natgillin/translations-raw huggingface dataset:
GS-331007 is not an inhibitor of OAT1, OCT2, and MATE1.
GS-331007 ni zaviralec OAT1, OCT2 in MATE1.
It is not known whether sofosbuvir, the active substance of Sovaldi, passes into human breast milk.
Ni znano, ali sofosbuvir, učinkovina v zdravilu Sovaldi, prehaja v materino mleko.
No patient experienced on-treatment virologic failure or relapse.
Noben od bolnikov ni imel virološkega neuspeha ali ponovitve med zdravljenjem.
Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Sovaldi.
Kadar se presodi, da je sočasna uporaba amiodarona potrebna, se ob uvajanju zdravljenja z zdravilom Sovaldi priporoča skrbno spremljanje bolnikov.
No clinically relevant pharmacokinetic differences due to gender or race have been identified for sofosbuvir and GS-331007.
Klinično pomembnih farmakokinetičnih razlik zaradi spola ali rase za sofosbuvir in GS-331007 niso ugotovili.
Consult the Summary of Product Characteristics for co-prescribed medicinal products before starting therapy with Sovaldi.
Glejte povzetek glavnih značilnosti zdravila za sočasno predpisovanje zdravil, preden začnete s terapijo z zdravilom Sovaldi.
Forty patients (33 with HCV genotype 1 infection, 6 with HCV genotype 3 infection, and 1 with HCV genotype 4 infection) were enrolled, 35 of whom had previously failed interferon-based treatment, and 16 of whom had cirrhosis.
Vključenih je bilo štirideset bolnikov (33 z okužbo s HCV genotipa 1, 6 z okužbo s HCV genotipa 3 in 1 bolnik z okužbo s HCV genotipa 4), pri čemer je bilo pri 35 bolnikih predhodno zdravljenje na podlagi interferona neuspešno, 16 pa jih je imelo cirozo.
A summary of the effect of varying degrees of renal impairment (RI) on the exposures of sofosbuvir and GS-331007 compared to subjects with normal renal function, as described in the text below, are provided in Table 24.
Povzetek učinka različnih stopenj ledvične okvare na izpostavljenost sestavinam sofosbuvirja in GS-331007 v primerjavi z osebami z normalnim delovanjem ledvic, kot je opisano spodaj, so na voljo v preglednici 24.
The safety and efficacy of Sovaldi in children and adolescents aged <12 years have not yet been established.
Pediatrična populacija Varnost in učinkovitost zdravila Sovaldi pri otrocih in mladostnikih, starih < 12 let, še nista bili dokazani.
Table 24: Effect of varying degrees of renal impairment on exposures (AUC) of sofosbuvir and GS-331007 compared to subjects with normal renal function
Preglednica 24: Učinek različnih stopenj ledvične okvare na izpostavljenosti (AUC) sofosbuvirju in GS-331007 v primerjavi z osebami z normalnim delovanjem ledvic
Sovaldi should be used in combination with other medicinal products.
Zdravilo Sovaldi je treba uporabljati v kombinaciji z drugimi zdravili.
The dose linearity of sofosbuvir and its primary metabolite, GS-331007, was evaluated in fasted healthy subjects.
Linearnost odmerka sofosbuvirja in njegovega primarnega presnovka, GS-331007, so ocenili pri zdravih teščih osebah.
The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV infected patients with moderate and severe hepatic impairment (CPT class B and C).
Farmakokinetiko sofosbuvirja so proučili po 7-dnevnem odmerjanju 400 mg sofosbuvirja pri bolnikih, okuženih s HCV, z zmerno in hudo jetrno okvaro (stopnja B ali C po CPT).
HCV/HBV (hepatitis B virus) co-infection
Sočasna okužba z virusoma HCV in HBV (virus hepatitisa B)
Concerning co-administration with other direct-acting antivirals against HCV, see section 4.4.
Za sočasno dajanje z drugimi zdravili proti HCV z direktnim delovanjem na viruse glejte poglavje 4.4.
Patients had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic HCV infection pre-transplantation.
Bolniki so imeli pri presejanju HCV RNA ≥ 104 i.e./ml in dokumentirano dokazano kronično okužbo s HCV pred presaditvijo.
Interferon-free regimens for patients with genotype 1, 4, 5 and 6 HCV infection with Sovaldi have not been investigated in Phase 3 studies (see section 5.1).
Režimov zdravljenja bolnikov z okužbo s HCV genotipa 1, 4, 5 in 6 brez interferona z zdravilom Sovaldi niso preučili v študijah 3. faze (glejte poglavje 5.1).
Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity; however, exposure to the major metabolite GS-331007 at the adverse dose was 29 times (rat) and 123 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Izpostavljenosti sofosbuvirju v študijah pri glodavcih ni bilo mogoče zaznati, verjetno zaradi visoke aktivnosti esteraze; vendar pa je bila izpostavljenost glavnemu presnovku GS-331007 pri odmerku, ki je povzročil neželeni učinek, 29-krat (podgana) in 123-krat (pes) večja kot je klinična izpostavljenost sofosbuvirju pri odmerku 400 mg.
If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice.
Če ste vzeli večji odmerek zdravila Sovaldi, kot bi smeli Če ste pomotoma vzeli večji odmerek od priporočenega, se takoj posvetujte z zdravnikom ali pojdite na najbližji oddelek nujne pomoči.
The predominant inactive circulating metabolite GS-331007 that accounts for greater than 90% of drug-related material systemic exposure is formed through pathways sequential and parallel to formation of active metabolite.
GS-331007, ki predstavlja več kot 90 % sistemske izpostavljenosti, povezane z zdravilom, nastaja zaporedno in vzporedno z nastajanjem aktivnega presnovka.
Talk to your doctor or pharmacist before taking this medicine if you:
Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom ali farmacevtom, če:
Sovaldi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Zdravilo Sovaldi se lahko pri teh bolnikih uporablja brez prilagajanja odmerka, ko druge ustrezne možnosti zdravljenja niso na voljo (glejte poglavja 4.8, 5.1 in 5.2).
When taking Sovaldi together with other medicines for the treatment of hepatitis C infection, patients have reported tiredness, dizziness, blurred vision and reduced attention.
Vpliv na sposobnost upravljanja vozil in strojev Pri jemanju zdravila Sovaldi skupaj z drugimi zdravili za zdravljenje okužbe s hepatitisom C so bolniki poročali o utrujenosti, omotičnosti, zamegljenem vidu in zmanjšani pozornosti.
Patients awaiting liver transplantation
Bolniki, ki čakajo na presaditev jeter
However, if ribavirin is co-administered with sofosbuvir, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics for ribavirin).
Vendar obstajajo pri sočasni uporabi ribavirina s sofosbuvirjem kontraindikacije za uporabo ribavirina med nosečnostjo (glejte tudi povzetek glavnih značilnosti zdravila za ribavirin).
• Rifapentine (a medicine used to treat infections, including tuberculosis);
• rifapentin (zdravilo za zdravljenje okužb, vključno s tuberkulozo).
Patients also taking beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone.
Bolniki, ki jemljejo blokatorje receptorjev beta, ali tisti z osnovnimi pridruženimi srčnimi motnjami oziroma napredovalo boleznijo jeter imajo lahko pri sočasnem dajanju amiodarona povečano tveganje za simptomatsko bradikardijo.
Sofosbuvir was studied in HCV infected patients prior to undergoing liver transplantation in an open-label clinical study evaluating the safety and efficacy of sofosbuvir and ribavirin administered pre-transplant to prevent post-transplant HCV reinfection.
Sofosbuvir so preučili pri bolnikih, okuženih z virusom HCV, pred načrtovano transplantacijo jeter v odprti klinični študiji, v kateri so ocenjevali varnost in učinkovitost sofosbuvirja in ribavirina, ki so ga dajali pred presaditvijo, da se prepreči ponovna okužba s HCV po presaditvi.
What Sovaldi looks like and contents of the pack
Izgled zdravila Sovaldi in vsebina pakiranja
Patients should be instructed that if vomiting occurs within 2 hours of dosing an additional tablet should be taken.
Bolnikom je treba naročiti, naj vzamejo dodatno tableto, če bruhajo v 2 urah po odmerjanju.
Sovaldi tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
Tablete zdravila Sovaldi so dobavljene v plastenkah iz polietilena visoke gostote (HDPE) z za otroke varno zaporko iz polipropilena, s sušilnim sredstvom iz silikagela in poliestrskim navojem, ki vsebujejo 28 filmsko obloženih tablet.
Baseline NS5B sequences were obtained for 1,292 patients from Phase 3 studies by population sequencing and the S282T substitution was not detected in any subject with available baseline sequence.
Izhodiščna zaporedja NS5B so pridobili za 1.292 bolnikov iz študij 3. faze z določanjem populacijskega zaporedja genoma, pri čemer substitucije S282T niso odkrili pri nobeni osebi, za katero je bilo na voljo izhodiščno zaporedje.
• trouble sleeping (insomnia)
• nespečnost (insomnija)
The pharmacokinetics of sofosbuvir and GS-331007 have not been established in paediatric patients < 12 years of age.
Farmakokinetike sofosbuvirja in GS-331007 pri pediatričnih bolnikih < 12 let starosti niso ugotavljali.
While subject to active tubular secretion, GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or 3, OCT2, MRP2, P-gp, BCRP or MATE1.
Čeprav se aktivno tubularno izloča, GS-331007 ni substrat za ledvične prenašalce, vključno s prenašalcem organskih anionov (OAT-organic anion transporter) 1 ali 3, OCT2, MRP2, P-gp, BCRP ali MATE1.
Sovaldi + ribavirin + peginterferon alfa
Zdravilo Sovaldi + ribavirin + peginterferon alfa
A 4-hour haemodialysis session removed 18% of the administered dose.
S 4-urno hemodializo se je izločilo približno 18 % uporabljenega odmerka.
A starting ribavirin dose of 400 mg administered orally in two divided doses with food is recommended.
Priporoča se dajanje začetnega odmerka ribavirina 400 mg peroralno v dveh razdeljenih odmerkih s hrano.
The difference in the overall SVR12 rates between sofosbuvir + ribavirin and peginterferon alfa + ribavirin treatment groups was 0.3% (95% confidence interval: -7.5% to 8.0%) and the study met the predefined non-inferiority criterion.
Razlika v stopnjah celokupnega SVR12 med skupinami, zdravljenimi s sofosbuvirjem + ribavirinom in peginterferonom alfa + ribavirinom, je bila 0,3 % (95-odstotni interval zaupanja: -7,5 % do 8,0 %),
In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50) value ranging from 0.7 to 2.6 μM.
V biokemičnem testu je GS-461203 zavrl aktivnost polimeraze rekombinantnega NS5B HCV genotipa 1b, 2a, 3a in 4a z vrednostjo 50-odstotne inhibitorne koncentracije (IC50) v razponu od 0,7 do 2,6 μM.
Intracellular hydrolytic prodrug cleavage catalysed by enzymes including carboxylesterase 1 and sequential phosphorylation steps catalysed by nucleotide kinases result in formation of the pharmacologically active uridine nucleoside analogue triphosphate.
Hidrolitska cepitev predzdravila v celicah, ki jo katalizirajo encimi, vključno s karboksilesterazo 1, in zaporedni fosforilacijski koraki, ki jih katalizirajo z nukleotidne kinaze, povzročijo nastanek farmakološko aktivnega uridinskega nukleozidnega analoga trifosfata.
Following treatment with sofosbuvir 200 mg or 400 mg in combination with ribavirin the SVR12 rate in patients with ESRD was 40% and 60%, respectively.
400 mg v kombinaciji z ribavirinom je bila stopnja SVR12 pri bolnikih z ESRD 40 % oz. 60 %.
The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level.
Farmakokinetične lastnosti sofosbuvirja in prevladujočega cirkulirajočega presnovka GS-331007 so ocenili pri zdravih odraslih osebah in pri bolnikih s kroničnim hepatitisom C. Po peroralni uporabi se je sofosbuvir hitro absorbiral in dosegel najvišje koncentracije v plazmi ~0,5-2 uri po odmerku, neodvisno od ravni odmerka.
b. pTVR: post-transplant virologic response (HCV RNA <LLOQ at 12 weeks post-procedure).
b. pTVR: virološki odziv po presaditvi (RNA HCV < LLOQ 12 tednov po posegu).
Efficacy, in terms of rapid virologic response, has been shown to correlate with exposure to sofosbuvir as well as GS 331007.
Pokazalo se je, da učinkovitost v smislu hitrega virološkega odziva korelira z izpostavljenostjo sofosbuvirju in GS-331007.
Population pharmacokinetic analysis in HCV infected patients showed that within the age range (19 to 75 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Populacijska farmakokinetična analiza pri bolnikih, okuženih s HCV, je pokazala, da znotraj analiziranega starostnega razpona (19 do 75 let) starost ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju in GS-331007.
No shift in the phenotypic susceptibility to sofosbuvir or ribavirin of subject isolates with these substitutions was detected.
Premika fenotipske dovzetnosti za sofosbuvir ali ribavirin pri izolatih oseb s temi substitucijami niso odkrili.
and <80 mL/min/1.73 m2)
< 80 ml/min/ 1,73 m2)
• Ribavirin, or
• z ribavirinom ali
Microcrystalline cellulose (E460(i)) Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
mikrokristalna celuloza (E460(i)) premrežen natrijev karmelozat brezvodni koloidni silicijev dioksid (E551)
Afterwards, close monitoring and potential dose adjustment of tacrolimus may be required.
Morda bo kasneje potrebno skrbno spremljanje in morebitna prilagoditev odmerka takrolimusa.
Sovaldi has not been studied in a Phase 3 study in treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection.
Zdravila Sovaldi niso preučili v študiji 3. faze pri predhodno že zdravljenih bolnikih z okužbo s HCV genotipa 1, 4, 5 in 6.
Table 19: Virologic response post-transplant in patients with HCV RNA <LLOQ at the time of liver transplantation
Preglednica 19: Virološki odziv po presaditvi pri bolnikih z RNA HCV < LLOQ v času presaditve jeter
Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 24 weeks of treatment with sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C. Eligible patients were ≥18 years old and had undergone liver transplantation 6 to 150 months prior to screening.
Sofosbuvir so preučili v odprti klinični študiji, v kateri so ocenjevali varnost in učinkovitost 24-tedenskega zdravljenja s sofosbuvirjem in ribavirinom pri prejemnikih presajenih jeter s kroničnim hepatitisom C. Primerni bolniki so bili stari ≥ 18 let in so imeli presaditev jeter 6 do 150 mesecev pred presejanjem.
When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment as recommended in the Summary of Product Characteristics for ribavirin.
Pri uporabi zdravila Sovaldi v kombinaciji z ribavirinom ali s peginterferonom alfa/ribavirinom, morajo ženske v rodni dobi ali njihovi moški partnerji med zdravljenjem in še v obdobju po zaključku zdravljenja uporabljati učinkovito kontracepcijo, kot je priporočeno v povzetku glavnih značilnosti zdravila za ribavirin.
You should not breast-feed during treatment with Sovaldi.
Med zdravljenjem z zdravilom Sovaldi ne smete dojiti.
The intracellular metabolic activation pathway of sofosbuvir is mediated by generally low affinity and high capacity hydrolase and nucleotide phosphorylation pathways that are unlikely to be affected by concomitant medicinal products (see section 5.2).
Pri znotrajcelični poti presnovne aktivacije sofosbuvirja posredujeta poti hidrolaze in nukleotidne fosforilacije, ki imata običajno nizko afiniteto in veliko kapaciteto, pri katerih ni verjetno, da bi nanje vplivala sočasno uporabljena zdravila (glejte poglavje 5.2).
28 out of 40 (70%) patients achieved SVR12: 22/33 (73%) with HCV genotype 1 infection, 6/6 (100%) with HCV genotype 3 infection, and 0/1 (0%) with HCV genotype 4 infection.
28 od 40 (70 %) bolnikov je doseglo SVR12: 22/33 (73 %) bolnikov z okužbo s HCV genotipa 1, 6/6 (100 %) z okužbo s HCV genotipa 3 in 0/1
Monotherapy of Sovaldi is not recommended.
Monoterapija z zdravilom Sovaldi se ne priporoča.
No specific antidote is available for overdose with Sovaldi.
Specifični antidot za prevelik odmerek zdravila Sovaldi ni na voljo.
If you do miss a dose:
Če pozabite vzeti odmerek:
Your doctor will test your blood before, during and after your treatment with Sovaldi.
Vaš zdravnik bo pred zdravljenjem z zdravilom Sovaldi, med njim in po njem opravil krvne preiskave.
In biochemical assays, recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution showed reduced susceptibility to GS-461203 compared to respective wild-types.
V biokemičnem testu je rekombinantna polimeraza NS5B genotipov 1b, 2a, 3a in 4a z izraženo substitucijo S282T pokazala zmanjšano dovzetnost za GS-461203 v primerjavi z nemutiranimi tipi virusa.
Special patient populations
Posebne populacije bolnikov Starejši bolniki
Adults The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2).
Priporočeni odmerek je ena 400-miligramska tableta peroralno enkrat na dan s hrano (glejte poglavje 5.2).
NA = not available/not applicable a. Mean ratio (90% CI) of co-administered drug pharmacokinetics with/without sofosbuvir and mean ratio of sofosbuvir and GS-331007 with/without co-administered drug.
n/n = podatkov ni na voljo/navedba ni smiselna/potrebna a. Povprečno razmerje (90-odstotni IZ) farmakokinetike sočasno uporabljenih zdravil s sofosbuvirjem ali brez njega in povprečno razmerje sofosbuvirja in GS-331007 s sočasno uporabljenimi zdravili ali brez njih.
Table 5: Interactions between Sovaldi and other medicinal products
Preglednica 5: Interakcije med zdravilom Sovaldi in drugimi zdravili Zdravila po terapevtskih področjih
The ribavirin dose was weight-based at 1,000-1,200 mg daily administered in two divided doses, and the peginterferon alfa 2a dose, where applicable, was 180 μg per week.
1.000-1.200 mg na dan, uporabljen v dveh razdeljenih odmerkih, odmerek peginterferona alfa 2a pa je bil, kjer je bil uporabljen, 180 μg na teden.
Each film-coated tablet contains 400 mg of sofosbuvir.
Ena filmsko obložena tableta vsebuje 400 mg sofosbuvirja.
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Sofosbuvir je nukleotidno predzdravilo, ki se znotraj celice presnavlja in tvori farmakološko aktivni uridinski analog trifosfat (GS-461203), ki ga polimeraza NS5B lahko vgradi v RNA HCV, in deluje kot terminator verige.
The S282T substitution in NS5B was detected in a single subject receiving Sovaldi monotherapy in a Phase 2 study.
Substitucijo S282T so v NS5B odkrili pri eni sami osebi, ki je prejemala monoterapijo z zdravilom Sovaldi v študiji 2. faze.
Recommendation concerning co-administration with Sovaldi
Priporočila glede sočasne uporabe z zdravilom Sovaldi
Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Zdravljenje z zdravilom Sovaldi mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi bolnikov s
Common alopecia, dry skin, pruritus alopecia, dry skin
zelo pogosti izpuščaj, pruritus pogosti alopecija, suha koža, pruritus alopecija, suha koža
Genotype 2 and 3 patients were either treatment-naïve or experienced, whereas genotype 1 patients were naïve to prior treatment.
Bolniki z genotipom 2 in 3 bodisi predhodno še niso bili zdravljenji ali pa so bili, medtem ko bolniki z genotipom 1 predhodno še niso bili zdravljeni.
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin (see section 4.4).
Pri vseh živalskih vrstah, izpostavljenih ribavirinu, so dokazali pomembne teratogene in/ali embriocidne okvare (glejte poglavje 4.4).
Hepatobiliary disorders: Very common blood bilirubin increased blood bilirubin increased
zelo pogosti povišana raven bilirubina v krvi povišana raven bilirubina v krvi
Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level (<6 log10 IU/mL versus ≥6 log10 IU/mL).
Bolniki so bili randomizirani v razmerju 1:1 in stratificirani glede na cirozo (prisotnost v primerjavi z odsotnostjo), genotip HCV (2 v primerjavi s 3) in raven RNA HCV ob izhodišču (< 6 log10 i.e./ml v primerjavi z ≥ 6 log10 i.e./ml).
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Sofosbuvir in GS-331007 nista zaviralca prenašalcev zdravil P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 in OCT1.
Dose modification in adolescents Dose reduction of Sovaldi is not recommended.
Prilagajanje odmerka pri mladostnikih Zmanjšanje odmerka zdravila Sovaldi se ne priporoča.
Monotherapy of Sovaldi is not recommended (see section 5.1).
Monoterapija z zdravilom Sovaldi se ne priporoča (glejte poglavje 5.1).
FUSION was a randomised, double-blinded study that evaluated 12 or 16 weeks of treatment with sofosbuvir and ribavirin in patients who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders).
Študija FUSION je bila randomizirana, dvojno slepa študija, v kateri so ocenili 12- ali 16-tedensko zdravljenje s sofosbuvirjem in ribavirinom pri bolnikih, ki niso dosegli SVR s predhodnim zdravljenjem na podlagi interferona (bolniki z relapsom ali neodzivni bolniki).
Emtricitabinef (200 mg once daily)d
Emtricitabinf (200 mg enkrat na dan)d
Patients were randomised in 3:1 ratio and stratified by cirrhosis (presence versus absence).
Bolniki so bili randomizirani v razmerju 3:1 in stratificirani glede na cirozo (prisotnost v primerjavi z odsotnostjo).
Treatment-experienced 90% (37/41) Non-cirrhotic
Predhodno nezdravljeni 97 % (31/32) Brez ciroze
Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to <18 years (see sections 4.2, 4.4 and 5.1).
(CHC-chronic hepatitis C) pri odraslih in mladostnikih, starih 12 do < 18 let (glejte poglavja 4.2, 4.4 in 5.1).
No drug-drug interaction data exists regarding the co-administration of Sovaldi with boceprevir or telaprevir.
Ni podatkov o interakcijah med zdravili, kar zadeva sočasno uporabo zdravila Sovaldi z boceprevirjem ali telaprevirjem.
When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Pri uporabi zdravila Sovaldi v kombinaciji z ribavirinom ali peginterferonom alfa/ribavirinom, je potrebna izjemna previdnost, da se prepreči nosečnost bolnic in partnerk bolnikov.
Dosed 1 hr After Dialysis Sofosbuvir 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 21-fold↑
Sofosbuvir 1,6-krat↑ 2,1-krat↑ 2,7-krat↑ 1,3-krat↑ 1,6-krat↑ ~2-krat↑ 1,9-krat↑ GS-331007 1,6-krat↑ 1,9-krat↑ 5,5-krat↑ ≥10-krat↑ ≥20-krat↑ ~7-krat↑ 21-krat ↑