natgillin/translations-raw huggingface dataset:
paritaprevir used together with dasabuvir + ombitasvir/paritaprevir/ ritonavir, administer sirolimus 0.2 mg twice a week (every 3 or 4 days on the same two days each week).
Če je sirolimus uporabljen skupaj z dasabuvirjem + kombinacijo ombitasvir/paritap revir/ritonavir, dajte sirolimus 0,2 mg dvakrat na teden (vsake 3 ali 4 dni na enaka dva dni vsak teden).
Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Mehanizem: morda zavrtje UGT s paritaprevirjem, ombitasvirjem in dasabuvirjem.
800 mg once daily (given at the same time)
800 mg enkrat na dan (dan ob istem času)
Dasabuvir was greater than 99.5%, and M1 major metabolite of dasabuvir was 94.5% bound to human plasma proteins over a concentration range of 0.05 to 5 µg/mL.
Dasabuvir je bil v razponu koncentracij od 0,05 do 5 µg/ml več kot 99,5 % vezan na beljakovine v človeški plazmi in glavni presnovek M1 dasabuvirja je bil 94,5 %
Clinical monitoring and dose adjustment may be required for levothyroxine.
Morda bo potrebno klinično nadziranje in sprememba odmerka levotiroksina.
The overall safety profile in HCV-infected transplant recipients who were administered dasabuvir and ombitasvir/paritaprevir/ritonavir and ribavirin (in addition to their immunosuppressant medicinal products) was similar to subjects treated with dasabuvir and ombitasvir/paritaprevir/ritonavir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Celotne varnostne značilnosti pri prejemnikih presadka, okuženih s HCV, ki so prejemali dasabuvir in kombinacijo ombitasvir/paritaprevir/ritonavir ter ribavirin (poleg imunosupresivnih zdravil), je bila podobna kot pri preiskovancih, zdravljenih z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir ter ribavirinom v kliničnih preskušanjih 3. faze, čeprav so bili nekateri neželeni učinki pogostejši.
Dasabuvir safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin.
Varnost in učinkovitost dasabuvirja sta bili ugotovljeni v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem, z ribavirinom ali brez njega.
With compensated cirrhosis
S kompenzirano cirozo
NS3 variants V36A/M and R155K and NS5B variants M414T and S556G remained detectable at posttreatment Week 48, whereas NS3 variant D168V and all other NS5B variants were not observed at post-treatment Week 48.
Varianti V36A/M in R155K gena NS3 in varianti M414T in S556G gena NS5B so ostale zaznavne 48. teden po zdravljenju, medtem ko variante D168V gena NS3 in vseh drugih variant gena NS5B 48. teden po zdravljenju niso ugotovili.
As the incidence of such elevations was 26% among women taking a concomitant ethinyloestradiol-containing medicine, such medicinal products are contraindicated with dasabuvir and ombitasvir/paritaprevir/ritonavir.
Ker je bila incidenca takšnih zvišanj med ženskami, ki so sočasno jemale zdravilo z etinilestradiolom, 26 %, so takšna zdravila med uporabo dasabuvirja in ombitasvirja/paritaprevirja/ritonavirja kontraindicirana.
When coadministered they exert mutual effects on each other (see section 5.2).
Med sočasno uporabo zdravilo in kombinacija vplivata eden na drugega (glejte poglavje 5.2).
Pharmacokinetics of the combination of dasabuvir 400 mg, with ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg were evaluated in subjects with mild (Child-Pugh A), moderate (ChildPugh B) and severe (Child-Pugh C) hepatic impairment, relative to subjects with normal hepatic function.
Farmakokinetiko kombinacije 400 mg dasabuvirja s 25 mg ombitasvirja, 200 mg paritaprevirja in 100 mg ritonavirja so ocenili pri preiskovancih z blago (Child-Pugh A), zmerno (Child-Pugh B) in hudo (Child-Pugh C) okvaro jeter glede na preiskovance z normalnim delovanjem jeter.
It may not be excluded that the systemic exposure of dabigatran etexilate is increased by dasabuvir due to inhibition of P-gp in the intestine.
Ni mogoče izključiti, da dasabuvir zaradi zavrtja P-gp v črevesju zveča izpostavljenost dabigatran eteksilatu.
Strong CYP2C8 inhibitors are contraindicated with dasabuvir (see section 4.3 and Table 2).
Močni zaviralci CYP2C8 so z dasabuvirjem kontraindicirani (glejte poglavje 4.3 in preglednico 2).
ANTICOAGULANTS Warfarin
ANTIKOAGULANTI varfarin
Dasabuvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (2 g/kg/day), resulting in dasabuvir AUC exposures approximately 19-fold higher than those in humans at the recommended dose of 500 mg (250 mg twice daily).
Dasabuvir v 6-mesečni študiji transgenskih miši ni bil kancerogen vse do največjega testiranega odmerka (2 g/kg/dan), ob čemer je bila izpostavljenost dasabuvirju glede na AUC 19-krat večja od izpostavljenosti pri človeku ob priporočenem odmerku 500 mg (250 mg dvakrat na dan).
Co-administration of dasabuvir with medicinal products that are primarily metabolized by UGT1A1 result in increased plasma concentrations of such medicinal products; routine clinical monitoring is recommended for narrow therapeutic index medicinal products (i.e. levothyroxine).
Sočasna uporaba dasabuvirja z zdravili, ki se presnavljajo predvsem z UGT1A1, povzroči zvečanje koncentracije takšnih zdravil v plazmi; med uporabo zdravil z ozkim terapevtskim indeksom (npr. levotiroksina) so priporočljive redne klinične kontrole.
For dosing recommendations with calcineurin inhibitors refer to section 4.5.
Za priporočila o odmerjanju z zaviralci kalcinevrina glejte poglavje 4.5.
12 weeks N = 770 n (%)
12 tednov N = 770 n (%)
If statin treatment is required during the treatment period, a switch to a reduced dose of pravastatin/rosuvastatin is possible (see section 4.5, Table 2).
Če je med obdobjem zdravljenja potrebno zdravljenje s statinom, je treba preiti na zmanjšan odmerek pravastatina/rosuvastatina, če je mogoče (glejte poglavje 4.5, preglednico 2).
What Exviera looks like and contents of the pack
Izgled zdravila Exviera in vsebina pakiranja
As liver function may change during treatment with dasabuvir administered with ombitasvir/paritaprevir/ritonavir, a close monitoring of International Normalised Ratio (INR) values is recommended.
Ker se delovanje jeter med zdravljenjem z dasabuvirjem ob sočasnem jemanju z ombitasvirjem/paritaprevirjem/ritonavirjem lahko spremeni, je priporočljivo skrbno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR - International Normalised Ratio).
In the 67 genotype 1a infected subjects, NS3 variants were observed in 50 subjects, NS5A variants were observed in 46 subjects, NS5B variants were observed in 37 subjects, and treatmentemergent variants were seen in all 3 drug targets in 30 subjects.
Pri 67 preiskovancih, okuženih z genotipom 1a, so variante NS3 opažali pri 50 preiskovancih, variante NS5A pri 46 preiskovancih, variante NS5B pri 37 preiskovancih; med zdravljenjem nastale variante so ugotovili pri vseh 3 tarčnih genih zdravil pri 30 preiskovancih.
200 mg once daily followed by 200 mg twice daily
200 mg enkrat na dan in nato 200 mg dvakrat na dan
Compared to subjects without cirrhosis, in subjects with compensated cirrhosis there was an increased rate of indirect hyperbilirubinemia when ribavirin was part of the regimen.
V primerjavi s preiskovanci brez ciroze, je bil pri preiskovancih s kompenzirano cirozo povečan delež posredne hiperbilirubinemije ob jemanju z ribavirinom.
The pharmacokinetics of dasabuvir with ombitasvir/paritaprevir/ritonavir in paediatric patients has not been investigated (see section 4.2).
Farmakokinetika dasabuvirja in kombinacije ombitasvir/paritaprevir/ritonavir pri pediatričnih bolnikih ni raziskana (glejte poglavje 4.2).
If the combination is used, repeated ECGmonitoring should be done, see section 4.4.
QT Če je takšna kombinacija uporabljena, je treba ponavljati kontrole EKG, glejte poglavje
In subjects receiving dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin, the most commonly reported adverse reactions (greater than 20% of subjects) were fatigue and nausea.
Pri preiskovancih, ki so prejemali dasabuvir in ombitasvir/paritaprevir/ritonavir z ribavirinom, sta bila najpogosteje opisana neželena učinka (pri več kot 20 % preiskovancev) utrujenost in navzea.
5 days after completion of dasabuvir + ombitasvir/paritaprevir/ ritonavir treatment, the sirolimus dose and dosing frequency prior to receiving dasabuvir ombitasvir/paritaprevir/ ritonavir should be resumed, along with routine monitoring of sirolimus blood concentrations.
5 dni po zaključenem zdravljenju z dasabuvirjem + kombinacijo ombitasvir/paritap revir/ritonavir je potrebno ponovno vzpostaviti odmerek in pogostnost odmerjanja sirolimusa kot pred začetkom jemanja dasabuvirja + kombinacije ombitasvir/paritap revir/ritonavir, skupaj z rutinskim spremljanjem koncentracij sirolimusa v krvi.
Darunavir combined with ombitasvir/paritaprevir/ ritonavir + dasabuvir is not recommended in patients with extensive PI resistance.
Darunavir skupaj s kombinacijo ombitasvir/paritap revir/ritonavir + dasabuvir ni priporočljiv pri bolnikih z obsežno odpornostjo proti PI.
For patients that require ribavirin, refer to the ribavirin Summary of Product Characteristics for information regarding use in patients with renal impairment.
Za bolnike, ki potrebujejo ribavirin, za informacije glede uporabe pri bolnikih z okvaro ledvic glejte povzetek glavnih značilnosti zdravila za ribavirin.
− Tablet core: microcrystalline cellulose (E 460(i)), lactose monohydrate, copovidone, croscarmellose sodium, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
− Jedro tablete: mikrokristalna celuloza (E 460(i)), laktoza monohidrat, kopovidon, premreženi natrijev karmelozat, koloidni brezvodni silicijev dioksid (E 551), magnezijev stearat (E 470b).
randomised, global multicentre, double-blind, regimen-controlled
randomizirano, globalno, multicentrično, dvojno slepo, s kontrolirano shemo
Target Emergent amino acid substitutionsa
Tarčni gen Nastale aminokislinske substitucijea
No clinically relevant changes in dasabuvir, paritaprevir, and ombitasvir exposures (based on comparison with historical data) were observed during the coadministration.
Med sočasno uporabo niso opazili klinično pomembnih sprememb izpostavljenosti dasabuvirju, paritaprevirju in ombitasvirju (na podlagi primerjave historičnih podatkov).
Hydrocodone (as given in a fixed-dose hydrocodone /paracetamol
Hidrokodon (kot fiksni odmerek kombinacije hidrokodon/parac etamol)
Adverse events of anaemia were not seen in the 18 GT1b-infected subjects who did not receive ribavirin.
Pri 18 bolnikih, okuženih z GT1b, ki niso prejeli ribavirina, niso opazili neželenih učinkov anemije.
24 weeks
12 ali 24 tednov
Plasma protein binding of dasabuvir and its M1 metabolite were not meaningfully different in subjects with hepatic impairment compared to normal control subjects (see sections 4.2, 4.4 and 4.8).
Vezava dasabuvirja in njegovega presnovka M1 na beljakovine v plazmi se pri preiskovancih z okvaro jeter nista bistveno razlikovali od tistih pri zdravih kontrolnih osebah (glejte poglavja 4.2, 4.4 in 5.2).
Exviera 250 mg film-coated tablets
Exviera 250 mg filmsko obložene tablete
No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and 2 subjects with HCV genotype 1b infection experienced relapse.
Nobeden izmed preiskovancev z okužbo s HCV genotipa 1b ni doživel virusne neodzivnosti med zdravljenjem in 2 preiskovanca z okužbo s HCV genotipa 1b sta doživela ponovitev bolezni.
Co-administration of dasabuvir with medicinal products that are moderate or strong enzyme inducers is expected to decrease dasabuvir plasma concentrations and reduce its therapeutic effect.
Sočasna uporaba dasabuvirja z zdravili, ki zmerno ali močno inducirajo encime, predvidoma zmanjša koncentracijo dasabuvirja v plazmi in zmanjša njegov terapevtski učinek.
Monitor ciclosporin levels and adjust dose and/or dosing frequency as needed.
Kontrolirajte koncentracijo ciklosporina in prilagodite odmerek in/ali pogostnost uporabe, kot je potrebno.
Three interrupted dasabuvir and ombitasvir/paritaprevir/ritonavir for one to seven days, including one on ethinyloestradiol.
Tri so prekinile zdravljenje z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir za obdobje od enega do sedmih dni, med njimi ena, ki je jemala etinilestradiol.
Female patients: Women of childbearing potential should not receive ribavirin unless they are using an effective form of contraception during treatment with ribavirin and for 4 months after treatment.
Bolnice: Ženske v rodni dobi ne smejo dobivati ribavirina, če med zdravljenjem z ribavirinom in še 4
In subjects who received the recommended regimen, 97% achieved SVR overall (among which 181 subjects with compensated cirrhosis achieved 97% SVR), while 0.5% experienced virologic breakthrough and 1.2% experienced post-treatment relapse.
preiskovancev s kompenzirano cirozo doseglo 97 % SVR), medtem ko se je pri 0,5 % pojavil virusni preboj, pri 1,2 % pa recidiv po zdravljenju.
OPIOIDS Methadone
OPIOIDI metadon
Atazanavir can be used in combination with dasabuvir with ombitasvir/paritaprevir/ritonavir if administered at the same time.
Atazanavir se lahko uporablja v kombinaciji z dasabuvirjem z ombitasvirjem/paritaprevirjem/ritonavirjem, če se dajejo ob istem času.
Dasabuvir is not recommended for administration as monotherapy and must be used in combination with other medicinal products for the treatment of hepatitis C infection (see section 4.2 and 5.1).
Dasabuvirja ni priporočljivo uporabljati kot samostojno zdravljenje (monoterapijo); za zdravljenje okužbe s hepatitisom C ga je treba uporabljati z drugimi zdravili za zdravljenje okužbe s hepatitisom C (glejte poglavji 4.2 in 5.1).
In biochemical assays, dasabuvir inhibited a panel of genotype 1a and 1b polymerases with a mean IC50 value of 4.2 nM (range 2.2 to 10.7 nM; n=7).
V biokemičnih preizkusih je dasabuvir zavrl skupino polimeraz genotipa 1a in 1b s povprečno IC50 4,2 nM (razpon od 2,2 do 10,7 nM, n = 7).
Tell your doctor or pharmacist before taking Exviera if you are also using hormonal contraceptives.
Pred začetkom jemanja zdravila Exviera svojemu zdravniku povejte, če jemljete hormonske kontraceptive.
Ombitasvir treatment-emergent variants M28T, M28V or Q30R in NS5A were observed in 32 subjects.
Med zdravljenjem z ombitasvirjem nastale variante M28T, M28V ali Q30R v genu NS5A so ugotovili pri 32 preiskovancih.
Dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin were assessed in 68 subjects with genotype 1 infection with or without cirrhosis who have severe renal impairment or ESRD (see Section 5.1).
Dasabuvir in ombitasvir/paritaprevir/ritonavir z ali brez ribavirina je bil ovrednoten pri 68 preiskovancih z okužbo genotipa 1 z ali brez ciroze, ki so imeli hudo okvaro ledvic ali končno ledvično odpoved (glejte poglavje 5.1).
Note: Doses used for dasabuvir + ombitasvir/paritaprevir/ritonavir were: ombitasvir 25 mg paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily.
Opomba: Uporabljeni odmerki za dasabuvir + ombitasvir/paritaprevir/ritonavir so bili: paritaprevir 150 mg, ritonavir 100 mg, ombitasvir 25 mg enkrat na dan in dasabuvir 400 mg dvakrat na dan ali 250 mg dvakrat na dan.
The AUC values of dasabuvir M1 metabolite were unchanged, 57% lower, and 77% higher, respectively.
AUC presnovka dasabuvirja M1 je bila pri prvih nespremenjena, pri drugih 57 % večja in pri tretjih 77 % večja.
Clinical trial in subjects with compensated cirrhosis
Klinično preskušanje pri preiskovancih s kompenzirano cirozo
Contraindicated enzyme inducers are provided in section 4.3 and Table 2.
Kontraindicirani induktorji encimov so navedeni v poglavju 4.3 in preglednici 2.
NA No dose adjustment is necessary for duloxetine.
NP Prilagoditev odmerka ni potrebna za duloksetin.
Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir together with medicinal products that are substrates of BCRP may increase plasma concentrations of these transporter substrates, potentially requiring dose adjustment/clinical monitoring.
Sočasna uporaba dasabuvirja s kombinacijo ombitasvir/paritaprevir/ritonavir in z zdravili, ki so substrati BCRP, lahko v plazmi zveča koncentracijo teh substratov prenašalcev in to lahko zahteva prilagoditev odmerka oz. klinični nadzor.
Inhibition of P-gp and BCRP is not expected to show clinically relevant increases in exposures of dasabuvir (Table 2).
Ni pričakovati, da bi zavrtje P-gp in BCRP klinično pomembno zvečalo izpostavljenost dasabuvirju
Subjects with renal transplant and no cirrhosis were dosed for 12 weeks (with RBV for GT1a [n=9], without RBV for GT1b [n=3]).
Preiskovanci s presajenimi ledvicami in brez ciroze so zdravilo prejemali 12 tednov (z RBV za GT1a [n=9], brez RBV za GT1b [n=3]).
Rilpivirine was also administered with food in the evening and 4 hours after dinner with dasabuvir + ombitasvir/paritaprevir/ritonavir in the study.
V študiji je bil rilpivirin uporabljen tudi s hrano zvečer in 4 ure po večerji z dasabuvirjem + kombinacijo ombitasvir/paritaprevir/ritonavir.
TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HCV GT1 or GT4/HIV-1 coinfection, without cirrhosis or with compensated cirrhosis
TURQUOISE-I - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s sočasno HCV GT1 ali GT4/HIV1 okužbo, brez ciroze ali s kompenzirano cirozo
Tell your doctor or pharmacist if you notice any of the following side effects: Side effects when taking Exviera with ombitasvir/paritaprevir/ritonavir:
Obvestite zdravnika ali farmacevta, če opazite kateri koli neželeni učinek naveden v nadaljevanju: Neželeni učinki pri jemanju zdravila Exviera s kombinacijo ombitasvir/paritaprevir/ritonavir
Medicines you must tell your doctor about before taking Exviera Medicine or active substance
Zdravila, o katerih morate obvestiti zdravnika, preden vzamete zdravilo Exviera
The effect on Cmax and AUC of DAAs and lopinavir was similar to that observed when lopinavir/ritonavir 400/100 mg twice daily was administered with dasabuvir and ombitasvir/paritaprevir/ritonavir.
Vpliv na Cmax in AUC DAA in lopinavirja je bil podoben, kot ko sta bila lopinavir/ritonavir 400mg/100 mg dvakrat na dan uporabljena skupaj z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir.
− Tablet film-coating: poly(vinyl alcohol) (E 1203), titanium dioxide (E 171), macrogol (3350), talc (E 553b), iron oxide yellow (E 172), iron oxide red (E 172) and iron oxide black (E 172).
− Filmska obloga tablete: polivinilalkohol (E 1203), titanov dioksid (E 171), makrogol 3350, smukec (E 553b), rumeni železov oksid (E 172), rdeči železov oksid (E 172), črni železov oksid (E 172).
Norgestimate metabolites:
Presnovki norgestimata:
In subjects with mild, moderate and severe renal impairment, dasabuvir mean AUC values were 21% higher, 37% higher and 50% higher, respectively.
Pri preiskovancih z blago, zmerno in hudo okvaro ledvic so bile v primerjavi s preiskovanci z normalnim delovanjem ledvic vrednosti AUC za 21 %, 37 % oziroma 50 % večje.
If ribavirin is co-administered with dasabuvir and ombitasvir/paritaprevir/ritonavir, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics of ribavirin).
Če se ribavirin uporablja sočasno z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir, je treba upoštevati kontraindikacije za uporabo ribavirina med nosečnostjo (glejte tudi povzetek glavnih značilnosti zdravila za ribavirin).
The recommended dose is one tablet, twice a day.
Priporočeni odmerek je ena tableta dvakrat na dan. Vzemite eno tableto zjutraj in eno tableto zvečer.
CYP2C8 inhibitor:
Zaviralec CYP2C8:
The pharmacokinetic properties of the combination of dasabuvir with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 18 shows mean Cmax and AUC of dasabuvir 250 mg twice daily with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily following multiple doses with food in healthy volunteers.
Farmakokinetične lastnosti kombinacije dasabuvirja in kombinacije ombitasvir/paritaprevir/ritonavir so ocenili pri zdravih odraslih in pri bolnikih s kroničnim hepatitisom C. Preglednica 18 prikazuje povprečni Cmax in AUC za dasabuvir 250 mg dvakrat na dan s kombinacijo ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg enkrat na dan po večkratnih odmerkih s hrano pri zdravih prostovoljcih.
Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir can decrease exposures of medicinal products that are metabolized by CYP2C19 (e.g. lansoprazole, esomeprazole, smephenytoin), which may require dose adjustment/clinical monitoring.
Sočasna uporaba dasabuvirja s kombinacijo ombitasvir/paritaprevir/ritonavir lahko zmanjša izpostavljenost zdravilom, ki se presnavljajo s CYP2C19 (npr. lansoprazol, esomeprazol, s mefenitoin), zaradi česar bo morda potrebna prilagoditev odmerka in klinično spremljanje.
Exviera contains the active substance dasabuvir.
Zdravilo Exviera vsebuje učinkovino dasabuvir.
A pooled analysis of subjects with genotype 1 HCV infection, who were treated with dasabuvir, ombitasvir and paritaprevir with or without ribavirin in Phase 2b and 3 clinical trials, was conducted to explore the association between baseline NS3/4A, NS5A or NS5B substitutions/polymorphisms and treatment outcome in these recommended regimens.
Opravljena je bila kumulativna analiza preiskovancev, okuženih s HCV genotipa 1, ki so bili v kliničnih preskušanjih faze 2b in 3 zdravljeni z dasabuvirjem, ombitasvirjem in paritaprevirjem, z ribavirinom ali brez njega, za preučitev povezanosti izhodiščnih substitucij/polimorfizmov NS3/4A, NS5A oziroma NS5B na izid zdravljenja pri teh priporočenih shemah.
Drug interaction studies
Študije medsebojnega delovanja zdravil
SVR12 window.
HCV RNA znotraj okna SVR12.
The M1 metabolite of dasabuvir had EC50 values of 39 and 8 nM against genotype 1a-H77 and 1bCon1 strains in HCV replicon cell culture assays, respectively, and the activity of the M1 metabolite was attenuated 3- to 4-fold in the presence of 40% human plasma.
Presnovek dasabuvirja M1 je imel v preskusih z replikonsko celično kulturo HCV vrednosti EC50 proti sevu genotipa 1a-H77 39 nM in sevu genotipa 1b-Con1 8 nM; aktivnost presnovka M1 je bila v prisotnosti 40 % človeške plazme 3- do 4-krat zmanjšana.
Dasabuvir treatment-emergent variants M414T, G554S, S556G, G558R or D559G/N in NS5B were observed in 34 subjects.
Med zdravljenjem z dasabuvirjem nastale variante M414T, G554S, S556G, G558R ali D559G/N v genu NS5B so ugotovili pri 34 preiskovancih.
Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Ena filmsko obložena tableta vsebuje 250 mg dasabuvirja (kot natrijev monohidrat).
Overall SVR12 HCV genotype 1a HCV genotype 1b Outcome for subjects without SVR12 On-treatment VFa Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL
Celotni SVR12 HCV genotip 1a HCV genotip 1b Izid pri preiskovancih brez SVR12 VN med zdravljenjema Recidiv Drugob a. Potrjen HCV ≥ 25 i.e./ml po HCV RNA < 25 i.e./ml med zdravljenjem, potrjeno zvečanje HCV RNA za 1
Recommendations for co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir for a number of medicinal products are provided in Table 2.
Priporočila za sočasno uporabo dasabuvirja in kombinacije ombitasvir/paritaprevir/ritonavir s številnimi zdravili so navedena v preglednici 2.
Serum ALT elevations
Zvišanje ALT v serumu
The mean EC50 of dasabuvir against replicons containing NS5B from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.77 nM (range 0.4 to 2.1 nM; n=11) and 0.46 nM (range 0.2 to 2 nM; n=10), respectively.
Povprečna EC50 dasabuvirja proti replikonom, ki so vsebovali NS5B iz skupine izolatov še nezdravljenih in z genotipom 1a in 1b, je bila v preizkusu replikonske celične kulture HCV 0,77 nM (razpon od 0,4 do 2,1 nM, n = 11) za 1a in 0,46 nM (razpon od 0,2 do 2 nM, n = 10) za 1b.