FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration with inducers of cytochrome P450 3A (CYP3A) or P-glycoprotein (P-gp), such as efavirenz, phenytoin, carbamazepine, bosentan, etravirine, modafinil or St. John's wort (Hypericum perforatum) (see sections 4.4 and 4.5).
Slovenian: Sočasna uporaba z induktorji citokroma P450 3A (CYP3A) ali P-glikoproteina (P-gp), kot so efavirenz, fenitoin, karbamazepin, bosentan, etravirin, modafinil ali šentjanževka (Hypericum perforatum) (glejte poglavji 4.4 in 4.5).
English: The frequency of serious adverse reactions and discontinuations due to adverse reactions in subjects with compensated cirrhosis were comparable to those seen in subjects without cirrhosis.
Slovenian: Pogostnost resnih neželenih učinkov in ukinitve zdravljenja zaradi neželenih učinkov so bile pri preiskovancih s kompenzirano cirozo primerljive s tistimi pri preiskovancih brez ciroze.
English: Viral populations with treatment-emergent NS5A resistance-associated substitutions were generally more persistent than NS3 resistance associated substitutions.
Slovenian: Virusne populacije, ki imajo med zdravljenjem z nastankom odpornosti povezane substitucije NS5A, so na splošno trajnejše kot z odpornostjo povezane substitucije NS3.
English: Due to the limited number of genotype 4-infected subjects with treatment emergent NS5A and NS3 resistance associated substitutions, trends in persistence of treatment emergent substitutions in this genotype could not be established.
Slovenian: Zaradi majhnega števila preiskovancev, okuženih z genotipom 4, ki so imeli med zdravljenjem z nastankom odpornosti povezane substitucije NS5A in NS3, trendov trajnosti teh substitucij pri tem genotipu ni bilo mogoče ugotoviti.
English: Recommendation concerning coadministration with ZEPATIER
Slovenian: Priporočilo glede sočasne uporabe z zdravilom ZEPATIER
English: In population pharmacokinetic analyses, there was no effect of weight on elbasvir pharmacokinetics.
Slovenian: V populacijskih farmakokinetičnih analizah telesna masa ni vplivala na farmakokinetiko elbasvirja.
English: Concentrations of dabigatran may increase when co-administered with elbasvir, with possible increased bleeding risk.
Slovenian: Med sočasno uporabo z elbasvirjem se koncentracije dabigatrana lahko zvišajo, kar lahko poveča tveganje za krvavitve.
English: The following adverse reactions were identified in patients taking ZEPATIER without ribavirin for 12 weeks.
Slovenian: Spodaj navedeni neželeni učinki so bili ugotovljeni pri bolnikih, ki so 12 tednov jemali zdravilo ZEPATIER brez ribavirina.
English: Beige, oval tablet of dimensions 21 mm x 10 mm debossed with “770” on one side and plain on the other.
Slovenian: Ovalna, 21 mm x 10 mm velika tableta bež barve, ki ima na eni strani vtisnjeno oznako "770", na drugi strani pa je brez oznake.
English: Elbasvir was excreted into the milk of lactating rats with concentrations 4-fold that of the maternal plasma concentrations.
Slovenian: Elbasvir se je v mleku doječih podgan izločal v koncentraciji, ki je bila 4-krat tolikšna kot koncentracija v plazmi samice.
English: Co-administration of ZEPATIER and OATP1B inhibitors is contraindicated because it may significantly increase grazoprevir plasma concentrations.
Slovenian: Sočasna uporaba zdravila ZEPATIER in zaviralcev OATP1B je kontraindicirana, ker lahko pomembno zviša koncentracijo grazoprevirja v plazmi.
English: No human data on the effect of elbasvir and grazoprevir on fertility are available.
Slovenian: Podatkov o vplivu elbasvirja in grazoprevirja na plodnost pri človeku ni na voljo.
English: • feeling very tired (fatigue)
Slovenian: • izrazita utrujenost
English: Do not stop taking ZEPATIER
Slovenian: Ne prenehajte jemati zdravila ZEPATIER
English: • check how your liver is working - tell your doctor straight away if you have any of the following signs of liver problems: loss of appetite; feeling or being sick; feeling tired or weak;
Slovenian: Zdravnika morate takoj obvestiti, če se pri vas pojavi kateri koli od naslednjih znakov težav z jetri: izguba apetita; siljenje na bruhanje ali bruhanje,
English: ZEPATIER is sometimes taken with another medicine, ribavirin.
Slovenian: Zdravilo ZEPATIER se včasih jemlje skupaj z zdravilom, ki vsebuje drugo učinkovino, in sicer ribavirin.
English: Adverse reactions Metabolism and nutrition disorders: Common decreased appetite
Slovenian: Presnovne in prehranske motnje: Pogosti zmanjšanje apetita
English: Tell your doctor or pharmacist if you notice any of the following side effects.
Slovenian: Zdravniku ali farmacevtu povejte, če opazite katerega koli izmed naslednjih neželenih učinkov.
English: A should be considered in patients with baseline HCV RNA level >800,000 IU/ml and/or the presence of specific NS5A polymorphisms causing at least a 5-fold reduction in activity of elbasvir to minimise the risk of treatment failure (see section 5.1).
Slovenian: A - o tem načinu zdravljenja je treba razmisliti pri bolnikih, ki imajo izhodiščno koncentracijo HCV RNA > 800.000 i.e./ml in/ali prisotne specifične polimorfizme NS5A, ki povzročajo najmanj 5-kratno zmanjšanje aktivnosti elbasvirja, saj se tako zmanjša tveganje za neuspeh zdravljenja (glejte poglavje 5.1).
English: • You or your partner must use an effective method of contraception during treatment with ZEPATIER with ribavirin and for some time afterwards.
Slovenian: • Vi ali vaša partnerka morate med zdravljenjem s kombinacijo zdravila ZEPATIER in ribavirina ter še nekaj časa po zdravljenju uporabljati ustrezno kontracepcijo.
English: Expected: ↑ Grazoprevir
Slovenian: Pričakovano: ↑ grazoprevir
English: The frequency of late ALT elevations was higher in subjects with higher grazoprevir plasma concentration (see sections 4.4, 4.5 and 5.2).
Slovenian: Zakasnela zvišanja ALT so bila pogostejša pri preiskovancih, ki so imeli višjo koncentracijo grazoprevirja v plazmi (glejte poglavja 4.4, 4.5 in 5.2).
English: Treatment-emergent substitutions were detected in both HCV drug targets in 23/37 (62 %) genotype 1a, 1/8 (13 %) genotype 1b and 2/5 (40 %) genotype 4 subjects.
Slovenian: Med zdravljenjem nastale substitucije so pri tarčnih molekulah obeh HCV zdravil odkrili pri 23/37 (62 %) preiskovancih z genotipom 1a, 1/8 (13 %) z genotipom 1b in 2/5 (40 %) z genotipom 4.
English: Based on in vitro data, a potential for GZR to inhibit BSEP cannot be excluded.
Slovenian: Glede na podatke in vitro ni mogoče izključiti možnosti, da GZR (grazoprevir) zavira BSEP.
English: Some NS3 substitutions at A156 and at D168 confer reduced antiviral activity to grazoprevir as well as to other NS3/4A protease inhibitors.
Slovenian: Nekatere substitucije NS3 na A156 in D168 povzročijo manjšo protivirusno aktivnost grazoprevirja in tudi drugih zaviralcev proteaz NS3/4A.
English: C-EDGE TN (double-blind)
Slovenian: C-EDGE TN (dvojno slepa)
English: Carbamazepine Phenytoin
Slovenian: Karbamazepin Fenitoin
English: Patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2 and 5.2).
Slovenian: Bolniki z zmerno ali hudo okvaro jeter (Child-Pugh B ali C) (glejte poglavji 4.2 in 5.2).
English: • ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalised ratio (INR).
Slovenian: • Če zvišanje ALT spremljajo znaki ali simptomi vnetja jeter ali zvišan konjugiran bilirubin, alkalna fosfataza ali internacionalno normalizirano razmerje (INR), je treba zdravljenje z zdravilom ZEPATIER ukiniti.
English: Co-administration with ZEPATIER is contraindicated.
Slovenian: Sočasna uporaba z zdravilom ZEPATIER je kontraindicirana.
English: Lamivudine Abacavir Entecavir
Slovenian: Lamivudin Abakavir Entekavir
English: In general, other NS5A substitutions conferring resistance to NS5A inhibitors may also confer resistance to elbasvir.
Slovenian: Na splošno lahko druge substitucije NS5A, ki povzročijo odpornost na zaviralce NS5A, povzročijo tudi odpornost na elbasvir.
English: In a pooled analysis of subjects treated with regimens containing elbasvir/grazoprevir or elbasvir + grazoprevir with or without ribavirin in Phase 2 and 3 clinical studies, resistance analyses were conducted for 50 subjects who experienced virologic failure and had sequence data available (6 with on-treatment virologic failure, 44 with post-treatment relapse).
Slovenian: V združeni analizi preiskovancev, zdravljenih po shemah, ki so vključevale elbasvir/grazoprevir ali elbasvir + grazoprevir (z ribavirinom ali brez njega) v kliničnih študijah 2. in 3. faze, so odpornost analizirali pri 50 preiskovancih z virološkim neuspehom, pri katerih so bili na voljo podatki o zaporedjih (6 preiskovancev z virološkim neuspehom med zdravljenjem, 44 z recidivom po zdravljenju).
English: Following administration of elbasvir/grazoprevir to HCV-infected subjects, elbasvir peak plasma concentrations occur at a median Tmax of 3 hours (range of 3 to 6 hours); grazoprevir peak plasma concentrations occur at a median Tmax of 2 hours (range of 30 minutes to 3 hours).
Slovenian: Po uporabi elbasvirja/grazoprevirja pri preiskovancih, okuženih s HCV, je največja koncentracija elbasvirja v plazmi dosežena po medianem tmax 3 ure (v razponu od 3 do 6 ur), največja koncentracija grazoprevirja v plazmi pa po medianem tmax 2 uri (v razponu od 30 minut do 3 ur).
English: Grazoprevir pharmacokinetics increased in a greater than dose-proportional manner over the range of 10-800 mg once daily in HCV-infected subjects.
Slovenian: Farmakokinetika grazoprevirja se je pri preiskovancih, okuženih s HCV, v razponu odmerkov od 10 do 800 mg enkrat na dan povečevala bolj kot odmerku sorazmerno.
English: The geometric mean apparent terminal half-life (% geometric mean coefficient of variation) is approximately 24 (24 %) hours at 50 mg elbasvir and approximately 31 (34 %) hours at 100 mg grazoprevir in HCV-infected subjects.
Slovenian: Pri preiskovancih, okuženih s HCV, je geometrična sredina navideznega terminalnega razpolovnega časa (% geometrične sredine koeficienta variacije) pri odmerku 50 mg elbasvirja približno 24 (24 %) ur in pri odmerku 100 mg grazoprevirja približno 31 (34 %) ur.
English: C-WORTHY (open-label)
Slovenian: C-WORTHY (odprta)
English: Recommended regimens and treatment durations are provided in Table 1 below (see sections 4.4 and 5.1):
Slovenian: Preglednica 1 prikazuje priporočene režime in trajanje zdravljenja (glejte poglavji 4.4 in 5.1):
English: Grazoprevir AUC is estimated to be 15 % higher in a 53 kg subject compared to a 77 kg subject.
Slovenian: Ocenjujejo, da je AUC grazoprevirja 15 % večja pri preiskovancih s telesno maso 53 kg kot pri tistih s telesno maso 77 kg.
English: Elderly No dose adjustment of ZEPATIER is required for elderly patients (see sections 4.4 and 5.2).
Slovenian: Pri starejših bolnikih prilagoditev odmerka zdravila ZEPATIER ni potrebna (glejte poglavji 4.4 in 5.2).
English: During clinical studies with ZEPATIER with or without ribavirin, < 1 % of subjects experienced elevations of ALT from normal levels to greater than 5 times the upper limit of normal (ULN), (see section 4.8).
Slovenian: V kliničnih študijah z zdravilom ZEPATIER v kombinaciji z ribavirinom ali brez njega so zvišanja ALT na več kot 5-krat nad zgornjo normalno mejo (ZNM) zabeležili pri < 1 % preiskovancev (glejte poglavje 4.8).
English: ZEPATIER with ribavirin
Slovenian: Zdravilo ZEPATIER z ribavirinom
English: ZEPATIER 50 mg/100 mg film-coated tablets elbasvir/grazoprevir
Slovenian: ZEPATIER 50 mg/100 mg filmsko obložene tablete elbasvir/grazoprevir
English: NS5A substitutions conferring resistance to elbasvir may reduce the antiviral activity of other NS5A inhibitors.
Slovenian: Substitucije NS5A, ki povzročijo odpornost na elbasvir, lahko zmanjšajo protivirusno aktivnost drugih zaviralcev NS5A.
English: Relative to fasting conditions, the administration of a single dose of elbasvir/grazoprevir with a highfat (900 kcal, 500 kcal from fat) meal to healthy subjects resulted in decreases in elbasvir AUC0-inf and Cmax of approximately 11 % and 15 %, respectively, and increases in grazoprevir AUC0-inf and Cmax of approximately 1.5-fold and 2.8-fold, respectively.
Slovenian: V primerjavi z uporabo na tešče je uporaba enkratnega odmerka elbasvirja/grazoprevirja z zelo mastnim obrokom (900 kcal, 500 kcal iz maščob) pri zdravih preiskovancih zmanjšala AUC0-inf elbasvirja za približno 11 % in njegovo Cmax za približno 15 % ter povečala AUC0-inf grazoprevirja za približno 1,5-krat in njegovo Cmax za približno 2,8-krat.
English: • have had a liver transplant
Slovenian: • so vam presadili jetra,
English: Common asthenia, irritability
Slovenian: Pogosti astenija, razdražljivost
English: The safety and efficacy of ZEPATIER have not been established in liver transplant recipients.
Slovenian: Pri prejemnikih darovanih jeter varnost in učinkovitost zdravila ZEPATIER nista bili dokazani.
English: Sustained virologic response (SVR) was the primary endpoint in all studies and was defined as HCV RNA less than the lower limit of quantification (LLOQ: 15 HCV RNA IU/mL except in C-WORTHY and C-SCAPE [25 HCV RNA IU/mL]) at 12 weeks after the cessation of treatment (SVR12).
Slovenian: Opredeljen je bil kot HCV RNA pod spodnjo mejo količinske zaznave (LLOQ - lower limit of quantification: 15 HCV RNA i.e./ml razen v C-WORTHY in C-SCAPE [25 HCV RNA i.e./ml]) v 12. tednu po koncu zdravljenja (SVR12).
English: • oral ketoconazole for fungal infections
Slovenian: • ketokonazol, ki ga vzamete skozi usta za glivne okužbe,
English: If more than 16 hours have passed since ZEPATIER is usually taken, then the patient should be instructed that the missed dose should NOT be taken and to take the next dose per the usual dosing schedule.
Slovenian: Če je od časa, ko po navadi vzame zdravilo ZEPATIER, minilo že več kot 16 ur, NE SME vzeti izpuščenega odmerka, naslednji odmerek pa mora vzeti po običajnem urniku jemanja.
English: In non-HCV-infected subjects with dialysis-dependent, severe renal impairment, elbasvir and grazoprevir AUC values were unchanged compared to subjects with normal renal function.
Slovenian: Pri preiskovancih, neokuženih s HCV in s hudo okvaro ledvic, odvisnih od dialize, sta bili AUC elbasvirja in grazoprevirja nespremenjeni v primerjavi s preiskovanci z normalnim delovanjem ledvic.
English: Table 6: Treatment-emergent amino acid substitutions in the pooled analysis of ZEPATIER with and without ribavirin regimens in Phase 2 and Phase 3 clinical studies
Slovenian: Preglednica 6: Med zdravljenjem nastale aminokislinske substitucije v združeni analizi shem zdravljenja z zdravilom ZEPATIER z ribavirinom ali brez njega v kliničnih študijah 2. in 3. faze
English: • If it has been more than 16 hours since you should have taken your dose, do not take the missed dose.
Slovenian: • če je od takrat, ko bi morali vzeti odmerek, minilo že več kot 16 ur, izpuščenega odmerka ne vzemite.
English: GT 4, 6 TN without cirrhosis
Slovenian: GT 4, 6 TN brez ciroze
English: Dabigatran etexilate
Slovenian: Dabigatran eteksilat
English: • If you or your partner becomes pregnant while taking ZEPATIER with ribavirin or in the months that follow, tell your doctor straight away.
Slovenian: • Če ženska zanosi v obdobju jemanja zdravila ZEPATIER skupaj z ribavirinom ali v mesecih po zdravljenju, je treba o tem takoj obvestiti zdravnika.
English: Genotype 1a N = 37 % (n)
Slovenian: Genotip 1a n = 37 % (n)
English: In case a dose of ZEPATIER is missed and it is within 16 hours of the time ZEPATIER is usually taken, the patient should be instructed to take ZEPATIER as soon as possible and then take the next dose of ZEPATIER at the usual time.
Slovenian: Če bolnik izpusti odmerek zdravila ZEPATIER in je od časa, ko po navadi vzame zdravilo, minilo manj kot 16 ur, mora vzeti zdravilo ZEPATIER čim prej, naslednji odmerek pa ob običajnem času.
English: The persistence of elbasvir and grazoprevir treatment-emergent amino acid substitutions in NS5A, and NS3, respectively, was assessed in genotype 1-infected subjects in Phase 2 and 3 studies whose virus had treatment-emergent resistance-associated substitution in the drug target, and with available data through at least 24 weeks post-treatment using population (or Sanger) sequencing.
Slovenian: Trajnost aminokislinskih substitucij na NS5A oziroma NS3, nastalih med zdravljenjem z elbasvirjem in grazoprevirjem, so raziskali pri preiskovancih, okuženih z genotipom 1, v študijah 2. in 3. faze, pri katerih je imel virus med zdravljenjem nastale in z odpornostjo povezane substitucije v tarčni molekuli, in sicer pri tistih preiskovancih, pri katerih so bili na voljo podatki za vsaj 24 tednov po zdravljenju (pridobljeni s pomočjo populacijskega sekvenciranja (po Sangerju)).
English: C-SCAPE (open-label)
Slovenian: C-SCAPE (odprta)
English: Potential for ZEPATIER to affect other medicinal products
Slovenian: Možen vpliv zdravila ZEPATIER na druga zdravila
English: As liver function may change during treatment with ZEPATIER, a close monitoring of International
Slovenian: Ker se delovanje jeter v času zdravljenja z zdravilom ZEPATIER lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR).
English: ENDOTHELIN ANTAGONIST
Slovenian: ANTAGONISTI ENDOTELINA
English: Frequent monitoring of tacrolimus whole blood concentrations, changes in renal function, and tacrolimus-associated adverse events upon the initiation of coadministration is recommended.
Slovenian: Po začetku sočasne uporabe so priporočljive pogoste kontrole koncentracije takrolimusa v polni krvi, sprememb delovanja ledvic in neželenih učinkov povezanih s takrolimusom.
English: Genotype 4 N = 5 % (n)
Slovenian: Genotip 4 n = 5 % (n)
English: If you take more ZEPATIER than you should, talk to a doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila ZEPATIER, kot bi smeli Če ste vzeli večji odmerek zdravila ZEPATIER, kot bi smeli, morate nemudoma obiskati zdravnika.
English: yellowing of your skin or eyes; colour changes in your stool.
Slovenian: utrujenost ali šibkost, porumenelost kože ali oči, spremenjena barva blata.
English: Table 7: SVR in GT1a-, GT1b- or treatment-experienced GT4-infected subjects bearing baseline NS5A or NS3 polymorphisms SVR12 by Treatment Regimen ZEPATIER, 12 Weeks
Slovenian: Preglednica 7: SVR pri preiskovancih, okuženih z genotipom 1a, genotipom 1b ali predhodno zdravljenih preiskovancih, okuženih z genotipom 4, z izhodiščnimi polimorfizmi NS5A oziroma NS3 SVR12 glede na režim zdravljenja ZEPATIER 12 tednov
English: The highest dose of grazoprevir was 1,000 mg once daily for 10 days, and a single dose of 1,600 mg.
Slovenian: Največji odmerek grazoprevirja je bil 1.000 mg enkrat na dan 10 dni in največji enkratni odmerek je bil
English: A should be considered in patients with baseline HCV RNA level >800,000 IU/ml to minimise the risk of treatment failure (see section 5.1).
Slovenian: A - o tem načinu zdravljenja je treba razmisliti pri bolnikih, ki imajo izhodiščno koncentracijo HCV RNA > 800.000 i.e./ml, saj se tako zmanjša tveganje za neuspeh zdravljenja (glejte poglavje 5.1).
English: Based on pooled data from patients treated with ZEPATIER for 12 weeks without ribavirin
Slovenian: *na podlagi združenih podatkov pri bolnikih, ki so se 12 tednov zdravili z zdravilom ZEPATIER brez ribavirina
English: Haemodialysis does not remove elbasvir or grazoprevir.
Slovenian: Hemodializa ne odstrani ne elbasvirja ne grazoprevirja.
English: GT4 (treatmentexperienced)
Slovenian: Genotip 4 (predhodno zdravljeni)
English: ↑ Simvastatin (primarily due to intestinal BCRP inhibition and CYP3A inhibition)
Slovenian: ↑ simvastatin (predvsem zaradi zaviranja črevesne BCRP in zaviranja CYP3A)
English: ↑ Lovastatin (CYP3A inhibition)
Slovenian: ↑ lovastatin (zaviranje CYP3A)
English: C-SALVAGE (open-label)
Slovenian: C-SALVAGE (odprta)
English: If you are taking ZEPATIER with ribavirin, please make sure that you read the "Do not take" section of the ribavirin package leaflet.
Slovenian: Če jemljete zdravilo ZEPATIER z ribavirinom, morate prebrati tudi poglavje "Ne jemljite zdravila" v navodilu za uporabo za ribavirin.
English: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172) Carnauba wax
Slovenian: Filmska obloga laktoza monohidrat hipromeloza titanov dioksid triacetin rumeni železov oksid (E172) rdeči železov oksid (E172) črni železov oksid (E172) karnauba vosek
English: HIV ANTIVIRAL AGENTS: PROTEASE INHIBITORS
Slovenian: PROTIVIRUSNA ZDRAVILA ZA ZDRAVLJENJE HIV: ZAVIRALCI PROTEAZ
English: Subjects were randomised in a 1:1:1:1 ratio to the study arms.
Slovenian: Preiskovanci so bili v skupine randomizirani v razmerju 1:1:1:1.
English: Schering-Plough Labo N.V. Industriepark 30 - Zone A 2220 Heist-op-den-Berg BELGIUM
Slovenian: Industriepark 30 - Zone A 2220 Heist-op-den-Berg Belgija
English: (combination of mechanisms including CYP3A inhibition)
Slovenian: (kombinacija mehanizmov vključno z zaviranjem CYP3A)
English: NS3 Any of the following NS3 substitutions: V36L/M, Y56F/H, V107I, R155I/K, A156G/M/T/V, V158A, D168A/C/E/G/N/V/Y, V170I
Slovenian: NS3 katera koli od naslednjih substitucij NS3: V36L/M, Y56F/H, V107I, R155I/K, A156G/M/T/V, V158A, D168A/C/E/G/N/V/Y, V170I
English: In non-HCV-infected subjects with severe renal impairment (eGFR < 30 mL/min/1.73 m2) who were not on dialysis, elbasvir and grazoprevir AUC values were increased by 86 % and 65 %, respectively, compared to non-HCV-infected subjects with normal renal function (eGFR > 80 mL/min/1.73 m2).
Slovenian: Okvara ledvic Pri preiskovancih, neokuženih s HCV in s hudo okvaro ledvic (eGFR < 30 ml/min/1,73 m2), ki niso bili na dializi, sta bili AUC elbasvirja za 86 %, AUC grazoprevirja pa za 65 % večji kot pri preiskovancih, ki niso bili okuženi s HCV in so imeli normalno delovanje ledvic (eGFR > 80 ml/min/1,73 m2).
English: ALT elevations
Slovenian: Zvišanje ALT
English: Subjects who had failed prior treatment with boceprevir, simeprevir, or telaprevir in combination with peg-IFN + RBV received EBR + GZR with RBV for 12 weeks.
Slovenian: Preiskovanci, pri katerih predhodno zdravljenje z boceprevirjem, simeprevirjem ali telaprevirjem v kombinaciji s peg-IFN + RBV ni bilo uspešno, so 12 tednov prejemali EBR + GZR z RBV.
English: OPIOID-SUBSTITUTION THERAPY
Slovenian: NADOMESTNO ZDRAVLJENJE Z OPIOIDI
English: Therefore, no dose adjustment is required for CYP3A substrates when co-administered with ZEPATIER.
Slovenian: Odmerka substratov CYP3A med sočasno uporabo z zdravilom ZEPATIER zato ni treba prilagoditi.
English: In pooled analyses of subjects who achieved SVR12 or met criteria for virologic failure, the prevalence and impact of NS5A polymorphisms (including M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D, and Y93C/H/N) and NS3 polymorphisms (substitutions at positions 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, and 175) that confer greater than 5-fold reduction of elbasvir and grazoprevir antiviral activity respectively in vitro were evaluated.
Slovenian: V združenih analizah preiskovancev, ki so dosegli SVR12 ali so ustrezali kriterijem za virološki neuspeh, so ocenili razširjenost in vpliv polimorfizmov NS5A (vključno z M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D in Y93C/H/N) in polimorfizmov NS3 (substitucije na položajih 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170 in 175), ki in vitro za več kot 5-krat zmanjšajo protivirusno aktivnost elbasvirja in grazoprevirja.
English: Less than 0.5 % of grazoprevir was recovered in dialysate over a 4-hour dialysis session.
Slovenian: Med 4-urno dializo se je v dializatu pojavilo manj kot 0,5 % grazoprevirja.
English: Median EC50 (range) nM
Slovenian: Klinični izolati mediana vrednot EC50 (razpon) nM
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting ZEPATIER.
Slovenian: Po začetku jemanja zdravila ZEPATIER morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.