FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment duration was 12 weeks for treatment naïve subjects, 12-24 weeks for treatment experienced subjects and 24 weeks for subjects with cirrhosis.
Slovenian: Pri še nezdravljenih bolnikih je zdravljenje trajalo 12 tednov, pri že zdravljenih od 12 do 24 tednov, in pri bolnikih s cirozo 24 tednov.
English: If tacrolimus with Viekirax and dasabuvir are used concomitantly, tacrolimus should not be administered on the day Viekirax and dasabuvir are initiated.
Slovenian: Če so takrolimus in zdravilo Viekirax in dasabuvir uporabljeni skupaj, se takrolimus ne sme dati na isti dan kot je začetek uporabe zdravila Viekirax in dasabuvirja.
English: Genotype 4, without cirrhosis or with compensated cirrhosis
Slovenian: Genotip 4, brez ciroze ali s kompenzirano cirozo
English: Dasabuvir treatment-emergent variants M414T, G554S, S556G, G558R or D559G/N in NS5B were observed in 34 subjects.
Slovenian: Med zdravljenjem z dasabuvirjem nastale variante M414T, G554S, S556G, G558R ali D559G/N gena NS5B so ugotovili pri 34 preiskovancih.
English: Clinical studies in subjects with genotype 1 hepatitis C infection The efficacy and safety of Viekirax in combination with dasabuvir with and without ribavirin was evaluated in eight Phase 3 clinical trials, including two trials exclusively in subjects with cirrhosis (ChildPugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Slovenian: Učinkovitost in varnost zdravila Viekirax v kombinaciji z dasabuvirjem (z ribavirinom ali brez njega) so preučili v osmih kliničnih preskušanjih 3. faze (vključno z dvema preskušanjema izključno pri bolnikih s cirozo (Child-Pugh A)) pri več kot 2.360 preiskovancih s kronično okužbo s hepatitisom C genotipa 1, kot povzema preglednica 6.
English: Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
Slovenian: Zdravilo Viekirax je v kombinaciji z drugimi zdravili indicirano za zdravljenje kroničnega hepatitisa C pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
English: To be noted, darunavir should be taken without ritonavir, since ritonavir 100 mg once daily is provided as part of Viekirax.
Slovenian: Poudariti velja, da je treba darunavir uporabljati brez ritonavirja, kajti 100 mg ritonavirja enkrat na dan je sestavina zdravila Viekirax.
English: Sulfamethoxazole, Trimethoprim
Slovenian: sulfametoksa zol, trimetoprim
English: 300 mg once daily (given at the same time)
Slovenian: 300 mg enkrat na dan (uporabljen ob istem času)
English: HIV ANTIVIRALS: NUCLEOSIDE INHIBITORS Abacavir/ lamivudine
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV: NUKLEOZIDNI ZAVIRALCI abakavir/lamivu din
English: These metabolites are not expected to have antiviral activity or off-target pharmacologic activity.
Slovenian: Za te presnovke ni pričakovati, da bi delovali protivirusno ali da bi imeli farmakološko delovanje drugje kot na svojem tarčnem mestu.
English: Pooled analyses of clinical trials
Slovenian: Kumulativne analize kliničnih preskušanj
English: Following a 600 mg dose of 14C -ritonavir oral solution, 86.4% of the radioactivity was recovered in the faeces and 11.3% of the dose was excreted in the urine.
Slovenian: Po uporabi odmerka 600 mg 14C-ritonavirja v peroralni raztopini se je 86,4 % radioaktivnosti pojavilo v blatu in 11,3 % odmerka se je izločilo v urinu.
English: TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HCV GT1 or GT4/HIV-1 coinfection, without cirrhosis or with compensated cirrhosis
Slovenian: TURQUOISE-I - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s sočasno HCV GT1 ali GT4/HIV-1 okužbo, brez ciroze ali s kompenzirano cirozo
English: Recommendations for co-administration of Viekirax with and without dasabuvir for a number of medicinal products are provided in Table 2.
Slovenian: Priporočila za sočasno uporabo zdravila Viekirax (z dasabuvirjem ali brez njega) s številnimi zdravili so navedena v preglednici 2.
English: To be noted, atazanavir should be taken without ritonavir, since ritonavir 100 mg once daily is provided as part of Viekirax.
Slovenian: Poudariti velja, da je treba atazanavir uporabljati brez ritonavirja, kajti 100 mg ritonavirja enkrat na dan je sestavina zdravila Viekirax.
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
English: NA A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with Viekirax with or without dasabuvir .
Slovenian: NP Razmisliti je treba o 50 % zmanjšanju odmerka hidrokodona in/ali kliničnem spremljanju pri sočasnem dajanju s kombinacijo Viekirax z ali brez dasabuvirja.
English: 0.75 mg single dose
Slovenian: 0,75 mg enkratni odmerek
English: In the presence of dasabuvir, paritaprevir exposures increased by 50% to 65% while there was no change in ombitasvir exposures.
Slovenian: Vpliv dasabuvirja na paritaprevir/ritonavir in ombitasvir V prisotnosti dasabuvirja se je izpostavljenost paritaprevirju povečala za 50 do 65 %, izpostavljenost ombitasvirju pa se ni spremenila.
English: ↑ voriconazole ↑ dasabuvir ↑ paritaprevir
Slovenian: ↑ dasabuvir ↑ paritaprevir
English: Pink, oblong, biconvex, film-coated tablets of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘AV1'.
Slovenian: Rožnate, podolgovate bikonveksne filmsko obložene tablete velikosti 18,8 mm x 10,0 mm, ki imajo na eni strani vtisnjeno oznako "AV1".
English: Co-administration of Viekirax and dasabuvir with systemic tacrolimus, sirolimus or everolimus increases the concentrations of the immunosuppressant due to CYP3A inhibition by ritonavir (see section 4.5).
Slovenian: Sočasna uporaba zdravila Viekirax in dasabuvirja s sistemsko delujočimi takrolimusom, sirolimusom ali everolimusom poveča koncentracije imunosupresiva zaradi CYP3A inhibicije z ritonavirjem (glejte poglavje 4.5).
English: Plasma protein binding is not meaningfully altered in subjects with renal or hepatic impairment.
Slovenian: Vezava na beljakovine v plazmi pri bolnikih z okvaro ledvic ali jeter ni pomembno spremenjena.
English: Other CYP2C9 substrates (NSAIDs (e.g. ibuprofen), antidiabetics (e.g. glimepiride, glipizide) are not expected to require dose adjustments.
Slovenian: Za druge substrate CYP2C9 (NSAID (npr. ibuprofen), antidiabetiki (npr. glimepirid,
English: < 90, n (%)
Slovenian: < 90, n (%) ≥ 90, n (%)
English: Note: For laboratory abnormalities, refer to Table 4
Slovenian: Opomba: Za laboratorijske nepravilnosti glejte preglednico 4.
English: Phase 3 global multicentre studies conducted with Viekirax and dasabuvir with or without ribavirin (RBV).
Slovenian: Preglednica 6: Globalne multicentrične študije 3. faze z zdravilom Viekirax in dasabuvirjem, z ribavirinom (RBV) ali brez njega.
English: Following a 25 mg single dose of 14C-ombitasvir given alone, unchanged parent drug accounted for 8.9% of total radioactivity in human plasma; a total of 13 metabolites were identified in human plasma.
Slovenian: 14C-ombitasvirja, uporabljenega samega, je šlo na račun nespremenjenega matičnega zdravila 8,9 % celotne radioaktivnosti v človeški plazmi; skupno so v človeški plazmi ugotovili 13 presnovkov.
English: Following dosing of ombitasvir/paritaprevir /ritonavir with or without dasabuvir, mean plasma half-life of paritaprevir was approximately 5.5 hours.
Slovenian: Po uporabi ombitasvirja/paritaprevirja/ritonavirja (z dasabuvirjem ali brez njega) je bil povprečni plazemski razpolovni čas paritaprevirja približno 5,5 ure.
English: Paritaprevir/ritonavir has shown malformations (open eye lids) at a low incidence in mice at exposures 32/8-fold higher than the exposure in humans at the recommended clinical dose.
Slovenian: S paritaprevirjem/ritonavirjem so pri miših ugotovili malformacije (odprte očesne veke) z majhno incidenco ob izpostavljenostih, ki so bile 32-/8-krat večje od izpostavljenosti človeka ob priporočenih kliničnih odmerkih.
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 (except GARNET which used COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
Slovenian: COBAS TaqMan HCV test (verzija 2.0), ki je namenjen za uporabo s sistemom High Pure System.
English: ↑ nifedipine
Slovenian: ↑ nifedipin
English: Medicines you must tell your doctor about before taking Viekirax Medicine or active substance
Slovenian: Zdravila, o katerih morate obvestiti zdravnika, preden vzamete zdravilo Viekirax
English: Emergent amino acid substitutionsa
Slovenian: Nastale aminokislinske substitucijea
English: The recommended dose of darunavir is 800 mg once daily, without ritonavir, when administered at the same time as Viekirax + dasabuvir (ritonavir dose in Viekirax will provide darunavir pharmacokinetic enhancement).
Slovenian: Priporočeni odmerek darunavirja je 800 mg enkrat na dan, brez ritonavirja, če se da ob istem času kot zdravilo Viekirax in dasabuvir (odmerek ritonavirja v zdravilu Viekirax zagotavlja okrepitev
English: Co-administration of Viekirax with or without dasabuvir with medicinal products primarily metabolized by CYP3A may result in increased plasma concentrations of these medicinal products.
Slovenian: Sočasna uporaba zdravila Viekirax z dasabuvirjem ali brez njega skupaj z zdravili, ki se presnavljajo predvsem s CYP3A, lahko poveča koncentracijo takšnih zdravil v plazmi.
English: Overall SVR12 Outcome for subjects without SVR12 On-treatment VF Relapse Other * Ombitasvir tablets, paritaprevir tablets and ritonavir capsules administered separately.
Slovenian: Celotni SVR12 Izid pri preiskovancih brez SVR12 VN med zdravljenjem Recidiv Drugo * Tablete ombitasvirja, tablete paritaprevirja in kapsule ritonavirja so bile uporabljene ločeno.
English: The maximum daily dose of rosuvastatin should be 10 mg (see section 4.4).
Slovenian: Največji dnevni odmerek rosuvastatina sme biti 10 mg (glejte poglavje 4.4).
English: ↑ fluvastatin ↑ pitavastatin
Slovenian: Pričakovano: ↑ fluvastatin ↑ pitavastatin
English: Genotype 1a, without cirrhosis
Slovenian: Genotip 1a, brez ciroze
English: ANTI-DIURETIC HORMONE Conivaptan
Slovenian: ANTIDIURETIČNI HORMON
English: Propylene glycol monolaurate Sorbitan monolaurate Colloidal anhydrous silica (E 551) Sodium stearyl fumarate
Slovenian: Jedro tablete kopovidon tokofersolan propilenglikol monolavrat sorbitan monolavrat koloidni brezvodni silicijev dioksid (E 551) natrijev stearilfumarat
English: Paritaprevir, ritonavir and dasabuvir are inhibitors of BCRP in vivo.
Slovenian: Paritaprevir, ritonavir in dasabuvir in vivo zavirajo BCRP.
English: Following a single 25 mg dose of 14C- ombitasvir approximately 90% of the radioactivity was recovered in faeces and 2% in urine.
Slovenian: Po uporabi posameznega odmerka 25 mg 14C-ombitasvirja se je približno 90 % radioaktivnosti pojavilo v blatu in 2 % v urinu.
English: Increase in paritaprevir exposures may be due to
Slovenian: povečanje izpostavljenosti paritaprevirju je
English: Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg, with or without dasabuvir 400 mg were evaluated in subjects with mild (CrCl: 60 to 89 ml/min), moderate (CrCl: 30 to 59 ml/min) and severe (CrCl: 15 to 29 ml/min) renal impairment.
Slovenian: Farmakokinetiko kombinacije 25 mg ombitasvirja, 150 mg paritaprevirja in 100 mg ritonavirja (s 400 mg dasabuvirja ali brez njega) so ocenili pri preiskovancih z blago (očistek kreatinina od 60 do 89 ml/min), zmerno (očistek kreatinina od 30 do 59 ml/min) in hudo (očistek kreatinina od 15 do 29 ml/min) okvaro ledvic.
English: Tell your doctor or pharmacist before taking Viekirax also if you are using hormonal contraceptives.
Slovenian: Pred začetkom jemanja zdravila Viekirax svojemu zdravniku povejte, če jemljete hormonske kontraceptive.
English: In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine +/- naloxone (N=19) received 12 weeks of Viekirax and dasabuvir with ribavirin.
Slovenian: V multicentrični, odprti študiji 2. faze z eno samo skupino, je 38 še nezdravljenih bolnikov oz. bolnikov, že zdravljenih s pegIFN/RBV, brez ciroze, in okuženih z genotipom 1, ki so dobivali stabilne odmerke metadona (N = 19) ali buprenorfina, z naloksonom ali brez njega (N = 19), 12 tednov prejemalo zdravilo Viekirax in dasabuvir skupaj z ribavirinom.
English: randomised, global multicentre, double-blind, placebo-controlled
Slovenian: Oblika preskušanja: randomizirano, globalno, multicentrično, dvojno slepo, s placebom kontrolirano
English: NARCOTIC ANALGESICS Paracetamol (as given in a fixed-dose hydrocodone/ paracetamol)
Slovenian: Paracetamol (kot fiksni odmerek kombinacije hidrokodon/par acetamol)
English: In genotype 1b, substitutions L28T, L31F/V, as well as Y93H alone or in combination with L28M, R30Q, L31F/M/V or P58S in HCV NS5A reduced susceptibility to ombitasvir.
Slovenian: Pri genotipu 1b so substitucije L28T, L31F/V, pa tudi Y93H sama ali v kombinaciji z L28M, R30Q, L31F/M/V ali P58S v NS5A HCV zmanjšala občutljivost za ombitasvir.
English: Following administration of Viekirax, the changes in ombitasvir, paritaprevir, and ritonavir exposures in subjects with mild, moderate and severe renal impairment were similar to those observed when Viekirax was administered with dasabuvir, and are not considered to be clinically significant.
Slovenian: Po uporabi zdravila Viekirax Po uporabi zdravila Viekirax so bile spremembe izpostavljenosti ombitasvirju, paritaprevirju in ritonavirju pri preiskovancih z blago, zmerno in hudo okvaro ledvic podobni, kot če je bilo zdravilo Viekirax uporabljeno z dasabuvirjem, in ne veljajo za klinično pomembne.
English: Medicinal Product/Poss ible Mechanism of Interaction
Slovenian: Zdravilo/može n mehanizem medsebojnega delovanja
English: BCRP substrates evaluated in drug interaction studies include rosuvastatin (see Table 2).
Slovenian: Med substrati BCRP, raziskanimi v študijah medsebojnega delovanja zdravil, je rosuvastatin (glejte preglednico 2).
English: The impact of prior ombitasvir, paritaprevir or dasabuvir treatment experience on the efficacy of other NS5A inhibitors, NS3/4A protease inhibitors, or NS5B inhibitors has not been studied.
Slovenian: Vpliv predhodnega zdravljenja z ombitasvirjem, paritaprevirjem ali dasabuvirjem na učinkovitost drugih zaviralcev NS5A, zaviralcev proteaz NS3/4A ali zaviralcev NS5B ni raziskan.
English: CYP3A4 substrates:
Slovenian: Substrati CYP3A4:
English: Following dosing of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, mean plasma half-life of ombitasvir was approximately 21 to 25 hours.
Slovenian: Po uporabi ombitasvirja/paritaprevirja/ritonavirja (z dasabuvirjem ali brez njega) je bil povprečni plazemski razpolovni čas ombitasvirja približno 21 do 25 ur.
English: GT1b Viekirax and dasabuvir (8 weeks) Peginterferon+ribavirin experienced -, without cirrhosis SAPPHIRE II
Slovenian: GT1b Viekirax in dasabuvir (8 tednov) Že zdravljeni s peginterferonom + ribavirinom, brez ciroze SAPPHIRE II
English: Viekirax 12.5 mg/75 mg/50 mg film-coated tablets
Slovenian: Viekirax 12,5 mg/75 mg/50 mg filmsko obložene tablete
English: Subjects with HCV GT4 received Viekirax with ribavirin for 12 or 24 Weeks.
Slovenian: Preiskovanci s HCV GT4 so prejemali zdravilo Viekirax z ribavirinom 12 ali 24 tednov.
English: Following a 200 mg 14C -paritaprevir dose with 100 mg ritonavir, approximately 88% of the radioactivity was recovered in faeces with limited radioactivity (8.8%) in urine.
Slovenian: Po uporabi odmerka 200 mg 14C-paritaprevirja s 100 mg ritonavirja se je približno 88 % radioaktivnosti pojavilo v blatu in le malo radioaktivnosti (približno 8,8 %) v urinu.
English: Expected ↑ alfuzosin
Slovenian: Pričakovano: ↑ alfuzosin
English: Genotype 1b, without cirrhosis or with compensated cirrhosis
Slovenian: Genotip 1b, brez ciroze ali s kompenzirano cirozo
English: Ombitasvir treatment-emergent variants M28T, M28V or Q30R in NS5A were observed in 32 subjects.
Slovenian: Med zdravljenjem z ombitasvirjem nastale variante M28T, M28V ali Q30R gena NS5A so ugotovili pri 32 preiskovancih.
English: Mechanism: decrease possibly due to CYP1A2 induction by ritonavir
Slovenian: Mehanizem: Možno zmanjšanje zaradi zavrtja CYP1A2 z ritonavirjem.
English: Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events are contraindicated (see section 4.3 and Table 2).
Slovenian: Kontraindicirana so zdravila, ki so zelo odvisna od očistka s CYP3A in katerih zvišana koncentracija v plazmi je povezana z resnimi učinki (glejte poglavje 4.3 in preglednico 2).
English: The doses of ombitasvir, paritaprevir, ritonavir were 25 mg 150 mg, 100 mg once daily in PEARL-I, while the dose of paritaprevir was 100 mg or 150 mg in study M12-536.
Slovenian: Odmerki ombitasvirja, paritaprevirja in ritonavirja so bili v študiji PEARL-I 25 mg,150 mg in 100 mg 1-krat na dan, odmerek paritaprevirja v študiji M12-536 pa je bil 100 mg ali 150 mg.
English: Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving Viekirax and dasabuvir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Slovenian: Pri preiskovancih, ki so dobivali zdravilo Viekirax in dasabuvir z ribavirinom, so opažali prehodno zvišanje bilirubina v serumu (pretežno indirektnega), ki je povezano z zavrtjem bilirubinskih prenašalcev OATP1B1/1B3 s paritaprevirjem in s hemolizo zaradi ribavirina.
English: ANTITPLATELET AGENTS Ticagrelor
Slovenian: ZAVIRALCI AGREGACIJE TROMBOCITOV ticagrelor
English: Co-administration of Viekirax with or without dasabuvir together with medicinal products that are substrates of BCRP may increase plasma concentrations of these transporter substrates, potentially requiring dose adjustment/clinical monitoring.
Slovenian: Sočasna uporaba zdravila Viekirax z dasabuvirjem ali brez njega skupaj z zdravili, ki so substrati BCRP, lahko zvišajo koncentracijo teh substratov prenašalcev v plazmi, zato sta lahko potrebna prilagoditev odmerka oziroma klinični nadzor.
English: ↑ repaglinide
Slovenian: ↑ repaglinid
English: Clinical Comments
Slovenian: Klinične opombe
English: Viekirax without dasabuvir may increase the plasma concentrations of dabigatran etexilate.
Slovenian: Zdravilo Viekirax brez dasabuvirja lahko poveča plazemske koncentracije dabigatran eteksilata.
English: Atazanavir must be administered at the same time as Viekirax with dasabuvir.
Slovenian: Atazanavir je treba dajati ob istem času kot zdravilo Viekirax in dasabuvir.
English: In subjects with liver transplant, no cirrhosis and GT1 infection, patients were dosed with Viekirax and dasabuvir for 12-24 weeks, with and without RBV.
Slovenian: Preiskovanci s presajenimi jetri, brez ciroze in z okužbo GT1, so prejemali zdravilo Viekirax in dasabuvir 12-24 tednov, z ali brez RBV.
English: Clinical Comments inhibition of OATP1B1/B3 and CYP3A by atazanavir and CYP3A by the additional dose of ritonavir.
Slovenian: OATP1B1/B3 in CYP3A z atazanavirjem ter CYP3A z dodatnim odmerkom ritonavirja.
English: The overall safety profile in HCV-infected transplant recipients who were administered Viekirax and dasabuvir and ribavirin (in addition to their immunosuppressant medications) was similar to subjects treated with Viekirax and dasabuvir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Slovenian: Celotne varnostne značilnosti pri prejemnikih presadka, okuženih s HCV, ki so (poleg imunosupresivnih zdravil) prejemali zdravilo Viekirax in dasabuvir ter ribavirin, je bila podobna kot pri preiskovancih,
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral medicinal products.
Slovenian: Med zdravljenjem ali po zdravljenju z zdravili z direktnim delovanjem na viruse so poročali o reaktivaciji virusa hepatitisa B (HBV), nekateri primeri so bili smrtni.
English: Medicinal products metabolised by CYP2C9
Slovenian: Zdravila, ki se presnovijo s CYP2C9
English: 200 mg once daily/300 mg once daily
Slovenian: 200 mg enkrat na dan/300 mg enkrat na dan
English: Treatment-naïve, without cirrhosis SAPPHIRE I
Slovenian: Še nezdravljeni, brez ciroze SAPPHIRE I
English: • Hepatic laboratory testing including direct bilirubin levels should be performed at baseline, during the first 4 weeks of starting treatment and as clinically indicated thereafter.
Slovenian: • na začetku, v prvih 4 tednih po začetku zdravljenja in pozneje kot je klinično indicirano je treba opraviti jetrne laboratorijske teste, vključno z ravnjo direktnega bilirubina,
English: For immunosuppressive medication, most subjects were taking tacrolimus (81%), with the remainder taking cyclosporine.
Slovenian: 61 % jih je bilo pred presaditvijo že zdravljenih za HCV. Kot imunosupresivno terapijo je večina preiskovancev dobivala takrolimus (81 %), ostali pa ciklosporin.
English: 5 mg single dose and other vitamin K antagonists
Slovenian: ANTIKOAGULANTI varfarin enkraten odmerek 5 mg in drugi antagonisti vitamina K
English: On-treatment virologic failure Post-treatment relapse Other
Slovenian: Virusna neodzivnost med zdravljenjem Recidiv po zdravljenju Drugo
English: Poly(vinyl alcohol) (E 1203) Macrogol (3350) Talc (E 553b)
Slovenian: Filmska obloga polivinilalkohol (E 1203) makrogol 3350 smukec (E 553b) titanov dioksid (E 171)
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Viekirax.
Slovenian: Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Viekirax, nizke ravni sladkorja v krvi
English: ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4)
Slovenian: (3. stopnja) > 20 × ZNM (4. stopnja)
English: In this combination, the maximum daily dose of rosuvastatin should be 10 mg (see section 4.5, Table 2).
Slovenian: V tej kombinaciji sme biti največji dnevni odmerek rosuvastatina 10 mg (glejte poglavje 4.5, preglednico 2).
English: Sirolimus 0.5 mg single dose5
Slovenian: sirolimus 0,5 mg enkratni odmerek5
English: • alfuzosin hydrochloride
Slovenian: • alfuzosinijev klorid
English: Liver transplant subjects with cirrhosis were dosed with Viekirax and dasabuvir with RBV (GT1a for 24 weeks [n=4], GT1b for 12 weeks [n=2]).
Slovenian: Preiskovanci s presajenimi jetri z cirozo so prejemali zdravilo Viekirax in dasabuvir z RBV (GT1a 24 tednov [n=4], GT1b 12 tednov [n=2]).
English: Concomitant use of tacrolimus with Viekirax and dasabuvir is not recommended unless the benefits outweigh the risks (see section 4.4).
Slovenian: Sočasna uporaba takrolimusa z zdravilom Viekirax in dasabuvirjem ni priporočljiva, razen kadar koristi prevladajo nad tveganji (glejte poglavje 4.4).
English: Paritaprevir is an inhibitor of the hepatic uptake transporters OATP1B1 and OATP1B3, and paritaprevir and ritonavir are inhibitors of OATP2B1.
Slovenian: Paritaprevir zavira jetrna privzemna prenašalca OATP1B1 in OATP1B3, paritaprevir in ritonavir pa zavirata OATP2B1.
English: Cross-resistance is expected among NS5A inhibitors, NS3/4A protease inhibitors, and non-nucleoside NS5B inhibitors by class.
Slovenian: Po skupini je mogoče navzkrižno odpornost pričakovati med zaviralci NS5A, zaviralci proteaz NS3/4A in nenukleozidnimi zaviralci NS5B.
English: The mean EC50 of paritaprevir against replicons containing NS3 from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.86 nM (range 0.43 to 1.87 nM; n=11) and 0.06 nM (range 0.03 to 0.09 nM; n=9), respectively.
Slovenian: Povprečna EC50 paritaprevirja proti replikonom, ki so vsebovali NS3 iz skupine izolatov še nezdravljenih bolnikov z genotipom 1a in 1b, je bila v preizkusu replikonske celične kulture HCV 0,86 nM (razpon od 0,43 do 1,87 nM, n = 11) za 1a in 0,06 nM (razpon od 0,03 do 0,09 nM, n = 9) za 1b.