FrancophonIA/ELRC3.0 huggingface dataset:
English: In this limited clinical safety data set, the rate of adverse events and deaths was not clearly elevated from what is expected in ESRD patients.
Croatian: U tom ograničenom skupu kliničkih sigurnosnih podataka, stopa štetnih događaja i smrti nije bila očito viša od one kakva se očekuje u bolesnika s ESRD-om.
English: Patients should be instructed that if vomiting occurs within 5 hours of dosing an additional tablet should be taken.
Croatian: Bolesnike treba uputiti da uzmu dodatnu tabletu ako povraćanje nastupi u roku od 5 sati nakon primjene.
English: Famotidine dosed 12 hours prior to Harvonid
Croatian: 12 sati prije lijeka Harvonid
English: Baseline NS5A RAVs were overrepresented in patients who experienced relapse in the Phase 3 studies (see “Clinical efficacy and safety”).
Croatian: Početni NS5A RAV bili su više zastupljeni u bolesnika koji su u ispitivanjima faze 3 imali relaps (vidjeti dio „Klinička djelotvornost i sigurnost“).
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Harvoni compared to subjects with normal renal function, as described in the text below, are provided in Table 20.
Croatian: Sažeti prikaz utjecaja različitih stupnjeva oštećenja bubrega na izloženost komponentama lijeka Harvoni u usporedbi s ispitanicima s normalnom funkcijom bubrega, kako je opisano u nastavku, prikazan je u tablici 20.
English: Interactions cannot be excluded with other HMG-CoA reductase inhibitors.
Croatian: Ne mogu se isključiti interakcije s drugim inhibitorima reduktaze HMG-CoA.
English: Patients treated with vitamin K antagonists
Croatian: Bolesnici liječeni antagonistima vitamina
English: Table 5 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined equivalence boundaries).
Croatian: U tablici 5 prikazan je popis ustanovljenih ili potencijalno klinički značajnih interakcija lijekova (gdje je 90 % interval pouzdanosti [CI] omjera geometrijske srednje vrijednosti najmanjih kvadrata [GLSM] bio unutar “↔”, protezao se iznad “↑”, ili ispod “↓” unaprijed određenih granica ekvivalencije).
English: As Harvoni contains ledipasvir and sofosbuvir, any interactions that have been identified with these active substances individually may occur with Harvoni.
Croatian: Budući da Harvoni sadrži ledipasvir i sofosbuvir, sve interakcije koje su bile utvrđene s ove dvije djelatne tvari zasebno mogu nastati i s lijekom Harvoni.
English: If you are taking a proton pump inhibitor, take it at the same time as Harvoni.
Croatian: Ako uzimate inhibitor protonske pumpe, uzmite ga u isto vrijeme kad i Harvoni.
English: No specific antidote is available for overdose with Harvoni.
Croatian: Nije dostupan specifični antidot za predoziranje lijekom Harvoni.
English: All three Phase 3 studies evaluated the efficacy of ledipasvir/sofosbuvir with or without ribavirin.
Croatian: Sva tri ispitivanja faze 3 procjenjivala su djelotvornost ledipasvira/sofosbuvira s ribavirinom ili bez njega.
English: The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side.
Croatian: Filmom obložene tablete narančaste su tablete u obliku romba, s utisnutim “GSI” na jednoj strani i “7985” na drugoj strani.
English: ≥ 2 g/dL decrease in haemoglobin during any 4-week treatment period
Croatian: Sniženje hemoglobina za ≥ 2 g/dl tijekom bilo kojeg 4-tjednog razdoblja liječenja
English: Proton pump inhibitor doses comparable to omeprazole 20 mg can be administered simultaneously with Harvoni.
Croatian: Doze inhibitora protonske pumpe usporedive s dozom omeprazola od 20 mg mogu se primijeniti istovremeno s lijekom Harvoni.
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Croatian: Veći dio doze sofosbuvira otkrivene u mokraći činio je GS-331007 (78 %), dok je 3,5 % bilo otkriveno kao sofosbuvir.
English: In this limited clinical safety data set, the rate of adverse events was not clearly elevated from what is expected in patients with severe renal impairment.
Croatian: U tom ograničenom skupu kliničkih sigurnosnih podataka, stopa štetnih događaja nije bila očito viša od one kakva se očekuje u bolesnika s teškim oštećenjem bubrega.
English: For the combination of tenofovir/emtricitabine + atazanavir/ritonavir, please see below.
Croatian: Za kombinaciju tenofovir/emtricitabin + atazanavir/ritonavir, molimo vidjeti niže.
English: Adults-Genotype 1
Croatian: Odrasli - genotip 1
English: When administered to lactating rats, ledipasvir was detected in plasma of suckling rats likely due to excretion of ledipasvir via milk.
Croatian: Kad se primjenjivao u ženki štakora tijekom laktacije, ledipasvir je bio otkriven u plazmi dojenih štakora vjerojatno zbog izlučivanja ledipasvira u mlijeko.
English: Exposure to GS-331007 in these studies was up to 17 times (mouse) and 9 times (rat) higher than the clinical exposure at 400 mg sofosbuvir.
Croatian: Izloženost GS-331007 u ovim ispitivanjima bila je do 17 puta (miš) i 9 puta (štakor) veća od kliničke izloženosti kod doze od 400 mg sofosbuvira.
English: 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
Croatian: 1000 mg na dan za bolesnike < 75 kg i 1200 mg za one težine ≥ 75 kg
English: In a rat pre- and postnatal study, at a maternally toxic dose, the developing rat offspring exhibited mean decreased body weight and body weight gain when exposed in utero (via maternal dosing) and during lactation (via maternal milk) at a maternal exposure 4 times the exposure in humans at the recommended clinical dose.
Croatian: U prenatalnom i postnatalnom ispitivanju na štakorima, pri dozi toksičnoj za majku, potomstvo štakora je tijekom razvoja pokazalo prosječno smanjenu tjelesnu težinu i smanjeno povećanje tjelesne težine kad je bilo izloženo in utero (putem primjene u majke) i tijekom laktacije (putem majčinog mlijeka) kod izloženosti majke 4 puta većoj od izloženosti ljudi pri preporučenoj kliničkoj dozi.
English: Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant
Croatian: Ciroza Child-Pugh-Turcotte (CPT) stadija B prije transplantacije
English: Reduced susceptibility to ledipasvir was associated with the primary NS5A substitution Y93H in both genotype 1a and 1b.
Croatian: Smanjena osjetljivost na ledipasvir bila je povezana s primarnom NS5A supstitucijom Y93H u oba genotipa i 1a i 1b.
English: Ledipasvir was not carcinogenic in the 26-week rasH2 transgenic mouse and the 2-year rat carcinogenicity studies at exposures up to 26-times in mice and 8-times in rats higher than human exposure.
Croatian: Ledipasvir nije bio kancerogen u 26-tjednom ispitivanju na rasH2 transgeničnim miševima i u 2-godišnjem ispitivanju kancerogenosti u štakora pri izloženostima koje su u miševa bile do 26 puta veće, a u štakora 8 puta veće od izloženosti ljudi.
English: The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets and outer cartons containing 84 (3 bottles of 28) film-coated tablets.
Croatian: Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bocu s 28 filmom obloženih tableta i kutije koje sadrže 84 (3 boce s 28) filmom obloženih tableta.
English: If you forget to take Harvoni
Croatian: Ako ste zaboravili uzeti Harvoni
English: Sofosbuvir activity (EC50, nM)
Croatian: Djelovanje sofosbuvira (EC50, nM)
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Croatian: Slučajevi teške bradikardije i srčanog bloka uočeni su kada je Harvoni korišten s amiodaronom i/ili drugim lijekovima koji snižavaju srčanu frekvenciju (vidjeti dijelove 4.4 i 4.5).
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Croatian: Silikagel kao sredstvo za sušenje nalazi se u posebnoj vrećici ili spremniku i ne smije se progutati.
English: Median peak plasma concentration of GS-331007 was observed at 4 hours post-dose.
Croatian: Medijan vršne koncentracije GS-331007 u plazmi bio je opažen 4 sata nakon uzimanja doze.
English: HCV/HBV (hepatitis B virus) co-infection
Croatian: Istovremena infekcija HCV/HBV-om (virusom hepatitisa B)
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203.
Croatian: Sofosbuvir se opsežno metabolizira u jetri i nastaje farmakološki aktivan nukleozidni analog trifosfat GS-461203.
English: a TE: number of treatment-experienced patients.
Croatian: TE: broj bolesnika koji su prethodno bili liječeni.
English: NS5A RAVs: No genotype 2 infected patients experienced relapse in the clinical study and therefore there are no data regarding NS5A RAVs at the time of failure.
Croatian: NS5A RAV-ovi: Niti jedan bolesnik zaražen genotipom 2 nije imao relaps u kliničkom ispitivanju te stoga nema podataka o NS5A RAV-ovima u vrijeme virološkog neuspjeha.
English: Adolescents: for ribavirin dosing recommendations see table 3 below.
Croatian: Adolescenti: preporuke za doziranje ribavirina vidjeti u tablici 3 niže.
English: The safety assessment of Harvoni was mainly based on pooled Phase 3 clinical studies, without a control, in 1952 patients who received Harvoni for 8, 12 or 24 weeks, including 872 patients who received Harvoni in combination with ribavirin.
Croatian: Procjena sigurnosti lijeka Harvoni uglavnom se temeljila na objedinjenim podacima iz kliničkih ispitivanja faze 3 bez kontrolne skupine u kojima je 1952 bolesnika primalo Harvoni tijekom 8, 12 ili 24 tjedna (uključujući i 872 bolesnika koji su primali Harvoni u kombinaciji s ribavirinom).
English: Therefore, Harvoni should not be used during breast-feeding.
Croatian: Stoga se Harvoni ne bi trebao primjenjivati tijekom dojenja.
English: In clinical studies - Adults-Genotype 2, 3, 4, 5 and 6
Croatian: U kliničkim ispitivanjima - odrasli, genotip 2, 3, 4, 5 i 6
English: In rabbit studies exposure to sofosbuvir was 6 times the expected clinical exposure.
Croatian: U ispitivanjima na kunićima izloženost sofosbuviru bila je 6 puta veća od očekivane kliničke izloženosti.
English: * - If a more normalized dose of ribavirin (by weight and renal function) cannot be reached for reasons of tolerability, 24 weeks of Harvoni + ribavirin should be considered in order to minimize the risk for relapse.
Croatian: * Ako zbog podnošljivosti nije moguće postići normaliziraniju dozu ribavirina (prema težini i funkciji bubrega), potrebno je razmotriti 24-tjednu primjenu lijeka Harvoni + ribavirin kako bi se rizik od relapsa smanjio na najmanju moguću mjeru.
English: The proportion of such baseline NS5A RAVs seen with deep sequencing varied from very low (cut off for assay = 1%) to high (main part of the plasma population).
Croatian: Udio takvih početnih NS5A RAV-ova koji se vidio pomoću detaljnog sekvencioniranja kretao se od vrlo malog (granična vrijednost testa = 1 %) do velikog (veći dio populacije plazme).
English: • rifapentine (antibiotic used to treat infections, including tuberculosis);
Croatian: • rifapentin (antibiotik koji se primjenjuje za liječenje infekcija, uključujući tuberkulozu);
English: Orange, diamond-shaped, film-coated tablet of dimensions 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side.
Croatian: Narančasta, filmom obložena tableta u obliku romba, veličine 19 mm x 10 mm, s utisnutim “GSI” na jednoj strani i “7985” na drugoj strani.
English: Harvoni + ribavirinA for 12 weeks or
Croatian: Harvoni s ribavirinomA tijekom 12 tjedana ili
English: d Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2.
Croatian: d. Metavir-rezultat = 4 ili rezultat po Ishaku ≥ 5 na biopsiji jetre ili rezultat FibroTesta > 0,75 i (APRI) > 2.
English: Interactions between Harvoni and other medicinal products
Croatian: Interakcije između lijeka Harvoni i drugih lijekova
English: At baseline, two patients had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0-39.6).
Croatian: Na početku ispitivanja, dva su bolesnika imala cirozu i srednja vrijednost eGFR bila je 24,9 ml/min (raspon: 9,0-39,6).
English: In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite was approximately 5 times higher than the clinical exposure at 400 mg sofosbuvir.
Croatian: U ispitivanjima na štakorima, izloženost sofosbuviru nije se mogla odrediti, ali granice izloženosti na temelju glavnog metabolita u ljudi bile su približno 5 puta veće od kliničke izloženosti kod doze od 400 mg sofosbuvira.
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~6-fold↑ 23-fold↑ Ledipasvir
Croatian: 1,6 puta↑ 2,1 puta↑ 2,7 puta↑ 1,3 puta↑ 1,6 puta↑ ~2 puta↑ 1,9 puta↑ GS-331007 1,6 puta↑ 1,9 puta↑ 5,5 puta↑
English: Harvoni tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
Croatian: Harvoni tablete isporučuju se u bocama od polietilena visoke gustoće (HDPE), s polipropilenskim sigurnosnim zatvaračem za djecu, koje sadrže 28 filmom obloženih tableta sa sredstvom za sušenje od silikagela i poliesterskom vaticom.
English: When Harvoni is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
Croatian: Kad se Harvoni primjenjuje u kombinaciji s ribavirinom, pročitajte također sažetak opisa svojstava lijeka za ribavirin za bolesnike s klirensom kreatinina (CrCl) < 50 ml/min (vidjeti dio 5.2).
English: ↑ Rosuvastatin (Inhibition of drug transporters OATP and BCRP)
Croatian: ↑ Rosuvastatin (Inhibicija prijenosnika lijekova OATP i BCRP)
English: • digoxin used to treat heart conditions;
Croatian: • digoksin koji se primjenjuje za liječenje srčanih bolesti;
English: Previously treated adults with cirrhosis - SIRIUS - Genotype 1
Croatian: Prethodno liječeni odrasli bolesnici s cirozom - SIRIUS - genotip 1
English: Fifty-five percent (55%) of the patients were treatment-experienced.
Croatian: Prethodno je bilo liječeno 55 % bolesnika.
English: Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively.
Croatian: Podaci detaljnog sekvenciranja za NS5A i NS5B (granična vrijednost testa od 1 %) nakon početka ispitivanja bili su dostupni za 37/37 odnosno 36/37 bolesnika.
English: Male gender
Croatian: Spol muški ženski
English: Clinical efficacy and safety in genotype 2, 3, 4, 5 and 6 (see also section 4.4) Ledipasvir/sofosbuvir has been evaluated for the treatment of non-genotype 1 infection in small Phase 2 studies, as summarised below.
Croatian: Klinička djelotvornost i sigurnost kod genotipa 2, 3, 4, 5 i 6 (vidjeti također dio 4.4) Ledipasvir/sofosbuvir procijenjen je za liječenje infekcije koja nije uzrokovana genotipom 1 u malim ispitivanjima faze 2, kako je sažeto prikazano niže.
English: Haemoglobin in patients with history of stable cardiac disease
Croatian: Hemoglobin u bolesnika sa stabilnom srčanom bolesti u anamnezi
English: Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Croatian: Defosforilacija dovodi do stvaranja nukleozidnog metabolita GS-331007 koji se ne može učinkovito ponovno fosforilirati i nema anti-HCV djelovanje in vitro.
English: In clinical studies - Adults-Genotype 1
Croatian: U kliničkim ispitivanjima - odrasli, genotip 1
English: B For ribavirin dosing recommendations in patients with decompensated cirrhosis, see table 2 below.
Croatian: B Preporuke za doziranje ribavirina u bolesnika s dekompenziranom cirozom vidjeti u tablici 2 niže.
English: • If you are sick (vomit) more than 5 hours after taking Harvoni, you do not need to take another tablet until your next scheduled tablet.
Croatian: • Ako povratite nakon više od 5 sati nakon uzimanja lijeka Harvoni, ne trebate uzeti drugu tabletu prije sljedeće tablete prema rasporedu.
English: ↔ indicates no clinically relevant change in the exposure of Ledipasvir.
Croatian: ↔ nema klinički relevantne promjene u izloženosti ledipasviru.
English: Table 20: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Ledipasvir Compared to Subjects with Normal Renal Function
Croatian: Tablica 20: Utjecaj različitih stupnjeva oštećenja bubrega na izloženost (AUC) sofosbuviru, GS-331007 i ledipasviru u usporedbi s ispitanicima s normalnom funkcijom bubrega
English: Relative to patients 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.
Croatian: U odnosu na bolesnike s normalnom jetrenom funkcijom, AUC0-24 sofosbuvira bila je 126 % odnosno 143 % viša kod umjerenog i teškog oštećenja funkcije jetre, dok je AUC0-24 GS-331007 bila 18 % odnosno 9 % viša.
English: The NS5A substitution Y93C emerged in the HCV of 1 patient (genotype 4), while NS5A RAVs present at baseline were observed at the time of failure in all patients.
Croatian: NS5A supstitucija Y93C pojavila se u HCV-u kod 1 bolesnika (genotip 4), dok su NS5A RAV-ovi prisutni na početku bili opaženi u vrijeme neuspjeha u svih bolesnika.
English: GS-461203 (the active metabolite of sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Croatian: GS-461203 (djelatni metabolit sofosbuvira) nije inhibitor ni ljudskih DNK- i RNK-polimeraza niti je inhibitor mitohondrijske RNK-polimeraze.
English: The improvement in MELD scores observed was driven largely by improvements in total bilirubin.
Croatian: Opaženo poboljšanje MELD rezultata uglavnom je bilo odraz poboljšanja ukupnog bilirubina.
English: Both sofosbuvir and ledipasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
Croatian: I sofosbuvir i ledipasvir su bili potpuno djelatni protiv supstitucija povezanih s rezistencijom na druge direktno djelujuće antivirotike i različitim mehanizmom djelovanja, kao što su NS5B nenukleozidni inhibitori i NS3 inhibitori proteaze.
English: 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 doses which cause adverse effects was 16 times (rat) and 71 times (dog) higher than the clinical exposure at 400 mg sofosbuvir.
Croatian: Izloženost sofosbuviru u ispitivanjima na glodavcima nije se mogla otkriti, vjerojatno zbog jake aktivnosti esteraze; međutim, izloženost glavnom metabolitu GS-331007 u dozama koje uzrokuju štetne učinke bila je 16 puta (štakor) i 71 puta (pas) veća od kliničke izloženosti kod doze od 400 mg sofosbuvira.
English: Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis (see section 5.1).
Croatian: Sigurnost i djelotvornost ledipasvira/sofosbuvira ustanovljene su u bolesnika s dekompenziranom cirozom (vidjeti dio 5.1).
English: Close monitoring is recommended if this medicinal product is administered with Harvoni (see sections 4.4 and 4.8).
Croatian: Preporučuje se pažljivo praćenje ako se ovaj lijek primjenjuje s lijekom Harvoni (vidjeti dijelove 4.4 i 4.8).
English: In this setting, exposure of sofosbuvir metabolite GS331007 is 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials.
Croatian: U takvim okolnostima, izloženost metabolitu sofosbuvira GS-331007 povećana je 20 puta i premašuje razine pri kojima su nuspojave opažene u pretkliničkim ispitivanjima.
English: In the pooled analysis of the Phase 3 studies, 16% of patients had baseline NS5A RAVs identified by population or deep sequencing irrespective of subtype.
Croatian: U analizi objedinjenih podataka iz ispitivanja faze 3, 16 % bolesnika imalo je početne NS5A RAV utvrđene populacijskim ili detaljnim sekvencioniranjem bez obzira na podtip.
English: Site-directed mutagenesis of the Y93H substitution in both genotype 1a and 1b as well as the Q30R and L31M substitution in genotype 1a conferred high levels of reduced susceptibility to ledipasvir (fold-change in EC50 ranging from 544-fold to 1,677-fold).
Croatian: Ciljana mutageneza u vidu supstitucije Y93H u oba genotipa 1a i 1b, kao i Q30R i L31M supstitucija u genotipu 1a, dovela je do jako smanjene osjetljivosti na ledipasvir (promjena u EC50 u rasponu od 544 do 1677 puta).
English: The physician in charge of the diabetic care of the patient should be informed when direct-acting antiviral therapy is initiated.
Croatian: Liječnik zadužen za praćenje dijabetesa u bolesnika mora biti obaviješten o uvođenju terapije direktno djelujućim antivirotikom.
English: The SVR12 rate was 98% overall (98% [78/80] in treatment-naïve patients and 100% [20/20] in treatment experienced patients).
Croatian: Stopa SVR12 iznosila je ukupno 98 % (98 % [78/80] u prethodno neliječenih bolesnika i 100 % [20/20] u prethodno liječenih bolesnika).
English: Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
Croatian: Početna doza od 600 mg koja se može titrirati do najviše 1000/1200 mg (1000 mg za bolesnike težine < 75 kg i 1200 mg za one težine ≥ 75 kg) ako se dobro podnosi.
English: There were no effects on survival, physical and behavioural development and reproductive performance in the offspring at maternal exposures similar to the exposure in humans at the recommended clinical dose.
Croatian: Nije bilo učinaka na preživljenje, fizički i bihevioralni razvoj te reproduktivne sposobnosti potomstva pri izloženostima majke sličim izloženosti ljudi pri preporučenoj kliničkoj dozi.
English: Unchanged ledipasvir excreted in faeces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose.
Croatian: Na nepromijenjeni ledipasvir izlučen u stolici otpadala je srednja vrijednost od 70 % primijenjene doze, a na oksidativni metabolit M19 2,2 % doze.
English: At concentrations achieved in the clinic, ledipasvir is not an inhibitor of hepatic transporters including the OATP 1B1 or 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug and toxic compound extrusion (MATE) 1 transporter, multidrug resistance protein (MRP) 2 or MRP4.
Croatian: Pri koncentracijama koje se postižu u kliničkoj primjeni, ledipasvir nije inhibitor jetrenih prijenosnika, uključujući OATP 1B1 ili 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, prijenosnika za izbacivanje mnogih lijekova i toksičnih spojeva (MATE) 1, proteina odgovornog za rezistenciju na mnoge lijekove (MRP) 2 ili MRP4.
English: The adverse reactions are listed below by body system organ class and frequency.
Croatian: Nuspojave su navedene niže prema klasifikaciji organskih sustava i učestalosti.
English: Within ledipasvir/sofosbuvir, GS-331007 accounts for approximately 85% of total systemic exposure.
Croatian: Kod ledipasvira/sofosbuvira, na GS-331007 otpada približno 85 % ukupne sistemske izloženosti.
English: a Twelve patients transplanted prior to post-treatment Week 12 with HCV RNA< LLOQ at last measurement prior to transplant were excluded.
Croatian: Dvanaest bolesnika transplantiranih prije 12. tjedna nakon liječenja, s HCV RNK < LLOQ na zadnjem mjerenju prije transplantacije bilo je isključeno iz analize.