natgillin/translations-raw huggingface dataset:
Given the low virologic failure rates observed with recommended treatment regimens for HCV genotype 1a- and 1b-infected subjects, the presence of baseline variants appears to have little impact on the likelihood of achieving SVR. 
Glede na majhen delež neuspešnega zdravljenja, zabeležen ob uporabi priporočenih shem zdravljenja pri bolnikih, okuženih s HCV genotipa 1a in 1b, prisotnost izhodiščnih variant le malo vpliva na verjetnost za doseganje trajnega virusnega odziva (SVR).
13/15 (86.7)c a. Calculated using the normal approximation to the binomial distribution b. 1 patient discontinued due to non-compliance c. Relapse in 2/15 patients (confirmed HCV RNA ≥ 15 IU/mL post-treatment before or during SVR12 window among subjects with HCV RNA < 15 IU/mL at last observation with at least 51 days of treatment). 
13/15 (86,7)c a. Izračunano z uporabo normalnega približka za binomsko porazdelitev b. En bolnik je prenehal z zdravljenjem zaradi nekompliance c. Ponovitev pri 2/15 bolnikov (potrjena HCV RNA ≥ 15 i.e./mL po zdravljenju pred ali med SVR12 oknom med preiskovanci s HCV RNA < 15 i.e./mL pri zadnjem merjenju z najmanj 51 dnevi zdravljenja).
None of the subjects with hyperbilirubinemia had concomitant elevations of aminotransferases. 
Noben preiskovanec s hiperbilirubinemijo ni imel sočasno zvišanih aminotransferaz.
Use of ethinyloestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see sections 4.4 and 4.5). 
Uporaba zdravil, ki vsebujejo etinilestradiol, npr. takšnih, ki so v večini kombiniranih peroralnih kontraceptivov ali kontracepcijskih vaginalnih obročkov (glejte poglavji 4.4 in 4.5).
ALT elevations were asymptomatic and generally occurred during the first 4 weeks of treatment, without concomitant elevations of bilirubin, and declined within approximately two weeks of onset with continued dosing of dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin. 
Zvišanja ALT so bila asimptomatska in so se na splošno pojavila v prvih 4 tednih zdravljenja, brez hkratnega zvišanja bilirubina, ter so se znižala v približno dveh tednih po začetku stalne uporabe dasabuvirja ter kombinacije ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
Among all GT1 subjects who were post liver transplant, 111/114 (97.4%) achieved SVR12; with 2 relapsing post treatment and 1 breakthrough on treatment. 
Izmed vseh GT1 preiskovancev, ki so prestali presaditev jeter, jih je 111/114 (97,4 %) doseglo SVR12; z 2 primeroma ponovitve bolezni po zdravljenju in 1 primerom preboja med zdravljenjem.
SVR12 rates for recommended treatment regimens by patient population 
Preglednica 16: Deleži SVR12 glede na priporočene sheme zdravljenja in po populacijah bolnikov
Due to high SVR rates in genotype 1b, trends in persistence of treatment-emergent variants in this genotype could not be established. 
Zaradi visokih deležev SVR pri genotipu 1b trendov trajnosti med zdravljenjem nastalih variant pri tem genotipu ni bilo mogoče ugotoviti.
If statin treatment is required during the treatment period, a switch to dose reduced pravastatin or rosuvastatin is possible. 
Če je med obdobjem zdravljenja potrebno zdravljenje s statinom, je treba preiti na manjši odmerek pravastatina ali rosuvastatina, če je mogoče.
PVC/PE/PCTFE aluminium foil blister packs. 
Pretisni omoti iz PVC/PE/PCTFE aluminijaste folije.
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Exviera. 
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Exviera, nizke ravni sladkorja v krvi (hipoglikemija).
Genotype-specific activity 
Za genotip specifična aktivnost
Bilirubin elevations occurred after initiation of treatment, peaked by study Week 1, and generally resolved with ongoing therapy. 
Zvišanje bilirubina se je pojavilo po uvedbi zdravljenja, vrh je doseglo 1. teden študije in je med nadaljevanjem zdravljenja običajno izginilo.
Deferasirox may increase dasabuvir exposures and should be used with caution. 
Deferasiroks lahko zveča izpostavljenost dasabuvirju in ga je treba uporabljati previdno.
It is not known whether the active substance in Exviera (dasabuvir), passes into breast milk. 
Ni znano ali učinkovina v zdravilu Exviera (dasabuvir) prehaja v materino mleko.
12 or 24 weeks N = 380 n (%) 
12 ali 24 tednov N = 380 n (%)
There is no pharmacokinetic information in patients >75 years. 
Farmakokinetičnih informacij za bolnike, starejše od 75 let, ni. Spol ali telesna masa
AbbVie (as logo) 
AbbVie (kot logotip)
AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment 
AFP* < 20 ng/ml, trombociti ≥ 90 x 109/l IN albumin ≥ 35 g/l pred zdravljenjem Da (za vse tri zgoraj naštete parametre)
Glucose levels of diabetic patients initiating direct acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medicinal products modified when necessary. 
Pri sladkornih bolnikih, ki so se začeli zdraviti z neposredno delujočim protivirusnim zdravilom, je treba zlasti v prvih treh mesecih skrbno spremljati ravni krvnega sladkorja ter po potrebi prilagoditi zdravilo za zdravljenje sladkorne bolezni.
The High Pure system assay had a lower limit of quantification (LLOQ) of 25 IU per mL and the AmpliPrep assay had a LLOQ of 15 IU per mL. 
Preizkus s sistemom High Pure System je imel spodnjo mejo kvantifikacije (LLOQ) 25 i.e./ml in preizkus z AmpliPrep 15 i.e./ml.
Genotype 1b N=7 % (n) 
Genotip 1b N = 7 % (n)
Note: For laboratory abnormalities refer to Table 4. 
Opomba: Za laboratorijske nepravilnosti glejte preglednico 4.
Cirrhosis was not a risk factor for elevated ALT (see section 4.4). 
Ciroza ni bila dejavnik tveganja za zvišanje ALT (glejte poglavje 4.4).
Dasabuvir is an inhibitor of BCRP in vivo. 
Dasabuvir zavira BCRP in vivo.
It is not known whether dasabuvir and metabolites are excreted in human breast milk. 
Ni znano, ali se dasabuvir in njegovi presnovki pri človeku izločajo v materino mleko.
Mechanism: possible enzyme induction by efavirenz. 
Možna indukcija encimov z efavirenzom.
Although ALT elevations associated with dasabuvir and ombitasvir/paritaprevir/ritonavir have been asymptomatic, patients should be instructed to watch for early warning signs of liver inflammation, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice and discoloured faeces, and to consult a doctor without delay if such symptoms occur. 
Čeprav so bila zvišanja ALT, povezana z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir, asimptomatska, je treba bolnikom naročiti, da morajo biti pozorni na zgodnje opozorilne znake vnetja jeter, npr. na utrujenost, šibkost, pomanjkanje apetita, navzeo in bruhanje, pa tudi na poznejše znake, npr. zlatenico, spremembo barve blata, in da se morajo v primeru pojava simptomov brez odlašanja posvetovati z zdravnikom.
TURQUOISE II (open-label) 
TURQUOISE II (odprta)
Dasabuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays. 
Dasabuvir ni bil genotoksičen v skupini preizkusov in vitro ali in vivo, vključno s preizkusom mutagenosti pri bakterijah, preizkusom kromosomskih aberacij na človeških limfocitih iz periferne krvi in v mikrojedrnem preizkusu in vivo pri podganah.
ANTIHYPERLIPIDAEMICS Gemfibrozil 
ANTIHIPERLIPEMIKI gemfibrozil
b. Includes subjects who discontinued due to adverse event, lost to follow-up or subject withdrawal, and subjects with reinfection 
b. Vključuje preiskovance, ki so prenehali z zdravljenjem zaradi neželenih učinkov, ki so jih prenehali spremljati v zvezi z neželenimi učinki ali pa so sami odstopili, in preiskovance, ki so se ponovno okužili.
d. Observed in combination in genotype 1b-infected subjects. 
d. Opaženo v kombinaciji pri preiskovancih, okuženih z genotipom 1b.
20-120 mg once daily8 
20-120 mg enkrat na dan8
Enzyme inducers: 
Induktorji encimov:
Clinical trials in treatment-naïve adults 
Klinična preskušanja pri še nezdravljenih odraslih
Dasabuvir had reduced activity in biochemical assays against NS5B polymerases from HCV genotypes 2a, 2b, 3a and 4a (IC50 values ranging from 900 nM to >20 μM). 
Dasabuvir je v biokemičnih preizkusih zmanjšal aktivnost proti NS5b polimerazam HCV genotipov 2a, 2b, 3a in 4a (vrednosti IC50 vrednosti od 900 nM do > 20 µM).
Dasabuvir has also been found to inhibit UGT1A4, 1A6 and intestinal UGT2B7 in vitro at in vivo relevant concentrations. 
Ugotovljeno je bilo tudi, da dasabuvir in vitro zavira UGT1A4, 1A6 in črevesni UGT2B7 pri koncentracijah, ki so pomembne in vivo.
Recommended co-administered medicinal product(s) and treatment duration for dasabuvir by patient population 
Preglednica 1: Priporočena sočasna zdravila in trajanje zdravljenja z dasabuvirjem po populacijah bolnikov
** When assessing severity of liver disease using non-invasive methods, a combination of blood biomarkers or the combination of liver stiffness measurement and a blood test improves accuracy and should be undertaken prior to 8 week treatment in all patients with moderate fibrosis. 
** Pri oceni resnosti bolezni jeter z uporabo neinvazivnih metod kombinacija krvnih biomarkerjev ali kombinacija meritev togosti jeter in krvnega testa poveča natančnost in jo je potrebno izvesti pred 8
Drug interactions need to be carefully taken into account in the setting of HIV co-infection (for details see section 4.5, Table 2). 
Pri bolnikih, ki so sočasno okuženi s HIV, je treba skrbno upoštevati medsebojna delovanja zdravil (za podrobnosti glejte poglavje 4.5, preglednico 2).
TURQUOISE III (open-label) 
TURQUOISE III (odprta)
In Part 2, SVR12 was achieved by 27/28 (96.4%) subjects with HCV GT4/HIV-1 coinfection (95% CI: 82.3%, 99.4%) with no virologic failures. 
V delu 2 je bil SVR12 dosežen pri 27/28 (96,4 %) preiskovancih s sočasno okužbo HCV GT4/HIV-1 (95 % CI: 82,3 %, 99,4 %) brez primerov virusne neodzivnosti na zdravljenje.
At steady-state the exposures ratio of M1 to dasabuvir is approximately 0.6. 
M1 v primerjavi z dasabuvirjem približno 0,6.
Dasabuvir should not be used in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see sections 4.2, 4.3, 4.8 and 5.2). 
Dasabuvir se ne sme uporabljati pri bolnikih z zmerno do hudo okvaro jeter (Child-Pugh B ali C) (glejte poglavja 4.2, 4.3, 4.8 in 5.2.
CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (Table 2). 
Med substrati CYP2C19, raziskanimi v študijah medsebojnega delovanja zdravil, sta omeprazol in escitalopram (preglednica 2).
For dosing recommendations with HIV antiviral medicinal products, refer to sections 4.4 and 4.5. 
Za priporočila o odmerjanju s protivirusnimi zdravili proti HIV glejte poglavji 4.4 in 4.5.
Use in diabetic patients 
Uporaba pri sladkornih bolnikih
Resistance to dasabuvir conferred by variants in NS5B selected in cell culture or identified in Phase 2b and 3 clinical trials were phenotypically characterised in the appropriate genotype 1a or 1b replicons. 
Odpornost proti dasabuvirju, povezana z variantami NS5B, selekcioniranih v celičnih kulturah ali identificiranih v kliničnih preskušanjih faze 2b in 3, so fenotipsko opredelili v ustreznih replikonih genotipa 1a ali 1b.
12 weeks N = 509 n (%) 
12 tednov N = 509 n (%)
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. 
so dobivali odmerek 1000 mg ribavirina na dan, če so tehtali manj kot 75 kg, oziroma odmerek 1200 mg na dan, če so tehtali 75 kg ali več.
Apalutamide, enzalutamide for prostate cancer ethinyloestradiol 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 
apalutamid, 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)
Patients who are taking ethinyloestradiol -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 dasabuvir with ombitasvir/paritaprevir/ritonavir therapy (see sections 4.3 and 4.5). 
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 dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir (glejte poglavji 4.3 in 4.5).
How long to take Exviera for 
Kako dolgo jemati zdravilo Exviera
• Read the “Contraception” section of the package leaflet for ribavirin very carefully. 
• V navodilih za uporabo za ribavirin natančno preberite poglavje »Kontracepcija«.
NA Clinical monitoring of patients is recommended. 
NP Bolnike je priporočljivo klinično nadzirati.
In Part 1b, SVR12 was achieved by 22/22 (100%) subjects (95% CI: 85.1%, 100%). 
V delu 1b je bil SVR12 dosežen pri 22/22 (100 %) preiskovancih (95 % CI:
Number of subjects treated 
Število zdravljenih preiskovancev
In contrast, the rate of ALT elevations in subjects using other types of oestrogens as typically used in hormonal replacement therapy (i.e., oral and topical oestradiol and conjugated oestrogens) was similar to the rate observed in subjects who were not using oestrogen-containing products (approximately 1% in each group). 
V nasprotju s tem so bila zvišanja ALT pri tistih, ki so uporabljale druge vrste estrogenov, kakršne so tipično sestavine hormonskega nadomestnega zdravljenja (tj. peroralni in lokalni estradiol in konjugirani estrogeni), opažena v podobnem deležu kot med neuporabnicami zdravil z estrogenom (približno 1 % v vsaki skupini).
Among the GT1 subjects who were post renal transplant, 9/12 (75%) achieved SVR12; however, there were no virologic failures. 
Izmed vseh GT1 preiskovancev, ki so prestali presaditev ledvic, jih je 9/12 (75 %) doseglo SVR12; vendar pa ni bilo virusne neodzivnosti.
Sirolimus dose and/or dosing frequency should be adjusted as needed. 
Odmerek sirolimusa in/ali pogostnost odmerjanja je potrebno ustrezno prilagoditi.
Enzyme inducers 
Induktorji encimov
HCV ANTIVIRAL Sofosbuvir 
PROTIVIRUSNA ZDRAVILA PROTI HCV sofosbuvir
The European Medicines Agency has deferred the obligation to submit the results of studies with dasabuvir and ombitasvir/paritaprevir/ritonavir in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use). 
Pediatrična populacija Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z dasabuvirjem in ombitasvir/paritaprevir/ritonavir za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje
Patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see section 5.2). 
Bolniki z zmerno do hudo okvaro jeter (Child-Pugh B ali C) (glejte poglavje 5.2).
Medicinal products that are strong CYP2C8 inhibitors may increase dasabuvir plasma concentrations and must not be co-administered with dasabuvir (see section 4.5). 
Zdravila, ki močno zavirajo CYP2C8, lahko zvečajo koncentracijo dasabuvirja v plazmi in se jih ne sme uporabljati sočasno z dasabuvirjem (glejte poglavje 4.5).
HIV ANTIVIRALS: PROTEASE INHIBITORS 
PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI PROTEAZ
Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, female subjects would have approximately 14 to 30% higher dasabuvir exposures than male subjects. 
Na podlagi populacijske farmakokinetične analize podatkov kliničnih študij 3. faze bi bila izpostavljenost preiskovank dasabuvirju približno 14 do 30 % večja kot izpostavljenost preiskovancev.
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 
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.
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. 
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.
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. 
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.
Multipack: 56 (4 packs of 14) film-coated tablets 
Večkratno pakiranje: 56 (4 škatle po 14) filmsko obloženih tablet
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. 
Zaradi neželenih učinkov je zdravljenje trajno prekinilo 0,2 % preiskovancev (5/2.044) in 4,8 % (99/2.044)
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. 
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.
The recommended co-administered medicinal product(s) and treatment duration for dasabuvir combination therapy are provided in Table 1. 
Priporočena sočasna zdravila in trajanje zdravljenja za kombinirano zdravljenje z dasabuvirjem so prikazana v preglednici 1.
Avoid concomitant use of tacrolimus or sirolimus with dasabuvir and ombitasvir/paritaprevir/ritonavir unless the benefits outweigh the risks. 
Izogibajte se sočasni uporabi takrolimusa ali sirolimusa z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir, razen kadar koristi uporabe prevladajo nad tveganji.
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). 
Če je med obdobjem zdravljenja potrebno zdravljenje z rosuvastatinom, sme biti največji dnevni odmerek rosuvastatina 5 mg (glejte poglavje 4.5, preglednico 2).
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. 
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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of multipack of 14 film-coated tablets - without blue box 
PODATKI NA ZUNANJI OVOJNINI Notranja škatla (večkratno pakiranje) s 14 filmsko obloženimi tabletami - brez modrega okenca
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. 
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.
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. 
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.
Table 16. 
NAVODILA ZA UPORABO 16.
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). 
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).
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. 
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.
No genotype 1b infected subjects had treatment-emergent variants in all 3 drug targets. 
Noben preiskovanec, okužen z genotipom 1b, ni imel med zdravljenjem nastalih variant pri vseh 3 tarčnih genih zdravil.
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. 
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.
Co-administration of dasabuvir with medicinal products that inhibit CYP2C8 (e.g. teriflunomide, deferasirox) may increase dasabuvir plasma concentrations. 
Sočasna uporaba dasabuvirja z zdravili, ki zavirajo CYP2C8 (npr. teriflunomid, deferasiroks), lahko zveča koncentracijo dasabuvirja v plazmi.
Dasabuvirderived material was minimally transferred through the placenta in pregnant rats. 
Iz dasabuvirja nastale snovi so minimalno prehajale skozi placento brejih podgan.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Exviera. 
Če kar koli od zgoraj navedenega velja za vas (ali če ste negotovi), se pred začetkom jemanja zdravila
24 weeks n/N % CIa n/N % CIa 
24 tednov n/N % IZa n/N % IZa
If you are not sure, talk to your doctor or pharmacist before taking Exviera. 
Če ste negotovi, se pred začetkom jemanja zdravila Exviera posvetujte z zdravnikom ali farmacevtom.
Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment. 
Vezava na beljakovine v plazmi pri bolnikih z okvaro ledvic ali jeter ni pomembno spremenjena.
Package leaflet: Information for the patient Exviera 250 mg film-coated tablets dasabuvir This medicine is subject to additional monitoring. 
Navodilo za uporabo Exviera 250 mg filmsko obložene tablete dasabuvir Za to zdravilo se izvaja dodatno spremljanje varnosti.