FrancophonIA/ELRC3.0 huggingface dataset:
English: The increase in the bioavailability of diclofenac is most probably caused by a reduction of its high first-pass effect.
Danish: Stigningen i diclofenacs biotilgængelighed skyldes sandsynligvis først og fremmest en reduktion i diclofenacs høje first-pass effekt.
English: Concomitant use of ciclosporin and tacrolimus should be avoided due to the risk for nephrotoxicity and pharmacokinetic interaction via CYP3A4 and/or P-gp (see section 4.4).
Danish: Samtidig brug af ciclosporin og tacrolimus skal undgås pga. risikoen for nefrotoksicitet og farmakokinetisk interaktion via CYP3A4 og/eller P-gp (se pkt.
English: Table 1 Summary of exposure changes of commonly used statins with ciclosporin
Danish: Tabel 1 Resumé af ændring i eksponering for almindeligt anvendte statiner ved administration sammen med ciclosporin
English: Mothers receiving treatment with Sandimmun should not breast-feed because of the potential of Sandimmun to cause serious adverse drug reactions in breast-fed newborns/infants.
Danish: Mødre, som behandles med Sandimmun, bør ikke amme, da Sandimmun potentielt kan forårsage alvorlige bivirkninger hos nyfødte/spædbørn, der ammes.
English: Ciclosporin is extensively metabolised to approximately 15 metabolites.
Danish: Ciclosporin metaboliseres ekstensivt til ca. 15 metabolitter.
English: • Liver problems and damage with or without yellow skin and eyes, nausea, loss of appetite and dark urine.
Danish: • Leverproblemer og -skade med eller uden gul hud og øjne, kvalme, appetitløshed og mørk urin.
English: Ciclosporin doses may need to be increased 3- to 5-fold during co-administration.
Danish: Det kan være nødvendigt at øge ciclosporindosis 3-5 gange ved samtidig administration.
English: 50 ml amber glass bottles with an aluminium cap and rubber stopper.
Danish: 50 ml ravgule glasflasker med aluminiumshætte og gummiprop.
English: These conditions are often related to a high total immunosuppressive burden and should be considered in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Danish: Disse tilstande ses typisk hos patienter, som er svært immunsupprimeret, og bør derfor overvejes differentialdiagnostisk hos immunsuprimerede patienter med samtidig svigtende nyrefunktion eller neurologiske symptomer.
English: Then, take the syringe out of the bottle
Danish: Fjern derefter sprøjten fra flasken.
English: Lymphadenopathy observed on treatment with ciclosporin should be regularly monitored.
Danish: Hvis der observeres lymfadenopati i forbindelse med behandling med ciclosporin, skal den monitoreres regelmæssigt.
English: Usually, higher doses are used before and just after your transplant.
Danish: Der anvendes ofte højere doser inden og umiddelbart efter transplantation.
English: Forced emesis and gastric lavage may be of value within the first few hours after oral intake.
Danish: Fremkaldelse af opkastning og maveskylning kan være en fordel inden for de først par timer efter oral indtagelse.
English: The ethanol content of the Sandimmun formulations should also be taken into account in pregnant women (see section 4.4).
Danish: Indholdet af ethanol i Sandimmun-formuleringer skal også tages med i overvejelserne hos gravide kvinder (se pkt.
English: In rheumatoid arthritis clinical trials with ciclosporin, patients aged 65 or older were more likely to develop systolic hypertension on therapy, and more likely to show serum creatinine rises ≥50% above the baseline after 3 to 4 months of therapy.
Danish: I kliniske studier med ciclosporin til behandling af reumatoid artrit udviklede patienter på 65 år eller derover hyppigere systolisk hypertension på behandlingen og havde hyppigere stigning i serumkreatinin på ≥50 % i forhold til baseline efter 3-4 måneders behandling.
English: Sandimmun prevents rejection of transplanted organs by blocking the development of certain cells which would normally attack the transplanted tissue.
Danish: Sandimmun forhindrer afstødning af transplanterede organer ved at blokere for udviklingen af visse celler, som normalt angriber transplanteret væv.
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: Forholdsregler, der skal tages før håndtering eller administration af lægemidlet For instruktion om fortynding af dette lægemiddel før administration, se pkt.
English: Sandimmun contains around 12% vol. ethanol.
Danish: Sandimmun indeholder 12 % vol. ethanol.
English: Pregnant women receiving immunosuppressive therapies after transplantation, including ciclosporin and ciclosporin-containing regimens, are at risk of premature delivery (<37 weeks).
Danish: Gravide kvinder, der får immunsuppressiv behandling efter transplantation, inklusive ciclosporin og ciclosporinholdige regimer, har øget risiko for præmatur fødsel (< 37. uge).
English: Sandimmun should only be prescribed by, or in close collaboration with, a physician with experience of immunosuppressive therapy and/or organ transplantation.
Danish: Sandimmun bør kun ordineres af en læge eller i tæt samarbejde med en læge, der har erfaring med immunsuppressiv behandling og/eller organtransplantationer.
English: A 500 mg dose of Sandimmun contains 500 mg ethanol, equivalent to nearly 15 ml beer or 5 ml wine.
Danish: Én dosis på 500 mg Sandimmun indeholder 500 mg ethanol, svarende til omtrent 15 ml øl eller 5 ml vin.
English: Pink, oval soft gelatin capsules Corn yellow, oblong soft gelatin capsules Dusty rose, oblong soft gelatin capsules
Danish: Pink, ovale bløde gelatinekapsler Korngul, aflange bløde gelatinekapsler Støvet rød, aflange bløde gelatinekapsler
English: When Sandimmun is used in transplant patients, routine monitoring of ciclosporin blood levels is an important safety measure.
Danish: 4.2) Når transplantationspatienter behandles med Sandimmun, er rutinemæssig monitorering af ciclosporinkoncentrationen en vigtig sikkerhedsforanstaltning.
English: • Low level of red blood cells or platelets.
Danish: • Lavt niveau af røde blodlegemer eller blodplader.
English: Do not take Sandimmun if any of the above applies to you.
Danish: Tag ikke Sandimmun, hvis noget af ovenstående gælder for dig.
English: Your doctor will discuss with you the potential risks of taking Sandimmun during pregnancy.
Danish: Din læge vil drøfte de mulige risici ved at få Sandimmun under graviditet med dig.
English: Sandimmun 25 mg soft capsules Sandimmun 50 mg soft capsules Sandimmun 100 mg soft capsules ciclosporin
Danish: Sandimmun 25 mg bløde kapsler Sandimmun 50 mg bløde kapsler Sandimmun 100 mg bløde kapsler ciclosporin
English: Steroid-dependent and steroid-resistant nephrotic syndrome, due to primary glomerular diseases such as minimal change nephropathy, focal and segmental glomerulosclerosis, or membranous glomerulonephritis.
Danish: Steroidafhængig og steroidresistent nefrotisk syndrom, som skyldes primær glomerulær sygdom, som f.eks. nefropati med minimale ændringer, fokal og segmental glomerulosklerose eller membranøs glomerulonefritis.
English: In 15 renal transplant patients aged 3 -16 years, ciclosporin whole blood clearance after intravenous administration of Sandimmun was 10.6±3.7 ml/min/kg (assay: Cyclo-trac specific RIA).
Danish: Hos 15 nyretransplanterede patienter i alderen 3-16 år var ciclosporins fuldblodsclearance efter intravenøs administration af Sandimmun 10,6±3,7 ml/min/kg (analyse: Cyclo-trac specifik RIA).
English: • your blood lipids (fats).
Danish: • dine blodlipider (fedt i blodet).
English: In patients with nephrotic syndrome treated with immunosuppressants (including ciclosporin), the occurrence of malignancies (including Hodgkin's lymphoma) has occasionally been reported.
Danish: Hos patienter med nefrotisk syndrom, der behandles med immunsuppressiva (herunder ciclosporin), har der i visse tilfælde været rapporteret maligniteter (herunder Hodgkins lymfom).
English: It contains the active substance ciclosporin.
Danish: Den indeholder det aktive stof ciclosporin.
English: Experience with Sandimmun in pregnancy is limited.
Danish: Erfaringerne med Sandimmun under graviditet er begrænsede.
English: Maize oil interesterified
Danish: Majsolie, interesterificeret
English: Additional precautions in endogenous uveitis
Danish: Yderligere forsigtighedsregler ved endogen uveitis
English: If you stop taking Sandimmun
Danish: Hvis du holder op med at tage Sandimmun
English: Each mark on the syringe is 0.1 ml.
Danish: Hver afmærkning på sprøjten svarer til 0,1 ml.
English: • If you have had an organ transplant, bone marrow and stem cell transplantation, the function of Sandimmun is to control your body's immune system.
Danish: • Hvis du har fået en organtransplantation, knoglemarvs- eller stamcelletransplantation fungerer Sandimmun ved at kontrollere kroppens immunsystem.
English: In general, Sandimmun should not be taken during pregnancy.
Danish: Som hovedregel må du ikke tage Sandimmun under graviditet.
English: If any of the above applies to you before or during treatment with Sandimmun, tell your doctor straight away.
Danish: Hvis noget af ovenstående gælder for dig før eller i løbet af din behandling med Sandimmun, skal du øjeblikkeligt fortælle det til lægen.
English: How Sandimmun will be used
Danish: Hvordan Sandimmun vil blive brugt
English: • Changes in your sight, loss of coordination, being clumsy, memory loss, difficulty speaking or understanding what others say, and muscle weakness.
Danish: • Synsændringer, manglende koordinationsevne, klodsethed, hukommelsestab, talebesvær eller manglende forståelse af, hvad andre siger, samt muskelsvaghed.
English: Nephrotic syndrome For inducing remission, the recommended daily dose is given in 2 divided oral doses.
Danish: Nefrotisk syndrom Til fremkaldelse af remission gives den anbefalede dosis i 2 orale doser.
English: Ciclosporin may reduce the clearance of digoxin, colchicine, HMG-CoA reductase inhibitors (statins) and etoposide.
Danish: Ciclosporin kan reducere clearance af digoxin, colchicin, HMG-CoA-reduktasehæmmere (statiner) og etoposid.
English: • Nerve problems with numbness or tingling in fingers and toes.
Danish: • Nerveproblemer med følelsesløshed eller snurrende fornemmelse i fingre og tær.
English: It is a potent immunosuppressive agent, which in animals prolongs survival of allogeneic transplants of skin, heart, kidney, pancreas, bone marrow, small intestine or lung.
Danish: Det er et potent immunsuppressivt stof, som hos dyr øger overlevelsen af allogene transplantationer af hud, hjerte, nyre, pancreas, knoglemarv, tyndtarm og lunge.
English: This is because this medicine contains alcohol (see section below “Sandimmun contains ethanol”).
Danish: Det skyldes, at denne medicin indeholder alkohol (se punktet "Sandimmun indeholder ethanol" nedenfor).
English: Expel any large bubbles by depressing and withdrawing the plunger a few times before removing the syringe containing the prescribed dose from bottle.
Danish: Eventuelle store bobler fjernes ved at skubbe stemplet et par gange frem og tilbage, mens sprøjten med den ordinerede dosis stadig sidder i flasken.
English: Sandimmun oral solution is provided with two syringes for measuring the doses.
Danish: Sandimmun oral opløsning leveres med to sprøjter til at afmåle dosis.
English: Special caution is therefore necessary in patients who have previously received preparations containing polyethoxylated castor oil (e.g. a preparation containing Cremophor® EL) by intravenous injection or infusion, and in patients with an allergic predisposition.
Danish: Særlig forsigtighed er derfor nødvendig hos patienter, der tidligere har fået intravenøse injektionseller infusionspræparater indeholdende polyoxyleret ricinusolie (f.eks. præparater indeholdende Cremophor® EL), samt hos patienter, der er prædisponeret for allergi.
English: It is a clear, yellow to yellow-brownish liquid with a small amount of very fine sediment.
Danish: Det er en klar, gul til gul-brunlig væske med en lille mængde meget fint bundfald.
English: The concomitant use of diclofenac and ciclosporin has been found to result in a significant increase in the bioavailability of diclofenac, with the possible consequence of reversible renal function impairment.
Danish: Samtidig anvendelse af diclofenac og ciclosporin medførte en betydelig stigning i diclofenacs biotilgængelighed, hvilket kan føre til reversibelt nedsat nyrefunktion.
English: In the various indications the overall spectrum of side effects is essentially the same; there are, however, differences in incidence and severity.
Danish: Bivirkningerne er stort set uafhængige af de forskellige indikationer, men med forskellig forekomst og sværhedsgrad.
English: In such cases an initial oral loading dose of 10 to 12.5 mg/kg should be given, followed by daily oral administration of the maintenance dose previously found to be satisfactory.
Danish: I disse tilfælde skal der gives en oral initialdosis på 10-12,5 mg/kg efterfulgt af daglig, oral administration af den vedligeholdelsesdosis, som tidligere var tilfredsstillende.
English: Carefully follow all the instructions given to you by your doctor.
Danish: Følg omhyggeligt alle lægens anvisninger.
English: Like other immunosuppressants, ciclosporin increases the risk of developing lymphomas and other malignancies, particularly those of the skin.
Danish: Som andre immunsuppressiva øger ciclosporin risikoen for udvikling af lymfomer og andre maligniteter, især i huden.
English: It does not matter if there are a few tiny bubbles in the syringe.
Danish: Det gør ikke noget, hvis der stadig er nogle få små luftbobler tilbage.
English: Tear off the sealing ring completely.
Danish: Riv forseglingsringen helt af.
English: If this affects you severely, tell your doctor.
Danish: Hvis dette påvirker dig i alvorlig grad, skal du sige det til din læge.
English: These reactions can consist of flushing of the face and upper thorax, and non-cardiogenic pulmonary oedema, with acute respiratory distress, dyspnoea, wheezing, blood pressure changes and tachycardia.
Danish: Disse reaktioner kan bestå af rødme i ansigt og øvre thorax, samt ikke-hjerterelateret lungeødem med akut respirationsbesvær, dyspnø, hiven efter vejret, ændring i blodtryk og takykardi.
English: Activation of latent polyomavirus infections that may lead to polyomavirus associated nephropathy (PVAN), especially to BK virus nephropathy (BKVN), or to JC virus associated progressive multifocal leukoencephalopathy (PML), have been observed in patients receiving ciclosporin.
Danish: Aktivering af latente polyomavirus-infektioner, som kan medføre polyomavirus-associeret nefropati (PVAN), særligt BK-virusnefropati (BKVN) eller JC-virus-associeret progressiv multifokal leukoencefalopati (PML), er set hos patienter i ciclosporinbehandling.
English: Co-administration with telaprevir resulted in approximately 4.64-fold increase in ciclosporin dose normalised exposure (AUC).
Danish: Samtidig administration med telaprevir resulterede i ca. 4,64 gange stigning i ciclosporins dosisnormaliserede eksponering (AUC).
English: Swallow the capsules whole with water.
Danish: Slug kapslerne hele med et glas vand.
English: Experience with acute overdosage of ciclosporin is limited.
Danish: Der er begrænset erfaring med akut overdosering af ciclosporin.
English: Atopic dermatitis Sandimmun is indicated in patients with severe atopic dermatitis when systemic therapy is required.
Danish: Sandimmun er indiceret til patienter med svær atopisk dermatitis, hvor systemisk behandling er nødvendig.
English: Various agents are known to either increase or decrease plasma or whole blood ciclosporin levels usually by inhibition or induction of enzymes involved in the metabolism of ciclosporin, in particular CYP3A4.
Danish: Det er påvist, at forskellige stoffer enten øger eller mindsker plasma- eller fuldblodskoncentrationen af ciclosporin, normalt ved hæmning eller induktion af enzymer, der indgår i ciclosporins metabolisme, især CYP3A4.
English: • Low level of white blood cells.
Danish: • Lavt niveau af hvide blodlegemer.
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 kontrolmed medicin.
English: If you have been prescribed Sandimmun to treat your psoriasis or atopic dermatitis, you must not be exposed to any UVB-rays or phototherapy during treatment.
Danish: Hvis du har fået ordineret Sandimmun til behandling af psoriasis eller atopisk dermatitis, må du ikke udsættes for UV-B-stråler eller lysbehandling i løbet af behandlingen.
English: If you forget to take Sandimmun
Danish: Hvis du har glemt at tage Sandimmun
English: Special excipients: Ethanol
Danish: Særlige hjælpestoffer: ethanol
English: This depends on your body weight and what you are being given the medicine for.
Danish: Det afhænger af din kropsvægt, og hvad du skal have medicinen for.
English: In view of the potential risk of skin malignancy, patients on Sandimmun, in particular those treated for psoriasis or atopic dermatitis, should be warned to avoid excess unprotected sun exposure and should not receive concomitant ultraviolet B irradiation or PUVA photochemotherapy.
Danish: Da der er en potentiel risiko for hudmalignitet, bør patienter, der behandles med Sandimmun, specielt patienter i behandling for psoriasis eller atopisk dermatitis, advares mod at være for længe i solen uden beskyttelse, og disse patienter bør ikke samtidig modtage behandling med UV-B-bestråling eller PUVA-fotokemoterapi.
English: If you stop taking Sandimmun Do not stop taking Sandimmun unless your doctor tells you to.
Danish: Hvis du holder op med at tage Sandimmun Hold ikke op med at tage Sandimmun, medmindre din læge siger det.
English: A significantly increased exposure to anthracycline antibiotics (e.g. doxorubicine, mitoxanthrone, daunorubicine) was observed in oncology patients with the intravenous co-administration of anthracycline antibiotics and very high doses of ciclosporin.
Danish: Der sås en signifikant øget eksponering af antracyklin-antibiotika (f.eks. doxorubicin, mitoxanthron, daunorubicin) hos kræftpatienter ved samtidig intravenøs administration af antracyklin-antibiotika og meget høje doser ciclosporin.
English: When concurrently administered with ciclosporin, the dosage of the statins should be reduced and concomitant use of certain statins should be avoided according to their label recommendations.
Danish: Når statiner administreres samtidig med ciclosporin, skal statin-dosis reduceres, og samtidig brug af visse statiner skal undgås i overensstemmelse med produktinformationen.
English: Octreotide decreases oral absorption of ciclosporin and a 50% increase in the ciclosporin dose or a switch to intravenous administration could be necessary.
Danish: Octreotid nedsætter absorptionen af ciclosporin efter oral administration, og det kan være nødvendigt at øge ciclosporindosis med 50% eller skifte til intravenøs administration.
English: After use, wipe the syringe on the outside only with a dry tissue and replace it in its cover.
Danish: Efter brug tørres sprøjten på ydersiden med en tør klud og lægges tilbage i hylsteret.
English: The medicine will be diluted before use with saline or 5% glucose and then given to you by slow infusion.
Danish: Medicinen vil blive fortyndet før brug med natriumchloridinfusionsvæske eller 5 % glucoseinfusionsvæske, hvorefter du får den som en langsom infusion.
English: Amiodarone substantially increases the plasma ciclosporin concentration concurrently with an increase in serum creatinine.
Danish: Amiodaron øger ciclosporins plasmakoncentration væsentligt samtidig med en stigning i serumkreatinin.
English: Sandimmun soft capsules contain 12.8% v/v ethanol (10.2% m/v).
Danish: Sandimmun bløde kapsler indeholder 12,8% v/v ethanol (10,2% m/v).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Ciclosporin [To be completed nationally]
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Ciclosporin [Udfyldes nationalt]
English: Before and during treatment with Sandimmun, tell your doctor straight away:
Danish: Inden og i løbet af behandlingen med Sandimmun skal du øjeblikkeligt fortælle det til din læge:
English: Carcinogenicity studies were carried out in male and female rats and mice.
Danish: Der blev udført karcinogenicitetsstudier på han- og hunrotter og -mus.
English: Following concomitant administration of ciclosporin and lercanidipine, the AUC of lercanidipine was increased three-fold and the AUC of ciclosporin was increased 21%.
Danish: Efter samtidig administration af ciclosporin og lercanidipin var lercanidipins AUC øget 3 gange, og ciclosporins AUC var øget 21 %.
English: It is used by your doctor or nurse to prepare a solution which will be given to you by slow intravenous infusion.
Danish: Ud fra koncentratet fremstiller din læge eller sundhedspersonalet en infusionsvæske, som du vil få langsomt intravenøst.
English: The 1-ml syringe is used to measure doses less than or equal to 1 ml (each graduation of 0.05 ml corresponds to 5 mg of ciclosporin).
Danish: 1 ml-sprøjten anvendes til at afmåle doser på 1 ml eller mindre (hver inddeling på 0,05 ml svarer til 5 mg ciclosporin).
English: Co-administration of ciclosporin significantly increases blood levels of everolimus and sirolimus.
Danish: Samtidig administration af ciclosporin øgede signifikant plasmakoncentrationerne af everolimus og sirolimus.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse
English: In some patients, it may be difficult to detect Sandimmun-induced renal dysfunction because of changes in renal function related to the nephrotic syndrome itself.
Danish: Hos visse patienter kan det være svært at opdage nedsat nyrefunktion forårsaget af Sandimmun, da det nefrotiske syndrom i sig selv kan forårsage ændringer i nyrefunktionen.
English: Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Bivirkninger Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: LIST OF EXCIPIENTS Contains ethanol (see leaflet for further information).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder ethanol (se indlægsseddel for yderligere information).
English: Sandimmun 50 mg/ml concentrate for solution for infusion contains around 34% v/v ethanol (27.8% m/v ethanol).
Danish: Sandimmun 50 mg/ml koncentrat til infusionsvæske indeholder ca. 34% v/v ethanol (27,8% m/v ethanol).
English: The concomitant intake of grapefruit and grapefruit juice has been reported to increase the bioavailability of ciclosporin.
Danish: Interaktion med fødevarer Samtidig indtagelse af grapefrugt og grapejuice er vist at øge ciclosporins biotilgængelighed.
English: Draw up the prescribed volume of solution (position the lower part of the plunger ring in front of the graduation corresponding to the prescribed volume).
Danish: Træk den ordinerede dosis opløsning op (placer den nederste del af stempelringen ud for den inddeling, der svarer til den ordinerede dosis).
English: With the exception of patients being treated for nephrotic syndrome, patients with impaired renal function should not receive ciclosporin (see subsection on additional precautions in nontransplantation indications in section 4.4).
Danish: Bortset fra patienter, der behandles for nefrotisk syndrom, bør patienter med nedsat nyrefunktion ikke få ciclosporin (se underpunktet om yderligere forsigtighedsregler ved andre indikationer end transplantation i pkt.
English: The 4-ml syringe is used to measure doses greater than 1 ml and up to 4 ml (each graduation of 0.1 ml corresponds to 10 mg of ciclosporin).
Danish: 4 mlsprøjten anvendes til at afmåle doser større end 1 ml og op til 4 ml (hver inddeling på 0,1 ml svarer til 10 mg ciclosporin).
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 til hos gravide og ammende kvinder, hos patienter med leversygdomme og epilepsi samt hos børn.