natgillin/translations-raw huggingface dataset:
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Viekirax. 
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Viekirax, nizke ravni sladkorja v krvi
ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4) 
(3. stopnja) > 20 × ZNM (4. stopnja)
In this combination, the maximum daily dose of rosuvastatin should be 10 mg (see section 4.5, Table 2). 
V tej kombinaciji sme biti največji dnevni odmerek rosuvastatina 10 mg (glejte poglavje 4.5, preglednico 2).
Sirolimus 0.5 mg single dose5 
sirolimus 0,5 mg enkratni odmerek5
• alfuzosin hydrochloride 
• alfuzosinijev klorid
Liver transplant subjects with cirrhosis were dosed with Viekirax and dasabuvir with RBV (GT1a for 24 weeks [n=4], GT1b for 12 weeks [n=2]). 
Preiskovanci s presajenimi jetri z cirozo so prejemali zdravilo Viekirax in dasabuvir z RBV (GT1a 24 tednov [n=4], GT1b 12 tednov [n=2]).
Concomitant use of tacrolimus with Viekirax and dasabuvir is not recommended unless the benefits outweigh the risks (see section 4.4). 
Sočasna uporaba takrolimusa z zdravilom Viekirax in dasabuvirjem ni priporočljiva, razen kadar koristi prevladajo nad tveganji (glejte poglavje 4.4).
Paritaprevir is an inhibitor of the hepatic uptake transporters OATP1B1 and OATP1B3, and paritaprevir and ritonavir are inhibitors of OATP2B1. 
Paritaprevir zavira jetrna privzemna prenašalca OATP1B1 in OATP1B3, paritaprevir in ritonavir pa zavirata OATP2B1.
Cross-resistance is expected among NS5A inhibitors, NS3/4A protease inhibitors, and non-nucleoside NS5B inhibitors by class. 
Po skupini je mogoče navzkrižno odpornost pričakovati med zaviralci NS5A, zaviralci proteaz NS3/4A in nenukleozidnimi zaviralci NS5B.
The mean EC50 of paritaprevir against replicons containing NS3 from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.86 nM (range 0.43 to 1.87 nM; n=11) and 0.06 nM (range 0.03 to 0.09 nM; n=9), respectively. 
Povprečna EC50 paritaprevirja proti replikonom, ki so vsebovali NS3 iz skupine izolatov še nezdravljenih bolnikov z genotipom 1a in 1b, je bila v preizkusu replikonske celične kulture HCV 0,86 nM (razpon od 0,43 do 1,87 nM, n = 11) za 1a in 0,06 nM (razpon od 0,03 do 0,09 nM, n = 9) za 1b.
Some patients have reported feeling very tired when taking Viekirax with other medicines for their hepatitis C infection. 
Nekateri bolniki so poročali o hudi utrujenosti med jemanjem zdravila Viekirax in drugih zdravil za zdravljenje hepatitisa C. Če ste utrujeni, ne vozite ali upravljajte stroje.
Table 2. 
preglednico 2).
Nifedipine Mechanism: CYP3A4 inhibition 
nifedipin Mehanizem: Zavrtje CYP3A4
PHARMACEUTICAL FORM AND CONTENTS 
SEZNAM POMOŽNIH SNOVI FARMACEVTSKA OBLIKA IN VSEBINA
Effect of baseline HCV substitutions/polymorphisms on treatment outcome A pooled analysis of subjects with genotype 1 HCV infection, who were treated with ombitasvir, paritaprevir, and dasabuvir (a non-nucleotide NS5B inhibitor) with or without ribavirin in the Phase 2b and 3 clinical trials was conducted to explore the association between baseline NS3/4A, NS5A or NS5B substitutions/polymorphisms and treatment outcome in recommended regimens. 
Opravljena je bila kumulativna analiza preiskovancev, okuženih s HCV genotipa 1, ki so bili zdravljeni z ombitasvirjem, paritaprevirjem in dasabuvirjem (nenukleozidnim zaviralcem NS5B), z ribavirinom ali brez njega, v kliničnih preskušanjih faze 2b in 3, za preučitev vpliva izhodiščnih substitucij/polimorfizmov NS3/4A, NS5A oziroma NS5B na izid zdravljenja pri priporočenih shemah.
Mechanism: CYP3A4 induction apalutamide enzalutamide or mitotane. 
Indukcija CYP3A4 z apalutamidom, enzalutamidom ali mitotanom
Tacrolimus or sirolimus whole blood concentrations should be monitored upon initiation and throughout co-administration with Viekirax and dasabuvir and the dose and/or dosing frequency should be adjusted as needed. 
Koncentracije takrolimusa ali sirolimusa v polni krvi je potrebno spremljati na začetku in vseskozi med sočasno uporabo z zdravilom Viekirax in dasabuvirjem, odmerek in/ali pogostnost odmerjanja je potrebno ustrezno prilagoditi.
Medicinal products renally excreted via transport proteins Ombitasvir, paritaprevir, and ritonavir do not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate). 
Ombitasvir, paritaprevir in ritonavir in vivo ne zavirajo prenašalca organskih anionov (OAT1), kar se kaže z odsotnostjo medsebojnega delovanja s tenofovirjem (substrat OAT1).
In Part 2, subjects with HCV GT1 received Viekirax and dasabuvir with or without ribavirin for 12 or 24 weeks. 
V delu 2 so preiskovanci s HCV GT1 prejemali zdravilo Viekirax in dasabuvir z ali brez ribavirina 12 ali 24 tednov.
In Part 1b, all subjects received Viekirax and dasabuvir with ribavirin for 12 weeks. 
V delu 1b so vsi preiskovanci prejemali zdravilo Viekirax in dasabuvir z ribavirinom 12 tednov.
Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, a 10 year increase or decrease in age from 54 years (median age in the Phase 3 studies) would result in approximately 10% 
Na osnovi analize populacijske farmakokinetike iz kliničnih študij 3. faze bi 10-letno povečanje ali zmanjšanje starosti od 54 let (mediana starost v študijah 3. faze) imela za posledico približno 10 % spremembo izpostavljenosti ombitasvirju in ≤ 20 % spremembo izpostavljenosti paritaprevirju.
Viekirax is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see sections 4.2, 4.3, 4.8 and 5.2). 
Zdravilo Viekirax je kontraindicirano pri bolnikih z zmerno do hudo okvaro jeter (Child-Pugh B ali C) (glejte poglavja 4.2, 4.8 in 5.2.
In genotype 1a, substitutions F43L, R155K, A156T, and D168A/F/H/V/Y in HCV NS3 reduced susceptibility to paritaprevir. 
Pri genotipu 1a so substitucije F43L, R155K, A156T in D168A/F/H/V/Y v genu NS3 HCV zmanjšale občutljivost za paritaprevir.
In vitro studies show that ombitasvir, paritaprevir, and ritonavir are not inhibitors of organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations. 
Študije in vitro kažejo, da ombitasvir, paritaprevir in ritonavir v klinično pomembnih koncentracijah ne zavirajo prenašalcev organskih kationov (OCT2), prenašalcev organskih anionov (OAT3) ali ekstruzijskih beljakovin več zdravil in toksinov (MATE1 in MATE2K).
Side effects when taking Viekirax with dasabuvir and ribavirin: 
Neželeni učinki pri jemanju zdravila Viekirax z dasabuvirjem in ribavirinom:
800/160 mg twice daily 
800/160 mg dvakrat na dan
Each carton contains 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each). 
Ena škatla vsebuje 56 tablet (večkratno pakiranje, ki vsebuje 4 škatle, vsaka s po 14 tabletami).
Viekirax tablets are usually taken with other anti-viral medicines such as “dasabuvir” and “ribavirin”. 
Tablete zdravila Viekirax se običajno jemljejo z drugimi protivirusnimi zdravili, kot sta “dasabuvir” in
The combination was not linked to any particular safety issues in a limited set of patients treated for 12-24 weeks. 
Pri majhnem številu bolnikov, zdravljenih od 12 do 24 tednov, kombinacije niso spremljale kakšne posebne težave z varnostjo.
Paritaprevir -derived material was minimally transferred through the placenta in pregnant rats. 
Iz paritaprevirja nastale snovi so minimalno prehajale skozi placento brejih podgan.
Viekirax with ribavirin & without dasabuvir was evaluated for 12 weeks in genotype 1 treatment naive and treatment experienced non-cirrhotic subjects in a phase 2 study M11-652 (AVIATOR). 
Zdravilo Viekirax z ribavirinom in brez dasabuvirja so preučevali 12 tednov pri preiskovancih, okuženih z genotipom 1, brez ciroze, in sicer takih, ki še niso bili zdravljeni kot tudi takih, ki so že bili zdravljeni v študiji 2. faze M11-652 (AVIATOR).
Trazodone should be used with caution and a lower dose of trazodone may be considered. 
Trozadon naj se uporablja previdno, v poštev pridejo manjši odmerki.
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 Viekirax and dasabuvir with or without ribavirin. 
tednih zdravljenja, brez hkratnega zvišanja bilirubina; znižala so se v približno dveh tednih po začetku stalne uporabe zdravila Viekirax z dasabuvirjem, z ribavirinom ali brez njega.
The highest documented single dose administered to healthy volunteers was 400 mg for paritaprevir (with 100 mg ritonavir), 200 mg for ritonavir (with 100 mg paritaprevir) and 350 mg for ombitasvir. 
Največji dokumentirani enkratni odmerek, uporabljen pri zdravih prostovoljcih, je bil za paritaprevir 400 mg (s 100 mg ritonavirja), za ritonavir 200 mg (s 100 mg paritaprevirja) in za ombitasvir 350 mg. S paritaprevirjem, ritonavirjem ali ombitasvirjem niso opažali s študijo povezanih neželenih učinkov.
Elderly No dose adjustment of Viekirax is warranted in elderly patients (see section 5.2). 
Starejši bolniki Starejšim bolnikom odmerkov zdravila Viekirax ni treba prilagoditi (glejte poglavje 5.2).
The European Medicines Agency has deferred the obligation to submit the results of studies with Viekirax 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). 
Viekirax za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with Viekirax with dasabuvir. 
300 mg brez ritonavirja, v kombinaciji z zdravilom Viekirax in dasabuvirjem.
Cyclobenzapr ine 5 mg single dose 
ciklobenzaprin Posamezni odmerek 5 mg
Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim 
Mehanizem: Možno povečanje dasabuvirja zaradi zavrtja CYP2C8 s trimetoprimom.
In the 8.5% of subjects who had ribavirin dose adjustments during therapy, the SVR rate (98.5%) was comparable to subjects who maintained their starting ribavirin dose throughout treatment. 
je bil delež SVR (98,5 %) primerljiv tistemu med preiskovanci, ki so začetni odmerek ribavirina ohranili ves čas zdravljenja.
In the genotype 1a replicon, the activity of ombitasvir was reduced by 896-, 58- and 243-fold against the M28T/V and H58D substitutions, respectively, and 1326-, 800-, 155-foldand 1675- to 66740- fold by the Q30E/R, L31V and Y93C/H/N substitutions, respectively. 
H58D zmanjšale aktivnost ombitasvirja za 896-,58- in 243-krat, substitucije Q30E/R, L31V in Y93C/H/N pa za 1326-, 800-, 155-krat in 1675- do 66740-krat.
*Note: Follow the genotype 1a dosing recommendations in patients with an unknown genotype 1 subtype or with mixed genotype 1 infection. 
12 tednov *Opomba: Pri bolnikih z neznano podvrsto genotipa 1 ali z mešano okužbo z genotipom 1 upoštevajte priporočila za odmerjanje pri genotipu 1a.
Dose normalized sirolimus ratios are shown for interaction with Viekirax + dasabuvir. 
Za odmerek normalizirana razmerja sirolimusa so prikazana za medsebojno delovanje z zdravilom Viekirax + dasabuvir.
Note: Doses used for Viekirax and dasabuvir were: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily. 
Opomba: Uporabljeni odmerki zdravila Viekirax in dasabuvirja so bili: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg enkrat na dan in dasabuvir 400 mg dvakrat na dan ali 250 mg dvakrat na dan. Izpostavljenosti dasabuvirju, ki so bile dosežene pri 400 mg formulaciji in 250 mg tableti so podobne.
Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir. 
Mehanizem: morda zavrtje UGT1A1 s paritaprevirjem, ombitasvirjem in dasabuvirjem.
The following section describes the specific transporters and metabolizing enzymes that are affected by Viekirax with or without dasabuvir. 
Naslednje poglavje opisuje specifične prenašalce in presnovne encime, na katere vpliva zdravilo Viekirax
SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis 
SAPPHIRE-I - genotip 1, še nezdravljeni, brez ciroze
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of multipack of 14 film-coated tablets - without blue box 
Notranja škatla (večkratno pakiranje) vsebuje 14 filmsko obloženih tablet -brez modrega okenca IME ZDRAVILA
Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects. 
Med zdravljenjem s paritaprevirjem nastale variante V36A/M, R155K ali D168V gena NS3 so ugotovili pri 47 preiskovancih.
If you are not sure, talk to your doctor or pharmacist before taking Viekirax. 
Če ste negotovi, se pred začetkom jemanja zdravila Viekirax posvetujte z zdravnikom ali farmacevtom.
Overall SVR12 HCV genotype 1a Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers HCV genotype 1b Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers Outcome for subjects without SVR12 On-treatment VF Relapse Other a. 97.5% confidence intervals are used for the primary efficacy endpoints (overall SVR12 rate); 95% confidence intervals are used for additional efficacy endpoints (SVR12 rates in HCV genotype 1a and 1b-infected subjects). 
Celotni SVR12 HCV genotip 1a Še nezdravljeni Predhodno brez odziva na pegIFN/RBV Predhodno delno odzivni na pegIFN/RBV Predhodno recidiv ob pegIFN/RBV HCV genotip 1b Še nezdravljeni Predhodno brez odziva na pegIFN/RBV Predhodno delno odzivni na pegIFN/RBV Predhodno recidiv ob pegIFN/RBV Izid pri preiskovancih brez SVR12 VN med zdravljenjem 1/208 0,5 Recidiv Drugo a. Za primarne opazovane dogodke učinkovitosti (celotni delež SVR12) so uporabljeni 97,5 % intervali zaupanja; za dodatne opazovane dogodke učinkovitosti (deleži SVR12 pri preiskovancih, okuženih s
The mean EC50 of ombitasvir against replicons containing NS5A from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.66 pM (range 0.35 to 0.88 pM; n=11) and 1.0 pM (range 0.74 to 1.5 pM; n=11), respectively. 
Povprečna EC50 ombitasvirja proti replikonom, ki so vsebovali NS5A iz skupine izolatov še nezdravljenih bolnikov z genotipom 1a in 1b, je bil v preizkusu replikonske celične kulture HCV 0,66 pM (razpon od 0,35 do 0,88 pM, n = 11) za 1a in 1,0 pM (razpon od 0,74 do
Methadone ↔ paritaprevir /ombitasvir/dasabuvir (based on the cross study comparison) 
↔ S-metadon ↔ paritaprevir/ombitasvir/dasabuvir (na podlagi primerjave med študijami)
Viekirax and dasabuvir with RBV for 12 weeks n/N % 95% CI 
Viekirax in dasabuvir z RBV 12 tednov n/N % 95 % IZ
Ethinyloestradiolcontaining oral contraceptives are contraindicated (see section 4.3). 
Peroralni kontraceptivi z etinilestradiolom so kontraindicirani (glejte poglavje 4.3).
NA No dose adjustment is necessary for zolpidem. 
NA Prilagoditev odmerka zolpidema ni potrebna.
CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (see Table 2). 
Med substrati CP2C19, raziskanimi v študijah medsebojnega delovanja zdravil, sta omeprazol in escitalopram (glejte preglednico 2).
Treatment with atazanavir + Viekirax without dasabuvir is not recommended-(↑ paritaprevir). 
Zdravljenje z atazanavirjem in zdravilom Viekirax brez dasabuvirja ni priporočljivo - (↑
4.8 Undesirable effects 
4.8 Neželeni učinki Povzetek varnostnih značilnosti
Two patients discontinued Viekirax and dasabuvir due to elevated ALT, including one on ethinyloestradiol. 
Zaradi zvišanja ALT sta zdravilo Viekirax in dasabuvir prenehali uporabljati dve osebi; ena od njiju je dobivala etinilestradiol.
Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 18% to 21% higher ombitasvir exposures, and 37% to 39% higher paritaprevir exposures than non-Asian subjects. 
Na osnovi analize populacijske farmakokinetike iz kliničnih študij 3. faze so imeli aziati od 18 % do 21 %
The interaction between Viekirax with or without dasabuvir and colchicine has not been evaluated. 
Medsebojno delovanje med zdravilom Viekirax z dasabuvirjem ali brez njega ter kolhicinom ni ovrednoteno.
In patients with renal or hepatic impairment, use of colchicine with Viekirax with or without dasabuvir is contraindicated (see sections 4.3 and 4.5). 
Pri bolnikih z okvaro ledvic ali jeter je uporaba kolhicina skupaj z zdravilom Viekirax z dasabuvirjem ali brez njega kontraindicirana (glejte poglavji 4.3 in 4.5).
In Part 1a, all subjects received Viekirax and dasabuvir with ribavirin for 12 or 24 weeks. 
V delu 1a so vsi preiskovanci prejemali zdravilo Viekirax in dasabuvir z ribavirinom 12 ali 24 tednov.
Package leaflet: Information for the patient Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir This medicine is subject to additional monitoring. 
Navodilo za uporabo Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete ombitasvir/paritaprevir/ritonavir Za to zdravilo se izvaja dodatno spremljanje varnosti.
NA If clinically indicated higher doses of omeprazole should be used. 
NP Če je klinično indicirano, uporabite večje odmerke omeprazola.
Arm B: Viekirax and dasabuvir + RBV (24 weeks) 
Skupina B: Viekirax in dasabuvir + RBV (24 tednov)
Medicinal products that inhibit CYP3A4 and transport proteins Paritaprevir is eliminated via CYP3A4 mediated metabolism and biliary excretion (substrate of the hepatic transporters OATP1B1, P-gp and BCRP). 
Paritaprevir se odstranjuje s presnovo, ki poteka preko CYP3A4, in z izločanjem v žolču (substrat jetrnih prenašalcev OATP1B1, P-gp in BCRP).
600/300 mg once daily 
600/300 mg enkrat na dan
In all eight trials, the Viekirax dose was 25 mg/150 mg/100 mg once daily and the dasabuvir dose was 250 mg twice daily. 
V vseh osmih preskušanjih je bil odmerek zdravila Viekirax 25 mg/150 mg/100 mg enkrat na dan in odmerek dasabuvirja 250 mg dvakrat na dan. Preiskovanci, ki so dobivali ribavirin, so dobivali odmerek
Contraindicated enzyme inducers are provided in section 4.3 and Table 
Primeri kontraindiciranih induktorjev encimov so navedeni v poglavju 4.3 in preglednici 2.
Ombitasvir-derived material was minimally transferred through the placenta in pregnant rats. 
Iz ombitasvirja nastale snovi so minimalno prehajale skozi placento brejih podgan.
Co-administration of Viekirax with or without dasabuvir with strong inhibitors of CYP3A may increase paritaprevir concentrations (see section 4.3 and Table 2). 
Sočasna uporaba zdravila Viekirax z dasabuvirjem ali brez njega skupaj z močnimi zaviralci CYP3A lahko poveča koncentracijo paritaprevirja (glejte poglavje 4.3 in preglednico 2).
Not studied; No interaction expected when gemfibrozil is used in combination with Viekirax without dasabuvir. 
brez interakcije, če je gemfibrozil uporabljen v kombinaciji z zdravilom Viekirax brez dasabuvirja.
Treated subjects (N=68) had a median age of 58 years (range: 32-77 years); 83.8% were male; 58.8% were Black; 73.5% of subjects were infected with HCV GT1a; 75.0%% had Stage 5 CKD and 69.1% were on haemodialysis. 
Zdravljeni preiskovanci (N = 68) so imeli povprečno starost 58 let (razpon: 32-77 let); 83,8 % je bilo moških; 58,8 % je bilo črne rase; 73,5 % preiskovancev je bilo okuženih s HCV GT1a; 75,0 % je imelo
Sirolimus 2 mg was dosed alone, 0.5 mg administered with Viekirax + dasabuvir. 
Sirolimus 2 mg je bil uporabljen samostojno, odmerek 0,5 mg pa skupaj z zdravilom Viekirax + dasabuvir.
The efficacy of Viekirax in patients previously exposed to Viekirax, or to medicinal products of the same classes as those of Viekirax (NS3/4A inhibitors or NS5A inhibitors), has not been demonstrated. 
Viekirax ali zdravilom iz iste skupine, v katero spada zdravilo Viekirax (zaviralci NS3/4A ali zaviralci NS5A).
randomised, global multicentre, double-blind, regimen-controlled 
Oblika preskušanja: randomizirano, globalno, multicentrično, dvojno slepo, s kontrolirano shemo
5 subjects required erythropoietin, all of whom initiated ribavirin at the starting dose of 1000 to 1200 mg daily. 
5 preiskovancev je potrebovalo eritropoetin; pri vseh se je zdravljenje z ribavirinom začelo z odmerkom od 1000 do 1200 mg na dan. Noben preiskovanec ni dobil transfuzije krvi.
ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 8-57 days) and most resolved with ongoing therapy. 
Z drugimi vrstami estrogenov, ki se pogosto uporabljajo za hormonsko nadomestno zdravljenje (npr. z estradiolom in konjugiranimi estrogeni), niso opažali večje incidence zvišanj ALT. Zvišanja ALT so bila praviloma asimptomatska, po navadi so se pojavila v prvih 4 tednih zdravljenja (povprečni čas 20 dni, razpon od 8 do 57 dni) in so večinoma minila med nadaljevanjem zdravljenja.
Primary SVR12 Assessment for Part 2 Subjects with HCV GT1/HIV-1 co-infection in TURQUOISE-I 
Preglednica 17: Primarna SVR12 ocena za del 2, preiskovanci, sočasno okuženi s HCV GT1/HIV-1, v študiji TURQUOISE-I
Ombitasvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (150 mg/kg/day), resulting in ombitasvir AUC exposures approximately 26-fold higher than those in humans at the recommended clinical dose of 25 mg. 
Ombitasvir ni bil kancerogen v 6-mesečni študiji pri transgenskih miših vse do največjega testiranega odmerka (150 mg/kg/dan), ki je povzročil približno 26-krat večjo AUC izpostavljenost ombitasvirju, kot je dosežena pri človeku ob priporočenem kliničnem odmerku 25 mg.
How to take Viekirax 
Kako jemati zdravilo Viekirax
These medicinal products may show clinically relevant increases in exposures of paritaprevir (e.g., ritonavir with atazanavir, erythromycin, diltiazem or verapamil). 
(npr. ritonavir z atazanavirjem, eritromicin, diltiazem ali verapamil).
Viekirax + dasabuvir amlodipine 
Viekirax + dasabuvir amlodipin
St. John's Wort (hypericum perforatum) 
šentjanževka (hypericum perforatum)
Duloxetine 60 mg single dose 
paritaprevir duloksetin enkraten odmerek 60 mg
Treatment-naïve Without RBV 
Še nezdravljeni Brez RBV
The activity of paritaprevir was attenuated 24 to 27 -fold in the presence of 40% human plasma. 
V prisotnosti 40 % človeške plazme je aktivnost paritaprevirja oslabela za 24- do 27-krat.
OATP1B1 inhibition by paritaprevir. 
OATP1B1 z paritaprevirjem.
NA No dose adjustment required for carisoprodol; increase dose if clinically indicated. 
NP Prilagoditev odmerka karisoprodola ni potrebna; povečajte odmerek, če je klinično indicirano.
NA No dose adjustment is necessary for duloxetine. 
NP Prilagoditev odmerka duloksetina ni potrebna.
The treatment-experienced subjects studied were primarily pegIFN/RBV null responders. 
so bili primarno neodzivni na pegIFN/RBV.
While no change to the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists. 
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 Viekirax + dasabuvir.
Arm A: Viekirax and dasabuvir + RBV (12 weeks) 
Skupina A: Viekirax in dasabuvir + RBV (12 tednov)
Treatment-emergent amino acid substitutions in the pooled analysis of Viekirax and dasabuvir with and without RBV regimens in Phase 2b and Phase 3 clinical trials (N=2510) 
Preglednica 5: Med zdravljenjem nastale aminokislinske substitucije v kumulativni analizi shem z zdravilom Viekirax in dasabuvirjem (z RBV ali brez njega) v kliničnih preskušanjih faze 2b in 3
SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatmentnaïve or previously treated with pegIFN/RBV 
Preglednica 13: 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.