FrancophonIA/ELRC3.0 huggingface dataset:
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑ = increase (more than 20%), ↓ = decrease (of more than 20%), ↔ = no change or change less than 20%).
Slovenian: Smer puščice kaže smer spremembe izpostavljenosti (Cmax in AUC) paritaprevirju, ombitasvirju, dasabuvirju in sočasno uporabljenemu zdravilu (↑ = povečanje za več kot 20 %, ↓ = zmanjšanje za več kot
English: Available pharmacokinetic data in animals have shown excretion of active substance and metabolite in milk (see section 5.3).
Slovenian: Farmakokinetični podatki, ki so na voljo za živali, so pokazali izločanje zdravilne učinkovine in presnovka v mleko (glejte poglavje 5.3).
English: Darunavir, dosed 800 mg once daily, if administered at the same time as Viekirax and dasabuvir, can be used in the absence of extensive PI resistance (darunavir exposure lowered).
Slovenian: Darunavir v odmerku 800 mg enkrat na dan, če se ga da ob istem času kot zdravilo Viekirax in dasabuvir, se lahko uporablja, če ni obsežne odpornosti proti PI (zmanjšanje izpostavljenosti darunavirju).
English: Although buprenorphine and zolpidem are also metabolized by CYP3A, drug interaction studies indicate that no dose adjustment is needed when co-administering these medicinal products with Viekirax with or without dasabuvir (see Table 2).
Slovenian: Sicer se tudi buprenorfin in zolpidem presnavljata s CYP3A, vendar študije medsebojnega delovanja zdravil kažejo, da med sočasno uporabo teh zdravil z zdravilom Viekirax (z dasabuvirjem ali brez njega) odmerka ni treba prilagoditi (glejte preglednico 2).
English: Coadministration with ethinylestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Slovenian: Sočasna uporaba z etinilestradiolom lahko poveča tveganje za zvišanje ALT (glejte poglavji 4.3 in 4.4).
English: No subjects experienced on-treatment virologic failure or relapse.
Slovenian: Pri nobenem preiskovancu se med zdravljenjem ni pojavil virološki neuspeh ali recidiv.
English: Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Slovenian: COBAS TaqMan HCV test (verzija 2.0), ki je namenjen za uporabo s sistemom High Pure System.
English: In subjects receiving Viekirax and dasabuvir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
Slovenian: Pri preiskovancih, ki so prejemali zdravilo Viekirax in dasabuvir brez ribavirina, so bili neželeni učinki, ki so običajno povezani z ribavirinom (npr.navzea, insomnia, anemija), manj pogosti in noben preiskovanec (0/588) ni trajno prekinil zdravljenja zaradi neželenih učinkov.
English: • enzalutamide
Slovenian: • enzalutamid
English: Co-administration of Viekirax with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QT-prolongation comedications.
Slovenian: Sočasna uporaba zdravila Viekirax z rilpivirinom enkrat na dan pride v poštev le pri bolnikih brez znanega podaljšanja intervala QT, ki ob tem tudi ne uporabljajo kakšnih drugih zdravil, ki podaljšajo interval
English: Recommended co-administered medicinal product(s) and treatment duration for Viekirax by patient population
Slovenian: Priporočena sočasna zdravila in trajanje zdravljenja z zdravilom Viekirax glede na populacijo bolnikov
English: In the genotype 1b replicon, the activity of ombitasvir was reduced by less than 10-fold by variants at amino acid positions 30 and 31.
Slovenian: V replikonu genotipa 1b so variante na aminokislinskih mestih 30 in 31 zmanjšale aktivnost ombitasvirja za manj kot 10-krat.
English: Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing ombitasvir, paritaprevir, and dasabuvir with or without ribavirin (for 8, 12, or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
Slovenian: Od 2.510 oseb s HCV genotipa 1, zdravljenih s shemami, ki so vsebovale ombitasvir, paritaprevir in dasabuvir, z ribavirinom ali brez njega (v obdobju 8, 12 ali 24 tednov) v kliničnih preskušanjih faze 2b in 3, je virološki neuspeh (primarni recidiv po zdravljenju) doživelo skupno 74 (3 %).
English: You will take Viekirax for either 12 or 24 weeks.
Slovenian: Kako dolgo jemati zdravilo Viekirax Zdravilo Viekirax boste jemali bodisi 12 ali 24 tednov.
English: When starting coadministration with Viekirax, administer 0.5 mg tacrolimus once every week.
Slovenian: Na začetku sočasnega odmerjanja z zdravilom Viekirax uporabite 0,5 mg takrolimusa enkrat na teden.
English: Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see section 4.4 and 4.5).
Slovenian: 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).
English: • ranolazine
Slovenian: • ranolazin
English: Outcome for subjects without SVR12 On-treatment virologic failure Post-treatment relapse Other
Slovenian: Izid pri preiskovancih brez SVR12 Virološki neuspeh med zdravljenjem Recidiv po zdravljenju Drugo
English: For dosing recommendations with HIV antiviral agents, refer to section 4.4 (Treatment of patients with HIV co-infection) and section 4.5.
Slovenian: Za priporočila o odmerjanju s protivirusnimi zdravili proti HIV glejte poglavje 4.4 (Zdravljenje bolnikov, sočasno okuženih s HIV) in poglavje 4.5.
English: Viekirax and dasabuvir + ribavirin 12 or 24 weeks N = 380 n (%)
Slovenian: Viekirax in dasabuvir + ribavirin 12 ali 24 tednov N = 380 n (%)
English: Simvastatin, lovastatin and atorvastatin are contraindicated (see section 4.3 and 4.5).
Slovenian: Simvastatin, lovastatin in atorvastatin so kontraindicirani (glejte poglavji 4.3 in 4.5).
English: Not Studied.
Slovenian: Ni raziskano.
English: Coadministration with enzyme inducers may increase the risk of adverse events and ALT elevations (see Table 2).
Slovenian: Sočasna uporaba z induktorji encimov lahko poveča tveganje za neželene učinke in zvišanje ALT (glejte preglednico 2).
English: Indinavir Saquinavir Tipranavir
Slovenian: ↑ paritaprevir indinavir sakvinavir tipranavir
English: Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Slovenian: Zdravila Viekirax se ne priporoča pri bolnikih z zmerno okvaro jeter (Child-Pugh B).
English: 4-24 mg/16 mg once daily
Slovenian: 4-24 mg/1-6 mg enkrat na dan
English: Asthenia Fatigue *Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.
Slovenian: *Nabor podatkov obsega vse preiskovance, okužene z genotipom 1, vključene v preskušanja 2. in 3. faze, tudi preiskovance s cirozo.
English: CORAL-I: treatment-naïve or pegIFN + RBV-experienced, at least 12 months post liver transplant
Slovenian: CORAL-I: še nezdravljeni ali že zdravljeni s pegIFN + RBV, vsaj 12 mesecev po presaditvi jeter
English: In subjects who received the recommended regimen, 97% achieved SVR overall (among which 181 subjects with compensated cirrhosis achieved 97% SVR), while 0.5% experienced virologic breakthrough and 1.2% experienced post-treatment relapse.
Slovenian: preiskovancev s kompenzirano cirozo doseglo 97 % SVR), medtem ko se je pri 0,5 % pojavil virološki preboj, pri 1,2 % pa recidiv po zdravljenju.
English: Polyvinyl alcohol (E1203) Polyethylene glycol 3350 Talc (E553b) Titanium dioxide (E171) Iron oxide red (E172)
Slovenian: Filmska obloga: polivinilalkohol (E1203) polietilenglikol 3350 smukec (E553b) titanov dioksid (E171)
English: Ethinylestradiol is contraindicated in combination with Viekirax (see sections 4.3 and 4.4).
Slovenian: Etinilestradiol je kontraindiciran v kombinaciji z zdravilom Viekirax (glejte poglavji 4.3 in 4.4).
English: 5 of 6 subjects with compensated cirrhosis in each arm achieved SVR12.
Slovenian: SVR12 je doseglo 5 od 6 preiskovancev s kompenzirano cirozo v vsaki skupini.
English: − Tablet film-coating: polyvinyl alcohol (E1203), polyethylene glycol 3350, talc (E553b), titanium dioxide (E171) and red iron oxide (E172).
Slovenian: − Filmska obloga tablete: polivinilalkohol (E1203), polietilenglikol 3350, smukec (E553b), titanov dioksid (E171), rdeči železov oksid (E172).
English: Patients who are taking ethinylestradiol-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 Viekirax and dasabuvir therapy (see sections 4.3 and 4.5).
Slovenian: Bolnice, ki uporabljajo zdravila z etinilestradiolom (takšna je večina kombiniranih peroralnih kontraceptivov ali kontracepcijskih vaginalnih obročkov), jih morajo prenehati uporabljati ali preiti na drugačen način kontracepcije (npr. na samo progestinsko kontracepcijo ali na nehormonske načine), preden začnejo zdravljenje z zdravilom Viekirax in dasabuvirjem (glejte poglavji 4.3 in 4.5).
English: Medicines you must not take with Viekirax Medicine or active substance
Slovenian: Zdravila, ki jih ne smete jemati z zdravilom Viekirax Zdravilo ali zdravilna učinkovina
English: Phase 3 global multicentre studies conducted with Viekirax and dasabuvir with or without ribavirin (RBV).
Slovenian: Globalne multicentrične študije 3. faze z zdravilom Viekirax in dasabuvirjem, z ribavirinom (RBV) ali brez njega.
English: 20-120 mg once daily
Slovenian: 20-120 mg enkrat na dan
English: Table 3 lists adverse reactions for which a causal relationship between paritaprevir/ombitasvir/ritonavir, in combination with dasabuvir and/or ribavirin, and the adverse event is at least a reasonable possibility.
Slovenian: Seznam neželenih učinkov v preglednici Preglednica 3 navaja neželene učinke, za katere je vzročna povezanost med kombinacijo paritaprevir/ombitasvir/ritonavir skupaj z dasabuvirjem in/ali ribavirinom ter neželenim učinkom vsaj upravičeno možna.
English: Monitor tacrolimus levels and adjust dose and/or dosing frequency as needed.
Slovenian: Kontrolirajte koncentracijo takrolimusa in prilagodite odmerek in/ali pogostnost uporabe, kot je potrebno.
English: CONTRACEPTIVES Ethinylestradiol/ norgestimate
Slovenian: KONTRACEPTIVI etinilestradiol/n orgestimat
English: Mechanism: decrease possibly due to CYP1A2 induction by ritonavir
Slovenian: Mehanizem: Možno zmanjšanje zaradi zavrtja CYP1A2 z ritonavirjem
English: The safety profile of Viekirax and dasabuvir was similar in subjects without cirrhosis, and with compensated cirrhosis with the exception of increased rates of transient hyperbilirubinemia when ribavirin was part of the regimen.
Slovenian: Varnostne značilnosti zdravila Viekirax in dasabuvirja so bile podobne pri preiskovancih brez ciroze in pri tistih s kompenzirano cirozo, z izjemo večjega deleža prehodne hiperbilirubinemije ob jemanju z ribavirinom.
English: ↑ quinidine ↑ ranolazine
Slovenian: ↑ kinidin ↑ ranolazin
English: − Tablet core: copovidone, vitamin E polyethylene glycol succinate, propylene glycol monolaurate, sorbitan monolaurate, colloidal anhydrous silica (E551), sodium stearyl fumarate.
Slovenian: − Jedro tablete: kopovidon, vitamin E, poletilenglikol sukcinat, propilenglikol monolavrat, sorbitan monolavrat, koloidni brezvodni silicijev dioksid (E551), natrijev stearilfumarat.
English: In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1).
Slovenian: V študiji po presaditvi jeter je bilo odmerjanje ribavirina individualizirano in večina preiskovancev ga je prejemala od 600 do 800 mg na dan
English: Interactions between Viekirax with or without dasabuvir and other medicinal products
Slovenian: Interakcije med zdravilom Viekirax (z dasabuvirjem ali brez njega) in drugimi zdravili
English: D168Y V36Ac, V36Mc, F43Lc, D168H, E357Kc NS5A M28T M28Ve Q30Re Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Observed in at least 2 subjects of the same subtype.
Slovenian: Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Opažene pri vsaj 2 preiskovancih istega podtipa.
English: What Viekirax looks like and contents of the pack Viekirax tablets are pink, oblong film-coated tablets of dimmensions 18.8 mm x 10.0 mm, marked with ‘AV1'.
Slovenian: Tablete zdravila Viekirax so rožnate, podolgovate, filmsko obložene tablete velikosti 18,8 mm x 10,0 mm, z oznako "AV1".
English: It contains the active substances ombitasvir, paritaprevir and ritonavir.
Slovenian: Zdravilo vsebuje zdravilne učinkovine ombitasvir, paritaprevir in ritonavir.
English: The majority of adverse reactions presented in Table 3 were of grade 1 severity in Viekirax and dasabuvircontaining regimens.
Slovenian: Večina neželenih učinkov, predstavljenih v preglednici 3, je bila v shemah, ki so vključevale zdravilo Viekirax in dasabuvir, 1. stopnje glede na resnost.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of multipack of 14 film-coated tablets - without blue box
Slovenian: Notranja škatla (večkratno pakiranje) vsebuje 14 filmsko obloženih tablet -brez modrega okenca
English: Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim
Slovenian: Mehanizem: Možno povečanje dasabuvirja zaradi zavrtja CYP2C8 s trimetoprimom
English: 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.
Slovenian: 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.
English: Clinical studies in subjects with genotype 1 hepatitis C infection
Slovenian: Klinična učinkovitost in varnost Klinične študije pri preiskovancih, okuženih s hepatitisom C genotipa 1
English: Table 18.
Slovenian: Preglednica 18.
English: AMINOSALICYLATE Sulfasalazine
Slovenian: Klinične opombe sulfasalazin
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4)
Slovenian: ALT > 5-20 × ZNM*
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu
English: ↑ telithromycin ↑ paritaprevir
Slovenian: ↑ dasabuvir ↑ paritaprevir
English: In a pooled analysis of clinical trials with Viekirax and dasabuvir with and without ribavirin, 1% of subjects experienced serum ALT levels greater than 5 times the upper limit of normal (ULN) after starting treatment.
Slovenian: V kumulativni analizi kliničnih preskušanj zdravila Viekirax in dasabuvirja, z ribavirinom ali brez njega, se je zvišanje ALT v serumu nad 5-kratno zgornjo normalno mejo (ZNM) po začetku zdravljenja pojavilo pri 1 % preiskovancev.
English: What Viekirax contains
Slovenian: Kaj vsebuje zdravilo Viekirax
English: Relapse rates in GT1a cirrhotic subjects by baseline laboratory values are presented in Table 13.
Slovenian: Deleži recidivov pri preiskovancih z GT1a in cirozo so predstavljeni v preglednici 13 glede na izhodiščne laboratorijske vrednosti.
English: Table 16.
Slovenian: Preglednica 16.
English: 56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Slovenian: 56 tablet (večkratno pakiranje, ki vsebuje 4 škatle, vsaka s po 14 tabletami).
English: Table 17.
Slovenian: Preglednica 17.
English: Vitamin E polyethylene glycol succinate Propylene glycol monolaurate Sorbitan monolaurate Colloidal anhydrous silica (E551) Sodium stearyl fumarate
Slovenian: Jedro tablete kopovidon vitamin E poletilenglikol sukcinat propilenglikol monolavrat sorbitan monolavrat koloidni brezvodni silicijev dioksid (E551) natrijev stearilfumarat
English: • quinidine
Slovenian: • kinidin
English: SVR12 for HIV-1 co-infected Subjects in TURQUOISE-I
Slovenian: SVR12 pri preiskovancih, sočasno okuženih s HIV-1, v študiji TURQUOISE-I
English: The safety and efficacy of Viekirax in children below 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Viekirax nista bili ugotovljeni pri otrocih, mlajših od 18 let.
English: ≥ 90, n (%)
Slovenian: < 90, n (%) ≥ 90, n (%)
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 56 (4 packs of 14) film-coated tablets
Slovenian: Večkratno pakiranje: 56 (4 škatle po 14) filmsko obloženih tablet
English: Two patients discontinued Viekirax and dasabuvir due to elevated ALT, including one on ethinylestradiol.
Slovenian: Zaradi zvišanja ALT sta zdravilo Viekirax in dasabuvir prenehali uporabljati dve osebi; ena od njiju je dobivala etinilestradiol.
English: Some patients have reported feeling very tired when taking Viekirax with other medicines for their hepatitis C infection.
Slovenian: 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 s stroji.
English: NAME OF THE MEDICINAL PRODUCT Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
Slovenian: IME ZDRAVILA Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
Slovenian: trombocite ≥ 90 x 109/l in albumin ≥ 35 g/l), so bili deleži recidiva, pri zdravljenih 12 tednov in zdravljenih 24 tednov, podobni.
English: Effect of paritaprevir/ritonavir on ombitasvir and dasabuvir
Slovenian: Vpliv paritaprevirja/ritonavirja na ombitasvir in dasabuvir
English: Table 15.
Slovenian: Preglednica 15.
English: Side effects when taking Viekirax with dasabuvir:
Slovenian: Neželeni učinki pri jemanju zdravila Viekirax z dasabuvirjem:
English: SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatmentnaïve or previously treated with pegIFN/RBV
Slovenian: 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.
English: As liver function may change during treatment with Viekirax administered with or without dasabuvir, a close monitoring of International Normalised Ratio (INR) values is recommended.
Slovenian: Bolniki zdravljeni z antagonisti vitamina K Ker se delovanje jeter med zdravljenjem z zdravilom Viekirax ob jemanju z ali brez dasabuvirja lahko spremeni, je priporočljivo skrbno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR
English: Clinical trials in peginterferon+ribavirin-experienced adults
Slovenian: Klinična preskušanja pri odraslih, že zdravljenih s peginterferonom + ribavirinom
English: Talk to your doctor or pharmacist before taking Viekirax if you: - have liver disease other than hepatitis C;
Slovenian: Pred začetkom jemanja zdravila Viekirax se posvetujte z zdravnikom ali farmacevtom, če: - imate tudi bolezen jeter, ki ni hepatitis C; - imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal.
English: 800/100 mg once daily
Slovenian: 800/100 mg enkrat na dan
English: NAME OF THE MARKETING AUTHORISATION HOLDER AbbVie Ltd
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM AbbVie Ltd
English: Table 12.
Slovenian: Preglednica 12.
English: 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)
Slovenian: 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
English: TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HIV-1 co-infection, without cirrhosis or with compensated cirrhosis
Slovenian: TURQUOISE-I - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s sočasno okužbo s HIV-1, brez ciroze ali s kompenzirano cirozo
English: In patients with renal or hepatic impairment, use of colchicine with Viekirax with or without dasabuvir is contraindicated (see section 4.3 and 4.5).
Slovenian: 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).
English: The safety summary is based on pooled data from phase 2 and 3 clinical trials in more than 2,600 subjects who received Viekirax and dasabuvir with or without ribavirin.
Slovenian: Povzetek o varnosti temelji na kumulativnih podatkih kliničnih preskušanj 2. in 3. faze pri več kot 2.600
English: 24 weeks (see section 5.1.)
Slovenian: (glejte poglavje 5.1).
English: See section 4.2 for dosing recommendations in HCV/HIV-1 co-infected patients.
Slovenian: Za priporočila o odmerjanju pri bolnikih, sočasno okuženih s HCV/HIV-1, glejte poglavje 4.2.
English: Table 13.
Slovenian: Preglednica 13.
English: treatment naïve: Viekirax without ribavirin or with weight-based ribavirin for 12 weeks pegIFN + RBV experienced: Viekirax with weight-based ribavirin for 12 weeks
Slovenian: Zdravljenje: še nezdravljeni: Viekirax brez ribavirina ali z ribavirinom, odvisnim od telesne mase, 12 tednov že zdravljeni s kombinacijo pegIFN + RBV: Viekirax z ribavirinom, odvisnim od telesne mase, 12 tednov
English: België/Belgique/Belgien AbbVie SA
Slovenian: België/Belgique/Belgien
English: Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B) (see sections 4.4 and 4.8).
Slovenian: Uporaba zdravila Viekirax pri bolnikih z zmerno okvaro jeter (Child-Pugh B) se ne priporoča (glejte poglavji 4.4 in 4.8).
English: Ethinylestradiol-containing oral contraceptives are contraindicated (see section 4.3).
Slovenian: Peroralni kontraceptivi z etinilestradiolom so kontraindicirani (glejte poglavje 4.3).
English: Other a. These virologic failures appear to have resulted from reinfection based on analyses of baseline and virologic failure samples
Slovenian: Drugo a. Glede na analize izhodiščnih vzorcev in vzorcev ob virološkem neuspehu se zdi, da so bili ti virološki neuspehi posledica ponovne okužbe.
English: Viekirax is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.3, 4.8 and
Slovenian: Zdravilo Viekirax je kontraindicirano pri bolnikih s hudo okvaro jeter (Child-Pugh C) (glejte poglavja 4.2, 4.8 in 5.2.).
English: Patients should be informed that fatigue has been reported during treatment with Viekirax in combination with dasabuvir and ribavirin (see section 4.8).
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Bolnikom je treba povedati, da je bila med zdravljenjem z zdravilom Viekirax v kombinaciji z dasabuvirjem in ribavirinom opisana utrujenost (glejte poglavje 4.8).
English: SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
Slovenian: SVR12 pri preiskovancih, že zdravljenih s peginterferonom + ribavirinom, okuženih z genotipom 1, v preskušanju SAPPHIRE-II