FrancophonIA/ELRC3.0 huggingface dataset:
English: Sirolimus trough concentration data in 35 renal transplant patients above 65 years of age were similar to those in the adult population (n=822) from 18 to 65 years of age.
Danish: Data på sirolimus-dalkoncentration fra 35 nyretransplanterede patienter over 65 år er de samme som fra en voksenpopulation (n = 822) i alderen 18-65 år.
English: If you stop taking Rapamune
Danish: Hvis De holder op med at tage Rapamune
English: Undesirable effects observed with prophylaxis of organ rejection in renal transplantation
Danish: Bivirkninger observeret ved forebyggelse af organafstødning ved nyretransplantation
English: The adverse drug reactions observed in patients with S-LAM were consistent with the known safety profile of the product for the indication prophylaxis of organ rejection in renal transplantation with the addition of weight decreased, which was reported in the study at a greater incidence with Rapamune when compared to that observed with placebo (common, 9.5% vs. common, 2.6%).
Danish: Bivirkningerne, som blev observeret hos patienterne med S-LAM, var sammenlignelige med den kendte sikkerhedsprofil af produktet til indikationen forebyggelse af organafstødning ved nyretransplantation med tilføjelse af vægttab, hvilket blev rapporteret i forsøget med en højere incidens for Rapamune sammenlignet med incidensen, der blev observeret for placebo (almindelig; 9,5 % vs. almindelig; 2,6 %).
English: S-LAM patients experienced similar side effects to those of kidney transplant patients, with the addition of weight loss, which may affect up to 1 in 10 people.
Danish: S-LAM patienter oplevede samme bivirkninger som nyretransplanterede patienter derudover vægttab, hvilket forekommer hos mere end 1 ud af 10 personer.
English: Clinical studies with Rapamune oral solution did not include a sufficient number of patients above 65 years of age to determine whether they will respond differently than younger patients (see section 5.2).
Danish: Kliniske forsøg med Rapamune oral opløsning inkluderede ikke et tilstrækkeligt antal patienter over 65 år til at kunne afgøre, om de vil respondere anderledes end yngre patienter (se pkt.
English: HMG-CoA reductase inhibitors
Danish: HMG-CoA-reduktasehæmmere
English: 60 mL oral solution.
Danish: 60 ml oral opløsning
English: You should see your doctor immediately if you experience symptoms, such as swollen face, tongue and/or back of the mouth (pharynx) and/or difficulties in breathing (angioedema), or a skin condition whereby the skin can peel off (exfoliative dermatitis).
Danish: De skal omgående kontakte Deres læge, hvis De får symptomer som f.eks. hævelse af ansigt, tunge og/eller bagerste del af munden (svælget) og/eller åndedrætsbesvær (angioødem), eller hvis huden skaller af (eksfoliativ dermatitis).
English: Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant.
Danish: Rapamune anvendes til forebyggelse af organafstødning hos voksne nyretransplanterede patienter med lav til moderat immunologisk risiko.
English: Sirolimus did not affect the pharmacokinetics of either diltiazem or its metabolites desacetyldiltiazem and desmethyldiltiazem.
Danish: Sirolimus påvirker ikke farmakokinetikken for hverken diltiazem eller dennes metabolitter desacetyldiltiazem og desmethyldiltiazem.
English: Please inform your doctor if you are taking any of these medicines.
Danish: Fortæl Deres læge, hvis De tager denne type medicin.
English: Increased susceptibility to infection and the possible development of lymphoma and other malignancies, particularly of the skin, may result from immunosuppression (see section 4.8).
Danish: Øget modtagelighed for infektion og mulig udvikling af lymfom og andre maligniteter, specielt i huden, kan være et resultat af immunsuppression (se pkt.
English: The safety and efficacy of Rapamune as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore such use is not recommended.
Danish: Sikkerhed og effekt af Rapamune som immunsuppressiv behandling er ikke dokumenteret hos leverog lungetransplanterede patienter, og derfor frarådes denne brug.
English: Loss of TSC gene function activates the mTOR signaling pathway, resulting in cellular proliferation and release of lymphangiogenic growth factors.
Danish: Tab af TSCgenfunktionen aktiverer mTOR-signalvejen, hvilket resulterer i celleproliferation og frigivelse af lymfangiogene vækstfaktorer.
English: Lactose monohydrate Macrogol
Danish: Lactosemonohydrat Macrogol
English: There have been reports of impaired or delayed wound healing in patients receiving Rapamune, including lymphocele in renal transplant patients and wound dehiscence.
Danish: Der har været rapporter om forringet eller forsinket sårheling hos patienter i behandling med Rapamune, herunder lymfocele hos nyretransplanterede patienter og sårruptur.
English: Sirolimus inhibits T-cell activation induced by most stimuli, by blocking calcium-dependent and calcium-independent intracellular signal transduction.
Danish: Sirolimus hæmmer T-celleaktivering fremkaldt af de fleste stimuli, idet calciumafhængige og calciumuafhængige intracellulære signaltransduktioner blokeres.
English: An initial dose of 6 mg contains up to 150 mg of alcohol which is equivalent to 3.80 mL beer or 1.58 mL wine.
Danish: En initial dosis på 6 mg indeholder op til 150 mg alkohol, hvilket svarer til 3,80 ml øl eller 1,58 ml vin.
English: If you forget to take Rapamune
Danish: Hvis De har glemt at tage Rapamune
English: At 48 months, there was a statistically significant difference in graft survival in favour of the Rapamune following ciclosporin elimination group compared to the Rapamune with ciclosporin therapy group (including and excluding loss to follow-up).
Danish: I måned 48 var der en statistisk signifikant forskel på implantatoverlevelsen til fordel for den gruppe, som fik Rapamune efter ciclosporin-elimination, sammenlignet med den behandlingsgruppe, som fik Rapamune med ciclosporin (med og uden de patienter, som var tabt for opfølgning).
English: At 2 years, the rate of non-melanoma skin malignancies was significantly lower in the Rapamune conversion group as compared to the calcineurin inhibitors continuation group (1.8% and 6.9%).
Danish: Efter 2 år er hyppigheden af non-melanomhudcancer signifikant lavere i den gruppe, som er skiftet til Rapamune, end i den gruppe, hvor behandlingen med calcineurinhæmmere fortsatte (1,8% og 6,9%).
English: The use of live vaccines should be avoided with the use of Rapamune.
Danish: Brug af levende vacciner bør undgås under behandling med Rapamune.
English: Rapamune tablets administered to 12 renal transplant patients above 65 years of age gave similar results to adult patients (n=167) 18 to 65 years of age.
Danish: Resultaterne for Rapamune tabletter indgivet til 12 nyretransplanterede patienter over 65 år var de samme som hos voksne patienter (n = 167) i alderen 18-65 år.
English: There were more adverse events (99.2% vs. 91.1%, p=0.002*) and more discontinuations from the treatment due to adverse events (26.7% vs. 4.1%, p<0.001*) in the group converted to sirolimus compared to the tacrolimus group.
Danish: Der var flere bivirkninger (99,2 % vs. 91,1 %, p=0,002*) og flere behandlingsseponeringer på grund af bivirkninger (26,7 % vs. 4,1 %, p <0,001*)) i den gruppe, som skiftede til sirolimus sammenlignet med tacrolimus-gruppen.
English: In patients with delayed graft function, sirolimus may delay recovery of renal function.
Danish: Hos patienter med forsinket funktion af transplantatet, kan sirolimus forsinke genoprettelsen af nyrefunktionen.
English: Administration of multiple doses of rifampicin decreased sirolimus whole blood concentrations following a single 10 mg dose of Rapamune oral solution.
Danish: Administration af flere doser rifampicin nedsætter koncentrationen af sirolimus i fuldblod efter en enkelt dosis på 10 mg Rapamune oral opløsning .
English: Patients at low to moderate immunological risk were studied in the phase 3 ciclosporin elimination-Rapamune maintenance study, which included patients receiving a renal allograft from a cadaveric or living donor.
Danish: Patienter med lav til moderat immunologisk risiko blev undersøgt i et fase 3 ciclosporin eliminationsRapamune-vedligeholdelsesforsøg, som inkluderede patienter, der fik en nyre transplanteret fra en afdød eller levende donor.
English: The use of Rapamune is not recommended in this population.
Danish: Brug af Rapamune til denne aldersgruppe frarådes.
English: Refill the glass with at least 120 mL of water or orange juice, stir well, and drink immediately.
Danish: Fyld igen glasset med mindst 120 ml vand eller appelsinjuice, rør godt og drik det med det samme.
English: It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months.
Danish: Rapamune bør initialt anvendes sammen med ciclosporin mikroemulsion og kortikosteroider i 2-3 måneder.
English: Lung and liver transplant populations
Danish: Lunge- og levertransplanterede populationer
English: Suggested ciclosporin trough concentration ranges for the first 2-3 months after transplantation are 150-400 ng/mL (monoclonal assay or equivalent technique) (see section 4.5).
Danish: Foreslåede ciclosporin-dalkoncentration de første 2-3 måneder efter transplantation er 150-400 ng/ml (monoklonal analyse eller tilsvarende teknik) (se pkt.
English: Cases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when sirolimus has been used as part of an immunosuppressive regimen.
Danish: Tilfælde af bronkieanastomoseruptur, oftest dødelige, er rapporteret hos de novo lungetransplanterede patienter, hvor sirolimus er brugt som del af den immunsuppressive behandling.
English: The mean calculated glomerular filtration rate (GFR) at 12, 24, 36, 48 and 60 months was significantly higher for patients receiving Rapamune following ciclosporin elimination than for those in the Rapamune with ciclosporin therapy group.
Danish: Den gennemsnitlige beregnede glomerulære filtrationshastighed (GFR) i måned 12, 24, 36, 48 og 60 er signifikant højere hos de patienter, som fik Rapamune efter ciclosporin-elimination end hos den behandlingsgruppe, som fik Rapamune med ciclosporin.
English: Multiple-dose administration of verapamil and sirolimus oral solution significantly affected the rate and extent of absorption of both medicinal products.
Danish: Flerdosisadministration af verapamil og sirolimus oral opløsning påvirker signifikant hastigheden og graden af absorptionen af begge lægemidler.
English: To minimise variability, Rapamune should be taken at the same time in relation to ciclosporin, 4 hours after the ciclosporin dose, and consistently either with or without food (see section 5.2).
Danish: For at mindske variabiliteten bør Rapamune tages på samme tidspunkt i forhold til ciclosporinindtagelse, 4 timer efter ciclosporindosis, og konsekvent med eller uden mad (se pkt.
English: Similarly the risk/benefit of continued Rapamune therapy should be re-evaluated in patients with severe refractory hyperlipidaemia.
Danish: Ligeledes bør fordele og ulemper ved fortsat behandling med Rapamune revurderes ved alvorlig refraktær hyperlipidæmi.
English: The corresponding results for the oral solution in the same clinical study were Cmin,ss 5.40  2.50 ng/mL, Cmax,ss 14.4  5.3 ng/mL, tmax,ss 2.12  0.84 hours, AUC,ss 194  78 ng.h/mL, CL/F/W 173  50 mL/h/kg.
Danish: De tilsvarende resultater for den orale opløsning i samme kliniske forsøg er Cmin,ss, 5,40  2,50 ng/ml; Cmax,ss, 14,4  5,3 ng/ml; tmax,ss, 2,12  0,84 timer; AUC,ss, 194  78 ng.time/ml; CL/F/WT, 173  50 ml/time/kg.
English: In renal transplant patients with delayed graft function, sirolimus may delay recovery of renal function.
Danish: Hos nyretransplanterede patienter med forsinket funktion af transplantatet kan sirolimus forsinke genoprettelsen af nyrefunktionen.
English: The usual dose regimen for Rapamune is a 6 mg single oral loading dose, administered as soon as possible after transplantation, followed by 2 mg once daily until results of therapeutic monitoring of the medicinal product are available (see Therapeutic monitoring of the medicinal product and dose adjustment).
Danish: Initial behandling (2-3 måneder efter transplantationen) Den sædvanlige dosering af Rapamune er en mætningsdosis på 6 mg så hurtigt som muligt efter transplantation, efterfulgt af 2 mg dagligt, indtil resultaterne af den terapeutiske lægemiddelmonitorering af lægemidlet er til rådighed (se Terapeutisk lægemiddelmonitorering og dosisjustering).
English: The combined use of Rapamune with angiotensin-converting enzyme (ACE) inhibitors (a type of medicine used to lower blood pressure) may result in allergic reactions.
Danish: Samtidig brug af Rapamune og ACE-hæmmere (medicin, som bruges til at sænke blodtrykket) kan forårsage overfølsomhedsreaktioner.
English: In a retrospective review of hepatic veno-occlusive disease (VOD) in patients who underwent myeloablative stem cell transplantation using cyclosphophamide and total body irradiation, an increased incidence of hepatic VOD was observed in patients treated with Rapamune, especially with concomitant use of methotrexate.
Danish: I en retrospektiv gennemgang af venookklusiv sygdom (VOD) i leveren hos patienter, som gennemgik myeloablativ stamcelletransplantation med brug af cyclophosphamid og helkrops-strålebehandling, blev der observeret en øget hyppighed af VOD i leveren hos patienter i behandling med Rapamune, særligt ved samtidig brug af methotrexat.
English: Since half-life is prolonged in these patients, therapeutic monitoring of the medicinal product after a loading dose or a change of dose should be performed for a prolonged period of time until stable concentrations are reached (see sections 4.2 and 5.2).
Danish: Eftersom halveringstiden er forlænget hos disse patienter, bør der efter en støddosis eller dosisændring udføres terapeutisk lægemiddelmonitorering over en længere periode, indtil stabile koncentrationer er opnået (se pkt.
English: Posterior reversible encephalopathy syndrome
Danish: Posteriort reversibelt encefalopatisyndrom
English: Based on information from subsequent clinical studies, the use of Rapamune, mycophenolate mofetil, and corticosteroids, in combination with IL-2 receptor antibody (IL2R Ab) induction, is not recommended in the de novo renal transplant setting (see section 5.1).
Danish: Baseret på oplysninger fra efterfølgende kliniske forsøg frarådes brug af Rapamune, mycophenolatmofetil og kortikosteroider i kombination med IL-2-receptorantistof (IL2R Ab) induktion ved de novo nyretransplantationer (se pkt.
English: Reductions in testicular weights and/or histological lesions (e.g. tubular atrophy and tubular giant cells) were observed in rats and in a monkey study.
Danish: Fald i testikelvægt og/eller histologiske skader (f.eks. tubulær atrofi og tubulære gigantceller) er set hos rotter og i et forsøg med aber.
English: Then place the capped dosing syringe in the carrying case provided.
Danish: Derefter placeres den lukkede doseringssprøjte i det medfølgende transportæske.
English: If you have a body mass index (BMI) greater than 30 kg/m2, you may be at increased risk of abnormal wound healing.
Danish: - Hvis Deres body mass index (BMI) er højere end 30 kg/m2, kan De have øget risiko for unormal sårheling.
English: Rifampicin increased the clearance of sirolimus by approximately 5.5-fold and decreased AUC and Cmax by approximately 82% and 71%, respectively.
Danish: Rifampicin øger sirolimus-clearance med ca. 5,5 gange og nedsætter AUC med ca. 82% og Cmax med ca.71%.
English: St. John's Wort (Hypericum perforatum).
Danish: - perikon (Hypericum perforatum).
English: Infections (including life-threatening infections) Blood clots in the legs
Danish: - infektioner (herunder livstruende infektioner) - blodpropper i benene - blodpropper i lungen - sår i munden
English: Initial Therapy (2 to 3 months post-transplant): In most patients receiving Rapamune tablets with a loading dose of 6 mg followed by an initial maintenance dose of 2 mg, whole blood sirolimus trough concentrations rapidly achieved steady-state concentrations within the recommended target range (4 to 12 ng/mL, chromatographic assay).
Danish: Initial behandling (2-3 måneder efter transplantation): Hos de fleste patienter, som får Rapamune tabletter i en støddosis på 6 mg efterfulgt af en initial vedligeholdelsesdosis på 2 mg, når dalkoncentrationer af sirolimus i fuldblod hurtigt steady-state-koncentrationer inden for det anbefalede målområde (4-12 ng/ml, kromatografisk analyse).
English: Cases of interstitial lung disease (including pneumonitis and infrequently bronchiolitis obliterans organising pneumonia (BOOP) and pulmonary fibrosis), some fatal, with no identified infectious aetiology have occurred in patients receiving immunosuppressive regimens including Rapamune.
Danish: Tilfælde af interstitiel lungesygdom (herunder pneumonit og sjældent bronchiolitis obliterans organising pneumonia (BOOP) og lungefibrose), nogle dødelige, uden identificeret infektiøs ætiologi er opstået hos patienter, som fik immunsupressiv behandling, herunder Rapamune.
English: Several assay methodologies have been used to measure the whole blood concentrations of sirolimus.
Danish: Adskillige prøvemetoder har været anvendt til at måle koncentrationer af sirolimus i fuldblod.
English: These effects have been reversible upon discontinuation of Rapamune in most cases (see section 5.3).
Danish: I de fleste tilfælde har denne virkning været reversibel efter ophør med Rapamune (se pkt.
English: If further dose adjustment(s) are required during maintenance therapy (after discontinuation of ciclosporin), in most patients these adjustments can be based on simple proportion: new Rapamune dose=current dose x (target concentration/current concentration).
Danish: Hvis yderligere dosisjustering(er) er nødvendig(e) under vedligeholdelsesbehandling (efter seponering af ciclosporin), kan disse justeringer hos de fleste patienter baseres på simple forhold: ny Rapamunedosis = nuværende dosis x (mål for koncentration/nuværende koncentration).
English: The Rapamune group failed to demonstrate superiority to the control group in terms of the first occurrence of biopsy confirmed acute rejection, graft loss, or death.
Danish: Det kunne ikke påvises, at behandlingen med Rapamune var bedre end den behandling, som kontrolgruppen fik, når de blev vurderet ud fra den første forekomst af biopsibekræftet akut afstødning, transplantattab eller død.
English: Rapamune is also used for the treatment of patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or declining lung function.
Danish: Rapamune anvendes også til behandling af patienter med sporadisk lymphangioleiomyomatosis (SLAM) med moderat lungesygdom eller faldende lungefunktion.
English: Inducers of CYP3A4 (such as rifampin or rifabutin) increase the metabolism of sirolimus and decrease sirolimus levels.
Danish: CYP3A4-induktorer (som f.eks. rifampin eller rifabutin) øger metaboliseringen af sirolimus og nedsætter sirolimusniveauet.
English: You must use an effective method of contraception during treatment with Rapamune and for 12 weeks after treatment has stopped.
Danish: De skal anvende effektiv prævention under behandlingen med Rapamune og i 12 uger efter, at behandlingen er stoppet.
English: In two multi-centre clinical studies, de novo renal transplant patients treated with sirolimus, mycophenolate mofetil (MMF), corticosteroids, and an IL-2 receptor antagonist had significantly higher acute rejection rates and numerically higher death rates compared to patients treated with a calcineurin inhibitor, MMF, corticosteroids, and an IL-2 receptor antagonist (see section 4.4).
Danish: I 2 kliniske multicenterforsøg havde de novo nyretransplanterede patienter, som blev behandlet med sirolimus, mycophenolatmofetil, kortikosteroider og en IL-2-receptorantagonist, en signifikant højere akut afstødningsfrekvens og en numerisk højere dødsfrekvens end de patienter, som blev behandlet med en calcineurinhæmmer, mycophenolatmofetil, kortikosteroider og en IL-2-receptorantagonist (se pkt.
English: In hepatically impaired patients, it is recommended that sirolimus whole blood trough levels be closely monitored.
Danish: Hos patienter med nedsat leverfunktion anbefales det, at sirolimus-dalkoncentrationen i fuldblod monitoreres omhyggeligt.
English: Inhibitors of CYP3A4 may decrease the metabolism of sirolimus and increase sirolimus blood levels.
Danish: CYP3A4-hæmmere kan nedsætte metaboliseringen af sirolimus og øge sirolimusniveauet i blodet.
English: In rats, sirolimus caused embryo/foetotoxicity that was manifested as mortality and reduced foetal weights (with associated delays in skeletal ossification) (see section 4.6).
Danish: Hos rotter forårsager sirolimus embryo-/føtotoksicitet, som manifesterer sig ved død og nedsat fødselsvægt (med tilhørende forsinkelse af knogledannelsen) (se pkt.
English: Pancytopaenia; Thrombotic thrombocytopaenic purpura
Danish: Pancytopeni, trombotisk trombocytopenisk purpura
English: After dilution, the preparation should be used immediately.
Danish: Præparatet skal anvendes straks efter fortynding.
English: Store in the original bottle in order to protect from light.
Danish: Opbevares i originalflasken for at beskytte mod lys.
English: Grapefruit juice affects CYP3A4-mediated metabolism and must, therefore, be avoided.
Danish: Grapefrugtjuice påvirker den CYP3A4formidlede metabolisme og skal derfor undgås.
English: Other medicines and Rapamune
Danish: Brug af anden medicin sammen med Rapamune
English: A 6 mg loading dose contains up to 150 mg of alcohol which is equivalent to 3.80 mL beer or 1.58 mL wine.
Danish: En startdosis på 6 mg indeholder op til 150 mg alkohol, hvilket svarer til 3,80 ml øl eller 1,58 ml vin.
English: In some cases, the interstitial lung disease has resolved upon discontinuation or dose reduction of Rapamune.
Danish: I nogle tilfælde er den interstitielle lungesygdom svundet ved ophør med eller dosisreduktion af Rapamune.
English: No clinically significant pharmacokinetic interaction was observed between sirolimus and any of the following substances: acyclovir, atorvastatin, digoxin, glibenclamide, methylprednisolone, nifedipine, prednisolone, and trimethoprim/sulfamethoxazole.
Danish: Der ses ingen klinisk signifikant farmakokinetisk interaktion mellem sirolimus og følgende stoffer: aciclovir, atorvastatin, digoxin, glibenclamid, methylprednisolon, nifedipin, prednisolon og trimethoprim/sulfamethoxazol.
English: Patients who were successfully withdrawn from ciclosporin had lower serum creatinine levels and higher calculated glomerular filtration rates, as well as lower incidence of malignancy, compared to patients remaining on ciclosporin.
Danish: Patienter, som med held ophørte med ciclosporin, havde lavere serum-kreatininniveauer og højere beregnede glomerulære filtrationsrater samt lavere hyppighed af malignitet end patienter i vedligeholdelsesbehandling med ciclosporin.
English: Multiple-dose ketoconazole administration significantly affected the rate and extent of absorption and sirolimus exposure from Rapamune oral solution as reflected by increases in sirolimus Cmax, tmax, and AUC of 4.4-fold, 1.4-fold, and 10.9-fold, respectively.
Danish: Indgivelse af flere doser ketoconazol påvirker signifikant absorptionshastigheden og -graden samt sirolimus-eksponeringen fra Rapamune oral opløsning, hvilket afspejledes i en stigning i sirolimus Cmax på 4,4 gange, tmax på 1,4 gange og AUC på 10,9 gange.
English: Do not store above 25˚C.
Danish: Må ikke opbevares ved temperaturer over 25°C.
English: Because of the potential for adverse reactions in breast-fed infants from sirolimus, breast-feeding should be discontinued during treatment with Rapamune.
Danish: På grund af risikoen for uønskede virkninger af sirolimus hos det ammede barn, bør amning ophøre under behandling med Rapamune.