FrancophonIA/ELRC3.0 huggingface dataset:
English: Common abdominal discomfort, constipation, dyspepsia constipation, dry mouth, gastroesophageal reflux
Slovenian: Bolezni prebavil: zelo pogosti navzea driska, navzea, bruhanje pogosti nelagodje v trebuhu, konstipacija, dispepsija konstipacija, suha usta, gastroezofagealni refluks
English: FUSION was a randomised, double-blinded study that evaluated 12 or 16 weeks of treatment with sofosbuvir and ribavirin in subjects who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders).
Slovenian: Predhodno zdravljeni odrasli - študija FUSION (študija 108) Študija FUSION je bila randomizirana, dvojno slepa študija, v kateri so ocenili 12- ali 16-tedensko zdravljenje s sofosbuvirjem in ribavirinom pri osebah, ki niso dosegle SVR s predhodnim zdravljenjem na podlagi interferona (osebe z relapsom ali neodzivne osebe).
English: Table 14 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
Slovenian: V preglednici 14 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in izpostavljenost predhodnemu zdravljenju HCV.
English: Table 16 presents the subgroup analysis by genotype for cirrhosis.
Slovenian: V preglednici 16 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo.
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30) Cmin (NA)
Slovenian: Sofosbuvir ↑ Cmax 2,54 (1,87; 3,45)
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
English: Cardiac arrhythmias
Slovenian: Bolezni živčevja:
English: Sovaldi in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
Slovenian: Prejemniki presajenih jeter Pri prejemnikih presajenih jeter se priporoča 24-tedenska uporaba zdravila Sovaldi v kombinaciji z ribavirinom.
English: Clinical studies in subjects with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231)
Slovenian: Klinične študije pri osebah s kroničnim hepatitisom C genotipa 2 in 3
English: Table 21: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Slovenian: Preglednica 21: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipov 4, 5 in 6
English: Table 9: Response rates in study POSITRON SOF+RBV
Slovenian: Preglednica 9: Stopnje odziva v študiji POSITRON SOF+RBV
English: The sofosbuvir-associated resistance substitution S282T was not detected in any of these subjects by deep sequencing or population sequencing.
Slovenian: Substitucije S282T, povezane z odpornostjo na sofosbuvir, s karakterizacijo strukture genoma ali karakterizacijo nukleotidnih sledi genoma niso odkrili pri nobeni od teh oseb.
English: No dose adjustment of sofosbuvir or tenofovir disoproxil fumarate is required when sofosbuvir and tenofovir disoproxil fumarate are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in dizoproksiltenofovirat fumarata odmerka sofosbuvirja ali dizoproksiltenofovirat fumarata ni treba prilagajati.
English: • dry skin
Slovenian: • izpuščaj, srbeča koža
English: Overall SVR12 Genotype 2 Genotype 3 Outcome for subjects without SVR12 On-treatment virologic failure 0/103 Relapse b
Slovenian: Izid za osebe brez SVR12 Virološki neuspeh med zdravljenjem Relaps a
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Darunavir boosted with ritonavirf
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI PROTEAZE HIV Z ritonavirjem okrepljeni darunavirf (800/100 mg enkrat na dan)
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 s očistkom kreatinina
English: Clinical studies in subjects with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve subjects - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 1, 4, 5 or 6 HCV infection.
Slovenian: Osebe, ki se predhodno še niso zdravile - NEUTRINO (študija 110) Študija NEUTRINO je bila odprta študija z enim krakom, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem v kombinaciji s peginterferonom alfa 2a in ribavirinom pri zdravljenju bolnikov z okužbo s HCV genotipa 1, 4, 5 ali 6, ki se predhodno še niso zdravili.
English: Sofosbuvir retained activity against the NS5B substitutions L159F and L320F associated with resistance to other nucleoside inhibitors.
Slovenian: Navzkrižna odpornost Replikoni HCV z izraženo substitucijo S282T, povezano z odpornostjo na sofosbuvir, so bili v celoti dovzetni za druge razrede učinkovin proti HCV. Sofosbuvir je ohranil aktivnost proti substitucijama NS5B L159F in L320F, povezanima z odpornostjo na druge nukleozidne zaviralce.
English: Table 7: Response rates in study FISSION SOF+RBV
Slovenian: Preglednica 7: Stopnje odziva v študiji FISSION SOF+RBV
English: Sovaldi is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3).
Slovenian: Zdravilo Sovaldi je kontraindicirano v kombinaciji s karbamazepinom, fenobarbitalom in fenitoinom, ki so močni induktorji P-gp v črevesju (glejte poglavje 4.3).
English: GS-331007 ↓ Cmax 0.77 (0.70, 0.84) ↔ AUC 0.84 (0.76,
Slovenian: GS-331007 ↓ Cmax 0,77 (0,70; 0,84)
English: Česká republika Gilead Sciences s.r.o.
Slovenian: Gilead Sciences s.r.o.
English: NAME OF THE MEDICINAL PRODUCT Sovaldi 400 mg film-coated tablets sofosbuvir
Slovenian: Navodilo za uporabo Sovaldi 400 mg filmsko obložene tablete sofosbuvir
English: The safety and appropriate dose of Sovaldi have not been established in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Slovenian: < 30 ml/min/1,73 m2) ali pri bolnikih z boleznijo ledvic v končni fazi (ESRD, end stage renal disease), zaradi katere bolnik potrebuje hemodializo (glejte poglavje 5.2).
English: In particular, do not take Sovaldi if you are taking any of the following medicines:
Slovenian: Obvestite zdravnika, če jemljete katero koli od naslednjih zdravil:
English: GS-331007 ↓ Cmax 0.60 (0.53, 0.69) ↔ AUC 1.04 (0.90,
Slovenian: GS-331007 ↓ Cmax 0,60 (0,53; 0,69)
English: No dose adjustment of sofosbuvir or ciclosporin is required when sofosbuvir and ciclosporin are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in ciklosporina odmerka sofosbuvirja ali ciklosporina ni treba prilagajati.
English: Table 18: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 1 HCV infection
Slovenian: Preglednica 18: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 1
English: Based on population pharmacokinetic analysis in subjects 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: 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: ANTICOAGULANTS
Slovenian: Okskarbazepin
English: Table 2: Ribavirin dose modification guideline for co-administration with Sovaldi Laboratory values
Slovenian: Preglednica 2: Smernice za prilagajanje odmerka ribavirina pri sočasnem dajanju z zdravilom
English: The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected subjects was similar to that observed in mono-infected HCV subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Slovenian: Sočasna okužba z virusoma HIV in HCV Profil varnosti sofosbuvirja in ribavirina pri osebah, sočasno okuženih z virusoma HCV in HIV, je bil podoben tistemu, ki so ga opazili pri osebah, okuženih samo z virusom HCV, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another direct-acting antiviral (DAAs, including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone with or without other drugs that lower heart rate.
Slovenian: Pri uporabi sofosbuvirja v kombinaciji z drugo učinkovino z direktnim delovanjem na viruse (vključno z daklatasvirjem, simeprevirjem in ledipasvirjem) in sočasni uporabi amiodarona, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
English: No dose adjustment of sofosbuvir or darunavir (ritonavir boosted) is required when sofosbuvir and darunavir are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in darunavirja odmerka sofosbuvirja ali darunavirja (okrepljenega z ritonavirjem) ni treba prilagajati.
English: Treated subjects (n = 201) had a median age of 56 years (range: 24 to 70); 70% of the subjects were male; 87% were White; 3% were Black; 9% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 19 to 44 kg/m2); 73% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Slovenian: Mediana starost zdravljenih oseb (n = 201) je bila 56 let (razpon: 24 do 70); 70 % oseb je bilo moških; 87 % je bilo belcev; 3 % je bilo črncev; 9 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 29 kg/m2 (razpon: 19 do 44 kg/m2); 73 % jih je imelo ravni RNA
English: If you forget to take Sovaldi It is important not to miss a dose of this medicine.
Slovenian: Če ste pozabili vzeti zdravilo Sovaldi
English: Treated subjects (n = 278) had a median age of 54 years (range: 21 to 75); 54% of the subjects were male; 91% were White; 5% were Black; 11% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 18 to 53 kg/m2); 70% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Slovenian: Mediana starost zdravljenih oseb (n = 278) je bila 54 let (razpon: 21 do 75); 54 % oseb je bilo moških; 91 % je bilo belcev; 5 % je bilo črncev; 11 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 28 kg/m2 (razpon: 18 do 53 kg/m2); 70 % jih je imelo ravni RNA
English: ineligible or unwilling subjects, one in subjects previously treated with an interferon-based regimen, and one in all subjects irrespective of prior treatment history or ability to receive treatment with interferon.
Slovenian: Druge štiri študije pa so opravili pri osebah s kroničnim hepatitisom C genotipa 2 ali 3 v kombinaciji z ribavirinom, in sicer eno študijo z osebami, ki se predhodno še niso zdravile, eno študijo z osebami, ki niso prenašale interferona ali za zdravljenje z njim niso bile primerne ali voljne, eno študijo z osebami, ki so bile predhodno zdravljene z režimom na podlagi interferona in eno študijo z vsemi osebami, ne glede na predhodno anamnezo zdravljenja ali zmožnost zdravljenja z interferonom.
English: 0.085 ± 0.034 μM for genotype 3a (n = 106).
Slovenian: 0,11 ± 0,029 μM za genotip 1b (n = 29), 0,035 ± 0,018 μM za genotip 2 (n = 15) in 0,085 ± 0,034 μM za genotip 3a (n = 106).
English: Cirrhotic
Slovenian: Ciroza
English: Treated subjects (n = 499) had a median age of 50 years (range: 19 to 77); 66% of the subjects were male; 87% were White; 3% were Black; 14% were Hispanic or Latino; mean body mass index was 28 kg/m2 (range: 17 to 52 kg/m2); 57% had baseline HCV RNA levels greater than 6 log10 IU/mL;
Slovenian: Mediana starost zdravljenih oseb (n = 499) je bila 50 let (razpon: 19 do 77); 66 % oseb je bilo moških; 87 % je bilo belcev; 3 % je bilo črncev; 14 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 28 kg/m2 (razpon: 17 do 52 kg/m2); 57 % jih je imelo ravni RNA
English: • chest pain, feeling weak
Slovenian: • bolečine v hrbtu, mišični krči • bolečine v prsnem košu, občutek šibkosti
English: No dose adjustment of sofosbuvir or tacrolimus is required when sofosbuvir and tacrolimus are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in takrolimusa odmerka sofosbuvirja ali takrolimusa ni treba prilagajati.
English: Darunavir ↔ Cmax 0.97 (0.94, ↔ AUC 0.97 (0.94, ↔ Cmin 0.86 (0.78, 0.96) Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
Slovenian: ↔ Cmin 0,86 (0,78; 0,96) Sofosbuvir ↑ Cmax 1,45 (1,10; 1,92)
English: Tell your doctor if you take any of the following medicines: • amiodarone, used to treat irregular heartbeats.
Slovenian: Zdravila Sovaldi še zlasti ne jemljite, če uporabljate katero od naslednjih zdravil: • okskarbazepin (zdravilo, ki se uporablja za zdravljenje epilepsije in preprečevanje epileptičnih napadov);
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus DAAs.
Slovenian: Med kliničnim razvojem sofosbuvirja v kombinaciji z zdravili z direktnim delovanjem na viruse je bila sočasna uporaba amiodarona omejena.
English: Sovaldi is contraindicated with rifabutin, a potent intestinal P-gp inducer (see section 4.3).
Slovenian: Zdravilo Sovaldi je kontraindicirano v kombinaciji z rifabutinom, ki je močan induktor P-gp v črevesju (glejte poglavje 4.3).
English: Overall No cirrhosis Cirrhosis
Slovenian: Skupaj Brez ciroze Ciroza
English: 20% had cirrhosis; 72% had HCV genotype 3.
Slovenian: HCV ob izhodišču višje od 6 log10 i.e./ml; 20 % jih je imelo cirozo; 72 % jih je imelo HCV genotipa 3.
English: Table 20: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 3 HCV infection
Slovenian: Preglednica 20: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 3
English: Sovaldi is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Slovenian: Zdravilo Sovaldi je kontraindicirano v kombinaciji z rifampicinom, ki je močan induktor P-gp v črevesju (glejte poglavje 4.3).
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57) Cmin (NA)
Slovenian: Sofosbuvir ↓ Cmax 0,97 (0,65; 1,43)
English: ↔ Cmin 0.99 (0.91, 1.07)
Slovenian: ↓ AUC 0,73 (0,59; 0,91)
English: Musculoskeletal and connective tissue disorders: Very common arthralgia, myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva: zelo pogosti artralgija, mialgija pogosti artralgija, bolečine v hrbtu, mišični spazmi, mialgija bolečine v hrbtu, mišični spazmi
English: Table 19: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 2 HCV infection
Slovenian: Preglednica 19: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipa 2
English: 16% had cirrhosis; 49% had HCV genotype 3.
Slovenian: HCV ob izhodišču višje od 6 log10 i.e./ml; 16 % jih je imelo cirozo; 49 % jih je imelo HCV genotipa 3.
English: Population pharmacokinetics analysis in HCV infected subjects indicated that cirrhosis had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Slovenian: da ciroza ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju in GS-331007.
English: SOF+PEG+RBV 12 weeks Overallc
Slovenian: SOF+PEG+RBV 12 tednov Skupajc
English: The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 4).
Slovenian: Pri uporabi sofosbuvirja v kombinaciji z ribavirinom ali v kombinaciji s peginterferonom alfa in ribavirinom so ugotovili naslednje neželene učinke zdravila (preglednica 4).
English: No dose adjustment of Sovaldi is required for patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno ledvično okvaro odmerka zdravila Sovaldi ni treba prilagajati.
English: 12 weeks (n = 103)a
Slovenian: 12 tednov (n = 103)
English: HCV/HIV co-infected patients - PHOTON-1 (study 123) Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 12 or 24 weeks of treatment with sofosbuvir and ribavirin in subjects with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Slovenian: Klinična učinkovitost in varnost pri posebnih populacijah Bolniki s sočasno okužbo z virusoma HCV in HIV - PHOTON-1 (študija 123) Sofosbuvir so preučili v odprti klinični študiji, v kateri so ocenjevali varnost in učinkovitost 12- ali
English: Emtricitabine ↔ Cmax 0.97 (0.88, ↔ AUC 0.99 (0.94, ↔ Cmin 1.04 (0.98, 1.11) Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10) ↔ AUC 0.94 (0.76, Cmin (NA)
Slovenian: ↔ Cmin 1,04 (0,98; 1,11) Sofosbuvir ↓ Cmax 0,81 (0,60; 1,10)
English: NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
Slovenian: Metadonf (vzdrževalna terapija z metadonom [30 do 130 mg/dan])
English: Respiratory, thoracic and mediastinal disorders: Very common dyspnoea, cough
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora: zelo pogosti dispneja, kašelj pogosti dispneja, dispneja ob naporu, kašelj dispneja ob naporu
English: The efficacy of sofosbuvir was evaluated in five Phase 3 studies in a total of 1,568 subjects with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve subjects with genotype 1, 4, 5 or 6 chronic hepatitis C in combination with peginterferon alfa 2a and ribavirin and the other four studies were conducted in subjects with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve subjects, one in interferon intolerant,
Slovenian: Eno študijo so opravili pri bolnikih, ki se predhodno še niso zdravili, s kroničnim hepatitisom C genotipa 1, 4, 5 ali 6 v kombinaciji s peginterferonom alfa 2a in ribavirinom.
English: and up to every 4 weeks until the appropriate weight-based dose was reached (1,000 mg daily in subjects <75 kg, 1,200 mg daily in subjects ≥75 kg).
Slovenian: Če se je pri osebah ohranila raven hemoglobina ≥ 12 g/dl, so odmerek ribavirina povečali v 2. in 4. tednu in nato vsake 4 tedne, dokler ni bil dosežen ustrezen odmerek na podlagi telesne mase (1.000 mg na dan pri osebah < 75 kg, 1.200 mg na dan pri osebah ≥ 75 kg).
English: 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.
Slovenian: morajo ženske v rodni dobi ali njihovi moški partnerji med zdravljenjem in še v obdobju po zaključku zdravljenja uporabljati učinkovito obliko kontracepcije, kot je priporočeno v povzetku glavnih značilnosti zdravila za ribavirin.
English: b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
Slovenian: b. Razmisliti je treba o možnem podaljšanju trajanja zdravljenja na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (npr. napredovala fibroza/ciroza,
English: Rilpivirine ↔ Cmax 1.05 (0.97, ↔ AUC 1.06 (1.02, ↔ Cmin 0.99 (0.94, 1.04) Sofosbuvir ↑ Cmax 1.21 (0.90, 1.62) ↔ AUC 1.09 (0.94, Cmin (NA)
Slovenian: ↔ Cmin 0,99 (0,94; 1,04) Sofosbuvir ↑ Cmax 1,21 (0,90; 1,62)
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Slovenian: Biotransformacija Sofosbuvir se obširno presnovi v jetrih, kjer tvori v farmakološko aktivni nukleozidni analog trifosfat
English: Infections and infestations: Common nasopharyngitis Blood and lymphatic system disorders:
Slovenian: Infekcijske in parazitske bolezni: pogosti nazofaringitis
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90) ↔ AUC 1.09 (0.84, Cmin (NA)
Slovenian: Takrolimus ↓ Cmax 0,73 (0,59; 0,90)
English: Treated subjects (n = 419) had a median age of 51 years (range: 19 to 74); 60% of the subjects were male; median body mass index was 25 kg/m2 (range: 17 to 44 kg/m2); the mean baseline HCV RNA
Slovenian: Mediana starost zdravljenih oseb (n = 419) je bila 51 let (razpon: 19 do 74); 60 % oseb je bilo moških; mediani indeks telesne mase je bil 25 kg/m2 (razpon: 17 do 44 kg/m2); povprečna raven RNA HCV ob izhodišču je bila 6,4 log10 i.e./ml; 21 % jih je imelo cirozo; 78 % jih je imelo HCV genotipa 3; 65 % jih je imelo predhodno relaps.
English: HCV infection pre-transplantation.
Slovenian: Odziv na predhodno zdravljenje HCV Osebe z relapsom Neodzivne osebe
English: R-methadone ↔ Cmax 0.99 (0.85, ↔ AUC 1.01 (0.85, ↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, ↔ AUC 0.95 (0.77, ↔ Cmin 0.95 (0.74, 1.22) Sofosbuvir ↓ Cmax 0.95c (0.68, 1.33) ↑ AUC 1.30c (1.00, Cmin (NA)
Slovenian: ↔ Cmin 0,95 (0,74; 1,22) Sofosbuvir ↓ Cmax 0,95c (0,68; 1,33)
English: Tablet core:
Slovenian: Očesne bolezni:
English: Non-cirrhotic
Slovenian: Brez ciroze
English: GS-331007 ↔ Cmax 1.09 (0.99, ↔ AUC 1.03 (0.97, Cmin (NA)
Slovenian: Cmin (n/n) GS-331007 ↔ Cmax 1,09 (0,99;
English: Treated subjects (n = 327) had a median age of 54 years (range: 19 to 70); 64% of the subjects were male; 79% were White; 17% were Black; 14% were Hispanic or Latino; mean body mass index was 29 kg/m2 (range: 18 to 56 kg/m2); 78% had baseline HCV RNA greater than 6 log10 IU/mL; 17% had cirrhosis; 89% had HCV genotype 1 and 11% had HCV genotype 4, 5 or 6.
Slovenian: Mediana starost zdravljenih oseb (n = 327) je bila 54 let (razpon: 19 do 70); 64 % oseb je bilo moških; 79 % je bilo belcev; 17 % je bilo črncev; 14 % je bilo španskega ali latinskoameriškega porekla; povprečni indeks telesne mase je bil 29 kg/m2 (razpon: 18 do 56 kg/m2); 78 % jih je imelo ravni RNA
English: • palpitations
Slovenian: • hujšanje
English: Efavirenz ↔ Cmax 0.95 (0.85, ↔ AUC 0.96 (0.91, ↔ Cmin 0.96 (0.93, 0.98) Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10) ↔ AUC 0.94 (0.76, Cmin (NA)
Slovenian: ↔ Cmin 0,96 (0,93; 0,98) Sofosbuvir ↓ Cmax 0,81 (0,60; 1,10)
English: GS-331007 ↔ Cmax 1.06 (0.99, ↔ AUC 1.01 (0.97, Cmin (NA)
Slovenian: Cmin (n/n) GS-331007 ↔ Cmax 1,06 (0,99;
English: Sofosbuvir ↓ Cmax 0.81 (0.60, 1.10) ↔ AUC 0.94 (0.76,
Slovenian: ↔ Cmin 0,99 (0,91; 1,07) Sofosbuvir ↓ Cmax 0,81 (0,60; 1,10)
English: SOF+RBV 16 weeks (n = 98)a
Slovenian: SOF+RBV 16 tednov (n = 98)
English: Race
Slovenian: SERIJ
English: When you take Sovaldi with ribavirin or both peginterferon alfa and ribavirin, you may get one or more of the side effects below:
Slovenian: Pri jemanju zdravila Sovaldi z ribavirinom ali tako s peginterferonom alfa kot z ribavirinom se lahko pojavi en ali več od spodaj navedenih neželenih učinkov: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: Raltegravir ↓ Cmax 0.57 (0.44, 0.75) ↓ AUC 0.73 (0.59, 0.91) ↔ Cmin 0.95 (0.81, 1.12) Sofosbuvir ↔ Cmax 0.87 (0.71, ↔ AUC 0.95 (0.82, Cmin (NA)
Slovenian: ↔ Cmin 0,95 (0,81; 1,12) Sofosbuvir ↔ Cmax 0,87 (0,71;
English: General
Slovenian: c
English: HIV/HCV co-infection
Slovenian: UČINKOVINE ZA ZDRAVLJENJE INFEKCIJ Z MIKOBAKTERIJAMI
English: GS-331007 ↔ Cmax 0.97 (0.83, ↔ AUC 1.00 (0.87, Cmin (NA)
Slovenian: Cmin (n/n) GS-331007 ↔ Cmax 0,97 (0,83;
English: Thereafter national approval was obtained in most of the EU countries.
Slovenian: Nato je bilo nacionalno dovoljenje pridobljeno v večini držav EU.
English: Therefore this interaction is included in section 4.5.
Slovenian: Zato je ta interakcija vključena v poglavje 4.5.