FrancophonIA/ELRC3.0 huggingface dataset:
English: Cirrhosis n = number of patients with SVR12 response; N = total number of patients per group.
Slovenian: Brez ciroze Ciroza n = število bolnikov z odzivom SVR12; N = skupno število bolnikov v skupini.
English: Sofosbuvir and GS-331007 exposures in adolescents aged 12 to <18 years were similar to those in adults from Phase 2/3 studies following administration of sofosbuvir (400 mg).
Slovenian: Izpostavljenosti sofosbuvirju in GS-331007 pri mladostnikih, starih 12 do < 18 let, so bile podobne kot pri odraslih iz študij 2./3.
English: HCV genotype 3
Slovenian: HCV genotipa 3
English: HIV/HCV co-infection
Slovenian: Sočasna okužba z virusoma HIV in HCV
English: Patients with genotype 2 CHC
Slovenian: Bolniki z genotipom 2 CHC
English: Common abdominal discomfort, constipation, dyspepsia constipation, dry mouth, gastroesophageal reflux
Slovenian: dispepsija konstipacija, suha usta, gastroezofagealni refluks
English: Patients with HCV genotype 2 or 3 infection in the trial were treated with sofosbuvir with ribavirin for 12 or 24 weeks, respectively.
Slovenian: Bolniki z okužbo s HCV genotipa 2 ali 3 v preskušanju so bili zdravljeni s sofosbuvirjem in ribavirinom 12 oz. 24 tednov.
English: Common pyrexia, asthenia chest pain, asthenia a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
Slovenian: zelo pogosti utrujenost, razdražljivost mrzlica, utrujenost, gripi podobna bolezen, razdražljivost, bolečine, pireksija pogosti pireksija, astenija bolečine v prsih, astenija a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa
English: Treatment duration was 12 weeks in treatment-naïve patients with genotype 2 or 3 HCV infection, and 24 weeks in treatment-experienced patients with genotype 3 HCV infection, as well as patients with genotype 1 HCV infection.
Slovenian: Zdravljenje je trajalo 12 tednov pri predhodno nezdravljenih bolnikih z okužbo s HCV genotipa 2 ali 3 in 24 tednov pri predhodno zdravljenih bolnikih z okužbo s HCV genotipa 3 in bolnikih z okužbo s HCV genotipa 1.
English: Sovaldi has been studied in combination with ribavirin, with or without peginterferon alfa.
Slovenian: Zdravilo Sovaldi so proučili v kombinaciji z ribavirinom, s peginterferonom alfa ali brez njega.
English: If the other medicinal products used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued (see section 4.2).
Slovenian: Ob trajni ukinitvi drugih zdravil, ki se uporabljajo v kombinaciji z zdravilom Sovaldi, je treba ukiniti tudi uporabo zdravila Sovaldi (glejte poglavje 4.4).
English: Based on population pharmacokinetic analysis in patients with genotypes 1 to 6 HCV infection (n = 986), steady-state AUC0-24 for sofosbuvir and GS-331007 was 1,010 ng•h/mL and 7,200 ng•h/mL, respectively.
Slovenian: Na podlagi analize populacijske farmakokinetike pri bolnikih z okužbo s HCV genotipa 1 do 6 (n = 986) je bila vrednost AUC0-24 za sofosbuvir v stanju dinamičnega ravnovesja 1.010 ng•h/ml, za GS-331007 pa 7.200 ng•h/ml.
English: Patients should be informed that fatigue and disturbance in attention, dizziness and blurred vision have been reported during treatment with sofosbuvir in combination with peginterferon alfa and ribavirin (see section 4.8).
Slovenian: Bolnikom je treba povedati, da so med zdravljenjem s sofosbuvirjem v kombinaciji s peginterferonom alfa in ribavirinom poročali o utrujenosti in motnji pozornosti, omotičnosti in zamegljenem vidu (glejte poglavje 4.8).
English: Sovaldi + ribavirin a for 24 weeks
Slovenian: Sovaldi + ribavirin a 24 tednov
English: Sovaldi + ribavirin
Slovenian: Zdravilo Sovaldi + ribavirin
English: • stomach discomfort, constipation, dry mouth, indigestion, acid reflux
Slovenian: • nelagodje v trebuhu, zaprtost, suha usta, težave s prebavo, refluks kisline
English: Overall No cirrhosis Cirrhosis n = number of patients with SVR12 response; N = total number of patients per group.
Slovenian: Brez cirozec Cirozac n = število bolnikov z odzivom SVR12; N = skupno število bolnikov v skupini.
English: HCV genotype 2
Slovenian: HCV genotipa 2
English: The pharmacokinetics of sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n = 94) for 8, 12, or 24 weeks or sofosbuvir/velpatasvir (n = 59) for 12 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir and sofosbuvir/velpatasvir Phase 2/3 trials (see section 4.4).
Slovenian: Farmakokinetiko sofosbuvirja in GS-331007 so preučili pri bolnikih, okuženih s HCV, z ESRD, zaradi katere je potrebna dializa, zdravljenih z ledipasvirjem/sofosbuvirjem (n = 94) 8, 12 ali 24 tednov ali sofosbuvirjem/velpatasvirjem (n = 59) 12 tednov in primerjali z bolniki brez ledvične okvare v preskušanjih 2./3.
English: ANTIMYCOBACTERIALS Rifampicinf (600 mg single dose)
Slovenian: Rifampicinf (600 mg enkratni odmerek)
English: Table 6: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Slovenian: Preglednica 6: Neželeni učinki zdravila, identificirani pri sofosbuvirju v kombinaciji z ribavirinom ali s peginterferonom alfa in ribavirinom Pogostnost
English: Close monitoring is recommended if this medicinal product is administered with Sovaldi (see sections 4.4 and 4.8).
Slovenian: Kadar se to zdravilo uporablja sočasno z zdravilom Sovaldi, se priporoča skrbno spremljanje (glejte poglavji 4.4 in 4.8).
English: Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
Slovenian: UGT1A1 ali encimov CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in CYP2D6.
English: At baseline, two patients had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0-39.6).
Slovenian: Ob izhodišču sta imela dva bolnika cirozo, povprečni eGFR pa je bil 24,9 ml/min
English: Patients received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for patients weighing <75 kg or 1,200 mg for patients weighing ≥75 kg).
Slovenian: Bolniki so prejeli 400 mg sofosbuvirja in odmerek ribavirina na podlagi telesne mase (1.000 mg za bolnike s telesno maso < 75 kg ali 1.200 mg za bolnike s telesno maso ≥ 75 kg).
English: Table 1: Recommended co-administered medicinal product(s) and treatment duration for adults treated with Sovaldi combination therapy
Slovenian: Preglednica 1: Priporočeno(a) zdravilo(a), ki se daje(jo) sočasno, in trajanje zdravljenja za odrasle, zdravljene s kombinirano terapijo z zdravilom Sovaldi Populacija bolnikov* Zdravljenje
English: Drug interaction information for Sovaldi with potential concomitant medicinal products is summarised in Table 5 below (where 90% confidence interval (CI) of the geometric least-squares mean (GLSM)
Slovenian: Informacije o interakcijah med zdravili za zdravilo Sovaldi z možnimi sočasnimi zdravili so povzete v spodnji preglednici 5 (pri čemer je bil 90-odstotni interval zaupanja (IZ) razmerja geometričnega povprečja najmanjših kvadratov (GLSM-geometric least-squares mean) znotraj "↔", razširjenimi nad "↑" ali razširjenimi pod "↓" vnaprej določenih mej ekvivalentnosti).
English: Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Slovenian: V preglednici 13 so predstavljene stopnje odziva za skupine, zdravljene s sofosbuvirjem + ribavirinom za 12 tednov in 16 tednov.
English: The ribavirin doses used in the sofosbuvir + ribavirin and peginterferon alfa 2a + ribavirin arms were weight-based 1,000-1,200 mg/day and 800 mg/day regardless of weight, respectively.
Slovenian: Odmerki ribavirina, ki so jih uporabili v kraku sofosbuvir + ribavirin, so temeljili na telesni masi in so bili 1.000-1.200 mg/dan, v kraku peginterferon alfa 2a + ribavirin pa 800 mg/dan, neodvisno od telesne mase.
English: Table 15: Response rates in study VALENCE
Slovenian: Preglednica 15: Stopnje odziva v študiji VALENCE Genotip 2
English: The SVR rates for the 8, 12, and 24 week ledipasvir/sofosbuvir treatment groups were 93% (42/45), 100% (31/31), and 79% (15/19), respectively.
Slovenian: za skupine, zdravljene 8, 12 in 24 tednov z ledipasvirjem/sofosbuvirjem, so bile 93 % (42/45), 100 %
English: Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults and adolescents from the age of 12 years up to the age of 18 years.
Slovenian: Kaj je zdravilo Sovaldi in za kaj ga uporabljamo Zdravilo Sovaldi vsebuje učinkovino sofosbuvir, ki se daje za zdravljenje okužbe z virusom hepatitisa C pri odraslih in mladostnikih, starih 12 do 18 let.
English: Non-Black
Slovenian: Črna rasa Ne-črna rasa
English: No liver or heart findings were observed in chronic toxicity studies at exposures 9 times (rat) and 27 times (dog) higher than the clinical exposure.
Slovenian: V študijah kronične toksičnosti pri izpostavljenostih, ki so bile 9-krat (podgana) oz. 27-krat večje od klinične izpostavljenosti, ni bilo izsledkov na jetrih ali srcu.
English: Table 15 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Slovenian: V preglednici 15 so predstavljene stopnje odziva za skupine, zdravljene s sofosbuvirjem + ribavirinom za 12 tednov in 24 tednov.
English: Patients with genotype 3 CHC
Slovenian: Bolniki z genotipom 3 CHC
English: Patients with genotype 1, 4, 5 or 6 CHC
Slovenian: Bolniki s CHC genotipa 1, 4, 5 ali 6
English: Two NS5B substitutions, L159F and V321A, were detected in post-treatment relapse samples from multiple genotype 3 HCV infected patients in the Phase 3 clinical studies.
Slovenian: V kliničnih študijah 3. faze so odkrili dve substituciji NS5B, L159F in V321A, v vzorcih relapsa po zdravljenju več bolnikov, okuženih z virusom HCV genotipa 3.
English: Expected: ↓ Sofosbuvir ↔ GS-331007
Slovenian: ↓ sofosbuvir ↔ GS-331007
English: There are no data to support the co-administration of Sovaldi and telaprevir or boceprevir.
Slovenian: Podatkov, ki bi podprli sočasno uporabo zdravila Sovaldi s telaprevirjem ali boceprevirjem, ni.
English: • changes in your liver (as shown by increased amounts of a substance called bilirubin in the blood)
Slovenian: • spremembe na jetrih (kar kaže povečanje snovi, imenovane bilirubin, v krvi) Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin and St. John's wort).
Slovenian: Zdravila, ki so močni induktorji P-glikoproteina (P-gp) v črevesju (karbamazepin, fenobarbital,
English: If the starting dose of ribavirin is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (1,000 mg for patients weighing <75 kg and 1,200 mg for patients weighing ≥75 kg).
Slovenian: Če bolnik začetni odmerek ribavirina dobro prenaša, se lahko odmerek titrira na največ 1.000 do 1.200 mg na dan (1.000 mg za bolnike s telesno maso < 75 kg in 1.200 mg za bolnike s telesno maso ≥ 75 kg).
English: An interim analysis was conducted on 61 patients who received sofosbuvir and ribavirin; the majority of patients had HCV genotype 1, 44 patients were CPT class A and 17 patients were CPT class B. Of these 61 patients, 44 patients underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA <LLOQ at the time of transplantation.
Slovenian: Vmesno analizo so opravili pri 61 bolnikih, ki so prejeli sofosbuvir in ribavirin; večina bolnikov je imela HCV genotipa 1, 44 bolnikov je imelo stopnjo A po CPT in 17 bolnikov je imelo stopnjo B po CPT.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sovaldi when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Slovenian: Primeri so lahko smrtno nevarni, zato se lahko amiodaron pri bolnikih, ki prejemajo zdravilo Sovaldi, uporablja samo,
English: Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Slovenian: • Druge sestavine zdravila so Jedro tablete: manitol, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvodni koloidni silicijev dioksid, magnezijev stearat.
English: Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo.
Slovenian: preglednici 11 so predstavljene stopnje odziva za skupine, zdravljenje s sofosbuvirjem + ribavirinom in za placebo.
English: • low red blood cell count (anaemia); the signs may include feeling tired, headaches, shortness of breath when exercising
Slovenian: Krvne preiskave lahko pokažejo tudi: • nizko število rdečih krvnih celic (anemija); znaki lahko vključujejo občutek utrujenosti,
English: Table 12 presents the subgroup analysis by genotype for cirrhosis and interferon classification.
Slovenian: V preglednici 12 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in razvrstitev glede na interferon.
English: HCV ANITIVIRAL AGENTS: HCV PROTEASE INHIBITORS Boceprevir (BOC)
Slovenian: PROTIVIRUSNE UČINKOVINE PROTI HCV: ZAVIRALCI PROTEAZNE HCV
English: Study 4063 was an open-label study that evaluated a fixed dose combination of sofosbuvir and ledipasvir in 95 patients with HCV-infection and ESRD requiring dialysis.
Slovenian: Študija 4063 je bila odprta študija, v kateri so ocenili kombinacijo s fiksim odmerkom sofosbuvirja in ledipasvirja pri 95 bolnikih z okužbo s HCV in ESRD, zaradi katere je potrebna dializa.
English: Table 3: Recommended treatment regimen and durations for adolescents aged 12 to < 18 years treated with Sovaldi
Slovenian: Preglednica 3: Priporočeni režim in trajanje zdravljenja z zdravilom Sovaldi za mladostnike, stare od 12 do < 18 let
English: HCV infected patients, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria received 400 mg sofosbuvir and 1,000-1,200 mg ribavirin daily for a maximum of 24 weeks, subsequently amended to 48 weeks, or until the time of liver transplantation, whichever occurred first.
Slovenian: Bolniki, okuženi s HCV, neodvisno od genotipa, s hepatoceličnim karcinomom (HCC-hepatocellular carcinoma), ki so izpolnjevali kriterije po lestvici MILAN, so prejemali 400 mg sofosbuvirja in 1.000-1.200 mg ribavirina na dan za največ 24 tednov,
English: Otherb a. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
Slovenian: Drugob a. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
English: In HCV replicon assays, the effective concentration (EC50) values of sofosbuvir against full-length replicons from genotype 1a, 1b, 2a, 3a and 4a were 0.04, 0.11, 0.05, 0.05 and 0.04 μM, respectively, and EC50 values of sofosbuvir against chimeric 1b replicons encoding NS5B from genotype 2b, 5a or 6a were 0.014 to 0.015 μM.
Slovenian: V replikonskem sistemu HCV so bile vrednosti učinkovite koncentracije (EC50) sofosbuvirja proti replikonom polne dolžine genotipa 1a, 1b, 2a, 3a in 4a kot sledi: 0,04, 0,11, 0,05, 0,05 oz. 0,04 μM;
English: Adolescents (12 to 18 years of age) The recommended dose of Sovaldi is one tablet once daily with food (see section 5.2).
Slovenian: Priporočeni odmerek zdravila Sovaldi je ena tableta enkrat na dan s hrano (glejte poglavje 5.2).
English: Table 7 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin.
Slovenian: V preglednici 7 so predstavljene stopnje odziva za skupino, zdravljeno s sofosbuvirjem + peginterferonom alfa + ribavirinom.
English: ↔ GS-331007 (Induction of P-gp)
Slovenian: ↓ Sofosbuvir ↔ GS-331007 (indukcija P-gp)
English: Refer to the ribavirin prescribing information for guidance on dose modification or discontinuation.
Slovenian: Za smernice glede prilagajanja odmerka ali ukinitev glejte navodila za predpisovanje ribavirina.
English: Sovaldi + ribavirin Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
Slovenian: Uporablja se samo za bolnike, ki za zdravljenje peginterferonom alfa niso primerni ali ga ne prenašajo (glejte poglavje 4.4)
English: Mean ratio (90% confidence interval) for
Slovenian: Povprečno razmerje (90odstotni interval zaupanja) za AUC, Cmax,
English: Table 18: SVR12 rates for selected subgroups by genotype in study PHOTON-1
Slovenian: Preglednica 18: Stopnje SVR12 za izbrane podskupine po genotipu v študiji PHOTON-1
English: No dose adjustment of Sovaldi is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Slovenian: Pri bolnikih z blago, zmerno ali hudo jetrno okvaro (stopnja A, B ali C po Child-Pugh-Turcotteu [CPT]) odmerka zdravila Sovaldi ni treba prilagajati (glejte poglavje 5.2).
English: Sovaldi 400 mg film-coated tablets
Slovenian: IME ZDRAVILA Sovaldi 400 mg filmsko obložene tablete
English: Tenofovir disoproxilf (245 mg once daily)d
Slovenian: Dizoproksiltenofoviratf (245 mg enkrat na dan)d
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Sovaldi.
Slovenian: Po začetku jemanja zdravila Sovaldi morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
English: (n = 327)
Slovenian: 12 tednov (n = 327)
English: Table 2: Ribavirin dose modification guideline for co-administration with Sovaldi in adults
Slovenian: Preglednica 2: Smernice za prilagajanje odmerka ribavirina pri sočasnem dajanju z zdravilom Sovaldi pri odraslih
English: How to store Sovaldi
Slovenian: Shranjevanje zdravila Sovaldi
English: Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Slovenian: Defosforilacija povzroči nastanek nukleozidnega presnovka GS-331007, ki ga ni mogoče učinkovito ponovno refosforilati in ki in vitro ni aktiven proti HCV. Sofosbuvir in GS-331007 nista substrata ali zaviralca
English: Sofosbuvir is not a substrate for hepatic uptake transporters, organic anion-transporting polypeptide (OATP) 1B1 or 1B3, and organic cation transporter (OCT) 1.
Slovenian: (OATP-organic anion-transporting polypeptide) 1B1 ali 1B3 in prenašalca organskih kationov (OCT
English: Study 4062 was an open-label study that evaluated a fixed dose combination of sofosbuvir and velpatasvir in 59 HCV-infected patients with ESRD requiring dialysis.
Slovenian: Študija 4062 je bila odprta študija, v kateri so ocenili kombinacijo s fiksim odmerkom sofosbuvirja in ledipasvirja pri 59 bolnikih z okužbo s HCV in ESRD, zaradi katere je potrebna dializa.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Sovaldi.
Slovenian: Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Sovaldi,
English: Such co-administration is not recommended (see also section 4.5).
Slovenian: Taka sočasna uporaba ni priporočljiva (glejte poglavje 4.5).
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir .
Slovenian: Med kliničnim razvojem sofosbuvirja je bila sočasna uporaba amiodarona omejena.
English: No effects on foetal development have been observed in rats and rabbits at the highest doses tested.
Slovenian: Pri najvišjih testiranih odmerkih pri podganah in kuncih niso opazili učinkov na razvoj ploda.
English: Interferon intolerant, ineligible or unwilling adults - POSITRON (study 107) POSITRON was a randomised, double-blinded, placebo-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared to placebo (n = 71) in patients who are interferon intolerant, ineligible or unwilling.
Slovenian: Odrasli, ki niso prenašali interferona, niso bili primerni ali voljni - POSITRON (študija 107) Študija POSITRON je bila randomizirana, dvojno slepa, s placebom kontrolirana študija, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem in ribavirinom (n = 207) v primerjavi s placebom
English: Sovaldi in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
Slovenian: Pri prejemnikih presajenih jeter se priporoča 24-tedenska uporaba zdravila Sovaldi v kombinaciji z ribavirinom.
English: • diarrhoea, feeling sick (nausea), being sick (vomiting)
Slovenian: • driska, siljenje na bruhanje (navzea), bruhanje
English: Sovaldi + ribavirina for 12 weeks b
Slovenian: Sovaldi + ribavirina 12 tednovb
English: No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in norgestimata/etinilestradiola odmerka norgestimata/etinilestradiola ni treba prilagajati.
English: Refer to the peginterferon alfa Summary of Product Characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose.
Slovenian: Za dodatne informacije o zmanjšanju in/ali ukinitvi odmerka peginterferona alfa glejte povzetek glavnih značilnosti zdravila za peginterferon alfa.
English: Hepatic impairment
Slovenian: Predhodno nezdravljeni
English: After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively.
Slovenian: Po enkratnem 400-miligramskem peroralnem odmerku [14C]-sofosbuvirja je sofosbuvir prispeval približno 4 % sistemske izpostavljenosti z zdravilom povezanega materiala (vsota vrednosti AUC
English: Table 16 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
Slovenian: V preglednici 16 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in izpostavljenost predhodnemu zdravljenju HCV.
English: ≥2 g/dL decrease in haemoglobin during any 4 week treatment period
Slovenian: Hemoglobin pri bolnikih s stabilno boleznijo srca v anamnezi zmanjšanje hemoglobina za ≥ 2 g/dl v 4-tedenskem obdobju zdravljenja
English: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
Slovenian: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC) ↔ GS-331007 (TPV ali
English: • fever, chills, flu-like symptoms
Slovenian: • povečana telesna temperatura, mrzlica, gripi podobni simptomi
English: The safety profile of sofosbuvir and ribavirin in liver transplant adult recipients with chronic hepatitis C was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Slovenian: Profil varnosti sofosbuvirja in ribavirina pri odraslih prejemnikih presajenih jeter s kroničnim hepatitisom C je bil podoben tistemu, ki so ga opazili pri bolnikih, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
English: What Sovaldi is and what it is used for What you need to know before you take Sovaldi How to take Sovaldi
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Sovaldi Kako jemati zdravilo Sovaldi
English: Sovaldi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Slovenian: Zdravilo Sovaldi je kontraindicirano v kombinaciji s fenobarbitalom in fenitoinom (glejte poglavje 4.3).
English: In addition, S282R and L320F substitutions were detected on treatment by deep sequencing in a pre-transplant subject with a partial treatment response.
Slovenian: S podatki karakterizacije strukture genoma med zdravljenjem so pri osebah pred presaditvijo z delnim odzivom na zdravljenje odkrili tudi substituciji S282R in L320F.
English: Table 14 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.
Slovenian: V preglednici 14 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in odziv na predhodno zdravljenje HCV.
English: IMMUNOSUPPRESSANTS Ciclosporine (600 mg single dose)
Slovenian: Ciklosporine (600 mg enkratni odmerek)