natgillin/translations-raw huggingface dataset:
There are no clinical data on the efficacy of simeprevir in patients with a history of exposure to the NS3/4A PIs telaprevir or boceprevir.
Kliničnih podatkov o učinkovitosti simeprevirja pri bolnikih, ki so bili že izpostavljeni zaviralcema proteaze HCV NS3/4A telaprevirju ali boceprevirju, ni.
Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin, and interferon-intolerant patients.
Vključuje bolnike s ponovitvijo bolezni, bolnike z delnim odzivom ali brez odziva na predhodno zdravljenje z interferonom (pegiliranim ali nepegiliranim), z ribavirinom ali brez ribavirina, in bolnike, ki ne prenešajo interferona.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Če karkoli od zgoraj navedenega velja za vas (ali če o tem niste prepričani), se pred začetkom uporabe zdravila OLYSIO posvetujte z zdravnikom ali farmacevtom.
Laboratory parameter WHO toxicity range
Laboratorijski parameter
Increased simeprevir exposures have been observed in individuals with severe renal impairment.
Pri posameznikih s hudo okvaro ledvic so opažali povečano izpostavljenost simeprevirju.
Caution is warranted and therapeutic drug monitoring for these antiarrhythmics and/or clinical monitoring (ECG etc.) when orally administered are recommended.
Pri peroralni uporabi je priporočljivo terapevtsko spremljanje uporabe teh antiaritmikov in/ali klinično spremljanje bolnikov (npr. z EKG).
Chimeric replicons carrying NS3 sequences derived from HCV PI treatment-naïve genotype 1a and genotype 1b patients displayed median fold change (FC) in simeprevir EC50 values of 1.4 (N = 78) and 0.4 (N = 59) compared to reference genotype 1b replicon, respectively.
Himerni replikoni, ki so vsebovali sekvence za NS3, pridobljene pri bolnikih s HCV genotipa 1a in genotipa 1b, ki pred tem še niso prejemali zaviralcev proteaz, so pokazali mediano 1,4-kratno (N = 78) oziroma 0,4-kratno (N = 59) spremembo vrednosti EC50 simeprevirja v primerjavi z referenčnim replikonom genotipa 1b.
Includes one prior null responder who experienced relapse after SVR12, who was considered to have an HCV re-infection (based on phylogenetic analyses).
Vključno s podatki enega bolnika, pri katerem ni bilo odziva na predhodnje zdravljenje; po dosegu SVR12 v študiji je prišlo do ponovitve bolezni, in za katerega (na podlagi filogenetske analize) menijo, da je se je ponovno okužil s HCV.
See section 4.
stopnja 4
The clinical relevance of this difference in viral breakthrough rates is
Klinični pomen razlik v stopnjah virusnega preboja med različnimi podskupinami ni znan.
2; the median baseline HCV RNA level was 6.01 log10 IU/ml; 37% had cirrhosis; 30% had HCV genotype 4a, and 56% HCV genotype 4c or 4d; 79% had non-CC IL28B alleles (CT or TT); 52% were treatment-naïve, and 48% were treatment-experienced.
je imelo ITM ≥ 30 kg/m2; mediana izhodiščne koncentracije HCV RNK je bila 6,01 log10 i.e./ml; 37% jih je imelo cirozo; 30% je bilo okuženih s HCV genotipa 4a, in 56% okužbo s HCV genotipa 4c ali 4d; 79% jih je imelo ne-CC IL28B alele (CT ali TT); 52% bolnikov še ni bilo zdravljenih, in 48% bolnikov je že bilo zdravljenih.
The dosing recommendation is applicable to the recommended dose of simeprevir 150 mg once daily.
Priporočilo za odmerjanje se nanaša na priporočeni odmerek 150 mg
Simeprevir in combination with sofosbuvir: Photosensitivity reactions were reported in 3.1% of simeprevir-treated patients receiving 12 weeks of treatment compared to 6.5% in patients receiving 24 weeks of treatment (all grades).
Simeprevir v kombinaciji s sofosbuvirjem: o fotosenzitivnih reakcijah so poročali pri 3,1% bolnikov, ki so zdravljenje s simeprevirjem prejemali 12 tednov, v primerjavi s 6,5% bolnikov, ki so zdravljenje prejemali 24 tednov (vse stopnje).
Mild increases in concentrations of amiodarone may be expected when amiodarone
Pri peroralni uporabi je mogoče pričakovati blago zvečanje koncentracije amiodarona.
What OLYSIO looks like and contents of the pack The hard capsules are white, with ‘TMC435 150' printed in black ink.
Trde kapsule so bele barve in imajo s črnim barvilom natisnjeno oznako "TMC435 150".
Seventy-one percent (37/52), 93% (14/15), 80% (8/10) and 36% (10/28) of simeprevir-treated treatment-naïve patients, prior relapsers, prior partial responders and prior null responders had undetectable HCV RNA at week 4.
Enainsedemdeset odstotkov (37/52) bolnikov brez predhodnega zdravljenja, 93% (14/15) bolnikov s ponovitvijo bolezni po predhodnem zdravljenju, 80% (8/10) bolnikov z delnim odzivom na predhodno zdravljenje in 36% (10/28) bolnikov brez odziva na predhodno zdravljenje (vsi navedeni bolniki so prejemali simeprevir) je imelo po 4 tednih nezaznavno koncentracijo HCV RNK.
8 or 12 weeks SMV + sofosbuvir
8 ali 12 tednov SMV + sofosbuvir
Table 15: Treatment outcome in HCV genotype 1 infected patients with cirrhosis receiving 12 or 24 weeks simeprevir + sofosbuvir, with or without ribavirin
Preglednica 15: Izidi zdravljenja bolnikov, okuženih s HCV genotipa 1, s cirozo, ki so 12 ali 24 tednov prejemali simeprevir + sofosbuvir, z ribavirinom ali brez ribavirina
The days of the week are printed on
Na pretisnem traku so natisnjene okrajšave imen dni v tednu.
12 weeks OLYSIO + sofosbuvir
12 tednov OLYSIO + sofosbuvir
No emerging NS5B amino acid substitutions associated with sofosbuvir resistance were observed in patients who did not achieve SVR following treatment of simeprevir in combination with sofosbuvir (with or without ribavirin) for 12 or 24 weeks.
Substitucije aminokislin NS5B, povezane z odpornostjo na sofosbuvir, pri bolnikih, ki po 12 ali 24 tednih zdravljenja s simeprevirjem v kombinaciji s sofosbuvirjem (z ribavirinom ali brez ribavirina)
Body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin.
Odmerjanje ribavirina glede na telesno maso, dvakrat na dan, v skladu s povzetkom glavnih značilnosti zdravila za
Plasma concentrations of midazolam were not affected when administered intravenously as simeprevir does not inhibit hepatic CYP3A4.
Pri intravenskem vnosu midazolama ni prišlo do spremembe njegove koncentracije v plazmi, ker simeprevir ne zavira encima CYP3A4 v jetrih.
The persistence of simeprevir-resistant NS3 amino acid substitutions was assessed following treatment failure.
Po neuspehu zdravljenja so ocenjevali trajnost substitucij aminokislin NS3, ki povzročajo odpornost na simeprevir.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih
In study HPC2002, increased bilirubin was reported in 0% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 9.3% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
V študiji HPC2002 so o zvečanju koncentracije bilirubina poročali pri 0% bolnikov, ki so12 tednov prejemali simeprevir in sofosbuvir brez ribavirina, v primerjavi z 9,3% bolnikov, ki so 12 tednov prejemali simeprevir s sofosbuvirjem in ribavirinom
Refer to table 3 for treatment stopping rules based on HCV RNA levels at weeks 4, 12 and 24 for patients receiving treatment with OLYSIO, peginterferon alfa and ribavirin.
Smernice za ukinitev zdravljenja glede na koncentracije RNK virusa hepatitisa C (HCV RNA) po 4, 12 in 24 tednih zdravljenja bolnikov, ki so prejemali zdravilo OLYSIO, peginterferon alfa in ribavirin, so navedene v preglednici 3.
These increases in bilirubin levels were not associated with any adverse liver safety finding.
Zvečanje koncentracije bilirubina ni bilo povezano s pojavom neželenih učinkov na jetrih.
Amylase and lipase elevations were not
Zvečanje koncentracij amilaze in lipaze ni bilo povezano s pankreatitisom.
Use of a sensitive quantitative HCV RNA assay for monitoring HCV RNA levels during treatment is recommended.
Za spremljanje koncentracije HCV RNK med zdravljenjem je priporočljiva uporaba občutljive kvantitativne metode
Data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Podatki iz študije faze 2 pri 11 bolnikih s presaditvijo jeter, okuženih
Plasma Cmax and the area under the plasma concentration time curve (AUC) increased more than dose proportional after multiple doses between 75 mg and 200 mg once daily, with accumulation occurring following repeated dosing.
Po večkratnih odmerkih od 75 mg do 200mg enkrat na dan sta se Cmax v plazmi in površina pod krivuljo časovnega poteka koncentracije v plazmi (AUC) povečali bolj kot sorazmerno z odmerkom, ker je pri ponavljanju odmerjanja prišlo do kopičenja.
HCV/Human immunodeficiency virus type 1 (HIV-1) co-infection No dose adjustment of OLYSIO is required in HCV/HIV-1 co-infected patients (see sections 4.8, 5.1
Sočasna okužba s HCV/virusom humane imunske pomanjkljivosti-1 (HIV-1) Pri bolnikih s sočasno okužbo s HCV/HIV-1 prilagajanje odmerkov zdravila OLYSIO ni potrebno
Simeprevir in combination with peginterferon alfa and ribavirin The safety profile of simeprevir in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection is based on the pooled data from the phase 2 studies and phase 3 studies C205, C206, C208, C216 and HPC3007 which included 924 patients who received simeprevir 150 mg once daily for 12 weeks and 540 patients who received placebo with peginterferon alfa and
Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom Varnostni profil simeprevirja v kombinaciji s peginterferonom alfa in ribavirinom pri bolnikih, okuženih s HCV genotipa 1, temelji na združenih podatkih iz študij faze 2 in študij faze 3 (študije C205, C206, C208, C216 in HPC3007), v katerih je sodelovalo 924 bolnikov, ki so prejemali 150 mg simeprevirja enkrat na dan 12 tednov in 540 bolnikov, ki so prejemali placebo s peginterferonom alfa in z ribavirinom.
Table 7: Treatment-emergent laboratory abnormalities observed at a higher incidence in patients receiving simeprevir in combination with peginterferon alfa and ribavirin (pooled phase 3 studies C208, C216 and HPC3007; first 12 weeks of treatments)
Preglednica 7: Z zdravljenjem povzročene nenormalnosti laboratorijskih izvidov, ki so jih pogosteje opažali pri bolnikih, ki so prejemali simeprevir v kombinaciji s peginterferonom alfa in ribavirinom (združeni podatki iz študij faze 3: študije C208, C216 in HPC3007; prvih 12 tednov zdravljenja)
Caution is warranted when this medicinal product with narrow therapeutic index is co-administered with OLYSIO via the oral route.
Pri peroralnem vnosu tega zdravila z ozkim terapevtskim indeksom in sočasni uporabi zdravila OLYSIO je potrebna previdnost.
The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
V tej interakcijski študiji so 50 mg simeprevirja v kombinaciji z darunavirjem oziroma ritonavirjem primerjali s 150 mg
Therefore, it is not expected that renal impairment will have a clinically relevant effect on the exposure to simeprevir.
Obseg izločanja simeprevirja skozi ledvice je zanemarljiv, zato ni pričakovati, da bi okvara ledvic lahko klinično pomembno vplivala na izpostavljenost simeprevirju.
It is not recommended to co-administer OLYSIO with cisapride.
Sočasna uporaba zdravila OLYSIO s cisapridom ni priporočljiva.
Read the package leaflets for the other medicines used for treating your hepatitis C infection for side
Za podatke o neželenih učinkih ostalih zdravil za zdravljenje okužbe z virusom hepatitisa C preberite
In study HPC2002, photosensitivity reactions (grouped term) was reported in 7.1% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 5.6% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
V študiji HPC2002 so o fotosenzitivnih reakcijah (skupni termin) po poročali pri 7,1% bolnikov, ki so12 tednov prejemali simeprevir in sofosbuvir brez ribavirina, v primerjavi s 5,6% bolnikov, ki so 12 tednov prejemali simeprevir s sofosbuvirjem in ribavirinom
Table 16: Treatment outcome in HCV genotype 4 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC2014 and HPC3021) Treatment outcome
Preglednica 16: Izid zdravljenja pri bolnikih, okuženih s HCV genotipa 4, ki so 12 tednov prejemali simeprevir + sofosbuvir (študiji HPC2014 in HPC3021)
The overall safety profile of simeprevir is based on data from 580 HCV genotype 1 infected patients who received simeprevir in combination with sofosbuvir with or without ribavirin (pooled data from the clinical phase 2 study HPC2002 and the clinical phase 3 studies HPC3017 and HPC3018) and 1,486 HCV genotype 1 infected patients who received simeprevir (or placebo) in combination with peginterferon alfa and ribavirin (pooled data from the clinical phase 2 studies C205 and C206 and the clinical phase 3 studies C208, C216 and HPC3007).
Celokupni varnostni profil simeprevirja temelji na podatkih 580 bolnikov, okuženih s HCV genotipa 1, ki so prejemali simeprevir v kombinaciji s sofosbuvirjem, z ribavirinom ali brez ribavirina (združeni podatki iz klinične študije faze 2 (študija HPC2002) in kliničnih študij faze 3 (HPC3017 in HPC3018)) in na podatkih 1.486 bolnikov, okuženih s HCV genotipa 1, ki so prejemali simeprevir (ali placebo) v kombinaciji s peginterferonom alfa in ribavirinom (združeni podatki kliničnih študij faze 2 (študiji C205 in C206) in kliničnih študij faze 3 (študije C208, C216 in HPC3007).
No dose adjustment of daclatasvir or OLYSIO is required.
Prilagajanje odmerkov daklatasvirja ali zdravila OLYSIO ni potrebno.
OLYSIO in combination with peginterferon alfa and ribavirin: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients, except for co-infected patients with cirrhosis who should receive 36 weeks of treatment with peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin (total treatment
Uporaba zdravila OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom: bolnike s sočasno okužbo s HCV/HIV-1 je treba zdraviti enako dolgo kot bolnike, ki so okuženi samo s HCV, razen v primeru bolnikov s sočasno okužbo z obema virusoma in s cirozo: ti bolniki naj po zaključenem 12-tedenskem zdravljenju z zdravilom OLYSIO, peginterferonom alfa in ribavirinom dodatno 36 tednov prejemajo peginterferon alfa in ribavirin (do skupnega trajanja zdravljenja 48 tednov).
Therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients (see section 4.6).
Ribavirin lahko povzroča prirojene nepravilnosti in/ali smrt izpostavljenega ploda, zato je treba zelo skrbno preprečevati nosečnost pri bolnicah in partnerkah moških bolnikov (glejte poglavje 4.6).
No dose adjustment of OLYSIO is required in elderly patients (see section 5.2).
Pri starostnikih prilagajanje odmerkov zdravila OLYSIO ni potrebno (glejte poglavje 5.2).
The safety profile of simeprevir in combination with sofosbuvir in patients with HCV genotype 1 infection with or without cirrhosis is based on pooled data from the phase 2 study HPC2002 and the phase 3 studies HPC3017 and HPC3018 which included 472 patients who received simeprevir with sofosbuvir without ribavirin (155, 286 and 31 patients received 8, 12 or 24 weeks of treatment, respectively) and 108 patients who received simeprevir with sofosbuvir and ribavirin (54 patients each received 12 or 24 weeks of treatment).
Varnostni profil simeprevirja v kombinaciji s sofosbuvirjem pri bolnikih, okuženih s HCV genotipa 1, s cirozo ali brez ciroze, temelji na na združenih podatkih iz študije faze 2 (študija HPC2002) in študij faze 3 (študiji HPC3017 in HPC3018), v katere so vključili 472 bolnikov, ki so prejemali simeprevir s sofosbuvirjem brez ribavirina (155, 286 in 31 bolnikov je prejelo 8, 12 oziroma 24 tednov zdravljenja) in 108 bolnikov, ki so prejemali simeprevir s sofosbuvirjem in ribavirinom (po 54 bolnikov je prejelo
Simeprevir inhibits OATP1B1/3, P-gp and BCRP transporters.
Simeprevir zavira prenašalce OATP1B1/3, P-glikoprotein (P-gp) in BCRP.
- If it is more than 12 hours until your next dose, take the missed dose as soon as possible with food.
Če ste pozabili vzeti zdravil OLYSIO - Če je do naslednjega odmerka več kot 12 ur, vzemite pozabljeni odmerek čimprej skupaj s hrano.
The impact of prior exposure to simeprevir in patients not achieving SVR on the efficacy of subsequent HCV NS3/4A PI-based treatment regimens has not been established.
Vpliva predhodne izpostavljenosti simeprevirju na učinkovitost nadaljnjega zdravljenja z zaviralci proteaze HCV NS3/4A pri bolnikih, ki niso dosegli SVR, niso dokazali.
To prior treatment with peginterferon alfa and ribavirin.
Predhodno zdravljenje s peginterferonom alfa in ribavirinom.
In a pooled analysis of patients treated with 150 mg simeprevir in combination with peginterferon alfa and ribavirin who did not achieve SVR in the controlled phase 2 and phase 3 clinical studies (studies C205, C206, C208, C216, HPC3007), emerging amino acid substitutions at NS3 positions 80, 122, 155 and/or 168 were observed in 180 out of 197 (91%) patients.
Rezultati analize združenih podatkov bolnikov, ki so prejemali 150 mg simeprevirja v kombinaciji s peginterferonom alfa in z ribavirinom in v nadzorovanih študijah faze 2b in faze 3 (študije C205, C206, C208, C216, HPC3007) niso dosegli trajnega virološkega odziva, kažejo da je prišlo do substitucij aminokislin NS3 na položajih 80, 122, 155 in/ali 168 pri 180 od 197 (91%) bolnikov.
OLYSIO combination treatment with sofosbuvir may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone, a medicine used to treat irregular heart beat.
Pri jemanju zdravila OLYSIO skupaj s sofosbuvirjem in amiodaronom (zdravilo za uravnavanje srčnega ritma) lahko pride do zmanjšanja srčne frekvence (pulza).
The 40 enrolled patients had a median age of 51 years (range 29 to 69 years; with 5% above 65 years); 73% were male; 18% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.35 log10 IU/ml; 18% had cirrhosis; 25% had HCV genotype 4a, and 73% HCV genotype 4d; 85%
40 vključenih bolnikov je imelo mediano starost 51 let (razpon 29 do 69 let; s 5% starejših od 65 let); 73% je bilo moških; 18% jih je imelo ITM ≥ 30 kg/m2; mediana izhodiščne koncentracije HCV RNK je bila 6,35 log10 i.e./ml; 18% jih je imelo cirozo; 25% bolnikov je bilo okuženih s HCV genotipa 4a in 73% okužbo s HCV genotipa 4d; 85% jih je imelo ne-CC IL28B alele (CT ali TT); 33% bolnikov še ni bilo zdravljenih, in 68% bolnikov je že bilo zdravljenih.
Two patients had HIV virologic failure defined as confirmed HIV-1 RNA ≥ 200 copies/ml after previous < 50 copies/ml; these failures occurred 36 and 48 weeks after end of simeprevir treatment.
Pri dveh bolnikih je prišlo do HIV virološkega neuspeha zdravljenja, ki je bil opredeljen kot potrjeno zvečanje koncentracije kopij HIV-1 RNK na ≥ 200 kopij/ml po predhodno < 50 kopij/ml.
Table 13: Treatment outcome in HCV genotype 1 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC3017 and HPC3018)
Preglednica 13: Izid zdravljenja bolnikov, okuženih s HCV genotipa 1, ki so 12 tednov prejemali simeprevir + sofosbuvir (študiji HPC3017 in HPC3018)
Antiviral activity in vitro
Protivirusno delovanje in vivo
Simeprevir in combination with sofosbuvir: Rash and pruritus were reported in 8.0% and 8.4%, respectively, of patients receiving 12 weeks of treatment compared to 12.9% and 3.2%, respectively, of patients receiving 24 weeks of treatment (all grades).
Simeprevir v kombinaciji s sofosbuvirjem: o izpuščaju in srbenju so poročali pri 8,0% oziroma 8,4% bolnikov, ki so zdravljenje prejemali 12 tednov, v primerjavi z 12,9% oziroma 3,2% bolnikov, ki so zdravljenje prejemali 24 tednov (vse stopnje).
If you develop a rash during treatment, contact your doctor immediately.
Če se pri vas med zdravljenjem pojavi izpuščaj, se nemudoma obrnite na svojega zdravnika.
Do not take OLYSIO if this applies to you.
Če to velja za vas, ne jemljite zdravila OLYSIO.
Refer to the Summary of Product Characteristics of peginterferon alfa and ribavirin for pre-treatment, on-treatment and post-treatment laboratory testing requirements including haematology, biochemistry (including hepatic enzymes and bilirubin), and pregnancy testing requirements.
Za laboratorijske preiskave, ki jih je treba opraviti pred, med ter po zaključku zdravljenja s peginterferonom alfa in ribavirinom, vključno s hematološkimi in biokemijskimi preiskavami (koncentracije jetrnih encimov in bilirubina) ter test nosečnosti, preberite povzetek glavnih značilnosti
In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated
Pri bolnikih, starih > 45 let, so o dispneji poročali pri 16,4% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 9,1% bolnikov, ki so prejemali placebo (vse stopnje, združeni podatki iz študij faze 3).
Then continue taking OLYSIO at the usual scheduled time.
Nato vzemite naslednji odmerek zdravila OLYSIO kot običajno.
(OATP1B1 transporter and/or CYP3A4 enzyme
(zaviranje prenašalca OATP1B1/3 in/ali CYP3A4)
Alternative therapy should be considered for patients infected with HCV genotype 1a with the Q80K polymorphism or in cases where testing is not accessible.
Pri bolnikih, okuženih s HCV genotipa 1a in s polimorfizmom Q80K in v primerih kjer testiranje ni možno, je treba razmisliti o alternativnem zdravljenju.
Table 3: Treatment stopping rules in patients receiving OLYSIO in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
Preglednica 3: Smernice za ukinitev zdravljenja pri bolnikih z nezadostnim virološkim odzivom v času zdravljenja z zdravilom OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom
Median simeprevir FC values against genotype 2 and genotype 3 baseline isolates tested were 25 (N = 4) and 1,014 (N = 2), respectively.
Mediana vrednost količnika spremembe aktivnosti simeprevirja proti testiranim izhodiščnim izolatom genotipa 2 (N = 4) je bila 25, proti izolatom genotipa 3 (N = 2) pa 1.014.
CALCIUM CHANNEL BLOCKERS (oral administration) Amlodipine
ZAVIRALCI KALCIJEVIH KANALČKOV (peroralna uporaba)
When used together with other medicines to treat chronic hepatitis C infection, OLYSIO helps to clear HCV from
Kadar se zdravilo OLYSIO jemlje z drugimi zdravili za zdravljenje kronične okužbe z virusom hepatitisa C pomaga telesu, da odstrani virus hepatitisa C iz telesa.
Pharmacokinetic parameters of simeprevir were comparable between patients with HCV genotype 1 infection with or without HIV-1 co-infection.
Farmakokinetični parametri simeprevirja so pri bolnikih z okužbo s HCV genotipa 1 s sočasno okužbo s HIV-1 podobni kot pri bolnikih brez sočasne okužbe s HIV-1.
It is not recommended to co-administer OLYSIO with clarithromycin or telithromycin.
Sočasna uporaba zdravila OLYSIO s klaritromicinom ali telitromicinom ni priporočljiva.
You may experience a rash during treatment with OLYSIO.
Med zdravljenjem z zdravilom OLYSIO se lahko pojavi izpuščaj.
In the pooled analysis of studies C208 and C216, 69% (58/84) of the simeprevir-treated HCV genotype 1a infected patients with Q80K polymorphism at baseline were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 78%.
V združeni analizi študij C208 in C216 je bilo 69% (58/84) bolnikov, okuženih s HCV genotipa 1a s polimorfizmom Q80K na začetku zdravljenja, zdravljenih s simeprevirjem, primernih za skupno trajanje zdravljenja 24 tednov.
Hepatic impairment
Okvara ledvic
- If you are a man, your female partner must not become pregnant during your treatment and
- Če ste moški, vaša partnerka ne sme zanositi v času, ko vi jemljete zdravila in še nekaj mesecev po zaključku zdravljenja z njimi.
Hepatic decompensation and hepatic failure
Dekompenzacija in odpoved jeter
The response rates for patients with cirrhosis (METAVIR score F4) receiving 12 or 24 weeks of simeprevir
Stopnje odzivov bolnikov s cirozo (ocena po klasifikaciji METAVIR F4), ki so 12 ali 24 tednov prejemali simeprevir + sofosbuvir, so