natgillin/translations-raw huggingface dataset:
Table 15: Response rates in study PHOTON-1 Genotype 2/3 treatment-naïve
Tablica 15: Stope odgovora u ispitivanju PHOTON-1 Ispitanici s genotipom 2/3 koji prethodno nisu liječeni
Very common nausea diarrhoea, nausea, vomiting
Vrlo često mučnina proljev, mučnina, povraćanje
b. pTVR: post-transplant virologic response (HCV RNA <LLOQ at 12 weeks post-procedure).
b. pTVR: virološki odgovor nakon transplantacije (HCV RNK < donje granice kvantifikacije u 12. tjednu nakon postupka).
The film-coated tablet is for oral use.
Filmom obložene tablete primjenjuju se peroralno.
Table 10: SVR12 rates for selected subgroups by genotype in POSITRON SOF+RBV 12 weeks
Tablica 10: Stope SVR12 u odabranim podskupinama prema genotipu u ispitivanju POSITRON SOF+RBV 12 tjedana
Microcrystalline cellulose (E460(i)) Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni (E551) magnezijev stearat (E470b)
Response rates for subjects with cirrhosis at baseline are presented in Table 8 by HCV genotype.
Stope odgovora kod ispitanika s cirozom na početku prikazane su u tablici 8 prema genotipu HCV-a.
Keep this medicine out of the sight and reach of children.
Kako čuvati Sovaldi Ovaj lijek čuvajte izvan pogleda i dohvata djece.
Elimination Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Nakon jedne peroralne doze od 400 mg [14C]-sofosbuvira, srednja vrijednost ukupno otkrivene doze bila je veća od 92% i sastojala se od približno 80% one otkrivene u mokraći, 14% u stolici i 2,5% u izdahnutom zraku.
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.
Liječenje je trajalo 12 tjedana u ispitanika s infekcijom genotipom 2 ili 3 HCV-a koji prethodno nisu bili liječeni, a 24 tjedna u prethodno liječenih ispitanika s infekcijom genotipom 3 HCV-a, kao i ispitanika s infekcijom genotipom 1 HCV-a.
Effect of baseline HCV polymorphisms on treatment outcome Baseline NS5B sequences were obtained for 1,292 subjects from Phase 3 studies by population sequencing and the S282T substitution was not detected in any subject with available baseline sequence.
Početne sekvence NS5B dobivene su populacijskim sekvenciranjem za 1292 ispitanika u ispitivanjima faze 3, a S282T supstitucija nije bila otkrivena ni u jednog ispitanika s dostupnom početnom sekvencom.
• Peginterferon alfa and ribavirin
• ribavirinom ili • peginterferonom alfa i ribavirinom
Skin and subcutaneous tissue disorders: Very common rash, pruritus
Poremećaji kože i potkožnog tkiva: Vrlo često osip, pruritus
In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 subjects) experiencing a decline in haemoglobin to <10 g/dL, 1 of whom also had a decline to <8.5 g/dL.
U ispitivanju 0126, sniženje hemoglobina tijekom liječenja bilo je vrlo često, s 32,5% (13/40) ispitanika u kojih je hemoglobin bio snižen na < 10 g/dl,
Subjects were randomised in 3:1 ratio and stratified by cirrhosis (presence versus absence).
Ispitanici su bili randomizirani u omjeru 3:1 i stratificirani prema cirozi (prisutna naspram odsutna).
a. For previously treated patients with genotype 1 HCV infection, no data exists with the combination of sofosbuvir, peginterferon alfa and ribavirin.
Za prethodno liječene bolesnike s infekcijom genotipom 1 HCV-a ne postoje podaci za kombinaciju sofosbuvira, peginterferona i ribavirina.
Common side effects (may affect up to 1 in 10 people)
(mogu se javiti u do 1 na 10 osoba)
• diarrhoea, feeling sick (nausea), being sick (vomiting)
• proljev, mučnina, povraćanje • poteškoće sa spavanjem (nesanica)
12 weeks (n = 207)
12 tjedana (n = 207)
The AUC0-inf of GS-331007 in subjects with ESRD could not be reliably determined.
AUC0-inf GS-331007 u ispitanika s završnim stadijem bolesti bubrega nije se mogao pouzdano utvrditi.
NAME OF THE MEDICINAL PRODUCT Sovaldi 400 mg film-coated tablets
NAZIV LIJEKA Sovaldi 400 mg filmom obložene tablete
Patients with genotype 1, 4, 5 or 6 CHC
Bolesnici s CHCom uzrokovanim genotipom 1, 4, 5 ili 6
Cirrhosis n = number of subjects with SVR12 response; N = total number of subjects per group.
S cirozomc n = broj ispitanika s odgovorom SVR12; N = ukupni broj ispitanika u skupini.
Haemodialysis can efficiently remove (53% extraction ratio) the predominant circulating metabolite GS-331007.
Hemodijalizom se može učinkovito odstraniti glavni cirkulirajući metabolit GS-331007 (omjer ekstrakcije 53%).
Breast-feeding It is unknown whether sofosbuvir and its metabolites are excreted in human milk.
Nije poznato izlučuju li se sofosbuvir i njegovi metaboliti u majčino mlijeko.
Table 1: Recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy
Tablica 1: Preporučeni lijek(ovi) za istodobnu primjenu i trajanje liječenja kombiniranom terapijom sa Sovaldijem Populacija bolesnika*
12 weeks (n = 327)
12 tjedana (n = 327)
• slow or irregular heartbeat or heart rhythm problems
• usporene ili nepravilne otkucaje srca ili tegobe sa srčanim ritmom • nedostatak zraka ili pogoršanje već prisutnog nedostatka zraka
No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly.
Nije potrebna prilagodba doze norgestimata/etinil estradiola kad se sofosbuvir i norgestimat/etinil estradiol primjenjuju istodobno.
If the other medicinal products used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued (see section 4.4).
Ako se trajno prekine primjena drugih lijekova u kombinaciji sa Sovaldijem, potrebno je također prekinuti primjenu Sovaldija (vidjeti dio 4.4).
Recommended dose
Prilagodba doze
Sovaldi + ribavirin + peginterferon alfa 12 weeksa,b
Sovaldi + ribavirin + peginterferon alfa 12 tjedanaa, b
However, data indicate at least 10-fold and 20-fold higher exposure to GS-331007 in ESRD compared to normal subjects when Sovaldi was administered 1 hour before or 1 hour after haemodialysis, respectively.
20 puta veću izloženost GS-331007 u ispitanika s završnim stadijem bolesti bubrega u usporedbi s ispitanicima s normalnom funkcijom bubrega kad se Sovaldi primijenio 1 sat prije odnosno 1 sat nakon hemodijalize.
The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 4).
Sljedeće nuspojave utvrđene su za sofosbuvir u kombinaciji s ribavirinom ili u kombinaciji s peginterferonom alfa i ribavirinom (tablica 4).
Cmin (NA) Norgestrel ↔ Cmax 1.18 (0.99,
Cmin (ND/NP) Norgestrel ↔ Cmax 1,18 (0,99;
• shortness of breath when exercising
• nedostatak zraka kod fizičkog napora
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus DAAs.
Istodobna primjena amiodarona bila je ograničena tijekom kliničkog razvoja sofosbuvira uz izravno djelujuće antivirotike.
The safety and efficacy of Sovaldi in children and adolescents aged <18 years have not yet been established.
Sigurnost i djelotvornost Sovaldija u djece i adolescenata u dobi
Table 15 presents the response rates by genotype and exposure to prior HCV treatment.
Tablica 15 prikazuje stope odgovora prema genotipu i izloženosti prethodnom liječenju HCV-a
Table 9 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo.
Tablica 9 prikazuje stope odgovora u terapijskim skupinama koje su primale sofosbuvir + ribavirin i placebo.
Table 4: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Tablica 4: Nuspojave utvrđene uz sofosbuvir u kombinaciji s ribavirinom ili peginterferonom alfa i ribavirinom
Treatment-experienced co-infected with HIV (PHOTON-1)
Prethodno liječeni bolesnici koji su istodobno zaraženi HIV-om (PHOTON-1)
Medicinal products that are moderate P-gp inducers in the intestine (e.g. oxcarbazepine and modafinil) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi.
Lijekovi koji su umjereni induktori P-gp-a u crijevima (npr. okskarbazepin i modafinil) mogu smanjiti koncentraciju sofosbuvira u plazmi i tako dovesti do smanjenog terapijskog učinka Sovaldija.
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)
Podaci o interakcijama Sovaldija s drugim lijekovima koji bi se mogli istodobno primjenjivati sažeto su prikazani u tablici 3 niže (gdje je 90% interval pouzdanosti (CI) omjera geometrijske srednje vrijednosti najmanjih kvadrata (GLSM) bio unutar “↔”, protezao se iznad “↑”, ili ispod “↓” unaprijed određenih granica ekvivalencije).
Genotype 1a 92% (206/225) Genotype 1b 83% (55/66) No cirrhosis
Genotip 1b 83% (55/66) Bez ciroze
In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite ranged from 8 to 28 times higher than the clinical exposure at 400 mg sofosbuvir.
U ispitivanjima na štakorima, izloženost sofosbuviru nije se mogla odrediti, ali granice izloženosti na temelju glavnog metabolita u ljudi bile su od 8 do
• feeling tired and irritable
• umor i razdražljivost
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).
Ako se početna doza ribavirina dobro podnosi, doza se može postpuno povisiti na najviše 1000-1200 mg na dan (1000 mg u bolesnika tjelesne težine < 75 kg, a
Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Sofosbuvir je nukleotidni predlijek iz kojeg unutarstaničnim metabolizmom nastaje farmakološki djelatan uridinu analogni trifosfat (GS-461203), koji se može ugraditi u
PROTONb)
(ELECTRONb i PROTONb)
NA = not available/not applicable a. Mean ratio (90% CI) of co-administered drug pharmacokinetics with/without sofosbuvir and mean ratio of sofosbuvir and GS-331007 with/without co-administered drug.
Srednja vrijednost omjera (90% CI) farmakokinetike istodobno primijenjenog lijeka sa/bez sofosbuvira i srednja vrijednost omjera sofosbuvira i GS-331007 sa/bez istodobno primijenjenog lijeka.
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).
Režimi bez interferona za bolesnike s infekcijom HCV-om genotipa 1, 4, 5 i 6 sa Sovaldijem nisu ispitani u kliničkim ispitivanjima faze 3 (vidjeti dio 5.1).
Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
4.2 Doziranje i način primjene Liječenje lijekom Sovaldi treba započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s
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).
Lijekovi koji su jaki induktori P-gp-a u crijevima (rifampicin, rifabutin, gospina trava, karbamazepin,
Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Tablica 13 prikazuje stope odgovora u terapijskim skupinama koje su primale sofosbuvir + ribavirin tijekom 12 tjedana i 24 tjedna.
No dose adjustment of Sovaldi is required for patients with mild or moderate renal impairment.
Nije potrebna prilagodba doze Sovaldija u bolesnika s blagim ili umjerenim oštećenjem bubrega.
Sovaldi + ribavirin + peginterferon alfa 12 weeksb
Sovaldi + ribavirin + peginterferon alfa 12 tjedanab
Women of childbearing potential / contraception in males and females When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Kad se Sovaldi primjenjuje u kombinaciji s ribavirinom ili peginterferonom alfa/ribavirinom, potreban je krajnji oprez kako bi se izbjegla trudnoća u bolesnica i partnerica muških bolesnika.
Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Tablica 11 prikazuje stope odgovora u terapijskim skupinama koje su primale sofosbuvir + ribavirin tijekom 12 tjedana i 16 tjedana.
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.
Primjenjivane doze ribavirina u skupini koja je primala sofosbuvir + ribavirin bile su temeljene na tjelesnoj težini i iznosile su 1000-1200 mg na dan, a u skupini koja je primala peginterferon alfa 2a + ribavirin iznosile su 800 mg na dan bez obzira na tjelesnu težinu.
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).
Potrebno je razmotriti mogućnost liječenja tih bolesnika i mogućnost produljenja trajanja terapije sofosbuvirom, peginterferonom i ribavirinom na više od 12 tjedana do najviše 24 tjedna, osobito u podskupina s jednim ili više čimbenika koji se otprije povezuju s nižim stopama odgovora na terapiju temeljenu na interferonu (prethodni izostanak odgovoraterapiju peginterferonom alfa i ribavirinom, uznapredovala fibroza/ciroza, visoke početne koncentracije virusa, crna rasa, ne-CC genotip IL28B).
In biochemical assays, recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution showed reduced susceptibility to GS-461203 compared to respective wild-types.
genotipova 1b, 2a, 3a i 4a koji su izražavali supstituciju S282T pokazala je smanjenu osjetljivost na
Interferon classification Ineligible Intolerant Unwilling
Klasifikacija prema interferonu Nisu pogodni
NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
OPIOIDNI ANALGETICI Metadonf (terapija održavanja metadonom [30 do 130 mg na dan])
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.
Izloženost sofosbuviru u ispitivanjima na glodavcima nije se mogla otkriti, vjerojatno zbog jake aktivnosti esteraze; međutim, izloženost glavnom metabolitu GS-331007 u štetnoj dozi bila je 29 puta
Table 7 presents the response rates for the treatment groups of sofosbuvir + ribavirin and peginterferon alfa + ribavirin.
Tablica 7 prikazuje stope odgovora u terapijskim skupinama koje su primale sofosbuvir + ribavirin i peginterferon alfa + ribavirin.
Genotype 2 and 3 subjects were either treatment-naïve or experienced, whereas genotype 1 subjects were naïve to prior treatment.
Ispitanici s infekcijom genotipom 2 ili 3 prethodno nisu ili jesu bili liječeni, dok ispitanici s genotipom 1 prethodno nisu bili liječeni.
• stomach discomfort, constipation, dry mouth, indigestion, acid reflux
• nelagoda u trbuhu, zatvor, suha usta, probavne tegobe, povrat želučane kiseline
Subjects had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic
HCV RNK ≥ 104 IU/ml i dokumentiran dokaz kronične infekcije HCV-om prije transplantacije.
Genotype 1a 82% (74/90) Genotype 1b 54% (13/24) No cirrhosis
Genotip 1b 54% (13/24) Bez ciroze
Tacrolimuse (5 mg single dose)
Rifampicin (jedna doza od 600 mg)
Table 14: SVR12 rates for selected subgroups by genotype in study VALENCE Genotype 2
Tablica 14: Stope SVR12 za odabrane podskupine prema genotipu u ispitivanju VALENCE Genotip 2
Table 5: Response rates in study NEUTRINO SOF+PEG+RBV
Tablica 5: Stope odgovora u ispitivanju NEUTRINO SOF+PEG+RBV
• and you notice 18 hours or more after the time you usually take Sovaldi, wait and take the next dose at your usual time.
• i to opazite nakon što je prošlo 18 sati ili više od vremena kad obično uzimate Sovaldi,
The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Veći dio doze sofosbuvira otkrivene u mokraći činio je GS-331007 (78%), dok je
Cirrhotic
Ciklosporine
Table 10 presents the subgroup analysis by genotype for cirrhosis and interferon classification.
Tablica 10 prikazuje analizu prisutnosti ciroze i klasifikacije prema interferonu u podskupinama prema genotipu.
No clinically relevant pharmacokinetic differences due to gender or race have been identified for sofosbuvir and GS-331007.
Nisu utvrđene nikakve klinički važne razlike u farmakokinetici sofosbuvira i GS-331007 zbog spola ili rase.
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.
Privremena analiza bila je provedena na 61 ispitaniku koji je primao sofosbuvir i ribavirin; većina ispitanika imala je HCV-genotip 1, 44 ispitanika imalo CPT stadij A, a 17 ispitanika imalo je CPT stadij B.
Table 8: SVR12 rates by cirrhosis and genotype in study FISSION
Tablica 8: Stope SVR12 prema cirozi i genotipu u ispitivanju FISSION Genotip 2
Expected:
Nadalje,
• rash, itchy skin
• osip, svrbež kože
Ciclosporin ↔ Cmax 1.06 (0.94,
Ciklosporin ↔ Cmax 1,06 (0,94;
Common anaemia
Često anemija
No dose adjustment is required for patients with mild or moderate renal impairment.
Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem bubrega.
Sustained virologic response (SVR) was the primary endpoint to determine the HCV cure rate for all studies which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12).
Održan virološki odgovor (SVR) bio je primarni ishod prema kojem se određivala stopa izlječenja HCV-a u svim ispitivanjima, a definirao se kao HCV RNK
Treatment-naïve and previously treated adults - VALENCE (study 133) VALENCE was a Phase 3 study that evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects with compensated cirrhosis.
VALENCE je bilo ispitivanje faze 3 u kojem se procijenio sofosbuvir u kombinaciji s ribavirinom primjenjivanim na temelju tjelesne težine u liječenju infekcije genotipovima 2 ili 3 HCV-a u ispitanika koji prethodno nisu bili liječeni i ispitanika koji nisu postigli SVR uz prethodno liječenje temeljeno na interferonu, uključujući ispitanike s kompenziranom cirozom.
If you forget to take Sovaldi It is important not to miss a dose of this medicine.
Važno je da ne propustite uzeti dozu ovog lijeka.
Eleven HCV genotype 3 subjects had already completed treatment with sofosbuvir and ribavirin for 12 weeks at the time of the amendment.
HCV-a bilo završilo liječenje sofosbuvirom i ribavirinom tijekom 12 tjedana.
• Have kidney problems.
• imate tegobe s bubrezima.
HCV genotype 3
genotip 2 HCV-a genotip 3 HCV-a
Otherb a. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.
Nazivnik za relaps je broj ispitanika s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja terapije.
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).
Sigurnosni profil sofosbuvira i ribavirina u bolesnika s kroničnim hepatitisom C kojima je transplantirana jetra bio je sličan onome opaženom u ispitanika liječenih sofosbuvirom i ribavirinom u kliničkim ispitivanjima faze 3 (vidjeti dio 5.1).
Table 12: SVR12 rates for selected subgroups by genotype in study FUSION Genotype 2
Tablica 12: Stope SVR12 za odabrane podskupine prema genotipu u ispitivanju FUSION
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
Srednja vrijednost ± SD EC50 sofosbuvira za kimerične replikone koji kodiraju sekvence NS5B iz kliničkih izolata iznosila je 0,068 ± 0,024 μM za genotip 1a (n = 67),
Sovaldi is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3).
Sovaldi je kontraindiciran s karbamazepinom, fenobarbitalom i fenitoinom, jakim induktorima intestinalnog P-gp-a (vidjeti dio 4.3).
Otherc a. The efficacy analysis includes 6 subjects with recombinant genotype 2/1 HCV infection.
Analiza djelotvornosti uključuje 6 ispitanika s infekcijom rekombinantnim genotipom 2/1 HCV-a.
12 weeks (n = 68)
12 tjedana (n = 73)
Tenofovir disoproxil fumaratef (300 mg once daily)d
Darunavir pojačan ritonaviromf (800/100 mg jedanput na dan)
No dose adjustment of sofosbuvir or tenofovir disoproxil fumarate is required when sofosbuvir and tenofovir disoproxil fumarate are used concomitantly.
Nije potrebna prilagodba doze sofosbuvira ili tenofovir dizoproksil fumarata kad se sofosbuvir i tenofovir dizoproksil fumarat primjenjuju istodobno.
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).
Sigurnosni profil sofosbuvira i ribavirina kod ispitanika istodobno zaraženih HCV/HIV-om bio je sličan onome opaženom kod ispitanika zaraženih samo HCV-om koji su bili liječeni sofosbuvirom i ribavirinom u kliničkim ispitivanjima faze 3 (vidjeti dio 5.1).
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).
Sigurnosni profil sofosbuvira i ribavirina kod ispitanika zaraženih HCV-om prije transplantacije jetre bio je sličan onome opaženom u ispitanika liječenih sofosbuvirom i ribavirinom u kliničkim ispitivanjima faze 3 (vidjeti dio 5.1).
Table 11: Response rates in study FUSION SOF+RBV
Tablica 11: Stope odgovora u ispitivanju FUSION SOF+RBV
You can also report any side effects directly to the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.
Liver transplant recipients
Do transplantacije jetrec
Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a,b
Srednja vrijednost omjera (90% interval pouzdanosti) za AUC,
Otherc a. The efficacy analysis includes 3 subjects with recombinant genotype 2/1 HCV infection.
Analiza djelotvornosti uključuje 3 ispitanika s infekcijom rekombinantnim genotipom 2/1 HCV-a.
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).
(procjena brzine glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) ili završnim stadijem bolesti bubrega koje zahtijeva hemodijalizu (vidjeti dio 5.2).