FrancophonIA/ELRC3.0 huggingface dataset:
English: When mTOR activity is inhibited, its ability to phosphorylate, and thereby control the activity of protein translation factors (4E-BP1 and S6K, both downstream of mTOR in the P13 kinase/AKT pathway) that control cell division, is blocked.
Danish: Når aktiviteten af mTOR hæmmes, blokeres dets evne til at fosforylere og derved kontrollere aktiviteten af proteintranslationsfaktorer (4E-BP1 og S6K, begge i strømretningen af mTOR i P13 kinase/AKT-vejen), som kontrollerer celledelingen.
English: If clinically significant respiratory symptoms develop, temsirolimus administration may be withheld until after recovery of symptoms and improvement of radiographic findings related to pneumonitis.
Danish: Hvis der opstår et klinisk signifikant luftvejssymptom, kan administration af temsirolimus pauseres, indtil symptomerne er forsvundet, og der er sket en forbedring af de radiologiske fund, der er relateret til pneumonitis.
English: In vivo, the effect of P-gp inhibition has not been investigated in a clinical drugdrug interaction study, however, recent preliminary data from a Phase 1 study of combined lenalidomide (dose of 25 mg) and temsirolimus (dose of 20 mg) seem to support the in vitro findings and suggest an increased risk of adverse events.
Danish: Effekten af P-gp-hæmning er ikke undersøgt in vivo i et klinisk interaktionsstudie, men nye præliminære data fra et fase 1 studie af kombinationen lenalidomid (dosis 25 mg) og temsirolimus (dosis 20 mg) ser ud til at understøtte in vitro fundene og antyder en øget risiko for bivirkninger.
English: Dilute before use
Danish: Skal fortyndes før brug
English: The incidence and severity of adverse events is dose-dependent.
Danish: Hyppigheden og sværhedsgraden af bivirkninger er dosisafhængig.
English: During handling and preparation of admixtures, Torisel should be protected from excessive room light and sunlight.
Danish: Under håndtering og tilberedning af tilsætninger skal Torisel beskyttes mod kraftig rumbelysning og sollys.
English: The effect of a 175 or 75 mg temsirolimus dose on CYP3A4/5 substrates has not been studied.
Danish: Effekten af en dosis på 175 eller 75 mg temsirolimus på CYP3A4/5-substrater er ikke undersøgt.
English: Dose reduction level
Danish: Dosisreduktionsniveau
English: In the MCL clinical trial, there was no difference in efficacy in patients with respect to age, sex, race, geographic region, or baseline disease characteristics.
Danish: I MCL-studiet sås der ingen forskel i effekten ud fra patienternes alder, køn, etniske baggrund, geografiske område eller sygdomskarakteristika ved baseline.
English: Torisel 30 mg concentrate must not be added directly to aqueous infusion solutions.
Danish: Torisel 30 mg koncentrat må ikke tilsættes direkte til vandige infusionsopløsninger.
English: a Based on log-rank test stratified by prior nephrectomy and region.
Danish: Baseret på log-rank test stratificeret på tidligere nephrectomistatus og region.
English: No clinically significant effect is anticipated when temsirolimus is co-administered with agents that are metabolised by CYP2D6.
Danish: Der forventes ingen klinisk signifikant påvirkning, når temsirolimus administreres sammen med stoffer, der metaboliseres af CYP2D6.
English: However, it is unlikely that whole blood concentrations of temsirolimus after intravenous administration of temsirolimus will inhibit the metabolic clearance of concomitant medicinal products that are substrates of CYP2C9, CYP2C8, CYP2B6 or CYP2E1.
Danish: Det er dog usandsynligt, at helblodskoncentrationer af temsirolimus efter intravenøs indgivelse vil hæmme den metaboliske clearance af samtidigt indgivne lægemidler, som er substrater for CYP2C9, CYP2C8, CYP2B6 eller CYP2E1.
English: At the discretion of the physician, treatment may be resumed after the administration of an H1-receptor antagonist (diphenhydramine or similar antihistamine) and a H2-receptor antagonist (intravenous famotidine 20 mg or intravenous ranitidine 50 mg) approximately 30 minutes before restarting the temsirolimus infusion.
Danish: Behandlingen kan efter lægens skøn genoptages efter indgift af en H1receptorantagonist (diphenhydramin eller tilsvarende antihistamin) og en H2-receptorantagonist (famotidin 20 mg intravenøst eller ranitidin 50 mg intravenøst) ca. 30 minutter før genoptagelsen af infusionen med temsirolimus.
English: In vitro, at high concentrations (10-20 M), temsirolimus can bind and inhibit mTOR in the absence of FKBP-12.
Danish: Ved høje koncentrationer (10-20 µM) kan temsirolimus in vitro binde og hæmme mTOR i fravær af FKBP-12.
English: In reproduction studies in animals, temsirolimus caused embryo/foetotoxicity that was manifested as mortality and reduced foetal weights (with associated delays in skeletal ossification) in rats and rabbits.
Danish: I reproduktionsforsøg på dyr, medførte temsirolimus toksiske virkninger på embryoet/fostret, der manifesterede sig som mortalitet og reduceret fostervægt (med ledsagende forsinket ossifikation af skelettet) hos rotter og kaniner.
English: Concomitant use of temsirolimus with sunitinib
Danish: Samtidig brug af temsirolimus og sunitinib
English: Temsirolimus binds to an intracellular protein (FKBP-12), and the protein/temsirolimus complex binds and inhibits the activity of mTOR that controls cell division.
Danish: Temsirolimus bindes til et intracellulært protein (FKBP-12), protein/temsirolimuskomplekset binder og hæmmer aktiviteten af mTOR, der kontrollerer celledelingen.
English: In contrast, exposure to sirolimus was commensurately reduced in paediatric patients, such that the net exposure as measured by the sum of temsirolimus and sirolimus AUCs (AUCsum) was comparable to that for adults.
Danish: I modsætning hertil var ekspositionen for sirolimus tilsvarende reduceret hos pædiatriske patienter i en sådan grad, at nettoekspositionen målt ved summen af AUC for temsirolimus og sirolimus (AUCsum) var sammenlignelig med AUCsum hos voksne.
English: Sepsis* (including septic shock) Candidiasis (including oral and anal candidiasis) and fungal infection/fungal skin infections Urinary tract infection (including cystitis)
Danish: Almindelig Sepsis* (herunder septisk shock) Candidiasis (herunder oral og anal candidiasis) og svampeinfektion/svampeinfektion i huden
English: Temsirolimus has been associated with phospholipidosis in rats.
Danish: Temsirolimus er blevet sat i forbindelse med fosfolipidose hos rotter.
English: The safety and efficacy of intravenous temsirolimus for the treatment of relapsed and/or refractory MCL were studied in the following Phase 3 clinical study.
Danish: Sikkerheden ved og effekten af intravenøs behandling med temsirolimus mod recidiverende og/eller refraktært MCL blev undersøgt i følgende kliniske studie i fase 3.
English: Physiologically-based pharmacokinetic modelling has shown that after four weeks treatment with temsirolimus, the AUC of midazolam can be increased 3-to-4 fold and Cmax around 1.5-fold when midazolam is taken within a few hours after the start of the temsirolimus infusion.
Danish: Fysiologisk baseret farmakokinetisk modelberegning har vist, at efter 4 ugers temsirolimus-behandling øges midazolams AUC 3-4 gange og Cmax ca 1,5 gang, når midazolam indtages få timer inden infusion af temsirolimus.
English: Temsirolimus and sirolimus pharmacokinetics have been investigated in an open-label, dose-escalation study in 110 patients with advanced malignancies and either normal or impaired hepatic function.
Danish: Farmakokinetikken for temsirolimus og sirolimus er undersøgt i et åbent dosis-eskaleringsstudie med 110 patienter med fremskreden malign sygdom og enten normal eller nedsat leverfunktion.
English: This medicine contains ethanol (alcohol), equivalent to 17.6 ml beer, 7.3 ml wine per 25 mg dose.
Danish: Denne medicin indeholder ethanol (alkohol) svarende til 17,6 ml øl eller 7,3 ml vin pr. 25 mg dosis.
English: Temsirolimus distribution is dose-dependent with mean (10th, 90th percentiles) maximal specific binding in blood cells of 1.4 mg (0.47 to 2.5 mg).
Danish: Temsirolimus-fordelingen er dosisafhængig med middel (10%, 90% percentiler) maksimal specifik binding til blodceller på 1,4 mg (0,47 til 2,5 mg).
English: Months (95% CI) Overall response rate by independent assessment % (95% CI)
Danish: Måneder (95% CI) Samlet responsrate ved uafhængig vurdering % (95% CI)
English: Unexplained muscle pain, tenderness or weakness which could indicate muscle damage
Danish: Uforklarlige muskelsmerter, ømhed eller svaghed, som kunne tyde på muskelbeskadigelse (rabdomyolyse).
English: If a suspected reaction is not manageable with dose delays, then temsirolimus may be reduced by 5 mg/week decrements.
Danish: Hvis en formodet bivirkning ikke kan kontrolleres ved udsættelse af dosis, kan temsirolimus reduceres med formindskelser på 5 mg/uge.
English: Anhydrous ethanol
Danish: Vandfri ethanol
English: The diluted solution must be administered by intravenous infusion.
Danish: Den fortyndede opløsning skal gives som en intravenøs infusion.
English: Thrombocytopenia, neutropenia, and anaemia
Danish: Trombocytopeni, neutropeni og anæmi
English: Temsirolimus and sirolimus pharmacokinetics are not significantly affected by gender.
Danish: Farmakokinetikken for temsirolimus og sirolimus påvirkes ikke signifikant af køn.
English: Following administration of [14C] temsirolimus, excretion was predominantly via the faeces (78%), with renal elimination of active substance and metabolites accounting for 4.6% of the administered dose.
Danish: C]-mærket temsirolimus, var udskillelsen hovedsageligt gennem fæces (78%), hvor renal udskillelse af aktivt stof og metabolitter udgjorde 4,6% af den indgivne dosis.
English: Table 2: Adverse reactions reported in post-marketing setting System Organ class
Danish: Skema 2: Bivirkninger rapporteret efter markedsføring
English: In in vitro studies in human liver microsomes, temsirolimus inhibited CYP3A4/5, CYP2D6, CYP2C9 and CYP2C8 catalytic activity with Ki values of 3.1, 1.5, 14 and 27 μM, respectively.
Danish: I in vitro-studier i humane levermikrosomer hæmmede temsirolimus den katalytiske aktivitet af CYP3A4/5, CYP2D6, CYP2C9 og CYP2C8 med Ki-værdier på henholdsvis 3,1, 1,5, 14 og 27 µM.
English: An increased rate of fatal events was observed in patients with moderate and severe hepatic impairment.
Danish: Der blev observeret en øget forekomst af letale hændelser hos patienter med moderat og svær leverinsufficiens.
English: In preparing the solution, the following two-step process must be carried out in an aseptic manner according to local standards for handling cytotoxic/cytostatic medicinal products:
Danish: Ved tilberedning af opløsningen skal følgende totrins-procedure udføres på aseptisk måde i henhold til lokale standarder for håndtering af cytotoksiske/cytostatiske lægemidler:
English: Among patients receiving 175 mg/week for the treatment of MCL, infections (including Grade 3 and 4 infections) were substantially increased compared to lower doses and compared to conventional chemotherapy.
Danish: Blandt de patienter, der fik 175 mg om ugen til behandling af mantlecellelymfom, var forekomsten af infektioner (herunder infektioner af grad 3 og 4) væsentligt øget sammenlignet med forekomsten ved lavere doser og ved konventionel kemoterapi.
English: Therefore, when temsirolimus is co-administered with medicinal products which are P-gp substrates (e.g. digoxin, vincristine, colchicine, dabigatran, lenalidomide, and paclitaxel) close monitoring for adverse events related to the co-administered medicinal products should be observed.
Danish: Hvis temsirolimus indgives samtidigt med lægemidler, som er P-gp-substrater (f.eks. digoxin, vincristin, colchicin, dabigatran, lenalidomid og paclitaxel) tilrådes derfor tæt monitorering for bivirkninger relateret til disse samtidigt indgivne lægemidler.
English: Direct addition of Torisel 30 mg concentrate to aqueous solutions will result in precipitation of medicinal product.
Danish: Direkte tilsætning af Torisel 30 mg koncentrat til vandige opløsninger vil medføre udfældning af lægemidlet.
English: Temsirolimus and sirolimus were demonstrated to be substrates for P-gp in vitro.
Danish: Det blev påvist, at temsirolimus og sirolimus er substrater for P-glykoprotein (P-gp) in vitro.
English: It is harmful if you are suffering from alcoholism, and it is to be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Danish: Det er skadeligt for alkoholikere, og det skal tages i betragtning ved behandling af gravide og ammende kvinder, børn og patienter i højrisikogrupper, herunder patienter med leversygdomme og epilepsi.
English: Adverse reactions that were reported in RCC and MCL patients in the phase 3 studies are listed below (Table 1), by system organ class, frequency and grade of severity (NCI-CTCAE).
Danish: Bivirkninger set hos patienter med RCC og MCL i fase 3 studier ses herunder grupperet efter organklasse, hyppighed og alvorlighed (skema 1).
English: The known association of temsirolimus with hyperlipaemia may predispose to myocardial infarction.
Danish: Den kendte forbindelse mellem temsirolimus og hyperlipæmi kan disponere for myokardieinfarkt.
English: • Torisel, when diluted, contains polysorbate 80, and therefore appropriate administration materials must be used.
Danish: • Torisel indeholder, når det er fortyndet, polysorbat 80, og der skal derfor anvendes hensigtsmæssige materialer til administration.
English: Opportunistic infections such as PCP should be considered in the differential diagnosis.
Danish: Opportunistiske infektioner som Pneumocystis jiroveci pneumoni (PJP) bør tages i betragtning i differentialdiagnosen.
English: Population PK analysis based on sparse sampling indicated no clinically significant interaction effect on AUC and Cmax of the CYP2D6 substrate desipramine.
Danish: Baseret på sparsomme data fra farmakokinetiske populationsanalyser, var der ingen tegn på klinisk betydende interaktionseffekt på AUC og Cmax af CYP2D6-substratet desipramin.
English: Tell your doctor if you are taking blood thinning medicines or have any bleeding or bruising while you are on Torisel.
Danish: Fortæl det til lægen, hvis du tager blodfortyndende medicin eller har blødninger eller blå mærker, mens du bliver behandlet med Torisel.
English: Temsirolimus was found to be ineffective in paediatric patients with neuroblastoma, rhabdomyosarcoma, and high-grade glioma (n = 52).
Danish: Man konstaterede, at temsirolimus var ineffektivt hos pædiatriske patienter med neuroblastom, rabdomyosarkom og høj-grads gliom (n = 52).
English: You should seek medical advice immediately if you feel confused, unusually tired, have difficulty in speaking or in swallowing and your pupils have different sizes.
Danish: Kontakt straks læge, hvis du føler dig forvirret, usædvanlig træt, har tale- eller synkebesvær og forskel i pupilernes størrelse.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: Venous thromboembolism (including deep vein thrombosis, venous thrombosis)
Danish: Almindelig Venøs tromboemboli (herunder dyb venetrombose, venetrombose) Tromboflebit
English: In a Phase 1/2 safety and exploratory efficacy study, 71 patients (59 patients, aged from 1 to 17 years, and 12 patients, aged from 18 to 21 years) received temsirolimus as a 60-minute intravenous infusion once weekly in three-week cycles.
Danish: I et fase 1/2-sikkerheds- og eksplorativt effektstudie fik 71 patienter (59 patiener i alderen fra 1-17 år og 12 patienter i alderen 18-21 år) temsirolimus som en 60 minutters intravenøs infusion en gang ugentlig i en 3-ugers cyklus.
English: Patients should be given intravenous diphenhydramine 25 mg to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose of temsirolimus (see section 4.4).
Danish: Det anbefales at give patienterne 25 mg til 50 mg diphenhydramin (eller et lignende antihistamin) intravenøst ca. 30 minutter før starten af hver temsirolimusdosis (se pkt.
English: Aphthous stomatitis
Danish: Aftøs stomatitis
English: Solvent
Danish: Solvens
English: Summary of the safety profile
Danish: Sikkerhedsprofil
English: RCC clinical trial 1 was a Phase 3, multi-centre, 3-arm, randomised, open-label study in previously untreated patients with advanced RCC and with 3 or more of 6 pre-selected prognostic risk factors (less than 1 year from time of initial RCC diagnosis to randomisation, Karnofsky performance status of 60 or 70, haemoglobin less than the lower limit of normal, corrected calcium of greater than 10 mg/dl, lactate dehydrogenase1.5 times the upper limit of normal, more than 1 metastatic organ site).
Danish: RCC-klinisk studie 1 var et fase-3, multicenter, 3-armet, randomiseret, åbent studie med tidligere ubehandlede patienter med fremskredent RCC og med 3 eller flere af 6 forud valgte prognostiske risikofaktorer (mindre end 1 år fra tidspunktet for den første diagnose af RCC til randomisering, Karnofsky performance status på 60 eller 70, hæmoglobin mindre end den nedre normalgrænse, korrigeret calcium større end 10 mg/dl, laktatdehydrogenase >1,5 gange den øvre normalgrænse, mere end 1 organ med metastaser).
English: Patients with central nervous system (CNS) tumours (primary CNS tumours or metastases) and/or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (including fatal outcomes) while receiving therapy with temsirolimus.
Danish: Patienter med tumorer i centralnervesystemet (CNS) (primære CNS-tumorer eller metastaser), og/eller patienter, som får antikoagulationsbehandling, kan have en forøget risiko for at udvikle intracerebral blødning (herunder med dødelig udgang), når de bliver behandlet med temsirolimus.
English: One hundred eleven (111) patients were randomly assigned in a 1:1:1 ratio to receive 25 mg, 75 mg, or 250 mg intravenous temsirolimus weekly.
Danish: Ethundredeelleve (111) patienter blev randomiseret i en ratio på 1:1:1 til at få 25 mg, 75 mg eller 250 mg intravenøs temsirolimus ugentlig.
English: Torisel can decrease the number of blood cells that help in clotting and resisting infection.
Danish: - Torisel kan nedsætte antallet af de blodlegemer, som får blodet til at størkne eller som hjælper med at modvirke infektion.
English: Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin).
Danish: Temsirolimus er en selektiv hæmmer af mTOR (mammalian target of rapamycin ~ mål for rapamycin hos pattedyr).
English: Cases of PCP, some with fatal outcomes, have been reported (see section 4.4).
Danish: Der er rapporteret tilfælde af PJP, nogle med dødelig udgang (se pkt.
English: The concentrate-solvent mixture is stable below 25°C for up to 24 hours.
Danish: Blandingen af koncentrat og solvens er stabil ved temperaturer under 25 °C i op til 24 timer.
English: STEP 1: DILUTION OF THE CONCENTRATE FOR SOLUTION FOR INFUSION WITH THE SUPPLIED SOLVENT
Danish: TRIN 1: FORTYNDING AF KONCENTRATET TIL INFUSIONSVÆSKE, OPLØSNING, MED DEN MEDFØLGENDE SOLVENS
English: Following a single 25 mg intravenous dose in patients with cancer, sirolimus AUC was 2.7-fold that of temsirolimus AUC, due principally to the longer half-life of sirolimus.
Danish: Efter en enkelt intravenøs dosis på 25 mg til patienter med cancer var sirolimus AUC 2,7 gange højere end temsirolimus AUC, hovedsageligt på grund af den længere halveringstid for sirolimus.
English: The following effects were reported in mice and/or rats in the carcinogenicity studies conducted: granulocytic leukaemia, lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.
Danish: Følgende virkninger blev rapporteret i de gennemførte carcinogenicitetsstudier med mus og/eller rotter: granulocytleukæmi, lymphom, hepatocellulært adenom og karcinom samt testikeladenom.
English: IC50 values for inhibition of CYP2B6 and CYP2E1 by temsirolimus were 48 and 100 μM, respectively.
Danish: IC50-værdierne for temsirolimus for hæmning af CYP2B6 og CYP2E1 var henholdsvis 48 og 100 µM.
English: c Based on Cochran-Mantel-Hansel test stratified by prior nephrectomy and region.
Danish: Baseret på Cochran-Mantel-Haenszel test stratificeret på tidligere nephrectomistatus og region.
English: One vial of 2.2 ml solvent.
Danish: Et hætteglas med 2,2 ml solvens.
English: Caution should be exercised when temsirolimus is given concomitantly with ACE inhibitors (e.g. ramipril) and/or calcium channel blockers (e.g. amlodipine).
Danish: Der skal udvises forsigtighed, når temsirolimus gives samtidigt med ACE-hæmmere (f.eks. ramipril) og/eller calciumantagonister (f.eks. amlopidin).
English: Therefore, for patients with RCC, continuous administration beyond 5-7 days with agents that have CYP3A4/5 induction potential should be avoided.
Danish: Kontinuerlig behandling af patienter med RCC ud over 5-7 dage med stoffer, der har et CYP3A4/5-induktionspotentiale, bør derfor undgås.
English: Side effects may be more pronounced with the higher dose of 175 mg per week during initial treatment for mantle cell lymphoma.
Danish: Bivirkningerne kan være mere udtalte med den høje dosis på 175 mg om ugen i begyndelsen af behandlingen mod mantlecellelymfom.
English: Talk to your doctor, pharmacist, nurse if you have any concern.
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis du er bekymret.
English: Patients receiving the starting dose of 175 mg weekly for the treatment of MCL must be followed closely to decide on dose reductions/delays.
Danish: Patienter, som begynder med startdosen på 175 mg om ugen i behandlingen af mantlecellelymfom, skal følges nøje med henblik på dosisreduktion/udsættelse.
English: In an open-label, dose-escalation Phase 1 study in 110 subjects with advanced malignancies and either normal or impaired hepatic function, concentrations of temsirolimus and its metabolite sirolimus were increased in patients with elevated aspartate aminotransferase (AST) or bilirubin levels.
Danish: I et åbent dosis-eskalerings fase 1-studie med 110 patienter med fremskreden malign sygdom og enten normal eller nedsat leverfunktion var koncentrationen af temsirolimus og dets metabolit sirolimus forhøjet hos patienter med forhøjet aspartat-aminotransferase (ASAT)- eller bilirubinniveau.
English: For patients treated weekly with 25 mg temsirolimus OS was 13.8 months (95% CI: 9.0, 18.7 months); ORR was 5.6% (95% CI: 0.7, 18.7%).
Danish: Patienterne, der var blevet behandlet ugentlig med 25 mg temsirolimus, havde en OS på 13,8 måneder (95% CI: 9,0-18,7 måneder); ORR var 5,6% (95% CI: 0,7-18,7%).
English: Temsirolimus was not genotoxic in a battery of in vitro (bacterial reverse mutation in Salmonella typhimurium and Escherichia coli, forward mutation in mouse lymphoma cells, and chromosome aberrations in Chinese hamster ovary cells) and in vivo (mouse micronucleus) assays.
Danish: Temsirolimus var ikke genotoksisk i en række in vitro analyser (bakteriel omvendt mutation i Salmonella typhimurium og Escherichia coli, fremadrettet mutation i lymphomceller fra mus og kromosomfejl i kinesiske hamsterovarieceller) og in vivo (musemikronukleus).
English: PVC bags and medical devices must not be used for the administration of preparations containing polysorbate 80, because polysorbate 80 leaches DEHP from PVC.
Danish: Poser og medicinsk udstyr af PVC må ikke anvendes til indgift af præparater, der indeholder polysorbat 80, fordi polysorbat 80 udvasker DEHP fra PVC.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere information om Torisel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: If a suspected reaction is not manageable with dose delays and/or optimal medical therapy, then the dose of temsirolimus should be reduced according to the dose reduction table below.
Danish: Hvis en formodet bivirkning ikke kan behandles med dosisudskydelse og/eller optimal medicinsk behandling, skal dosen af temsirolimus reduceres i henhold til dosisreduktionstabellen nedenfor.