FrancophonIA/ELRC3.0 huggingface dataset:
English: An in-line polyethersulfone filter with a pore size of not greater than 5 microns is recommended for administration to avoid the possibility of particles bigger than 5 microns being infused.
Danish: Til indgivelsen anbefales et integreret polyethersulfon-filter i slangen med en porestørrelse ikke større end 5 µ, for at undgå at partikler større end 5 µ bliver infunderet.
English: Patients were stratified for prior nephrectomy status within 3 geographic regions and were randomly assigned (1:1:1) to receive IFN-α alone (n = 207), temsirolimus alone (25 mg weekly; n = 209), or the combination of IFN-α and temsirolimus (n = 210).
Danish: Patienterne blev stratificeret med hensyn til tidligere nephrectomistatus inden for 3 geografiske regioner og blev randomiseret (1:1:1) til at få IFN- alene (n = 207), temsirolimus alene (25 mg ugentlig; n = 209), eller en kombination af IFN- og temsirolimus(n = 210).
English: However, sirolimus, the main metabolite of temsirolimus, is excreted in milk of lactating rats.
Danish: Sirolimus, hovedmetabolitten fra temsirolimus, udskilles imidlertid i mælken fra diegivende rotter.
English: Temsirolimus should not be used in the paediatric population for the treatment of neuroblastoma, rhabdomyosarcoma or high-grade glioma, because of efficacy concerns based on the available data (see section 5.1).
Danish: Temsirolimus bør ikke anvendes til behandling af neuroblastom, rabdomyosarkom eller høj-grads gliom i den pædiatrisk population på grund af problemstillinger vedrørende virkning i de tilgængelige data (se pkt.
English: Torisel may increase blood glucose levels and worsen diabetes mellitus.
Danish: - Torisel kan få blodsukkeret til at stige og forværre diabetes mellitus.
English: • Torisel, when diluted, contains polysorbate 80,and therefore appropriate administration materials must be used (see sections 6.1 and 6.2).
Danish: • Torisel indeholder, når det er fortyndet, polysorbat 80, og der skal derfor anvendes hensigtsmæssige materialer til administration (se pkt 6.1 og 6.2).
English: if you have or have had liver problems.
Danish: - hvis du har eller har haft leverproblemer.
English: Talk to your doctor, pharmacist or nurse before receiving Torisel:
Danish: Kontakt lægen eller sundhedspersonalet, før du får Torisel
English: Uncommon Laryngitis
Danish: Ikke almindelig Laryngitis
English: One vial of 1.2 ml concentrate.
Danish: Et hætteglas med 1,2 ml koncentrat.
English: Therefore, substances that are potent inhibitors of CYP3A4 activity (e.g. nelfinavir, ritonavir, itraconazole, ketoconazole, voriconazole, nefazodone) increase sirolimus blood concentrations.
Danish: Stoffer, der er potente hæmmere af CYP3A4-aktiviteten (f.eks. nelfinavir, ritonavir, itraconazol, ketoconazol, voriconazol, nefazodon), øger derfor blodkoncentrationerne af sirolimus.
English: Treatment with the combination of temsirolimus and IFN-α resulted in a statistically significant increase in the incidence of certain Grade 3-4 adverse events (weight loss, anaemia, neutropenia, thrombocytopenia and mucosal inflammation) when compared to the adverse events observed in the IFN-α or temsirolimus-alone arms.
Danish: Behandling med kombinationen af temsirolimus og IFN-α resulterede i en statistisk signifikant stigning i incidensen af visse grad 3-4 bivirkninger (vægttab, anæmi, neutropeni, trombocytopeni og slimhindeinflammation) sammenlignet med bivirkningerne, der blev observeret i armene med IFN-α eller temsirolimus-alene.
English: Based on the results of a Phase 3 study in RCC, elderly patients (65 years of age) may be more likely to experience certain adverse reactions, including oedema, diarrhoea, and pneumonia.
Danish: Resultaterne af et fase-3 studie vedrørende RCC har vist, at ældre patienter (≥65 år) kan have større sandsynlighed for at få visse bivirkninger, herunder ødemer, diaré og pneumoni.
English: Therefore, caution is advised during concomitant administration of temsirolimus at a dose of 175 mg with medicinal products that are metabolised predominantly via CYP3A4/5 and that have a narrow therapeutic index.
Danish: Derfor tilrådes forsigtighed ved samtidig indgivelse af temsirolimus i doser på 175 mg og lægemidler, som overvejende metaboliseres via CYP3A4/5, og som har et snævert terapeutisk indeks.
English: MCL clinical trial
Danish: MCL-klinisk studie
English: Keep the vial in the outer carton.
Danish: Opbevar hætteglasset i den ydre karton.
English: Torisel is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) (see section 5.1).
Danish: Torisel er indiceret til behandling af voksne patienter med recidiverende og/eller refraktært mantlecellelymfom (MCL) (se pkt.
English: It is unknown whether temsirolimus is excreted in human breast milk.
Danish: Det vides ikke, om temsirolimus udskilles i modermælk.
English: Therefore, concomitant treatment with agents that have strong CYP3A4 inhibition potential should be avoided.
Danish: Samtidig behandling med stoffer, der har et kraftigt CYP3A4-hæmmende potentiale bør derfor undgås.
English: Different end-filters can be used ranging in filter pore size from 0.2 microns up to 5 microns.
Danish: Der kan bruges forskellige endefiltre varierende i porestørrelse fra 0,2 µ til 5 µ.
English: Temsirolimus has no or negligible influence on the ability to drive and use machines based on the evidence available.
Danish: Temsirolimus påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Temsirolimus is cleared predominantly by the liver.
Danish: Temsirolimus elimineres hovedsageligt via leveren.
English: Concomitant use of angiotensin-converting enzyme (ACE) inhibitors and/or calcium channel blockers
Danish: Samtidig brug af angiotensin-konverterende enzymhæmmere (ACE-hæmmere) og/eller calciumantagonister
English: Tell your doctor if you develop any of the following signs and symptoms of liver problems during Torisel treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area.
Danish: Fortæl det til lægen, hvis du får nogle af de følgende symptomer på leverproblemer under behandlingen med Torisel: kløe, gule øjne og hud, mørk urin eller smerter og ubehag i den øverste del af maven.
English: Serious reactions of the skin and/or mucous membranes which may include painful blisters and fever
Danish: Alvorlige reaktioner på hud og/eller slimhinder (Stevens-Johnsons syndrom); kan omfatte smertefulde blister og feber.
English: Concentrate and solvent for solution for infusion (sterile concentrate).
Danish: Koncentrat og solvens til infusionsvæske, opløsning (sterilt koncentrat).
English: Other medicines and Torisel
Danish: Brug af anden medicin sammen med Torisel
English: Subjects with MCL (that was confirmed by histology, immunophenotype, and cyclin D1 analysis) who had received 2 to 7 prior therapies that included anthracyclines and alkylating agents, and rituximab (and could include haematopoietic stem cell transplant) and whose disease was relapsed and/or refractory were eligible for the study.
Danish: Forsøgspersoner med MCL (som er bekræftet ved histologi, bestemmelse af immunofænotype og cyklin D1-analyse), som havde fået 27 tidligere behandlinger, der omfattede antracykliner og alkylerende stoffer samt rituximab (og kunne omfatte hæmatopoietisk stamcelletransplantation), og hvis sygdom var recidiverende og/eller refraktær, var egnede til studiet.
English: Do not use if particulates are present, or if discoloured.
Danish: Anvend ikke Torisel, hvis der ses partikler eller misfarvning.
English: Objective response rateb % (95% CI)
Danish: Objektiv responsrate % (95 % CI)
English: The use of temsirolimus was associated with increases in serum triglycerides and cholesterol.
Danish: Brugen af temsirolimus til patienter med renalcellekarcinom var forbundet med stigninger i serumtriglycerid og cholesterol.
English: Adverse reactions that were reported in post-marketing experience are listed below (Table 2).
Danish: Bivirkninger rapporteret efter markedsføring ses herunder (skema 2).
English: Women of childbearing potential must avoid pregnancy by using an effective method of birth control during treatment with Torisel.
Danish: Kvinder i den fødedygtige alder skal undgå at blive gravide ved at bruge en sikker svangerskabsforebyggende metode under behandlingen med Torisel.
English: Hypersensitivity to temsirolimus, its metabolites (including sirolimus), polysorbate 80, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for temsirolimus, dets metabolitter (herunder sirolimus), polysorbat 80, eller over for et eller flere af hjælpestofferne anført i pkt.
English: Your doctor may prescribe you an x-ray examination of your chest.
Danish: Lægen kan anbefale at du får taget et røntgenbillede af brystkassen.
English: Following administration of a single 25 mg intravenous dose of temsirolimus in patients with cancer, mean Cmax in whole blood was 585 ng/ml (coefficient of variation [CV] = 14%), and mean AUC in blood was 1627 ng•h/ml (CV = 26%).
Danish: Efter indgift af en enkelt intravenøs dosis på 25 mg temsirolimus til patienter med cancer, var middel Cmax i fuldblod 585 ng/ml (variationskoefficient CV=14%), og middel AUC i blod var 1.627 ng•h/ml (CV=26%).
English: General inflammatory responses, as indicated by increased fibrinogen and neutrophils, and/or changes in serum protein, were observed in mice, rats, and monkeys, although in some cases these clinical pathology changes were attributed to skin or intestinal inflammation as noted above.
Danish: Hos mus, rotter og aber blev der observeret et generelt inflammatorisk repons, som blev vist ved øget fibrinogen og neutrofile og/eller ændringer i serumprotein, selv om disse kliniske patologiændringer i nogle tilfælde, som ovenfor anført, blev henført til hud- eller tarminflammation.
English: Tell your doctor if you experience symptoms such as pain or sensation of pressure in chest, arm, shoulders or jaw, shortness of breath, feeling sick (nausea), anxiety, sweating or dizziness.
Danish: Fortæl det til lægen, hvis du får symptomer som smerter eller en trykkende fornemmelse i brystkassen, armen, skuldrene eller kæben, åndenød, utilpashed (kvalme), angst, sveden eller svimmelhed.
English: However, feeling or being sick (nausea and vomiting) and difficulty in falling or staying asleep are very common side effects.
Danish: Imidlertid er bivirkninger som: en følelse af at være syg (kvalme og opkastning) og besvær med at falde i søvn eller sove igennem meget almindelige.
English: RCC clinical trial 2 was a randomised, double-blind, multi-centre, outpatient trial to evaluate the efficacy, safety, and pharmacokinetics of three dose levels of temsirolimus when administered to previously treated patients with advanced RCC.
Danish: RCC-klinisk studie 2 var et randomiseret, dobbelt-blindt, multi-centerstudie med ambulante patienter med henblik på at evaluere effekten, sikkerheden og farmakokinetikken ved tre dosisniveauer af temsirolimus, når det blev givet til tidligere behandlede patienter med fremskreden RCC.
English: After first dilution of the concentrate with 1.8 ml of the supplied solvent, the concentrate-solvent mixture contains 35% volume ethanol (alcohol), i.e., up to 0.693 g per 25 mg dose of temsirolimus, equivalent to 17.6 ml beer or 7.3 ml wine per dose.
Danish: Efter fortynding af koncentratet med 1,8 ml af den medfølgende solvens indeholder blandingen af koncentrat og solvens 35 vol% ethanol (alkohol), dvs. op til 0,693 g pr. 25 mg dosis temsirolimus, svarende til 17,6 ml øl eller 7,3 ml vin pr. dosis.
English: It is recommended that patients undergo baseline radiographic assessment by lung computed tomography scan or chest radiograph prior to the initiation of temsirolimus therapy.
Danish: Det anbefales, at patienterne får foretaget baseline radiologiske undersøgelser med CT-scanning af lungerne eller røntgen af thorax forud for behandling med temsirolimus.
English: If the patient cannot maintain ANC 1.0 x 109/l and platelets 50 x 109/l on the new dose reduction level, then the next lower dose should be given once the counts have recovered.
Danish: Hvis der ikke kan opretholdes et absolut neutrofiltal på > 1,0 x 10 9/l og et trombocyttal på > 50 x 10 9/l ved det nye, reducerede dosisniveau, skal patienten have den næstfølgende lavere dosis, når værdierne igen er normale.
English: The evaluations of PFS and ORR were based on blinded independent radiologic assessment of tumour response using the International Workshop Criteria.
Danish: Evalueringerne af den progressionsfrie overlevelse og den objektive responsrate var baseret på en blindet, uafhængig radiologisk vurdering af tumorresponsen ved brug af IWC (International Workshop Criteria).
English: MCL clinical trial is a controlled, randomised, open-label, multicentre, outpatient study comparing 2 different dosing regimens of temsirolimus with an investigator's choice of therapy in patients with relapsed and/or refractory MCL.
Danish: MCL-klinisk studie er et kontrolleret, randomiseret, åbent multicenterstudie med ambulante patienter, hvor to forskellige doseringsregimer med temsirolimus sammenlignes med investigators valg af behandling hos patienter med recidiverende og/eller refraktært MCL.
English: Your doctor will monitor your kidney function.
Danish: Lægen vil måle nyrefunktionen.
English: For this reason, your doctor may recommend a lung assessment by computed tomography scan or chest x-ray before and during your Torisel treatment.
Danish: Derfor kan lægen foreslå en CT-skanning (computer tomografi) af lungerne eller et røntgenbillede før og under din behandling med Torisel.
English: Therefore, concomitant treatment with agents that have CYP3A4/5 induction potential should be avoided (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John's wort) (see section 4.4).
Danish: Samtidig behandling med stoffer, der har CYP3A4/5-induktionspotentiale, bør derfor undgås (f.eks. carbamazepin, phenobarbital, phenytoin, rifampicin og perikon) (se pkt.
English: Treatment of suspected adverse reactions may require temporary interruption and/or dose reduction of temsirolimus therapy.
Danish: Behandling af formodede bivirkninger kan kræve midlertidig afbrydelse og/eller dosisreduktion af temsirolimusbehandlingen.
English: Agents such as carbamazepine, phenobarbital, phenytoin, rifampicin, and St. John's wort are strong inducers of CYP3A4/5 and may decrease composite exposure of the active drug substances, temsirolimus and its metabolite, sirolimus.
Danish: Stoffer som f.eks. carbemazepin, phenobarbital, phenytoin, rifampicin og perikon er kraftige CYP3A4/5-induktorer og kan nedsætte den sammensatte eksposition af de aktive lægemiddelstoffer, temsirolimus og dets metabolit, sirolimus.
English: The combination of temsirolimus 15 mg and IFN-α did not result in a significant increase in overall survival when compared to IFN-α alone at either the interim analysis (median 8.4 vs. 7.3 months, hazard ratio = 0.96, p = 0.6965) or final analysis (median 8.4 vs. 7.3 months, hazard ratio = 0.93, p = 0.4902).
Danish: Kombinationen af 15 mg temsirolimus og IFN-medførte ikke en signifikant forøgelse af den samlede overlevelse sammenlignet med hverken IFN-α alene ved enten den foreløbige analyse (median 8,4 versus 7,3 måneder, risikoratio = 0,96, p = 0,6965) eller ved den endelige analyse (median 8,4 versus 7,3 måneder, risikoratio = 0,93, p = 0,4902).
English: Do not use this medicine after the expiry date, which is stated on the vial label and carton.
Danish: Brug ikke Torisel efter den udløbsdato, der står på pakningen.
English: if you have or have had eye problems like cataracts.
Danish: - hvis du har eller har haft problemer med øjnene, som f.eks. grå stær.
English: Alternative treatments with agents that do not have CYP3A4 inhibition potential should be considered (see section
Danish: Det bør overvejes at anvende alternative behandlinger med stoffer, der ikke har et CYP3A4-hæmmende potentiale (se pkt.
English: In a Phase 1/2 study, 71 patients (59 patients, aged from 1 to 17 years old, and 12 patients, aged 18 to 21 years) were administered temsirolimus at doses ranging from 10 mg/m2 to 150 mg/m2 (see section 5.1).
Danish: I et fase 1/2-studie fik 71 patienter (59 patienter i alderen fra 1-17 år og 12 patienter i alderen 18-21 år) temsirolimus i dosisintervallet fra 10 mg/m 2 til 150 mg/m 2 (se pkt.
English: Patients should be advised to report excessive thirst or any increase in the volume or frequency of urination.
Danish: Patienterne skal tilrådes at indberette usædvanlig stor tørst eller en øgning af urinmængde eller vandladningshyppighed.
English: Model-predicted values for clearance from plasma, after applying a 175 mg dose for 3 weeks, and subsequently 75 mg for 3 weeks, indicate temsirolimus and sirolimus metabolite trough concentrations of approximately 1.2 ng/ml and 10.7 ng/ml, respectively.
Danish: De model-forventede værdier for plasma-clearance efter indgivelse af 175 mg i 3 uger og efterfølgende 75 mg i 3 uger indikerer temsirolimus og sirolimus metabolit-dalkoncentrationer på henholdsvis ca. 1,2 ng/ml og 10,7 ng/ml .
English: However, in vitro studies in human liver microsomes followed by physiologically-based pharmacokinetic modelling indicate that the blood concentrations achieved after a 175 mg dose of temsirolimus most likely leads to relevant inhibition of CYP3A4/5 (see section 5.2).
Danish: Men in vitro-studier i humane levermikrosomer efterfulgt af fysiologisk baseret farmakokinetisk modelberegning antyder, at plasmakoncentrationen efter en dosis på 175 mg temsirolimus sandsynligvis medfører relevant hæmning af CYP3A4/5 (se pkt.
English: Patients on temsirolimus who develop thrombocytopenia may be at increased risk of bleeding events, including epistaxis (see section 4.8).
Danish: Patienter, som får temsirolimus, og som udvikler trombocytopeni, kan have øget risiko for blødningshændelser, herunder epistaxis (se pkt.
English: If you get any side effect, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Following a single 25 mg temsirolimus intravenous dose, mean steady-state volume of distribution in whole blood of patients with cancer was 172 liters.
Danish: Efter indgift af en enkelt intravenøs dosis på 25 mg temsirolimus var fordelingsvolumens middel-steady-state i fuldblod hos patienter med cancer 172 liter.
English: The amount of alcohol in this medicine may impair your ability to drive or alter the effects of other medicines (see sections “Warning and precautions” and “Driving and using machines”).
Danish: Indholdet af alkohol i lægemidlet kan påvirke evnen til at køre bil eller virkningen af andre lægemidler (se afsnittet Advarsler og forsigtighedsregler og Trafik- og arbejdssikkerhed).
English: For patients receiving 175 mg weekly for 3 weeks followed by 75 mg weekly, estimated Cmax in whole blood at end of infusion was 2457 ng/ml during Week 1, and 2574 ng/ml during Week 3.
Danish: Hos patienter, der fik 175 mg/uge i 3 uger efterfulgt af 75 mg/uge, var den estimerede Cmax i helblod ved afslutning af infusionen 2.457 ng/ml i uge 1 og 2.574 ng/ml i uge 3.
English: In the MCL clinical trial, hyperlipaemia was reported as an adverse event in 9.3% of patients.
Danish: I MCL-studiet blev hyperlipæmi rapporteret som bivirkning hos 9,3% af patienterne.
English: Polysorbate 80 (E 433) Macrogol 400
Danish: Polysorbat 80 (E-433) Macrogol 400
English: Always dilute Torisel 30 mg concentrate with 1.8 ml of the supplied solvent before adding to the infusion solution.
Danish: Fortynd altid Torisel 30 mg koncentrat med 1,8 ml af den medfølgende solvens, inden det tilsættes infusionsopløsningen.
English: P-value
Danish: p-værdi
English: Torisel may lead to a higher risk of bleeding into your brain.
Danish: Torisel kan øge risikoen for at få hjerneblødning.
English: Treatment of suspected adverse reactions may require temporary interruption and/or dose reduction of temsirolimus therapy according to the guidelines in the following tables.
Danish: Behandlingen af formodede bivirkninger kan kræve midlertidig afbrydelse af behandlingen med temsirolimus og/eller dosisreduktion i henhold til retningslinjerne i nedenstående tabeller.
English: It is important that the recommendations in sections 4.2 and 6.6 be followed closely.
Danish: 4.2 og 6.6 følges nøje.
English: In the MCL clinical trial, a Phase 3 clinical trial for MCL, 11% of patients reported hyperglycaemia as an adverse event.
Danish: I MCL-studiet, et fase 3 klinisk studie vedrørende MCL, rapporterede 11% af patienterne hyperglykæmi som bivirkning.
English: This may increase the risk of bleeding in your body.
Danish: Dette kan øge risikoen for indre blødning.
English: if the number of platelet (a type of blood cell that helps to clot blood) has decreased.
Danish: - hvis antallet af blodplader falder (blodceller, der får blodet til at størkne).
English: Very common Hyperglycaemia Hypercholesterolaemia Hypertriglyceridaemia Decreased appetite Hypokalaemia
Danish: Hyperkolesterolæmi Hypertriglyceridæmi Nedsat appetit
English: The AUCsum of temsirolimus and sirolimus on day 8 in patients with mild and moderate hepatic impairment receiving 25 mg temsirolimus was similar to that observed in patients without hepatic impairment receiving 75 mg (mean AUCsum mild: approximately 9770 ng*h/ml, n=13; moderate: approximately 12380 ng*h/ml, n=6; normal approximately 10580 ng*h/ml, n=4).
Danish: AUCsum af temsirolimus og sirolimus på dag 8 hos patienter med let og moderat leverinsufficiens, som fik 25 mg temsirolimus, var sammenlignelig med den, der observeredes hos patienter uden leverinsufficiens, som fik 75 mg (middel-AUCsum let: cirka 9.770 ng•h/ml, n=13; moderat: cirka 12.380 ng•h/ml, n=6; normal: cirka 10.580 ng•h/ml, n=4).
English: This may result in the need for an increase in the dose of, or initiation of, insulin and/or hypoglycaemic agent therapy.
Danish: Dette kan medføre et behov for dosisøgning, eller start på insulin og/eller behandling med hypoglykæmisk stof.
English: Median PFS of the temsirolimus 175/75 mg group (4.8 months) was prolonged by 2.9 months compared to the investigator's choice group (1.9 months).
Danish: Medianen af den progressionsfrie overlevelse hos den gruppe, der fik 175/75 mg temsirolimus (4,8 måneder), var 2,9 måneder længere end hos den gruppe, der fik investigators valg af behandling (1,9 måneder).
English: While temsirolimus has been safely administered to patients with renal cancer with repeated intravenous doses as high as 220 mg/m2, in MCL, two administrations of 330 mg temsirolimus/week in one patient resulted in Grade 3 rectal bleeding and Grade 2 diarrhoea.
Danish: Mens temsirolimus er blevet sikkert indgivet til patienter med nyrecancer med gentagne intravenøse doser på op til 220 mg/m resulterede to indgivelser af 330 mg temsirolimus/uge hos en MCL-patient i rektal blødning grad 3 og diaré grad 2.
English: Promptly tell your doctor of any new or worsening respiratory symptoms such as shortness of breath or difficulty breathing.
Danish: Kontakt straks lægen, hvis du får nye eller forværrede vejrtrækningsproblemer som f.eks. åndenød eller vejrtrækningsbesvær.
English: PFIZER ΕΛΛΑΣ A.E. Tηλ: +30 210 67 85 800
Danish: PFIZER ΕΛΛΑΣ A.E. T :+30 2 10 67 85 800
English: Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis and hypersensitivity vasculitis, have been associated with the oral administration of sirolimus.
Danish: Overfølsomhedsreaktioner herunder anafylaktiske/anafylaktoide reaktioner, angioødem, eksfoliativ dermatitis og allergisk vasculitis er blevet sat i forbindelse med oral indgift af sirolimus.
English: The infusion may then be resumed at a slower rate (up to 60 minutes) and should be completed within six hours from the time that temsirolimus is first added to sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Infusionen kan derefter genoptages med en langsommere hastighed (op til 60 minutter) og bør afsluttes inden for seks timer fra det tidspunkt, hvor temsirolimus blev tilsat natriumchlorid 9 mg/ml (0,9%) opløsningen til injektion.