FrancophonIA/ELRC3.0 huggingface dataset:
English: • and you notice 18 hours or more after the time you usually take Sovaldi, wait and take the next dose at your usual time.
Slovenian: • in se tega spomnite več kot 18 ur od takrat, ko običajno vzamete zdravilo Sovaldi, počakajte in vzemite naslednji odmerek ob običajnem času.
English: In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 patients) experiencing a decline in haemoglobin to <10 g/dL, 1 of whom also had a decline to <8.5 g/dL.
Slovenian: V študiji 0126 so bila med zdravljenjem zelo pogosta zmanjšanja hemoglobina, pri čemer je prišlo pri 32,5 % (13/40 bolnikov) do zmanjšanja hemoglobina na < 10 g/dl, pri 1 osebi celo do zmanjšanja na < 8,5 g/dl.
English: Baseline NS5B sequences were obtained for 47 patients in the Phase 2 study.
Slovenian: Izhodiščna zaporedja NS5B so pridobili za 47 bolnikov iz študije 2. faze.
English: Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with Sovaldi.
Slovenian: Glejte tudi povzetek glavnih značilnosti zdravila za zdravila, ki se uporabljajo v kombinaciji z zdravilom Sovaldi.
English: Afterwards, close monitoring and potential dose adjustment of ciclosporin may be required.
Slovenian: Morda bo kasneje potrebno skrbno spremljanje in morebitna prilagoditev odmerka ciklosporina.
English: In an analysis evaluating the effect of baseline polymorphisms on treatment outcome, no statistically significant association was observed between the presence of any HCV NS5B variant at baseline and treatment outcome.
Slovenian: V analizi, s katero so ocenjevali učinek izhodiščnega polimorfizma na izid zdravljenja, niso opazili pomembne povezave med prisotnostjo katere koli od različic proteaze NS5B v virusu HCV ob izhodišču in izidom zdravljenja.
English: However, based on emerging data, the study was unblinded and all HCV genotype 2 patients continued to receive sofosbuvir and ribavirin for 12 weeks, whilst treatment for HCV genotype 3 patients was extended to 24 weeks.
Slovenian: Vendar pa je bila študija na podlagi nastalih podatkov razkrita in vsi bolniki s HCV genotipa 2 so še naprej 12 tednov prejemali sofosbuvir in ribavirin, medtem ko se je zdravljenje za bolnike s HCV genotipa 3 podaljšalo na 24 tednov.
English: Sofosbuvir is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) while GS-331007 is not.
Slovenian: Sofosbuvir je substrat prenašalca P-gp in proteina rezistence pri raku dojke (BCRP-breast cancer resistance protein), GS-331007 pa ni.
English: - a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Slovenian: - široko razširjen hud izpuščaj z luščenjem kože, ki ga lahko spremljajo zvišana telesna temperatura, gripi podobni simptomi ter mehurji v ustih, očeh in/ali po spolovilu
English: The virologic response rates of the 41 patients transplanted with HCV RNA <LLOQ is described in Table 19.
Slovenian: Stopnje virološkega odziva za prvih 41 bolnikov s presaditvijo, z RNA HCV < LLOQ, so navedene v preglednici 19.
English: When you take Sovaldi in combination with amiodarone (a medicine used for heart problems), you may get one or more of the side effects below:
Slovenian: Ko vzamete zdravilo Sovaldi v kombinaciji z amiodaronom (zdravilo za zdravljenje težav s srcem), se lahko pojavi en ali več neželenih učinkov, navedenih spodaj:
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Slovenian: Pot presnovne aktivacije vključuje sekvenčno hidrolizo karboksil-esternega dela, ki jo katalizira humani katepsin A (CatA) ali karboksilesteraza 1 (CES1) in cepitev fosforamidata z nukleotid-vezajočo beljakovino s histidinsko triado 1 (HINT1-histidine triad nucleotide-binding protein 1), čemur sledi fosforilacija po biosintezni poti pirimidinskih nukleotidov.
English: • Sovaldi is commonly used together with ribavirin.
Slovenian: • Zdravilo Sovaldi se pogosto uporablja skupaj z ribavirinom.
English: The adverse reactions observed were consistent with those observed in clinical studies of Sovaldi plus ribavirin in adults (see Table 6).
Slovenian: Neželeni učinki, ki so jih opazili, so bili skladni s tistimi, ki so jih opazili v kliničnih študijah zdravila Sovaldi z ribavirinom pri odraslih (glejte preglednico 6).
English: • Peginterferon alfa and ribavirin
Slovenian: • s peginterferonom alfa in ribavirinom
English: GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Slovenian: GS-461203 (aktivni presnovek sofosbuvirja) ni zaviralec DNA in RNA polimeraz pri človeku in ne zavira mitohondrijske
English: Rilpivirinef (25 mg once daily)
Slovenian: Rilpivirinf (25 mg enkrat na dan)
English: Co-administration will significantly decrease sofosbuvir plasma concentration and could result in loss of efficacy of Sovaldi (see section 4.5).
Slovenian: Sočasna uporaba bo močno zmanjšala koncentracije sofosbuvirja v plazmi in lahko povzroči izgubo učinkovitosti zdravila Sovaldi (glejte poglavje 4.5).
English: The film-coated tablet should not be chewed or crushed, due to the bitter taste of the active substance.
Slovenian: Filmsko obložene tablete naj ne žvečijo in ne drobijo, saj ima učinkovina grenak okus.
English: It is formed through sequential and parallel pathways to the formation of active metabolite.
Slovenian: Nastaja zaporedno in vzporedno z nastajanjem aktivnega presnovka.
English: It is unknown whether sofosbuvir and its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se sofosbuvir in njegovi presnovki izločajo v materino mleko.
English: • hair loss and thinning hair
Slovenian: • izpadanje las in tanjšanje las
English: • muscle aches and pains, pain in the joints
Slovenian: • skeleče in boleče mišice, bolečine v sklepih
English: Patients with CHC awaiting liver transplantation
Slovenian: Bolniki s CHC, ki čakajo na presaditev jeter
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Sovaldi.
Slovenian: Zdravnik bo morda moral skrbno spremljati zdravljenje z drugimi zdravili, ki jih jemljete, in po uvedbi zdravila Sovaldi prilagoditi njihov odmerek.
English: Sofosbuvir was fully active against substitutions associated with resistance to other direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors, NS3 protease inhibitors and NS5A inhibitors.
Slovenian: Sofosbuvir je bil povsem aktiven pri substitucijah, povezanih z odpornostjo na druga zdravila z direktnim delovanjem na viruse z različnimi mehanizmi delovanja, kot so nenukleozidni zaviralci NS5B, zaviralci proteaze NS3 in zaviralci NS5A.
English: As a precautionary measure, it is preferable to avoid the use of Sovaldi during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Sovaldi bolje izogibati.
English: In the ELECTRON study (N = 11), the duration of peginterferon alfa ranged from 4-12 weeks in combination with sofosbuvir + ribavirin.
Slovenian: V študiji ELECTRON (N = 11) je bil razpon trajanja zdravljenja s peginterferonom alfa 4-12 tednov v kombinaciji s sofosbuvirjem + ribavirinom.
English: Duration of viral suppression prior to transplantation was the most predictive factor for pTVR in those who were HCV RNA <LLOQ at the time of transplantation.
Slovenian: Trajanje virusne supresije pred presaditvijo je bilo dejavnik, ki je najbolje napovedal pTVR pri osebah z RNA HCV < LLOQ ob času presaditve.
English: Sovaldi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Slovenian: Sovaldi se lahko pri teh bolnikih uporablja brez prilagajanja odmerka, ko druge ustrezne možnosti zdravljenja niso na voljo (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
English: When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) <50 mL/min (see also section 5.2).
Slovenian: Pri uporabi zdravila Sovaldi v kombinaciji z ribavirinom ali s peginterferonom alfa/ribavirinom, glejte tudi povzetek glavnih značilnosti zdravila za ribavirin za bolnike z očistkom kreatinina (CrCl) < 50 ml/min (glejte tudi poglavje 5.2).
English: Interferon classification Ineligible
Slovenian: Razvrstitev glede na interferon Neprimerni
English: In this setting, exposure of sofosbuvir metabolite GS-331007 is 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials.
Slovenian: V teh pogojih se je izpostavljenost presnovku sofosbuvirja GS-331007 povečala za 20-krat, kar je preseglo ravni, pri katerih so v predkliničnih preskušanjih opazili neželene učinke.
English: On-treatment virologic failure 0/207 Relapsea
Slovenian: Virološki neuspeh med zdravljenjem 0/207
English: (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
Slovenian: Vrednosti AUC za Sofosbuvir in GS-331007 sta skoraj sorazmerni z odmerkom v razponu odmerka od 200 mg do 400 mg.
English: If you vomit more than 2 hours after taking it you do not need to take another tablet until your next regularly scheduled tablet.
Slovenian: Če bruhate več kot 2 uri po uporabi zdravila, ne vzemite še ene tablete do naslednje načrtovane tablete.
English: Yellow, capsule-shaped, film-coated tablet of dimensions 20 mm x 9 mm, debossed on one side with “GSI” and “7977” on the other side.
Slovenian: Rumene filmsko obložene tablete v obliki kapsule z merami 20 mm x 9 mm, z vtisnjeno oznako »GSI« na eni in »7977« na drugi strani.
English: Sovaldi is always taken with other medicines to treat hepatitis C. It will not work on its own.
Slovenian: Zdravilo Sovaldi se vedno jemlje z drugimi zdravili za zdravljenje hepatitisa C. Zdravilo ne deluje samo po sebi.
English: The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Slovenian: Na farmakokinetiko zdravil, ki se presnavljajo v jetrih (npr. imunosupresivi, kot so zaviralci kalcinevrina), lahko vplivajo spremembe delovanja jeter med zdravljenjem z DAA, ki so povezane z odstranitvijo virusa HCV.
English: The safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir in 18 genotype 1 HCV-infected patients with severe renal impairment not requiring dialysis was also studied in Study 0154.
Slovenian: Varnost in učinkovitost 12-tedenskega zdravljenja z ledipasvirjem/sofosbuvirjem pri 18 bolnikih, okuženih s HCV genotipa 1, s hudo okvaro ledvic, zaradi katere ni potrebna dializa, so preučili tudi v študiji 0154.
English: This subject harboured <1% HCV S282T at baseline and developed S282T (>99%) at 4 weeks post-treatment which resulted in a 13.5-fold change in sofosbuvir EC50 and reduced viral replication capacity.
Slovenian: HCV S282T in je razvila S282T (> 99 %) 4 tedne po zdravljenju, kar je povzročilo 13,5-kratno spremembo EC50 za sofosbuvir in zmanjšalo replikacijsko sposobnost virusa.
English: Therefore, Sovaldi should not be used during breast-feeding.
Slovenian: Zato se zdravila Sovaldi med dojenjem ne sme uporabljati.
English: In clinical pharmacology studies, both sofosbuvir and GS-331007 were monitored for purposes of pharmacokinetic analyses.
Slovenian: V kliničnih farmakoloških študijah so sofosbuvir in GS-331007 spremljali zaradi farmakokinetičnih analiz.
English: After oral administration of Sovaldi, sofosbuvir is rapidly absorbed and subject to extensive first-pass hepatic and intestinal metabolism.
Slovenian: Po peroralni uporabi zdravila Sovaldi se sofosbuvir hitro absorbira in obsežno presnovi pri prvem prehodu skozi jetra in črevesje.
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol
Slovenian: PERORALNI KONTRACEPTIVI Norgestimat/etinilestradiol
English: Co-administration of Sovaldi with medicinal products that inhibit P-gp and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma concentration, thus Sovaldi may be co-administered with P-gp and/or BCRP inhibitors.
Slovenian: Sočasno dajanje zdravila Sovaldi z zdravili, ki zavirajo P-gp in/ali BCRP, lahko poveča koncentracijo sofosbuvirja v plazmi brez povečanja koncentracije GS-331007 v plazmi, zato se lahko zdravilo Sovaldi daje sočasno z zaviralci P-gp in/ali BCRP.
English: Do not stop taking Sovaldi
Slovenian: Ne prenehajte jemati zdravila Sovaldi
English: GS-331007 is not an inhibitor of OAT1, OCT2, and MATE1.
Slovenian: GS-331007 ni zaviralec OAT1, OCT2 in MATE1.
English: It is not known whether sofosbuvir, the active substance of Sovaldi, passes into human breast milk.
Slovenian: Ni znano, ali sofosbuvir, učinkovina v zdravilu Sovaldi, prehaja v materino mleko.
English: No patient experienced on-treatment virologic failure or relapse.
Slovenian: Noben od bolnikov ni imel virološkega neuspeha ali ponovitve med zdravljenjem.
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Sovaldi.
Slovenian: Kadar se presodi, da je sočasna uporaba amiodarona potrebna, se ob uvajanju zdravljenja z zdravilom Sovaldi priporoča skrbno spremljanje bolnikov.
English: Genotype 2 (n = 109)
Slovenian: Genotip 2 (n = 109)
English: No clinically relevant pharmacokinetic differences due to gender or race have been identified for sofosbuvir and GS-331007.
Slovenian: Klinično pomembnih farmakokinetičnih razlik zaradi spola ali rase za sofosbuvir in GS-331007 niso ugotovili.
English: Consult the Summary of Product Characteristics for co-prescribed medicinal products before starting therapy with Sovaldi.
Slovenian: Glejte povzetek glavnih značilnosti zdravila za sočasno predpisovanje zdravil, preden začnete s terapijo z zdravilom Sovaldi.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The safety and efficacy of Sovaldi in children and adolescents aged <12 years have not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Sovaldi pri otrocih in mladostnikih, starih < 12 let, še nista bili dokazani.
English: Table 24: Effect of varying degrees of renal impairment on exposures (AUC) of sofosbuvir and GS-331007 compared to subjects with normal renal function
Slovenian: Preglednica 24: Učinek različnih stopenj ledvične okvare na izpostavljenosti (AUC) sofosbuvirju in GS-331007 v primerjavi z osebami z normalnim delovanjem ledvic
English: Genotype 3 (n = 98)
Slovenian: Genotip 3 (n = 98)
English: Sovaldi should be used in combination with other medicinal products.
Slovenian: Zdravilo Sovaldi je treba uporabljati v kombinaciji z drugimi zdravili.
English: The dose linearity of sofosbuvir and its primary metabolite, GS-331007, was evaluated in fasted healthy subjects.
Slovenian: Linearnost odmerka sofosbuvirja in njegovega primarnega presnovka, GS-331007, so ocenili pri zdravih teščih osebah.
English: 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).
Slovenian: 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).
English: HCV/HBV (hepatitis B virus) co-infection
Slovenian: Sočasna okužba z virusoma HCV in HBV (virus hepatitisa B)
English: Treatment-experienced (LONESTAR-2b)
Slovenian: (LONESTAR-2b)
English: Concerning co-administration with other direct-acting antivirals against HCV, see section 4.4.
Slovenian: Za sočasno dajanje z drugimi zdravili proti HCV z direktnim delovanjem na viruse glejte poglavje 4.4.
English: Patients had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic HCV infection pre-transplantation.
Slovenian: Bolniki so imeli pri presejanju HCV RNA ≥ 104 i.e./ml in dokumentirano dokazano kronično okužbo s HCV pred presaditvijo.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice.
Slovenian: 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.
English: 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.
Slovenian: GS-331007, ki predstavlja več kot 90 % sistemske izpostavljenosti, povezane z zdravilom, nastaja zaporedno in vzporedno z nastajanjem aktivnega presnovka.
English: Talk to your doctor or pharmacist before taking this medicine if you:
Slovenian: Pred začetkom jemanja tega zdravila se posvetujte z zdravnikom ali farmacevtom, če:
English: 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).
Slovenian: 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).
English: When taking Sovaldi together with other medicines for the treatment of hepatitis C infection, patients have reported tiredness, dizziness, blurred vision and reduced attention.
Slovenian: 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.
English: Patients awaiting liver transplantation
Slovenian: Bolniki, ki čakajo na presaditev jeter
English: 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).
Slovenian: Vendar obstajajo pri sočasni uporabi ribavirina s sofosbuvirjem kontraindikacije za uporabo ribavirina med nosečnostjo (glejte tudi povzetek glavnih značilnosti zdravila za ribavirin).
English: • Rifapentine (a medicine used to treat infections, including tuberculosis);
Slovenian: • rifapentin (zdravilo za zdravljenje okužb, vključno s tuberkulozo).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: What Sovaldi looks like and contents of the pack
Slovenian: Izgled zdravila Sovaldi in vsebina pakiranja
English: Patients should be instructed that if vomiting occurs within 2 hours of dosing an additional tablet should be taken.
Slovenian: Bolnikom je treba naročiti, naj vzamejo dodatno tableto, če bruhajo v 2 urah po odmerjanju.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • trouble sleeping (insomnia)
Slovenian: • nespečnost (insomnija)
English: The pharmacokinetics of sofosbuvir and GS-331007 have not been established in paediatric patients < 12 years of age.
Slovenian: Farmakokinetike sofosbuvirja in GS-331007 pri pediatričnih bolnikih < 12 let starosti niso ugotavljali.
English: 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.
Slovenian: 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.
English: Sovaldi + ribavirin + peginterferon alfa
Slovenian: Zdravilo Sovaldi + ribavirin + peginterferon alfa
English: A 4-hour haemodialysis session removed 18% of the administered dose.
Slovenian: S 4-urno hemodializo se je izločilo približno 18 % uporabljenega odmerka.
English: ANTICONVULSANTS Phenobarbital Phenytoin
Slovenian: Fenobarbital Fenitoin
English: A starting ribavirin dose of 400 mg administered orally in two divided doses with food is recommended.
Slovenian: Priporoča se dajanje začetnega odmerka ribavirina 400 mg peroralno v dveh razdeljenih odmerkih s hrano.