FrancophonIA/ELRC3.0 huggingface dataset:
English: None of these cases were fatal or life-threatening.
Danish: Ingen af disse tilfælde var dødelige eller livstruende.
English: At the recommended dose, this is the desired effect.
Danish: Ved den anbefalede dosis er det den ønskede virkning.
English: The recommended dose and schedule of administration is:
Danish: Den anbefalede dosis og plan for administration er:
English: No specific measure has been proven to be recommendable.
Danish: Der er ikke påvist nogen specifik foranstaltning, der kan anbefales.
English: Further results are shown in Table 1.
Danish: Yderligere resultater er vist i tabel 1.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstiderne og forholdene under anvendelse brugerens ansvar.
English: • high blood sugar level
Danish: • højt blodsukkerniveau
English: No dose adjustment is necessary in any subset of the elderly population.
Danish: Ingen dosisjustering er nødvendig i nogen undergruppe i den ældre population.
English: The primary endpoint of this study was event-free survival (EFS) after 2 years.
Danish: Det primære endepunkt i dette studie var hændelsesfri overlevelse (event-free survival, EFS) efter 2 år.
English: The possible risk of a second malignancy should be explained to the patient.
Danish: Den mulige risiko for en sekundær malignitet skal forklares for patienten.
English: • allergic reactions
Danish: • allergiske reaktioner
English: 64% of patients had AML and 36% MDS.
Danish: 64 % af patienterne havde AML og 36 % MDS.
English: • Administration of live vaccine
Danish: • Administration af levende vaccine
English: If extravasation is suspected, general safety measures should be implemented.
Danish: Hvis der er mistanke om ekstravasation, skal der implementeres almindelige sikkerhedsforanstaltninger.
English: Trecondi may increase the risk of having another cancer in the future.
Danish: Trecondi kan øge risikoen for at få en anden type kræft i fremtiden.
English: A list of all other side effects is set out below according to how common they are.
Danish: En liste over alle andre bivirkninger er opstillet nedenunder i henhold til, hvor almindelige de er.
English: The volume of distribution in adult patients is about 20-30 litres.
Danish: Fordelingsvoluminet hos voksne patienter er ca. 20-30 liter.
English: Non-inferiority of FT10 versus the reference FB2 was statistically proven (Figure 1).
Danish: Non-inferioritet af FT10 versus referencen FB2 blev statistisk bevist (figur 1).
English: This medicine will be given to you by your doctor.
Danish: Du vil få givet dette lægemiddel af din læge.
English: Trained personnel should reconstitute the medicinal product.
Danish: Trænet personale skal rekonstituere lægemidlet.
English: Unopened vial 5 years
Danish: Uåbnet hætteglas 5 år
English: • Active non-controlled infectious disease
Danish: • Aktiv ikke-kontrolleret infektionssygdom
English: No dose accumulation with the recommended daily treatment on three consecutive days was observed.
Danish: Der blev ikke observeret nogen dosisakkumulation med den anbefalede daglige behandling i 3 på hinanden følgende dage.
English: Eleven patients had a relapse/progression.
Danish: 11 patienter oplevede recidiv/progression.
English: The two-year projected overall survival was 90%.
Danish: Den forventede samlede overlevelse efter to år var 90 %.
English: You will have regular blood tests during treatment to check your blood cell counts do not fall too low.
Danish: Du vil få taget regelmæssige blodprøver i løbet af behandlingen for at kontrollere, at dine antal af blodlegemer ikke bliver for lave.
English: If you are affected, do not drive or use machines.
Danish: Hvis du påvirkes af det, må du ikke føre motorkøretøj eller betjene maskiner.
English: Use an effective method of contraception when either you or your partner is receiving this medicine.
Danish: Anvend en sikker præventionsmetode, når enten du eller din partner får dette lægemiddel.
English: If this happens, vigorously shake the vial to redissolve the cake.
Danish: Hvis dette sker, skal hætteglasset rystes kraftigt for at opløse kagen igen.
English: After intravenous administration, peak plasma levels are reached at the end of the infusion time.
Danish: Efter intravenøs administration nås de maksimale plasmaniveauer ved slutningen af infusionstiden.
English: Pregnant personnel should be excluded from handling cytotoxics.
Danish: Gravide medarbejdere skal udelukkes fra at håndtere cytotoksiske lægemidler.
English: Your child will be monitored for signs of side effects affecting nerves and breathing problems.
Danish: Dit barn vil blive overvåget for tegn på bivirkninger, der påvirker nerverne, og for åndedrætsproblemer.
English: Juvenile animal studies
Danish: Juvenile dyreforsøg
English: A total of 37 patients (52.9%) were younger than 12 years.
Danish: I alt 37 patienter (52,9 %) var yngre end 12 år.
English: The treosulfan concentrations in brain tissue were 95%-98% lower than in plasma.
Danish: Treosulfankoncentrationerne i hjernevævet var 95 %-98 % lavere end i plasma.
English: Solutions showing any sign of precipitation should not be used.
Danish: Opløsninger, der viser tegn på udfældning, må ikke anvendes.
English: Use Luer-lock fittings on all syringes and sets.
Danish: Anvend Luer-lock-tilslutninger på alle sprøjter og sæt.
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.
Danish: I alt 7 ud af 70 patienter (10,0 %) døde, 2 patienter som følge af recidiv/progression, 3 patienter transplantationsrelateret og yderligere 2 patienter af andre årsager.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}><{måned ÅÅÅÅ}>.
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.
Danish: Medicinrester samt alle materialer, der er brugt til rekonstitution og administration, skal destrueres i overensstemmelse med standardprocedurer, der gælder for antineoplastiske stoffer, under hensyntagen til gældende lovgivning med relation til bortskaffelse af farligt affald.
English: No difference in terms of outcome was observed between children and adults (Bernardo ME et al.; Blood 2012; 120(2):473-6).
Danish: Der blev ikke observeret nogen forskel hvad angår udfaldet mellem børn og voksne (Bernardo ME et al.; Blood 2012; 120(2):473-6).
English: Children younger than 1 year may have more severe side effects that affect breathing than older ones.
Danish: Børn under 1 år kan have sværere bivirkninger, der påvirker vejrtrækningen, end ældre børn.
English: This medicine may make you infertile and it may not be possible for you to get pregnant after treatment with it.
Danish: Dette lægemiddel kan gøre dig ufrugtbar, og det kan være, at du ikke kan blive gravid, efter du er blevet behandlet med det.
English: • Hypersensitivity to the active substance
Danish: • Overfølsomhed over for det aktive stof
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.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: a Adjusted for donor type as factor, and risk group and centre as strata using Cox regression model.
Danish: Justeret for donortype som faktor og risikogruppe og center som strata ved hjælp af Cox regressionsmodel.
English: One of 564 adult patients (0.2%) developed a second malignancy (breast cancer).
Danish: En ud af 564 voksne patienter (0,2 %) udviklede en sekundær malignitet (brystcancer).
English: Large bore needles are recommended to minimise pressure and the possible formation of aerosols.
Danish: Kanyler med store huller anbefales for at minimere trykket og den mulige dannelse af aerosoler.
English: Guidelines for the safe disposal of antineoplastic agents must be observed.
Danish: Retningslinjer for en sikker bortskaffelse af antineoplastiske stoffer skal overholdes.
English: Therefore, treosulfan is unlikely to participate in, or contribute to, potential CYP450-mediated interactions in vivo.
Danish: Derfor er det usandsynligt, at treosulfan deltager i eller bidrager til mulige CYP450-medierede interaktioner in vivo.
English: Intravenous administration should be performed using a safe technique to avoid extravasation (see section 4.4).
Danish: Intravenøs administration skal udføres med en sikker teknik for at undgå ekstravasation (se pkt.
English: This medicine contains no other ingredients.
Danish: Dette lægemiddel indeholder ingen andre indholdsstoffer.
English: However, an approximately 3-fold higher exposure in brain tissue of juvenile rats in comparison to young adults was found.
Danish: Der var imidlertid en ca. 3 gange større eksponering i hjernevævet hos juvenile rotter sammenlignet med unge voksne rotter.
English: The most serious side effects of treosulfan therapy or the transplant procedure include:
Danish: De mest alvorlige bivirkninger ved behandlingen med treosulfan eller transplantationsproceduren omfatter:
English: Results of GvHD are shown in Table 2.
Danish: Resultater for GvHD er vist i tabel 2.
English: All five paediatric patients received alloHSCT for primary immunodeficiencies, i.e. diseases with an increased risk for neoplasias per se.
Danish: 5 pædiatriske patienter fik alloHSCT for primære immundefekter, dvs. sygdomme, der i sig selv har en øget risiko for neoplasier.
English: Vaccines
Danish: Vacciner
English: No patient experienced a primary graft failure but one patient with ALL experienced a secondary graft failure.
Danish: Ingen af patienterne oplevede et primært transplantationssvigt, men en patient med ALL oplevede et sekundært transplantationssvigt.
English: The overall incidence of infections in 88 paediatric patients was 11.4% (10/88) and thus comparable to that seen in adults.
Danish: Den samlede forekomst af infektioner hos 88 pædiatriske patienter var 11,4 % (10/88) og svarer dermed til, hvad der observeres hos voksne.
English: Plasma concentrations of treosulfan decline exponentially and are best described by a first order elimination process fitted by a two-compartment model.
Danish: Plasmakoncentrationerne af treosulfan falder eksponentielt, og de kan bedst beskrives som en førsteordens-eliminationsproces tilpasset til en two compartment-model.
English: Conventional dose calculation simply based on BSA results in a significantly higher exposure (AUC) of smaller children and infants with low BSA compared to adolescents or adults.
Danish: Traditionel dosisberegning blot baseret på BSA fører til en signifikant højere eksponering (AUC) af mindre børn og spædbørn med lav BSA sammenlignet med unge eller voksne.
English: Therefore, infants ≤ 4 months of age should be monitored for signs of neurological adverse reactions.
Danish: Derfor skal spædbørn ≤ 4 måneder overvåges for tegn på neurologiske bivirkninger.
English: Therefore, nappies should be changed frequently up to 6-8 hours after each infusion of treosulfan.
Danish: Derfor skal bleen skiftes hyppigt i op til 6-8 timer efter hver infusion af treosulfan.
English: The haematologic status should be closely monitored and vigorous supportive measures instituted as medically indicated.
Danish: Den hæmatologiske status skal overvåges nøje, og der skal iværksættes kraftige støtteforanstaltninger, hvis det er medicinsk indiceret.
English: Treosulfan does not bind to plasma proteins.
Danish: Treosulfan binder ikke til plasmaproteiner.
English: Table 1: Treatment results at 24 months (Full analysis set) Parameter
Danish: Tabel 1: Behandlingsresultater efter 24 måneder (fuldstændigt analysesæt) Parameter
English: 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.
Danish: Ca. 25-40 % af treosulfandosen udskilles uændret i urinen i løbet af 24 timer, hvoraf næsten 90 % i løbet af de første 6 timer efter administration.
English: Secondary malignancies are well-established complications in long-term survivors after alloHSCT.
Danish: Sekundære maligniteter er velunderbyggede komplikationer hos patienter, der overlever i lang tid efter alloHSCT.
English: • decrease in blood cell counts which is the intended effect of the medicine to prepare you for your transplant infusion (all patients: very common)
Danish: • nedsat antal blodlegemer, hvilket er den tilsigtede virkning af lægemidlet, så du forberedes på din transplantationsinfusion (alle patienter: meget almindelig)
English: Septic shockc
Danish: Septisk shockc
English: The latter may also be reduced by the use of a venting needle.
Danish: Sidstnævnte kan også reduceres ved at anvende en ventilationskanyle.
English: Very common Pruritus
Danish: Meget almindelig Pruritus
English: • pain in arms or legs
Danish: • smerter i arme eller ben
English: Blood cell counts usually recover after HSCT.
Danish: Antallet af blodlegemer normaliseres sædvanligvis efter HSCT.
English: You must not get pregnant during treatment with this medicine and up to 6 months after treatment.
Danish: Du må ikke blive gravid under behandlingen med dette lægemiddel, og i op til 6 måneder efter behandlingen.
English: Administration of treosulfan should be supervised by a physician experienced in conditioning treatment followed by alloHSCT.
Danish: Administration af treosulfan skal overvåges af en læge med erfaring i konditionerende behandling efterfulgt af alloHSCT.
English: Mean apparent terminal half-life of treosulfan was comparable between the different age groups and ranged between 1.3 and 1.6 hours.
Danish: Den gennemsnitlige tilsyneladende terminale halveringstid for treosulfan var sammenlignelig i de forskellige aldersgrupper og i intervallet fra 1,3 til 1,6 timer.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter rekonstitution.
English: Seizure in the context of an encephalitis infection was reported in one of 88 paediatric patients.
Danish: Krampeanfald i forbindelse med en encefalitisinfektion blev rapporteret hos 1 ud af 88 pædiatriske patienter.
English: As with all cytotoxic substances, appropriate precautions should be taken when handling treosulfan.
Danish: Som for alle cytotoksiske stoffer, skal der tages passende forholdsregler, når treosulfan håndteres.
English: The age of the patients ranged from 0.4 to 30.5 years, and 29% had HCT-CI scores > 2.
Danish: Patienternes alder var fra 0,4 til 30,5 år, og 29 % havde HCT-CI-scores på > 2.
English: Trecondi is a cell-killing (cytotoxic) medicine that is used to decrease the number of blood cells.
Danish: Trecondi er et celledræbende (cytotoksisk) lægemiddel, der anvendes til at nedsætte antallet af blodlegemer.
English: Events were defined as relapse of disease, graft failure or death (whatever occurred first).
Danish: Hændelser blev defineret som sygdomsrecidiv, transplantationssvigt eller dødsfald (den hændelse, der fandt sted først).
English: Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Danish: Lægen vil overvåge dine blodtal og leverenzymer regelmæssigt for at opdage og behandle disse hændelser.
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%]).
Danish: Hyppigheden var højere i den pædiatriske gruppe på 12-17 år (6/35 [17,1 %]) sammenlignet med yngre børn (4/53 [7,5 %]).
English: Regression analysis of the area under the curve (AUC0-∞) versus treosulfan dose indicated a linear correlation.
Danish: Regressionsanalyse af arealet under kurven (AUC0-∞) versus treosulfandosis indikerede en lineær korrelation.
English: • problems sleeping (insomnia)
Danish: • søvnbesvær (søvnløshed)
English: No pharmacokinetic studies with treosulfan were done in patients with severe renal or hepatic impairment, because such patients are generally excluded from alloHSCT.
Danish: Der blev ikke udført nogen farmakokinetiske studier med treosulfan hos patienter med svært nedsat nyre- eller leverfunktion, da sådanne patienter generelt er udelukket fra alloHSCT.
English: However, if you think you have received more of this medicine than you should, tell your doctor or nurse as soon as possible.
Danish: Hvis du imidlertid mener, at du har fået for meget af dette lægemiddel, skal du fortælle det til din læge eller sundhedspersonalet så hurtigt som muligt.
English: • blocking of a vein into the liver (adults: uncommon; children and adolescents: not known)
Danish: • blokering af en vene til leveren (voksne: ikke almindelig, børn og unge: ikke kendt)
English: White crystalline powder.
Danish: Hvidt, krystallinsk pulver.
English: There are no data from the use of treosulfan in pregnant women.
Danish: Der er ingen data fra anvendelse af treosulfan til gravide kvinder.
English: 4.5 Interaction with other medicinal products and other forms of interaction No interaction of treosulfan was observed in high-dose chemotherapy.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Der blev ikke observeret nogen interaktion med treosulfan ved højdosis kemoterapi.
English: This medicine can cause nausea, vomiting and dizziness which may reduce your ability to drive or use machines.
Danish: Dette lægemiddel kan give dig kvalme, få dig til at kaste op og gøre dig svimmel, hvilket kan nedsætte din evne til at føre motorkøretøj eller betjene maskiner.
English: Treosulfan is considered an irritant.
Danish: Treosulfan anses for at være et irriterende stof.
English: The overall incidence of infections was 13.1% (74/564).
Danish: Den samlede forekomst af infektioner var 13,1 % (74/564).
English: Figure 1: Kaplan-Meier estimates of event-free survival (Full Analysis Set)
Danish: Figur 1: Kaplan-Meier-estimater af hændelsesfri overlevelse (fuldstændigt analysesæt)
English: For storage conditions after reconstitution of the medicine, see the information below for healthcare professionals.
Danish: For opbevaringsbetingelser efter rekonstitution af lægemidlet, se oplysningerne nedenfor til læger og sundhedspersonale.
English: How much treosulfan contributes to their occurrence is unknown.
Danish: I hvor høj grad treosulfan bidrager til forekomsten er ukendt.
English: Name and address of the manufacturer(s) responsible for batch release medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: This medicine is used in combination with fludarabine and in most cases also with thiotepa.
Danish: Dette lægemiddel anvendes i kombination med fludarabin og i de fleste tilfælde også med thiotepa.
English: An Italian group treated 60 TM patients (age range 1-37 years; including 12 adults) with the FT14 plus thiotepa regimen.
Danish: En italiensk gruppe behandlede 60 TM-patienter (alder fra 1-37 år, herunder 12 voksne) med FT14- plus thiotepa-programmet.
English: If possible it is recommended to work on a special safety workbench, equipped with laminar flow, with liquid-impermeable, absorbent disposable foil.
Danish: Hvis det er muligt, anbefales det at arbejde på et specielt sikkerhedsarbejdsbord udstyret med laminært flow og absorberende engangsfolie, som er uigennemtrængeligt for væske.
English: Although it cannot be proved that treosulfan was the cause, the use of clonazepam prophylaxis for children younger than 1 year might be considered.
Danish: Selvom det ikke kan verificeres, at treosulfan var årsagen, kan det overvejes at bruge clonazepamprofylakse hos børn under 1 år.
English: Treosulfan is for intravenous use as a two-hour infusion.
Danish: Treosulfan er til intravenøs anvendelse som en 2-timers infusion.
English: Since inflammation of the oral mucosa is a common side effect of this medicine, you should pay attention to adequate oral hygiene.
Danish: Da betændelse af slimhinden i munden er en almindelig bivirkning ved dette lægemiddel, skal du være opmærksom på en tilstrækkelig mundhygiejne.
English: The most frequent adverse reaction was febrile neutropenia (11.3%).
Danish: Den hyppigste bivirkning var febril neutropeni (11,3 %).
English: The most frequent type was lung infection (12/74 [16.2%]).
Danish: Den hyppigste type var lungeinfektion (12/74 [16,2 %]).
English: In one study, 31 NMD patients were treated with the FT14 regimen plus anti-thymocyte globulin.
Danish: I et studie blev 31 NMD-patienter behandlet med FT14-programmet plus anti-thymocytglobulin.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal produktet anvendes straks, med mindre rekonstitutionsmetoden udelukker risikoen for mikrobiel forurening.
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.
Danish: Efter langvarig behandling med konventionelle doser af oral treosulfan hos patienter med faste tumorer blev akut myeloid leukæmi observeret hos 1,4 % ud af 553 patienter.
English: It is unknown whether treosulfan is excreted in human milk.
Danish: Det er ukendt, om treosulfan udskilles i human mælk.
English: Remove the treosulfan powder carefully from the inner surface of the vial by shaking.
Danish: Fjern treosulfan-pulveret omhyggeligt fra indersiden af hætteglasset ved at ryste det.
English: Table 2: Cumulative incidence of GvHD (Full analysis set) Parameter
Danish: Tabel 2: Kumulativ forekomst af GvHD (fuldstændigt analysesæt) Parameter
English: The overall incidence of veno-occlusive liver disease (VOD) was 0.9% (5/564).
Danish: Den samlede forekomst af venookklusiv leversygdom (VOD) var 0,9 % (5/564).
English: EU/1/18/1351/001 (1 g, 1 vial) EU/1/18/1351/002 (1 g, 5 vials) EU/1/18/1351/003 (5 g, 1 vial) EU/1/18/1351/004 (5 g, 5 vials)
Danish: EU/1/18/1351/001 (1 g, 1 hætteglas) EU/1/18/1351/002 (1 g, 5 hætteglas) EU/1/18/1351/003 (5 g, 1 hætteglas) EU/1/18/1351/004 (5 g, 5 hætteglas)
English: Instructions for reconstitution of treosulfan:
Danish: Anvisninger i rekonstitution af treosulfan:
English: Do not store in a refrigerator (2 °C-8 °C) as this might cause precipitation.
Danish: Må ikke opbevares i køleskab (2 °C-8 °C), da det kan forårsage udfældning.
English: On the basis of human data, treosulfan has been classified by the International Agency for Research on Cancer (IARC) as a human carcinogen.
Danish: På basis af humane data er treosulfan blevet klassificeret som karcinogent for mennesker af International Agency for Research on Cancer (IARC).
English: It is therefore recommended to monitor blood cell counts frequently until recovery of the haematopoietic system.
Danish: Det anbefales derfor at overvåge antallet af blodlegemer hyppigt, indtil det hæmatopoietiske system er restitueret.
English: Women of childbearing potential/Contraception in males and females Both sexually active men and women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder Både seksuelt aktive mænd og kvinder i den fertile alder skal anvende sikker kontraception under behandlingen og i op til 6 måneder efter behandlingen.
English: You should stop breast-feeding before starting treatment with this medicine.
Danish: Du skal holde op med at amme, før du påbegynder behandlingen med dette lægemiddel.