FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Iasibon
Croatian: Ostale informacije o lijeku Iasibon
English: • as an infusion to treat hypercalcaemia (high levels of calcium in the blood) caused by tumours.
Croatian: • kao infuzija za liječenje hiperkalemije (visokih razina kalcija u krvi) koju uzrokuju tumori.
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.
Croatian: Za potrebe liječenja hiperkalkemije koju uzrokuju tumori, Iasibon se primjenjuje tijekom 2 sata kao infuzija od 2 ili 4 mg, ovisno o tome koliko je hiperkalkemija ozbiljna.
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);
Croatian: • kao infuzija ili tablete za sprječavanje "skeletnih poremećaja" (fraktura [slomljenih kostiju] ili koštanih komplikacija koje zahtijevaju liječenje) u bolesnika s rakom dojke i metastazama u kostima (ako se rak proširio u kosti);
English: Iasibon treatment should only be started by a doctor who has experience in the treatment of cancer.
Croatian: Terapija lijekom Iasibon mora se primjenjivati pod nadzorom liječnika koji ima iskustva u primjeni lijekova protiv raka.
English: A risk management plan has been developed to ensure that Iasibon is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Iasibon.
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.
Croatian: Bolesnici s umjerenim ili ozbiljnim problemima s bubrezima trebaju primiti infuziju lijeka Iasibon u manjim dozama tijekom sat vremena ili kao tablete svaka dva dana ili svaki tjedan.
English: What is Iasibon?
Croatian: Što je Iasibon?
English: In the prevention of skeletal events, Iasibon is either given as a 6-mg infusion lasting at least 15 minutes every three to four weeks, or as one tablet once a day.
Croatian: Za sprječavanje skeletalnih poremećaja Iasibon se primjenjuje kao infuzija od 6-mg koja traje najmanje 15 minuta svaka tri do četiri tjedna ili kao jedna tableta jednom na dan.
English: Iasibon ibandronic acid
Croatian: Iasibon ibandronatna kiselina
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.
Croatian: Budući da je Iasibon generički lijek te je bioekvivalent referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
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.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Iasibon nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Croatian: Snižavanjem gubitka kosti doprinosi se rjeđim slučajevima prijeloma kostiju, što je korisno za sprječavanje fraktura u bolesnika s rakom i metastazama u kostima.
English: The Committee recommended that Iasibon be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Iasibon u promet.
English: Iasibon is a medicine that contains the active substance ibandronic acid.
Croatian: Iasibon je lijek koji kao djelatnu tvar sadrži ibandronatnu kiselinu.
English: The active substance in Iasibon, ibandronic acid, is a bisphosphonate.
Croatian: Djelatna tvar u lijeku Iasibon, ibandronatna kiselina je bisfosfonat.
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.
Croatian: Budući da je Iasibon generički lijek, ispitivanja na bolesnicima bile su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku.
English: Why has Iasibon been approved?
Croatian: Zašto je lijek Iasibon odobren?
English: The CHMP concluded that, in accordance with EU requirements, Iasibon has been shown to have comparable quality and to be bioequivalent to Bondronat.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu s preduvjetima EU-a, lijek Iasibon posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Bondronat.
English: What is Iasibon used for?
Croatian: Za što se Iasibon koristi?
English: Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Bondronat.
English: By preventing the breakdown of bones, Iasibon also helps to reduce the amount of calcium released into the blood.
Croatian: Iasibon također doprinosi snižavanju količine kalcija koja se oslobađa u krv time što sprječava razgradnju kostiju.
English: How is Iasibon used?
Croatian: Kako se Iasibon koristi?
English: How has Iasibon been studied?
Croatian: Kako je Iasibon ispitivan?
English: How does Iasibon work?
Croatian: Kako djeluje Iasibon?
English: The primary changes requested in the variation were:
Croatian: Primarne promjene zatražene u izmjene bile su:
English: In this context and considering
Croatian: S obzirom na sljedeće:
English: • The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008.
Croatian: • Odbor je razmotrio arbitražni postupak prema članku 13. Uredbe (EZ) br. 1234/2008.
English: The mutual recognition procedure FR/H/0283/001/II/27G started on 28/11/2015.
Croatian: Postupak međusobnog priznavanja lijeka FR/H/0283/001/II/27G započet je 28. studenoga 2015.
English: This usually occurs during treatment or within the first years post treatment.
Croatian: To se obično događa tijekom liječenja ili unutar nekoliko godina poslije liječenja.
English: The CMDh 60 day procedure was initiated on 02/12/2016.
Croatian: CMDhov postupak od 60 dana započeo je 2. prosinca 2016.
English: • removal of the contraindication in children and adolescents
Croatian: • uklanjanje kontraindikacije u djece i adolescenata.
English: The studies may not have been sufficiently powered to observe a statistically confirmed increase of SPM.
Croatian: Ispitivanja možda nisu imala dovoljnu snagu da se opazi statistički potvrđeno povećanje broja SPM-ova.
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.
Croatian: • Odbor smatra da su potrebne izmjene upute o lijeku, a također i uvođenje rutinskih aktivnosti u području farmakovigilancije u obliku specifičnih upitnika za praćenje kako bi se prikupili podatci o sigurnosti i djelotvornosti primjene lijeka u djece.
English: • widening of the indication from “advanced and/or metastatic adult breast cancer patients” to “cancer patients”.
Croatian: • proširenje indikacije „odrasli bolesnici s uznapredovalim i/ili metastatskim rakom dojke” u „bolesnici s rakom”
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.
Croatian: Nadalje, u kratkoročnom (do 5 godina poslije liječenja) ili srednjoročnom razdoblju (do 12 godina poslije liječenja) primjena deksrazoksana nije ugrozila protutumorsku djelotvornost antraciklina.
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.
Croatian: Ujedinjena Kraljevina nije se složila s procjenom referentne države članice prema kojoj treba ukloniti kontraindikaciju za određenu podskupinu pedijatrijske populacije.
English: The concerned Member States (CMS) are: CZ, DE, ES, IT, NL, PL and UK.
Croatian: Države sudionice u postupku su: Češka Republika, Njemačka, Španjolska, Italija, Nizozemska, Poljska i Ujedinjena Kraljevina.
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.
Croatian: Prema tome, ne postoje pouzdani dugoročni podatci koji dokazuju da primjena deksrazoksana sprječava kronične ili dugoročne kardiotoksične učinke antraciklina u pedijatrijske populacije.
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.
Croatian: Prihvaćeno je da deksrazoksan može povećati rizik od mijelosupresije i infekcija, međutim ti se rizici mogu smanjiti odgovarajućim mjerama koje su sada uvedene u standardne protokole liječenja pedijatrijskih bolesnika.
English: Moreover, there is evidence that there is no delay to chemotherapy treatment as a result of a potential DRZ myelosuppression effect.
Croatian: Osim toga, postoji dokaz da nema odgode u kemoterapijskom liječenju zbog potencijalnog mijelosupresivnog učinka deksrazoksana.
English: However there are still remaining uncertainties with regard to long term effects for DRZ in children.
Croatian: Međutim, i dalje ima nesigurnosti s obzirom na dugoročne učinke deksrazoksana u djece.
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.
Croatian: Međutim, trenutačno nema utvrđenih korelacija između upotrijebljenih srčanih biljega i dugoročnih kardioprotektivnih učinaka deksrazoksana jer zbog potrebnog dugog praćenja nema dostupnih podataka.
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.
Croatian: Nadalje, s obzirom na iznesene podatke, referentna država članica nije smatrala prihvatljivim potpuno brisanje kontraindikacije u djece, kao što je tražio nositelj odobrenja.
English: Delayed effects usually manifest as congestive heart failure which can occur up to 20 years post treatment.
Croatian: Odgođeni učinci očituju se kao kongestivno srčano zatajenje koje se može pojaviti i do 20 godina poslije liječenja.
English: A type II grouping of variations application was submitted under the mutual recognition procedure for Cardioxane 500 mg powder for solution for infusion.
Croatian: U okviru postupka međusobnog priznavanja dostavljen je zahtjev za grupiranje izmjena uvjeta odobrenja tipa II. za Cardioxane 500 mg prašak za otopinu za infuziju.
English: Although studies suggest there is no safe dose of anthracycline, it is known that the risk of anthracycline induced cardiotoxicity increases with higher cumulative dosing; guidelines imply that above 250 mg/m2 there is sufficient cardiac risk to provide recommendations on lifelong surveillance1.
Croatian: Iako ispitivanja ukazuju na to da nema sigurne doze antraciklina, poznato je da se rizik pojave kardiotoksičnosti izazvane antraciklinom povećava s višim kumulativnim dozama; iz smjernica proizlazi da pri dozi iznad 250 mg/m2 postoji rizik srčane insuficijencije dovoljan za davanje preporuka o cjeloživotnom nadzoru1.
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.
Croatian: Referentna država članica smatrala je da podatci koje je iznio nositelj odobrenja nisu bili dovoljno potkrepljujući za proširenje indikacije u odraslih; stoga je prva tražena izmjena koja se odnosi na proširenje indikacije na „bolesnici s rakom” bila odbijena.
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.
Croatian: Posljedično tomu, Odbor preporučuje odobrenje izmjena uvjeta odobrenja za stavljanje u promet lijekova iz Priloga I. mišljenja CHMP-a, pod uvjetom da se informacije o lijeku izmijene kao što je navedeno u Prilogu III. mišljenja CHMP-a te da se plan upravljanja rizikom izmijeni kako je prethodno opisano.
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.
Croatian: S obzirom na potencijalnu ozbiljnu opasnost po javno zdravlje na koju je ukazala Ujedinjena Kraljevina, Francuska je 4. studenoga 2016. postupak uputila Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) prema članku 13. stavku 1. Uredbe (EZ) br. 1234/2008.
English: The assessment of this risk is confounded by concomitant chemotherapy treatments, small numbers of patients and the overall rarity of SPM events.
Croatian: Procjenu ovog rizika otežavaju istodobna kemoterapijska liječenja, mali broj bolesnika i sveukupno rijetka pojava SPM-a.
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.
Croatian: Visoke kumulativne doze antraciklina rijetko se primjenjuju u pedijatrijskoj populaciji, međutim one su potrebne za liječenje nekih patoloških stanja kao što su sarkomi i relapsi akutne mijeloične leukemije.
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.
Croatian: Iako srčani biljezi upotrijebljeni u izvornim ispitivanjima možda nisu imali istu snagu dokaza kao ovi sadašnji, oni su ipak neka potvrda akutnog kardioprotektivnog učinka deksrazoksana.
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.
Croatian: Uz više kumulativne doze antraciklina, ispitivanja (uključujući nekoliko randomiziranih kliničkih ispitivanja i nerandomizirana ispitivanja) pokazala su da bi deksrazoksan mogao poboljšati surogatne srčane biljege te stoga smanjiti supkliničku akutnu kardiotoksičnost.
English: Whereas
Croatian: Dan 60.
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.
Croatian: Oštećenje srca povezano s antraciklinom može biti akutno i manifestirati se kao akutno zatajenje srca, smanjenje frakcije skraćenja ili promjene zadebljanja stijenke klijetke.
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.)
Croatian: CHMP je napomenuo da će nositelj odobrenja za stavljanje u promet u svom planu upravljanja rizikom (RMP) na odgovarajući način prikazati opservacijsko ispitivanje koje je u tijeku (Effects of Dexrazoxane Hydrochloride on Biomarkers Associated with Cardiomyopathy and Heart Failure after Cancer Treatment, NCT01790152).
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.
Croatian: Razlog je ili mala stopa kliničkih događaja povezanih sa srcem u bolesnika uključenih u randomizirana klinička ispitivanja (RCT) ili mali broj bolesnika liječenih nižim kumulativnim dozama antraciklina i relativno kratko trajanje praćenja tih bolesnika.
English: Unravelling confounders for the cause of SPM would be difficult and overall the long term risk of SPM remains unknown at present.
Croatian: Bilo bi teško razotkriti čimbenike koji otežavaju određivanje uzroka SPM-a te sveukupni dugoročni rizik za pojavu SPM-a zasad ostaje nepoznat.
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.
Croatian: CMDh-ova postupka bio je 30. siječnja 2017., a kako nije bilo moguće postići dogovor, postupak i prigovore Ujedinjene Kraljevine oko uklanjanja kontraindikacije za podskupinu pedijatrijske populacije liječene antraciklinom referentna država članica uputila je CHMP-u 31. siječnja 2017.
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.
Croatian: Podatci procijenjeni tijekom arbitražnog postupka prema članku 31., koji je proveden 2011. godine, odnosili su se na karcinogeni potencijal deksrazoksana zbog njegove citotoksične aktivnosti te pojavu drugih zloćudnih novotvorina u pedijatrijskoj populaciji; takvi podaci opravdali su uvođenje kontraindikacije za lijek u djece u dobi između 0 i 18 godina.
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
Croatian: • Odbor je primio na znanje uvjerljive sigurnosne podatke o pojavi sekundarnih primarnih zloćudnih bolesti, osobito akutne mijeloične leukemije i mijelodisplastičnih sindroma, u djece i adolescenata u dobi između 0 i 18 godina, visokom riziku dugoročne pojave teške kardiomiopatije kada se visoke kumulativne doze antraciklina primjenjuju u djece i adolescenata te medicinsku potrebu za primjenom režima s visokim dozama antraciklina u slučajevima patoloških stanja kao što je sarkom ili relapsi akutne mijeloične leukemije u djece i adolescenata.
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.
Croatian: Ocjena podataka dostavljenih kao dio tog postupka omogućila je bolju karakterizaciju rizika kratkoročnih učinaka na druge primarne zloćudne bolesti (SPM), mijelosupresiju i infekcije nakon liječenja deksrazoksanom u djece podvrgnute kemoterapiji režimima temeljenima na antraciklinu.
English: However, data assessed are still insufficient to provide reassurance concerning the occurrence of long-term risk of SPM particularly solid SPMs.
Croatian: Međutim, procijenjeni podatci još uvijek ne daju dovoljnu sigurnost s obzirom na dugoročni rizik za pojavu SPM-a, osobito solidnih tumora.
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.
Croatian: • Odbor je razmotrio podatke koje je dostavio nositelj odobrenja za stavljanje u promet u vezi s prigovorima u pogledu uklanjanja kontraindikacije za Cardioxane u djece i adolescenata koji primaju visoke kumulativne doze antraciklina.
English: DRZ efficacy as a cardioprotectant has not been demonstrated in children for cumulative anthracycline doses of less than 300 mg/m2.
Croatian: Djelotvornost deksrazoksana kao kardioprotektivnog lijeka nije dokazana u djece za kumulativne doze antraciklina niže od 300 mg/m2.
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).
Croatian: CHMP je obaviješten da će nositelj odobrenja za stavljanje u promet provesti prospektivno sigurnosno ispitivanje u djece na temelju postojećeg registra oboljelih od raka kako bi prikupio podatke o primjeni deksrazoksana u pedijatrijske populacije, incidencije štetnih događaja (npr. sekundarnih malignih bolesti, mijelosupresije i infekcija) te dugoročnih (>12 godina) učinaka na srce (uključujući zatajenje srca, zatajenje lijeve klijetke).
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)
Croatian: • Odbor je zaključio da je, s obzirom na prethodno navedeno, opravdano ograničiti kontraindikaciju za Cardioxane u djece u dobi između 0 i 18 godina koja primaju niske kumulativne doze antraciklina (manje od 300 mg/m2 doksorubicina ili ekvivalentnog lijeka).
English: Data are reassuring as regard to occurrence of SPMs in children after being exposed to DRZ, up to 12 years post treatment.
Croatian: Podatci su uvjerljivi s obzirom na pojavu SPM-ova do 12 godina poslije liječenja u djece koja su bila izložena deksrazoksanu.
English: 1 Armenian S.H., Hudson M.M., Mulder R.L., Chen M.H., Constine L.S., et al. ‘Recommendations for Cardiomyopathy Surveillance for Survivors of Childhood Cancer: A Report from the International Late Effects of Childhood Cancer Guideline Harmonization Group' Lancet Oncology, Vol. 16(3), March 2015, p. e123-e136
Croatian: ‘Recommendations for Cardiomyopathy Surveillance for Survivors of Childhood Cancer: A Report from the International Late Effects of Childhood Cancer Guideline Harmonization Group' Lancet Oncology, Vol. 16(3), svibanj 2015., str. e123-e136
English: The reference Member State (RMS) is: FR
Croatian: Referentna članica država je Francuska.
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).
Croatian: Međutim, smatrala je prihvatljivim da se kontraindikacija u djece ublaži i predložila ograničenje kontraindikacije na djecu koja primaju niske kumulativne doze antraciklina (manje od 300 mg/m2 doksorubicina ili ekvivalentnog lijeka).
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.
Croatian: izazvane antraciklinom zbog primjene visokih doza kemoterapije; stoga je tom vrlo malom broju bolesnika potrebno liječenje kardioprotektivnim agensom.
English: The infusion is given over two hours, three times daily.
Croatian: Infuzija se daje tijekom dva sata tri puta na dan.