FrancophonIA/ELRC3.0 huggingface dataset:
English: In these healthy volunteer studies, there were no untoward effects observed at these dose levels, and adverse reactions were similar in frequency and severity to those reported in the placebo groups.
Croatian: U tim ispitivanjima sa zdravim dobrovoljcima nije bilo nepovoljnih učinaka opaženih pri ovim razinama doze, a nuspojave su imale sličnu učestalost i težinu kao i one zabilježene u skupinama koje su primale placebo.
English: Table 4 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration and cardiac status.
Croatian: Tablica 4 nudi smjernice za prilagodbu doze i prekid primjene na temelju koncentracije hemoglobina i srčanog statusa bolesnika.
English: Adults-Genotype 2, 3, 4, 5 and 6
Croatian: Odrasli - genotip 2, 3, 4, 5 i 6
English: Your liver function may change with treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.).
Croatian: Liječenjem hepatitisa C može se promijeniti funkcija Vaše jetre, što pak može utjecati na druge lijekove (npr. lijekove koji se primjenjuju za potiskivanje aktivnosti imunološkog sustava, itd.).
English: If the starting dose is not well tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels
Croatian: Ako se početna doza ne podnosi dobro, tu je dozu potrebno sniziti kako je klinički indicirano na temelju razina hemoglobina.
English: Although adverse events, including serious adverse events, occurred more frequently in this study compared to studies that excluded decompensated patients and/or patients who were postliver transplantation, the adverse events observed were those expected as clinical sequelae of advanced liver disease and/or transplantation or were consistent with the known safety profile of ribavirin (see section 5.1 for details of this study).
Croatian: Iako su se štetni događaji, uključujući ozbiljne štetne događaje, češće javljali u ovom ispitivanju nego u ispitivanjima iz kojih su bili isključeni dekompenzirani bolesnici i/ili bolesnici poslije transplantacije jetre, opaženi štetni događaji bili su očekivani kao kliničke posljedice uznapredovale bolesti jetre i/ili transplantacije ili su bile u skladu s poznatim sigurnosnim profilom ribavirina (vidjeti dio 5.1 za detalje ovog ispitivanja).
English: Tell your doctor or pharmacist if you have problems swallowing tablets.
Croatian: Obavijestite svog liječnika ili ljekarnika ako imate poteškoće s gutanjem tableta.
English: A coagulation test helps to identify patients with an increased bleeding risk due to increased dabigatran exposure.
Croatian: Pomoću testova koagulacije mogu se prepoznati bolesnici s povećanim rizikom od krvarenja zbog povećane izloženosti dabigatranu.
English: Other effects that may be seen during treatment with sofosbuvir:
Croatian: Ostale nuspojave koje se mogu opaziti tijekom liječenja sofosbuvirom:
English: In the SOLAR-2 study, one patient with genotype 4d developed NS5B substitution E237G at the time of relapse.
Croatian: U ispitivanju SOLAR-2 jedan bolesnik s genotipom 4d razvio je NS5B supstituciju E237G u vrijeme relapsa.
English: In repeat dose toxicology studies in rat and dog, high doses of the 1:1 diastereomeric mixture caused adverse liver (dog) and heart (rat) effects and gastrointestinal reactions (dog).
Croatian: U ispitivanjima toksičnosti ponovljene doze u štakora i psa, visoke doze dijastereomerne mješavine u omjeru 1:1 uzrokovale su štetne učinke na jetru (pas) i srce (štakor) i gastrointestinalne reakcije (pas).
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of ledipasvir by 12-fold against genotype 1a HCV replicons.
Croatian: Prisutnost 40 % ljudskog seruma nije imala učinka na anti-HCV djelovanje sofosbuvira, ali je smanjila anti-HCV djelovanje ledipasvira 12 puta protiv replikona genotipa 1a HCV-a.
English: ANTIARRHYTHMICS Amiodarone
Croatian: ANTIARITMICI Amiodaron
English: Ledipasvir plasma exposure (AUCinf) was similar in patients with severe hepatic impairment and control patients with normal hepatic function.
Croatian: Izloženost ledipasviru u plazmi (AUCinf) bila je slična u bolesnika s teškim oštećenjem jetre i kontrolnih bolesnika s normalnom jetrenom funkcijom.
English: Harvoni contains lactose
Croatian: Harvoni sadrži laktozu
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza “Rok valjanosti”.
English: SVR rates for selected subgroups Genotype
Croatian: Stope SVR-a u odabranim podskupinama Genotip
English: Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to < 18 years (see sections 4.2, 4.4 and 5.1).
Croatian: Harvoni je indiciran za liječenje kroničnog hepatitisa C (CHC) u odraslih i adolescenata u dobi od 12 do < 18 godina (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Due to the limited size of studies, the impact of baseline NS5A RAVs on treatment outcome for patients with genotype 2, 3, 4, 5 or 6 CHC has not been fully evaluated.
Croatian: Zbog ograničene veličine ispitivanja, utjecaj početnih NS5A RAV-ova na ishod liječenja bolesnika s CHC-om uzrokovanim genotipom 2, 3, 4, 5 ili 6 nije u potpunosti procijenjen.
English: EU/1/14/958/001 28 film-coated tablets EU/1/14/958/002 84 (3 bottles of 28) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/958/001 28 filmom obloženih tableta EU/1/14/958/002 84 (3 boce s 28) filmom obloženih tableta
English: • kidney problems or if you are on kidney dialysis, since Harvoni has not been fully tested in patients with severe kidney problems;
Croatian: • tegobe s bubrezima ili ako se liječite dijalizom, budući da Harvoni nije u potpunosti ispitan u bolesnika koji imaju teške tegobe s bubrezima;
English: d Lack of pharmacokinetics interaction bounds 70-143%.
Croatian: d. Raspon u kojem nema farmakokinetičkih interakcija je od 70 % do 143 %. e.
English: Ledipasvir had no adverse effects on mating and fertility.
Croatian: Ledipasvir nije imao štetne učinke na parenje i plodnost.
English: Each film-coated tablet contains 156.8 mg of lactose (as monohydrate) and 261 micrograms of sunset yellow FCF aluminium lake.
Croatian: Jedna filmom obložena tableta sadrži 156,8 mg laktoze (u obliku hidrata) i 261 mikrogram boje sunset yellow FCF aluminium lake.
English: 7% of liver transplant recipients had a modification of their immunosuppressive agents.
Croatian: U 7 % bolesnika kojima je transplantirana jetra, primjena imunosupresivnih lijekova bila je modificirana.
English: Once ribavirin has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily.
Croatian: Nakon što se prekine primjena ribavirina bilo zbog poremećenih laboratorijskih nalaza ili kliničkih manifestacija, može se pokušati ponovno započeti s primjenom ribavirina u dozi od 600 mg na dan i dalje povisivati dozu do 800 mg na dan.
English: Harvoni is a medicine that contains the active substances ledipasvir and sofosbuvir in a single tablet.
Croatian: Harvoni je lijek koji sadrži djelatne tvari, ledipasvir i sofosbuvir, u jednoj tableti.
English: HCV-Negative Subjects
Croatian: HCV-negativni ispitanici
English: As liver function may change during treatment with Harvoni, a close monitoring of International Normalised Ratio (INR) values is recommended.
Croatian: Budući da tijekom liječenja lijekom Harvoni može doći do promjene u funkciji jetre, preporučuje se pomno praćenje vrijednosti međunarodnog normaliziranog omjera (INR).
English: As a precautionary measure, it is preferable to avoid the use of Harvoni during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Harvoni tijekom trudnoće.
English: Table 7: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons
Croatian: Tablica 7: Djelovanje ledipasvira i sofosbuvira protiv kimeričkih replikona Genotip replikona
English: (Inhibition of P-gp)
Croatian: (Inhibicija P-gp)
English: Women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded as recommended in the Summary of Product Characteristics for ribavirin.
Croatian: 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.
English: Do not stop taking Harvoni
Croatian: Nemojte prestati uzimati Harvoni
English: Reduce ribavirin dose to 600 mg/day if:
Croatian: Sniziti dozu ribavirina na 600 mg/dan ako:
English: In adolescent patients aged 12 to < 18 years the following ribavirin dosing is recommended where ribavirin is divided into two daily doses and given with food:
Croatian: U adolescenata u dobi od 12 do < 18 godina preporučuje se sljedeće doziranje ribavirina, s tim da je ribavirin podijeljen u dvije doze na dan i uzima se s hranom:
English: NS5A substitutions conferring resistance to ledipasvir may reduce the antiviral activity of other NS5A inhibitors.
Croatian: Supstitucije NS5A koje nose rezistenciju na ledipasvir mogu smanjiti antivirusno djelovanje drugih inhibitora NS5A.
English: All 5 patients who did not achieve SVR12 relapsed after having end-of-treatment response (see section “Resistance” - “In clinical studies” above).
Croatian: Svih 5 bolesnika koji nisu postigli SVR12 imalo je relaps nakon terapijskog odgovora na kraju liječenja (vidjeti dio “Rezistencija” - “U kliničkim ispitivanjima”, gore).
English: However, it has not been possible to fully estimate exposure margins achieved for sofosbuvir in the rat relative to the exposure in humans at the recommended clinical dose (see section 5.3).
Croatian: Međutim, nije bilo moguće u potpunosti procijeniti granice izloženosti sofosbuviru koje se postižu kod štakora u odnosu na izloženost u ljudi pri preporučenoj kliničkoj dozi (vidjeti dio 5.3).
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir.
Croatian: Istovremena primjena amiodarona bila je ograničena tijekom kliničkog razvoja sofosbuvira.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Harvoni when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Croatian: Slučajevi su potencijalno opasni po život, stoga se amiodaron smije koristiti samo u bolesnika koji primaju Harvoni u slučajevima kada se drugi zamjenski antiaritmici ne podnose ili su kontraindicirani.
English: In genotype 3-infection, the use of Harvoni (always in combination with ribavirin) should only be considered for patients who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
Croatian: Kod infekcije genotipom 3, primjena lijeka Harvoni (uvijek u kombinaciji s ribavirinom) smije se razmotriti samo u bolesnika za koje se smatra da imaju visok rizik od progresije kliničke bolesti i koji nemaju druge mogućnosti liječenja.
English: Site-directed mutagenesis of the S282T substitution in replicons of 8 genotypes conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the viral replication capacity by 89% to 99% compared to the corresponding wild-type.
Croatian: Ciljana mutageneza u vidu supstitucije S282T u replikonima 8 genotipova dovela je do 2 do 18 puta smanjene osjetljivosti na sofosbuvir i smanjila je kapacitet umnažanja virusa za 89 % do 99 % u usporedbi s odgovarajućim divljim tipom.
English: Serum HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Croatian: Vrijednosti HCV RNK u serumu tijekom kliničkih ispitivanja bile su mjerene pomoću testa COBAS TaqMan HCV (verzija 2.0), koji se koristi sa sustavom High Pure System.
English: Table 1: Recommended treatment duration for Harvoni and the recommended use of co-administered ribavirin for certain subgroups
Croatian: Tablica 1: Preporučeno trajanje liječenja lijekom Harvoni i preporučena istovremena primjena ribavirina u određenih podskupina
English: Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered sofosbuvir dose.
Croatian: Nakon jedne doze od 400 mg sofosbuvira, tijekom 4 sata hemodijalize uklonilo se 18 % primijenjene doze sofosbuvira.
English: SVR was the primary endpoint to determine the HCV cure rate which was defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment.
Croatian: SVR bio je primarni ishod prema kojem se određivala stopa izlječenja HCV-a, koje se definiralo kao HCV RNK manji od LLOQ 12 tjedana nakon završetka liječenja.
English: Carcinogenicity studies in mice and rats do not indicate any carcinogenicity potential of sofosbuvir administered at doses up to 600 mg/kg/day in mouse and 750 mg/kg/day in rat.
Croatian: Ispitivanja kancerogenosti u miševa i štakora ne pokazuju nikakvu kancerogenost sofosbuvira primijenjenog u dozama do 600 mg/kg na dan u miša i 750 mg/kg na dan u štakora.
English: Haemoglobin in patients with no cardiac disease
Croatian: Hemoglobin u bolesnika bez srčane bolesti
English: • if you are awaiting a liver transplant; • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Croatian: • ako imate ili ste prethodno imali infekciju virusom hepatitisa B, jer će Vas liječnik možda htjeti pobliže pratiti;
English: Outcome for patients without SVR On-treatment virologic failure 0/215 Relapsea
Croatian: Virološki neuspjeh uz liječenje 0/215 Relapsa
English: Each bottle contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets.
Croatian: Jedna boca sadrži silikagel kao sredstvo za sušenje koje se mora držati u boci kao pomoć u zaštiti tableta.
English: Table 15 presents relapse rates with the 12-week regimens (with or without ribavirin) for selected subgroups (see also previous section “Effect of baseline HCV resistance-associated variants on treatment outcome”).
Croatian: Tablica 15 prikazuje stope relapsa kod 12-tjednih režima (s ribavirinom ili bez njega) za odabrane podskupine (vidjeti također prethodni dio „Utjecaj početnih varijanti HCV-a povezanih s rezistencijom na ishod liječenja“).
English: Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed (see section 5.2).
Croatian: Zbog gorkog okusa, preporučuje se ne žvakati niti drobiti filmom obloženu tabletu (vidjeti dio 5.2).
English: No dose adjustment of Harvoni is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Croatian: Nije potrebna prilagodba doze lijeka Harvoni u bolesnika s blagim, umjerenim ili teškim oštećenjem jetre (Child-Pugh-Turcotte [CPT] stadij A, B ili C) (vidjeti dio 5.2).
English: • antacids (such as aluminium/magnesium hydroxide or calcium carbonate).
Croatian: • antacide (kao što su aluminijev/magnezijev hidroksid ili kalcijev karbonat).
English: GS-331007 is efficiently removed by haemodialysis with an extraction coefficient of approximately 53%.
Croatian: GS-331007 se učinkovito odstranjuje hemodijalizom uz koeficijent ekstrakcije od približno 53 %.
English: Biochemical confirmation of NS5A inhibition by ledipasvir is not currently possible as NS5A has no enzymatic function.
Croatian: Biokemijska potvrda inhibicije NS5A ledipasvirom trenutno nije moguća, jer NS5A nema enzimsku funkciju.
English: Protein binding of GS-331007 was minimal in human plasma.
Croatian: Vezanje GS-331007 za proteine u ljudskoj plazmi bilo je minimalno.
English: The improvement in CPT scores observed was driven largely by improvements in total bilirubin and albumin.
Croatian: Opaženo poboljšanje CPT rezultata uglavnom je bilo odraz poboljšanja ukupnog bilirubina i albumina.
English: All patients receiving Harvoni 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.
Croatian: Sve bolesnike koji primaju Harvoni u kombinaciji s amiodaronom i drugim lijekovima koji snižavaju frekvenciju srca ili bez njih treba također upozoriti na simptome bradikardije i srčanog bloka te im treba savjetovati da hitno potraže liječnički savjet ukoliko osjete iste.
English: b Two patients who did not have decompensated cirrhosis and had also not received a liver transplant were excluded due to failure to meet the inclusion criteria for any of the treatment groups.
Croatian: b. Dva bolesnika koja nisu imala dekompenziranu cirozu i nisu bila podvrgnuta transplantaciji jetre isključena su jer nisu ispunjavali kriterije uključenja u bilo koju terapijsku skupinu.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Harvoni.
Croatian: U nekih bolesnika sa šećernom bolesti zabilježene su niske razine šećera u krvi (hipoglikemija) nakon početka liječenja lijekovima kao što je Harvoni.
English: H2-receptor antagonists may be administered simultaneously with or staggered from Harvoni at a dose that does not exceed doses comparable to famotidine 40 mg twice daily.
Croatian: H2-receptora mogu se primijeniti istovremeno s lijekom Harvoni ili u nekom vremenskom razmaku od lijeka Harvoni u dozi koja ne prelazi doze usporedive s dozom famotidina od 40 mg dvaput na dan.
English: • amiodarone used to treat irregular heartbeats;
Croatian: • amiodaron, koji se koristi za liječenje nepravilnih otkucaja srca;
English: 84 (3 bottles of 28) film-coated tablets.
Croatian: 84 (3 boce s 28) filmom obloženih tableta.
English: Additionally a Q30E substitution developed in genotype 1a replicons.
Croatian: Uz to, izazvana je Q30E supstitucija u replikonima genotipa 1a.
English: Some medicines should not be taken with Harvoni.
Croatian: Neki lijekovi ne smiju se uzimati s lijekom Harvoni:
English: Effect of baseline HCV resistance-associated variants on treatment outcome
Croatian: Utjecaj početnih varijanti HCV-a povezanih s rezistencijom na ishod liječenja
English: Haemodialysis is unlikely to result in significant removal of ledipasvir as ledipasvir is highly bound to plasma protein.
Croatian: Hemodijaliza najvjerojatnije neće dovesti do značajnog uklanjanja ledipasvira, jer je ledipasvir u visokom postotku vezan za proteine plazme.
English: Genotype 6e
Croatian: Genotip 6e
English: The safety of Harvoni has been evaluated in a 12-week non-controlled study including 95 patients with ESRD requiring dialysis (Study 4063).
Croatian: Sigurnost lijeka Harvoni procijenjena je u 12-tjednom nekontroliranom ispitivanju koje je obuhvatilo 95 bolesnika s ESRD-om koji je zahtijevao dijalizu (ispitivanje 4063).
English: Sofosbuvir was absorbed quickly and the median peak plasma concentrations were observed ~ 1 hour post-dose.
Croatian: Sofosbuvir se brzo apsorbirao i medijan vršne koncentracije u plazmi opažen je ~ 1 sat nakon uzimanja doze.
English: The exposures to GS-331007 and ledipasvir were not altered in the presence of either meal type.
Croatian: Izloženosti GS-331007 i ledipasviru nisu bile promijenjene u prisutnosti ni jedne ni druge vrste obroka.
English: • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: • Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Harvoni.
Croatian: Vaš će liječnik možda morati pažljivo pratiti druge lijekove koje uzimate i prilagoditi njihovu dozu nakon što počnete uzimati lijek Harvoni.
English: Elderly No dose adjustment is warranted for elderly patients (see section 5.2).
Croatian: Nije potrebna prilagodba doze u starijih bolesnika (vidjeti dio 5.2).
English: Patients with compensated cirrhosis and/or prior treatment failure
Croatian: Bolesnici s kompenziranom cirozom i/ili prethodno neuspješnim lječenjem
English: Atazanavir concentrations are also increased, with a risk for an increase in bilirubin levels/icterus.
Croatian: Koncentracije atazanavira također su povišene, uz rizik od povišenja razine bilirubina/žutice.
English: a HCV RNA values were determined using the Roche TaqMan Assay; a patient's HCV RNA may vary from visit to visit.
Croatian: Vrijednosti HCV RNK bile su utvrđene pomoću testa Roche TaqMan; HCV RNK bolesnika može se razlikovati od posjeta do posjeta.
English: • If it's 18 hours or more after the time you usually take Harvoni, wait and take the next dose at your usual time.
Croatian: • Ako je prošlo 18 sati ili više od vremena kad obično uzimate Harvoni, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: Clinically significant medicinal product interactions with ledipasvir/sofosbuvir mediated by CYP450s or UGT1A1 enzymes are not expected.
Croatian: Ne očekuju se klinički značajne interakcije lijekova s ledipasvirom/sofosbuvirom posredovane enzimima CYP450 ili UGT1A1.
English: (Induction of P-gp)
Croatian: (Indukcija P-gp)
English: Glucose levels of diabetic patients initiating direct-acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Croatian: Razine glukoze u bolesnika s dijabetesom koji započinju liječenje direktno djelujućim antivirusnim lijekom treba pažljivo nadzirati, posebno unutar prva tri mjeseca, te prema potrebi prilagoditi lijek protiv dijabetesa.
English: • statins used to treat high cholesterol;
Croatian: • statine koji se primjenjuju za liječenje visokog kolesterola.
English: Table 5: Interactions between Harvoni and other medicinal products Medicinal product by therapeutic areas
Croatian: Tablica 5: Interakcije između lijeka Harvoni i drugih lijekova Lijekovi prema terapijskim područjima
English: Of the seven patients who did not achieve SVR12, none experienced virologic failure or relapsed.
Croatian: Ni u jednog od sedmero bolesnika koji nisu postigli SVR12 nije zabilježen virološki neuspjeh ili relaps.
English: A total of 80 patients (80%) were treatment-naïve, while 20 patients (20%) were treatment-experienced.
Croatian: Ukupno 80 bolesnika (80 %) prethodno nije bilo liječeno, a 20 bolesnika (20 %) već je bilo liječeno.
English: • proton pump inhibitors (such as omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole).
Croatian: • inhibitore protonske pumpe (kao što je omeprazol, lanzoprazol, rabeprazol, pantoprazol i esomeprazol).
English: • If you notice within 18 hours of the time you usually take Harvoni, you must take the tablet as soon as possible.
Croatian: • Ako to opazite u roku od 18 sati od vremena kad obično uzimate Harvoni, morate što prije uzeti tabletu.
English: HCV replicons with reduced susceptibility to sofosbuvir have been selected in cell culture for multiple genotypes including 1b, 2a, 2b, 3a, 4a, 5a and 6a.
Croatian: Replikoni HCV-a sa smanjenom osjetljivošću na sofosbuvir odabrani su u staničnoj kulturi za više genotipova uključujući 1b, 2a, 2b, 3a, 4a, 5a i 6a.
English: If it is after 18 hours then patients should be instructed to wait and take the next dose at the usual time.
Croatian: Ako je proteklo više od 18 sati, onda bolesnicima treba savjetovati da pričekaju i uzmu sljedeću dozu u uobičajeno vrijeme.
English: Available pharmacokinetic data in animals has shown excretion of ledipasvir and metabolites of sofosbuvir in milk (see section 5.3).
Croatian: Dostupni farmakokinetički podaci u životinja pokazuju da se ledipasvir i metaboliti sofosbuvira izlučuju u mlijeku (vidjeti dio 5.3).