FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile of Exviera and ombitasvir/paritaprevir/ritonavir was similar in patients without cirrhosis, and with compensated cirrhosis, with exception of increased rates of transient hyperbilirubinemia when ribavirin was part of the regimen.
Slovenian: Varnostne značilnosti zdravila Exviera in kombinacije ombitasvir/paritaprevir/ritonavir so bile podobne pri preiskovancih brez ciroze in pri tistih s kompenzirano cirozo, z izjemo večjega deleža prehodne hiperbilirubinemije ob jemanju z ribavirinom.
English: The majority of these ALT elevations were transient and assessed as related to Exviera and ombitasvir/paritaprevir/ritonavir.
Slovenian: Večina teh zvišanj ALT je bila prehodnih in so jih ocenili kot povezane z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir.
English: Genotype 1a, without cirrhosis
Slovenian: genotipa 1a brez ciroze.
English: Patients who are taking ethinylestradiol -containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Exviera with ombitasvir/paritaprevir/ritonavir therapy (see sections 4.3 and 4.5).
Slovenian: Bolnice, ki uporabljajo zdravila z etinilestradiolom (tj. večina kombiniranih peroralnih kontraceptivov ali kontracepcijskih vaginalnih obročkov), morajo preiti na drugačen način kontracepcije (npr. na samo progestinsko kontracepcijo ali na nehormonske načine), preden začnejo zdravljenje z zdravilom
English: Two patients discontinued Exviera and ombitasvir/paritaprevir/ritonavir due to elevated ALT, including one on ethinylestradiol.
Slovenian: Dve osebi sta prenehali uporabljati zdravilo Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir zaradi zvišanja ALT, od teh ena, ki je jemala etinilestradiol.
English: Exviera + ombitasvir/paritaprevir/ ritonavir may increase the plasma concentrations of dabigatran etexilate.
Slovenian: Exviera + ombitasvir/paritap revir/ritonavir lahko zveča koncentracijo dabigatran eteksilata.
English: NAME OF THE MEDICINAL PRODUCT Exviera 250 mg film-coated tablets
Slovenian: IME ZDRAVILA Exviera 250 mg filmsko obložene tablete
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Polyethylene glycol 3350 Talc (E553b) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
Slovenian: titanov dioksid (E171) polietilenglikol 3350 smukec (E553b) rumeni železov oksid (E172) rdeči železov oksid (E172) črni železov oksid (E172)
English: Clinical monitoring and dose adjustment maybe needed for smephenytoin.
Slovenian: Morda bo potrebno klinično spremljanje in prilagoditev odmerka smefenitoina.
English: Wort (hypericum perforatum)
Slovenian: • šentjanževka (Hypericum perforatum)
English: TURQUOISE-III is a Phase 3b, open-label, single-arm, multicentre study evaluating the efficacy and safety of Exviera and ombitasvir/paritaprevir/ritonavir (without ribavirin) administered for 12 weeks in HCV GT1b-infected, treatment-naïve and pegIFN/RBV treatment-experienced adults with compensated cirrhosis.
Slovenian: TURQUOISE-III je preskušanje faze 3.b, odprto, z eno samo skupino, multicentrično, v katerem se ugotavlja učinkovitost in varnost zdravila Exviera in kombinacije ombitasvir/paritaprevir/ritonavir (brez ribavirina), ki ju odrasli, okuženi s HCV GT1b, ki še niso bili zdravljeni in taki, ki so bili predhodno zdravljeni s pegIFN/RBV ter s kompenzirano cirozo, prejemajo 12 tednov.
English: NAME OF THE MEDICINAL PRODUCT Exviera 250 mg tablets dasabuvir
Slovenian: IME ZDRAVILA Exviera 250 mg tablete dasabuvir
English: The efficacy of dasabuvir has not been established in patients with HCV genotypes other than genotype 1; Exviera should not be used for the treatment of patients infected with other genotypes than
Slovenian: Učinkovitost dasabuvirja ni ugotovljena pri bolnikih z drugimi genotipi HCV razen genotipa 1;
English: Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection enzalutamide for prostate cancer ethinylestradiol containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception gemfibrozil to lower cholesterol and other fats in the blood mitotane for some tumours of the adrenal glands rifampicin for bacterial infections
Slovenian: enzalutamid pri raku prostate zdravila, ki vsebujejo etinilestradiol, kot je večina kontracepcijskih tablet in vaginalnih obročkov, ki se uporabljajo kot kontracepcija kontracepcija gemfibrozil za zniževanje holesterola in drugih maščob v krvi mitotan pri nekaterih tumorjih nadledvičnih žlez rifampicin pri bakterijskih okužbah šentjanževka (hypericum perforatum)
English: In subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
Slovenian: so bili neželeni učinki, ki so običajno povezani z ribavirinom (npr. navzea, insomnia, anemija), manj pogosti in noben preiskovanec (0/588) ni trajno prekinil zdravljenja zaradi neželenih učinkov.
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Slovenian: Pri preiskovancih, ki so dobivali zdravili Exviera in ombitasvir/paritaprevir/ritonavir z ribavirinom, so opažali prehodno zvišanje bilirubina v serumu (pretežno indirektnega), ki je povezano z zavrtjem bilirubinskih prenašalcev OATP1B1/1B3 s paritaprevirjem in s hemolizo zaradi ribavirina.
English: The overall safety profile in HCV-infected transplant recipients who were administered Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin (in addition to their immunosuppressant medicinal products) was similar to subjects treated with Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Slovenian: Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir ter ribavirin (poleg imunosupresivnih zdravil), je bila podobna kot pri preiskovancih, zdravljenih z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir ter ribavirinom v kliničnih preskušanjih 3. faze, čeprav so bili nekateri neželeni učinki pogostejši.
English: Medicinal products transported by Pgp in the intestine While dasabuvir is an in vitro inhibitor of P-gp, no significant change was observed in the exposure of the P-gp substrate, digoxin, when administered with Exviera with ombitasvir/paritaprevir/ritonavir.
Slovenian: Dasabuvir sicer in vitro zavira P-gp, vendar niso ugotovili pomembne spremembe izpostavljenosti substratu P-gp digoksinu, če je bil uporabljen skupaj z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir.
English: Genotype 1a, with compensated cirrhosis
Slovenian: 12 tednov genotip 1a, s kompenzirano cirozo
English: NA Concomitant use is contraindicated (see the Summary of Product Characteristics for ombitasvir/paritaprevir/ ritonavir).
Slovenian: NP Sočasna uporaba je kontraindicirana (glejte povzetek glavnih značilnosti zdravila za ombitasvir/paritap revir/ritonavir).
English: Phase 3 global multicentre trials conducted with Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin (RBV).
Slovenian: Globalna multicentrična preskušanja 3. faze z zdravili Exviera in ombitasvir/paritaprevir/ritonavir, z ribavirinom (RBV) ali brez njega.
English: SAPPHIRE-I - genotype 1, treatment-naïve
Slovenian: SAPPHIRE-I - genotip 1, še nezdravljeni
English: Some patients have reported feeling very tired when taking Exviera with other medicines for their hepatitis C infection.
Slovenian: Nekateri bolniki so poročali o hudi utrujenosti med jemanjem zdravila Exviera in drugih zdravil za zdravljenje hepatitisa C. Če ste utrujeni, ne vozite ali upravljajte s stroji.
English: A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 68.4% had IL28B non-CC genotype; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
Slovenian: vsaj 800.000 i.e./ml in večina (84,2 %) je bila okužena z genotipom 1a; 68,4 % jih je imelo genotip IL28B ne-CC; 15,8 % jih je imelo portalno fibrozo (F2) in 5,3 % jih je imelo fibrozo z mostiči (F3); 94,7 % jih predhodno še ni bilo zdravljenih za HCV.
English: Tacrolimus 2 mg single dose4
Slovenian: Posamezen odmerek 2 mg 4
English: When taking Exviera and ombitasvir/paritaprevir/ritonavir, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - Feel sick (nauseous), are sick (vomit) or lose your appetite.
Slovenian: Če zdravilo Exviera jemljete s kombinacijo ombitasvir/paritaprevir/ritonavir, obvestite svojega zdravnika, če imate naslednje simptome, ki so lahko znak poslabšanja težav z jetri:
English: Note: The following variants were selected in cell culture but were not treatment-emergent: NS3 variants A156T in genotype 1a, and R155Q and D168H in genotype 1b; NS5A variants Y93C/H in genotype 1a, and L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
Slovenian: varianta gena NS3A156T v genotipu 1a ter R155Q in D168H v genotipu 1b; varianta gena NS5A Y93C/H v genotipu 1a in L31F/V ali Y93H v kombinaciji z L28M, L31F/V ali P58S v genotipu 1b; in Y448H NS5B v genotipu 1a in M414T in Y448H v genotipu 1b.
English: 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
Slovenian: Recidiv Drugo b a. Potrjen HCV ≥ 25 i.e./ml po HCV RNA < 25 i.e./ml med zdravljenjem, potrjeno zvečanje HCV RNA za 1
English: The replicon activity of dasabuvir was attenuated 12- to 13
Slovenian: V prisotnosti 40 % človeške plazme je replikonska aktivnost dasabuvirja oslabela za 12- do 13-krat.
English: PEARL-IV- genotype 1a, treatment-naïve
Slovenian: PEARL-IV- genotip 1a, še nezdravljeni
English: Rilpivirine was also administered with food in the evening and 4 hours after dinner with Exviera + ombitasvir/paritaprevir/ritonavir in the study.
Slovenian: V študiji je bil rilpivirin uporabljen tudi s hrano zvečer in 4 ure po večerji z zdravilom Exviera +
English: • Anaemia (low number of red blood cells).
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov • anemija (majhno število rdečih krvnih celic).
English: Exviera and ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
Slovenian: Exviera in ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2.044
English: ↑ darunavir ↓ dasabuvir ombitasvir paritaprevir lopinavir / ritonavir 400/100 mg
Slovenian: ↓ dasabuvir ↔ ombitasvir ↓ paritaprevir lopinavir / ritonavir 400/100 mg dvakrat na dan1 Mehanizem:
English: ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 857 days) and most resolved with ongoing therapy.
Slovenian: tednih zdravljenja (povprečni čas 20 dni, razpon od 8 do 57 dni) in so večinoma minila med nadaljevanjem zdravljenja.
English: Tacrolimus 2 mg was dosed alone and 2 mg was administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Slovenian: Takrolimus 2 mg je bil uporabljen sam in 2 mg skupaj z zdravilom Exviera + kombinacijo ombitasvir/paritaprevir/ritonavir.
English: - Confusion - Notice swelling of your stomach area
Slovenian: − opazite oteklino v predelu trebuha.
English: fold in the presence of 40% human plasma.
Slovenian: vezan na beljakovine v humani plazmi.
English: In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had similar SVR12 rates (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (99.5%).
Slovenian: V tej študiji so bili deleži SVR12 z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir brez ribavirina (100 %) podobni kot z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom (99,5 %).
English: Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
Slovenian: Zdravilo Exviera in kombinacija ombitasvir/paritaprevir/ritonavir skupaj z ribavirinom so pri prejemnikih presajenih jeter priporočljivi 24 tednov.
English: SAPPHIRE-II - genotype 1, peginterferon+ribavirin-experienced
Slovenian: SAPPHIRE-II - genotip 1, že zdravljeni s peginterferonom+ribavirinom
English: PEARL-II - genotype 1b, peginterferon+ribavirin-experienced
Slovenian: PEARL-II - genotip 1b, že zdravljeni s peginterferonom+ribavirinom
English: OPIOIDS Methadone Exviera
Slovenian: OPIOIDI metadon
English: In the CORAL-1 study, the safety and efficacy of Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin for 24 weeks was studied in 34 HCV genotype 1-infected liver transplant recipients who were at least 12 months post-transplant at study enrolment.
Slovenian: Klinična preskušanja pri prejemnikih presajenih jeter V študiji CORAL-1 so varnost in učinkovitost zdravila Exviera in kombinacije ombitasvir/paritaprevir/ritonavir skupaj z ribavirinom v obdobju 24 tednov raziskali pri 34 prejemnikih presajenih jeter, okuženih s HCV genotipa 1, ki so bili v študijo vključeni vsaj
English: In an open-label clinical trial (TURQUOISE-I) the safety and efficacy of 12 or 24 weeks of treatment with Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin was evaluated in 63 subjects with genotype 1 chronic hepatitis C co-infected with HIV-1.
Slovenian: Klinična preskušanja pri preiskovancih s sočasno okužbo s HCV genotipa 1/HIV-1 V odprtem kliničnem preskušanju (TURQUOISE-I) so varnost in učinkovitost 12- ali 24-tedenskega zdravljenja z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir ter ribavirinom ocenili pri 63 preiskovancih, s kroničnim hepatitisom s HCV genotipa 1 in sočasno okužbo s HIV-1.
English: SAPPHIRE-II was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 394 subjects with genotype 1 chronic hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV.
Slovenian: Preskušanje SAPPHIRE-II je bilo globalno, multicentrično, randomizirano, dvojno slepo in s placebom kontrolirano preskušanje pri 394 preiskovancih, ki so imeli kronično okužbo z virusom hepatitisa C genotipa 1 brez ciroze in s predhodnim zdravljenjem s pegIFN/RBV niso dosegli SVR.
English: PEARL-III - genotype 1b, treatment-naïve
Slovenian: PEARL-III - genotip 1b, še nezdravljeni
English: No dose adjustment of Exviera is warranted in elderly patients (see section 5.2).
Slovenian: Starejšim bolnikom odmerkov zdravila Exviera ni treba prilagoditi (glejte poglavje 5.2).
English: Table 12 shows the SVR12 rates for genotype 1-infected subjects with compensated cirrhosis who were treatment-naïve or previously treated with pegIFN/RBV.
Slovenian: Preglednica 12 prikazuje deleže SVR12 pri preiskovancih, okuženih z genotipom 1, ki so imeli kompenzirano cirozo in še niso bili zdravljeni ali so bili predhodno zdravljeni s pegIFN/RBV.
English: Clinical trials in peginterferon+ribavirin-experienced adults
Slovenian: Klinična preskušanja pri odraslih, ki so že bili zdravljeni s peginterferonom+ribavirinom
English: In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had a similar SVR12 rate (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (97.7%).
Slovenian: V tej študiji so bili deleži SVR12 z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir brez ribavirina (100 %) podobni kot z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom (97,7 %).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 250 mg dasabuvirja (kot natrijev monohidrat).
English: HCV Genotype 1a Exviera and ombitasvir/paritaprevir/ritonavir with RBV
Slovenian: HCV Genotip 1a Exviera in ombitasvir/paritaprevir/ritonavir Z RBV
English: In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine with or without naloxone (N=19) received 12 weeks of Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
Slovenian: bolnikov, že zdravljenih s pegIFN/RBV, brez ciroze in okuženih z genotipom 1, ki so dobivali stabilne odmerke metadona (N = 19) ali buprenorfina, z naloksonom ali brez njega, (N = 19) 12 tednov prejemalo zdravilo Exviera v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem in ribavirinom.
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Slovenian: SVR12 pri preiskovancih, ki so bili že zdravljeni s peginterferonom+ribavirinom, okuženih z genotipom 1, v preskušanju SAPPHIRE-II
English: SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatment-naïve or previously treated with pegIFN/RBV
Slovenian: SVR12 pri preiskovancih, okuženih z genotipom 1, ki so imeli kompenzirano cirozo in še niso bili zdravljeni ali so bili predhodno zdravljeni s pefIFN/RBV.
English: Mechanism: OATP1B inhibition by paritaprevir.
Slovenian: OATP1B s paritaprevirjem.
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 81% of subjects had IL28B non-CC genotype; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
Slovenian: Mediana starost zdravljenih preiskovancev (N = 63) je bila 51 let (razpon: od 31 do 69); 24 % preiskovancev je bilo črncev, 81 % preiskovancev je imelo genotip IL28B ne-CC, 19 % preiskovancev je imelo kompenzirano cirozo, 67 % preiskovancev še ni bilo zdravljenih zaradi HCV, 33 % preiskovancev je doživelo neuspeh predhodnega zdravljenja pegIFN/RBV, 89 % preiskovancev je imelo okužbo s HCV genotipa 1a.
English: What you need to know before you take Exviera 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Exviera Ne jemljite zdravila Exviera:
English: CONTRACEPTIVES ethinylestradi ol/ norgestimate 0.035/0.25 m g once daily
Slovenian: 0,035/0,25 mg enkrat na dan
English: Following a 400 mg 14C-dasabuvir dose in humans, unchanged dasabuvir was the major component (approximately
Slovenian: 14C-dasabuvirja pri človeku je bil nespremenjeni dasabuvir glavna sestavina (približno 60 %) z zdravilom povezane radioaktivnosti v plazmi.
English: Adverse reactions identified with Exviera in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Slovenian: Neželeni učinki ugotovljeni z zdravilom Exviera v kombinaciji z ombitasvir/paritaprevir/ritonavir ali z ombitasvir/paritaprevir/ritonavir in ribavirinom
English: Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing dasabuvir, ombitasvir and paritaprevir with or without ribavirin (for 8, 12 or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
Slovenian: V kliničnih študijah Virološki neuspeh (primarni recidiv po zdravljenju) se je v kliničnih preskušanjih faze 2b in 3 pojavil pri skupno 74 od 2.510 preiskovancev (3 %), okuženih s HCV genotipa 1 in zdravljenih s shemami, ki so vsebovale dasabuvir, ombitasvir in paritaprevir z ribavirinom ali brez njega (v obdobju 8, 12 ali 24 tednov).
English: While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Slovenian: Čeprav ni pričakovati nobenih sprememb v farmakokinetiki varfarina, je priporočljivo skrbno spremljanje mednarodnega normaliziranega razmerja (INR) pri vseh antagonistih vitamina K. To je zaradi sprememb delovanja jeter med zdravljenjem z zdravilom Exviera + ombitasvir/paritap revir/ritonavir.
English: Subjects randomised to the placebo arm received placebo for 12 weeks, after which they received open-label Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks.
Slovenian: Preiskovanci, randomizirani v placebo skupino, so 12 tednov prejemali placebo, potem pa so 12 tednov odprto prejemali zdravilo Exviera in ombitasvir/paritaprevir/ritonavir v kombinaciji z ribavirinom.
English: Geometric mean Cmax, AUC of multiple doses of Exviera 250 mg twice daily and ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily with food in healthy volunteers
Slovenian: 250 mg dvakrat na dan in kombinacijo ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg enkrat na dan s hrano pri zdravih prostovoljcih.
English: Digoxin 0.5 mg single dose
Slovenian: Alprazolam Posamezen odmerek 0,5 mg
English: Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo and is not expected to inhibit organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations; therefore, Exviera does not affect medicinal product transport by these proteins.
Slovenian: (OCT2 - organic cation transporters), prenašalce organskih anionov (OAT3) ali ekstruzijskih beljakovin več zdravil in toksinov (MATE1 in MATE2K - multidrug and toxin extrusion proteins).
English: Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir combines three direct-acting antiviral agents with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Slovenian: Sočasna uporaba dasabuvirja s kombinacijo ombitasvir/paritaprevir/ritonavir združuje tri direktno delujoča protivirusna zdravila z različnimi mehanizmi delovanja.
English: TURQUOISE-II- genotype 1, treatment-naïve or peginterferon+ribavirin-experienced subjects with compensated cirrhosis
Slovenian: TURQUOISE-II - še nezdravljeni ali že zdravljeni preiskovanci s peginterferonom+ribavirinom, z genotipom 1 in s cirozo
English: SAPPHIRE-I was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 631 treatment-naïve adults with genotype 1 chronic hepatitis C virus infection without cirrhosis.
Slovenian: Preskušanje SAPPHIRE-I je bilo globalno, multicentrično, randomizirano, dvojno slepo in s placebom kontrolirano preskušanje pri 631 še nezdravljenih odraslih, ki so imeli kronično okužbo z virusom hepatitisa C genotipa 1 brez ciroze.
English: Mechanism: Increase in dasabuvir exposure is due to
Slovenian: Večja izpostavljenost dasabuvirju je posledica zavrtja
English: Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Slovenian: CYP3A4 z ritonavirjem in zavrtje UGT s paritaprevirjem, ombitasvirjem in dasabuvirjem
English: Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Placebo
Slovenian: Skupina A: Exviera in ombitasvir/paritaprevir/ritonavir + RBV Skupina B: Placebo
English: Subjects randomised to the placebo arm received placebo for 12 weeks, after which they received Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks.
Slovenian: Preiskovanci, randomizirani v placebo skupino, so 12 tednov prejemali placebo, potem pa so 12 tednov prejemali zdravili Exviera in ombitasvir/paritaprevir/ritonavir v kombinaciji z ribavirinom.
English: For subjects who received ribavirin, the ribavirin dose was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg.
Slovenian: oziroma odmerek 1200 mg na dan, če so tehtali 75 kg ali več.