FrancophonIA/ELRC3.0 huggingface dataset:
English: During the treatment period in patients with S-LAM, the mean ±SE FEV1 slope was -12±2 mL per month in the placebo group and 0.3±2 mL per month in the Rapamune group (p<0.001).
Danish: I løbet af behandlingsperioden, hos patienterne med S-LAM, var den gennemsnitlige ±SE hældning af FEV1 -12 ±2 ml pr. måned i placebogruppen og 0,3 ±2 ml pr. måned i Rapamune-gruppen (p < 0,001).
English: Remove the safety cap from the bottle by squeezing the tabs on the cap and twisting.
Danish: Fjern sikkerhedskapslen fra flasken ved at trykke kapslens flapper ind og dreje.
English: Calcium sulfate
Danish: Calciumsulfat
English: Then you will need to take 2 mg of Rapamune each day, until otherwise directed by your doctor.
Danish: Derefter skal De tage 2 mg Rapamune hver dag, indtil Deres læge angiver noget andet.
English: The effective half-life, however, is shorter and mean steady-state concentrations were achieved after 5 to 7 days.
Danish: Den biologiske halveringstid er dog kortere og gennemsnitlig steady-statekoncentration nås efter 5-7 dage.
English: When switching patients between oral solution and tablet formulations, it is recommended to give the same dose and to verify the sirolimus trough concentration 1 to 2 weeks later to assure that it remains within recommended target ranges.
Danish: Ved skift af patienter fra oral opløsning til tabletformulering anbefales det at give samme dosis og verificere dalkoncentration af sirolimus 1-2 uger efter, for at sikre at koncentrationen er inden for de anbefalede målområder.
English: Inform your doctor if you have difficulty taking the oral solution.
Danish: Fortæl det til lægen, hvis De har besvær med at tage den orale opløsning.
English: The treatment regimen studied (continuous use of Rapamune in combination with calcineurin inhibitor) is not indicated for adult or paediatric patients (see section 4.1).
Danish: Det undersøgte behandlingsregime (kontinuerlig brug af Rapamune i kombination med en calcineurinhæmmer) er ikke indiceret til voksne eller børn (se afsnit 4.1).
English: Rapamune should not be taken with grapefruit juice.
Danish: De må ikke tage Rapamune sammen med grapefrugtjuice.
English: So if you are taking Rapamune, you may therefore catch more infections than usual, such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract (see list below).
Danish: Hvis De tager Rapamune, kan De derfor få flere infektioner end normalt, som f.eks infektioner i huden, munden, mave-tarmsystemet, lungerne og urinvejene (se liste nedenfor).
English: Special populations Black population
Danish: Negroid population
English: The use of live vaccines should be avoided during treatment with Rapamune.
Danish: Brugen af levende vacciner bør undgås under behandling med Rapamune.
English: The safety and efficacy of Rapamune for treatment of S-LAM were assessed in a randomised, double-blind, multicentre, controlled trial.
Danish: Sikkerheden og effekten af Rapamune i behandlingen af S-LAM blev undersøgt i et randomiseret, dobbeltblindet, kontrolleret multicenterforsøg.
English: The rates of acute rejection, graft loss, and death were similar, but urinary protein excretion was increased in the Rapamune treatment arm of this subset.
Danish: Hyppigheden af akut afstødning, transplantattab og død er den samme, men udskillelsen af urinprotein er forøget i Rapamune-armen i denne patientundergruppe.
English: The use of Rapamune was associated with increased serum cholesterol and triglycerides that may require treatment.
Danish: Anvendelse af Rapamune var forbundet med forhøjet serum-kolesterol og -triglycerider, som kan kræve behandling.
English: In healthy subjects, the mean extent of bioavailability of sirolimus after single-dose administration of the tablet formulation is about 27% higher relative to the oral solution.
Danish: Hos raske frivillige personer er biotilgængeligheden af sirolimus efter en enkelt dosis af tabletformuleringen ca. 27% højere end den orale opløsning.
English: This dose could potentially be harmful for those suffering from alcoholism and should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Danish: Denne dosis kan potentielt være skadelig for alkoholikere, og der skal tages højde for den hos gravide og ammende kvinder, børn og højrisikogrupper som f.eks. patienter med leversygdom eller epilepsi.
English: There was a higher rate of serious adverse events, including pneumonia, acute rejection, graft loss and death, in this sirolimus treatment arm (n=60, median time post-transplant 36 months).
Danish: Der var en højere frekvens af alvorlige bivirkninger herunder pneumoni, akut afstødning, transplantattab og død i gruppen behandlet med sirolimus (n=60, mediantid efter transplantation 36 måneder).
English: The rate of death in the sirolimus conversion group was higher than the CNI continuation group, although the rates were not significantly different.
Danish: Dødeligheden var højere i gruppen, der skiftede til sirolimus, end i gruppen, der fortsatte med CNI-behandling, men forskellen var ikke signifikant.
English: This medicine contains approximately 350 mg propylene glycol (E1520) in each mL.
Danish: Dette lægemiddel indeholder ca. 350 mg propylenglycol (E1520) for hver ml.
English: Most rejections occurred within the first six months following conversion and were mild in severity; no graft losses were reported during the study (see section 4.4).
Danish: De fleste afstødninger forekom inden for de første 6 måneder efter skiftet og var af let grad. Der blev ikke rapporteret transplantattab under forsøget (se pkt.
English: Rapamune must not be diluted in grapefruit juice or any other liquid other than water or orange juice (see section 6.6).
Danish: Rapamune må ikke fortyndes i grapefrugtjuice eller anden væske end vand eller appelsinjuice (se pkt.
English: Single-dose sirolimus did not affect the pharmacokinetics of ciclosporin (microemulsion) in healthy volunteers when administered simultaneously or 4 hours apart.
Danish: En enkelt dosis sirolimus påvirker ikke farmakokinetikken af ciclosporin (mikroemulsion) hos raske, frivillige personer ved samtidig indgivelse eller indgift med 4 timers mellemrum.
English: Ovarian cysts and menstrual disorders (including amenorrhoea and menorrhagia) have been reported.
Danish: Ovariecyster og menstruationsforstyrrelser (inklusive amenorré og menoragi) er rapporteret.
English: The continued co-administration of ciclosporin and Rapamune as maintenance therapy cannot be recommended.
Danish: Fortsat samtidig administration af ciclosporin og Rapamune som vedligeholdelsesbehandling frarådes.
English: The terminal half-life in stable renal transplant patients after multiple oral doses was 62  16 hours.
Danish: Eliminationshalveringstiden hos stabile nyretransplanterede patienter efter indgift af flere orale doser er 62  16 timer.
English: In general, the adverse effects of overdose are consistent with those listed in section 4.8.
Danish: Generelt er bivirkningerne ved overdosering de samme som dem, der er beskrevet i pkt.
English: Mycobacterial infection (including tuberculosis); Epstein-Barr virus infection
Danish: Clostridium difficile colitis, mykobakteriel infektion (herunder tuberkulose), Epstein-Barr virusinfektion
English: Sirolimus administered concomitantly (5 mg), and at 2 hours (5 mg) and 4 hours (10 mg) after CsA (300 mg), resulted in increased sirolimus AUC by approximately 183%, 141% and 80%, respectively.
Danish: Sirolimus administreret samtidigt (5 mg), og 2 timer (5 mg) og 4 timer (10 mg) efter CsA (300 mg) øger sirolimusAUC med henholdsvis ca. 183%, 141% og 80%.
English: Sirolimus trough concentrations should be monitored at least 3 to 4 days after a loading dose(s).
Danish: Dalkoncentrationer af sirolimus bør monitoreres i mindst 3-4 dage efter støddosis/-doser.
English: This amount of alcohol may be harmful for those suffering from alcoholism as well as for pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Danish: Denne mængde alkohol kan være skadelig for alkoholikere, gravide og ammende kvinder, børn og højrisikogrupper som f.eks. patienter med leversygdom eller epilepsi.
English: A loading dose should be considered in addition to a new maintenance dose when it is necessary to considerably increase sirolimus trough concentrations: Rapamune loading dose=3 x (new maintenance dose - current maintenance dose).
Danish: En indledende dosis bør overvejes i tillæg til en ny vedligeholdelsesdosis, når det er nødvendigt at øge dalkoncentration af sirolimus væsentligt: Rapamune støddosis = 3 x (ny vedligeholdelsesdosis - nuværende vedligeholdelsesdosis).
English: Posterior reversible encephalopathy syndrome (PRES), a serious nervous system syndrome that has the following symptoms: headache, nausea, vomiting, confusion, seizures, and visual loss.
Danish: - posteriort reversibelt encefalopatisyndrom (PRES), en alvorlig nervesygdom med følgende symptomer: hovedpine, kvalme, opkastning, forvirring, krampeanfald og synstab.
English: Pharmacokinetic interactions may be observed with gastrointestinal prokinetic agents, such as cisapride and metoclopramide.
Danish: Farmakokinetiske interaktioner kan muligvis ses ved gastrointestinale prokinetiske midler som f.eks. cisaprid og metoclopramid.
English: Sirolimus is also a substrate for the multidrug efflux pump, P-glycoprotein (P-gp) located in the small intestine.
Danish: Sirolimus er også substrat for multistof-efflux-pumpen, P-glykoprotein (P-gp) i tyndtarmen.
English: Your doctor will also perform tests to monitor your kidney function, your blood fat (cholesterol and/or triglycerides) levels and possibly your liver function, during treatment with Rapamune.
Danish: Deres læge vil også tage prøver for at måle nyrefunktionen, indholdet af fedt (kolesterol og/eller triglycerider) i Deres blod og muligvis leverfunktionen under behandlingen med Rapamune.
English: The study also failed to demonstrate non-inferiority of the rate of combined graft loss, missing survival data, or death for the sirolimus conversion group compared to the CNI continuation group.
Danish: Forsøget viste heller ikke noninferioritet af frekvensen af samlet implantattab, manglende overlevelsesdata eller død hos gruppen, der skiftede til sirolimusbehandling, end i gruppen, der fortsatte med CNI-behandling.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
English: Focal segmental glomerulosclerosis has been reported.
Danish: Der er set indberetninger af fokal segmentær glomerulosklerose.
English: Glycerol monooleate
Danish: Glycerolmonooleat
English: The net result is the inhibition of lymphocyte activation, which results in immunosuppression.
Danish: Nettoresultatet er hæmning af lymfocytaktiveringen, hvilket fører til immunhæmning.
English: Rapamune therapy should be optimised with a tapering regimen of steroids and ciclosporin microemulsion.
Danish: Rapamune-behandlingen bør optimeres med gradvist aftagende behandling med steroider og ciclosporin mikroemulsion.
English: Uncommon (≥1/1,000 to
Danish: Ikke almindelig (≥1/1000 til
English: The rate and extent of sirolimus absorption was significantly increased by ciclosporin A (CsA).
Danish: Absorptionshastighed og -grad af sirolimus øges signifikant af ciclosporin (CsA).
English: The younger children had a higher weight-normalized Cl/F (214 mL/h/kg) compared with the adolescents (136 mL/h/kg).
Danish: De yngre børn havde en højere vægtnormaliseret CL/F (214 ml/time/kg) end de unge (136 ml/time/kg).
English: Sirolimus whole blood trough concentrations should be measured in 10 to 20 days, with dosage adjustment to maintain concentrations between 5 to 15 ng/mL.
Danish: Dalkoncentrationer af sirolimus i fuldblod skal måles efter 10 til 20 dage med dosisjusteringer for at bibeholde koncentrationer mellem 5 til 15 ng/ml.
English: Subjects were to receive Rapamune (sirolimus target concentrations of 5 to 15 ng/mL) in combination with a calcineurin inhibitor and corticosteroids or to receive calcineurin-inhibitor-based immunosuppression without Rapamune.
Danish: Forsøgspersonerne fik Rapamune (med målkoncentrationer af sirolimus på 5-15 ng/ml) i kombination med en calcineurinhæmmer og kortikosteroider, eller de fik calcineurinhæmmerbaseret immunsuppression uden Rapamune.
English: The 0.5 mg and 2 mg tablets also contain yellow iron oxide (E172) and brown iron oxide (E172).
Danish: Tabletterne på 0,5 mg og 2 mg indeholder også gul jernoxid (E172) og brun jernoxid (E172).
English: Hypertension; Lymphocele
Danish: Hypertension, lymfocele
English: Marketing Authorisation Holder: Pfizer Europe MA EEIG Boulevard de la Plaine 17
Danish: Indehaver af markedsføringstilladelsen: Pfizer Europe MA EEIG Boulevard de la Plaine 17
English: Rapamune contains lactose and sucrose
Danish: Rapamune indeholder lactose og saccharose
English: There was a significantly higher rate of first biopsy-proven rejection in the ciclosporin elimination group compared to the ciclosporin maintenance group during the period post-randomisation to 12 months (9.8% vs. 4.2%, respectively).
Danish: Der er en signifikant højere hyppighed af biopsiverificerede førstegangs-afstødninger i gruppen med ciclosporin-elimination end i ciclosporin-vedligeholdelsesgruppen i perioden efter randomisering og op til 12 måneder (henholdsvis 9,8% vs. 4,2%).
English: Multiples of the 0.5 mg tablets should therefore not be used as a substitute for other tablet strengths.
Danish: Der bør derfor ikke tages flere 0,5 mg tabletter som erstatning for andre tabletstyrker.
English: Patients taking Rapamune should discontinue breast-feeding.
Danish: Patienter, som tager Rapamune, skal stoppe med at amme.
English: It is unknown whether sirolimus is excreted in human milk.
Danish: Det vides ikke, om sirolimus udskilles i modermælken hos mennesker.
English: In such patients, when clinically appropriate, Rapamune should be discontinued and an alternative immunosuppressive regimen instituted.
Danish: Hvis det er klinisk hensigtsmæssigt, bør Rapamune seponeres hos sådanne patienter, og en alternativ immunsuppressiv behandling indledes.
English: This study compared Rapamune (dose adjusted to 5-15 ng/mL) with placebo for a 12-month treatment period, followed by a 12-month observation period in patients with TSC-LAM or S-LAM. Eighty-nine (89) patients were enrolled at 13 study sites in the United States, Canada, and Japan of which 81 patients had S-LAM; of these patients with S-LAM, 39 were randomised to receive placebo and 42 to receive Rapamune.
Danish: Dette forsøg sammenlignede Rapamune (dosis justeret til 5-15 ng/ml) med placebo i en behandlingsperiode på 12 måneder, efterfulgt af en observationsperiode på 12 måneder, hos patienter med TSC-LAM eller S-LAM. Niogfirs (89) patienter blev inkluderet ved 13 forsøgscentre i USA, Canada og Japan hvoraf 81 patienter havde SLAM; 39 patienter blev randomiseret til at modtage placebo, og 42 patienter blev randomiseret til at modtage Rapamune.
English: Hypersensitivity (including angioedema, anaphylactic reaction, and anaphylactoid reaction)
Danish: Overfølsomhed (herunder angioødem, anafylaktisk reaktion og anafylaktoid reaktion)
English: It is recommended that sirolimus whole blood trough levels be closely monitored in patients with impaired hepatic function (see Therapeutic monitoring of the medicinal product and dose adjustment).
Danish: Det anbefales, at dalkoncentrationen af sirolimus i fuldblod monitoreres omhyggeligt hos patienter med nedsat leverfunktion (se Terapeutisk lægemiddelmonitorering og dosisjustering).
English: Patients receiving sirolimus should be monitored closely if taking ACE inhibitors concomitantly.
Danish: Patienter, der får sirolimus, skal monitoreres nøje, hvis de samtidig behandles med ACE-hæmmere.
English: It is recommended that Rapamune be used first in combination with ciclosporin and corticosteroids.
Danish: Det anbefales, at Rapamune i starten bruges i kombination med ciclosporin og kortikosteroider.
English: In patients with S-LAM, enrolled patients had moderately advanced lung disease, with baseline FEV1 of 49.2±13.6% (mean ±SD) of the predicted value.
Danish: Hos patienterne med SLAM havde de inkluderede patienter moderat fremskreden lungesygdom med FEV1 på 49,2 ± 13,6% (gennemsnit ±SD) af den forventede værdi.
English: The pharmacokinetics of sirolimus were similar in various populations, with renal function ranging from normal to absent (dialysis patients).
Danish: De farmakokinetiske egenskaber for sirolimus er de samme hos forskellige grupper med en nyrefunktion, der strækker sig fra normal til manglende (dialysepatienter).
English: Immunosuppression increases the susceptibility to the development of lymphoma and other malignancies, particularly of the skin (see section 4.4).
Danish: Immunsuppression øger modtageligheden for udvikling af lymfom og andre maligniteter, især på huden (se pkt.
English: Ciclosporin inhibits the metabolism of sirolimus, and consequently sirolimus levels will decrease when ciclosporin is discontinued, unless the sirolimus dose is increased.
Danish: Ciclosporin hæmmer metaboliseringen af sirolimus, og derfor vil sirolimus niveauet falde ved seponering af ciclosporin, medmindre dosis af sirolimis øges.
English: The use of Rapamune may lead to increased levels of cholesterol and triglycerides (blood fats) in your blood that may require treatment.
Danish: Brugen af Rapamune kan medføre forhøjede niveauer af kolesterol og triglycerid (fedt) i blodet, hvilket kan kræve behandling.
English: Patients at high immunological risk of graft loss were not studied in sufficient number in the ciclosporin elimination-Rapamune maintenance studies and are not recommended for this treatment regimen.
Danish: Patienter med stor immunologisk risiko for transplantattab blev ikke undersøgt i tilstrækkeligt antal i ciclosporin-eliminations-Rapamune-vedligeholdelsesforsøgene, og dette behandlingsregime frarådes.
English: In paediatric patients on dialysis (30% to 50% reduction in glomerular filtration rate) within age ranges of 5 to 11 years and 12 to 18 years, the mean weight-normalised CL/F was larger for younger paediatric patients (580 mL/h/kg) than for older paediatric patients (450 mL/h/kg) as compared with adults (287 mL/h/kg).
Danish: Hos pædiatriske patienter i dialyse (fald på 30-50% i det glomerulære filtreringsforhold) inden for aldersgruppen 5-11 år og 12-18 år er den gennemsnitlige vægtnormaliserede CL/F større hos yngre pædiatriske patienter (580 ml/time/kg) end hos ældre pædiatriske patienter (450 ml/time/kg) sammenlignet med voksne (287 ml/time/kg).
English: Patients treated with ciclosporin and Rapamune beyond 3 months had higher serum creatinine levels and lower calculated glomerular filtration rates compared to patients treated with ciclosporin and placebo or azathioprine controls.
Danish: Patienter, der blev behandlet med ciclosporin og Rapamune ud over 3 måneder, havde højere serumkreatininniveauer og lavere beregnede glomerulære filtrationsrater end kontrolpatienter behandlet med ciclosporin og placebo eller azathioprin.
English: An unacceptably high frequency of PTLD was seen in a paediatric clinical transplant study when full-dose Rapamune was administered to children and adolescents in addition to full-dose calcineurin inhibitors with basiliximab and corticosteroids (see section 4.8).
Danish: Der blev set en uacceptabel høj frekvens af PTLD i et pædiatrisk klinisk transplantationsforsøg, når den fulde dosis Rapamune blev administreret til børn og unge som supplement til den fulde dosis af calcineurinhæmmere samt basiliximab og kortikosteroider (se afsnit 4.8).
English: At steady-state, 8 children aged 6-11 years received mean  SD doses of 1.75  0.71 mg/day (0.064  0.018 mg/kg, 1.65  0.43 mg/m2) while 14 adolescents aged 12-18 years received mean  SD doses of 2.79  1.25 mg/day (0.053  0.0150 mg/kg, 1.86  0.61 mg/m2).
Danish: Ved steady-state fik 8 børn i alderen 6-11 år gennemsnitlige  SD-doser på 1,75  0,71 mg/dag (0,064  0,018 mg/kg, 1,65  0,43 mg/m2), mens 14 unge i alderen 12-18 år fik gennemsnitlige  SD-doser på 2,79  1,25 mg/dag (0,053  0,0150 mg/kg, 1,86  0,61 mg/m2).
English: The safety and efficacy of Rapamune in children and adolescents less than 18 years of age have not been established.
Danish: Pædiatrisk population Rapamunes sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: It is recommended that a trough concentration be taken 1 or 2 weeks after switching formulations or tablet strength to confirm that the trough concentration is within the recommended target range.
Danish: Det anbefales, at dalkoncentrationen måles 1-2 uger efter, at der er skiftet formulering eller tabletstyrke for at bekræfte, at dalkoncentrationen er inden for det anbefalede målområde.
English: Pale yellow to yellow solution.
Danish: Lysegul til gul opløsning.
English: Liver function test abnormal (including alanine aminotransferase increased and aspartate aminotransferase increased)
Danish: Unormale leverfunktionsprøver (herunder forhøjet alanin-aminotransferase og forhøjet
English: Cases of Pneumocystis carinii pneumonia have been reported in renal transplant patients not receiving antimicrobial prophylaxis.
Danish: Tilfælde af Pneumocystis jiroveci pneumoni er rapporteret hos nyretransplanterede patienter, der ikke fik antimikrobiel profylakse.
English: When refrigerated the solution in the bottle may develop a slight haze.
Danish: Ved nedkøling kan opløsningen i flasken blive lidt tåget at se på.
English: In a randomised, comparative evaluation of ramipril versus placebo for the prevention of proteinuria in kidney transplant patients converted from calcineurin inhibitors to sirolimus, a difference in the number of patients with BCAR through 52 weeks was observed [13 (9.5%) vs. 5 (3.2%), respectively; p=0.073].
Danish: I en randomiseret komparativ evaluering af ramipril vs. placebo til forebyggelse af proteinuri hos nyretransplanterede patienter, som var skiftet fra calcineurinhæmmere til sirolimus, blev der observeret en forskel i antallet af patienter med BCAR igennem 52 uger [henholdsvis 13 (9,5%) vs. 5 (3,2%); p = 0,073].
English: 30 coated tablets 100 coated tablets
Danish: 30 overtrukne tabletter 100 overtrukne tabletter
English: Following administration of the Rapamune oral solution, sirolimus is rapidly absorbed, with a time to peak concentration of 1 hour in healthy subjects receiving single doses and 2 hours in patients with stable renal allografts receiving multiple doses.
Danish: Efter indgift af Rapamune oral opløsning absorberes sirolimus hurtigt med en maksimal koncentration efter 1 time hos raske frivillige personer, der fik enkeltdoser, og 2 timer hos patienter med stabile nyretransplantater, der fik flere doser.
English: In two clinical studies in de novo liver transplant patients, the use of sirolimus plus ciclosporin or tacrolimus was associated with an increase in hepatic artery thrombosis, mostly leading to graft loss or death.
Danish: I 2 kliniske forsøg med de novo levertransplanterede patienter blev brugen af sirolimus plus ciclosporin eller tacrolimus forbundet med en stigning i hepatisk arterietrombose, oftest førende til implantattab eller død.
English: In some cases, ovarian cysts and these menstrual disorders have resolved upon discontinuation of Rapamune.
Danish: Ovariecyster og disse menstruationsforstyrrelser er i nogle tilfælde ophørt efter seponering af Rapamune.
English: After a single dose of [14C] sirolimus in healthy volunteers, the majority (91.1%) of radioactivity was recovered from the faeces, and only a minor amount (2.2%) was excreted in urine.
Danish: C] sirolimus til raske frivillige personer blev størstedelen (91,1%) af radioaktiviteten genfundet i fæces, og kun en mindre del (2,2%) blev udskilt i urinen.
English: Grapefruit juice affects CYP3A4-mediated metabolism, and should therefore be avoided.
Danish: Grapefrugtjuice påvirker CYP3A4-medieret metabolisering og bør derfor undgås.