natgillin/translations-raw huggingface dataset:
Available pharmacokinetic data in animals has shown excretion of metabolites in milk (for details see section 5.3).
Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje presnovkov v mleko (za podrobnosti glejte poglavje 5.3).
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%)].
Stopnje SVR12 so bile podobne pri osebah z izhodiščnim alelom C/C IL28B [94/95 (99 %)] in alelom ne-C/C (C/T ali T/T) [202/232 (87 %)].
MARKETING AUTHORISATION NUMBER(S) EU/1/13/894/001 28 film-coated tablets EU/1/13/894/002 84 (3 bottles of 28) film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/894/001 28 filmsko obloženih tablet EU/1/13/894/002 84 (3 plastenke po 28) filmsko obloženih tablet
(600 mg single dose)
(600 mg enkratni odmerek)
Outcome for subjects without SVR12
Izid za osebe brez SVR12
(400 mg twice daily)
(400 mg dvakrat na dan)
The AUC0-inf of GS-331007 in subjects with ESRD could not be reliably determined.
AUC0-inf GS-331007 pri osebah z ESRD ni bilo mogoče zanesljivo določiti.
The European Medicines Agency has deferred the obligation to submit the results of studies with sofosbuvir in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s sofosbuvirjem za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
IMMUNOSUPPRESSANTS Ciclosporine
IMUNOSUPRESIVI Ciklosporine
INFORMATION IN BRAILLE Sovaldi [Outer packaging only]
PODATKI V BRAILLOVI PISAVI Sovaldi [samo zunanja ovojnina]
What Sovaldi is and what it is used for What you need to know before you take Sovaldi How to take Sovaldi
Kaj je zdravilo Sovaldi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Sovaldi Kako jemati zdravilo Sovaldi
What Sovaldi is and what it is used for
Kaj je zdravilo Sovaldi in za kaj ga uporabljamo
Treatment duration was fixed in each study and was not guided by subjects' HCV RNA levels (no response guided algorithm).
Trajanje zdravljenja je bilo določeno za vsako študijo in se ni usmerjalo glede na ravni RNA HCV oseb (brez algoritma, vodenega z odzivi).
• Modafinil (a medicine to treat people with narcolepsy to help them stay awake).
• modafinil (zdravilo za zdravljenje oseb z narkolepsijo, da ostanejo budni).
Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill, County Cork Ireland
Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill,County Cork Irska
The assay had a lower limit of quantification (LLOQ) of 25 IU/mL.
Test je imel spodnjo mejo kvantifikacije (LLOQ, lower limit of quantification) 25 i.e./ml.
The use of Sovaldi in children and adolescents has not yet been studied.
Uporabe zdravila Sovaldi pri otrocih in mladostnikih niso preučili.
Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide.
Filmska obloga: polivinilalkohol, titanov dioksid, makrogol 3350, smukec, rumeni železov oksid.
Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Zdravljenje z zdravilom Sovaldi mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi bolnikov s CHC.
Posology The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2).
Priporočeni odmerek je ena 400-miligramska tableta peroralno enkrat na dan s hrano (glejte poglavje 5.2).
On-treatment virologic failure
Virološki neuspeh med zdravljenjem
↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
Pričakovane: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
c. Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
c. Med drugo so bile vključene osebe, ki niso dosegle SVR12 in niso izpolnjevale kriterijev za virološki neuspeh (npr. izgubljeni za spremljanje).
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).
Trajni virološki odziv (SVR, sustained virologic response) je bil primarni opazovani dogodek za ugotovitev stopnje ozdravljenja HCV za vse študije, ki je bil opredeljen kot RNA HCV manj kot LLOQ 12 tednov po koncu zdravljenja (SVR12).
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b) Yellow iron oxide (E172)
Filmska obloga polivinilalkohol (E1203) titanov dioksid (E171) makrogol 3350 (E1521) smukec (E553b) rumeni železov oksid (E172)
HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf
PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI INTEGRAZE Raltegravirf
b. Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
b. Med drugo so bile vključene osebe, ki niso dosegle SVR12 in niso izpolnjevale kriterijev za virološki neuspeh (npr. izgubljeni za spremljanje).
The predominant inactive circulating metabolite GS-331007 that accounts for greater than 90% of drug-related material systemic exposure is formed through pathways sequential and parallel to formation of active metabolite.
Prevladujoči neaktivni cirkulirajoči presnovek GS-331007, ki predstavlja več kot 90 % sistemske izpostavljenosti, povezane z zdravilom, nastaja zaporedno in vzporedno z nastajanjem aktivnega presnovka.
Post-baseline NS5B sequences were available for 225 of the 226 subjects, with deep sequencing data (assay cutoff of 1%) from 221 of these subjects.
Zaporedja NS5B po izhodišču so bila na voljo za 225 od 226 oseb, s podatki karakterizacije strukture genoma (deep sequencing) (mejna vrednost testa 1 %) za 221 od teh oseb.
Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Sovaldi in combination with another DAA.
Zaradi dolge razpolovne dobe amiodarona je treba ustrezno spremljati tudi bolnike, ki so prekinili zdravljenje z amiodaronom v zadnjih nekaj mesecih in bodo začeli zdravljenje z zdravilom Sovaldi v kombinaciji z drugim zdravilom z direktnim delovanjem na viruse.
Cirrhosis n = number of subjects with SVR12 response; N = total number of subjects per group.
Ciroza n = število oseb z odzivom SVR12; N = skupno število oseb v skupini.
Haemoglobin in subjects with no cardiac disease
Hemoglobin pri osebah brez bolezni srca
Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults of 18 years and older.
Zdravilo Sovaldi vsebuje zdravilno učinkovino sofosbuvir, ki se daje za zdravljenje okužbe z virusom hepatitisa C pri odraslih, starih 18 let in več.
No effect = 1.00 b. All interaction studies conducted in healthy volunteers c. Comparison based on historical control d. Administered as Atripla e. Bioequivalence boundary 80%-125% f. Equivalence boundary 70%-143%
b. Vse študije interakcij so opravili pri zdravih prostovoljcih c. Primerjava temelji na zgodovinskih kontrolnih podatkih d. Uporabljeno kot zdravilo Atripla e. Meje bioekvivalence 80 %-125 % f. Meje ekvivalence 70 %-143 %
Table 3: Interactions between Sovaldi and other medicinal products Medicinal product by therapeutic areas
Preglednica 3: Interakcije med zdravilom Sovaldi in drugimi zdravili Zdravila po terapevtskih področjih
This subject harboured <1% HCV S282T at baseline and developed S282T (>99%) at 4 weeks post-treatment which resulted in a 13.5-fold change in sofosbuvir EC50 and reduced viral replication capacity.
Ta oseba je bila ob izhodišču nosilec < 1 % HCV S282T in je razvila S282T (> 99 %) 4 tedne po zdravljenju, kar je povzročilo 13,5-kratno spremembo EC50 za sofosbuvir in zmanjšalo replikacijsko sposobnost virusa.
If you take more Sovaldi than you should
Če ste vzeli večji odmerek zdravila Sovaldi, kot bi smeli
• changes in your liver (as shown by increased amounts of a substance called bilirubin in the blood)
• spremembe na jetrih (kar kaže povečanje snovi, imenovane bilirubin, v krvi) Pogosti neželeni učinki
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.
Vendar pa podatki kažejo vsaj 10-krat oz. 20-krat večjo izpostavljenost GS-331007 pri osebah z ESRD v primerjavi z osebami z normalnim delovanjem ledvic pri dajanju zdravila Sovaldi 1 uro pred hemodializo oz. 1 uro po njej.
The safety of Sovaldi has not been assessed in patients with severe renal impairment or ESRD (see section 4.4).
Varnosti zdravila Sovaldi niso ocenili pri bolnikih s hudo ledvično okvaro ali ESRD (glejte poglavje 4.4).
Treatment-experienced (FUSION)
Predhodno zdravljeni (FUSION)
The proportion of subjects who permanently discontinued treatment due to adverse reactions was 1.4% for subjects receiving placebo, 0.5% for subjects receiving sofosbuvir + ribavirin for 12 weeks, 0% for subjects receiving sofosbuvir + ribavirin for 16 weeks, 11.1% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2.4% for subjects receiving sofosbuvir + peginterferon alfa + ribavirin for 12 weeks.
Delež oseb, ki so zaradi neželenih učinkov trajno prekinile zdravljenje, je bil 1,4 % oseb, ki so prejemale placebo, 0,5 % oseb, ki so 12 tednov prejemale sofosbuvir + ribavirin, 0 % oseb, ki so 16 tednov prejemale sofosbuvir + ribavirin, 11,1 % oseb, ki so 24 tednov prejemale peginterferon alfa + ribavirin in 2,4 % oseb, ki so 12 tednov prejemale sofosbuvir + peginterferon alfa + ribavirin.
Treatment-naïve (QUANTUMb and
Predhodno nezdravljeni (QUANTUMb in
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.
V študiji 0126 so bila med zdravljenjem zelo pogosta zmanjšanja hemoglobina, pri čemer je prišlo pri 32,5 % (13/40 oseb) do zmanjšanja hemoglobina na < 10 g/dl, pri 1 osebi celo do zmanjšanja na < 8,5 g/dl.
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.
V združeni analizi 991 oseb, ki so prejele sofosbuvir v študijah 3. faze je bilo 226 oseb primernih za analizo odpornosti zaradi virološkega neuspeha ali predčasne prekinitve uporabe preiskovanega zdravila in zaradi HCV RNA > 1.000 i.e./ml.
• If you or your partner become pregnant during Sovaldi treatment or in the months that follow, you must contact your doctor immediately.
• Če vi ali vaša partnerka med zdravljenjem z zdravilom Sovaldi ali v mesecu, ki mu sledi,
• low red blood cell count (anaemia); the signs may include feeling tired, headaches, shortness of breath when exercising
• nizko število rdečih krvnih celic (anemija); znaki lahko vključujejo občutek utrujenosti,
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.
Vendar pa je bila študija na podlagi nastalih podatkov razkrita in vse osebe s HCV genotipa 2 so še naprej 12 tednov prejemale sofosbuvir in ribavirin, medtem ko se je zdravljenje za osebe s HCV genotipa 3 podaljšalo na 24 tednov.
However, neither of these entities has been evidenced to be a general surrogate marker for efficacy (SVR12) at the therapeutic 400 mg dose.
Vendar pa ni bilo za nobeno od teh spojin dokumentirano, da sta splošna nadomestna kazalca učinkovitosti (SVR12) pri terapevtskem odmerku 400 mg. 5.3 Predklinični podatki o varnosti
Sovaldi is always taken with other medicines.
Zdravilo Sovaldi se vedno jemlje z drugimi zdravili.
Sofosbuvir is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) while GS-331007 is not.
Sofosbuvir je substrat prenašalca P-gp in proteina rezistence pri raku dojke (BCRP, breast cancer resistance protein), GS-331007 pa ni.
Tacrolimuse (5 mg single dose)
Takrolimuse (5 mg enkratni odmerek)
All patients receiving Sovaldi and another DAA in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Vse bolnike, ki prejemajo zdravilo Sovaldi in drugo zdravilo z direktnim delovanjem na viruse v kombinaciji z amiodaronom in drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, je treba prav tako opozoriti na simptome bradikardije in srčnega bloka ter jim svetovati, naj ob pojavu simptomov takoj poiščejo zdravniško pomoč.
After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7.
Po enem 400-miligramskem odmerku [14C]-sofosbuvirja pri zdravih osebah je bilo razmerje radioaktivnosti 14C v krvi in plazmi približno 0,7.
ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
ANTIKONVULZIVI Karbamazepin Fenobarbital Fenitoin
Common pyrexia, asthenia chest pain, asthenia a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
pireksija pogosti pireksija, astenija bolečine v prsih, astenija a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa Druge posebne populacije
Microcrystalline cellulose (E460(i)) Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
Jedro tablete manitol (E421) mikrokristalna celuloza (E460(i)) premrežen natrijev karmelozat brezvodni koloidni silicijev dioksid (E551) magnezijev stearat (E470b)
Co-administration with other direct-acting antivirals against HCV Sovaldi should only be co-administered with other direct-acting antiviral medicinal products if the benefit is considered to outweigh the risks based upon available data.
Sočasno dajanje z drugimi zdravili proti HCV z direktnim delovanjem na viruse Zdravilo Sovaldi se sme dajati sočasno z drugimi zdravili z direktnim delovanjem na viruse le, če se na podlagi razpoložljivih podatkov oceni, da je korist zdravljenja večja od tveganj.
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.
Populacijska farmakokinetična analiza pri osebah, okuženih s HCV, je pokazala, da znotraj analiziranega starostnega razpona (19 do 75 let) starost ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju in GS-331007.
Patients should be instructed that if vomiting occurs within 2 hours of dosing an additional tablet should be taken.
Bolnikom je treba naročiti, naj vzamejo dodatno tableto, če v 2 urah po odmerjanju bruhajo.
The film-coated tablet should not be chewed or crushed, due to the bitter taste of the active substance.
Filmsko obložene tablete naj ne žvečijo in ne drobijo, saj ima zdravilna učinkovina grenak okus.
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.
Pri osebah z ESRD je bila v primerjavi z osebami z normalnim delovanjem ledvic vrednost AUC0-inf sofosbuvirja za 28 % višja pri odmerjanju sofosbuvirja 1 uro pred hemodializo v primerjavi s 60 % višjo vrednostjo pri odmerjanju sofosbuvirja 1 uro po hemodializi.
Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sovaldi and another DAA when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Primeri so lahko smrtno nevarni, zato se lahko amiodaron pri bolnikih, ki prejemajo zdravilo Sovaldi in drugo zdravilo z direktnim delovanjem na viruse, uporablja samo, če drugih nadomestnih antiaritmikov ne prenašajo ali če so ti pri njih kontraindicirani.
The safety and efficacy of Sovaldi in children and adolescents aged <18 years have not yet been established.
Pediatrična populacija Varnost in učinkovitost zdravila Sovaldi pri otrocih in mladostnikih, starih < 18 let, še nista bili dokazani.
No dose adjustment is warranted for elderly patients (see section 5.2).
Pri starejših bolnikih odmerka ni treba prilagajati (glejte poglavje 5.2).
When you take Sovaldi in combination with another medicine to treat hepatitis C virus infection (including daclatasvir, simeprevir and ledipasvir) and amiodarone (a medicine used for heart problems), you may get one or more of the side effects below:
Ko vzamete zdravilo Sovaldi v kombinaciji z drugim zdravilom za zdravljenje okužbe z virusom hepatitisa C (vključno z daklatasvirjem, simeprevirjem in ledipasvirjem) in amiodaronom (zdravilo za zdravljenje težav s srcem), se lahko pojavi en ali več neželenih učinkov, navedenih spodaj:
The virologic response rates of the 41 subjects transplanted with HCV RNA <LLOQ is described in Table 17.
Stopnje virološkega odziva za prvih 41 oseb s presaditvijo, z RNA HCV < LLOQ, so navedene v preglednici 17.
HCV infected subjects, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria received 400 mg sofosbuvir and 1,000-1,200 mg ribavirin daily for a maximum of 24 weeks, subsequently amended to 48 weeks, or until the time of liver transplantation, whichever occurred first.
Osebe, okužene s HCV, neodvisno od genotpa, s hepatoceličnim karcinomom (HCC, hepatocellular carcinoma), ki so izpolnjevale kriterije po lestvici MILAN, so prejemale 400 mg sofosbuvirja in 1.000-1.200 mg ribavirina na dan za največ 24 tednov, naknadno popravljeno na 48 tednov, ali do presaditve jeter, kar je bilo prej.
12 weeks (n = 256)a
12 tednov (n = 256)a
Genotype 4, 5 or 6 97% (34/35) Cirrhosis
Genotip Genotip 1 Genotip 4, 5 ali 6 97 % (34/35) Ciroza Ne Da Rasa
• The active substance is sofosbuvir.
• Zdravilna učinkovina je sofosbuvir.
Dose modification Dose reduction of Sovaldi is not recommended.
Zmanjšanje odmerka zdravila Sovaldi se ne priporoča.
A 4-hour haemodialysis session removed approximately 18% of administered dose.
S 4-urno hemodializo se je izločilo približno 18 % uporabljenega odmerka.
Sofosbuvir is not a substrate for hepatic uptake transporters, organic anion-transporting polypeptide (OATP) 1B1 or 1B3, and organic cation transporter (OCT) 1.
Sofosbuvir ni substrat za jetrne privzemne prenašalce, transportni polipeptid organskih anionov (OATP, organic anion-transporting polypeptide) 1B1 ali 1B3 in prenašalca organskih kationov (OCT,
It is not known whether sofosbuvir, the active substance of Sovaldi, passes into human breast milk.
Ni znano, ali sofosbuvir, zdravilna učinkovina v zdravilu Sovaldi, prehaja v materino mleko.
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).
Farmakokinetiko sofosbuvirja so proučili po 7-dnevnem odmerjanju 400 mg sofosbuvirja pri osebah, okuženih s HCV, z zmerno in hudo jetrno okvaro (stopnja B ali C po CPT).
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.
Najpogostejši neželeni učinki zdravila, ki so se pojavili pri osebah, ki so dobivale sofosbuvir in ribavirin ali sofosbuvir, ribavirin in peginterferon alfa, so bile utrujenost, glavobol, navzea in nespečnost.
Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 24 weeks of treatment with sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C. Eligible subjects were ≥18 years old and had undergone liver transplantation 6 to 150 months prior to screening.
Sofosbuvir so preučili v odprti klinični študiji, v kateri so ocenjevali varnost in učinkovitost 24tedenskega zdravljenja s sofosbuvirjem in ribavirinom pri prejemnikih presajenih jeter s kroničnim hepatitisom C. Primerne osebe so bile stare ≥ 18 let in so imele presaditev jeter 6 do 150 mesecev pred presejanjem.
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.
Vključenih je bilo štirideset oseb (33 z okužbo s HCV genotipa 1, 6 z okužbo s HCV genotipa 3 in 1 oseba z okužbo s HCV genotipa 4), pri čemer je bilo pri 35 osebah predhodno zdravljenje na podlagi interferona neuspešno, 16 pa jih je imelo cirozo.
Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Jedro tablete: manitol, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvodni koloidni silicijev dioksid, magnezijev stearat.
The pharmacokinetics of sofosbuvir and GS-331007 in paediatric subjects have not been established (see section 4.2).
Pediatrična populacija Farmakokinetike sofosbuvirja in GS-331007 pri pediatričnih osebah niso ugotavljali (glejte poglavje 4.2).
Subjects were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1
Osebe bodisi niso prejemale protiretrovirusne terapije s številom celic CD4+ > 500 celic/mm3 ali so imele
Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
Uporablja se samo za bolnike, ki za zdravljenje peginterferonom alfa niso primerni ali ga ne prenašajo (glejte poglavje 4.4)
Treatment-naïve (ELECTRONb and
Predhodno nezdravljeni (ELECTRONb in
Sofosbuvir is a nucleotide prodrug that is extensively metabolised.
Sofosbuvir je nukleotidno predzdravilo, ki se obsežno presnavlja.
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenzf (600 mg once daily)d
PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI REVERZNE TRANSKRIPTAZE Efavirenzf (600 mg enkrat na dan)d
The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level.
Farmakokinetične lastnosti sofosbuvirja in prevladujočega cirkulirajočega presnovka GS-331007 so ocenili pri zdravih odraslih osebah in pri osebah s kroničnim hepatitisom C. Po peroralni uporabi se je sofosbuvir hitro absorbiral in dosegel najvišje koncentracije v plazmi ~0,5-2 uri po odmerku,
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.
Učinki izhodiščnega polimorfizma HCV na izid zdravljenja Izhodiščna zaporedja NS5B so pridobili za 1.292 oseb iz študij 3. faze z določanjem populacijskega zaporedja genoma, pri čemer substitucije S282T niso odkrili pri nobeni osebi, za katero je bilo na voljo izhodiščno zaporedje.
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 so preučili pri osebah, okuženih z virusom HCV, pred načrtovano transplantacijo jeter v odprti klinični študiji, v kateri so ocenjevali varnost in učinkovitost sofosbuvirja in ribavirina, ki so ga dajali pred presaditvijo, da se prepreči ponovna okužba s HCV po presaditvi.
with a CD4+ cell count >200 cells/mm3.
HIV-1 z virološko supresijo s številom celic CD4+ > 200 celic/mm3.
The safety of Sovaldi has not been assessed in subjects with severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD requiring haemodialysis.
Varnosti zdravila Sovaldi niso ocenili pri osebah s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) ali ESRD, zaradi katere bolnik potrebuje hemodializo.