FrancophonIA/ELRC3.0 huggingface dataset:
English: More extensive bleeding in joints, muscle bleeding or haematoma
Croatian: Krvarenje u zglobove većeg opsega, krvarenje u mišić ili hematom.
English: Special precautions for disposal and other handling
Croatian: Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.* Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.
English: Early signs of bleeding in joints, muscle bleeding or oral bleeding
Croatian: Rani znakovi krvarenja u zglobove, mišićno krvarenje ili krvarenje u usnu šupljinu
English: Tilt the product vial when transferring the solvent to allow the solvent to flow down the side of the vial.
Croatian: Nagnite bočicu s lijekom prilikom prijenosa otapala kako biste omogućili otapalu da se slijeva niz stijenke bočice.
English: Adverse reaction (PT)
Croatian: Nuspojava (preporučeni pojam)
English: The adverse reaction flushing is reported in a clinical trial.
Croatian: Tijekom kliničkog ispitivanja opažena je nuspojava navale crvenila.
English: Dissolving the powder
Croatian: Otapanje praška
English: On demand treatment
Croatian: Liječenje po potrebi
English: Prophylaxis
Croatian: Profilaksa
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Bolesnike treba upoznati s ranim znakovima reakcija preosjetljivosti uključujući koprivnjaču, generaliziranu utikariju, stezanje u prsištu, piskanje pri disnaju, hipotenziju i anafilaksiju.
English: Major surgery
Croatian: Veći kirurški zahvati
English: Sodium chloride Sucrose
Croatian: Natrijev klorid saharoza histidin.
English: VIAL OF SOLVENT 5 ml VIAL OF SOLVENT 10 ml
Croatian: BOČICA S 5 ml OTAPALA BOČICA S 10 ml OTAPALA
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Croatian: Bolesnici s hemofilijom B mogu razviti neutralizirajuća protutijela (inhibitore) na faktor IX. U slučaju pojave inhibitora stanje će se pokazati kao nedostatan klinički odgovor.
English: Haemorrhage
Croatian: Doziranje
English: For reconstitution of Nonafact.
Croatian: Za pripremu lijeka Nonafact.
English: Allergic type hypersensitivity reactions are possible with Nonafact The product contains traces of mouse proteins.
Croatian: Moguće su reakcije preosjetljivosti alergijskog tipa s lijekom Nonafact.
English: Nonafact contains approximately 500 or 1000 IU (100 IU/ml) of human coagulation factor IX after reconstitution.
Croatian: - Djelatna tvar je ljudski koagulacijski faktor IX. Svaka bočica sadrži 500 IU ili 1000 IU ljudskog koagulacijskog faktora IX. Nonafact sadrži 100 IU po ml nakon rekonstitucije s vodom za injekcije.
English: Early haemarthrosis, muscle bleeding or oral bleeding
Croatian: Rano krvarenje u zglobove, krvarenje u mišić ili krvarenje u usnoj šupljini
English: B. PACKAGE LEAFLET
Croatian: Tablični sažetak nuspojava
English: • A vial water for injections containing 5 ml or 10 ml
Croatian: • Bočicu koja sadrži 5 ml ili 10 ml vode za injekcije Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Sanquin Plasma Products B.V.
English: MA (EU) Number (Invented) name
Croatian: EMA broj postupka
English: 1 vial
Croatian: Put primjene
English: Pack size
Croatian: Unutarnje pakovanje
English: Content (concentration)
Croatian: Sastav
English: 5 vials
Croatian: 5 bočice
English: At the recommended dose, this is the desired effect.
Croatian: Pri preporučenoj dozi to je željeni učinak.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka)
English: • allergic reactions
Croatian: • alergijske reakcije
English: None of these cases were fatal or life-threatening.
Croatian: Nijedan od tih slučajeva nije imao smrtni ishod ili bio životno opasan.
English: If extravasation is suspected, general safety measures should be implemented.
Croatian: Ako se sumnja na ekstravazaciju, potrebno je uvesti opće mjere sigurnosti.
English: If you are affected, do not drive or use machines.
Croatian: Ako Vam se to dogodi, nemojte voziti ni upravljati strojevima.
English: No specific measure has been proven to be recommendable.
Croatian: Nije dokazana nikakva specifična mjera koja bi mogla poslužiti kao preporuka.
English: DNA (which carries your genetic information),  if you are pregnant, or think you may be pregnant.
Croatian: DNK (koja nosi Vaše genetske informacije)  ako ste trudni ili mislite da biste mogli biti trudni.
English: This medicine will be given to you by your doctor.
Croatian: Ovaj lijek primijenit će Vam liječnik.
English: No dose adjustment is necessary in any subset of the elderly population.
Croatian: Prilagodba doze nije potrebna ni u jednoj podskupini starije populacije.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}>.
English: System Organ Class (SOC)
Croatian: Klasifikacija organskih sustava (SOC)
English: Eleven patients had a relapse/progression.
Croatian: Jedanaest bolesnika imalo je recidiv/progresiju.
English: Use an effective method of contraception when either you or your partner is receiving this medicine.
Croatian: Primjenjujte učinkovite metode kontracepcije kada Vi ili Vaš partner/partnerica primate ovaj lijek.
English: Further results are shown in Table 1.
Croatian: Daljnji rezultati prikazani su u tablici 1.
English: This medicine contains no other ingredients.
Croatian: Ovaj lijek ne sadrži druge sastojke.
English: What you need to know before you are given Trecondi
Croatian: Što morate znati prije nego što primite Trecondi
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući bezreceptne lijekove.
English: • problems sleeping (insomnia)
Croatian: • teškoće sa spavanjem (nesanica)
English: This procedure is very important, because moistening of powder that sticks to the surface results in caking.
Croatian: Taj je postupak vrlo važan, jer vlaženje praška koji se zalijepi za površinu rezultira zgrudnjavanjem.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, osim ako metoda rekonstitucije sprječava rizik od kontaminacije mikrobima, lijek treba primijeniti odmah.
English: Children younger than 1 year may have more severe side effects that affect breathing than older ones.
Croatian: Djeca mlađa od 1 godine mogu imati teže nuspojave koje utječu na disanje nego starija djeca.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika.
English: Results of GvHD are shown in Table 2.
Croatian: Rezultati GvHD-a prikazani su u tablici 2.
English: Other medicines and Trecondi
Croatian: Drugi lijekovi i Trecondi
English: The two-year projected overall survival was 90%.
Croatian: Projekcija dvogodišnjeg ukupnog preživljenja iznosila je 90%.
English: 64% of patients had AML and 36% MDS.
Croatian: Među bolesnicima 64% je imalo AML, a 36% MDS.
English: Non-inferiority of FT10 versus the reference FB2 was statistically proven (Figure 1).
Croatian: Neinferiornost FT10 naspram referentnog FB2 bila je statistički dokazana (slika 1).
English: Contents of the pack and other information What Trecondi contains
Croatian: Sadržaj pakiranja i druge informacije Što Trecondi sadrži
English: However, if you think you have received more of this medicine than you should, tell your doctor or nurse as soon as possible.
Croatian: Međutim, ako mislite da ste primili više lijeka nego što je trebalo, kažite to liječniku ili medicinskoj sestri što prije.
English: However, an approximately 3-fold higher exposure in brain tissue of juvenile rats in comparison to young adults was found.
Croatian: Međutim, ustanovljena je približno 3 puta veća izloženost u tkivu mozga juvenilnih štakora u usporedbi s mlađim odraslim štakorima.
English: The volume of distribution in adult patients is about 20-30 litres.
Croatian: U odraslih bolesnika volumen distribucije je oko 20 - 30 litara.
English: • Active non-controlled infectious disease
Croatian: • Aktivna nekontrolirana zarazna bolest.
English: Large bore needles are recommended to minimise pressure and the possible formation of aerosols.
Croatian: Igle većeg promjera preporučuju se kako bi se minimizirao tlak i moguće stvaranje aerosola.
English: What Trecondi is and what it is used for
Croatian: Što je Trecondi i za što se koristi
English: The primary endpoint of this study was event-free survival (EFS) after 2 years.
Croatian: Primarna mjera ishoda ovog ispitivanja bilo je preživljenje bez događaja (engl. event-free survival, EFS) nakon 2 godine.
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.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
English: Trecondi may increase the risk of having another cancer in the future.
Croatian: Trecondi može povećati rizik od pojave druge vrste raka u budućnosti.
English: Intravenous application should be performed using a safe technique.
Croatian: Intravensku primjenu treba provesti sigurnom tehnikom.
English: Intravenous administration should be performed using a safe technique to avoid extravasation (see section 4.4).
Croatian: Intravensku primjenu treba provesti sigurnom tehnikom kako bi se izbjegla ekstravazacija (vidjeti dio 4.4).
English: • high blood sugar level
Croatian: • visoka razina šećera u krvi
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Croatian: Ako ste zabrinuti hoćete li moći imati djece, trebate o tome razgovarati s liječnikom prije liječenja.
English: If you were given more Trecondi than you should Because this medicine is given by a doctor, you will be given the correct dose.
Croatian: Ako ste primili više lijeka Trecondi nego što ste trebali Budući da Vam ovaj lijek daje liječnik, primit ćete točnu dozu.
English: A total of 7 of the 70 patients (10.0%) died, two patients because of relapse/progression, three patients transplant-related and two further patients for other reasons.
Croatian: Umrlo je ukupno 7 od 70 bolesnika (10,0%), dva bolesnika zbog recidiva/progresije, tri bolesnika zbog uzroka povezanog s transplantatom, a dva dodatna bolesnika zbog drugih razloga.
English: No difference in terms of outcome was observed between children and adults (Bernardo ME et al.; Blood 2012; 120(2):473-6).
Croatian: Nije opažena razlika između djece i odraslih u pogledu ishoda (Bernardo ME et al.; Blood 2012; 120(2):473-6).
English: This medicine can cause nausea, vomiting and dizziness which may reduce your ability to drive or use machines.
Croatian: Ovaj lijek može prouzročiti mučninu, povraćanje i omaglicu što Vam može smanjiti sposobnost upravljanja vozilima ili strojevima.
English: The treosulfan concentrations in brain tissue were 95%-98% lower than in plasma.
Croatian: Koncentracije treosulfana u tkivu mozga bile su 95% - 98% niže od onih u plazmi.
English: Seizure in the context of an encephalitis infection was reported in one of 88 paediatric patients.
Croatian: Napadaj u kontekstu infektivnog encefalitisa zabilježen je u jednog od 88 pedijatrijskih bolesnika.
English: The recommended dose and schedule of administration is:
Croatian: Preporučena doza i raspored primjene:
English: The safety and efficacy of treosulfan in children less than 1 month of age has not yet been established.
Croatian: Sigurnost i djelotvornost treosulfana u djece u dobi manjoj od 1 mjeseca nisu još ustanovljene.
English: The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.
Croatian: Hematološki status treba pomno pratiti i uvesti intenzivne potporne mjere kako je medicinski indicirano.
English: Fax:
Croatian: Faks:
English: Treosulfan is considered an irritant.
Croatian: Treosulfan se smatra iritansom.
English: • pain in arms or legs
Croatian: • bol u rukama ili nogama
English: Juvenile animal studies
Croatian: Ispitivanja u juvenilnih životinja
English: Solutions showing any sign of precipitation should not be used.
Croatian: Otopine koje pokazuju bilo kakve znakove taloženja ne smiju se upotrijebiti.
English: Events were defined as relapse of disease, graft failure or death (whatever occurred first).
Croatian: Događaji su definirani kao recidiv bolesti, zatajenje presatka ili smrt (štogod je nastupilo prije).
English: The most serious side effects of treosulfan therapy or the transplant procedure include:
Croatian: Najozbiljnije nuspojave terapije treosulfanom ili postupka transplantacije uključuju:
English: Fits (seizures) may occur very rarely in infants of less than 4 months of age.
Croatian: Napadaji (konvulzije) mogu se pojaviti vrlo rijetko u dojenčadi mlađe od 4 mjeseca.
English: Treosulfan does not bind to plasma proteins.
Croatian: Treosulfan se ne veže za proteine plazme.
English: Table 1: Treatment results at 24 months (Full analysis set) Parameter
Croatian: Tablica 1: Rezultati liječenja u 24. mjesecu (potpuni skup podataka za analizu) Parametar
English: Trecondi is available in packs of 1 or 5 vials.
Croatian: Trecondi je dostupan u pakiranjima od 1 ili 5 bočica.
English: Body surface area (m²) Treosulfan dose (g/m²)
Croatian: Tjelesna površina (m²) Doza treosulfana (g/m²)
English: The overall incidence of infections in 88 paediatric patients was 11.4% (10/88) and thus comparable to that seen in adults.
Croatian: Ukupna incidencija infekcija u 88 pedijatrijskih bolesnika bila je 11,4% (10/88), što znači usporediva s onom u odraslih.
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)
Croatian: EU/1/18/1351/001 (1 g, 1 bočica) EU/1/18/1351/002 (1 g, 5 bočica) EU/1/18/1351/003 (5 g, 1 bočica) EU/1/18/1351/004 (5 g, 5 bočica)
English: Plasma concentrations of treosulfan decline exponentially and are best described by a first order elimination process fitted by a two-compartment model.
Croatian: Koncentracije treosulfana u plazmi opadaju eksponencijalno i najbolje ih opisuje proces eliminacije prvog reda podešen modelom s dva odjeljka.
English: a Adjusted for donor type as factor, and risk group and centre as strata using Cox regression model.
Croatian: Prilagođeno za tip davatelja kao čimbenik i rizičnu skupinu i centar kao slojeve primjenom Coxovog regresijskog modela.
English: The most frequent adverse reaction was febrile neutropenia (11.3%).
Croatian: Najčešća nuspojava bila je febrilna neutropenija (11,3%).
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.
Croatian: Ostatke lijeka kao i sav pribor upotrijebljen za rekonstituciju i primjenu treba uništiti prema standardnim postupcima koji se primjenjuju za antineoplastične lijekove, poštujući postojeće zakone u pogledu odlaganja opasnog otpada.
English: Instructions for reconstitution of treosulfan:
Croatian: Upute za rekonstituciju treosulfana:
English: You should stop breast-feeding before starting treatment with this medicine.
Croatian: Morate prestati dojiti prije nego što započnete liječenje ovim lijekom.
English: The most frequent type was lung infection (12/74 [16.2%]).
Croatian: Najčešća vrsta bila je infekcija pluća (12/74 [16,2%]).
English: Treosulfan is rapidly distributed in the body; however, its penetration through the blood-brain-barrier is quite limited (see section 5.3).
Croatian: Treosulfan se brzo raspodjeljuje u tijelu; međutim, njegov prolaz kroz krvno-moždanu barijeru prilično je ograničen (vidjeti dio 5.3).
English: Table 2: Cumulative incidence of GvHD (Full analysis set) Parameter
Croatian: Tablica 2: Kumulativna incidencija GvHD-a (potpuni skup podataka za analizu) Parametar
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.
Croatian: Nakon dugoročne terapije konvencionalnim dozama oralnog treosulfana u bolesnika sa solidnim tumorima, akutna mijeloična leukemija opažena je u 1,4% od 553 bolesnika.
English: The overall incidence of infections was 13.1% (74/564).
Croatian: Ukupna incidencija infekcija bila je 13,1% (74/564).
English: Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „EXP“ (rok valjanosti).
English: Reconstituted solutions of treosulfan may be combined into a larger glass vial, PVC bag or PE bag.
Croatian: Rekonstituirane otopine treosulfana mogu se zajedno dodati u veću staklenu bočicu, PVC vrećicu ili PE vrećicu.
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).
Croatian: Nuspojave su navedene ispod, prema klasifikaciji organskih sustava i učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Blood disorders were observed in 67 of 564 adult patients (11.9%).
Croatian: Poremećaji krvi opaženi su u 67 od 564 odrasla bolesnika (11,9%).
English: Guidelines for the safe disposal of antineoplastic agents must be observed.
Croatian: Treba se pridržavati smjernica za sigurno zbrinjavanje antineoplastičnih lijekova.
English: Treosulfan is contraindicated during pregnancy (see section 4.3).
Croatian: Treosulfan je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: Cumulative incidence of relapse/progression; % (95% CI)
Croatian: Kumulativna incidencija recidiva/progresije; % (95% CI)
English: However, during chronic toxicity tests in rats spermatogenesis and ovarian function were significantly affected.
Croatian: Međutim, tijekom testova kronične toksičnosti u štakora, spermatogeneza i funkcija jajnika bile su značajno oštećene.
English: Treosulfan is reconstituted in its original glass container.
Croatian: Treosulfan se rekonstituira u svom originalnom staklenom spremniku.
English: The overall incidence of veno-occlusive liver disease (VOD) was 0.9% (5/564).
Croatian: Ukupna incidencija veno-okluzivne bolesti jetre bila je 0,9% (5/564).
English: Treosulfan has mutagenic and carcinogenic potential.
Croatian: Treosulfan ima mutageni i kancerogeni potencijal.
English: Figure 1: Kaplan-Meier estimates of event-free survival (Full Analysis Set)
Croatian: Slika 1: Kaplan-Meierove procjene preživljenja bez događaja (potpuni skup podataka za analizu)
English: A list of all other side effects is set out below according to how common they are.
Croatian: Popis svih drugih nuspojava naveden je ispod prema tome koliko su te nuspojave česte.
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.
Croatian: Kontaminirane dijelove tijela treba pažljivo isprati vodom i sapunom, oči treba isprati 0,9%-tnom otopinom natrijevog klorida (9 mg/ml).
English: Cumulative incidence of transplant-related mortality; % (95% CI) a Based on Kaplan-Meier estimates; b adjusted for donor type, risk group and centre using Cox regression model
Croatian: Kumulativna incidencija smrtnosti povezane s transplantacijom; % (95% CI) a Na temelju Kaplan-Meierovih procjena; b prilagođeno za tip davatelja, rizičnu skupinu i centar primjenom Coxovog regresijskog modela.
English: • changes and abnormalities in heart rhythm (heartbeat is irregular, too fast or too slow)
Croatian: • promjene i poremećaji u srčanom ritmu (otkucaji srca su nepravilni, prebrzi ili prespori)
English: • infections caused by bacteria, viruses and fungi (all patients: very common)
Croatian: • infekcije prouzročene bakterijama, virusima i gljivicama (svi bolesnici: vrlo često)
English: Rare Epistaxis, pneumonitis
Croatian: Rijetko epistaksa, pneumonitis
English: Therefore, treosulfan is unlikely to participate in, or contribute to, potential CYP450-mediated interactions in vivo.
Croatian: Stoga nije vjerojatno da će treosulfan sudjelovati ili pridonijeti potencijalnim interakcijama posredovanim enzimima CYP450 in vivo.
English: Mean apparent terminal half-life of treosulfan was comparable between the different age groups and ranged between 1.3 and 1.6 hours.
Croatian: Srednja vrijednost prividnog terminalnog poluvijeka treosulfana bila je usporediva među različitim dobnim skupinama i imala je raspon od 1,3 do 1,6 sati.
English: It is likely that certain adverse reactions of treosulfan like nausea, vomiting or dizziness could affect these functions.
Croatian: Moguće je da će određene nuspojave treosulfana kao što su mučnina, povraćanje ili omaglica utjecati na te funkcije.
English: You will have regular blood tests during treatment to check your blood cell counts do not fall too low.
Croatian: Tijekom liječenja redovito će Vam provoditi krvne pretrage radi provjere da Vam vrijednosti krvne slike nisu postale preniske.
English: Use Luer-lock fittings on all syringes and sets.
Croatian: Na svim štrcaljkama i kompletima upotrijebite luer-lock nastavke.
English: After intravenous administration, peak plasma levels are reached at the end of the infusion time.
Croatian: Nakon intravenske primjene vršne razine u plazmi dosegnute su na kraju trajanja infuzije.
English: For storage conditions after reconstitution of the medicine, see the information below for healthcare professionals.
Croatian: Za uvjete čuvanja nakon rekonstitucije lijeka pogledajte informacije za zdravstvene radnike u nastavku.
English: • a type of rash with red spots and sometimes with purple or blistered areas in the centre
Croatian: • vrsta osipa s crvenim mrljama i katkad s ljubičastim ili mjehurićastim područjem u sredini
English: Concomitant use of live attenuated vaccines is not recommended.
Croatian: Ne preporučuje se istodobna primjena živih atenuiranih cjepiva.
English: It is therefore recommended to monitor blood cell counts frequently until recovery of the haematopoietic system.
Croatian: Stoga se preporučuje često pratiti krvnu sliku, sve do oporavka krvotvornog sustava.
English: • Fanconi anaemia and other DNA breakage repair disorders
Croatian: • Fanconijeva anemija i drugi poremećaji popravka DNK.
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%]).
Croatian: Učestalost je bila veća u pedijatrijskoj dobnoj skupini od 12 do 17 godina (6/35 [17,1%]) nego u mlađe djece (4/53 [7,5%]).
English: A report from an investigator-initiated trial performed in children with primary immunodeficiencies lists four cases of seizures occurring after other treosulfan-based conditioning regimens (see section 4.4).
Croatian: Izvještaj iz ispitivanja koje je pokrenuo ispitivač, a provedeno je u djece s primarnim imunodeficijencijama, navodi četiri slučaja napadaja koja su se dogodila nakon drugih režima kondicioniranja treosulfanom (vidjeti dio 4.4).