FrancophonIA/ELRC3.0 huggingface dataset:
English: The consequence of treatment with thiotepa at the recommended dose and schedule is profound myelosuppression, occurring in all patients.
Danish: Som følge af behandlingen med thiotepa ved den anbefalede dosis og doseringsplan opstår der svær myelosuppression hos alle patienter.
English: During the concomitant use of thiotepa and inhibitors of CYP2B6 or CYP3A4, patients should be carefully monitored clinically (see section 4.5).
Danish: Under samtidig brug af thiotepa og CYP2B6- eller CYP3A4-inhibitorer skal patienterne klinisk monitoreres omhyggeligt (se pkt.
English: Phenytoin: risk of exacerbation of convulsions resulting from the decrease of phenytoin digestive absorption by cytotoxic medicinal product or risk of toxicity enhancement and loss of efficacy of the cytotoxic medicinal product due to increased hepatic metabolism by phenytoin.
Danish: Fenytoin: risiko for forværring af kramper som følge af den nedsættelse af den fordøjelsesmæssige absorption af fenytoin, som det cytotoksiske lægemiddel forårsager, eller risikoen for forstærket toksicitet og tab af effekt af det cytotoksiske lægemiddel som følge af den øgede levermetabolisme, der forårsages af fenytoin.
English: Alkylating chemotherapeutic agents, including thiotepa, inhibit plasma pseudocholinesterase by 35% to 70%.
Danish: Alkylerende kemoterapeutika, herunder thiotepa, hæmmer pseudocholinesterase i plasma med 3570 %.
English: Posology in adults
Danish: Dosering for voksne
English: TEPADINA may have major influence on the ability to drive and use machines.
Danish: TEPADINA kan i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: BREAST CANCER
Danish: BRYSTKRÆFT
English: Constipation Gastrointestinal perforation Ileus
Danish: Forstoppelse Gastrointestinal perforation Ileus
English: As alkylating agent, thiotepa produces the most profound inhibition of tumour cell growth in vitro with the smallest increase in medicinal product concentration.
Danish: Som et alkylerende middel producerer thiotepa den mest udtalte hæmning af tumorvækst in vitro med den mindste stigning i lægemiddelkoncentration.
English: Therefore, a clinical monitoring should be exercised during the concomitant use of thiotepa and these medicinal products.
Danish: Patienter skal derfor monitoreres klinisk under samtidig brug af thiotepa og disse lægemidler.
English: Calculation of dose of TEPADINA
Danish: Beregning af dosis af TEPADINA
English: Treatment related second malignancy
Danish: Behandlingsrelateret sekundær malignitet
English: As with other cytotoxic compounds, caution needs to be exercised in handling and preparation of TEPADINA solutions to avoid accidental contact with skin or mucous membranes.
Danish: Som med andre cytotoksiske stoffer skal der udvises forsigtighed ved håndtering og klargøring af TEPADINA-opløsninger for at forhindre utilsigtet kontakt med hud eller slimhinder.
English: Thiotepa is a weak inhibitor for CYP2B6, and may thereby potentially increase plasma concentrations of substances metabolised via CYP2B6, such as ifosfamide, tamoxifen, bupropion, efavirenz and cyclophosphamide.
Danish: Thiotepa er en svag CYP2B6-inhibitor og kan derved potentielt øge plasmakoncentrationen af stoffer, der metaboliseres via CYP2B6, f.eks. ifosfamid, tamoxifen, bupropion, efavirenz og cyclofosfamid.
English: In pre-clinical studies thiotepa, as most alkylating agents, has been shown to cause embryofoetal lethality and teratogenicity (see section 5.3).
Danish: I prækliniske undersøgelser har thiotepa som de fleste alkylerende midler vist sig at forårsage embryoføtal letalitet og teratogenicitet (se pkt.
English: You should tell your doctor if you have: - liver or kidney problems, - heart or lung problems, - seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin).
Danish: Vær ekstra forsigtig med at bruge TEPADINA Fortæl det til din læge, hvis du har: - lever- eller nyreproblemer - hjerte- eller lungeproblemer - kramper/anfald (epilepsi), eller du tidligere har haft dette (hvis du behandles med phenytoin eller fosphenytoin).
English: Thiotepa is a highly lipophilic compound.
Danish: Thiotepa er en højlipofil forbindelse.
English: Thiotepa undergoes oxidative desulphuration via the cytochrome P450 CYP2B and CYP3A isoenzyme families to the major and active metabolite TEPA (triethylenephosphoramide).
Danish: Thiotepa gennemgår oxidativ afsvovling via de cytokrome P450 CYP2B- og CYP3A-isoenzym-familier til den væsentligste og aktive metabolit TEPA (triethylen-phosphoramid).
English: There is no experience with overdoses of thiotepa.
Danish: Der er ingen erfaring med overdosering af thiotepa.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER
English: These data support the efficacy of conditioning regimens based on thiotepa in all haematological diseases.
Danish: Disse tal støtter effekten af konditioneringer baseret på thiotepa ved behandling af alle hæmatologiske sygdomme.
English: During conversion of GSH conjugates to N-acetylcysteine conjugates, GSH, cysteinylglycine, and cysteine conjugates are formed.
Danish: Under omdannelse af GSH-konjugater til N-acetylcysteinkonjugater, dannes der GSH-, cysteinylglycin- og cystein-konjugater.
English: Mental disorder due to a general medical condition
Danish: Psykisk lidelse som følge af almen sygdomstilstand
English: In order to prevent and manage infections, you will be given anti-infectives.
Danish: Du får midler mod infektion for at forebygge og behandle infektioner.
English: Platelet and red blood cell support, as well as the use of growth factors such as Granulocytecolony stimulating factor (G-CSF), should be employed as medically indicated.
Danish: Trombocyttransfusion og erytrocyttransfusion samt brug af vækstfaktorer, som f.eks. G-CSF, skal benyttes, hvis det er medicinsk indiceret.
English: TEPADINA contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.
Danish: TEPADINA indeholder det aktive stof thiotepa, som tilhører en gruppe af lægemidler mod kræft, som kaldes alkylerende midler.
English: TEPADINA is administered by a qualified healthcare professional as an intravenous infusion (drip in a vein) after dilution of the individual vial.
Danish: TEPADINA indgives af en kvalificeret sundhedsfaglig person som en intravenøs infusion (drop i en vene) efter fortynding i det individuelle hætteglas.
English: Thiotepa has marrow ablation as its dose-limiting toxicity, allowing significant dose escalation with the infusion of autologous HPCT.
Danish: Thiotepa har ablation af marv som dosisbegrænsende toksicitet, så der tillades betydelig dosisoptrapning ved infusion af autolog HPCT.
English: Inject the content of the syringe into the vial through the rubber stopper.
Danish: Injicer indholdet af den fyldte sprøjte i hætteglasset gennem gummiproppen.
English: After dilution, use within 24 hours when stored in a refrigerator.
Danish: Efter fortynding skal lægemidlet anvendes inden for 24 timer, hvis det opbevares i køleskab.
English: Relapse: In all the reported conditioning regimens containing thiotepa, relapse rates at 12 to 57 months ranged from 33% to 57%.
Danish: Tilbagefald: For alle de rapporterede konditioneringer, der omfatter thiotepa, varierede tilbagefaldsprocenten ved 12 til 57 måneder fra 33 % til 57 %.
English: Due to its pharmacological properties and its potential toxicity for breast-fed newborns/infants, breast-feeding is contraindicated during treatment with thiotepa.
Danish: Som følge af stoffets farmakologiske egenskaber og dets potentielle toksicitet for nyfødte/spædbørn, der ammes, er amning kontraindiceret under behandling med thiotepa.
English: TEPADINA is administered at different doses, in combination with other chemotherapeutic medicinal products, in patients with haematological diseases or solid tumours prior to HPCT.
Danish: TEPADINA indgives i forskellige doser i kombination med andre kemoterapeutika ved behandling af patienter med hæmatologiske sygdomme eller solide tumorer før HPCT.
English: Investigation
Danish: Undersøgelse
English: TEPADINA must be administered by a qualified healthcare professional as a 2-4 hours intravenous infusion via a central venous catheter.
Danish: TEPADINA skal indgives af en kvalificeret sundhedsfaglig person som en 2-4 timer lang intravenøs infusion via et centralvenekateter.
English: Further dilution in the infusion bag
Danish: Yderligere fortynding i infusionspose
English: Engraftment: It has been achieved with all reported conditioning regimens including thiotepa.
Danish: Engraftment: Engraftment er opnået med alle rapporterede konditioneringer, der omfatter thiotepa.
English: Hearing impaired Ototoxicity Tinnitus
Danish: Høreskade Ototoksicitet Tinnitus
English: Solutions containing a precipitate should be discarded.
Danish: Opløsninger med bundfald skal kasseres.
English: More generally, live virus and bacterial vaccines must not be administered to a patient receiving an immunosuppressive chemotherapeutic agent and at least three months must elapse between discontinuation of therapy and vaccination.
Danish: Generelt må vacciner med levende vira eller levende bakterier ikke gives til patienter, der modtager immunsuppressiv kemoterapi, og der skal gå mindst tre måneder mellem afslutning af behandlingen og vaccination.
English: Therefore, the use of gloves is recommended in preparing the solution for infusion.
Danish: Det tilrådes derfor at anvende handsker, når opløsningen forberedes til infusion.
English: Therefore it can be concluded that conditioning treatments including thiotepa are myeloablative.
Danish: Det kan derfor konkluderes, at konditioneringer, der omfatter thiotepa, er myeloablative.
English: CYP2B6 catalyzes the metabolic conversion of cyclophosphamide to its active form 4-hydroxycyclophosphamide (4-OHCP) and co-administration of thiotepa may therefore lead to decreased concentrations of the active 4-OHCP.
Danish: CYP2B6 fungerer som katalysator for den metaboliske omdannelse af cyclofosfamid til dets aktive form 4-hydroxycyclofosfamid (4-OHCP), og samtidig indgivelse af thiotepa kan derfor føre til lavere koncentration af aktivt 4-OHCP.
English: Thiotepa might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents (busulfan, fludarabine and cyclophosphamide) (see section 4.8).
Danish: Thiotepa kan forårsage pulmonar toksicitet, som kan være additiv til den påvirkning der er forårsaget af andre cytotoksiske stoffer (busulfan, fludarabin og cyklofosfamid) (se pkt.
English: Since thiotepa is mainly metabolized through the liver, caution needs to be exercised when thiotepa is used in patients with preexisting impairment of liver function, especially in those with severe hepatic impairment.
Danish: Da thiotepa hovedsagelig metaboliseres via leveren, skal der udvises forsigtighed, når thiotepa bruges til patienter med allerede eksisterende nedsat leverfunktion, især patienter med svær leverinsufficiens.
English: These include infection and Graft-versus host disease (GvHD) which, although not directly related, were the major causes of morbidity and mortality, especially in allogeneic HPCT.
Danish: Disse omfatter infektion og GvHD (graft versus host-sygdom), som var hovedårsagen til morbiditet og mortalitet, især ved allogen HPCT, selv om der ikke var direkte sammenhæng.
English: In some cases, relapse rates lower than 40% have also been reported at 5 years and 10 years.
Danish: I nogle tilfælde er der endvidere rapporteret tilbagefaldsprocenter på under 40 % efter henholdsvis fem og 10 år.
English: TEPADINA is unstable in acid medium.
Danish: TEPADINA er ustabilt i surt miljø.
English: Caution must be used in patients with history of cardiac diseases, and cardiac function must be monitored regularly in patients receiving thiotepa.
Danish: Der skal udvises forsigtighed ved patienter med hjertelidelser i anamnesen, og hjertefunktionen skal monitoreres regelmæssigt hos patienter, der behandles med thiotepa.
English: Studies in renally impaired patients have not been conducted.
Danish: Der er ikke foretaget undersøgelser hos patienter med nedsat nyrefunktion.
English: Caution must be used in patients with history of renal diseases and periodic monitoring of renal function should be considered during therapy with thiotepa.
Danish: Der skal udvises forsigtighed ved patienter med tidligere nyrelidelser, og periodisk overvågning af nyrefunktionen skal overvejes under behandling med thiotepa.
English: The most frequently adverse reactions reported in the different conditioning treatments including thiotepa are: infections, cytopenia, acute GvHD and chronic GvHD, gastrointestinal disorders, haemorrhagic cystitis, mucosal inflammation.
Danish: De hyppigst indberettede uønskede reaktioner i de forskellige konditioneringer, der omfatter thiotepa, er: infektioner, cytopeni, akute GvHD og kronisk GvHD, gastrointestinale sygdomme, hæmorragisk cystitis og slimhindeinflammation.
English: Live virus and bacterial vaccines must not be administered to a patient receiving an immunosuppressive chemotherapeutic agent and at least three months must elapse between discontinuation of therapy and vaccination.
Danish: Vacciner med levende vira eller levende bakterier må ikke gives til patienter, der modtager immunsuppressiv kemoterapi, og der skal gå mindst tre måneder mellem afslutning af behandlingen og vaccination.
English: TEPADINA infusion solution should be inspected visually for particulate matter prior to administration.
Danish: TEPADINA-opløsning til infusion skal kontrolleres visuelt for partikler før indgivelse.
English: The identified metabolites TEPA, monochlorotepa and thiotepa-mercapturate are all excreted in the urine.
Danish: De identificerede metabolitter, dvs. TEPA, monokloro-tepa og thiotepamerkapturat, udskilles alle i urinen.
English: Thrombocytopenic purpura
Danish: Trombocytopenis k purpura
English: TEPADINA must be reconstituted and diluted prior to administration.
Danish: TEPADINA skal rekonstitueres og fortyndes, før det indgives.
English: Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.
Danish: Lægen vil regelmæssigt overvåge niveauet af dine blodlegemer og leverenzymer for at konstatere og afhjælpe de ovenfor nævnte hændelser.
English: However, caution is recommended (see sections 4.4 and 5.2).
Danish: 4.4 og 5.2).
English: Co-administration of inducers of cytochrome P450 (such as rifampicin, carbamazepine, phenobarbital) may increase the metabolism of thiotepa leading to increased plasma concentrations of the active metabolite.
Danish: Samtidig indgivelse af induktorer af cytochrom P450 (f.eks. rifampicin, carbamazepin og phenobarbital) kan øge metaboliseringen af thiotepa, hvilket kan føre til øget plasmakoncentration af den aktive metabolit.
English: Thiotepa is unreliably absorbed from the gastrointestinal tract: acid instability prevents thiotepa from being administered orally.
Danish: Thiotepa absorberes ikke pålideligt fra mave-tarm-kanalen: Manglende syrestabilitet bevirker, at thiotepa ikke kan indgives peroralt.
English: The concomitant use of thiotepa and other myelosuppressive or myelotoxic agents (i.e. cyclophosphamide, melphalan, busulfan, fludarabine, treosulfan) may potentiate the risk of haematologic adverse reactions due to overlapping toxicity profiles of these medicinal products.
Danish: Samtidig brug af thiotepa og andre myelosuppressive eller myelotoksiske stoffer (dvs. cyclofosfamid, melphalan, busulfan, fludarabin eller treosulfan) kan forstærke risikoen for hæmatologiske bivirkninger som følge af disse lægemidlers overlappende toksicitetsprofiler.
English: After reconstitution, use within 8 hours when stored in a refrigerator.
Danish: Efter rekonstitution skal lægemidlet anvendes inden for otte timer, hvis det opbevares i køleskab.
English: The fraction unbound to proteins in plasma is 70-90%; insignificant binding of thiotepa to gamma globulin and minimal albumin binding (10-30%) has been reported.
Danish: Der er rapporteret ubetydelig binding af thiotepa til gammaglobulin og minimal albuminbinding (10-30 %).
English: TEPADINA administration must be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Danish: Indgivelse af TEPADINA skal monitoreres af en læge med erfaring i konditionering før hæmatopoietisk progenitorcelletransplantation.
English: Accord Healthcare GmbH Tel: +49 89 700 9951 0
Danish: Deutschland Accord Healthcare GmbH Tel: +49 89 700 9951 0
English: TEPADINA must be delivered after the completion of any cyclophosphamide infusion.
Danish: TEPADINA skal indgives efter gennemførelsen af en cyklofosfamidinfusion.
English: TEPADINA should be aseptically administered as a 2-4 hours infusion under room temperature (about 25°C) and normal light conditions.
Danish: TEPADINA skal indgives under aseptiske forhold som en 2-4 timer lang infusion ved stuetemperatur og under normale lysforhold (ca. 25°C .
English: TEPADINA posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease.
Danish: TEPADINA-dosering beskrives for voksne og børn alt efter typen af HPCT (autolog eller allogen) og sygdom.
English: As most alkylating agents, thiotepa might impair male and female fertility.
Danish: Som de fleste alkylerende midler kan thiotepa nedsætte fertiliteten hos mænd og kvinder.
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): low values have been reported, confirming the safety of the conditioning treatments including thiotepa for allogeneic HPCT in adult patients with haematological diseases.
Danish: Behandlingsrelateret mortalitet (BRM) og transplantationsrelateret mortalitet (TRM): Der er rapporteret lave værdier, hvilket bekræfter sikkerheden ved konditioneringerne med thiotepa til allogen HPCT hos voksne med hæmatologiske sygdomme.
English: Investigation Weight increased Blood bilirubin increased
Danish: Vægtstigning Forhøjet bilirubin i blodet
English: Considering that all patients were treated for high risk solid tumours, DFS results confirm that conditioning treatments containing thiotepa following autologous HPCT are effective therapeutic strategies for treating paediatric patients with solid tumours.
Danish: I betragtning af at alle patienter blev behandlet for solide højrisikotumorer, bekræfter resultaterne for samlet overlevelse, at konditioneringer, der omfatter thiotepa efter autolog HPCT, er effektive behandlingsstrategier til behandling af børn med solide tumorer.
English: What you need to know before you use TEPADINA Do not use TEPADINA
Danish: Det skal du vide, før du begynder at bruge TEPADINA Sådan skal du bruge TEPADINA Bivirkninger
English: Cardiomyopathy Myocarditis
Danish: Kardiomyopati Myokarditis
English: Co-administration with inhibitors of CYP2B6 (for example clopidogrel and ticlopidine) or CYP3A4 (for example azole antifungals, macrolides like erythromycin, clarithromycin, telithromycin, and protease inhibitors) may increase the plasma concentrations of thiotepa and potentially decrease the concentrations of the active metabolite TEPA.
Danish: Samtidig indgivelse med CYP2B6inhibitorer (f.eks. clopidogrel og ticlopidin) eller CYP3A4-inhibitorer (f.eks. azol-svampemidler, makrolider, herunder erytromycin, clarithromycin og telithromycin, og proteasehæmmere) kan forøge plasmakoncentrationen af thiotepa og potentielt sænke koncentrationen af den aktive metabolit TEPA.
English: Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines (see section 4.5).
Danish: Samtidig vaccination med vaccine mod gul feber og vacciner med levende vira eller levende bakterier (se pkt.
English: Hypopituitarism
Danish: Hypopituitarisme
English: SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Danish: REGLER FOR DESTRUKTION OG ANDEN HÅNDTERING
English: Relapse: In all the reported conditioning regimens containing thiotepa, the relapse rate was in the range of 15% - 44%.
Danish: Tilbagefald: For alle de rapporterede konditioneringer, der omfatter thiotepa, varierede tilbagefaldsprocenten fra 15 % til 44 %.
English: Erythema Desquamation Pigmentation disorder
Danish: Erytem Deskvamation Pigmentforandringer
English: THALASSEMIA
Danish: THALASSÆMI
English: - The active substance is thiotepa.
Danish: TEPADINA indeholder: - Aktivt stof: thiotepa.
English: Store and transport refrigerated (2°C-8°C).
Danish: Opbevares i køleskab og transporteres nedkølet (2 C - 8 C).
English: For instructions on reconstitution and further dilution prior to administration, see section 6.6.
Danish: 6.6 for instruktioner i rekonstitution og fortynding før administration.
English: Blood bilirubin increased Transaminases increased Blood creatinine increased Aspartate aminotransferase increased Alanine aminotransferase increased
Danish: Forhøjet blodkreatinin Forhøjet aspartataminotransferase Forhøjet alaninaminotransferase
English: It is likely that certain adverse reactions of thiotepa like dizziness, headache and blurred vision could affect these functions.
Danish: Det er sandsynligt, at visse bivirkninger ved thiotepa, som f.eks. svimmelhed, hovedpine og sløret syn, kan påvirke disse funktioner.
English: Due to the increase of thrombotic risk in case of malignancy, the use of anticoagulative treatment is frequent.
Danish: Interaktion, der er almindelig for alle cytotoksiske stoffer Som følge af den øgede thrombotiske risiko i tilfælde af malignitet anvendes der ofte antikoagulerende midler.
English: Prior to and following each infusion, the indwelling catheter line should be flushed with approximately 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Før og efter hver infusion skal det fast indlagte kateter skylles med ca. 5 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %).
English: Not known: frequency cannot be estimated from the available data - increased blood pressure in the arteries (blood vessels) of the lungs (pulmonary arterial hypertension) - severe skin damage (e.g. severe lesions, bullae, etc.) potentially involving the full body surface which can be even life-threatening - damage to a component of the brain (the so called white matter) which can be even lifethreatening (leukoencephalopathy).
Danish: Ikke kendt: hyppigheden kan ikke vurderes ud fra tilgængelige data - forhøjet blodtryk i venerne (blodkar) i lungerne (pulmonal arteriel hypertension) - alvorlige hudskader (f.eks. alvorlige læsioner, væskefyldte blærer, etc.), der kan involvere hele kroppen, hvilket endog kan være livstruende - skader i et område i hjernen (den såkaldte hvide substans), der endog kan være livsfarlige
English: Dysuria Oliguria Renal failure Cystitis Haematuria
Danish: Dysuria Oliguri Nyresvigt Cystitis Hæmatori
English: Renal impairment The effects of renal impairment on thiotepa elimination have not been assessed.
Danish: Nyreinsufficiens: Virkningen af nyreinsuffiens på eliminering af thiotepa er ikke blevet vurderet.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept (jf. bilag I: Produktresumé; pkt.
English: Thiotepa was shown to impair fertility and interfere with spermatogenesis in male mice, and to impair ovarian function in female mice.
Danish: Thiotepa har vist sig at forringe fertiliteten og påvirke spermatogenese hos hanmus og at forringe æggestokfunktionen hos hunmus.
English: If thiotepa solution accidentally contacts the skin, the skin must be immediately thoroughly washed with soap and water.
Danish: Hvis thiotepa-opløsningen utilsigtet kommer i kontakt med huden, skal huden omgående vaskes grundigt med vand og sæbe.
English: How TEPADINA is given
Danish: Sådan gives TEPADINA
English: TEPADINA must be delivered after the completion of any cyclophosphamide infusion (see section 4.5).
Danish: TEPADINA skal indgives efter gennemførelsen af en cyklofosfamidinfusion (se pkt.
English: Accord Healthcare bvba Tèl/Tel: +32 51 79 40 12
Danish: Luxembourg/Luxemburg Accord Healthcare bvba Tèl/Tel: +32 51 79 40 12