FrancophonIA/ELRC3.0 huggingface dataset:
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 subjects 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 (n = 71) pri osebah, ki interferona ne prenašajo oz. niso primerne ali voljne.
English: Treatment duration was 12 weeks in treatment-naïve subjects with genotype 2 or 3 HCV infection, and 24 weeks in treatment-experienced subjects with genotype 3 HCV infection, as well as subjects with genotype 1 HCV infection.
Slovenian: Zdravljenje je trajalo 12 tednov pri predhodno nezdravljenih osebah z okužbo s HCV genotipa 2 ali 3 in 24 tednov pri predhodno zdravljenih osebah z okužbo s HCV genotipa 3 in osebah z okužbo s HCV genotipa 1.
English: Breast-feeding 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: Sovaldi has moderate influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Sovaldi ima zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: Treatment of patients with genotype 5 or 6 HCV infection The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1).
Slovenian: Klinični podatki, ki bi podprli uporabo zdravila Sovaldi pri bolnikih z okužbo s HCV genotipa 5 in 6, so zelo omejeni (glejte poglavje 5.1).
English: How to take Sovaldi
Slovenian: Kako jemati zdravilo Sovaldi
English: • feeling tired and irritable
Slovenian: • nespečnost (insomnija) • občutek utrujenosti in razdražljivosti
English: 12 weeks (n = 68)
Slovenian: 12 tednov (n = 68)
English: Table 15 presents the response rates by genotype and exposure to prior HCV treatment.
Slovenian: V preglednici 15 so predstavljene stopnje odziva po genotipu in izpostavljenost predhodnemu zdravljenju HCV.
English: Patients with genotype 3 CHC
Slovenian: Bolniki s CHC genotipa 3
English: Cmin (NA) Norgestrel ↔ Cmax 1.18 (0.99,
Slovenian: Cmin (n/n) Norgestrel ↔ Cmax 1,18 (0,99;
English: b. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.
Slovenian: b. Denominator za relaps je število oseb z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
English: Film-coated tablet.
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta.
English: 12 weeks (n = 327)
Slovenian: 12 tednov (n = 327)
English: Previously treated adults - FUSION (study 108)
Slovenian: Odrasli, ki se predhodno še niso zdravili - FISSION (študija 1231)
English: Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a,b
Slovenian: (90-odstotni interval zaupanja) za AUC,
English: Overview of outcomes by therapeutic regimen and treatment duration, a comparison across studies The following tables (Table 18 to Table 21) present data from Phase 2 and Phase 3 studies relevant to the dosing to help clinicians determine the best regimen for individual patients.
Slovenian: Pregled izidov zdravljenja glede na režime in trajanje zdravljenja, primerjava med študijami V naslednjih preglednicah (preglednica 18 do preglednice 21) so predstavljeni podatki študij 2. faze in
English: Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Slovenian: V preglednici 11 so predstavljene stopnje odziva za skupine, zdravljene s sofosbuvirjem + ribavirinom za 12 tednov in 16 tednov.
English: Relative to subjects with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Slovenian: V primerjavi z osebami z normalnim delovanjem jeter je bila vrednost AUC0-24 za sofosbuvir za 126 % višja pri zmerni jetrni okvari in za 143 % višja pri hudi jetrni okvari, medtem ko je bila vrednost AUC0-24 za GS-331007 višja za 18 % oz. 9 %.
English: Drug interaction information for Sovaldi with potential concomitant medicinal products is summarised in Table 3 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 3 (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: Sovaldi has mainly been studied in combination with ribavirin, with or without peginterferon alfa.
Slovenian: Zdravilo Sovaldi so preučili pretežno v kombinaciji z ribavirinom, s peginterferonom alfa ali brez njega.
English: Table 10: SVR12 rates for selected subgroups by genotype in POSITRON SOF+RBV 12 weeks
Slovenian: Preglednica 10: Stopnje SVR12 za izbrane podskupine po genotipu v študiji POSITRON SOF+RBV 12 tednov
English: 12 weeks (n = 207)
Slovenian: 12 tednov (n = 207)
English: Interferon classification Ineligible Intolerant Unwilling
Slovenian: Neprimerni Ne prenašajo Niso voljni
English: Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Slovenian: V preglednici 13 so predstavljene stopnje odziva za skupine, zdravljene s sofosbuvirjem + ribavirinom za 12 tednov in 24 tednov.
English: What Sovaldi looks like and contents of the pack The film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with “GSI” and “7977” on the other side.
Slovenian: Filmsko obložene tablete so rumene tablete v obliki kapsule, z vtisnjeno oznako »GSI« na eni in »7977« na drugi strani.
English: • hair loss and thinning hair
Slovenian: • izpadanje las in tanjšanje las • suha koža
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol
Slovenian: PERORALNI KONTRACEPTIVI Norgestimat/etinilestradio l
English: No dose adjustment is required for patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno ledvično okvaro odmerka ni treba prilagajati.
English: 28 out of 40 (70%) subjects 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.
Slovenian: (73 %) oseb z okužbo s HCV genotipa 1, 6/6 (100 %) z okužbo s HCV genotipa 3 in 0/1 (0 %) z okužbo s HCV genotipa 4.
English: Cmin (NA) Ethinyl estradiol ↔ Cmax 1.14 (0.96,
Slovenian: Cmin (n/n) Etinilestradiol ↔ Cmax 1,14 (0,96;
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Sofosbuvir je nukleotidno predzdravilo.
English: Table 1: Recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy
Slovenian: Preglednica 1: Priporočeno(a) zdravilo(a), ki se daje(jo) sočasno, in trajanje zdravljenja s kombinirano terapijo z zdravilom Sovaldi Populacija bolnikov*
English: Pharmacokinetics in special populations
Slovenian: Farmakokinetika pri posebnih skupinah bolnikov Spol in rasa
English: 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.
Slovenian: 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
English: FISSION was a randomised, open-label, active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 2 or 3 HCV infection.
Slovenian: Študija FISSION je bila randomizirana, odprta, z aktivno učinkovino kontrolirana študija, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem in ribavirinom v primerjavi s 24-tedenskim zdravljenjem s peginterferonom alfa 2a in ribavirinom za zdravljenje bolnikov, ki se predhodno še niso zdravili, z okužbo s HCV genotipa 2 ali 3.
English: Subjects received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for subjects weighing <75 kg or 1,200 mg for subjects weighing ≥75 kg).
Slovenian: Osebe so prejele 400 mg sofosbuvirja in odmerek ribavirina na podlagi telesne mase (1.000 mg za osebe s telesno maso < 75 kg ali 1.200 mg za osebe s telesno maso ≥ 75 kg).
English: Genotype 1a 92% (206/225) Genotype 1b 83% (55/66) No cirrhosis
Slovenian: Genotip 1b 83 % (55/66) Brez ciroze
English: Table 4: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Slovenian: Preglednica 4: Neželeni učinki zdravila, identificirani pri sofosbuvirju v kombinaciji z ribavirinom ali s peginterferonom alfa in ribavirinom Pogostnost
English: Table 16: SVR12 rates for selected subgroups by genotype in study PHOTON-1 HCV genotype 2
Slovenian: Preglednica 16: Stopnje SVR12 za izbrane podskupine po genotipu v študiji PHOTON-1 HCV genotipa 2
English: Treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection Sovaldi has not been studied in a Phase 3 study in treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection.
Slovenian: Predhodno zdravljeni bolniki z okužbo s HCV genotipa 1, 4, 5 in 6 Zdravila Sovaldi niso preučili v študiji 3. faze pri predhodno že zdravljenih bolnikih z okužbo s HCV
English: What Sovaldi contains
Slovenian: Kaj vsebuje zdravilo Sovaldi
English: Sofosbuvir and GS-331007 are not inhibitors of P-gp and BCRP and thus are not expected to increase exposures of medicinal products that are substrates of these transporters.
Slovenian: P-gp in BCRP, zato se ne pričakuje, da bi povečala izpostavljenost zdravilom, ki so substrati teh prenašalcev.
English: • muscle aches and pains, pain in the joints
Slovenian: • občutek omotičnosti • skeleče in boleče mišice, bolečine v sklepih
English: The pharmacokinetics of sofosbuvir were studied in HCV negative subjects with mild (eGFR ≥50 and <80 mL/min/1.73 m2), moderate (eGFR ≥30 and <50 mL/min/1.73 m2), severe renal impairment (eGFR <30 mL/min/1.73 m2) and subjects with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
Slovenian: < 80 ml/min/1,73 m2), zmerno (eGFR ≥ 30 in < 50 ml/min/1,73m2) in hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) ter pri osebah z ESRD, zaradi katere bolnik potrebuje hemodializo, po enkratnem 400-miligramskem odmerku sofosbuvirja.
English: Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin).
Slovenian: Zdravila, ki so močni induktorji P-glikoproteina (P-gp) v črevesju (rifampicin, rifabutin, šentjanževka
English: Two NS5B substitutions, L159F and V321A, were detected in post-treatment relapse samples from multiple genotype 3 HCV infected subjects 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 oseb, okuženih z virusom HCV genotipa 3.
English: Table 10 presents the subgroup analysis by genotype for cirrhosis and interferon classification.
Slovenian: V preglednici 10 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in razvrstitev glede na interferon.
English: Table 6: SVR12 rates for selected subgroups in NEUTRINO SOF+PEG+RBV
Slovenian: Preglednica 6: Stopnje SVR12 za izbrane podskupine v študiji NEUTRINO SOF+PEG+RBV
English: Sovaldi + ribavirin + peginterferon alfa 12 weeksa,b
Slovenian: Zdravilo Sovaldi + ribavirin + peginterferon alfa 12 tednova, b
English: Subjects had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic
Slovenian: Osebe so imele pri presejanju HCV RNA ≥ 104 i.e./ml in dokumentirano dokazano kronično okužbo s HCV pred presaditvijo.
English: ↓ Sofosbuvir
Slovenian: Pričakovane: ↓ sofosbuvir
English: Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Slovenian: (CHC, chronic hepatitis C) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
English: Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
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 UGT1A1 ali encimov CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in CYP2D6.
English: Table 7 presents the response rates for the treatment groups of sofosbuvir + ribavirin and peginterferon alfa + ribavirin.
Slovenian: V preglednici 7 so predstavljene stopnje odziva za skupine, zdravljene s sofosbuvirjem + ribavirinom in peginterferonom alfa + ribavirinom.
English: Frequency SOFa + RBVb
Slovenian: SOFa + RBVb
English: Very common side effects (may affect more than 1 in 10 people)
Slovenian: (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin 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 (prior null response to peginterferon alfa and ribavirin therapy, advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Slovenian: Razmisliti je treba o zdravljenju teh bolnikov in morebitnem podaljšanju trajanja zdravljenja s sofosbuvirjem, peginterferonom alfa in ribavarinom 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 (predhodni ničelni odziv na zdravljenje s peginterferonom alfa in ribavirinom, napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črnci, genotip ne-CC IL28B).
English: Treatment-experienced 90% (37/41) Non-cirrhotic
Slovenian: Predhodno nezdravljeni Brez ciroze S cirozo Predhodno zdravljeni 90 % (37/41) Brez ciroze S cirozo
English: HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
Slovenian: Šentjanževka (Hypericum perforatum)
English: Table 9 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo.
Slovenian: preglednici 9 so predstavljene stopnje odziva za skupine, zdravljenje s sofosbuvirjem + ribavirinom in za placebo.
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin 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 (advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Slovenian: Razmisliti je treba o zdravljenju teh bolnikov in morebitnem podaljšanju trajanja zdravljenja s sofosbuvirjem, peginterferonom alfa in ribavirinom 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 (napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črnci, genotip ne-CC IL28b).
English: Otherb a. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.
Slovenian: Drugob a. Denominator za relaps je število oseb z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Sovaldi and another DAA.
Slovenian: Kadar se presodi, da je sočasna uporaba amiodarona potrebna, se ob uvajanju zdravljenja z zdravilom Sovaldi in drugim zdravilom z direktnim delovanjem na viruse priporoča skrbno spremljanje bolnikov.
English: Genotype 1a 82% (74/90) Genotype 1b 54% (13/24) No cirrhosis
Slovenian: Genotip 1b 54 % (13/24) Brez ciroze
English: Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection 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: Common alopecia, dry skin, pruritus alopecia, dry skin
Slovenian: Bolezni kože in podkožja: zelo pogosti izpuščaj, pruritus pogosti alopecija, suha koža, pruritus alopecija, suha koža
English: Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected subjects.
Slovenian: V primerjavi z zdravimi osebami (n = 284) je bila pri osebah, okuženih s HCV, vrednost AUC0-24 za sofosbuvir za 57 % višja in vrednost AUC0-24 za GS-331007 za 39 % nižja.
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Slovenian: GS-331007 (78 %), medtem ko je bilo 3,5 % izoliranega kot sofosbuvir.
English: ≥2 g/dL decrease in haemoglobin during any 4 week treatment period
Slovenian: Hemoglobin pri osebah s stabilno boleznijo srca v anamnezi zmanjšanje hemoglobina za ≥ 2 g/dl v 4-tedenskem obdobju zdravljenja
English: The safety profile of sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C was similar to that observed in subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Slovenian: Profil varnosti sofosbuvirja in ribavirina pri prejemnikih presajenih jeter s kroničnim hepatitisom C je bil podoben tistemu, ki so ga opazili pri osebah, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
English: Tenofovir ↑ Cmax 1.25 (1.08, 1.45) ↔ AUC 0.98 (0.91,
Slovenian: Tenofovir ↑ Cmax 1,25 (1,08; 1,45)
English: Table 5 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin.
Slovenian: V preglednici 5 so predstavljene stopnje odziva za skupino, zdravljeno s sofosbuvirjem + peginterferonom alfa + ribavirinom.
English: Table 5: Response rates in study NEUTRINO SOF+PEG+RBV
Slovenian: Preglednica 5: Stopnje odziva v študiji NEUTRINO SOF+PEG+RBV
English: The primary endpoint of the study was post-transplant virologic response (pTVR, HCV RNA <LLOQ at 12 weeks post-transplant).
Slovenian: Primarni opazovani dogodek študije je bil virološki odziv po presaditvi (pTVR, post-transplant virologic response;
English: The mean ± SD EC50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and
Slovenian: ki kodirajo zaporedje NS5B iz kliničnih izolatov, je bilo 0,068 ± 0,024 μM za genotip 1a (n = 67),
English: Table 14: SVR12 rates for selected subgroups by genotype in study VALENCE Genotype 2
Slovenian: Preglednica 14: Stopnje SVR12 za izbrane podskupine po genotipu v študiji VALENCE Genotip 2
English: Table 8: SVR12 rates by cirrhosis and genotype in study FISSION
Slovenian: Preglednica 8: Stopnje SVR12 po cirozi in genotipu v študiji FISSION Genotip 2
English: An interim analysis was conducted on 61 subjects who received sofosbuvir and ribavirin; the majority of subjects had HCV genotype 1, 44 subjects were CPT class A and 17 subjects were CPT class B. Of these 61 subjects, 44 subjects 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: Med temi 61 osebami jih je imelo 44 oseb presaditev jeter po do 48 tednih zdravljenja s sofosbuvirjem in ribavirinom; 41 jih je imelo RNA HCV < LLOQ v času presaditve.
English: Efficacy, in terms of rapid virologic response, has been shown to correlate with exposure to sofosbuvir as well as GS 331007.
Slovenian: Farmakokinetično/farmakodinamično razmerje Pokazalo se je, da učinkovitost v smislu hitrega virološkega odziva korelira z izpostavljenostjo sofosbuvirju in GS-331007.
English: Otherc a. The efficacy analysis includes 6 subjects with recombinant genotype 2/1 HCV infection.
Slovenian: Drugoc a. Analiza učinkovitosti vključuje 6 oseb z okužbo s HCV z rekombinantnim genotipom 2/1.
English: Table 12: SVR12 rates for selected subgroups by genotype in study FUSION Genotype 2
Slovenian: Preglednica 12: Stopnje SVR12 za izbrane podskupine po genotipu v študiji FUSION Genotip 2
English: level was 6.4 log10 IU/mL; 21% had cirrhosis; 78% had HCV genotype 3; 65% were prior relapsers.
Slovenian: HCV ob izhodišču višje od 6 log10 i.e./ml; 34 % jih je imelo cirozo; 63 % jih je imelo HCV genotipa 3; 75 % jih je imelo predhodno relaps.
English: Close monitoring is recommended if this medicinal product is administered with Sovaldi and another DAA (see sections 4.4 and 4.8).
Slovenian: Kadar se to zdravilo uporablja sočasno z zdravilom Sovaldi in drugim zdravilom z direktnim delovanjem na viruse, se priporoča skrbno spremljanje (glejte poglavji 4.4 in 4.8).
English: If sofosbuvir is used in combination with peginterferon alfa, and a patient has a serious adverse reaction potentially related to this drug, the peginterferon alfa dose should be reduced or discontinued.
Slovenian: Če se sofosbuvir uporablja v kombinaciji s peginterferonom alfa in ima bolnik resne neželene učinke,
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,
English: Table 12 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.
Slovenian: V preglednici 12 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in odziv na predhodno zdravljenje HCV.
English: Otherc a. The efficacy analysis includes 3 subjects with recombinant genotype 2/1 HCV infection.
Slovenian: Drugoc a. Analiza učinkovitosti vključuje 3 osebe z okužbo s HCV z rekombinantnim genotipom 2/1.
English: Ciclosporin ↔ Cmax 1.06 (0.94,
Slovenian: Ciklosporin ↔ Cmax 1,06 (0,94;
English: Table 11: Response rates in study FUSION SOF+RBV
Slovenian: Preglednica 11: Stopnje odziva v študiji FUSION SOF+RBV
English: Cirrhosis No Yes a. The efficacy analysis includes 3 subjects with recombinant genotype 2/1 HCV infection.
Slovenian: Ciroza Ne Da a. Analiza učinkovitosti vključuje 3 osebe z okužbo s HCV z rekombinantnim genotipom 2/1.
English: Sovaldi + ribavirin + peginterferon alfa 12 weeksb
Slovenian: Zdravilo Sovaldi + ribavirin + peginterferon alfa 12 tednovb
English: The safety profile of sofosbuvir and ribavirin in HCV infected subjects prior to liver transplantation was similar to that observed in subjects treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Slovenian: Profil varnosti sofosbuvirja in ribavirina pri osebah, okuženih z virusom HCV, pred presaditvijo jeter, je bil podoben tistemu, ki so ga opazili pri osebah, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).