FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be informed that fatigue has been reported during treatment with dasabuvir in combination with ombitasvir/paritaprevir/ritonavir and ribavirin (see section 4.8).
Slovak: Je potrebné informovať pacientov, že počas liečby dasabuvirom v kombinácii s ombitasvirom/paritaprevirom/ritonavirom a ribavirínom bola hlásená únava (pozri časť 4.8). 4.8 Nežiaduce účinky
English: A pooled analysis of subjects with genotype 1 HCV infection, who were treated with dasabuvir, ombitasvir and paritaprevir with or without ribavirin in 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 these recommended regimens.
Slovak: Súhrnná analýza pacientov s infekciou HCV genotypu 1 liečených dasabuvirom, ombitasvirom a paritaprevirom s ribavirínom alebo bez neho v klinických skúšaniach fázy 2b a 3 bola vykonaná s cieľom preskúmať vzťah medzi východiskovými substitúciami/polymorfizmami NS3/4A, NS5A
English: Side effects when taking Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin:
Slovak: Vedľajšie účinky, keď sa užíva Exviera a ombitasvir/paritaprevir/ritonavir s ribavirínom:
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.
Slovak: (N = 63) mali medián veku 51 rokov (rozsah: 31 až 69); 24 % boli černosi; 19 % malo kompenzovanú cirhózu; 67 % pacientov bolo predtým neliečených u 33 % zlyhala predchádzajúca liečba pomocou pegIFN/RBV; 89 % malo infekciu HCV genotypu 1a.
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see section 5.2).
Slovak: B alebo C podľa Childa-Pugha) (pozri časť 5.2).
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral treatment.
Slovak: (direct acting antiviral, DAA) zlepšiť kontrola glykémie, čo môže potenciálne viesť k symptomatickej hypoglykémii.
English: 0.75 mg single dose
Slovak: 0,75 mg jednorazová dávka
English: In genotype 1a, substitutions C316Y, M414T, Y448H, A553T, G554S, S556G/R, and Y561H in HCV NS5B reduced susceptibility to dasabuvir.
Slovak: V prípade genotypu 1a mala substitúcia C316Y, M414T, Y448H, A553T, G554S, S556G/R a Y561H v NS5B HCV zníženú citlivosť na dasabuvir.
English: • St. John's Wort (Hypericum perforatum)
Slovak: • ľubovník bodkovaný (Hypericum perforatum).
English: Beginning the day after dasabuvir and ombitasvir/paritaprevir/ ritonavir are initiated; reinitiate tacrolimus at a reduced dose based on tacrolimus blood concentrations.
Slovak: Nasledujúci deň po začatí liečby dasabuvirom a ombitasviromu/paritaprevirom/ritonavirom začnite opäť podávať takrolimus v zníženej dávke podľa koncentrácie takrolimu v krvi.
English: SVR12 for Genotype 1b-infected treatment-naïve subjects without cirrhosis dasabuvir and ombitasvir/paritaprevir/ritonavir for 8 weeks n/N (%)
Slovak: Tabuľka 10. SVR12 u predtým neliečených pacientov s infekciou genotypu 1b bez cirhózy dasabuvir a ombitasvir/paritaprevir/ritonavir počas 8 týždňov n/N
English: Ritonavir dose in ombitasvir/paritaprevir/ ritonavir will provide atazanavir pharmacokinetic enhancement.
Slovak: Dávka ritonaviru v ombitasvire/paritaprevire/ritonavire bude zlepšovať farmakokinetiku atazanaviru.
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Slovak: Tabuľka 11. SVR12 u pacientov v minulosti liečených peginterferónom + ribavirínom infikovaných genotypom 1 v štúdii SAPPHIRE-II
English: SAPPHIRE-II - genotype 1, pegIFN+RBV-experienced, without cirrhosis
Slovak: SAPPHIRE-II - genotyp 1, predtým liečení pegIFN + RBV, bez cirhózy
English: Pitavastatin
Slovak: Pitavastatín
English: Also see section 4.6.
Slovak: EKG, pozri časť 4.4.
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, dasabuvir and ombitasvir and CYP3A4 inhibition by ritonavir dasabuvi r + ombitas vir/parit aprevir/r itonavir dolutegravir
Slovak: Mechanizmus: pravdepodobne v dôsledku inhibície UGT1A1 paritaprevirom, dasabuvirom a ombitasvirom a inhibície CYP3A4 ritonavirom dasabuvir + ombitasvir/ paritaprevir/ ritonavir dolutegravir
English: Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects.
Slovak: Mutácie V36A/M, R155K alebo D168V, ktoré sa objavili počas liečby paritaprevirom, boli pozorované v NS3
English: See leaflet for further information.
Slovak: Túto písomnú informáciu si uschovajte.
English: Co-administration of dasabuvir with medicinal products that are strong or moderate enzyme inducers is expected to decrease dasabuvir plasma concentrations and reduce its therapeutic effect (see section 4.5.
Slovak: Predpokladá sa, že súbežné podávanie dasabuviru s liekmi, ktoré sú silnými alebo stredne silnými induktormi enzýmov by viedlo k zníženiu jeho terapeutického účinku (pozri čať 4.5).
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.
Slovak: Súhrn bezpečnostného profilu U pacientov užívajúcich dasabuvir a ombitasvir/paritaprevir/ritonavir s ribavirínom boli najčastejšie hlásenými nežiaducimi účinkami (viac ako 20 % pacientov) únava a nevoľnosť.
English: Dasabuvir treatment-emergent variants M414T, G554S, S556G, G558R or D559G/N in NS5B were observed in 34 subjects.
Slovak: Mutácie M414T, G554S, S556G, G558R alebo D559G/N v NS5B, ktoré sa objavili počas liečby dasabuvirom, boli pozorované u 34 pacientov.
English: How to take
Slovak: PODĽA SPÔSOBU
English: Efavirenz/ emtricitabine / tenofovir disoproxil fumarate mg once daily
Slovak: Efavirenz/ emtricitabín/ tenofovir dizoproxilfumarát
English: If tacrolimus with dasabuvir and ombitasvir/paritaprevir/ ritonavir are used concomitantly, tacrolimus should not be administered on the day dasabuvir and ombitasvir/paritaprevir/ ritonavir are initiated.
Slovak: Pri súbežnom používaní takrolimu s dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom sa takrolimus nemá podávať v deň začatia liečby dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom.
English: open-label, single-arm, global multicentre
Slovak: otvorené, jednoramenné, globálne multicentrické
English: Clinical monitoring and dose adjustment may be needed for other CYP1A2 substrates (e.g. ciprofloxacin, cyclobenzaprine, theophylline and caffeine).
Slovak: U iných substrátov CYP1A2 (napr. ciprofloxacín, cyklobenzaprin, teofylín a kofeín) môže byť potrebné klinické sledovanie a úprava dávky.
English: If the combination is used, repeated ECGmonitoring should be done, see section 4.4.
Slovak: Ak sa táto kombinácia používa, je nutné vykonávať opakované monitorovanie cestou
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.
Slovak: Súbežné podávanie dasabuviru s ombitasvirom/paritaprevirom/ritonavirom môže viesť k zmene funkcie pečene, odporúča sa pravidelne sledovať hodnoty medzinárodného normalizovaného pomeru
English: Exviera 250 mg film-coated tablets dasabuvir
Slovak: Exviera 250 mg filmom obalené tablety dasabuvir
English: increase in HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment.
Slovak: 25 IU/ml v priebehu liečby, potvrdený nárast o 1 log10 IU/ml v HCV RNA z najnižšej úrovne alebo HCV RNA trvalo ≥ 25 IU/ml pri liečbe trvajúcej aspoň 6 týždňov.
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).
Slovak: Podrobnosti o substrátoch OATP1B1, OATP1B3 a rovnako a OATP2B1 pozri v súhrne charakteristických vlastností pre ombitasvir/paritaprevir/ritonavir (pozri aj tabuľku 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.
Slovak: Účinnosť a bezpečnosť dasabuviru v kombinácii s ombitasvirom/paritaprevirom/ritonavirom s ribavirínom alebo bez neho bola hodnotená v ôsmich randomizovaných klinických skúšaniach fázy 3, vrátane dvoch štúdií výhradne u pacientov s kompenzovanou cirhózou (trieda
English: PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis Design:
Slovak: PEARL-II - genotyp 1b, predtým liečení pegIFN + RBV, bez cirhózy Dizajn:
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
Slovak: Tabuľka 18. Geometrický priemer Cmax, AUC opakovaných dávok dasabuviru 250 mg dvakrát denne a ombitasviru/paritapreviru/ritonaviru 25 mg/150 mg/100 mg jedenkrát denne s jedlom u zdravých dobrovoľníkov
English: ANTICANCER AGENTS
Slovak: ANTITUBERKULOTIKÁ
English: randomised, global multicentre, double-blind, regimen-controlled
Slovak: randomizované, globálne multicentrické, dvojito zaslepené, s kontrolovaným režimom
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.
Slovak: Celkovú koncentráciu takrolimu v krvi je potrebné monitorovať na začiatku a počas súbežného podávania s dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom a dávka a/alebo frekvencia dávkovania sa má upraviť podľa potreby.
English: Genotype 1b N=7 % (n)
Slovak: Genotyp 1b N =
English: Overall, 37 (97.4%) of 38 subjects achieved SVR12.
Slovak: %) z 38 pacientov dosiahlo SVR12.
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.
Slovak: V ďalšej otvorenej štúdii fázy 3b, ktorá hodnotila 12 týždňov liečby ombitasvirom/paritaprevirom/ritonavirom s dasabuvirom alebo bez neho a bez RBV u pacientov infikovaných GT1a a GT4 bez cirhózy, bez predchádzajúcej liečby, vo 4. alebo 5. štádiu (Ruby II)
English: 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).
Slovak: B alebo C podľa Childa-Pugha) (pozri časti 4.2, 4.3, 4.8 a 5.2).
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Slovak: Ak máte akékoľvek otázky týkajúce sa vášho lieku, obráťte sa na svojho lekára alebo lekárnika.
English: Upon completion of dasabuvir and ombitasvir/paritaprevir/ ritonavir treatment, the appropriate dose and dosing frequency of tacrolimus should be guided by assessment of tacrolimus blood concentrations.
Slovak: Po ukončení liečby dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom sa má vhodná dávka a frekvencia dávkovania upraviť podľa celkovej koncentrácie takrolimu v krvi.
English: Concomitant use of tacrolimus with dasabuvir and ombitasvir/paritaprevir/ ritonavir is not recommended unless the benefits outweigh dasabuvir ombitasvir
Slovak: Súbežné používanie takrolimu s dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom sa neodporúča, pokiaľ prínosy neprevyšujú
English: AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (gebührenfrei) Tel: +49 (0) 611 / 1720-0
Slovak: KG Tel.: 00800 222843 33 (gebührenfrei)
English: The mean EC50 of dasabuvir against replicons containing NS5B from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.77 nM (range 0.4 to 2.1 nM; n=11) and 0.46 nM (range 0.2 to 2 nM; n=10), respectively.
Slovak: EC50 dasabuviru proti replikónom obsahujúcim NS5B zo skupiny doteraz neliečených izolátov genotypu 1a respektíve 1b v teste zameranom na replikónové bunkové kultúry HCV bola 0,77 nM (rozsah 0,4 až 2,1 nM, n =
English: Mechanism: OATP1B inhibition by paritaprevir.
Slovak: Mechanizmus: inhibícia OATP1B paritaprevirom.
English: 5 mg single dose
Slovak: 5 mg jednorazová dávka
English: Sirolimus 2 mg was dosed alone, 0.5 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir.
Slovak: Sirolimus 2 mg bol podávaný samostatne, 0,5 mg bolo podaných s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
English: Adverse reactions identified with dasabuvir in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Slovak: Nežiaduce reakcie zistené pri dasabuviru v kombinácii s ombitasvirom/paritaprevirom/ritonavirom alebo s ombitasvirom/paritaprevirom/ritonavirom a ribavirínom
English: Side effects when taking Exviera with ombitasvir/paritaprevir/ritonavir with or without ribavirin:
Slovak: Vedľajšie účinky, keď sa užíva Exviera a ombitasvir/paritaprevir/ritonavir s ribavirínom alebo bez neho:
English: When starting coadministration with dasabuvir and ombitasvir/paritaprevir/ ritonavir, give one fifth of the total daily dose of ciclosporin once daily with ombitasvir/ paritaprevir /ritonavir.
Slovak: Pri začatí súbežného podávania s dasabuvirom a s ombitasvirom/paritaprevirom/ritonavirom podávajte jednu pätinu celkovej dennej dávky cyklosporínu jedenkrát
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.
Slovak: Celková koncentrácia takrolimu alebo sirolimu v krvi sa má monitorovať na začiatku liečby a počas súbežného podávania s dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom a dávka a/alebo frekvencia dávkovania sa má upraviť podľa potreby.
English: Duloxetine 60 mg single dose dasabu vir + ombitas vir/parit aprevir/ ritonavi r duloxetine
Slovak: Duloxetín 60 mg jednorazová dávka dasabuvir + ombitasvir/ paritaprevir/ ritonavir duloxetín nevzťahuje sa
English: ↑ dabigatran etexilate dasabuvir + ombitasvir/paritaprevir/ ritonavir may increase the plasma concentrations of dabigatran etexilate.
Slovak: Dasabuvir + ombitasvir/ paritaprevir/ritonavir môžu zvýšiť plazmatické koncentrácie dabigatránetexilátu.
English: Mechanism: CYP3A inhibition by ritonavir.
Slovak: Mechanizmus: inhibícia CYP3A ritonavirom.
English: 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).
Slovak: Používanie liekov obsahujúcich etinylestradiol, aké sú obsiahnuté vo väčšine kombinovaných perorálnych antikoncepčných prípravkov alebo v antikoncepčných vaginálnych krúžkoch (pozri časti
English: NN:
Slovak: *Poznámka:
English: 12 weeks N = 509 n (%)
Slovak: 509 n (%)
English: HIV-1 Co-infection
Slovak: Infekcia HCV so súbežnou infekciou vírusom HIV-1
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).
Slovak: ↔ dasabuvir jedenkrát denne, bez ritonaviru, keď je podávaná v kombinácii s ombitasvirom/paritaprevirom/ritonavirom + dasabuvirom v rovnakú dobu (dávka ritonaviru v ombitasvire/paritaprevire/ritonavire bude zlepšovať farmakokinetiku darunaviru).
English: Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
Slovak: Mechanizmus: inhibícia CYP3A4 ritonavirom a inhibícia UGT paritaprevirom, ombitasvirom a dasabuvirom.
English: Concomitant use is contraindicated (see section 4.3).
Slovak: Súbežné podávanie je kontraindikované (pozri časť 4.3).
English: paritaprevir the risks (see section
Slovak: paritaprevir riziká (pozri časť 4.4).
English: 0.5 mg single dose5
Slovak: 0,5 mg jednorazová dávka5
English: Relapse
Slovak: Relaps
English: Clinical monitoring and dose adjustment maybe needed for smephenytoin.
Slovak: Môže byť potrebné klinické monitorovanie a úprava dávkovania S-metfenytoínu.
English: Mechanism: OATP1B1 inhibition by paritaprevir.
Slovak: Mechanizmus: inhibícia OATP1B1 paritaprevirom.
English: Other
Slovak: Ostatné
English: 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.
Slovak: %) pacientov s koinfekciou HCV GT4/HIV-1 (95 % CI: 82,3
English: No dose adjustment of dasabuvir is required for patients with mild, moderate, or severe renal impairment or end-stage-renal disease on dialysis (see section 5.2).
Slovak: U pacientov s miernou, stredne ťažkou alebo ťažkou poruchou funkcie obličiek alebo v konečnom štádiu ochorenia obličiek na dialýze nie je potrebná úprava dávky dasabuviru (pozri časť 5.2).
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.
Slovak: virom/ritonavirom treba obnoviť dávku a frekvenciu dávkovania sirolimu, ktorá bola určená pred používaním dasabuviru + ombitasviru/paritaprevi/ ru/ritonaviru spolu s pravidelným monitorovaním koncentrácie sirolimu v krvi.
English: 5 mg once daily
Slovak: 5 mg jedenkrát denne
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.
Slovak: V replikóne genotypu 1a aktivita dasabuviru bola znížená 21- až 32-násobne substitúciou M414T, S556G alebo Y561H; 152- až 261-násobne substitúciou A553T, G554S alebo S556R; a 1472- respektíve 975-násobne substitúciou C316Y respektíve substitúciou Y448H. G558R a D559G/N boli pozorované ako substitúcie, ktoré sa objavili počas liečby, ale aktivita dasabuviru proti týmto mutáciám nemohla byť vyhodnotená vzhľadom na nízku schopnosť replikácie.
English: multicentre, open-label
Slovak: multicentrické, otvorené
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
Slovak: • všimli ste si zožltnutie kože alebo očných bielkov; • váš moč je tmavší ako normálne;
English: For immunosuppressive medication, most subjects were taking tacrolimus (81%), with the remainder taking cyclosporine.
Slovak: Z imunosupresívnych liekov užívala väčšina pacientov takrolimus (81
English: 12 weeks N = 770 n (%)
Slovak: 770 n (%)
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in the paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑= increase more than 20%, ↓ = decrease more than 20%, ↔ = no change or change less than 20%).
Slovak: Smer šípky udáva smer zmeny v expozíciách (Cmax a AUC) v prípade paritapreviru, ombitasviru, dasabuviru a súbežne podávaného lieku (↑
English: Serum ALT elevations
Slovak: Zvýšenie hladiny ALT
English: In Part 1b, all subjects received dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin for 12 weeks.
Slovak: V časti 1b boli všetci pacienti liečení dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom s ribavirínom počas 12 týždňov.
English: Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Slovak: Mechanizmus: inhibícia UGT1A1 paritaprevirom, ombitasvirom a dasabuvirom.
English: 500 mg single dose dasabu vir +
Slovak: 500 mg jednorazová dávka dasabuvir
English: Among the GT1 subjects who were post renal transplant, 9/12 (75%) achieved SVR12; however, there were no virologic failures.
Slovak: Spomedzi pacientov s GT1, ktorí boli po transplantácii obličiek, 9/12 (75
English: Subjects with HCV GT4 received ombitasvir/paritaprevir/ritonavir with ribavirin for 12 or 24 Weeks.
Slovak: Pacienti s HCV GT4 boli liečení ombitasvirom/paritaprevirom/ritonavirom s ribavirínom počas 12 alebo 24 týždňov.
English: • mitotane
Slovak: • mitotán;
English: In Part 2, subjects with HCV GT1 received dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 weeks.
Slovak: V časti 2 pacienti s HCV GT1 boli liečení dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom s ribavirínom alebo bez neho počas 12 alebo 24 týždňov.
English: Enzalutamid e
Slovak: Enzalutamid
English: Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser Outcome for subjects without SVR12 On-treatment VF
Slovak: Pacienti s predchádzajúcou nulovou odpoveďou na pegIFN/RBV Pacienti s predchádzajúcou čiastočnou odpoveďou na pegIFN/RBV Pacienti s relapsom po predchádzajúcej liečbe pegIFN/RBV Výsledok pre pacientov bez SVR12
English: Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Slovak: Mechanizmus: pravdepodobne dôsledkom inhibície UGT1A1 paritaprevirom, ombitasvirom a dasabuvirom.
English: Expected: ↓ dasabuvir ↓ombitasvir ↓ paritaprevir
Slovak: Očakáva sa: ↓ dasabuvir ↓ ombitasvir ↓ paritaprevir
English: Mechanism: BCRP inhibition by paritaprevir, ritonavir and dasabuvir.
Slovak: Mechanizmus: inhibícia BCRP paritaprevirom, ritonavirom a dasabuvirom.
English: Common: may affect up to 1 in 10 people
Slovak: Časté: môžu postihnúť až 1 z 10 ľudí
English: AbbVie Deutschland GmbH & Co. KG Knollstrasse
Slovak: AbbVie Deutschland GmbH
English: Dasabuvir safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin.
Slovak: Bezpečnosť a účinnosť dasabuviru bola stanovená v kombinácii s ombitasvirom/ paritaprevirom
English: In Part 1a, all subjects received dasabuvir and ombitasvir/paritaprevir/ritonavir with ribavirin for 12 or 24 weeks.
Slovak: V časti 1a boli všetci pacienti liečení dasabuvirom a ombitasvirom/paritaprevirom/ritonavirom s ribavirínom počas 12 alebo 24 týždňov.
English: Mechanism: CYP3A4 induction by carbamazepi ne.
Slovak: Mechanizmus: indukcia CYP3A4 karbamazepínom.
English: Genotype 1a, without cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Slovak: Genotyp 1a, bez cirhózy dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirín*
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.
Slovak: % interval spoľahlivosti) vplyv na koncentráciu dasabuviru a ombitasviru/paritapreviru/ritonaviru a súbežne podávaných liekov.
English: Genotype 1a, with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Slovak: Genotyp 1a, s kompenzovanou cirhózou dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirín*
English: Dasabuvir must always be administered together with ombitasvir/paritaprevir/ritonavir .
Slovak: Dasabuvir sa musí vždy podávať spolu s ombitasvirom/paritaprevirom/ritonavirom.
English: SAPPHIRE I
Slovak: SAPPHIRE
English: CONTRACEPTIVES ethinyloestra diol/ norgestimate 0.035/0.25 m g once daily
Slovak: KONTRACEPTÍVA Etinylestradiol/ norgestimát 0,035/0,25 mg jedenkrát denne dasabuvir + ombitasvir/ paritaprevir/ ritonavir
English: ↔ carba mazepine
Slovak: AbbVie GmbH