FrancophonIA/ELRC3.0 huggingface dataset:
English: For prophylaxis of transplant rejection in adult heart, lung, pancreas, or intestine allograft recipients clinical data are not yet available for Envarsus.
Danish: Til profylakse af transplantatafstødning hos voksne patienter, der har fået hjerte-, lunge-, pancreaseller intestinalallograft-transplantationer, foreligger der endnu ikke kliniske data for Envarsus.
English: Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed in tacrolimus treated patients on rare occasions.
Danish: I sjældne tilfælde er ventrikulær hypertrofi eller hypertrofi af septum, rapporteret som kardiomyopati, observeret hos patienter, der er blevet behandlet med tacrolimus.
English: This has led to serious adverse reactions, including graft rejection, or other adverse reactions which could be a consequence of either under- or over-exposure to tacrolimus.
Danish: Dette har ført til alvorlige bivirkninger, herunder transplantatafstødning, eller andre bivirkninger som mulig konsekvens af enten under- eller overeksponering for tacrolimus.
English: Mycophenolic acid
Danish: Mycophenolsyre
English: The efficacy failure rate as measured by the composite endpoint of death, graft loss, locally read BPAR and loss to follow-up was 2.5% in both the Envarsus and Prograf groups.
Danish: Raten af virkningssvigt målt ved det sammensatte endepunkt af død, transplantattab, lokalt aflæst BPAR og umulig opfølgning var 2,5 % i både Envarsus- og Prograf-gruppen.
English: Envarsus is taken once daily and is not interchangeable with other existing medicines containing tacrolimus (immediate release or prolonged release) on an equal dose by dose basis.
Danish: Envarsus tages én gang dagligt og kan ikke erstattes med andre eksisterende lægemidler, der indeholder tacrolimus (med øjeblikkelig udløsning eller depottabletter) på et tilsvarende dosis-fordosis-grundlag.
English: In stable patients converted from tacrolimus immediate-release products (twice daily) to Envarsus (once daily) on a 1:0.7 (mg:mg) total daily dose basis, the mean systemic exposure to tacrolimus (AUC0-24) was similar to that of immediate-release tacrolimus.
Danish: Hos stabile patienter, der skiftede fra tacrolimus-præparater med øjeblikkelig udløsning (to gange dagligt) til Envarsus (én gang dagligt) i forholdet 1:0,7 (mg:mg) total daglig dosis, var den gennemsnitlige systemiske eksponering for tacrolimus (AUC0-24) sammenlignelig med den for tacrolimus med øjeblikkelig udløsning.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including tacrolimus.
Danish: Der er rapporteret om tilfælde af BK-virus-associeret nefropati samt tilfælde af JC-virus-associeret progressiv multifokal leukoencefalopati (PML) hos patienter, der er behandlet med immunosuppressiva, herunder tacrolimus.
English: Concomitant use of substances known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels.
Danish: Samtidig brug af stoffer, som vides at hæmme eller inducere CYP3A4, kan påvirke metabolismen af tacrolimus og derved øge eller nedsætte blodkoncentrationerne af tacrolimus.
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, der vides at have nefrotoksiske eller neurotoksiske bivirkninger, kan øge disse bivirkninger (f.eks. aminoglycosider, gyrasehæmmere, vancomycin, cotrimoxazol, NSAID'er, ganciclovir og aciclovir).
English: Treatment-emergent fatal adverse events occurred in 1.8% of Envarsus patients and 2.5% of Prograf patients.
Danish: Behandlingsafledte, fatale bivirkninger forekom hos 1,8 % af Envarsus-patienter og 2,5 % af Prograf-patienter.
English: The event rate for locally read BPAR during the 360-day study was 1.2% in the Envarsus group (N=162) post conversion from Prograf at a dose ratio of 1:0.7 (mg:mg) and 1.2% in the group maintained on Prograf (N=162).
Danish: Bivirkningsraten for lokalt aflæst BPAR i løbet af det 360-dages studie var 1,2 % i Envarsus-gruppen (N=162) efter skift fra Prograf med et dosisforhold på 1:0,7 (mg:mg) og 1,2 % i gruppen vedligeholdt på Prograf (N=162).
English: Herbal preparations containing St. John's Wort (Hypericum perforatum) should be avoided when taking tacrolimus due to the risk of interactions that lead to a decrease in both blood concentrations and the therapeutic effect of tacrolimus (see section 4.5).
Danish: Naturlægemidler, der indeholder prikbladet perikum (Hypericum perforatum), bør undgås ved behandling med tacrolimus på grund af risikoen for interaktioner, som kan forårsage et fald i både blodkoncentrationer og den terapeutiske virkning af tacrolimus (se pkt.
English: Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.
Danish: Såvel benigne som maligne neoplasmer, herunder EBV-associerede lymfoproliferative lidelser og maligne tilstande i huden er rapporteret i forbindelse med behandling med tacrolimus.
English: It is strongly recommended to closely monitor tacrolimus blood levels, as well as renal function and other undesirable effects, whenever substances which have the potential to alter CYP3A4 metabolism or otherwise influence tacrolimus blood levels are used concomitantly, and to interrupt or adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and
Danish: Det anbefales kraftigt at monitorere koncentrationen af tacrolimus i blodet såvel som nyrefunktionen og andre bivirkninger ved samtidig brug af lægemidler, der har potentiale til at ændre CYP3A4metabolismen eller på en anden måde at øve indflydelse på blodkoncentrationer af tacrolimus, og at afbryde eller justere dosis af tacrolimus som relevant for at opretholde en tilsvarende tacrolimuseksponering (se pkt.
English: The efficacy failure rate as measured by the composite endpoint of death, graft loss, centrally read BPAR and loss to follow-up was 18.3% in the Envarsus group and 19.6% in the Prograf group.
Danish: Raten af virkningssvigt målt ved den sammensatte endepunkt af død, transplantattab, centralt aflæst BPAR og umulig opfølgning var 18,3 % i Envarsus-gruppen og 19,6 % i Prograf-gruppen.
English: The most commonly reported adverse reactions for tacrolimus (occurring in >10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Danish: De mest almindeligt rapporterede bivirkninger ved tacrolimus (der forekommer hos >10 % af patienter) er tremor, nedsat nyrefunktion, hyperglykæmiske tilstande, diabetes mellitus, hyperkaliæmi, infektioner, hypertension og insomnia.
English: Envarsus contains lactose (milk sugar).
Danish: Envarsus indeholder lactose (mælkesukker).
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus.
Danish: Der er rapporteret tilfælde af ren erytrocyt aplasi (PRCA) hos patienter behandlet med tacrolimus.
English: You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Envarsus.
Danish: Mens du tager Envarsus, skal du begrænse din udsættelse for sollys og UV- (ultraviolet) lys.
English: The percentage of patients with one or greater than one episode of clinically-suspected and treated rejections during the 360-day study was 13.8% for the Envarsus group (N=268) and 15.6% for the Prograf group (N=275).
Danish: Procentdelen af patienter med en eller flere end en episode af klinisk formodede og behandlede afstødninger under det 360-dages studie var 13,8 % for Envarsus-gruppen (N=268) og 15,6 % for Prograf-gruppen (N=275).
English: Eye disorders eye disorders, vision blurred, photophobia cataract blindness optic neuropathy
Danish: Øjne øjenlidelser, tågesyn, fotofobi katarakt blindhed optisk neuropati
English: How to store Envarsus 6.
Danish: Sådan skal du tage Envarsus 4.
English: 30 prolonged-release tablets 60 prolonged-release tablets 90 prolonged-release tablets
Danish: 30 depottabletter 60 depottabletter 90 depottabletter
English: 3 blisters are packed together in an aluminium foil wrapper containing a desiccant.
Danish: 3 blisterkort er pakket sammen i en alufoliepakning med et tørremiddel.
English: Lansoprazol and ciclosporin may potentially inhibit CYP3A4-mediated metabolism of tacrolimus and, thereby, increase tacrolimus whole blood concentrations.
Danish: Lansoprazol og ciclosporin kan potentielt hæmme tacrolimus' CYP3A4-medierede metabolisme og derved øge fuldblodskoncentrationerne af tacrolimus.
English: As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) should be avoided (see section 4.4).
Danish: Da behandling med tacrolimus kan være forbundet med hyperkaliæmi eller forværring af eksisterende hyperkaliæmi, skal indtagelse af store mængder kalium eller kaliumbesparende diuretika (f.eks. amilorid, triamteren eller spironolacton) undgås (se pkt.
English: Benign and malignant tumours have been reported following Envarsus treatment.
Danish: Der er rapporteret godartede og ondartede svulster efter behandling med Envarsus.
English: Human data demonstrate that tacrolimus is excreted in breast milk.
Danish: Humane data viser, at taclolimus udskilles i modermælk.
English: The Marketing Authorisation Holder should ensure that, at launch, all Healthcare Professionals who are expected to prescribe or dispense Envarsus are provided with an Educational pack.
Danish: Indehaveren af markedsføringstilladelsen skal samtidig med lanceringen af Envarsus sikre, at sundhedspersonale, som vil udskrive, udlevere eller administrere Envarsus, får en pakke med uddannelsesmateriale til læger og sundhedspersonale.
English: Eye disorders, sometimes progressing to loss of vision, have been reported in patients treated with tacrolimus.
Danish: Øjensygdomme, der i nogle tilfælde udvikler sig til synstab, er rapporteret hos patienter i behandling med tacrolimus.
English: Symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine and alanine aminotransferase levels.
Danish: Blandt symptomerne har været tremor, hovedpine, kvalme og opkastning, infektioner, urticaria, letargi og forhøjede koncentrationer af urinkvælstof i blodet samt forhøjede koncentrationer af serumkreatinin og alanin-aminotransferase.
English: As tacrolimus is a substance with low clearance, following adjustments to the Envarsus dose regimen it may take several days before the targeted steady state is achieved.
Danish: Da tacrolimus er et stof med lav clearance, kan det efter justering af dosisregimet for Envarsus tage adskillige dage, før den ønskede steady state opnås.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS ALUMINIUM FOIL WRAPPER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ALUFOLIEPAKNING
English: Envarsus contains the active substance tacrolimus presented in a prolonged release formulation.
Danish: Envarsus indeholder det aktive stof tacrolimus i en depotformulering (med forlænget udløsning).
English: Unknown side effects (frequency not known): - Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), - Agranulocytosis (a severely lowered number of white blood cells) - Haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) - Abnormality of the optic nerve (optic neuropathy)
Danish: - Tilfælde af ren erytrocyt aplasi (et meget stærkt nedsat antal røde blodlegemer) - Agranulocytose (et stærkt nedsat antal hvide blodlegemer) - Hæmolytisk anæmi (nedsat antal røde blodlegemer på grund af abnorm nedbrydning) - Forandring i synsnerven (optisk neuropati
English: • Envarsus 1 mg tablets:
Danish: • Envarsus 1 mg tabletter:
English: Envarsus is a once-a-day oral formulation of tacrolimus.
Danish: Envarsus er en oral formulering af tacrolimus, der tages én gang dagligt.
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 fungal infections), antibiotics (used to treat bacterial infections, e.g. aminoglycosides, vancomycin or clotrimazole) 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 (der anvendes til behandling af feber, betændelse og smerter), amphotericin B (der anvendes til behandling af svampeinfektioner) antibiotika (der anvendes til at behandle bakterieinfektioner, f.eks. aminoglykosider, vancomycin eller clotrimazol) eller virusmidler (der anvendes til behandling af virusinfektioner, f.eks. aciclovir).
English: As tacrolimus is a substance with low clearance, adjustments to the dose regimen may take several days before steady state is achieved.
Danish: Da tacrolimus er et stof med lav clearance, kan det efter justering af dosisregimet tage adskillige dage, før steady-state opnås.
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Danish: Behandling af allograft-afstødning hos voksne patienter, der ikke responderer på behandling med andre immunsuppressive lægemidler.
English: Psychiatric disorders insomnia confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare psychotic disorder
Danish: Psykiske forstyrrelser søvnløshed konfusion og desorientering, depression, angstsymptomer, hallucinationer, psykiske lidelser, nedtrykthed, humørsvingninger og -forstyrrelser, mareridt psykotiske lidelser
English: • Envarsus 4 mg tablets:
Danish: • Envarsus 4 mg tabletter:
English: Packs of 30, 60 and 90 prolonged-release tablets are available.
Danish: De findes i pakninger med 30, 60 og 90 depottabletter.
English: For these reasons, the combined administration of ciclosporin and tacrolimus is not recommended, and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.4).
Danish: Af disse grunde frarådes den kombinerede administration af ciclosporin og tacrolimus, og der skal udvises forsigtighed ved administration af tacrolimus til patienter, der tidligere har fået ciclosporin (se pkt.
English: Skin and subcutaneous tissue disorders rash, pruritus, alopecias, acne, sweating increased dermatitis, photosensitivity toxic epidermal necrolysis (Lyell's syndrome)
Danish: Hud og subkutane væv udslæt, pruritus, alopeci, akne, øget svedtendens dermatitis, lysoverfølsomhed toksisk epidermal nekrolyse (Lyells syndrom)
English: As in kidney transplant recipients, there appears to be no meaningful difference in the pattern of suspected adverse drug reactions between once daily Envarsus and tacrolimus immediate-release capsules (Prograf).
Danish: Ligesom hos nyretransplanterede patienter lader der ikke til at være nogen betydningsfuld forskel i mønsteret af formodede bivirkninger mellem Envarsus-tabletter, der tages én gang dagligt og tacrolimus-kapsler med øjeblikkelig udløsning (Prograf).
English: Other factors observed to increase the risk of these clinical conditions included pre-existing heart disease, corticosteroid usage, hypertension, renal or hepatic dysfunction, infections, fluid overload and oedema.
Danish: Andre faktorer, som kan øge risikoen for disse kliniske tilstande, er tidligere forekommende hjertesygdom, behandling med kortikosteroider, hypertension, nedsat nyreeller leverfunktion, infektion, overhydrering og ødem.
English: In man tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract.
Danish: Hos mennesker er det påvist, at tacrolimus kan absorberes i hele mave-tarm-kanalen.
English: Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section 4.4).
Danish: Immunsystemet Allergiske og anafylaktoide reaktioner er observeret hos patienter, der får tacrolimus (se pkt.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept (se bilag I: Produktresumé, pkt.
English: For treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients clinical studies are not yet available for the prolonged-release formulation Envarsus.
Danish: Til behandling af allograft-afstødning hos voksne patienter, der ikke responderer på behandling med andre immunsuppressive lægemidler, foreligger der endnu ikke kliniske studier for Envarsusformuleringen af depottabletter.
English: cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Danish: Benigne, maligne og uspecificerede tumorer (inkl cyster og polypper) Patienter i immunsuppressiv behandling har øget risiko for at udvikle maligne lidelser.
English: The combined administration of ciclosporin and tacrolimus should be avoided and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.5).
Danish: Den kombinerede administration af ciclosporin og tacrolimus bør undgås, og der skal udvises forsigtighed ved administration af tacrolimus til patienter, der tidligere har fået ciclosporin (se pkt.
English: Common side effects (may affect up to 1 in 10 people): - reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts (seen in blood tests) - reduced magnesium, phosphate, potassium, calcium or sodium in the blood, fluid overload,
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede): - Nedsat antal blodceller (blodplader, røde eller hvide blodlegemer), øget antal hvide blodlegemer, ændret antal røde blodlegemer (set i blodprøver) - Nedsat indhold af magnesium, fosfat, kalium, calcium eller natrium i blodet, overhydrering,
English: The relationship between tacrolimus trough levels and systemic exposure (AUC0-24) is well correlated and is similar between the immediate-release formulation and Envarsus.
Danish: Der er god korrelation af sammenhængen mellem dalkoncentrationer af tacrolimus og den systemiske eksponering (AUC0-24) og ligeledes mellem formuleringen med øjeblikkelig udløsning og Envarsus.
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.2 and 4.8).
Danish: Patienterne skal behandles med kun én formulering af tacrolimus i overensstemmelse med det tilsvarende daglige dosisregime; ændringer i formulering eller regime bør kun ske under nøje supervision af en speciallæge i transplantation (se pkt.
English: When substances with a potential for interaction (see section 4.5), particularly strong inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin, or clarithromycin) or inducers of CYP3A4 (such as rifampicin or rifabutin), are being combined with tacrolimus, tacrolimus blood levels should be monitored to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure.
Danish: 4.5), især stærke CYP3A4-hæmmere (f.eks. telaprevir, boceprevir, ritonavir, ketoconazol, voriconazol, itraconazol, telithromycin eller clarithromycin) eller CYP3A4-inducere (f.eks. rifampicin eller rifabutin), kombineres med tacrolimus, skal tacrolimus-blodkoncentrationen monitoreres, og om nødvendigt skal dosen af tacrolimus justeres for at vedligeholde den tilsvarende eksponering for tacrolimus.
English: High potassium intake or potassium-sparing diuretics should be avoided (see section 4.5).
Danish: Indtagelse af store mængder kalium eller kaliumbesparende diuretika bør undgås (se pkt.
English: Systemically available tacrolimus is metabolised by hepatic CYP3A4.
Danish: Systemisk tilgængeligt tacrolimus metaboliseres via CYP3A4 i leveren.
English: Tacrolimus passes into breast milk.
Danish: Tacrolimus udskilles i modermælk.
English: Package leaflet: Information for the patient Envarsus 0.75 mg prolonged-release tablets Envarsus 1 mg prolonged-release tablets Envarsus 4 mg prolonged-release tablets tacrolimus
Danish: Indlægsseddel: Information til patienten Envarsus 0,75 mg depottabletter Envarsus 1 mg depottabletter Envarsus 4 mg depottabletter tacrolimus
English: In clinical studies in kidney transplant patients receiving Envarsus, the most frequent adverse reactions (at least in 2% of patients) were tremor, diabetes mellitus, blood creatinine increased, urinary tract infection, hypertension, BK virus infection, renal impairment, diarrhoea, toxicity to various agents, and toxic nephropathy all of which are known to occur in the respective patient population under immunosuppressive treatment.
Danish: I kliniske studier med nyretransplanterede patienter, der fik Envarsus, var de hyppigste bivirkninger (hos mindst 2 % af patienter) tremor, diabetes mellitus, forhøjet blodkreatinin, urinvejsinfektion, hypertension, BK-virus infektion, nedsat nyrefunktion, diarré, toksicitet over for forskellige midler og toksisk nefropati, som alle vides at forekomme hos den pågældende patientpopulation i immunsuppressiv behandling.
English: Care should be taken when converting patients from ciclosporin-based to tacrolimus-based therapy (see sections 4.4 and 4.5).
Danish: Der bør udvises forsigtighed, når patienter skifter fra ciclosporinbaseret til tacrolimusbaseret behandling (se pkt.
English: Inadvertent, unintentional, or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe.
Danish: Utilsigtet, uforsætlig eller uovervåget substitution af øjeblikkeligt udløste eller depotformuleringer af tacrolimus er farlig.
English: Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient aided by whole blood tacrolimus trough level monitoring.
Danish: Doseringen af Envarsus skal primært baseres på kliniske vurderinger af afstødning og tolerance hos den enkelte patient vejledt af monitorering af dalkoncentrationen af tacrolimus i fuldblod.
English: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Danish: Profylakse af transplantatafstødning hos voksne patienter, der har fået nyre- eller leverallograft.
English: Liver transplantation
Danish: Levertransplantation
English: Very rare side effects (may affect up to 1 in 10,000 people): - Muscular weakness - Impaired hearing - Abnormal heart scan - Liver failure - Painful urination with blood in the urine - Increase of fat tissue
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 behandlede): - Muskelsvækkelse - Nedsat hørelse - Unormal hjertescanning - Leversvigt - Smertefuld vandladning med blod i urinen - Øget fedtvæv
English: The event rate for centrally read, biopsy-confirmed acute rejection (BPAR) during the 360-day study was 13.1% in the Envarsus group (N=268) and 13.5% in the Prograf group (N=275).
Danish: Bivirkningsraten for centralt aflæst, biopsibekræftet akut afstødning (BPAR) under det 360 dages studie var 13,1 % i Envarsus-gruppen (N=268) og 13,5 % i Prografgruppen (N=275).
English: The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Danish: Toksicitetsstudier med rotter og bavianer viste, at de primære organer, der blev påvirket, var nyrer og pancreas.
English: • Summary of Product Characteristics and Patient Information Leaflet
Danish: • Produktresumé og indlægsseddel