FrancophonIA/ELRC3.0 huggingface dataset:
English: In subjects receiving Viekirax and dasabuvir with ribavirin, the most commonly reported adverse reactions (greater than 20% of subjects) were fatigue and nausea.
Slovenian: Pri preiskovancih, ki so prejemali zdravili Viekirax in dasabuvir z ribavirinom, sta bila najpogosteje opisana neželena učinka (pri več kot 20 % preiskovancev) utrujenost in navzea.
English: Viekirax in combination with ribavirin is recommended in genotype 4 infection.
Slovenian: Uporaba zdravila Viekirax z ribavirinom je priporočljiva pri okužbah genotipa 4.
English: b. Includes subjects who discontinued due to adverse event, loss 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: See Table 2 for guidance regarding potential interactions with other medicinal products and dosing recommendations.
Slovenian: Za vodila glede možnih medsebojnih delovanj z drugimi zdravili in priporočila za odmerjanje glejte preglednico 2.
English: Concomitant use of inhaled glucocorticoids metabolised with CYP3A can increase systemic exposures of the glucocorticoids, and cases of Cushing's syndrome and subsequent adrenal suppression have been reported with ritonavir-containing regimens.
Slovenian: Sočasna uporaba inhaliranih glukokortikoidov, ki se presnavljajo s CYP3A, lahko poveča sistemsko izpostavljenost glukokortikoidom; med uporabo shem zdravljenja z ritonavirjem so bili opisani primeri Cushingovega sindroma in posledične supresije nadledvičnih žlez.
English: Table 19.
Slovenian: Preglednica 19.
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: 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: Ritonavir is a strong inhibitor of CYP3A.
Slovenian: Ritonavir močno zavira CYP3A.
English: What you need to know before you take Viekirax Do not take Viekirax
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Viekirax Ne jemljite zdravila Viekirax:
English: The increase in exposure was similar regardless of meal type (e.g., high-fat versus moderate-fat) or calorie content (approximately 600 Kcal versus approximately 1000 Kcal).
Slovenian: Povečanje izpostavljenosti je bilo podobno ne glede na vrsto obroka (npr. zelo masten obrok v primerjavi z zmerno mastnim) ali kalorično vrednost (približno
English: Viekirax administered with or without dasabuvir did not affect the exposures of the CYP2D6/CYP1A2 substrate, duloxetine.
Slovenian: Zdravilo Viekirax, uporabljeno z dasabuvirjem ali brez njega, ni vplivalo na izpostavljenost substratu CYP2D6/CYP1A2, duloksetinu.
English: NA Patients should be monitored for clinical effects; a decrease in furosemide dose of up to 50% may be required.
Slovenian: potrebno je lahko do 50 % zmanjšanje odmerka furosemida.
English: In the presence of paritaprevir/ritonavir, dasabuvir exposures decreased by approximately 50% to 60% while ombitasvir exposures increased by 31-47%.
Slovenian: Vpliv paritaprevirja/ritonavirja na ombitasvir in dasabuvir V prisotnosti paritaprevirja/ritonavirja se je izpostavljenost dasabuvirju zmanjšala za približno 50 do 60 %, izpostavljenost ombitasvirju pa se je povečala za 31 do 47 %.
English: In the greater than 200 genotype 1b baseline samples in this analysis, the most frequently observed resistance-associated variants observed were Y93H (7.5%) in NS5A, and C316N (17.0%) and S556G (15%) in NS5B.
Slovenian: V več kot 200 izhodiščnih vzorcih genotipa 1b v tej analizi sta bili najpogosteje opaženi z odpornostjo povezani varianti Y93H (7,5 %) v NS5A in C316N (17,0 %) v NS5B.
English: Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper limit of normal according to testing laboratory.
Slovenian: (3. stopnja) > 10 × ZNM (4. stopnja) *ZNM: zgornja normalna meja v laboratoriju, ki je opravil testiranje.
English: Lurasidone Pimozide Quetiapine
Slovenian: ANTIPSIHOTIKI lurasidon pimozid kvetiapin
English: Severe renal impairment or ESRD includes CKD Stage 4 defined as eGFR <30-15 mL/min/1.73 m2 or CKD Stage 5 defined as <15 mL/min/1.73 m2 or requiring haemodialysis.
Slovenian: ml/min/1,73 m2, ali CKD 5. stopnje, definirane kot <15 mL/min/1,73 m2 ali če je potrebna hemodializa.
English: Ombitasvir is metabolised via amide hydrolysis followed by oxidative metabolism.
Slovenian: Ombitasvir se presnovi z amidno hidrolizo, ki ji sledi oksidativna presnova.
English: No clinically relevant changes in dasabuvir, paritaprevir and ombitasvir exposures (based on comparison with historical data) were observed during co-administration.
Slovenian: Med sočasno uporabo niso opazili klinično pomembnih sprememb izpostavljenosti dasabuvirju, paritaprevirju in ombitasvirju (na podlagi primerjave historičnih podatkov).
English: − Tablet core: copovidone, tocofersolan, 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: NA Clinical monitoring of patients is recommended.
Slovenian: NA Bolnike je priporočljivo klinično
English: 5 days after completion of Viekirax + dasabuvir treatment, the sirolimus dose and dosing frequency prior to receiving Viekirax should be resumed, along with routine monitoring of sirolimus blood concentrations.
Slovenian: 5 dni po zaključenem zdravljenju z zdravilom Viekirax in dasabuvirjem je potrebno ponovno vzpostaviti odmerek in pogostnost odmerjanja sirolimusa kot pred začetkom jemanja zdravila Viekirax in dasabuvirja, skupaj z rutinskim spremljanjem koncentracij sirolimusa v krvi.
English: In vitro data indicate that paritaprevir is a substrate for the human hepatic uptake transporters, OATP1B1 and OATP1B3.
Slovenian: Podatki in vitro kažejo, da je paritaprevir substrat humanih jetrnih privzemnih prenašalcev OATP1B1 in OATP1B3.
English: • ergotamine, dihydroergotamine, ergonovine, methylergometrine
Slovenian: • ergotamin, dihidroergotamin, ergonovin, metilergometrin
English: ↓ esomeprazole, lansoprazole
Slovenian: ↓ esomeprazol, lansoprazol
English: Resistance to paritaprevir and ombitasvir conferred by variants in NS3 and NS5A respectively, 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: Genotip 1 Odpornost proti paritaprevirju in ombitasvirju, povezana z variantami NS3 in NS5A, selekcioniranih v celičnih kulturah ali identificiranih v kliničnih preskušanjih faze 2b in 3, so fenotipsko opredelili v ustreznih replikonih genotipa 1a ali 1b.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Viekirax Vsebina pakiranja in dodatne informacije
English: Administration of Viekirax with or without dasabuvir with erythromycin may result in increased concentrations of erythromycin and paritaprevir.
Slovenian: Sočasna uporaba zdravila Viekirax z ali brez dasabuvirja in eritromicina lahko povzroči povečanje koncentracij eritromicina in paritaprevirja.
English: Itraconazole Posaconazole
Slovenian: itrakonazol posakonazol
English: 300/100 mg once daily (administered 12 hours apart)
Slovenian: 300/100 mg enkrat na dan (uporabljena v razmaku 12 ur)
English: When taking Viekirax with dasabuvir, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems:
Slovenian: Če zdravilo Viekirax jemljete z dasabuvirjem, obvestite svojega zdravnika, če imate naslednje simptome,
English: Concomitant use with fluvastatin and pitavastatin is not recommended (see section 4.4).
Slovenian: Sočasna uporaba s fluvastatinom in pitavastatinom ni priporočljiva (glejte poglavje 4.4).
English: During clinical trials with Viekirax and dasabuvir with or without ribavirin, transient elevations of ALT to greater than 5 times the upper limit of normal occurred in approximately 1% of subjects (35 of 3,039).
Slovenian: Med kliničnimi preskušanji z zdravilom Viekirax in dasabuvirjem skupaj z ribavirinom ali brez njega se je prehodno zvišanje ALT v serumu na več kot 5-kratno zgornjo normalno mejo pojavilo pri približno 1 % preiskovancev (35 od 3.039).
English: Beginning the day after Viekirax and dasabuvir are initiated; reinitiate tacrolimus at a reduced dose based on tacrolimus blood concentrations.
Slovenian: En dan po začetku uporabe zdravila Viekirax in dasabuvirja se lahko ponovno uvede takrolimus v zmanjšanem odmerku, ki temelji na koncentracijah takrolimusa v krvi.
English: Viekirax without ribavirin and without dasabuvir was also evaluated in genotype 1b infected subjects in Phase 2 studies M13-393 (PEARL-I) and M12-536.
Slovenian: Pri preiskovancih, okuženih z genotipom 1b, so raziskali tudi zdravilo Viekirax brez ribavirina in brez dasabuvirja, in sicer v študijah 2. faze M13-393 (PEARL-I) in M12-536.
English: Viekirax contains the active substances ombitasvir, paritaprevir and ritonavir.
Slovenian: Zdravilo Viekirax vsebuje učinkovine ombitasvir, paritaprevir in ritonavir.
English: Viekirax and dasabuvir with or without ribavirin were assessed in 68 subjects with genotype 1 infection with or without cirrhosis who have severe renal impairment or ESRD (see Section 5.1).
Slovenian: Zdravilo Viekirax in dasabuvir z ali brez ribavirina je bilo ovrednoteno pri 68 preiskovancih z okužbo genotipa 1 z ali brez ciroze, ki so imeli hudo okvaro ledvic ali končno ledvično odpoved (glejte poglavje 5.1).
English: Ombitasvir, paritaprevir and ritonavir were absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Slovenian: Ombitasvir, paritaprevir in ritonavir so se po peroralni uporabi absorbirali s povprečnim tmax približno 4 do 5 ur.
English: Viekirax and dasabuvir 12 weeks N = 509 n (%)
Slovenian: Viekirax in dasabuvir 12 tednov N = 509 n (%)
English: 14 film-coated tablets Component of a multipack, can't be sold separately.
Slovenian: Komponenta večkratnega pakiranja, ni za ločeno prodajo.
English: • lomitapide
Slovenian: • lomitapid
English: Nearly the entire plasma radioactivity after a single 600 mg dose of 14C-ritonavir oral solution in humans was attributed to unchanged ritonavir.
Slovenian: Skoraj vsa radioaktivnost v plazmi, po enkratnem 600 mg odmerku peroralne raztopine 14C-ritonavirja pri človeku, je izvirala od nespremenjenega ritonavirja.
English: Viekirax tablets are taken with other antiviral medicines such as dasabuvir and ribavirin.
Slovenian: Tablete zdravila Viekirax se jemljejo skupaj z drugimi protivirusnimi zdravili, kot sta dasabuvir in ribavirin.
English: The recommended oral dose of Viekirax is two 12.5 mg / 75 mg / 50 mg tablets once daily with food.
Slovenian: Priporočeni peroralni odmerek zdravila Viekirax sta dve tableti 12,5 mg/75 mg/50 mg 1-krat na dan s hrano.
English: You should not breast-feed during treatment with Viekirax.
Slovenian: Med zdravljenjem z zdravilom Viekirax ne smete dojiti.
English: TURQUOISE-II: Relapse Rates by Baseline Laboratory Values after 12 and 24 Weeks of Treatment in Subjects with Genotype 1a Infection and Compensated Cirrhosis
Slovenian: Preglednica 14: TURQUOISE-II: Deleži recidivov glede na izhodiščne laboratorijske vrednosti, po 12 in 24 tednih zdravljenja, pri preiskovancih s kompenzirano cirozo, okuženih z genotipom 1a
English: Overall, 107 of 113 subjects without cirrhosis and 147 of 155 subjects with cirrhosis achieved SVR12 after 12-24 weeks of treatment.
Slovenian: V celoti je po 12 do 24 tednih zdravljenja SVR12 doseglo 107 od 113 bolnikov brez ciroze in 147 od 155 bolnikov s cirozo.
English: Tell your doctor or pharmacist if you notice any of the following side effects.
Slovenian: Obvestite zdravnika ali farmacevta, če opazite kateri koli neželeni učinek, naveden v nadaljevanju.
English: Compared to the subjects with normal renal function, ombitasvir exposures were comparable in subjects with mild, moderate and severe renal impairment.
Slovenian: V primerjavi s preiskovanci z normalnim delovanjem ledvic je bila izpostavljenost ombitasvirju primerljiva kot pri preiskovancih z blago, zmerno in hudo okvaro ledvic.
English: Expected: ↑ amiodarone
Slovenian: Pričakovano: ↑ amiodaron
English: NS3 variants V36A/M and R155K and NS5B variants M414T and S556G remained detectable at posttreatment Week 48, whereas NS3 variant D168V and all other NS5B variants were not observed at posttreatment Week 48.
Slovenian: Varianti V36A/M in R155K gena NS3 in varianti M414T in S556G gena NS5B so ostale zaznavne 48. teden po zdravljenju, medtem ko variante D168V gena NS3 in vseh drugih variant gena NS5B 48. teden po zdravljenju niso ugotovili.
English: 800 mg once daily (given at the same time)
Slovenian: 800 mg enkrat na dan (uporabljen ob istem času)
English: 4-24 mg/16 mg once daily8
Slovenian: 4-24 mg/1-6 mg enkrat na dan8
English: 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: Viekirax is not recommended for administration as monotherapy and must be used in combination with other medicinal products for the treatment of hepatitis C infection (see sections 4.2 and 5.1).
Slovenian: Zdravilo Viekirax ni priporočljivo za uporabo v monoterapiji in ga je treba uporabljati v kombinaciji z drugimi zdravili za zdravljenje okužbe s hepatitisom C (glejte poglavji 4.2 in 5.1).
English: Results from the pharmacokinetic evaluation of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg can be extrapolated to the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg.
Slovenian: Rezultate farmakokinetične ocene kombinacije 25 mg ombitasvirja, 200 mg paritaprevirja in 100 mg ritonavirja, s 400 mg dasabuvirja, je mogoče ekstrapolirati na kombinacijo 25 mg ombitasvirja, 200 mg paritaprevirja in 100 mg ritonavirja.
English: • Swelling of the layers of skin which can affect any part of the body including the face, tongue or throat and may cause difficulty swallowing or breathing (angioedema)
Slovenian: Redki: pojavijo se lahko pri največ 1 od 1000 bolnikov • Otekanje plasti kože, ki lahko prizadane katerikoli del telesa, vključno z obrazom, jezikom ali grlom, in lahko povzroči oteženo požiranje ali dihanje (angioedem).
English: Co-administration of Viekirax with or without dasabuvir with medicinal products that are substrates of OATP1B1, OATP1B3, OATP2B1 or OCT1 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 OATP1B1, OATP1B3, OATP2B1 ali OTC1, lahko poveča koncentracijo teh substratov prenašalcev v plazmi in to lahko zahteva prilagoditev odmerka in klinično spremljanje.
English: Clinical monitoring and dose adjustment may be required for levothyroxine
Slovenian: Morda bo potrebno klinično spremljanje in prilagoditev odmerka levotiroksina.
English: Ombitasvir has shown malformations in rabbits at maximal feasible exposures 4-fold higher than the AUC exposure at recommended clinical dose.
Slovenian: Z ombitasvirjem so pri kuncih ugotovili malformacije pri največjih možnih izpostavljenostih, 4-krat večjih od AUC izpostavljenosti ob priporočenih kliničnih odmerkih.
English: Ethinyloestradiol 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: - have liver disease other than hepatitis C; -have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
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: Paritaprevir was positive in an in vitro human chromosome aberration test. Paritaprevir was negative in a bacterial mutation assay, and in two in vivo genetic toxicology assays (rat bone marrow micronucleus and rat liver Comet tests).
Slovenian: Paritaprevir je bil negativen v preizkusu bakterijskih mutacij ter v dveh genetskih toksikoloških preizkusih in vivo (mikrojedrni preizkus na kostnem mozgu podgan in kometni test na podganjih jetrih).
English: The safety of Viekirax in children and adolescents aged < 18 years has not yet been established.
Slovenian: Varnost zdravila Viekirax še ni ugotovljena pri otrocih in mladostnikih, starih < 18 let.
English: If statin treatment is required during the treatment period, a switch to a reduced dose of pravastatin/rosuvastatin is possible (see section 4.5, Table 2).
Slovenian: Če je med obdobjem zdravljenja potrebno zdravljenje s statinom, je treba preiti na zmanjšan odmerek pravastatina/rosuvastatina, če je mogoče (glejte poglavje 4.5,
English: The activity of paritaprevir was reduced 96-fold by D168V, and 50- to 219-fold by each of the other D168 substitutions.
Slovenian: Substitucija D168V je zmanjšala aktivnost paritaprevirja za 96-krat, vsaka od drugih substitucij D168 pa od 50- do 219-krat.
English: Viekirax and dasabuvir for 8 weeks n/N (%)
Slovenian: Zdravilo Viekirax in dasabuvir 8 tednov n/N (%)
English: Appropriate monitoring of serum digoxin levels is recommended.
Slovenian: Priporočljivo je ustrezno kontrolirati koncentracijo digoksina v serumu.
English: In another open-label phase 3b study evaluating 12 weeks of Viekirax with or without dasabuvir and without RBV in non-cirrhotic, treatment-naive GT1a and GT4 patients with CKD stage 4 or 5 (Ruby II), the SVR12 rate was 94.4% (17/18), with no subjects experiencing on-treatment virologic failure or relapse.
Slovenian: V drugi odprti študiji faze 3b, ki je ocenila zdravilo Viekirax z ali brez dasabuvirja 12 tednov in brez RBV pri še nezdravljenih GT1a in GT4 bolnikih brez ciroze, s CKD stopnje 4 ali 5 (Ruby II), je bila stopnja SVR12 94,4 % (17/18); pri tem se pri nobenem preiskovancu nista pojavila virusna neodzivnost med zdravljenjem ali ponovitev bolezni.
English: Viekirax administered with or without dasabuvir did not affect the exposures of the CYP2C9 substrate, warfarin.
Slovenian: Zdravilo Viekirax, uporabljeno z dasabuvirjem ali brez njega, ni vplivalo na izpostavljenost substratu CYP2C9, varfarinu.
English: Viekirax and dasabuvir for 12 or 24 weeks with or without ribavirin ( investigator chosen dose ) for GT1 and GT4 infection
Slovenian: Zdravljenje: Zdravilo Viekirax in dasabuvir 12 ali 24 tednov z ali brez ribavirina (odmerki določeni s strani raziskovalca), za okužbo s GT1 in GT4
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: 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: Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Slovenian: Skupno je imelo v kliničnih preskušanjih 2. in 3. faze rezultate HCV RNA za SVR12 in za SVR24 660
English: However, co-administration of digoxin with Viekirax without dasabuvir may result in increased plasma concentrations (see Table 2).
Slovenian: Vendar pa lahko sočasna uporaba digoksina z zdravilom Viekirax brez dasabuvirja poveča koncentracijo v plazmi (glejte preglednico 2).
English: Use with statins
Slovenian: Uporaba s statini
English: Ritonavir dose in Viekirax will provide atazanavir pharmacokinetic enhancement).
Slovenian: Odmerek ritonavirja v zdravilu Viekirax bo povzročilo okrepitev farmakokinetike atazanavirja.
English: GT1b Viekirax and dasabuvir (12 weeks)
Slovenian: GT1b Viekirax in dasabuvir (12 tednov)
English: If dose adjustments of concomitant medicinal products are made due to treatment with Viekirax or Viekirax with dasabuvir, doses should be re-adjusted after administration of Viekirax or Viekirax with dasabuvir is completed.
Slovenian: Če se odmerek sočasnih zdravil zaradi zdravljenja z zdravilom Viekirax ali z zdravilom Viekirax in dasabuvirjem prilagodi, je treba odmerek ponovno prilagoditi, ko se zdravljenje z zdravilom Viekirax ali zdravilom Viekirax in dasabuvirjem konča.
English: Medicinal products that inhibit transport proteins
Slovenian: Zdravila, ki zavrejo prenašalne proteine
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 virusno neodzivnost (primarni recidiv po zdravljenju) doživelo skupno 74 (3 %).
English: Food increased the exposure (AUC) of ombitasvir, paritaprevir and ritonavir by up to 82%, 211% and 49%, respectively relative to the fasting state.
Slovenian: V primerjavi s stanjem na tešče je hrana povečala izpostavljenost (AUC) ombitasvirju do 82 %, paritaprevirju do 211 % in ritonavirju do 49 %.
English: Co-administration of Viekirax and dasabuvir with medicinal products that are moderate or strong enzyme inducers is expected to decrease ombitasvir, paritaprevir, ritonavir and dasabuvir plasma concentrations and reduce their therapeutic effect.
Slovenian: Pričakovati je, da sočasna uporaba zdravila Viekirax in dasabuvirja z zdravili, ki zmerno ali močno inducirajo encime, zmanjša koncentracijo ombitasvirja, paritaprevirja, ritonavirja in dasabuvirja v plazmi in zmanjša njihov terapevtski učinek.
English: Theoretically, Viekirax with and without dasabuvir is expected to increase the exposure to pitavastatin and fluvastatin.
Slovenian: Teoretično je treba pričakovati, da zdravilo Viekirax z dasabuvirjem ali brez njega poveča izpostavljenost pitavastatinu in fluvastatinu.
English: Following dosing of ombitasvir/paritaprevir /ritonavir, mean plasma half-life of ritonavir was approximately 4 hours.
Slovenian: Po uporabi ombitasvirja/paritaprevirja/ritonavirja je bil povprečni plazemski razpolovni čas ritonavirja približno 4 ure.
English: HIV ANTIVIRALS: PHARMACOKINETIC ENHANCER Cobicistatcontaining regimens
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV: FARMAKOKINETIČNI OJAČEVALEC sheme, ki vsebujejo kobicistat
English: OATP1B1/3 substrates evaluated in drug interaction studies include pravastatin and rosuvastatin (see Table 2).
Slovenian: Med substrati OATP1B1/3, ocenjenimi v študijah medsebojnega delovanja zdravil, so pravastatin in rosuvastatin (glejte preglednico 2).
English: Co-administration of Viekirax with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QT-prolongation co ombitasvir paritaprevir
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: Following administration of a single 200 mg/100 mg oral dose of 14C paritaprevir /ritonavir to humans, the parent drug was the major circulating component, accounting for approximately 90% of the plasma radioactivity.
Slovenian: Po uporabi enkratnega peroralnega odmerka 200 mg/100 mg 14C-paritaprevirja/ritonavirja pri človeku, je bilo matično zdravilo glavna sestavina v obtoku; na njen račun je šlo približno 90 % radioaktivnosti v plazmi.