FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Iasibon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Iasibon preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Iasibon
Slovenian: Druge informacije o zdravilu Iasibon
English: A risk management plan has been developed to ensure that Iasibon is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Iasibon je bil pripravljen načrt obvladovanja tveganj.
English: This is a summary of the European public assessment report (EPAR) for Iasibon.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Iasibon.
English: It is available as a concentrate that is made up into a solution for infusion (drip into a vein) and as tablets (50 mg).
Slovenian: Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije v veno) in tablet (50 mg).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Iasibon.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: By preventing the breakdown of bones, Iasibon also helps to reduce the amount of calcium released into the blood.
Slovenian: S preprečevanjem razgrajevanja kosti zdravilo Iasibon prav tako pomaga zmanjševati količino kalcija, ki se sprošča v kri.
English: Because Iasibon is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Iasibon generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: In the treatment of hypercalcaemia caused by tumours, Iasibon is given over 2 hours as an infusion of either 2 or 4 mg, depending on how severe the hypercalcaemia is.
Slovenian: Pri zdravljenju tumorsko povzročene hiperkalciemije se zdravilo Iasibon daje v obliki dveurne infuzije v odmerku 2 ali 4 mg, odvisno od resnosti hiperkalciemije.
English: The Committee recommended that Iasibon be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Iasibon izda dovoljenje za promet.
English: Iasibon ibandronic acid
Slovenian: Iasibon ibandronska kislina
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Iasibon, 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 in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Iasibon is a ‘generic medicine'.
Slovenian: Zdravilo Iasibon je „generično zdravilo“.
English: Patients with moderate or severe kidney problems should receive Iasibon infusions at a lower dose over an hour, or the tablets every two days or every week.
Slovenian: Bolniki z zmernimi do hudimi težavami z ledvicami morajo prejeti manjši odmerek infuzije zdravila Iasibon v trajanju ene ure ali tablete vsak drugi dan ali vsak teden.
English: Because Iasibon is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Bondronat.
Slovenian: Ker je zdravilo Iasibon generično zdravilo, so bile študije pri bolnikih omejene na preizkuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Bondronat.
English: The CHMP concluded that, in accordance with EU requirements, Iasibon has been shown to have comparable quality and to be bioequivalent to Bondronat.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo za zdravilo Iasibon v skladu z zahtevami EU dokazano, da ima primerljivo kakovost in je biološko enakovredno zdravilu Bondronat.
English: The patient must not lie down for one hour after taking the tablet.
Slovenian: Vsaj eno uro po zaužitju tablete ne sme leči.
English: Iasibon is a medicine that contains the active substance ibandronic acid.
Slovenian: Iasibon je zdravilo, ki vsebuje zdravilno učinkovino ibandronsko kislino.
English: Why has Iasibon been approved?
Slovenian: Zakaj je bilo zdravilo Iasibon odobreno?
English: This leads to less bone loss.
Slovenian: S tem se zmanjša izguba kostnega tkiva.
English: The active substance in Iasibon, ibandronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina zdravila Iasibon, ibandronska kislina, je difosfonat.
English: The tablets must always be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day.
Slovenian: Pri preprečevanju z okostjem povezanih dogodkov se zdravilo Iasibon daje kot 6-miligramska infuzija v trajanju najmanj 15 minut vsake tri do štiri tedne ali kot ena tableta enkrat na dan. Bolnik mora tableto vzeti na tešče vsaj šest ur po zadnjem zaužitem večernem obroku in vsaj 30 minut pred prvim obrokom ali pijačo zjutraj.
English: What is Iasibon?
Slovenian: Kaj je zdravilo Iasibon?
English: Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi tako kot pri zdravilu Bondronat odtehtajo z njim povezana tveganja.
English: What is Iasibon used for?
Slovenian: Za kaj se zdravilo Iasibon uporablja?
English: How has Iasibon been studied?
Slovenian: Kako je bilo zdravilo Iasibon raziskano?
English: How does Iasibon work?
Slovenian: Kako zdravilo Iasibon deluje?
English: • as an infusion or as a tablet to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
Slovenian: ali zapletov s kostmi, pri katerih je potrebno zdravljenje) pri bolnikih z rakom dojke in metastazami v kosteh (kadar se rak razširi na kosti);
English: How is Iasibon used?
Slovenian: Kako se zdravilo Iasibon uporablja?
English: The concerned Member States (CMS) are: CZ, DE, ES, IT, NL, PL and UK.
Slovenian: Zadevne države članice so: CZ, DE, ES, IT, NL, PL in UK.
English: • The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008.
Slovenian: • odbor je obravnaval napotitev v skladu s členom 13 Uredbe (ES) št. 1234/2008;
English: The reference Member State (RMS) is: FR
Slovenian: Referenčna država članica je: FR
English: The mutual recognition procedure FR/H/0283/001/II/27G started on 28/11/2015.
Slovenian: Postopek z medsebojnim priznavanjem FR/H/0283/001/II/27G se je začel 28. novembra 2015.
English: • removal of the contraindication in children and adolescents
Slovenian: • odstranitev kontraindikacije pri otrocih in mladostnikih.
English: • widening of the indication from “advanced and/or metastatic adult breast cancer patients” to “cancer patients”.
Slovenian: • razširitev indikacije z „odrasli bolniki z napredovalim in/ali metastatskim rakom dojk“ na „bolniki z rakom“;
English: This usually occurs during treatment or within the first years post treatment.
Slovenian: Do tega običajno pride med zdravljenjem ali v nekaj letih po zdravljenju.
English: • The Committee was of the view that amendments to the product information are required, as well as the introduction of routine pharmacovigilance activities in the form of specific follow-up questionnaires to collect safety and efficacy on the use of the medicinal product in children.
Slovenian: • odbor je menil, da so potrebne spremembe informacij o zdravilu in uvedba rutinskih farmakovigilančnih dejavnosti v obliki posebnih vprašalnikov za nadaljnje spremljanje, namenjenih zbiranju podatkov o varnosti in učinkovitosti uporabe zdravila pri otrocih.
English: Delayed effects usually manifest as congestive heart failure which can occur up to 20 years post treatment.
Slovenian: Zapozneli učinki se običajno pokažejo kot kongestivna srčna odpoved, ki se lahko pojavi do 20 let po zdravljenju.
English: It is acknowledged that DRZ may increase the risk of myelosuppression and infections; however these risks can be minimised by appropriate measures currently in place in standard paediatric treatment protocols.
Slovenian: Priznava se, da deksrazoksan lahko poveča tveganje za mielosupresijo in okužbe, vendar je ta tveganja mogoče zmanjšati z ustreznimi ukrepi, ki so trenutno uveljavljeni v okviru standardnih protokolov pediatričnega zdravljenja.
English: UK did not concur with the RMS assessment related to the removal of the contra-indication for a certain subset of the paediatric population.
Slovenian: Združeno kraljestvo se ni strinjalo z oceno referenčne države članice v zvezi z odpravo kontraindikacije za določeno podskupino pediatrične populacije.
English: There is therefore no robust long term efficacy data that demonstrate that the use of DRZ prevents the chronic or long term cardiotoxic effects of anthracyclines in the paediatric population.
Slovenian: Zato torej ni robustnih podatkov o dolgoročni učinkovitosti, ki bi dokazovali, da uporaba deksrazoksana preprečuje kronične ali dolgoročne kardiotoksične učinke antraciklinov pri pediatrični populaciji.
English: The Committee, as a consequence, recommends the granting of the variation to the terms of the marketing authorisation for the medicinal products referred to in Annex I of the CHMP opinion subject to the amendments to the product information as set out in Annex III of the CHMP opinion and the amendments of the risk management plan as described above.
Slovenian: Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravilom za zdravila, navedena v Prilogi I mnenja odbora CHMP, v skladu s spremembami informacij o zdravilu, opredeljenimi v Prilogi III mnenja odbora CHMP, in zgoraj opisanimi spremembami načrta za obvladovanje tveganj.
English: The RMS considered that none of the data presented by the Marketing Authorisation Holder (MAH) were sufficiently supportive to widen the indication in adults; therefore, the first requested change on the widening of the indication to “cancer patients” was rejected.
Slovenian: Referenčna država članica je presodila, da nobeden od podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, v zadostni meri ne podpira razširitve indikacije pri odraslih, zato je bila prva zahtevana sprememba glede razširitve indikacije na „bolnike z rakom“ zavrnjena.
English: The CMDh 60 day procedure was initiated on 02/12/2016.
Slovenian: 60-dnevni rok za izvedbo postopka skupine CMDh je začel teči 2. decembra 2016.
English: However there are still remaining uncertainties with regard to long term effects for DRZ in children.
Slovenian: Obstaja pa še nekaj nejasnosti glede dolgoročnih učinkov deksrazoksana pri otrocih.
English: However, there is currently no established correlation between the used cardiac markers and the long term cardioprotective effects of DRZ as data are unavailable due to the length of follow-up needed.
Slovenian: Vendar pa trenutno ni ugotovljene povezave med uporabljenimi srčnimi označevalci in dolgoročnim zaščitnim učinkom deksrazoksana na srce, saj podatki zaradi potrebne dolžine spremljanja še niso na voljo.
English: The studies may not have been sufficiently powered to observe a statistically confirmed increase of SPM.
Slovenian: Študije morda nimajo zadostne moči za opazovanje statistično potrjenega povečanja pojavnosti novih primarnih malignosti.
English: The primary changes requested in the variation were:
Slovenian: Glavni predloženi spremembi sta bili:
English: Although the cardiac markers used in the original studies may not be as robust as those used currently, they provide some evidence of DRZ acute cardioprotective effect.
Slovenian: Čeprav srčni označevalci, ki so jih uporabljali v izvirnih študijah, morda niso tako robustni kot tisti, ki se uporabljajo sedaj, do neke mere dokazujejo akutni zaščitni učinek deksrazoksana na srce.
English: Day 60 of the CMDh procedure was on 30/01/2017 and as no agreement could be reached, the procedure and the objections raised by the UK to the lifting of the contraindication for a subset of anthracycline treated paediatric population were referred to the CHMP on 31/01/2017 by the RMS.
Slovenian: 60. dan postopka skupine CMDh je bil 30. januarja 2017 in ker ni bilo mogoče doseči dogovora, je referenčna država članica postopek in ugovore Združenega kraljestva glede odprave kontraindikacije za podskupino pediatrične populacije, zdravljene z antraciklinom, 31. januarja 2017 predložila odboru CHMP.
English: A type II grouping of variations application was submitted under the mutual recognition procedure for Cardioxane 500 mg powder for solution for infusion.
Slovenian: Po postopku z medsebojnim priznavanjem je bila predložena vloga za skupino sprememb tipa II za zdravilo Cardioxane 500 mg prašek za raztopino za infundiranje.
English: In view of the potential serious risk to public health raised by UK, the procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), under Article 13(1) of Regulation (EC) No 1234/2008 by France on 04/11/2016.
Slovenian: Glede na morebitno resno tveganje za javno zdravje, na katero je opozorilo Združeno kraljestvo, je Francija postopek 4. novembra 2016 v skladu s členom 13(1) Uredbe (ES) št. 1234/2008 predložila Skupini za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh).
English: Anthracycline related cardiac damage can be acute, manifesting as acute heart failure, reduction in the shortening fraction or changes to the ventricular wall thickening.
Slovenian: Z antraciklinom povezane poškodbe srca so lahko akutne in se kažejo kot akutna odpoved srca, zmanjšanje deleža skrčenja ali spremembe zadebelitve stene prekata.
English: With higher cumulative doses of anthracyclines, studies (including several RCTS and non-randomised studies) have showed that DRZ could improve the surrogate cardiac markers and therefore reduce subclinical acute cardiotoxicity.
Slovenian: Pri večjih kumulativnih odmerkih antraciklinov so študije (vključno z več randomiziranimi nadzorovanimi preskušanji in nerandomiziranimi študijami) pokazale, da deksrazoksan lahko izboljša nadomestne srčne označevalce in tako zmanjša subklinično akutno kardiotoksičnost.
English: High cumulative doses of anthracycline are rarely used in the paediatric population; however, they are requested for the treatment of some pathologies such as sarcomas and relapsed acute myeloid leukaemia.
Slovenian: Veliki kumulativni odmerki antraciklina se pri pediatrični populaciji le redko uporabljajo, a kljub temu so potrebni pri zdravljenju določenih patologij, kot so sarkomi in ponovljena akutna mieloična levkemija.
English: Unravelling confounders for the cause of SPM would be difficult and overall the long term risk of SPM remains unknown at present.
Slovenian: Izločitev vplivov pri ugotavljanju vzroka novih primarnih malignosti bi bilo težavno in trenutno splošno dolgoročno tveganje za nove primarne malignosti ostaja neznano.
English: Furthermore, in the short (up to 5 years post treatment) to medium term (up to 12 years post treatment) anthracycline's anti-tumour efficacy was not compromised by DRZ use.
Slovenian: Poleg tega protitumorska aktivnost antraciklina kratkoročno (do 5 let po zdravljenju) in srednjeročno (do 12 let po zdravljenju) zaradi uporabe deksrazoksana ni bila okrnjena.
English: This is due either to a low rate of clinical cardiac events in patients in the included RCTs or to the small numbers of patients who were treated with lower cumulative doses of anthracyclines and the relatively short duration of follow-up of these patients.
Slovenian: To je posledica bodisi nizke pojavnosti kliničnih srčnih dogodkov pri bolnikih, vključenih v randomizirana nadzorovana preskušanja, bodisi majhnega števila bolnikov, zdravljenih z majhnimi kumulativnimi odmerki antraciklinov, in sorazmerno kratkotrajnega spremljanja teh bolnikov.
English: Moreover, in the view of the presented data, the RMS considered not acceptable to fully remove the contra-indication in children, as requested by the MAH.
Slovenian: Referenčna država članica je na podlagi predloženih podatkov tudi menila, da ni sprejemljivo v celoti odpraviti kontraindikacije pri otrocih, kot je zaprosil imetnik dovoljenja za promet z zdravilom.
English: The CHMP was informed that the MAH will conduct a prospective safety study in children using existing cancer disease registries to collect data on dexrazoxane use in the paediatric population, the incidence of adverse events (e.g. secondary malignancies, myelosuppression and infections) and the long-term (>12 years) cardiac effects (including cardiac failure, left ventricular failure).
Slovenian: Odbor CHMP je bil obveščen, da bo imetnik dovoljenja za promet z zdravilom opravil prospektivno študijo varnosti pri otrocih z obstoječimi registri rakavih bolezni in zbral podatke o uporabi deksrazoksana pri pediatrični populaciji, pojavnosti neželenih učinkov (npr. sekundarnih malignosti, mielosupresije in okužb) in dolgoročnih (> 12 let) učinkih na srce (vključno z odpovedjo srca in odpovedjo levega prekata).
English: The evaluation of the data submitted as part of this procedure have allowed a better characterisation of the risk of the short term effects on SPM, myelosuppression and infections, following treatment with DRZ in children undergoing chemotherapy with anthracycline based regimens.
Slovenian: Ovrednotenje podatkov, predloženih v okviru tega postopka, je omogočilo boljšo opredelitev tveganja za kratkoročne učinke na pojav nove primarne malignosti, mielosupresije in okužb po zdravljenju z deksrazoksanom pri otrocih, ki se zdravijo s kemoterapijo po shemi z antraciklini.
English: • The Committee noted the reassuring safety data on the occurrence of secondary primary malignancies in particular acute myelogenous leukaemia and myelodysplastic syndrome in children and adolescents aged 0 to 18 years, the high risk for long term occurrence of severe cardiomyopathy when using high cumulated dose of anthracycline in children and adolescents and the medical need of high anthracycline dosing regimen for pathology such as sarcoma or acute myelogenous leukaemia relapses in children and adolescents
Slovenian: • odbor je upošteval spodbudne podatke o varnosti glede pojava novih primarnih malignosti, zlasti akutne mieloične levkemije in mielodisplastičnega sindroma, pri otrocih in mladostnikih, starih od 0 do 18 let, veliko tveganje za dolgoročni pojav resne kardiomiopatije ob uporabi velikih kumulativnih odmerkov antraciklina pri otrocih in mladostnikih ter zdravstveno potrebo po shemah z velikimi odmerki antraciklina pri patologijah, kot so sarkom in relapsi akutne mieloične levkemije pri otrocih in mladostnikih;
English: • The Committee considered the data submitted by the MAH in relation to the objections raised on the lifting of the contraindication for Cardioxane in children and adolescents receiving high cumulative doses of anthracycline.
Slovenian: • odbor je preučil podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom glede ugovorov v zvezi z odpravo kontraindikacije za zdravilo Cardioxane pri otrocih in mladostnikih, ki prejemajo velike kumulativne odmerke antraciklina;
English: The affected paediatric patients consequently treated are at high risk of acute anthracycline cardiotoxicity, as a consequence of the high doses of chemotherapy received; therefore, a treatment with a cardioprotective agent is needed in this very small number of patients.
Slovenian: Pri nadaljnje zdravljenih obolelih pediatričnih bolnikih obstaja visoko tveganje za akutno kardiotoksičnost antraciklina kot posledica velikih odmerkov prejete kemoterapije, zato je pri tem zelo majhnem številu bolnikov potrebno zdravljenje z zdravilom za zaščito srca.
English: • The Committee concluded that, in view of the above, it is justified to limit the contraindication for Cardioxane in children aged 0 to 18 years receiving low cumulative anthracycline doses (less than 300 mg/m2 of doxorubicin or equivalent)
Slovenian: • odbor je glede na zgoraj navedeno zaključil,, da je upravičeno omejiti kontraindikacijo za zdravilo Cardioxane pri otrocih, starih od 0 do 18 let, ki prejemajo majhne kumulativne odmerke antraciklina (manj kot 300 mg/m2 doksorubicina ali enakovrednega zdravila);
English: The assessment of this risk is confounded by concomitant chemotherapy treatments, small numbers of patients and the overall rarity of SPM events.
Slovenian: Na oceno tega tveganja vplivajo sočasno zdravljenje s kemoterapijo, majhno število bolnikov in splošna redkost novih primarnih malignosti.
English: Data are reassuring as regard to occurrence of SPMs in children after being exposed to DRZ, up to 12 years post treatment.
Slovenian: Podatki v zvezi s pojavom novih primarnih malignosti pri otrocih po izpostavitvi deksrazoksanu do 12 let po zdravljenju so spodbudni.
English: DRZ efficacy as a cardioprotectant has not been demonstrated in children for cumulative anthracycline doses of less than 300 mg/m2.
Slovenian: Pri otrocih učinkovitost deksrazoksana kot zdravila za zaščito srca pri kumulativnih odmerkih antraciklina pod 300 mg/m2 ni bila dokazana.
English: The CHMP noted that the MAH will reflect the ongoing observational study (Effects of Dexrazoxane Hydrochloride on Biomarkers Associated with Cardiomyopathy and Heart Failure after Cancer Treatment, NCT01790152.)
Slovenian: Odbor CHMP je poudaril, da bo imetnik dovoljenja za promet z zdravilom potekajočo opazovalno študijo (učinki deksrazoksanijevega klorida na biološke označevalce, povezane s kardiomiopatijo in odpovedjo srca, po zdravljenju raka, NCT01790152) vključil v svoj načrt za obvladovanje tveganj, kot bo primerno.
English: However, the RMS considered acceptable to alleviate the contra-indication in children and proposed limiting it to children receiving low cumulative anthracycline doses (less than 300mg/m2 of doxorubicin or equivalent).
Slovenian: Vendar pa je presodila, da je sprejemljivo kontraindikacijo pri otrocih omiliti, in je predlagala, da se omeji na otroke, ki prejemajo majhne kumulativne odmerke antraciklina (manj kot 300 mg/m2 doksorubicina ali enakovrednega zdravila).
English: However, data assessed are still insufficient to provide reassurance concerning the occurrence of long-term risk of SPM particularly solid SPMs.
Slovenian: Vendar ocenjeni podatki še vedno ne zadoščajo za zagotovilo glede pojavnosti dolgoročnega tveganja za nove primarne malignosti, zlasti nove primarne malignosti čvrstih organov.
English: Moreover, there is evidence that there is no delay to chemotherapy treatment as a result of a potential DRZ myelosuppression effect.
Slovenian: Obstajajo tudi dokazi, da zaradi morebitnega mielosupresivnega učinka deksrazoksana ni zakasnitve kemoterapije.
English: The data assessed during the Art.31 referral procedure in 2011 regarded the carcinogenic potential of dexrazoxane due its cytotoxic activity and on the occurrence of second malignant neoplasms in the paediatric population; such data justified the introduction of a contraindication of the product in children aged 0 to 18 years.
Slovenian: V podatkih, ocenjenih med napotitvenim postopkom v skladu s členom 31 leta 2011, so preučevali kancerogeni potencial deksrazoksana zaradi njegove citotoksične aktivnosti in pojav novih malignih neoplazem v pediatrični populaciji.