FrancophonIA/ELRC3.0 huggingface dataset:
English: Rapamune is used in adults to prevent your body from rejecting transplanted kidneys and is normally used with other immunosuppressant medicines called corticosteroids and initially (the first 2 to 3 months) with ciclosporin.
Danish: Rapamune anvendes til voksne patienter for at forhindre, at kroppen afstøder en transplanteret nyre, og anvendes normalt sammen med andre immunhæmmende lægemidler, der kaldes kortikosteroider, og i starten (de første 2-3 måneder) med ciclosporin.
English: In mouse, chronic ulcerative skin lesions were increased.
Danish: Hos mus øges kroniske ulcerøse hudskader.
English: Upon repeated administration, the average blood concentration of sirolimus is increased approximately 3-fold.
Danish: Ved gentaget indgift øges den gennemsnitlige koncentration af sirolimus i blodet ca. 3 gange.
English: Appropriate adjustment of the immunosuppression regimen should be considered in patients with elevated serum creatinine levels.
Danish: Passende regulering af den immunsupprimerende behandling bør overvejes hos patienter med forhøjede serumkreatininniveauer.
English: Rapamune has no known influence on the ability to drive and use machines.
Danish: Rapamune har ingen kendt virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: The blood to plasma ratio (B/P) of 36 indicates that sirolimus is extensively partitioned into formed blood elements.
Danish: Blodplasma-ratio (B/P) på 36 tyder på, at sirolimus i meget høj grad opdeles i formede blodelementer.
English: A lower incidence of squamous cell carcinoma of the skin was observed in the sirolimus group (0% vs. 4.9%).
Danish: Der blev observeret en lavere forekomst af pladecellekarcinom i sirolimus-gruppen (0 % vs. 4,9 %).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede lægemiddelovervågningsaktiviter og foranstaltninger, som beskrevet i den godkendte RMP, der fremgår af modul 1.8.2. i markeds føringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Patients who had both antibody-mediated rejection and T-cell-mediated rejection on the same biopsy were counted once for each category.
Danish: Patienter, som havde både antistofmedieret afstødning og T-cellemedieret afstødning på den samme biopsi, blev talt én gang for hver kategori.
English: Rapamune oral solution contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Danish: Rapamune oral opløsning indeholder polysorbat-80, som er kendt for at øge hastigheden af di-(2ethylhexyl)phthalat-ekstraktionen fra polyvinylchlorid (PVC).
English: When given 2 hours before CsA administration, sirolimus Cmax and AUC were not affected.
Danish: Indgift 2 timer før administration af CsA påvirker ikke sirolimus-Cmax og -AUC.
English: Also, when switching between different tablet strengths, verification of trough concentrations is recommended.
Danish: Ved skift mellem forskellige tabletstyrker anbefales også kontrol af dalkoncentrationer.
English: The 0.5 mg tablet is not fully bioequivalent to the 1 mg, 2 mg and 5 mg tablets when comparing Cmax.
Danish: 0,5 mg tabletten er ikke fuldt bioækvivalent til 1 mg, 2 mg og 5 mg tabletterne ved sammenligning af Cmax.
English: Sucrose and lactose
Danish: Saccharose og lactose
English: One patient experienced an episode of atrial fibrillation after ingestion of 150 mg of Rapamune.
Danish: En patient oplevede et tilfælde af atrieflimren efter indtagelse af 150 mg Rapamune.
English: Coated tablet (tablet).
Danish: Overtrukne tabletter (tabletter).
English: Do not stop taking Rapamune unless your doctor tells you to, as you risk losing your transplant.
Danish: Hold ikke op med at tage medicinen, medmindre lægen giver Dem besked på det, da De risikerer, at transplantatet afstødes.
English: Medicines known as “statins” and “fibrates” used to treat elevated cholesterol and triglycerides have been associated with an increased risk of muscle breakdown (rhabdomyolysis).
Danish: Lægemidler kendt som ”statiner” og ”fibrater” til behandling af forhøjet kolesterol og triglycerid er blevet forbundet med en øget risiko for muskelnedbrydning (rabdomyolyse).
English: Patients administered Rapamune should be monitored for hyperlipidaemia using laboratory tests and if hyperlipidaemia is detected, subsequent interventions such as diet, exercise, and lipid-lowering agents should be initiated.
Danish: Patienter, der får Rapamune, bør kontrolleres for hyperlipidæmi med laboratorieundersøgelser, og hvis hyperlipidæmi opdages, bør efterfølgende interventioner som f.eks. diæt, motion og lipid-sænkende lægemidler iværksættes.
English: Frequent Rapamune dose adjustments based on non-steady-state sirolimus concentrations can lead to overdosing or underdosing because sirolimus has a long half-life.
Danish: Hyppige dosisjusteringer af Rapamune, som er baseret på sirolimus-koncentrationer som ikke er i steady-state, kan føre til overdosering eller underdosering, fordi sirolimus har lang halveringstid.
English: The absolute between-group difference in the mean change in FEV1 during the treatment period was 152 mL, or approximately 11% of the mean FEV1 at enrollment.
Danish: Den absolutte forskel i den gennemsnitlige ændring af FEV1 mellem grupperne i behandlingsperioden var 152 ml eller ca. 11 % af den gennemsnitlige FEV1 på inklusionstidspunktet.
English: If diltiazem is administered, sirolimus blood levels should be monitored and a dose adjustment may be necessary.
Danish: Hvis der gives diltiazem, bør niveauet af sirolimus i blodet kontrolleres, og det kan være nødvendigt at justere dosis.
English: The simultaneous oral administration of 10 mg of Rapamune oral solution and 120 mg of diltiazem significantly affected the bioavailability of sirolimus.
Danish: Samtidig oral indgivelse af 10 mg Rapamune oral opløsning og 120 mg diltiazem har en signifikant virkning på biotilgængeligheden af sirolimus.
English: Renal function should be monitored during concomitant administration of Rapamune and ciclosporin.
Danish: Nyrefunktionen bør kontrolleres ved samtidig administration af Rapamune og ciclosporin.
English: It is not necessary to modify the Rapamune loading dose.
Danish: Det er ikke nødvendigt at ændre støddosis af Rapamune.
English: In animals, sirolimus has a direct effect on T- and B-cell activation, suppressing immune-mediated reactions, such as allograft rejection.
Danish: Hos dyr har sirolimus en direkte virkning på T- og B-celleraktiveringen, idet der sker hæmning af immunmedierende reaktioner som f.eks. afstødning af homologt transplantat.
English: The mean Cmax was decreased by 35%, and mean tmax increased by 82%.
Danish: Gennemsnitlig Cmax faldt med 35% og gennemsnitlig tmax steg med 82%.
English: TEXT FOR 60 mL OUTER CARTON (CONTAINING SYRINGES/BOTTLE IN CARTON)
Danish: TEKST TIL 60 ml YDRE EMBALLAGE (INDEHOLDENDE SPRØJTER/FLASKE I ÆSKEN)
English: It is not known whether Rapamune passes into breast milk.
Danish: Man ved ikke, om Rapamune går over i mælken.
English: Once Rapamune maintenance dose is adjusted, patients should continue on the new maintenance dose for at least 7 to 14 days before further dosage adjustment with concentration monitoring.
Danish: Når vedligeholdelsesdosis af Rapamune er blevet justeret, skal patienter fortsætte med den nye vedligeholdelsesdosis i mindst 7 til 14 dage, inden der foretages yderligere dosisjustering med monitorering af koncentrationen.
English: If you have taken more medicine than you were told to, contact a doctor or go to the nearest hospital emergency department as soon as possible.
Danish: Hvis De har taget mere medicin, end De har fået besked på, skal De kontakte en læge eller henvende Dem på skadestuen på det nærmeste hospital.
English: Following administration of radiolabelled sirolimus, radioactivity is excreted in the milk of lactating rats.
Danish: Efter indgivelse af radioaktivt mærket sirolimus udskilles radioaktivitet i mælk fra diegivende rotter.
English: Studies demonstrated that its effects are mediated by a mechanism that is different from that of ciclosporin, tacrolimus, and other immunosuppressive agents.
Danish: Forsøg viser, at virkningen formidles af en mekanisme, der adskiller sig fra ciclosporins, tarcrolimus og andre immunosupprimerende stoffers mekanisme.
English: Although sirolimus inhibits human liver microsomal cytochrome P450 CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 in vitro, the active substance is not expected to inhibit the activity of these isozymes in vivo since the sirolimus concentrations necessary to produce inhibition are much higher than those observed in patients receiving therapeutic doses of Rapamune.
Danish: Skønt sirolimus hæmmer det humane levermikrosomale cytokrom P450, CYP2C9, CYP2C19, CYP2D6 og CYP3A4/5 in vitro, forventes det aktive indholdsstof ikke at hæmme aktiviteten af disse isozymer in vivo, eftersom de sirolimuskoncentrationer, som er nødvendige for hæmningen er meget højere end koncentrationerne set hos patienter, der får terapeutiske doser af Rapamune.
English: Sirolimus is a substrate for both cytochrome P450 IIIA4 (CYP3A4) and P-glycoprotein.
Danish: Sirolimus er et substrat for både cytokrom P450 IIIA4 (CYP3A4) og P-glykoprotein.
English: Optimally, adjustments in Rapamune dose should be based on more than a single trough level obtained more than 5 days after a previous dosing change.
Danish: Optimalt set bør regulering af Rapamune-dosis være baseret på mere end en enkelt måling af dalniveau målt mere end 5 dage efter en tidligere dosisændring.
English: Withdraw the exact amount of Rapamune oral solution as prescribed by your doctor by gently pulling out the plunger of the dosing syringe until the level of the oral solution is even with the appropriate mark on the dosing syringe.
Danish: Træk nøjagtig den mængde oral Rapamune-opløsning op, som lægen har foreskrevet ved forsigtigt at trække stemplet ud af doseringssprøjten, indtil niveauet af den orale opløsning er ved det relevante mærke på doseringssprøjten.
English: Decreased sperm count has been associated with the use of Rapamune and usually returns to normal once treatment is stopped.
Danish: Nedsat antal sædceller er set i forbindelse med brugen af Rapamune, men sædvanligvis bliver det normalt igen, efter behandlingen er stoppet.
English: The inhibition of mTOR results in blockage of several specific signal transduction pathways.
Danish: Hæmning af mTOR resulterer i blokering af flere specifikke signaltransduktionsbaner.
English: Safety was assessed in a controlled study involving 89 patients with LAM, of which 81 patients had S-LAM and 42 of whom were treated with Rapamune (see section 5.1).
Danish: Sikkerheden blev vurderet i et kontrolleret forsøg, der involverede 89 patienter med LAM, hvoraf 81 patienter af disse havde S-LAM, og af hvilke 42 blev behandlet med Rapamune (se pkt.
English: After 3 months, your doctor may discontinue either Rapamune or ciclosporin, as it is not recommended that these medicines be taken together beyond this period.
Danish: Efter 3 måneder kan Deres læge stoppe behandlingen med enten Rapamune eller ciclosporin, da det ikke kan anbefales at tage begge slags medicin ud over denne periode.
English: This leaflet was last revised in MM/YYYY
Danish: Denne indlægsseddel blev senest ændret i MM/ÅÅÅÅ
English: Do not use this medicine after the expiry date, which is stated on the blister and carton after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på blisterkortet og pakningen efter “EXP”.
English: If bubbles form in the oral solution in the dosing syringe during withdrawal, empty the Rapamune solution back into the bottle and repeat the withdrawal procedure.
Danish: Hvis der dannes bobler i den orale opløsning i doseringssprøjten under optrækningen, tømmes Rapamune-opløsningen tilbage i flasken, og optrækningsproceduren gentages.
English: The rates of acute rejection, graft loss, and death were similar at 1 and 2 years.
Danish: Hyppigheden af akut afstødning, transplantattab og død er den samme efter 1 og 2 år.
English: For patients with S-LAM, the initial Rapamune dose should be 2 mg/day.
Danish: For patienter med S-LAM er den indledende Rapamune-dosis 2 mg/dag.
English: If you experience symptoms such as bruising or rash, changes in your urine, or changes in behaviour or any others that are serious, unusual or prolonged, contact your doctor.
Danish: Hvis De får symptomer som f.eks. blå mærker eller udslæt, ændringer i urinen, ændringer i opførsel eller andet, som er alvorligt, usædvanligt eller langvarigt, skal De kontakte lægen.
English: Sirolimus concentrations, following the administration of Rapamune tablets (5 mg) to healthy subjects as single doses are dose proportional between 5 and 40 mg.
Danish: Koncentrationerne af sirolimus efter indgivelse af Rapamune tabletter (5 mg) som enkeltdosis til raske personer er dosisproportional mellem 5 og 40 mg.
English: Plasma S-(-) verapamil Cmax and AUC were both increased 1.5-fold, and tmax was decreased 24%.
Danish: Plasma-S-(-) verapamil Cmax og AUC stiger begge 1,5 gange, og tmax falder 24%.
English: If you are considered to be at high risk for kidney rejection, such as if you had a previous transplant that was lost to rejection.
Danish: - Hvis det vurderes, at De har en stor risiko for afstødning, f.eks. hvis et tidligere nyretransplantat er blevet afstødt.
English: Please inform your doctor if you are taking medicines to lower your blood fats.
Danish: Fortæl det til Deres læge, hvis De tager lægemidler, der bruges til at sænke fedtindholdet i Deres blod.
English: Experimental evidence suggests that sirolimus binds to the specific cytosolic protein FKPB-12, and that the FKPB 12-sirolimus complex inhibits the activation of the mammalian Target Of Rapamycin (mTOR), a critical kinase for cell cycle progression.
Danish: Forsøgsresultater tyder på, at sirolimus bindes til det specifikke cytosoliske protein FKPB-12, og at FKPB 12-sirolimuskompleks hæmmer aktiveringen af det mammale mål for Rapamycin (mTOR), en kritisk kinase for cellecyklusprogression.
English: Stir well for one minute and drink immediately at once.
Danish: Rør omhyggeligt i ét minut og drik opløsningen med det samme.
English: In rat, testicular interstitial cell adenomas were likely indicative of a species-dependent response to lutenising hormone levels and are usually considered of limited clinical relevance.
Danish: Hos rotter er testikulær interstitiel celleadenom sandsynligvis tegn på en artsafhængig respons over for luteiniseringshormon-niveauer og betragtes normalt som værende af begrænset klinisk relevans.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA10.
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, selektive immunsuppressiva, ATCkode:L04AA10.
English: Currently in clinical practice, sirolimus whole blood concentrations are being measured by both chromatographic and immunoassay methodologies.
Danish: I nuværende kliniske praksis bliver koncentrationen af sirolimus i fuldblod målt ved både kromatografiske og immunologiske metoder.
English: Venous thrombosis (including deep vein thrombosis)
Danish: Venetrombose (herunder dyb venetrombose)
English: The bottle should remain in an upright position when withdrawing the solution.
Danish: Flasken bør forblive oprejst, når opløsningen trækkes op.
English: In clinical studies, the concomitant administration of Rapamune and HMG-CoA reductase inhibitors and/or fibrates was well-tolerated.
Danish: I kliniske forsøg er samtidig administration af Rapamune og HMG-CoA reduktasehæmmere og/eller fibrater veltolereret.
English: Grapefruit juice should be avoided (see section 4.5).
Danish: Grapefrugtjuice bør undgås (se pkt.
English: In patients with severe hepatic impairment, it is recommended that the maintenance dose of Rapamune be reduced by approximately one-half.
Danish: Hos patienter med svært nedsat leverfunktion anbefales det, at vedligeholdelsesdosis af Rapamune reduceres til ca. det halve.
English: 24 hours in the dosing syringe (at room temperature, but not to exceed 25C).
Danish: 24 timer i doseringssprøjten (ved stuetemperatur, må dog ikke overstige 25°C).
English: Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections, and sepsis.
Danish: Oversuppression af immunsystemet kan også øge modtageligheden for infektion, herunder opportunistiske infektioner (bakteriel, svamp, viral og protozoal), livstruende infektioner og sepsis.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Danish: Oplysninger om fortynding af lægemidlet før administration, se pkt.
English: The tablets are supplied in blister packs of 30 and 100 tablets.
Danish: Tabletterne leveres i blisterpakninger med 30 og 100 tabletter.
English: Inform your doctor if you have difficulty taking the tablet.
Danish: Fortæl det til lægen, hvis De har besvær med at tage tabletten.
English: Your doctor will give you 2 mg of Rapamune each day, until otherwise directed by your doctor.
Danish: Deres læge vil give Dem 2 mg Rapamune hver dag, indtil andet angives af lægen.
English: Dermatitis exfoliative
Danish: Eksfoliativ dermatitis
English: Sirolimus is extensively metabolised by the CYP3A4 isozyme in the intestinal wall and liver.
Danish: Sirolimus metaboliseres i vid udstrækning af CYP3A4-isozym i tarmvæggen og leveren.
English: No other liquids, including grapefruit juice, should be used for dilution.
Danish: Der må ikke anvendes andre væsker, herunder grapefrugtjuice, til fortynding.
English: Clinical studies of Rapamune did not include a sufficient number of patients above 65 years of age to determine whether they will respond differently than younger patients.
Danish: Kliniske forsøg med Rapamune omfatter ikke et tilstrækkeligt antal patienter over 65 år til at kunne afgøre, om de vil respondere anderledes end yngre patienter.
English: Do not crush, chew or split.
Danish: Må ikke knuses, tygges eller deles.
English: Alveolar proteinosi s
Danish: Alveolær proteinose
English: All sirolimus concentrations reported in this Summary of Product Characteristics were either measured using chromatographic methods or have been converted to chromatographic method equivalents.
Danish: Alle sirolimuskoncentrationer, der er nævnt i dette produktresumé, er enten målt ved at anvende kromatografiske metoder eller er omsat til kromatografiske metodeækvivalenter.
English: The dosing syringe and cap are to be used once and then discarded.
Danish: Doseringssprøjten og hætten må kun anvendes én gang og skal derefter kasseres.
English: Renal function was not better in the treatment arms with de novo sirolimus without a calcineurin inhibitor.
Danish: Nyrefunktionen er ikke bedre i behandlingsarmene med de novo sirolimus uden en calcineurinhæmmer.
English: Some medicines can interfere with the action of Rapamune and, therefore, dose adjustment of Rapamune may be required.
Danish: Noget medicin kan gribe forstyrrende ind i den måde, som Rapamune virker på, og derfor kan det være nødvendigt at justere dosis af Rapamune.
English: Sirolimus concentrations were measured in concentration-controlled studies of paediatric renal-transplant patients who were also receiving ciclosporin and corticosteroids.
Danish: Koncentrationerne af sirolimus blev målt i koncentrationskontrollerede forsøg hos pædiatriske nyretransplanterede patienter, der også fik ciclosporin og kortikosteroider.
English: Based on the poor aqueous solubility and high erythrocyte and plasma protein binding of Rapamune, it is anticipated that Rapamune will not be dialysable to any significant extent.
Danish: På grund af Rapamunes ringe vandopløselighed og høje erytrocytog plasmaproteinbinding forventes Rapamune ikke at kunne fjernes ved dialyse i signifikant grad.
English: Protein build-up in the air sacs of the lungs that may interfere with breathing Serious allergic reactions that can affect blood vessels (see above paragraph on allergic reactions)
Danish: - proteinopbygning i luftsækkene i lungerne, som kan påvirke vejrtrækningen - alvorlige allergiske reaktioner, som kan påvirke blodkarrene (se ovenfor om allergiske reaktioner).
English: If you have any liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Rapamune that you receive and may result in your having additional blood tests.
Danish: - Hvis De har nogen form for leverproblemer eller har haft en sygdom, der kan have påvirket leveren, skal De oplyse Deres læge herom, idet dette kan have indflydelse på den dosis af Rapamune, som De skal have.
English: In patients with severe hepatic impairment, monitoring should be performed every 5 to 7 days until 3 consecutive trough levels have shown stable concentrations of sirolimus after dose adjustment or after loading dose due to the delay in reaching steady-state because of the prolonged half-life.
Danish: Hos patienter med svært nedsat leverfunktion bør monitorering udføres hver 5.-7. dag, indtil 3 på hinanden følgende dalkoncentrationer har vist stabile sirolimuskoncentrationer efter dosisjustering eller efter støddosis, da opnåelse af steady state forsinkes på grund af den forlængede halveringstid.
English: Ciclosporin was not withdrawn in patients experiencing Banff Grade 3 acute rejection episodes, who were dialysis-dependent, who had a serum creatinine higher than 400 mol/L, or who had inadequate renal function to support ciclosporin withdrawal.
Danish: Ciclosporin blev ikke seponeret hos patienter, som oplevede Banff Grade 3 akutte afstødningsepisoder, som var dialyseafhængige, som havde serum-kreatinin over 400 mol/l, eller som havde utilstrækkelig nyrefunktion til at støtte seponering af ciclosporin.
English: LAM involves lung tissue infiltration with smooth muscle-like cells that harbour inactivating mutations of the tuberous sclerosis complex (TSC) gene (LAM cells).
Danish: LAM involverer infiltration af lungevæv med glatte, muskellignende celler, som indeholder inaktiverende mutationer i genet for tuberøst sklerosekompleks (TSC) (LAM celler).
English: Rapamune oral solution contains up to 3.17 vol % ethanol (alcohol).
Danish: Rapamune oral opløsning indeholder op til 3,17 vol % ethanol (alkohol).
English: Your dose will be adjusted depending on the level of Rapamune in your blood.
Danish: Deres dosis vil blive justeret afhængigt af niveauet af Rapamune i Deres blod.
English: Adjustments to the targeted range should be made according to the assay being utilised to determine the sirolimus trough concentrations.
Danish: Justeringer af målområdet bør foretages i henhold til den prøvemetode, der bliver brugt til bestemmelse af sirolimuskoncentrationen.
English: Once in the syringe the medication may be kept at room temperature (not exceeding 25C) or refrigerated and should be used within 24 hours.
Danish: Når medicinen er i sprøjten, kan den opbevares ved stuetemperatur (ikke over 25 oC) eller i køleskab, og den skal anvendes inden for
English: Rapamune contains up to 3.17 vol % ethanol (alcohol).
Danish: Rapamune indeholder op til 3,17 vol % ethanol (alkohol).
English: It is important to follow the instructions to drink Rapamune oral solution at once when a plastic container is used for the dilution and/or administration (see section 6.6).
Danish: Det er vigtigt at følge instruktionerne og drikke Rapamune oral opløsning med det samme, hvis en plastikbeholder bruges til fortynding og/eller indtagelse (se pkt.
English: Menstrual disorder (including amenorrhoea and menorrhagia)
Danish: Menstruationsforstyrrelser (inklusive amenorré og menoragi)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS