FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will usually reduce your <Invented name> dose once your condition has stabilised.
Danish: Lægen vil sædvanligvis reducere <[(Sær)navn]> dosis når din tilstand er stabiliseret.
English: 114 rue Victor Hugo 92300 Levallois Perret France
Danish: 114 rue Victor Hugo 92300 Levallois Perret Frankrig
English: There is a risk for premature delivery (<37 week) as well as for hyperkalaemia in the newborn, which, however, normalizes spontaneously.
Danish: Der er risiko for præmatur fødsel (<37 uger) såvel som hyperkalæmi hos den nyfødte, hvilket dog normaliseres spontant.
English: Metabolism and biotransformation
Danish: Metabolisme og biotransformation
English: The other metabolites have only weak or no immunosuppressive activity.
Danish: De andre metabolitter har kun svag eller ingen immunsuppressiv effekt.
English: If you have forgotten to take your <Invented name> capsules, wait until it is time for the next dose, and then continue as before.
Danish: Hvis De har glemt at tage en dosis <[(Sær)navn]> kapsler, skal De vente til det er tid for næste dosis og fortsætte som tidligere.
English: Like all medicines, <Invented name> can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan <[(Sær)navn]> have bivirkninger, selvom ikke alle får bivirkninger.
English: You will receive <Invented name> as a continuous 24-hour infusion and never as a short injection.
Danish: De vil få <[(Sær)navn]> som en kontinuert 24 timers infusion , aldrig som en kort injektion.
English: Data on cardiac transplantation in children are sparse due to the low number of transplantations performed each year.
Danish: Oplysningerne om hjertetransplantation hos børn er sparsomme på grund af det lave årlige antal transplantationer.
English: toxic epidermal necrolysis (Lyell's syndrome)
Danish: toksisk epidermal nekrolyse (Lyell's syndrom)
English: Middlesex TW18 3AZ United Kingdom
Danish: Middlesex, TW18 3AZ Det Forenede Kongerige
English: The consequences of long-term immunosuppression, infections and tumour formation, are likely to increase with time, but this issue was not addressed.
Danish: Følgerne af langvarig immunosuppression - infektioner og tumordannelse - vil formodentlig forstærkes med tiden, men dette spørgsmål er ikke behandlet.
English: A strong correlation exists between AUC and whole blood trough levels at steady-state.
Danish: Der er god korrelation mellem AUC og fuldblodskoncentrationerne ved steady-state.
English: This is quite normal and will help your doctor to decide on the most appropriate dose of <Invented name> for you.
Danish: Dette er helt normalt og hjælper din læge med at finde den bedst mulige dosering af <[(Sær)navn]> til dig.
English: <Invented name> may cause mild irritation if it is not infused directly into a vein.
Danish: <[(Sær)navn]> kan forårsage mild irritaion hvis det ikke infunderes direkte i en vene.
English: Adverse drug reactions are listed below in descending order by frequency of occurrence: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000, including isolated reports).
Danish: Bivirkningerne nedenfor er grupperede efter faldende hyppighed: Meget almindelige (> 1/10), almindelige (>1/100 , <1/10), usædvanlige (>1/1000, <1/100), sjældne (>1/10.000, <1/1000), meget sjældne (<1/10.000 inkl.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt den {MM/ÅÅÅÅ}
English: The ISHLT's annual report therefore adds important information to the use of heart transplantation in children.
Danish: ISHLT's årsberetning føjer derfor et værdifuldt bidrag til vor viden om brug af hjertetransplantation hos børn.
English: But in a scenario where re-transplantation or death is a likely outcome a more liberal attitude toward the indication is in place.
Danish: I et scenario, hvor den sandsynlige udgang er retransplantation eller patientens død, er en mere liberal holdning over denne indikation imidlertid på sin plads.
English: Treatment with <Invented name> should not continue for more than 7 days.
Danish: Behandlingen en <[(Sær)navn]> bør ikke fortsætte i længere end 7 dage.
English: During treatment, careful monitoring with EBV-PCR is recommended.
Danish: Under behandlingen anbefales hyppig kontrol med EBV-PCR.
English: <Invented name> is taken orally twice daily, usually in the morning and evening.
Danish: <[(Sær)navn]> tages 2 gange om dagen, sædvanligvis morgen og aften.
English: Both generalised and localised infections can occur.
Danish: Systemiske såvel som lokale infektioner kan forekomme.
English: Capsules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption (see section 5.2).
Danish: Kapslerne bør som en regel tages på fastende mave eller mindst 1 time før eller 2 til 3 timer efter et måltid for at opnå maksimal absorption (se afsnit 5.2).
English: An alternative strategy was published where oral tacrolimus was administered within 12 hours post transplantation.
Danish: En alternativ strategi er publiceret hvor oral tacrolimus givet indenfor 12 timer efter transplantationen.
English: Pharmacotherapeutic group: Macrolide immunosuppressant, ATC code: L04A A05
Danish: Farmakoterapeutisk klassifikation: Macrolid immunosuppressant, ATC-kode: L04A A05
English: The long-term safety profile of tacrolimus has not been systematically studied.
Danish: Sikkerheden af langtidsbehandling med tacrolimus er ikke systematisk undersøgt.
English: Limited knowledge of interactions between tacrolimus and statins is available.
Danish: Der er begrænset erfaring med interaktioner mellem tacrolimus og statiner.
English: Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Danish: Måling af fuldblodskoncentrationer giver derfor et godt skøn over den systemiske eksponering.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY (IES) OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET FREMLAGT AF EMEA
English: Based on these data the efficacy of tacrolimus appears to be well established.
Danish: På grundlag af disse oplysninger synes virkningen af tacrolimus at være velunderbygget.
English: This approach was reserved for patients without organ dysfunction (e.g. renal dysfunction).
Danish: Denne fremgangsmåde blev anvendt til patienter uden organsvigt (f.eks. nyresvigt).
English: Capsules should be taken immediately following removal from the blister.
Danish: Kapslerne skal tages umiddelbart efter de er fjernet fra blisterkortet.
English: As shown in both the published data and the ISHLT's annual report tacrolimus can substitute ciclosporin as primary immunosuppression therapy.
Danish: Som påvist i både de offentliggjorte beretninger og i ISHLT's årsberetning, kan tacrolimus erstatte cyklosporin som primær immunosuppressiv behandling.
English: Following your organ transplant (e.g. liver, kidney, heart), your body's immune system will try to reject the new organ.
Danish: Efter din organtransplantation (f.eks. lever, nyre, hjerte), vil kroppens immunsystem forsøge at afstøde det nye organ.
English: United Kingdom Astellas Pharma Ltd. Lovett House, Lovett Road Staines
Danish: Astellas Pharma Ltd. Lovett House, Lovett Road Staines
English: Due to the fact that the original product Prograf and associated names does not have the same Summary of Product Characteristics (SPC) in the various Member States in the European Union and due to divergent national decisions, a harmonisation of the SPC for Prograf and associated names, throughout Europe became necessary.
Danish: Da der på grund af forskellige nationale beslutninger ikke gælder samme produktresumé (SPC) for det originale produkt Prograf og tilknyttede navne i de forskellige medlemsstater i Den Europæiske Union, har det været nødvendigt at gennemføre en harmonisering af produktresuméet for Prograf og tilknyttede navne i hele Europa.
English: • the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
Danish: • formålet med indbringelsen var at harmonisere produktresuméet,
English: Several amendments to various sections of the SPC were introduced.
Danish: Der er foretaget en række ændringer i forskellige afsnit af produktresuméet.
English: Many of the adverse drug reactions stated below are reversible and/or respond to dose reduction.
Danish: Nogle af de nedennævnte bivirkninger er reversible og/eller responderer på reduktion af doseringen.
English: Hypersensitivity to tacrolimus or other macrolides.
Danish: Kendt overfølsomhed overfor tacrolimus eller andre macrolider.
English: In general, paediatric patients require doses 1½ - 2 times higher than the adult doses to achieve similar blood levels.
Danish: Generelt behøver børn en dosering, der er 1½ - 2 gange højere end doseringen for voksne for at opnå samme blodkoncentrationer.
English: In some patients, tacrolimus appears to be continuously absorbed over a prolonged period yielding a relatively flat absorption profile.
Danish: I nogle patienter synes tacrolimus dog at blive kontinuerligt absorberet over en længere periode, således at man får en relativ flad absorptionsprofil.
English: Due to the need of treatment, tacrolimus can be considered in pregnant women when there is no safer alternative and when the perceived benefit justifies the potential risk to the foetus.
Danish: På grund af behandlingsbehovet kan tacrolimus overvejes til gravide kvinder, når der ikke findes andre sikre alternativer, og de opnåede fordele opvejer den potentielle risiko for fosteret.
English: In general, dosing may commence orally; if necessary, by administering the capsule contents suspended in water, via nasogastric tubing.
Danish: Sædvanligvis kan doseringen begynde oralt; om nødvendigt ved at administrere indholdet af kapsler suspenderet i vand via nasogastrisk sonde.
English: Inconsistencies between section 4.6 (Pregnancy and lactation) and section 5.3 (Preclinical safety data) have been corrected and more information has been included on male fertility.
Danish: Uoverensstemmelserne mellem afsnit 4.6 (Graviditet og amning) og 5.3 (Prækliniske sikkerhedsdata) er rettet, og der er indføjet mere information om mandlig fertilitet.
English: Do not swallow the desiccant contained in the foil wrapper.
Danish: Slug ikke tørremidlet som findes ind i folien.
English: [Method of administration to be completed nationally] Read the package leaflet before use.
Danish: [Administrationsmetode udfyldes nationalt] Læs indlægssedlen inden brug.
English: <Invented name> can be administered intravenously or orally.
Danish: <[(Sær)navn]> kan administreres intravenøst eller oralt.
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Danish: Som ved andre potente immunosuppressive midler er risikoen for sekundær cancer ukendt (se afsnit
English: Astellas Pharma S.A Paseo del Club Deportivo n°1, Bloque 14
Danish: Paseo del Club Deportivo n° 1, Bloque 14
English: If overdosage occurs, general supportive measures and symptomatic treatment should be conducted.
Danish: I tilfælde af overdosering må man benytte almene understøttende midler og symptomatisk behandling.
English: Do not use <Invented name> after the expiry date which is stated on the carton after {abbreviation used for expiry date [To be completed nationally]}.
Danish: Anvend ikke efter udløbsdatoen, som er angivet på æsken efter {forkortelse for udløb [Udfyldes nationalt]}.
English: Only anecdotal descriptions of isolated patients or small numbers of patients in differing organ transplant indications were provided.
Danish: Kun anekdotiske beskrivelser af enkeltpatienter eller få patienter ved forskellige transplantationsindikationer er blevet forelagt.
English: Severe effects have been reported, including allergic and anaphylactic reactions.
Danish: Der er set alvorlige bivirkninger inklusive allergiske og anafylaktiske reaktioner.
English: Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Danish: Positiv EBV-PCR kan vedvare i måneder og er ikke som sådan en indikation på lymfoproliferativ lidelse eller lymfom.
English: Very young (< 2 years), EBV-VCA-negative children have been reported to have an increased risk of developing lymphoproliferative disorders.
Danish: Der er rapporteret at små (< 2 år) EBV-VCA-negative børn har en øget risiko for at udvikle lymfoproliferative lidelser.
English: Astellas Farma Limitada Edifício Cinema Rua José Fontana, n° 1, 1° andar 2770-101 Paço de Arcos Portugal
Danish: Astellas Farma Limitida Edifício Cinema Rua José Fontana, n°1, 1° andar 2770-101 Paço de Arcos Portugal
English: The mean oral bioavailability of tarolimus is in the range of 20% - 25%.
Danish: Den perorale middelbiotilgængelighed ligger mellem 20% - 25%.
English: Only one of these has been shown in vitro to have immunosuppressive activity similar to that of tacrolimus.
Danish: Kun en af disse er vist in vitro at have immunsuppressiv aktivitet som tacrolimus.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: De bør konsultere din læge eller apotek, hvis De er usikker.
English: Tacrolimus may prolong the QT interval but at this time lacks substantial evidence for causing Torsades de Pointes.
Danish: Tacrolimus kan forlænge QT intervallet men der mangler væsentligt bevis for at det forårsager Torsades de Pointes.
English: Limited data from organ transplant recipients show no evidence of an increased risk of adverse effects on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Danish: Begrænsede data fra organtransplantations recipienter viser ikke tegn på en øget risiko for skadelige effekter på forløb og resultat af graviditet under tacrolimusbehandling i sammenligning med andre immunosuppressive midler.
English: Caution should be exercised in patients with diagnosed or suspected Congenital Long QT Syndrome.
Danish: Der skal udvises forsigtighed hos patienter med konstanteret eller mistanke om medfødt langt QT syndrom.
English: To suppress graft rejection, immunosuppression must be maintained; consequently, no limit to the duration of oral therapy can be given.
Danish: For at undertrykke transplantatafstødning skal immunosuppression vedligeholdes, man kan derfor ikke angive nogen tidsbegrænsning for den orale behandling.
English: Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective.
Danish: Immunosuppressorer kan påvirke respons på vaccinationer, der under behandling med tacrolimus kan vise sig mindre effektive.
English: Carbamazepine, metamizole and isoniazid have the potential to decrease tacrolimus concentrations.
Danish: Carbamazepin, metamizol og isoniazid kan potentielt nedsætte tacrolimus koncentrationen.
English: <Invented name> therapy requires careful monitoring by adequately qualified and equipped personnel.
Danish: Behandling med <[(Sær)navn]> kræver omhyggelig monitorering af et velkvalificeret og specielt uddannet personale.
English: The incidences of acute rejection were numerically lower with tacrolimus in all three studies and one of the studies reported a significantly lower incidence of bronchiolitis obliterans syndrome with tacrolimus.
Danish: Incidensen af akut afstødning var numerisk lavere med tacrolimus i alle 3 studier og et af studierne rapporterede signifikant lavere incidens af oblitererende bronchiolitis syndrom med tacrolimus.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PROGRAF / PROGRAFT HARD CAPSULES AND CONCENTRATE FOR INFUSION
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF PROGRAF/PROGRAFT I FORM AF HÅRDE KAPSLER OG KONCENTRAT TIL INFUSIONSVÆSKE
English: Concomitant use of these substances may require decreased tacrolimus doses in nearly all patients.
Danish: Samtidig brug af disse lægemidler nødvendiggør nedsættelse af doseringen af tacrolimus i næsten alle patienter.
English: The concentrate should be used for intravenous infusion only after it is diluted with suitable carrier media (see section 6.6).
Danish: Koncentratet må kun benyttes til intravenøs infusion efter fortynding med passende infusionsvæske (se afsnit 6.6).
English: In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids.
Danish: I dette tilfælde er en initial oral tacrolimusdosis på 2-4 mg/dag givet sammen med mycophenolat mofetil og kortikosteroider eller sammen med sirolimus og kortikosteroider.
English: Available data suggests that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
Danish: Tilgængelige data tyder på at statinernes farmakokinetik stort set er uændret ved samtidig administration af tacrolimus.
English: Therefore, metabolites do not contribute to pharmacological activity of tacrolimus.
Danish: Derfor bidrager metabolitter ikke til tacrolimus farmakologiske effekt.
English: As an aid to optimise dosing, several immunoassays are available for determining tacrolimus concentrations in whole blood including a semi-automated microparticle enzyme immunoassay (MEIA).
Danish: Som en hjælp til at optimere doseringen findes der adskillige immunoassays til bestemmelse af fuldblodskoncentrationen af tacrolimus, blandt andet et semi-automatiseret mikropartikel enzym immunoassay (MEIA).
English: In plasma, tacrolimus is highly bound (> 98.8%) to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Danish: I plasma er tacrolimus stærkt bundet (>98,8%) til plasmaprotein, hovedsagelig til serumalbumin og surt alfa-1-glykoprotein.
English: Regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Danish: Lægen har brug for jævnlige blodprøver for et fastlægge den rigtige dosering og for løbende at justere dosis.
English: Tacrolimus is extensively distributed in the body.
Danish: Tacrolimus er ekstensivt fordelt i kroppen.
English: In addition, findings on clinical pharmacology were introduced in the sections on special warnings and precautions for use (4.4), interaction with other medicinal products and other forms of interaction (4.5) and the section on pharmacokinetic properties (5.2).
Danish: Endvidere er de klinisk-farmakologiske resultater indføjet i afsnittene Særlige advarsler og forsigtighedsregler vedrørende brugen (4.4), Interaktion med andre lægemidler og andre former for interaktion (4.5) samt Farmakokinetiske egenskaber (5.2).
English: <Invented name> belongs to a group of medicines called immunosuppressants.
Danish: <[(Sær)navn]> tilhører en gruppe lægemidler kaldet immunosuppressanter.
English: Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments.
Danish: Tacrolimus er et meget potent immunosuppressivt middel, der har vist aktivitet i både in vitro og in vivo undersøgelser.
English: You may also be given <Invented name> for an ongoing rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation.
Danish: De kan også få ordineret <[(Sær)navn]> ved en igangværende afstødning af den transplanterede lever, nyre, hjerte eller andet organ eller hvis din tidligere behandling ikke kunne kontrollere immunreaktionen efter din transplanation.
English: Heart transplantation in paediatric patients:
Danish: Hjertetransplantation hos pædiatriske patienter:
English: The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Danish: Nyrer og pankreas var de primære organer, der blev påvirket i toksicitetsstudier på rotter og bavianer.
English: Bile flow does not influence the absorption of <Invented name>.
Danish: Galdeflow påvirker ikke absorption af <[(Sær)navn]>.
English: If signs of toxicity are noted (e.g. pronounced adverse reactions - see section 4.8) the dose of <Invented name> may need to be reduced.
Danish: Hvis man ser tegn på toksicitet (f.eks. udtalte bivirkninger se afsnit 4.8) kan det være nødvendigt at reducere doseringen af <[(Sær)navn]>.
English: In case of in utero exposure, monitoring of the newborn for the potential adverse effects of tacrolimus is recommended (in particular the effects on the kidneys).
Danish: I tilfælde af eksponering i uterus anbefales overvågning af den nyfødte for tacrolimus bivirkninger ( især for effekter på nyrerne).
English: Take special care with <Invented name> - You will need to take <Invented name> every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Danish: Vær særlig forsigtig med at anvende <[(Sær)navn]>: - Det er nødvendigt, at De tager <[(Sær)navn]> hver dag så længe De har brug for immunosuppresion for at forhindre afstødning af det transplanterede organ.
English: Dose reduction may be necessary in patients with severe liver impairment in order to maintain the blood trough levels within the recommended target range.
Danish: Dosisreduktion kan være nødvendig ved patienter med svær nedsat leverfunktion for at holde blodkoncentrationerne indenfor de anbefalede grænser.
English: In rats, tacrolimus caused toxic effects to the nervous system and the eyes.
Danish: Hos rotter forårsagede tacrolimus toksiske virkninger på nervesystem og øjne.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, Labelling and Package Leaflet are set out in Annex III of the CHMP Opinion for Prograf and associated names (see Annex I).
Danish: anbefaler CHMP ændring af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III til CHMP's udtalelse om Prograf og de tilknyttede navne (se bilag I).
English: Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised.
Danish: Administrationen bør begynde inden 5 dage efter operationen så snart patienten er stabil.
English: In current clinical practice, whole blood levels are monitored using immunoassay methods.
Danish: I nuværende klinisk praksis måles fuldblodskoncentrationer med immunoassay metoder.
English: Meteor Office Centre Park Sokolovská 100/94
Danish: Astellas Pharma s.r.o Meteor Office Centre Park Sokolovská 100/94
English: Increased clearance rates contribute to the shorter half-life observed in transplant recipients.
Danish: Øget clearance medfører kortere halveringstid hos transplanterede patienter.
English: Read all of this leaflet carefully before you start taking this medicine.
Danish: Læs hele denne indlægsseddel omhyggeligt, inden De begynder at tage dette lægemiddel.
English: The recommended initial dosages presented below are intended to act solely as a guideline.
Danish: Begyndelsesdoseringen angivet nedenfor er kun vejledende.
English: echocardiogram abnormal
Danish: unormalt ekkokardiogram
English: Rejection therapy - adults and children
Danish: Behandling af afstødning - voksne og børn
English: This effect may be enhanced if <Invented name> is administered in association with alcohol.
Danish: Denne effekt kan forøges, hvis <[(Sær)navn]> er administreret sammen med alkohol.
English: Tacrolimus is extensively bound to plasma proteins.
Danish: Tacrolimus bindes kraftigt til plasmaproteiner.
English: Injury, poisoning and procedural complications common:
Danish: Skader, forgiftninger og komplikationer ved medicinske procedurer Almindelige:
English: - If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide antibiotics.
Danish: - Hvis De er allergisk (overfølsom) overfor ethvert antibiotikum tilhørende makrolidgruppen.
English: Embryofoetal toxicity was observed in rats and rabbits and was limited to doses that caused significant toxicity in maternal animals.
Danish: Embryoføtal toksicitet sås hos rotter og kaniner og var begrænset til doser, som forårsagede signifikant toksicitet hos moderdyrene.