FrancophonIA/ELRC3.0 huggingface dataset:
English: With regards to the review of HCC with DAAs, MAHs were requested to perform a comprehensive review of all available data from clinical trials, observational studies, spontaneous reports and published literature on HCC in patients with chronic hepatitis C after treatment with DAAs.
Croatian: U pogledu procjene hepatocelularnog karcinoma s direktno djelujućim antivirusnim lijekovima, od MAH-a je zatraženo da provede opsežnu procjenu svih dostupnih podataka iz kliničkih ispitivanja, opservacijskih ispitivanja, spontanih izvješća i objavljene literature o hepatocelularnom karcinomu u bolesnika s kroničnim hepatitisom C nakon liječenja direktno djelujućim antivirusnim lijekovima.
English: With regards to the risk of hepatitis B reactivation, since chronic hepatitis B infection (HbsAg+) was generally considered an exclusion criterion and the collection of data regarding HBV serology and DNA was not mandatory in the development programme of DAAs agents, there is limited information on hepatitis B reactivation obtainable from the completed clinical trials.
Croatian: Budući da se kronični hepatitis B (HbsAg+) općenito smatrao kao kriterij za isključivanje, a prikupljanje podataka u pogledu serologije HBV-a i DNK-a nije bilo obavezno u razvojnom programu za direktno djelujuće antivirusne lijekove, informacije o riziku od ponovne aktivacije hepatitisa B koje se mogu nabaviti iz dovršenih kliničkih ispitivanja ograničene su.
English: Overall, the PRAC was of the view that evidence exists of a risk of HBV reactivation in HBV/HCV coinfected patients treated with DAAs and therefore HBV reactivation in co-infected patients should be considered as an important identified risk which should be closely monitored through routine risk minimisation activities.
Croatian: PRAC je smatrao da postoje dokazi o riziku ponovne aktivacije HBV-a u bolesnika koji su koinficirani HBV-om/HCV-om i koji se liječe direktno djelujućim antivirusnim lijekovima te bi se stoga ponovna aktivacija HBV-a u koinficiranih bolesnika trebala smatrati važnim utvrđenim rizikom koji bi se trebao pobliže nadzirati tijekom provedbe rutinskih mjera za smanjenje rizika.
English: All MAHs of DAAs shall conduct a prospective safety study in a well-defined group of patients based on an agreed protocol setting out criteria for entry and follow-up.
Croatian: Svi MAH-ovi direktno djelujućih antivirusnih lijekova provest će prospektivno ispitivanje sigurnosti na pomno definiranoj skupini bolesnika na temelju dogovorenog protokola koji uspostavlja kriterije za sudjelovanje i praćenje.
English: Therefore data on HBV reactivation with DAAs mostly arose post-marketing.
Croatian: Stoga su se podaci o ponovnoj aktivaciji HBV-a uz direktno djelujuće antivirusne lijekove uglavnom pojavili nakon stavljanja lijeka u promet.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
Croatian: CHMP stoga preporučuje izmjene uvjeta za izdavanje odobrenja za stavljanje lijeka u promet za lijekove Daklinza, Exviera, Harvoni, Olysio, Sovaldi i Viekirax.
English: The PRAC, as a consequence, recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
Croatian: Slijedom toga, PRAC preporučuje izmjene uvjeta odobrenja za stavljanje lijekova Daklinza, Exviera, Harvoni, Olysio, Sovaldi i Viekirax.
English: • The PRAC was also of the opinion that the impact of DAAs treatment on the incidence and type of de novo hepatocellular carcinoma should be further investigated though a prospective cohort study in HCV infected patients with cirrhosis.
Croatian: • PRAC također smatra da bi se utjecaj liječenja direktno djelujućim antivirusnim lijekovima na učestalost i vrstu de novo hepatocelularnog karcinoma trebao dodatno istražiti u prospektivnom kohortnom ispitivanju na bolesnicima s HCV-om i cirozom.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax remains favourable subject to the amendments to the product information and to the conditions described above.
Croatian: CHMP slijedom toga zaključuje da omjer koristi i rizika lijekova Daklinza, Exviera, Harvoni, Olysio, Sovaldi i Viekirax ostaje povoljan, podložno izmjenama informacija o lijeku i gore opisanim uvjetima.
English: Overall conclusion
Croatian: Znanstveni zaključci
English: Overall summary of the scientific evaluation by the PRAC In its assessment, the PRAC considered all the data submitted by the MAHs, as well as literature and additional information from a scientific advisory group in relation to the risk of hepatitis B reactivation and to the recurrence and occurrence of hepatocellular carcinoma.
Croatian: PRAC je u svojoj ocjeni razmotrio sve podatke koje su nositelji odobrenja (MAH-ovi) podnijeli, kao i literaturu te dodatne informacije iz znanstvene savjetodavne skupine u vezi s rizikom od ponovne aktivacije hepatitisa B i od vraćanja te pojavljivanja hepatocelularnog karcinoma.
English: • Concerning HBV reactivation, the PRAC concluded that available data provide evidence of a risk of HBV reactivation in patients co-infected with HBV/HCV treated for chronic hepatitis C with DAAs.
Croatian: • U pogledu ponovne aktivacije HBV-a PRAC je zaključio da dostupni podaci ukazuju na rizik od ponovne aktivacije HBV-a u bolesnika koji su koinficirani HBV-om/HCV-om i liječe se od kroničnog hepatitisa direktno djelujućim antivirusnim lijekovima.
English: Clinical trial data on incidence of new on-set HCC show higher point estimates for HCC after reaching SVR with IFN-free regimens compared to IFN-containing regimens, also when stratifying by presence of cirrhosis.
Croatian: Podaci kliničkih ispitivanja o učestalosti novog hepatocelularnog karcinoma pokazuju procjene veće učestalosti hepatocelularnog karcinoma nakon dostizanja SVR-a u liječenju bez IFN-a u usporedbi s liječenjem s IFN-a, kao i tijekom raslojavanja zbog prisutnosti ciroze.
English: Still, it was considered that the impact of DAAs therapies on the incidence and type of de novo HCC should be further investigated by the MAHs through a prospective cohort study to be conducted in HCV infected patients with compensated cirrhosis (CPT-A) without history of HCC and treated with DAAs.
Croatian: No, zaključeno je da bi MAH trebao dodatno istražiti učinak liječenja direktno djelujućim antivirusnim lijekovima na učestalost i vrstu de novo hepatocelularnog karcinoma putem prospektivnog kohortnog ispitivanja na bolesnicima s HCV-om i kompenziranom cirozom (CPT-a) bez povijesti hepatocelularnog karcinoma koji su liječeni direktno djelujućim antivirusnim lijekovima.
English: In accordance with the PRAC recommendation, in order to evaluate the recurrence of hepatocellular carcinoma associated with direct-acting antivirals, the MAHs shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and method for screening.
Croatian: U skladu s preporukom PRAC-a, MAH-ovi bi za ocjenu povezanosti vraćanja hepatocelularnog karcinoma i primjene direktno djelujućih antivirusnih lijekova trebali provesti prospektivno ispitivanje sigurnosti pomoću podataka iz kohortnog ispitivanja pomno definirane skupine bolesnika na temelju dogovorenog protokola koji utvrđuje kriterije za ulazak i praćenje bolesnika u pogledu vremena i metode probira te podnijeti rezultate tog ispitivanja.
English: Based on the findings of Reig et al, concerns on the development of de novo HCC in cirrhotic HCV patients treated with DAA were also raised, as these patients may harbour not yet diagnosed HCC.
Croatian: Na temelju ispitivanja koje je proveo Reig i dr. pojavila se zabrinutost u pogledu razvoja de novo hepatocelularnog karcinoma u bolesnika s cirotičnim HCV-om koji su liječeni direktno djelujućim antivirusnim lijekovima jer ti bolesnici mogu imati hepatocelularni karcinom koji još nije dijagnosticiran.
English: Taking all available data into account, the PRAC was of the view that MAHs should conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and method for screening.
Croatian: PRAC je u obzir uzeo sve dostupne podatke i zaključio da bi MAH-ovi trebali provesti prospektivno ispitivanje sigurnosti pomoću podataka iz kohortnog ispitivanja pomno definirane skupine bolesnika na temelju dogovorenog protokola koji utvrđuje kriterije za sudjelovanje i praćenje bolesnika u pogledu vremena i metode probira te podnijeti rezultate tog ispitivanja.
English: • Concerning the risk of recurrence of HCC in patients using DAAs, the PRAC considered that further data are required on the impact of DAAs treatment on the incidence of HCC recurrence.
Croatian: • U pogledu rizika od vraćanja hepatocelularnog karcinoma u bolesnika koji primjenjuju direktno djelujuće antivirusne lijekove, PRAC smatra da su potrebni dodatni podaci o utjecaju liječenja direktno djelujućim antivirusnim lijekovima na učestalost vraćanja hepatocelularnog karcinoma.
English: In view of the above, the PRAC considers that the benefit-risk balance of direct-acting antivirals remains favourable subject to the amendments to the terms of the marketing authorisations.
Croatian: Naposljetku, PRAC je zaključio da je omjer koristi i rizika kod lijekova koji sadrže direktno djelujuće antivirusne lijekove i dalje povoljan, pod uvjetom izmjene uvjeta odobrenja za stavljanje lijeka u promet.
English: The RMP of the relevant medicinal products will be updated accordingly.
Croatian: Plan upravljanja rizikom trebalo bi na odgovarajući način ažurirati za sve relevantne lijekove.
English: A feasibility assessment of the use of existing data sources for this purpose should be submitted for PRAC assessment by 15 June 2017.
Croatian: PRAC-u treba na ocjenu predati procjenu provedivosti u pogledu upotrebe postojećih izvora podataka za tu svrhu.
English: HBV replication after starting treatment with DAAs for HCV infection is not currently described in the product information of currently authorised products and in view of the seriousness of the events described, the need for intervention on HBV replication and the biological plausibility of the replication it was considered that further investigation was warranted.
Croatian: Replikacija HBV-a nakon početka liječenja direktno djelujućim antivirusnim lijekovima za infekciju HCVom trenutačno nije opisana u informacijama o lijeku trenutačno odobrenih lijekova.
English: ANNEX IV SCIENTIFIC CONCLUSIONS
Croatian: Cjelokupan sažetak znanstvene ocjene PRAC-a
English: Such effects could still be seen after the recovery period of 2 weeks.
Croatian: Takvi učinci još su se mogli vidjeti nakon razdoblja oporavka od 2 tjedna.
English: This is in addition to the educational material which all potential users should receive.
Croatian: To je dodatak edukativnom materijalu koji svi potencijalni korisnici trebaju primiti.
English: • At the request of the European Medicines Agency.
Croatian: • Na traženje Europske agencije za lijekove.
English: Not relevant.
Croatian: Nije značajno.
English: You may be checked regularly for these conditions.
Croatian: Redovito će Vas pregledavati zbog ovih stanja.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}.>
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}.>
English: Not known (cannot be estimated from the available data)
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: Experience with NexoBrid in elderly patients (>65 years) is limited.
Croatian: Iskustvo s NexoBridom u starijih bolesnika (>65 godina) je ograničeno.
English: Allergic reactions can be severe and require medical treatment.
Croatian: Alergijske reakcije mogu biti teške i zahtijevati liječenje.
English: NN: {number} >
Croatian: NN: {broj} >
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8 i 5.1, međutim, nije moguće dati preporuku o doziranju.
English: • The risk of increased mortality in patients with cardiopulmonary diseases
Croatian: • Rizik od povećane smrtnosti u bolesnika s kardiopulmonalnim bolestima
English: See section 6.6 for instructions on NexoBrid gel preparation.
Croatian: Vidjeti dio 6.6 za upute o pripremi gela NexoBrid.
English: These patients should be carefully monitored.
Croatian: Ove bolesnike treba pažljivo pratiti.
English: Date of first authorisation: 18.12.2012
Croatian: Datum prvog odobrenja: 18.12.2012.
English: All wounds (ITT
Croatian: Sve rane (ITT
English: Burns for which there is limited or no experience
Croatian: Opekline s kojima je iskustvo ograničeno ili ne postoji
English: *These comparisons should be interpreted with caution since they are based on groups that are not fully randomized.
Croatian: *Te usporedbe treba interpretirati s oprezom jer se temelje na skupinama koje nisu potpuno randomizirane.
English: The following table shows results in mixed wounds.
Croatian: Sljedeća tablica prikazuje rezultate kod mješovitih rana.
English: The specific components responsible for this effect have not been identified.
Croatian: Nije utvrđeno koje su komponente točno odgovorne za taj učinak.
English: You may receive medicines to prevent or treat infections.
Croatian: Možda ćete dobiti lijekove za sprječavanje ili liječenje infekcija.
English: What NexoBrid looks like and contents of the pack
Croatian: Kako NexoBrid izgleda i sadržaj pakiranja
English: The Healthcare Professional information pack should be a step by step treatment guide that includes information on the following key elements:
Croatian: Paket s informacijama za zdravstvenog djelatnika treba predstavljati vodič koji korak po korak opisuje liječenje i uključuje informacije o sljedećim ključnim elementima:
English: Very common side effects (may affect more than 1 in 10 people) - Fever
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - vrućica
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before this medicine is used.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego što će se primijeniti ovaj lijek.
English: These medicines include, for example, sleep medications, so-called tranquilizers, some pain medications and antidepressants.
Croatian: Ti lijekovi uključuju, na primjer, lijekove za spavanje, tzv. sredstva za smirenje, neke lijekove protiv boli i antidepresive.
English: • The wound assessment and the warning against any repeat treatment
Croatian: • Procjena rane i upozorenje protiv ponavljanja liječenja
English: From these data it is expected that the overall safety profile in children 4 years of age and older and in adolescents is similar to the profile in adults.
Croatian: Iz tih se podataka očekuje da je cjelokupni sigurnosni profil u djece u dobi od 4 ili više godina i u adolescenata sličan onome u odraslih.
English: Warnings and precautions Talk to your doctor or nurse before NexoBrid is used if
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili medicinskoj sestri prije primjene NexoBrida ako
English: However, maternal exposure levels were considerably lower than those maximally reported in clinical setting (10-500 times lower than human AUC, 3-50 times lower than the human Cmax).
Croatian: Međutim, razine maternalne izloženosti bile su znatno niže od maksimalnih kakve su zabilježene u kliničkoj primjeni (10-500 puta niže od ljudskog AUC, 3-50 puta niže od ljudskog Cmax).
English: Tmax for 10 of the 15 patients was 2 hours and in 5 patients Tmax was 4 hours.
Croatian: Tmax u 10 od 15 bolesnika iznosio je 2 sata, a u 5 bolesnika Tmax iznosio je 4 sata.
English: Eye protection
Croatian: Zaštita očiju
English: If you are not sure whether you are taking any of the medicines mentioned above, ask your doctor before NexoBrid is used.
Croatian: Ako niste sigurni uzimate li koji od gore navedenih lijekova, upitajte svog liječnika prije primjene NexoBrida.
English: • The need for pain management
Croatian: • Potreba za liječenjem boli
English: Date of latest renewal: 10.11.2017
Croatian: Datum posljednje obnove odobrenja: 10.11.2017.
English: • The fact that patients should be monitored for signs and symptoms of wound and systemic infections
Croatian: • Činjenica da bolesnike treba nadzirati i paziti na znakove i simptome infekcije rane i sistemskih infekcija
English: The powder should not be inhaled.
Croatian: Prašak se ne smije udisati.
English: Local pain*
Croatian: lokalna bol*
English: The following definitions apply to the frequency terminology used hereafter: Very common (≥1/10)
Croatian: Učestalost se u daljnjem tekstu prikazuje prema sljedećim definicijama: Vrlo često (≥1/10)
English: 48 wounds
Croatian: 48 rana
English: There is only limited safety data from the use in the paediatric population.
Croatian: Postoje samo ograničeni sigurnosni podaci iz primjene na pedijatrijskoj populaciji.
English: See also section 4.2 and 4.8.
Croatian: Vidjeti također dio 4.2 i 4.8.
English: MediWound Ltd. 42 Hayarkon St. 81227 Yavne Israel
Croatian: MediWound Ltd. 42 Hayarkon St. 81227 Yavne Izrael
English: It will be prepared directly before use and applied by a doctor or another healthcare professional.
Croatian: Lijek se priprema neposredno prije primjene i primjenjuje ga liječnik ili drugi zdravstveni radnik.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • U roku od 60 dana od novih važnih saznanja (farmakovigilancijskih ili u sklopu minimalizacije rizika)
English: Since NexoBrid was poorly tolerated by the parent animals, these studies are not considered relevant for human risk assessment.
Croatian: Budući da su roditeljske životinje slabo podnosile NexoBrid, ta se ispitivanja ne smatraju važnima za procjenu rizika u ljudi.
English: Patients should be monitored for increased toxicity.
Croatian: Bolesnike treba pratiti zbog povećane toksičnosti.
English: - wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.
Croatian: - Ranama koje su kontaminirane radioaktivnim i drugim opasnim tvarima kako bi se izbjegle nepredvidive reakcije s lijekom i povećani rizik od širenja štetne tvari.
English: In 4 patients, having received a dose of 5, 9, 12 and 17 g, respectively, there were indications of markedly higher systemic absorption.
Croatian: U 4 bolesnika, koji su primili dozu od 5, 9, 12 g odnosno 17 g, postojali su znakovi izrazito povišene sistemske apsorpcije.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA < PC: {number}
Croatian: JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM < PC: {broj}
English: Store and transport refrigerated (2C-8C).
Croatian: Čuvati i prevoziti na hladnom (2C-8C).
English: Direct contact with the eyes should be avoided.
Croatian: Treba izbjegavati izravni kontakt s očima.
English: Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Croatian: Prije stavljanja lijeka u promet u svakoj državi članici nositelj odobrenja za stavljanje lijeka u promet dogovorit će se o sadržaju i formatu edukacijskog programa s državnim odgovornim tijelima.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: • UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: What NexoBrid is and what it is used for
Croatian: Što je NexoBrid i za što se koristi
English: Pyrexia/hyperthermia*
Croatian: pireksija/hipertermija*
English: Remaining antibacterial medicinal products may interfere with the activity of NexoBrid by decreasing its efficacy.
Croatian: Preostali antibakterijski lijekovi mogu ometati djelovanje NexoBrida smanjujući njegovu djelotvornost.
English: 60 wounds
Croatian: 60 rana
English: Hypersensitivity reactions, skin exposure
Croatian: Reakcije preosjetljivosti, izlaganje kože
English: • NexoBrid should not be applied to more than 15% (one eighth) of the total body surface.
Croatian: • NexoBrid se ne smije nanijeti na više od 15% (jednu osminu) cjelokupne površine tijela.
English: Infections and infestations Common:
Croatian: Infekcije i infestacije Često:
English: A second and subsequent application is not recommended.
Croatian: Ne preporučuje se primjenjivati dva ili više puta.
English: Bromelain may enhance the actions of fluorouracil and vincristine.
Croatian: Bromelain može pojačati djelovanje fluorouracila i vinkristina.
English: Cross-sensitivity
Croatian: Križna osjetljivost
English: During the clinical development of NexoBrid, there was no indication of an increased bleeding tendency or bleeding at the site of debridement.
Croatian: Tijekom kliničkog razvoja NexoBrida nije bilo znakova pojačane sklonosti krvarenju niti krvarenju na mjestu debridmana.
English: ** Informed Consent Form
Croatian: ** Obrazac za informirani pristanak
English: Sensitisation may have occurred due to inhalation of bromelain powder.
Croatian: Senzibilizacija se mogla dogoditi zbog udisanja praška bromelaina.
English: The frequency of pain and pyrexia/hyperthermia was higher without these precautionary measures (see below).
Croatian: Učestalost boli i pireksije/hipertermije bila je viša kad ove mjere opreza nisu bile primijenjene (vidjeti niže).
English: In case of skin exposure, NexoBrid should be rinsed off with water to reduce the likelihood of skin sensitisation (see section 6.6).
Croatian: U slučaju izloženosti kože, NexoBrid treba isprati vodom kako bi se smanjila vjerojatnost senzibilizacije kože (vidjeti dio 6.6).
English: If there is a risk of eye contact, the patient's eyes should be protected with fatty ophthalmic ointment.
Croatian: Ako postoji rizik od kontakta s očima, bolesnikove oči treba zaštititi oftalmološkom mašću.
English: It should be used within 15 minutes after mixing.
Croatian: Treba se primijeniti u roku od 15 minuta nakon miješanja.
English: Bromelain may enhance the hypotensive effect of ACE inhibitors, causing larger decreases in blood pressure than expected.
Croatian: Bromelain može pojačati hipotenzivni učinak ACE inhibitora uzrokujući veće sniženje krvnog tlaka od očekivanog.
English: - cause an unwanted drop in blood pressure when you are treated with medicines called ACE inhibitors, which are used to treat high blood pressure and other conditions.
Croatian: - prouzročiti neželjeno sniženje krvnog tlaka kad se liječite lijekovima koji se zovu ACE inhibitori, a koriste se za liječenje povišenog krvnog tlaka i drugih stanja.
English: Pyrexia/hyperthermia
Croatian: Pireksija/hipertermija
English: The safety and efficacy of NexoBrid in children and adolescents younger than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost NexoBrida u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
English: - chemical burn wounds.
Croatian: - Opeklinama uzrokovanim kemikalijama.
English: Since the safe use of NexoBrid during pregnancy has not yet been established, NexoBrid is not recommended during pregnancy.
Croatian: Budući da sigurna primjena NexoBrida tijekom trudnoće još nije utvrđena, ne preporučuje se koristiti NexoBrid tijekom trudnoće.
English: Paediatric population Pharmacokinetic parameters and the extent of absorption have not been studied in children.
Croatian: Pedijatrijska populacija Farmakokinetički parametri i opseg apsorpcije u djece nisu ispitani.