FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of published clinical studies supporting the efficacy of thiotepa are summarised:
Danish: Resultaterne af offentliggjorte kliniske undersøgelser, der støtter effekten af thiotepa, er sammenfattet i det følgende:
English: The increased risk of a secondary malignancy with thiotepa, a known carcinogen in humans, must be explained to the patient.
Danish: Den øgede risiko for sekundær malignitet i forbindelse med thiotepa, et kendt carcinogen for mennesker, skal forklares for patienten.
English: However, in clinical studies, a proportion of patients over the age of 65 received the same cumulative dose as the other patients.
Danish: I kliniske undersøgelser modtog en andel af patienterne på 65 år og derover den samme kumulerede dosis som de øvrige patienter.
English: Urinary excretion of thiotepa and TEPA is nearly complete after 6 and 8 hours respectively.
Danish: Urinudskillelse af thiotepa og TEPA er næsten fuldstændig efter henholdsvis seks og otte timer.
English: You must tell your doctor if you are pregnant or you think you may be pregnant before you receive TEPADINA.
Danish: Fortæl det til lægen, hvis du er gravid, eller hvis du tror, at du kan være gravid, inden du modtager TEPADINA.
English: Remove the syringe and the needle and mix manually by repeated inversions.
Danish: Fjern sprøjten og kanylen, og bland manuelt ved gentagne inversioner.
English: GvHD (graft versus host disease): all conditioning treatments evaluated assured a low incidence of acute GvHD grade III-IV (from 4% to 24%).
Danish: GvHD (graft versus host-sygdom): Alle de vurderede konditioneringer sikrede en lav forekomst af akut GvHD klasse III-IV (fra 4 % til 24 %).
English: Like all medicines, TEPADINA can cause side effects, although not everybody gets them.
Danish: TEPADINA kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Previous brain irradiation or craniospinal irradiation may contribute to severe toxic reactions (e.g. encephalopathy).
Danish: Tidligere hjernebestråling eller kraniospinal bestråling kan bidrage til svære toksiske reaktioner (f.eks. encefalopati).
English: Delirium Nervousness Hallucination Agitation
Danish: Delirium Nervøsitet Hallucination Agitation
English: The safety of thiotepa has been examined through a review of adverse events reported in published data from clinical trials.
Danish: Thiotepas sikkerhed er blevet undersøgt ved en gennemgang af bivirkninger rapporteret i publicerede data fra kliniske studier.
English: Because TEPADINA destroys bone marrow cells responsible for producing blood cells, regular blood tests will be taken during treatment to check your blood cell counts.
Danish: Da TEPADINA ødelægger knoglemarvsceller, som er ansvarlige for at producere blodceller, bliver der taget regelmæssige blodprøver under behandlingen for at kontrollere dine blodlegemer.
English: In these studies, a total of 6,588 adult patients and 902 paediatric patients received thiotepa for conditioning treatment prior to haematopoietic progenitor cell transplantation.
Danish: I disse studier har i alt 6.588 voksne og 902 børn fået thiotepa som konditionerende behandling før hæmatopoietisk stamcelletransplantation.
English: Concomitant use not recommended
Danish: Samtidig brug tilrådes ikke
English: Pharmacotherapeutic group: Antineoplastic agents, Alkylating Agents, ATC code: L01AC01
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler, alkylerende midler , ATC-kode: L01AC01
English: You will receive your infusions every 12 or 24 hours.
Danish: Du modtager dine infusioner med 12 eller 24 timers mellemrum.
English: It is unknown whether thiotepa is excreted in human milk.
Danish: Det er ukendt, om thiotepa udskilles i human mælk.
English: All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Danish: Alle overførselsprocedurer kræver streng overholdelse af aseptiske teknikker, og der bør anvendes sikkerhedsskærm med vertikalt laminarflow.
English: The conditioning treatment must provide cytoreduction and ideally disease eradication.
Danish: Konditioneringen skal sikre cytoreduktion og ideelt sygdomsudryddelse.
English: When treating such patients it is recommended that serum transaminase, alkaline phosphatase and bilirubin are monitored regularly following transplant, for early detection of hepatotoxicity.
Danish: Ved behandling af sådanne patienter anbefales det, at serumtransaminase, alkalisk fosfatase og bilirubin regelmæssigt monitoreres efter transplantation med henblik på tidlig påvisning af hepatoksicitet.
English: There are no data on the use of thiotepa during pregnancy.
Danish: Der foreligger ingen data om anvendelse af thiotepa under graviditet.
English: The metabolites are active alkylating agents but the role they play in the antitumor activity of thiotepa remains to be elucidated.
Danish: Metabolitterne er aktive alkylerende stoffer, men den rolle, de spiller for thiotepas antitumor-aktivitet, skal stadig belyses.
English: The mean urinary recovery of thiotepa and its metabolites is 0.5% for the unchanged medicinal product and monochlorotepa, and 11% for TEPA and thiotepa-mercapturate.
Danish: Middelværdien for urinrestitution for thiotepa og dets metabolitter er 0,5 % for det uændrede lægemiddel og monokloro-tepa og 11 % for TEPA og thiotepa-merkapturat.
English: As a precautionary measure, women must not breast-feed during treatment with TEPADINA.
Danish: Som en sikkerhedsforanstaltning må kvinder ikke amme under behandling med TEPADINA.
English: No conventional acute and repeat dose toxicity studies were performed.
Danish: Der er ikke gennemført konventionelle undersøgelser af toksicitet efter akutte og gentagne doser.
English: Thiotepa must not be concurrently administered with cyclophosphamide when both medicinal products are present in the same conditioning treatment.
Danish: Thiotepa må ikke indgives samtidig med cyklofosfamid, når begge lægemidler er til stede i samme konditionering.
English: The apparent volume of distribution of thiotepa appears independent of the administered dose.
Danish: Det umiddelbare fordelingsvolumen for thiotepa er tilsyneladende uafhængigt af den indgivne dosis.
English: Daily white blood cell counts and platelet counts are recommended during therapy with thiotepa and after transplant for at least 30 days.
Danish: Daglig tælling af hvide blodlegemer og trombocyttal anbefales under behandling med thiotepa og efter transplantation i mindst 30 dage.
English: It is not known whether this medicinal product is excreted in breast milk.
Danish: Det vides ikke, om denne medicin udskilles i modermælk.
English: Live attenuated vaccines (except yellow fever): risk of systemic, possibly fatal disease.
Danish: Levende svækkede vacciner (med undtagelse af gul feber): risiko for systemisk, muligvis dødelig sygdom.
English: Infection susceptibility increased Sepsis
Danish: Øget følsomhed for infektioner Sepsis
English: Frequent complete blood counts, including differential white blood cell counts, and platelet counts need to be performed during the treatment and until recovery is achieved.
Danish: Der skal foretages hyppige komplette blodtællinger, herunder differential tælling af hvide blodlegemer, samt trombocyttællinger under behandlingen, og indtil restituering opnås.
English: Concomitant use to take into consideration Ciclosporine, tacrolimus: excessive immunosuppression with risk of lymphoproliferation.
Danish: Samtidig brug skal overvejes Ciclosporin, tacrolimus: overdreven immunsuppression med risiko for lymfoproliferation.
English: Procedures for proper handling and disposal of anticancer medicinal products must be considered.
Danish: Der skal anvendes procedurer for korrekt håndtering og destruktion af anticancer-lægemidler.
English: TEPADINA is indicated, in combination with other chemotherapy medicinal products:
Danish: TEPADINA er indiceret i kombination med andre kemoterapeutika:
English: In some cases, relapse rates of 35% and of 45% have been reported at 5 years and 6 years respectively.
Danish: I nogle tilfælde er der rapporteret tilbagefaldsprocenter på 35 % og 45 % efter henholdsvis fem og seks år.
English: Dose modification is not recommended for transient alterations of hepatic parameters (see section 4.4).
Danish: Dosisjustering anbefales ikke ved forbigående ændringer af leverparametre (se pkt.
English: Thiotepa undergoes rapid and extensive hepatic metabolism and metabolites could be detected in urine within 1 hour after infusion.
Danish: Thiotepa gennemgår hurtig og omfattende levermetabolisme, og metabolitter kan registreres i urinen inden for en time efter infusion.
English: These metabolites are not found in urine, and, if formed, are probably excreted in bile or as intermediate metabolites rapidly converted into thiotepa-mercapturate.
Danish: Disse metabolitter findes ikke i urin og udskilles, hvis de dannes, sandsynligvis via galden eller som intermediære metabolitter, der hurtigt omdannes til thiotepa-merkapturat.
English: The infusion solution must be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Danish: Infusionsopløsningen skal indgives til patienter ved hjælp af et infusionssæt, der er forsynet med et 0,2 µm integreret filter.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis præparatet ikke anvendes omgående, er opbevaringstid og -forhold før anvendelse brugerens ansvar og må normalt ikke overstige ovennævnte forhold, når fortynding har fundet sted under kontrollerede og godkendte aseptiske forhold.
English: Both women and men using TEPADINA must use effective contraceptive methods during treatment.
Danish: Både kvinder og mænd, der modtager TEPADINA, skal anvende effektiv prævention under behandlingen.
English: After intravenous administration, plasma concentrations of the active substance fit a two compartment model with a rapid distribution phase.
Danish: Efter intravenøs indgivelse passer koncentrationen af det aktive stof i plasma ind i en torumsmodel med en hurtig fordelingsfase.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret således: meget almindelig (≥1/10), almindelig (≥1/100 to <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).
English: Do not use TEPADINA after the expiry date which is stated on the carton and vial label, after EXP.
Danish: Brug ikke TEPADINA efter den udløbsdato, der står på æsken og etiketten på hætteglasset.
English: This risk is increased in subjects who are already immunosuppressed by their underlying disease.
Danish: Risikoen er forhøjet hos forsøgspersoner, hvis immunforsvaret i forvejen er svækket som følge af deres underliggende sygdom.
English: Pulmonary arterial hypertension
Danish: Pulmonal arteriel hypertension
English: The haematological status needs to be closely monitored and vigorous supportive measures instituted as medically indicated.
Danish: Den hæmatologiske tilstand skal monitoreres nøje, og effektive støtteforanstaltninger skal iværksættes, hvis det er medicinsk indiceret.
English: Mental status changes
Danish: Ændringer i psykisk tilstand
English: TEPADINA is for single use only.
Danish: TEPADINA er kun til engangsbrug.
English: Serious toxicities involving the haematologic, hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Danish: Alvorlig toksicitet, der involverer det hæmatologiske system, leversystemet og luftvejene, blev betragtet som forventede følger af konditioneringen og transplantationsprocessen.
English: Therefore, during the concomitant use of thiotepa and these medicinal products, patients should be carefully monitored clinically.
Danish: Under samtidig brug af thiotepa og disse lægemidler skal patienterne derfor omhyggeligt monitoreres klinisk.
English: As thiotepa and its metabolites are poorly excreted in the urine, dose modification is not recommended in patients with mild or moderate renal insufficiency.
Danish: Da thiotepa og dets metabolitter kun i ringe grad udskilles i urinen, anbefales dosisjustering ikke hos patienter med mild eller moderat nyreinsufficiens.
English: Reconstituted solutions may occasionally show opalescence; such solutions can still be administered.
Danish: Rekonstituerede opløsninger kan af og til være opaliserede.
English: The volume of distribution of thiotepa is large and it has been reported as ranging from 40.8 l/m2 to 75 l/m2, indicating distribution to total body water.
Danish: Fordelingsvoluminet for thiotepa er stort, og det varierer i henhold til rapporter fra 40,8 l/m til 75 l/m2, hvilket angiver, at thiotepa fordeles til total body water.
English: PRESENTATION
Danish: PRÆSENTATION
English: TEPADINA is used to prepare patients for bone marrow transplantation.
Danish: TEPADINA bruges til forberedelse af patienter til knoglemarvstransplantation.
English: The radiomimetic action of thiotepa is believed to occur through the release of ethylene imine radicals that, as in the case of irradiation therapy, disrupt the bonds of DNA, e.g. by alkylation of guanine at the N-7, breaking the linkage between the purine base and the sugar and liberating alkylated guanine.
Danish: Thiotepas radiomimetiske virkning menes at opstå gennem frigivelsen af ethylenimin-radikaler, der ligesom ved strålebehandling forstyrrer DNA-strengene, f.eks. ved alkylering af guanin i N-7, så sammenkædningen mellem purinbaser og sukker brydes, og alkyleret guanin frigives.
English: Patients who have received prior radiation therapy, greater than or equal to three cycles of chemotherapy, or prior progenitor cell transplant may be at an increased risk of hepatic veno-occlusive disease (see section 4.8).
Danish: Patienter, der tidligere har modtaget strålebehandling, mere end eller svarende til 3 cykler kemoterapi eller tidligere progenitorcelletransplantation, kan have en øget risiko for hepatisk venookklusiv sygdom (se pkt.
English: TEPADINA can be used in adults and children and adolescents.
Danish: TEPADINA kan anvendes til voksne ,børn og unge.
English: Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Danish: Profylaktisk eller empirisk brug af lægemidler mod bakterie-, svampe- og virusinfektioner skal overvejes med henblik på at forebygge og håndtere infektioner i perioden med neutropeni.
English: Severe granulocytopenia, thrombocytopenia, anaemia or any combination thereof may develop.
Danish: Svær granulocytopeni, trombocytopeni, anæmi eller en kombination heraf kan udvikles.
English: The pharmacokinetics of high dose thiotepa in children between 2 and 12 years of age do not appear to vary from those reported in children receiving 75 mg/m2 or adults receiving similar doses.
Danish: De farmakokinetiske værdier for højdosis-thiotepa hos børn på 2-12 år varierer tilsyneladende ikke fra de værdier, der er rapporteret hos børn, der modtog 75 mg/m2, eller voksne, der modtog tilsvarende doser.
English: You must not use TEPADINA during pregnancy.
Danish: Du må ikke anvende TEPADINA under graviditet.
English: The total excreted amount of thiotepa and its identified metabolites accounts for 54-100% of the total alkylating activity, indicating the presence of other alkylating metabolites.
Danish: Den samlede mængde udskilt thiotepa og dets identificerede metabolitter tegner sig for 54 % til 100 % af den samlede alkylerende aktivitet, hvilket angiver, at andre alkylerende metabolitter er til stede.
English: It was teratogenic in mice and in rats, and foeto-lethal in rabbits.
Danish: Det var teratogent hos mus og rotter og føtoletalt hos kaniner.
English: The most important adverse reactions expected in case of overdose is myeloablation and pancytopenia.
Danish: De vigtigste bivirkninger, der forventes i tilfælde af overdosering, er myeloablation og pancytopeni.
English: Each carton contains 1 vial.
Danish: Hver æske indeholder 1 hætteglas.
English: Toxic shock syndrome
Danish: Toksisk shocksyndrom
English: • when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.
Danish: • når højdosis-kemoterapi med HPCT-støtte er hensigtsmæssig til behandling af solide tumorer hos børn og voksne.
English: CSF and plasma concentrations of TEPA, the first reported active metabolite of thiotepa, exceed the concentrations of the parent compound.
Danish: CSF- og plasmakoncentrationen af TEPA, den første rapporterede aktive metabolit af thiotepa, overstiger koncentrationen af udgangsstoffet.
English: Due to its lack of extramedullary toxicity despite dose escalation beyond myelotoxic doses, thiotepa has been used for decades in combination with other chemotherapy medicinal products prior to autologous and allogeneic HPCT.
Danish: Som følge af dets mangel på ekstramedullær toksicitet trods dosisoptrapning ud over myelotoksiske doser er thiotepa blevet anvendt i årtier i kombination med andre kemoterapeutika før autolog og allogen HPCT.
English: Engraftment: Engraftment has been achieved (92%-100%) in all reported conditioning treatments and it was considered to occur at the expected time.
Danish: Engraftment: Engraftment blev opnået (92 % til 100 %) ved alle rapporterede konditioneringer og angiveligt på det forventede tidspunkt.
English: 20867 Caponago (MB) Italy
Danish: 20867 Caponago (MB) Italien
English: Pancytopenia Granulocytopenia
Danish: Pancytopeni Granulocytopeni
English: In allogeneic HPCT, the conditioning treatment must be sufficiently immunosuppressive and myeloablative to overcome host rejection of the graft.
Danish: Ved allogen HPCT skal konditioneringen være tilstrækkeligt immunsuppressiv og myeloablativ til at overvinde værtsafstødning af graften.
English: The high intra-individual variability of the coagulation state during malignancy, and the potential interaction between oral anticoagulants and anticancer chemotherapy require, if it is decided to treat the patient with oral anticoagulants, to increase the frequency of the INR (International Normalised Ratio) monitoring.
Danish: Som følge af den høje intraindividuelle variabilitet af koagulationstilstanden under malignitet og den potentielle interaktion mellem perorale antikoagulerende midler og kemoterapi mod kræft er øget overvågning af INR (International Normalised Ratio) påkrævet, hvis det besluttes at behandle patienten med perorale antikoagulerende midler.
English: RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald Germany
Danish: RIEMSER Pharma GmbH Bahnhofstraße 44b 17489 Greifswald Tyskland
English: The administration of thiotepa has not been specifically investigated in elderly patients.
Danish: Thiotepa er ikke undersøgt specifikt hos ældre patienter.
English: Engraftment: It has been achieved with all evaluated conditioning regimens including thiotepa with a success rate of 96% - 100%.
Danish: Engraftment: Engraftment er opnået med alle vurderede konditioneringer, der omfatter thiotepa, med en succesprocent på 96 % til 100 %.
English: The total clearance of thiotepa ranged from 11.4 to 23.2 l/h/m2.
Danish: Eliminering Den samlede clearance for thiotepa varierede fra 11,4 til 23,2 l/t/m2.
English: Thiotepa appears to be metabolised via CYP2B6 and CYP3A4.
Danish: Thiotepa metaboliseres tilsyneladende via CYP2B6 og CYP3A4.
English: Women of childbearing potential have to use effective contraception during treatment and a pregnancy test should be performed before treatment is started.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen, og en graviditetstest skal udføres, inden behandlingen påbegyndes.
English: Concomitant use with live attenuated vaccines (except yellow fever vaccines), phenytoin and fosphenytoin is not recommended (see section 4.5).
Danish: Samtidig brug med levende svækkede vacciner (med undtagelse af vacciner mod gul feber), fenytoin og fosphenytoin anbefales ikke (se pkt.
English: Cases of leukoencephalopathy have been observed following treatment with thiotepa in adult and paediatric patients with multiple previous chemotherapies, including methotrexate and radiotherapy.
Danish: Tilfælde af leukoencefalopati er blevet observeret efter behandling med thiotepa hos voksne og pædiatriske patienter, der tidligere havde fået adskillige kemoterapiregimer, inklusive methotrexat og radioterapi.
English: From a microbiological point of view, the product should be used immediately after dilution.
Danish: Ud fra en mikrobiologisk betragtning bør præparatet anvendes umiddelbart efter fortynding.
English: Thiotepa was shown to be genotoxic in vitro and in vivo, and carcinogenic in mice and rats.
Danish: Thiotepa har vist sig at være genotoksisk in vitro og in vivo og kræftfremkaldende hos mus og rotter.
English: Contraindications of concomitant use Yellow fever vaccine: risk of fatal generalized vaccine-induced disease.
Danish: Kontraindikationer for samtidig brug Vaccine mod gul feber: risiko for dødelig generaliseret vaccinefremkaldt sygdom.
English: There is no known antidote for thiotepa.
Danish: Der er ingen kendt antidot til thiotepa.
English: Severe toxic skin reactions including cases of StevensJohnson syndrome and toxic epidermal necrolysis
Danish: Alvorlige toksiske hudreaktioner, heriblandt Stevens-Johnson syndrom og toksisk epidermal nekrolyse
English: Disease Free Survival (DFS): Percentages of 40% - 75% with follow-up of more than 1 year have been reported.
Danish: Sygdomsfri overlevelse: Der er rapporteret procentdele på 40 % til 75 % med en opfølgningsperiode på mere end ét år.
English: Thiotepa is a polyfunctional cytotoxic agent related chemically and pharmacologically to the nitrogen mustard.
Danish: Thiotepa er et polyfunktionelt cytotoksisk stof, der kemisk og farmakologisk er relateret til kvælstofsennepgas.
English: MULTIPLE MYELOMA
Danish: MULTIPELT MYELOM
English: Disease Free Survival (DFS): With a follow-up of 36 to 57 months, DFS ranged from 46% to 70% in the reported studies.
Danish: Sygdomsfri overlevelse: Med en opfølgningsperiode på 36 til 57 måneder varierede den sygdomsfri overlevelse (DFS) fra 46 % til 70 % i alle rapporterede undersøgelser.
English: • with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;
Danish: • med eller uden helkropsbestråling (TBI), som konditionering før allogen eller autolog hæmatopoietisk progenitorcelletransplantation (HPCT) hos børn og voksne med hæmatologiske sygdomme
English: Intravenous use, after reconstitution and dilution.
Danish: Intravenøs brug efter rekonstitution og fortynding.
English: Considering that all patients suffer of recurrence or poor prognosis solid tumours, these rates support the efficacy of conditioning regimens based on thiotepa.
Danish: I betragtning af at alle patienter lider af recidiv af solide tumorer eller har solide tumorer med dårlige prognoser, støtter disse tal effekten af konditioneringer baseret på thiotepa.
English: In some of the conditioning treatments evaluated, relapse rates lower than 60% have also been reported at 5 years.
Danish: For nogle af de vurderede konditioneringer er der også rapporteret lavere tilbagefaldsprocenter end 60 % efter fem år.
English: - if you are allergic to thiotepa, - if you are pregnant or think you may be pregnant, - if you are breast-feeding, - if you are receiving yellow fever vaccination, live virus and bacterial vaccines.
Danish: Brug ikke TEPADINA - hvis du er allergisk over for thiotepa - hvis du er gravid eller overvejer at blive gravid - hvis du ammer - hvis du skal vaccineres mod gul feber eller med vacciner, der indeholder levende virus eller bakterier.