FrancophonIA/ELRC3.0 huggingface dataset:
English: These transcription factors regulate the ability of tumours to adapt to hypoxic microenvironments and to produce the angiogenic factor vascular endothelial growth factor (VEGF).
Danish: Disse transskriptionsfaktorer regulerer tumorernes evne til at tilpasse sig hypoksiske mikromiljøer og til at producere den angiogene faktor, vaskulær endotelial vækstfaktor (VEGF).
English: Frequencies are defined as follows: 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) and not known (cannot be estimated from the available data).Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Hyppighederne er defineret som: meget almindelig (≥1/10), almindelig (≥1/100 til <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 forhåndenværende data).
English: Read the package leaflet before use and for dilution instructions.
Danish: Læs indlægssedlen inden brug og for fortyndingsvejledning.
English: Hypersensitivity/infusion reactions
Danish: Overfølsomhed/reaktioner på infusionen
English: The use of an infusion pump is the preferred method of administration to ensure accurate delivery of the medicinal product.
Danish: Brug af en infusionspumpe er den foretrukne indgivelsesmetode for at sikre nøjagtig indgivelse af lægemidlet.
English: Dry skin
Danish: Tør hud
English: Because it is recommended that an H1 antihistamine be administered to patients before the start of the intravenous temsirolimus infusion, temsirolimus should be used with caution in patients with known hypersensitivity to the antihistamine or in patients who cannot receive the antihistamine for other medical reasons.
Danish: Da det anbefales, at der indgives et H1-antihistamin til patienterne inden starten på den intravenøse temsirolimus-infusion, skal temsirolimus anvendes med forsigtighed til patienter med kendt overfølsomhed over for antihistaminer eller til patienter, der ikke kan få antihistaminer af andre lægelige grunde.
English: All grades n (%)
Danish: Alle grader n (%)
English: Your doctor will decide when to start Torisel again.
Danish: Lægen afgør, hvornår behandligen med Torisel kan påbegyndes igen.
English: Temsirolimus is not recommended for use in paediatric patients (see sections 4.2, 4.8 and 5.1).
Danish: Temsirolimus bør ikke anvendes til pædiatriske patienter (se pkt 4.2, 4.8 og 5.1).
English: In RCC clinical trial 1, 31% of patients treated with temsirolimus were 65 or older.
Danish: I RCC-klinisk studie 1 var 31% af patienterne, der blev behandlet med temsirolimus, 65 eller ældre.
English: Sulfate or glucuronide conjugates were not detected in the human faecal samples, suggesting that sulfation and glucuronidation do not appear to be major pathways involved in the excretion of temsirolimus.
Danish: Sulfat- eller glukuronidkonjugater blev ikke påvist i humane fæcesprøver, hvilket indikerer, at sulfonering og glukuronidation tilsyneladende ikke er de primære veje ved udskillelse af temsirolimus.
English: For intravenous use.
Danish: Til intravenøs anvendelse.
English: Tell your doctor if you experience new or worsening symptoms, or if you are taking or have recently taken medicines that weaken your immune system.
Danish: Fortæl det til lægen, hvis du får nye symptomer eller oplever en forværring af disse symptomer, eller hvis du tager eller for nylig har taget medicin, som svækker immunsystemet.
English: if you are receiving Torisel, you may be at increased risk of heart attack.
Danish: - hvis du får Torisel, kan du have en større risiko for at få et hjerteanfald.
English: If you feel sick (nausea and vomiting) or you have difficulty in falling or staying asleep, take special care when driving or using machines.
Danish: Hvis du føler dig syg (kvalme og opkastning) eller har svært ved at falde i søvn eller sove igennem, skal du være forsigtig med at køre bil eller betjene maskiner.
English: The safety and efficacy of temsirolimus in the treatment of advanced RCC were studied in the following two randomised clinical trials:
Danish: Temsirolimus' sikkerhed og effekt ved behandling af fremskredent RCC blev undersøgt i følgende to randomiserede kliniske studier:
English: Women of childbearing potential/Contraception in males and females
Danish: Kvinder i den fertile alder/ Kontraception til mænd og kvinder
English: In rats, these changes were accompanied by a decreased weight of accessory sex organs (epididymides, prostate, seminal vesicles).
Danish: Hos rotter blev disse forandringer ledsaget af nedsat vægt af de accessoriske kønsorganer (epididymis, prostata, vesiculae seminales).
English: Bags/containers that come in contact with Torisel must be made of glass, polyolefin, or polyethylene.
Danish: Poser/beholdere, der kommer i kontakt med Torisel skal være fremstillet af glas, polyolefin eller polyethylen.
English: The starting dose of 175 mg was associated with a significant incidence of adverse events and required dose reductions/delays in the majority of patients.
Danish: Startdosen på 175 mg er forbundet med en signifikant forekomst af bivirkninger og kræver dosisreduktioner/-udskydelser hos størstedelen af patienterne.
English: Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), clinical benefit rate, time to treatment failure (TTF), and quality adjusted survival measurement.
Danish: Sekundære endemål omfattede progressionsfri overlevelse (PFS), objektiv responsgrad (ORR), klinisk nyttegrad, tid til behandlingssvigt (TTF) og kvalitetsjusteret overlevelsesmåling.
English: if you have or have had high cholesterol levels.
Danish: - hvis du har eller har haft højt kolesteroltal.
English: Temsirolimus exhibits a polyexponential decline in whole blood concentrations, and distribution is attributable to preferential binding to FKBP-12 in blood cells.
Danish: Temsirolimus udviser et polyeksponentielt fald i fuldblodskoncentrationerne, og fordelingen kan tilskrives en fortrinsbinding til FKBP-12 i blodceller.
English: Although phospholipidosis has not been shown to be a risk for patients administered temsirolimus, it is possible that combined administration of temsirolimus with other amphiphilic agents such as amiodarone or statins could result in an increased risk of amphiphilic pulmonary toxicity.
Danish: Selv om det ikke er blevet vist, at fosfolipidose udgør en risiko for patienter, der har fået temsirolimus, er det muligt, at kombineret indgift af temsirolimus sammen med andre amfifile stoffer som f.eks. amiodaron eller statiner vil kunne medføre en øget risiko for amphiphil pulmonal toksicitet.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Torisel in all subsets of the paediatric population in MCL (see section 4.2 on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Torisel hos alle undergrupper af den pædiatriske population ved MCL (se pkt.
English: Phospholipidosis has not been observed in mice or monkeys treated with temsirolimus, nor has it been documented in patients treated with temsirolimus.
Danish: Fosfolipidose er ikke blevet observeret hos mus eller aber, der er blevet behandlet med temsirolimus, ej heller er det blevet dokumenteret hos patienter, der er blevet behandlet med temsirolimus.
English: This includes any possibleside effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denne indlægsseddel.
English: 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: Skal tages i betragtning hos gravide eller ammende kvinder, børn og patienter i højrisikogrupper som f.eks. patienter med leversygdom eller epilepsi.
English: 6 hours when stored below 25°C and protected from light.
Danish: 6 timer ved opbevaring ved temperaturer under 25 °C og beskyttet mod lys.
English: if you are receiving Torisel, you may be at increased risk of cancers such as skin cancers and lymph node cancers (lymphoma).
Danish: - hvis du får Torisel, kan du have en større risiko for at få kræftformer såsom hudkræft og lymfeknudekræft (lymfomer).
English: If the administration set available does not have an in-line filter incorporated, a filter should be added at the end of the set (i.e., an end-filter) before the admixture reaches the vein of the patient.
Danish: Hvis infusionssættet, som er til rådighed, ikke har et integreret filter i slangen, skal der sættes et filter for enden af sættet (d.v.s. et endefilter), før tilblandingen når patientens vene.
English: These symptoms might be caused by a sudden decrease of kidney function.
Danish: Disse symptomer kan skyldes pludselig nedsat nyrefunktion.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Treatment with Torisel should continue until you are no longer benefiting from therapy or until unacceptable side effects occur.
Danish: Behandling med Torisel bør fortsætte, indtil du ikke længere har fordel af behandlingen, eller hvis du oplever uacceptable bivirkninger.
English: No specific dose adjustment is necessary in elderly patients.
Danish: Ældre Det er ikke nødvendigt med særlig dosisjustering hos ældre patienter.
English: Temsirolimus also was associated with statistically significant advantages over investigator's choice in the secondary endpoint of ORR.
Danish: Temsirolimus blev også forbundet med statistisk signifikante fordele sammenlignet med investigators valg, hvad angår det sekundære endepunktpoint vedrørende ORR.
English: Some medicines can interfere with the breakdown or metabolism of Torisel and therefore dose adjustment of Torisel may be required.
Danish: Visse lægemidler kan gribe ind i nedbrydningen eller omsætningen af Torisel, og derfor kan det være nødvendigt at justere dosis af Torisel.
English: Starting dose 175 mg
Danish: Startdosis 175 mg
English: You will usually be taken off Torisel if you are having an operation.
Danish: Behandligen med Torisel vil normalt blive stoppet, hvis du skal opereres.
English: • Mix the solvent and the concentrate well by inversion of the vial.
Danish: • Bland solvens og koncentrat godt ved at vende hætteglasset.
English: if you have or have had tumours in your brain or spinal cord, bleeding problems or bruising, or if you are taking medicines which prevent your blood from clotting (such as warfarin and acenocoumarole).
Danish: - hvis du har eller har haft svulster i hjernen eller i rygmarven, blødningsproblemer eller tendens til blå mærker, eller tager medicin for at forebygge blodpropper (som f.eks. warfarin og acenocoumarol).
English: There have been cases of non-specific interstitial pneumonitis, including fatal reports, occurring in patients who received weekly intravenous temsirolimus.
Danish: Der har været tilfælde af ikke-specifik interstitiel pneumonitis, herunder rapporter med letale tilfælde, hos patienter, der ugentlig fik temsirolimus intravenøst.
English: Sirolimus, an equally potent metabolite to temsirolimus, was observed as the principal metabolite in humans following intravenous treatment.
Danish: Sirolimus, en ligeså potent temsirolimusmetabolit, blev betragtet som hovedmetabolitten hos mennesker efter intravenøs behandling.
English: Diarrhoea with mixed cell inflammation of the caecum or colon was observed in monkeys and was associated with an inflammatory response, and may have been due to a disruption of the normal intestinal flora.
Danish: Diaré med blandet celleinflammation i coecum eller colon blev set hos aber og var forbundet med et inflammatorisk respons, og det kan skyldes forstyrrelse af den normale tarmflora.
English: For subjects with neuroblastoma, the objective response rate was 5.3% (95% CI: 0.1%, 26.0%).
Danish: For patienter med neuroblastom var den objektive reponsrate 5,3 % (95 % CI: 0,1 %; 26,0 %).
English: The active substance is temsirolimus.
Danish: Det aktive stof er temsirolimus.
English: b Disease assessment is based on radiographic review by independent radiologists and review of clinical data by independent oncologists.
Danish: Sygdomsvurderingen er baseret på en røntgenologisk gennemgang foretaget af uafhængige radiologer og en gennemgang af de kliniske data foretaget af uafhængige onkologer.
English: A benefit-risk assessment should be done prior to the continuation of temsirolimus therapy in patients with severe or life-threatening reactions.
Danish: Der bør foretages en vurdering af fordele og risici, før behandlingen med temsirolimus fortsættes hos patienter med alvorlige eller livstruende reaktioner.
English: Biphasic dose response of cell growth inhibition was observed.
Danish: Der blev observeret bifasisk dosisrespons på hæmning af cellevæksten.
English: Torisel will always be prepared and given to you by a doctor or another healthcare professional as an intravenous infusion (into your vein).
Danish: Torisel vil altid blive klargjort og givet til dig som en intravenøs infusion (ind i en blodåre) af en læge eller en anden sundhedsperson.
English: High concentrations resulted in complete cell growth inhibition in vitro, whereas inhibition mediated by FKBP-12/temsirolimus complex alone resulted in approximately 50% decrease in cell proliferation.
Danish: Høje koncentrationer resulterede i fuldstændig hæmning af cellevæksten in vitro, hvorimod hæmning medieret af FKBP12/temsirolimus-komplekset alene resulterede i ca. 50% fald i celleproliferationen.
English: Torisel contains the active substance temsirolimus.
Danish: Torisel indeholder det virksomme stof temsirolimus.
English: Bleeding into the brain in patients with brain tumours or who are on blood thinners, eye bleeding.
Danish: Blødning i hjernen hos patienter med hjernesvulster, eller som fik blodfortyndende medicin, blødning i øjet.
English: Concentrate
Danish: Koncentrat
English: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium
Danish: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgien
English: The anti-tumour effect of temsirolimus, therefore, may also in part stem from its ability to depress levels of HIF and VEGF in the tumour or tumour microenvironment, thereby impairing vessel development.
Danish: Anti-tumorvirkningen af temsirolimus kan derfor også delvis stamme fra dets evne til at sænke niveauet af HIF og VEGF i tumor eller tumors mikromiljø og derved svække udviklingen af blodkar.
English: The solutions are essentially free from visible particulates.
Danish: Opløsningerne er i al væsentlighed frie for synlige partikler.
English: The temsirolimus infusion should be interrupted in all patients with severe infusion reactions and appropriate medical therapy administered.
Danish: Infusionen af temsirolimus bør afbrydes hos alle patienter med alvorlige reaktioner på infusionen, og der bør gives relevant, lægelig behandling.
English: Patients should be advised that treatment with temsirolimus may be associated with an increase in blood glucose levels in diabetic and non-diabetic patients.
Danish: Patienterne skal informeres om, at behandlingen med temsirolimus kan være forbundet med en øgning af blodglucoseniveauet hos patienter med eller uden diabetes.
English: After 12 weeks of treatment, no response was observed in subjects with rhabdomyosarcoma or high-grade glioma.
Danish: Efter 12 ugers behandling blev der ikke observeret nogen respons hos patienter med rabdomyosarkom eller høj-grads gliom.
English: Lung infection caused by Pneumocystis jiroveci (Pneumocystis jiroveci pneumonia).
Danish: Lungebetændelse forårsaget af Pneumocystis jiroveci (Pneumocystis jiroveci pneumoni).
English: Store in a refrigerator
Danish: Opbevares i køleskab
English: Torisel is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors (see section 5.1).
Danish: Torisel er indiceret som første valg til behandling af patienter med fremskredent renalcellekarcinom (RCC), som mindst har tre af seks prognostiske risikofaktorer (se pkt.
English: Due to the unknown risk related to potential exposure during early pregnancy, women of childbearing potential must be advised not to become pregnant while using Torisel.
Danish: På grund af den ukendte risiko, der er relateret til en potentiel påvirkning i det tidlige graviditetsforløb, skal kvinder i den fertile alder rådes til ikke at blive gravide, imens de er i behandling med Torisel.
English: Treatment with Torisel should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Danish: Behandlingen med Torisel skal fortsætte, indtil patienten ikke længere har klinisk nytte af behandlingen, eller indtil der opstår uacceptabel toksicitet.
English: Pneumocystis jiroveci pneumonia
Danish: Pneumocystis jiroveci pneumoni
English: Teratogenic effects (omphalocele) were seen in rabbits (see section 5.3).
Danish: Der blev set teratogene virkninger (omphalocele) hos kaniner (se pkt.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors; ATC code: L01X E09
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, proteinkinase-hæmmer, ATC-kode: L01X E09.
English: Grade n (%)
Danish: Grad n (%)
English: Investigator's choice therapies included: gemcitabine (intravenous: 22 [41.5%]), fludarabine (intravenous: 12 [22.6%] or oral: 2 [3.8%]), chlorambucil (oral: 3 [5.7%]), cladribine (intravenous: 3 [5.7%]), etoposide (intravenous: 3 [5.7%]), cyclophosphamide (oral: 2 [3.8%]), thalidomide (oral: 2 [3.8%]), vinblastine (intravenous: 2 [3.8%]), alemtuzumab (intravenous: 1 [1.9%]), and lenalidomide (oral: 1 [1.9%]).
Danish: Investigator kunne vælge mellem følgende behandlinger: gemcitabin (intravenøst: 22 [41,5 %]), fludarabin (intravenøst: 12 [22,6 %] eller oralt: 2 [3,8 %]), chlorambucil (oralt: 3 [5,7 %]), cladribin (intravenøst: 3 [5,7 %]), etoposid (intravenøst: 3 [5,7 %]), cyclophosphamid (oralt: 2 [3,8 %]), thalidomid (oralt: 2 [3,8 %]), vinblastin (intravenøst: 2 [3,8 %]), alemtuzumab (intravenøst: 1 [1,9 %]) og lenalidomid (oralt: 1[1,9 %]).
English: This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: In population pharmacokinetic-based data analysis, increased body weight (between 38.6 and 158.9 kg) was associated with a two-fold range of trough concentration of sirolimus in whole blood.
Danish: Ved analyse af populationsbaserede farmakokinetiske data var øget legemsvægt (mellem 38,6 og 158,9 kg) relateret til en fordobling af dalkoncentrationen af sirolimus i helblod.
English: if the number of white cells in your blood has decreased.
Danish: - hvis antallet af hvide blodlegemer falder.
English: Some patients were asymptomatic or had minimal symptoms with pneumonitis detected on computed tomography scan or chest radiograph.
Danish: Nogle patienter var asymptomatiske eller havde minimale symptomer, hvor pneumonitis blev fundet ved CT-scanning eller røntgenundersøgelse af thorax.
English: You may be at risk of getting an infection of the blood, skin, upper respiratory tract (including pneumonia), and/or urinary tract while you are taking Torisel.
Danish: Du kan derfor have risiko for at få en infektion i blodet, huden eller i de øvre luftveje (herunder lungebetændelse), og/eller urinvejsinfektion, mens du får Torisel.
English: You should receive an injection of antihistamine (to try to prevent allergic reaction to Torisel) directly into your vein approximately 30 minutes before your dose of Torisel.
Danish: Du bør få en indsprøjtning af antihistamin (for at undgå en allergisk reaktion) direkte i en blodåre ca. 30 minutter før din Torisel-dosis.
English: The mean ±standard deviation (SD) dissociation constant (Kd) of binding was 5.1 ± 3.0 ng/ml, denoting the concentration at which 50% of binding sites in blood cells were occupied.
Danish: Middel- (±standard afvigelse (SD)) dissociationskonstanten (Kd) for binding var 5,1 ±3,0 ng/ml, der angiver den koncentration, ved hvilken 50% af bindingsstederne i blodcellerne var optaget.
English: This may require initiation, or increase, in the dose of lipid-lowering agents.
Danish: Dette kan kræve start på eller stigning i doseringen af lipid-sænkende stoffer.
English: if your blood levels of cholesterol and triglycerides have increased.
Danish: - hvis niveauet af kolesterol og triglycerider i blodet stiger.
English: Patients on temsirolimus with baseline neutropenia may be at risk of developing febrile neutropenia.
Danish: Patienter, som får temsirolimus, og som har neutropeni ved baseline, kan have risiko for at udvikle febril neutropeni.
English: Keep the vials in the outer carton in order to protect from light.
Danish: Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: Inhibition of CYP isoforms
Danish: Hæmning af CYP-isoformer
English: Torisel, when diluted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl) phthalate extraction (DEHP) from polyvinyl chloride (PVC).
Danish: Torisel indeholder, når det er fortyndet, polysorbat 80, som er kendt for at øge graden af ekstraktion af di-(2-ethylhexyl)phthalat (DEHP) fra polyvinylchlorid (PVC).
English: if you have shortness of breath, cough, and/or fever.
Danish: hvis du har åndenød, hoste og feber.
English: What you need to know before you receive Torisel
Danish: Det skal du vide, før du begynder at få Torisel
English: In an in vitro study, temsirolimus inhibited the transport of P-glycoprotein (P-gp) substrates with an IC50 value of 2 µM.
Danish: I et in vitro-studie hæmmede temsirolimus transporten af P-glykoprotein (P-gp)-substrater med en IC50-værdi på 2 µM.
English: Assessment of AST and bilirubin levels is recommended before initiation of temsirolimus and periodically after.
Danish: Det anbefales at vurdere ASAT- og bilirubinniveauet før initiering af temsirolimusbehandling og regelmæssigt herefter.
English: Manufacturer Wyeth Lederle S.r.l.
Danish: Fremstiller Wyeth Lederle S.r.l.
English: Inhibition of mTOR activity results in a G1 growth delay at nanomolar concentrations and growth arrest at micromolar concentrations in treated tumour cells resulting from selective disruption of translation of cell cycle regulatory proteins, such as D-type cyclins, c-myc, and ornithine decarboxylase.
Danish: Hæmning af mTOR-aktiviteten medfører en G1-væksthæmning ved nanomolare koncentrationer og vækststandsning ved mikromolare koncentrationer i de behandlede tumorceller som resultat af et selektivt sammenbrud i translationen af regulerende proteiner, der regulerer cellecyklus som f.eks. D-type cycliner, c-myc og ornithindecarboxylase.
English: Monitoring of complete blood count is recommended prior to initiating temsirolimus therapy and peridically thereafter.
Danish: Fuldstændig blodtælling anbefales før initiering af temsirolimusbehandling og regelmæssigt herefter.
English: • Withdraw 1.8 ml of the supplied solvent.
Danish: • Træk 1,8 ml af den medfølgende solvens op
English: Your doctor may prescribe a visual examination before or during Torisel treatment.
Danish: Din læge kan foreslå en øjenundersøgelse før og under behandlingen med Torisel.
English: Examples of live vaccines are: measles, mumps, rubella, oral polio, Bacillus CalmetteGuérin (BCG), yellow fever, varicella, and TY21a typhoid vaccines.
Danish: Eksempler på levende vacciner er: morbilli-, parotitis-, rubella-, oral polio-, Bacillus Calmette-Guérin (BCG)-, gul feber-, varicella- og TY21a tyfusvacciner.