FrancophonIA/ELRC3.0 huggingface dataset:
English: Motor polyneuropathy
Danish: Motorisk polyneuropati
English: Lymphomas and other malignancies
Danish: Lymfomer og andre maligniteter
English: {e-mail}
Danish: {Navn}
English: Tremor, headache
Danish: Tremor, hovedpine
English: The inter- and intrasubject variability ranges between 18 to 74%.
Danish: Den inter- og intraindividuelle variation er imellem 18-74 %.
English: Sandimmun suppresses your immune system.
Danish: Sandimmun undertrykker dit immunsystem.
English: • Tell your doctor if you are pregnant or intend to become pregnant.
Danish: • Fortæl det til din læge, hvis du er gravid eller planlægger at blive gravid.
English: All indications
Danish: Alle indikationer
English: For severe rash, the treatment usually lasts for 8 weeks.
Danish: I forbindelse med alvorligt udslæt varer behandlingen typisk 8 uger.
English: Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide consisting of 11 amino acids.
Danish: Ciclosporin (også kaldet ciclosporin A) er et cyklisk polypeptid, som består af 11 aminosyrer.
English: • if you have any type of cancer.
Danish: • hvis du har en eller anden form for kræft.
English: • Swelling at the back of the eye.
Danish: • Hævelse i det bagerste af øjnene.
English: This summary of product characteristics, labelling and package leaflet is the version valid at the time of Commission Decision.
Danish: Dette produktresumé, etikettering og indlægsseddel er den gældende version på tidspunktet for Kommisionsbeslutningen.
English: • how well your liver and kidneys are working,
Danish: • hvor godt din lever og dine nyrer fungerer
English: - For subsequent use, follow steps 5 to 9.
Danish: - Ved efterfølgende brug skal du følge trin 5 til 9.
English: The absorption of ciclosporin is variable and may be influenced by intake of food.
Danish: Ciclosporins absorption varierer og kan blive påvirket af indtag af mad.
English: Combinations with increased risk for nephrotoxicity
Danish: Kombinationer med øget risiko for nefrotoksicitet
English: Your doctor should monitor how well your kidneys work.
Danish: Din læge vil overvåge, hvor godt dine nyrer fungerer.
English: The medicine can be mixed just before it is taken.
Danish: Medicinen skal blandes, lige inden den indtages.
English: Not known*
Danish: Ikke kendt
English: • if you have kidney problems (except for nephrotic syndrome).
Danish: • hvis du har nyreproblemer (bortset fra nefrotisk syndrom).
English: • Swelling at the back of the eye which may be associated with an increase in pressure inside the head and eyesight disturbances.
Danish: • Hævelse i det bagerste af øjnene, som kan være forbundet med øget tryk inde i hovedet og synsforstyrrelser.
English: Store in the original package.
Danish: Opbevares i original emballage.
English: • Store at room temperature (15°C to 30°C).
Danish: • Opbevares ved stuetemperatur (15°C til 30°C).
English: Posology The dose ranges given for oral administration are intended to serve as guidelines only.
Danish: Dosering Dosisintervallerne for oral administration er udelukkende tiltænkt som retningslinjer.
English: These might be signs of an infection of the brain called progressive multifocal leukoencephalopathy.
Danish: Dette kan være tegn på en infektion i hjernen, som kaldes progressiv multifokal leukoencefalopati.
English: if you have epilepsy.
Danish: • hvis du har epilepsi.
English: • Medicines which may increase or decrease the level of ciclosporin (the active substance of Sandimmun) in your blood.
Danish: • Medicin, som kan øge eller reducere mængde af ciclosporin (det aktive stof i Sandimmun) i blodet.
English: Your doctor might check the level of ciclosporin in your blood when starting or stopping treatment with other medicines.
Danish: Din læge vil muligvis undersøge mængde af ciclosporin i blodet, når du starter eller standser behandlingen med andre lægemidler.
English: Results should therefore serve only as a guide to dosage in relationship to other clinical and laboratory parameters.
Danish: Resultaterne er derfor kun vejledende for doseringen og skal anvendes sammen med andre kliniske og laboratoriemæssige parametre.
English: In several studies, paediatric patients required and tolerated higher doses of ciclosporin per kg body weight than those used in adults.
Danish: I flere studier sås det, at pædiatriske patienter krævede og tolererede højere doser af ciclosporin pr. kg kropsvægt end voksne.
English: You may need medical attention.
Danish: Det kan være nødvendigt med lægebehandling.
English: Additional side effects in children and adolescents There are no additional side effects to be expected in children and adolescents compared to adults.
Danish: Hos børn og teenagere kan endvidere ses følgende bivirkninger Der forventes ikke yderligere bivirkninger hos børn og teenagere i forhold til hos voksne.
English: Everolimus and sirolimus had only a minor influence on ciclosporin pharmacokinetics.
Danish: Everolimus og sirolimus havde kun mindre indflydelse på ciclosporins farmakokinetik.
English: Effects of ciclosporin on other drugs
Danish: Ciclosporins effekt på andre lægemidler
English: Ciclosporin is distributed largely outside the blood volume, with an average apparent distribution volume of 3.5 l/kg.
Danish: Ciclosporin distribueres hovedsageligt uden for blodvolumen, med et gennemsnitligt tilsyneladende fordelingvolumen på 3,5 l/kg.
English: The advice in this leaflet may vary depending on whether you are taking the medicine for a transplant or for an autoimmune disease.
Danish: Rådgivningen i denne indlægsseddel varierer afhængigt af, om du tager medicinen i forbindelse med en transplantation eller en autoimmun sygdom.
English: Not all pack sizes may be available.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Remove the capsules from the blister.
Danish: Fjern kapslerne fra blisteren.
English: If considered necessary, magnesium supplementation should be given.
Danish: Hvis det er nødvendigt, gives magnesiumtilskud.
English: Your doctor will closely monitor you if you are elderly and are being treated for psoriasis or atopic dermatitis.
Danish: Din læge vil overvåge dig omhyggeligt, hvis du er ældre og behandles for psoriasis eller atopisk dermatitis.
English: If it is necessary for you to take this medicine, your doctor will discuss with you the benefits and potential risks of taking it during pregnancy.
Danish: Hvis det er nødvendigt at tage denne medicin, vil din læge drøfte fordelene og de mulige risici ved at tage den under graviditet med dig.
English: Pregnancy Animal studies have shown reproductive toxicity in rats and rabbits.
Danish: Graviditet Dyrestudier har påvist reproduktionstoksicitet hos rotter og kaniner.
English: The physician responsible for maintenance therapy should receive complete information for the follow-up of the patient.
Danish: Den læge, der er ansvarlig for vedligeholdelsesbehandlingen, skal have alle tilgængelige oplysninger med henblik på opfølgning af patienten.
English: Although an 8-week course of therapy may be sufficient to achieve clearing, up to 1 year of therapy has been shown to be effective and well tolerated, provided the monitoring guidelines are followed.
Danish: Selv om 8 ugers behandling kan være tilstrækkeligt til at opnå afglatning, har behandling med ciclosporin i op til 1 år vist sig at være effektiv og godt tolereret, forudsat at retningslinjerne for monitorering følges.
English: However, if it is almost time for your next dose, skip the missed dose.
Danish: Hvis det næsten er tid til næste dosis, skal du dog springe den glemte dosis over.
English: This increases your risk of developing cancers, particularly of the skin and lymphoid system.
Danish: Dette øger din risiko for at udvikle kræft, især i huden og lymfesystemet.
English: Within the therapeutic dose range the peak plasma concentration and the area under the plasma concentration/time curve are proportional to the dose; for whole blood, however, the relationship is non-linear.
Danish: Indenfor det terapeutiske område er peak plasmakoncentration og arealet under plasmakoncentration/tid kurven proportional med dosis, men for fuldblod er forholdet non-lineært.
English: Initial doses of 5 mg/kg/day are justified in patients whose condition requires rapid improvement.
Danish: Initialdoser på 5 mg/kg/dag er berettiget hos patienter, hvis tilstand hurtigt skal forbedres.
English: This effect is often reversible with ciclosporin dose reduction.
Danish: Denne effekt er ofte reversibel ved reduktion i ciclosporin-dosis.
English: It is recommended that Sandimmun be administered on a consistent schedule with regard to time of day and in relation to meals.
Danish: Det anbefales, at Sandimmun administreres efter et konsistent skema med hensyn til tidspunkt på dagen og i forhold til måltider.
English: These functional changes are dose-dependent and are initially reversible, usually responding to dose reduction.
Danish: Disse funktionsændringer er dosisrelaterede, er i begyndelsen reversible og kan normalt afhjælpes ved dosisreduktion.
English: Some side effects could be serious.
Danish: Nogle bivirkninger kan være alvorlige.
English: This can lead to symptomatic hypomagnesaemia, especially in the peri-transplant period.
Danish: Dette kan medføre symptomatisk hypomagnesiæmi, især i peritransplantationsperioden.
English: Renal toxicity
Danish: Renal toksicitet
English: If hypertension develops, appropriate antihypertensive treatment must be instituted.
Danish: Hvis der opstår hypertension, skal der iværksættes passende antihypertensiv behandling.
English: Transplantation patients receiving this medicinal product should be managed in facilities with adequate laboratory and supportive medical resources.
Danish: Transplantationspatienter, som behandles med dette lægemiddel, bør overvåges på afdelinger med tilstrækkelig laboratoriekapacitet og understøttende medicinsk udstyr.
English: During treatment with ciclosporin, vaccination may be less effective and the use of live attenuated vaccines should be avoided.
Danish: Under behandling med ciclosporin kan vaccination være mindre effektiv, og brug af levende svækkede vacciner bør undgås.
English: Special excipients: Sorbitol
Danish: Særlige hjælpestoffer: Sorbitol
English: Avoid any contact between the syringe and the liquid in the glass.
Danish: Undgå kontakt mellem sprøjten og væsken i glasset.
English: Clarithromycin has been reported to double the exposure of ciclosporin.
Danish: Clarithromycin er blevet rapporteret at fordoble ciclosporins eksponering.
English: If you have fructose intolerance, inform your doctor before taking this medicine, as it contains sorbitol.
Danish: Hvis du har fructoseintolerans, skal du fortælle din læge dette, før du tager dette lægemiddel, da det indeholder sorbitol.
English: • Shaking of your body which you cannot control.
Danish: • Rystelser i kroppen, som du ikke kan kontrollere.
English: Azole antibiotics: Ketoconazole, fluconazole, itraconazole and voriconazole could more than double ciclosporin exposure.
Danish: Azolantibiotika: Ketoconazol, fluconazol, itraconazol og voriconazol kan mere end fordoble ciclosporins eksponering.
English: Your doctor may give you magnesium supplements to take, especially just after your transplant operation.
Danish: Din læge kan ordinere magnesiumtilskud, som du skal tage, specielt lige efter din transplantation.
English: Sandimmun suppresses the immune system and may also affect your body's ability to fight against infection.
Danish: Sandimmun undertrykker immunsystemet og kan også påvirke kroppens evne til at bekæmpe infektion.
English: Tell your doctor straight away if you notice any of the following serious side effects:
Danish: Fortæl det øjeblikkeligt til lægen, hvis du oplever nogle af følgende alvorlige bivirkninger:
English: - Stir and drink the whole contents of the glass straight away.
Danish: - Rør rund og drik al indholdet i glasset med det samme.
English: Once the bottle has been opened, the content must be used within 2 months.
Danish: Efter åbning skal indholdet bruges inden for 2 måneder.
English: These medicines are used to lower the body's immune reactions.
Danish: Denne type medicin bruges til at undertrykke kroppens immunforsvar.
English: If available, glass containers should be used for infusion.
Danish: Hvis muligt bør glasbeholdere anvendes til infusion.
English: • When a blister is opened, a characteristic smell is noticeable.
Danish: • Når blisteren åbnes, kan du mærke en karakteristisk lugt.
English: As a consequence of the higher initial doses and longer maintenance therapy required after transplantation, side effects are more frequent and usually more severe in transplant patients than in patients treated for other indications.
Danish: Da der kræves en højere initialdosis og længere vedligeholdelsesbehandling efter transplantation, forekommer bivirkninger hyppigere og er normalt mere alvorlige hos transplanterede patienter end hos patienter, der behandles for andre indikationer.
English: These were responsive to prompt discontinuation.
Danish: Disse responderede på øjeblikkelig seponering.
English: Infectious causes of uveitis should be ruled out before immunosuppressants can be used.
Danish: Infektiøses årsager til uveitis skal udelukkes, før immunsuppressiva kan anvendes.
English: In refractory cases, the dose can be increased to 7 mg/kg/day for a limited period.
Danish: I refraktære tilfælde kan dosis øges til 7 mg/kg/dag i en begrænset periode.
English: After 3 months, the dose of corticosteroids may be tapered to the lowest effective dose.
Danish: Efter 3 måneder kan kortikosteroid nedtrappes til den laveste effektive dosis.
English: If you have been given more Sandimmun than you should Too much of the medicine can affect your kidneys.
Danish: Hvis du har fået mere Sandimmun, end du skulle For meget medicin kan påvirke dine nyrer.
English: Diltiazem (at doses of 90 mg/day) can increase ciclosporin plasma concentrations by up to 50%.
Danish: Diltiazem (ved doser på 90 mg/dag) kan øge ciclosporins plasmakoncentration med up til 50 %.
English: • Often applying a sunscreen with a high protection factor.
Danish: • smøre dig hyppigt med solcreme med en høj beskyttelsesfaktor.
English: Never change your dose yourself, unless a doctor has told you to.
Danish: Du må aldrig selv ændre din dosis, medmindre lægen har bedt dig om det.
English: The frequency of malignancies increases with the intensity and duration of therapy (see section 4.4).
Danish: Hyppigheden af maligniteter øges med intensiteten og varigheden af behandlingen (se pkt.
English: There have been reports from clinical trials and from the post-marketing setting associated with the use of Sandimmun.
Danish: Der har været rapporter fra kliniske studier og postmarketing, relateret til brug af Sandimmun.
English: Examples of drugs that decrease ciclosporin levels are:
Danish: Eksempler på lægemidler, som reducerer ciclosporinkoncentrationen, er:
English: Thus, patients receiving Sandimmun concentrate for solution for infusion should be under continuous observation for at least the first 30 minutes after the start of the infusion and at frequent intervals thereafter.
Danish: Patienter, der får Sandimmun koncentrat til infusionsvæske, skal være under konstant observation i mindst 30 minutter efter start af infusion og med hyppige intervaller herefter.
English: The estimated glomerular filtration rate (eGFR) by the MDRD formula can be used for estimation of renal function in adults and an appropriate formula should be used to assess eGFR in paediatric patients.
Danish: Den estimerede glomerulære filtrationshastighed (e-GFR) ud fra MDRD-formlen kan bruges til at vurdere nyrefunktionen hos voksne, og en passende formel skal bruges til at vurdere e-GFR hos pædiatriske patienter.
English: You will have regular blood tests and visits to the hospital, especially after a transplant.
Danish: Du vil regelmæssigt få taget blodprøver og blive undersøgt på hospitalet, særligt efter en transplantation.
English: In very severe cases, rapid and adequate control of the disease is more likely to occur with a starting dose of 5 mg/kg/day.
Danish: I meget svære tilfælde opnås hurtig og tilstrækkelig sygdomskontrol med større sandsynlighed med en initialdosis på 5 mg/kg/dag.
English: The dose can still be measured correctly with the syringe.
Danish: Dosis kan stadigt måles korrekt med sprøjten.
English: Clinical studies have included children from 1 year of age using standard ciclosporin dosage with a comparable safety profile to adults.
Danish: Kliniske studier har omfattet børn fra 1 år med anvendelse af ciclosporin i standarddoser med en sikkerhedsprofil svarende til sikkerhedsprofilen hos voksne.
English: Consultation with a physician with experience of use of ciclosporin is recommended.
Danish: Det anbefales at konsultere en læge med erfaring i anvendelse af ciclosporin.
English: After 6 months of therapy, renal function needs to be assessed every 4 to 8 weeks depending on the stability of the disease, its co- medication, and concomitant diseases.
Danish: Efter 6 måneders behandling skal nyrefunktionen vurderes hver 4. til 8. uge alt efter sygdommens stabilitet, samtidig behandling med andre lægemidler og samtidige sygdomme.
English: Containers and stoppers should be free of silicone oil and fatty substances.
Danish: Beholdere og propper bør være fri for siliconeolie og ”fede substanser”.
English: A limited number of observations in children exposed to ciclosporin in utero are available, up to an age of approximately 7 years.
Danish: Der findes et begrænset antal observationer af børn op til ca. 7 år, der var blevet eksponeret for ciclosporin in utero.
English: • Do not take a double dose to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Keep taking Sandimmun even if you feel well.
Danish: Du skal fortsætte med at tage Sandimmun, selvom du føler dig rask.
English: All metabolites identified so far contain the intact peptide structure of the parent compound; some possess weak immunosuppressive activity (up to one-tenth that of the unchanged drug).
Danish: Alle metabolitter, der er identificeret indtil videre, har intakt peptidstruktur fra det oprindelige stof, nogle udviser svag immunsuppressiv aktivitet (op til en tiendedel af det uomdannede lægemiddel).
English: • You may have some side effects.
Danish: • Du kan opleve visse bivirkninger.
English: To achieve full effectiveness, up to 12 weeks of Sandimmun therapy may be required.
Danish: For at opnå fuld terapeutisk effekt kan det være nødvendigt at behandle med Sandimmun i op til 12 uger.
English: This may affect your ability to drive and use machines.
Danish: Det kan påvirke evnen til at køre bil og betjene maskiner.
English: Ciclosporin gave no evidence of mutagenic or teratogenic effects in the standard test systems with oral application (rats up to 17 mg/kg/day and rabbits up to 30 mg/kg/day orally).
Danish: Ciclosporin udviste ingen mutagene eller teratogene virkninger i standardtestsystemer med oral administration (rotter op til 17 mg/kg/dag og kaniner op til 30 mg/kg/dag).
English: Sandimmun oral solution should be diluted in a glass (not plastic) container with cold chocolate drink, milk, fruit juice or cola immediately before being taken, stirred well and drunk at once.
Danish: Sandimmun oral opløsning skal fortyndes i et glas (ikke plastik) med kold kakaomælk, mælk, frugtjuice eller cola umiddelbart før den tages, omrøres grundigt og drikkes med det samme.
English: Macrolide antibiotics: Erythromycin can increase ciclosporin exposure 4- to 7-fold, sometimes resulting in nephrotoxicity.
Danish: Makrolidantibiotika: Erythromycin kan øge ciclosporins eksponering 4-7 gange, nogle gange resulterende i nefrotoksicitet.
English: • Muscle weakness, loss of muscle strength, pain in muscles of the legs or hands or anywhere in the body.
Danish: • Muskelsvaghed, tab af muskelstyrke, smerter i musklerne i ben eller hænder eller andre steder i kroppen.
English: Ciclosporin was tested in a number of in vitro and in vivo tests for genotoxicity with no evidence for a clincally relevant mutagenic potential.
Danish: Ciclosporin blev testet i et antal in vitro og in vivo tests for genotoksicitet uden tegn på klinisk relevant mutagent potentiale.
English: Ciclosporin has been used successfully both in hepatitis C virus (HCV) positive and HCV negative liver transplants recipients.
Danish: Ciclosporin er anvendt med gode resultater hos både hepatitis C-virus (HCV)-positive og HCV-negative levertransplantationspatienter.
English: Plastic bottles should be used only if they conform to the requirements for “Sterile plastic containers for human blood and blood components” or “Empty sterile containers of plasticised polyvinyl chloride for human blood and blood components” of the current European Pharmacopoeia.
Danish: Plastikbeholdere bør kun anvendes, hvis de opfylder den gældende europæiske farmakopés krav til ”Sterile plastic containers for human blood and blood components” eller ”Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components”.
English: However, there are no adequate and well-controlled studies in pregnant women and therefore Sandimmun should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus.
Danish: Der findes dog ikke tilstrækkelige og velkontrollerede studier hos gravide kvinder, og derfor bør Sandimmun ikke anvendes under graviditet, medmindre de mulige fordele for moderen opvejer de mulige risici for fosteret.
English: If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Sandimmun if your condition is particularly severe.
Danish: Hvis du er over 65 år og har psoriasis eller atopisk dermatitis, må du kun behandles med Sandimmun, hvis din tilstand er særlig alvorlig.
English: <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000) very rare (<1/10,000), not known
Danish: III): meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne ordnet efter frekvens med de hyppigste bivirkninger først.
English: Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Graviditet og amning Spørg din læge eller apoteket til råds, før du tager dette lægemiddel.
English: CARTON AND BOTTLE LABEL
Danish: KARTON OG LABEL PÅ FLASKE
English: Monitoring during your treatment with Sandimmun Your doctor will check:
Danish: Overvågning under behandling med Sandimmun Din læge vil undersøge:
English: {Name of the Member State} {Name of the medicinal product} {Name of the Member State} {Name of the medicinal product}
Danish: {Medlemslandets navn} {Lægemidlets navn} {Medlemslandets navn} {Lægemidlets navn}
English: Treatment of Behçet uveitis with repeated inflammatory attacks involving the retina in patients without neurological manifestations.
Danish: Behandling af Bechet's uveitis med gentagne inflammatoriske episoder, der involverer retina, hos patienter uden neurologiske manifestationer.
English: Blood lipids increased
Danish: Forhøjede blodlipider
English: The name of your medicine is Sandimmun.
Danish: Navnet på din medicin er Sandimmun.
English: Control of serum magnesium levels is therefore recommended in the peri-transplant period, particularly in the presence of neurological symptom/signs.
Danish: Serumkoncentrationen af magnesium i peritransplantationsperioden bør derfor kontrolleres, især ved neurologiske symptomer/tegn.
English: More frequent checks are necessary when the Sandimmun dose is increased, or concomitant treatment with an NSAID is initiated or its dosage increased.
Danish: Der kræves hyppigere kontroller, når Sandimmun-dosis øges, eller hvis der samtidig iværksættes behandling med et NSAID, eller hvis dosis heraf øges.