FrancophonIA/ELRC3.0 huggingface dataset:
English: What were the CHMP's main concerns that led to the initial negative opinion?
Croatian: Koji su bili glavni razlozi za zabrinutost CHMP-a koji su doveli do prvobitnog negativnog mišljenja?
English: Opdivo has been authorised since June 2015.
Croatian: Lijek Opdivo odobren je od lipnja 2015.
English: Yervoy has been authorised since July 2011.
Croatian: Lijek Yervoy odobren je od srpnja 2011.
English: Further information on Opdivo and Yervoy's current uses can be found on the Agency's website.
Croatian: Dodatne informacije o trenutačnim primjenama lijekova Opdivo i Yervoy nalaze se na internetskim stranicama Agencije.
English: The company that applied for the change to the authorisation is Bristol-Myers Squibb Pharma EEIG.
Croatian: Zahtjev za izmjenu odobrenja podnijela je tvrtka Bristol-Myers Squibb Pharma EEIG.
English: The study looked at the patients' response to treatment and how long patients lived, or lived without their disease getting worse.
Croatian: Promatrao se odgovor bolesnika na liječenje i koliko dugo su bolesnici živjeli, odnosno koliko dugo su živjeli bez pogoršanja bolesti.
English: During the re-examination, the CHMP looked again at all the data and consulted a group of cancer experts and patients with cancer.
Croatian: Za vrijeme ponovnog razmatranja CHMP je ponovno razmotrio sve podatke te se savjetovao sa skupinom stručnjaka za rak i bolesnicima oboljelim od raka.
English: However, the company must conduct a study to determine the precise contribution of Yervoy in the combination and if the risks could be further minimised.
Croatian: Međutim, tvrtka mora provesti ispitivanje kako bi utvrdila točan doprinos lijeka Yervoy u kombinaciji, kao i je li moguće dodatno smanjiti rizike.
English: The CHMP also discussed the possibility to request that further data be collected following the authorisation of the combination.
Croatian: CHMP je također razgovarao o mogućnosti prikupljanja dodatnih podataka nakon izdavanja odobrenja za kombinaciju.
English: What were the conclusions of the CHMP following the re-examination?
Croatian: Koji su bili zaključci CHMP-a nakon ponovnog razmatranja?
English: It is also used to treat the following other cancers: melanoma (a skin cancer), non-small cell lung cancer, classical Hodgkin lymphoma (a blood cancer), squamous cell cancer of the head and neck, and urothelial (bladder) cancer.
Croatian: Upotrebljava se i za liječenje sljedećih vrsta raka: melanoma (raka kože), raka pluća nemalih stanica, klasičnog Hodgkinovog limfoma (raka krvi), raka skvamoznih stanica glave i vrata te urotelnog raka (raka mokraćnog mjehura).
English: It is used to treat adults with advanced melanoma.
Croatian: Primjenjuje se za liječenje odraslih osoba s uznepredovalim melanomom.
English: The company presented the results of a main study involving 1,096 patients with previously untreated advanced renal cell carcinoma.
Croatian: Tvrtka je dostavila rezultate glavnog ispitivanja kojim je bilo obuhvaćeno 1 096 bolesnika s uznapredovalim karcinomom bubrežnih stanica koji nisu prethodno liječeni.
English: 16 November 2018 EMA/799169/2018
Croatian: EMA/852829/2018
English: Although the precise contribution of Yervoy was not clear, the CHMP reassessed data from other non-clinical and clinical studies, including studies with the combination in relevant other cancer types, and considered that the benefit of Yervoy in the combination has been sufficiently demonstrated.
Croatian: Iako točan doprinos lijeka Yervoy nije bio jasan, CHMP je ponovno ocijenio podatke drugih nekliničkih i kliničkih ispitivanja, uključujući ispitivanja kombinacija u relevantnim drugim vrstama raka, te je smatrao da je utvrđena dostatna korist od lijeka Yervoy u kombinaciji.
English: Nivolumab attaches to a receptor called PD-1 which is found on certain cells of the immune system called T cells.
Croatian: Nivolumab se veže na receptor naziva PD-1 koji se nalazi na određenim stanicama imunosnog sustava naziva T stanice.
English: On 15 November 2018, the Committee for Medicinal Products for Human Use (CHMP) recommended that a change to the marketing authorisation for the medicinal products Opdivo (nivolumab) and Yervoy (ipilimumab) be granted.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) preporučio je 15. studenoga 2018. prihvaćanje izmjene odobrenja za stavljanje u promet lijekova Optivo (nivolumab) i Yervoy (ipilimumab).
English: Therefore, at that point in time, the CHMP considered that the combination could not be approved because of the lack of knowledge of the contribution of Yervoy.
Croatian: Stoga je, u tom trenutku, CHMP smatrao da se zbog nedostatka saznanja o doprinosu lijeka Yervoy kombinacija ne može odobriti.
English: Although improvements in survival were seen in previously untreated patients given the combination of Opdivo and Yervoy compared with sunitinib, there was no evidence showing if Yervoy contributed to these results and if so, how much.
Croatian: Iako su opažena poboljšanja u preživljenju prethodno neliječenih bolesnika koji su uzimali kombinaciju lijekova Opdivo i Yervoy u usporedbi sa sunitinibom, nije bilo dokaza o tome je li lijek Yervoy pridonio tim rezultatima te ako jest, u kojoj mjeri.
English: Following the re-examination, the CHMP adopted a final positive opinion on 15 November 2018 recommending that the change to the marketing authorisation be granted for Opdivo and Yervoy, but requested the company to conduct a study to collect further data.
Croatian: Nakon ponovnog razmatranja, CHMP je donio pozitivno mišljenje 15. studenoga 2018. i preporučio prihvaćanje izmjene odobrenja za stavljanje u promet lijekova Opdivo i Yervoy, no od tvrtke je zatražio provođenje ispitivanja kako bi se prikupili dodatni podatci.
English: The CHMP considered that the results from the main study comparing Opdivo and Yervoy with sunitinib showed a clinically important increase in patients' survival with the combination, and side effects were considered acceptable.
Croatian: CHMP je smatrao da su rezultati glavnog ispitivanja u kojem su lijekovi Opdivo i Yervoy uspoređeni s sunitinibom pokazali klinički značajno povećanje stope preživljenja bolesnika kad je riječ o kombinaciji, a nuspojave su se smatrale prihvatljivima.
English: Opdivo and Yervoy are to be used together in patients with previously untreated advanced renal cell carcinoma that is considered to be of moderate or high risk of worsening.
Croatian: Lijekovi Opdivo i Yervoy trebaju se primjenjivati zajedno u bolesnika s uznapredovalim karcinomom bubrežnih stanica koji se prethodno nisu liječili i izloženi su umjerenom ili velikom riziku od pogoršanja.
English: The CHMP was of the opinion that the benefits of the combination largely outweigh its risks and therefore recommended granting the change to the marketing authorisation.
Croatian: Stoga je CHMP smatrao da koristi od kombinacije uvelike nadmašuju s njom povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Croatian: Stanice raka mogu proizvesti bjelančevine (PD-L1 i PD-L2) koje se vežu na taj receptor i gase aktivnost T stanica, tako ih sprječavajući da napadaju rak.
English: The study compared treatment with Opdivo and Yervoy versus treatment with another cancer medicine, sunitinib.
Croatian: U ispitivanju se usporedilo liječenje lijekovima Opdivo i Yervoy u odnosu na liječenje drugim lijekom protiv raka, sunitinibom.
English: On 26 July 2018, the CHMP had originally adopted a negative opinion for the use of Opdivo and Yervoy for the treatment of renal cell carcinoma.
Croatian: CHMP je 26. srpnja 2018. prvobitno donio negativno mišljenje o uporabi lijekova Opdivo i Yervoy za liječenje karcinoma bubrežnih stanica.
English: By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Croatian: Vezivanjem na receptor, nivolumab sprječava da PD-L1 i PD-L2 prekinu aktivnost T-stanica, čime se povećava sposobnost imunosnog sustava da ubija stanice raka.
English: By blocking CTLA-4, ipilimumab causes activation and increase of T cells, which enter into tumours and kill the tumour cells.
Croatian: Blokirajući CTLA-4 ipilimumab uzrokuje aktiviranje i porast broja T-stanica, koje ulaze u tumore i uništavaju tumorske stanice.
English: This means that the CHMP had no way to know if the addition of Yervoy to Opdivo treatment produced additional benefit.
Croatian: To znači da CHMP nije mogao znati proizvodi li se dodavanjem lijeka Yervoy lijeku Opdivo dodatna korist.
English: The active substance in both medicines, nivolumab and ipilimumab, are monoclonal antibodies, a type of protein that has been designed to recognise and attach to a specific structure.
Croatian: Djelatne tvari u oba lijeka, nivolumab i ipilimumab, monoklonska su protutijela, vrsta bjelančevine namijenjena prepoznavanju i vezivanju na određeno ciljno mjesto.
English: They contain the active substances nivolumab and ipilimumab respectively.
Croatian: Sadržavaju djelatne tvari nivolumab, odnosno ipilimumab.
English: Opdivo and Yervoy are cancer medicines.
Croatian: Opdivo and Yervoy lijekovi su za liječenje raka.
English: At the same time it was clear that combination with Yervoy resulted in more side effects than are seen with Opdivo alone.
Croatian: Istodobno je bilo jasno da u kombinaciji s lijekom Yervoy nastaje više nuspojava u odnosu na one koje se pojavljuju pri primjeni lijeka Opdivo kao monoterapije.
English: The change concerns the use of both medicines together to treat renal cell carcinoma (kidney cancer).
Croatian: Izmjena se odnosi na zajedničku uporabu lijekova za liječenje karcinoma bubrežnih stanica (raka bubrega).
English: It is already used on its own to treat renal cell carcinoma in patients who have previously been treated with other cancer medicines.
Croatian: Opdivo se upotrebljava kao monoterapija za liječenje karcinoma bubrežnih stanica u bolesnika koji su prethodno bili liječeni drugim lijekovima protiv raka.
English: What are Opdivo and Yervoy?
Croatian: Što su lijekovi Opdivo i Yervoy?
English: What are Opdivo and Yervoy to be used for?
Croatian: Za što se lijek Opdivo i Yervoy trebaju primjenjivati?
English: It is known that Opdivo alone produces benefit in previously treated patients with renal cell carcinoma.
Croatian: Poznato je da lijek Opdivo kao monoterapija stvara koristi za bolesnike s karcinomom bubrežnih stanica koji su prethodno bili liječeni.
English: Ipilimumab attaches to and blocks the activity of CTLA-4, a protein that controls the activity of T cells.
Croatian: Ipilimumab se vezuje na CTLA-4, bjelančevinu koja upravlja aktivnošću T-stanica i blokira njegovo djelovanje.
English: How do Opdivo and Yervoy work?
Croatian: Kako djeluju lijekovi Opdivo i Yervoy?
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Croatian: Dodatak I Navedite naziv (e) oblik (e) farmaceutska (e) oblik (e) lijek (e), rute (e)
English: 4.5 mg (1:1:1) film-coated tablet
Croatian: 4.5 mg (1:1:1) filmom obložene tableta
English: Defiante Farmacêutica, S.A. PRT
Croatian: Portugalija Defiante Farmacêutica, S.A. PRT
English: Luxembourg Defiante Farmacêutica, S.A.
Croatian: Luksemburg Defiante Farmacêutica, S.A.
English: CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule soft capsule
Croatian: CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule kapsula
English: Hydergin SRO 6 mg Kapseln modified-release capsule, hard
Croatian: Hydergin SRO 6 mg Kapseln kapsula
English: Hydergin Fas 4,5 mg Filmtabletten
Croatian: Hydergin Fas 4,5 mg Filmtabletaten
English: Gastro-resistant tablet
Croatian: Želučanootporne tableta
English: Redergin 1,5 mg tablete 1,5 mg
Croatian: Redergin 1,5 mg tabletae 1,5 mg
English: Verovskova 57, 1526 Ljubljana, Slovenia
Croatian: LEK PHARMACEUTICALS d.d. Verovskova 57, 1526 Ljubljana, Slovenia
English: HYDERGINE 1 mg/ml, solution buvable en gouttes
Croatian: HYDERGINE 1 mg/ml, otopina buvable en gouttes
English: Hydergin 2 mg Tabletten 2 mg (1:1:1)
Croatian: Hydergin 2 mg Tabletaten 2 mg (1:1:1)
English: Redergin 4,5 mg tablete 4,5 mg
Croatian: Redergin 4,5 mg tabletae 4,5 mg
English: Belgium Defiante Farmacêutica S.A., Rua dos Ferreiros 260, 9000-082 Funchal, Portugal
Croatian: Defiante Farmacêutica S.A., Rua dos Ferreiros 260, 9000-082 Funchal, Portugal
English: Hydergin 1 mg Tabletten 1 mg (1:1:1)
Croatian: Hydergin 1 mg Tabletaten 1 mg (1:1:1)
English: Rua dos Ferreiros, 260 9000-082 FunchalMadeira
Croatian: Rua dos Ferreiros, 260 9000-082 Funchal Portugal
English: Hydergin 3 mg/ml Tropfen 3 mg/ml (1:1:1) oral drops, solution oral use
Croatian: Hydergin 3 mg/ml Tropfen 3 mg/ml (1:1:1) oralne kapi, otopina oralno
English: Hydergin 1 mg/ml Tropfen 1 mg/ml (1:1:1) oral drops, solution oral use
Croatian: Hydergin 1 mg/ml Tropfen 1 mg/ml (1:1:1) oralne kapi, otopina oralno
English: What is Septanest?
Croatian: Što je Septanest?
English: 27 May 2019
Croatian: 27. svibnja 2019.
English: It is given by injection.
Croatian: Daje se injekcijom.
English: Why was Septanest reviewed?
Croatian: Zašto je Septanest preispitivan?
English: Septanest has been authorised in the EU via national procedures.
Croatian: Lijek Septanest odobren je u EU-u nacionalnim postupcima.
English: After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data or were considered redundant.
Croatian: Nakon pregleda dostupnih podataka zaključeno je da brojne druge kontraindikacije, koje su vrijedile samo u nekim zemljama, nisu potkrijepljene s dovoljno podataka ili se smatraju redundantnima.
English: It must also not be given to patients with epilepsy who are not adequately controlled by treatment.
Croatian: Ne smije se davati ni bolesnicima s epilepsijom u kojih se terapijom ne postiže zadovoljavajuća kontrola bolesti.
English: The maximum recommended dose in all ages is 7 mg of articaine per kg body weight, up to a maximum total dose of 500 mg in adults and 385 mg in children.
Croatian: Najveća preporučena doza za sve dobne skupine iznosi 7 mg artikaina po kilogramu tjelesne težine, do najveće ukupne doze od 500 mg u odraslih i 385 mg u djece.
English: The recommended dose of Septanest depends on the patient's body weight.
Croatian: Preporučena doza lijeka Septanest ovisi o tjelesnoj težini bolesnika.
English: Where justified by data, some of the previous contraindications have been included in section 4.4 (special warnings and precautions for use).
Croatian: Ako je to bilo opravdano podatcima, neke od prethodnih kontraindikacija uvrštene su u dio 4.4. (posebna upozorenja i mjere opreza pri uporabi).
English: Septanest is also available in the EU under other trade names including Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest with Adrenaline, Septanestepi and Septocaine.
Croatian: Lijek Septanest dostupan je u EU-u i pod drugim trgovačkim nazivima, uključujući Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest s adrenalinom, Septanestepi i Septocaine.
English: A European Commission decision valid throughout the EU was issued on 27/05/2019.
Croatian: Odluka Europske komisije valjana u cijelom EU-u donesena je 27. svibnja 2019.
English: Septanest is now authorised for use as a local anaesthetic in dental procedures in adults, adolescents and children above 4 years of age (or weighing at least 20 kg).
Croatian: Septanest je trenutačno odobren za primjenu kao lokalni anestetik prilikom stomatoloških postupaka u odraslih, adolescenata i djece starije od četiri godine (ili koja teže najmanje 20 kg).
English: Other harmonised sections of the SmPC include section 4.4 (special warnings and precautions for use), 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), 4.8 (side effects), and 4.9 (overdose).
Croatian: Drugi usklađeni dijelovi sažetka opisa svojstava lijeka obuhvaćaju dijelove 4.4. (posebna upozorenja i mjere opreza pri uporabi), 4.5. (interakcije s drugim lijekovima), 4.6. (plodnost, trudnoća i dojenje), 4.7. (utjecaj na sposobnost upravljanja vozilima i strojevima), 4.8. (nuspojave) i 4.9. (predoziranje).
English: Septanest is a local anaesthetic (a medicine for preventing pain and discomfort in a part of the body during medical procedures).
Croatian: Septanest je lokalni anestetik (lijek koji sprječava bol i nelagodu u određenom dijelu tijela tijekom medicinskih postupaka).
English: This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information - that is, the summary of product characteristics (SmPC), labelling and package leaflet - in the countries where the medicine is marketed.
Croatian: To je dovelo do neujednačenosti među državama članicama u pogledu načina proizvodnje i primjene lijeka, što se odražava u razlikama među informacijama za propisivanje, tj. sažetku opisa svojstava lijeka, označivanju i uputi o lijeku, u zemljama u kojima se lijek stavlja u promet.
English: In addition, parts of Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) have also been harmonised.
Croatian: Nadalje, usklađeni su i dijelovi 3. modula dosjea o lijeku (u kojem se opisuje način proizvodnje lijeka i kontrole njegove kakvoće).
English: Septanest must not be used in patients who are allergic to articaine or similar local anaesthetics (known as amide-type local anaesthetics) or to any other ingredient of the medicine.
Croatian: Septanest se ne smije primjenjivati u bolesnika koji su alergični na artikain ili slične lokalne anestetike (poznate kao lokalni anestetici amidnog tipa) ili bilo koji drugi sastojak lijeka.
English: Septanest contains the active ingredient articaine together with adrenaline (epinephrine), which helps prolong articaine's effects and restrict it to a particular area of the body.
Croatian: Septanest sadržava djelatnu tvar artikain u kombinaciji s adrenalinom (epinefrinom), koji produžava učinke artikaina i ograničava ih na određeni dio tijela.
English: On 28 March 2019, the European Medicines Agency (EMA) completed a review of Septanest (also known by various other names) and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Croatian: Europska agencija za lijekove (EMA) završila je 28. ožujka 2019. preispitivanje lijeka Septanest (koji je poznat i pod nekim drugim imenima) te preporučila izmjene informacija o propisivanju kako bi se uskladio način primjene lijeka u EU-u.
English: EMA/186900/2019 Rev 1 EMEA/H/A-30/1461
Croatian: 1 EMEA/H/A-30/1461
English: After considering the available data on the use of Septanest, the Agency concluded that the SmPC should be harmonised.
Croatian: Nakon razmatranja dostupnih podataka o primjeni lijeka Septanest Agencija je zaključila da je sažetak opisa svojstava lijeka potrebno uskladiti.
English: On 4 June 2018, Septodont, the company that markets Septanest, referred the matter to EMA in order to harmonise the marketing authorisations for Septanest in the EU.
Croatian: Septodont, tvrtka koja lijek Septanest stavlja u promet, to je pitanje 4. lipnja 2018. uputila EMA-i radi usklađivanja odobrenjâ za stavljanje lijeka Septanest u promet u EU-u.
English: The review of Septanest was initiated on 29 June 2018 at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
Croatian: Preispitivanje lijeka Septanest započelo je na zahtjev nositelja odobrenja za stavljanje u promet, tvrtke Septodont, u skladu s člankom 30.
English: The package leaflet has been updated accordingly.
Croatian: U skladu s tim ažurirana je i uputa o lijeku.
English: It is important that both men and women read the information.
Croatian: Važno je da te informacije pročitaju i muškarci i žene.
English: This is so your doctor can:
Croatian: Vaš liječnik može:
English: Talk to your doctor about different contraception methods that are suitable for you.
Croatian: Razgovarajte sa svojim liječnikom o različitim metodama kontracepcije prikladnima za Vas.
English: Date of first authorisation: 22 July 2016
Croatian: Datum prvog odobrenja: 22. srpnja 2016.
English: This allows the infection to be permanently removed from the body.
Croatian: To omogućuje trajno uklanjanje infekcije iz tijela.
English: • Do not take a double dose (two doses together) to make up for a forgotten dose.
Croatian: • Nemojte uzeti dvostruku dozu (dvije doze zajedno) kako biste nadoknadili zaboravljenu dozu.
English: Clinical and laboratory monitoring is recommended.
Croatian: Preporučuje se kliničko i laboratorijsko praćenje.
English: Take the medicine pack with you so that you can show the doctor what you have taken.
Croatian: Ponesite pakiranje lijeka sa sobom kako biste mogli liječniku pokazati što ste uzeli.
English: Driving and using machines Do not drive or operate machines if you feel tired after taking your medicine.
Croatian: Nemojte upravljati vozilima niti raditi sa strojevima ako se osjećate umorno nakon uzimanja lijeka.
English: Number of isolates tested: a=5, b=4, c=14, d=10, e=9
Croatian: Broj ispitanih izolata: a=5, b=4, c=14, d=10, e=9
English: Your doctor will tell you how many weeks you should take ZEPATIER for.
Croatian: Vaš liječnik će Vam reći koliko tjedana trebate uzimati ZEPATIER.
English: Store in the original package until use to protect from moisture.
Croatian: Čuvati u originalnom pakiranju do uporabe radi zaštite od vlage.
English: Do not chew, crush or split the tablet.
Croatian: Nemojte žvakati, drobiti ni lomiti tabletu.
English: • sunitinib to treat certain cancers
Croatian: • sunitinib, za liječenje određenih vrsta raka
English: Patients should be instructed not to take a double dose.
Croatian: Bolesnike treba upozoriti da ne smiju uzeti dvostruku dozu.
English: Use with caution; dose adjustment of sunitinib may be required.
Croatian: Primjenjivati uz oprez; možda će biti potrebna prilagoba doze sunitiniba.
English: Then take your next dose at your usual time.
Croatian: Zatim uzmite sljedeću dozu u uobičajeno vrijeme.
English: The tablet is 21 mm long and 10 mm wide.
Croatian: Tableta je 21 mm duga i 10 mm široka.
English: GT = Genotype
Croatian: GT = genotip
English: Animal studies do not indicate harmful effects with respect to reproductive toxicity.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke u smislu reproduktivne toksičnosti.
English: Changes in selected laboratory parameters are described in Table 4.
Croatian: Promjene u odabranim laboratorijskim vrijednostima prikazane su u Tablici 4.
English: ZEPATIER for 12 weeks
Croatian: ZEPATIER tijekom 12 tjedana
English: • 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: Wait and take your next dose at your usual time.
Croatian: Pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: This change is not clinically relevant for grazoprevir.
Croatian: Ta promjena nije klinički značajna za grazoprevir.
English: Elbasvir and grazoprevir are extensively bound (> 99.9 % and 98.8 %, respectively) to human plasma proteins.
Croatian: Elbasvir i grazoprevir se u velikoj mjeri (> 99,9% odnosno 98,8%) vezuju za proteine u plazmi ljudi.
English: • It is very important that you read the information concerning pregnancy and contraception in the ribavirin package leaflet very carefully.
Croatian: • Vrlo je važno da jako pažljivo pročitate informacije o trudnoći i kontracepciji u uputi o lijeku za ribavirin.
English: • You must not become pregnant if you are taking ZEPATIER with ribavirin.
Croatian: • Ne smijete zatrudnjeti ako uzimate ZEPATIER zajedno s ribavirinom.
English: Population Study Arms and Duration (Number of Subjects Treated)
Croatian: Populacija Ispitivane skupine i trajanje (broj liječenih ispitanika)