FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljenje na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu.
English: Do not give Viekirax to children and adolescents under 18 years of age.
Slovenian: Ne dajajte zdravila Viekirax otrokom in mladostnikom, mlajšim od 18 let.
English: When co-administered, they exert mutual effects on each other (see section 5.2).
Slovenian: Če sta uporabljena skupaj, vplivata eden na drugega (glejte poglavje 5.2).
English: The use of Viekirax in children and adolescents has not yet been studied.
Slovenian: Uporaba zdravila Viekirax pri otrocih in mladostnikih še ni bila raziskana.
English: Sex or body weight
Slovenian: Spol ali telesna masa
English: Coadministration of Viekirax with other antivirals has not been studied and, therefore, cannot be recommended.
Slovenian: Sočasna uporaba zdravila Viekirax z drugimi protivirusnimi zdravili ni bila raziskana in je zato ni mogoče priporočati.
English: Laboratory Parameters
Slovenian: Laboratorijske vrednosti
English: This regimen can be used in the absence of extensive PI resistance (i.e. lack of darunavir associated RAMs), see also section
Slovenian: To shemo je mogoče uporabiti, če ni obsežne odpornosti proti PI (tj. odsotnost RAM, povezanih z darunavirjem), glejte tudi poglavje 4.4.
English: Tell your doctor or pharmacist if you are taking, have recently taken and before starting any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Such medicinal products include some statins (see Table 2), fexofenadine, repaglinide and angiotensin II receptor antagonists (e.g., valsartan).
Slovenian: Med takšnimi zdravili so nekateri statini (glejte preglednico 2), feksofenadin, repaglinid in antagonisti receptorjev angiotenzina II (npr. valsartan).
English: ALPHA 1-ADRENORECEPTOR ANTAGONIST Alfuzosin
Slovenian: ANTAGONISTI ADRENERGIČNIH RECEPTORJEV ALFA 1
English: The absolute bioavailability of ombitasvir and paritaprevir was approximately 50% when administered with food as Viekirax.
Slovenian: Absolutna biološka uporabnost ombitasvirja in paritaprevirja je bila približno 50 %, če sta bila uporabljena s hrano v obliki zdravila Viekirax.
English: Changes for ombitasvir, paritaprevir and dasabuvir the same as shown for paracetamol above
Slovenian: Spremembe za ombitasvir, paritaprevir in dasabuvir so enake kot tiste prikazane za paracetamol zgoraj.
English: • pimozide
Slovenian: • pimozid
English: What Viekirax is and what it is used for
Slovenian: Kaj je zdravilo Viekirax in za kaj ga uporabljamo
English: Overall, 72 of 79 treatment-naive subjects (45 of 52 GT1a and 27 of 27 GT1b) and 40 of 45 treatment-experienced subjects (21 of 26 GT1a and 19 of 19 GT1b) achieved SVR12 after 12 weeks of treatment.
Slovenian: Skupno je 72 od 79 preiskovancev, ki še niso bili zdravljeni (45 od 52 GT1a in 27 od 27 GT1b) in 40 od 45 preiskovancev, ki so že bili zdravljeni (21 od 26 GT1a in 19 od 19 GT1b) doseglo SVR12 po 12 tednih zdravljenja.
English: 0.035/0.25 mg once daily
Slovenian: 0,035/0,25 mg enkrat na dan
English: Rilpivirine was also administered in the evening with food and at night 4 hours after dinner with Viekirax + dasabuvir in other two arms in the study.
Slovenian: V študiji je bil rilpivirin uporabljen tudi zvečer s hrano in ponoči, 4 ure po večerji, z zdravilom Viekirax + dasabuvirjem v drugih dveh skupinah.
English: Unchanged parent drug accounted for 88% of total radioactivity recovered in faeces, indicating that biliary excretion is a major elimination pathway for ombitasvir.
Slovenian: Na račun nespremenjene matične spojine je bilo 88 % celotne radioaktivnosti v blatu; to kaže, da je biliarno izločanje glavna pot odstranjevanja ombitasvirja.
English: Paritaprevir and its hydrolysis product M13 were the predominant components observed in the milk of lactating rats, without effect on nursing pups.
Slovenian: Paritaprevir in njegov hidrolitični produkt M13 sta bila glavni snovi v mleku doječih podgan, brez vpliva na dojene mladiče.
English: Viekirax should not be used during pregnancy or in women of childbearing potential not using effective contraception.
Slovenian: Zdravila Viekirax se ne sme uporabljati med nosečnostjo ali pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Viekirax may increase the plasma exposure to medicinal products that are sensitive for changed intestinal P-gp activity (such as dabigatran etexilate).
Slovenian: Zdravilo Viekirax lahko poveča plazemsko izpostavljenost zdravilom, občutljivim za spremembe črevesne aktivnosti P-gp (takšen je npr. dabigatran eteksilat).
English: ↑ cisapride
Slovenian: ↑ cisaprid
English: Serious and/or life threatening events have been observed with co-administration of Viekirax and dasabuvir with systemic tacrolimus, and a similar risk can be expected with sirolimus and everolimus.
Slovenian: Resni in/ali življenje ogrožajoči dogodki so bili opaženi ob sočasni uporabi zdravila Viekirax in dasabuvirja s sistemsko delujočim takrolimusom in podobno tveganje se lahko pričakuje pri sirolimusu in everolimusu.
English: All other double substitutions of Y93H in combination with substitutions at positions 28, 31, or 58 reduced the activity of ombitasvir by more than 400-fold.
Slovenian: Vse druge dvojne substitucije Y93H v kombinaciji s substitucijami na mestih 28, 31 ali 58 so zmanjšale aktivnost ombitasvirja za več kot 400-krat.
English: b. Other includes early drug discontinuation not due to virologic failure missing HCV RNA values in the SVR12
Slovenian: b. "Drugo" vključuje zgodnjo ukinitev zdravila, ki ni posledica virusne neodzivnosti in manjkajoče vrednosti HCV RNA znotraj okna SVR12.
English: In Phase 3 clinical trials, 91.5% of subjects did not require ribavirin dose adjustments during therapy.
Slovenian: V kliničnih preskušanjih 3. faze 91,5 % preiskovancev med zdravljenjem ni potrebovalo prilagoditve odmerka ribavirina.
English: Y93H, Y93N or M28V in combination with Q30R reduced the activity of ombitasvir by more than 42,802-fold.
Slovenian: Y93H, Y93N ali M28V so v kombinaciji s Q30R zmanjšale aktivnost ombitasvirja za več kot 42.802-krat.
English: Y56H alone could not be evaluated due to poor replication capacity, however, the combination of Y56H and D168A/V/Y reduced the activity of paritaprevir by 700- to 4118fold.
Slovenian: Y56H same ni bilo mogoče oceniti zaradi slabe replikacijske sposobnosti, a kombinacija Y56H in D168A/V/Y je zmanjšala aktivnost paritaprevirja za 700- do 4118-krat.
English: Age, median (range) years Male gender, n (%) Prior HCV Treatment: naïve, n (%) Peg-IFN + RBV, n (%) Baseline albumin, median g/L < 35, n (%)
Slovenian: Starost, mediana leta (razpon) Moški spol, n (%) Predhodno zdravljenje za HCV: nezdravljeni, n (%) Peg-IFN + RBV, n (%) Izhodiščni albumin, median g/L < 35, n (%)
English: Use with colchicine
Slovenian: Uporaba s kolhicinom
English: Decrease digoxin dose by 30-50%.
Slovenian: Zmanjšajte odmerek digoksina za 30 do
English: All 3 (100%) subjects with GT4 infection who were post liver transplant achieved SVR12.
Slovenian: Vsi 3 (100 %) preiskovanci z okužbo GT4, ki so prestali presaditev jeter, so dosegli SVR12.
English: If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is, therefore, not recommended.
Slovenian: Če je dodan zaviralec proteaze HIV (atazanavir, darunavir), se lahko izpostavljenost rilpivirinu še dodatno poveča, zato takšna uporaba ni priporočljiva.
English: Ritonavir is not active against HCV. Ritonavir is a CYP3A inhibitor that increases the systemic exposure of the CYP3A substrate paritaprevir.
Slovenian: Ritonavir ni aktiven proti HCV, temveč je zaviralec CYP3A, ki poveča sistemsko izpostavljenost substratu CYP3A paritaprevirju.
English: No human data on the effect of Viekirax on fertility are available.
Slovenian: Podatkov o vplivu zdravila Viekirax na plodnost pri človeku ni.
English: HMG CoA REDUCTASE INHIBITOR Rosuvastatin
Slovenian: ZAVIRALCI REDUKTAZE HMG CoA rosuvastatin
English: These ALT elevations were significantly more frequent in the subgroup of subjects who were using ethinyloestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (6 of 25 subjects); (see section 4.3).
Slovenian: Ta zvišanja ALT so bila bistveno pogostejša v podskupini preiskovank, ki so uporabljale zdravila z etinilestradiolom, na primer kombinirane peroralne kontraceptive ali kontracepcijske vaginalne obročke (6 od 25 oseb); (glejte poglavje 4.3).
English: Ritonavir did not exhibit a direct antiviral effect on the replication of HCV subgenomic replicons, and the presence of ritonavir did not affect the in vitro antiviral activity of paritaprevir.
Slovenian: Ritonavir ni imel neposrednega protivirusnega učinka na replikacijo subgenomskih replikonov HCV in prisotnost ritonavirja in vitro ni vplivala na protivirusno delovanje paritaprevirja.
English: Paritaprevir was approximately 97-98.6% bound to human plasma proteins.
Slovenian: Paritaprevir je bil približno 97 do 98,6 % vezan na beljakovine v človeški plazmi.
English: salmeterol for asthma sildenafil when used to treat a heart and lung disorder called “pulmonary arterial hypertension”
Slovenian: salmeterol pri astmi sildenafil kadar se uporablja za zdravljenje bolezni srca in pljuč, imenovane “pljučna arterijska hipertenzija”
English: Impact of ribavirin dose adjustment on probability of SVR
Slovenian: Vpliv prilagoditve odmerka ribavirina na verjetnost SVR
English: Examples of contraindicated strong CYP3A4 inhibitors are provided below.
Slovenian: Primeri kontraindiciranih močnih zaviralcev CYP3A4 so navedeni spodaj.
English: While ombitasvir exposures increased in a dose proportional manner, paritaprevir and ritonavir exposures increased in a more than dose proportional manner.
Slovenian: Izpostavljenost ombitasvirju se je povečevala sorazmerno odmerku, izpostavljenost paritaprevirju in ritonavirju pa se je povečevala bolj kot sorazmerno odmerku.
English: INSULIN SECRETAGOGUES Repaglinide
Slovenian: INSULINSKI SEKRETAGOGI repaglinid
English: When starting coadministration with Viekirax, give one fifth of the total daily dose of ciclosporin once daily with Viekirax.
Slovenian: Na začetku sočasne uporabe z zdravilom Viekirax dajte eno petino celotnega dnevnega odmerka ciklosporina enkrat na dan z zdravilom Viekirax.
English: If tacrolimus or sirolimus are used together with Viekirax and dasabuvir, caution is advised, and recommended doses and monitoring strategies can be found in section 4.5.
Slovenian: Če je takrolimus ali sirolimus uporabljen skupaj z zdravilom Viekirax in dasabuvirjem, se svetuje previdnost; priporočljive odmerke in strategije spremljanja se lahko najde v poglavju 4.5.
English: With RBV
Slovenian: Z RBV
English: Clinical trials in subjects with genotype 4 chronic hepatitis C
Slovenian: Klinična preskušanja pri preiskovancih s kroničnim hepatitisom C z genotipom 4
English: Studies with ombitasvir and paritaprevir/ritonavir in animals have shown malformations (see section 5.3).
Slovenian: Študije ombitasvirja in paritaprevirja/ritonavirja pri živalih so pokazale malformacije (glejte poglavje 5.3).
English: It is not known whether paritaprevir /ritonavir or ombitasvir and their metabolites are excreted in human breast milk.
Slovenian: Ni znano, ali se paritaprevir/ritonavir ali ombitasvir in njihovi presnovki pri človeku izločajo v materino mleko.
English: These medicines can affect the way Viekirax works and Viekirax can affect the way these other medicines work.
Slovenian: Ta zdravila lahko vplivajo na delovanje zdravila Viekirax in obratno; zdravilo Viekirax lahko vpliva na delovanje teh zdravil.
English: Potential for Viekirax to affect the pharmacokinetics of other medicinal products In vivo drug interaction studies evaluated the net effect of the combination treatment, including ritonavir.
Slovenian: Možni vplivi zdravila Viekirax na farmakokinetiko drugih zdravil V študijah medsebojnega delovanja zdravil in vivo so ocenili neto učinek kombiniranega zdravljenja,
English: Cases of depression and more rarely of suicidal ideation and suicide attempt have been reported with Viekirax with or without dasabuvir treatment in combination with ribavirin in the majority of the cases.
Slovenian: Primeri depresije in redkeje samomorilnih misli in poskusov samomora so bili poročani pri zdravljenju z zdravilom Viekirax z ali brez dasabuvirja v kombinaciji z ribavirinom v večini primerov.
English: Inhibition of these transporters is not expected to show clinically relevant increases in exposures of ombitasvir and dasabuvir.
Slovenian: Ni pričakovati, da bi zavrtje teh prenašalcev klinično pomembno povečalo izpostavljenost ombitasvirju in dasabuvirju.
English: Ombitasvir had no effect on fertility when evaluated in mice.
Slovenian: Ombitasvir ni vplival na plodnost, ocenjeno pri miših.
English: Other medicines and Viekirax
Slovenian: Druga zdravila in zdravilo Viekirax
English: In order to evaluate the recurrence of hepatocellular carcinoma associated withViekirax, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Slovenian: Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom Viekirax, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
English: If ribavirin is co-administered with Viekirax, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics of ribavirin).
Slovenian: Če se ribavirin uporablja sočasno z zdravilom Viekirax, je treba upoštevati kontraindikacije za uporabo ribavirina med nosečnostjo (glejte tudi povzetek glavnih značilnosti ribavirina).
English: The major, inactive human metabolites of ombitasvir were not teratogenic in mice at exposures approximately 26 times higher than in humans at the recommended clinical dose.
Slovenian: Glavni, neaktivni presnovki ombitasvirja pri človeku niso bili teratogeni za miši v izpostavljenostih, ki so bile približno 26-krat večje od izpostavljenosti pri človeku ob priporočenem kliničnem odmerku.
English: A side-by-side tabulation is shown to simplify presentation; direct comparison across trials should not be made due to differing trial designs.
Slovenian: Za enostavnejšo predstavitev je tabeliranje vzporedno, vendar se ne sme neposredno primerjati preskušanj, ki so imela različne načrte.
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 0.2% (5/2,044) and 4.8% (99/2,044) of subjects had ribavirin dose reductions due to adverse reactions.
Slovenian: Zaradi neželenih učinkov je zdravljenje trajno prekinilo 0,2 % preiskovancev (5/2.044) in 4,8 % (99/2.044) preiskovancem so zaradi neželenih učinkov zmanjšali odmerek ribavirina.
English: Co-administration may result in increased risk for adverse events.
Slovenian: Sočasna uporaba lahko povzroči povečano tveganje za pojav neželenih učinkov.
English: Because of the potential for adverse reactions from the medicinal product in breastfed infants, a decision must be made whether to discontinue breast-feeding or discontinue treatment with Viekirax, taking into account the importance of the therapy to the mother.
Slovenian: Ker ima zdravilo lahko neželene učinke na dojenčke, se je treba odločiti, ali naj ženska prekine dojenje ali zdravljenje z zdravilom Viekirax, pri čemer je treba upoštevati pomen zdravljenja za mater.
English: Tell your doctor or pharmacist before taking Viekirax, if you are taking any of the medicines in the table below.
Slovenian: Obvestite svojega zdravnika ali farmacevta preden boste začeli jemati zdravilo Viekirax, če jemljete katero koli od zdravil v spodnji preglednici.
English: Ritonavir is an in vitro inhibitor of OCT1, but the clinical relevance is unknown.
Slovenian: Ritonavir in vitro zavira OCT1, a klinični pomen tega ni znan.
English: ↑ pravastatin 1.37
Slovenian: ↑ trimetoprim 1,17
English: The combination carries an increased risk for hyperbilirubinemia (including ocular icterus), in particular when ribavirin is part of the hepatitis C regimen.
Slovenian: Kombinacijo spremlja večje tveganje za hiperbilirubinemijo (vključno z očesnim ikterusom), še zlasti, če shema za hepatitis C vključuje ribavirin.
English: HIV co-infected patients without suppressive antiretroviral therapy should not be treated with Viekirax.
Slovenian: Bolnikov, sočasno okuženih s HIV in brez supresivnega protiretrovirusnega zdravljenja, se ne sme zdraviti z zdravilom Viekirax.
English: If more than 12 hours have passed since Viekirax is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule.
Slovenian: Če je od časa, ko po navadi vzame zdravilo Viekirax, minilo že več kot 12 ur, NE SME vzeti izpuščenega odmerka, temveč mora vzeti naslednji odmerek po običajnem urniku jemanja.
English: PHOSPHODIESTERASE-(PDE-5) INHIBITORS Sildenafil (when used for treatment of pulmonary hypertension)
Slovenian: ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE-5) sildenafil (ko je uporabljen za zdravljenje pljučne hipertenzije)
English: The dose of ribavirin was left to the discretion of the investigator, with most subjects receiving 600 to 800 mg per day as a starting dose, and most subjects also receiving 600 to 800 mg per day at the end of treatment.
Slovenian: Odmerek ribavirina je bil prepuščen raziskovalčevi presoji; večina bolnikov je kot začetni odmerek prejemala od 600 do 800 mg na dan in večina bolnikov je tudi na koncu zdravljenja prejemala od 600 do 800 mg na dan.
English: To maximise absorption, Viekirax tablets should be taken with food, without regard to fat and calorie content (see section 5.2).
Slovenian: Da bi bila absorpcija čim večja, je treba tablete zdravila Viekirax vzeti s hrano, ne glede na vsebnost maščob in kalorij (glejte poglavje 5.2).
English: Treatment outcome
Slovenian: Izid zdravljenja
English: There are very limited data from the use of Viekirax in pregnant women.
Slovenian: Podatki o uporabi zdravila Viekirax pri nosečnicah so zelo omejeni.
English: Paritaprevir is an inhibitor of HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
Slovenian: Paritaprevir je zaviralec proteaze NS3/4A HCV, ki je potrebna za proteolitično cepitev HCV-kodiranega poliproteina (v zrele oblike proteinov NS3, NS4A, NS4B, NS5A in NS5B) in je nujna za replikacijo virusov.
English: Avoid concomitant use of tacrolimus or sirolimus with Viekirax and dasabuvir unless the benefits outweigh the risks.
Slovenian: Izogibajte se sočasni uporabi takrolimusa ali sirolimusa z zdravilom Viekirax in dasabuvirjem, razen kadar koristi uporabe prevladajo nad tveganji.
English: • Check for side effects of Viekirax or other antiviral medicines your doctor has prescribed for you to use with Viekirax (such as “dasabuvir” and “ribavirin”).
Slovenian: • preveri neželene učinke zdravila Viekirax ali drugih protivirusnih zdravil, ki vam jih je predpisal za uporabo skupaj z zdravilom Viekirax (kot sta “dasabuvir” in “ribavirin”).
English: • colchicine in patients with renal or hepatic impairment
Slovenian: • kolhicin pri bolnikih z okvarami ledvic ali jeter
English: • itraconazole, ketoconazole, posaconazole, voriconazole
Slovenian: • itrakonazol, ketokonazol, posakonazol, vorikonazol
English: In Part 1b, SVR12 was achieved by 22/22 (100%) subjects (95% CI: 85.1%, 100%).
Slovenian: V delu 1b je bil SVR12 dosežen pri 22/22 (100 %) preiskovancih (95 % CI: 85,1 %, 100 %).
English: However, no dose-adjustment based on gender is warranted.
Slovenian: Vseeno pa prilagajanje odmerkov glede na spol ni potrebno.
English: For specific dosage instructions for dasabuvir and ribavirin, including dose modification, refer to the respective Summaries of Product Characteristics.
Slovenian: Za specifična navodila o odmerjanju dasabuvirja in ribavirina, vključno s prilagajanjem odmerka, glejte ustrezna povzetka glavnih značilnosti zdravila.
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: 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. Opažene pri vsaj 2 preiskovancih istega podtipa.
English: Therefore, Viekirax with or without dasabuvir is not expected to affect medicinal products which are primarily excreted by the renal route via these transporters (see section 5.2).
Slovenian: Zato ni pričakovati, da bi zdravilo Viekirax z dasabuvirjem ali brez njega vplivalo na zdravila, ki se v prvi vrsti izločajo skozi ledvice preko teh prenašalcev (glejte poglavje 5.2).
English: Ombitasvir + paritaprevir + ritonavir* for 12 weeks Treatment-naïve
Slovenian: Ombitasvir + paritaprevir + ritonavir* 12 tednov Še nezdravljeni
English: The safety and efficacy of Viekirax in children less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Viekirax ni ugotovljena pri otrocih, mlajših od 18 let.
English: Ritonavir was greater than 99% bound to human plasma proteins.
Slovenian: Ritonavir je bil več kot 99 % vezan na beljakovine v človeški plazmi.
English: Paritaprevir is metabolised predominantly by CYP3A4 and to a lesser extent CYP3A5.
Slovenian: Paritaprevir se pretežno presnovi s CYP3A4 in v manjši meri s CYP3A5.
English: The effect on rilpivirine exposures was similar to that observed when rilpivirine was administered in the morning with food with Viekirax + dasabuvir (shown in the table above).
Slovenian: Vpliv na izpostavljenost rilpivirinu je bil podoben, kot so ga opažali, če je bil rilpivirin uporabljen zjutraj s hrano z zdravilom Viekirax + dasabuvir (prikazano v zgornji preglednici).
English: The interactions between pitavastatin and fluvastatin and Viekirax have not been investigated.
Slovenian: Pitavastatin in fluvastatin Medsebojna delovanja med pitavastatinom in fluvastatinom ter zdravilom Viekirax niso raziskana.
English: − Feel sick (nauseous), are sick (vomit) or lose your appetite
Slovenian: − občutite slabost (siljenje na bruhanje), bruhate ali izgubite apetit;
English: • apalutamide,enzalutamide
Slovenian: • apalutamid, enzalutamid
English: As the incidence of such elevations was 26% among women taking a concomitant ethinyloestradiol-containing medicinal product, such medicinal products are contraindicated with Viekirax with or without dasabuvir.
Slovenian: Ker je bila incidenca takšnih zvišanj med ženskami, ki so sočasno jemale zdravila z etinilestradiolom, 26 %, so takšna zdravila kontraindicirana med uporabo zdravila Viekirax z dasabuvirjem ali brez njega.
English: Viekirax should be used in combination with other medicinal products for the treatment of HCV (see Table 1).
Slovenian: Zdravilo Viekirax je treba uporabljati v kombinaciji z drugimi zdravili za zdravljenje HCV (glejte preglednico 1).
English: Not studied:
Slovenian: Ni raziskan:
English: If you accidentally take more than the recommended dose, you should contact your doctor or go to the nearest hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Viekirax, kot bi smeli Če ste pomotoma vzeli večji odmerek od priporočenega, takoj obvestite svojega zdravnika ali pojdite v najbližjo bolnišnico.