FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the available data and the scientific discussion within the Committee, the CHMP agreed that the study had convincingly shown that Oxynal and Targin are beneficial in the treatment of symptoms of severe to very severe restless legs syndrome when standard therapy has failed.
Croatian: Na temelju ocjene dostupnih podataka i znanstvene rasprave unutar CHMP-a, on je suglasan da ispitivanje uvjerljivo potvrđuje kako postoje koristi od lijekova Oxynal i Targin u liječenju simptoma ozbiljnog do vrlo ozbiljnog sindroma nemirne noge u slučaju kada standardna terapija nije uspješna.
English: However, the Member States were unable to reach agreement on whether to accept this new indication and on 2 May 2014, Germany referred the matter to the CHMP for arbitration.
Croatian: No, države članice nisu uspjele postići dogovor o prihvaćanju te nove indikacije te je dana 2. svibnja 2014.
English: The grounds for the referral were concerns from the Netherlands that the data on Oxynal and Targin submitted in the application were not sufficient to demonstrate a positive benefit-risk balance in restless legs syndrome.
Croatian: Razlog za upućivanje bila je zabrinutost Nizozemske da podaci o lijekovima Oxynal i Targin dostavljeni u zahtjevu nisu dostatni kako bi potvrdili pozitivan omjer koristi i rizika za sindrom nemirne noge.
English: The CHMP therefore concluded that the benefits of Oxynal and Targin for restless legs syndrome outweigh their risks and recommended that the change to the marketing authorisation be granted in Germany and the concerned Member States.
Croatian: CHMP je stoga zaključio da koristi od lijekova Oxynal i Targin za sindrom nemirnih nogu nadmašuju s njim povezane rizike te je preporučio odobravanje izmjene odobrenja za stavljanje u promet lijekova u Njemačkoj i državama članicama u postupku.
English: In particular, there were concerns that the use of Oxynal and Targin could lead to tolerance and misuse and that this was not adequately studied in the clinical trial and the proposed measures to reduce the risk of tolerance and misuse were not considered sufficient.
Croatian: Posebice je prisutna zabrinutost da primjena lijekova Oxynal i Targin može rezultirati tolerancijom i zlouporabom, te da ovo pitanje nije primjereno ispitano u kliničkom ispitivanju.
English: --1 Per 1 ml dose: live feline calicivirus (strain F9) 104.6-106.1 CCID50; live feline viral rhinotracheitis virus (strain F2) 105.0-106.6 CCID50 ; live feline panleucopenia virus (strain LR 72) 103.7-104.5 CCID50; and purified p45 FeLV-envelope antigen, minimum quantity 102 μg
Croatian: --1 Po dozi 1 ml: Atenuirani živi mačji kalicivirus (soj F9) 104,6 -106,1 CCID50; atenuirani živi virus mačjeg rinotraheitisa (soj F2) 105,0 -106,6 CCID50; atenuirani živi virus panleukopenije mačaka (soj LR 72) 103,7 -104,5 CCID50 i antigen omotača p45 FeLV u najmanjoj količini od 102 µg
English: 150 mg Film-coated tablet Oral use
Croatian: 150 mg Filmom obložena tableta
English: 150 (3x50) capsules
Croatian: Blister (PVC/PCTFE/Alu) 150 (3x50) kapsula
English: 84 tablets
Croatian: Blister (PVC/PCTFE/Alu) 84 tableta
English: This summary was last updated in 09-2017.
Croatian: Sažetak je posljednji put ažuriran u 09. 2017.
English: The full EPAR for Hirobriz Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti (EPAR) za lijek Hirobriz Breezhaler nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Croatian: Djeluje tako što se veže na beta-2 receptore koji se nalaze u stanicama mišića mnogih organa, a to dovodi do opuštanja mišića.
English: This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Croatian: To uzrokuje opuštanje mišića dišnih putova, što pomaže da dišni putovi ostanu otvorenima i omogućava bolesniku lakše disanje.
English: The medicine contains the active substance indacaterol.
Croatian: Lijek sadrži djelatnu tvar indakaterol.
English: Overall, the effects of the 150 and 300 microgram doses of Hirobriz Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Croatian: Sveukupno, učinci doza lijeka Hirobriz Breezhaler od 150 i 300 mikrograma bili su slični, ali rezultati su pokazali da bolesnicima s težom bolesti veće olakšanje može pružiti doza od 300 mikrograma.
English: European Commission granted a marketing authorisation valid throughout the European Union for Hirobriz Breezhaler on 30 November 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Hirobriz Breezhaler u promet koje vrijedi na prostoru Europske unije od 30. studenoga 2009.
English: In three main studies involving over 4,000 patients with COPD, Hirobriz Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Croatian: U tri glavna ispitivanja koja su obuhvatila više od 4000 bolesnika s KOPB-om, Hirobriz Breezhaler uspoređen je s placebom (prividno liječenje), tiotropijem ili formoterolom (drugi lijekovi za inhalaciju kojima se liječi KOPB).
English: The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.
Croatian: Glavna mjera učinkovitosti lijeka Hirobriz Breezhaler temeljila se na promjenama forsiranog izdisajnog volumena u bolesnika (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u jednoj sekundi) nakon 12 tjedana.
English: The most common side effects with Hirobriz Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Croatian: Najčešće nuspojave lijeka Hirobriz Breezhaler (koje se mogu javiti u više od 1 na 10 osoba) jesu nazofaringitis (upala nosa i grla) i infekcija gornjeg dišnog sustava (infekcija nosa i grla).
English: On average, the increase in FEV1 in patients who received Hirobriz Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Croatian: Povećanje vrijednosti FEV1 u bolesnika koji su primili Hirobriz Breezhaler iznosilo je u prosjeku između 150 i 190 ml, dok se u bolesnika koji su primali placebo promjena FEV1 kretala u rasponu od smanjenja od 10 ml do povećanja od 20 ml.
English: This is a summary of the European public assessment report (EPAR) for Hirobriz Breezhaler.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Hirobriz Breezhaler.
English: Hirobriz Breezhaler capsules, which contain a powder for inhalation, are only used with a Hirobriz Breezhaler inhaler and must not be swallowed.
Croatian: Kapsule lijeka Hirobriz Breezhaler, koje sadrže prašak inhalata, primjenjuju se samo s inhalatorom za Hirobriz Breezhaler i ne smiju se progutati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hirobriz Breezhaler have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Hirobriz Breezhaler nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Therefore, the Agency decided that Hirobriz Breezhaler's benefits are greater that its risks and recommended that it be given marketing authorisation.
Croatian: Agencija je stoga odlučila da koristi lijeka Hirobriz Breezhaler nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: Hirobriz Breezhaler is used for maintenance (regular) treatment.
Croatian: Hirobriz Breezhaler primjenjuje se za (redovitu) terapiju održavanja.
English: The Agency also noted that there were no major safety concerns with Hirobriz Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Croatian: Agencija je također zaključila da nisu ustanovljeni razlozi za ozbiljnu zabrinutost u pogledu sigurnosti lijeka Hirobriz Breezhaler te da se nuspojave mogu liječiti i slične su onima drugih agonista beta-2 adrenergičkih receptora.
English: Hirobriz Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Croatian: Hirobriz Breezhaler je lijek koji se primjenjuje kako bi se dišne putove u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (KOPB) držalo otvorenima.
English: The European Medicines Agency concluded that Hirobriz Breezhaler was shown to be effective at improving lung function in COPD.
Croatian: Europska agencija za lijekove zaključila je da se Hirobriz Breezhaler pokazao učinkovitim u poboljšanju funkcije pluća kod KOPB-a.
English: The active substance in Hirobriz Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Croatian: Djelatna tvar lijeka Hirobriz Breezhaler je indakaterol, agonist beta-2 adrenergičkih receptora.
English: What measures are being taken to ensure the safe and effective use of Hirobriz Breezhaler?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Hirobriz Breezhaler?
English: For more information about treatment with Hirobriz Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Hirobriz Breezhaler pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Hirobriz Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Croatian: Hirobriz Breezhaler pokazao se učinkovitijim od placeba u poboljšanju rada pluća u bolesnika s KOPBom.
English: When Hirobriz Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them.
Croatian: Udisanjem lijeka Hirobriz Breezhaler, indakaterol dospijeva do receptora u dišnim putovima i aktivira ih.
English: The doctor may increase the dose to one 300 microgram capsule once a day in cases of severe COPD.
Croatian: U slučaju teškog KOPB-a liječnik može povećati dozu na jednu kapsulu od 300 mikrograma jednom dnevno.
English: Hirobriz Breezhaler indacaterol
Croatian: Hirobriz Breezhaler indakaterol
English: What is Hirobriz Breezhaler and what is it used for?
Croatian: Što je Hirobriz Breezhaler i za što se koristi?
English: It is not intended to provide practical advice on how to use Hirobriz Breezhaler.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Hirobriz Breezhaler.
English: For practical information about using Hirobriz Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Hirobriz Breezhaler bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: For the full list of all side effects and restrictions with Hirobriz Breezhaler, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Hirobriz Breezhaler potražite u uputi o lijeku.
English: Other information about Hirobriz Breezhaler
Croatian: Ostale informacije o lijeku Hirobriz Breezhaler
English: Hirobriz Breezhaler can only be obtained with a prescription.
Croatian: Hirobriz Breezhaler izdaje se samo na liječnički recept.
English: What are the risks associated with Hirobriz Breezhaler?
Croatian: Koji su rizici povezani s lijekom Hirobriz Breezhaler?
English: Why is Hirobriz Breezhaler approved?
Croatian: Zašto je lijek Hirobriz Breezhaler odobren?
English: How does Hirobriz Breezhaler work?
Croatian: Kako djeluje Hirobriz Breezhaler?
English: How is Hirobriz Breezhaler used?
Croatian: Kako se Hirobriz Breezhaler koristi?
English: What benefits of Hirobriz Breezhaler have been shown in studies?
Croatian: Koje su koristi lijeka Hirobriz Breezhaler utvrđene u ispitivanjima?
English: - Take this medicine by mouth.
Croatian: - Ovaj lijek uzmite kroz usta.
English: OPTIMIST-1 and OPTIMIST-2
Croatian: OPTIMIST-1 i OPTIMIST-2
English: - The days of the week are printed on the blister strip - this will help you remember to take your capsule.
Croatian: - Dani u tjednu otisnuti su na traci blistera - što će Vam pomoći da se podsjetite uzeti kapsulu.
English: 4 Patients with these combinations are also included in other rows describing the individual substitutions.
Croatian: 4 Bolesnici s tim kombinacijama su također uključeni u druge redove u kojima su opisane individualne supstitucije.
English: 2 Alone or in combination with other substitutions (includes mixtures).
Croatian: 2 Sam ili u kombinaciji s drugim supstitucijama (uključuje miješane).
English: This can damage or break open the capsule.
Croatian: To može oštetiti ili razlomiti kapsulu.
English: Propulsive Cisapride
Croatian: Propulzivi Cisaprid
English: In particular tell your doctor or pharmacist if you take any of the following medicines:
Croatian: Naročito recite svom liječniku ili ljekarniku ako uzimate bilo koji od sljedećih lijekova:
English: ULN = Upper Limit of Normal.
Croatian: GGN = gornja granica normale.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 May 2014
Croatian: Datum prvog odobrenja: 14. svibnja 2014.
English: Laboratory parameter
Croatian: Laboratorijski parametar
English: Use only if no other alternative is available.
Croatian: Primijeniti samo ako nije dostupna niti jedna, druga,
English: Do not press the capsule from the center of the pocket.
Croatian: Nemojte pritiskati kapsulu preko središnjeg dijela džepića.
English: Pack sizes of 7 or 28 capsules.
Croatian: Veličine pakiranja od 7 ili 28 kapsula.
English: If you do, your medicine may not work properly.
Croatian: lijek Vam možda neće djelovati kako bi trebao.
English: Sensitivity to sunlight
Croatian: Osjetljivost na sunčevu svjetlost
English: - This medicine may pose a risk to the environment.
Croatian: Ovaj lijek može predstavljati rizik za okoliš.
English: 30-150 mg once daily, individualised dose
Croatian: 30-150 mg jedanput na dan, individualizirana doza
English: C212 (Phase 3)
Croatian: C212 (Faza 3)
English: The capsule should be swallowed as a whole.
Croatian: Kapsula se mora progutati cijela.
English: 3 Recommended duration of treatment provided that patient does not meet a stopping rule (see table 3).
Croatian: 3 Preporučeno trajanje liječenja pod uvjetom da bolesnik ne dostigne pravilo za prekid liječenja (vidjeti tablicu 3).
English: Clinical study examining QT interval
Croatian: Kliničko ispitivanje QT intervala
English: 48 weeks3
Croatian: 48 tjedana3
English: There were no adverse effects of simeprevir on vital functions (cardiac, respiratory and central nervous system) in animal studies.
Croatian: Nije bilo štetnih učinaka simeprevira na vitalne funkcije (srčani, dišni i središnji živčani sustav) u ispitivanjima na životinjama.
English: Ketoconazole*
Croatian: Ketokonazol*
English: Maximum plasma concentrations (Cmax) are typically achieved between 4 to 6 hours post dose.
Croatian: Maksimalne koncentracije u plazmi (Cmax) obično se postižu unutar 4 do 6 sati nakon doze.
English: Amylase and lipase elevations were not associated with pancreatitis.
Croatian: Povišenja amilaze i lipaze nisu bila povezana s pankreatitisom.
English: No serious adverse reactions were reported.
Croatian: Nisu bile prijavljene ozbiljne nuspojave.
English: Emerging amino-acid substitutions in NS3
Croatian: Nastale supstitucije aminokiselina na NS3
English: The clinical relevance of this difference in viral breakthrough rates is unknown.
Croatian: Klinički značaj ove razlike u stopama virološkog proboja nije poznat.
English: Elderly (over 65 years of age)
Croatian: Starije osobe (u dobi iznad 65 godina)
English: In addition, tell your doctor if you take any medicines used to treat irregular heart beat or high blood pressure.
Croatian: Dodatno, obavijestite svog liječnika ako uzimate bilo koji lijek za liječenje nepravilnih otkucaja srca ili visokog krvnog tlaka.
English: 4 Patient individualised dose at the discretion of the physician, according to local clinical practice.
Croatian: 4 Doza određena individualno za bolesnika kako je odredio liječnik, prema lokalnoj kliničkoj praksi.
English: What OLYSIO is and what it is used for What you need to know before you take OLYSIO How to take OLYSIO
Croatian: Što je OLYSIO i za što se koristi Što morate znati prije nego počnete uzimati OLYSIO
English: C208 - C216 (QUEST-1 and QUEST-2;
Croatian: C208 - C216 (QUEST-1 i QUEST-2; Faza 3)
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Croatian: Bolesnici u kojih je prepoznat visok rizik za bradiaritmije trebaju biti kontinuirano praćeni tijekom 48 sati u prikladnom kliničkom okruženju.
English: These blood tests help your doctor to - check if the treatment is working for you - check your liver function.
Croatian: Krvne pretrage pomažu Vašem liječniku - provjeriti je li liječenje za Vas učinkovito
English: The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava (SOC) i učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko
English: 5 Two patients had emerging single substitution I170T.
Croatian: Dva bolesnika imala su nastalu pojedinačnu supstituciju I170T.
English: - If you are a woman, you must not become pregnant during treatment and for several months afterwards.
Croatian: - Ako ste žena, ne smijete zatrudniti tijekom liječenja i nekoliko mjeseci nakon toga.
English: If the capsule shell is indented or bent - without being broken or opened - the capsule can still be used.
Croatian: Ako je ovojnica kapsule udubljena ili savijena - bez da se razlomila ili otvorila- kapsula se još može uzeti.
English: Simeprevir was not irritating to rabbit skin, and is not likely to cause skin sensitisation.
Croatian: Simeprevir nije bio iritans za kožu zeca i nije vjerojatno da će uzrokovati preosjetljivost kože.
English: In Europe, the prevalence was lower, 19% (73/377) in patients with HCV genotype 1a and 0.3% (3/877) in genotype 1b.
Croatian: U Europi, prevalencija je bila niža, 19% (73/377) u bolesnika s HCV genotipom 1a i 0,3% (3/877) u genotipu 1b.
English: The type of food does not affect exposure to simeprevir.
Croatian: Vrsta hrane ne utječe na izloženost simepreviru.
English: Q80K3, S122A/G/I/T3, S122R,
Croatian: Q80K3, S122A/G/I/T3,
English: Carcinogenicity studies with simeprevir have not been conducted.
Croatian: Ispitivanja kancerogenosti sa simeprevirom nisu bila provedena.
English: Environmental Risk Assessment (ERA) Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Croatian: Procjena rizika za okoliš (ERA) Simeprevir je klasificiran kao PBT (postojana, bioakumulativna i toksična) tvar (vidjeti dio 6.6).
English: 1 This interaction study has been performed with a dose higher than the recommended dose for simeprevir assessing the maximal effect on the co-administered drug.
Croatian: 1 Ovo ispitivanje interakcije bilo je provedeno s dozom koja je viša od preporučene doze za simeprevir procjenjujući maksimalni učinak na istovremeno primijenjeni lijek.
English: 122, 155 and/or 168.
Croatian: 155 i/ili 168.
English: Table 4: Interactions and dose recommendation with other medicinal products Medicinal products by therapeutic areas
Croatian: Tablica 4: Interakcije i preporuke za doziranje s drugim lijekovima Lijekovi prema terapijskim skupinama
English: Following a single oral administration of 200 mg 14C-simeprevir to healthy subjects, the majority of the radioactivity in plasma (up to 98%) was accounted for by unchanged drug and a small part of the radioactivity in plasma was related to metabolites (none being major metabolites).
Croatian: Nakon jedne peroralne primjene 200 mg 14C-simeprevira zdravim ispitanicima, većina radioaktivnosti u plazmi (do 98%) brojala se kao nepromijenjen lijek, a mali dio radioaktivnosti u plazmi bio je povezan s metabolitima (nijedan nije bio metabolit u većini).
English: Resistance in cell culture
Croatian: Rezistencija u kulturi stanica
English: 3 Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80,
Croatian: Supstitucije uočene samo u kombinacijama s drugim nastalim supstitucijama na jednom ili više NS3 položaja 80, 122,
English: SEDATIVES/ANXIOLYTICS Midazolam
Croatian: SEDATIVI/ANKSIOLITICI Midazolam
English: C206 (ASPIRE; Phase 2)
Croatian: C206 (ASPIRE; Faza 2)
English: - Swallow the capsule whole.
Croatian: - Kapsulu progutajte cijelu.
English: Simeprevir is extensively bound to plasma proteins (> 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein.
Croatian: Distribucija Simeprevir se opsežno veže na proteine plazme (> 99,9%), primarno na albumin te u manjoj mjeri na alfa-1-kiseli glikoprotein.
English: - If you are a man, your female partner must not become pregnant during your treatment and for several months afterwards.
Croatian: - Ako ste muškarac, Vaša partnerica ne smije zatrudniti tijekom Vašeg liječenja i nekoliko mjeseci nakon toga.
English: Study HPC3007
Croatian: Ispitivanje HPC3007
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: This is due to potential liver function changes during treatment with OLYSIO.
Croatian: zbog mogućih promjena u funkciji jetre tijekom liječenja lijekom OLYSIO.
English: Antiviral activity in vivo
Croatian: Antivirusna aktivnost in vivo
English: HIV PRODUCTS Antiretroviral - CCR5 antagonist Maraviroc
Croatian: Antiretrovirusni - CCR5 antagonisti Maravirok
English: 1 HCV/HIV-1 co-infected patients.
Croatian: 1 HCV/HIV-1 koinficirani bolesnici.
English: Co-administration is not recommended.
Croatian: Istovremena primjena se ne preporučuje.
English: This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite - confusion.
Croatian: Navedeno je od posebnog značaja ako je praćeno bilo kojim od sljedećih simptoma: - ako osjećate mučninu, povraćanje ili gubitak apetita
English: Study HPC3007: includes 5 simeprevir-treated patients who experienced relapse after SVR12.
Croatian: Ispitivanje HPC3007: uključuje 5 bolesnika liječenih simeprevirom koji su doživjeli relaps nakon SVR12.
English: Simeprevir does not inhibit OCT2 in vitro.
Croatian: Simeprevir ne inhibira OCT2 in vitro.
English: 2 Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event.
Croatian: 2 Od 3 bolesnika s neuspjehom tijekom liječenja, 2 bolesnika su doživjela virološki proboj i jedan bolesnik je ranije prekinuo liječenje zbog štetnog događaja.
English: Hyperbilirubinemia Grade 1
Croatian: Hiperbilirubinemija Stupanj 1