FrancophonIA/ELRC3.0 huggingface dataset:
English: • Further to the review of the preliminary analyses available, the underlying mechanism for the increased risks of fracture and mortality observed in ERA 233, and therefore the potential impact of these findings in the authorised indication, remain uncertain.
Slovenian: • Na podlagi pregleda predhodne analize, ki je na voljo, ostaja nejasen osnovni mehanizem za večje tveganje zlomov in smrtnosti, ugotovljen v študiji ERA 223, ter s tem morebitni učinek teh ugotovitev pri odobreni indikaciji.
English: The PRAC also considered data from the pivotal clinical trial ALSYMPCA which supported the marketing authorisation of Xofigo, as well as data from other completed and ongoing studies which became available since the marketing authorisation.
Slovenian: Proučil je tudi podatke iz osrednjega kliničnega preskušanja ALSYMPCA, s katerim se je podprlo dovoljenje za promet z zdravilom Xofigo, ter podatke iz drugih zaključenih in začetih študij, ki so bili na voljo od začetka veljave dovoljenja za promet.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisation for Xofigo (radium Ra223 dichloride).
Slovenian: Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom Xofigo ([223Ra]radijev diklorid).
English: Whilst the exact extent of use of radium-223 in combination with abiraterone acetate and prednisolone/prednisone in clinical practice is not known, interim data from an observational study (REASSURE) reported that 5% of patients were treated with this combination.
Slovenian: Čeprav natančen obseg uporabe [223Ra]radijevega diklorida v kombinaciji z abirateron acetatom in prednizonom/prednizolonom v klinični praksi ni znan, se je v vmesnih podatkih iz opazovalne študije (REASSURE) poročalo, da je bilo s to kombinacijo zdravljenih 5 % bolnikov.
English: The current recommendation relates only to provisional measures recommended by the PRAC for radium-223 dichloride based on the preliminary data available at this time.
Slovenian: Trenutno priporočilo se nanaša le na začasne ukrepe, ki jih na podlagi predhodnih podatkov, ki so ob tem času na voljo, za [223Ra]radijev diklorid priporoča odbor PRAC.
English: The clinical efficacy of radium-223 dichloride in the authorised indication was established during the initial marketing authorisation application based on the assessment of data from one pivotal phase III study (15245/BC1-06, ALSYMPCA), in which an improved overall survival and delayed symptomatic skeletal events were observed.
Slovenian: Klinična učinkovitost [223Ra]radijevega diklorida pri odobreni indikaciji je bila ugotovljena med vlogo za prvotno dovoljenje za promet na podlagi ocene podatkov iz ene osrednje študije faze III (15245/BC1-06, ALSYMPCA), pri kateri so bili ugotovljeni boljše celokupno preživetje in zapozneli simptomatski dogodki v kosteh.
English: • The PRAC noted that the use of radium Ra223 dichloride in Study ERA 223 was at earlier stages of the disease, albeit partially overlapping with that included in the authorised indication.
Slovenian: • Odbor PRAC je opozoril, da se je [223Ra]radijev diklorid v študiji ERA 223 uporabljal na začetnih stopnjah bolezni, čeprav se je to delno prekrivalo z uporabo, vključeno v odobreno indikacijo.
English: In view of the above, the Committee considers that the benefit-risk balance of Xofigo (radium Ra223 dichloride) remains favourable subject to the agreed provisional amendments to the product information.
Slovenian: Odbor glede na navedeno meni, da je razmerje med tveganji in koristmi zdravila Xofigo ([223Ra]radijev diklorid) še naprej ugodno, če se upoštevajo dogovorjene začasne spremembe informacij o zdravilu.
English: Whilst at this stage it is not excluded that the concurrent administration of radium-223 + abiraterone + prednisolone/prednisone is critical to the subsequent increased risks of fractures and death, it cannot be excluded either that the risks observed could apply to other effective androgen receptor antagonists.
Slovenian: Čeprav na tej stopnji ni izključeno, da je sočasna uporaba [223Ra]radijevega diklorida v kombinaciji z abirateron acetatom in prednizonom/prednizolonom bistvena za poznejše večje tveganje zlomov in smrtnosti, prav tako ni mogoče izključiti, da bi se ugotovljena tveganja lahko nanašala na druge učinkovite antagoniste androgenskega receptorja.
English: The PRAC also noted that data available show that radium Ra223 dichloride is used to some extent in clinical practice in combination with anti-androgens such as abiraterone and enzalutamide.
Slovenian: Opozoril je tudi, da razpoložljivi podatki kažejo, da se [223Ra]radijev diklorid v klinični praksi v določenem obsegu uporablja v kombinaciji z antiandrogeni, kot sta abirateron in enzalutamid.
English: The PRAC also considered other available data, including further data from the ALSYMPCA clinical trial submitted in support of the initial marketing authorisation, in relation to the potential impact of results of Study ERA 223 on the benefit-risk balance of radium Ra223 dichloride in its authorised indication.
Slovenian: Proučil je tudi druge razpoložljive podatke, vključno z dodatnimi podatki kliničnega preskušanja ALSYMPCA, predloženimi ob izdaji prvega dovoljenja za promet, v povezavi z morebitnim učinkom rezultatov študije ERA 223 na razmerje med tveganji in koristmi [223Ra]radijevega diklorida pri njegovi odobreni indikaciji.
English: In view of the significance of the findings of the ERA 223 clinical trial, it was considered that they should be thoroughly reviewed in the context of all available data related to radium-223 dichloride (including evidence from non-authorised use that might impact the authorised use) in order to assess their potential impact on the benefit-risk balance of Xofigo in the authorised indication of the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Slovenian: Glede na pomembnost ugotovitev klinične študije ERA 223 se je zdelo, da bi morale biti analize temeljito pregledane ob upoštevanju vseh razpoložljivih podatkov, povezanih z [223Ra]radijevim dikloridom (vključno z dokazi o neodobreni uporabi, ki bi lahko vplivali na odobreno uporabo), da se oceni morebitni učinek na razmerje med tveganji in koristmi zdravila Xofigo pri odobreni indikaciji za zdravljenje odraslih moških z na kastracijo odpornim rakom prostate (CRPC - castration resistant prostate carcinoma), s simptomatskimi kostnimi metastazami in brez znanih metastaz v notranjih organih.
English: In view of the seriousness of these results, the fact that they were observed in a patient population with earlier disease characteristics but partly overlapping with that described in the authorised indication, and considering that the mechanism behind the events observed remain largely unexplained at this stage, the PRAC considered that, as a provisional measure, the use of radium-223 in combination with abiraterone acetate and prednisone/prednisolone should be contraindicated.
Slovenian: Glede na resnost teh rezultatov je odbor PRAC ob upoštevanju dejstva, da so bili opaženi v populaciji bolnikov s predhodnimi značilnostmi bolezni, ki pa so se delno prekrivale z značilnostmi, opisanimi pri odobreni indikaciji, in tega, da ostaja mehanizem, na katerem temeljijo opaženi dogodki, na tej stopnji večinoma nepojasnjeni, menil, da bi morala biti uporaba [223Ra]radijevega diklorida v kombinaciji z abirateron acetatom in prednizonom/prednizolonom začasno kontraindicirana.
English: Considering current therapeutic options available for patients with symptomatic castration resistant prostate cancer with bone metastases, the PRAC considered that as a provisional measure, a warning that the safety and efficacy of Xofigo in combination with second-generation androgen receptor antagonists such as enzalutamide have not been established, should be included in the product information.
Slovenian: Odbor PRAC je ob upoštevanju trenutnih terapevtskih možnosti, ki so na voljo bolnikom s simptomatskim na kastracijo odpornim rakom prostate s kostnimi metastazami, menil, da bi bilo treba v informacije o zdravilu kot začasni ukrep vključiti opozorilo, da varnost in učinkovitost zdravila Xofigo v kombinaciji z antagonisti androgenskega receptorja druge generacije, kot je enzalutamid, nista bili dokazani.
English: Therefore and in view of the seriousness of the events observed, the PRAC recommended provisional amendments to the product information to contraindicate the use of radium Ra223 dichloride in combination with abiraterone acetate and prednisone/prednisolone and inform on the results of Study ERA 223.
Slovenian: Odbor PRAC je zato in glede na resnost ugotovljenih dogodkov priporočil začasne spremembe informacij o zdravilu, da se kontraindicira uporaba [223Ra]radijevega diklorida v kombinaciji z abirateron acetatom in prednizonom/prednizolonom ter obvesti o rezultatih študije ERA 223.
English: Annex IV Scientific conclusions radium Ra223 dichloride
Slovenian: [223Ra]radijev diklorid
English: • The PRAC reviewed the preliminary data analyses of Study ERA 223 that suggested an increased risk of fracture and mortality when radium Ra223 dichloride treatment, compared to placebo, is initiated concurrently with abiraterone acetate and prednisone/prednisolone treatment.
Slovenian: • Odbor PRAC je pregledal analizo predhodnih podatkov študije ERA 223, iz katerih je razvidno večje tveganje zlomov in smrtnosti, če je zdravljenje z [223Ra]radijevim dikloridom, v primerjavi s placebom, začeto sočasno z zdravljenjem z abirateron acetatom in prednizonom/prednizolonom.
English: The PRAC considered preliminary data analyses from a randomized, placebo-controlled multicentre phase III study (15396/ERA-223) in chemotherapy-naïve patients with asymptomatic or mildly symptomatic castration resistant prostate cancer with bone metastases (CRPC).
Slovenian: Odbor PRAC je proučil analizo predhodnih podatkov iz randomizirane, s placebom kontrolirane multicentrične klinične raziskave faze III (15396/ERA-223) pri bolnikih z na kastracijo odpornim rakom prostate brez simptomov ali z blagimi simptomi, ki niso bili zdravljeni s kemoterapijo, pri katerih se pojavljajo kostne metastaze.
English: • In addition, in the absence of definite evidence that the results observed were specific to the combination with abiraterone acetate and prednisone/prednisolone, the PRAC considered that healthcare professionals and patients should be warned that the safety and efficacy of radium Ra223 dichloride in combination with second-generation androgen receptor antagonists including enzalutamide have not been established.
Slovenian: • Ker ni bilo dokončno dokazano, da so bili ugotovljeni rezultati značilni za kombinacijo z abirateron acetatom in prednizonom/prednizolonom, odbor PRAC prav tako meni, da je treba zdravstvene strokovnjake in bolnike opozoriti, da varnost in učinkovitost [223Ra]radijevega diklorida v kombinaciji z antagonisti androgenskega receptorja druge generacije, vključno z enzalutamidom, nista bili dokazani.
English: These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 of Regulation (EC) No
Slovenian: Ti začasni ukrepi ne posegajo v izid potekajočega pregleda v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: Healthcare professionals should be informed of the increased incidence of fractures and deaths among patients receiving Xofigo in combination with abiraterone acetate and prednisone/prednisolone compared to patients receiving placebo in combination with abiraterone acetate and prednisone/prednisolone in Study ERA-223, and of the reduced incidence of fractures observed in both treatment arms with concurrent use of bisphosphonates or denosumab bone health agents.
Slovenian: Zdravstvene delavce je treba obvestiti o povečani incidenci zlomov in smrtnosti med bolniki, ki so prejemali Xofigo v kombinaciji z abirateron acetatom in prednizonom/prednizolonom, v primerjavi z bolniki, ki so prejemali placebo v kombinaciji z abirateron acetatom in prednizonom/prednizolonom v študiji ERA 223, ter o manjši incidenci zlomov, opaženih pri obeh vejah zdravljenja s sočasno uporabo bisfosfonatov ali učinkovin za zdrave kosti, ki jih vsebuje denosumab.
English: Xofigo (radium Ra223 dichloride, also radium-223 herein) is a centrally authorised product indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Slovenian: Zdravilo Xofigo (z zdravilno učinkovino [223Ra]radijev diklorid), je zdravilo, odobreno na nacionalni ravni, indicirano za zdravljenje odraslih moških z na kastracijo odpornim rakom prostate, s simptomatskimi kostnimi metastazami in brez znanih metastaz v notranjih organih.
English: Analyses of uncleaned preliminary data of a clinical trial evaluating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in a patient population with asymptomatic or mildly symptomatic prostate cancer (ERA 223), found that the incidences of treatment emergent fractures and deaths were increased in the treatment arm (radium-223 dichloride plus abiraterone acetate and prednisone/prednisolone) compared to the control arm (placebo plus abiraterone acetate and prednisone/prednisolone).
Slovenian: Z analizami neprečiščenih predhodnih podatkov o kliničnem preskušanju, ki ocenjuje zdravilo Xofigo v kombinaciji z abirateron acetatom in prednizonom/prednizolonom v populaciji bolnikov brez simptomov ali z blagimi simptomi raka prostate (študija ERA 223), je bilo ugotovljeno, da je incidenca zlomov in smrtnosti, ki jih je povzročilo zdravljenje, povečana pri veji zdravljenja (z [223Ra]radijevim dikloridom v kombinaciji z abirateron acetatom in prednizonom/prednizolonom) v primerjavi s kontrolno vejo (placebo v kombinaciji z abirateron acetatom in prednizonom/prednizolonom).
English: Based on the available data, Study 15396 shows that in chemotherapy-naïve asymptomatic or mildly symptomatic patients with CRPC, radium-223 in combination with concurrent abiraterone acetate and prednisolone/prednisone decreases overall survival and increases the risk of fractures compared to placebo in combination with abiraterone acetate and prednisone/prednisolone.
Slovenian: Študija 15396 na podlagi razpoložljivih podatkov kaže, da pri bolnikih z na kastracijo odpornim rakom prostate brez simptomov ali z blagimi simptomi, ki niso bili zdravljeni s kemoterapijo, [223Ra]radijev diklorid v kombinaciji s sočasnim zdravljenjem z abirateron acetatom in prednizonom/prednizolonom, zmanjšuje celokupno preživetje in povečuje tveganje zlomov v primerjavi z zdravljenjem s placebom v kombinaciji z abirateron acetatom in prednizonom/prednizolonom.
English: Scientific conclusions
Slovenian: Priloga IV
English: Abasaglar is given once a day at the same time each day.
Slovenian: Zdravilo Abasaglar se daje enkrat na dan, vsak dan ob istem času.
English: This means that Abasaglar is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: What measures are being taken to ensure the safe and effective use of Abasaglar?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Abasaglar?
English: It is used in adults and children over the age of two for the treatment of diabetes.
Slovenian: Uporablja se pri odraslih in otrocih, starejših od dveh let, za zdravljenje sladkorne bolezni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Abasria on 9 September 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Abasria, veljavno po vsej Evropski uniji, izdala 09. septembra 2014.
English: The full EPAR and risk management plan summary for Abasaglar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Abasaglar sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults.
Slovenian: Reakcije na mestu injiciranje (rdečino, bolečino, srbenje in otekanje) ter kožne reakcije (izpuščaj) so pogosteje opažali pri otrocih kot pri odraslih.
English: It is not intended to provide practical advice on how to use Abasaglar.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Patients can inject themselves with Abasaglar if they have been trained appropriately.
Slovenian: Bolniki si lahko zdravilo Abasaglar injicirajo sami, če so bili za to ustrezno usposobljeni.
English: A risk management plan has been developed to ensure that Abasaglar is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Abasaglar je bil pripravljen načrt obvladovanja tveganj.
English: This is a summary of the European public assessment report (EPAR) for Abasaglar.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Abasaglar.
English: The most common side effect with Abasaglar (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Slovenian: Najpogostejši neželeni učinek zdravila Abasaglar (ki lahko prizadene več kot 1 osebo od 10) je hipoglikemija (nizka raven glukoze v krvi).
English: The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected.
Slovenian: Mesto injiciranja je treba ob vsakem injiciranju zamenjati, da se preprečijo spremembe kože (na primer odebelitev), ki lahko povzročijo slabše delovanje insulina od pričakovanega.
English: The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action.
Slovenian: Ta razlika pomeni, da se po injiciranju v telesu absorbira počasneje in enakomerneje ter da je njegovo delovanje dolgotrajno.
English: The name of the medicine was changed to Abasaglar on 3 December
Slovenian: Ime zdravila je bilo 3. decembra 2014 spremenjeno v Abasaglar.
English: Average starting HbA1c was 8.3%, and this fell to below 7% in 48.8% of those given Abasaglar, and 52.5% of those given Lantus, with an average percentage point fall of 1.29 and 1.34 respectively.
Slovenian: Povprečna vrednost HbA1c ob izhodišču je bila 8,3 % in je nato padla pod 7 % pri 48,8 % bolnikov, ki so prejemali zdravilo Abasaglar, in pri 52,5 % bolnikov, ki so prejemali zdravilo Lantus, pri čemer je povprečno znižanje znašalo 1,29 oziroma 1,34 odstotne točke.
English: Insulin glargine is slightly different from human insulin.
Slovenian: Insulin glargin se nekoliko razlikuje od človeškega insulina.
English: The dose is adjusted individually, and the patient's blood glucose (sugar) should be regularly tested to find the lowest effective dose.
Slovenian: Odmerek se prilagaja posamezniku, pri čemer je treba pri bolniku redno preverjati ravni glukoze (sladkorja) v krvi, da se določi najmanjši učinkoviti odmerek.
English: Other information about Abasaglar
Slovenian: Druge informacije o zdravilu Abasaglar
English: In both studies, the main measure of effectiveness was the change after 6 months of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Slovenian: V obeh študijah je bila glavno merilo učinkovitosti sprememba, ki so jo po šestih mesecih zdravljenja zabeležili v ravni snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki odraža uspešnost uravnavanja glukoze v krvi.
English: Why is Abasaglar approved?
Slovenian: Zakaj je bilo zdravilo Abasaglar odobreno?
English: What are the risks associated with Abasaglar?
Slovenian: Kakšna tveganja so povezana z zdravilom Abasaglar?
English: Studies were carried out to show that the way Abasaglar is absorbed into the body and the way it acts on blood glucose were similar to Lantus.
Slovenian: Izvedene so bile študije, v katerih so dokazovali, da sta način absorpcije zdravila Abasaglar v telesu in način njegovega delovanja na glukozo v krvi podobna kot pri zdravilu Lantus.
English: The active substance in Abasaglar, insulin glargine, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce insulin glargine.
Slovenian: Zdravilna učinkovina v zdravilu Abasaglar, insulin glargin, se proizvaja z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri so v bakterije vstavili gen (DNK), s katerim lahko tvorijo insulin glargin.
English: Their average HbA1c before treatment was 7.8% and the average fall after 6 months was similar (0.35% in the Abasaglar group and 0.46% in the Lantus group); 34.5% of those given Abasaglar, and 32.2% of those given Lantus were below the target of 7%.
Slovenian: Povprečna vrednost HbA1c pri teh bolnikih je bila pred zdravljenjem 7,8 %, povprečno znižanje po šestih mesecih pa je bilo podobno (0,35 % v skupini z zdravilom Abasaglar in 0,46 % v skupini z zdravilom Lantus); pri 34,5 % bolnikov, ki so prejemali zdravilo Abasaglar, in 32,2 % bolnikov, ki so prejemali zdravilo Lantus, so bile vrednosti pod ciljno vrednostjo 7 %.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Abasaglar has been shown to have a comparable quality, safety and effectiveness to Lantus.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Abasaglar po kakovosti,
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose.
Slovenian: Sladkorna bolezen je bolezen, pri kateri v telesu ne nastaja dovolj insulina za uravnavanje ravni glukoze v krvi.
English: What is Abasaglar and what is it used for?
Slovenian: Kaj je zdravilo Abasaglar in za kaj se uporablja?
English: For more information about treatment with Abasaglar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Abasaglar preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Abasaglar have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Abasaglar izkazalo v študijah?
English: Therefore, the CHMP's view was that, as for Lantus, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Lantus odtehtajo znana tveganja.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abasaglar, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Abasaglar in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The reference medicine for Abasaglar is Lantus.
Slovenian: Referenčno zdravilo za zdravilo Abasaglar je zdravilo Lantus.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Slovenian: Nadomestni insulin deluje enako kot naravno tvorjeni insulin in pomaga pri prehodu glukoze iz krvi v celice.
English: For the full list of all side effects and restrictions with Abasaglar, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Abasaglar glejte navodilo za uporabo.