natgillin/translations-raw huggingface dataset:
Velpatasvir had no adverse effects on mating and fertility.
Velpatasvir nima neželenih učinkov na parjenje in plodnost.
d Data from a chimeric NS5A replicon carrying NS5A amino acids 9-184.
d. Podatki iz himeričnega replikona NS5A, ki prenaša aminokisline NS5A 9-184.
See Table 3 for examples of interactions with sensitive substrates of P-gp (digoxin), BCRP (rosuvastatin), and OATP (pravastatin).
Primere interakcij z občutljivimi substrati P-gp (digoksin), BCRP (rosuvastatin) in OATP (pravastatin) si oglejte v preglednici 3.
Table 2: Guidance for ribavirin dosing when administered with Epclusa to patients with decompensated cirrhosis
Preglednica 2: Smernice za odmerjanje ribavirina v primeru dajanja skupaj z zdravilom Epclusa bolnikom z dekompenzirano cirozo
86% (6/7)c a n = 4 for genotype 2 and n = 4 for genotype 4.
86 % (6/7)c a. n = 4 za genotip 2 in n = 4 za genotip 4 b. n = 4 za genotip 2 in n = 2 za genotip 4 c. n = 4 za genotip 2, n = 2 za genotip 4 in n = 1 za genotip 6
No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007 or velpatasvir.
Klinično pomembnih farmakokinetičnih razlik zaradi rase ali spola za sofosbuvir, GS-331007 ali velpatasvir niso ugotovili.
• carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).
• karbamazepin, fenobarbital in fenitoin (zdravila, ki se uporabljajo za zdravljenje epilepsije in preprečevanje epileptičnih napadov).
No specific antidote is available for overdose with Epclusa.
Specifični antidot za prevelik odmerek zdravila Epclusa ni na voljo.
Post-treatment Week 24 (N = 236), % (n/N) Decreased score (Improvement)
24. teden po zdravljenju (N = 236), % (n/N) Nižji rezultat
SVR12 was achieved in all 77 patients who had baseline NS5B NI RAVs including N142T, L159F, E/N237G, C/M289L/I, L320F/I/V, V321A/I, and S282G+V321I.
SVR12 je doseglo vseh 77 bolnikov z izhodiščnimi RAV NI NS5B, vključno z N142T, L159F, E/N237G, C/M289L/I, L320F/I/V, V321A/I in S282G+V321I.
Of the 1,035 patients treated with sofosbuvir/velpatasvir in the three Phase 3 clinical studies, 1,023 patients were included in the analysis of NS5A RAVs; 7 patients were excluded as they neither achieved sustained virologic response (SVR12) nor had virologic failure and 5 additional patients were excluded as NS5A gene sequencing failed.
Od 1.035 bolnikov, ki so prejemali zdravljenje s sofosbuvirjem/velpatasvirjem v treh kliničnih študijah 3. faze, je bilo 1.023 bolnikov vključenih v analizo RAV NS5A; 7 bolnikov je bilo izključenih, ker niso dosegli niti trajnega virološkega odziva (sustained virological response - SVR12) niti virološkega neuspeha, 5 dodatnih bolnikov pa je bilo izključenih zaradi neuspešnega sekvenciranja gena NS5A.
• rifapentine (antibiotic used to treat infections, including tuberculosis);
• rifapentin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo);
The median terminal half-life of velpatasvir following administration of Epclusa was approximately 15 hours.
Mediani končni razpolovni čas za velpatasvir po uporabi zdravila Epclusa je bil približno 15 ur.
• proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole).
• zaviralce protonske črpalke (kot so omeprazol, lansoprazol, rabeprazol, pantoprazol in esomeprazol).
The efficacy of Epclusa has not been assessed in patients who have previously failed treatment with other regimens that include an NS5A inhibitor.
Učinkovitosti zdravila Epclusa niso ocenili pri bolnikih, pri katerih predhodno zdravljenje z drugimi režimi, ki so vključevali zaviralec NS5A, ni bilo uspešno.
Among the 87 patients who were treated with Epclusa + RBV for 12 weeks, decreases in haemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were experienced by 23% and 7% patients, respectively.
Od 87 bolnikov, ki so prejemali zdravljenje z zdravilom Epclusa + RBV 12 tednov, se je zmanjšanje ravni hemoglobina med zdravljenjem na manj kot 10 g/dl pojavilo pri 23 % bolnikov, zmanjšanje na manj kot 8,5 g/dl pa pri 7 % bolnikov.
One additional patient with genotype 3 HCV infection at baseline was reinfected with genotype 1a HCV at virologic failure and was excluded from the virological analysis.
En dodaten bolnik z okužbo s HCV genotipa 3 ob izhodišču se je znova okužil s HCV genotipa 1a v času virološkega neuspeha in je bil izključen iz virološke analize.
Total (n = 328)
Skupaj (n = 328)
• rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
• rifampicin in rifabutin (antibiotika, ki se uporabljata za zdravljenje okužb, vključno s tuberkulozo);
The moderate or high fat meal did not alter GS-331007 AUC0-inf, but resulted in a 25% and 37% decrease in its Cmax, respectively.
Obrok z zmerno ali visoko vsebnostjo maščobe ni vplival na vrednost AUC0-inf za GS-331007, vendar je povzročil zmanjšanje vrednosti Cmax, za 25 % in 37 %.
Potential for Epclusa to affect other medicinal products Velpatasvir is an inhibitor of drug transporter P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3.
Možnost vpliva zdravila Epclusa na druga zdravila Velpatasvir je zaviralec prenašalca P-gp, proteina odpornosti pri raku dojke (BCRP, breast cancer resistance protein), transportnega polipeptida organskih anionov (OATP, organic anion-transporting polypeptide) 1B1 in OATP1B3.
Total (n = 78)
Skupaj (n = 78)
The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma.
Monohidroksilirani in demetilirani velpatasvir sta bila presnovka, ugotovljena v plazmi pri človeku.
The EC50 values of sofosbuvir and velpatasvir against clinical isolates are presented in Table 5.
Vrednosti EC50 za sofosbuvir in velpatasvir proti kliničnim izolatom so prikazane v preglednici 5.
Co-administration of Epclusa with rosuvastatin increases the concentration of rosuvastatin, which is associated with increased risk of myopathy, including rhabdomyolysis.
Sočasno dajanje zdravila Epclusa z rosuvastatinom lahko poveča koncentracijo rosuvastatina, kar je povezano z večjim tveganjem za miopatijo, vključno z rabdomiolizo.
Unchanged velpatasvir was the major species in faeces accounting for a mean of 77% of the administered dose, followed by monohydroxylated velpatasvir (5.9%) and desmethylated velpatasvir (3.0%).
Nespremenjeni velpatasvir je bila glavna vrsta, prisotna v blatu, in je predstavljala povprečno 77 % uporabljenega odmerka, sledila pa sta mu monohidroksilirani velpatasvir (5,9 %) in demetilirani velpatasvir (3,0 %).
• If you are sick (vomit) more than 3 hours after taking Epclusa, you do not need to take another tablet until your next scheduled tablet.
• Če bruhate več kot 3 ure po uporabi zdravila Epclusa, ne vzemite še ene tablete do naslednje načrtovane tablete.
SOF+RBV 24 weeksa
SOF + RBV 24 tednova
The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Pot presnovne aktivacije vključuje sekvenčno hidrolizo karboksil-esternega dela, ki jo katalizira humani katepsin A (CatA) ali karboksilesteraza 1 (CES1) in cepitev fosforamidata z nukleotid-vezajočo beljakovino s histidinsko triado 1 (HINT1, histidine triad nucleotide-binding protein 1), čemur sledi fosforilacija po biosintezni poti pirimidinskih nukleotidov.
Replicons containing NS5B from clinical isolates
Replikoni, ki vsebujejo NS5B iz kliničnih izolatov
1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
1.000 mg na dan pri bolnikih s telesno maso < 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg.
c One patient had on-treatment virologic failure.
c. Pri enem bolniku je prišlo do virološkega neuspeha med zdravljenjem.
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Tenofovir disoproxil fumarate
ZDRAVILA ZA ZDRAVLJENJE OKUŽBE Z VIRUSOM HIV: ZAVIRALCI REVERZNE TRANSKRIPTAZE Dizoproksiltenofovirijev fumarat
Randomisation was stratified by HCV genotype (1, 2, 4, 6, and indeterminate) and the presence or absence of cirrhosis.
Randomizacija je bila stratificirana glede na genotip (1, 2, 4, 6 in nedoločen) in prisotnost ali odsotnost ciroze.
3a 4a 4d
4a 4d
What Epclusa looks like and contents of the pack
Izgled zdravila Epclusa in vsebina pakiranja
All Subjects (n = 274)
Vse osebe (n = 274)
ACID REDUCING AGENTS
ZDRAVILA ZA ZMANJŠEVANJE ŽELODČNE KISLINE
The increase in tenofovir exposure (AUC and Cmax) was around 40-80% during cotreatment with Epclusa and tenofovir disoproxil fumarate/emtricitabine as part of various HIV regimens.
Zvečanje izpostavljenosti tenofovirju (AUC in Cmax) je bilo med sočasnim zdravljenjem z zdravilom Epclusa in dizoproksiltenofovirijevim fumaratom/emtricitabinom kot delom različnih režimov HIV približno
• digoxin used to treat heart conditions;
• digoksin, ki se uporablja za zdravljenje bolezni srca;
Both sofosbuvir and velpatasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
Tako sofosbuvir kot velpatasvir sta bila povsem aktivna pri substitucijah, povezanih z odpornostjo na druga zdravila z direktnim delovanjem na viruse z različnimi mehanizmi delovanja, kot so nenukleozidni zaviralci NS5B in zaviralci proteaze NS3.
Three patients in the Epclusa + RBV 12 week group had baseline NS5B NI RAVs (N142T and L159F) and all three patients achieved SVR12.
Trije bolniki v skupini, ki je prejemala zdravilo Epclusa + RBV 12 tednov, so imeli izhodiščne RAV NI NS5B (N142T in L159F) in vsi trije bolniki so dosegli SVR12.
The effects of Epclusa during pregnancy are not known.
Učniki zdravila Epclusa med nosečnostjo niso znani.
Epclusa tablets are supplied in high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil.
Tablete zdravila Epclusa so dobavljene v plastenkah iz polietilena visoke gostote (HDPE) z za otroke varno zaporko iz polipropilena in poliestrskim navojem, ki vsebujejo 28 filmsko obloženih tablet.
Velpatasvir was not carcinogenic in the 6-month rasH2 transgenic mouse and 2-year rat carcinogenicity studies at exposures at least 50-times and 5-times higher than human exposure, respectively.
Velpatasvir v 6-mesečni študiji karcinogenosti pri transgeni miši rasH2 in 2-letni študiji kancerogenosti pri podganah ob izpostavljenosti, ki je bila vsaj 50-krat in 5-krat večja, kot je izpostavljenost pri človeku, ni bil kancerogen.
Epclusa can be administered without regard to food.
Zdravilo Epclusa se lahko daje ne glede na hrano.
• dabigatran used to thin the blood;
• dabigatran, ki se uporablja za redčenje krvi;
Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and “7916” on the other side.
Rožnate filmsko obložene tablete v obliki romba z merami 20 mm × 10 mm, z vtisnjeno oznako „GSI“ na eni in „7916“ na drugi strani.
The median terminal half-lives of sofosbuvir and GS-331007 following administration of Epclusa were 0.5 and 25 hours, respectively.
Mediani končni razpolovni čas za sofosbuvir in GS-331007 po uporabi zdravila Epclusa je bil 0,5 ure oz. 25 ur.
The 50% effective concentration (EC50) values of sofosbuvir and velpatasvir against full-length or chimeric replicons encoding NS5B and NS5A sequences from the laboratory strains are presented in Table 4.
Vrednosti 50-odstotne učinkovite koncentracije (EC50) za sofosbuvir in velpatasvir proti replikonom polne dolžine ali himeričnim replikonom, ki kodirajo zaporedje NS5B in NS5A iz laboratorijskih sevov, so prikazane v preglednici 4.
In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Pri bolnikih, okuženih s HCV, s hudo ledvično okvaro, zdravljenih s sofosbuvirjem 200 mg z ribavirinom (n = 10) ali sofosbuvirjem 400 mg z ribavirinom (n = 10) 24 tednov ali ledipasvirjem/sofosbuvirjem 90/400 mg (n = 18) 12 tednov, je bila farmakokinetika sofosbuvirja in GS-331007 v skladu s tisto, ki so jo opazili pri bolnikih, negativnih za HCV, s hudo ledvično okvaro.
If a dose of Epclusa is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time.
Če bolnik izpusti odmerek zdravila Epclusa in je preteklo manj kot 18 ur od običajnega časa za jemanje zdravila, bolniku naročite, naj tableto vzame takoj, ko je mogoče, nato pa naj naslednji odmerek vzame ob običajnem času.
Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 µg/mL to 20 µg/mL.
Vezava sofosbuvirja na humane beljakovine v plazmi je približno 61-65 %, ni pa odvisna od koncentracije zdravila v razponu 1-20 μg/ml.
Pharmacokinetics in special populations
Farmakokinetika pri posebnih skupinah bolnikov Rasa in spol
If it is after 18 hours then patients should be instructed to wait and take the next dose of Epclusa at the usual time.
Če je preteklo več kot 18 ur, bolniku naročite, naj počaka in vzame naslednji odmerek zdravila Epclusa ob običajnem času.
Your doctor will test your blood before, during and after your treatment with Epclusa.
Zdravnik vam bo pred zdravljenjem z zdravilom Epclusa, med njim in po njem opravil krvne preiskave.
TN and TE, without cirrhosis or with compensated cirrhosis, with HCV/HIV-1 co-infection
PN in PZ, brez ciroze ali s kompenzirano cirozo s sočasno okužbo s HCV/HIV-1
Table 5: Activity of sofosbuvir and velpatasvir against transient replicons containing NS5A or NS5B from clinical isolates
Preglednica 5: Aktivnost sofosbuvirja in velpatasvirja proti prehodnim replikonom, ki vsebujejo NS5A ali NS5B iz kliničnih izolatov Genotip replikona
Study 4062 was an open-label clinical trial that evaluated 12 weeks of treatment with Epclusa in 59 HCV-infected patients with ESRD requiring dialysis.
Študija 4062 je bila odprto klinično preskušanje, v katerem so ocenjevali 12-tedensko zdravljenje z zdravilom Epclusa pri 59 bolnikih, okuženih s HCV, z ESRD, zaradi katere je potrebna dializa.
Cirrhotic (n = 80)
S cirozo (n = 80)
Relative to fasting conditions, the administration of a single dose of Epclusa with a moderate fat (~600 kcal, 30% fat) or high fat (~800 kcal, 50% fat) meal resulted in a 34% and 21% increase in velpatasvir AUC0-inf, respectively, and a 31% and 5% increase in velpatasvir Cmax, respectively.
V primerjavi s pogoji na tešče je dajanje enkratnega odmerka zdravila Epclusa z obrokom z zmerno vsebnostjo maščobe (~600 kcal, 30 % maščobe) ali visoko vsebnostjo maščobe (~800 kcal, 50 % maščobe) vrednost AUC0-inf za velpatasvir povečalo za 34 % in 21 %, vrednost Cmax pa za 31 % in 5 %.
Of the 10 genotype 3 virologic failure patients, Y93H was observed in all 10 patients at failure (6 had Y93H emerge post-treatment and 4 patients had Y93H at baseline and post-treatment).
Od 10 bolnikov genotipa 3 z virološkim neuspehom so Y93H zabeležili pri vseh 10 bolnikih ob neuspehu (pri 6 se je Y93H pojavil po zdravljenju, pri 4 pa ob izhodišču in po zdravljenju).
Site-directed mutagenesis of known NS5A RAVs showed that substitutions conferring a > 100-fold reduction in velpatasvir susceptibility are M28G, A92K and Y93H/N/R/W in genotype 1a, A92K in genotype 1b, C92T and Y93H/N in genotype 2b, Y93H in genotype 3, and L31V and P32A/L/Q/R in genotype 6.
Usmerjena mutageneza znanih RAV NS5A je pokazala, da so substitucije, ki doprinesejo k > 100-kratnemu zmanjšanju dovzetnosti za velpatasvir, M28G, A92K in Y93H/N/R/W v genotipu 1a, A92K v genotipu 1b, C92T in Y93H/N v genotipu 2b, Y93H v genotipu 3 ter L31V in P32A/L/Q/R v genotipu 6.
2D barcode carrying the unique identifier included.
ENOLIČNI IDENTIFIKATOR - ČRTNA KODA 2D Vsebuje dvodimenzionalno črtno kodo z enoličnim identifikatorjem.
Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 82 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir, GS-331007, or velpatasvir.
Populacijska farmakokinetična analiza pri bolnikih, okuženih s HCV, je pokazala, da znotraj analiziranega starostnega razpona (18-82 let) starost ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju, GS-331007 ali velpatasvirju.
Velpatasvir was fully active against the sofosbuvir resistance-associated substitution S282T in NS5B while all velpatasvir resistance-associated substitutions in NS5A were fully susceptible to sofosbuvir.
Velpatasvir je bil v celoti aktiven proti substituciji S282T v polimerazi NS5B, povezani z odpornostjo na sofosbuvir, medtem ko so bile vse substitucije NS5A, povezane z odpornostjo na velpatasvir, v celoti dovzetne za sofosbuvir.
• If you are sick (vomit) less than 3 hours after taking Epclusa, take another tablet.
• Če bruhate manj kot 3 ure po uporabi zdravila Epclusa, vzemite še eno tableto.
If it is considered necessary to co-administer, then Epclusa should be administered with food and taken 4 hours before proton pump inhibitor at max doses comparable to omeprazole 20 mg.
Kadar se presodi, da je potrebna sočasna uporaba, je treba zdravilo Epclusa dajati skupaj s hrano in jemati 4 ure pred zaviralcem protonske črpalke v največjem odmerku, ki je primerljiv z odmerkom omeprazola 20 mg.
Medicinal products that inhibit OATP, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentration of velpatasvir.
Zdravila, ki zavirajo OATP, CYP2B6, CYP2C8 ali CYP3A4, lahko povečajo koncentracijo velpatasvirja v plazmi.
Co-administration is not recommended (see section 4.4).
Sočasna uporaba ni priporočljiva (glejte poglavje 4.4).
SVR12 in patients with or without baseline NS5A RAVs in the Epclusa + RBV 12 week group for this study is shown in Table 8.
SVR12 za to študijo pri bolnikih z izhodiščnimi RAV NS5A ali brez njih v skupini, ki je prejemala zdravilo Epclusa + RBV 12 tednov, je prikazan v preglednici 8.
The safety assessment of Epclusa was based on pooled Phase 3 clinical study data from patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection (with or without compensated cirrhosis) including 1,035 patients who received Epclusa for 12 weeks.
Ocena varnosti zdravila Epclusa je temeljila na združenih podatkih iz klinične študije 3. faze pri bolnikih z okužbo s HCV genotipa 1, 2, 3, 4, 5 ali 6 (s kompenzirano cirozo ali brez), vključno s 1.035 bolniki, ki so zdravilo Epclusa prejemali 12 tednov.
If ribavirin is used in genotype 3 infected patients with compensated cirrhosis (pre- or post-transplant) the recommended dose of ribavirin is 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg).
Če se ribavirin uporablja pri bolnikih, okuženih z genotipom 3, s kompenzirano cirozo (pred presaditvijo ali po njej), je priporočeni odmerek ribavirina 1.000 oz.1.200 mg (1.000 mg za bolnike s telesno maso < 75 kg in 1.200 mg za bolnike s telesno maso ≥ 75 kg).
When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Če se uporablja v kombinaciji z ribavirinom, glejte tudi povzetek glavnih značilnosti zdravila, ki vsebuje ribavirin.
In this study, 2 patients treated with Epclusa for 12 or 24 weeks without ribavirin had emergent NS5B S282T at low levels (< 5%) along with L159F.
V tej študiji so se pri 2 bolnikih, ki sta prejemala zdravilo Epclusa 12 ali 24 tednov brez ribavirina, poleg L159F pojavile tudi nizke ravni (< 5 %) NS5B S282T.
Patients without cirrhosis and patients with compensated cirrhosis
Bolniki brez ciroze in bolniki s kompenzirano cirozo
Other medicines and Epclusa
Druga zdravila in zdravilo Epclusa
The proportion of patients who permanently discontinued treatment due to adverse events was 0.2% and the proportion of patients who experienced any severe adverse events was 3.2% for patients receiving Epclusa for 12 weeks.
Pri bolnikih, ki so zdravilo Epclusa prejemali 12 tednov, je bil delež bolnikov, ki so zaradi neželenih učinkov trajno prekinili zdravljenje, 0,2 %, delež bolnikov, pri katerih so se pojavili kateri koli hudi neželeni učinki, pa 3,2 %.
Patients with genotype 5 HCV infection were enrolled to the Epclusa group.
Bolniki z okužbo s HCV genotipa 5 so bili vključeni v skupino, ki je prejemala zdravilo Epclusa.
b Stable chimeric 1b replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing.
b. Za preskušanje so bili uporabljeni stabilni himerični replikoni 1b, ki prenašajo gene NS5B od genotipa 2b, 5a ali 6a.
The pharmacokinetic properties of sofosbuvir, GS-331007 and velpatasvir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration of Epclusa, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 1 hour post-dose.
Farmakokinetične lastnosti sofosbuvirja, presnovka GS-331007 in velpatasvirja so ocenili pri zdravih odraslih osebah in pri osebah s kroničnim hepatitisom C. Po peroralni uporabi zdravila Epclusa se je sofosbuvir hitro absorbiral in dosegel najvišje koncentracije v plazmi 1 uro po odmerku.
In vitro resistance selection and cross-resistance studies indicate velpatasvir targets NS5A as its mode of action.
Študije selekcije odpornosti in navzkrižne odpornosti in vitro kažejo, da je način delovanja velpatasvirja usmerjen na NS5A.
Demographics and baseline characteristics were balanced between the Epclusa and placebo group.
Demografske in izhodiščne značilnosti so bile uravnotežene pri skupini, ki je prejemala zdravilo Epclusa, in pri skupini, ki je prejemala placebo.
What you need to know before you take Epclusa Do not take Epclusa
Kaj morate vedeti, preden boste vzeli zdravilo Epclusa Ne jemljite zdravila Epclusa:
Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Epclusa.
Kadar se presodi, da je sočasna uporaba amiodarona potrebna, se ob uvajanju zdravljenja z zdravilom Epclusa priporoča skrbno spremljanje bolnikov.
Replicons containing NS5A from clinical isolates
Replikoni, ki vsebujejo NS5A iz kliničnih izolatov
d Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria.
d. Med drugo so bile vključene osebe, ki niso dosegle SVR12 in niso izpolnjevale meril za virološki neuspeh.
Increased score (Worsening) No assessment
(poslabšanje) Ocena ni bila izvedena
Velpatasvir solubility decreases as pH increases.
Topnost velpatasvirja se z večanjem vrednosti pH manjša.
Co-administration with medicinal products that inhibit P-gp or BCRP may increase sofosbuvir or velpatasvir plasma concentrations.
Sočasna uporaba z zdravili, ki zavirajo P-gp ali BCRP, lahko poveča koncentracije sofosbuvirja ali velpatasvirja v plazmi.
Epclusa can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Zdravilo Epclusa se lahko pri teh bolnikih uporablja brez prilagajanja odmerka, ko druge ustrezne možnosti zdravljenja niso na voljo (glejte poglavja 4.8, 5.1 in 5.2).
Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 for sofosbuvir (n = 982), GS-331007 (n = 1,428) and velpatasvir (n = 1,425) were 1,260, 13,970 and 2,970 ng•h/mL, respectively.
Na podlagi analize populacijske farmakokinetike pri bolnikih z okužbo s HCV so bile povprečne vrednosti AUC0-24 v stanju dinamičnega ravnovesja za sofosbuvir (n = 982), GS-331007 (n = 1.428) in velpatasvir (n = 1.425), kot sledi: 1.260, 13.970 oz. 2.970 ng•h/ml.