FrancophonIA/ELRC3.0 huggingface dataset:
English: The glass must be rinsed well with some more diluent to ensure that all of the dose is taken.
Danish: Glasset skal renses grundigt med mere fortyndingsvæske for at sikre at hele dosissen er taget.
English: The determination of bilirubin and parameters that assess hepatic function are required prior to starting therapy and close monitoring during treatment is recommended.
Danish: Bestemmelsen af bilirubin og parametre til vurdering af leverfunktionen er nødvendig inden behandlingsstart og tæt monitorering under behandlingen anbefales.
English: You might get swollen gums that might grow over your teeth if you are taking nifedipine during your treatment with ciclosporin.
Danish: Dit tandkød kan hæve op og vokse ud over tænderne, hvis du tager nifedipin under din behandling med ciclosporin.
English: Starting a new bottle of Sandimmun oral solution Lift the flap in the centre of the metal sealing ring.
Danish: Åbning af en ny flaske med Sandimmun oral opløsning Løft flappen i midten af metalforseglingsringen.
English: Too much of the medicine can affect your kidneys.
Danish: For meget medicin kan påvirke dine nyrer.
English: Your doctor will carry out regular blood tests and may change your dose if necessary.
Danish: Din læge vil regelmæssigt tager blodprøver og kan om nødvendigt ændre din dosis.
English: The combination of Sandimmun with low doses of oral corticosteroids is recommended if the effect of Sandimmun alone is not satisfactory, especially in steroid-resistant patients.
Danish: Kombinationen af Sandimmun med lave, orale doser kortikosteroid anbefales, hvis virkningen af Sandimmun alene ikke er tilstrækkelig, særligt hos steroidresistente patienter.
English: Ciclosporin enhances the clearance of magnesium.
Danish: Ciclosporin øger magnesiums clearance.
English: Stopping your treatment with Sandimmun may increase the risk of your transplanted organ being rejected.
Danish: Hvis du stopper behandlingen med Sandimmun, kan det øge risikoen for, at det transplanterede organ afstødes.
English: Paediatric population: Ciclosporin has been shown to be efficacious in steroid-dependent nephrotic syndrome.
Danish: Pædiatrisk population: Ciclosporin er vist effektivt ved steroidafhængig nefrotisk syndrom.
English: In non-transplant patients the relationship between blood level and clinical effects is less well established.
Danish: Hos ikke-transplanterede patienter er relationen mellem plasmakoncentration og klinisk effekt mindre etableret.
English: Pharmacokinetic data from paediatric patients given Sandimmun Neoral or Sandimmun are very limited.
Danish: Farmakokinetiske data fra pædiatriske patienter behandlet med Sandimmun Neoral eller Sandimmun er meget begrænsede.
English: If you accidentally take too much of your medicine, tell your doctor immediately or go to your nearest hospital emergency unit.
Danish: Hvis du er kommet til at tage for meget medicin, skal du øjeblikkeligt fortælle det til din læge eller henvende dig på den nærmeste skadestue.
English: It can also be used to maintain steroidinduced remission, allowing withdrawal of steroids.
Danish: Det kan også bruge til at opretholde steroidinduceret remission, hvorved steroid kan seponeres.
English: • if this medicine is being prescribed for a child.
Danish: • hvis denne medicin er ordineret til et barn.
English: Since Sandimmun can impair renal function, it is necessary to assess renal function frequently.
Danish: Da Sandimmun Neural kan påvirke nyrefunktionen, er det nødvendigt at vurdere nyrefunktionen hyppigt.
English: Live-attenuated vaccines
Danish: Levende, svækkede vacciner
English: Sandimmun contains approximately 12.0 vol. % ethanol (alcohol), which corresponds to up to 500 mg per dose used in transplant patients.
Danish: Sandimmun indeholder ca. 12,0 vol. % ethanol (alkohol), hvilket svarer til op til 500 mg pr. dosis, der anvendes til transplantationspatienter.
English: When using Sandimmun in any of the established non-transplantation indications, the following general rules should be adhered to:
Danish: Når Sandimmun anvendes til andre, godkendte indikationer end transplantation, skal følgende generelle bestemmelser overholdes:
English: If any of these drugs are used concurrently with ciclosporin, close clinical observation is required in order to enable early detection of toxic manifestations of the medicinal products, followed by reduction of its dosage or its withdrawal.
Danish: Hvis nogle af disse lægemidler bruges sammen med ciclosporin, er tæt klinisk observation nødvendig for at sikre tidlig detektion af toksiske manifestationer af lægemidlet, efterfulgt af dosisreduktion eller seponering.
English: • Bleeding underneath the skin or purple skin patched, sudden bleeding with no apparent cause.
Danish: • Blødninger under huden eller blå mærker, pludselig blødning tilsyneladende uden nogen grund.
English: Blister packs of double-sided aluminium consisting of aluminium foil on the bottom side and aluminium foil on the upper side.
Danish: Blister med dobbelt-sidet aluminium, bestående af aluminiumsfolie i bunden og på toppen.
English: It may also be harmful if this medicine is given to children.
Danish: Det kan også være skadeligt, hvis medicinen gives til børn.
English: Patients with malignant or pre-malignant alterations of the skin should be treated with Sandimmun only after appropriate treatment of such lesions, and if no other option for successful therapy exists.
Danish: Patienter med maligne eller præmaligne forandringer i huden bør kun behandles med Sandimmun efter passende behandling af disse læsioner, og kun hvis der ikke er andre muligheder for vellykket behandling.
English: Alcohol may be harmful if you have alcohol-related problems, epilepsy, brain injury, liver problems or if you are pregnant or breast-feeding.
Danish: Alkohol kan være skadeligt, hvis du har alkoholrelaterede problemer, epilepsi, hjerneskade, leverproblemer, eller hvis du er gravid eller ammer.
English: Sandimmun contains sorbitol If you have an intolerance to some sugars, inform your doctor before taking this medicine.
Danish: Sandimmun indeholder sorbitol Hvis du ikke tåler visse sukkerarter, skal du kontakte lægen, før du tager denne medicin.
English: Uncoloured glass (type I) ampoule.
Danish: Ufarvede glasampuller (type I).
English: Psoriasis Treatment of severe psoriasis in patients in whom conventional therapy is inappropriate or ineffective.
Danish: Behandling af svær psoriasis hos patienter, hvor konventionel behandling er uhensigtsmæssig eller ineffektiv.
English: It is available in a 50 ml glass bottle, with two syringes for measuring the dose.
Danish: Den fås i en 50 ml glasflaske med to sprøjter til opmåling af dosis.
English: Exposure changes of commonly used statins with ciclosporin are summarised in Table 1.
Danish: Ændring i eksponering for almindeligt anvendte statiner ved administration sammen med ciclosporin er opsummeret i Tabel 1.
English: Therefore the simultaneous combination of ciclosporin and lercanidipine should be avoided.
Danish: Derfor skal samtidig administration af ciclosporin og lercanidipin undgås.
English: At the cellular level it inhibits production and release of lymphokines including interleukin 2 (T-cell growth factor, TCGF).
Danish: På celleniveau hæmmer ciclosporin produktion og frigivelse af lymfokiner, herunder interleukin 2 (T-cellevækstfaktor, TCGF).
English: The doses need to be adjusted individually according to efficacy (proteinuria) and safety, but should not exceed 5 mg/kg/day in adults and 6 mg/kg/day in children.
Danish: Doserne skal tilpasses individuelt alt efter virkning (proteinuri) og sikkerhed, men bør ikke overstige 5 mg/kg/dag for voksne og 6 mg/kg/dag for børn.
English: Only remove them when it is time to take your medicine.
Danish: Udtag først kapslerne, når det er tid til at tage medicinen.
English: Prophylactic administration of an antihistamine (H1 + H2 blocker) prior to Sandimmun concentrate for solution for infusion has also been successfully employed to prevent the occurrence of anaphylactoid reactions.
Danish: Profylaktisk administration af antihistamin (H1 + H2-blokker) inden Sandimmun koncentrat til infusionsvæske er også blevet anvendt med succes for at hindre forekomst af anafylaktoide reaktioner.
English: • Medicines that may affect your potassium levels.
Danish: • Medicin, som kan påvirke dit kaliumniveau.
English: During long-term treatment, some patients may develop structural changes in the kidney (e.g. interstitial fibrosis) which, in renal transplant patients, must be differentiated from changes due to chronic rejection.
Danish: Ved langvarig behandling kan visse patienter udvikle strukturelle ændringer i nyrerne (f.eks. interstitiel fibrose), som hos nyretransplanterede patienter skal differentieres fra ændringer, der skyldes kronisk afstødning.
English: Benign lymphadenopathy is commonly associated with flares in atopic dermatitis and invariably disappears spontaneously or with general improvement in the disease.
Danish: Benign lymfadenopati forbindes ofte med opblussen af atopisk dermatitis og forsvinder altid spontant eller ved en generel bedring af sygdommen.
English: Frequent monitoring of renal function is therefore required according to local guidelines for the indication in question (see sections 4.2 and
Danish: Derfor er regelmæssig monitorering af nyrefunktionen i henhold til lokale guidelines for den pågældende indikation nødvendig (se pkt.
English: Sandimmun should be prescribed only by physicians who are experienced in immunosuppressive therapy and can provide adequate follow-up, including regular full physical examination, measurement of blood pressure and control of laboratory safety parameters.
Danish: Sandimmun bør kun ordineres af læger med erfaring i immunsuppressiv behandling, og som kan udføre tilstrækkelig opfølgning, inklusive regelmæssig fuld, objektiv undersøgelse, måling af blodtryk og kontrol af laboratoriemæssige sikkerhedsparametre.
English: Nephrotic syndrome
Danish: Nefrotisk syndrom
English: This depends on whether you are taking it after a transplant or for the treatment of a severe skin condition, rheumatoid arthritis, uveitis or nephrotic syndrome.
Danish: Det afhænger af, om du tager det efter en transplantation eller for behandling af en alvorlig hudlidelse, leddegigt, uveitis eller nefrotisk syndrom.
English: The intravenous LD50 is 148 mg/kg in mice, 104 mg/kg in rats, and 46 mg/kg in rabbits.
Danish: Intravenøs LD50 er 148 mg/kg hos mus, 104 mg/kg hos rotter og 46 mg/kg hos kaniner.
English: Since Sandimmun has been reported to induce a reversible slight increase in blood lipids, it is advisable to perform lipid determinations before treatment and after the first month of therapy.
Danish: Da det er rapporteret, at Sandimmun inducerer en lille, reversibel stigning i blodlipider, anbefales det, at lipiderne måles før behandlingen og efter den første måneds behandling.
English: If there is no alternative, it is recommended to closely monitor blood levels of ciclosporin, renal function, and for side effects of ciclosporin.
Danish: Hvis der ikke er noget alternativ, anbefales det nøje at monitorere plasma-ciclosporin og nyrefunktionen og for bivirkninger af ciclosporin.
English: As with other long-term immunosuppressive treatments, an increased risk of lymphoproliferative disorders must be borne in mind.
Danish: Som med andre langvarige immunsuppressive behandlinger skal en øget risiko for lymfoproliferative sygdomme tages i betragtning.
English: Maintenance treatment should be continued for at least 3 months (and preferably for 6 months) before the dose is gradually decreased to zero by 1 year after transplantation.
Danish: Vedligeholdelsesbehandlingen fortsættes i mindst 3 måneder (helst i 6 måneder), før dosis gradvis reduceres, og behandlingen seponeres 1 år efter transplantationen.
English: • If you have an autoimmune disease, in which your body's immune response attacks your body's own cells, Sandimmun stops this immune reaction.
Danish: • Hvis du har en autoimmun sygdom, hvor kroppens immunforsvar angriber kroppens egne celler, standser Sandimmun denne immunreaktion.
English: The use of live attenuated vaccines should be avoided (see section 4.5).
Danish: Brug af levende, svækkede vacciner bør undgås (se pkt.
English: Once an ampoule has been opened, the contents should be used immediately.
Danish: Når først en ampul er åbnet, skal indholdet anvendes straks.
English: Push the medicine out of the syringe into a small glass with some liquid (not grapefruit juice).
Danish: Pres medicinen ud af sprøjten og ned i et lille glas med væske (ikke grapefrugtjuice).
English: Prevention of graft rejection following solid organ transplantation.
Danish: Forebyggelse af graftafstødning efter transplantation af solide organer.
English: Sandimmun should be administered with caution in patients with neurological Behcet`s syndrome.
Danish: Sandimmun skal administreres med forsigtighed hos patienter med neurologisk Behcets syndrom.
English: What Sandimmun is used for and how it works Sandimmun is used to control the body's immune system following an organ transplant, including bone marrow and stem cell transplantation.
Danish: Hvad Sandimmun anvendes til, og hvordan det virker Sandimmun bruges til at kontrollere kroppens immunsystem efter en organtransplantation, inklusive knoglemarv- og stamcelletransplantation.
English: In a study performed in severe liver disease patients with biopsy-proven cirrhosis, the terminal half-life was 20.4 hours (range between 10.8 to 48.0 hours) compared to 7.4 to 11.0 hours in healthy subjects.
Danish: I et studie med patienter med svær leversygdom med biopsiverificeret cirrose var den terminale halveringstid 20,4 timer (interval fra 10,8 til 48,0 timer) sammenlignet med 7,4 til 11,0 timer hos raske forsøgspersoner.
English: The absolute oral bioavailability following administration of Sandimmun is 20 to 50%.
Danish: Ciclosporins absolutte orale biotilgængelighed efter administration af Sandimmun er 20-50%.
English: Ensure that the correct amount of medicine is in the syringe.
Danish: Sørg for, at der er den korrekte dosis medicin i sprøjten.
English: Another well-established use of the concentrate for solution for infusion is the initial treatment of patients undergoing bone marrow transplantation.
Danish: En anden veletableret brug af Sandimmun koncentrat til infusionsvæske er initial behandling af patienter, der skal undergå knoglemarvstranplantation.
English: Do not take Sandimmun:
Danish: Tag ikke Sandimmun:
English: If the renal function (except for proteinuria) is normal, the recommended daily dose is the following: - adults: 5 mg/kg - children: 6 mg/kg
Danish: Hvis nyrefunktionen (bortset fra proteinuri) er normal, er den anbefalede daglige dosis følgende: - Voksne: 5 mg/kg - Børn: 6 mg/kg
English: In a study performed in patients with terminal renal failure, the systemic clearance was approximately two thirds of the mean systemic clearance in patients with normally functioning kidneys.
Danish: I et studie med patienter med terminal nyresvigt var den systemiske clearance ca. to tredjedele af den mediane systemiske clearance hos patienter med normal nyrefunktion.
English: {Name and address} {tel} {fax} {e-mail}
Danish: {Navn og adresse} {tlf.} {fax} {e-mail}
English: When Sandimmun is given with other immunosuppressants (e.g. with corticosteroids or as part of a triple or quadruple medicinal product therapy), lower doses (e.g. 3 to 6 mg/kg given in 2 divided doses for the initial treatment) may be used.
Danish: Når Sandimmun anvendes sammen med andre immunsuppressiva (f.eks. kortikosteroider eller som et af tre eller fire lægemidler i polyterapi), kan der gives en lavere dosis (f.eks. 3-6 mg/kg oralt fordelt på 2 doser som initialbehandling).
English: This is divided in two doses.
Danish: Denne dosis fordeles på to doser.
English: The dose of this medicine will be carefully adjusted to your individual needs by your doctor.
Danish: Lægen justerer dosis omhyggeligt efter dine individuelle behov.
English: In the blood, 33 to 47% is present in plasma, 4 to 9% in lymphocytes, 5 to 12% in granulocytes, and 41 to 58% in erythrocytes.
Danish: I blodet er der 33-47 % ciclosporin i plasma, 4-9 % i lymfocytter, 512 % i granulocytter og 41-58 % i erytrocytter.
English: Elevations in serum creatinine were observed in the studies using everolimus or sirolimus in combination with full-dose ciclosporin for microemulsion.
Danish: Der er observeret kreatininstigning i studier, hvor der anvendtes everolimus eller sirolimus i kombination med fuld dosis af ciclosporin som mikroemulsion.
English: Imatinib could increase ciclosporin exposure and Cmax by around 20%.
Danish: Imatinib kan øge ciclosporins eksponering og Cmax med omkring 20 %.
English: All available evidence suggests that ciclosporin acts specifically and reversibly on lymphocytes.
Danish: Al foreliggende evidens tyder på, at ciclosporin virker specifikt og reversibelt på lymfocytter.
English: Higher doses of Sandimmun, or the use of Sandimmun intravenous therapy, may be necessary in the presence of gastrointestinal disturbances which might decrease absorption.
Danish: Højere doser af Sandimmun eller brug af Sandimmun intravenøs behandling kan være nødvendig i tilfælde af gastrointestinale forstyrrelser, som kan medføre nedsat absorption.
English: If a significant impairment of renal function occurs, the dosage of the co-administered medicinal product should be reduced or alternative treatment considered.
Danish: Hvis signifikant nedsat nyrefunktion opstår, skal dosis af det samtidigt administrerede lægemiddel reduceres eller alternativ behandling overvejes.
English: In patients in whom within a given time (for specific information see below) no adequate response is achieved or the effective dose is not compatible with the established safety guidelines, treatment with Sandimmun should be discontinued.
Danish: Hos patienter, hvor der inden for en given periode (se nedenfor for specifikke oplysninger) ikke opnås tilstrækkelig respons, eller den effektive dosis ikke er kompatibel med de fastlagte sikkerhedsretningslinjer, skal Sandimmun seponeres.
English: Pharmacotherapeutic group: Immunosuppressive agents, calcineurin inhibitors, ATC code: L04AD01
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, calcineurinhæmmere, ATC-kode: L04AD01
English: • if you need to have a vaccination.
Danish: • hvis du skal vaccineres.
English: If you have any questions about how Sandimmun works or why this medicine has been prescribed for you, ask your doctor.
Danish: Hvis du har spørgsmål til, hvordan Sandimmun virker, eller hvorfor det er ordineret til dig, skal du spørge din læge.
English: Pregnant rats which received 12 mg/kg/day of ciclosporin intravenously (twice the recommended human intravenous dose) had foetuses with an increased incidence of ventricular septal defect.
Danish: Drægtige rotter, som fik intravenøs ciclosporin 12 mg/kg/dag (2 gange anbefalet human intravenøs dosis), havde fostre med øget incidens af ventrikel-septum-defekt.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
English: Sandimmun can be given in combination with low-dose corticosteroids and/or non-steroidal antiinflammatory drugs (NSAIDs) (see section 4.4).
Danish: Sandimmun kan anvendes sammen med en lav dosis af kortikosteroider og/eller non-steroide antiinflammatoriske stoffer (NSAID'er) (se pkt.
English: The oral LD50 of ciclosporin is 2,329 mg/kg in mice, 1,480 mg/kg in rats and > 1,000 mg/kg in rabbits.
Danish: LD50 for oral ciclosporin er 2.329 mg/kg hos mus, 1.480 mg/kg hos rotter og >1.000 mg/kg hos kaniner.
English: Effective pre-emptive and therapeutic strategies should be employed, particularly in patients on multiple long-term immunosuppressive therapy.
Danish: Effektiv forebyggende og terapeutiske tiltag kræves derfor, især hos patienter i langvarig behandling med flere immunsuppressiva.
English: Danazol has been reported to increase ciclosporin blood concentrations by approximately 50%.
Danish: Danazol er blevet rapporteret at øge ciclosporins blodkoncentration med omkring 50 %.
English: If no improvement has been observed after this time to improvement period, Sandimmun therapy should be discontinued.
Danish: Hvis der ikke er observeret bedring efter denne forbedringsperiode, bør Sandimmun seponeres.
English: PHARMACEUTICAL FORM AND CONTENTS Capsule, soft [To be completed nationally]
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Kapsel, blød [Udfyldes nationalt]
English: Like other immunosuppressants, ciclosporin predisposes patients to the development of a variety of bacterial, fungal, parasitic and viral infections, often with opportunistic pathogens.
Danish: Som andre immunsuppressiva prædisponerer ciclosporin patienterne for udvikling af en række bakterie-, svampe-, parasit- og virusinfektioner, ofte med opportunistiske patogener.
English: • Low level of red blood cells, low level of platelets in your blood which could increase the risk of bleeding.
Danish: • Lavt niveau af røde blodlegemer, lavt niveau af blodplader, som kan føre til øget risiko for blødning.
English: It prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue.
Danish: Det forhindrer afstødning af transplanterede organer ved at blokere for udviklingen af visse celler, som normalt angriber transplanteret væv.
English: Ciclosporin appears to block the resting lymphocytes in the G0 or G1 phase of the cell cycle, and inhibits the antigen-triggered release of lymphokines by activated T-cells.
Danish: Ciclosporin blokerer tilsyneladende de hvilende lymfocytter i fase G0 eller G1 i cellecyklussen og hæmmer den antigentriggerede frigivelse af lymfokiner fra aktiverede T-celler.
English: Elderly population (age 65 years and above) In elderly patients, renal function should be monitored with particular care.
Danish: Ældre patienter (65 år og derover) Hos ældre patienter bør nyrefunktionen monitoreres med særlig omhu.
English: Low doses of Sandimmun should be used to treat mild, chronic GVHD.
Danish: Lave doser Sandimmun skal anvendes til behandling af let, kronisk GVHD.
English: Determinations of serum lipids, potassium, magnesium and uric acid are advisable before treatment and periodically during treatment.
Danish: Det anbefales at bestemme serumlipider, kalium, magnesium og urinsyre inden behandling og periodisk under behandlingen.
English: • Kidney problems which may greatly reduce the amount of urine you produce.
Danish: • Nyreproblemer, som kan nedsætte din urinproduktion betydeligt.
English: if you have low levels of magnesium in your body.
Danish: • hvis du har lavt magnesiumniveau i kroppen.
English: If your doctor switches you from one oral formulation of ciclosporin to another After you change from one oral formulation of ciclosporin to another:
Danish: Hvis din læge skifter dig fra en oral lægemiddelform af ciclosporin til en anden Når du skifter fra en oral lægemiddelform af ciclosporin til en anden:
English: In comparison to adult transplant populations, the differences in bioavailability between Sandimmun Neoral and Sandimmun in paediatrics are comparable to those observed in adults.
Danish: Sammenlignet med voksne transplantationspopulationer er forskellen i biotilgængelighed mellem Sandimmun Neoral og Sandimmun hos børn sammenlignelig med det, der blev observeret hos voksne.
English: Treatment should be discontinued in patients in whom sufficient response of psoriatic lesions cannot be achieved within 6 weeks on 5 mg/kg/day, or in whom the effective dose is not compatible with the established safety guidelines (see section 4.4).
Danish: Behandlingen bør seponeres hos patienter med psoriasislæsioner, som ikke viser tilstrækkelig respons inden for 6 uger på 5 mg/kg/dag, eller hvor den effektive dosis ikke er forenelig med de etablerede sikkerhedsretningslinjer (se pkt.