FrancophonIA/ELRC3.0 huggingface dataset:
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 1 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Croatian: Smeđa staklena boca od 300 ml (staklo tip III) s bijelim sigurnosnim zatvaračem za djecu (polipropilen) u kartonskoj kutiji koja također sadrži graduiranu štrcaljku za usta od 1 ml
English: 150 mg (1.5 ml) twice daily
Croatian: 150 mg (1,5 ml) dva puta na dan 450 mg (4,5 ml) dva puta na dan
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily (2)
Croatian: 7 do 14 mg/kg (0,07 do 0,14 ml/kg) jedanput na dan
English: 0.45 ml twice daily
Croatian: 0,45 ml dva puta na dan
English: 1 ml twice daily
Croatian: 1 ml dva puta na dan
English: Use the 10 ml oral syringe included in the package
Croatian: 300 ml oralna otopina Koristite štrcaljku za usta od 10 ml koja se nalazi u pakiranju.
English: 6 ml twice daily
Croatian: 6 ml dva puta na dan
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 1 ml syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za bocu od 300 ml sa štrcaljkom od 1 ml
English: 1.05 ml twice daily
Croatian: 1,05 ml dva puta na dan
English: If you get any side effects talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Blood cell counts
Croatian: Krvna slika
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 10 ml syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za bocu od 300 ml sa štrcaljkom od 10 ml
English: 2.4 ml twice daily
Croatian: 2,4 ml dva puta na dan
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 3 ml syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija za bocu od 300 ml sa štrcaljkom od 3 ml
English: 0.3 ml twice daily
Croatian: 0,3 ml dva puta na dan
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 1 ml syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na boci od 300 ml sa štrcaljkom od 1 ml
English: 2 ml twice daily
Croatian: 2 ml dva puta na dan
English: Laxatives
Croatian: Laksativi
English: Choreoathetosis,
Croatian: poremećaj osobnosti,
English: Maximum dose: 21 mg/kg twice daily
Croatian: 21 mg/kg dva puta na dan
English: 3 ml twice daily
Croatian: 3 ml dva puta na dan
English: Rare disorders headache disorder, dizziness, lethargy, tremor impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention dyskinesia, hyperkinesia, gait disturbance, encephalopathy
Croatian: Konvulzije, poremećaj ravnoteže, omaglica, letargija, tremor
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 3 ml syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na boci od 300 ml sa štrcaljkom od 3 ml
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 10 ml syringe
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na boci od 300 ml sa štrcaljkom od 10 ml
English: 72 x serum creatinine (mg/dl)
Croatian: Maximum Recommended Human Dose, izraženom u mg/m2).
English: Maximum dose: 30 mg/kg twice daily
Croatian: 30 mg/kg dva puta na dan
English: Starting dose: 10 mg/kg twice daily
Croatian: 10 mg/kg dva puta na dan
English: Levetiracetam is excreted in human breast milk.
Croatian: Levetiracetam se izlučuje u majčino mlijeko pa se dojenje ne preporučuje.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
Croatian: parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od prvog mjeseca života miokloničkih napadaja (kratki, iznenadni trzaj mišića ili skupine mišića) u odraslih i adolescenata starijih od 12 godina života s juvenilnom miokloničnom epilepsijom primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u odraslih i adolescenata starijih od 12 godina života s idiopatskom generaliziranom epilepsijom (oblik epilepsije za koji se smatra da je genetski uvjetovan).
English: Adverse reactions reported in clinical studies (adults, adolescents, children and infants> 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
Croatian: Nuspojave zabilježene tijekom kliničkih ispitivanja (odrasli, adolescenti, djeca i dojenčad starija od 1
English: Completed suicide, personality disorder, thinking abnormal, delirium
Croatian: poremećaj mišljenja, delirij
English: 1.5 ml twice daily
Croatian: 1,5 ml dva puta na dan
English: 2.5 ml twice daily
Croatian: 2,5 ml dva puta na dan
English: Use the 3 ml oral syringe and adaptor included in the package
Croatian: 300 ml oralna otopina Koristite štrcaljku za usta od 3 ml i nastavak koji se nalaze u pakiranju.
English: Use the 1 ml syringe and adaptor included in the package.
Croatian: 300 ml oralna otopina Koristite štrcaljku za usta od 1 ml i nastavak koji se nalaze u pakiranju.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (3) (5)
Croatian: 10 do 20 mg/kg (0,10 do 0,20 ml/kg) jednaput na dan
English: Whereas,
Croatian: Budući da:
English: Hepatocellular carcinoma
Croatian: Hepatocelularni karcinom
English: A joint study is encouraged.
Croatian: Preporučuje se zajedničko ispitivanje.
English: Should the use of existing data sources not show feasible, a proposal for a prospective collection of data should be provided.
Croatian: Ako se pokaže da postojeći izvori podataka nisu provedivi, treba dostaviti prijedlog za prospektivno prikupljanje podataka.
English: The product information should reflect these recommendations and inform healthcare professionals about this risk.
Croatian: Informacije o lijeku trebaju odražavati te preporuke i obavještavati zdravstvene radnike o tom riziku.
English: Hepatitis B virus reactivation
Croatian: Ponovna aktivacija hepatitisa B
English: Other published data from larger cohorts did not support the findings (Pol et al, 2016).
Croatian: Drugi podaci iz većih kohortnih ispitivanja ne podržavaju te nalaze (Pol i dr., 2016.).
English: Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions and grounds for recommendation.
Croatian: Nakon što je pregledao preporuku PRAC-a, CHMP se složio s općim znanstvenim zaključcima i razlozima za preporuku.
English: However, the difficulty of fully controlling confounding in this non-randomised comparison was recognised.
Croatian: Međutim, otkrivene su poteškoće u pogledu potpune kontrole u ovoj usporedbi koja nije randomizirana.
English: As both requests for the triggered procedure result from the evaluation of data resulting from pharmacovigilance activities, the EC requested the opinion to be adopted by the Committee for Medicinal Products for Human Use (CHMP) on the basis of a recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Budući da oba zahtjeva za pokrenuti postupak proizlaze iz ocjenjivanja podataka na temelju aktivnosti farmakovigilancije, Europska komisija zatražila je od Odbora za lijekove za humanu uporabu (CHMP) da donese mišljenje na temelju preporuke Odbora za procjenu rizika u području farmakovigilancije (PRAC).
English: After further consideration of the timelines proposed for the submission of the final study report and taking into account that the protocol is due to be submitted by 15 June 2017, the CHMP was of the opinion that the date for the submission of the final study report should be postponed to Q2 2021 in order to allow sufficient time for agreement on a joint protocol and for collection of sufficient data to adequately respond to the scientific question.
Croatian: Nakon dodatnog razmatranja vremenskih rokova koji su predloženi pri podnošenju konačnog izvješća o ispitivanju i uzimajući u obzir da se protokol treba podnijeti do 15. lipnja 2017., CHMP smatra da bi se datum za podnošenje konačnog izvješća o ispitivanju trebao odgoditi na 2. tromjesečje 2021. kako bi ostalo dovoljno vremena za dogovaranje o zajedničkom protokolu i za prikupljanje podataka za odgovarajući odgovor na znanstveno pitanje.
English: CHMP opinion and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Croatian: Mišljenje CHMP-a i detaljno objašnjenje znanstvene osnove za odstupanja od preporuke PRAC-a
English: The PRAC was also of the view that ‘emergence of hepatocellular carcinoma' and ‘recurrence of hepatocellular carcinoma' should be considered as important potential risks.
Croatian: PRAC također smatra da bi se „hitnost hepatocelularnog karcinoma” i „vraćanje hepatocelularnog karcinoma” trebali smatrati važnim mogućim rizicima.
English: Direct-acting antiviral agents (DAAs) target specific non-structural proteins of the hepatitis C virus and result in disruption of viral replication and infection.
Croatian: Direktno djelujući antivirusni lijekovi (DAA) ciljaju određene, nestrukturirane proteine virusa hepatitisa C i dovode do replikacije virusa i infekcije.
English: The protocol of this study shall be submitted to the PRAC by 15 June 2017 and the final study results by Q4 2019.
Croatian: Protokol tog ispitivanja treba se podnijeti PRAC-u do 15. lipnja 2017., a konačne rezultate ispitivanja do 4. tromjesečja 2019.
English: In addition, ‘patients with previous HCC' should be considered as missing information, since this population was excluded from available clinical trials.
Croatian: Osim toga, „bolesnici koji su prije bolovali od hepatocelularnog karcinoma” trebali bi se smatrati informacijama koje nedostaju jer je ta skupina isključena iz dostupnih kliničkih ispitivanja.
English: In addition, patients should be advised to contact their doctor if they have ever been infected with HBV as close monitoring is required.
Croatian: Nadalje, bolesnike bi trebalo savjetovati da se obrate svojem liječniku ako su ikada bili zaraženi HBV-om jer je u tom slučaju potreban pomniji nadzor.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for direct-acting antiviral agents (DAAs) indicated in the treatment chronic hepatitis C.
Croatian: • PRAC je razmatrao postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 iz podataka o farmakovigilanciji za lijekove koji sadrže antivirusne lijekove (DAA) indicirane za liječenje kroničnog hepatitisa C.
English: The RMP should be updated accordingly within 3 months of this CHMP opinion.
Croatian: Plan upravljanja rizikom trebalo bi na odgovarajući način ažurirati u roku od 3 mjeseca od donošenja ovog mišljenja CHMP-a.
English: Some of the cases identified with DAAs had serious outcomes, with worsening of hepatic status and at least one case where the patient required liver transplantation.
Croatian: Neki od slučajeva s direktno djelujućim antivirusnim lijekovima imali su ozbiljne ishode, odnosno pogoršanje stanja jetre, a u barem jednom slučaju bolesnik je trebao transplantaciju jetre.
English: The wording of the condition to the marketing authorisation has been amended accordingly.
Croatian: U skladu s tim izmijenjen je tekst uvjeta odobrenja za stavljanje lijeka u promet.
English: Literature cases (Balagopal et al., 2015; Collins et al., 2015; Ende et al., 2015) described HBV viral load increase after a rapid decline of HCV viral load in patients treated with direct acting antivirals (DAA) in interferon-free regimens, and further cases have been identified in EudraVigilance.
Croatian: Slučajevi iz literature (Balagopal i drugi, 2015.; Collins i drugi, 2015.; Ende i drugi, 2015.) opisuju povećanje virusnog opterećenja HCV-om nakon rapidnog smanjenja virusnog opterećenja HBV-om u bolesnika koji se liječe direktno djelujućim antivirusnim lijekovima (DAA) bez interferona.
English: The product information will include a warning to inform about the risk of hepatitis B reactivation and reflect these recommendations.
Croatian: Informacije o lijeku uključivat će upozorenje u kojem se navode rizici ponovne aktivacije hepatitisa B i koje održava ove preporuke.
English: Patients with HBV/HCV co-infection should be monitored during and after treatment according to current clinical guidelines.
Croatian: Bolesnici koji su koinficirani HBV-om/HCV-om trebali bi se nadzirati tijekom i nakon liječenja u skladu s trenutačnim kliničkim smjernicama.
English: It was considered that in addition to the hepatitis B virus reactivation, the risk of hepatocellular carcinoma should also be further investigated and that consideration should be given for adequate measures to optimise the safe and effective use of these medicinal products.
Croatian: Smatra se da bi se uz rizik od ponovne aktivacije hepatitisa B trebao istražiti i rizik od hepatocelularnog karcinoma te da bi se trebale donijeti odgovarajuće mjere za optimizaciju sigurne i učinkovite upotrebe tih lijekova.
English: The European Commission therefore extended the scope of the procedure in April 2016 to allow consideration of other data to assess the risk of hepatocellular carcinoma and its impact on the benefit-risk balance for all DAAs in the treatment of chronic hepatitis C.
Croatian: Europska je komisija stoga u travnju 2016. proširila područje primjene postupka kako bi omogućila razmatranje drugih podataka za procjenu rizika od hepatocelularnog karcinoma i njegova utjecaja na omjer koristi i rizika za sve direktno djelujuće lijekove u liječenju kroničnog hepatitisa C.
English: Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested unexpected early HCC recurrence.
Croatian: Nakon pokretanja ove procjene, rezultati istraživanja (Reig i drugi, 2016.) provedenog između listopada 2014. i prosinca 2015. na hepatološkim odjelima četiriju španjolskih bolnica na bolesnicima koji imaju kronični hepatitis C i anamnezu hepatocelularnog karcinoma (HCC) te su liječeni direktno djelujućim antivirusnim lijekovima, pokazuju neočekivano rano vraćanje HCC-a.
English: The research should capture prospectively the known risk factors for HCC and the periodic image testing for HCC diagnosis, according to current European clinical guidelines (EASL).
Croatian: Ispitivanje bi trebalo prospektivno obuhvatiti poznate čimbenike rizika za HCC i povremeno slikovno ispitivanje za dijagnozu hepatocelularnog karcinoma u skladu s važećim europskim kliničkim smjernicama (EASL).
English: The European Association for the Study of the Liver (EASL) recommendations on treatment of hepatitis C makes reference to the potential risk of HBV reactivation during or after HCV clearance.
Croatian: Preporuke Europskog društva za bolesti jetre (EASL) u vezi s liječenjem hepatitisa C navode mogući rizik od ponovne aktivacije HBV-a tijekom ili nakon čišćenja HCV-a.
English: It may be assumed however that patients with more advanced liver disease may have a higher risk of severe clinical complications should HBV reactivation occur.
Croatian: Međutim, može se pretpostaviti da bolesnici s uznapredovalom bolesti jetre mogu imati veći rizik od ozbiljnih kliničkih komplikacija u slučaju ponovne aktivacije.
English: Although severe and even fatal cases of HBV reactivation have been described in the literature, the available data indicate that reactivation of HBV replication may mostly be mild and without clinical consequences.
Croatian: Iako su u literaturi opisani ozbiljni, čak i smrtonosni slučajevi ponovne aktivacije HBV-a, dostupni podaci pokazuju da je ponovna aktivacija replikacije HBV-a uglavnom blaga i bez kliničkih posljedica.
English: The impact of chronic HCV infection characteristics, such as HCV genotype, viral load and histopathologic staging, on the risk of occurrence of HBV reactivation could not be clarified from the available data.
Croatian: Učinak karakteristika kronične infekcije HCV-a, kao što su HCV genotip, virusno opterećenje i histopatološko stupnjevanje, na rizik od pojavljivanja ponovne aktivacije HBV-a ne može se razjasniti iz dostupnih podataka.
English: Hepatitis В virus (HBV) and hepatitis C virus (HCV) co-infection is not uncommon due to overlapping transmission modes.
Croatian: Koinfekcija virusa hepatitisa B (HBV) i virusa hepatitisa C (HCV) nije neuobičajena zbog preklapajućih načina prijenosa.
English: Although liver disease activity and progression are generally more severe in the presence of double infection, HBV replication is often suppressed in the presence of HCV coinfection.
Croatian: Iako su bolesti jetre i progresija uglavnom ozbiljnije kod dvostruke infekcije, replikacija HVB-a često je potisnuta ako postoji koinfekcija HCV-a.
English: A study from Reig et al. (2016) showed a signal of HCC recurrence in patients treated with DAAs; similar results were obtained by Conti et al. (2016).
Croatian: Istraživanje Reiga i dr. (2016.) pokazalo je vraćanje hepatocelularnog karcinoma u bolesnika koji su liječeni direktno djelujućim antivirusnim lijekovima; slične rezultate dobili su Conti i dr. (2016.)
English: The current referral procedure was triggered by the European Commission (EC) to allow further investigation of the risk of hepatitis B virus replication after starting treatment with DAAs and recommend any appropriate measure to minimise the risk.
Croatian: Europska komisija (EC) pokrenula je trenutačni postupak upućivanja radi dodatnog istraživanja rizika od replikacije virusa hepatitisa B nakon početka liječenja direktno djelujućim antivirusnim lijekovima i preporučivanja odgovarajućih mjera za smanjenje rizika.
English: The virological and immunological aspects of HBV/HCV co-infection are not fully comprehended.
Croatian: Virološki i imunološki aspekti koinfekcije virusom hepatitisa B (HBV) / hepatitisa C (HCV) nisu u potpunosti razumljivi.
English: However, these cohorts were either not designed for assessing HCC recurrence, as is the case of the ANRS CO22 HEPATHER cohort, or included a limited number of patients with a previous HCC reaching complete radiological response and subsequently treated with DAAs as in the ANRS CO12 CirVir cohort.
Croatian: Međutim, ta kohortna ispitivanja nisu osmišljena za procjenu vraćanja hepatocelularnog karcinoma (na primjer u kohorti ANRS CO22 HEPATHER) ili su uključivala ograničen broj bolesnika koji su imali hepatocelularni karcinom, postigli su potpuni radiološki odgovor i nakon toga su se liječili direktno djelujućim antivirusnim lijekovima (na primjer u kohorti ANRS CO12 CirVir).
English: The available data provide evidence that the reactivation of HBV replication may occur in the context of the treatment of chronic HCV active infection with any form of effective treatment in patients coinfected with HBV and HCV.
Croatian: Dostupni podaci pokazuju da se ponovna aktivacija replikacije HBV-a može dogoditi u kontekstu liječenja kronične aktivne infekcije HCV-a bilo kakvim liječenjem bolesnika koji su koinficirani HBV-om i HCV-om.
English: The reactivation may occur mostly in subjects with detectable HBsAg and active HBV replication of any level, as evaluated by measurable levels of HBV-DNA, but may also occur in subjects without detectable HBsAg though with detectable anti-HBc antibody, of which a small percentage may also present with variable levels of active HBV replication.
Croatian: Ponovna aktivacija događa se uglavnom kod subjekata s uočljivim antigenom HBsAg i aktivnom replikacijom HBV-a bilo koje razine na temelju ocjene mjerljivih razina HBV-a/DNK-a, no može se javiti i kod bolesnika bez uočljivog antigena HBsAg, bez obzira na to što imaju antitijelo antiHBc, od kojih mali postotak može imati i promjenjive razine replikacije aktivnog HBV-a.
English: HCV infection is known to cause suppression of HBV replication in co-infected patients.
Croatian: Poznato je da infekcija HCV-a uzrokuje potiskivanje replikacije HBV-a u koinficiranih bolesnika.
English: In addition, interim results should be submitted for PRAC assessment by Q4 2019.
Croatian: Nadalje, sve rezultate potrebno je predati PRAC-u na ocjenu do 4. tromjesečja 2019.
English: Overall, the PRAC considered that further studies were warranted to further characterise the risk of HCC recurrence associated with DAAs, in order to address remaining uncertainties about this potential risk and conclude on the need for any additional advice on clinical management.
Croatian: PRAC je smatrao da treba provesti dodatna istraživanja za dodatno određivanje karakteristika rizika od vraćanja hepatocelularnog karcinoma povezanog s direktno djelujućim antivirusnim lijekovima kako bi se riješile preostale nesigurnosti u pogledu tog mogućeg rizika i donio zaključak o potrebi za dodatnim savjetom o kliničkom upravljanju.
English: Given their increased potency against HCV and lack of anti-HBV activity, the risk of HBV reactivation may be greater with newer HCV treatment regimens than with the previously approved interferon-based HCV treatments.
Croatian: Budući da ti lijekovi imaju jako djelovanje protiv HCV-a i manjak djelovanja protiv HBV-a, rizik od ponovne aktivacije HBV-a može biti veći uz nove načine liječenja HCV-a nego kod prethodno odobrenih načina liječenja HCV-a koja se temelje na interferonu.
English: The PRAC was of the view that all patients should be screened for hepatitis B virus infection before initiation of treatment with DAAs.
Croatian: PRAC smatra da bi se svi bolesnici trebali testirati na virus hepatitisa B prije početka liječenja direktno djelujućim antivirusnim lijekovima.
English: Generally, the reactivation occurred shortly after the initiation of treatment in a pattern that implies a correlation with the rapid decrease in HCV viral load which characterises the viral load dynamics with DAAs.
Croatian: Ponovna aktivacija općenito se dogodila kratko nakon uvođenja liječenja u obrascu koji ukazuje na povezanost brzog smanjenja virusnog opterećenja HCV-a, što karakterizira dinamiku virusnog opterećenja s direktno djelujućim antivirusnim lijekovima.
English: In order to minimise the risk of HBV reactivation, the PRAC recommended that all patients should be screened for HBV infection before initiation of treatment with DAAs and that patients presenting a coinfection HBV/HCV should be monitored and managed according to current clinical guidelines.
Croatian: Kako bi se smanjio rizik od ponovne aktivacije HBV-a, PRAC je preporučio da bi se svi bolesnici trebali testirati na HBV prije početka liječenja direktno djelujućim antivirusnim lijekovima i da bi bolesnike koji su koinficirani HBV-om/HCV-om trebalo nadzirati i njima upravljati u skladu s trenutačnim kliničkim smjernicama.
English: • The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral diseases.
Croatian: • PRAC je ocijenio sveukupne pismeno podnesene podatke i usmena objašnjenja nositelja odobrenja za stavljanje lijekova u promet u pogledu rizika za ponovnu aktivaciju hepatitisa B i zabrinutosti koje su proizašle iz izvješća o hepatocelularnom karcinomu u bolesnika koji primjenjuju antivirusne lijekove, kao i rezultate sastanka znanstvene savjetodavne skupine za virusne bolesti / HIV.