FrancophonIA/ELRC3.0 huggingface dataset:
English: By 60 months, the incidence of non-skin malignancies was significantly higher in the cohort who continued ciclosporin as compared with the cohort who had ciclosporin withdrawn (8.4% vs. 3.8%, respectively).
Danish: Efter 60 måneder er forekomsten af andre kræftformer end hudkræft signifikant højere i den patientgruppe, som fortsatte med at tage ciclosporin, end i den patientgruppe, hvor ciclosporin blev seponeret (henholdsvis 8,4% vs. 3,8%).
English: After dilution (see section 6.6), the preparation should be used immediately.
Danish: 6.6) skal opløsningen anvendes straks.
English: Safety was assessed in a controlled clinical study enrolling renal transplant patients below 18 years of age considered of high immunologic risk, defined as a history of one or more acute allograft rejection episodes and/or the presence of chronic allograft nephropathy on a renal biopsy (see section 5.1).
Danish: Sikkerheden blev vurderet i et kontrolleret klinisk forsøg, hvor der var inkluderet nyretransplanterede patienter på under 18 år, som ansås for at have en høj immunologisk risiko, defineret som havende én eller flere akutte episoder med afstødning af homologt transplantat i anamnesen og/eller med tilstedeværelsen af kronisk afstødning af nyretransplantat bekræftet ved nyrebiopsi (se afsnit 5.1).
English: The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, serum lipid abnormalities (including, but not limited to, increased serum triglycerides and total cholesterol), and urinary tract infections (see section 4.8).
Danish: Brugen af Rapamune i kombination med calcineurinhæmmere og kortikosteroider blev forbundet med en øget risiko for svækkelse af nyrefunktionen, abnorme niveauer af serum-lipider (herunder, men ikke begrænset til, forhøjede niveauer af serum-triglycerider og serum-kolesterol) samt urinvejsinfektioner (se afsnit 4.8).
English: Polysorbate 80 (E433) and phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids, and ascorbyl palmitate).
Danish: Polysorbat 80 (E433) og phosal 50 PG (fosfatidylcholin, propylenglycol [E1520], mono- og diglycerider, ethanol, sojafedtsyrer og ascorbylpalmitat).
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Danish: 6.3 vedrørende opbevaringsforhold for lægemidlet efter fortynding.
English: The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients (6-120 months after transplantation) was assessed in a randomised, multicentre, controlled trial, stratified by calculated GFR at baseline (20-40 mL/min vs. above 40 mL/min).
Danish: Sikkerheden ved og effekten af skift fra calcineurinhæmmere til vedligeholdelsesbehandling med Rapamune hos nyretransplanterede patienter (6-120 måneder efter transplantation) blev vurderet i et randomiseret, kontrolleret multicenterforsøg, som blev stratificeret efter beregning af den glomerulære filtrationshastighed ved baseline (20-40 ml/min.
English: What you need to know before you take Rapamune
Danish: Det skal De vide, før De begynder at tage Rapamune
English: antibiotics or antifungal medicines used to treat infection e.g. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazole, fluconazole, itraconazole.
Danish: - al anden immunhæmmende medicin - antibiotika eller antisvampemedicin, der anvendes til behandling af infektioner, f.eks. clarithromycin, erythromycin, telithromycin, troleandomycin, rifabutin, clotrimazol, fluconazol, itraconazol.
English: On average, the sirolimus dose will need to be 4-fold higher to account for both the absence of the pharmacokinetic interaction (2-fold increase) and the augmented immunosuppressive requirement in the absence of ciclosporin (2-fold increase).
Danish: I gennemsnit vil det være nødvendigt at firedoble sirolimusdosis for at udligne både manglen på farmakokinetisk interaktion (dobbelt øgning) og det øgede immunsuppressive behov på grund af manglen på ciclosporin (dobbelt øgning).
English: What you need to know before you take Rapamune 3.
Danish: 2 Det skal De vide, før De begynder at tage Rapamune
English: To minimise variability, Rapamune tablets should be taken consistently with or without food.
Danish: For at mindske variationen bør Rapamune tabletter tages konsekvent med eller uden mad.
English: Phosal 50 PG (phosphatidylcholine, propylene glycol [E1520], mono-and diglycerides, ethanol, soya fatty acids and ascorbyl palmitate).
Danish: Phosal 50 PG (phosphatidylcholin, propylenglycol [E1520], mono- og diglycerider, ethanol, sojafedtsyrer og ascorbylpalmitat).
English: Printing ink (Shellac, Iron Oxide Red, Propylene Glycol [E1520], Concentrated Ammonia Solution, Simethicone)
Danish: Prægeblæk (shellac, rød jernoxid, propylenglycol [E1520], koncentreret ammoniakopløsning, simeticon)
English: Empty the contents of the dosing syringe into only a glass or plastic container holding at least 60 mL of water or orange juice.
Danish: Tøm doseringssprøjtens indhold ud i et glas eller plastikbeholder med mindst 60 ml vand eller appelsinjuice.
English: Rapamune 2 mg coated tablets EU/1/01/171/009-010
Danish: Rapamune 2 mg overtrukne tabletter EU/1/01/171/009-010
English: 4.4 Special warnings and precautions for use Rapamune has not been adequately studied in renal transplant patients at high immunological risk, therefore use is not recommended in this group of patients (see section 5.1).
Danish: Rapamune er ikke blevet tilstrækkeligt undersøgt hos nyretransplanterede patienter med høj immunologisk risiko, og derfor anbefales det ikke til denne patientgruppe (se pkt.
English: Rapamune contains 86.4 mg of lactose and up to 215.8 mg of sucrose.
Danish: Rapamune indeholder 86,4 mg lactose og op til 215,8 mg saccharose.
English: With the plunger fully depressed, insert one of the dosing syringes into the opening in the adapter.
Danish: Sæt en af doseringssprøjterne i adapterens åbning med stemplet trykket helt ned.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose/galactosemalabsorption og sucrase-isomaltasemangel.
English: In a clinical trial of patients with LAM, the median whole blood sirolimus trough concentration after 3 weeks of receiving sirolimus tablets at a dose of 2 mg/day was 6.8 ng/mL (interquartile range 4.6 to 9.0 ng/mL; n=37).
Danish: I et klinisk forsøg med patienter med LAM var medianen for dalkoncentrationen af sirolimus i fuldblod 6,8 ng/ml efter 3 uger med indtagelse af sirolimustabletter i en dosis på 2 mg/dag (interkvartilområde 4,6 til 9,0 ng/ml; n=37).
English: Lymphoma*; Malignant melanoma*;
Danish: Lymfom*, malignt melanom*, lymfoproliferative sygdomme efter transplantation
English: Oral solution 60 mL bottle
Danish: Oral opløsning 60 ml flaske
English: Refill the container with an additional volume (minimum of 120 mL) of water or orange juice, stir vigorously, and drink at once.
Danish: Beholderen fyldes igen med yderligere mindst 120 ml vand eller appelsinjuice, der omrøres kraftigt og drikkes med det samme.
English: Rapamune 1 mg/mL oral solution:
Danish: Rapamune 1 mg/ml, oral opløsning:
English: Rapamune 1 mg coated tablets EU/1/01/171/007-8
Danish: Rapamune 1 mg overtrukne tabletter EU/1/01/171/007-8
English: Co-administration of sirolimus and ketoconazole is not recommended (see section 4.4).
Danish: Samtidig administration af sirolimus og ketoconazol frarådes (se pkt.
English: Ciclosporin (CYP3A4 substrate)
Danish: Ciclosporin (CYP3A4-substrat)
English: Co-administration of sirolimus with strong inhibitors of CYP3A4 (such as ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampin, rifabutin) is not recommended (see section 4.5).
Danish: Samtidig administration af sirolimus og stærke CYP3A4-hæmmere (f.eks. ketoconazol, voriconazol, itraconazol, telithromycin eller clarithromycin) eller CYP3A4-induktorer (f.eks. rifampin, rifabutin) frarådes (se pkt.
English: The rate at which the dose of sirolimus is increased should correspond to the rate of ciclosporin elimination.
Danish: Dosis af sirolimus bør øges i samme takt, som ciclosporindosis nedsættes.
English: Fungal infection; Viral infection; Bacterial infection;
Danish: Pneumoni, svampeinfektion, viral infektion, bakteriel infektion, herpes simplexinfektion, urinvejsinfektion
English: BOTTLE LABEL: 60 mL BOTTLE
Danish: FLASKEETIKET, 60 ml FLASKE
English: Rapamune 0.5 mg coated tablets 2 years.
Danish: Rapamune 0,5 mg overtrukne tabletter 2 år.
English: Co-administration of sirolimus with strong inhibitors of CYP3A4 or inducers of CYP3A4 is not recommended (see section 4.4).
Danish: Samtidig administration af sirolimus og stærke CYP3A4-hæmmere eller -induktorer frarådes (se pkt.
English: The Rapamune dose should then be individualised to obtain whole blood trough levels of 4 to 12 ng/mL (chromatographic assay).
Danish: Dosis af Rapamune skal derefter individualiseres for at opnå dalkoncentration i fuldblod på 4-12 ng/ml (kromatografisk analyse).
English: Among these conditions in renal transplant patients are BK virus-associated nephropathy and JC virus-associated progressive multifocal leukoencephalopathy (PML).
Danish: Hos patienter behandlet med immunsuppressiva, herunder Rapamune, er der rapporteret tilfælde af både BK-virusassocieret nefropati og JC-virusassocieret progressiv multifokal leukoencefalopati (PML).
English: Co-administration of sirolimus and rifampicin is not recommended (see section 4.4).
Danish: Samtidig administration af sirolimus og rifampicin frarådes (se pkt.
English: Rapamune 1 mg/mL oral solution sirolimus
Danish: Rapamune 1 mg/ml oral opløsning sirolimus
English: The Cmax, tmax, and AUC of plasma erythromycin base were increased 1.6-fold, 1.3-fold, and 1.7-fold, respectively.
Danish: Cmax, tmax og AUC for plasma-erythomycinbasis stiger henholdsvis 1,6 gange, 1,3 gange og 1,7 gange.
English: (1) in patients with hepatic impairment (2) when inducers or inhibitors of CYP3A4 are concurrently administered and after their discontinuation (see section 4.5) and/or (3) if ciclosporin dosing is markedly reduced or discontinued, as these populations are most likely to have special dosing requirements.
Danish: (1) patienter med nedsat leverfunktion (2) når CYP3A4-induktorer eller -hæmmere administreres samtidigt og efter seponering af disse (se pkt.
English: Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function (see sections 4.2 and 5.1).
Danish: Rapamune er indiceret til behandling af patienter med sporadisk lymphangioleiomyomatosis med moderat lungesygdom eller faldende lungefunktion (se pkt.
English: Whole blood sirolimus levels should be closely monitored in the following populations:
Danish: Terapeutisk lægemiddelmonitorering og dosisjustering Sirolimusniveau i fuldblod bør nøje monitoreres hos følgende patientgrupper:
English: The risk may be increased as the trough sirolimus level increases.
Danish: Risikoen kan være forhøjet, når dalkoncentrationen af sirolimus stiger.
English: New onset nephrosis (nephrotic syndrome) was also reported (see section 4.8).
Danish: Der blev også indberettet et nyt tilfælde af nefrose (nefrotisk syndrom) (se pkt.
English: Investigations Blood lactate dehydrogenase increased;
Danish: Undersøgelser Forhøjet laktatdehydrogenase, forhøjet kreatinin i blodet
English: The concomitant use of Rapamune with a calcineurin inhibitor may increase the risk of calcineurin inhibitor-induced haemolytic uraemic syndrome/thrombotic thrombocytopenic purpura/thrombotic microangiopathy (HUS/TTP/TMA).
Danish: Samtidig brug af Rapamune og calcineurinhæmmere øger muligvis risikoen for calcineurinhæmmerinduceret hæmolytisk uræmisk syndrom/trombotisk trombocytopenisk purpura/trombotisk mikroangiopati (HUS/TTP/TMA).
English: INFORMATION IN BRAILLE Rapamune 1 mg/mL
Danish: Rapamune 1 mg/ml
English: Ciclosporin should be progressively discontinued over 4 to 8 weeks, and the Rapamune dose should be adjusted to obtain whole blood trough levels of 12 to 20 ng/mL (chromatographic assay; see
Danish: Ciclosporin bør seponeres gradvist i løbet af 4-8 uger og dosis af Rapamune justeres for at opnå dalkoncentration i fuldblod på 12-20 ng/ml (kromatografisk analyse; se Terapeutisk lægemiddelmonitorering og dosisjustering).
English: EU/1/01/171/013 30 tablets EU/1/01/171/014 100 tablets
Danish: EU/1/01/171/013 30 tabletter EU/1/01/171/014 100 tabletter
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: To minimise variability, Rapamune should consistently be taken either with or without food.
Danish: For at mindske variabiliteten bør Rapamune tages konsekvent enten med eller uden mad.
English: Rapamune 1 mg coated tablets 3 years.
Danish: Rapamune 1 mg overtrukne tabletter 3 år.
English: Cancer of the lymph tissue (lymphoma/post-transplant lympho-proliferative disorder), combined lowering of red blood cells, white blood cells and blood platelets Bleeding from the lung
Danish: - kræft i lymfevæv (lymfom/lymfoproliferativ sygdom efter transplantation), en kombination af faldende antal røde og hvide blodlegemer og blodplader - blødning fra lungen - protein i urinen, lejlighedsvis alvorligt og forbundet med bivirkninger som f.eks. oppustning
English: There have also been reports of fluid accumulation, including peripheral oedema, lymphoedema, pleural effusion and pericardial effusions (including haemodynamically significant effusions in children and adults), in patients receiving Rapamune.
Danish: Der har også været rapporter om væskeansamlinger, herunder perifert ødem, lymfødem, pleuraeffusion og perikardie-effusion (herunder hæmodynamisk signifikant effusion hos børn og voksne) hos patienter i behandling med Rapamune.
English: Your doctor will need to perform blood tests to measure Rapamune concentrations.
Danish: Deres læge skal tage blodprøver for at måle koncentrationerne af Rapamune.
English: Hyperglycaemia; Hypertriglyceridaemia; Diabetes mellitus
Danish: Hypokaliæmi, hypofosfatæmi, hyperlipidæmi (herunder hyperkolesterolæmi), hyperglykæmi, hypertriglyceridæmi, diabetes mellitus
English: In a study evaluating the safety and efficacy of conversion from calcineurin inhibitors to sirolimus (target levels of 12 - 20 ng/mL in maintenance renal transplant patients, enrollment was stopped in the subset of patients (n=90) with a baseline glomerular filtration rate of less than 40 mL/min (see section 5.1).
Danish: I et forsøg til vurdering af sikkerhed og virkning af skift fra calcineurinhæmmer til sirolimus (målniveau på 12-20 ng/ml) hos nyretransplanterede patienter i vedligeholdelsesbehandling blev inklusionen stoppet i undergruppen af patienter (n=90) med glomerulær filtrationshastighed på mindre end 40 ml/min.
English: There have also been reports of fluid accumulation, including peripheral oedema, lymphoedema, pleural effusion and pericardial effusions (including haemodynamically significant effusions in children and adults) in patients receiving Rapamune.
Danish: Der har også været rapporter om væskeansamlinger, herunder perifere ødemer, lymfødem, pleuraeffusion og perikardie-effusion (herunder hæmodynamisk signifikant effusion hos børn og voksne) hos patienter i behandling med Rapamune.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: any high blood pressure medicines or medicines for heart problems including nicardipine, verapamil and diltiazem.
Danish: - al medicin mod forhøjet blodtryk eller medicin for hjerteproblemer herunder nicardipin, verapamil og diltiazem - medicin mod epilepsi herunder carbamazepin, phenobarbital, phenytoin.
English: Sporadic Lymphangioleiomyomatosis (S-LAM)
Danish: Sporadisk lymphangioleiomyomatosis (S-LAM)
English: Such inhibitors include certain antifungals (e.g. clotrimazole, fluconazole, itraconazole, voriconazole), certain antibiotics (e.g. troleandomycin, telithromycin, clarithromycin), certain protease inhibitors (e.g. ritonavir, indinavir, boceprevir, telaprevir), nicardipine, bromocriptine, cimetidine, and danazol.
Danish: Sådanne hæmmere omfatter visse antimykotika (f.eks. clotrimazol, fluconazol, itraconazol, voriconazol), visse antibiotika (f.eks. troleandomycin, telithromycin, clarithromycin), visse proteasehæmmere (f.eks. ritonavir, indinavir, boceprevir, telaprevir), nicardipin, bromocriptin, cimetidin og danazol.
English: Co-administration of sirolimus and voriconazole is not recommended (see section 4.4).
Danish: Samtidig administration af sirolimus og voriconazol frarådes (se pkt.
English: EU/1/01/171/007 30 tablets EU/1/01/171/008 100 tablets
Danish: EU/1/01/171/007 30 tabletter EU/1/01/171/008 100 tabletter
English: EU/1/01/171/009 30 tablets EU/1/01/171/010 100 tablets
Danish: EU/1/01/171/009 30 tabletter EU/1/01/171/010 100 tabletter
English: As compared with the placebo group, the sirolimus group had improvement from baseline to 12 months in measures of forced vital capacity (-12±3 vs. 7±3 mL per month, respectively, p<0.001), serum vascular endothelial growth factor D (VEGF-D; -8.6±15.2 vs. -85.3±14.2 pg/mL per month, respectively, p<0.001), and quality of life (Visual Analogue Scale - Quality of Life [VAS-QOL] score: -0.3±0.2 vs. 0.4±0.2 per month, respectively, p=0.022) and functional performance (-0.009±0.005 vs. 0.004±0.004 per month, respectively, p=0.044) in patients with S-LAM.
Danish: Sirolimusgruppen udviste en forbedring efter 12 måneder i forhold til baseline i målingerne af forceret vitalkapacitet (henholdsvis -12 ±3 vs. 7 ±3 ml pr. måned, p < 0,001), vaskulær endotelial vækstfaktor D i serum (VEGF-D, henholdsvis -8,6 ±15,2 vs. -85,3 ±14,2 pg/ml pr. måned, p < 0,001) og livskvalitet (visuel analog skala - Quality of Life [VAS-QOL]-score, henholdsvis -0,3 ±0,2 vs. 0,4 ±0,2 pr. måned, p = 0,022) og funktionel præstation (henholdsvis -0,009 ±0.005 vs. 0,004 ±0,004 pr. måned, p = 0,044) hos patienter med S-LAM. Der var ingen signifikant forskel mellem grupperne i dette interval i ændringen i funktionel residualkapacitet, en 6-minutters gangtest, lungernes diffusionskapacitet for karbonmonoxid eller scoren for generelt velbefindende hos patienterne med SLAM.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Impaired healing following transplant surgery has been reported, including fascial dehiscence, incisional hernia, and anastomotic disruption (e.g., wound, vascular, airway, ureteral, biliary).
Danish: Der er rapporteret om nedsat heling efter transplantation, herunder omfattende sårruptur i ansigtet, ventralhernie og anastomotisk sprængning (f.eks. sår, kar, luftveje, urinveje, galdeveje).
English: Increased rates of biopsy confirmed acute rejection (BCAR) in renal transplant patients have been observed with concomitant use of sirolimus with ACE inhibitors (see section 5.1).
Danish: Der har været observeret en højere hyppighed af biopsiverificeret akut afstødning (BCAR) hos nyretransplanterede patienter ved samtidig brug af sirolimus og ACE-hæmmere (se pkt.
English: Each 60 mL bottle contains 60 mg sirolimus.
Danish: Hver 60 ml flaske indeholder 60 mg sirolimus.
English: Patients with sporadic lymphangioleiomyomatosis (S-LAM)
Danish: Patienter med sporadisk lymphangioleiomyomatosis (S-LAM)
English: Following the discontinuation of ciclosporin therapy, a target trough range of 12 to 20 ng/mL (chromatographic assay) is recommended.
Danish: Ved seponering af ciclosporin anbefales det at sigte efter en dalkoncentration i blodet på 12-20 ng/ml (kromatografisk analyse).
English: Patients with a body mass index (BMI) greater than 30 kg/m2 may be at increased risk of abnormal wound healing based on data from the medical literature.
Danish: Baseret på data fra den medicinske litteratur kan patienter med et body mass index (BMI) på mere end 30 kg/m2 have øget risiko for unormal sårheling.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN DEN YDRE EMBALLAGE
English: In a subset of the study patients with a baseline GFR above 40 mL/min and normal urinary protein excretion, calculated GFR was higher at 1 and 2 years in patients converted to Rapamune than for the corresponding subset of calcineurin inhibitor continuation patients.
Danish: og normal udskillelse af urinprotein er den beregnede GFR højere efter 1 og 2 år hos de patienter, som er skiftet til Rapamune, end hos den tilsvarende patientundergruppe, hvor behandlingen med calcineurinhæmmere fortsatte.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé; pkt.
English: Rapamune 2 mg coated tablets 3 years.
Danish: Rapamune 2 mg overtrukne tabletter 3 år.
English: Should any of these occur together, please contact your physician.
Danish: Hvis De får to eller flere af disse symptomer samtidigt, skal De kontakte Deres læge.
English: Each coated tablet contains 0.5 mg sirolimus.
Danish: Hver overtrukken tablet indeholder 0,5 mg sirolimus.
English: Rapamune 0.5 mg coated tablets, Rapamune 1 mg coated tablets, Rapamune 2 mg coated tablets:
Danish: Rapamune 0,5 mg overtrukne tabletter, Rapamune 1 mg overtrukne tabletter, Rapamune 2 mg overtrukne tabletter:
English: In the patient stratum with baseline calculated GFR above 40 mL/min, renal function was not improved overall.
Danish: I patientgruppen med en beregnet baseline-GFR på over 40 ml/min.
English: The incidence of any adverse reaction(s) may increase as the trough sirolimus level increases.
Danish: Hyppigheden af alle bivirkninger kan øges, når dalniveauet af sirolimus stiger.
English: Pneumonitis*; Pleural effusion;
Danish: Lungeemboli, pneumonitis*, pleuraeffusion, epistaxis
English: Each 60 mL bottle of Rapamune contains 60 mg sirolimus.
Danish: Hver 60 ml flaske Rapamune indeholder 60 mg sirolimus.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: pancreatic islet cell vacuolation, testicular tubular degeneration, gastrointestinal ulceration, bone fractures and calluses, hepatic haematopoiesis, and pulmonary phospholipidosis.
Danish: Følgende bivirkninger er set i dyreforsøg ved eksponering, der svarer til human-terapeutiske doser: øcellevakuolisering i pancreas, tubulær testikeldegeneration, gastrointestinal ulceration, knoglefrakturer og -callus, hepatisk hæmatopoiese og pulmonal fosfolipidose.
English: Each Rapamune 0.5 mg coated tablet contains 0.5 mg of sirolimus.
Danish: Hver Rapamune 0,5 mg overtrukken tablet indeholder 0,5 mg sirolimus.
English: bromocriptine (used in the treatment of Parkinson's disease and various hormonal disorders), danazol (used in the treatment of gynaecological disorders), or protease inhibitors (e.g., for HIV and hepatitis C such as ritonavir, indinavir, boceprevir, and telaprevir).
Danish: - medicin til behandling af mavesår eller andre mave-tarmsygdomme som f.eks. cisaprid, cimetidin, metoclopramid - bromocriptin (til behandling af Parkinsons sygdom og forskellige hormonale sygdomme), danazol (til behandling af gynækologiske sygdomme) eller protease-hæmmere (f.eks. mod hiv og hepatitis C, f.eks. ritonavir, indinavir, boceprevir og telaprevir).