FrancophonIA/ELRC3.0 huggingface dataset:
English: With the 200/100 mg daily dose regimen at an infusion rate of 1.1 mg/min, the steady state Cmax and trough concentrations (Cmin) could reach approximately 7 and 3 mg/l, respectively, with an average steady state AUC of approximately 110 mgh/l.
Danish: Med et dagligt dosisregimen på 200/100 mg og en infusionshastighed på 1,1 mg/min kunne en steady state Cmax på ca. 7 mg/l og en Cmin på ca. 3 mg/ml opnås med en gennemsnitlig steady state AUC på ca. 110 mg time/l.
English: Rats in the high dose group experienced infusion-related reactions that were exacerbated by anaesthesia.
Danish: Rotter i højdosis-gruppen oplevede infusionsrelaterede bivirkninger, der blev forværret af anæstesien.
English: However, brain concentrations increased in uninfected neonatal rats after five daily doses (brain to plasma ratio of approximately 0.7).
Danish: Koncentrationen i hjernen øgedes dog hos uinficerede nyfødte rotter efter 5 daglige doser (hjerne:plasma-ratio på ca. 0,7).
English: Although weight was identified as a source of variability in clearance in the population pharmacokinetic analysis, weight has little clinical relevance on the pharmacokinetics of anidulafungin.
Danish: Selvom det i en populationsfarmakokinetisk analyse blev fundet, at vægten var årsag til variabilitet i clearance, har vægten kun ringe klinisk betydning for anidulafungins farmakokinetik.
English: In multiple dose studies in rabbits with disseminated candidiasis and in mice with CNS candida infection, anidulafungin has been shown to reduce fungal burden in the brain.
Danish: I fler-dosisstudier med kaniner med dissemineret candidiasis samt hos mus med candidainfektion i centralnervesystemet er det vist, at anidulafungin kan reducere svampebelastningen i hjernen.
English: Patients with fungal infections
Danish: Patienter med svampeinfektioner
English: All-cause mortality up to the 6 Week FollowUp visit for anidulafungin (MITT population) was 4/11 (36.4%) and 2/3 (66.7%) for caspofungin.
Danish: Mortalitet uanset årsag frem til opfølgningsbesøget ved uge 6 var 4/11 (36,4 %) for anidulafungin (MITT-population) og 2,3 (66,7 %) for caspofungin.
English: Global Response of Success at EOT All-Cause Mortality
Danish: Succesfuldt globalt respons ved EOT Mortalitet uanset årsag
English: Neutropenic (ANC, cells/mm At Other Endpoints End of All Therapy e
Danish: Non-neutropene (ANC, celler/mm Neutropene (ANC, celler/mm Ved andre endemål Afslutning af al behandling e
English: Dilution and infusion
Danish: Fortynding og infusion
English: Alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholestasis
Danish: Forhøjet alaninaminotransferase, forhøjet serum alkalisk fosfatase, forhøjet aspartataminotransferase, forhøjet serumbilirubin, kolestase
English: The following information is intended for medical or healthcare professionals only and applies only to the single vial ECALTA 100 mg powder for concentrate for solution for infusion presentation:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale og gælder kun for et enkelt hætteglas ECALTA 100 mg pulver til koncentrat til infusionsvæske, opløsning:
English: Anidulafungin selectively inhibits 1,3-β-D glucan synthase, an enzyme present in fungal, but not mammalian cells.
Danish: Anidulafungin hæmmer selektivt 1,3-β-D-glucan-syntase, et enzym, der findes i svamp, men ikke i pattedyrceller.
English: In vitro and in vivo genotoxicity studies with anidulafungin provided no evidence of genotoxic potential.
Danish: In vitro- og in vivo-genotoksicitetsstudie med anidulafungin viser ingen tegn på genotoksicitet.
English: Systemic exposure following daily maintenance dose of 0.75 and 1.5 mg/kg/day in this population were comparable to those observed in adults following 50 and 100 mg/day, respectively.
Danish: I denne population er systemisk eksponering efter daglig vedligeholdelsesdosis på 0,75 mg/kg/dag og 1,5 mg/kg/dag sammenlignelig med den, der ses hos voksne, der får henholdsvis 50 mg/dag og 100 mg/dag.
English: Your doctor may prescribe another medicine following your treatment with ECALTA to continue treating your fungal infection or prevent it from returning.
Danish: Lægen vil måske give dig anden medicin, når du har stoppet behandlingen med ECALTA for at forhindre, at svampeinfektionen kommer igen.
English: Treatment of invasive candidiasis in adult patients (see sections 4.4 and 5.1).
Danish: Behandling af invasiv candidiasis hos voksne patienter (se pkt.
English: However tell your doctor or pharmacist if you think that a dose has been forgotten.
Danish: Spørg lægen, hvis du mener, at en dosis er blevet glemt.
English: Fructose content
Danish: Fructoseindhold
English: The pharmacokinetics of anidulafungin have been characterised in healthy subjects, special populations and patients.
Danish: Anidulafungins farmakokinetik er beskrevet hos raske forsøgspersoner, i specielle populationer og hos patienter.
English: In the clinical trials the outcome for anidulafungin with C. parapsilosis was not statistically different from other species however, the use of echinocandins in candidaemia due to C. parapsilosis may not be regarded as therapy of first choice
Danish: I de kliniske studier var udfaldet for anidulafungin med C. parapsilosis ikke statistisk forskelligt fra andre arter, men echinocandiner bør ikke betragtes som førstevalg til behandling af candidæmi forårsaget af C. parapsilosis.
English: A total of 14 neutropenic patients with microbiologically confirmed invasive candidiasis (MITT population) were enrolled in the study (11 anidulafungin; 3 caspofungin).
Danish: I alt 14 neutropene patienter med mikrobiologisk bekræftet invasiv candidiasis (MITT-population) blev inkluderet i studiet (11 anidulafungin, 3 caspofungin).
English: This will be followed by a daily dose of 100 mg (maintenance dose).
Danish: Derefter vil du få 100 mg dagligt (vedligeholdelsesdosis).
English: 30 mL Type 1 glass vial with an elastomeric stopper (butyl rubber with an inert polymer coating on the product contact surface and lubricant on the top surface for easier machinability, or alternatively bromobutyl rubber with a lubricant) and aluminium seal with flip-off cap.
Danish: 30 ml hætteglas (type 1glas) med elastomer-prop (butylgummi med en inaktiv polymerfilm på kontakt fladen til præparatet og med lubrikant på den udvendige overflade for at lette maskinpåsætning af prop eller alternativt af bromobutylgummi med lubrikant) og aluminiumsforsegling med flip-off hætte.
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Danish: Parenterale lægemidler skal kontrolleres visuelt for partikler og misfarvning før administration, når opløsning og beholder tillader det.
English: Although a slight decrease in AUC was observed in patients with Child-Pugh C hepatic insufficiency, the decrease was within the range of population estimates noted for healthy subjects.
Danish: Skønt der ses et lille fald i AUC hos patienter med Child-Pugh C nedsat leverfunktion, er faldet inden for de grænser, der er estimeret hos raske forsøgspersoner.
English: Pharmacotherapeutic group: - Antimycotics for systemic use, other antimycotics for systemic use.ATC code: JO2AX06
Danish: Farmakoterapeutisk klassifikation: Echinocandiner (systemiske svampeinfektioner), ATC-kode: J02AX06.
English: If you get any side effects, talk to your doctor or, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: The successful global response rate at End of Intravenous Treatment and End of All Treatment were both 7/13 (53.8%) in the 13 patients with neutropenia assessed by investigators at baseline.
Danish: Den succesfulde globale responsrate var 7/13 (53,8 %) både ved afslutning af intravenøs behandling og ved afslutning af al behandling hos de 13 patienter med neutropeni, der blev vurderet af investigatorerne ved baseline.
English: The in vitro degradation half-life of anidulafungin under physiologic conditions is approximately 24 hours.
Danish: Under fysiologiske betingelser er anidulafungins nedbrydningshalveringstid ca. 24 timer in vitro.
English: Dosage adjustments are not required based on HIV positivity, irrespective of concomitant antiretroviral therapy.
Danish: hiv-status Dosisjustering er ikke nødvendig i tilfælde af hiv-infektion, uanset samtidig anti-retroviralbehandling.
English: ECALTA can be given without regard to the timing of haemodialysis (see section 5.2).
Danish: ECALTA kan gives uden hensyntagen til tidspunkt for dialyse (se pkt.
English: Talk to your doctor or pharmacist or nurse before using ECALTA.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De bruger ECALTA.
English: C. parapsilosis harbours an intrinsic alteration in the target gene, which is the likely mechanism for the higher MICs than with other Candida species.
Danish: Utilstrækkelig evidens C. parapsilosis har en iboende forandring i målgenet, som sandsynligvis er mekanismen bag de højere MIC-værdier sammenlignet med andre Candida-arter.
English: ECALTA contains fructose
Danish: ECALTA indeholder fructose
English: ECALTA should be reconstituted with water for injections to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL.
Danish: ECALTA skal rekonstitueres med vand til injektionsvæsker til en koncentration på 3,33 mg/ml, og derefter fortyndes til en koncentration på 0,77 mg/ml.
English: No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly (see section 5.2).
Danish: Dosisjustering på grund af køn, vægt, race, hiv-status og alder er ikke nødvendig hos voksne patienter (se pkt.
English: The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 18/35 (51.4%) and 16/35 (45.7%) at the End of All Treatment.
Danish: Den succesfulde globale responsrate ved afslutningen af intravenøs behandling (primære endemål) var 18/35 (51,4 %) og 16/35 (45,7 %) ved afslutningen af al behandling.
English: Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm and hypotension.
Danish: Der er rapporteret infusionsrelaterede reaktioner efter brug af anidulafungin, herunder udslæt, urticaria, flushing, pruritus, dyspnø, bronkospasmer og hypotension.
English: From a microbiological point of view, following good aseptic practices, the reconstituted solution can be utilized for up to 24 hours when stored at 25ºC.
Danish: Ud fra et mikrobiologisk synspunkt, og hvis god aseptisk praksis følges, kan den rekonstituerede opløsning anvendes i op til 24 timer, ved opbevaring ved 25 ºC.
English: Pfizer Pharma PFE GmbH
Danish: Pfizer Pharma GmbH
English: The most common pathogens isolated at baseline were C. tropicalis (4 anidulafungin, 0 caspofungin), C. parapsilosis (2 anidulafungin, 1 caspofungin), C. krusei (2 anidulafungin, 1 caspofungin), and C. ciferrii (2 anidulafungin, 0 caspofungin).
Danish: De hyppigst isolerede patogener ved baseline var C. tropicalis (4 anidulafungin, 0 caspofungin), C. parapsilosis (2 anidulafungin, 1 caspofungin), C. krusei (2 anidulafungin, 1 caspofungin) og C. ciferrii (2 anidulafungin, 0 caspofungin).
English: The infusion solution may be stored at 25ºC for 48 hours or stored frozen for at least 72 hours.
Danish: Infusionsopløsningen kan opbevares ved 25 ºC i 48 timer eller opbevares nedfrosset i mindst 72 timer.
English: Total infusion volume
Danish: Total infusionsvolumen
English: From a microbiological point of view, following good aseptic practices, the infusion solution can be utilized for up to 48 hours from preparation when stored at 25ºC.
Danish: Ud fra et mikrobiologisk synspunkt, og hvis god aseptisk praksis følges, kan infusionsopløsningen anvendes i op til 48 timer efter opblanding, når den opbevares ved 25 ºC.
English: There were no adverse reactions in the low-dose animals in the presence or absence of anaesthesia, and no infusion-related reactions in the mid-dose group in the absence of anaesthesia.
Danish: Der var ingen bivirkninger i lavdosis-gruppen uanset om de fik anæstesi eller ej, og ingen infusionsrelaterede bivirkninger i middeldosis-gruppen, når anæstesi ikke blev givet.
English: Excipients: fructose, mannitol, polysorbate 80, tartaric acid, NaOH and/or HCl.
Danish: Hjælpestoffer: fructose, mannitol, polysorbate 80, vinsyre, NaOH og/eller HCl.
English: In some patients with serious underlying medical conditions who were receiving multiple concomitant medicines along with anidulafungin, clinically significant hepatic abnormalities have occurred.
Danish: Hos visse patienter med alvorligt tilgrundliggende sygdom, som samtidigt fik flere slags medicin sammen med anidulafungin, forekom klinisk signifikant leverpåvirkning.
English: - Convulsion (seizure) - Headache - Vomiting - Changes in blood tests of liver function - Rash, pruritis (itching) - Changes in blood tests of kidney function - Abnormal flow of bile from the gallbladder into the intestine (cholestasis) - High blood sugar - High blood pressure - Low blood pressure - Sudden contraction of the muscles around the airways resulting in wheezing or coughing - Difficulty of breathing
Danish: - Kramper (anfald) - Hovedpine - Opkastning - Ændringer i blodprøver for leverfunktionen - Udslæt, kløe - Ændringer i blodprøver for nyrefunktionen - Unormal strøm af galde fra galdeblæren ind i tarmen (kolestase) - Højt sukkerindhold i blodet - Højt blodtryk - Lavt blodtryk - Pludselig sammentrækning af musklerne i luftvejene, der fører til hvæsende vejrtrækning eller hoste - Åndedrætsbesvær
English: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Danish: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgien
English: Other medicines and ECALTA
Danish: Brug af anden medicin sammen med ECALTA
English: The efficacy of anidulafungin in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm
Danish: Effekten af anidulafungin hos voksne neutropene patienter (defineret som absolut neutrofiltal ≤ 500 celler/mm
English: Gammaglutamyltrans ferase increased
Danish: Forhøjet gammaglutamyl -transferase
English: Pack size of 1 vial.
Danish: Pakningsstørrelse:1 hætteglas .
English: The most common pathogens isolated at baseline were C. tropicalis (12 patients), C. albicans (7 patients), C. glabrata (7 patients), C. krusei (7 patients), and C. parapsilosis (6 patients).
Danish: De hyppigst isolerede patogener ved baseline var C. tropicalis (12 patienter), C. albicans (7 patienter), C. glabrata (7 patienter), C. krusei (7 patienter) og C. parapsilosis (6 patienter).
English: Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes.
Danish: Anidulafungin er ikke et klinisk betydende substrat, en induktor eller hæmmer af cytochrom P450-isoenzymer.
English: The infusion solution may be stored at 25°C (room temperature) for 48 hours or stored frozen for at least 72 hours, and should be administered at 25C (room temperature) within 48 hours.
Danish: Infusionsopløsningen kan opbevares ved 25 °C i 48 timer eller nedfrosset i mindst 72 timer, og bør gives ved stuetemperatur (25 °C) inden for 48 timer.
English: During clinical trials, a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose.
Danish: I kliniske studier er en enkeltdosis på 400 mg ved en fejltagelse blevet givet som initialdosis.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Denne medicin bør ikke anvendes til patienter med hereditær fructoseintolerans.
English: All-cause mortality up to the end of the study (6 Week Follow-up Visit) was 21/46 (45.7%).
Danish: Mortalitet uanset årsag frem til studiets afslutning (opfølgningsbesøg ved uge 6) var 21/46
English: It is recommended that ECALTA be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions).
Danish: Det anbefales, at ECALTA administreres med en infusionshastighed, der ikke overstiger 1,1 mg/minut (svarende til 1,4 ml/minut efter rekonstitution og fortynding jvf.
English: What ECALTA contains
Danish: ECALTA indeholder:
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: The powder is white to off-white.
Danish: Pulveret er et hvidt til råhvidt pulver.
English: In case of overdose, adverse reactions may occur as mentioned in section 4.8.
Danish: I tilfælde af overdosering kan de bivirkninger, som er anført i pkt.
English: End of IV Therapy (1º endpoint) Candidaemia only Other sterile sites Peritoneal fluid/IA c abscess
Danish: Afslutning af i.v.-behandling (primære endemål) Kun candidæmi Andre sterile steder Peritonealvæske/IA
English: MIC breakpoint (mg/L) ≤S (Susceptible) >R (Resistant)
Danish: MIC-breakpoint (mg/l)
English: Very common side effects (may affect more than 1 in 10 people) are:
Danish: Meget almindelige bivirkninger (det sker hos flere end 1 ud af 10 behandlede):
English: Ethnicity Anidulafungin pharmacokinetics were similar among Caucasians, Blacks, Asians, and Hispanics.
Danish: Anidulafungins farmakokinetik var ens blandt personer af europæisk, sort, asiatisk og latinamerikansk afstamning.
English: Common to
Danish: Almindelig til
English: Patients were randomised to receive either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or fluconazole (800 mg intravenous loading dose followed by 400 mg intravenous daily), and were stratified by APACHE II score (≤20 and >20) and the presence or absence of neutropaenia.
Danish: Patienterne blev randomiseret til enten at få anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) eller fluconazol (800 mg intravenøs initialdosis efterfulgt af 400 mg intravenøst dagligt) og blev stratificeret ved APACHE II-score (20 og >20) og tilstedeværelse eller fravær af neutropeni.
English: The effect of ECALTA in breast-feeding women is not known.
Danish: Virkningen af ECALTA på ammende kvinder kendes ikke.
English: Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ringopened peptide that lacks antifungal activity.
Danish: Ved fysiologisk temperatur og pH undergår anidulafungin en langsom kemisk nedbrydning til et peptid med åben ring, som mangler fungicid aktivitet.
English: Nevertheless, care should be taken when co-administering anidulafungin and anaesthetic agents.
Danish: Alligevel tilrådes forsigtighed, når anidulafungin anvendes sammen med anæstetika.
English: A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Danish: En enkelt initialdosis på 200 mg bør administreres på dag 1.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om ECALTA på Det Europæiske Lægemiddelagenturs hjemmesidehttp://www.ema.europa.eu/
English: cells/mm or classified by the investigator as neutropenic at baseline) with microbiologically confirmed invasive candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative versus caspofungin and 4 open-label, non-comparative).
Danish: 500 celler/mm eller klassificeret af investigator som neutropene ved baseline) med mikrobiologisk bekræftet invasiv candidiasis blev vurderet i en analyse af indsamlede data fra 5 prospektive studier (1 komparativt versus caspofungin og 4 åbne, non-komparative studier).
English: If you stop using ECALTA You should not experience any effects from ECALTA if your doctor stops ECALTA treatment.
Danish: Du skulle ikke opleve nogle bivirkninger, når du stopper behandlingen med ECALTA.
English: Eligible patients received either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or caspofungin (70 mg intravenous loading dose followed by 50 mg intravenous daily) (2:1 randomization).
Danish: Egnede patienter fik enten anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) eller caspofungin (70 mg intravenøs initialdosis efterfulgt af 50 mg intravenøst dagligt) (2:1 randomisering).
English: The successful global response rate at End of Intravenous Treatment (primary endpoint) was 26/46 (56.5%) and End of All Treatment was 24/46 (52.2%).
Danish: Den succesfulde globale responsrate ved afslutning af intravenøs behandling (primært endemål) var 26/46 (56,5 %) og ved afslutning af al behandling 24/46
English: Infusion volume
Danish: Infusionsvolumen
English: The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult patients with microbiologically confirmed deep tissue candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative and 4 open-label).
Danish: Effekten af anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) hos voksne med mikrobiologisk bekræftet candidiasis i dybtliggende væv blev vurderet i en analyse af indsamlede data fra 5 prospektive studier (1 komparativt og 4 åbne studier).
English: The most common pathogens isolated at baseline were C. tropicalis (34.8%; 16/46), C. krusei (19.6%; 9/46), C. parapsilosis (17.4%; 8/46), C. albicans (15.2%; 7/46), and C. glabrata (15.2%; 7/46).
Danish: De hyppigst isolerede patogener ved baseline var C. tropicalis (34,8 %; 16/46), C. krusei (19,6 %; 9/46), C. parapsilosis (17,4 %; 8/46), C. albicans (15,2 %; 7/46) og C. glabrata (15,2 %; 7/46).
English: Patients with microbiologically confirmed invasive candidiasis (MITT population) and neutropenia were identified in an analysis of pooled data from 4 similarly designed prospective, open-label, noncomparative studies.
Danish: Patienter med mikrobiologisk bekræftet candidiasis (MITT-population) og neutropeni blev identificeret i en analyse af indsamlede data fra 4 prospektive, åbne, non-komparative studier med sammenligneligt design.
English: Ask your doctor or pharmacist for advice before taking ECALTA while breast-feeding.
Danish: Spørg lægen eller apoteket til råds, før du tager ECALTA, hvis du ammer.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret:
English: No clinical adverse reactions were reported.
Danish: Der blev ikke rapporteret om bivirkninger.
English: What you need to know before you use ECALTA
Danish: Det skal du vide, før du bliver behandlet med ECALTA
English: Anaphylacti c shock, anaphylactic reaction*
Danish: Anafylaktis k shock, anafylaktis k reaktion*
English: - The other ingredients are: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide
Danish: - Øvrige indholdsstoffer: Fructose, mannitol, polysorbat 80, vinsyre, natriumhydroxid (til pH-justering), saltsyre (til pHjustering)
English: Therefore, no information is available about the penetration of anidulafungin into the cerebrospinal fluid (CSF) and/or across the blood-brain barrier.
Danish: Der er ikke udført specifikke vævsdistributionsstudier med anidulafungin på mennesker, hvorfor der ikke findes information vedrørende anidulafungins penetration af cerebrospinalvæsken og/eller over blod-hjernebarrieren.
English: After subsequent dilution, the solution is to be discarded if particulate matter or discoloration is identified.
Danish: Opløsningen skal smides væk, hvis der ses partikler eller misfarvning.
English: In the 4 open-label studies, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Danish: I de 4 åbne studier var det tilladt at skifte til oral azolbehandling efter mindst 5-10 dage med anidulafungin.
English: Hypokalaemia Hyperglycaemia
Danish: Hyperglykæmi