FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Na splošno je odbor PRAC ocenil, da so potrebne nadaljnje študije za podrobnejšo opredelitev tveganja za ponovitev hepatocelularnega karcinoma, povezanega z neposredno delujočimi protivirusnimi učinkovinami, s čimer bi ocenili preostale negotovosti za ta morebitna tveganja in sprejeli sklep o potrebi po dodatnem svetovanju o kliničnem vodenju.
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.
Slovenian: Na splošno je odbor PRAC menil, da obstajajo dokazi o tveganju za reaktivacijo HBV pri bolnikih s sočasno okužbo s HBV/HCV, zdravljenih z neposredno delujočimi protivirusnimi učinkovinami, zato je treba reaktivacijo HBV pri bolnikih s sočasno okužbo upoštevati kot pomembno ugotovljeno tveganje, ki ga je treba skrbno spremljati z rutinskimi dejavnostmi za zmanjševanje tveganja.
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.
Slovenian: • odbor PRAC je pregledal vse podatke, ki so jih pisno in z ustno obrazložitvijo predložili imetniki dovoljenj za promet z zdravilom v povezavi s tveganjem za reaktivacijo hepatitisa B in s pomisleki, ki so se pojavili med poročili o hepatocelularnem karcinomu pri bolnikih, ki uporabljajo neposredno delujoče protivirusne učinkovine, ter izid sestanka znanstvene svetovalne skupine o HIV/virusnih boleznih;
English: Hepatitis В virus (HBV) and hepatitis C virus (HCV) co-infection is not uncommon due to overlapping transmission modes.
Slovenian: Sočasna okužba z virusoma hepatitisa B (HBV) in hepatitisa C (HCV) zaradi prekrivajočih se načinov prenosa ni redek pojav.
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.
Slovenian: Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil Daklinza, Exviera, Harvoni, Olysio, Sovaldi in Viekirax še naprej ugodno, če se upoštevajo zgoraj opisane spremembe informacij o zdravilu in pogojev.
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.
Slovenian: Zaradi njihove večje učinkovitosti proti virusu hepatitisa C in odsotnosti delovanja proti virusu hepatitisa B je tveganje za reaktivacijo HBV večje pri novih shemah zdravljenja HCV, ki so v primerjavi s predhodno odobrenimi zdravili za zdravljenje HCV na podlagi interferonov močnejše.
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.
Slovenian: Odbor PRAC je v svoji oceni upošteval vse podatke, ki so jih predložili imetniki dovoljenj za promet z zdravilom, ter literaturo in dodatne informacije znanstvene svetovalne skupine v zvezi s tveganjem za reaktivacijo hepatitisa B ter s ponovitvijo in pojavom hepatocelularnega 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.
Slovenian: odbor PRAC meni, da je razmerje med tveganji in koristmi neposredno delujočih protivirusnih učinkovin še naprej ugodno, če se upoštevajo spremembe pogojev dovoljenj za promet z zdravilom.
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.
Slovenian: Kar zadeva tveganje za reaktivacijo hepatitisa B, so informacije o reaktivaciji hepatitisa B, ki jih je mogoče pridobiti iz zaključenih kliničnih preskušanj, omejene, saj je bila okužba s kroničnim hepatitisom B (HbSAg+) na splošno izključitveno merilo kriterij, zbiranje podatkov o serologiji HBV in DNK pa v programu razvoja neposredno delujočih protivirusnih učinkovin ni bilo obvezno.
English: The PRAC, as a consequence, recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
Slovenian: Odbor PRAC zato priporoča spremembo pogojev dovoljenj za promet z zdravilom Daklinza, Exviera, Harvoni, Olysio, Sovaldi in Viekirax.
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.
Slovenian: Ob upoštevanju vseh razpoložljivih podatkov je odbor PRAC menil, da morajo imetniki dovoljenj za promet z zdravilom opraviti prospektivno študijo varnosti in predložiti njene rezultate, in sicer z uporabo podatkov iz kohorte dobro opredeljene skupine bolnikov na podlagi dogovorjenega protokola, ki določa merila za vključitev in spremljanje bolnikov glede časa in metode presejalnega testiranja.
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.
Slovenian: Kar zadeva pregled hepatocelularnega karcinoma pri zdravljenju z neposredno delujočimi protivirusnimi učinkovinami, so od imetnikov dovoljenj za promet z zdravilom zahtevali, naj opravijo celovit pregled vseh razpoložljivih podatkov iz kliničnih preskušanj, opazovalnih študij, spontanih poročil in objavljene literature o hepatocelularnem karcinomu pri bolnikih s kroničnim hepatitisom C po zdravljenju z neposredno delujočimi protivirusnimi učinkovinami.
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.
Slovenian: Čeprav sta delovanje in napredovanje bolezni jeter pri dvojni okužbi na splošno hujši, je razmnoževanje virusa hepatitisa B v prisotnosti sočasne okužbe z virusom hepatitisa C pogosto zavrto.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax.
Slovenian: Zato priporoča spremembo pogojev dovoljenj za promet z zdravili Daklinza, Exviera, Harvoni, Olysio, Sovaldi in Viekirax.
English: Therefore data on HBV reactivation with DAAs mostly arose post-marketing.
Slovenian: Zato podatki o reaktivaciji virusa hepatitisa B z neposredno delujočimi protivirusnimi učinkovinami večinoma izhajajo iz obdobja trženja.
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.
Slovenian: Vsi imetniki dovoljenja za promet z zdravili z neposredno delujočimi protivirusnimi učinkovinami bodo opravili prospektivno študijo varnosti pri dobro opredeljeni skupini bolnikov na podlagi dogovorjenega protokola, ki določa merila za vključitev in spremljanje preizkušancev.
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.
Slovenian: Odbor PRAC je za zmanjševanje tveganja za reaktivacijo HBV priporočil presejalno testiranje vseh bolnikov za okužbo z virusom hepatitisa B pred začetkom zdravljenja z neposredno delujočimi protivirusnimi učinkovinami, bolnike s sočasno okužbo z virusom hepatitisa Bin C pa je treba spremljati in voditi v skladu s trenutnimi kliničnimi smernicami.
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.
Slovenian: Da bi ovrednotili ponovitev hepatocelularnega karcinoma, povezano z neposredno delujočimi protivirusnimi učinkovinami, bodo imetniki dovoljenj za promet z zdravilom v skladu s priporočilom odbora PRAC opravili prospektivno študijo varnosti in predložili njene rezultate, in sicer z uporabo podatkov iz kohorte dobro opredeljene skupine bolnikov na podlagi dogovorjenega protokola, ki določa merila za vključitev in spremljanje bolnikov glede časa in metode presejalnega testiranja.
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.
Slovenian: Podatki iz kliničnih preskušanj o pojavnosti novega hepatocelularnega karcinoma kažejo višje točkovne ocene za hepatocelularni karcinom po dosegu trajnega virološkega odziva pri shemah, ki ne vsebujejo interferonov, kot pri shemah, ki vsebujejo interferone, tudi pri stratifikaciji glede na prisotnost ciroze.
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.
Slovenian: Razpoložljivi podatki dokazujejo, da do reaktivacije razmnoževanja virusa hepatitisa B lahko pride pri zdravljenju kronične aktivne okužbe z virusom hepatitisa C s katero koli obliko učinkovitega zdravljenja pri bolnikih s sočasno okužbo z virusom hepatitisa B in C. Do reaktivacije večinoma lahko pride pri preiskovancih z zaznavno ravnijo HBsAg in aktivnim razmnoževanjem virusa hepatitisa B katere koli ravni, kot se določi z merljivimi ravnmi HBV-DNK, lahko pa se pojavi tudi pri preiskovancih brez zaznavne ravni HBsAg, a z zaznavnimi protitelesi proti HBc, od katerih jih ima lahko majhen odstotek spremenljive ravni aktivnega razmnoževanja virusa hepatitisa B.
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.
Slovenian: Na podlagi izsledkov študije, ki so jo opravili Reig in drugi, so bili izraženi pomisleki o pojavu hepatocelularnega karcinoma de novo pri bolnikih s cirozo zaradi okužbe z virusom hepatitisa C, zdravljenih z neposredno delujočimi protivirusnimi učinkovinami, saj je pri teh bolnikih lahko prisoten še ne diagnosticiran hepatocelularni karcinom.
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.
Slovenian: • odbor PRAC je menil tudi, da je treba podrobneje preučiti vpliv zdravljenja z neposredno delujočimi protivirusnimi učinkovinami na pojavnost in vrsto hepatocelularnega karcinoma de novo s prospektivno kohortno študijo pri bolnikih, okuženih z virusom hepatitisa C, ki imajo cirozo.
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.
Slovenian: • glede tveganja za ponovitev hepatocelularnega karcinoma pri bolnikih, ki se zdravijo z neposredno delujočimi protivirusnimi učinkovinami, je odbor PRAC menil, da so potrebni nadaljnji podatki o vplivu zdravljenja z neposredno delujočimi protivirusnimi učinkovinami na pojavnost ponovitve hepatocelularnega karcinoma.
English: In conclusion, the PRAC considered that the benefit-risk balance of DAAs-containing products remained favourable subject to the amendments of the terms of the marketing authorisations.
Slovenian: Odbor PRAC je zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo neposredno delujoče protivirusne učinkovine, še naprej ugodno, če se upoštevajo spremembe pogojev dovoljenj za promet z zdravilom.
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.
Slovenian: Kljub temu je bilo ocenjeno, da morajo imetniki dovoljenj za promet z zdravilom podrobneje raziskati vpliv zdravljenja z neposredno delujočimi protivirusnimi učinkovinami na pojavnost in vrsto hepatocelularnih karcinomov de novo, in sicer s prospektivno kohortno študijo pri bolnikih, okuženih z virusom hepatitisa C, s kompenzirano cirozo (CPT-A) brez anamneze hepatocelularnega karcinoma in zdravljenih z neposredno delujočimi protivirusnimi učinkovinami.
English: ANNEX IV SCIENTIFIC CONCLUSIONS
Slovenian: PRILOGA IV
English: The virological and immunological aspects of HBV/HCV co-infection are not fully comprehended.
Slovenian: Znano je, da okužba z virusom hepatitisa C pri bolnikih s sočasno okužbo povzroči supresijo razmnoževanja virusa hepatitisa B. Virološki in imunološki vidiki sočasne okužbe s HBV/HCV niso popolnoma znani.
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.
Slovenian: Domneva pa se lahko, da imajo bolniki z napredovalo boleznijo jeter večje tveganje za resne klinične zaplete, če pride do reaktivacije HBV. Na splošno je do reaktivacije prišlo kmalu po začetku zdravljenja, in sicer na način, ki nakazuje vzporednico s hitrim zmanjšanjem virusnega bremena HCV, kar je značilno za dinamiko virusnega bremena pri neposredno delujočih protivirusnih učinkovinah.
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.
Slovenian: • glede reaktivacije HBV je odbor PRAC zaključil, da razpoložljivi podatki dokazujejo tveganje za reaktivacijo HBV pri bolnikih s sočasno okužbo z virusom hepatitisa B in C, zdravljenih z neposredno delujočimi protivirusnimi učinkovinami zaradi hepatitisa C. Odbor PRAC je menil, da je treba vse bolnike pred začetkom zdravljenja z neposredno delujočimi protivirusnimi učinkovinami presejalno testirati za okužbo z virusom hepatitisa B. Bolnike s sočasno okužbo z virusom hepatitisa B in C je treba spremljati med zdravljenjem in po njem v skladu s trenutnimi kliničnimi smernicami.
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.
Slovenian: Razmnoževanje virusa hepatitisa B po začetku zdravljenja z neposredno delujočimi protivirusnimi učinkovinami zaradi okužbe z virusom hepatitisa C v informacijah o zdravilu za trenutno odobrena zdravila trenutno ni opisano.
English: Such effects could still be seen after the recovery period of 2 weeks.
Slovenian: Ti učinki so bili po 2-tedenskem obdobju okrevanja še vedno prisotni.
English: Average TBSA was 10%.
Slovenian: Povprečna CPT je bila 10 %.
English: The specific components responsible for this effect have not been identified.
Slovenian: Specifične sestavine, odgovorne za ta učinek, niso bile ugotovljene.
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8 in 5.1, vendar priporočil o odmerjanju ni mogoče dati.
English: The educational pack should contain the following:
Slovenian: Izobraževalni paket bo vseboval naslednje:
English: It should be used within 15 minutes after mixing.
Slovenian: Uporabiti ga je treba v roku 15 minut po mešanju.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}.>
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> <{mesec LLLL}>
English: All wounds (ITT
Slovenian: Vse rane (ITT
English: All randomised patients for whom data for complete wound closure were available.
Slovenian: Vsi randomizirani bolniki, za katere so bili na voljo podatki o popolnem zaprtju ran.
English: *These comparisons should be interpreted with caution since they are based on groups that are not fully randomized.
Slovenian: *Te primerjave je treba razlagati previdno, saj temeljijo na skupinah, ki niso povsem randomizirane.
English: You may receive medicines to prevent or treat infections.
Slovenian: Morda boste prejeli zdravilo za preprečevanje ali zdravljenje okužb.
English: Allergic reactions can be severe and require medical treatment.
Slovenian: Alergijske reakcije so lahko hude in jih je treba zdraviti.
English: These patients should be carefully monitored.
Slovenian: Te bolnike je treba skrbno spremljati.
English: This is in addition to the educational material which all potential users should receive.
Slovenian: Poleg tega mora prejeti tudi izobraževalno gradivo, ki ga morajo sicer prejeti vsi možni uporabniki zdravila.
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.
Slovenian: Na podlagi teh podatkov se pričakuje, da je splošni varnostni profil pri otrocih, starih 4 leta ali več, in pri mladostnikih, podoben profilu pri odraslih.
English: The frequency of pain and pyrexia/hyperthermia was higher without these precautionary measures (see below).
Slovenian: Pogostnost bolečine in pireksije/hipertermije je bila višja brez teh previdnostnih ukrepov (glejte spodaj).
English: It will be prepared directly before use and applied by a doctor or another healthcare professional.
Slovenian: Zdravilo bo pripravljeno tik pred uporabo in ga bo nanesel zdravnik ali drug zdravstveni delavec.
English: Experience with NexoBrid in elderly patients (>65 years) is limited.
Slovenian: Izkušenj z zdravilom NexoBrid pri starejših bolnikih (> 65 let) je malo.
English: From a microbiological point of view and as the enzymatic activity of the product decreases progressively following mixing, the reconstituted product should be used immediately after preparation (within 15 minutes).
Slovenian: Iz mikrobiološkega vidika in ker se encimska aktivnost zdravila po mešanju progresivno manjša, je treba rekonstituirano zdravilo uporabiti takoj po pripravi (v roku 15 minut).
English: See section 6.6 for instructions on NexoBrid gel preparation.
Slovenian: Glejte poglavje 6.6 za navodila o pripravi zdravila NexoBrid gel.
English: Tmax for 10 of the 15 patients was 2 hours and in 5 patients Tmax was 4 hours.
Slovenian: Tmax za 10 od 15 bolnikov je bil 2 uri in pri 5 bolnikih je bil Tmax 4 ure.
English: • The fact that patients should be monitored for signs and symptoms of wound and systemic infections
Slovenian: • Dejstvo, da je treba bolnike spremljati glede znakov in simptomov okužb rane in sistemskih okužb
English: You may be checked regularly for these conditions.
Slovenian: Morda vas bodo redno spremljali zaradi pojava teh stanj.
English: See also section 4.2 and 4.8.
Slovenian: Glejte tudi poglavji 4.2 in 4.8.
English: - increase drowsiness when used at the same time with medicines that can cause drowsiness.
Slovenian: - poveča dremavost, če se uporablja sočasno z zdravili, ki lahko povzročijo dremavost.
English: Instructions for the preparation of the NexoBrid gel are given at the end of this leaflet in the section intended for medical or healthcare professionals.
Slovenian: Navodila za pripravo zdravila NexoBrid gel so navedena na koncu tega navodila v poglavju, namenjenemu medicinskemu ali zdravstvenemu osebju.
English: The following table shows results in mixed wounds.
Slovenian: Naslednja preglednica prikazuje rezultate mešanih ran.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernico CHMP o sistemih za obvladovanje tveganj za zdravila za uporabo v humani medicini je treba posodobljen RMP predložiti hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
English: Date of first authorisation: 18.12.2012 Date of latest renewal: 10.11.2017
Slovenian: Datum prve odobritve: 18. december 2012 Datum zadnjega podaljšanja: 10. november 2017
English: Eye protection
Slovenian: Zaščita oči
English: Since NexoBrid was poorly tolerated by the parent animals, these studies are not considered relevant for human risk assessment.
Slovenian: Ker so starševske živali zdravilo NexoBrid slabo prenašale, se te študije ne obravnavajo kot pomembne za oceno tveganja pri ljudeh.
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.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden uporabite to zdravilo.
English: The following table shows the time to complete wound closure from start of debridement.
Slovenian: Naslednja preglednica prikazuje čas do popolnega zaprtja rane od začetka čiščenja.
English: Patients should be monitored for possible signs of coagulation abnormalities.
Slovenian: Bolnike je treba nadzirati za možne znake nenormalnosti pri koagulaciji.
English: (mean ± SD)
Slovenian: SD)
English: • The risk of increased mortality in patients with cardiopulmonary diseases
Slovenian: • Tveganje večje smrtnosti pri bolnikih z boleznimi srca in pljuč
English: The Healthcare Professional information pack should be a step by step treatment guide that includes information on the following key elements:
Slovenian: Izobraževalni paket za zdravstvene delavce mora biti pripravljen v obliki vodnika, ki po korakih opisuje zdravljenje, in vsebuje informacije o naslednjih ključnih elementih:
English: Paediatric population Pharmacokinetic parameters and the extent of absorption have not been studied in children.
Slovenian: Pediatrična populacija Farmakokinetičnih parametrov in obsega absorpcije niso preučili pri otrocih.
English: The powder should not be inhaled.
Slovenian: Praška ni dovoljeno inhalirati.