natgillin/translations-raw huggingface dataset:
The lowest frequencies of these adverse reactions were seen with the dose regimen of 10 g/m² per day, day -4 to -2 (20.4%, 30.3%, 13.1%, 5.0%, and 5.5% respectively).
10 g/m² na dan od dneva -4 do -2 (20,4 %, 30,3 %, 13,1 %, 5,0 % oziroma 5,5 %).
The principal toxic effect of treosulfan is profound myeloablation and pancytopenia.
Glavni toksični učinek treosulfana je močna mieloablacija in pancitopenija.
Immune system disorders*
Bolezni imunskega sistema*
Headache, peripheral sensory neuropathy
Glavobol, periferna senzorična nevropatija
* See detailed sections below a Case reports (> 1) after treosulfan-based conditioning obtained from other sources b Bronze pigmentation c Fever in the absence of neutropenia where neutropenia is defined as ANC < 1.0 x 109/L
* Glejte podrobna poglavja v nadaljevanju a Poročila o primeru (> 1) po kondicioniranju na podlagi treosulfana, pridobljena iz drugih virov b Bronasta pigmentiranost c Zvišana telesna temperatura v odsotnosti nevtropenije, kjer je nevtropenija definirana kot
A few further cases of second malignancies after treosulfan-based conditioning have been reported by other investigators.
Drugi raziskovalci so poročali še o nekaj primerih drugih malignih bolezni po kondicioniranju na podlagi treosulfana.
Men should seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility.
Moški naj se posvetujejo o možnosti zamrznitve sperme pred začetkom zdravljenja, ker obstaja možnost nepovratne neplodnosti.
Contents of the pack and other information
Shranjevanje zdravila Trecondi Vsebina pakiranja in dodatne informacije
Grade 3-4 Adverse Reactions / Frequency
Neželeni učinki stopnje 3-4 /
Approximately 25-40% of the treosulfan dose is excreted unchanged with the urine within 24 hours, nearly 90% of which within the first 6 hours after administration.
Približno 25-40 % odmerka treosulfana se izloči v nespremenjeni obliki z urinom v 24 urah, od tega skoraj
The latter may also be reduced by the use of a venting needle.
Nastajanje aerosolov se lahko zmanjša tudi z uporabo igel z odzračevanjem.
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.
Ogrejte vehikel, raztopino natrijevega klorida 4,5 mg/ml (0,45 %), na 25 °C - 30 °C (ne pa na višjo temperaturo), na primer z uporabo vodne kopeli, da se boste izognili težavam s topnostjo.
• increased acidity in the blood, abnormal control of blood sugar level, abnormal blood level of electrolytes (salts in the blood)
• zvečana kislost krvi, nenormalna kontrola ravni krvnega sladkorja, nenormalna raven elektrolitov v krvi (soli v krvi), • nemir,
Published data concerning treatment of mice and rats with L-diepoxibutane (the alkylating transformation product of treosulfan) revealed impairment of fertility, uterine-ovarian and sperm development.
Objavljeni podatki o dajanju L-diepoksibutana (alkilirajoči pretvorbeni produkt treosulfana) mišim in podganam so razkrili okvare plodnosti, razvoja maternice in jajčnikov in razvoja sperme.
Secondary malignancies
Sekundarne maligne bolezni
• bloodstream infection (sepsis)
• okužba krvi v obtoku (sepsa),
Common Transaminases (ALT/AST)
Zvišani transaminazi (ALT/AST)
The most frequent adverse reactions were cardiac arrhythmias, e.g. atrial fibrillation (1.2%), sinus tachycardia (0.9%), supraventricular tachycardia (0.4%), and ventricular extrasystole (0.4%).
npr. atrijska fibrilacija (1,2 %), sinusna tahikardija (0,9 %), supraventrikularna tahikardija (0,4 %) in ventrikularne ekstrasistole (0,4 %).
• Treosulfan should be administered before fludarabine on days -6, -5, -4 (FT14 regimen).
• Treosulfan je treba dati pred fludarabinom na dneve -6, -5, -4 (shema FT14).
• Treosulfan should be administered before fludarabine on days -4, -3, -2 (FT10 regimen).
• Treosulfan je treba dati pred fludarabinom na dneve -4, -3, -2 (shema FT10).
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).
Popolne odzive bolezni, izmerjene s kliničnimi simptomi in laboratorijskimi testi, so ugotovili pri 28 bolnikih (90 %) (Burroughs LM et al., Biology of Blood and
Treosulfan has moderate influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Treosulfan ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Adults with non-malignant disease
Odrasli z nemaligno boleznijo
Each vial contains 5 g treosulfan.
Ena viala vsebuje 5 g treosulfana.
You should stop breast-feeding before starting treatment with this medicine.
Preden se začnete zdraviti s tem zdravilom, morati prenehati dojiti.
When reconstituted according to section 6.6, 1 mL of the solution for infusion contains 50 mg treosulfan.
Po rekonstituciji v skladu s poglavjem 6.6, 1 ml raztopine za infundiranje vsebuje 50 mg treosulfana.
Profound myelosuppression with pancytopenia is the desired therapeutic effect of treosulfan-based conditioning treatment, occurring in all patients.
Močna mielosupresija s pancitopenijo je želeni terapevtski učinek pripravljalnega zdravljenja na podlagi treosulfana, ki nastopi pri vseh bolnikih.
• 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)
• nenormalno delovanje možganov (encefalopatija), krvavitev v možganih, nemirni, ponavljajoči se ali nehotni gibi in hiter govor (ekstrapiramidna bolezen), omedlevica, občutek mravljinčenja,
The freedom from transplant-related mortality until day +100 after HSCT (primary endpoint) is 98.6% (90% CI 93.4-99.7%) because one of the 70 patients died due to transplantation/treatment-related cause until day +100 after HSCT.
Odsotnost smrtnosti, povezane s presadkom, do dneva +100 po HSCT (primarno končno stanje) je bilo 98,6 % (90 % IZ 93,4-99,7 %), ker je eden od
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.
ali mielodisplastičnim sindromom (MDS) in zvečanim tveganjem za standardna pripravljalna zdravljenja zaradi večje starosti (≥ 50 let) ali sočasnih drugih bolezni (rezultat indeksa komorbidnosti za transplantacijo hematopetičnih celic [HCT-CI] > 2) na prejemanje sheme kondicioniranja s 3 × 10 g/m² treosulfana v kombinaciji s fludarabinom (FT10; n = 220) ali sheme intravenskega busulfana (skupni odmerek 6,4 mg/kg) v kombinaciji s fludarabinom (FB2; n = 240), ki mu je sledila alloHSCT.
No difference in terms of outcome was observed between children and adults (Bernardo ME et al.; Blood 2012; 120(2):473-6).
Razlik v izidih med otroki in odraslimi niso opazili (Bernardo ME et al.; Blood
All Adverse Reactions / Frequency
Organski sistem Vsi neželeni učinki / Pogostnost
The lowest incidence was noted with the dose regimen of 10 g/m²/day, day -4 to -2 (4.1%).
Najmanjšo pogostnost so ugotovili pri shemi odmerjanja 10 g/m²/dan od dneva -4 do -2 (4,1 %).
Treosulfan was administered in a dose range of 10-14 g/m² BSA on three consecutive days.
Treosulfan so dajali v razponu odmerkov 10-14 g/m² BSA tri zaporedne dni.
Treosulfan was administered in a dose range of 10-14 g/m² BSA on 3 consecutive days.
Treosulfan so dajali v razponu odmerkov 10-14 g/m² BSA 3 zaporedne dni.
It is given by drip (infusion) into a vein over 2 hours for 3 days before blood stem cell infusion.
Daje se s (kapalno) infuzijo v veno v času 2 ur 3 zaporedne dni pred infuzijo matičnih krvničk.
• throat pain, decrease in the oxygen supply to a tissue (hypoxia), hoarseness
• bolečina v žrelu, zmanjšana preskrba tkiva s kisikom (hipoksija), hripavost,
Use of mucositis prophylaxis (e.g. topical antimicrobials, barrier protectants, ice and adequate oral hygiene) is recommended.
Priporočljiva je uporaba profilakse mukozitisa (npr. lokalna protimikrobna sredstva, sredstva za zaščito pregrade, led in ustrezna oralna higiena).
• reddening of the skin(generalised erythema), inflammation of skin (dermatitis), death of skin tissue, skin ulcer, bronze pigmentation of skin, dry skin
• pordečitev kože (generalizirani eritem), vnetje kože (dermatitis), odmrtje kožnega tkiva, razjeda kože, bronasta obarvanost kože, suha koža,
Not known Veno-occlusive liver disease
Neznana Venookluzivna bolezen jeter
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.
(kondicioniranja) pred transplantacijo alogenih krvotvornih matičnih celic (allogeneic haematopoietic stem cell transplantation - alloHSCT) pri odraslih bolnikih z malignimi in nemalignimi boleznimi in pri pediatričnih bolnikih starejših od enega meseca z malignimi boleznimi..
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
• blockage of a blood vessel (embolism), bleeding
• zapora krvne žile (embolija), krvavitev,
Isolated cases of cardiac arrest, cardiac failure, and myocardial infarction occurred.
Opazili so posamezne primere srčnega zastoja, srčnega popuščanja in miokardnega infarkta.
The active substance is treosulfan.
Učinkovina je treosulfan.
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).
stiku s kožo in stiku s sluznicami (priporočljiva je uporaba ustreznih zaščitnih rokavic, zaščitnih očal, halje in maske za enkratno uporabo).
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
a Na podlagi Kaplan-Meierjevih ocen; b popravljeno za vrsto donatorja, skupino tveganja in center z uporabo Coxovega regresijskega modela
After reconstitution 1 mL of solution contains 50 mg treosulfan.
Po rekonstituciji 1 ml raztopine vsebuje 50 mg treosulfana.
There is not sufficient information on the use of treosulfan in children aged less than 1 month.
O uporabi treosulfana pri otrocih, mlajših od 1 meseca, ni dovolj informacij.
Breast-feeding should be discontinued during treatment with treosulfan.
Med zdravljenjem s treosulfanom je treba prenehati z dojenjem.
Psychiatric disorders Common Insomnia
Psihiatrične motnje Pogosti Nespečnost
Ovarian suppression and amenorrhoea with menopausal symptoms commonly occur in pre-menopausal patients (see section 4.6).
Pri bolnicah pred menopavzo se pogosto pojavita supresija jajčnikov in amenoreja s simptomi menopavze (glejte poglavje 4.6).
Therefore, medicinal products with a narrow therapeutic index (e.g. digoxin) that are substrates for CYP3A4, CYP2C19 or P-gp should not be given during treatment with treosulfan.
Zato med zdravljenjem s treosulfanom ne smemo dajati zdravil z ozkim terapevtskim indeksom (npr. digoksina), ki so substrati za CYP3A4, CYP2C19 ali P-gp.
The cumulative incidence of relapse/progression is 15.7% (90% CI 8.6-22.9%) at month +12.
15,7 % (90 % IZ 8,6-22,9 %) v mesecu +12.
Common Bilirubin increased
Pogosti Zvišan bilirubin
• increased blood level of a liver enzyme (gamma-glutamyl transferase)
• zvišana raven jetrnega encima (gama glutamiltransferaze) v krvi.
Skin ulcer, erythema multiforme, urticaria, dermatitis bullous, dermatitis acneiform, palmar-plantar erythrodysaesthesia syndrome, dermatitis diapera
Kožna razjeda, multiformni eritem, urtikarija, bulozni dermatitis, akneiformni dermatitis, sindrom palmarnoplantarne eritrodizestezije,
• increased blood level of bilirubin (a liver pigment, often a sign of liver problems)
• zvišana raven krvnega bilirubina (jetrno barvilo, pogosto znak težav z jetri).
Not known Blood LDH increased
Neznana Zvišan LDH v krvi
Reconstitute each vial of Trecondi containing 1 g treosulfan in 20 mL of pre-warmed (maximum 30 °C) sodium chloride 4.5 mg/mL (0.45%) solution by shaking.
Rekonstituirajte vsako vialo zdravila Trecondi, ki vsebuje 1 g treosulfana, v 20 ml prej ogrete (na največ 30 °C) raztopine natrijevega klorida 4,5 mg/ml (0,45 %) s stresanjem.
• bruising, low blood pressure
• nastajanje modric, znižan krvni tlak,
Encephalopathy, intracranial haemorrhage, syncope
Encefalopatija, intrakranialna krvavitev, sinkopa
increased, γGT increased, blood alkaline phosphatase increased, C-reactive protein increased, weight decreased, weight increased
zvišana γGT, zvišana alkalna fosfataza v krvi, zvišan C-reaktivni protein, zmanjšana telesna masa,
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.
Pri dojenčkih in majhnih otrocih, ki imajo plenice, se lahko pojavi plenični izpuščaj z razjedami predela okrog zadnjika (perianalni predel), ker treosulfan, izločen v urinu, lahko poškoduje kožo.
• increased liver enzymes, increased blood level of bilirubin (a liver pigment, often a sign of liver problems)
• zvišani jetrni encimi, zvišana raven krvnega bilirubina (jetrno barvilo, pogosto znak težav z jetri).
Dry eye
Neznana Suho oko
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva
What you need to know before you are given Trecondi
Kaj morate vedeti, preden vam bodo dali zdravilo Trecondi Ne uporabljajte zdravila Trecondi:
Reconstitute each vial of Trecondi containing 5 g treosulfan in 100 mL of pre-warmed (maximum 30 °C) sodium chloride 4.5 mg/mL (0.45%) solution by shaking.
Rekonstituirajte vsako vialo zdravila Trecondi, ki vsebuje 5 g treosulfana, v 100 ml prej ogrete (na največ 30 °C) raztopine natrijevega klorida 4,5 mg/ml (0,45 %) s stresanjem.
Erythema multiforme, dermatitis acneiform, rash, hyperhidrosis
Multiformni eritem, akneiformni dermatitis, izpuščaj, hiperhidroza
• less acid than normal in the blood (alkalosis), abnormal blood level of electrolytes, decreased blood level of magnesium
• zmanjšano število belih krvničk z zvišano telesno temperaturo (febrilna nevtropenija), • manj kisline v krvi kot normalno (alkaloza), nenormalna raven elektrolitov v krvi, znižana raven magnezija v krvi,
Treosulfan is a prodrug of a bifunctional alkylating agent with cytotoxic activity to haematopoietic precursor cells.
Treosulfan je prekurzor bifunkcijskega alkilirajočega sredstva s citotoksičnim delovanjem na krvotvorne prekurzorske celice.
You must not receive live vaccines during treatment with treosulfan.
Med zdravljenjem s treosulfanom vas ne smejo cepiti z živim cepivom.
The total treosulfan dose is 42 g/m²;
Skupni odmerek treosulfana je 42 g/m²;
Capillary leak syndrome, hypertension, hypotension
Sindrom zvečane prepustnosti kapilar, hipertenzija, hipotenzija
• Severe concomitant cardiac, lung, liver, and renal impairment
• težka sočasna okvara srca, pljuč, jeter ali ledvic
• redness of scrotal skin
• rdečica kože modnika,
Package leaflet: Information for the user Trecondi 1 g powder for solution for infusion Trecondi 5 g powder for solution for infusion treosulfan
Navodilo za uporabo: Informacije za uporabnika Trecondi 1 g prašek za raztopino za infundiranje Trecondi 5 g prašek za raztopino za infundiranje treosulfan
Septic shockc
Septični šokc
The total treosulfan dose is 30 g/m²;
Skupni odmerek treosulfana je 30 g/m²;
Cardiac arrhythmias (e.g. atrial fibrillation, sinus arrhythmia)
Srčne aritmije (npr. atrijska fibrilacija, sinusna aritmija) Neznana
• reddening and flaking of most of the skin of the body (dermatitis exfoliative), a type of rash with flat or raised red bumps on the skin (maculopapular rash), rash, redness of skin (erythema), skin pain, bronze pigmentation of skin, hair loss
• pordečitev in luščenje večjega dela kože telesa (eksfoliativni dermatitis), vrsta izpuščaja s ploskimi ali izbočenimi rdečimi bulicami na koži (makulopapularni izpuščaj), izpuščaj, rdečina kože (eritem), boleča koža, bronasta obarvanost kože, izguba las,
Not known Paraesthesia
Neznana Parestezije
• bleeding in the mouth, feeling bloated, gullet or stomach pain, dry mouth
• krvavitve v ustih, občutek napihnjenosti, bolečina v požiralniku ali želodcu, suha usta,
Uncommon Non-cardiac chest pain, pain
Nekardialna bolečina v prsih, bolečina
Encephalopathy, intracranial haemorrhage, extrapyramidal disorder, syncope, paraesthesia
Encefalopatija, intrakranialna krvavitev, ekstrapiramidna bolezen, sinkopa, parestezije
E-mail: contact@medac.de
E-mail: contact@medac.de Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}><{mesec LLLL}>
Veno-occlusive liver disease, hepatomegaly, hepatotoxicity
Venookluzivna bolezen jeter, hepatomegalija,
VOD occurred only with the dose regimen of 14 g/m²/day treosulfan.
VOD se je pojavljala samo pri shemi odmerjanja treosulfana 14 g/m²/dan.
Treosulfan can impair fertility.
Plodnost Treosulfan lahko zmanjša plodnost.
• liver damage
bolečina v jetrih
About 25-40% of treosulfan is excreted in urine; however, an influence of renal function on renal clearance of treosulfan was not observed.
Okrog 25-40 % treosulfana se izloči v urinu;
• Thiotepa 5 mg/kg twice a day, given as two intravenous infusions over 2-4 hours on day -2 before stem cell infusion (day 0).
• Tiotepa 5 mg/kg dvakrat na dan v obliki dveh intravenskih infuzij v času 2-4 ur na dan -2 pred infuzijo matičnih celic (dan 0).
Acute kidney injury, renal failure
Akutna okvara ledvic, odpoved ledvic
• high blood pressure, flushing
• zvišan krvni tlak, rdečica,
Hazard ratiob (95% CI)
(95 % IZ)
Conjunctival haemorrhage, dry eye
Konjunktivalne krvavitve, suho oko
How to store Trecondi
Kako dajemo zdravilo Trecondi
The volume of distribution in adult patients is about 20-30 litres.
Porazdelitveni volumen pri odraslih bolnikih je okrog
Not known Hypoxia
Neznana Hipoksija
Cardiac arrest, cardiac failure, myocardial infarction, pericardial effusion
Zastoj srca, miokardni infarkt
• fluid around the lung (pleural effusion), inflammation of throat, inflammation of or pain in voice box, cough, hiccups
• tekočina okrog pljuč (plevralni izliv), vnetje žrela, vnetje ali bolečina v grlu, kašelj, kolcanje,
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution.
Za intravensko uporabo po rekonstituciji.
Maculo-papular rash, purpura, erythema, palmar-plantar erythrodysaesthesia syndrome, pruritus, alopecia
eritem, sindrom palmarno-plantarne eritrodizestezije, pruritus, alopecija
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.
Pri ravnanju s treosulfanom se izogibajte vdihavanju, stiku s kožo in stiku s sluznicami.
Infections (bacterial, viral, fungal)
Pogosti Infekcije (bakterijske, virusne,
Not known Treatment-related second malignancy
Druga maligna bolezen, povezana z zdravljenjem
Very common Stomatitis/mucositis, nausea
Zelo pogosti Stomatitis/mukozitis, navzea
• mouth pain, inflammation of the stomach, upset stomach, constipation, difficulty in swallowing
• bolečina v ustih, vnetje želodca, vznemirjen želodec, zaprtje, oteženo požiranje,
• kidney failure, inflammation of the urinary bladder (cystitis), pain on passing urine (dysuria)
• odpoved ledvic, vnetje sečnika (cistitis), bolečina pri odvajanju vode (dizurija),
• headache, sensation of tingling, pricking or numbness (paraesthesia), seizure
• glavobol, občutek mravljinčenja, zbadanja ali odrevenelosti (parestezije), epileptični napad,
Dyspnoea, pleural effusion, pharyngeal or laryngeal inflammation
Dispnea, plevralni izliv, faringitis ali laringitis
Not known Chills, fatigue, pain
Mrzlica, utrujenost, bolečina
• liver failure, enlarged liver, liver pain
• odpoved jeter, zvečana jetra, bolečina v jetrih,
Extensive chronic GvHDa; % (95% CI) 18.4 (12.0, 24.8) 26.1 (19.2, 33.1) 0.1099 a Up to 2 years after alloHSCT
Obsežna kronična GvHDa; % (95 % IZ) 18,4 (12,0; 24,8) 26,1 (19,2; 33,1) 0,1099
Maculo-papular rash, purpura, erythema
Makulopapularni izpuščaj, purpura,
Pneumonitis, pleural effusion, pharyngeal or laryngeal inflammation, cough, laryngeal pain, hiccups
Pnevmonitis, plevralni izliv, faringitis ali laringitis, kašelj,
There was a significant association between age and respiratory toxicity in paediatric patients treated with treosulfan-based conditioning.
Bolezni dihal, prsnega koša in mediastinalnega prostora Pri pediatričnih bolnikih, zdravljenih s kondicioniranjem na podlagi treosulfana, obstaja značilna povezava med starostjo in toksičnostjo za dihala.
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.
(v katera je bilo vključenih skupaj 564 bolnikov), v katerih so raziskovali treosulfan v kombinaciji s fludarabinom kot pripravljalno zdravljenje pred alloHSCT pri odraslih bolnikih.
b
Pb
• skin ulcer, a type of rash with red spots and sometimes with purple or blistered areas in the centre (erythema multiforme), hives, skin condition with fluid-filled blisters (dermatitis bullous), acne, hand and foot syndrome (palms of the hands or soles of the feet tingle, become numb, painfully swollen, or red), nappy rash with ulceration in the area surrounding the anus
• razjeda kože, vrsta izpuščaja z rdečimi pegami in včasih s škrlatnimi ali mehurjastimi predeli v sredini (multiformni eritem), koprivnica (urtikarija), bolezen kože z mehurji, napolnjenimi s tekočino (bulozni dermatitis), akne, sindrom dlani in stopal (dlani ali stopala srbijo, odrevenijo,
Infections and infestations* Very common Infections (bacterial, viral, fungal)
Zelo pogosti Infekcije (bakterijske, virusne,
Very common Myelosuppression, pancytopenia
Zelo pogosti Mielosupresija, pancitopenija
Sepsisa
Mukozitis
Cardiac disorders* Common Cardiac arrhythmias (e.g. atrial fibrillation, sinus arrhythmia)
Občasni Srčne aritmije (npr. atrijska fibrilacija, sinusna aritmija) Neznana
Hepatobiliary disorders
hepatotoksičnost
Common Dyspnoea, epistaxis
Pogosti Dispnea, epistaksa
• inflammation of the lining of various parts of the body, especially in the mouth (which can cause ulcers), diarrhoea, nausea, vomiting, belly (abdominal) pain
• vnetje sluznice v različnih delih telesa, posebno v ustih (kjer lahko povzroči razjede), driska,
• throat pain, nosebleeds
• bolečina v žrelu, krvavitve iz nosu,
Generalised erythema, dermatitis, skin necrosis or ulcer, skin hyperpigmentationd, dry skin
kožna nekroza ali razjeda, hiperpigmentacija kožed, suha koža
Uncommon Hypertension
Hipertenzija Neznana
Renal and urinary disorders Not known Acute kidney injury, renal failure, noninfective cystitis
Akutna okvara ledvic, odpoved ledvic, neinfektivni cistitis
• difficulty in swallowing, mouth pain
Disfagija, bolečina v ustih
• decrease of kidney function, kidney failure, inflammation of the urinary bladder (cystitis)
• zmanjšano delovanje ledvic, odpoved ledvic, vnetje sečnika (cistitis),
Five cases of a second malignancy (myelodysplastic syndrome, acute lymphoblastic leukaemia, Ewing's sarcoma) were reported by other investigators after treosulfan-based conditioning.
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Drugi raziskovalci so po kondicioniranju na podlagi treosulfana poročali o petih primerih druge maligne bolezni (mielodisplastični sindrom, akutna limfoblastna levkemija, Ewingov sarkom).
Cardiac disorders
Srčne bolezni*