natgillin/translations-raw huggingface dataset:
To maximise absorption, Exviera tablets should be taken with food, without regard to fat and calorie content (see section 5.2).
Da bi bila absorpcija čim večja, je treba tablete zdravila Exviera vzeti s hrano, ne glede na vsebnost maščob in kalorij (glejte poglavje
Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Zdravilo Exviera se ne priporoča pri bolnikih z zmerno okvaro jeter (Child-Pugh B).
− Tablet film-coating: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), iron oxide yellow (E172), iron oxide red (E172) and iron oxide black (E172).
− Filmska obloga tablete: polivinilalkohol (E1203), titanov dioksid (E171), polietilenglikol 3350, smukec (E553b), rumeni železov oksid (E172), rdeči železov oksid (E172), črni železov oksid (E172).
Ombitasvir treatment-emergent variants M28T, M28V or Q30R in NS5A were observed in 32 subjects.
Med zdravljenjem z ombitasvirjem nastale variante M28T, M28V ali Q30R v genu NS5A so ugotovili pri 32
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na poseben recept in le s posebnim režimom (glejte Prilogo I:
Exviera should not be used in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.8 and 5.2).
Zdravilo Exviera se ne sme uporabljati pri bolnikih s hudo okvaro jeter (Child-Pugh C) (glejte poglavja 4.2, 4.8 in 5.2.).
No dose adjustment of Exviera is required for patients with mild, moderate, or severe renal impairment, or end-stage-renal disease on dialysis (see section 4.2).
Prilagoditev odmerka zdravila Exviera ni potrebna pri bolnikih z blago, zmerno ali hudo okvaro ledvic ali z ledvično odpovedjo na dializi (glejte poglavje 4.2).
Table 16 shows the SVR12 rates for subjects with HCV genotype 1 infection and HIV-1 co-infection in TURQUOISE-I.
Preglednica 16 prikazuje deleže SVR12 pri preiskovancih s HCV genotipom 1 in sočasno okuženih s HIV-1 v študiji TURQUOISE-I.
b. Other includes early drug discontinuation not due to virologic failure and missing HCV RNA values in the SVR12 window.
b. "Drugo" vključuje zgodnjo ukinitev zdravila, ki ni posledica virološkega neuspeha in manjkajoče vrednosti
The long-term clinical impact of the emergence or persistence of virus containing Exviera and ombitasvir/paritaprevir/ritonavir -resistanceassociated substitutions on future treatment is unknown.
Dolgoročni klinični vpliv pojava oziroma vztrajanja virusov s substitucijami, povezanimi z odpornostjo proti zdravilu Exviera in kombinaciji ombitasvir/paritaprevir/ritonavir na zdravljenje v prihodnje ni znan.
Note: Doses used for Exviera + ombitasvir/paritaprevir/ritonavir were: ombitasvir 25 mg paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily.
Opomba: Uporabljeni odmerki za zdravilo Exviera + ombitasvir/paritaprevir/ritonavir so bili: paritaprevir 150 mg, ritonavir 100 mg, ombitasvir 25 mg enkrat na dan in dasabuvir 400 mg dvakrat na dan ali 250 mg dvakrat na dan.
No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and 2 subjects with HCV genotype 1b infection experienced relapse.
Nobeden izmed preiskovancev z okužbo s HCV genotipa 1b ni doživel virološkega neuspeha med zdravljenjem in 2 preiskovanca z okužbo s HCV genotipa 1b sta doživela ponovitev bolezni.
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Exviera with ombitasvir/paritaprevir/ritonavir with and without ribavirin.
Tveganje za dekompenzacijo jeter in okvaro jeter pri bolnikih s cirozo Pri bolnikih, ki so jih zdravili z zdravilom Exviera z ombitasvirjem/paritaprevirjem/ritonavirjem z ali brez ribavarina so po prihodu zdravila na trg poročali o dekompenzaciji jeter in okvari jeter, vključno s presaditvijo jeter ali smrtnimi izidi.
Patient population
Posebne populacije bolnikov
When starting coadministration with dasabuvir and ombitasvir/paritaprevir/ ritonavir administer 0.5 mg tacrolimus once every week.
Na začetku sočasne uporabe z dasabuvirjem in kombinacijo ombitasvir/paritap revir/ritonavir uporabite 0,5 mg takrolimusa enkrat na teden.
ANTICANCER AGENTS Enzalutamid e
ZDRAVILA PROTI RAKU enzalutamid mitotan
Treatment-emergent amino acid substitutions in the pooled analysis of Exviera and ombitasvir/paritaprevir/ritonavir, with and without RBV regimens in Phase 2b and Phase 3 clinical trials (N=2510)
Med zdravljenjem nastale aminokislinske substitucije v kumulativni analizi shem z zdraviloma Exviera in ombitasvir/paritaprevir/ritonavir (z RBV ali brez njega) v kliničnih preskušanjih faze 2b in 3 (N = 2510)
The mean EC50 of dasabuvir against replicons containingNS5B from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.77 nM (range 0.4 to 2.1 nM; n=11) and 0.46 nM (range 0.2 to 2 nM; n=10), respectively.
Povprečna EC50 dasabuvirja proti replikonom, ki so vsebovali NS5B iz skupine izolatov še nezdravljenih in z genotipom 1a in 1b, je bila v preizkusu replikonske celične kulture HCV 0,77 nM (razpon od 0,4 do 2,1 nM, n = 11) za 1a in 0,46 nM (razpon od 0,2 do 2 nM, n = 10) za 1b.
In the 7 genotype 1b infected subjects,treatment-emergent variants were observed in NS3 in 4 subjects, in NS5A in 2 subjects, and in both NS3 and NS5A in 1 subject.
Pri 7 preiskovancih, okuženih z genotipom 1b, so med zdravljenjem nastale variante NS3 ugotovili pri 4 preiskovancih, variante NS5A pri 2 preiskovancih ter NS3 in NS5A pri 1 preiskovancu.
naïve, n (%)
nezdravljeni, n (%)
A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with Exviera + ombitasvir/paritaprevir /ritonavir.
NP Razmisliti je treba o 50 % zmanjšanju odmerka hidrokodona in/ali kliničnem spremljanju pri sočasnem dajanju s kombinacijo Exviera + ombitasvir/paritap revir/ritonavir.
Exviera is recommended in combination with paritaprevir/ombitasvir/ritonavir, and ritonavir may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy.
Uporaba zdravila Exviera je priporočljiva v kombinaciji s paritaprevirjem/ombitasvirjem/ritonavirjem ter ritonavirjem, ki lahko dosežejo selekcijo za odpornost na PI pri bolnikih, sočasno okuženih s HIV in brez potekajočega protiretrovirusnega zdravljenja.
If dose adjustments of concomitant medicinal products are made due to treatment with Exviera and ombitasvir/paritaprevir/ritonavir, doses should be re-adjusted after administration of Exviera and ombitasvir/paritaprevir/ritonavir is completed.
Če se odmerek sočasno uporabljenih zdravil zaradi zdravljenja z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir prilagodi, je treba odmerek ponovno prilagoditi, ko se zdravljenje z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir konča.
Recommendations for co-administration of Exviera with ombitasvir/paritaprevir/ritonavir for a number of medicinal products are provided in Table 2.
Priporočila za sočasno uporabo zdravila Exviera in kombinacije ombitasvir/paritaprevir/ritonavir s številnimi zdravili so navedena v preglednici 2.
In Phase 3 clinical trials, 91.5% of subjects did not require ribavirin dose adjustments during therapy.
Vpliv prilagoditve odmerka ribavirina na verjetnost SVR V kliničnih preskušanjih 3. faze 91,5 % preiskovancev med zdravljenjem ni potrebovalo prilagoditve odmerka ribavirina.
The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with Exviera + ombitasvir/paritaprevir/ ritonavir.
Priporočeni odmerek atazanavirja je 300 mg, brez ritonavirja, v kombinaciji Exviera + ombitasvir/paritap revir/ritonavir.
Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B) (see sections 4.4 and 4.8).
Uporaba zdravila Exviera pri bolnikih z zmerno okvaro jeter (Child-Pugh B) se ne priporoča (glejte poglavji 4.4 in 4.8).
Mechanism: CYP3A4/CY P2C8 induction by rifampicin.
Mehanizem: Indukcija CYP3A4/CYP2 C8 z rifampicinom.
The safety profile of Exviera and ombitasvir/paritaprevir/ritonavir was similar in patients without cirrhosis, and with compensated cirrhosis, with exception of increased rates of transient hyperbilirubinemia when ribavirin was part of the regimen.
Varnostne značilnosti zdravila Exviera in kombinacije ombitasvir/paritaprevir/ritonavir so bile podobne pri preiskovancih brez ciroze in pri tistih s kompenzirano cirozo, z izjemo večjega deleža prehodne hiperbilirubinemije ob jemanju z ribavirinom.
The majority of these ALT elevations were transient and assessed as related to Exviera and ombitasvir/paritaprevir/ritonavir.
Večina teh zvišanj ALT je bila prehodnih in so jih ocenili kot povezane z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir.
Genotype 1a, without cirrhosis
genotipa 1a brez ciroze.
Patients who are taking ethinylestradiol -containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Exviera with ombitasvir/paritaprevir/ritonavir therapy (see sections 4.3 and 4.5).
Bolnice, ki uporabljajo zdravila z etinilestradiolom (tj. večina kombiniranih peroralnih kontraceptivov ali kontracepcijskih vaginalnih obročkov), morajo preiti na drugačen način kontracepcije (npr. na samo progestinsko kontracepcijo ali na nehormonske načine), preden začnejo zdravljenje z zdravilom
Two patients discontinued Exviera and ombitasvir/paritaprevir/ritonavir due to elevated ALT, including one on ethinylestradiol.
Dve osebi sta prenehali uporabljati zdravilo Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir zaradi zvišanja ALT, od teh ena, ki je jemala etinilestradiol.
Exviera + ombitasvir/paritaprevir/ ritonavir may increase the plasma concentrations of dabigatran etexilate.
Exviera + ombitasvir/paritap revir/ritonavir lahko zveča koncentracijo dabigatran eteksilata.
NAME OF THE MEDICINAL PRODUCT Exviera 250 mg film-coated tablets
IME ZDRAVILA Exviera 250 mg filmsko obložene tablete
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Polyethylene glycol 3350 Talc (E553b) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
titanov dioksid (E171) polietilenglikol 3350 smukec (E553b) rumeni železov oksid (E172) rdeči železov oksid (E172) črni železov oksid (E172)
Clinical monitoring and dose adjustment maybe needed for smephenytoin.
Morda bo potrebno klinično spremljanje in prilagoditev odmerka smefenitoina.
Wort (hypericum perforatum)
• šentjanževka (Hypericum perforatum)
TURQUOISE-III is a Phase 3b, open-label, single-arm, multicentre study evaluating the efficacy and safety of Exviera and ombitasvir/paritaprevir/ritonavir (without ribavirin) administered for 12 weeks in HCV GT1b-infected, treatment-naïve and pegIFN/RBV treatment-experienced adults with compensated cirrhosis.
TURQUOISE-III je preskušanje faze 3.b, odprto, z eno samo skupino, multicentrično, v katerem se ugotavlja učinkovitost in varnost zdravila Exviera in kombinacije ombitasvir/paritaprevir/ritonavir (brez ribavirina), ki ju odrasli, okuženi s HCV GT1b, ki še niso bili zdravljeni in taki, ki so bili predhodno zdravljeni s pegIFN/RBV ter s kompenzirano cirozo, prejemajo 12 tednov.
NAME OF THE MEDICINAL PRODUCT Exviera 250 mg tablets dasabuvir
IME ZDRAVILA Exviera 250 mg tablete dasabuvir
The efficacy of dasabuvir has not been established in patients with HCV genotypes other than genotype 1; Exviera should not be used for the treatment of patients infected with other genotypes than
Učinkovitost dasabuvirja ni ugotovljena pri bolnikih z drugimi genotipi HCV razen genotipa 1;
Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection enzalutamide for prostate cancer ethinylestradiol containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception gemfibrozil to lower cholesterol and other fats in the blood mitotane for some tumours of the adrenal glands rifampicin for bacterial infections
enzalutamid pri raku prostate zdravila, ki vsebujejo etinilestradiol, kot je večina kontracepcijskih tablet in vaginalnih obročkov, ki se uporabljajo kot kontracepcija kontracepcija gemfibrozil za zniževanje holesterola in drugih maščob v krvi mitotan pri nekaterih tumorjih nadledvičnih žlez rifampicin pri bakterijskih okužbah šentjanževka (hypericum perforatum)
In subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
so bili neželeni učinki, ki so običajno povezani z ribavirinom (npr. navzea, insomnia, anemija), manj pogosti in noben preiskovanec (0/588) ni trajno prekinil zdravljenja zaradi neželenih učinkov.
Transient elevations in serum bilirubin (predominantly indirect) were observed in subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin, related to the inhibition of the bilirubin transporters OATP1B1/1B3 by paritaprevir and ribavirin-induced haemolysis.
Pri preiskovancih, ki so dobivali zdravili Exviera in ombitasvir/paritaprevir/ritonavir z ribavirinom, so opažali prehodno zvišanje bilirubina v serumu (pretežno indirektnega), ki je povezano z zavrtjem bilirubinskih prenašalcev OATP1B1/1B3 s paritaprevirjem in s hemolizo zaradi ribavirina.
The overall safety profile in HCV-infected transplant recipients who were administered Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin (in addition to their immunosuppressant medicinal products) was similar to subjects treated with Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir ter ribavirin (poleg imunosupresivnih zdravil), je bila podobna kot pri preiskovancih, zdravljenih z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir ter ribavirinom v kliničnih preskušanjih 3. faze, čeprav so bili nekateri neželeni učinki pogostejši.
Medicinal products transported by Pgp in the intestine While dasabuvir is an in vitro inhibitor of P-gp, no significant change was observed in the exposure of the P-gp substrate, digoxin, when administered with Exviera with ombitasvir/paritaprevir/ritonavir.
Dasabuvir sicer in vitro zavira P-gp, vendar niso ugotovili pomembne spremembe izpostavljenosti substratu P-gp digoksinu, če je bil uporabljen skupaj z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir.
Genotype 1a, with compensated cirrhosis
12 tednov genotip 1a, s kompenzirano cirozo
NA Concomitant use is contraindicated (see the Summary of Product Characteristics for ombitasvir/paritaprevir/ ritonavir).
NP Sočasna uporaba je kontraindicirana (glejte povzetek glavnih značilnosti zdravila za ombitasvir/paritap revir/ritonavir).
Phase 3 global multicentre trials conducted with Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin (RBV).
Globalna multicentrična preskušanja 3. faze z zdravili Exviera in ombitasvir/paritaprevir/ritonavir, z ribavirinom (RBV) ali brez njega.
SAPPHIRE-I - genotype 1, treatment-naïve
SAPPHIRE-I - genotip 1, še nezdravljeni
Some patients have reported feeling very tired when taking Exviera with other medicines for their hepatitis C infection.
Nekateri bolniki so poročali o hudi utrujenosti med jemanjem zdravila Exviera in drugih zdravil za zdravljenje hepatitisa C. Če ste utrujeni, ne vozite ali upravljajte s stroji.
A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 68.4% had IL28B non-CC genotype; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
vsaj 800.000 i.e./ml in večina (84,2 %) je bila okužena z genotipom 1a; 68,4 % jih je imelo genotip IL28B ne-CC; 15,8 % jih je imelo portalno fibrozo (F2) in 5,3 % jih je imelo fibrozo z mostiči (F3); 94,7 % jih predhodno še ni bilo zdravljenih za HCV.
Tacrolimus 2 mg single dose4
Posamezen odmerek 2 mg 4
When taking Exviera and ombitasvir/paritaprevir/ritonavir, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - Feel sick (nauseous), are sick (vomit) or lose your appetite.
Če zdravilo Exviera jemljete s kombinacijo ombitasvir/paritaprevir/ritonavir, obvestite svojega zdravnika, če imate naslednje simptome, ki so lahko znak poslabšanja težav z jetri:
Note: The following variants were selected in cell culture but were not treatment-emergent: NS3 variants A156T in genotype 1a, and R155Q and D168H in genotype 1b; NS5A variants Y93C/H in genotype 1a, and L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
varianta gena NS3A156T v genotipu 1a ter R155Q in D168H v genotipu 1b; varianta gena NS5A Y93C/H v genotipu 1a in L31F/V ali Y93H v kombinaciji z L28M, L31F/V ali P58S v genotipu 1b; in Y448H NS5B v genotipu 1a in M414T in Y448H v genotipu 1b.
Overall SVR12 HCV genotype 1a HCV genotype 1b Outcome for subjects without SVR12 On-treatment VFa Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL
Recidiv Drugo b a. Potrjen HCV ≥ 25 i.e./ml po HCV RNA < 25 i.e./ml med zdravljenjem, potrjeno zvečanje HCV RNA za 1
The replicon activity of dasabuvir was attenuated 12- to 13
V prisotnosti 40 % človeške plazme je replikonska aktivnost dasabuvirja oslabela za 12- do 13-krat.
PEARL-IV- genotype 1a, treatment-naïve
PEARL-IV- genotip 1a, še nezdravljeni
Rilpivirine was also administered with food in the evening and 4 hours after dinner with Exviera + ombitasvir/paritaprevir/ritonavir in the study.
V študiji je bil rilpivirin uporabljen tudi s hrano zvečer in 4 ure po večerji z zdravilom Exviera +
• Anaemia (low number of red blood cells).
Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov • anemija (majhno število rdečih krvnih celic).
Exviera and ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044
Exviera in ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2.044
↑ darunavir ↓ dasabuvir ombitasvir paritaprevir lopinavir / ritonavir 400/100 mg
↓ dasabuvir ↔ ombitasvir ↓ paritaprevir lopinavir / ritonavir 400/100 mg dvakrat na dan1 Mehanizem:
ALT elevations were typically asymptomatic, generally occurred during the first 4 weeks of treatment (mean time 20 days, range 857 days) and most resolved with ongoing therapy.
tednih zdravljenja (povprečni čas 20 dni, razpon od 8 do 57 dni) in so večinoma minila med nadaljevanjem zdravljenja.
Tacrolimus 2 mg was dosed alone and 2 mg was administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Takrolimus 2 mg je bil uporabljen sam in 2 mg skupaj z zdravilom Exviera + kombinacijo ombitasvir/paritaprevir/ritonavir.
- Confusion - Notice swelling of your stomach area
− opazite oteklino v predelu trebuha.
fold in the presence of 40% human plasma.
vezan na beljakovine v humani plazmi.
In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had similar SVR12 rates (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (99.5%).
V tej študiji so bili deleži SVR12 z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir brez ribavirina (100 %) podobni kot z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom (99,5 %).
Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
Zdravilo Exviera in kombinacija ombitasvir/paritaprevir/ritonavir skupaj z ribavirinom so pri prejemnikih presajenih jeter priporočljivi 24 tednov.
SAPPHIRE-II - genotype 1, peginterferon+ribavirin-experienced
SAPPHIRE-II - genotip 1, že zdravljeni s peginterferonom+ribavirinom
PEARL-II - genotype 1b, peginterferon+ribavirin-experienced
PEARL-II - genotip 1b, že zdravljeni s peginterferonom+ribavirinom
OPIOIDS Methadone Exviera
OPIOIDI metadon
In the CORAL-1 study, the safety and efficacy of Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin for 24 weeks was studied in 34 HCV genotype 1-infected liver transplant recipients who were at least 12 months post-transplant at study enrolment.
Klinična preskušanja pri prejemnikih presajenih jeter V študiji CORAL-1 so varnost in učinkovitost zdravila Exviera in kombinacije ombitasvir/paritaprevir/ritonavir skupaj z ribavirinom v obdobju 24 tednov raziskali pri 34 prejemnikih presajenih jeter, okuženih s HCV genotipa 1, ki so bili v študijo vključeni vsaj
In an open-label clinical trial (TURQUOISE-I) the safety and efficacy of 12 or 24 weeks of treatment with Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin was evaluated in 63 subjects with genotype 1 chronic hepatitis C co-infected with HIV-1.
Klinična preskušanja pri preiskovancih s sočasno okužbo s HCV genotipa 1/HIV-1 V odprtem kliničnem preskušanju (TURQUOISE-I) so varnost in učinkovitost 12- ali 24-tedenskega zdravljenja z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir ter ribavirinom ocenili pri 63 preiskovancih, s kroničnim hepatitisom s HCV genotipa 1 in sočasno okužbo s HIV-1.
SAPPHIRE-II was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 394 subjects with genotype 1 chronic hepatitis C virus infection without cirrhosis who did not achieve SVR with prior treatment with pegIFN/RBV.
Preskušanje SAPPHIRE-II je bilo globalno, multicentrično, randomizirano, dvojno slepo in s placebom kontrolirano preskušanje pri 394 preiskovancih, ki so imeli kronično okužbo z virusom hepatitisa C genotipa 1 brez ciroze in s predhodnim zdravljenjem s pegIFN/RBV niso dosegli SVR.
PEARL-III - genotype 1b, treatment-naïve
PEARL-III - genotip 1b, še nezdravljeni
No dose adjustment of Exviera is warranted in elderly patients (see section 5.2).
Starejšim bolnikom odmerkov zdravila Exviera ni treba prilagoditi (glejte poglavje 5.2).
Table 12 shows the SVR12 rates for genotype 1-infected subjects with compensated cirrhosis who were treatment-naïve or previously treated with pegIFN/RBV.
Preglednica 12 prikazuje deleže SVR12 pri preiskovancih, okuženih z genotipom 1, ki so imeli kompenzirano cirozo in še niso bili zdravljeni ali so bili predhodno zdravljeni s pegIFN/RBV.
Clinical trials in peginterferon+ribavirin-experienced adults
Klinična preskušanja pri odraslih, ki so že bili zdravljeni s peginterferonom+ribavirinom
In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had a similar SVR12 rate (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (97.7%).
V tej študiji so bili deleži SVR12 z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir brez ribavirina (100 %) podobni kot z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom (97,7 %).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Ena filmsko obložena tableta vsebuje 250 mg dasabuvirja (kot natrijev monohidrat).
HCV Genotype 1a Exviera and ombitasvir/paritaprevir/ritonavir with RBV
HCV Genotip 1a Exviera in ombitasvir/paritaprevir/ritonavir Z RBV