FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypromellose 2910, ethylcellulose, lactose, magnesium stearate.
Danish: Hypromellose 2910, ethylcellulose, lactose, magnesiumstearat.
English: Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor.
Danish: Tacrolimus hæmmer T-celleaktivering og T-hjælpercelleafhængig B-celleproliferation, samt dannelsen af lymfokiner (såsom interleukin-2 og -3 og γ-interferon) og nedreguleringen af interleukin 2-receptorer.
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 koncentrationsniveauerne hyppigt de to første uger efter transplantation og at følge op med periodisk overvågning under vedligeholdelsesbehandlingen.
English: However, Tacforius prolonged-release capsules are taken once daily, whereas the immediate release capsules are taken twice daily.
Danish: Tacforius depotkapsler tages dog kun en gang daglig, mens kapslerne, der virker umiddelbart, tages to gange daglig.
English: Accordingly, highrisk patients receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9 - 12 months).
Danish: Derfor skal patienter i risikogruppen, og patienter i intensiv immunsuppression kontrolleres med f.eks. ekkokardiografi eller EKG før og efter transplantation (f.eks. efter 3 måneder i begyndelsen af behandlingen og igen efter 9 - 12 måneder).
English: The 1 - year patient survival was 83% in the tacrolimus and 71% in the ciclosporin group, the 2 - year survival rates were 76% and 66%, respectively.
Danish: 1-års patientoverlevelsesraten var 83 % i tacrolimusgruppen og 71 % i ciclosporingruppen, 2-års patientoverlevelsen var henholdsvis 76 % og 66 %.
English: Grapefruit juice has been reported to increase the blood level of tacrolimus and should therefore be avoided.
Danish: Det er rapporteret, at grapefrugtjuice øger koncentrationen af tacrolimus, hvorfor det bør undgås.
English: Published clinical experience from a single centre on the use of oral tacrolimus immediate release capsules 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 orale tacrolimuskapsler med umiddelbar udløsning som primær behandling efter intestinale transplantationer viste, at overlevelsesraten hos 155 patienter (65 intestinal alene, 75 lever og tarm og 25 multiviscerale), der fik tacrolimus og prednison, var på 75 % efter 1 år, på 54 % efter 5 år og på 42 % efter 10 år.
English: Active substances which interfere with mycophenolic acid's enterohepatic cycle have potential to reduce the plasma level and efficacy of mycophenolic acid.
Danish: Aktive stoffer, der interfererer med mycophenolsyres enterohepatiske cyklus kan potentielt reducere plasmaniveauet og virkningen af mycophenolsyre.
English: When converting from tacrolimus immediate release capsules to Tacforius prolonged-release capsules, trough levels should be measured prior to conversion and within two weeks after conversion.
Danish: Ved omstilling fra tacrolimus kapsler med umiddelbar udløsning til depotkapsler med Tacforius bør tacrolimus-dalværdierne måles før omstillingen og inden for to uger efter omstillingen.
English: What you need to know before you take Tacforius 3.
Danish: Det skal du vide, før du begynder at tage Tacforius 3.
English: Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed in patients treated with immediate release tacrolimus on rare occasions and may also occur with prolonged-release tacrolimus.
Danish: Ventrikulær hypertrofi eller hypertrofi af septum, rapporteret som kardiomyopati, er blevet observeret hos patienter, som er blevet behandlet med tacrolimus med umiddelbar udløsning i enkelte tilfælde, og kan også forekomme i forbindelse med tacrolimus som depot.
English: Absorption is variable and the mean oral bioavailability of tacrolimus (immediate release capsules 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 (formuleringen med umiddelbar udløsning) ligger mellem 20 % - 25 % (individuelt hos voksne 6 % - 43 %).
English: Tacrolimus blood trough levels should be determined approximately 24 hours post-dosing of Tacforius, just prior to the next dose.
Danish: Dalværdierne for tacrolimuskoncentrationer i blod bør tages ca. 24 timer efter Tacforiusdosering, umiddelbart før næste dosering.
English: Therefore, you may be more prone to infections while you are taking Tacforius.
Danish: Derfor kan du få flere infektioner, når du tager Tacforius.
English: The use of live attenuated vaccines should be avoided (see section
Danish: Brug af levende, afsvækkede vacciner skal undgås (se pkt.
English: 98.8%) to plasma proteins, mainly to serum albumin and α - 1-acid glycoprotein.
Danish: I plasma er tacrolimus stærkt bundet (>98,8 %) til plasmaproteiner, hovedsagelig til serumalbumin og surt alfa-1-glykoprotein.
English: As tacrolimus may reduce the clearance of steroid-based contraceptives leading to increased hormone exposure, particular care should be exercised when deciding upon contraceptive measures.
Danish: Da tacrolimus kan reducere clearance af steroidbaseret kontraception med øget hormoneksponering til følge, skal valg af prævention ske med omtanke.
English: The FKBP12-tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calcium-dependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of cytokine genes.
Danish: FKBP12-tacrolimuskomplekset bindes specifikt, kompetitivt hæmmende til calcineurin, hvilket medfører en calciumafhængig hæmning af T-cellernes signaltransduktion, således at transskriptionen af visse cytokingener forhindres.
English: Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Danish: Herefter vil lægen regelmæssigt tage blodprøver for at fastlægge den korrekte dosis og for løbende at justere dosis.
English: Patients treated with immunosuppressants, including tacrolimus are at increased risk for infections including opportunistic infections (bacterial, fungal, viral and protozoal) such as BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Danish: Patienter behandlet med immunsuppressiva, herunder tacrolimus, har en øget risiko for infektioner, herunder opportunistiske infektioner (bakteriel, fungal, viral og protozoal) såsom BK-virus associeret nefropati og JC-virus associeret progressiv multifokal leukoencefalopati (PML).
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Danish: Behandling af transplantatafstødning der er resistent for behandling med andre immunsuppressive lægemidler hos voksne.
English: The 1 - year patient survival rate was 80.8% in the tacrolimus and 83% in the ciclosporin group.
Danish: 1-års patientoverlevelsesraten var 80,8 % i tacrolimusgruppen og 83 % i ciclosporingruppen.
English: In patients unable to take oral medicinal products during the immediate post-transplant period, tacrolimus therapy can be initiated intravenously (see Summary of Product Characteristics for tacrolimus 5 mg/ml concentrate for solution for infusion) at a dose approximately 1/5th of the recommended oral dose for the corresponding indication.
Danish: Til patienter, som ikke kan tage oral medicin i den umiddelbare posttransplanterede periode, kan tacrolimusbehandlingen påbegyndes intravenøst (se produktresuméet for tacrolimus 5 mg/ml koncentrat til infusionsvæske, opløsning) med en dosis på cirka 1/5 af den anbefalede orale dosis til den tilsvarende indikation.
English: Tacrolimus passes into breast milk.
Danish: Tacrolimus passerer over i modermælken.
English: Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed.
Danish: Medicineringsfejl, herunder utilsigtet, uforsætlig eller uovervåget substitution af umiddelbart udløste eller depotformuleringer af tacrolimus, er set.
English: The 1 - year survival rates were 73.1% in the tacrolimus versus 79.2% in the ciclosporin group.
Danish: 1-års overlevelsesraterne lå på 73,1 % i tacrolimusgruppen versus 79,2 % i ciclosporingruppen.
English: Clinically the following substances have been shown to decrease tacrolimus blood levels: Strong interactions have been observed with rifampicin, phenytoin, St. John's Wort (Hypericum perforatum) which may require increased tacrolimus doses in almost all patients.
Danish: Det er påvist klinisk, at de følgende midler nedsætter tacrolimus' blodkoncentrationer: Der er set kraftige interaktioner med rifampicin, fenytoin og perikon (Hypericum perforatum), som kan kræve øget dosering af tacrolimus hos næsten alle patienter.
English: Treatment of allograft rejection after kidney or liver transplantation For conversion from other immunosuppressants to once daily Tacforius, treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for prophylaxis of transplant rejection.
Danish: Afstødningsbehandling efter nyre- eller levertransplantation Ved overførelse til Tacforius én gang daglig fra andre immunsuppressive midler bør behandlingen påbegyndes med henholdsvis den anbefalede orale startdosis for nyre- og levertransplantater og dosisprofylakse for transplantatafstødning.
English: Do not swallow the desiccant contained in the foil pouch.
Danish: Indtag ikke tørremidlet, som findes i folieposen.
English: A strong correlation exists between AUC and whole blood trough levels at steady-state for tacrolimus prolonged-release capsules.
Danish: Der er god korrelation mellem AUC og fuldblodskoncentrationerne ved steady state for tacrolimus depotkapsler.
English: Capsule content Ethylcellulose Hypromellose 2910 Lactose monohydrate Magnesium stearate
Danish: Kapselindhold Ethylcellulose Hypromellose 2910 Lactosemonohydrat Magnesiumstearat
English: Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Danish: Patienter i immunsuppressiv behandling har en øget risiko for at få maligne lidelser.
English: In comparison to Caucasians, black patients may require higher tacrolimus doses to achieve similar trough levels.
Danish: Sammenlignet med kaukasiske patienter, kan det være nødvendigt med en højere dosis af tacrolimus til sorte patienter for at opretholde samme dalniveau.
English: The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly.
Danish: Ciclosporins halveringstid er forlænget ved samtidig administration af tacrolimus.
English: The use of Tacforius is not recommended in children and adolescents under 18 years.
Danish: Børn og unge Tacforius bør ikke gives til børn og unge under 18 år.
English: The oral bioavailability of tacrolimus prolonged-release capsules was reduced when it was administered after a meal.
Danish: Den orale biotilgængelighed af tacrolimus depotkapsler var reduceret, hvis det blev indgivet efter et måltid.
English: Comparisons of concentrations from the published literature to individual values in clinical practice should be assessed with care and knowledge of the assay methods employed.
Danish: Man skal være varsom med at sammenligne koncentrationer nævnt i publicerede undersøgelser med individuelle værdier i klinikken, uden at vide hvilket assay og hvilken metode der blev benyttet.
English: A combination of immunosuppressives such as antilymphocytic antibodies (e.g. basiliximab, daclizumab) given concomitantly increases the risk of EBV associated lymphoproliferative disorders.
Danish: En kombination af immunsuppressiva - såsom antilymfocytiske antistoffer (f.eks. basiliximab, daclizumab) administreret samtidig - øger risikoen for EBV-associerede, lympfoproliferative sygdomme.
English: In de novo kidney and liver transplant patients AUC0-24 of tacrolimus for the prolonged-release capsules on Day 1 was 30% and 50% lower respectively, when compared with that for the immediate release capsules at equivalent doses.
Danish: Hos de novo nyre- og levertransplanterede patienter var AUC0-24 af tacrolimus for depotkapslerne på dag 1 henholdsvis 30 % og 50 % lavere, når den blev sammenlignet med en tilsvarende dosis af den umiddelbart udløste kapsel.
English: In stable patients converted from tacrolimus immediate release capsules (twice daily) to tacrolimus prolonged-release capsules (once daily) on a 1:1 (mg:mg) total daily dose basis, the systemic exposure to tacrolimus (AUC0-24) for tacrolimus prolonged-release capsules was approximately 10% lower than that for tacrolimus immediate release capsules.
Danish: Hos stabile patienter, som overførtes fra tacrolimus kapsler med umiddelbar udløsning (to gange daglig) til depotkapsler med tacrolimus (en gang daglig) i forholdet 1:1 (mg:mg) total daglig dosis, var den systemiske eksponering for tacrolimus (AUC0-24) for depotkapsler med tacrolimus cirka 10 % lavere end for tacrolimus kapsler med umiddelbar udløsning.
English: Inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe.
Danish: Utilsigtet, uforsætlig eller uovervåget substitution af umiddelbart udløste eller depotformuleringer af tacrolimus er farligt.
English: In cases of oral intoxication, gastric lavage and/or the use of adsorbents (such as activated charcoal) may be helpful, if used shortly after intake.
Danish: Ved oral overdosering kan maveskylning og/eller indgift af adsorberende stoffer (såsom medicinsk kul) forsøges kort tid efter indtagelse.
English: Overall, the safety profile of oral tacrolimus immediate release capsules in these published studies appeared to be similar to what was reported in the large studies, where tacrolimus immediate release capsules was used as primary treatment in liver, kidney and heart transplantation.
Danish: Tolerans for orale tacrolimus kapsler med umiddelbar udløsning i disse publicerede undersøgelser svarer til, hvad der blev rapporteret fra store undersøgelser, hvor tacrolimus kapsler med umiddelbar udløsning blev benyttet til primær behandling efter lever-, nyre- og hjertetransplantationer.
English: The most commonly reported adverse reactions (occurring in >10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Danish: De mest almindeligt rapporterede bivirkninger (forekommer hos >10 % af patienterne) er tremor, nyreinsufficiens, hyperglykæmi, diabetes mellitus, hyperkaliæmi, infektioner, hypertension og insomnia.
English: If abnormalities develop, dose reduction of Tacforius, or change of treatment to another immunosuppressive agent should be considered.
Danish: Ved tegn på anomalier bør man overveje at reducere doseringen af Tacforius eller skifte til en anden immunsuppressiv behandling.
English: Factors such as low haematocrit and protein levels, which result in an increase in the unbound fraction of tacrolimus, or corticosteroid-induced increased metabolism, are considered to be responsible for the higher clearance rates observed following transplantation.
Danish: Faktorer såsom lav hæmatokrit og lave proteinniveauer, der giver en øget ubunden fraktion af tacrolimus, samt kortikoidinduceret øget metabolisme, betragtes som hovedårsagerne til den højere clearance, man finder hos transplanterede.
English: Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), amphotericin B (used to treat bacterial infections) or antivirals (used to treat viral infections e.g. aciclovir).
Danish: Fortæl det til din læge, hvis du tager eller har brug for at tage ibuprofen (behandling af feber, betændelsestilstande og smerte), amphotericin B (behandling af bakterielle infektioner) eller antivirale midler (behandling af virusinfektioner f.eks. aciclovir).
English: Certain combinations of tacrolimus with substances known to have nephrotoxic or neurotoxic effects may increase the risk of these effects (see section 4.5).
Danish: Samtidig brug af tacrolimus og stoffer med nefrotoksisk eller neurotoksisk effekt kan øge risikoen for disse bivirkninger (se pkt.
English: In prospective studies oral tacrolimus immediate release capsules was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Danish: I publicerede, prospektive undersøgelser var orale tacrolimus kapsler med umiddelbar udløsning primært immunsuppressivum hos omkring 175 lungetransplanterede patienter, 475 pancreastransplanterede patienter og 630 intestinaltransplanterede patienter.
English: Other interactions potentially leading to increased tacrolimus blood levels
Danish: Andre interaktioner som potentielt kan øge tacrolimus' blodkoncentrationer
English: Tacforius dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below under “Therapeutic drug monitoring”).
Danish: Doseringen af Tacforius bør primært baseres på en klinisk bedømmelse af afstødning og tolerans for hver enkelt patient vejledt af overvågninger af blodkoncentrationer (se nedenfor under ”Terapeutisk lægemiddelovervågning”).
English: Tacforius prolonged-release hard capsules should be taken immediately following removal from the blister.
Danish: Tacforius depotkapsler, hårde, bør tages umiddelbart efter, at de er taget ud af blisterkortet.
English: The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Danish: Lægen vil beregne den rigtige startdosis for at undgå afstødning af det transplanterede organ ud fra din vægt.
English: The interim analysis of a recent multicentre study using oral tacrolimus immediate release capsules discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Danish: Interimanalysen af en nyligt afsluttet multicenterundersøgelse med orale tacrolimus kapsler med umiddelbar udløsning omfatter 110 patienter, der blev randomiseret i forholdet 1:1 til enten tacrolimus eller ciclosporin.
English: - The active substance is tacrolimus.
Danish: Aktivt stof: tacrolimus.
English: A multicentre study using oral tacrolimus immediate release capsules included 205 patients undergoing simultaneous pancreas-kidney transplantation who were randomised to tacrolimus (n = 103) or to ciclosporin (n = 102).
Danish: En multicenterundersøgelse med oral tacrolimus kapsler med umiddelbar udløsning, hvori der indgik 205 patienter, der gennemgik simultan pancreas-nyretransplantation blev randomiseret til tacrolimus(n=103) eller til ciclosporinbehandling (n=102).
English: Treatment of allograft rejection after transplantation of other allografts Although there is no clinical experience with tacrolimus prolonged-release capsules in lung-, pancreas- or intestine-transplanted patients, tacrolimus immediate release capsules have been used in lung-transplanted patients at an initial oral dose of 0.10 - 0.15 mg/kg/day, in pancreas-transplanted patients at an initial oral dose of 0.2 mg/kg/day and in intestinal transplantation at an initial oral dose of 0.3 mg/kg/day.
Danish: Afstødningsbehandling efter andre allotransplantater Selvom der ikke er nogen klinisk erfaring med depotkapsler med tacrolimus hos lunge-, pancreaseller intestinaltransplanterede patienter, er tacrolimus kapsler med umiddelbar udløsning blevet anvendt hos lungetransplanterede patienter med en initial oral dosis på 0,10 - 0,15 mg/kg/dag, i pancreastransplanterede patienter med en initial oral dosis på 0,2 mg/kg/dag og ved intestinaltransplantation med en initial dosis på 0,3 mg/kg/dag.
English: - if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Tacforius hvis du er allergisk over for tacrolimus eller et af de øvrige indholdsstoffer i Tacforius (angivet i punkt 6).
English: Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (e.g., aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir or aciclovir).
Danish: Samtidig brug af tacrolimus og lægemidler med kendt nefrotoksisk eller neurotoksisk effekt kan øge disse virkninger (f.eks. aminoglycosider, gyrase-hæmmere, vancomysin, cotrimoxazol, NSAID, gangliclovir og aciclovir).
English: Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
Danish: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
English: If you stop taking Tacforius
Danish: Hvis du holder op med at tage Tacforius
English: TEVA GmbH Tel: +49 73140208
Danish: Deutschland TEVA GmbH Tel: +49 73140208
English: Transparent PVC/PVDC aluminium blister or perforated unit-dose blister wrapped in an aluminium pouch with a desiccant containing 10 capsules per blister.
Danish: Gennemsigtig PVC/PVDC aluminiumsblisterkort eller perforeret enkeltdosisblisterkort pakket i en aluminiumspose med et tørremiddel.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Tacforius.
Danish: Da man ikke kan udelukke skadelige virkninger på fosteret, bør kvinder i behandling med Tacforius ikke amme.
English: If you forget to take Tacforius
Danish: Hvis du har glemt at tage Tacforius
English: Allograft transplant patients maintained on twice daily immediate release capsules dosing requiring conversion to once daily Tacforius should be converted on a 1:1 (mg:mg) total daily dose basis.
Danish: Transplanterede patienter på vedligeholdelsesdosis med kapsler med umiddelbar udløsning 2 gange daglig, som skal overføres til Tacforius én gang daglig, bør overføres på en 1:1 (mg:mg) total daglig basisdosis.
English: Each capsule contains 537.25 mg lactose and 0.0154 mg ponceau 4R.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver kapsel indeholder 537,25 mg lactose og 0,0154 mg ponceau 4R.
English: Tacforius contains lactose (milk sugar).
Danish: Tacforius indeholder lactose (mælkesukker).
English: Do not stop your treatment unless your doctor tells you to do so.
Danish: Du må ikke ophøre med behandlingen uden at have talt med lægen.
English: The treatment difference was -3.0% (tacrolimus prolonged-release capsules - ciclosporin) (95.2% confidence interval [-9.9%, 4.0%]) for tacrolimus prolonged-release capsules vs. ciclosporin and1.9% (tacrolimus immediate release capsules - ciclosporin) (95.2% confidence interval [-8.9%, 5.2%]) for tacrolimus immediate release capsules vs. ciclosporin.
Danish: Behandlingsforskellen var -3,0 % (tacrolimus depotkapsler - ciclosporin) (95,2 % konfidensinterval [-9,9 %, 4,0 %]) for tacrolimus depotkapsler vs. ciclosporin og -1,9 % (tacrolimus kapsler med umiddelbar udløsning - ciclosporin (95,2 % konfidensinterval [-8,9 %, 5,2 %]) for tacrolimus kapsler med umiddelbar udløsning vs. ciclosporin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM POUCH
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ALUMINIUMSPOSE
English: For treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients clinical data are not yet available for the prolonged-release formulation of tacrolimus.
Danish: Til behandling af afstødning af allograf hos voksne patienter, som er resistente over for andre immunsuppressive lægemidler, er de kliniske data endnu ikke tilgængelige for depotformuleringen af tacrolimus.