FrancophonIA/ELRC3.0 huggingface dataset:
English: Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine.
Danish: Sørg for at De får den samme tacrolimusmedicin hver gang, De henter Deres medicin, medmindre Deres transplantationslæge har godkendt at skifte til en anden tacrolimusmedicin.
English: Advagraf therapy requires careful monitoring by adequately qualified and equipped personnel.
Danish: Behandling med Advagraf kræver omhyggelig monitorering af velkvalificeret og specielt uddannet personale.
English: If you need to have any vaccinations, please tell your doctor before.
Danish: Hvis De har brug for at blive vaccineret, så fortæl Deres læge det på forhånd.
English: Printing ink (Opacode S-1-15083): Shellac
Danish: Printblæk (Opakode S-1-15083): Shellac
English: Your doctor will usually reduce your Advagraf dose once your condition has stabilised.
Danish: Lægen vil sædvanligvis reducere Advagraf-dosis når Deres tilstand er stabiliseret.
English: pancreatic pseudocyst, subileus
Danish: pseudocyster i pancreas, subileus
English: Advagraf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Danish: Advagraf administreres rutinemæssigt sammen med andre immunsuppressive stoffer i den initiale, postoperative periode.
English: No studies on the effects of tacrolimus (Advagraf) on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af tacrolimus' (Advagraf) virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: The oral bioavailability of Advagraf was reduced when it was administered after a meal.
Danish: Den orale biotilgængelighed af Advagraf var reduceret, hvis det blev indgivet efter et måltid.
English: Administration should commence approximately 12-18 hours after the completion of surgery.
Danish: Administrationen bør indledes cirka 12 - 18 timer efter afslutningen af indgrebet.
English: These may worsen kidney or nervous system problems when taken together with Advagraf.
Danish: Disse kan forværre problemer med nyrerne eller centralnervesystemet, hvis de tages sammen med Advagraf.
English: Pain in extremity has been described in a number of published case reports as part of CalcineurinInhibitor Induced Pain Syndrome (CIPS).
Danish: Smerte i ekstremiteterne er blevet beskrevet i en række offentliggjorte casestudier som del af Calcineurin-Inhibitor Induced Pain Syndrome (CIPS).
English: This medicine should only be prescribed to you by a doctor with experience in the treatment of transplant patients.
Danish: Denne medicin bør kun udskrives til Dem af en speciallæge med erfaring i behandling af transplanterede patienter.
English: Do not take a double dose the next morning.
Danish: De må ikke tage en dobbeltdosis den næste morgen.
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 undersøgelser, og en af undersøgelserne rapporterede signifikant lavere incidens af oblitererende bronchiolitis-syndrom med tacrolimus.
English: Not known (frequency cannot be estimated from the available data): - Abnormality of the optic nerve (optic neuropathy)
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data): - Forandring i synsnerven (optisk neuropati)
English: Diarrhoea, nausea
Danish: diarré, kvalme
English: Your doctor may need to adjust your dose of Advagraf.
Danish: Deres læge skal måske justere Deres Advagrafdosis.
English: Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
Danish: Efter oral og efter intravenøs administration af 14C-mærket tacrolimus blev størstedelen af radioaktiviteten elimineret i fæces.
English: In patients who are hypersensitive to peanut or soya, the risk and severity of hypersensitivity should be weighed against the benefit of using Advagraf.
Danish: Hos patienter, som er overfølsomme over for jordnødder eller soja, skal risikoen og overfølsomhedens sværhedsgrad opvejes i forhold til fordelen ved at anvende Advagraf.
English: Astellas Ireland Co., Ltd. Killorglin, County Kerry Ireland
Danish: Astellas Irland Co., Ltd. Killorglin, County Kerry Irland
English: After opening the aluminium wrapper: 1 year
Danish: 3 år Efter åbning af aluminiumfolie: 1 år
English: Tubing, syringes and other equipment used to prepare a suspension of Advagraf capsule contents must not contain PVC.
Danish: Slanger, sprøjter og andet udstyr, som anvendes til at fremstille en suspension af Advagraf kapsler, må ikke indeholde PVC.
English: Effect on hepatic clearance is less pronounced.
Danish: Effekten på clearance for leveren er mindre tydelig.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler
English: A strong correlation exists between AUC and whole blood trough levels at steady-state for Advagraf.
Danish: Der er god korrelation mellem AUC og fuldblodskoncentrationerne ved steady state for Advagraf.
English: Advagraf is a prolonged-release formulation of tacrolimus resulting in an extended oral absorption profile with an average time to maximum blood concentration (Cmax) of approximately 2 hours (tmax).
Danish: Advagraf er en formulering med forlænget frigivelse af tacrolimus, hvilket medfører en forlænget oral absorptionsprofil med en gennemsnitstid til maksimal blodkoncentration (Cmax) på ca. 2 timer (tmax).
English: Most cases have been reversible, occurring with tacrolimus blood trough concentrations much higher than the recommended maximum levels.
Danish: De fleste tilfælde har været reversible og er forekommet ved tacrolimusblodkoncentrationer, der har været langt højere end den anbefalede maksimale koncentration.
English: Advagraf is not recommended for use in children below 18 years due to limited data on safety and/or efficacy.
Danish: Advagraf anbefales ikke til børn under 18 år på grund af begrænsede sikkerheds- og effektdata.
English: It is recommended that the oral daily dose of Advagraf be administered once daily in the morning.
Danish: Det anbefales, at den daglige orale dosis af Advagraf administreres én gang daglig om morgenen.
English: You will need to take Advagraf every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Danish: De skal tage Advagraf hver dag så længe, De har behov for immundæmpende medicin, for at forebygge afstødning af Deres transplanterede organ.
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Advagraf.
Danish: Derfor bør EBV-VCA-serologien for denne patientgruppe være klarlagt inden behandling med Advagraf.
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningernes frekvens er defineret som følger: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden
English: Take the capsules immediately following removal from the blister.
Danish: Tag kapslerne umiddelbart efter, at de er fjernet fra blisterkortet.
English: The safety and efficacy of Advagraf in children under 18 years of age have not yet been established.
Danish: Advagrafs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Therefore, you may be more prone to infections while you are taking Advagraf.
Danish: Derfor kan De få flere infektioner, når De tager Advagraf.
English: Bile flow does not influence the absorption of tacrolimus and therefore treatment with Advagraf may commence orally.
Danish: Galdeflow påvirker ikke absorptionen af tacrolimus, og derfor kan behandling med Advagraf påbegyndes oralt.
English: There is a risk for premature delivery (<37 week) (incidence of 66 of 123 births, i.e. 53.7%; however, data showed that the majority of the newborns had normal birth weight for their gestational age) as well as for hyperkalaemia in the newborn (incidence 8 of 111 neonates, i.e. 7.2 %) which, however normalises spontaneously.
Danish: Der er risiko for præmatur fødsel (<37 uger) (forekom ved 66 ud af 123 fødsler, dvs. 53,7 %; dog viste data, at størstedelen af de nyfødte havde normal fødselsvægt for deres gestationsalder) såvel som hyperkaliæmi hos den nyfødte (forekomst hos 8 ud af 111 nyfødte, dvs. 7,2 %), hvilket dog normaliseres spontant.
English: There is limited experience in non-Caucasian patients and patients at elevated immunological risk (e.g. retransplantation, evidence of panel reactive antibodies, PRA).
Danish: Der er begrænset erfaring med ikke-kaukasiske patienter og patienter med forhøjet immunologisk risiko (f.eks. retransplantation, påvisning af panelreaktive antistoffer (PRA)).
English: Both the rate and extent of absorption of Advagraf were reduced when administered with food.
Danish: Både hastighed og absorptionsmængden af Advagraf blev reduceret ved indgift sammen med mad.
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and antipyrine.
Danish: Data fra dyreundersøgelser har vist, at tacrolimus kunne nedsætte clearance og forøge halveringstiden af pentobarbital og antipyrin.
English: It is not recommended that Advagraf is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Danish: Advagraf må ikke tages sammen med ciclosporin (anden medicin der anvendes til at undgå afstødning af transplanteret organ).
English: Stopping your treatment with Advagraf may increase the risk of rejection of your transplanted organ.
Danish: Afbrydelse af behandlingen med Advagraf kan øge risikoen for afstødning af det transplanterede organ.
English: If you are allergic to peanut or soya, talk to your doctor to determine whether you should use this medicine.
Danish: Hvis De er overfølsom over for jordnødder eller soja, så tal med Deres læge om, hvorvidt De bør tage denne medicin.
English: All patients reported risk factors for PRCA such as parvovirus B19 infection, underlying disease or concomitant medications associated with PRCA.
Danish: Alle patienter havde risikofaktorer for PRCA såsom parvovirus B19-infektion, underliggende sygdom eller samtidig behandling med lægemidler associeret med PRCA.
English: Advagraf is taken orally once daily in the morning.
Danish: Advagraf tages oralt én gang daglig om morgenen.
English: The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition).
Danish: Printblækket, som bruges til at stemple kapslen med, indeholder små mængder sojalecithin (0,48 % af den totale printblæksammensætning).
English: Absorption is variable and the mean oral bioavailability of tacrolimus (investigated with the Prograf formulation) is in the range of 20% - 25% (individual range in adult patients 6% - 43%).
Danish: Absorptionen er variabel og den orale gennemsnitlige biotilgængelighed af tacrolimus (undersøgt vha. Prografformuleringen) ligger mellem 20 % - 25 % (individuelt hos voksne 6 % - 43 %).
English: What you need to know before you take Advagraf Do not take Advagraf
Danish: Det skal De vide, før De begynder at tage Advagraf Tag ikke Advagraf
English: In case of in utero exposure, monitoring of the newborn for the potential adverse events of tacrolimus is recommended (in particular effects on the kidneys).
Danish: I tilfælde af eksponering in utero anbefales det at overvåge den nyfødte for tacrolimusbivirkninger (især effekt på nyrerne).
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis Deres læge har fortalt Dem, at De ikke tåler visse sukkerarter, skal De kontakte lægen, før De anvender denne medicin.
English: This typically presents as a bilateral and symmetrical, severe, ascending pain in the lower extremities and may be associated with supra-therapeutic levels of tacrolimus.
Danish: Dette fremstår typisk som en bilateral og symmetrisk, svær stigende smerte i underekstremiteterne og kan være associeret med supraterapeutiske niveauer af tacrolimus.
English: In rats, tacrolimus caused toxic effects to the nervous system and the eyes.
Danish: Hos rotter forårsagede tacrolimus toksiske virkninger på nervesystemet og øjne.
English: Advagraf is used to control your body's immune response, enabling your body to accept the transplanted organ.
Danish: Advagraf benyttes til at kontrollere Deres krops immunreaktion, således at kroppen kan acceptere det nye transplanterede organ.
English: In adult liver, kidney and heart transplant patients, values of 4.1 l/h, 6.7 l/h and 3.9 l/h, respectively, have been observed.
Danish: Hos voksne lever-, nyre- og hjertetransplanterede har man set værdier på henholdsvis 4,1 l/time, 6,7 l/time og 3,9 l/time.
English: Also contains lactose and traces of soya lecithin.
Danish: Indeholder også lactose og spor af sojalecithin.
English: Advagraf reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Danish: Advagraf nedsætter kroppens egen forsvarsmekanisme (immunsystemet), som så ikke vil kunne bekæmpe infektioner så godt som normalt.
English: You may also be given Advagraf for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation.
Danish: De kan også få ordineret Advagraf ved en igangværende afstødning af den transplanterede lever, nyre, hjerte eller andet organ, hvis Deres tidligere behandling ikke kunne kontrollere immunreaktionen efter transplantationen.
English: Advagraf passes into breast milk.
Danish: Advagraf passerer over i modermælken.
English: In practice, tacrolimus-based therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Danish: I praksis kan behandling med tacrolimus starte 12-24 timer efter seponering af ciclosporinbehandlingen.
English: Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed in Prograf treated patients on rare occasions and may also occur with Advagraf.
Danish: Ventrikulær hypertrofi eller hypertrofi af septum, rapporteret som kardiomyopati, er blevet observeret hos patienter, som er blevet behandlet med Prograf i enkelte tilfælde, og kan også forekomme i forbindelse med Advagraf.
English: If you have accidentally taken too much Advagraf, contact your doctor or nearest hospital emergency department immediately.
Danish: Hvis De ved en fejltagelse har taget for mange Advagraf-kapsler, skal De straks kontakte lægen eller den nærmeste skadestue.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med arvelig galactose-intolerans, en særlig form for arvelig lactasemangel (Lapp lactase deficiency) eller glucose/galactose-malabsorption bør derfor ikke anvende dette lægemiddel.
English: If you forget to take Advagraf
Danish: Hvis De har glemt at tage Advagraf
English: Peak blood concentrations achieved with these doses were above 150 ng/mL which is more than 6-fold higher than mean peak concentrations observed with Advagraf in clinical transplantation.
Danish: Peak-blodkoncentrationer opnået med disse doser var over 150 ng/ml, hvilket er mere end 6 gange højere end gennemsnitlige peakkoncentrationer observeret med Advagraf i forbindelse med transplantation.
English: Published clinical experience from a single centre on the use of oral Prograf for primary treatment following intestinal transplantation showed that the actuarial survival rate of 155 patients (65 intestine alone, 75 liver and intestine, and 25 multivisceral) receiving tacrolimus and prednisone was 75% at 1 year, 54% at 5 years, and 42% at 10 years.
Danish: Publicerede kliniske resultater fra et enkelt center om brug af oral Prograf som primær behandling efter intestinale transplantationer viste, at overlevelsesraten hos 155 patienter (65 intestinal alene, 75 lever og tarm og 25 multivicerale), der fik tacrolimus og prednison, var på 75 % efter 1 år, på 54 % efter 5 år og på 42 % efter 10 år.
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2. i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.
Danish: Man bør fortsætte med at måle ciclosporins blodkoncentrationer efter skiftet, da ciclosporinets clearance kan være påvirket.
English: Overall, the safety profile of oral Prograf in these published studies appeared to be similar to what was reported in the large studies, where Prograf was used as primary treatment in liver, kidney and heart transplantation.
Danish: Oral Prograf-tolerans i disse publicerede undersøgelser svarer til, hvad der blev rapporteret fra store undersøgelser, hvor Prograf blev benyttet til primær behandling efter lever-, nyre- og hjertetransplantationer.
English: Patients are also at an increased risk of infections with viral hepatitis (for example, hepatitis B and C reactivation and de novo infection, as well as hepatitis E, which may become chronic).
Danish: Patienterne har desuden en øget risiko for infektion med viral hepatitis (f.eks. reaktivering af infektion og de novoinfektion med hepatitis B og C samt hepatitis E, som kan blive kronisk).
English: If you stop taking Advagraf
Danish: Hvis De holder op med at tage Advagraf
English: It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to Advagraf monotherapy.
Danish: Det er i visse tilfælde muligt at seponere anden samtidig immunsuppressiv behandling, som resulterer i Advagrafmonoterapi.
English: When converting from Prograf capsules to Advagraf, trough levels should be measured prior to conversion and within two weeks after conversion.
Danish: Ved omstilling fra Prografkapsler til Advagraf bør tacrolimus-dalværdierne måles før omstillingen og inden for to uger efter omstillingen.
English: Advagraf should be administered in the morning.
Danish: Advagraf bør gives om morgenen.
English: From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Advagraf.
Danish: Fra tid til anden kan det være nødvendigt for lægen at tage blod- eller urinprøver eller undersøge Deres hjerte eller øjne for at bestemme den rette Advagrafdosis.
English: Significantly more ciclosporintreated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995;60:580).
Danish: Der var signifikant flere patienter i ciclosporingruppen (n=13), som måtte overføres til tacrolimus end tacrolimusbehandlede patienter, der måtte overføres til ciclosporin (n=2) (p=0,02) (Keenan et al.; Ann Thoracic Surg 1995; 60:580).
English: Data from clinical studies suggest that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 ng/ml.
Danish: Data fra kliniske undersøgelser viser, at behandlingen forløber godt hos de fleste patienter, hvis tacrolimus' blodkoncentrationer holdes under 20 ng/ml.
English: The use of Advagraf is not recommended in children and adolescents under 18 years.
Danish: Advagraf bør ikke gives til børn og unge under 18 år.
English: At the molecular level, the effects of tacrolimus appear to be mediated by binding to a cytosolic protein (FKBP12) which is responsible for the intracellular accumulation of the compound.
Danish: På molekylært niveau synes virkningen af tacrolimus at være medieret af binding til cytosolprotein (FKBP12), som også er ansvarlig for den intracellulære akkumulering af præparatet.
English: If PRES is diagnosed, adequate blood pressure and seizure control and immediate discontinuation of systemic tacrolimus is advised.
Danish: Hvis PRES diagnosticeres tilrådes det, at der udføres passende blodtryks- og anfaldskontrol, samt at systemisk tacrolimus omgående afbrydes.
English: Less than 1% of unchanged tacrolimus was detected in the urine and faeces, indicating that tacrolimus is almost completely metabolised prior to elimination: bile being the principal route of elimination.
Danish: Mindre end 1 % af intakt tacrolimus blev fundet i urin og fæces, hvilket indikerer at næsten al tacrolimus metaboliseres før eliminering, idet størstedelen bliver elimineret med galden.
English: Results from clinical trials performed with once-daily tacrolimus Advagraf Liver transplantation
Danish: Resultater fra kliniske studier udført med Advagraf, tacrolimus en gang daglig Levertransplantation
English: In healthy subjects, the average total body clearance estimated from whole blood concentrations was 2.25 l/h.
Danish: Hos raske forsøgspersoner var den gennemsnitlige totale body clearance beregnet ud fra koncentrationer i fuldblod 2,25 l/time.
English: Therefore, metabolites do not contribute to the pharmacological activity of tacrolimus.
Danish: Derfor bidrager metabolitter ikke til tacrolimus farmakologiske effekt.
English: Following the initiation of your treatment with Advagraf, frequent blood tests will be taken by your doctor to define the correct dose.
Danish: Efter behandlingen med Advagraf er påbegyndt, vil Deres læge ofte tage blodprøver for at bestemme den korrekte dosis.
English: Dose reduction may be necessary in patients with severe liver impairment (see section 4.2).
Danish: Det kan være nødvendigt at reducere dosis hos patienter med kraftigt nedsat leverfunktion (se pkt.
English: Metabolism and nutrition disorders very common:
Danish: Metabolisme og ernæring Meget almindelig:
English: Tacrolimus blood trough levels should be determined approximately 24 hours post-dosing of Advagraf, just prior to the next dose.
Danish: Dalværdierne for tacrolimuskoncentrationer i blod bør tages ca. 24 timer efter Advagraf-dosering, umiddelbart før næste dosering.
English: Frequent trough level monitoring in the initial two weeks post transplantation is recommended, followed by periodic monitoring during maintenance therapy.
Danish: Det anbefales at overvåge koncentrations-niveauerne hyppigt de to første uger efter transplantation og at følge op med periodisk overvågning under vedligeholdelsesbehandlingen.
English: Do not swallow the desiccant contained in the foil wrapper.
Danish: Slug ikke tørremidlet, som findes i folien.
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. kapsel, dvs. den er i det væsentlige natrium-fri.
English: Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
Danish: Kliniske data tyder, på at statinernes farmakokinetik stort set er uændret ved samtidig administration af tacrolimus.