
Ako je bolesnik propustio uzeti dozu lijeka, a prošlo je manje od 18 sati od uobičajena vremena uzimanja doze, bolesnik treba što prije uzeti Vemlidy i potom ga nastaviti uzimati prema uobičajenom rasporedu.
HIV antibody testing should be offered to all HBV infected patients whose HIV-1 infection status is unknown before initiating therapy with Vemlidy. 
Svim bolesnicima zaraženima HBV-om u kojih stanje infekcije virusom HIV-1 nije poznato, prije početka terapije lijekom Vemlidy potrebno je ponuditi testiranje antitijela na HIV.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women. 
Nema podataka ili su podaci o primjeni tenofoviralafenamida u trudnica ograničeni (manje od 300 trudnoća).
(may affect up to 1 in 10 people) 
Česte nuspojave (mogu se pojaviti u do 1 na 10 osoba)
• Do not breast-feed during treatment with Vemlidy. 
• Nemojte dojiti tijekom liječenja lijekom Vemlidy.
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. 
Očekuje se da će lijekovi koji su induktori P-gp-a (npr. rifampicin, rifabutin, karbamazepin, fenobarbital ili gospina trava) smanjiti koncentraciju tenofoviralafenamida u plazmi, što može uzrokovati gubitak terapijskog učinka lijeka Vemlidy.
Steady state Cmax for tenofovir alafenamide and tenofovir were 0.18 and 0.02 µg/mL, respectively. 
Cmax u stanju dinamičke ravnoteže za tenofoviralafenamid i tenofovir bio je 0,18 odnosno 0,02 µg/ml.
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). 
Izolati HBV-a koji eksprimiraju pojedinačne supstitucije rtA181T, rtA181V ili rtN236T povezane s rezistencijom na adefovir ostale su osjetljive na tenofoviralafenamid, no izolat HBV-a koji eksprimira rtA181V plus rtN236T pokazao je smanjenu osjetljivost na tenofoviralafenamid (3,7-struka promjena u EC50).
In vitro, tenofovir alafenamide is not metabolised by CYP1A2, CYP2C8, CYP2C9, CYP2C19, or CYP2D6. 
Tenofoviralafenamid se in vitro ne metabolizira enzimima CYP1A2, CYP2C8, CYP2C9, CYP2C19 ili
HBV DNA < 29 IU/mL Baseline HBV DNA < 7 log10 IU/mL ≥ 7 log10 IU/mL 
HBV DNK < 29 IU/ml HBV DNK na početku < 7 log10 IU/ml ≥ 7 log10 IU/ml
The antiviral activity of tenofovir alafenamide was assessed in HepG2 cells against a panel of HBV clinical isolates representing genotypes A-H. 
Antivirusno djelovanje tenofoviralafenamida procjenjivano je u stanicama HepG2 u odnosu na seriju kliničkih izolata HBV-a koji predstavljaju genotipe A-H.
No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between adolescent and adult HIV-1 infected subjects. 
Ne postoje klinički značajne razlike u farmakokinetici tenofoviralafenamida ili tenofovira između adolescenata i odraslih osoba zaraženih virusom HIV-1.
The CC50 (50% cytotoxicity concentration) in HepG2 cells was > 44,400 nM. 
Vrijednost CC50 (50% citotoksične koncentracije) u stanicama HepG2 iznosila je
• adefovir dipivoxil 
• adefovirdipivoksil
No dose adjustment of Vemlidy is required in patients with hepatic impairment (see sections 4.4 and 5.2). 
Prilagodba doze lijeka Vemlidy nije potrebna u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
HBV isolates expressing the rtL180M, rtM204V plus rtT184G, rtS202G, or rtM250V substitutions associated with resistance to entecavir remained susceptible to tenofovir alafenamide. 
Izolati HBV-a koji eksprimiraju supstitucije rtL180M, rtM204V plus rtT184G, rtS202G ili rtM250V povezane s rezistencijom na entekavir ostale su osjetljive na tenofoviralafenamid.
Co-administration of such medicinal products with Vemlidy is not recommended. 
Ne preporučuje se istodobna primjena takvih lijekova s lijekom Vemlidy.
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). 
Promjene u izmjerenoj bubrežnoj funkciji U oba je ispitivanja nakon 96 tjedana liječenja tenofoviralafenamid povezan s manjim promjenama parametara sigurnosti bubrega (manji medijan smanjenja u procijenjenom CrCl prema CockcroftGaultu i manji medijan postotka povećanja u omjeru proteina koji veže retinol i kreatinina u urinu te omjeru beta-2-mikroglobulina i kreatinina u urinu) u usporedbi s onim postignutim nakon 96 tjedana liječenja tenofovirdizoproksilfumaratom (vidjeti i dio 4.4).
Normalised ALT (Central lab)c Normalised ALT (AASLD)d Serology 
Normalizirani ALT (AASLD)c Serologija
g The predominant circulating nucleoside metabolite of sofosbuvir. 
Glavni cirkulirajući mukleozidni metabolit sofosbuvira h.
Each tablet contains 95 mg lactose (as monohydrate). 
Pomoćna tvar s poznatim učinkom Jedna tableta sadrži 95 mg laktoze (u obliku hidrata).
These patients may be at higher risk of experiencing serious hepatic or renal adverse reactions. 
U takvih bolesnika može postojati veći rizik od ozbiljnih jetrenih ili bubrežnih nuspojava.
Lactose monohydrate Microcrystalline cellulose (E460(i)) Croscarmellose sodium (E468) Magnesium stearate (E470b) 
Jezgra tablete laktoza hidrat mikrokristalična celuloza (E460(i)) umrežena karmelozanatrij (E468) magnezijev stearat (E470b)
Co-administration of Vemlidy with certain anticonvulsants (e.g. carbamazepine, oxcarbazepine, phenobarbital and phenytoin), antimycobacterials (e.g. rifampicin, rifabutin and rifapentine) or St. John's wort, all of which are inducers of P-glycoprotein (P-gp) and may decrease tenofovir alafenamide plasma concentrations, is not recommended. 
Ne preporučuje se istodobna primjena lijeka Vemlidy s određenim antikonvulzivima (npr. karbamazepinom, okskarbazepinom, fenobarbitalom i fenitoinom), antimikobaktericima (npr. rifampicinom, rifabutinom i rifapentinom) ili gospinom travom, koji su svi induktori P-glikoproteina (P-gp) i mogu smanjiti koncentracije tenofoviralafenamida u plazmi.
The use of Vemlidy is not recommended in patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.2). 
Upotreba lijeka Vemlidy ne preporučuje se u bolesnika s CrCl < 15 ml/min koji nisu na hemodijalizi (vidjeti dio 4.2).
This is an antiviral medicine, known as a nucleotide reverse transcriptase inhibitor (NtRTI). 
Riječ je o lijeku za liječenje virusnih infekcija, poznatom kao nukleotidni inhibitor reverzne transkriptaze.
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. 
U oku pasa bila je prisutna minimalna infiltracija histiocita pri izloženostima tenofoviralafenamidu ili tenofoviru od približno 4 odnosno 17 puta većim od onih očekivanih nakon primjene tenofoviralafenamida.
Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate. 
Unutarstanični tenofovir zatim se fosforilira u farmakološki aktivan metabolit tenofovirdifosfat.
Co-administration of Vemlidy with medicinal products that inhibit P-gp and BCRP may increase plasma concentrations of tenofovir alafenamide. 
Istodobna primjena lijeka Vemlidy s lijekovima koji inhibiraju P-gp i BCRP može povećati koncentracije tenofoviralafenamida u plazmi.
Tenofovir alafenamide is primarily hydrolysed to form tenofovir by carboxylesterase 1 in primary hepatocytes. 
Tenofoviralafenamid se primarno hidrolizira u tenofovir karboksilesterazom 1 u primarnim hepatocitima.
Co-administration of Vemlidy with strong inhibitors of P-gp (e.g. itraconazole and ketoconazole) may increase tenofovir alafenamide plasma concentrations. 
Istodobna primjena lijeka Vemlidy sa snažnim inhibitorima P-gp-a (npr. itrakonazolom i ketokonazolom) može povisiti koncentracije tenofoviralafenamida u plazmi.
The safety of Vemlidy is also supported by pooled data from patients in Studies 108 and 110 who remained on blinded treatment from Week 96 through Week 120 and additionally from patients in the open-label phase of Studies 108 and 110 from Week 96 through Week 120 (N = 361 remained on Vemlidy; N = 180 switched from tenofovir disoproxil fumarate to Vemlidy at Week 96). 
Sigurnost lijeka Vemlidy potkrepljuju i objedinjeni podaci bolesnika iz Ispitivanja 108 i 110 koji su ostali na zaslijepljenom liječenju od 96. do 120. tjedna te podaci bolesnika iz otvorene faze Ispitivanja 108 i 110 od 96. do 120. tjedna (N = 361 bolesnik koji je ostao na lijeku Vemlidy; N = 180 bolesnika koji su prešli s tenofovirdizoproksilfumarata na Vemlidy u 96. tjednu).
Keep this medicine out of the sight and reach of children. 
Kako čuvati Vemlidy Lijek čuvajte izvan pogleda i dohvata djece.
HBV DNA < 29 IU/mL Treatment differenceb 
HBV DNK < 29 IU/ml Razlika u liječenjub
At baseline, mean plasma HBV DNA was 5.8 log10 IU/mL, mean serum ALT was 94 U/L, and 9% of patients had a history of cirrhosis. 
Na početku, srednja vrijednost HBV DNK u plazmi bila je 5,8 log10 IU/ml, srednja vrijednost ALT-a u serumu 94 U/L, a 9% bolesnika u anamnezi je imalo cirozu.
Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro. 
Tenofoviralafenamid je supstrat prijenosnika OATP1B1 i OATP1B3 in vitro.
• tenofovir disoproxil fumarate 
• tenofovirdizoproksilfumarat
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. 
U bolesnika koji su ostali na zaslijepljenom liječenju nakon 96. tjedna u Ispitivanju 108 i Ispitivanju 110 promjene u vrijednostima laboratorijskih parametara za bubrežnu funkciju od početnih vrijednosti u svakoj je skupini u 120. tjednu bila slična onoj u 96. tjednu.
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). 
Izolati HBV-a koji eksprimiraju supstitucije rtV173L, rtL180M i rtM204V/I povezane s rezistencijom na lamivudin ostale su osjetljive na tenofoviralafenamid (< 2-struka promjena u EC50).
Midazolamd (2.5 mg orally, s.d.) 
Midazolamd (2,5 mg peroralno, s.d.)
Lactose monohydrate, microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), magnesium stearate (E470b). 
Jezgra tablete: laktoza hidrat, mikrokristalična celuloza (E460(i)), umrežena karmelozanatrij (E468), magnezijev stearat (E470b).
Sertraline (50 mg orally, s.d.) 
Sertralin (50 mg peroralno, s.d.)
Hepatitis B and HIV co-infection 
Istodobna infekcija hepatitisom B i HIV-om
Based on Phase 3 population pharmacokinetic analysis in subjects with chronic hepatitis B, mean steady state AUC0-24 for tenofovir alafenamide (N = 698) and tenofovir (N = 856) were 0.22 µg•h/mL and 0.32 µg•h/mL, respectively. 
srednja vrijednost AUC0-24 u stanju dinamičke ravnoteže za tenofoviralafenamid (N = 698) i tenofovir (N = 856) bila je 0,22 µg•h/ml odnosno 0,32 µg•h/ml.
Vemlidy contains lactose monohydrate. 
Vemlidy sadrži laktozu hidrat.
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. 
Pri ispitivanjima tenofoviralafenamida nisu uočene nikakve klinički relevantne razlike u farmakokinetici tenofoviralafenamida ili tenofovira između zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjen CrCl > 15, ali < 30 ml/min).
d The population used for analysis of ALT normalisation included only patients with ALT above ULN of the AASLD criteria (> 30 U/L males and > 19 U/L females) at baseline. 
d. Populacija korištena za analizu normalizacije ALT-a obuhvaćala je samo bolesnike čiji je ALT bio iznad GGN-a prema kriterijima AASLD-a (> 30 U/l za muškarce i > 19 U/l za žene) na početku liječenja.
Vemlidy should not be co-administered with medicinal products containing tenofovir disoproxil fumarate, tenofovir alafenamide or adefovir dipivoxil. 
Vemlidy se ne smije istodobno primjenjivati s lijekovima koji sadrže tenofoviralafenamid, tenofovirdizoproksilfumarat ili adefovirdipivoksil.
Vemlidy 25 mg film-coated tablets. 
NAZIV LIJEKA Vemlidy 25 mg filmom obložene tablete.
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. 
Ispitivanje provedeno s dodatnom dozom voksilaprevira od 100 mg kako bi se postigle izloženosti voksilapreviru očekivane u bolesnika zaraženih HCV-om.
Ledipasvir/sofosbuvir (90 mg/400 mg orally, q.d.) 
Ledipasvir/sofosbuvir (90 mg/400 mg peroralno, q.d.)
Vemlidy has no or negligible influence on the ability to drive and use machines. 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Vemlidy ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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. 
Tablete lijeka Vemlidy pakirane su u boce od polietilena visoke gustoće (engl. „high density polyethylene”, HDPE) zatvorene polipropilenskim navojnim čepom sigurnim za djecu i zaštitnom aluminijskom folijom.
If the patient vomits more than 1 hour after taking Vemlidy, the patient does not need to take another tablet. 
Ako bolesnik povraća nakon više od 1 sata od uzimanja lijeka Vemlidy, nije potrebno uzeti još jednu tabletu.
e The population used for serology analysis included only patients with antigen (HBeAg) positive and antibody (HBeAb) negative or missing at baseline. 
Populacija korištena za serološku analizu obuhvaćala je samo bolesnike koji su na početku liječenja bili pozitivni na antigen (HBeAg) i negativni na antitijelo (HBeAb) te one u kojih je taj podatak nedostajao.
Tell your doctor immediately if you become pregnant. 
Ako zatrudnite, odmah o tome obavijestite liječnika.
Recommendation concerning co-administration with Vemlidy 
Preporuka za istodobnu primjenu s lijekom Vemlidy
The mean age was 46 years, 61% were male, 72% were Asian, 25% were White and 2% (8 subjects) were Black. 
Prosječna dob bila je 46 godina; 61% ispitanika bili su muškarci, 72% Azijati, 25% bijelci, a 2% (8 ispitanika) crnci; 24% imalo je HBV genotipa B, 38% genotipa C, a 31% genotipa D.
Table 2: Adverse drug reactions identified with tenofovir alafenamide 
Tablica 2: Nuspojave identificirane tijekom primjene tenofoviralafenamida
c Treatment-naïve subjects received < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue including tenofovir disoproxil fumarate or tenofovir alafenamide. 
b. Ispitanici koji prethodno nisu liječeni primali su peroralno antivirusno liječenje < 12 tjedana s bilo kojim analogom nukleozida ili nukleotida uključujući tenofovirdizoproksilfumarat ili tenofoviralafenamid.