natgillin/translations-raw huggingface dataset:
(600 mg single dose)
(jedna doza od 600 mg)
Sovaldi is not recommended for administration as monotherapy and should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection.
Općenito Sovaldi se ne preporučuje primjenjivati kao monoterapiju, nego ga treba propisivati u kombinaciji s drugim lijekovima za liječenje infekcije hepatitisom C.
95% of patients received antiretroviral therapy at the time of enrolment.
U vrijeme uključenja, 95% ispitanika primalo je antiretrovirusnu terapiju.
Treatment-experienced (LONESTAR-2b)
(LONESTAR-2b)
Dose modification Dose reduction of Sovaldi is not recommended.
Ne preporučuje se sniženje doze Sovaldija.
HCV ANITIVIRAL AGENTS: HCV PROTEASE INHIBITORS Boceprevir (BOC)
HCV ANTIVIRUSNI LIJEKOVI: INHIBITORI PROTEAZE HCV-a Boceprevir (BOC)
In subjects with ESRD, relative to subjects with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis.
U ispitanika s završnim stadijem bolesti bubrega, u odnosu na ispitanike s normalnom funkcijom bubrega, AUC0-inf sofosbuvira bio je 28% viši kad se doza sofosbuvira dala 1 sat prije hemodijalize u usporedbi sa 60% višim vrijednostima kad se doza sofosbuvira dala 1 sat nakon hemodijalize.
Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30) Cmin (NA)
Sofosbuvir ↑ Cmax 2,54 (1,87; 3,45) ↑ AUC 4,53 (3,26; 6,30) Cmin (ND/NP)
Haemoglobin in subjects with history of stable cardiac disease
Hemoglobin u ispitanika sa stabilnom srčanom bolesti u anamnezi
However, if ribavirin is co-administered with sofosbuvir, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics for ribavirin).
Međutim, ako se ribavirin primjenjuje istodobno sa sofosbuvirom, vrijede kontraindikacije za primjenu ribavirina tijekom trudnoće (vidjeti također Sažetak opisa svojstava lijeka za ribavirin).
The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV infected subjects with moderate and severe hepatic impairment (CPT class B and C).
Farmakokinetika sofosbuvira bila je ispitana nakon 7 dana doziranja 400 mg sofosbuvira u ispitanika zaraženih HCV-om s umjerenim i teškim oštećenjem jetre (CPT stadij B i C).
• muscle aches and pains, pain in the joints
• bol u mišićima, bol u zglobovima
SVR12 rates were similarly high in subjects with baseline IL28B C/C allele [94/95 (99%)] and non-C/C (C/T or T/T) allele [202/232 (87%)].
IL28B C/C alelom (94/95 [99%]) i ne-C/C (C/T or T/T) alelom (202/232 [87%]).
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.
Ako se sofosbuvir primjenjuje u kombinaciji s peginterferonom alfa, a bolesnik ima ozbiljnu nuspojavu potencijalno povezanu s tim lijekom, dozu peginterferona alfa potrebno je sniziti ili prekinuti njegovu primjenu.
Efficacy, in terms of rapid virologic response, has been shown to correlate with exposure to sofosbuvir as well as GS 331007.
Pokazalo se da djelotvornost, u smislu brzog virološkog odgovora, korelira s izloženošću kako sofosbuviru tako i GS-331007.
Forty subjects (33 with HCV genotype 1 infection, 6 with HCV genotype 3 infection, and 1 with HCV genotype 4 infection) were enrolled, 35 of whom had previously failed interferon-based treatment, and 16 of whom had cirrhosis.
Bilo je uključeno 40 ispitanika (33 s infekcijom HCV-om genotipa 1, 6 s infekcijom HCV-om genotipa 3 i 1 s infekcijom HCV-om genotipa 4), od kojih je 35 prethodno bilo neuspješno liječeno terapijom temeljenom na interferonu, a 16 je imalo cirozu.
b. Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Ostalo uključuje ispitanike koji nisu postigli SVR12 i nisu zadovoljili kriterije virološkog neuspjeha (npr. izgubljeni iz praćenja).
≥2 g/dL decrease in haemoglobin during any 4 week treatment period
Sniženje hemoglobina za ≥ 2 g/dl tijekom bilo kojeg 4
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).
Kad se Sovaldi primjenjuje u kombinaciji s ribavirinom ili peginterferonom alfa/ribavirinom, pročitajte također Sažetak opisa svojstava lijeka za ribavirin za bolesnike s klirensom kreatinina (CrCl) < 50 ml/min (vidjeti također dio 5.2).
Haemoglobin in subjects with no cardiac disease
Hemoglobin u ispitanika bez srčane bolesti
Co-administration of Sovaldi with medicinal products that inhibit P-gp and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma concentration, thus Sovaldi may be co-administered with P-gp and/or BCRP inhibitors.
Sovaldija s lijekovima koji inhibiraju P-gp i/ili BCRP može povećati koncentraciju sofosbuvira u plazmi bez povećavanja koncentracije GS-331007 u plazmi pa se stoga Sovaldi može istodobno primjenjivati s inhibitorima P-gp i/ili BCRP.
The pharmacokinetics of sofosbuvir and GS-331007 in paediatric subjects have not been established (see section 4.2).
Farmakokinetika sofosbuvira i GS-331007 u pedijatrijskih ispitanika nisu ustanovljene (vidjeti dio 4.2).
However, based on emerging data, the study was unblinded and all HCV genotype 2 subjects continued to receive sofosbuvir and ribavirin for 12 weeks, whilst treatment for HCV genotype 3 subjects was extended to 24 weeks.
Međutim, na temelju podataka koji su se pojavili, uklonilo se maskiranje u ispitivanju i svi ispitanici s genotipom 2 HCV-a nastavili su primati sofosbuvir i ribavirin tijekom 12 tjedana, dok je liječenje ispitanika s genotipom 3 HCV-a bilo produljeno na 24 tjedna.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/894/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/894/001
Subjects were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1
Ispitanici ili nisu primali antiretrovirusnu terapiju i imali su broj CD4+ stanica > 500 stanica/mm3 ili su imali virološki potisnut HIV-1 i broj CD4+
General disorders and administration site conditions: Very common fatigue, irritability chills, fatigue, influenza-like illness, irritability, pain, pyrexia
Opći poremećaji i reakcije na mjestu primjene: Vrlo često umor, razdražljivost zimica, umor, bolest nalik gripi, razdražljivost, bol, pireksija
In clinical pharmacology studies, both sofosbuvir and GS-331007 were monitored for purposes of pharmacokinetic analyses.
U ispitivanjima kliničke farmakologije, i sofosbuvir i GS-331007 bili su praćeni u svrhu farmakokinetičkih analiza.
Overallc Genotype 1a c
Genotip 1a
<1/1,000) or very rare (<1/10,000).
manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) ili vrlo rijetko (< 1/10 000).
HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
BILJNI PRIPRAVCI Gospina trava (Hypericum perforatum)
• Rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
• Ako trenutno uzimate neke od sljedećih lijekova: • rifampicin i rifabutin (antibiotici koji se primjenjuju za liječenje infekcija, uključujući tuberkulozu);
A single subject with genotype 5 and all 6 subjects with genotype 6 HCV infection in this study achieved SVR12.
Jedan ispitanik s infekcijom genotipom 5 i svih 6 ispitanika s infekcijom genotipom 6 HCV-a u ovom ispitivanju postiglo je SVR12.
• Oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
• okskarbazepin (lijek koji se primjenjuje za liječenje epilepsije i sprječavanje napadaja);
Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
Sofosbuvir i GS-331007 nisu supstrati ili inhibitori UGT1A1 ili enzima CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP2D6.
In a pooled analysis of 991 subjects who received sofosbuvir in Phase 3 studies, 226 subjects qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA >1,000 IU/mL.
U analizi objedinjenih podataka o 991 ispitanika koji su primali sofosbuvir u ispitivanjima faze 3, 226 ispitanika zadovoljilo je mjerila za analizu rezistencije zbog virološkog neuspjeha ili ranog prekida primjene lijeka tijekom ispitivanja i imalo je HCV RNK > 1000 IU/ml.
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.
U testu s replikonima HCV-a, vrijednosti učinkovite koncentracije (EC50) sofosbuvira protiv replikona pune duljine iz genotipova 1a, 1b, 2a, 3a i 4a bile su 0,04, 0,11, 0,05, 0,05 odnosno 0,04 μM, a vrijednosti EC50 sofosbuvira protiv kimeričnih replikonia 1b koji kodiraju NS5B iz genotipova 2b, 5a ili 6a bile su 0,014 do 0,15 μM.
Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Sovaldi and another DAA.
Ako se istodobna primjena amiodarona smatra neophodnom, preporučuje se da se bolesnike pažljivo prati na početku uzimanja Sovaldija i drugog izravno djelujućeg antivirotika.
Hepatobiliary disorders: Very common blood bilirubin increased blood bilirubin increased
Poremećaji jetre i žuči: Vrlo često povišen bilirubin u krvi povišen bilirubin u krvi
When you take Sovaldi with ribavirin or both peginterferon alfa and ribavirin, you may get one or more of the side effects below:
Kad uzmete Sovaldi s ribavirinom ili peginterferonom alfa i ribavirinom, možete dobiti jednu ili više sljedećih nuspojava: Vrlo česte nuspojave
Refer to the peginterferon alfa Summary of Product Characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose.
Pročitajte Sažetak opisa svojstava lijeka za peginterferon alfa zbog dodatnih informacija o tome kako sniziti dozu i/ili prekinuti primjenu peginterferona alfa.
• shortness of breath or worsening of any shortness of breath you already have
• nedostatak zraka ili pogoršanje već prisutnog nedostatka zraka
Treatment duration was fixed in each study and was not guided by subjects' HCV RNA levels (no response guided algorithm).
Trajanje liječenja bilo je fiksno u svakom ispitivanju i nije ovisilo o razini HCV RNK kod ispitanika (nije se koristio postupnik za liječenje prema odgovoru bolesnika).
Peak plasma concentration of GS-331007 was observed between 2 to 4 hours post-dose.
Vršna koncentracija GS-331007 u plazmi bila je opažena 2 do 4 sata nakon doze.
Nervous system disorders: Very common headache dizziness, headache
Poremećaji živčanog sustava: Vrlo često glavobolja omaglica, glavobolja
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.
Farmakokinetika sofosbuvira bila je ispitana u HCV-negativnih ispitanika s blagim (eGFR ≥ 50 i < 80 ml/min/1,73m2), umjerenim (eGFR ≥ 30 i < 50 ml/min/1,73m2), teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i ispitanika s završnim stadijem bolesti bubrega koji su trebali hemodijalizu, nakon jedne doze od 400 mg sofosbuvira.
Close monitoring is recommended if this medicinal product is administered with Sovaldi and another DAA (see sections 4.4 and 4.8).
Preporučuje se pažljivo praćenje ako se ovaj lijek primjenjuje sa Sovaldijem i drugim izravno djelujućim antivirotikom (vidjeti dijelove 4.4 i 4.8).
• low blood platelet count
• smanjen broj krvnih pločica
HCV replicons expressing the sofosbuvir-associated resistance substitution S282T were fully susceptible to other classes of anti-HCV agents.
Replikoni HCV-a s S282T supstitucijom povezanom s rezistencijom na sofosbuvir bili su potpuno osjetljivi na druge skupine lijekova protiv HCV-a.
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.
Kad se Sovaldi primjenjuje u kombinaciji s ribavirinom ili peginterferonom alfa/ribavirinom, žene reproduktivne dobi ili njihovi partneri moraju koristiti učinkoviti oblik kontracepcije tijekom liječenja i u razdoblju nakon završetka liječenja kako je preporučeno u Sažetku opisa svojstava lijeka za ribavirin.
Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected subjects.
U odnosu na zdrave ispitanike (n = 284), AUC0-24 sofosbuvira bio je 57% viši, a GS-331007 39% niži u ispitanika zaraženih HCV-om.
Population pharmacokinetic analysis in HCV infected subjects showed that within the age range (19 to 75 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Analiza populacijske farmakokinetike u ispitanika zaraženih HCV-om pokazala je da unutar analiziranog raspona dobi (19 do 75 godina), dob nije imala klinički važan učinak na izloženost sofosbuviru i GS-331007.
Discontinuation of dosing
Prekid doziranja
Virologic response in evaluable subjectsa a. Evaluable subjects are defined as those who have reached the specified time point at the time of the interim analysis.
Ispitanici koji su se mogli procijeniti definirani su kao oni koji su postigli određenu vremensku točku u vrijeme privremene analize.
In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50) value ranging from 0.7 to 2.6 μM.
GS-461203 inhibirao je aktivnost rekombinantne polimeraze NS5B HCV-a genotipa 1b, 2a, 3a i 4a uz 50% inhibitorne koncentracije (IC50) u rasponu od 0,7 do 2,6 μM.
Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Učestalost se definira kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10),
During treatment with sofosbuvir in combination with ribavirin or with peginterferon alfa and ribavirin, the most frequently reported adverse drug reactions were consistent with the expected safety profile of ribavirin and peginterferon alfa treatment, without increasing the frequency or severity of the expected adverse drug reactions.
Tijekom liječenja sofosbuvirom u kombinaciji s ribavirinom ili peginterferonom alfa i ribavirinom, najčešće zabilježene nuspojave bile su sukladne očekivanom sigurnosnom profilu kod liječenja ribavirinom i peginterferonom alfa, bez povećanja učestalosti ili težine tih očekivanih nuspojava na lijek.
The ribavirin dose was weight-based at 1,000-1,200 mg daily administered in two divided doses, and the peginterferon alfa 2a dose, where applicable, was 180 μg per week.
Doza ribavirina temeljena na tjelesnoj težini iznosila je 1000-1200 mg na dan primijenjena u dvije odvojene doze, a doza peginterferona alfa 2a, kad se primjenjivala, iznosila je 180 µg tjedno.
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.
U odnosu na ispitanike s normalnom jetrenom funkcijom, AUC0-24 sofosbuvira bio je 126% odnosno 143% viši kod umjerenog i teškog oštećenja funkcije jetre, dok je AUC0-24 GS-331007 bio 18% odnosno 9% viši.
Sovaldi has mainly been studied in combination with ribavirin, with or without peginterferon alfa.
Sovaldi je uglavnom ispitan u kombinaciji s ribavirinom, s peginterferonom alfa ili bez njega.
Black
Crnci
12 weeks (n = 256)a
12 tjedana (n = 256)a
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).
Liječenje bolesnika s infekcijom HCV-om genotipa 5 ili 6 Klinički podaci koji mogu poduprijeti primjenu Sovaldija u bolesnika s infekcijom HCV-om genotipa 5 i 6 vrlo su ograničeni (vidjeti dio 5.1).
The most common adverse drug reactions occurring in subjects receiving sofosbuvir and ribavirin or sofosbuvir, ribavirin and peginterferon alfa were fatigue, headache, nausea and insomnia.
Najčešće nuspojave na lijek koje su nastajale u ispitanika koji su primali sofosbuvir i ribavirin ili sofosbuvir, ribavirin i peginterferon alfa bile su umor, glavobolja, mučnina i nesanica.
Subjects were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level (<6 log10 IU/mL versus ≥6 log10 IU/mL).
Ispitanici su bili randomizirani u omjeru 1:1 i stratificirani prema cirozi (prisutna naspram odsutna), genotipu HCV-a (2 naspram 3) i početnoj razini HCV RNK (< 6 log10 IU/ml naspram ≥ 6 log10 IU/ml).
• weight loss
• gubitak na tjelesnoj težini
Consult the Summary of Product Characteristics for co-prescribed medicinal products before starting therapy with Sovaldi.
Pročitajte Sažetke opisa svojstava lijeka za lijekove koji se propisuju zajedno sa Sovaldijem prije početka liječenja Sovaldijem.
↓ Sofosbuvir
Očekuje se: ↓ Sofosbuvir
Sofosbuvir was fully active against substitutions associated with resistance to other direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors, NS3 protease inhibitors and NS5A inhibitors.
Sofosbuvir je bio potpuno djelatan protiv supstitucija povezanih s rezistencijom na druge antivirusne lijekove izravnog djelovanja s različitim mehanizmima djelovanja, kao što su NS5B ne-nukleozidni inhibitori,
Patients with genotype 3 CHC
Bolesnici s CHC
Table 17: Virologic response post-transplant in subjects with HCV RNA <LLOQ at the time of liver transplantation
Tablica 17: Virološki odgovor nakon transplantacije u ispitanika s HCV RNK < donje granice kvantifikacije u vrijeme transplantacije jetre
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.
Odrasli koji ne podnose, nisu pogodni ili nisu pristali na interferon - POSITRON (ispitivanje 107) POSITRON je bilo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u kojem se ocjenjivalo 12 tjedana liječenja sofosbuvirom i ribavirinom (n = 207) u usporedbi s placebom (n = 71) u ispitanika koji nisu podnosili, nisu bili pogodni ili nisu pristali na interferon.
• changes in your mood, feeling depressed, feeling anxious and feeling agitated
• promjene raspoloženja, deprimiranost, tjeskobnost i uznemirenost
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).
Ispitanici su primali 400 mg sofosbuvira i ribavirin na temelju tjelesne težine (1000 mg za ispitanike tjelesne težine < 75 kg ili 1200 mg za ispitanike tjelesne težine ≥ 75 kg).
• low red blood cell count (anaemia); the signs may include feeling tired, headaches, shortness of breath when exercising
• smanjen broj crvenih krvnih stanica (anemija); znakovi mogu uključivati umor, glavobolje,
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.
Slučajevi teške bradikardije i srčanog bloka opaženi su kada se sofosbuvir koristi u kombinaciji s drugim izravno djelujućim antivirotikom (uključujući daklatazvir, simeprevir i ledipasvir) i istodobno s amiodaronom s ili bez drugih lijekova koji snižavaju srčanu frekvenciju.
BOTTLE AND CARTON LABELLING
NALJEPNICA BOČICE I KUTIJE
Cmin (NA) Ethinyl estradiol ↔ Cmax 1.14 (0.96,
Cmin (ND/NP) Etinil estradiol ↔ Cmax 1,14 (0,96;
Eye disorders: Common vision blurred
Poremećaji oka: Često zamagljen vid
Population pharmacokinetics analysis in HCV infected subjects indicated that cirrhosis had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Analiza populacijske farmakokinetike u ispitanika zaraženih HCV-om pokazala je da ciroza nije imala klinički važan utjecaj na izloženost sofosbuviru i GS-331007.
with a CD4+ cell count >200 cells/mm3.
stanica > 200 stanica/mm3.
The median terminal half-lives of sofosbuvir and GS-331007 were 0.4 and 27 hours respectively.
Medijan terminalnog poluvijeka sofosbuvira iznosio je 0,4 sata, a GS-331007 27 sati.
Table 13: Response rates in study VALENCE Genotype 2
Tablica 13: Stope odgovora u ispitivanju VALENCE Genotip 2
Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with Sovaldi.
Pročitajte također Sažetak opisa svojstava lijeka za lijekove koji se primjenjuju u kombinaciji sa Sovaldijem.
Pharmacokinetics in special populations
Farmakokinetika u posebnim populacijama Spol i rasa
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of sofosbuvir.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 400 mg sofosbuvira.
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).
FUSION je bilo randomizirano, dvostruko slijepo ispitivanje u kojem se ocjenjivalo 12 ili 16 tjedana liječenja sofosbuvirom i ribavirinom u ispitanika koji nisu postigli SVR uz prethodno liječenje temeljeno na interferonu (relaps ili bez odgovora).
27/28 patients with genotype 4 HCV achieved SVR12.
SVR12 postiglo je 27/28 bolesnika s genotipom 4 HCV-a.
Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another DAA (including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Slučajevi teške bradikardije i srčanog bloka uočeni su kada se sofosbuvir koristio u kombinaciji s drugim izravno djelujućim antivirotikom (uključujući daklatazvir, simeprevir i ledipasvir) i istodobno s amiodaronom i/ili drugim lijekovima koji snižavaju srčanu frekvenciju (vidjeti dijelove 4.4 i 4.5).
Subjects were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence) and HCV genotype (2 versus 3).
Ispitanici su bili randomizirani u omjeru 1:1 i stratificirani prema cirozi (prisutnost naspram odsutnost) i genotipu HCV-a (2 naspram 3).
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Sofosbuvir i GS-331007 nisu inhibitori prijenosnika lijekova P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 i OCT1.
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.
Filmom obložene tablete su žute tablete u obliku kapsule, s utisnutim “GSI” na jednoj strani i “7977” na drugoj strani.
Sofosbuvir was studied in HCV infected subjects prior to undergoing liver transplantation in an open-label clinical study evaluating the safety and efficacy of sofosbuvir and ribavirin administered pre-transplant to prevent post-transplant HCV reinfection.
Sofosbuvir je bio ispitan u ispitanika zaraženih HCV-om prije transplantacije jetre u otvorenom kliničkom ispitivanju u kojem se ocjenjivala sigurnost i djelotvornost sofosbuvira i ribavirina primijenjenih prije transplantacije kako bi se spriječila ponovna infekcija HCV-om nakon transplantacije.
12 weeks (n = 103)a
12 tjedana (n = 103)a