natgillin/translations-raw huggingface dataset:
In healthy adult subjects receiving single doses up to 600 mg or once daily doses up to 400 mg for 5 days, and in HCV infected adult patients receiving 200 mg once daily for 4 weeks, adverse reactions were consistent with those observed in clinical studies at the recommended dose (see section 4.8).
Pri zdravih odraslih osebah, ki so prejele enkraten odmerek do 600 mg ali pa so 5 dni enkrat na dan prejemale odmerke do 400 mg, in pri odraslih bolnikih z okužbo s HCV, ki so 4 tedne prejemali odmerek 200 mg enkrat na dan, so se neželeni učinki ujemali s tistimi, ki so jih opažali v kliničnih študijah pri uporabi priporočenega odmerka (glejte poglavje 4.8).
Viral breakthrough rates were 24% (11/45), 20% (5/25) and 11% (4/36) in patients with genotype 4a, 4d and 4/other, respectively.
Stopnje virusnega preboja so bile 24% (11/45) pri bolnikih z genotipom 4a, 20% (5/25) pri bolnikih z genotipom 4d in 11% (4/36) pri bolnikih z ostalimi podtipi genotipa 4.
Other substitutions such as Q80G or L, S122G, N or T did not reduce simeprevir activity (FC in EC50 ≤ 2).
Druge substitucije, kot so Q80G ali L in S122G, N ali T, niso zmanjšale delovanje simeprevirja (sprememba EC50 za ≤ 2-krat).
rash*, pruritus*
izpuščaj*, srbenje *
Because OLYSIO must be co-administered with other medicinal products, for the treatment of CHC, the contraindications and warnings applicable to those medicinal products also apply to their use in combination treatment with OLYSIO (see section 4.3).
Ker je treba zdravilo OLYSIO uporabljati sočasno z drugimi zdravili za zdravljenje CHC, veljajo kontraindikacije in opozorila pri teh zdravilih tudi za uporabo kombinacije z zdravilom OLYSIO (glejte poglavje 4.3).
May include few patients with HCV non-genotype 1a/1b.
Lahko vključuje nekaj bolnikov z virusom hepatitisa C, ki niso genotipa 1a ali 1b.
OLYSIO in combination with peginterferon alfa and ribavrin It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR), therefore discontinuation of treatment is recommended in these patients.
Zdravilo OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom Ker je malo verjetno, da bodo bolniki z nezadostnim virološkim odzivom dosegli trajni virološki odziv (SVR - sustained virologic response), je priporočljivo, da tem bolnikom zdravljenje ukinete.
Relapsers after prior interferon-based therapy.
Ponovitev bolezni po predhodnem zdravljenju na osnovi interferona.
If the capsule shell has been broken or opened, some medicine may be lost and you should take a new capsule.
Če je kapsula zlomljena ali odprta del zdravila lahko manjka, zato take kapsule ne smete uporabiti in morate vzeti novo.
Inhibitors of OATP1B1/3 such as eltrombopag or gemfibrozil may result in increases in simeprevir plasma concentrations.
Zaviralci OATP1B1/3, kot sta eltrombopag ali gemfibrozil, lahko povzročita zvečanje koncentracije simeprevirja v plazmi.
Female patients of childbearing potential and male patients with female partners of childbearing potential must use an effective form of contraception during treatment with ribavirin and after completion of ribavirin treatment for a duration as specified in the Summary of
Bolnice, ki so v rodni dobi, in bolniki s partnerkami v rodni dobi morajo uporabljati učinkovito metodo kontracepcije v času zdravljenja in po zaključku zdravljenja z ribavirinom še tako dolgo, kot je opredeljeno v Povzetku glavnih značilnosti zdravila za ribavirin.
Treatment regimen not containing sofosbuvir:
Režimi zdravljenja brez sofosbuvirja:
Table 21: SVR12 rates for selected subgroups (study HPC3007) simeprevir + peginterferon + ribavirin % (n/N)
Preglednica 21: Stopnje SVR12 za izbrane podskupine (študija HPC3007) simeprevir + peginterferon + ribavirin % (n/N)
Open-label, randomised, except for studies HPC3018 and HPC3021 which were single arm, and study HPC2014 which
Odprte, randomizirane študije, razen študij HPC3018 in HPC3021, ki sta bili enokraki, in študije HPC2014, ki je bila
Elevations in amylase and lipase were transient and mostly of mild or moderate severity.
Zvečanje koncentracij amilaze in lipaze je bilo prehodno in večinoma blago do zmerno.
Patients should be informed of the risk of photosensitivity reactions and on the importance of applying appropriate sun protective measures during treatment with OLYSIO.
Med zdravljenjem z zdravilom OLYSIO morajo biti bolniki seznanjeni glede tveganja za pojav fotosenzitivnostne reakcije in pomembnosti uporabe ustreznih sredstev za zaščito pred sončnimi žarki.
It is not recommended to co-administer OLYSIO with delavirdine, etravirine or nevirapine.
OLYSIO z delavirdinom, etravirinom ali nevirapinom ni priporočljiva.
Combination treatment of OLYSIO with other medicinal products for the treatment of CHC may affect a patient's ability to drive and use machines.
Kombinirano zdravljenje z zdravilom OLYSIO in drugimi zdravili za zdravljenje CHC, lahko zmanjša bolnikovo sposobnost vožnje in upravljanja s stroji.
Simeprevir was not irritating to rabbit skin, and is not likely to cause skin sensitisation.
Simeprevir ni dražil kože pri kuncih in verjetno ne povzroča senzitizacije kože.
Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event.
Med 3 bolniki z neuspehom v času zdravljenja sta imela 2 bolnika virusni preboj, en bolnik pa je zdravljenje kmalu
In 32 out of 48 patients (67%) with emerging single D168V and in 34 out of 66 (52%) patients with emerging single R155K, the respective emerging variants were no longer detected at end of the studies.
Pri 32 od 48 bolnikov (pri 67%), pri katerih je prišlo do enojne substitucije D168V, in pri 34 od 66 bolnikov (pri 52%), pri katerih je prišlo do enojne substitucije R155K, so bile ob koncu študije koncentracije te variante virusa nezaznavne.
In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis
V študijo HPC3017 so vključili bolnike brez ciroze, v študijo HPC3018 pa bolnike s
If treatment with OLYSIO is discontinued because of adverse reactions or inadequate on-treatment virologic response, OLYSIO treatment must not be reinitiated.
Če je treba zdravljenje z zdravilom OLYSIO prekiniti zaradi neželenih učinkov ali nezadostnega virološkega odziva v času zdravljenja, zdravila OLYSIO ne smete ponovno uvesti.
The long-term clinical impact of the emergence or persistence of simeprevir-resistance-associated
Dolgoročni klinični pomen pojavljanja oziroma vztrajanja substitucij, ki povzročajo odpornost na
- If you are a woman, you must not become pregnant during treatment and for several
- Če ste ženska, ne smete zanositi med zdravljenjem in še nekaj mesecev po zaključku zdravljenja.
Consider starting with the lowest dose of the PDE-5 inhibitor and increase as needed, with clinical monitoring as appropriate.
Razmisliti velja o začetku zdravljenja z najnižjim odmerkom zaviralca fosfodiesteraze tipa 5 in zviševanju odmerka po potrebi skupaj z ustreznim kliničnim spremljanjem bolnika.
Genotype 1a N = 116 % (n)
genotip 1a N = 116 % (n)
Ribavirin use and prior treatment status (treatment-naïve and prior null responders) did not impact treatment outcome.
Uporaba ribavirina in status pred zdravljenjem (predhodno nezdravljeni in bolniki brez odziva na zdravljenje) nista vplivala na izid zdravljenja.
- ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant
- ciklosporin, sirolimus ali takrolimus za zaviranje imunskega odgovora ali preprečevanje
In study C208, all patients received peginterferon alfa-2a; in study C216, 69% of the patients received peginterferon alfa-2a and 31% received peginterferon alfa-2b.
V študiji C208 so vsi bolniki prejemali peginterferon alfa-2a; v študij C216 je 69% bolnikov prejemalo peginterferon alfa-2a in
Substitutions D168V and R155K alone or in combinations with other mutations at these positions emerged most frequently (table 10).
Najpogosteje je prišlo do substitucij D168V in R155K, bodisi samostojno ali v kombinaciji z drugimi mutacijami na teh položajih (preglednica 10).
Grade 1
stopnja 3
OATP1B1/3 and MRP2 are involved in the transport of bilirubin into and out of hepatocytes.
Prenašalca OATP1B1/3 in MRP2 sta vpletena tudi v transport bilirubina v hepatocite in iz njih.
Co-administration of OLYSIO with substances that moderately or strongly induce or inhibit cytochrome P450 3A (CYP3A4) is not recommended as this may lead to significantly lower or higher
Sočasna uporaba zdravila OLYSIO z zdravili, ki zmerno ali močno inducirajo ali zavirajo citokrom P450 3A (CYP3A4), ni priporočljiva, saj lahko bistveno zmanjša oziroma poveča
During the first 12 weeks of treatment, the most frequently reported adverse reactions (incidence ≥ 5%) were nausea, rash, pruritus, dyspnoea, blood bilirubin increase and photosensitivity reaction
V prvih 12 tednih zdravljenja so najpogosteje (pri ≥ 5%) poročali o naslednjih neželenih učinkih: navzea, izpuščaj, srbenje, dispneja, zvečanje koncentracije bilirubina v krvi in fotosenzitivnostna
Therefore, co-administration of OLYSIO with substances that moderately or strongly inhibit or induce CYP3A4 is not recommended.
Zato sočasna uporaba zdravila OLYSIO z učinkovinami, ki zmerno ali močno zavirajo ali inducirajo CYP3A4, ni priporočljiva.
There is no specific antidote for overdose with OLYSIO.
Za preveliko odmerjanje zdravila OLYSIO ni specifičnega antidota.
The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic study in opioid-dependent adults on stable methadone maintenance therapy.
Medsebojno delovanje med simeprevirjem in tem zdravilom so ocenjevali v farmakokinetični študiji pri odraslih, odvisnih od opioidov, na stabilnem metadonskem vzdrževalnem zdravljenju.
Patients had compensated liver disease (including cirrhosis), HCV RNA of at least 10,000 IU/ml, and liver histopathology consistent with CHC (if available).
Bolniki so imeli kompenzirano bolezen jeter (vključno s cirozo), koncentracijo HCV RNK najmanj 10.000 i.e./ml in histopatološki izvid jetrne biopsije skladen z diagnozo kroničnega hepatitisa C (če je bil na voljo).
The planned total duration of HCV treatment was 24 weeks if the following on-treatment protocol-defined response-guided therapy criteria were met: HCV RNA < 25 IU/ml detectable or undetectable at week 4 AND undetectable HCV RNA at week 12.
Načrtovano skupno trajanje zdravljenja HCV je bilo 24 tednov, če so bili doseženi naslednji od odziva odvisni in v protokolu določeni kriteriji: zaznavna koncentracija HCV RNK < 25 i.e./ml ali nezaznavna po 4. tednu IN nezaznavna koncentracija HCV RNK po 12. tednu.
The contraindications and warnings regarding pregnancy and contraception requirements applicable to the co-administered medicinal products also apply to their use in OLYSIO combination treatment.
Kontraindikacije in opozorila glede nosečnosti in zahteve po kontracepcije pri uporabi sočasnih zdravil veljajo tudi za zdravljenje v kombinaciji z zdravilom OLYSIO.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Imetnik dovoljenja za promet z zdravilom Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgija
OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients (see sections 4.2, 4.4 and 5.1).
Zdravilo OLYSIO je indicirano v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C (CHC - chronic hepatitis C) pri odraslih bolnikih (glejte poglavja 4.2, 4.4 in 5.1).
OLYSIO helps to fight against hepatitis C infection by preventing HCV from multiplying.
Zdravilo OLYSIO pomaga zdraviti okužbo z virusom hepatitisa C tako, da preprečuje razmnoževanje HCV.
In these patients the SVR12 rates were 89%, 93%, 75% and 90%, respectively.
Med temi bolniki jih je 89%, 93%, 75% oziroma 90% doseglo SVR12.
In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic
In vitro je kombinacija simeprevirja z interferonom, ribavirinom, zaviralci NS5A ali NS5B delovala aditivno ali sinergistično.
Following a single oral administration of 200 mg
Po enkratnem peroralnem odmerjanju 200 mg s
If pregnancy occurs during this period, you must contact your doctor straight away.
Če v tem obdobju zanosite, morate takoj obvestiti zdravnika.
Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design
Preglednica 11: Študije s simeprevirjem in sofosbuvirjem: populacija in povzetek načrta
Cisapride has the potential to cause cardiac arrhythmias.
Cisaprid lahko povzroča aritmije.
Rash may become severe.
Izpuščaj lahko postane hud.
In study HPC3021 (PLUTO), patients received simeprevir + sofosbuvir for 12 weeks (see table 11).
V študiji HPC3021 (PLUTO) so bolniki 12 tednov prejemali simeprevir + sofosbuvir (glejte preglednico 11).
Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italija
In case of severe rash, OLYSIO and other co-administered medicinal products for the treatment of CHC should be discontinued and the patients should be monitored until the symptoms have resolved.
Če se pojavi hud izpuščaj je treba zdravljenje z zdravilom OLYSIO in drugimi sočasnimi zdravili za zdravljenje CHC ukiniti, bolnike pa skrbno spremljati dokler simptomi ne izginejo.
There is limited data on the use of simeprevir in patients older than 65 years.
Podatki o uporabi simeprevirja pri bolnikih, starejših od 65 let, so omejeni.
Simeprevir does not affect CYP2C9, CYP2C19 or CYP2D6 in vivo.
Simeprevir in vivo ne vpliva na CYP2C9, CYP2C19 in CYP2D6.
Like all medicines, OLYSIO can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Co-administration with other direct acting antivirals against HCV OLYSIO should only be co-administered with other direct acting antiviral medicinal products if the benefits are considered to outweigh the risks based upon available data.
Sočasno dajanje z drugimi zdravili proti HCV z neposrednim delovanjem na viruse Zdravilo OLYSIO se sme dajati sočasno z drugimi zdravili z neposrednim delovanjem na viruse le, če se na podlagi razpoložljivih podatkov oceni, da je korist zdravljenja večja od tveganj.
Women must use an effective method of contraception during treatment with OLYSIO.
Med zdravljenjem z zdravilom OLYSIO mora jo ženske uporabljati učinkovito metodo kontracepcije.
The overall SVR12 rate was similar in patients receiving simeprevir + sofosbuvir with or without ribavirin.
Celokupna stopnja SVR12 je bila pri bolnikih, ki so prejemali simeprevir + sofosbuvir, z ribavirinom ali brez ribavirina, podobna.
Treatment regimen with sofosbuvir:
Režimi zdravljenja s sofosbuvirjem:
Simeprevir exposure is significantly increased in patients with severe hepatic impairment (see section 5.2).
Izpostavljenost simeprevirju se pomembno zviša pri bolnikih s hudo okvaro jeter (glejte poglavje 5.2).
In addition, tell your doctor if you take any medicines used to treat irregular heart beat or high blood
Zdravniku povejte tudi, če jemljete katero koli zdravilo za zdravljenje motenj srčnega ritma ali
Genotype 1b N = 81 % (n)
genotip 1b N = 81 % (n)
Female patients of childbearing potential must use an effective form of contraception.
Bolnice v rodnem obdobju morajo uporabljati učinkovito obliko kontracepcije.
There are no data on the effect of simeprevir on human fertility.
Plodnost O vplivu simeprevirja na plodnost pri ljudeh ni podatkov.
No clinically relevant drug-drug interaction is expected.
Klinično pomembnih interakcij med zdraviloma ni pričakovati.
Astemizole and terfenadine have the potential for cardiac arrhythmias.
Astemizol in terfenadin lahko povzročata aritmije.
Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the
Prilagajanje odmerkov ali začasna prekinitev zdravljenja z zdravili, ki se uporabljajo v kombinaciji z
Dosage adjustment or interruption of OLYSIO treatment To prevent treatment failure, the dose of OLYSIO must not be reduced or interrupted.
Prilagajanje odmerkov ali začasna prekinitev zdravljenja z zdravilom OLYSIO Odmerjanja zdravila OLYSIO se ne sme zmanjšati ali prekinjati, da ne bi prišlo do neuspeha zdravljenja.
Dose adjustment of the PDE-5 inhibitor may be required when OLYSIO is co-administered with sildenafil or tadalafil administered chronically at doses used for the treatment of pulmonary arterial hypertension.
Prilagajanje odmerkov zaviralcev fosfodiesteraze tipa 5 je lahko potrebno pri sočasni uporabi zdravila OLYSIO s sildenafilom ali tadalafilom pri kronični uporabi v odmerkih, ki se uporabljajo pri zdravljenju pljučne arterijske hipertenzije.
OLYSIO is used with other medicines to treat chronic (long-term) hepatitis C infection in adults.
Zdravilo OLYSIO se jemlje skupaj z drugimi zdravili za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa C pri odraslih bolnikih.
The daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food; also refer to the Summary of Product Characteristics of ribavirin.
Dnevni odmerek ribavirina temelji na telesni masi (< 75 kg = 1.000 mg in ≥ 75 kg = 1.200 mg) in se daje peroralno v dveh razdeljenih odmerkih s hrano.
Includes 4 simeprevir-treated patients who experienced relapse after SVR12.
Vključuje tudi podatke 4 bolnikov, ki so prejemali simeprevir in pri katerih je prišlo do ponovitve bolezni po doseženem SVR12.
Laboratory testing during treatment with OLYSIO, peginterferon alfa and ribavirin HCV RNA levels should be monitored at weeks 4 and 12 and as clinically indicated (see also guidelines for treatment duration and stopping rules; section 4.2).
Laboratorijske preiskave med zdravljenjem z zdravilom OLYSIO, peginterferonom alfa in ribavirinom Koncentracije HCV RNK je treba spremljati v 4. in 12. tednu zdravljenja ter glede na klinične indikacije (glejte tudi smernice glede trajanja in ukinitve zdravljenja v poglavju 4.2).
Most of the photosensitivity reactions were of mild severity (grade 1); grade 2 photosensitivity reactions were reported in two patients (0.7%) receiving 12 weeks of treatment.
Večina fotosenzitivnih reakcij je bila blagih (stopnja 1), o fotosenzitivnih reakcijah stopnje 2 so poročali pri dveh bolnikih (0,7%), ki sta prejemala zdravljenje
Moderate or strong inhibitors of CYP3A4 significantly increase the plasma exposure of simeprevir, and moderate or strong inducers of CYP3A4 significantly reduce plasma exposure of simeprevir.
Zmerni ali močni zaviralci CYP3A4 pomembno povečajo izpostavljenost simeprevirju v plazmi, zmerni ali močni induktorji CYP3A4 pa pomembno zmanjšajo izpostavljenost simeprevirju v plazmi.
Warnings and precautions related to these medicinal products also apply to their use in OLYSIO combination treatment.
Opozorila in varnostni ukrepi povezani s temi zdravili veljajo tudi za uporabo pri zdravljenju v kombinaciji z zdravilom OLYSIO.
If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the
Če se pojavijo fotosenzitivnostne reakcije, je treba razmisliti o prenehanju uporabe zdravila OLYSIO, bolnika pa spremljati do izboljšanja.
One patient (3.2%) receiving 24 weeks of treatment experienced a grade 4 ‘blood bilirubin increased' event.
Pri enem bolniku (3,2%), ki je prejemal zdravljenje 24 tednov, je prišlo do 'zvečanja koncentracije bilirubina v krvi' stopnje 4.
24 weeks
12 tednov.
If adverse reactions, potentially related to the medicinal products that are used in combination with OLYSIO for the treatment of CHC, require dosage adjustment or interruption of the medicinal product(s), refer to the instructions outlined in the respective Summary of Product Characteristics for
Če se pojavijo neželeni učinki, ki bi bili lahko povezani z uporabo zdravil, ki se uporabljajo v kombinaciji z zdravilom OLYSIO za zdravljenje CHC in zaradi katerih bi bilo treba prilagoditi odmerjanje ali prekiniti zdravljenje s temi zdravili, je treba upoštevati navodila v povzetku glavnih
Dosing of animals resulted in similar (dogs) or lower (rats) exposures than those observed in humans at the recommended dose of 150 mg once daily.
Odmerjanje pri živalih je pokazalo podobno (psi) ali manjšo (podgane) izpostavljenost kot tisto, ki so jo opažali pri ljudeh pri uporabi priporočenega odmerka 150 mg enkrat na dan.
The median simeprevir EC50 and EC90 values against a HCV genotype 1b replicon were 9.4 nM (7.05 ng/ml) and 19 nM (14.25 ng/ml), respectively.
Mediani vrednosti EC50 in EC90 simeprevirja za replikon virusa hepatitisa C genotipa 1b sta bili 9,4 nM (7,05 ng/ml) in 19 nM (14,25 ng/ml).
No dose adjustment is necessary based on race.
Prilagajanje odmerkov glede na raso ni potrebno.
Short term monotherapy data of simeprevir from studies C201 (genotype 1) and C202 (genotype 2, 3, 4, 5 and 6) in patients receiving 200 mg once daily simeprevir for 7 days is presented in table 9.
Kratkoročni podatki o zdravljenju s simeprevirjem v monoterapiji v študiji C201 (genotip 1) in C202 (genotip 2, 3, 4, 5 in 6) pri bolnikih, ki so prejemali 200 mg simeprevirja enkrat na dan 7 dni so podani v preglednici 9.
Serious adverse reactions were reported in 0.3% of simeprevir-treated patients (2 photosensitivity events requiring hospitalisation) and in none of the patients receiving placebo with peginterferon alfa and ribavirin.
O resnih neželenih učinkih so poročali pri 0,3% bolnikov, ki so prejemali simeprevir (2 fotosenzitivnostna dogodka, ki sta zahtevala hospitalizacijo), in pri nobenem od tistih, ki so prejemali placebo skupaj s peginterferonom alfa in z ribavirinom.
Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating OLYSIO combination treatment with sofosbuvir.
Kadar je potrebno sočasno zdravljenje z amiodaronom, je priporočljivo skrbno spremljanje bolnika ob uvedbi kombiniranega zdravljenja z zdravilom OLYSIO in sofosbuvirjem.
If a dose of OLYSIO is missed, and the patient notices within 12 hours of the usual dosing time, the patient should take the missed dose of OLYSIO with food as soon as possible and then take the next dose of OLYSIO at the regularly scheduled time.
Če bolnik pozabi vzeti odmerek zdravila OLYSIO in to opazi v 12 urah od običajnega časa odmerjanja, mu naročite naj čimprej vzame pozabljeni odmerek zdravila OLYSIO s hrano, naslednji odmerek zdravila OLYSIO pa naj vzame po običajnem razporedu.
Patients with cirrhosis N = 103 % (n/N)
Bolniki s cirozo N = 103 % (n/N)
Maximum plasma concentrations (Cmax) are typically achieved between 4 to
Učinkovina doseže najvišjo koncentracijo v plazmi (Cmax) praviloma 4 do 6 ur po odmerjanju.
Treatment-emergent laboratory abnormalities in amylase and lipase have been observed in patients treated with simeprevir in combination with sofosbuvir (table 6).
Z zdravljenjem povzročene nenormalnosti laboratorijskih izvidov amilaze in lipaze so opazili pri bolnikih, zdravljenih s simeprevirjem v kombinaciji s sofosbuvirjem (preglednica 6).
Substitutions such as D168V or A, and R155K were usually associated with large reductions in susceptibility to simeprevir in vitro (FC in EC50 > 50), whereas other substitutions such as Q80K or R, S122R, and D168E displayed in vitro low level resistance (FC in EC50 between 2 and 50).
Substitucije, kot sta D168V ali A in R155K, običajno zmanjšajo občutljivost simeprevirja in vitro (več kot 50-kratno zvečanje EC50), medtem ko druge substitucije, kot so Q80K ali R, S122R in D168E, pomenijo in vitro nizko stopnjo odpornosti (od 2 do 50-kratno zvečanje EC50).
For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Za aktivnost, specifično za genotip virusa hepatitisa C (HCV), glejte poglavji 4.4 in 4.5.
Monitoring of blood concentrations of sirolimus is recommended.
Priporočeno je spremljanje koncentracije sirolimusa v krvi.
Based on the elimination pathway of azithromycin, no drug interactions are expected between azithromycin and simeprevir.
Na osnovi poti izločanja azitromicina se ne pričakuje interakcij med