FrancophonIA/ELRC3.0 huggingface dataset:
English: Dasabuvir should be used in combination with other medicinal products for the treatment of HCV (see section 5.1).
Slovenian: Dasabuvir je treba uporabljati skupaj z drugimi zdravili za zdravljenje HCV (glejte poglavje 5.1).
English: All 3 (100%) subjects with GT 4 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: Pregnancy and concomitant use with ribavirin
Slovenian: Nosečnost in sočasna uporaba ribavirina
English: You should not breastfeed during treatment with Exviera.
Slovenian: Med zdravljenjem z zdravilom Exviera ne smete dojiti.
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, Asian subjects had 29% to 39% higher dasabuvir exposures than non-Asian subjects.
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov kliničnih študij 3. faze so imeli azijski preiskovanci od 29 do 39 % večjo izpostavljenost dasabuvirju kot neazijski preiskovanci.
English: Dasabuvir retained full activity against replicons containing substitutions S282T in the nucleoside binding site, M423T in the lower thumb site, and P495A/S, P496S or V499A in the upper thumb site.
Slovenian: Dasabuvir je ohranil polno aktivnost proti replikonom, ki so imeli substitucije S282T na nukleozidnem vezavnem mestu, M423T na spodnjem palčevem mestu oziroma P495A/S, P496S ali V499A na zgornjem palčevem mestu.
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when dasabuvir is taken in combination with ribavirin (see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information).
Slovenian: Da bi se izognili nosečnosti pri bolnicah in partnericah bolnikov, kadar se dasabuvir jemlje v kombinaciji z ribavirinom, je potrebna skrajna previdnost (glejte poglavje 4.6 in za dodatne informacije povzetek glavnih značilnosti zdravila za ribavirin).
English: Tell your doctor or pharmacist before taking Exviera, if you are taking any of the medicines in the table below.
Slovenian: Obvestite svojega zdravnika ali farmacevta preden boste začeli jemati zdravilo Exviera, če jemljete katero koli od zdravil v spodnji preglednici.
English: Serious and/or life threatening events have been observed with co-administration of dasabuvir and ombitasvir/paritaprevir/ritonavir 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 dasabuvirja in kombinacije ombitasvir/paritaprevir/ritonavir s sistemsko delujočim takrolimusom in podobno tveganje se lahko pričakuje pri sirolimusu in everolimusu.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov, kar zadeva toksične vplive na sposobnost razmnoževanja (glejte poglavje 5.3).
English: • Check for side effects of Exviera or other antiviral medicines your doctor has prescribed for you to use with Exviera (such as “ombitasvir/paritaprevir/ritonavir” and “ribavirin”).
Slovenian: • preveri neželene učinke zdravila Exviera ali drugih protivirusnih zdravil, ki vam jih je predpisal za uporabo skupaj z zdravilom Exviera (kot sta zdravili “ombitasvir/paritaprevir/ritonavir” in “ribavirin”).
English: PEARL II (open-label)
Slovenian: PEARL II (odprta)
English: 10 subjects (29.4%) had at least one post baseline haemoglobin value of less than 10 g/dL.
Slovenian: 10 preiskovancev (29,4 %) je imelo vsaj eno poizhodiščno vrednost hemoglobina pod 10 g/dl.
English: If tacrolimus or sirolimus are used together with dasabuvir and ombitasvir/paritaprevir/ritonavir, 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 dasabuvirjem ter kombinacijo ombitasvir/paritaprevir/ritonavir, se svetuje previdnost; priporočljive odmerke in strategije spremljanja se lahko najde v poglavju 4.5.
English: NA If clinically indicated, higher doses of omeprazole should be used.
Slovenian: NP Če je klinično indicirano, je treba uporabiti večje odmerke omeprazola.
English: Co-administration with other direct-acting antivirals against HCV
Slovenian: Sočasna uporaba z drugimi neposredno delujočimi protivirusnimi zdravili proti HCV
English: 10 of 34 subjects (29.4%) dose modified ribavirin due to decrease in haemoglobin and 2.9% (1/34) had an interruption of ribavirin.
Slovenian: 10 od 34 preiskovancev (29,4 %) so zaradi znižanja hemoglobina prilagodili odmerek ribavirina, pri 2,9 % (1/34) pa so uporabo ribavirina začasno prekinili.
English: • carbamazepine, phenytoin, phenobarbital
Slovenian: • karbamazepin, fenitoin, fenobarbital
English: Teriflunomide may increase dasabuvir exposures and should be used with caution.
Slovenian: Teriflunomid lahko zveča izpostavljenost dasabuvirju in ga je treba uporabljati previdno.
English: Cases of depression and more rarely of suicidal ideation and suicide attempt have been reported with dasabuvir with or without ombitasvir/paritaprevir/ritonavir 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 dasabuvirjem z ali brez ombitasvirja/paritaprevirja/ritonavirja v kombinaciji z ribavirinom v večini primerov.
English: Patients should be monitored frequently for any changes in renal function or tacrolimus or sirolimus associated adverse reactions.
Slovenian: Bolnike je treba redno spremljati glede morebitnih sprememb v delovanju ledvic ali neželenih učinkov povezanih s takrolimusom ali sirolimusom.
English: Increase in paritaprevir exposures may be due to inhibition of OATPs by atazanavir.
Slovenian: Zvečanje izpostavljenosti paritaprevirju je lahko posledica zavrtja OATP z atazanavirjem.
English: Given the low virologic failure rates observed with recommended treatment regimens for HCV genotype 1a- and 1b-infected subjects, the presence of baseline variants appears to have little impact on the likelihood of achieving SVR.
Slovenian: Glede na majhen delež neuspešnega zdravljenja, zabeležen ob uporabi priporočenih shem zdravljenja pri bolnikih, okuženih s HCV genotipa 1a in 1b, prisotnost izhodiščnih variant le malo vpliva na verjetnost za doseganje trajnega virusnega odziva (SVR).
English: 13/15 (86.7)c a. Calculated using the normal approximation to the binomial distribution b. 1 patient discontinued due to non-compliance c. Relapse in 2/15 patients (confirmed HCV RNA ≥ 15 IU/mL post-treatment before or during SVR12 window among subjects with HCV RNA < 15 IU/mL at last observation with at least 51 days of treatment).
Slovenian: 13/15 (86,7)c a. Izračunano z uporabo normalnega približka za binomsko porazdelitev b. En bolnik je prenehal z zdravljenjem zaradi nekompliance c. Ponovitev pri 2/15 bolnikov (potrjena HCV RNA ≥ 15 i.e./mL po zdravljenju pred ali med SVR12 oknom med preiskovanci s HCV RNA < 15 i.e./mL pri zadnjem merjenju z najmanj 51 dnevi zdravljenja).
English: None of the subjects with hyperbilirubinemia had concomitant elevations of aminotransferases.
Slovenian: Noben preiskovanec s hiperbilirubinemijo ni imel sočasno zvišanih aminotransferaz.
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).
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: ALT elevations were asymptomatic and generally occurred during the first 4 weeks of treatment, without concomitant elevations of bilirubin, and declined within approximately two weeks of onset with continued dosing of dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin.
Slovenian: Zvišanja ALT so bila asimptomatska in so se na splošno pojavila v prvih 4 tednih zdravljenja, brez hkratnega zvišanja bilirubina, ter so se znižala v približno dveh tednih po začetku stalne uporabe dasabuvirja ter kombinacije ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
English: Among all GT1 subjects who were post liver transplant, 111/114 (97.4%) achieved SVR12; with 2 relapsing post treatment and 1 breakthrough on treatment.
Slovenian: Izmed vseh GT1 preiskovancev, ki so prestali presaditev jeter, jih je 111/114 (97,4 %) doseglo SVR12; z 2 primeroma ponovitve bolezni po zdravljenju in 1 primerom preboja med zdravljenjem.
English: SVR12 rates for recommended treatment regimens by patient population
Slovenian: Preglednica 16: Deleži SVR12 glede na priporočene sheme zdravljenja in po populacijah bolnikov
English: Due to high SVR rates in genotype 1b, trends in persistence of treatment-emergent variants in this genotype could not be established.
Slovenian: Zaradi visokih deležev SVR pri genotipu 1b trendov trajnosti med zdravljenjem nastalih variant pri tem genotipu ni bilo mogoče ugotoviti.
English: If statin treatment is required during the treatment period, a switch to dose reduced pravastatin or rosuvastatin is possible.
Slovenian: Če je med obdobjem zdravljenja potrebno zdravljenje s statinom, je treba preiti na manjši odmerek pravastatina ali rosuvastatina, če je mogoče.
English: PVC/PE/PCTFE aluminium foil blister packs.
Slovenian: Pretisni omoti iz PVC/PE/PCTFE aluminijaste folije.
English: AMINOSALICYLATE Sulfasalazine
Slovenian: AMINOSALICILATI sulfasalazin
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Exviera.
Slovenian: Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Exviera, nizke ravni sladkorja v krvi (hipoglikemija).
English: Genotype-specific activity
Slovenian: Za genotip specifična aktivnost
English: Bilirubin elevations occurred after initiation of treatment, peaked by study Week 1, and generally resolved with ongoing therapy.
Slovenian: Zvišanje bilirubina se je pojavilo po uvedbi zdravljenja, vrh je doseglo 1. teden študije in je med nadaljevanjem zdravljenja običajno izginilo.
English: Deferasirox may increase dasabuvir exposures and should be used with caution.
Slovenian: Deferasiroks lahko zveča izpostavljenost dasabuvirju in ga je treba uporabljati previdno.
English: It is not known whether the active substance in Exviera (dasabuvir), passes into breast milk.
Slovenian: Ni znano ali učinkovina v zdravilu Exviera (dasabuvir) prehaja v materino mleko.
English: 12 or 24 weeks N = 380 n (%)
Slovenian: 12 ali 24 tednov N = 380 n (%)
English: There is no pharmacokinetic information in patients >75 years.
Slovenian: Farmakokinetičnih informacij za bolnike, starejše od 75 let, ni. Spol ali telesna masa
English: AbbVie (as logo)
Slovenian: AbbVie (kot logotip)
English: AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
Slovenian: AFP* < 20 ng/ml, trombociti ≥ 90 x 109/l IN albumin ≥ 35 g/l pred zdravljenjem Da (za vse tri zgoraj naštete parametre)
English: Glucose levels of diabetic patients initiating direct acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medicinal products modified when necessary.
Slovenian: Pri sladkornih bolnikih, ki so se začeli zdraviti z neposredno delujočim protivirusnim zdravilom, je treba zlasti v prvih treh mesecih skrbno spremljati ravni krvnega sladkorja ter po potrebi prilagoditi zdravilo za zdravljenje sladkorne bolezni.
English: The High Pure system assay had a lower limit of quantification (LLOQ) of 25 IU per mL and the AmpliPrep assay had a LLOQ of 15 IU per mL.
Slovenian: Preizkus s sistemom High Pure System je imel spodnjo mejo kvantifikacije (LLOQ) 25 i.e./ml in preizkus z AmpliPrep 15 i.e./ml.
English: Genotype 1b N=7 % (n)
Slovenian: Genotip 1b N = 7 % (n)
English: Note: For laboratory abnormalities refer to Table 4.
Slovenian: Opomba: Za laboratorijske nepravilnosti glejte preglednico 4.
English: Cirrhosis was not a risk factor for elevated ALT (see section 4.4).
Slovenian: Ciroza ni bila dejavnik tveganja za zvišanje ALT (glejte poglavje 4.4).
English: Dasabuvir is an inhibitor of BCRP in vivo.
Slovenian: Dasabuvir zavira BCRP in vivo.
English: It is not known whether dasabuvir and metabolites are excreted in human breast milk.
Slovenian: Ni znano, ali se dasabuvir in njegovi presnovki pri človeku izločajo v materino mleko.
English: Mechanism: possible enzyme induction by efavirenz.
Slovenian: Možna indukcija encimov z efavirenzom.
English: Although ALT elevations associated with dasabuvir and ombitasvir/paritaprevir/ritonavir have been asymptomatic, patients should be instructed to watch for early warning signs of liver inflammation, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice and discoloured faeces, and to consult a doctor without delay if such symptoms occur.
Slovenian: Čeprav so bila zvišanja ALT, povezana z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir, asimptomatska, je treba bolnikom naročiti, da morajo biti pozorni na zgodnje opozorilne znake vnetja jeter, npr. na utrujenost, šibkost, pomanjkanje apetita, navzeo in bruhanje, pa tudi na poznejše znake, npr. zlatenico, spremembo barve blata, in da se morajo v primeru pojava simptomov brez odlašanja posvetovati z zdravnikom.
English: TURQUOISE II (open-label)
Slovenian: TURQUOISE II (odprta)
English: Dasabuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Slovenian: Dasabuvir ni bil genotoksičen v skupini preizkusov in vitro ali in vivo, vključno s preizkusom mutagenosti pri bakterijah, preizkusom kromosomskih aberacij na človeških limfocitih iz periferne krvi in v mikrojedrnem preizkusu in vivo pri podganah.
English: ANTIHYPERLIPIDAEMICS Gemfibrozil
Slovenian: ANTIHIPERLIPEMIKI gemfibrozil
English: b. Includes subjects who discontinued due to adverse event, lost to follow-up or subject withdrawal, and subjects with reinfection
Slovenian: b. Vključuje preiskovance, ki so prenehali z zdravljenjem zaradi neželenih učinkov, ki so jih prenehali spremljati v zvezi z neželenimi učinki ali pa so sami odstopili, in preiskovance, ki so se ponovno okužili.
English: d. Observed in combination in genotype 1b-infected subjects.
Slovenian: d. Opaženo v kombinaciji pri preiskovancih, okuženih z genotipom 1b.
English: • mitotane
Slovenian: • mitotan
English: 20-120 mg once daily8
Slovenian: 20-120 mg enkrat na dan8
English: Enzyme inducers:
Slovenian: Induktorji encimov:
English: Clinical trials in treatment-naïve adults
Slovenian: Klinična preskušanja pri še nezdravljenih odraslih
English: Dasabuvir had reduced activity in biochemical assays against NS5B polymerases from HCV genotypes 2a, 2b, 3a and 4a (IC50 values ranging from 900 nM to >20 μM).
Slovenian: Dasabuvir je v biokemičnih preizkusih zmanjšal aktivnost proti NS5b polimerazam HCV genotipov 2a, 2b, 3a in 4a (vrednosti IC50 vrednosti od 900 nM do > 20 µM).
English: Dasabuvir has also been found to inhibit UGT1A4, 1A6 and intestinal UGT2B7 in vitro at in vivo relevant concentrations.
Slovenian: Ugotovljeno je bilo tudi, da dasabuvir in vitro zavira UGT1A4, 1A6 in črevesni UGT2B7 pri koncentracijah, ki so pomembne in vivo.
English: Recommended co-administered medicinal product(s) and treatment duration for dasabuvir by patient population
Slovenian: Preglednica 1: Priporočena sočasna zdravila in trajanje zdravljenja z dasabuvirjem po populacijah bolnikov
English: ** When assessing severity of liver disease using non-invasive methods, a combination of blood biomarkers or the combination of liver stiffness measurement and a blood test improves accuracy and should be undertaken prior to 8 week treatment in all patients with moderate fibrosis.
Slovenian: ** Pri oceni resnosti bolezni jeter z uporabo neinvazivnih metod kombinacija krvnih biomarkerjev ali kombinacija meritev togosti jeter in krvnega testa poveča natančnost in jo je potrebno izvesti pred 8
English: Drug interactions need to be carefully taken into account in the setting of HIV co-infection (for details see section 4.5, Table 2).
Slovenian: Pri bolnikih, ki so sočasno okuženi s HIV, je treba skrbno upoštevati medsebojna delovanja zdravil (za podrobnosti glejte poglavje 4.5, preglednico 2).
English: TURQUOISE III (open-label)
Slovenian: TURQUOISE III (odprta)
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.
Slovenian: V delu 2 je bil SVR12 dosežen pri 27/28 (96,4 %) preiskovancih s sočasno okužbo HCV GT4/HIV-1 (95 % CI: 82,3 %, 99,4 %) brez primerov virusne neodzivnosti na zdravljenje.
English: At steady-state the exposures ratio of M1 to dasabuvir is approximately 0.6.
Slovenian: M1 v primerjavi z dasabuvirjem približno 0,6.
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).
Slovenian: Dasabuvir se ne sme uporabljati pri bolnikih z zmerno do hudo okvaro jeter (Child-Pugh B ali C) (glejte poglavja 4.2, 4.3, 4.8 in 5.2.
English: CYP2C19 substrates evaluated in drug interaction studies include omeprazole and escitalopram (Table 2).
Slovenian: Med substrati CYP2C19, raziskanimi v študijah medsebojnega delovanja zdravil, sta omeprazol in escitalopram (preglednica 2).
English: For dosing recommendations with HIV antiviral medicinal products, refer to sections 4.4 and 4.5.
Slovenian: Za priporočila o odmerjanju s protivirusnimi zdravili proti HIV glejte poglavji 4.4 in 4.5.
English: Use in diabetic patients
Slovenian: Uporaba pri sladkornih bolnikih
English: Resistance to dasabuvir conferred by variants in NS5B selected in cell culture or identified in Phase 2b and 3 clinical trials were phenotypically characterised in the appropriate genotype 1a or 1b replicons.
Slovenian: Odpornost proti dasabuvirju, povezana z variantami NS5B, selekcioniranih v celičnih kulturah ali identificiranih v kliničnih preskušanjih faze 2b in 3, so fenotipsko opredelili v ustreznih replikonih genotipa 1a ali 1b.
English: 12 weeks N = 509 n (%)
Slovenian: 12 tednov N = 509 n (%)
English: For subjects who received ribavirin, the ribavirin dose was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg.
Slovenian: so dobivali odmerek 1000 mg ribavirina na dan, če so tehtali manj kot 75 kg, oziroma odmerek 1200 mg na dan, če so tehtali 75 kg ali več.
English: • Dehydration
Slovenian: • dehidracija.
English: Apalutamide, enzalutamide for prostate cancer ethinyloestradiol containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception gemfibrozil to lower cholesterol and other fats in the blood mitotane for some tumours of the adrenal glands rifampicin for bacterial infections
Slovenian: apalutamid, enzalutamid pri raku prostate zdravila, ki vsebujejo etinilestradiol, kot je večina kontracepcijskih tablet in vaginalnih obročkov, ki se uporabljajo kot kontracepcija kontracepcija gemfibrozil za zniževanje holesterola in drugih maščob v krvi mitotan pri nekaterih tumorjih nadledvičnih žlez rifampicin pri bakterijskih okužbah šentjanževka (hypericum perforatum)
English: Patients who are taking ethinyloestradiol -containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating dasabuvir with ombitasvir/paritaprevir/ritonavir therapy (see sections 4.3 and 4.5).
Slovenian: Bolnice, ki uporabljajo zdravila z etinilestradiolom (tj. večina kombiniranih peroralnih kontraceptivov ali kontracepcijskih vaginalnih obročkov), morajo preiti na drugačen način kontracepcije (npr. na samo progestinsko kontracepcijo ali na nehormonske načine), preden začnejo zdravljenje z dasabuvirjem in kombinacijo ombitasvir/paritaprevir/ritonavir (glejte poglavji 4.3 in 4.5).
English: How long to take Exviera for
Slovenian: Kako dolgo jemati zdravilo Exviera
English: • Read the “Contraception” section of the package leaflet for ribavirin very carefully.
Slovenian: • V navodilih za uporabo za ribavirin natančno preberite poglavje »Kontracepcija«.
English: NA Clinical monitoring of patients is recommended.
Slovenian: NP Bolnike je priporočljivo klinično nadzirati.
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:
English: Number of subjects treated
Slovenian: Število zdravljenih preiskovancev
English: In contrast, the rate of ALT elevations in subjects using other types of oestrogens as typically used in hormonal replacement therapy (i.e., oral and topical oestradiol and conjugated oestrogens) was similar to the rate observed in subjects who were not using oestrogen-containing products (approximately 1% in each group).
Slovenian: V nasprotju s tem so bila zvišanja ALT pri tistih, ki so uporabljale druge vrste estrogenov, kakršne so tipično sestavine hormonskega nadomestnega zdravljenja (tj. peroralni in lokalni estradiol in konjugirani estrogeni), opažena v podobnem deležu kot med neuporabnicami zdravil z estrogenom (približno 1 % v vsaki skupini).
English: Among the GT1 subjects who were post renal transplant, 9/12 (75%) achieved SVR12; however, there were no virologic failures.
Slovenian: Izmed vseh GT1 preiskovancev, ki so prestali presaditev ledvic, jih je 9/12 (75 %) doseglo SVR12; vendar pa ni bilo virusne neodzivnosti.
English: Sirolimus dose and/or dosing frequency should be adjusted as needed.
Slovenian: Odmerek sirolimusa in/ali pogostnost odmerjanja je potrebno ustrezno prilagoditi.
English: Enzyme inducers
Slovenian: Induktorji encimov
English: HCV ANTIVIRAL Sofosbuvir
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HCV sofosbuvir
English: The European Medicines Agency has deferred the obligation to submit the results of studies with dasabuvir and ombitasvir/paritaprevir/ritonavir in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Slovenian: Pediatrična populacija Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z dasabuvirjem in ombitasvir/paritaprevir/ritonavir za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje
English: Patients with moderate to severe hepatic impairment (Child-Pugh B or C) (see section 5.2).
Slovenian: Bolniki z zmerno do hudo okvaro jeter (Child-Pugh B ali C) (glejte poglavje 5.2).
English: Medicinal products that are strong CYP2C8 inhibitors may increase dasabuvir plasma concentrations and must not be co-administered with dasabuvir (see section 4.5).
Slovenian: Zdravila, ki močno zavirajo CYP2C8, lahko zvečajo koncentracijo dasabuvirja v plazmi in se jih ne sme uporabljati sočasno z dasabuvirjem (glejte poglavje 4.5).
English: HIV ANTIVIRALS: PROTEASE INHIBITORS
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI PROTEAZ
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, female subjects would have approximately 14 to 30% higher dasabuvir exposures than male subjects.
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov kliničnih študij 3. faze bi bila izpostavljenost preiskovank dasabuvirju približno 14 do 30 % večja kot izpostavljenost preiskovancev.