natgillin/translations-raw huggingface dataset:
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.
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.
U bolesnika koji su ostali na zaslijepljenom liječenju poslije 96. tjedna, srednja vrijednost postotka promjene mineralne gustoće kostiju u svakoj je skupini u 120. tjednu bila slična promjeni u 96. tjednu.
In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate.
Tenofoviralafenamid se in vivo unutar stanica hidrolizira u tenofovir (glavni metabolit) koji se fosforilira u aktivni metabolit, tenofovirdifosfat.
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.
Na početku, srednja vrijednost HBV DNK u plazmi bila je 7,6 log10 IU/ml, srednja vrijednost ALT-a u serumu 120 U/L, a 7% bolesnika u anamnezi je imalo cirozu.
Musculoskeletal and connective tissue disorders Common
Poremećaji mišićno-koštanog sustava i vezivnog tkiva
d The population used for serology analysis included only patients with antigen (HBeAg) positive and antibody (HBeAb) negative or missing at baseline.
e. 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.
The antiviral activity of tenofovir alafenamide was evaluated against a panel of isolates containing nucleos(t)ide reverse transcriptase inhibitor mutations in HepG2 cells.
Antivirusna aktivnosti tenofoviralafenamida procijenjena je u odnosu na seriju izolata koji u stanicama HepG2 sadrže mutacije nukleoz(t)idnog inhibitora reverzne transkriptaze.
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.
In vitro ispitivanjima dokazano je da se tenofoviralafenamid metabolizira u tenofovir (glavni metabolit) pomoću karboksilesteraze-1 u hepatocitima; i te pomoću katepsina
Vemlidy contains the active substance tenofovir alafenamide.
Vemlidy sadrži djelatnu tvar tenofoviralafenamid.
Package leaflet: Information for the patient Vemlidy 25 mg film-coated tablets
Uputa o lijeku: Informacije za bolesnika Vemlidy 25 mg filmom obložene tablete tenofoviralafenamid
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.
Ispitivanju 110 bolesnici pozitivni na HBeAg koji prethodno nisu bili liječeni te oni koji su prethodno bili liječeni s kompenziranom funkcijom jetre randomizirani su u omjeru od 2:1 u skupinu koja bi primala Vemlidy (25 mg; N = 581) jedanput na dan ili u skupinu koja je primala tenofovirdizoproksilfumarat (300 mg; N = 292) jedanput na dan.
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.
Ispitivanju 108 bolesnici negativni na HBeAg koji prethodno nisu bili liječeni te oni koji su prethodno bili liječeni s kompenziranom funkcijom jetre randomizirani su u omjeru 2:1 u skupinu koja je primala Vemlidy (25 mg; N = 285) jedanput na dan ili u skupinu koja je primala tenofovirdizoproksilfumarat (300 mg; N = 140) jedanput na dan.
The active substance is tenofovir alafenamide.
Djelatna tvar je tenofoviralafenamid.
If the patient vomits within 1 hour of taking Vemlidy, the patient should take another tablet.
Ako bolesnik povraća u roku od 1 sata od uzimanja lijeka Vemlidy, treba uzeti još jednu tabletu.
No dosing recommendations can be given for patients with CrCl < 15 mL/min who are not receiving haemodialysis (see section 4.4).
Za bolesnike s CrCl < 15 ml/min koji nisu na hemodijalizi nije moguće dati preporuke za doziranje (vidjeti dio 4.4).
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.
Funkcija jetre treba se u redovitim intervalima nadzirati kliničkim i laboratorijskim pretragama tijekom najmanje 6 mjeseci nakon prekida liječenja hepatitisa B.
Vemlidy 25 mg film-coated tablets tenofovir alafenamide
NAZIV LIJEKA Vemlidy 25 mg filmom obložene tablete tenofoviralafenamid
ANTIMYCOBACTERIALS Rifampicin
Rifampicin Rifapentin
Rilpivirine (25 mg orally, q.d.)
Rilpivirin (25 mg peroralno, q.d.)
In the open-label phase of Studies 108 and 110, the mean (±SD) change in serum creatinine from Week 96 to Week 120 was -0.002 (0.10) mg/dL in those who remained on Vemlidy, compared to -0.008 (0.09) mg/dL in those who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
U otvorenoj fazi Ispitivanja 108 i Ispitivanja 110 srednja vrijednost promjene (±SD) kreatinina u serumu od 96. do 120. tjedna iznosila je -0,002 (0,10) mg/dl u bolesnika koji su i dalje primali lijek Vemlidy u usporedbi s -0,008 (0,09) mg/dl u bolesnika koji su prešli s tenofovirdizoproksilfumarata na lijek Vemlidy u 96. tjednu.
(may affect up to 1 in 100 people)
Manje česte nuspojave (mogu se pojaviti u više od 1 na 100 osoba)
It is not known whether tenofovir alafenamide is secreted in human milk.
Nije poznato izlučuje li se tenofoviralafenamid u majčino mlijeko.
Darunavir/ritonavir (800 mg/100 mg orally, q.d.)
Darunavir/ritonavir (800 mg/100 mg peroralno,
Exacerbation of hepatitis
Egzacerbacija hepatitisa
Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease.
Pogoršanja bolesti jetre u bolesnika s dekompenziranom bolešću jetre osobito su ozbiljna, a ponekad i smrtonosna.
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.
U otvorenoj fazi oba ispitivanja srednja vrijednost postotka promjene mineralne gustoće kostiju od 96. do 120. tjedna u bolesnika koji su i dalje primali lijek Vemlidy iznosila je +0,6% u području lumbalne kralježnice i 0% u području kuka u usporedbi s +1,7% u području lumbalne kralježnice i +0,6% u području kuka u bolesnika koji su prešli s tenofovirdizoproksilfumarata na lijek Vemlidy u 96. tjednu.
ANTICONVULSANTS Carbamazepine (300 mg orally, b.i.d.)
Karbamazepin (300 mg peroralno, b.i.d.)
Missing data during window but on study drug
Podaci tijekom navedena razdoblja nedostaju, no bolesnik i dalje koristi ispitivani lijek
b The population used for analysis of ALT normalisation included only patients with ALT above upper limit of normal (ULN) of the central laboratory range at baseline.
b. Populacija korištena za analizu normalizacije ALT-a obuhvaćala je samo bolesnike čiji je ALT bio iznad gornje granice normalne (GGN) raspona središnjeg laboratorija na početku liječenja.
In the open-label phase, the median change in eGFR from Week 96 to Week 120 was -0.6 mL/min in patients who remained on Vemlidy, compared to +1.8 mL/min in patients who switched from tenofovir disoproxil fumarate to Vemlidy at Week 96.
U otvorenoj je fazi medijan promjene u eGFR-u od 96. do 120. tjedna iznosio -0,6 ml/min u bolesnika koji su i dalje primali Vemlidy u usporedbi s +1,8 ml/min u bolesnika koji su prešli s tenofovirdizoproksilfumarata na lijek Vemlidy u 96. tjednu.
1,000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity associated with the use of tenofovir disoproxil fumarate.
Međutim, opsežni podaci (više od 1000 trudnoća) ukazuju da tenofovirdizoproksilfumarat ne uzrokuje malformacije i da nema feto/neonatalni toksični učinak.
No special hazard for humans was revealed in conventional studies of carcinogenic potential with tenofovir disoproxil (as fumarate) and toxicity to reproduction and development with tenofovir disoproxil (as fumarate) or tenofovir alafenamide.
Konvencionalna ispitivanja kancerogenog potencijala s tenofovirdizoproksilom (u obliku tenofovirdizoproksilfumarata) te reproduktivne toksičnosti i razvoja s tenofovirdizoproksilom (u obliku tenofovirdizoproksilfumaratom) ili tenofoviralafenamidom nisu ukazala na poseban rizik za ljude.
↔ Tenofovir alafenamide ↔ Maraviroc
↔ Tenofoviralafenamid ↔ Maravirok
1 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products.
1 Nuspojave prepoznate u praćenju lijekova koji sadrže tenofoviralafenamid nakon njihova stavljanja u promet.
• Feeling bloated
• osjećaj umora
Rash, pruritus
Osip, svrbež
TDF = tenofovir disoproxil fumarate a Missing = failure analysis.
TDF = tenofovirdizoproksilfumarat a.
Each film-coated tablet contains tenofovir alafenamide fumarate (equivalent to 25 mg of tenofovir alafenamide).
Jedna filmom obložena tableta sadrži tenofoviralafenamidfumarat (što odgovara 25 mg tenofoviralafenamida).
Baseline HBV DNA < 8 log10 IU/mL ≥ 8 log10 IU/mL
HBV DNK na početku < 8 log10 IU/ml
Each Vemlidy film-coated tablet contains tenofovir alafenamide fumarate, equivalent to 25 mg of tenofovir alafenamide.
Jedna filmom obložena tableta lijeka Vemlidy sadrži tenofoviralafenamidfumarat, što odgovara 25 mg tenofoviralafenamida.
Sofosbuvir/velpatasvir/ voxilaprevir (400 mg/100 mg/ 100 mg + 100 mgi orally, q.d.)
Sofosbuvir/velpatasvir/ voksilaprevir (400 mg/100 mg/
The distribution of tenofovir alafenamide in the body may be affected by the activity of OATP1B1 and/or OATP1B3.
Aktivnosti prijenosnika OATP1B1 i/ili OATP1B3 mogu utjecati na distribuciju tenofoviralafenamida u tijelu.
At Week 96, viral suppression as well as biochemical and serological responses were maintained with continued tenofovir alafenamide treatment (see Table 5).
Iskustvo nakon 48. tjedna u Ispitivanju 108 i Ispitivanju 110 U 96. tjednu s nastavkom liječenja tenofoviralafenamidom održana je virusna supresija, kao i biokemijski i serološki odgovori (vidjeti Tablicu 5).
c The population used for analysis of ALT normalisation included only patients with ALT above ULN of the central laboratory range at baseline.
c. Populacija korištena za analizu normalizacije ALT-a obuhvaćala je samo bolesnike čiji je ALT bio iznad GGN raspona središnjeg laboratorija na početku liječenja.
Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxic assays.
Na temelju konvencionalnih testova genotoksičnosti tenofoviralafenamid se nije pokazao mutagenim ni klastogenim.
Adverse reaction Nervous system disorders Very common Headache Common
Poremećaji živčanog sustava
Tenofovir alafenamide enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3.
Tenofoviralafenamid pasivnom difuzijom i prijenosnicima za unos u jetru OATP1B1 i OATP1B3 ulazi u primarne hepatocite.
Nucleoside-naïveb Nucleoside-experienced ALT
Prethodno liječeni nukleozidom
The following adverse drug reactions have been identified with tenofovir alafenamide in patients with chronic hepatitis B (Table 2).
U bolesnika s kroničnim hepatitisom B identificirane su sljedeće nuspojave prilikom korištenja tenofoviralafenamida (Tablica 2).
cobicistat and emtricitabine as a fixed-dose combination tablet (E/C/F/TAF; Genvoya).
virusom koji prethodno nisu liječeni i koji su primali tenofoviralafenamid (10 mg) s elvitegravirom, kobicistatom i emtricitabinom u tableti fiksne kombinacije (E/C/F/TAF; Genvoya).