FrancophonIA/ELRC3.0 huggingface dataset:
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4) Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4) Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper Limit of Normal
Slovenian: stopnja) > 20 × ZMN (4. stopnja) Hemoglobin < 100-80 g/l (2. stopnja) < 80-65 g/l (3. stopnja) < 65 g/l (4. stopnja) Celokupni bilirubin > 3-10 × ZNM (3.
English: The safety summary is based on pooled data from phase 2 and 3 clinical trials in subjects who received dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin.
Slovenian: Povzetek o varnosti temelji na kumulativnih podatkih kliničnih preskušanj 2. in 3. faze pri preiskovancih, ki so prejemali dasabuvir in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
English: dasabuvir + ombitasvir/paritaprevir/ritonavir was administered as multiple doses in all the drug interaction studies except the drug interaction studies with carbamazepine, gemfibrozil, ketoconazole, and sulfamethoxazole/trimethoprim.
Slovenian: Dasabuvir + kombinacijo ombitasvir/paritaprevir/ritonavir so uporabljali v večkratnih odmerkih v vseh študijah medsebojnega delovanja zdravil, razen v študijah s karbamazepinom, gemfibrozilom, ketokonazolom in kombinacijo sulfametoksazol/trimetoprim.
English: Multipack: 56 (4 packs of 14) film-coated tablets
Slovenian: Večkratno pakiranje: 56 (4 škatle po 14) filmsko obloženih tablet
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.2% (5/2,044) and 4.8% (99/2,044) of subjects had ribavirin dose reductions due to adverse reactions.
Slovenian: Zaradi neželenih učinkov je zdravljenje trajno prekinilo 0,2 % preiskovancev (5/2.044) in 4,8 % (99/2.044)
English: SVR12, n/N (%) [95% CI] Outcome for subjects not achieving SVR12 On-treatment virologic failure Post-treatment relapse Otherb a. Includes all HCV GT1 subjects in Part 2 excluding Arm G subjects that did not receive recommended regimen.
Slovenian: SVR12, n/N (%) [95 % CI] Izid pri preiskovancih, ki niso dosegli SVR12 Virusna neodzivnost med zdravljenjem Recidiv po zdravljenju Drugob a. Vključuje vse preiskovance s HCV GT1 v delu 2 in izključuje preiskovance iz skupine G, ki niso prejemali priporočenega režima zdravljenja.
English: The recommended co-administered medicinal product(s) and treatment duration for dasabuvir combination therapy are provided in Table 1.
Slovenian: Priporočena sočasna zdravila in trajanje zdravljenja za kombinirano zdravljenje z dasabuvirjem so prikazana v preglednici 1.
English: Avoid concomitant use of tacrolimus or sirolimus with dasabuvir and ombitasvir/paritaprevir/ritonavir unless the benefits outweigh the risks.
Slovenian: Izogibajte se sočasni uporabi takrolimusa ali sirolimusa z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir, razen kadar koristi uporabe prevladajo nad tveganji.
English: If rosuvastatin treatment is required during the treatment period, the maximum daily dose of rosuvastatin should be 5 mg (see section 4.5, Table 2).
Slovenian: Če je med obdobjem zdravljenja potrebno zdravljenje z rosuvastatinom, sme biti največji dnevni odmerek rosuvastatina 5 mg (glejte poglavje 4.5, preglednico 2).
English: The efficacy and safety of dasabuvir in combination with ombitasvir/paritaprevir/ritonavir with and without ribavirin was evaluated in eight Phase 3 clinical trials, including two trials exclusively in subjects with compensated cirrhosis (Child-Pugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Slovenian: Učinkovitost in varnost dasabuvirja v kombinaciji z ombitasvirjem/paritaprevijem/ritonavirjem (z ribavirinom ali brez njega) so preučili v osmih kliničnih preskušanjih 3. faze (vključno z dvema preskušanjema izključno pri bolnikih s kompenzirano cirozo (Child-Pugh A)) pri več kot 2.360 preiskovancih s kronično okužbo s hepatitisom C genotipa 1, kot povzema preglednica 6.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of multipack of 14 film-coated tablets - without blue box
Slovenian: PODATKI NA ZUNANJI OVOJNINI Notranja škatla (večkratno pakiranje) s 14 filmsko obloženimi tabletami - brez modrega okenca
English: The long-term clinical impact of the emergence or persistence of virus containing dasabuvir and ombitasvir/paritaprevir/ritonavirresistance-associated substitutions on future treatment is unknown.
Slovenian: Dolgoročni klinični vpliv pojava oziroma vztrajanja virusov s substitucijami, povezanimi z odpornostjo proti dasabuvirju in kombinaciji ombitasvir/paritaprevir/ritonavir na zdravljenje v prihodnje ni znan.
English: Table 17 shows the primary efficacy analysis of SVR12 performed on subjects with HCV GT1/HIV-1 co-infection that received recommended regimen in Part 2 of the TURQUOISE-I study.
Slovenian: Preglednica 17 prikazuje analizo primarne učinkovitosti SVR12 pri preiskovancih, sočasno okuženih s HCV GT1/HIV-1, ki so prejemali priporočen režim zdravljenja v delu 2 študije TURQUOISE-I.
English: Table 16.
Slovenian: NAVODILA ZA UPORABO 16.
English: If a patient is already taking medicinal product(s) or initiating a medicinal product while receiving dasabuvir and ombitasvir/paritaprevir/ritonavir for which potential for drug interaction is expected, dose adjustment of the concomitant medicinal product(s) or appropriate clinical monitoring should be considered (Table 2).
Slovenian: Če bolnik že jemlje zdravila ali med zdravljenjem z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir začne jemati zdravilo, za katero obstaja možnost medsebojnega delovanja, je treba razmisliti o prilagoditvi odmerka sočasno uporabljanega zdravila ali ustrezno klinično spremljanje (preglednica 2).
English: ↑ sulfasalazine
Slovenian: ↑ sulfasalazin
English: Ombitasvir/paritaprevir/ritonavir with or without dasabuvir was also evaluated without ribavirin in 18 GT1a- and GT4-infected patients; no adverse events of anaemia were seen in these subjects.
Slovenian: Ombitasvir/paritaprevir/ritonavir z ali brez dasabuvirja je bil ovrednoten tudi brez ribavirina pri 18 bolnikih, okuženih z GT1a in GT4; pri teh preiskovancih niso opazili nobenih neželenih učinkov anemije.
English: No genotype 1b infected subjects had treatment-emergent variants in all 3 drug targets.
Slovenian: Noben preiskovanec, okužen z genotipom 1b, ni imel med zdravljenjem nastalih variant pri vseh 3 tarčnih genih zdravil.
English: In the greater than 500 genotype 1a baseline samples in this analysis, the most frequently observed resistance-associated variants were M28V (7.4%) in NS5A and S556G (2.9%) in NS5B.
Slovenian: V več kot 500 izhodiščnih vzorcih genotipa 1a v tej analizi sta bili najpogosteje opaženi z odpornostjo povezani varianti M28V (7,4 %) v genu NS5A in S556G (2,9 %) v genu NS5B.
English: Co-administration of dasabuvir with medicinal products that inhibit CYP2C8 (e.g. teriflunomide, deferasirox) may increase dasabuvir plasma concentrations.
Slovenian: Sočasna uporaba dasabuvirja z zdravili, ki zavirajo CYP2C8 (npr. teriflunomid, deferasiroks), lahko zveča koncentracijo dasabuvirja v plazmi.
English: Dasabuvirderived material was minimally transferred through the placenta in pregnant rats.
Slovenian: Iz dasabuvirja nastale snovi so minimalno prehajale skozi placento brejih podgan.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Exviera.
Slovenian: Če kar koli od zgoraj navedenega velja za vas (ali če ste negotovi), se pred začetkom jemanja zdravila
English: 24 weeks n/N % CIa n/N % CIa
Slovenian: 24 tednov n/N % IZa n/N % IZa
English: If you are not sure, talk to your doctor or pharmacist before taking Exviera.
Slovenian: Če ste negotovi, se pred začetkom jemanja zdravila Exviera posvetujte z zdravnikom ali farmacevtom.
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Slovenian: Vezava na beljakovine v plazmi pri bolnikih z okvaro ledvic ali jeter ni pomembno spremenjena.
English: Package leaflet: Information for the patient Exviera 250 mg film-coated tablets dasabuvir This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Exviera 250 mg filmsko obložene tablete dasabuvir Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: CYP3A/efflu x transporters by lopinavir and higher dose of ritonavir.
Slovenian: CYP3A/efluksnih prenašalcev z lopinavirjem in večjimi odmerki ritonavirja.
English: • Each tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Slovenian: • Ena tableta vsebuje 250 mg dasabuvirja (kot natrijev monohidrat).
English: Contraindicated enzyme inducers are provided in section 4.3.
Slovenian: Kontraindicirani induktorji so navedeni v poglavju 4.3.
English: n/N % 95% CI
Slovenian: Brez RBV n/N % 95 % IZ n/N % 95 % IZ
English: 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.
Slovenian: 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.
English: Exviera 250 mg tablets dasabuvir
Slovenian: Exviera 250 mg tablete dasabuvir
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: b. Other includes early drug discontinuation not due to virologic failure and missing HCV RNA values in the
Slovenian: b. "Drugo" vključuje zgodnjo ukinitev zdravila, ki ni posledica virusne neodzivnosti in manjkajoče vrednosti
English: HCV genotype (GT)
Slovenian: Genotip (GT) HCV
English: 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).
Slovenian: 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).
English: The combination was not linked to any particular safety issues in a limited set of patients treated for 12-24 weeks.
Slovenian: Pri majhnem številu bolnikov, zdravljenih od 12 do 24 tednov, kombinacija ni bila povezana s kakšnimi posebnimi težavami z varnostjo.
English: 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
Slovenian: 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
English: Ethinyloestradiol is contraindicated in combination with dasabuvir (see section 4.3).
Slovenian: Etinilestradiol je kontraindiciran v kombinaciji z dasabuvirjem (glejte poglavje 4.3).
English: 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.
Slovenian: 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.
English: Pharmacokinetic interactions
Slovenian: Farmakokinetično medsebojno delovanje
English: This is because serious or lifethreatening effects can occur when Exviera and ombitasvir/paritaprevir/ritonavir are taken with these medicines.
Slovenian: 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.
English: Dasabuvir administered with ombitasvir/paritaprevir/ritonavir did not affect the exposures of the CYP2D6 /CYP1A2 substrate duloxetine.
Slovenian: Dasabuvir, uporabljen s kombinacijo ombitasvir/paritaprevir/ritonavir, ni vplival na izpostavljenost substratu CYP2D6/CYP1A2 duloksetinu.
English: All treatment-emergent variants in NS5A remained detectable at posttreatment Week 48.
Slovenian: Vse med zdravljenjem nastale variante gena NS5A so ostale zaznavne 48. teden po zdravljenju.
English: 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.
Slovenian: 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.
English: Patients receiving ribavirin should also refer to the Summary of Product Characteristics of ribavirin.
Slovenian: Pri osebah, ki prejemajo ribavirin, je treba upoštevati tudi povzetek glavnih značilnosti ribavirina.
English: Treated subjects had a median age of 51 years (range: 26 to 64); 65.8% were male and 5.3% were Black.
Slovenian: Mediana starost zdravljenih preiskovancev je bila 51 let (razpon: od 26 do 64); 65,8 % je bilo moških in 5,3 % je bilo črncev.
English: 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).
Slovenian: 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).
English: Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Slovenian: Mehanizem: morda zavrtje UGT s paritaprevirjem, ombitasvirjem in dasabuvirjem.
English: 800 mg once daily (given at the same time)
Slovenian: 800 mg enkrat na dan (dan ob istem času)
English: 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.
Slovenian: 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 %
English: Clinical monitoring and dose adjustment may be required for levothyroxine.
Slovenian: Morda bo potrebno klinično nadziranje in sprememba odmerka levotiroksina.
English: 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.
Slovenian: 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.
English: Dasabuvir safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin.
Slovenian: Varnost in učinkovitost dasabuvirja sta bili ugotovljeni v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem, z ribavirinom ali brez njega.
English: With compensated cirrhosis
Slovenian: S kompenzirano cirozo
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: When coadministered they exert mutual effects on each other (see section 5.2).
Slovenian: Med sočasno uporabo zdravilo in kombinacija vplivata eden na drugega (glejte poglavje 5.2).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Ni mogoče izključiti, da dasabuvir zaradi zavrtja P-gp v črevesju zveča izpostavljenost dabigatran eteksilatu.
English: Strong CYP2C8 inhibitors are contraindicated with dasabuvir (see section 4.3 and Table 2).
Slovenian: Močni zaviralci CYP2C8 so z dasabuvirjem kontraindicirani (glejte poglavje 4.3 in preglednico 2).
English: ANTICOAGULANTS Warfarin
Slovenian: ANTIKOAGULANTI varfarin
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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.
English: For dosing recommendations with calcineurin inhibitors refer to section 4.5.
Slovenian: Za priporočila o odmerjanju z zaviralci kalcinevrina glejte poglavje 4.5.
English: 12 weeks N = 770 n (%)
Slovenian: 12 tednov N = 770 n (%)
English: 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).
Slovenian: 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).
English: What Exviera looks like and contents of the pack
Slovenian: Izgled zdravila Exviera in vsebina pakiranja
English: 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.
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 200 mg once daily followed by 200 mg twice daily
Slovenian: 200 mg enkrat na dan in nato 200 mg dvakrat na dan
English: 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.
Slovenian: V primerjavi s preiskovanci brez ciroze, je bil pri preiskovancih s kompenzirano cirozo povečan delež posredne hiperbilirubinemije ob jemanju z ribavirinom.
English: The pharmacokinetics of dasabuvir with ombitasvir/paritaprevir/ritonavir in paediatric patients has not been investigated (see section 4.2).
Slovenian: Farmakokinetika dasabuvirja in kombinacije ombitasvir/paritaprevir/ritonavir pri pediatričnih bolnikih ni raziskana (glejte poglavje 4.2).
English: If the combination is used, repeated ECGmonitoring should be done, see section 4.4.
Slovenian: QT Če je takšna kombinacija uporabljena, je treba ponavljati kontrole EKG, glejte poglavje
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Darunavir combined with ombitasvir/paritaprevir/ ritonavir + dasabuvir is not recommended in patients with extensive PI resistance.
Slovenian: Darunavir skupaj s kombinacijo ombitasvir/paritap revir/ritonavir + dasabuvir ni priporočljiv pri bolnikih z obsežno odpornostjo proti PI.