FrancophonIA/ELRC3.0 huggingface dataset:
English: For inducing remission, initially 5 mg/kg/day orally given in 2 divided doses are recommended until remission of active uveal inflammation and improvement in visual acuity are achieved.
Danish: Til fremkaldelse af remission anbefales initialt 5 mg/kg/dag oralt fordelt på 2 doser, indtil der opnås remission af den aktive uveale inflammation og forbedring af synsskarpheden.
English: In some patients, GVHD occurs after discontinuation of ciclosporin treatment, but usually responds favourably to re-introduction of therapy.
Danish: Hos visse patienter opstår GVHD, efter at ciclosporin-behandlingen er ophørt, men disse patienter reagerer normalt positivt på fornyet behandling.
English: Interactions
Danish: Interaktioner
English: No data exist on the effects of Sandimmun on the ability to drive and use machines.
Danish: Der foreligger ingen data for Sandimmuns virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: If anaphylaxis occurs, the infusion should be discontinued.
Danish: Hvis anafylaksi opstår, skal infusionen stoppes.
English: If you have questions about how long to take Sandimmun, talk to your doctor or your pharmacist.
Danish: Hvis du har spørgsmål om, hvor længe du skal tage Sandimmun, skal du tale med din læge eller apoteket.
English: Contains ethanol (see leaflet for further information).
Danish: Indeholder ethanol (se indlægsseddel for yderligere information).
English: Skin infections with Staphylococcus aureus are not an absolute contraindication for Sandimmun therapy, but should be controlled with appropriate antibacterial agents.
Danish: Hudinfektioner med Staphylococcus aureus er ingen absolut kontraindikation for behandling med Sandimmun, men bør kontrolleres med passende antibakterielle midler.
English: Subsequent relapse may be managed with a further course of Sandimmun.
Danish: Et efterfølgende tilbagefald kan behandles med endnu et behandlingsforløb med Sandimmun.
English: Follow your doctor's instructions exactly and never change the dose yourself, even if you feel well.
Danish: Du skal altid følge lægens anvisninger nøjagtigt, og du må aldrig selv ændre dosis.
English: Renal biopsy should be considered for patients with steroid-dependent minimal-change nephropathy, in whom Sandimmun therapy has been maintained for more than 1 year.
Danish: Nyrebiopsi bør overvejes hos patienter med steroidafhængig nefropati med minimale ændringer, som er behandlet med Sandimmun i over 1 år.
English: During the remission phases, this should not exceed 5 mg/kg/day.
Danish: I remissionsfaserne må den ikke overstige 5 mg/kg/dag.
English: • Usually, higher doses are used before and just after your transplant.
Danish: • Der anvendes ofte højere doser inden og umiddelbart efter transplantation.
English: For maintenance treatment the lowest effective and well tolerated dosage should be determined individually.
Danish: Ved vedligeholdelsesbehandling skal den laveste effektive og veltolererede dosis bestemmes individuelt.
English: Successful solid organ and bone marrow transplantations have been performed in man using ciclosporin to prevent and treat rejection and GVHD.
Danish: Der er udført vellykkede organ- og knoglemarvstransplantationer på mennesker, hvor ciclosporin har været anvendt til at forebygge og behandle afstødning og GVHD.
English: In two published research studies, rabbits exposed to ciclosporin in utero (10 mg/kg/day subcutaneously) demonstrated reduced numbers of nephrons, renal hypertrophy, systemic hypertension, and progressive renal insufficiency up to 35 weeks of age.
Danish: I to publicerede videnskabelige studier viste kaniner eksponeret for ciclosporin in utero (10 mg/kg/dag subkutant) nedsat antal nefroner, renal hypertrofi, systemisk hypertension og progressiv nyreinsufficiens op til en alder på 35 uger.
English: Your doctor will tell you how long you need to take Sandimmun for.
Danish: Din læge vil fortælle dig, hvor længe du skal tage Sandimmun.
English: Beneficial effects of ciclosporin therapy have also been shown in a variety of conditions that are known, or may be considered to be of autoimmune origin.
Danish: Behandling med ciclosporin har også vist sig fordelagtig ved en række andre tilstande, som har en kendt autoimmun oprindelse eller regnes for at være af autoimmun oprindelse.
English: Additional precautions in psoriasis
Danish: Yderligere forsigtighedsregler ved psoriasis
English: If this happens, tell your doctor or pharmacist.
Danish: Hvis det sker, skal du fortælle det til lægen eller på apoteket.
English: • Like other medicines that act on the immune system, ciclosporin may influence your body's ability to fight against infection and may cause tumours or other cancers, particularly of the skin.
Danish: • Som anden medicin, der påvirker immunsystemet, kan ciclosporin påvirke kroppens evne til at bekæmpe infektioner; det kan også forårsage svulster eller andre kræfttyper, særligt i huden.
English: Anaphylactoid reactions have been observed following intravenous administration (see section 4.4).
Danish: Anafylaktoide reaktioner er blevet observeret efter intravenøs administration (se pkt.
English: Of the many drugs reported to interact with ciclosporin, those for which the interactions are adequately substantiated and considered to have clinical implications are listed below.
Danish: Blandt de mange lægemidler, hvor en interaktion med ciclosporin er rapporteret, anføres nedenfor de lægemidler, hvor interaktionen er tilstrækkeligt underbygget og anses for at have klinisk betydning.
English: Ciclosporin may increase the plasma concentrations of repaglinide and thereby increase the risk of hypoglycaemia.
Danish: Ciclosporin kan øge plasmakoncentrationen af repaglinid og dermed øge risikoen for hypoglykæmi.
English: The concentrate is used to prepare a solution which is administered by intravenous infusion.
Danish: Koncentratet bruges til at lave en opløsning, som administreres som en intravenøs infusion.
English: • Changes in menstrual cycle, breast enlargement in men.
Danish: • Ændringer i menstruationscyklus, udvikling af bryster hos mænd.
English: Administration of ciclosporin 3 hours after lercanidipine yielded no change of the lercanidipine AUC, but the ciclosporin AUC was increased by 27%.
Danish: Administration af ciclosporin 3 timer efter lercanidipin resulterede ikke i ændring i lercanidipins AUC, men ciclosporins AUC var øget 27 %.
English: Switching between oral ciclosporin formulations The switch from one oral ciclosporin formulation to another should be made under physician supervision, including monitoring of blood levels of ciclosporin for transplantation patients.
Danish: Skift mellem én oral formulering af ciclosporin til en anden skal foretages under lægelig supervision, inklusive monitorering af plasmaciclosporin for transplantationspatienter.
English: • Methotrexate.
Danish: • Methotrexat.
English: Sandimmun capsules should be swallowed whole.
Danish: Sandimmun kapsler skal synkes hele.
English: • Inflammation of the pancreas with severe upper stomach pain.
Danish: • Betændelse i bugspytkirtlen med svære smerter i den øvre del af maven.
English: If the eGFR decrease from baseline exceeds 35%, further reduction of the dose of Sandimmun should be considered.
Danish: Hvis e-GFR nedsættes mere end 35 % af baseline-niveau, skal yderligere reduktion af Sandimmun dosis overvejes.
English: Hyperuricaemia Caution is required when treating patients with hyperuricaemia.
Danish: Hyperurikæmi Der skal udvises forsigtighed ved behandling af patienter med hyperurikæmi.
English: The terminal half-life ranged from 6.3 hours in healthy volunteers to 20.4 hours in patients with severe liver disease.
Danish: Den terminale halveringstid varierede fra 6,3 timer hos raske frivillige personer til 20,4 timer hos patienter med svær leversygdom.
English: If dose reduction is not successful in improving eGFR within one month, Sandimmun treatment should be discontinued (see section 4.4).
Danish: Hvis dosisreduktion ikke er tilstrækkelig til at forbedre e-GFR inden for en måned, skal behandlingen med Sandimmun Neural stoppes (se pkt.
English: - For initial use, follow steps 1 to 9.
Danish: - Første gang, du tager medicinen, skal du følge trin 1 til 9.
English: For the initial monitoring of liver transplant patients, either the specific monoclonal antibody should be used, or parallel measurements using both the specific monoclonal antibody and the non-specific monoclonal antibody should be performed, to ensure a dosage that provides adequate immunosuppression.
Danish: I forbindelse med den indledende terapistyring hos levertransplanterede patienter skal enten det specifikke monoklonale antistof anvendes eller parallelle målinger med både det specifikke monoklonale antistof og det nonspecifikke monoklonale antistof for at sikre en dosis, som yder tilstrækkelig immunosuppression.
English: You will have regular blood tests and visits to the hospital.
Danish: Du vil regelmæssigt få taget blodprøver og blive undersøgt på hospitalet.
English: Pull up the plunger until you have drawn up the correct amount of medicine.
Danish: Træk stemplet op, indtil du har trukket den korrekte dosis medicin op i sprøjten.
English: Your doctor will check your blood pressure regularly and may give you a medicine to lower blood pressure if necessary.
Danish: Din læge vil regelmæssigt måle dit blodtryk og kan om nødvendigt ordinere medicin til at sænke blodtrykket.
English: The capsules should be left in the blister pack until required for use and stored at a temperature not exceeding 30°C.
Danish: Sandimmun kapsler skal opbevares i blisterpakningen indtil brug og ikke ved temperaturer over 30°C.
English: Sandimmun will only be prescribed for you by a doctor with experience in transplants.
Danish: Sandimmun vil kun blive ordineret til dig af en læge med erfaring inden for transplantationer.
English: Sandimmun 100 mg/ml oral solution ciclosporin
Danish: Sandimmun 100 mg/ml oral opløsning ciclosporin
English: In all cases of overdosage, general supportive measures should be followed and symptomatic treatment applied.
Danish: I alle tilfælde af overdosering skal der tages generelle understøttende forholdsregler og symptomatisk behandling iværksættes.
English: If you are taking Sandimmun following a transplant it will only be prescribed for you by a doctor with experience in transplants and/or autoimmune diseases.
Danish: Hvis du tager Sandimmun efter en transplantation, vil det kun blive ordineret til dig af en læge med erfaring inden for transplantation og/eller autoimmune sygdomme.
English: Treatment of sight-threatening intermediate or posterior uveitis of non-infectious aetiology in patients in whom conventional therapy has failed or caused unacceptable side effects.
Danish: Behandling af synstruende intermediær eller posterior uveitis med ikke-infektiøs ætiologi hos patienter, hvor konventionel behandling mislykkedes eller forårsagede uacceptable bivirkninger.
English: Skin lesions not typical for psoriasis, but suspected to be malignant or pre-malignant should be biopsied before Sandimmun treatment is started.
Danish: Ved hudlæsioner, som ikke er typiske for psoriasis, men som mistænkes for at være maligne eller præmaligne, bør der tages en biopsi, før behandlingen med Sandimmun påbegyndes.
English: At toxic doses (rats at 30 mg/kg/day and rabbits at 100 mg/kg/day orally), ciclosporin was embryo- and foetotoxic as indicated by increased prenatal and postnatal mortality, and reduced foetal weight together with related skeletal retardations.
Danish: Ved toksiske doser (rotter 30 mg/kg/dag og kaniner 100 mg/kg/dag oralt) var ciclosporin embryo- og føtotoksisk, hvilket indikeredes ved øget prænatal og postnatal dødelighed og reduceret fostervægt sammen med relateret forsinket knogledannelse.
English: Following concomitant administration of ciclosporin and aliskiren, a P-gp substrate, the Cmax of aliskiren was increased approximately 2.5-fold and the AUC approximately 5-fold.
Danish: Efter samtidig administration af ciclosporin og aliskiren, et P-gp-subtrat, var Cmax for aliskiren øget ca. 2,5 gange og AUC ca. 5 gange.
English: - The lower part of the plunger ring needs to be in front of the mark on the syringe which shows the amount of medicine.
Danish: - Den nederste del af stempelringen skal være ud for det mærke på sprøjten, som svarer til dosis af medicin.
English: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or medication and increased susceptibility for infections.
Danish: Der skal udvises forsigtighed ved dosisvalg hos ældre patienter med start i den lave ende af dosisintervallet og under hensyntagen til den øgede hyppighed af nedsat lever-, nyre- og hjertefunktion, anden samtidig sygdom eller medicinering og øget følsomhed for infektioner.
English: Unlike cytostatic agents, it does not depress haemopoiesis and has no effect on the function of phagocytic cells.
Danish: I modsætning til cytostatika undertrykker ciclosporin ikke hæmopoiesen og har ingen indvirkning på fagocytters funktion.
English: The presence of a few tiny bubbles is of no importance and will not affect the dose in any way.
Danish: Det gør ikke noget, hvis der stadig er nogle få små bobler, de påvirker ikke dosen på nogen måde.
English: Before initiation of treatment a reliable baseline level of renal function should be established by at least two measurements.
Danish: Inden påbegyndelse af behandlingen skal der etableres et pålideligt baseline-niveau for nyrefunktionen ved mindst to målinger.
English: For maintenance treatment, the dose should be slowly reduced to the lowest effective level.
Danish: Ved vedligeholdelsesbehandling reduceres dosis langsomt til det laveste effektive niveau.
English: During the concomitant use of a drug that may exhibit nephrotoxic synergy, close monitoring of renal function should be performed.
Danish: Under samtidig behandling med et lægemiddel, der kan udvise nefrotoksick synergi, skal nyrefunktion monitoreres tæt.
English: In a few psoriatic patients treated with Sandimmun, lymphoproliferative disorders have occurred.
Danish: Nogle få psoriasispatienter i behandling med Sandimmun har udviklet lymfoproliferative sygdomme.
English: If you think you have been given too much Sandimmun, tell your doctor immediately.
Danish: Hvis du tror, du har fået for meget Sandimmun, skal du straks fortælle det til din læge.
English: Before initiation of treatment a reliable baseline assessment of renal function should be established by at least two measurements of eGFR.
Danish: Før opstart af behandling skal en pålidelig vurdering af baseline for nyrefunktionen etableres i mindst to målinger af e-GFR.
English: This explains why, in rare cases, Sandimmun-associated structural kidney alterations have been observed without increases in serum creatinine.
Danish: Det forklarer de sjældne tilfælde, hvor der er observeret strukturelle nyreændringer i forbindelse med Sandimmun, uden serumkreatinin er steget.
English: Active herpes simplex infections should be allowed to clear before treatment with Sandimmun is initiated, but are not necessarily a reason for treatment withdrawal if they occur during therapy unless infection is severe.
Danish: Aktive herpes simplex-infektioner skal være overstået, før behandling med Sandimmun iværksættes, men behandlingen skal ikke nødvendigvis ophøre, hvis infektionerne opstår under behandlingen, medmindre der er tale om svære infektioner.
English: In some cases, mainly in transplant patients, fatal outcomes have been reported (see section 4.4).
Danish: I nogle tilfælde, især hos transplanterede patienter, er der rapporteret om dødeligt udfald (se pkt.
English: If eGFR decreases by more than 25% below baseline at more than one measurement, the dosage of Sandimmun should be reduced by 25 to 50%.
Danish: Hvis e-GFR nedsættes mere end 25 % i forhold til baseline-niveau ved mere end en måling, skal Sandimmun Neural dosis reduceres med 25-50 %.
English: The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related.
Danish: Hepatocellulære karcinomer og øcelleadenomer i pancreas var ikke dosisrelateret.
English: The syringe should not come in contact with the diluent.
Danish: Sprøjten må ikke komme i kontakt med fortyndingsvæsken.
English: If NSAIDs with a low first-pass effect (e.g. acetylsalicylic acid) are given together with ciclosporin, no increase in their bioavailability is to be expected.
Danish: Hvis der anvendes NSAIDer med lav first-pass-effekt (f.eks. acetylsalicylsyre) sammen med ciclosporin, forventes der ikke en stigning i stoffernes biotilgængelighed.
English: This depends on your body weight and what you are taking the medicine for.
Danish: Det afhænger af din kropsvægt, og hvad du tager medicinen for.
English: Oral doses of ciclosporin of up to 10 g (about 150 mg/kg) have been tolerated with relatively minor clinical consequences, such as vomiting, drowsiness, headache, tachycardia and in a few patients moderately severe, reversible impairment of renal function.
Danish: Indtagelse af orale doser på op til 10 g ciclosporin (ca. 150 mg/kg) er blevet tolereret med relativt lette kliniske konsekvenser som opkastning, døsighed, hovedpine, takykardi og hos nogle patienter en moderat svær, reversibelt nedsat nyrefunktion.
English: Yellow to brownish yellow liquid, clear or with a small amount of very fine sediment.
Danish: Gul til brunlig-gul væske, klar eller med en lille mængde meget fint bundfald.
English: Rheumatoid arthritis Treatment of severe, active rheumatoid arthritis.
Danish: Reumatoid artrit Behandling af svær, aktiv reumatoid artrit.
English: Psoriasis and atopic dermatitis
Danish: Psoriasis og atopisk dermatitis
English: Sandimmun oral solution and soft gelatin capsules are bioequivalent.
Danish: Sandimmun oral opløsning og bløde kaplser er bioækvivalente.
English: If medicinal products known to increase ciclosporin levels are given concomitantly, frequent assessment of renal function and careful monitoring for ciclosporin-related side effects may be more appropriate than blood level measurement.
Danish: Hvis lægemidler, som vides at øge ciclosporinkoncentrationen, gives samtidigt, kan jævnlig vurdering af nyrefunktionen og omhyggelig overvågning for ciclosporinrelaterede bivirkninger være mere hensigtsmæssigt end måling af plasmakoncentrationen.
English: Ciclosporin increases the exposure to HMG-CoA reductase inhibitors (statins).
Danish: Ciclosporin øger eksponeringen for HMG-CoA reduktasehæmmere (statiner).
English: Optic disc oedema, including papilloedema, with possible visual impairment secondary to benign intracranial hypertension
Danish: Meget sjælden Optisk disk-ødem, inklusive pupilødem, muligvis med nedsat syn sekundært til benign interkraniel hypertension
English: The concurrent administration of nifedipine with ciclosporin may result in an increased rate of gingival hyperplasia compared with that observed when ciclosporin is given alone.
Danish: Samtidig administration af nifedipin og ciclosporin kan resultere i øget frekvens af gingival hyperplasi sammenlignet med, når ciclosporin gives alene.
English: Once satisfactory response is achieved, Sandimmun may be discontinued and subsequent relapse managed with re-introduction of Sandimmun at the previous effective dose.
Danish: Når der er opnået en tilfredsstillende respons, kan Sandimmun seponeres, og efterfølgende tilbagefald kan behandles med Sandimmun i den tidligere effektive dosis.
English: A slight precipitate that may occur during storage does not affect the efficacy and safety of the drug.
Danish: Der kan dannes en smule bundfald under opbevaring, men det påvirker ikke lægemidlets effekt eller sikkerhed.
English: Solid organ transplantation
Danish: Transplantation af solide organer
English: • if you have an infection which is not under control with medication.
Danish: • hvis du har en infektion, som ikke er under kontrolmed medicin.
English: Medical supervision
Danish: Lægelig overvågning
English: Ciclosporin enhances the risk of hyperkalaemia, especially in patients with renal dysfunction.
Danish: Ciclosporin øger risikoen for hyperkaliæmi, især hos patienter med renal dysfunktion.
English: Renal function must be assessed frequently throughout therapy to allow dosage adjustment (see section 4.2).
Danish: Nyrefunktionen skal vurderes regelmæssigt under behandlingen for at kunne justere dosis (se pkt.
English: Many side effects associated with ciclosporin therapy are dose-dependent and responsive to dose reduction.
Danish: Mange af ciclosporins bivirkninger er dosisafhængige og responderer på dosisreduktion.
English: • Weight gain.
Danish: • Vægtstigning.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER LABEL
English: Flakes or small bits (sediments) in the medicine do not affect how the medicine works or how safe it is to use.
Danish: Flager eller lidt bundfald i medicinen påvirker ikke virkningen, eller om det er sikkert at bruge.
English: Children and adolescents There is limited experience with Sandimmun in children.
Danish: Børn og teenagere Der er begrænset erfaring med Sandimmun hos børn.
English: Lymphadenopathy which persists despite improvement in disease activity should be examined by biopsy as a precautionary measure to ensure the absence of lymphoma.
Danish: Hvis lymfadenopati fortsætter trods bedring af sygdommen, tages en biopsi som forholdsregel for at sikre, at der ikke er tale om lymfomer.
English: Your doctor will work out the correct dose of Sandimmun for you.
Danish: Lægen vil beregne din korrekte dosis Sandimmun.
English: Medicinal products known to reduce or increase the bioavailability of ciclosporin: In transplant patients frequent measurement of ciclosporin levels and, if necessary, ciclosporin dosage adjustment is required, particularly during the introduction or withdrawal of the co-administered medication.
Danish: Lægemidler, hvorom det vides, at de reducerer eller øger ciclosporins biotilgængelighed: Det er nødvendigt jævnligt at måle ciclosporinkoncentrationen hos transplanterede patienter, og om nødvendigt justere dosis, specielt under opstart eller seponering af samtidigt administrerede lægemidler.
English: - Then, put the syringe back in its cover.
Danish: - Derefter anbringes sprøjten i hylstret igen.
English: • The active substance is ciclosporin.
Danish: • Aktivt stof: ciclosporin.
English: Breast-feeding is not recommended during treatment with Sandimmun.
Danish: Amning anbefales ikke under behandling med Sandimmun.
English: Pre-existing infections may also be aggravated and reactivation of polyomavirus infections may lead to polyomavirus-associated nephropathy (PVAN) or to JC virus associated progressive multifocal leukopathy (PML).
Danish: Allerede eksisterende infektioner kan også blive forværret, og reaktivering af polyomavirus kan medføre polyomavirus-associeret nefropati (PVAN) eller JC-virus-associeret progressiv multifokal leukoenfalopati (PML).
English: In 9 liver transplant patients aged 0.65-6 years, clearance was 9.3±5.4 ml/min/kg (assay: HPLC).
Danish: Hos 9 levertransplanterede patienter i alderen 0,65,6 år var clearance 9,3±5,4 ml/min/kg (analyse: HPLC).
English: Treatment of transplant cellular rejection in patients previously receiving other immunosuppressive agents.
Danish: Behandling af celletransplantatafstødning hos patienter, som tidligere har fået andre immunsuppressiva.
English: In a study of 7 renal transplant patients aged 2-16 years, the ciclosporin clearance ranged from 9.8 to15.5 ml/min/kg.
Danish: I et studie med 7 nyretransplanterede patienter i alderen 2-16 år varierede ciclosporins clearance fra 9,8 til 15,5 ml/min/kg.
English: However, serious symptoms of intoxication have been reported following accidental parenteral overdosage with ciclosporin in premature neonates.
Danish: Der er imidlertid rapporteret alvorlige forgiftningssymptomer hos for tidligt fødte spædbørn efter utilsigtet parenteral overdosering af ciclosporin.