FrancophonIA/ELRC3.0 huggingface dataset:
English: Most reports included patients with significant co-morbidities, underlying conditions and other confounding factors including infectious complications and co-medications with hepatotoxic potential.
Danish: De fleste tilfælde omhandlede patienter med signifikante co-morbiditeter, underliggende sygdomme og andre medvirkende faktorer inklusive infektiøse komplikationer og samtidig administration af medicin med hepatotoksisk potentiale.
English: Such diseases include eye problems which threaten your vision (endogenous uveitis, including Behçet's uveitis), severe cases of certain skin diseases (atopic dermatitis, or eczema and psoriasis), severe rheumatoid arthritis and a kidney disease called nephrotic syndrome.
Danish: Sådanne sygdomme omfatter øjenproblemer, som truer synet (endogen uveitis, herunder Behçets uveitis), svære tilfælde af visse hudsygdomme (atopisk dermatitis (eksem) og psoriasis), svær leddegigt og en nyresygdom, der kaldes nefrotisk syndrom.
English: • The 1 ml syringe is used to measure doses of 1 ml or smaller.
Danish: • 1 ml-sprøjten bruges til at opmåle doser på 1 ml eller mindre.
English: The signs include pale skin, feeling tired, being breathless, having dark urine (this is a sign of the breakdown of red blood cells), bruising or bleeding with no obvious reasons, feeling confused, feeling disorientated, being less alert and having kidney problems.
Danish: Tegnene omfatter bleg hud, træthedsfølelse, åndenød, mørk urin (dette er et tegn på nedbrydning af røde blodlegemer), blå mærker eller blødning uden åbenlys årsag, forvirring, desorientering, nedsat opmærksomhed og nyreproblemer.
English: In the 24-month rat study conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate at the low dose level.
Danish: I rottestudiet, som varede 24 måneder og undersøgte doser på 0,5, 2 og 8 mg/kg/dag, oversteg øcelleadenomer i pancreas betydeligt kontrolhyppigheden ved den lave dosis.
English: It may be stored at room temperature not exceeding 30°C.
Danish: Opbevares ved temperaturer under 30°C.
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: 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 dosis hurtigt øges, men bør ikke overstige 5 mg/kg/dag.
English: Once satisfactory response is achieved, the dose should be reduced gradually and, if possible, Sandimmun should be discontinued.
Danish: Når der er opnået tilfredsstillende respons, bør dosis gradvis reduceres og Sandimmun om muligt seponeres.
English: Fertility There is limited data on the effect of Sandimmun human fertility (see section 5.3).
Danish: Fertilitet Data for effekten af Sandimmun på human fertilitet er begrænsede (se pkt.
English: Verapamil increases ciclosporin blood concentrations 2- to 3-fold.
Danish: Verapamil øger ciclosporins plasmakoncentration 2-3 gange.
English: In addition if you are taking Sandimmun 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:
Danish: Hvis du tager Sandimmun 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:
English: Preference should be given to an antihypertensive agent that does not interfere with the pharmacokinetics of ciclosporin, e.g. isradipine (see section 4.5).
Danish: Der bør anvendes antihypertensiva, som ikke interfererer med ciclosporins farmakokinetik, f.eks. isradipin (se pkt.
English: An approximate 2- to 3-fold increase in ciclosporin exposure may be observed in patients with hepatic impairment.
Danish: En cirka 2-3 gange stigning i ciclosporins eksponering kan ses hos patienter med leverinsufficiens.
English: • Gum tissue overgrowing and covering your teeth.
Danish: • Vækst af tandkød, der kan dække dine tænder.
English: If Sandimmun is used to initiate therapy, the recommended daily dose is 12.5 to 15 mg/kg given in 2 divided doses, starting on the day before transplantation.
Danish: Hvis Sandimmun bruges som initialbehandling, er den anbefalede orale daglig dosis 12,5-15 mg/kg fordelt på 2 doser med start på dagen inden transplantation.
English: There is limited experience with Sandimmun in elderly patients.
Danish: Der er begrænset erfaring med Sandimmun hos ældre patienter.
English: When to take Sandimmun Take Sandimmun at the same time every day.
Danish: Tag Sandimmun på samme tidspunkt hver dag.
English: Cases reporting chronic morphological changes included arteriolar hyalinosis, tubular atrophy and interstitial fibrosis (see section 4.4).
Danish: Rapporterede kroniske, morfologiske ændringer inkluderede arteriolær hyalinose, tubulær atrofi og interstitiel fibrose (se pkt.
English: Sandimmun oral solution contains 12.6% v/v ethanol (10.0% m/v ethanol).
Danish: Sandimmun oral opløsning indeholder 12,6 % v/v ethanol (10,0 % m/v ethanol).
English: Sandimmun concentrate for solution for infusion contains approximately 34.4 v/v ethanol (alcohol).
Danish: Sandimmun koncentrat til infusionsvæske indeholder ca. 34,4 v/v ethanol (alkohol).
English: For the first 6 weeks of treatment the recommended dose is 3 mg/kg/day orally given in 2 divided doses.
Danish: I de første 6 uger af behandlingen er den anbefalede dosis 3 mg/kg/dag oralt fordelt på 2 doser.
English: For maintenance treatment, doses have to be titrated individually to the lowest effective level, and should not exceed 5 mg/kg/day.
Danish: Ved vedligeholdelsesbehandling titreres dosis individuelt til det laveste effektive niveau, og dosis bør ikke overstige 5 mg/kg/dag.
English: Patients receiving immunosuppressive therapies, including ciclosporin and ciclosporin-containing regimens, are at increased risk of infections (viral, bacterial, fungal, parasitic) (see section 4.4).
Danish: Patienter, der får immunsuppressiv behandling, inklusive ciclosporin og ciclosporinholdige regimer, har øget risiko for infektioner (virus-, bakterie-, svampe- og parasitinfektioner) (se pkt.
English: A 100 mg dose of Sandimmun contains 556 mg ethanol.
Danish: En dosis Sandimmun på 100 mg indeholder 556 mg ethanol.
English: Do not use Sandimmun: - if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6; also see section “Sandimmun contains castor oil and ethanol”).
Danish: Få ikke Sandimmun: - hvis du er allergisk over for ciclosporin eller et af de øvrige indholdsstoffer i Sandimmun (angivet i punkt 6, se også afsnittet nedenfor “Sandimmun indeholder polyoxyleret ricinusolie og ethanol”).
English: Do not take Sandimmun: - if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Sandimmun: - hvis du er allergisk over for ciclosporin eller et af de øvrige indholdsstoffer i Sandimmun (angivet ipunkt 6).
English: • Migraine or severe headache often with feeling and being sick (nausea, vomiting) and being sensitive to light.
Danish: • Migræne eller kraftig hovedpine, ofte med kvalme og opkastning og lysfølsomhed.
English: • Excessive hair growth.
Danish: • Unormalt kraftig hårvækst.
English: • Serious liver problems both with and without yellowing of the eyes or skin, nausea (feeling sick), loss of appetite, dark coloured urine, swelling of the face, feet, hands and/or the whole body.
Danish: • Alvorlige leverproblemer både med og uden gule øjne og hud, kvalme, appetitmangel, mørk urin, hævelse i ansigt, fødder, hænder og/eller hele kroppen.
English: Metabolism mainly takes place in the liver via cytochrome P450 3A4 (CYP3A4), and the main pathways of metabolism consist of mono- and dihydroxylation and N-demethylation at various positions of the molecule.
Danish: Metabolismen foregår hovedsageligt i leveren via CYP3A4, og de primære metaboliseringsveje er mono- og dihydroxylering og Ndemethylering af forskellige positioner i molekylet.
English: The concentrate is a clear brown/yellow oily liquid.
Danish: Koncentratet er en klar, brun/gul, olieagtig opløsning.
English: Ciclosporin is not dialysable to any great extent, nor is it well cleared by charcoal haemoperfusion.
Danish: Ciclosporin er kun dialyserbart i lille udstrækning og udskilles ikke ved hæmoperfusion med aktivt kul.
English: In patients with kidney problems, the first dose taken each day should not be more than 2.5 mg per kilogram body weight.
Danish: Hos patienter med nyreproblemer må den første dosis, der tages hver dag, ikke være på mere end 2,5 mg pr. kilogram kropsvægt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml oral solution contains 100 mg ciclosporin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml oral opløsning indeholder 100 mg ciclosporin.
English: Co-administration of ciclosporin and aliskiren is not recommended (see section 4.3).
Danish: Samtidig administration af ciclosporin og aliskiren anbefales ikke (se pkt.
English: The principal adverse reactions observed in clinical trials and associated with the administration of ciclosporin include renal dysfunction, tremor, hirsutism, hypertension, diarrhoea, anorexia, nausea and vomiting.
Danish: De væsentligste bivirkninger, som er observeret i kliniske studier og er forbundet med administrationen af ciclosporin, omfatter renal dysfunktion, tremor, hirsutisme, hypertension, diaré, appetitmangel, kvalme og opkastning.
English: Concomitant administration of dabigatran extexilate is not recommended due to the P-gp inhibitory activity of ciclosporin (see section 4.3).
Danish: Samtidig administration af dabigatranetexilat anbefales ikke pga. ciclosporins hæmning af P-gp (se pkt.
English: The oral solution should not be refrigerated.
Danish: Den orale opløsning må ikke opbevares i køleskab.
English: Sandimmun treatment should be initiated by physicians with experience in the diagnosis and treatment of psoriasis.
Danish: Opstart af Sandimmun behandling skal foretages af en læge med erfaring i at diagnosticere og behandle psoriasis.
English: Oral erythromycin, which is known to have the potential to increase the blood concentration of ciclosporin (see section 4.5), should be avoided.
Danish: Oral erythromycin er kendt for potentielt at øge ciclosporins plasmakoncentrationen (se pkt.
English: • Brain problems with signs such as seizures, confusion, feeling disorientated, being less responsive, personality changes, feeling agitated, sleeplessness, changes to your sight, blindness, coma, paralysis of part or all of the body, stiff neck, loss of coordination with or without unusual speech or eye movements.
Danish: • Hjerneproblemer med tegn som fx krampeanfald, forvirring, desorientering, nedsat opmærksomhed, personlighedsændringer, uro, søvnløshed, synsændringer, blindhed, koma, lammelse af dele af eller hele kroppen, nakkestivhed, manglende koordinering med eller uden usædvanlig tale eller usædvanlige øjenbevægelser.
English: Studies suggest that ciclosporin inhibits the development of cell-mediated reactions, including allograft immunity, delayed cutaneous hypersensitivity, experimental allergic encephalomyelitis, Freund's adjuvant arthritis, graft-versushost disease (GVHD), and also T-cell dependent antibody production.
Danish: Studier viser, at ciclosporin hæmmer udviklingen af cellemedierede reaktioner, inklusive allograft immunitet, forsinket kutan overfølsomhed, eksperimentel allergisk encefalomyelitis, Freunds adjuvansartritis, graft-versus-hostsygdom (GVHD) og produktion af T-celleafhængige antistoffer.
English: Patients receiving calcineurin inhibitor (CNI) therapies, including ciclosporin and ciclosporincontaining regimens, are at increased risk of acute or chronic nephrotoxicity.
Danish: Patienter, der får behandling med calcineurinhæmmere (CNI), herunder ciclosporin og ciclosporinindeholdende behandling, har øget risiko for akut og kronisk nefrotoksicitet.
English: The white stopper and tube should remain in the bottle.
Danish: Den hvide prop og slangen skal blive siddende i flasken.
English: Ciclosporin undergoes minimal renal elimination and its pharmacokinetics are not extensively affected by renal impairment (see section 5.2).
Danish: Ciclosporin udskilles kun minimalt renalt, og dets farmakokinetik påvirkes ikke i udstrakt grad af nyreinsufficiens (se pkt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally]
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER [Udfyldes nationalt]
English: Ciclosporin is extensively metabolised by the liver.
Danish: Ciclosporin metaboliseres i stor udstrækning i leveren.
English: Haemolytic uraemic syndrome, microangiopathic haemolytic anaemia
Danish: Hæmolytisk uræmisk syndrom, mikroangiopatisk hæmolytisk anæmi
English: Co-administration of ciclosporin with bosentan is not recommended (see above subsection “Drugs that decrease ciclosporin levels” and section 4.3).
Danish: Samtidig administration af ciclosporin med bosentan anbefales ikke (se ovenstående afsnit ” Lægemidler, som mindsker ciclosporinkoncentrationen”, og pkt.
English: • Your doctor will adjust your dose to one that is ideal for you.
Danish: • Lægen vil justere din dosis, så den passer til dig.
English: Elderly patients should be treated only in the presence of disabling psoriasis, and renal function should be monitored with particular care.
Danish: Ældre bør kun behandles, hvis de har invaliderende psoriasis, og deres nyrefunktion bør overvåges særligt grundigt.
English: Endogenous uveitis
Danish: Endogen uveitis
English: Additional precautions in rheumatoid arthritis
Danish: Yderligere forsigtighedsregler ved reumatoid artrit
English: • High level of uric acid or potassium 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: Keep taking Sandimmun for as long as your doctor tells you.
Danish: Fortsæt med at tage Sandimmun, så længe din læge siger, at du skal gøre det.
English: For maintenance treatment the dose has to be titrated individually to the lowest effective level according to tolerability.
Danish: Ved vedligeholdelsesbehandling titreres dosis individuelt til det laveste effektive niveau afhængig af tolerabiliteten.
English: There is only limited experience with the use of Sandimmun in children with endogenous uveitis.
Danish: Der er kun begrænset erfaring med brug af Sandimmun hos børn med endogen uveitis.
English: Driving and using machines Sandimmun contains alcohol.
Danish: Trafik- og arbejdssikkerhed Sandimmun indeholder alkohol.
English: There is only limited experience with the use of Sandimmun in children with psoriasis.
Danish: Der er kun begrænset erfaring med brug af Sandimmun hos børn med psoriasis.
English: This is because ciclosporin, the active substance, passes into breast milk.
Danish: Dette skyldes, at det aktive stof ciclosporin udskilles i mælken.
English: An aqueous solution of adrenaline 1:1000 and a source of oxygen should be available by the bedside.
Danish: Adrenalininjektionsvæske 1 mg/ml og en form for ilt skal være tilgængeligt ved sengen.
English: After use, wipe the syringe on the outside only with a dry tissue.
Danish: Efter brug aftørres sprøjten på ydersiden med en tør klud.
English: Co-administration of bosentan and ciclosporin in healthy volunteers increases the bosentan exposure several-fold and there was a 35% decrease in ciclosporin exposure.
Danish: Samtidig administration af bosentan og ciclosporin hos raske frivillige øger eksponeringen af bosentan flere gange, og der var et 35 % fald i ciclosporins eksponering.
English: Elderly patients should be treated only in the presence of disabling atopic dermatitis and renal function should be monitored with particular care.
Danish: Ældre bør kun behandles i tilfælde af invaliderende atopisk dermatitis, og nyrefunktionen bør overvåges særligt grundigt.
English: The elimination half-life in kidney-transplanted patients was approximately 11 hours, with a range between 4 and 25 hours.
Danish: Eliminationshalveringstiden hos nyretransplanterede patienter var ca. 11 timer med et interval på 4 til 25 timer.
English: Sandimmun may also cause dose-dependent, reversible increases in serum bilirubin and in liver enzymes (see section 4.8).
Danish: Sandimmun kan også forårsage dosisrelaterede, reversible stigninger i serumbilirubin og i leverenzymer (se pkt.
English: This is used to treat tumours, severe psoriasis and severe rheumatoid arthritis.
Danish: Dette anvendes til behandling af svulster, svær psoriasis og svær leddegigt.
English: Choose the syringe depending on how much medicine you need to measure: - For 1 ml or less of medicine, use the 1 ml syringe.
Danish: Opmåling af din dosis Vælg sprøjten i forhold til den dosis medicin, du skal opmåle: - Til 1 ml eller mindre skal 1 ml-sprøjten anvendes.
English: These include medicines which contain potassium, potassium supplements, water tablets (diuretics) called potassium-sparing diuretics, and some medicines which lower your blood pressure.
Danish: Det omfatter medicin, som indeholder kalium, kaliumtilskud, vanddrivende medicin (diuretika), som kaldes kaliumbesparende diuretika, og visse lægemidler, som sænker blodtrykket.
English: Sandimmun 50 mg/ml concentrate for solution for infusion ciclosporin
Danish: Sandimmun 50 mg/ml koncentrat til infusionsvæske, opløsning ciclosporin
English: A treatment regimen containing multiple immunosuppressants (including ciclosporin) should therefore be used with caution as this could lead to lymphoproliferative disorders and solid organ tumours, some with reported fatalities.
Danish: Derfor bør der udvises forsigtighed ved polyterapi med flere immunsuppressiva (herunder ciclosporin), da dette kan medføre lymfoproliferative sygdomme og solide tumorer i organer, som i visse tilfælde har vist sig at være dødelige.
English: Once mixed it should be taken immediately after preparation.
Danish: Det er vigtigt, at medicinen tages umiddelbart efter tilberedningen.
English: Polyethoxylated castor oil: 650 mg/ml.
Danish: Ricinusolie, polyoxyleret: 650 mg/ml.
English: Organ, bone marrow and stem cell transplantation The total dose each day is usually between 2 mg and 15 mg per kilogram body weight.
Danish: Organ-, knoglemarvs eller stamcelletransplantation Den totale daglige dosis er sædvanligvis mellem 2 mg og 15 mg pr. kilogram kropsvægt.
English: • High level of lipids in your blood.
Danish: • Højt niveau af lipider i blodet.
English: • The 4 ml syringe is used to measure doses bigger than 1 ml and up to 4 ml.
Danish: • 4 ml-sprøjten bruges til at opmåle dosis på mere end 1 ml og op til 4 ml.
English: • Destruction of red blood cells, involving kidney problems with symptoms such as swelling of the face, stomach, hands and/or feet, decreased urination, breathing difficulty, chest pain, fits,
Danish: • Ødelæggelse af røde blodlegemer, der giver nyreproblemer med symptomer som fx hævelse af ansigt, mave, hænder og/eller fødder, mindre vandladning, vejrtrækningsbesvær, brystsmerter,
English: Elderly population (65 years of age and older) There is limited experience with Sandimmun in elderly patients.
Danish: Ældre patienter (65 år og derover) Erfaring med Sandimmun hos ældre patienter er begrænset.
English: If there is no improvement after 1 month, the daily dose may be gradually increased, but should not exceed 5 mg/kg.
Danish: Hvis der ikke er sket en forbedring efter 1 måned, kan dosis gradvist øges, men bør ikke overstige 5 mg/kg/dag.
English: Transplantation indications
Danish: Transplantationsindikationer
English: Renal dysfunction (see section 4.4) Reproductive system and breast disorders Rare
Danish: 4.4) Det reproduktive system og mammae Sjælden
English: INFORMATION IN BRAILLE [To be completed nationally]
Danish: INFORMATION I BRAILLESKRIFT [Udfyldes nationalt]
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous administration
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Intravenøs anvendelse
English: - with products containing dabigatran etexilate (used to avoid blood clots after surgery) or bosentan and aliskiren (used to reduce high blood pressure).
Danish: - sammen med produkter, der indeholder dabigatranetexilat (bruges til at undgå blodpropper efter operation) eller bosentan og aliskiren (bruges til behandling af højt blodtryk).
English: In the event of increased lipids being found, restriction of dietary fat and, if appropriate, a dose reduction, should be considered.
Danish: Hvis der konstateres et forhøjet lipidniveau, bør det overvejes at reducere fedtindholdet i kosten og eventuelt reducere dosis.
English: The ethanol content of the Sandimmun formulations should also be taken into account in women who are breast-feeding (see section 4.4).
Danish: Indholdet af ethanol i Sandimmun-formuleringer skal også tages med i overvejelserne hos ammende kvinder (se pkt.
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt]
English: In most cases, Sandimmun concentrate for solution for infusion is preferred for this purpose.
Danish: Generelt foretrækkes intravenøs infusion af Sandimmun koncentrat til infusionsvæske i denne forbindelse.
English: Remove the black stopper and throw it away.
Danish: Fjern og kasser den sorte prop.
English: Monitoring ciclosporin levels (see section 4.2)
Danish: Monitorering af ciclosporinkoncentrationen (se pkt.
English: In the 78-week mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value.
Danish: I musestudiet, som varede 78 uger, påvistes en statistisk signifikant tendens til lymfocytiske lymfomer hos hunmus ved en dosis på 1, 4 og 16 mg/kg/dag og en betydeligt højere forekomst af hepatocellulære karcinomer hos hanmus, der fik middeldosis, sammenlignet med kontrolværdien.
English: Patients with renal impairment
Danish: Patienter med nyreinsufficiens
English: If the concentrate for solution for infusion is used, careful consideration should be given to administering an adequate intravenous dose that corresponds to the oral dose.
Danish: Hvis Sandimmun koncentrat til infusionsvæske bruges, skal forsigtighed udvises, således at der administreres en passende intravenøs dosis svarende til den orale dosis.
English: Push the tube unit with the white stopper firmly into the neck of the bottle.
Danish: Pres slangen med den hvide prop godt ned i flaskehalsen.
English: Doses available Fold change in exposure with ciclosporin
Danish: Gange ændring i eksponering med ciclosporin
English: - Leave the white stopper and tube in the bottle.
Danish: - Lad den hvide prop og røret blive siddende i flasken.
English: The recommended dose range is 2.5 to 5 mg/kg/day given in 2 divided oral doses.
Danish: Den anbefalede dosis er 2,5-5 mg/kg/dag fordelt på 2 orale doser.
English: Sandimmun treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Danish: Opstart af Sandimmun behandling skal foretages af en læge med erfaring i at diagnosticere og behandle atopisk dermatitis.
English: Concomitant use of ciclosporin and tacrolimus should be avoided (see section 4.5).
Danish: Samtidig brug af ciclosporin og tacrolimus skal undgås (se pkt.
English: - if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for ciclosporin eller et af de øvrige indholdsstoffer i Sandimmun (angivet ipunkt 6).
English: Bone marrow transplantation Prevention of graft rejection following allogeneic bone marrow and stem cell transplantation.
Danish: Knoglemarvstransplantation Forebyggelse af graftafstødning efter allogen knoglemarvs- og stamcelletransplantation.