FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicinal product by therapeutic areas/Possible Mechanism of Interaction
Croatian: Lijek prema terapijskim područjima/mogući mehanizam interakcije
English: NA = Not available
Croatian: ND = nije dostupno
English: The tablet is 20 mm long and 10 mm wide.
Croatian: Tableta je dugačka 20 mm i široka 10 mm.
English: Increased score (Worsening)
Croatian: Povećani rezultat (pogoršanje)
English: Increased score (Worsening) No assessment
Croatian: Povećani rezultat (pogoršanje) Bez procjene
English: e These are medicinal products within class where similar interactions could be predicted.
Croatian: Ovo su lijekovi iz skupine u kojoj se mogu predvidjeti slične interakcije.
English: Swallow the tablet whole with or without food.
Croatian: Tabletu progutajte cijelu sa ili bez hrane.
English: Recommended dose The recommended dose is one tablet once a day for 12 weeks.
Croatian: Preporučena doza Preporučena doza je jedna tableta jedanput na dan tijekom 12 tjedana.
English: Talk to your doctor or pharmacist before taking Epclusa if:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Epclusa ako:
English: The human relevance of this finding is not known.
Croatian: Značajnost tog otkrića za ljude nije poznato.
English: The following dosing is recommended where ribavirin is divided in two daily doses and given with food:
Croatian: Sljedeća doza preporučuje se kada je ribavirin podijeljen u dvije dnevne doze i kada se daje uz obrok:
English: What Epclusa is and what it is used for
Croatian: Što je Epclusa i za što se koristi
English: Mean ratio (90% confidence interval)a,b
Croatian: Srednji omjer (90 % interval pouzdanosti)a,b
English: • have liver problems other than from hepatitis C, for instance
Croatian: • ako imate tegobe s jetrom osim hepatitisa C, na primjer
English: These medicines can decrease the amount of velpatasvir in your blood.
Croatian: Ovi lijekovi mogu smanjiti količinu velpatasvira u Vašoj krvi.
English:  If this applies to you, do not take Epclusa and tell your doctor immediately.
Croatian: Ako se ovo odnosi na Vas, nemojte uzimati lijek Epclusa i odmah obavijestite svog liječnika.
English: This change could be to Epclusa or another medicine you are taking.
Croatian: Ta promjena može biti za lijek Epclusa ili neki drugi lijek koji uzimate.
English: Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
Croatian: Odmah obavijestite svog liječnika ako uzimate bilo kakve lijekove za srčane probleme i tijekom liječenja osjetite:
English: Use only if no other alternative is available.
Croatian: Upotrebljavati samo ako nije dostupno niti jedno zamjensko liječenje.
English: Combinations of these variants often showed greater reductions in susceptibility to velpatasvir than single RAVs alone.
Croatian: Kombinacije ovih varijanti često su pokazale veća smanjenja osjetljivosti na velpatasvir nego samo jedan RAV.
English: The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Croatian: Djelatne tvari u ovom lijeku djeluju zajedno tako što blokiraju dva različita proteina koja su virusu potrebna za rast i umnažanje i time omogućuju trajno uklanjanje infekcije iz tijela.
English: No assessment
Croatian: Bez procjene
English: Virologic failure (relapse and on-treatment failure) Genotype 1a
Croatian: Virološki neuspjeh (relaps i neuspjeh za vrijeme liječenja) Genotip 1a
English: No patients in the placebo group achieved SVR12.
Croatian: Nijedan bolesnik u skupini s placebom nije postigao SVR12.
English: Pharmacotherapeutic group: Direct acting antiviral, ATC code: J05AP55
Croatian: Farmakoterapijska skupina: Antivirotik koji djeluje direktno, ATC šifra: J05AP55
English: 1.4-fold↑
Croatian: 1,4 puta↑
English: Skin disorders Frequency not known: Stevens-Johnson syndrome
Croatian: Poremećaji kože Nepoznata učestalost: Stevens-Johnsonov sindrom
English: • rosuvastatin or other statins used to treat high cholesterol.
Croatian: • rosuvastatin ili druge statine koji se primjenjuju za liječenje visokog kolesterola.
English: Clinical studies in patients with Renal Impairment - study 4062
Croatian: Klinička ispitivanja u bolesnika s oštećenjem bubrega - ispitivanje 4062
English: Treatment of overdose with Epclusa consists of general supportive measures including monitoring of vital signs, as well as observation of the clinical status of the patient.
Croatian: Liječenje predoziranja lijekom Epclusa sastoji se od općih potpornih mjera uključujući praćenje vitalnih znakova kao i promatranje kliničkog stanja bolesnika.
English: Epclusa can be administered without regard to food.
Croatian: Epclusa se može primjenjivati bez obzira na hranu.
English: Overall 95% CI
Croatian: Ukupno 95 % CI
English: Study arms (Number of patients treated)
Croatian: Skupine u ispitivanju (Broj liječenih bolesnika)
English: If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take that medicine.
Croatian: Ako uzimate jedan od ovih lijekova, Vaš će Vam liječnik dati drugi lijek za želučani vrijed, žgaravicu ili povrat želučane kiseline ili preporučiti kako i kada da uzimate taj lijek.
English: It is given to treat a chronic (long-term) viral infection of the liver called hepatitis C in adults of 18 years and older.
Croatian: Daje se za liječenje kronične (dugotrajne) virusne infekcije jetre koja se naziva hepatitis C u odraslih u dobi od 18 godina i starijih.
English: What Epclusa looks like and contents of the pack
Croatian: Kako Epclusa izgleda i sadržaj pakiranja
English: If you do miss a dose, work out how long it is since you last took your Epclusa:
Croatian: Ako propustite uzeti dozu, izračunajte koliko je vremena prošlo otkad ste zadnji put uzeli lijek Epclusa:
English: If you take more Epclusa than you should
Croatian: Ako uzmete više lijeka Epclusa nego što ste trebali
English: Clinical studies of Epclusa included 156 patients aged 65 and over (12% of total number of patients in the Phase 3 clinical studies).
Croatian: Klinička ispitivanja lijeka Epclusa uključivala su 156 bolesnika u dobi od 65 godina i više (12 % ukupnog broja bolesnika u kliničkim ispitivanjima faze 3).
English: Observed: Rosuvastatin ↑
Croatian: Rosuvastatin ↑
English: • If you are allergic to sofosbuvir, velpatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Croatian: • Ako ste alergični na sofosbuvir, velpatasvir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6 ove upute).
English: • are taking treatment for human immunodeficiency virus (HIV) infection, since your doctor may want to monitor you more closely.
Croatian: • ako se liječite zbog infekcije virusom humane imunodeficijencije (HIV), budući da bi Vas liječnik možda htio pažljivije pratiti.
English: Expected.
Croatian: Očekuje se.
English: The effects of higher doses/exposures are not known.
Croatian: Učinci viših doza/izloženosti nisu poznati.
English: It is very important that you also read the leaflets for the other medicines that you will be taking with Epclusa.
Croatian: Vrlo je važno da pročitate i upute o lijeku za druge lijekove koje ćete uzimati s lijekom Epclusa.
English: NA = Not available a Mean value from multiple experiments of same laboratory replicon.
Croatian: Srednja vrijednost iz višestrukih pokusa istog laboratorijskog replikona.
English: SVR12 for selected subgroups are presented in Table 13.
Croatian: SVR12 za odabrane podskupine prikazan je u tablici 13.
English: 1.5-fold↑
Croatian: 1,5 puta↑
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Epclusa, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Croatian: Kako bi se procijenilo ponovno pojavljivanje hepatocelularnog karcinoma povezanog s primjenom lijeka Epclusa, nositelj odobrenja mora provesti i dostaviti rezultate prospektivnog ispitivanja sigurnosti, koristeći podatake koji proizlaze iz kohorte dobro definirane skupine bolesnika, na temelju dogovorenog protokola.
English: ↔ Ketoconazole
Croatian: ↔ Ketokonazol
English: Effects on medicinal product levels.
Croatian: Učinci na razine lijeka.
English: If overdose occurs the patient must be monitored for evidence of toxicity.
Croatian: U slučaju predoziranja bolesnik se mora nadzirati zbog znakova toksičnosti.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Epclusa when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Croatian: Slučajevi su potencijalno opasni po život, stoga se amiodaron smije primjenjivati samo u pacijenata koji primaju lijek Epclusa u slučajevima kada se drugi alternativni antiaritmici ne podnose ili su kontraindicirani.
English: Treatment with Epclusa in accordance with the recommended posology (see section 4.2) should be guided by an assessment of the potential benefits and risks for the individual patient.
Croatian: Liječenje lijekom Epclusa sukladno preporučenom doziranju (vidjeti dio 4.2) treba provoditi prema procjeni mogućih koristi i rizika za pojedinog bolesnika.
English: No patient had HIV-1 rebound during the study, and CD4+ counts were stable during treatment.
Croatian: Nijedan bolesnik nije imao HIV-1 povrat (rebound) tijekom ispitivanja, a broj CD4+ stanica bio je stabilan tijekom liječenja.
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.8-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 18-fold↑ Velpatasvir
Croatian: 1,6 puta↑ 2,1 puta↑ 2,7 puta↑ 1,3 puta↑ 1,6 puta↑ ~2 puta↑ 1,8 puta↑ GS-331007 1,6 puta↑ 1,9 puta↑ 5,5 puta↑ ≥ 10 puta↑ ≥ 20 puta↑ ~7 puta↑ 18 puta↑ Velpatasvir
English: Overall SVR12 83% (75/90) Genotype 1
Croatian: Ukupni SVR12 83 % (75/90) Genotip 1
English: • 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: 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, dozu je potrebno sniziti kako je klinički indicirano na temelju razina hemoglobina.
English: Table 3: Interactions between Epclusa and other medicinal products
Croatian: Tablica 3: Interakcije između lijeka Epclusa i drugih lijekova
English: The safety and efficacy of Epclusa in children and adolescents aged less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Epclusa u djece i adolescenata u dobi manjoj od 18 godina nisu još ustanovljene.
English: Patients should be instructed to swallow the tablet whole with or without food (see section 5.2).
Croatian: Bolesnike treba uputiti da tabletu progutaju cijelu s hranom ili bez nje (vidjeti dio 5.2).
English: Sustained virologic response (SVR12), defined as HCV RNA less than LLOQ at 12 weeks after the cessation of treatment, was the primary endpoint to determine the HCV cure rate.
Croatian: Održani virološki odgovor (SVR12), definiran kao HCV RNK manje od LLOQ u 12. tjednu nakon prestanka liječenja, bio je primarni ishod za utvrđivanje stope izliječenja HCV-a.
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 može utjecati na druge lijekove (npr. lijekove koji se primjenjuju za potiskivanje aktivnosti imunološkog sustava, itd.).
English: Interactions cannot be excluded with other HMG-CoA reductase inhibitors.
Croatian: Ne mogu se isključiti interakcije s drugim inhibitorima HMGCoA reduktaze.
English: Your doctor will test your blood before, during and after your treatment with Epclusa.
Croatian: Liječnik će Vam napraviti krvne pretrage prije, tijekom i nakon liječenja lijekom Epclusa.
English: These should be taken at least 4 hours before or 4 hours after Epclusa;
Croatian: Njih treba uzeti najmanje 4 sata prije ili 4 sata poslije lijeka Epclusa;
English: 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 Epclusa.
Croatian: Zbog dugog poluvijeka amiodarona, treba također provesti odgovarajuće nadzor bolesnika koji su prekinuli uzimanje amiodarona unutar nekoliko posljednjih mjeseci, a započet će terapiju lijekom Epclusa.
English: Patients should be instructed not to take a double dose of Epclusa.
Croatian: Bolesnike treba uputiti da ne uzimaju dvostruku dozu lijeka Epclusa.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Epclusa.
Croatian: U nekih bolesnika sa šećernom bolesti zabilježene su niske razine šećera u krvi (hipoglikemija) nakon početka liječenja lijekovima kao što je Epclusa.
English: The effects of Epclusa during pregnancy are not known.
Croatian: Učinci lijeka Epclusa tijekom trudnoće nisu poznati.
English: Velpatasvir had no adverse effects on mating and fertility.
Croatian: Velpatasvir nije imao štetne učinke na parenje i plodnost.
English: If vomiting occurs more than 3 hours after dosing, no further dose of Epclusa is needed (see section 5.1).
Croatian: Ako povraćanje nastupi nakon više od tri sata od uzimanja doze, nije potrebno uzeti dodatnu dozu lijeka Epclusa (vidjeti dio 5.1).
English: The recommended dose of Epclusa is one tablet, taken orally, once daily with or without food (see section 5.2).
Croatian: Preporučena doza lijeka Epclusa je jedna tableta, peroralno, jedanput na dan s hranom ili bez nje (vidjeti dio 5.2).
English: Haemodialysis is unlikely to result in significant removal of velpatasvir, since velpatasvir is highly bound to plasma protein.
Croatian: Hemodijaliza najvjerojatnije neće dovesti do značajnog uklanjanja velpatasvira, jer je velpatasvir u visokom postotku vezan za proteine plazme.
English: What Epclusa is and what it is used for What you need to know before you take Epclusa How to take Epclusa
Croatian: Što je Epclusa i za što se koristi Što morate znati prije nego počnete uzimati lijek Epclusa Kako uzimati lijek Epclusa
English: Changes in the parameters found in the CPT score system in patients achieving SVR12 in ASTRAL-4 (all 3 regimens) are shown in Table 16.
Croatian: Promjene parametara pronađenih u sustavu bodovanja po CPT-u kod bolesnika koji su postigli SVR12 u ASTRAL-4 (sva tri režima) prikazane su u Tablici 16.
English: Other medicines and Epclusa
Croatian: Drugi lijekovi i Epclusa
English: In these healthy volunteer studies, there were no untoward effects observed at these dose levels, and adverse events 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 štetni događaji su imali sličnu učestalost i težinu kao i oni zabilježeni u skupinama koje su primale placebo.
English: As liver function may change during treatment with Epclusa, a close monitoring of International Normalised Ratio (INR) values is recommended.
Croatian: Budući da tijekom liječenja Epclusa može doći do promjene u funkciji jetre, preporučuje se pomno praćenje vrijednosti međunarodnog normaliziranog omjera (INR).
English: The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma.
Croatian: Monohidroksilirani i desmetilirani velpatasvir bili su metaboliti prepoznati u ljudskoj plazmi.
English: Q2 2023
Croatian: drugom tromjesečju 2023. godine
English: Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
Croatian: Zbog gorkog okusa preporučuje se ne žvakati niti drobiti filmom obloženu tabletu.
English: All patients receiving Epclusa in combination with amiodarone with or without other medicinal products 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 lijek Epclusa u kombinaciji s amiodaronom sa ili bez drugih lijekova koji snižavaju frekvenciju srca treba također upozoriti na simptome bradikardije i srčanog bloka te im treba savjetovati da hitno potraže liječnički savjet ako osjete iste.
English: No individual substitutions tested in genotypes 2a, 4a, or 5a conferred a > 100-fold reduction in velpatasvir susceptibility.
Croatian: Nikakve pojedinačne supstitucije ispitane u genotipovima 2a, 4a ili 5a nisu dovele do smanjenje osjetljivosti velpatasvira za > 100 puta.
English: The increase in tenofovir exposure (AUC and Cmax) was around 40-80% during cotreatment with Epclusa and tenofovir disoproxil fumarate/emtricitabine as part of various HIV regimens.
Croatian: Povećanje izloženosti tenofiviru (AUC i Cmax) iznosilo je otprilike 40-80 % tijekom istodobnog liječenja lijekom Epclusa i tenofovirdisoproksilfumaratom/emtricitabinom u sklopu različitih režima za HIV.
English: If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Epclusa.
Croatian: Ako uzimate antacid, uzmite ga najmanje 4 sata prije ili najmanje 4 sata poslije lijeka Epclusa.
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: The use of Epclusa in children and adolescents has not yet been studied.
Croatian: Primjena lijeka Epclusa u djece i adolescenata nije još ispitana.
English: Genotype 1a 88% (44/50)
Croatian: Genotip 1a 88 % (44/50)
English: Epclusa has been shown to increase tenofovir exposure (P-gp-inhibition).
Croatian: Pokazalo se da Epclusa povećava izloženost tenofoviru (inhibicija P-gpa).
English: Pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Croatian: Farmakokinetički podaci bolesnika bili su konzistentni s nepridržavanjem liječenja.
English: Epclusa is sometimes taken with another medicine, ribavirin.
Croatian: Epclusa se ponekad uzima s drugim lijekom, ribavirinom.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Epclusa in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Epclusa u jednoj ili više podskupina pedijatrijske populacije u liječenju kroničnog hepatitisa C (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you need high doses of these medicines your doctor may give you a different medicine instead or adjust the dose of the medicine you are taking.
Croatian: Ako su Vam potrebne visoke doze tih lijekova, liječnik Vam može dati drugi lijek ili prilagoditi dozu lijeka koji uzimate.
English: As a precautionary measure, Epclusa use is not recommended during pregnancy.
Croatian: Kao mjera opreza, Epclusa se ne preporučuje tijekom trudnoće.
English: SVR12 was achieved by 19/19 patients with cirrhosis.
Croatian: SVR12 postiglo je 19/19 bolesnika s cirozom.
English: Taking Epclusa with any of these may stop your medicines from working properly, or make any side effects worse.
Croatian: Uzimanje lijeka Epclusa s bilo kojim od ovih lijekova može spriječiti pravilno djelovanje Vaših lijekova ili pogoršati neke nuspojave.
English: Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Croatian: Epclusa je indicirana za liječenje kronične infekcije virusom hepatitisa C (HCV) u odraslih (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Co-administration of Epclusa with medicinal products that are substrates of these transporters may increase the exposure of such medicinal products.
Croatian: Istodobna primjena lijeka Epclusa s lijekovima koji su supstrati ovih prijenosnika može povećati izloženost takvih lijekova.
English: The moderate or high fat meal increased sofosbuvir AUC0-inf by 60% and 78%, respectively, but did not substantially affect the sofosbuvir Cmax.
Croatian: Obrok s umjerenim ili visokim udjelom masti povećao je AUC0-inf sofosbuvira za 60 % odnosno 78 %, no nije značajno utjecao na Cmax sofosbuvira.
English: SVR without Y93H 95% CI
Croatian: SVR bez Y93H 95 % CI
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of velpatasvir by 13-fold against genotype 1a HCV replicons.
Croatian: Prisutnost 40 % ljudskog seruma nije imala učinka na djelovanje sofosbuvira proitv HCV-a, ali je smanjila djelovanje velpatasvira protiv HCV-a za 13 puta protiv replikona HCV-a genotipa 1a.
English: Unchanged velpatasvir is the major species present in faeces.
Croatian: Nepromijenjeni velpatasvir je glavni oblik prisutan u stolici.
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir.
Croatian: Istodobna primjena amiodarona bila je ograničena tijekom kliničkog razvoja sofobuvira.
English: Epclusa has no or negligible influence on the ability to drive and use machines.
Croatian: Epclusa ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Velpatasvir is > 99.5% bound to human plasma proteins and binding is independent of drug concentration over the range of 0.09 µg/mL to 1.8 µg/mL.
Croatian: Velpatasvir je > 99,5 % vezan za proteine ljudske plazme i vezanje ne ovisi o koncentraciji lijeka u rasponu od 0,09 μg/ml do 1,8 μg/ml.
English: Compared to subjects with normal hepatic function velpatasvir total plasma exposure (AUCinf) was similar in patients with moderate or severe hepatic impairment.
Croatian: U usporedbi s ispitanicima s normalnom funkcijom jetre, ukupna izloženost velpatasviru u plazmi (AUCinf) bila je slična u bolesnika s umjerenim ili teškim oštećenjem jetre.
English: The film-coated tablets are pink, diamond-shaped tablets debossed with “GSI” on one side and “7916” on the other side.
Croatian: Filmom obložene tablete ružičaste su tablete u obliku dijamanta, s utisnutim „GSI“ na jednoj strani i „7916“ na drugoj strani.
English: Evaluation of sofosbuvir in combination with velpatasvir showed no antagonistic effect in reducing HCV RNA levels in replicon cells.
Croatian: Procjena sofosbuvira u kombinaciji s velpatasvirom nije pokazala nikakav antagonistički učinak u smanjenju razina HCV RNK u stanicama replikona.
English: You must read the “Pregnancy” section in the ribavirin package leaflet very carefully.
Croatian: Vrlo je važno da izrazito pažljivo pročitate dio „Trudnoća“ u uputi o lijeku za ribavirin.
English: The table is not all-inclusive.
Croatian: Tablica nije sveobuhvatna.
English: See Table 3 for examples of interactions with sensitive substrates of P-gp (digoxin), BCRP (rosuvastatin), and OATP (pravastatin).
Croatian: Vidjeti tablicu 3 za primjere interakcija s osjetljivim supstratima P-gp-a (digoksin), BCRP-a (rosuvastatin) i OATP-a (pravastatin).
English: The response rates in Phase 3 studies were similar in HCV-infected patients who received Epclusa with food or without food.
Croatian: Stope odgovora u ispitivanjima faze 3 bile su slične u bolesnika zaraženih HCV-om koji su primali lijek Epclusa s hranom ili bez nje.
English: Epclusa tablets are supplied in high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil.
Croatian: Epclusa tablete isporučuju se u boci od polietilena visoke gustoće (HDPE), s polipropilenskim zatvaračem sigurnim za djecu, koja sadrži 28 filmom obloženih tableta s poliesterskom vaticom.