FrancophonIA/ELRC3.0 huggingface dataset:
English: The impact of prior dasabuvir, ombitasvir, or paritaprevir treatment experience on the efficacy of other NS5A inhibitors, NS3/4A protease inhibitors, or NS5B inhibitors has not been studied.
Slovenian: ombitasvirjem ali paritaprevirjem na učinkovitost drugih zaviralcev NS5A, zaviralcev proteaz NS3/4A
English: Medicinal products metabolised by glucuronidation Dasabuvir is an inhibitor of UGT1A1 in vivo.
Slovenian: Dasabuvir zavira UGT1A1 in vivo.
English: Co-administration of dasabuvir and ombitasvir/paritaprevir/ritonavir with systemic tacrolimus, sirolimus or everolimus increases the concentrations of the immunosuppressant due to CYP3A inhibition by ritonavir (see section 4.5).
Slovenian: Uporaba s takrolimusom, sirolimusom in everolimusom Sočasna uporaba dasabuvirja in kombinacije obmitasvir/paritaprevir/ritonavir s sistemsko delujočimi takrolimusom, sirolimusom ali everolimusom poveča koncentracije imunosupresiva zaradi CYP3A
English: randomised, global multicentre, open-label
Slovenian: randomizirano, globalno, multicentrično, odprto
English: In Part 2, subjects with HCV GT1 received dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 weeks.
Slovenian: V delu 2 so preiskovanci s HCV GT1 prejemali dasabuvir in ombitasvir/paritaprevir/ritonavir z ali brez ribavirina 12 ali 24 tednov.
English: Mechanism: CYP3A4/CY P2C8 induction by rifampicin.
Slovenian: Indukcija CYP3A4/CYP2C 8 z rifampicinom.
English: Tacrolimus or sirolimus whole blood concentrations should be monitored upon initiation and throughout co-administration with dasabuvir and ombitasvir/paritaprevir/ritonavir and the dose and/or dosing frequency should be adjusted as needed.
Slovenian: Koncentracije takrolimusa ali sirolimusa v polni krvi je potrebno spremljati na začetku in vseskozi med sočasno uporabo z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir, odmerek in/ali pogostnost odmerjanja je potrebno ustrezno prilagoditi.
English: Medicinal products transported by the OATP family Refer to the ombitasvir/paritaprevir/ritonavir Summary of Product Characteristics for details on OATP1B1, OATP1B3 and OATP2B1 substrates (see also Table 2).
Slovenian: Za podrobnosti o substratih OATP1B1, OATP1B3 in OATP2B1 glejte povzetek glavnih značilnosti zdravila za ombitasvir/paritaprevir/ritonavir (glejte tudi preglednico 2).
English: In Part 1b, all subjects received dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin for 12 weeks.
Slovenian: V delu 1b so vsi preiskovanci prejemali dasabuvir in ombitasvir/paritaprevir/ritonavir z ribavirinom 12 tednov.
English: In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Slovenian: trombocite ≥ 90 x 109/l in albumin ≥ 35 g/l), so bili deleži recidiva podobni pri tistih, ki so bili zdravljeni 12 tednov, in pri tistih, ki so bili zdravljeni 24 tednov.
English: AUC Ctrough
Slovenian: AUC Ctrough Klinične opombe
English: Mechanism: CYP2C19 induction by ritonavir.
Slovenian: Mehanizem: Indukcija CYP2C19 z ritonavirjem.
English: Clinical monitoring and dose adjustment may be needed for other CYP1A2 substrates (e.g. ciprofloxacin, cyclobenzaprine, theophylline and caffeine).
Slovenian: CYP1A2 (npr. ciprofloksacin, ciklobenzaprin, teofilin in kofein).
English: ↔ S
Slovenian: V
English: Design:
Slovenian: Oblika:
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; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
Slovenian: 800.000 i.e./ml in večina (84,2 %) je bila okužena z genotipom 1a; 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: 400 mg twice daily
Slovenian: 400 mg dvakrat na dan
English: Symptoms include: o Feel sick (nauseous), are sick (vomit) or lose your appetite o Notice yellowing of your skin or eyes o Your urine is darker than normal o Confusion o Notice swelling of your stomach area
Slovenian: • opazna porumenelost kože ali oči • vaš urin je temnejši od običajnega
English: Prior pegIFN/RBV relapser
Slovenian: Predhodno recidiv ob pegIFN/RBV
English: Peg-IFN + RBV, n (%) Baseline albumin, median g/L < 35, n (%)
Slovenian: Starost, mediana leta (razpon) Moški spol, n (%) Predhodno zdravljenje za HCV: nezdravljeni, n (%) Peg-IFN + RBV, n (%) Izhodiščni albumin, median g/L < 35, n (%)
English: Exviera 250 mg film-coated tablets dasabuvir
Slovenian: Exviera 250 mg filmsko obložene tablete dasabuvir
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 dasabuvir 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 dasabuvir v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem in ribavirinom.
English: Methadone ↔ ombitasvir/paritaprevir and dasabuvir (based on the cross-study comparison)
Slovenian: NP ↔ ombitasvir /paritaprevir in dasabuvir (na podlagi primerjave med študijami)
English: • If you have any further questions, ask your doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: Tacrolimus whole blood concentrations should be monitored upon initiation and throughout coadministration with dasabuvir and ombitasvir/paritaprevir/ ritonavir and the dose and/or dosing frequency should be adjusted as needed.
Slovenian: Koncentracije takrolimusa v polni krvi je potrebno spremljati na začetku in vseskozi med sočasno uporabo z dasabuvirjem in kombinacijo ombitasvir/paritapre vir/ritonavir, odmerek in/ali pogostnost odmerjanja je potrebno ustrezno prilagoditi.
English: Ethinyloestradiol containing oral contraceptives are contraindicated (see section 4.3).
Slovenian: Peroralni kontraceptivi, ki vsebujejo etinilestradiol, so kontraindicirani (glejte poglavje
English: 5 mg once daily
Slovenian: 5 mg enkrat na dan
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of multipack containing 56 (4 packs of 14) film-coated tablets - including blue box
Slovenian: Zunanja škatla (večkratno pakiranje) vsebuje 56 (4 škatle po 14) filmsko obloženih tabletvključuje modro okence
English: The activity of dasabuvir was reduced by 5- and 11-fold by C316N and S556G, respectively; 46-fold by M414T or Y448H; and 1569-fold by the C316Y substitutions in the genotype 1b replicon.
Slovenian: Aktivnost dasabuvirja se je s substitucijo C316N v replikonu genotipa 1b zmanjšala za 5-krat, s S556G za 11-krat, z M414T ali Y448H za 46-krat in s C316Y za 1569-krat.
English: Esomeprazol e
Slovenian: ↓ omeprazol
English: Geometric mean Cmax, AUC of multiple doses of dasabuvir 250 mg twice daily and ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily with food in healthy volunteers
Slovenian: Preglednica 18: Geometrična sredina Cmax in AUC večkratnih odmerkov dasabuvirja 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: Selected treatment emergent laboratory abnormalities
Slovenian: Preglednica 4: Izbrane laboratorijske nepravilnosti, ki so se pojavile med zdravljenjem
English: In genotype 1a, substitutions C316Y, M414T, Y448H, A553T, G554S, S556G/R, and Y561H in HCV NS5B reduced susceptibility to dasabuvir.
Slovenian: Pri genotipu 1a so substitucije C316Y, M414T, Y448H, A553T, G554S, S556G/R in Y561H v genu
English: Medicines you must not take with Exviera Medicine or active substance
Slovenian: Zdravila, ki jih ne smete jemati z zdravili 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: GARNET - Genotype 1b, Treatment-Naïve without cirrhosis.
Slovenian: GARNET - genotip 1b, še nezdravljeni, brez ciroze
English: Mechanism: Increase in paritaprevir exposures may be due to inhibition of
Slovenian: Večja izpostavljenost paritaprevirju je lahko posledica zavrtja
English: Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Slovenian: (CHC - chronic hepatitis C) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
English: In the genotype 1a replicon, the activity of dasabuvir was reduced 21- to 32-fold by the M414T, S556G or Y561H substitutions; 152- to 261-fold by the A553T, G554S or S556R substitutions; and 1472- and 975-fold by the C316Y and Y448H substitutions, respectively.
Slovenian: S556G ali Y561H zmanjšale aktivnost dasabuvirja za 21- do 32-krat, substitucije A553T, G554S ali S556R za 152- do 261-krat in substituciji C316Y in Y448H za 1472- in 975-krat.
English: Treatment outcome dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Slovenian: Izid zdravljenja dasabuvir in ombitasvir/paritaprevir/ritonavir z RBV 12 tednov n/N % 95 % IZ
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Slovenian: Morda zavrtje UGT1A1 s paritaprevirjem, ombitasvirjem in dasabuvirjem.
English: Mechanism: OATP1B inhibition by paritaprevir.
Slovenian: Zavrtje OATP1B s paritaprevirjem.
English: Table 2 provides the Least Squares Means Ratio (90% Confidence Interval) effect on concentration of dasabuvir and ombitasvir/paritaprevir/ritonavir and concomitant medicinal products.
Slovenian: Preglednica 2 prikazuje vpliv na koncentracije dasabuvirja in kombinacije ombitasvir/paritaprevir/ritonavir ter sočasno uporabljanih zdravil z razmerjem povprečij po metodi najmanjših kvadratov (90 % interval zaupanja).
English: Very common
Slovenian: Zelo pogosti pruritus
English: CONTRACEPTIVES ethinyloestra diol/ norgestimate 0.035/0.25 m g once daily
Slovenian: 0,035/0,25 mg enkrat na dan
English: 9% had advanced fibrosis (F3) and 98.2% had HCV genotype 1b infection (one subject each had genotype 1a, 1d, and 6 infection).
Slovenian: RNA vsaj 6.000.000 i.e./ml; 9 % jih je imelo napredujočo fibrozo (F3) in 98,2 % jih je imelo okužbo s HCV genotipa 1b (en preiskovanec je imel okužbo genotipa 1a, eden genotipa 1d in eden genotipa 6).
English: Table 2.
Slovenian: (preglednica 2).
English: In Part 1a, all subjects received dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin for 12 or 24 weeks.
Slovenian: V delu 1a so vsi preiskovanci prejemali dasabuvir in ombitasvir/paritaprevir/ritonavir z ribavirinom 12 ali 24 tednov.
English: Treatment-naïve and peginterferon+ribavirin-experienced, with compensated cirrhosis
Slovenian: Še nezdravljeni in že zdravljeni s peginteferonom+ribavirinom, s kompenzirano cirozo
English: 400 mg once daily
Slovenian: 400 mg enkrat na dan
English: Alprazolam 0.5 mg single dose
Slovenian: Alprazolam Posamezen odmerek 0,5 mg
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg, with dasabuvir 400 mg were evaluated in subjects with mild (CrCl: 60 to 89 ml/min), moderate (CrCl: 30 to 59 ml/min) and severe (CrCl: 15 to 29 ml/min) renal impairment, relative to subjects with normal renal function.
Slovenian: 400 mg dasabuvirja) so ocenili pri preiskovancih z blago (očistek kreatinina od 60 do 89 ml/min), zmerno (očistek kreatinina od 30 do 59 ml/min) in hudo (očistek kreatinina od 15 do 29 ml/min)
English: Treated subjects (N = 22) had a median age of 54 years (range: 34 to 68); 41% were Black; 14% had compensated cirrhosis; 86% were HCV treatment-naïve; 14% had failed prior treatment with pegIFN/RBV; 68% had HCV genotype 1a infection.
Slovenian: Mediana starosti zdravljenih preiskovancev (N = 22) je bila 54 let(razpon: od 34 do 68); 41 % je bilo črncev; 14 % jih je imelo kompenzirano cirozo; 86 % jih še ni bilo zdravljenih; 14 % jih je doživelo neuspeh predhodnega zdravljenja s pegIFN/RBV; 68 % jih je imelo okužbo HCV genotipa 1a.
English: Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% were Black; 19% had compensated cirrhosis; 67% were treatment-naïve; 33% had failed prior treatment with pegIFN/RBV; 89% had HCV genotype 1a infection.
Slovenian: Mediana starost zdravljenih preiskovancev (N = 63) je bila 51 let (razpon: od 31 do 69); 24 % je bilo črncev, 19 % jih je imelo kompenzirano cirozo, 67 % jih še ni bilo zdravljenih, 33 % jih je doživelo neuspeh predhodnega zdravljenja pegIFN/RBV, 89 % jih je imelo okužbo s HCV genotipa 1a.
English: Pharmacodynamic interactions
Slovenian: Farmakodinamično medsebojno delovanje
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Slovenian: Preglednica 11: SVR12 pri preiskovancih, ki so bili že zdravljeni s peginterferonom+ribavirinom, okuženih z genotipom 1, v preskušanju SAPPHIRE-II
English: No dose adjustment of dasabuvir is warranted in elderly patients (see section 5.2).
Slovenian: Starejši bolniki Starejšim bolnikom odmerkov dasabuvirja ni treba prilagoditi (glejte poglavje 5.2).
English: Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir combines three direct-acting antiviral medicinal products 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: Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported post-marketing in patients treated with dasabuvir with ombitasvir/paritaprevir/ritonavir with and without ribavirin.
Slovenian: Tveganje za dekompenzacijo jeter in okvaro jeter pri bolnikih s cirozo Pri bolnikih, ki so jih zdravili z dasabuvirjem z ombitasvirjem/paritaprevirjem/ritonavirjem z ali brez ribavarina so po prihodu zdravila na trg poročali o dekompenzaciji jeter in okvari jeter, vključno s presaditvijo jeter ali smrtnimi izidi.
English: 40 mg once daily
Slovenian: 40 mg enkrat na dan
English: ↑ rilpivirine
Slovenian: ↑ rilpivirin
English: Side effects when taking Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin:
Slovenian: Neželeni učinki pri jemanju zdravila Exviera in kombinacije ombitasvir/paritaprevir/ritonavir z ribavirinom:
English: Expected: ↓ S-mephenytoin
Slovenian: ↓ s-mefenitoin
English: GT1-infected subjects with or without cirrhosis with severe renal impairment or end-stage renal disease (ESRD)
Slovenian: Preiskovanci, okuženi z genotipom GT1, z ali brez ciroze s hudo okvaro ledvic ali končno ledvično odpovedjo
English: Immune system disorders Frequency unknown
Slovenian: Bolezni imunskega sistema Neznana pogostnost anafilaktične reakcije anafilaktične reakcije
English: SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Slovenian: Preglednica 12: SVR12 pri preiskovancih, ki so bili že zdravljeni s peginterferonom+ribavirinom, okuženih z genotipom 1b, v preskušanju PEARL II
English: Tacrolimus 2 mg was dosed alone and 2 mg was administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Slovenian: Takrolimus 2 mg je bil uporabljen sam in 2 mg skupaj z dasabuvirjem + kombinacijo ombitasvir/paritaprevir/ritonavir.
English: SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis
Slovenian: SAPPHIRE-I - genotip 1, še nezdravljeni, brez ciroze Oblika:
English: Carisoprodol
Slovenian: ↓ karisoprodol
English: Coadministration with enzyme inducers may lead to an increased risk of adverse reactions and ALT elevations (see Table 2).
Slovenian: Sočasna uporaba z induktorji encimov lahko zveča tveganje za neželene učinke in zvišanje ALT
English: NARCOTIC ANALGESICS Paracetamol (given as fixed dose hydrocodone /paracetamol dasabu vir +
Slovenian: Paracetamol (kot fiksni odmerek kombinacije hidrokodon/parac etamol)
English: Endpoint dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 Weeks N = 200a
Slovenian: Opazovani dogodek dasabuvir in ombitasvir/paritaprevir/ritonavir z ali brez ribavirina, 12 ali 24 tednov N = 200a
English: Clinical monitoring and dose adjustment maybe needed for smephenytoin.
Slovenian: Morda bo potrebno klinično spremljanje in prilagoditev odmerka za druge substrate
English: GIVE N WITH
Slovenian: UPORAB LJENO Z
English: 50 mg once daily
Slovenian: 50 mg enkrat na dan
English: In all eight trials, the dasabuvir dose was 250 mg twice daily and the ombitasvir/paritaprevir/ritonavir dose was 25 mg/150 mg/100 mg once daily.
Slovenian: V vseh osmih preskušanjih je bil odmerek dasabuvirja 250 mg dvakrat na dan in odmerek kombinacije ombitasvir/paritaprevir/ritonavir 25/150/100 mg enkrat na dan. Preiskovanci, ki so dobivali ribavirin,
English: 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: Enzalutamid e
Slovenian: PRILOGA I
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, dasabuvir 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: Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
Slovenian: Zdravljeni preiskovanci (N = 419) so bili mediano stari 50 let (razpon: od 19 do 70); 45,8 % je bilo moških; 4,8 % je bilo črncev; 9,3 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 73,3 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 20,3 % jih je imelo portalno fibrozo (F2) in 10,0 % jih je imelo fibrozo z mostiči (F3).
English: PEARL-III - genotype 1b, treatment-naïve, without cirrhosis Design:
Slovenian: PEARL-III - genotip 1b, še nezdravljeni, brez ciroze Oblika:
English: PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis Design:
Slovenian: PEARL-II - genotip 1b, že zdravljeni s pegIFN + RBV, brez ciroze
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: pojavila 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: TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Slovenian: TURQUOISE-III - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s kompenzirano cirozo Oblika:
English: S-warfarin dasabuvir ombitasvir paritaprevir
Slovenian: S-varfarin dasabuvir ombitasvir
English: Mechanism: CYP3A4 induction by phenytoin.
Slovenian: Mehanizem: Indukcija CYP3A4 s fenitoinom.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis
Slovenian: TURQUOISE-II - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s kompenzirano cirozo Oblika:
English: The recommended dose of darunavir is 800 mg once daily, without ritonavir, when administered at the same time as ombitasvir/paritaprevir/ ritonavir + dasabuvir (ritonavir dose in ombitasvir/paritaprevir/ ritonavir will provide darunavir pharmacokinetic enhancement).
Slovenian: Mehanizem: ni znan paritaprevir se ga daje ob istem času kot ombitasvir/paritap revir/ritonavir + dasabuvir (odmerek ritonavirja v kombinaciji ombitasvir/paritap revir/ritonavir zagotavlja farmakokinetično okrepitev darunavirja).
English: Co-administration of efavirenz (enzyme inducer) based regimens with paritaprevir /ritonavir + dasabuvir resulted in ALT elevations and therefore, early discontinuation of the study.
Slovenian: + dasabuvir je povzročila zvišanje ALT in zaradi tega zgodnje prenehanje študije.
English: How to store Exviera
Slovenian: Shranjevanje zdravila Exviera
English: Genotype 1b, without cirrhosis or with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir
Slovenian: Trajanje genotip 1b, brez ciroze ali s kompenzirano cirozo dasabuvir + ombitasvir/paritaprevir/ritonavir
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir
Slovenian: Skupina A: dasabuvir in ombitasvir/paritaprevir/ritonavir + RBV Skupina B: dasabuvir in ombitasvir/paritaprevir/ritonavir
English: Expected: ↓ dasabuvir ↓ombitasvir ↓ paritaprevir
Slovenian: Pričakovano: ↓ dasabuvir ↓ ombitasvir ↓ paritaprevir
English: Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Placebo
Slovenian: Skupina A: dasabuvir in ombitasvir/paritaprevir/ritonavir + RBV Skupina B: Placebo
English: • There is a risk for birth defects when ribavirin is given to a female patient that becomes pregnant.
Slovenian: • Pri dajanju ribavirina bolnicam, ki zanosijo, obstaja tveganje prirojenih okvar pri novorojenčku.
English: See section 4.2 for dosing recommendations in HCV/HIV-1 co-infected patients.
Slovenian: Za priporočila o odmerjanju pri bolnikih, sookuženih s HCV/HIV-1, glejte poglavje 4.2.
English: Croscarmellose sodium Colloidal anhydrous silica (E 551) Magnesium stearate (E 470b)
Slovenian: mikrokristalna celuloza (E 460(i)) laktoza monohidrat kopovidon premreženi natrijev karmelozat koloidni brezvodni silicijev dioksid (E 551) magnezijev stearat (E 470b)
English: Refer to the tacrolimus or sirolimus Summary of Product Characteristics for additional dosing and monitoring instructions.
Slovenian: Za dodatne informacije glede odmerjanja in navodil za spremljanje glejte Povzetek glavnih značilnosti zdravila za takrolimus oziroma sirolimus.
English: ↑ dabigatran etexilate dasabuvir + ombitasvir/paritaprevir/ ritonavir may increase the plasma concentrations of dabigatran etexilate.
Slovenian: ↑ dabigatran eteksilat dasabuvir + ombitasvir/paritap revir/ritonavir lahko zveča koncentracijo dabigatran eteksilata.
English: ↔ ethinyl oestradiol
Slovenian: KG Knollstrasse
English: DIURETICS Furosemide 20 mg single dose
Slovenian: Posamezen odmerek 20 mg
English: CYP3A by atazanavir and CYP3A inhibition by the additional dose of ritonavir.
Slovenian: OATP1B1/B3 in CYP3A z atazanavirjem in zavrtja CYP3A z dodatnim odmerkom ritonavirja
English: Mechanism: P-gp inhibition by dasabuvir, paritaprevir, and ritonavir.
Slovenian: Zavrtje P-gp z dasabuvirjem, paritaprevirjem in ritonavirjem.
English: The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with dasabuvir + ombitasvir/paritaprevir/ ritonavir.
Slovenian: ombitasvir/ paritaprevi r/ritonavir dasabuvir atazanavirja je 300 mg, brez ritonavirja, v kombinaciji dasabuvir + ombitasvir/paritap revir/ritonavir.
English: Do not pass it on to others.
Slovenian: - Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.