natgillin/translations-raw huggingface dataset:
CYP3A/efflu x transporters by lopinavir and higher dose of ritonavir. 
CYP3A/efluksnih prenašalcev z lopinavirjem in večjimi odmerki ritonavirja.
• Each tablet contains 250 mg of dasabuvir (as sodium monohydrate). 
• Ena tableta vsebuje 250 mg dasabuvirja (kot natrijev monohidrat).
Contraindicated enzyme inducers are provided in section 4.3. 
Kontraindicirani induktorji so navedeni v poglavju 4.3.
n/N % 95% CI 
Brez RBV n/N % 95 % IZ n/N % 95 % IZ
Co-administration of dasabuvir + ombitasvir/paritaprevir/ ritonavir with everolimus is not recommended because of a significant increase in everolimus exposures which cannot be properly dose adjusted with available dose strengths. 
Sočasna uporaba dasabuvirja + kombinacije ombitasvir/paritap revir/ritonavir z everolimusom ni priporočljiva zaradi izrazitega povečanja izpostavljenosti everolimusu, katerega odmerek ne more biti ustrezno prilagojen z jakostmi odmerkov, ki so na voljo.
In another open-label phase 3b study evaluating 12 weeks of ombitasvir/paritaprevir/ritonavir with or without dasabuvir and without RBV in non-cirrhotic, treatment-naive GT1a and GT4 patients with CKD stage 4 or 5 (Ruby II), the SVR12 rate was 94.4% (17/18), with no subjects experiencing ontreatment virologic failure or relapse. 
V drugi odprti študiji faze 3b, ki je ocenila ombitasvir/paritaprevir/ritonavir 12 tednov z ali brez dasabuvirja in brez RBV pri še nezdravljenih GT1a in GT4 bolnikih brez ciroze, s CKD stopnje 4 ali 5 (Ruby II), je bila stopnja SVR12 94,4 % (17/18); pri tem se pri nobenem preiskovancu nista pojavila virusna neodzivnost med zdravljenjem ali ponovitev bolezni.
These medicines can affect the way Exviera and ombitasvir/paritaprevir/ritonavir work and Exviera and ombitasvir/paritaprevir/ritonavir can affect the way these other medicines work. 
Ta zdravila lahko vplivajo na delovanje zdravila Exviera in kombinacije ombitasvir/paritaprevir/ritonavir in obratno; zdravilo Exviera in kombinacija ombitasvir/paritaprevir/ritonavir lahko vplivata na delovanje teh zdravil.
b. Other includes early drug discontinuation not due to virologic failure and missing HCV RNA values in the 
b. "Drugo" vključuje zgodnjo ukinitev zdravila, ki ni posledica virusne neodzivnosti in manjkajoče vrednosti
HCV genotype (GT) 
Genotip (GT) HCV
Medicinal products renally excreted via transport proteins Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate). 
Zdravila, ki se v ledvicah izločajo s prenašalnimi beljakovinami Dasabuvir in vivo ne zavre prenašalca organskih anionov (OAT1), kar se kaže z odsotnostjo medsebojnega delovanja s tenofovirjem (substrat OAT1).
The combination was not linked to any particular safety issues in a limited set of patients treated for 12-24 weeks. 
Pri majhnem številu bolnikov, zdravljenih od 12 do 24 tednov, kombinacija ni bila povezana s kakšnimi posebnimi težavami z varnostjo.
CORAL-I: treatment-naïve or pegIFN + RBV-experienced, GT 1 or GT4 infected, at least 3 months post liver transplant or 12 months post renal transplant 
CORAL-1: še nezdravljeni ali že zdravljeni s pegIFN + RBV, okuženi z GT1 ali GT4, vsaj 3 mesece po presaditvi jeter ali 12 mesecev po presaditvi ledvic
Ethinyloestradiol is contraindicated in combination with dasabuvir (see section 4.3). 
Etinilestradiol je kontraindiciran v kombinaciji z dasabuvirjem (glejte poglavje 4.3).
Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, dolutegravir (Part 2 only), or darunavir (Part 1b and Part 2 GT4 only)-, co-administered with a backbone of tenofovir plus emtricitabine or lamivudine. 
Preiskovanci so prejemali stabilno shemo antiretrovirusne terapije (ART) za HIV1, ki je vključevala z ritonavirjem okrepljeni atazanavir ali raltegravir, dolutegravir (samo del 2) ali darunavir (samo del 1b in del 2 GT4) uporabljen z osnovno shemo tenofovirja ter emtricitabina ali lamivudina.
Pharmacokinetic interactions 
Farmakokinetično medsebojno delovanje
This is because serious or lifethreatening effects can occur when Exviera and ombitasvir/paritaprevir/ritonavir are taken with these medicines. 
To pa zato, ker se lahko pojavijo resni ali življenje ogrožajoči učinki, če se zdravilo Exviera in kombinacija ombitasvir/paritaprevir/ritonavir jemljeta sočasno s temi zdravili.
Dasabuvir administered with ombitasvir/paritaprevir/ritonavir did not affect the exposures of the CYP2D6 /CYP1A2 substrate duloxetine. 
Dasabuvir, uporabljen s kombinacijo ombitasvir/paritaprevir/ritonavir, ni vplival na izpostavljenost substratu CYP2D6/CYP1A2 duloksetinu.
All treatment-emergent variants in NS5A remained detectable at posttreatment Week 48. 
Vse med zdravljenjem nastale variante gena NS5A so ostale zaznavne 48. teden po zdravljenju.
The highest dasabuvir dose tested produced exposures equal to 16 to 24-fold (rat) or 6-fold (rabbit) the exposures in humans at the maximum recommended clinical dose. 
Največji testirani odmerek dasabuvirja je povzročil izpostavljenost, ki je bila pri podganah od 16- do 24-kratnik in pri kuncih 12-kratnik izpostavljenosti pri človeku ob največjem priporočenem kliničnem odmerku.
Patients receiving ribavirin should also refer to the Summary of Product Characteristics of ribavirin. 
Pri osebah, ki prejemajo ribavirin, je treba upoštevati tudi povzetek glavnih značilnosti ribavirina.
Treated subjects had a median age of 51 years (range: 26 to 64); 65.8% were male and 5.3% were Black. 
Mediana starost zdravljenih preiskovancev je bila 51 let (razpon: od 26 do 64); 65,8 % je bilo moških in 5,3 % je bilo črncev.
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.