FrancophonIA/ELRC3.0 huggingface dataset:
English: The effect of Episalvan on fertility has not been studied, but since the absorption of this medicine into the body is extremely low, it is not expected to have an effect on your fertility.
Croatian: Nije ispitan učinak Episalvana na plodnost, ali s obzirom na to da je apsorpcija ovog lijeka u tijelo iznimno niska, ne očekuje se da će utjecati na Vašu plodnost.
English: In the Grade 2a burn wound study, the mean wound size treated with Episalvan was 108 cm² (range 23-395 cm²).
Croatian: U ispitivanjima rana izazvanih opeklinama 2.a stupnja, srednja vrijednost površine rane liječena Episalvanom iznosila je 108 cm² (raspon 23 - 395 cm²).
English: ‘Primary' vs. ‘secondary' blinded read: In the primary blinded read evaluation a rigorous quality check was implemented to assure blinding of the observers.
Croatian: Skup podataka za populaciju koja se namjerava liječiti (ITT). „Primarno” naspram „sekundarno” očitanje na slijepo: kod procjene primarnog očitanja na slijepo uvedena je stroga provjera kvalitete kako bi se zajamčilo zasljepljivanje promatrača.
English: Extraction solvent: n-Heptane
Croatian: Otapalo za ekstrakciju: n-heptan
English: Do not use this medicine after the expiry date which is stated on the carton and tube after ‘EXP'.
Croatian: Ovaj se lijek ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i tubi iza oznake Rok valjanosti.
English: Overdosing with Episalvan is unlikely: in patients in which wound sizes >300 cm were repeatedly treated with Episalvan, no betulin plasma levels could be detected.
Croatian: Predoziranje Episalvanom malo je vjerojatno: u bolesnika kod kojih su rane površine >300 cm2 opetovano liječene Episalvanom nisu otkrivene koncentracije betulina u plazmi.
English: No studies have been performed to establish whether Episalvan will interact with other medicines.
Croatian: Nisu provedena ispitivanja kojima bi se ustanovila interakcija Episalvana s drugim lijekovima.
English: There is no clinical experience from use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers, venous leg ulcers or wounds in patients with epidermolysis bullosa.
Croatian: Ne postoje klinička iskustva na temelju uporabe Episalvana u liječenju kroničnih rana, npr. dijabetičkog stopala, venskih ulkusa nogu ili rana u bolesnika s buloznom epidermolizom.
English: If your wound shows no signs of improvement over time, talk to your doctor or nurse.
Croatian: Ako na rani nema poboljšanja nakon nekog vremena, obratite se svom liječniku ili medicinskoj sestri.
English: The tubes are closed with a tamper-evident aluminium membrane and fitted with a white polypropylene screw cap.
Croatian: Tube su zatvorene aluminijskom membranom s evidencijom otvaranja i opremljene bijelim polipropilenskim navojnim zatvaračem.
English: In the burn wound study with 61 patients, the mean study wound area was 216 cm2; the total burn injury of these patients was larger and affected 5.8% of the total body surface area.
Croatian: U ispitivanju rana izazvanih opeklinama u kojem je sudjelovao 61 iznosila je 81,5 cm2; ukupno bolesnik, srednja vrijednost površine ispitivane rane iznosila je 216 cm oštećenje izazvano opeklinama u tih bolesnika bilo je veće te je zahvatilo 5,8 % ukupne površine tijela.
English: Episalvan can be used during breast-feeding, unless the chest area is being treated.
Croatian: Episalvan se može upotrebljavati tijekom dojenja, osim ako se ne provodi liječenje u području prsišta.
English: Three Phase III studies were conducted to assess the efficacy and safety of Episalvan in the treatment of partial thickness wounds of the skin: two studies which investigated split-thickness skin graft donor site wounds, which included a total of 219 patients (ITT: N=217), and one further study in 61 patients with Grade 2a burn wounds (ITT: N=57).
Croatian: Tri ispitivanja faze III provedena su u svrhu procjene djelotvornosti i sigurnosti Episalvana u liječenju rana koje zahvaćaju djelomičnu debljinu kože: dva ispitivanja u kojima su ispitivane rane donorskog mjesta kožnog presatka djelomične debljine, u kojima je sudjelovalo ukupno 219 bolesnika (populacija koja se namjerava liječiti, engl.
English: Other wound types
Croatian: Druge vrste rana
English: No formal studies have been conducted with Episalvan in patients with renal or hepatic impairment.
Croatian: Nisu provedena službena ispitivanja s Episalvanom u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: White collapsible aluminium tube, interior lacquered with epoxy phenolic coating, and with a sealing compound in the fold.
Croatian: Bijela savitljiva aluminijska tuba s epoksi-fenolnim premazom u unutrašnjosti i zabrtvljenim krajem.
English: If you stop using Episalvan
Croatian: Ako prestanete primjenjivati Episalvan
English: The gel should be applied to the wound surface at a thickness of approximately 1 mm and covered by sterile wound dressing.
Croatian: Gel je potrebno nanijeti na površinu rane u sloju od oko 1 mm i prekriti sterilnom kompresom.
English: If you forget to use Episalvan
Croatian: Ako ste zaboravili primijeniti Episalvan
English: Episalvan gel Birch bark extract
Croatian: Episalvan gel ekstrakt brezove kore
English: No studies have been done on the effects of Episalvan on pregnant women, but since the absorption of this medicine into the body is extremely low, the risk to the unborn baby is negligible.
Croatian: Nisu provedena ispitivanja o učincima Episalvana na trudnice, ali s obzirom na to da je apsorpcija ovog lijeka u tijelo iznimno niska, rizik za plod je zanemariv.
English: Episalvan plus wound dressing was applied to half of the wound area, and the same kind of non-adhesive wound dressing alone was applied to the other half as the control in the split-thickness skin graft donor site studies.
Croatian: Na polovicu područja rane nanesen je Episalvan i kompresa, a na drugu polovicu nanesena je ista vrsta neljepljive komprese u svrhu kontrole u ispitivanjima donorskog mjesta kožnog presatka djelomične debljine.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Cutaneous use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Primjena za kožu.
English: No effects during pregnancy are anticipated, since systemic exposure to Episalvan is negligible.
Croatian: Ne očekuju se učinci na trudnoću jer je sistemska izloženost Episalvanu zanemariva.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: In the Grade 2a burn wound study an octenidine containing antiseptic wound gel and fatty gauze dressing were used as control.
Croatian: U ispitivanju rana izazvanih opeklinama 2.a stupnja u svrhu kontrole upotrijebljen je antiseptički gel za rane s oktenidinom i vazelinska gaza.
English: Driving and using machines Your ability to drive and use machines will not be affected by this medicine.
Croatian: Ovaj lijek ne utječe na Vašu sposobnost upravljanja vozilima i strojevima.
English: There is no experience of the use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers or venous leg ulcers.
Croatian: Ne postoje iskustva primjene Episalvana u liječenju kroničnih rana, npr. dijabetičkog stopala ili venskih vrijedova nogu.
English: 1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula pendula, Betula pubescens as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin.
Croatian: 1 g gela sadrži: 100 mg ekstrakta (kao suhi ekstrakt, rafiniran) iz brezove kore iz Betula pendula, Betula pubescens, kao i hibrida obiju vrsta (istovjetno 0,5 - 1,0 g brezove kore), što odgovara 72 - 88 mg betulina.
English: -1.0 days (CI: -1.4, -0.6) faster wound closure with Episalvan, p<0.0001a
Croatian: -1,0 dana (CI: -1,4, -0,6) brže zatvaranje rane s Episalvanom, p < 0,0001a a Na temelju dvostranog uparenog t-testa
English: The 219 patients with split-thickness skin graft donor site wounds had a mean age of 53 years; their donor site mean wound size was 81.5 cm2.
Croatian: 219 bolesnika s ranama donorskog mjesta kožnog presatka djelomične debljine bilo je prosječne dobi od 53 godine; srednja vrijednost površine njihove rane donorskog mjesta
English: Fresh wounds should achieve haemostasis prior to application of Episalvan.
Croatian: Svježe rane trebaju prestati krvariti prije nanošenja Episalvana.
English: The most frequently reported side effects are: Common side effects (may affect up to 1 in 10 people): - painful skin - itching - complications in the wound healing process
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): - bolna koža - svrbež - komplikacije tijekom cijeljenja rane
English: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Episalvan is negligible.
Croatian: Ne očekuju se učinci na dojenu novorođenčad/dojenčad jer je sistemska izloženost dojilja Episalvanu zanemariva.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1g gel contains: 100 mg birch bark extract (as dry extract, refined) from Betula pendula/Betula pubescens, corresponding to 72-88 mg betulin.
Croatian: 1 g gela sadrži: 100 mg ekstrakta iz brezove kore (kao suhi ekstrakt, rafiniran) iz Betula pendula / Betula pubescens, što odgovara 72 - 88 mg betulina.
English: How to use Episalvan
Croatian: Kako primjenjivati Episalvan
English: 75223 Niefern-Öschelbronn GERMANY
Croatian: 75223 Niefern-Öschelbronn Njemačka
English: How to store Episalvan
Croatian: Kako čuvati Episalvan
English: For cutaneous application.
Croatian: Za primjenu na koži.
English: How to store Episalvan 6.
Croatian: Kako primjenjivati Episalvan 4. Moguće nuspojave
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula pendula Roth, Betula pubescens Ehrh.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 g gela sadrži: 100 mg ekstrakta (kao suhi ekstrakt, rafiniran) iz brezove kore iz Betula pendula Roth, Betula pubescens Ehrh., kao i hibrida obiju vrsta (istovjetno 0,5 - 1,0 g brezove kore), što odgovara 72-88 mg betulina.
English: Partial thickness burn wounds
Croatian: Rane izazvane opeklinama koje zahvaćaju djelomičnu debljinu kože
English: Split-thickness skin graft donor site wound studies
Croatian: Ispitivanja rana donorskog mjesta kožnog presatka djelomične debljine (objedinjeno)
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: DATUM REVIZIJE TEKSTA
English: Elderly
Croatian: Svrbež
English: Grade 2a burn wound study
Croatian: Ispitivanje rana izazvanih opeklinama 2.a stupnja
English: Outcome of re-examination
Croatian: Ishod ponovnog ispitivanja
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 October 2015 EMA/684158/2015 EMEA/H/C/003750
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23. listopada 2015. EMA/684158/2015 EMEA/H/C/003750
English: The applicant had requested a re-examination of the opinion.
Croatian: Podnositelj zahtjeva zatražio je ponovno ispitivanje mišljenja.
English: What is Heparesc?
Croatian: Što je Heparesc?
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Heparesc can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Heparesc može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The effects of Heparesc were first tested in experimental models before being studied in humans.
Croatian: Djelovanje lijeka Heparesc prvi je put je ispitano u eksperimentalnim modelima prije početka ispitivanja u ljudi.
English: As a result, toxic waste products build up in the blood in the form of ammonia which can lead to brain damage, convulsions (fits), coma and death.
Croatian: Kao posljedica toga, u krvi se nakupljaju otrovni otpadni proizvodi u obliku amonijaka koji mogu uzrokovati oštećenja mozga, konvulzije (napadaje), komu i smrt.
English: On 25 June 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Heparesc, intended for the treatment of urea cycle disorders.
Croatian: Dana 25. lipnja 2015. godine Odbor za lijekove za humanu uporabu (CHMP) usvojio je negativno mišljenje, preporučujući odbijanje odobrenja za stavljanje u promet lijeka Heparesc, koji je namijenjen liječenju poremećaja ciklusa ureje.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 22 October 2015.
Croatian: Nakon razmatranja razloga za ovaj zahtjev, CHMP je ponovno ispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet od dana 22. listopada 2015.
English: Heparesc was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 14 September 2007 for ornithine transcarbamylase deficiency, and 17 December 2010 for the other above conditions.
Croatian: Heparesc je 14. rujna 2007. označen kao „lijek za rijetku bolest” (lijek koji se koristi za liječenje rijetkih bolesti) za liječenje nedostatka ornitin-transkarbamilaze, a 17. prosinca 2010. za liječene ostalih prethodno navedenih stanja.
English: The main measures of effectiveness were the change in the levels of 13C-labelled urea production (a test intended to show the ability to produce urea) after treatment as compared to before, and the number, length and severity of any episodes of high ammonia in the blood during the studies.
Croatian: Glavna mjerila učinkovitosti bile su promjene razina proizvodnje ureje s oznakom 13C (ispitivanje u kojemu je cilj bio pokazati sposobnost proizvodnje ureje) nakon primjene terapije, u usporedbi s prethodnim stanjem, te broj, duljina i ozbiljnost u pogledu pojave visoke razine amonijaka u krvi tijekom ispitivanja.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to cure, diagnose or prevent a disease.
Croatian: Riječ je o vrsti lijeka koji sadrži stanice ili tkiva koja su izmijenjena kako bi se mogla koristiti za liječenje, dijagnostiku ili sprječavanje bolesti.
English: The company presented the results of two main studies involving a total of 20 children with urea cycle disorders in which the effects of Heparesc were compared with historical results in children who had not received Heparesc treatment.
Croatian: Tvrtka je iznijela rezultate dvaju glavnih ispitivanja koja su uključivala ukupno 20-ero djece s poremećajima ciklusa ureje u kojima su učinci lijeka Heparesc uspoređeni s prošlim rezultatima u djece koja nisu primila terapiju lijekom Heparesc.
English: How is Heparesc expected to work?
Croatian: Kako je Heparesc trebao djelovati?
English: Heparesc was developed as a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Croatian: Heparesc je razvijen kao vrsta lijeka za naprednu terapiju koji se naziva „lijek za terapiju somatskim stanicama”.
English: Because Heparesc is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Croatian: Budući da je Heparesc lijek za naprednu terapiju, ocijenio ga je Odbor za napredne terapije (CAT).
English: Heparesc is a medicine that contains living cells from the liver of a healthy donor which have been manipulated and then frozen for long-term storage.
Croatian: Heparesc je lijek koji sadrži žive stanice jetre zdravog darivatelja koje su izmijenjene, a zatim zamrznute za dugoročnu pohranu.
English: The company that applied for authorisation is Cytonet GmbH & Ci KG.
Croatian: Tvrtka Cytonet GmbH & Ci KG podnijela je zahtjev za izdavanje odobrenja.
English: Both Committees confirmed their opinion that the effectiveness of Heparesc in the treatment of these disorders had not been sufficiently demonstrated.
Croatian: Oba su odbora potvrdila svoje mišljenje prema kojemu učinkovitost lijeka Heparesc u liječenju tih poremećaja nije bila prikazana na zadovoljavajući način.
English: In addition, the CHMP had concerns about the clinical relevance of the results of the tests that measured the ability to produce urea.
Croatian: Osim toga, CHMP je izrazio zabrinutost u vezi s kliničkom važnošću rezultata ispitivanja kojima se mjerila sposobnost proizvodnje ureje.
English: What was Heparesc expected to be used for?
Croatian: Za što se Heparesc trebao koristiti?
English: During the re-examination the CAT and CHMP looked again at the data from the company, and also consulted experts in the treatment of urea cycle disorders.
Croatian: CAT i CHMP su tijekom ponovnog ispitivanja još jedanput pregledali podatke tvrtke i savjetovali se sa stručnjacima u liječenju poremećaja ciklusa ureje.
English: The company informed the CHMP that the refusal had no consequences for patients in clinical trials or compassionate use programmes.
Croatian: Tvrtka je obavijestila CHMP da odbijanje nema posljedica za bolesnike koji su uključeni u klinička ispitivanja ili u programe milosrdnog davanja lijeka.
English: These are rare inborn conditions in which the liver does not produce particular enzymes involved in removing nitrogen from the body via a substance called urea.
Croatian: Riječ je o rijetkim prirođenim stanjima u kojima jetra ne proizvodi određene enzime uključene u uklanjanje dušika iz tijela s pomoću tvari koja se naziva ureja.
English: The Committee thus considered that the benefits of treatment had not been sufficiently demonstrated.
Croatian: Odbor je stoga razmotrio mogućnost toga da koristi od liječenja nisu prikazane na zadovoljavajući način.
English: When the medicine is injected into the portal vein leading to the liver, some of the liver cells it contains are expected to settle in the recipient's liver and start producing the missing liver enzyme, thus helping to reduce the symptoms of the disease.
Croatian: Kada se lijek unosi u portalnu venu koja vodi do jetre, pojedine stanice jetre koje lijek sadrži trebaju se nastaniti u jetri primatelja i početi proizvoditi enzim jetre koji nedostaje, te na taj način pomoći u smanjenju simptoma bolesti.
English: The medicine was to be given by slow injection through a tube inserted by a surgical procedure into the portal vein (a vein leading directly to the patient's liver).
Croatian: Lijek se trebao davati postupnom injekcijom kroz cjevčicu koja se operativnim zahvatom ugrađuje u portalnu venu (venu koja vodi izravno do jetre bolesnika).
English: Heparesc is made of liver cells from an organ donor who can produce the enzyme that is missing in patients with urea cycle disorders.
Croatian: Heparesc se proizvodi od stanica jetre darivatelja organa koji može proizvoditi enzim koji nedostaje u bolesnika s poremećajima ciklusa ureje.
English: Heparesc was intended to help temporary management of these conditions in children until they are big enough to be given a liver transplant to cure them.
Croatian: Heparesc se trebao koristiti za privremeno liječenje tih stanja u djece dok dovoljno ne odrastu za transplantaciju jetre u svrhu izlječenja.
English: The CHMP had concerns about the design and conduct of the studies, which cast doubt on their results and whether these could have occurred by chance.
Croatian: CHMP je izrazio zabrinutost u vezi s nacrtom i provođenjem ispitivanja, čime su dovedeni u pitanje rezultati ispitivanja te je navedena mogućnost da se do njih došlo slučajno.
English: Taking into account the assessments performed by the CAT, the CHMP concluded that Heparesc could not be approved for the treatment of children with urea cycle disorders.
Croatian: Uzevši u obzir ocjenjivanja koja je proveo CAT, CHMP je zaključio da se Heparesc ne može odobriti za liječenje djece s poremećajima ciklusa ureje.
English: Heparesc was to be used for the treatment of children from birth up to 3 years of age with specific urea cycle disorders.
Croatian: Heparesc se trebao koristiti za liječenje djece od u dobi od rođenja do 3 godine koja imaju određene poremećaje ciklusa ureje.
English: Although taking into account the challenges of developing the medicine, including the difficulty of enrolling patients due to the rarity of the disease, the CHMP therefore concluded that the benefits of Heparesc did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Croatian: Premda je razmotrio izazove u pogledu razvijanja lijeka, uz teškoće u pogledu uključivanja bolesnika zbog rijetkosti bolesti, CHMP je zaključio kako koristi od lijeka Heparesc ne nadmašuju s njime povezane rizike te je zadržao prethodnu preporuku da se odbije izdavanje odobrenja za stavljanje lijeka u promet.
English: Therefore, at the time of the initial evaluation, the CHMP was of the opinion that the benefits of Heparesc did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je u vrijeme početnog ocjenjivanja CHMP smatrao da koristi od lijeka Heparesc ne nadmašuju s njime povezane rizike te je preporučio da se odbije izdavanje odobrenja za stavljanje lijeka u promet.
English: The specific urea cycle disorders for which Heparesc was intended to be used are called carbamoylphosphate synthetase 1 deficiency, ornithine transcarbamylase deficiency, argininosuccinate synthetase deficiency (citrullinaemia type 1), argininosuccinate lyase deficiency (argininosuccinic aciduria) and arginase deficiency (hyperargininaemia).
Croatian: Određeni poremećaji ciklusa ureje za koje je Heparesc namijenjen nazivaju se nedostatak karbamilfosfat sintetaze I., nedostatak ornitin-transkarbamilaze, nedostatak argininosukcinat-sintetaze
English: Week 96
Croatian: 96.tjedan
English: - This medicine has been prescribed for you or your child only.
Croatian: Ovaj je lijek propisan samo Vama ili Vašem djetetu.
English: Stevens-Johnson syndrome, erythema multiforme
Croatian: Stevens-Johnsonov sindrom, erythema multiforme
English: Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.
Croatian: Drugi oblici ovog lijeka mogu biti prikladniji za djecu; pitajte svog liječnika ili ljekarnika.
English: This leaflet was last revised in .
Croatian: Ova uputa je zadnji puta revidirana u:
English: − Continue to take this medicine until your doctor tells you otherwise.
Croatian: Uzimajte ovaj lijek dok Vam liječnik ne kaže suprotno.
English: − If you cannot contact your doctor, go to the hospital.
Croatian: Ako ne možete obavijestiti svog liječnika, javite se u bolnicu.
English: Mylan SAS 117 Allee des Parcs 69800 Saint-Priest France
Croatian: Mylan SAS 117 Allee des Parcs 69800 Saint-Priest Francuska
English: If the condition persists or worsens, seek medical attention.
Croatian: Ukoliko simptomi potraju ili se pogoršaju, potražite medicinsku pomoć.
English: − For children, your doctor will decide the right dose (number of tablets) based on the child's height and weight.
Croatian: Liječnik će odlučiti o odgovarajućoj dozi (broju tableta) za dijete, na temelju djetetove težine i visine.
English: Effects on the electrocardiogram
Croatian: Utjecaj na elektrokardiogram
English: Animal studies have shown no effects on fertility.
Croatian: Ispitivanja na životinjama pokazala su da nema učinaka na plodnost.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
Croatian: Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) i nepoznato (ne može se procjeniti iz dostupnih podataka).
English: For plastic containers, use within 120 days after first opening.
Croatian: Za plastične spremnike, iskoristiti u roku od 120 dana nakon prvog otvaranja.
English: HCV protease inhibitors Boceprevir 800 mg three times daily
Croatian: HCV inhibitori proteaza Boceprevir 800 mg tri puta na dan