FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to prevent and treat infections, you will be given medicines, such as antibiotics, antifungals or antivirals.
Danish: For at forhindre og behandle infektioner vil du få lægemidler, såsom antibiotika, antimykotika (svampedræbende) eller antivirale midler.
English: Blood disorders were observed in 67 of 564 adult patients (11.9%).
Danish: Der blev observeret blodforstyrrelser hos 67 ud af 564 voksne patienter (11,9 %).
English: • decreased counts of white blood cells with fever (febrile neutropenia)
Danish: • nedsat antal hvide blodlegemer med feber (febril neutropeni)
English: Treosulfan is reconstituted in its original glass container.
Danish: Treosulfan rekonstitueres i den originale glasbeholder.
English: Rare Confusional state
Danish: Sjælden Forvirret tilstand
English: Intravenous application should be performed using a safe technique.
Danish: Præparatet skal indgives intravenøst med en sikker teknik.
English: The effect of treosulfan on the pharmacokinetics of fludarabine is not known.
Danish: Virkningen af treosulfan på fludarabins farmakokinetik er ukendt.
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.
Danish: Trecondi anvendes som en behandling før en blodstamcelletransplantation til voksne med kræft og sygdomme, som ikke er kræft, og til unge og børn over 1 måned med kræft.
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.
Danish: I løbet af faserne med svær neutropeni (medianvarighed af den neutropene periode er 14-17,5 dage hos voksne og 21-24 dage hos pædiatriske patienter) er risikoen for infektion øget.
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.
Danish: Forurenede legemsdele skal skylles grundigt med vand og sæbe, og øjnene skal skylles med natriumchloridopløsning 9 mg/ml (0,9 %).
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.
Danish: Børn under 1 år (primært ikke-maligne sygdomme, især immundefekter) oplevede flere tilfælde af grad III/IV-luftvejstoksicitet, muligvis på grund af lungeinfektioner, der allerede var til stede, før den konditionerende behandling blev påbegyndt.
English: A few further cases of second malignancies after treosulfan-based conditioning have been reported by other investigators.
Danish: Et par andre tilfælde af sekundær malignitet efter treosulfan-baseret konditionering er blevet rapporteret af andre investigatorer.
English: • different cancer caused by chemotherapeutic treatment (second malignancy)
Danish: • en anden kræft forårsaget af kemoterapibehandlingen (sekundær malignitet)
English: If you are concerned about having children, you should discuss this with your doctor before treatment.
Danish: Hvis du er bekymret for din frugtbarhed, skal du diskutere dette med lægen før behandlingen.
English: Prophylactic or empiric anti-infective treatment (bacterial, viral, fungal) should therefore be considered.
Danish: Profylaktisk eller empirisk behandling mod infektion (bakteriel, viral, mykotisk) bør derfor overvejes.
English: The safety and efficacy of treosulfan in children less than 1 month of age has not yet been established.
Danish: Treosulfans sikkerhed og virkning hos børn under 1 måned er endnu ikke klarlagt.
English: Adults with non-malignant disease
Danish: Voksne med ikke-malign sygdom
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Danish: Data fra dyreforsøg er utilstrækkelige, hvad angår reproduktionstoksicitet (se pkt.
English: It is likely that certain adverse reactions of treosulfan like nausea, vomiting or dizziness could affect these functions.
Danish: Det er sandsynligt, at visse bivirkninger ved treosulfan, som kvalme, opkastning eller svimmelhed, kan påvirke disse funktioner.
English: The median age of patients was 60 years (range 31-70 years); 25% of patients were older than 65 years.
Danish: Medianalderen for patienterne var 60 år (interval 31-70 år), 25 % af patienterne var over 65 år.
English: Secondary malignancies
Danish: Sekundære maligniteter
English: Peripheral sensory neuropathy Not known
Danish: Perifer sensorisk neuropati Ikke kendt
English: In the absence of haematopoietic stem cell transplantation, the recommended dose of treosulfan would constitute an overdose.
Danish: Hvis der ikke skulle udføres en hæmatopoietisk stamcelletransplantation, ville den anbefalede dosis af treosulfan udgøre en overdosering.
English: The reconstituted solution contains 50 mg treosulfan per mL and appears as a clear colourless solution.
Danish: Den rekonstituerede opløsning indeholder 50 mg treosulfan pr. ml og fremstår som en klar, farveløs opløsning.
English: • Fanconi anaemia and other DNA breakage repair disorders
Danish: • Fanconis anæmi og andre forstyrrelser i dna-brudreparationssystemet
English: 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.
Danish: Friheden fra transplantationsrelateret mortalitet indtil dag +100 efter HSCT (primært endepunkt) er 98,6 % (90 % CI 93,4-99,7 %), da en af de 70 patienter døde som følge af transplantations/behandlingsrelateret årsag indtil dag +100 efter HSCT.
English: Specific reproductive and developmental toxicity studies on treosulfan in animals were not conducted.
Danish: Der er ikke blevet udført specifikke studier af reproduktions- og udviklingstoksicitet med treosulfan hos dyr.
English: You must not receive live vaccines during treatment with treosulfan.
Danish: Du må ikke få levende vacciner i løbet af behandlingen med treosulfan.
English: The terminal half-life (T1/2ß) of intravenously administered treosulfan (up to 47 g/m²) is approximately 2 hours.
Danish: Den terminale halveringstid (T1/2ß) for intravenøst administreret treosulfan (op til 47 g/m²) er ca. 2 timer.
English: • changes and abnormalities in heart rhythm (heartbeat is irregular, too fast or too slow)
Danish: • ændring af og unormal hjerterytme (hjertet slår uregelmæssigt, for hurtigt eller for langsomt)
English: • infections caused by bacteria, viruses and fungi (all patients: very common)
Danish: • infektioner forårsaget af bakterier, vira og svampe (alle patienter: meget almindelig)
English: Therefore, nappies should be changed frequently during 6-8 hours after each dose of this medicine.
Danish: Derfor skal bleen skiftes hyppigt i 68 timer efter hver dosis af dette lægemiddel.
English: • blockage of a blood vessel (embolism), bleeding
Danish: • blokering af en blodåre (embolisme), blødning
English: 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.
Danish: Derfor må lægemidler med et snævert terapeutisk indeks (f.eks. digoxin), som er substrater for CYP3A4, CYP2C19 eller P-gp ikke gives i løbet af behandlingen med treosulfan.
English: Treosulfan is given in combination with fludarabine, with thiotepa (intensified regimen; FT10-14TT regimen) or without thiotepa (FT10-14 regimen).
Danish: Treosulfan gives i kombination med fludarabin, med thiotepa (forstærket program; FT10-14TTprogram) eller uden thiotepa (FT10-14-program).
English: Men should seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility.
Danish: Mænd skal søge rådgivning om kryokonservering af sæd før behandling på grund af muligheden for irreversibel infertilitet.
English: This procedure is very important, because moistening of powder that sticks to the surface results in caking.
Danish: Dette er meget vigtigt, da det kan føre til kagedannelse, hvis pulver, der klæber til overfladen, bliver fugtigt.
English: The epoxides formed alkylate nucleophilic centres of deoxyribonucleic acid (DNA) and are able to induce DNA cross-links which are considered responsible for the stem cell depleting and antineoplastic effects.
Danish: De dannede epoxider alkylerer nukleofile centre i deoxyribonukleinsyre (dna) og er i stand til at inducere dna-krydsbindinger, hvilket anses for at være ansvarlig for den stamcelledepleterende og antineoplastiske virkning.
English: Concomitant use of live attenuated vaccines is not recommended.
Danish: Bør ikke anvendes samtidig med levende, svækkede vacciner.
English: The total treosulfan dose is 30-42 g/m²; The dose of treosulfan should be adapted to the patient's BSA as follows (see section 5.2):
Danish: Den totale treosulfandosis er 30-42 g/m²; Dosis af treosulfan skal tilpasses til patientens BSA på følgende måde (se pkt.
English: Not known Febrile neutropenia
Danish: Ikke kendt Febril neutropeni
English: The principal toxic effect of treosulfan is profound myeloablation and pancytopenia.
Danish: De primære toksiske virkninger af treosulfan er markant myeloablation og pancytopeni.
English: The recommended dose is 10-14 g/m² body surface area (calculated using your height and weight).
Danish: Den anbefalede dosis er 10-14 g/m² legemsoverfladeareal (beregnes ud fra din højde og vægt).
English: With a median follow-up of 36 months (range, 4-73), the 5-year overall survival probability was 93% (95% CI 83-97%).
Danish: Med en median opfølgning på 36 måneder (interval 4-73), var sandsynligheden for samlet overlevelse efter 5 år 93 % (95 % CI 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.
Danish: Treosulfan ødelægger cellerne i knoglemarven og gør det muligt at transplantere nye knoglemarvsceller, som medfører, at der kan produceres raske blodlegemer.
English: There was a significant association between age and respiratory toxicity in paediatric patients treated with treosulfan-based conditioning.
Danish: Der var en signifikant forbindelse mellem alder og luftvejstoksicitet hos pædiatriske patienter i behandling med treosulfan-baseret konditionering.
English: Treosulfan has a broad antineoplastic and antileukaemic activity.
Danish: Treosulfan har en bred antineoplastisk og antileukæmisk aktivitet.
English: This medicine is used in combination with fludarabine.
Danish: Dette lægemiddel anvendes i kombination med fludarabin.
English: Reconstituted solutions of treosulfan may be combined into a larger glass vial, PVC bag or PE bag.
Danish: Rekonstituerede opløsninger med treosulfan kan kombineres i et større glas-hætteglas, en PVC-pose eller PE-pose.
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
Danish: Kumulativ forekomst af transplantationsrelateret mortalitet; % (95 % CI) a Baseret på Kaplan-Meier-estimater, b justeret for donortype, risikogruppe og center ved hjælp af
English: Adults with malignant disease
Danish: Voksne med malign sygdom
English: Detailed in vitro studies did not completely exclude potential interactions between high plasma concentrations of treosulfan and CYP3A4, CYP2C19, or P-gp substrates.
Danish: Detaljerede in-vitro-studier udelukkede ikke fuldstændigt mulige interaktioner mellem høje plasmakoncentrationer af treosulfan og CYP3A4, CYP2C19 eller P-gp-substrater.
English: For testing non-inferiority of treosulfan compared to busulfan.
Danish: For test af non-inferioritet af treosulfan sammenlignet med busulfan.
English: At concentrations up to 100 µM, treosulfan has no unequivocal effect on CYP1A2, 2C9, 2C19, 2D6, or 3A4 activities in vitro.
Danish: Ved koncentrationer på op til 100 µM har treosulfan ingen utvetydig virkning på CYP1A2-, 2C9-, 2C19-, 2D6- eller 3A4-aktiviteter in vitro.
English: No dose adjustment is necessary for mild or moderate impairment, but treosulfan is contraindicated in patients with severe impairment (see section 4.3).
Danish: Ingen dosisjustering er nødvendig for let eller moderat nedsættelse, men treosulfan er kontraindiceret hos patienter med svær nedsættelse (se pkt.
English: • Treosulfan should be administered before fludarabine;
Danish: • Treosulfan skal administreres før fludarabin,
English: Trecondi may cause symptoms of the menopause (absence of menstrual periods).
Danish: Trecondi kan forårsage symptomer på overgangsalderen (udeblevne menstruationer).
English: Headache, peripheral sensory neuropathy
Danish: Hovedpine, perifer sensorisk neuropati
English: Cardiac disorders were observed in 25 patients (4.4%).
Danish: Der blev observeret hjerteforstyrrelser hos 25 patienter (4,4 %).
English: Cumulative incidence of relapse/progression; % (95% CI)
Danish: Kumulativ forekomst af recidiv/progression; % (95 % CI)
English: Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There is not sufficient information on the use of treosulfan in children aged less than 1 month.
Danish: Der er ikke tilstrækkelige oplysninger om anvendelsen af treosulfan til børn under 1 måned.
English: • leakage of fluid from the capillaries (small blood vessels), high blood pressure, low blood pressure
Danish: • væskeudsivning fra kapillærerne (små blodårer), højt blodtryk, lavt blodtryk
English: 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.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Når treosulfan håndteres, skal inhalation, hudkontakt eller kontakt med slimhinder undgås.
English: • decrease in the oxygen supply to parts of the body (hypoxia)
Danish: • nedsat ilttilførsel til dele af kroppen (hypoksi)
English: In juvenile rat toxicity studies treosulfan induced slight retardation of physical development and a slightly delayed time-point of vaginal opening in females.
Danish: I toksicitetsstudier med juvenile rotter inducerede treosulfan let retardering af fysisk udvikling og et let forsinket tidspunkt for vaginal åbning hos hunner.
English: Treosulfan might impair fertility in men and women.
Danish: Treosulfan kan forringe fertiliteten hos mænd og kvinder.
English: • increased liver enzymes, increased C-reactive protein (a marker of inflammation in the body),
Danish: • forhøjede leverenzymer, forhøjet C-reaktivt protein (en markør for betændelse i kroppen),
English: Dermatitis diaper may occur in small children because of excretion of treosulfan in the urine.
Danish: Dermatitis i bleområdet kan opstå hos små børn som følge af, at treosulfan udskilles i urinen.
English: Not known Alkalosis
Danish: Ikke kendt Alkalose
English: Growth factors (G-CSF, GM-CSF), platelet and/or red blood cell support should be given as indicated.
Danish: Støttebehandling med vækstfaktorer (G-CSF, GM-CSF), trombocytter og/eller røde blodlegemer skal gives, hvis det er indiceret.
English: • inflammation of the lung (pneumonitis) (adults: uncommon)
Danish: • betændelse i lungen (pneumonitis) (voksne: ikke almindelig)
English: As known for other alkylating conditioning agents treosulfan can cause ovarian suppression and amenorrhoea with menopausal symptoms in pre-menopausal women.
Danish: Som det er kendt for andre alkylerende konditionerende midler, kan treosulfan forårsage ovariesuppression og amenoré med menopausale symptomer hos præmenopausale kvinder.
English: 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.
Danish: Publicerede data angående behandling af mus og rotter med L-diepoxibutan (det alkylerende transformationsprodukt af treosulfan) viser nedsat fertilitet, uterin-ovarial udvikling og sædudvikling.
English: Not known Hypoxia
Danish: Ikke kendt Hypoksi
English: A very low penetration of blood-brain-barrier by treosulfan was observed in rats.
Danish: Der blev observeret en meget lav gennemtrængning af blod-hjernebarrieren af treosulfan hos rotter.
English: However, during chronic toxicity tests in rats spermatogenesis and ovarian function were significantly affected.
Danish: Kroniske toksicitetsundersøgelser med rotter viste dog, at spermatogenese og ovariefunktion var signifikant påvirket.
English: Very common Bilirubin increased
Danish: Meget almindelig Forhøjet bilirubin
English: Treosulfan is used to prepare patients for bone marrow transplant (haematopoietic stem cell transplantation).
Danish: Treosulfan anvendes til at forberede patienter på en knoglemarvstransplantation (hæmatopoietisk stamcelletransplantation).
English: Treosulfan is contraindicated during pregnancy (see section 4.3).
Danish: Treosulfan er kontraindikeret under graviditet (se pkt.
English: Pharmacotherapeutic group: Antineoplastic agents, alkylating agents, ATC code: L01AB02
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, alkyleringsmidler, ATC-kode: L01AB02
English: Trecondi contains the active substance treosulfan, which belongs to a group of medicines called alkylating agents.
Danish: Trecondi indeholder det aktive stof treosulfan, som tilhører en gruppe lægemidler, der kaldes alkylerende stoffer.
English: Blood and lymphatic system disorders*
Danish: Blod og lymfesystem*
English: • sudden decrease of kidney function, blood in the urine
Danish: • pludseligt nedsat nyrefunktion, blod i urinen
English: Therefore, dosing of treosulfan in paediatric patients has to be adapted to the BSA (see section 4.2).
Danish: Derfor skal doseringen af treosulfan hos pædiatriske patienter tilpasses til BSA (se pkt.
English: Transplant-related mortality at 12 months is 2.9% (90% CI 0.9 - 8.9%).
Danish: Transplantationsrelateret mortalitet efter 12 måneder er 2,9 % (90 % CI 0,9-8,9 %).
English: • problems in the nerves of the arms or legs with symptoms such as numbness, reduced or increased sensitivity, tingling, burning pain (peripheral sensory neuropathy)
Danish: • problemer med nerverne i armene eller benene med symptomer såsom følelsesløshed, nedsat eller øget følsomhed, prikken, brændende smerter (perifer sensorisk neuropati)
English: • dry eye
Danish: • tørre øjne
English: • increased blood level of a liver enzyme (gamma-glutamyl transferase)
Danish: • forhøjet niveau af leverenzym i blodet (gamma-glutamyltransferase)
English: • heart not pumping enough blood for the body's needs (heart failure), heart attack, fluid in the sac around the heart (pericardial effusion)
Danish: • hjertet pumper ikke nok blod til kroppens behov (hjertesvigt), hjerteanfald, væske i hjertesækken (perikardiel effusion)
English: Very common Myelosuppression, pancytopenia
Danish: Meget almindelig Myelosuppression, pancytopeni
English: In addition, acidosis, skin toxicity, nausea, vomiting and gastritis may occur.
Danish: Desuden kan der opstå acidose, hudtoksicitet, kvalme, opkastning og gastritis.
English: Due to its alkylating mechanism of action treosulfan is characterised as a genotoxic compound with carcinogenic potential.
Danish: Som følge af den alkylerende virkningsmekanisme er treosulfan karakteriseret som et genotoksisk stof med karcinogent potentiale.
English: Treosulfan is given in combination with fludarabine with or without thiotepa.
Danish: Treosulfan gives i kombination med fludarabin med eller uden thiotepa.
English: There have been isolated reports of seizures in infants (≤ 4 months of age) with primary immunodeficiencies after conditioning treatment with treosulfan in combination with fludarabine or cyclophosphamide.
Danish: Der har været isolerede rapporter om krampeanfald hos spædbørn (≤ 4 måneder) med primære immundefekter efter konditionerende behandling med treosulfan i kombination med fludarabin eller cyclophosphamid.
English: If you are a man treated with this medicine, you should not father a child during and up to 6 months after treatment.
Danish: Hvis du er en mand, som bliver behandlet med dette lægemiddel, må du ikke gøre en kvinde gravid i løbet af eller op til 6 måneder efter behandlingen.
English: Men should seek advice about the possibility of sperm preservation before starting therapy.
Danish: Mænd skal søge rådgivning om muligheden for sædopbevaring, før de starter behandlingen.
English: • life-threatening condition after bloodstream infection (septic shock)
Danish: • livstruende tilstand efter infektion af blodomløbet (septisk shock)
English: Not known Septic shockc
Danish: Ikke kendt Septisk shockc
English: Treosulfan has moderate influence on the ability to drive and use machines.
Danish: Treosulfan påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Fits (seizures) may occur very rarely in infants of less than 4 months of age.
Danish: Der kan meget sjældent opstå krampeanfald hos spædbørn under 4 måneder.
English: Not known Renal failure, cystitisc, dysuria
Danish: Ikke kendt Nyresvigt, cystitisc, dysuri
English: 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).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af et studie med treosulfan-baseret konditionering hos pædiatriske patienter med ikke maligne sygdomme (se pkt.
English: The cumulative incidence of relapse/progression is 15.7% (90% CI 8.6-22.9%) at month +12.
Danish: Den kumulative forekomst af recidiv/progression er 15,7 % (90 % CI 8,6-22,9 %) ved måned +12.
English: Oral mucositis (including high-grade severity) is a very common undesirable effect of treosulfan-based conditioning followed by alloHSCT (see section 4.8).
Danish: Oral mukositis (herunder med høj sværhedsgrad) er en meget almindelig bivirkning ved treosulfan-baseret konditionerende behandling efterfulgt af alloHSCT (se pkt.
English: Psychiatric disorders Common Insomnia
Danish: Psykiske forstyrrelser Almindelig Insomni
English: • pain or inflammation at the injection site, feeling cold
Danish: • smerter eller betændelse på injektionsstedet, kuldefølelse
English: Common Decreased appetite
Danish: Almindelig Nedsat appetit
English: Pathogens included bacteria (e.g. Staphylococcus, Enterococcus, Corynebacterium), viruses (e.g. cytomegalovirus [CMV], Epstein-Barr virus [EBV], herpes) as well as fungi (e.g. candida).
Danish: Patogener omfattede bakterier (f.eks. Staphylococcus, Enterococcus, Corynebacterium), vira (f.eks. cytomegalovirus [CMV], Epstein-Barr-virus [EBV], herpes) samt svampe (f.eks. candida).
English: Not known Blood LDH increased
Danish: Ikke kendt Forhøjet LDH i blodet
English: The most frequent adverse reactions reported were nausea (39.5%), stomatitis (36%), vomiting (22.5%), diarrhoea (15.6%), and abdominal pain (10.4%).
Danish: De hyppigst rapporterede bivirkninger var kvalme (39,5 %), stomatitis (36 %), opkastning (22,5 %), diarré (15,6 %) og abdominalsmerter (10,4 %).
English: • bleeding in the eye, dry eye
Danish: • blødning i øjet, tørre øjne
English: The total fludarabine dose is 150 mg/m²;
Danish: Den totale fludarabindosis er 150 mg/m²;
English: Do not store the reconstituted solution in a refrigerator (2 °C - 8 °C) as this might cause precipitation.
Danish: Den rekonstituerede opløsning må ikke opbevares i køleskab (2 °C - 8 °C), da det kan forårsage udfældning.