FrancophonIA/ELRC3.0 huggingface dataset:
English: Remnants of the medicinal product as well as all materials that have been used for reconstitution and administration must be destroyed according to standard procedures applicable to antineoplastic agents, with due regard to current laws related to the disposal of hazardous waste.
Slovenian: Ostanke zdravila in vseh materialov, ki ste jih porabili pri rekonstituciji in dajanju zdravila, morate uničiti v skladu s standardnimi postopki, ki veljajo za antineoplastična sredstva, pri čemer upoštevajte trenutno zakonodajo, ki ureja odstranjevanje nevarnih odpadkov.
English: Table 1: Treatment results at 24 months (Full analysis set) Parameter
Slovenian: Preglednica 1: Rezultati zdravljenja pri 24 mesecih (celotni nabor za analizo)
English: The primary endpoint of this study was event-free survival (EFS) after 2 years.
Slovenian: Primarno končno stanje te študije je bilo preživetje brez dogodkov (event-free survival - EFS) po
English: Seizure in the context of an encephalitis infection was reported in one of 88 paediatric patients.
Slovenian: O epileptičnem napadu v okviru encefalitične infekcije so poročali pri 1 od 88 pediatričnih bolnikov.
English: However, an approximately 3-fold higher exposure in brain tissue of juvenile rats in comparison to young adults was found.
Slovenian: Vendar pa so ugotovili približno trikrat večjo izpostavljenost v možganskem tkivu mladih podgan kot pri mladih odraslih podganah.
English: The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.
Slovenian: Skrbno je treba spremljati hematološki status in v skladu z medicinskimi indikacijami uvajati učinkovite podporne ukrepe.
English: Within each frequency group, undesirable effects are presented in order of decreasing seriousness.
Slovenian: Znotraj vsake skupine pogostnosti so neželeni učinki razvrščeni po resnosti v padajočem vrstnem redu.
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Slovenian: Če ste zaskrbljeni glede tega, ali boste lahko imeli otroke, se pred zdravljenjem pogovorite o tem s svojim zdravnikom.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Slovenian: Če metoda rekonstitucije ne preprečuje tveganja mikrobne kontaminacije, je treba z mikrobiološkega stališča zdravilo uporabiti takoj.
English: The overall incidence of infections in 88 paediatric patients was 11.4% (10/88) and thus comparable to that seen in adults.
Slovenian: Infekcije Skupna pogostnost infekcij pri 88 pediatričnih bolnikih je bila 11,4 % (10/88) in tako primerljiva s tisto pri odraslih.
English: Children younger than 1 year may have more severe side effects that affect breathing than older ones.
Slovenian: Otroci, mlajši od 1 leta, utegnejo imeti težje neželene učinke, ki prizadenejo dihanje, kot starejši otroci.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden prejmete to zdravilo.
English: Plasma concentrations of treosulfan decline exponentially and are best described by a first order elimination process fitted by a two-compartment model.
Slovenian: Plazemske koncentracije treosulfana se zmanjšujejo eksponencialno in jih najbolje opisuje proces izločanja prvega reda, ki ustreza dvoprostorskemu modelu.
English: a Adjusted for donor type as factor, and risk group and centre as strata using Cox regression model.
Slovenian: aPopravljeno za vrsto donatorja kot faktor, in za skupino tveganja in center kot strata z uporabo Coxovega regresijskega modela.
English: Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Slovenian: Zdravnik bo redno spremljal število vaših krvničk in jetrne encime, da bi odkril in zdravil te dogodke.
English: The median age of patients was 60 years (range 31-70 years); 25% of patients were older than 65 years.
Slovenian: Mediana starost bolnikov je bila 60 let (razpon 31-70 let); 25 % bolnikov je bilo starejših od 65 let.
English: Do not store in a refrigerator (2 °C-8 °C) as this might cause precipitation.
Slovenian: Ne shranjujte v hladilniku (2 °C-8 °C), ker bi to lahko povzročilo precipitacijo.
English: Guidelines for the safe disposal of antineoplastic agents must be observed.
Slovenian: Ravnati se morate po smernicah za varno odstranjevanje antineoplastičnih sredstev.
English: The most frequent type was lung infection (12/74 [16.2%]).
Slovenian: Najpogostejša vrsta je bila pljučna infekcija (12/74 [16,2 %]).
English: Instructions for reconstitution of treosulfan:
Slovenian: Navodila za rekonstitucijo treosulfana:
English: One of 564 adult patients (0.2%) developed a second malignancy (breast cancer).
Slovenian: Pri enem od 564 odraslih bolnikov (0,2 %) se je razvila druga maligna bolezen (rak dojke).
English: Body surface area (m²) Treosulfan dose (g/m²)
Slovenian: Telesna površina (m²) Odmerek treosulfana (g/m²)
English: Treosulfan is contraindicated during pregnancy (see section 4.3).
Slovenian: Treosulfan je kontraindiciran med nosečnostjo (glejte poglavje 4.3).
English: The possible risk of a second malignancy should be explained to the patient.
Slovenian: Bolniku je treba razložiti možno tveganje druge maligne bolezni.
English: • different cancer caused by chemotherapeutic treatment (second malignancy)
Slovenian: • različne vrste raka, ki jih povzroča kemoterapevtsko zdravljenje (druga maligna bolezen),
English: Trecondi may cause symptoms of the menopause (absence of menstrual periods).
Slovenian: Zdravilo Trecondi lahko povzroči simptome menopavze (odsotnost mesečnega perila).
English: • Fanconi anaemia and other DNA breakage repair disorders
Slovenian: • Fanconijeva anemija in druge bolezni popravljanja prelomov DNA
English: Blood cell counts usually recover after HSCT.
Slovenian: Število krvničk se po HSCT navadno popravi.
English: Reconstituted solutions of treosulfan may be combined into a larger glass vial, PVC bag or PE bag.
Slovenian: Rekonstituirane raztopine treosulfana lahko združite v večji stekleni viali, PVC vrečki ali PE vrečki.
English: The frequency was higher in the paediatric age group 12-17 years (6/35 [17.1%]) compared to younger children (4/53 [7.5%]).
Slovenian: Pogostnost je bila večja v pediatrični starostni skupini 12-17 let (6/35 [17,1 %]) kot pri mlajših otrocih (4/53 [7,5 %]).
English: The most frequent adverse reaction was febrile neutropenia (11.3%).
Slovenian: Najpogostejši neželeni učinek je bila febrilna nevtropenija (11,3 %).
English: The safety and efficacy of treosulfan in children less than 1 month of age has not yet been established.
Slovenian: Varnost in učinkovitost treosulfana pri otrocih, mlajših od 1 meseca, še nista bili dokazani.
English: Large bore needles are recommended to minimise pressure and the possible formation of aerosols.
Slovenian: Priporočljiva je uporaba igel velikega kalibra, da se čim bolj zmanjša tlak in možnost nastajanja aerosolov.
English: Therefore, nappies should be changed frequently during 6-8 hours after each dose of this medicine.
Slovenian: Zato je treba 6-8 ur po vsakem odmerku tega zdravila pogosto menjati plenice.
English: The age of the patients ranged from 0.4 to 30.5 years, and 29% had HCT-CI scores > 2.
Slovenian: Bolniki so bili stari od 0,4 do 30,5 let, 29 % je imelo rezultat HCT-CI > 2.
English: Other medicines and Trecondi
Slovenian: Druga zdravila in zdravilo Trecondi
English: What Trecondi is and what it is used for
Slovenian: Kaj je zdravilo Trecondi in za kaj ga uporabljamo
English: The most serious side effects of treosulfan therapy or the transplant procedure include:
Slovenian: Najresnejši neželeni učinki zdravljenja s treosulfanom ali postopka presaditve vključujejo:
English: Children younger than one year (mainly non-malignant diseases, especially immunodeficiencies) experienced more respiratory grade III/IV toxicity, possibly due to pulmonary infections already existing before the start of conditioning treatment.
Slovenian: Pri otrocih, mlajših od enega leta (predvsem z nemalignimi boleznimi, posebno imunskimi pomanjkljivostmi), je bila pogostejša respiracijska toksičnost stopnje III/IV, mogoče zaradi okužb pljuč, ki so že obstajale pred začetkom pripravljalnega zdravljenja.
English: After intravenous administration, peak plasma levels are reached at the end of the infusion time.
Slovenian: Po intravenskem dajanju se najvišje plazemske koncentracije dosežejo ob koncu časa infundiranja.
English: On the basis of human data, treosulfan has been classified by the International Agency for Research on Cancer (IARC) as a human carcinogen.
Slovenian: Na podlagi podatkov, pridobljenih pri ljudeh, je Mednarodna agencija za raziskave raka (International Agency for Research on Cancer - IARC) klasificirala treosulfan kot rakotvorno snov za ljudi.
English: This medicine is used in combination with fludarabine.
Slovenian: To zdravilo se uporablja v kombinaciji s fludarabinom.
English: White crystalline powder.
Slovenian: Bel kristalen prašek.
English: If possible it is recommended to work on a special safety workbench, equipped with laminar flow, with liquid-impermeable, absorbent disposable foil.
Slovenian: Priporočljivo je, da po možnosti delate na posebni varnostni delovni mizi, opremljeni z laminarnim pretokom, pokriti z neprepustno vpojno folijo za enkratno uporabo.
English: No dose accumulation with the recommended daily treatment on three consecutive days was observed.
Slovenian: Ob priporočenem dnevnem zdravljenju tri zaporedne dni niso opazili kopičenja odmerka.
English: The overall incidence of infections was 13.1% (74/564).
Slovenian: Skupna pogostnost infekcij je bila 13,1 % (74/564).
English: Specific reproductive and developmental toxicity studies on treosulfan in animals were not conducted.
Slovenian: Specifičnih študij toksičnosti treosulfana za razmnoževanje in razvoj pri živalih niso izvedli.
English: Blood disorders were observed in 67 of 564 adult patients (11.9%).
Slovenian: Bolezni krvi so ugotovili pri 67 od 564 odraslih bolnikov (11,9 %).
English: Intravenous application should be performed using a safe technique.
Slovenian: Pri intravenskem dajanju je treba uporabljati varno tehniko.
English: Treosulfan does not bind to plasma proteins.
Slovenian: Treosulfan se ne veže na plazemske beljakovine.
English: Name and address of the manufacturer(s) responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: Figure 1: Kaplan-Meier estimates of event-free survival (Full Analysis Set)
Slovenian: Slika 1: Kaplan-Meierjeve ocene preživetja brez dogodkov (celotni nabor za analizo)
English: A list of all other side effects is set out below according to how common they are.
Slovenian: Seznam vseh drugih neželenih učinkov je naveden v nadaljevanju glede na to, kako pogosti so.
English: It is likely that certain adverse reactions of treosulfan like nausea, vomiting or dizziness could affect these functions.
Slovenian: Verjetno bi nekateri neželeni učinki treosulfana, na primer navzea, bruhanje ali omotica, vplivali na te funkcije.
English: • infections caused by bacteria, viruses and fungi (all patients: very common)
Slovenian: • okužbe, ki jih povzročijo bakterije, virusi in glivice (vsi bolniki: zelo pogosti),
English: It is therefore recommended to monitor blood cell counts frequently until recovery of the haematopoietic system.
Slovenian: Zato je priporočljivo pogosto spremljanje števila krvničk do okrevanja krvotvornega sistema.
English: In the absence of haematopoietic stem cell transplantation, the recommended dose of treosulfan would constitute an overdose.
Slovenian: Brez presaditve hematopoetičnih matičnih celic bi priporočeni odmerek treosulfana predstavljal prevelik odmerek.
English: • decrease in blood cell counts which is the intended effect of the medicine to prepare you for your transplant infusion (all patients: very common)
Slovenian: • zmanjšanje števila krvničk, kar je nameravani učinek zdravila, ki vas bo pripravil na infuzijo presadka (vsi bolniki: zelo pogosti),
English: Contents of the pack and other information What Trecondi contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Trecondi
English: Treosulfan is reconstituted in its original glass container.
Slovenian: Treosulfan rekonstituirajte v originalnem steklenem vsebniku.
English: The overall incidence of veno-occlusive liver disease (VOD) was 0.9% (5/564).
Slovenian: Skupna pogostnost venookluzivne bolezni jeter (veno-occlusive liver disease - VOD) je bila 0,9 % (5/564).
English: EU/1/18/1351/001 (1 g, 1 vial) EU/1/18/1351/002 (1 g, 5 vials) EU/1/18/1351/003 (5 g, 1 vial) EU/1/18/1351/004 (5 g, 5 vials)
Slovenian: EU/1/18/1351/001 (1 g, 1 viala) EU/1/18/1351/002(1 g, 5 vial) EU/1/18/1351/003 (5 g, 1 viala) EU/1/18/1351/004 (5 g, 5 vial)
English: Very common Pruritus
Slovenian: Zelo pogosti Pruritus
English: Intravenous administration should be performed using a safe technique to avoid extravasation (see section 4.4).
Slovenian: Zdravilo moramo dajati intravensko z uporabo varne tehnike za preprečitev ekstravazacije (glejte poglavje 4.4).
English: Common Decreased appetite
Slovenian: Pogosti Zmanjšan apetit
English: In order to prevent and treat infections, you will be given medicines, such as antibiotics, antifungals or antivirals.
Slovenian: Za preprečevanje in zdravljenje okužb vam bodo dali zdravila, na primer antibiotike, sredstva proti glivicam ali virusom.
English: No pharmacokinetic studies with treosulfan were done in patients with severe renal or hepatic impairment, because such patients are generally excluded from alloHSCT.
Slovenian: Farmakokinetičnih študij s treosulfanom pri bolnikih s težko okvaro ledvic ali jeter niso izvedli, ker pri takih bolnikih alloHSCT na splošno ne pride v poštev.
English: Results of GvHD are shown in Table 2.
Slovenian: Rezultate GvHD kaže preglednica 2.
English: Chronic GvHDa; % (95% CI)
Slovenian: Kronična GvHDa; % (95 % IZ)
English: Therefore, treosulfan is unlikely to participate in, or contribute to, potential CYP450-mediated interactions in vivo.
Slovenian: Zato ni verjetno, da bi treosulfan sodeloval v možnih interakcijah in vivo, ki bi jih posredoval CYP450, ali prispeval k njim.
English: The terminal half-life (T1/2ß) of intravenously administered treosulfan (up to 47 g/m²) is approximately 2 hours.
Slovenian: Končni razpolovni čas (T1/2ß) intravensko danega treosulfana (do 47 g/m²) je približno 2 uri.
English: In one study, 31 NMD patients were treated with the FT14 regimen plus anti-thymocyte globulin.
Slovenian: V eni študiji so 31 bolnikov z NMD zdravili s shemo FT14 plus anti-timocitnim globulinom.
English: • changes and abnormalities in heart rhythm (heartbeat is irregular, too fast or too slow)
Slovenian: • spremembe in nenormalnosti srčnega ritma (srčni utrip je nereden, prehiter ali prepočasen),
English: Treosulfan has mutagenic and carcinogenic potential.
Slovenian: Treosulfan ima mutageni in kancerogeni potencial.
English: Trained personnel should reconstitute the medicinal product.
Slovenian: Zdravilo naj rekonstituira usposobljeno osebje.
English: During phases of severe neutropenia (median duration of neutropenic period is 14-17.5 days in adults and 21-24 days in paediatric patients) the risk of infection is increased.
Slovenian: Med fazami težke nevtropenije (mediano trajanje nevtropeničnega obdobja je 14-17,5 dni pri odraslih in 21-24 dni pri pediatričnih bolnikih) se zveča tveganje okužb.
English: An Italian group treated 60 TM patients (age range 1-37 years; including 12 adults) with the FT14 plus thiotepa regimen.
Slovenian: Italijanska skupina je zdravila 60 bolnikov s TM (razpon starosti 1-37 let; vključenih je bilo 12 odraslih) s shemo FT14 plus tiotepa.
English: Treosulfan is rapidly distributed in the body; however, its penetration through the blood-brain-barrier is quite limited (see section 5.3).
Slovenian: Treosulfan se hitro porazdeli po telesu, vendar je njegova penetracija skozi krvno-možgansko pregrado precej omejena (glejte poglavje 5.3).
English: The recommended dose is 10-14 g/m² body surface area (calculated using your height and weight).
Slovenian: Priporočeni odmerek je 10-14 g/m² telesne površine (izračunan s pomočjo vaše telesne višine in telesne mase).
English: Cardiac disorders were observed in 25 patients (4.4%).
Slovenian: Srčne bolezni Srčne bolezni so ugotovili pri 25 bolnikih (4,4 %).
English: Women of childbearing potential/Contraception in males and females Both sexually active men and women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Slovenian: Ženske v rodni dobi/Kontracepcija pri moških in ženskah Spolno aktivni moški in ženske v rodni dobi morajo med zdravljenjem in do 6 mesecev po končanem zdravljenju uporabljati zanesljivo kontracepcijo.
English: Regression analysis of the area under the curve (AUC0-∞) versus treosulfan dose indicated a linear correlation.
Slovenian: Regresijska analiza površine pod krivuljo (AUC0-∞) proti odmerku treosulfana kaže na linearno korelacijo.
English: Contaminated body parts should be carefully rinsed with water and soap, the eyes should be rinsed with sodium chloride 9 mg/mL (0.9%) solution.
Slovenian: Kontaminirane dele telesa skrbno umijte z vodo in milom, oči sperite z raztopino natrijevega klorida 9 mg/ml (0,9 %).
English: After long-term therapy with conventional doses of oral treosulfan in patients with solid tumours acute myeloid leukaemia was observed in 1.4% of 553 patients.
Slovenian: Po dolgoročnem zdravljenju s konvencionalnimi odmerki peroralnega treosulfana pri bolnikih s čvrstimi tumorji so pri 1,4 % od 553 bolnikov ugotovili akutno mieloidno levkemijo.
English: Trecondi is used as a treatment before blood stem cell transplantation in adults with cancer and non-cancerous disorders, and in adolescents and children older than one month with cancer.
Slovenian: Zdravilo Trecondi se uporablja kot zdravljenje pred presaditvijo krvnih matičnih celic pri odraslih z rakastimi in nerakastimi boleznimi in pri mladostnikih in otrocih, starejših od enega meseca, z rakom.
English: • Pregnancy (see section 4.6)
Slovenian: • nosečnost (glejte poglavje 4.6) • uporaba živega cepiva
English: This medicine can cause nausea, vomiting and dizziness which may reduce your ability to drive or use machines.
Slovenian: To zdravilo lahko povzroči navzeo (občutek siljenja na bruhanje), bruhanje in omotico, ki lahko zmanjšajo vašo sposobnost upravljanja vozil in strojev.
English: Adverse reactions are listed below, by system organ class and by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so navedeni v nadaljevanju po organskih sistemih in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: Not known Febrile neutropenia
Slovenian: Neznana Febrilna nevtropenija
English: Since inflammation of the oral mucosa is a common side effect of this medicine, you should pay attention to adequate oral hygiene.
Slovenian: Ker je pogost neželeni učinek tega zdravila vnetje ustne sluznice, morate skrbeti za ustrezno ustno higieno.
English: With a median follow-up of 36 months (range, 4-73), the 5-year overall survival probability was 93% (95% CI 83-97%).
Slovenian: Pri medianem obdobju spremljanja 36 mesecev (razpon 4-73) je bila verjetnost 5-letnega skupnega preživetja 93 % (95 % IZ 83-97 %).
English: Treosulfan destroys the bone marrow cells and enables the transplant of new bone marrow cells which leads to the production of healthy blood cells.
Slovenian: Treosulfan uniči celice kostnega mozga in omogoči presaditev novih celic kostnega mozga, ki povzroči izdelavo zdravih krvničk.
English: In juvenile rat toxicity studies treosulfan induced slight retardation of physical development and a slightly delayed time-point of vaginal opening in females.
Slovenian: V študijah toksičnosti za mlade podgane je treosulfan povzročil rahlo zaostajanje telesnega razvoja in rahlo zakasnitev odprtja nožnice pri samicah.
English: Treosulfan has a broad antineoplastic and antileukaemic activity.
Slovenian: Treosulfan ima obsežno antineoplastično in antilevkemično aktivnost.
English: Oral mucositis (including high-grade severity) is a very common undesirable effect of treosulfan-based conditioning followed by alloHSCT (see section 4.8).
Slovenian: Oralni mukozitis (vključno z zelo težkim) je zelo pogost neželeni učinek kondicioniranja na podlagi treosulfana, ki mu sledi alloHSCT (glejte poglavje 4.8).
English: P value
Slovenian: Vrednost P
English: The effect of treosulfan on the pharmacokinetics of fludarabine is not known.
Slovenian: Vpliv treosulfana na farmakokinetiko fludarabina ni znan.
English: Therefore, nappies should be changed frequently up to 6-8 hours after each infusion of treosulfan.
Slovenian: Zato je treba do 6-8 ur po vsaki infuziji treosulfana pogosto menjavati plenice.
English: Although it cannot be proved that treosulfan was the cause, the use of clonazepam prophylaxis for children younger than 1 year might be considered.
Slovenian: Čeprav ni bilo mogoče dokazati, da je bil vzrok treosulfan, pride pri otrocih, mlajših od 1 leta, v poštev uporaba profilakse s klonazepamom.
English: After reconstitution with sodium chloride 4.5 mg/mL (0.45%) solution, chemical and physical stability has been demonstrated for 2 days at 25 °C.
Slovenian: Po rekonstituciji z raztopino natrijevega klorida 4,5 mg/ml (0,45 %) so dokazali kemijsko in fizikalno stabilnost za 2 dni pri 25 °C.
English: No patient experienced a primary graft failure but one patient with ALL experienced a secondary graft failure.
Slovenian: Noben bolnik ni imel primarne odpovedi presadka, pač pa je imel en bolnik z ALL sekundarno odpoved presadka.
English: This medicine may make you infertile and it may not be possible for you to get pregnant after treatment with it.
Slovenian: Zaradi tega zdravila lahko postanete neplodni in po končanem zdravljenju mogoče ne boste mogli zanositi.
English: Treosulfan might impair fertility in men and women.
Slovenian: Treosulfan lahko zmanjša plodnost pri moških in ženskah.
English: Do not store the reconstituted solution in a refrigerator (2 °C - 8 °C) as this might cause precipitation.
Slovenian: Rekonstituirane raztopine ne shranjujte v hladilniku (2 °C-8 °C), ker bi to lahko povzročilo precipitacijo.
English: Trecondi is available in packs of 1 or 5 vials.
Slovenian: Zdravilo Trecondi je na voljo v pakiranjih po 1 vialo ali 5 vial.
English: In addition, acidosis, skin toxicity, nausea, vomiting and gastritis may occur.
Slovenian: Poleg tega se lahko pojavijo acidoza, toksičnost za kožo, navzea, bruhanje in gastritis.
English: Treosulfan is given in combination with fludarabine, with thiotepa (intensified regimen; FT10-14TT regimen) or without thiotepa (FT10-14 regimen).
Slovenian: Treosulfan dajemo v kombinaciji s fludarabinom, s tiotepo (intenzivirana shema; shema FT10-14TT) ali brez tiotepe (shema FT10-14).
English: What Trecondi is and what it is used for What you need to know before you are given Trecondi How to use Trecondi
Slovenian: Kaj je zdravilo Trecondi in za kaj ga uporabljamo Kaj morate vedeti, preden vam bodo dali zdravilo Trecondi Kako uporabljati zdravilo Trecondi Možni neželeni učinki
English: • Hypersensitivity to the active substance
Slovenian: • preobčutljivost na učinkovino
English: For testing non-inferiority of treosulfan compared to busulfan.
Slovenian: Za preskus neinferiornosti treosulfana v primerjavi z busulfanom.