natgillin/translations-raw huggingface dataset:
The efficacy and safety of treosulfan-based conditioning was evaluated in 70 patients with acute lymphoblastic leukaemia (ALL), AML, MDS, or juvenile myelomonocytic leukaemia (JMML) who received a conditioning regimen with treosulfan and fludarabine with (n = 65) or without (n = 5) thiotepa (see section 4.2).
Djelotvornost i sigurnost kondicioniranja treosulfanom procijenjene su u 70 bolesnika s akutnom limfoblastičnom leukemijom (ALL), AML-om, MDS-om ili juvenilnom mijelomonocitnom leukemijom (JMML) kojima je primijenjen režim kondicioniranja treosulfanom i fludarabinom s tiotepom (n = 65) ili bez nje (n = 5) (vidjeti dio 4.2).
The active substance is treosulfan.
Djelatna tvar je treosulfan.
Therefore, nappies should be changed frequently during 6-8 hours after each dose of this medicine.
Stoga je tijekom 6 - 8 sati nakon svake doze ovog lijeka potrebno često mijenjati pelene.
As known for other alkylating conditioning agents treosulfan can cause ovarian suppression and amenorrhoea with menopausal symptoms in pre-menopausal women.
Kao što je poznato za druga alkilirajuća sredstva za kondicioniranje, treosulfan može prouzročiti supresiju jajnika i amenoreju sa simptomima menopauze u žena u predmenopauzi.
Remove the treosulfan powder carefully from the inner surface of the vial by shaking.
Protresanjem pažljivo ukonite prah treosulfana s unutarnje površine bočice.
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.
Spolno aktivni muškarci i žene reproduktivne dobi moraju primjenjivati učinkovitu kontracepciju tijekom liječenja te do 6 mjeseci nakon toga.
• bruising, low blood pressure
• modrice, nizak krvni tlak
Treosulfan is for intravenous use as a two-hour infusion.
Treosulfan je za intravensku primjenu kao dvosatna infuzija.
Profound myelosuppression/pancytopenia is the desired therapeutic effect of conditioning therapy and occurs in all patients.
Duboka mijelosupresija/pancitopenija željeni je učinak terapije kondicioniranja i događa se u svih bolesnika.
Dermatitis diaper may occur in small children because of excretion of treosulfan in the urine.
Pelenski dermatitis može se razviti u male djece zbog izlučivanja treosulfana u mokraći.
The European Medicines Agency has deferred the obligation to submit the results of a study with treosulfan-based conditioning in paediatric patients with non-malignant diseases (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja kondicioniranja treosulfanom u pedijatrijskoj populaciji s nemalignim bolestima (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
Under physiological conditions (pH 7.4, temperature 37 °C), the pharmacologically inactive treosulfan is converted spontaneously (non-enzymatically) into the active monoepoxide intermediate (S,S-EBDM = (2S,3S)-1,2-epoxybutane-3,4-diol-4-methanesulfonate) and finally to L-diepoxibutane (S,S-DEB = (2S,3S)-1,2:3,4-diepoxybutane).
U fiziološkim uvjetima (pH 7,4, temperatura 37 °C), farmakološki neaktivan treosulfan konvertira se spontano (ne-enzimski) u aktivni monoepoksidni intermedijer (S,S-EBDM = (2S,3S)-1,2-epoksibutan-3,4-diol-4-metansulfonat) i konačno u L-diepoksibutan (S,S-DEB = (2S,3S)-1,2:3,4-diepoksibutan).
There are no data from the use of treosulfan in pregnant women.
Nema podataka o primjeni treosulfana u trudnica.
Do not store the reconstituted solution in a refrigerator (2 °C - 8 °C) as this might cause precipitation.
Rekonstituiranu otopinu nemojte čuvati u hladnjaku (2 °C - 8 °C) jer to može prouzročiti taloženje.
Published literature data report on gonadotoxicity of treosulfan in pre-pubertal and pubertal male and female mice.
Objavljeni literaturni podaci ukazuju na gonadotoksičnost treosulfana u mužjaka i ženki miševa prije puberteta i u pubertetu.
Not known Septic shockc
Nepoznato septički šokc
This medicine is used in combination with fludarabine and in most cases also with thiotepa.
Ovaj lijek se daje u kombinaciji s fludarabinom te u većini slučajeva i s tiotepom.
Trecondi contains the active substance treosulfan, which belongs to a group of medicines called alkylating agents.
Trecondi sadrži djelatnu tvar treosulfan, koja spada u skupinu lijekova pod nazivom alkilirajući lijekovi.
• increased blood level of a liver enzyme (gamma-glutamyl transferase)
• povišena razina jetrenog enzima u krvi (gama glutamiltransferaze)
Since inflammation of the oral mucosa is a common side effect of this medicine, you should pay attention to adequate oral hygiene.
Budući da je upala sluznice usne šupljine česta nuspojava ovoga lijeka, morate posvetiti pažnju odgovarajućoj higijeni usne šupljine.
• less acid than normal in the blood (alkalosis), abnormal blood level of electrolytes, decreased blood level of magnesium
• manje kiseline u krvi nego što je to normalno (alkaloza), poremećene razine elektrolita u krvi, snižena razina magnezija u krvi
It is given by drip (infusion) into a vein over 2 hours for 3 days before blood stem cell infusion.
Daje se kapanjem (infuzijom) u venu u trajanju od 2 sata 3 dana prije infuzije matičnih krvnih stanica.
How much treosulfan contributes to their occurrence is unknown.
U kojoj mjeri treosulfan pridonosi njihovoj pojavi nije poznato.
The median (25%/75% percentiles) duration of neutropenia was 21 (16, 26) days in paediatric patients with malignant diseases and 24 (17, 26) days in patients with non-malignant disorders.
Medijan (25%/75% percentila) trajanja neutropenije iznosio je 21 (16, 26) dana u pedijatrijskih bolesnika s malignim bolestima i 24 (17, 26) dana u bolesnika s nemalignim poremećajima.
Treosulfan is a prodrug that is spontaneously converted under physiological conditions (pH 7.4; 37 °C) into a monoepoxide intermediate and L-diepoxybutane with a half-life of 2.2 hours.
Treosulfan je prolijek koji se u fiziološkim uvjetima (pH 7,4; 37 °C) spontano konvertira u monoepoksidni intermedijer i L-diepoksibutan s poluvijekom od 2,2 sata.
Common Decreased appetite
Često smanjen apetit
1 vial 5 vials
1 bočica 5 bočica
Gastrointestinal disorders were observed in 357 patients (63.3%).
Poremećaji probavnog sustava opaženi su u 357 bolesnika (63,3%).
The activity of treosulfan is due to the spontaneous conversion into a mono-epoxide intermediate and L-diepoxybutan (see section 5.2).
Za aktivnost treosulfana odgovorna je spontana konverzija u monoepoksidni intermedijer i L-diepoksibutan (vidjeti dio 5.2).
Therefore, men treated with treosulfan are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with treosulfan.
Stoga se muškarcima liječenim treosulfanom savjetuje da ne začinju dijete tijekom liječenja i do 6 mjeseci nakon toga, te da zbog moguće ireverzibilne neplodnosti izazvane terapijom treosulfanom potraže savjet o kriokonzervaciji sperme prije liječenja.
Not known Injection site reaction, feeling cold
Nepoznato reakcija na mjestu primjene, osjećaj hladnoće
The possible risk of a second malignancy should be explained to the patient.
Bolesniku je potrebno objasniti mogući rizik od pojave sekundarne maligne bolesti.
The overall survival at 12 months is 91.4% (90% CI 83.9-95.5%).
Ukupno preživljenje u 12. mjesecu bilo je 91,4% (90% CI 83,9 - 95,5%).
The total fludarabine dose is 150 mg/m²;
Ukupna doza fludarabina je 150 mg/m².
When handling treosulfan, inhalation, skin contact or contact with mucous membranes should be avoided (the use of adequate protective disposable gloves, goggles, gown and mask is recommended).
Pri rukovanju treosulfanom potrebno je izbjegavati udisanje, doticaj s kožom ili sluznicama (preporučuje se upotreba odgovarajućih jednokratnih zaštitnih rukavica, naočala, pregače i maske).
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution.
NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu nakon rekonstitucije.
The principal toxic effect of treosulfan is profound myeloablation and pancytopenia.
Glavni toksični učinak treosulfana jesu jaka mijeloablacija i pancitopenija.
Treosulfan is given in combination with fludarabine.
Treosulfan se daje u kombinaciji s fludarabinom.
Headache, peripheral sensory neuropathy
Rijetko glavobolja, periferna senzorna neuropatija
Transaminases (ALT/AST) increased, bilirubin increased
Često povišene transaminaze (ALT/AST), povišen bilirubin
Complete disease responses were observed in 28 patients (90%), as measured by clinical symptoms and laboratory assays (Burroughs LM et al., Biology of Blood and Marrow Transplantation 2014; 20(12):1996-2003).
Potpuni odgovor bolesti na liječenje, mjeren na temelju kliničkih simptoma i laboratorijskih testova (Burroughs LM et al., Biology of Blood and Marrow Transplantation 2014; 20(12):1996-2003), zabilježen je u 28 bolesnika (90%).
• Keep this leaflet.
 Sačuvajte ovu uputu.
Acute GvHD, all Grades; % (95% CI) 52.1 (45.5, 58.7) 58.8 (52.5, 65.0) 0.1276 Acute GvHD, Grades III/IV; % (95%
Akutni GvHD, svi stupnjevi; % (95% CI) 52,1 (45,5; 58,7) 58,8 (52,5; 65,0) 0,1276 Akutni GvHD, III./IV. stupanj; % (95%
• inflammation of the lung (pneumonitis) (adults: uncommon)
• upala pluća (pneumonitis) (odrasli: manje često).
For preparation of sodium chloride 4.5 mg/mL (0.45%) solution equivalent volumes of sodium chloride 9 mg/mL (0.9%) solution and water for injections can be mixed.
Za pripremu 0,45%-tne otopine natrijevog klorida (4,5 mg/ml) mogu se izmiješati jednaki volumeni 0,9%-tne otopine natrijevog klorida (9 mg/ml) i vode za injekcije.
• abnormal brain function (encephalopathy), bleeding in the brain, restless, repetitive, or involuntary movements and rapid speech (extrapyramidal disorder), fainting, sensation of tingling, pricking or numbness (paraesthesia)
• poremećena funkcija mozga (encefalopatija), krvarenje u mozgu, nemirni, ponavljajući ili nevoljni pokreti i brz govor (ekstrapiramidni poremećaj), nesvjestica, osjet peckanja, bockanja i utrnulosti (parestezija)
The adverse reactions reported in the table below are derived from two clinical trials (including a total of 88 patients; median age 8 years [range 0-17 years]) where treosulfan combined with fludarabine (and mostly with additional thiotepa) was administered as conditioning treatment prior to alloHSCT in paediatric patients with malignant or non-malignant diseases.
Nuspojave navedene u tablici ispod zabilježene su u dva klinička ispitivanja (uključivala su ukupno 88 bolesnika; medijan dobi bio je 8 godina [raspon od 0 do 17 godina]) u kojima je treosulfan u kombinaciji s fludarabinom (i u većini slučajeva s dodatnom tiotepom) bio primijenjen kao terapija kondicioniranja prije aloTKMS-a u pedijatrijskih bolesnika s malignim ili nemalignim bolestima.
Trained personnel should reconstitute the medicinal product.
Lijek treba rekonstituirati za to osposobljeno osoblje.
Oral mucositis (including high-grade severity) is a very common undesirable effect of treosulfan-based conditioning followed by alloHSCT (see section 4.8).
Oralni mukozitis (uključujući onaj visokog stupnja težine) vrlo je česta nuspojava kondicioniranja treosulfanom prije postupka aloTKMS (vidjeti dio 4.8).
The incidence of complete donor-type chimerism was 94.2% (90% CI 87.2-98.0%) at day +28 visit, 91.3% (90% CI 83.6-96.1%) at day +100 visit and 91.2% (90% CI 82.4-96.5%) at month 12 visit.
Incidencija potpunog davateljskog kimerizma bila je 94,2% (90% CI 87,2 - 98,0%) na kontroli +28. dan, 91,3% (90% CI 83,6 - 96,1%) na kontroli +100. dan i 91,2% (90% CI 82,4 - 96,5%) na kontroli u 12. mjesecu.
Nappy rash with ulceration of the area around the anus (perianal) may occur in infants, toddlers and children wearing nappies because treosulfan passed out in the urine can damage the skin.
Pelenski osip s ranicama u području oko čmara (perianalno) može se pojaviti u dojenčadi i male djece koja nose pelene jer treosulfan izlučen u mokraći može oštetiti kožu.
The most commonly observed adverse reactions (adults/paediatric patients) after treosulfan-based conditioning followed by alloHSCT include infections (13.1% /11.4%), gastrointestinal disorders (nausea [39.5%/30.7%], stomatitis [36.0%/69.3%], vomiting [22.5%/43.2%], diarrhoea [15.6%/33.0%], abdominal pain [10.4%/17%]), fatigue (15.1%/2.3%), febrile neutropenia (11.3%/1.1%), oedema (7.8%/0%), rash (7.2%/12.5%), and increases of alanine transaminase (ALT [5.1%/9.1%]), aspartate transaminase (AST [4.4%/8.0%]), gamma-glutamyl transferase (γGT [3.7%/2.3%]), and bilirubin (18.8%/5.7%).
Najčešće opažene nuspojave (odrasli/pedijatrijski bolesnici) nakon kondicioniranja treosulfanom, a prije postupka aloTKMS, uključuju infekcije (13,1%/11,4%), gastrointestinalne poremećaje (mučnina [39,5%/30,7%], stomatitis [36,0%/69,3%], povraćanje [22,5%/43,2%], proljev [15,6%/33,0%], bol u abdomenu [10,4%/17%]), umor (15,1%/2,3%), febrilnu neutropeniju (11,3%/1,1%), edem (7,8%/0%), osip (7,2%/12,5%) i povišenja alanin transaminaze (ALT [5,1%/9,1%]), aspartat transaminaze (AST [4,4%/8,0%]), gama glutamiltransferaze (GGT [3,7%/2,3%]) i bilirubina (18,8%/5,7%).
The median (25%/75% percentiles) duration of neutropenia was 14 (12, 20) days with the 10 g/m² treosulfan dose and 17.5 (14, 21) days with the 14 g/m² treosulfan dose.
Medijan (25%/75% percentila) trajanja neutropenije iznosio je 14 (12, 20) dana pri dozi treosulfana od 10 g/m² i 17,5 (14, 21) dana pri dozi treosulfana od 14 g/m².
Secondary malignancies
Sekundarne maligne bolesti
Acidosisb, glucose tolerance impaired, electrolyte imbalance
Nepoznato acidozab, oštećena tolerancija glukoze, neravnoteža elektrolita
weight gain, weight loss
gubitak težine
Not known Veno-occlusive liver disease
Nepoznato veno-okluzivna bolest jetre
• blockage of a blood vessel (embolism), bleeding
• začepljenje krvne žile (embolija), krvarenje
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.
Nakon rekonstitucije s 0,45%-tnom otopinom natrijevog klorida (4,5 mg/ml), kemijska i fizikalna stabilnost dokazana je u trajanju od 2 dana pri 25 °C.
Common (may affect up to 1 in 10 people)
Često (može se pojaviti u do 1 na 10 osoba)
Therefore, dosing of treosulfan in paediatric patients has to be adapted to the BSA (see section 4.2).
Stoga je doziranje treosulfana u pedijatrijskih bolesnika potrebno prilagoditi njihovoj tjelesnoj površini (vidjeti dio 4.2).
No specific antidote of treosulfan overdose is known.
Nije poznat specifični antidot za predoziranje treosulfanom.
In one study, 31 NMD patients were treated with the FT14 regimen plus anti-thymocyte globulin.
U jednom ispitivanju skupina od 31 bolesnika s nemalignim poremećajem liječena je režimom FT14 i antitimocitnim globulinom.
• If you have any further questions, ask your doctor, pharmacist or nurse.
 Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
• increased blood level of creatinine (a substance normally removed by the kidneys into the urine), increased blood level of lactate dehydrogenase (a substance that indicates tissue or cellular damage)
• povišena razina kreatinina u krvi (tvar koju normalno uklanjaju bubrezi u mokraću), povišena razina laktat dehidrogenaze u krvi (tvar koja ukazuje na oštećenje tkiva ili stanica)
If possible it is recommended to work on a special safety workbench, equipped with laminar flow, with liquid-impermeable, absorbent disposable foil.
Može se preporučiti rad na posebnom sigurnosnom radnom stolu opremljenom laminarnim protokom te s vodonepropusnom, upijajućom jednokratnom folijom.
The recommended dose is 10-14 g/m² body surface area.
Preporučena doza je od 10 do 14 g/m² tjelesne površine.
Analyses of EFS at 2 years for various pre-defined subgroups (donor type, risk group, disease, age group, HCT-CI score, remission status at study entry, and various combinations of these parameters) were always in favour of the treosulfan regimen (hazard ratio [HR] of FT10 vs. FB2 < 1), with only one exception (risk group I of MDS patients; HR 1.14 [95% CI 0.48, 2.63]).
Analize EFS-a nakon 2 godine provedene za različite unaprijed definirane podskupine (tip davatelja, rizična skupina, bolest, dobna skupina, rezultat HCT-CI, status remisije kod uključivanja u ispitivanje i različite kombinacije tih parametara) bile su uvijek u prilog režimu treosulfana (omjer hazarda [HR] od FT10 naspram FB2 < 1), sa samo jednom iznimkom (rizična skupina I bolesnika s MDS-om; HR 1,14 [95% CI 0,48; 2,63]).
Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with malignant and non-malignant diseases, and in paediatric patients older than one month with malignant diseases.
Treosulfan u kombinaciji s fludarabinom indiciran je kao dio terapije kondicioniranja prije alogene transplantacije krvotvornih matičnih stanica (aloTKMS) u odraslih bolesnika s malignom i nemalignom bolešću te pedijatrijskih bolesnika starijih od jednog mjeseca s malignom bolešću.
The main indications for an alloHSCT with treosulfan conditioning in adult NMD patients are haemoglobinopathies (e.g. sickle cell disease, thalassaemia major [TM]), primary immune deficiency, hemophagocytic disorder, immune dysregulatory disorder and bone marrow failure).
Glavna indikacija za aloTKMS s kondicioniranjem treosulfanom u odraslih bolesnika s nemalignim poremećajima jesu hemoglobinopatije (npr. bolest srpastih stanica, talasemija major), primarna imunodeficijencija, hemofagocitni poremećaj, imunološka disregulacija i zatajenje koštane srži.
When reconstituted according to section 6.6, 1 mL of the solution for infusion contains 50 mg treosulfan.
Kada se rekonstituira kako je opisano u dijelu 6.6, 1 ml otopine za infuziju sadrži 50 mg treosulfana.
Treosulfan is given in combination with fludarabine with or without thiotepa.
Treosulfan se daje u kombinaciji s fludarabinom, s tiotepom ili bez nje.
• pain or inflammation at the injection site, feeling cold
• bol ili upala na mjestu primjene infuzije, osjećaj hladnoće
How Trecondi is given
Kako se daje Trecondi
The immunosuppressive effects of treosulfan are attributed to its toxicity against primitive and committed progenitor cells, T and NK cells, reduction of cellularity of primary and secondary lymphatic organs and a preclusive effect on the ‘cytokine storm' that precedes the development of Graft-versus-Host-Disease (GvHD) and is involved in the pathogenesis of veno-occlusive disease.
Imunosupresivni učinci treosulfana pripisuju se njegovoj toksičnosti protiv primitivnih i usmjerenih prastanica, T i NK stanica, smanjenju celularnosti primarnih i sekundarnih limfnih organa i prekluzivnom učinku na „citokinsku oluju“ koja prethodi razvoju bolesti presatka protiv primatelja (engl.
In the pivotal phase III trial, adult patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) and increased risk for standard conditioning therapies because of higher age (≥ 50 years) or comorbidities (haematopoietic cell transplantation comorbidity index [HCT-CI] score > 2) were randomised to receive a conditioning regimen with 3 × 10 g/m² treosulfan combined with fludarabine (FT10; n = 220) or a regimen of intravenous busulfan (total dose 6.4 mg/kg) combined with fludarabine (FB2; n = 240), followed by alloHSCT.
U ključnom ispitivanju faze III, odrasli bolesnici s akutnom mijeloičnom leukemijom (AML) ili mijelodisplastičnim sindromom (MDS) i povećanim rizikom za standardne terapije kondicioniranja zbog starije dobi (≥ 50 godina) ili komorbiditeta (rezultat indeksa komorbiditeta transplantacije krvotvornih stanica [engl. haematopoietic cell transplantation comorbidity index, HCT-CI] > 2) bili su randomizirani u skupinu koja je primala režim kondicioniranja treosulfanom 3 × 10 g/m² u kombinaciji s fludarabinom (FT10; n = 220) ili režim intravenskog busulfana (ukupna doza 6,4 mg/kg) u kombinaciji s fludarabinom (FB2; n = 240), nakon čega je slijedio postupak aloTKMS.
To avoid solubility problems, warm the solvent, sodium chloride 4.5 mg/mL (0.45%) solution, to 25 °C - 30 °C (not higher), for example by using a water bath.
Kako bi se izbjegli problemi s topljivošću, zagrijte otapalo, 0,45%-tnu otopinu natrijevog klorida (4,5 mg/ml), na temperaturu 25 °C - 30 °C (ne višu), upotrebom primjerice vodene kupelji.
• sudden decrease of kidney function, blood in the urine
• naglo smanjenje bubrežne funkcije, krv u mokraći
Administration of treosulfan should be supervised by a physician experienced in conditioning treatment followed by alloHSCT.
Primjenu treosulfana treba nadzirati liječnik s iskustvom u terapiji kondicioniranja prije provedbe aloTKMS-a.
• Hypersensitivity to the active substance
• Preosjetljivost na djelatnu tvar.
• retention of fluid in the body causing swelling (oedema), fever, chills
• zadržavanje tekućine u tijelu koje uzrokuje oticanje (edem), vrućica, zimica
Use of mucositis prophylaxis (e.g. topical antimicrobials, barrier protectants, ice and adequate oral hygiene) is recommended.
Preporučuje se profilaksa mukozitisa (npr. topikalni antimikrobni lijekovi, mukoprotektivi, led i odgovarajuća oralna higijena).
Adults with non-malignant disease
Odrasli s nemalignom bolešću
Prophylactic use of mouthwashes (e.g. with barrier protectants, antimicrobials) or application of ice within the oral cavity (lessens blood flow to the oral mucosa and reduces the amount of treosulfan reaching the cell) is recommended.
Preporučuje se profilaktička upotreba vodica za ispiranje usta (npr. s mukoprotektivima, s tvarima protiv mikroba) ili primjena leda u usnoj šupljini (smanjuje dotok krvi u sluznicu usne šupljine i smanjuje količinu treosulfana koja dospijeva u stanicu).
Therefore, nappies should be changed frequently up to 6-8 hours after each infusion of treosulfan.
Stoga je tijekom 6 - 8 sati nakon svake infuzije treosulfana potrebno često mijenjati pelene.
Detailed in vitro studies did not completely exclude potential interactions between high plasma concentrations of treosulfan and CYP3A4, CYP2C19, or P-gp substrates.
Na temelju detaljnih ispitivanja in vitro potencijalne interakcije visokih koncentracija treosulfana u plazmi i supstrata CYP3A4, CYP2C19 ili P-gp-a nisu potpuno isključene.
Muscular weakness
• mišićna slabost
The frequencies of adverse reactions reported in the table below are derived from 5 clinical trials (including a total of 564 patients) where treosulfan combined with fludarabine was investigated as conditioning treatment prior to alloHSCT in adult patients.
Učestalosti nuspojava navedenih u tablici u nastavku zabilježene su u 5 kliničkih ispitivanja (uključivala su ukupno 564 bolesnika) u kojima je treosulfan u kombinaciji s fludarabinom ispitivan kao terapija kondicioniranja prije aloTKMS-a u odraslih bolesnika.
It is unknown whether treosulfan is excreted in human milk.
Nije poznato izlučuje li se treosulfan u majčino mlijeko.
If this happens, vigorously shake the vial to redissolve the cake.
Ako se to dogodi, energično tresite bočicu dok se zgrudani prah ne otopi.
Blood creatinine increased, blood lactate dehydrogenase (LDH) increased
Nepoznato povišen kreatinin u krvi, povišena laktat dehidrogenaza (LDH) u krvi
Precautions to be taken before handling or administering the medicinal product When handling treosulfan, inhalation, skin contact or contact with mucous membranes should be avoided.
Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka Pri rukovanju treosulfanom potrebno je izbjegavati njegovo udisanje, doticaj s kožom ili sluznicama.
Nervous system disorders* Not known Headache, paraesthesia, seizure
Poremećaji živčanog sustava* Nepoznato glavobolja, parestezija, napadaj
The recommended dose is 10-14 g/m² body surface area (calculated using your height and weight).
Preporučena doza je 10 - 14 g/m² tjelesne površine (izračuna se na temelju
• redness of scrotal skin
• crvenilo kože mošnji
Blood and lymphatic system disorders*
Poremećaji krvi i limfnog sustava*
Very common Bilirubin increased
Vrlo često povišen bilirubin
Myelosuppression, pancytopenia, febrile neutropenia
Vrlo često mijelosupresija, pancitopenija, febrilna neutropenija