natgillin/translations-raw huggingface dataset:
For this diagnosis, within 24 hours after the index PCI procedure, there had to be at least two CK-MB values ≥ 3 x the upper limit of normal; thus, validation by the CEC was not required.
Miokardni infarkt so ugotavljali na podlagi osrednjih laboratorijskih meril za CK-MB. Za to diagnozo sta morali biti v obdobju 24 ur po zadevnem perkutanem koronarnem posegu najmanj dve vrednosti
INTEGRILIN did not appear to increase the risk of major and minor bleeding associated with concomitant use of warfarin and dipyridamole.
Pri sočasni uporabi z varfarinom in dipiridamolom ni bilo videti, da bi zdravilo INTEGRILIN povečalo tveganje za pojav večjih ali manjših krvavitev.
− severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis
- hudo okvaro ledvic (kreatininski očistek < 30 ml/min) ali odvisnost od dialize; - klinično pomembno jetrno okvaro; - sočasno ali predvideno uporabo kakega drugega parenteralnega zaviralca glikoproteina (GP)
One 100 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Ena 100 ml viala iz stekla tipa I, zaprta z zamaškom iz butilne gume in zapečatena z aluminijasto zaporko.
If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
One 10 ml Type I glass vial, closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Ena 10 ml viala iz stekla tipa I, zaprta z zamaškom iz butilne gume in zapečatena z aluminijasto zaporko.
These may affect up to 1 in 100 people
Pojavijo se pri 1 do 10 bolnikih od 100 bolnikov - vnetje ven.
Patients were managed according to the usual standards of the investigational site; frequencies of angiography, PCI and CABG therefore differed widely from site to site and from country to country.
perkutanih koronarnih posegov in koronarnih premostitvenih operacij se je zato zelo razlikovala med posameznimi mesti in državami.
The recommended dosage is an intravenous bolus of 180 microgram/kg administered as soon as possible following diagnosis, followed by a continuous infusion of 2 microgram/kg/min for up to
Priporočeni odmerek je intravenski bolus 180 mikrogramov/kg čimprej po diagnozi.
Rash, application site disorders such as urticaria.
Bolezni kože in podkožja Zelo redki izpuščaj, težave na mestu aplikacije npr. urtikarija
Warfarin and dipyridamole
OVOJNINAH NALEPKA
The clear, colourless solution is contained in a 10 ml glass vial, which is closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Bistra brezbarvna raztopina v 10-ml stekleni viali, ki je zaprta z zamaškom iz butilne gume in zapečatena z aluminijskim pokrovčkom.
− severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure
- trombocitopenijo (< 100.000 celic/mm3); - protrombinskim časom > 1,2-krat večjim od kontrolne vrednosti ali mednarodnim normaliziranim količnikom (INR) ≥ 2,0; - hudo hipertenzijo (sistolični krvni tlak > 200 mm Hg ali diastolični krvni tlak > 110 mmHg ob antihipertenzivnem zdravljenju);
Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to the glycoprotein (GP) IIb/IIIa receptors.
Eptifibatid reverzibilno zavira agregacijo trombocitov, saj preprečuje vezavo fibrinogena, von
NAME OF THE MEDICINAL PRODUCT INTEGRILIN 2 mg/ml solution for injection eptifibatide
NAVODILO ZA UPORABO Integrilin 2 mg/ml raztopina za injiciranje eptifibatid
The clear, colourless solution is contained in a 100 ml glass vial, which is closed with a butyl rubber stopper and sealed with a crimped aluminium seal.
Bistra brezbarvna raztopina v 100-ml stekleni viali, ki je zaprta z zamaškom iz butilne gume in zapečatena z aluminijskim pokrovčkom.
Integrilin is an inhibitor of platelet aggregation.
Zdravilo INTEGRILIN je antitrombotično zdravilo, ki deluje tako, da zavira agregacijo trombocitov.
NAME OF THE MEDICINAL PRODUCT INTEGRILIN 0.75 mg/ml solution for infusion eptifibatide
NAVODILO ZA UPORABO Integrilin 0,75 mg/ml raztopina za infundiranje eptifibatid
MARKETING AUTHORISATION NUMBER EU/1/99/109/001
ŠTEVILKA DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/99/109/001
MARKETING AUTHORISATION NUMBER(S) EU/1/99/109/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/109/001
− If you get any side effects talk to your doctor or hospital pharmacist or nurse.
- Če opazite katerikoli neželeni učinek se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
MARKETING AUTHORISATION NUMBER(S) EU/1/99/109/002
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/99/109/002
MARKETING AUTHORISATION NUMBER EU/1/99/109/002
ŠTEVILKA DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/99/109/002
− reduction in the number of platelets (blood cells necessary for blood clotting).
Pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov - zmanjšanje števila trombocitov (krvnih celic, ki so potrebne za strjevanje krvi);
PHARMACEUTICAL FORM AND CONTENTS Solution for infusion
Izgled zdravila Integrilin in vsebina pakiranja
Thrombocytopaenia, including acute profound thrombocytopaenia, has been observed with eptifibatide administration post-marketing (see section
Pri uporabi eptifibatida v obdobju trženja so opažali trombocitopenijo, vključno z akutno hudo trombocitopenijo (glejte poglavje 4.8).
− age
Lot
− concomitant or planned administration of another parenteral glycoprotein (GP) IIb/IIIa inhibitor
- klinično pomembno jetrno okvaro; - sočasno ali predvideno uporabo kakega drugega parenteralnega zaviralca glikoproteina (GP)
What measures are being taken to ensure the safe and effective use of Iasibon?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Iasibon?
Iasibon is used in the following ways:
Zdravilo Iasibon se uporablja na naslednje načine:
The tablet should be taken while standing or sitting up, and it should not be chewed, sucked or crushed.
Bolnik mora tableto vzeti v stoječem ali sedečem položaju, te pa ne sme žvečiti, lizati ali zdrobiti.
The European Commission granted a marketing authorisation valid throughout the European Union for Iasibon on 21 January 2011.
Evropska komisija je dovoljenje za promet z zdravilom Iasibon, veljavno po vsej Evropski uniji, izdala 21. januarja 2011.
They must be taken with a full glass of plain water (in areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low mineral content should be used).
Tableto mora vzeti s polnim kozarcem navadne vode (na območjih s trdo vodo, kjer voda iz pipe vsebuje veliko raztopljenega kalcija, se lahko uporabi ustekleničena voda z nizko vsebnostjo mineralov).
What are the benefits and risks of Iasibon?
Kakšne so koristi in tveganja, povezani z zdravilom Iasibon?
The full EPAR for Iasibon can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Iasibon je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This means that Iasibon is similar to a ‘reference medicine' already authorised in the European Union (EU) called Bondronat.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Bondronat.
Iasibon treatment should only be started by a doctor who has experience in the treatment of cancer.
Zdravljenje z zdravilom Iasibon lahko začne le zdravnik, ki ima izkušnje z zdravljenjem raka.
For more information about treatment with Iasibon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
Other information about Iasibon
Druge informacije o zdravilu Iasibon
A risk management plan has been developed to ensure that Iasibon is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Iasibon je bil pripravljen načrt obvladovanja tveganj.
This is a summary of the European public assessment report (EPAR) for Iasibon.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Iasibon.
It is available as a concentrate that is made up into a solution for infusion (drip into a vein) and as tablets (50 mg).
Na voljo je v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije v veno) in tablet (50 mg).
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.
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.
By preventing the breakdown of bones, Iasibon also helps to reduce the amount of calcium released into the blood.
S preprečevanjem razgrajevanja kosti zdravilo Iasibon prav tako pomaga zmanjševati količino kalcija, ki se sprošča v kri.
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.
Ker je zdravilo Iasibon generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
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.
Pri zdravljenju tumorsko povzročene hiperkalciemije se zdravilo Iasibon daje v obliki dveurne infuzije v odmerku 2 ali 4 mg, odvisno od resnosti hiperkalciemije.
The Committee recommended that Iasibon be given marketing authorisation.
Priporočil je, da se za zdravilo Iasibon izda dovoljenje za promet.
Iasibon ibandronic acid
Iasibon ibandronska kislina
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.
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.
Iasibon is a ‘generic medicine'.
Zdravilo Iasibon je „generično zdravilo“.
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.
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.
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.
Ker je zdravilo Iasibon generično zdravilo, so bile študije pri bolnikih omejene na preizkuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Bondronat.
The CHMP concluded that, in accordance with EU requirements, Iasibon has been shown to have comparable quality and to be bioequivalent to Bondronat.
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.
The patient must not lie down for one hour after taking the tablet.
Vsaj eno uro po zaužitju tablete ne sme leči.
Iasibon is a medicine that contains the active substance ibandronic acid.
Iasibon je zdravilo, ki vsebuje zdravilno učinkovino ibandronsko kislino.
Why has Iasibon been approved?
Zakaj je bilo zdravilo Iasibon odobreno?
This leads to less bone loss.
S tem se zmanjša izguba kostnega tkiva.
The active substance in Iasibon, ibandronic acid, is a bisphosphonate.
Zdravilna učinkovina zdravila Iasibon, ibandronska kislina, je difosfonat.
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.
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.
What is Iasibon?
Kaj je zdravilo Iasibon?
Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi tako kot pri zdravilu Bondronat odtehtajo z njim povezana tveganja.
What is Iasibon used for?
Za kaj se zdravilo Iasibon uporablja?
How has Iasibon been studied?
Kako je bilo zdravilo Iasibon raziskano?
How does Iasibon work?
Kako zdravilo Iasibon deluje?
• 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);
ali zapletov s kostmi, pri katerih je potrebno zdravljenje) pri bolnikih z rakom dojke in metastazami v kosteh (kadar se rak razširi na kosti);
How is Iasibon used?
Kako se zdravilo Iasibon uporablja?
The concerned Member States (CMS) are: CZ, DE, ES, IT, NL, PL and UK.
Zadevne države članice so: CZ, DE, ES, IT, NL, PL in UK.
• The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008.
• odbor je obravnaval napotitev v skladu s členom 13 Uredbe (ES) št. 1234/2008;
The reference Member State (RMS) is: FR
Referenčna država članica je: FR
The mutual recognition procedure FR/H/0283/001/II/27G started on 28/11/2015.
Postopek z medsebojnim priznavanjem FR/H/0283/001/II/27G se je začel 28. novembra 2015.
• removal of the contraindication in children and adolescents
• odstranitev kontraindikacije pri otrocih in mladostnikih.
• widening of the indication from “advanced and/or metastatic adult breast cancer patients” to “cancer patients”.
• razširitev indikacije z „odrasli bolniki z napredovalim in/ali metastatskim rakom dojk“ na „bolniki z rakom“;
This usually occurs during treatment or within the first years post treatment.
Do tega običajno pride med zdravljenjem ali v nekaj letih po zdravljenju.
• 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.
• 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.
Delayed effects usually manifest as congestive heart failure which can occur up to 20 years post treatment.
Zapozneli učinki se običajno pokažejo kot kongestivna srčna odpoved, ki se lahko pojavi do 20 let po zdravljenju.
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.
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.
UK did not concur with the RMS assessment related to the removal of the contra-indication for a certain subset of the paediatric population.
Združeno kraljestvo se ni strinjalo z oceno referenčne države članice v zvezi z odpravo kontraindikacije za določeno podskupino pediatrične populacije.
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.
Zato torej ni robustnih podatkov o dolgoročni učinkovitosti, ki bi dokazovali, da uporaba deksrazoksana preprečuje kronične ali dolgoročne kardiotoksične učinke antraciklinov pri pediatrični populaciji.
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.
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.
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.
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.
The CMDh 60 day procedure was initiated on 02/12/2016.
60-dnevni rok za izvedbo postopka skupine CMDh je začel teči 2. decembra 2016.
However there are still remaining uncertainties with regard to long term effects for DRZ in children.
Obstaja pa še nekaj nejasnosti glede dolgoročnih učinkov deksrazoksana pri otrocih.
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.
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.
The studies may not have been sufficiently powered to observe a statistically confirmed increase of SPM.
Študije morda nimajo zadostne moči za opazovanje statistično potrjenega povečanja pojavnosti novih primarnih malignosti.
The primary changes requested in the variation were:
Glavni predloženi spremembi sta bili:
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.
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.
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.
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.
A type II grouping of variations application was submitted under the mutual recognition procedure for Cardioxane 500 mg powder for solution for infusion.
Po postopku z medsebojnim priznavanjem je bila predložena vloga za skupino sprememb tipa II za zdravilo Cardioxane 500 mg prašek za raztopino za infundiranje.
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.
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).
Anthracycline related cardiac damage can be acute, manifesting as acute heart failure, reduction in the shortening fraction or changes to the ventricular wall thickening.
Z antraciklinom povezane poškodbe srca so lahko akutne in se kažejo kot akutna odpoved srca, zmanjšanje deleža skrčenja ali spremembe zadebelitve stene prekata.
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.
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.
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.
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.
Unravelling confounders for the cause of SPM would be difficult and overall the long term risk of SPM remains unknown at present.
Izločitev vplivov pri ugotavljanju vzroka novih primarnih malignosti bi bilo težavno in trenutno splošno dolgoročno tveganje za nove primarne malignosti ostaja neznano.
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.
Poleg tega protitumorska aktivnost antraciklina kratkoročno (do 5 let po zdravljenju) in srednjeročno (do 12 let po zdravljenju) zaradi uporabe deksrazoksana ni bila okrnjena.
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.
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.
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.
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.
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).
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).