FrancophonIA/ELRC3.0 huggingface dataset:
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 gradvist reduceres, og behandlingen seponeres 1 år efter transplantationen.
English: Usually, higher doses are used before and just after your transplant.
Danish: Der anvendes ofte højere doser inden og umiddelbart efter transplantationen.
English: Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, see section 6.6.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet For instruktioner om fortynding af lægemidlet før administration, se pkt.
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 Neoral 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 Neoral seponeres.
English: Sandimmun Neoral 100 mg/ml oral solution ciclosporin
Danish: Sandimmun Neoral 100 mg/ml, oral opløsning ciclosporin
English: Ciclosporin trough concentrations in whole blood should be monitored initially within 4 to 7 days after the switch to Sandimmun Neoral.
Danish: Dal-koncentrationen af ciclosporin i fuldblod skal initialt monitoreres inden for 4-7 dage efter skiftet til Sandimmun Neoral.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS BLISTER
English: • Following your transfer from Sandimmun to Sandimmun Neoral, your doctor will monitor you more closely for a short time.
Danish: • Efter du er skiftet fra Sandimmun til Sandimmun Neoral vil din læge overvåge dig grundigere i en kort periode.
English: Patients with malignant or pre-malignant alterations of the skin should be treated with Sandimmun Neoral 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 Neoral efter passende behandling af disse læsioner, og kun hvis der ikke er andre muligheder for vellykket behandling.
English: Sandimmun Neoral 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 Neoral 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: More frequent checks are necessary when the Sandimmun Neoral dose is increased, or concomitant treatment with an NSAID is initiated or its dosage increased.
Danish: Der kræves hyppigere kontroller, når Sandimmun Neoral-dosis øges, eller hvis der samtidig iværksættes behandling med et NSAID, eller hvis dosis heraf øges.
English: Never lower your dose yourself, unless a doctor has told you to.
Danish: Sænk aldrig selv din dosis, medmindre lægen har bedt dig om det.
English: The combination of Sandimmun Neoral with low doses of oral corticosteroids is recommended if the effect of Sandimmun Neoral alone is not satisfactory, especially in steroid-resistant patients.
Danish: Kombinationen af Sandimmun Neoral med lave, orale doser kortikosteroid anbefales, hvis virkningen af Sandimmun Neoral alene ikke er tilstrækkelig, særligt hos steroidresistente patienter.
English: The formulation of Sandimmun Neoral is a microemulsion preconcentrate.
Danish: Formuleringen af Sandimmun Neoral er et mikroemulsion-prækoncentrat.
English: 4.5), should be avoided.
Danish: og bør derfor undgås.
English: When a blister is opened, a characteristic smell is noticeable.
Danish: Når en blister åbnes, vil en karakteristisk lugt være mærkbar.
English: • High level of uric acid or patassium in your blood, low levels of magnesium in your blood.
Danish: • Højt niveau af urinsyre eller kalium i blodet, lavt niveau af magnesium i blodet.
English: Some side effects could be serious 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: No data exist on the effects of Sandimmun Neoral on the ability to drive and use machines.
Danish: Der foreligger ingen data for Sandimmun Neorals virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: When Sandimmun Neoral 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 Neoral 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: 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 plasma-ciclosporin for transplantationspatienter.
English: Sandimmun Neoral contains approximately 12.0 vol. % ethanol (alcohol), which corresponds to up to 500 mg per dose used in transplant patients.
Danish: Sandimmun Neoral indeholder ca. 12,0 vol. % ethanol (alkohol), hvilket svarer til op til 500 mg pr. dosis, der anvendes til transplantationspatienter.
English: If you are taking Sandimmun Neoral 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 Neoral efter en transplantation, vil det kun blive ordineret til dig af en læge med erfaring inden for transplantation og/eller autoimmune sygdomme.
English: Your dose may need to be lowered.
Danish: Din dosis skal muligvis sænkes.
English: This means that the levels of ciclosporin in your blood stay more constant with Sandimmun Neoral than with Sandimmun.
Danish: Dette betyder, at mængden af ciclosporin i blodet forbliver mere konstant med Sandimmun Neoral end med Sandimmun.
English: To achieve full effectiveness, up to 12 weeks of Sandimmun Neoral therapy may be required.
Danish: For at opnå fuld terapeutisk effekt kan det være nødvendigt at behandle med Sandimmun Neoral i op til 12 uger.
English: Your doctor will discuss with you the potential risks of taking Sandimmun Neoral during pregnancy.
Danish: Din læge vil drøfte de mulige risici ved at tage Sandimmun Neoral under graviditet med dig.
English: If blood pressure significantly exceed the pre-switch levels or if eGFR decreases by more than 25% below the value measured prior to Sandimmun therapy at more than one measurement, the dose should be reduced (see also ‘Additional precautions' in section 4.4).
Danish: Hvis blodtrykket væsentligt overstiger niveauet inden skiftet, eller hvis e-GFR nedsættes mere end 25 % i forhold til den målte værdi inden Sandimmun-behandlingen ved mere end én måling, skal dosis reduceres (se også Yderligere forsigtighedsregler i pkt.
English: • if you have an infection which is not under control with medication.
Danish: • hvis du har en infektion, som ikke er under kontrol med medicin.
English: If you get high blood pressure during treatment and it cannot be controlled, Sandimmun Neoral should be stopped by your doctor.
Danish: Hvis du får for højt blodtryk i løbet af behandlingen, og det ikke kan kontrolleres, skal behandlingen med Sandimmun Neoral standses af din læge.
English: If you have any questions about how Sandimmun Neoral works or why this medicine has been prescribed for you, ask your doctor.
Danish: Hvis du har spørgsmål til, hvordan Sandimmun Neoral virker, eller hvorfor det er ordineret til dig, skal du spørge din læge.
English: Since Sandimmun Neoral 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: Stopping your treatment with Sandimmun Neoral may increase the risk of your transplanted organ being rejected.
Danish: Hvis du stopper behandlingen med Sandimmun Neoral, kan det øge risikoen for, at det transplanterede organ afstødes.
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 afen række bakterie-, svampe-, parasit- og virusinfektioner, ofte med opportunistiske patogener.
English: Sandimmun Neoral suppresses your immune system.
Danish: Sandimmun Neoral undertrykker dit immunsystem.
English: Sandimmun Neoral capsules should be left in the blister pack until required for use.
Danish: Sandimmun Neoral kapsler skal opbevares i blisterpakningen indtil brug.
English: In the event of unexpected toxicity or inefficacy of ciclosporin, blood trough levels should also be monitored.
Danish: I tilfælde af uventet toksicitet eller manglende virkning af ciclosporin, skal dal-koncentrationen også monitoreres.
English: {Name of the Member State} {Name of the medicinal product}
Danish: {Medlemslandets navn} {Lægemidlets navn} {Medlemslandets navn} {Lægemidlets navn}
English: This may be harmful in alcoholic patients and should be taken into account in pregnant or breast-feeding women, in patients presenting with liver disease or epilepsy, or if the patients is a child.
Danish: Dette kan være skadeligt for alkoholikere, og der skal tages hensyn hertil hos gravide og ammende kvinder, hos patienter med leversygdomme og epilepsi samt hos børn.
English: If you have questions about how long to take Sandimmun Neoral, talk to your doctor or your pharmacist.
Danish: Hvis du har spørgsmål om, hvor længe du skal tage Sandimmun Neoral, skal du tale med din læge eller apoteket.
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: If the ciclosporin trough blood levels are beyond the therapeutic range, and/or worsening of the clinical safety parameters occurs, the dosage must be adjusted accordingly.
Danish: Hvis dal-koncentrationen af ciclosporin ligger under det terapeutiske område, og/eller hvis der ses en forværring i de kliniske sikkerhedsparametre, skal dosis justeres i relation hertil.
English: It provides a more consistent absorption profile with less influence from concomitant food intake or from diurnal rhythm than Sandimmun.
Danish: Det giver en mere ensartet absorptionsprofil med mindre inflydelse fra samtidig fødeintagelse eller døgnrytme sammenlignet med Sandimmun.
English: Higher doses of Sandimmun Neoral, 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 Neoral eller brug af Sandimmun intravenøs behandling kan være nødvendig i tilfælde af gastrointestinale forstyrrelser, som kan medføre nedsat absorption.
English: Close monitoring of parameters that assess hepatic function is required and abnormal values may necessitate dose reduction (see sections 4.2 and 5.2).
Danish: Tæt monitorering af parametre til vurdering af leverfunktionen, er nødvendig, og unormale værdier kan nødvendiggøre dosisreduktion (se pkt.
English: Sandimmun Neoral contains around 12% vol. ethanol.
Danish: Sandimmun Neoral indeholder 12 % vol. ethanol.
English: Sandimmun Neoral capsules may be stored at room temperature not exceeding 25°C.
Danish: Sandimmun Neoral kapsler må ikke opbevares ved temperaturer over 25°C.
English: • Sandimmun Neoral is a different, improved formulation of ciclosporin compared to Sandimmun.
Danish: • Sandimmun Neoral er en forbedret formulering af ciclosporin sammenlignet med Sandimmun.
English: If no improvement has been observed after this time to improvement period, Sandimmun Neoral therapy should be discontinued.
Danish: Hvis der ikke er observeret bedring efter denne forbedringsperiode, bør Sandimmun Neoral seponeres.
English: Sandimmun Neoral can be given in combination with low-dose corticosteroids and/or non-steroidal anti-inflammatory drugs (NSAIDs) (see section 4.4).
Danish: Sandimmun Neoral kan anvendes sammen med en lav dosis af kortikosteroider og/eller non-steroide antiinflammatoriske stoffer (NSAID'er) (se pkt.
English: In addition if you are taking Sandimmun Neoral for a non-transplant disease (intermediary or posterior uveitis and Behçet's uveitis, atopic dermatitis, severe rheumatoid arthritis or nephrotic syndrome), do not take Sandimmun Neoral:
Danish: Hvis du tager Sandimmun Neoral for andet end en transplantation (intermediær eller posterior uveitis og Behçets uveitis, atopisk dermatitis, svær leddegigt eller nefrotisk syndrom), må du desuden ikke tage Sandimmun Neoral:
English: Sandimmun Neoral is indicated in patients with severe atopic dermatitis when systemic therapy is required.
Danish: Sandimmun Neoral er indiceret til patienter med svær atopisk dermatitis, hvor systemisk behandling er nødvendig.
English: The excretion is primarily biliary, with only 6% of the oral dose excreted in the urine; only 0.1% is excreted in the urine as unchanged parent compound.
Danish: Elimination er hovedsageligt biliær; kun 6 % af den orale dosis udskilles med urinen; kun 0,1 % udskilles uomdannet.
English: Ciclosporin is absorbed into your blood better with Sandimmun Neoral and absorption is less likely to be affected by taking the medicine with food.
Danish: Ciclosporin optages bedre i blodet fra Sandimmun Neoral, og det er mindre sandsynligt, at absorptionen bliver påvirket, når medicinen tages sammen med mad.
English: The relationship between administered dose and exposure (AUC) of ciclosporin is linear within the therapeutic dose range.
Danish: Forholdet mellem administreret dosis og eksponering (AUC) for ciclosporin er lineært i det terapeutiske område.
English: • if you have high blood pressure (hypertension) which is not under control with medication.
Danish: • hvis du har for højt blodtryk (hypertension), som ikke er under kontrol med medicin.
English: Renal biopsy should be considered for patients with steroid-dependent minimalchange nephropathy, in whom Sandimmun Neoral 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 Neoral i over 1 år.
English: If you take more Sandimmun Neoral than you should If you accidentally take too much of your medicine, tell your doctor immediately or go to your nearest hospital emergency unit.
Danish: Hvis du har taget for meget Sandimmun Neoral 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: Skin lesions not typical for psoriasis, but suspected to be malignant or pre-malignant should be biopsied before Sandimmun Neoral 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 Neoral påbegyndes.
English: This explains why, in rare cases, Sandimmun Neoral-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 Neoral, uden at serumkreatininniveauet er steget.
English: If a starting dose of 2.5 mg/kg/day does not achieve a satisfactory response within 2 weeks, the daily dose may be rapidly increased to a maximum of 5 mg/kg.
Danish: Hvis en initialdosis på 2,5 mg/kg/dag ikke giver et tilfredsstillende resultat inden for 2 uger, kan dagsdosis hurtigt øges til højst 5 mg/kg.
English: Monitoring during your treatment with Sandimmun Neoral Your doctor will check:
Danish: Overvågning under behandling med Sandimmun Neoral Din læge vil undersøge:
English: Do not take Sandimmun Neoral: - if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Sandimmun Neoral: - hvis du er allergisk over for ciclosporin eller et af de øvrige indholdsstoffer i Sandimmun Neoral (angivet ipunkt 6).
English: Your doctor will tell you how long you need to take Sandimmun Neoral for.
Danish: Din læge vil fortælle dig, hvor længe du skal tage Sandimmun Neoral.
English: • If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Sandimmun Neoral is to control your body's immune system.
Danish: • Hvis du har fået en organtransplantation, knoglemarvs- eller stamcelletransplantation fungerer Sandimmun Neoral ved at kontrollere kroppens immunsystem.
English: The elimination half-life in kidney-transplanted patients was approximately 11 hours, with a range between 4 and 25 hours.
Danish: Elimineringshalveringstiden hos nyretransplanterede patienter var ca. 11 timer med et interval på 4 til 25 timer.
English: Skin infections with Staphylococcus aureus are not an absolute contraindication for Sandimmun Neoral therapy, but should be controlled with appropriate antibacterial agents.
Danish: Hudinfektioner med Staphylococcus aureus er ingen absolut kontraindikation for behandling med Sandimmun Neoral, men bør kontrolleres med passende antibakterielle midler.
English: Atorvastatin 10-80 mg Simvastatin
Danish: Atorvastatin 10-80 mg Simvastatin 10-80 mg Fluvastatin 20-80 mg Lovastatin
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: Yderligere forsigtighedsregler ved reumatoid artrit 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: Treatment of Behçet uveitis with repeated inflammatory attacks involving the retina in patients without neurological manifestations.
Danish: Behandling af Bechets uveitis med gentagne inflammatoriske episoder, der involverer retina, hos patienter uden neurologiske manifestationer.
English: If the eGFR decrease from baseline exceeds 35%, further reduction of the dose of Sandimmun Neoral should be considered.
Danish: Hvis e-GFR nedsættes mere end 35 % af baseline-niveau, skal yderligere reduktion af Sandimmun Neoral dosis overvejes.
English: Low doses of Sandimmun Neoral should be used to treat mild, chronic GVHD.
Danish: Lave doser Sandimmun Neoral skal anvendes til behandling af let, kronisk GVHD.
English: Do not take Sandimmun Neoral if any of the above applies to you.
Danish: Tag ikke Sandimmun Neoral, hvis noget af ovenstående gælder for dig.
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: Sandimmun Neoral oral solution is provided with two syringes for measuring the doses.
Danish: Sandimmun Neoral oral opløsning leveres med to sprøjter til at afmåle dosis.
English: The name of your medicine is Sandimmun Neoral.
Danish: Navnet på din medicin, er Sandimmun Neoral.
English: If dose reduction is not successful in improving eGFR within one month, Sandimmun Neoral treatment should be discontinued (see section 4.4).
Danish: Hvis dosisreduktion ikke er tilstrækkeligt til at forbedre e-GFR inden for en måned, skal behandlingen med Sandimmun Neural stoppes (se pkt.
English: Push the medicine out of the syringe into a small glass containing liquid, preferably orange or apple juice.
Danish: Tryk derefter medicinen ud af sprøjten og ned i et lille glas med væske, gerne appelsin- eller æblejuice.
English: Ciclosporin increases the exposure to HMG-CoA reductase inhibitors (statins).
Danish: Ciclosporin øger eksponeringen for HMG-CoA-reduktasehæmmere (statiner).
English: If the syringe is to be cleaned, do not rinse it but wipe the outside with a dry tissue (see section 6.6).
Danish: Hvis sprøjten skal rengøres, må den ikke skylles, men aftørres udvendigt med en tør klud (se pkt.
English: In addition, the absorption of ciclosporin from Sandimmun Neoral is less variable and the correlation between ciclosporin trough concentrations and exposure (in terms of AUC) is stronger than with Sandimmun.
Danish: Derudover er absorptionen af ciclosporin fra Sandimmun Neoral mindre varierende, og korrelationen mellem dalkoncentration og eksponering for ciclosporin (i forhold til AUC) er bedre end med Sandimmun.
English: Each mark on the syringe is 0.05 ml.
Danish: Hver afmærkning på sprøjten svarer til 0,05 ml.
English: Since Sandimmun Neoral 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 Neoral inducerer en lille reversibel stigning i blodlipider, anbefales det, at lipiderne måles før behandlingen og efter den første måneds behandling.
English: Active herpes simplex infections should be allowed to clear before treatment with Sandimmun Neoral 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 Neoral iværksættes, men behandlingen skal ikke nødvendigvis ophøre, hvis infektionerne opstår under behandlingen, medmindre der er tale om svære infektioner.
English: Elderly population (age 65 years and above) Experience with Sandimmun Neoral in the elderly is limited.
Danish: Ældre patienter (65 år og derover) Erfaring med Sandimmun Neoral hos ældre patienter er begrænset.
English: Sandimmun Neoral administration improves dose linearity in ciclosporin exposure (AUCB).
Danish: Administration af Sandimmun Neoral forbedrer dosislineariteten for ciclosporineksponering (AUCB).
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: 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 nyreinsufficient op til en alder på 35 uger.