FrancophonIA/ELRC3.0 huggingface dataset:
English: Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and faeces 8 weeks post-dose.
Danish: Ubetydelige mængder af radioaktivt lægemiddelderivat blev genfundet i blod, urin og fæces 8 uger efter dosisindgift.
English: The infection is caused by fungal cells (yeasts) called Candida.
Danish: Infektionen forårsages af svampeceller (gærceller), som kaldes Candida.
English: Less than 1% of the administered radioactive dose was excreted in the urine, indicating negligible renal clearance.
Danish: Mindre end 1 % af den indgivne radioaktive dosis blev udskilt i urinen, hvilket tyder på en ubetydelig renal clearance.
English: Some rats in the mid dose group experienced similar reactions but only after administration of anaesthesia.
Danish: Nogle rotter i middeldosis-gruppen oplevede de samme reaktioner, men kun efter administration af anæstesi.
English: The reconstitution time can be up to 5 minutes.
Danish: Rekonstitutionstiden kan være op til 5 minutter.
English: The safety and efficacy of ECALTA in children and adolescents below 18 years have not been established.
Danish: ECALTAs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: The majority of patients had candidemia only (85.7%).
Danish: De fleste af patienterne havde kun candidæmi (85,7 %).
English: Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of anidulafungin.
Danish: Der er ikke udført langtidsstudier med dyr til vurdering af anidulafungins karcinogenicitet.
English: Approximately 30% of the administered radioactive dose was eliminated in the faeces over 9 days, of which less than 10% was intact drug.
Danish: Ca. 30 % af den indgivne radioaktive dosis blev udskilt i fæces over 9 dage, heraf mindre end 10 % som intakt lægemiddelstof.
English: Anidulafungin has a predominant elimination half-life of approximately 24 hours that characterizes the majority of the plasma concentration-time profile, and a terminal half-life of 40-50 hours that characterises the terminal elimination phase of the profile.
Danish: Anidulafungin har en overvejende eliminationshalveringstid på ca. 24 timer, som karakteriserer størstedelen af plasmakoncentrations-tidsprofilen, og har en halveringstid på 40-50 timer, som karakteriserer eliminationsfasen.
English: Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
Danish: Behandlingen kan initieres før dyrkningsresultat foreligger, og behandlingen kan herefter justeres, når resultaterne foreligger.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Danish: Hvis du har glemt at få ECALTADa du vil få denne medicin under tæt medicinsk overvågning, er det mindre sandsynligt, at en dosis vil blive glemt.
English: Anidulafungin did not produce any drug-related developmental toxicity in rats at the highest dose tested.
Danish: Anidulafungin producerede ikke nogen lægemiddelrelateret toksitet for udvikling hos rotter ved den højeste undersøgte dosis.
English: The efficacy of ECALTA has only been evaluated in a limited number of neutropenic patients (see section 5.1).
Danish: Effekten af ECALTA er kun blevet vurderet hos et begrænset antal neutropene patienter (se pkt.
English: All-cause mortality by Day 28 was 10/35 (28.6%).
Danish: Mortalitet uanset årsag frem til dag 28 var 10/35 (28,6 %).
English: This results in inhibition of the formation of 1,3--D-glucan, an essential component of the fungal cell wall.
Danish: Dette fører til hæmning af dannelsen af 1,3--D-glucan, der er en essentiel bestanddel af svampens cellevæg.
English: Duration of treatment In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Danish: Behandlingsvarighed Svampebehandling bør sædvanligvis fortsættes i mindst 14 dage efter sidste positive dyrkning.
English: A standardized technique for testing the susceptibility of Candida species to anidulafungin as well as the respective interpretative breakpoints has been established by European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Danish: En standardiseret teknik til test af Candida-arters følsomhed over for anidulafungin og af de respektive grænseværdier er blevet defineret af EUCAST (European Committee on Antimicrobial Susceptibility Testing).
English: C) anidulafungin (~88 mg) was administered to healthy subjects.
Danish: C) anidulafungin (~88 mg) givet til raske forsøgspersoner.
English: Anidulafungin treatment prolonged survival and also reduced the organ burden of Candida species, when determined at intervals from 24 to 96 hours after the last treatment.
Danish: Behandling med anidulafungin forlængede overlevelsen og reducerede også organskaden af Candida-arter, når den blev målt ved intervaller fra 24-96 timer efter sidste behandling.
English: Anidulafungin is a semi-synthetic echinocandin, a lipopeptide synthesised from a fermentation product of Aspergillus nidulans.
Danish: Anidulafungin er et semisyntetisk echinocandin, et lipopeptid syntetiseret fra et fermenteringsprodukt af Aspergillus nidulans.
English: ECALTA has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis.
Danish: ECALTA er ikke blevet undersøgt hos patienter med Candida endocarditis, osteomyelitis eller menigitis.
English: However, in animal experiments these mutations confer cross resistance to all three echinocandins and therefore such isolates are classified as echinocandin resistant until further clinical experience are obtained concerning anidulafungin.
Danish: Ved eksperimenter på dyr har disse mutationer imidlertid været forbundet med krydsresistens over for alle 3 echinocandiner, og derfor klassificeres sådanne isolater som echinocandin-resistente, indtil der er opnået mere klinisk erfaring med anidulafungin.
English: This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler eller elektrolytter end dem, der er anført under pkt.
English: Developmental effects observed in rabbits (slightly reduced foetal weights) occurred only at the highest dose tested, a dose that also produced maternal toxicity.
Danish: Udviklingspåvirkning, der er set hos kaniner (let reduceret fødselsvægt), opstod kun ved den højeste undersøgte dosis, der også producerede materneltoksicitet.
English: The treatment starts with 200 mg on the first day (loading dose).
Danish: Behandlingen starter med 200 mg den første dag (startdosis).
English: ECALTA must not be administered as a bolus injection.
Danish: ECALTA må ikke administreres som bolusinjektion.
English: Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were specifically excluded from the study.
Danish: Patienter med Candida-endocarditis, osteomyelitis eller meningitis eller patienter inficeret med C. krusei blev specifikt ekskluderet af studiet.
English: In general, your treatment should continue for at least 14 days after the last day Candida was found in your blood.
Danish: Du vil sædvanligvis blive behandlet i mindst 14 dage efter den sidste dag, hvor der er fundet Candida i blodet.
English: Isolates with mutations in the hot spot regions of the target gene have been associated with clinical failures or breakthrough infections.
Danish: Isolater med mutationer i hotspot-områderne i målgenet er blevet forbundet med klinisk svigt eller gennembrudsinfektion.
English: Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided that they were able to tolerate oral medicinal products and were afebrile for at least 24 hours, and that the most recent blood cultures were negative for Candida species.
Danish: Patienter i begge behandlingsgrupper fik tilladelse til at skifte til oral fluconazol efter mindst 10 dages intravenøs behandling på betingelse af, at de kunne tåle orale lægemidler, og at de var afebrile i mindst 24 timer, samt at den seneste bloddyrkning var negativ for Candida-arter.
English: Activity in vitro
Danish: In vitro-aktivitet
English: 3 in 22 patients or classified by the investigator as neutropenic at baseline in 13 patients.
Danish: 3 hos 22 patienter eller klassificeret som neutropene ved baseline af investigator for 13 patienter.
English: The in vitro activity of anidulafungin against Candida species is not uniform.
Danish: Anidulafungins in vitro-aktivitet over for forskellige Candida-arter er ikke ensartet.
English: Therefore ECALTA is not recommended during pregnancy.
Danish: Derfor bør ECALTA ikke bruges under graviditet.
English: Efficacy data, both overall and by various subgroups, are presented below in Table 3.
Danish: Effektdata, både totalt og i forskellige undergrupper, ses i skema 3 nedenfor.
English: Parenterally administered anidulafungin was effective against Candida species in immunocompetent and immunocompromised mouse and rabbit models.
Danish: Parenteralt administreret anidulafungin var virksomt over for Candida-arter i immunkompetente og immunkompromitterede modeller med mus og kaniner.
English: - Life-threatening allergic reactions
Danish: - Livstruende allergiske reaktioner
English: Administration of anidulafungin to rats did not indicate any effects on reproduction, including male and female fertility.
Danish: Administration af anidulafungin til rotter tyder ikke på påvirkning af reproduktion, herunder fertilitet hos hanner og hunner.
English: Rate of Successful Global Response a and All-Cause Mortality in Patients with Deep Tissue Candidiasis - Pooled Analysis MITT Population n/N (%)
Danish: Succesfuld global responsrate a og mortalitet uanset årsag hos patienter med candidiasis i dybtliggende væv - samlet analyse MITT-population n/N (%)
English: Plasma concentrations of anidulafungin in healthy men and women were similar.
Danish: Plasmakoncentrationen af anidulafungin var den samme hos raske mænd og kvinder.
English: Overall study mortality Mortality during study therapy Mortality attributed to Candida infection
Danish: Samlet mortalitet i studiet Mortalitet under forsøgsbehandling Mortalitet tilskrevet Candida-infektion
English: Cases of significant hepatic dysfunction, hepatitis, and hepatic failure were uncommon in clinical trials.
Danish: Tilfælde af signifikant leverdysfunktion, hepatitis og leversvigt var ikke almindelige i kliniske studier.
English: Steady state was achieved on the first day after a loading dose (twice the maintenance dose), and steady state Cmax and AUCss increase in a dose-proportional manner.
Danish: Steady state blev opnået den første dag efter en initialdosis (2 gange vedligeholdelsesdosis), og steady state Cmax og AUCss steg dosisproportionalt.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of anidulafungin in milk.
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at anidulafungin udskilles i mælk.
English: ECALTA should not be given to patients under 18 years of age.
Danish: ECALTA må ikke bruges til børn og unge under 18 år.
English: Bronchospasm, Dyspnoea
Danish: Bronkospasme, dyspnø
English: Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose.
Danish: Koncentrationen af anidulafungin faldt til under den nedre detektionsgrænse 6 dage efter dosisindgift.
English: The pharmacokinetics of anidulafungin after at least 5 daily doses were investigated in 24 immunocompromised paediatric (2 to 11 years old) and adolescent (12 to 17 years old) patients with neutropenia.
Danish: Farmakokinetikken af anidulafungin blev undersøgt efter mindst 5 daglige doser hos 24 immunkompromitterende børn (2-11 år) og unge (12-17 år) med neutropeni.
English: - The active substance is anidulafungin.
Danish: - Aktivt stof: anidulafungin.
English: Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
Danish: Anidulafungin er ikke et klinisk betydende substrat, en induktor eller hæmmer af cytochrom P450isoenzymerne (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
English: Minimum duration of infusion
Danish: Mindste varighed af Infusionen
English: Patients with increased hepatic enzymes during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy.
Danish: Patienter med stigning i leverenzymer under behandling med anidulafungin skal monitoreres for tegn på forværring af leverfunktionen og risk/benefit-forholdet ved fortsat anidulafungin-behandling vurderes.
English: The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to 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) and from spontaneous reports with frequency not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opført i henhold til MedDRA og opdelt i henhold til følgende frekvens: 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 (<1/10.000) samt fra spontan rapportering angivet med frekvensen ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Anidulafungin is not hepatically metabolised.
Danish: Anidulafungin metaboliseres ikke hepatisk.
English: Mortality rates in both the anidulafungin and fluconazole arms are presented below in Table 4:
Danish: Mortalitetsrater i både anidulafungingruppen og fluconazolgruppen er anført i skema 4 nedenfor.
English: 3 at baseline) with invasive candidiasis was assessed in a prospective, double-blind, randomized, controlled trial.
Danish: 3 ved baseline) med invasiv candidiasis blev vurderet i et prospektivt, dobbeltblindt, randomiseret, kontrolleret studie.
English: Experimental infections included disseminated C. albicans infection in neutropenic rabbits, oesophageal/oropharyngeal infection of neutropenic rabbits with fluconazole-resistant C. albicans and disseminated infection of neutropenic mice with fluconazole-resistant C. glabrata.
Danish: Eksperimentelle infektioner omfattede dissemineret C. albicans-infektion i neutropene kaniner, øsofageal/orofaryngeal-infektion af neutropene kaniner med fluconazol-resistente C. albicans og dissemineret infektion af neutropene mus med fluconazol-resistente C. glabrata.
English: Embryo-foetal development studies were conducted with doses between 0.2- and 2-fold (rats) and between 1- and 4-fold (rabbits) the proposed therapeutic maintenance dose of 100 mg/day.
Danish: Studier af embryoets/fostrets udvikling blev udført med doser på 0,2-2 gange (rotter) og 1-4 gange (kaniner) den foreslåede terapeutiske vedligeholdelsesdosis på 100 mg/døgn.
English: In vivo, the ring-opened product is subsequently converted to peptidic degradants and eliminated mainly through biliary excretion.
Danish: In vivo omdannes det ring-åbnede peptid efterfølgende til petid-nedbrydningsprodukter, og bliver hovedsageligt elimineret ved udskillelse gennem galden.
English: Additional Data in Patients with Deep Tissue Infections
Danish: Yderligere data for patienter med infektioner i dybtliggende væv
English: The steady state was achieved on the first day after a loading dose (twice the daily maintenance dose).
Danish: Steady state blev opnået den første dag efter initialdosis (dobbelt daglig vedligeholdelsesdosis).
English: Candidaemia and other forms of Invasive Candidiasis The safety and efficacy of anidulafungin were evaluated in a pivotal Phase 3, randomised, doubleblind, multicentre, multinational study of primarily non-neutropenic patients with candidaemia and a limited number of patients with deep tissue Candida infections or with abscess-forming disease.
Danish: Candidæmi og andre former for invasiv candidiasis Sikkerhed og effekt af anidulafungin er vurderet i et pivotal fase 3, randomiseret, dobbeltblindt, multicenter, multinationalt studie hos primært non-neutropene patienter med candidæmi og et begrænset antal patienter med Candida-infektioner i dybtliggende væv eller med abscesdannende tilstande.
English: - Low blood potassium (hypokalaemia) - Diarrhoea - Nausea
Danish: - For lavt kaliumindhold i blodet (hypokaliæmi) - Diarré - Kvalme
English: Diarrhoea, Nausea
Danish: Diarré, kvalme
English: All patients were treated for at least 14 days.
Danish: Alle patienter blev behandlet i mindst 14 dage.
English: No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let, moderat eller svært nedsat leverfunktion.
English: It is unlikely that anidulafungin will have clinically relevant effects on the metabolism of drugs metabolised by cytochrome P450 isoenzymes.
Danish: Det er ikke sandsynligt, at anidulafungin vil have klinisk betydende effekt på metabolismen af lægemidler, der metaboliseres via cytochrom P450-isoenzymer.
English: Anidulafungin is not dialysable and may be administered without regard to the timing of hemodialysis.
Danish: Anidulafungin er ikke dialyserbar, og kan gives uden hensyn til tidspunktet for hæmodialyse.
English: Infusion solution concentration is 0.77 mg/mL
Danish: Koncentration af infusionsopløsning er 0,77 mg/ml.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ecalta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre, eller behandling med ECALTA seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The solution should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Opløsningen bør kontrolleres visuelt for partikler og misfarvning før administration.
English: There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
Danish: Data for anvendelse af doser på 100 mg i mere end 35 dage er utilstrækkelige.
English: For instructions on reconstitution of the medicinal product before administration (see section 6.6).
Danish: For instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: Excipient with known effect: Fructose 102.5 mg per vial
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Fructose 102,5 mg pr. hætteglas
English: The population pharmacokinetic analysis showed that median clearance differed slightly between the elderly group (patients ≥ 65, median CL = 1.07 l/h) and the non-elderly group (patients < 65, median CL = 1.22 l/h), however the range of clearance was similar.
Danish: I den populationsfarmakokinetiske analyse var forskellen i den mediane clearance mellem ældregruppen (patienter ≥65 år, median CL=1,07 l/time) og ikke-ældregruppen (patienter <65 år, median CL=1,22 l/time) lille, mens spredningen af clearance var den samme.
English: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Danish: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgien
English: Patients were treated for at least 14 days.
Danish: Patienterne blev behandlet i mindst 14 dage.
English: The pharmacokinetics of anidulafungin are characterised by a rapid distribution half-life (0.5-1 hour) and a volume of distribution, 30-50 l, which is similar to total body fluid volume.
Danish: Anidulafungins farmakokinetik er karakteriseret ved en hurtig distributionshalveringstid (0,5-1 time) og et fordelingsvolumen på 30-50 l, svarende til kroppens totale væskevolumen.
English: Ask your doctor or pharmacist for advice before taking any medicines.
Danish: Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.
English: Hepatic metabolism of anidulafungin has not been observed.
Danish: Der er ikke observeret hepatisk metabolisme af anidulafungin.
English: 3 or WBC ≤ 500 cells/mm
Danish: 3 eller hvide blodceller ≤ 500 celler/mm
English: EUCAST has not determined non-species related breakpoints for anidulafungin
Danish: EUCAST har ikke fastlagt ikke-artsrelaterede grænseværdier for anidulafungin.
English: Anidulafungin displays linear pharmacokinetics across a wide range of once daily doses (15-130 mg).
Danish: Anidulafungin udviser lineær farmakokinetik over et bredt spektrum af doser givet 1 gang dagligt (15130 mg).
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Danish: 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering..
English: The effect of ECALTA in pregnant women is not known.
Danish: Virkningen af ECALTA på gravide kvinder kendes ikke.
English: Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikke ECALTA efter den udløbsdato, der står på pakningen.
English: The reconstituted solution contains 3.33 mg/mL anidulafungin and the diluted solution contains 0.77 mg/mL anidulafungin.
Danish: Den rekonstituerede opløsning indeholder 3,33 mg/ml anidulafungin, og den fortyndede opløsning indeholder 0,77 mg/ml anidulafungin.
English: The successful global response rate at the end of intravenous treatment (primary endpoint) and end of all treatment and all-cause mortality up to the 6 week follow-up visit is shown in Table 5.
Danish: Den succesfulde globale responsrate ved afslutning af intravenøs behandling (primære endemål) og ved afslutning af al behandling, samt mortalitet uanset årsag frem til opfølgningsbesøget ved uge 6fremgår af skema 5.
English: Anidulafungin crossed the placental barrier in rats and was detected in foetal plasma.
Danish: Anidulafungin krydser placentabarrieren hos rotter, og det er målt i fosterplasma.
English: Anidulafungin exhibited in-vitro activity against C. albicans, C. glabrata, C. parapsilosis, C. krusei and C. tropicalis.
Danish: Anidulafungin udviser in vitro-aktivitet over for C. albicans, C. glabrata, C. parapsilosis, C. krusei og C. tropicalis.
English: Do not use ECALTA - if you are allergic to anidulafungin, other echinocandins (e.g.caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for anidulafungin, andre echinocandiner (f.eks. capsofunginacetate) eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: In the primary efficacy analysis, global response in the MITT populations at the end of intravenous therapy, anidulafungin was compared to fluconazole in a pre-specified twostep statistical comparison (non-inferiority followed by superiority).
Danish: I den primære effektanalyse, blev det globale respons for anidulafungin sammenlignet med fluconazol i MITT-populationer ved afslutning af intravenøs behandling i en præ-specifik statistisk sammenligning i 2 trin (non-inferioritet efterfulgt af superioritet).
English: Specifically, for C. parapsilosis, the MICs of anidulafungin are higher than are those of other Candida species.
Danish: Specifikt gælder det for C. parapsilosis, at de mindste hæmmende koncentrationer (MIC) af anidulafungin er højere end for andre Candida-arter.
English: In a clinical study of subjects with mild, moderate, severe or end stage (dialysis-dependent) renal insufficiency, anidulafungin pharmacokinetics were similar to those observed in subjects with normal renal function.
Danish: I et klinisk studie med forsøgspersoner, der har let, moderat, svær eller end-stage (dialyseafhængig) nedsat nyrefunktion var anidulafungins farmakokinetik den samme som hos forsøgspersoner med normal nyrefunktion.
English: No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis.
Danish: Dosisjustering er ikke nødvendig hos patienter med alle grader af nedsat nyrefunktion, herunder patienter i dialyse.