FrancophonIA/ELRC3.0 huggingface dataset:
English: If the 50-mg/m2 daily dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg/m2 daily (not to exceed an actual daily dose of 70 mg).
Danish: Hvis den daglige dosis på 50 mg/m2 tåles godt men ikke giver tilstrækkelig klinisk respons, kan den daglige dosis øges til 70 mg/m2 dagligt (som ikke må overstige den faktiske daglige dosis på 70 mg).
English: The favourable response rate, by indication, at the end of caspofungin therapy was as follows in the MITT analysis: 81 % (30/37) in invasive candidiasis, 50 % (5/10) in invasive aspergillosis, and 100 % (1/1) in esophageal candidiasis.
Danish: Den gunstige responsfordeling, i henhold til indikation, var ved afslutningen af caspofunginbehandlingen følgende i MITT-analysen: 81% (30/37) ved invasiv candidiasis, 50% (5/10) ved invasiv aspergillosis og 100% (1/1) ved candidiasis i øsofagus.
English: Anaphylaxis has been reported during administration of caspofungin.
Danish: Der er rapporteret om anafylaksi under administration af caspofungin.
English: In clinical studies, caspofungin did not induce the CYP3A4 metabolism of other substances.
Danish: I kliniske undersøgelser, inducerede caspofungin ikke CYP3A4 metabolisme af andre stoffer.
English: Isolates of Candida with reduced susceptibility to caspofungin have been identified in a small number of patients during treatment (MICs for caspofungin >2 mg/L (4- to 30-fold MIC increases) have been reported using standardized MIC testing techniques approved by the CLSI).
Danish: Under behandling er der identificeret Candida-isolater med reduceret følsomhed over for caspofungin hos et lille antal patienter (MIC-værdier for caspofungin > 2 mg/l (stigning på 4 til 30 gange i MIC) er rapporteret ved anvendelse af standardiserede MIC-testteknikker godkendt af CLSI).
English: However, variability was seen in both C1 hr (Day 4 geometric mean 11.73 µg/mL, range 2.63 to 22.05 µg/mL) and C24 hr (Day 4 geometric mean 3.55 µg/mL, range 0.13 to 7.17 µg/mL).
Danish: Dog sås variationer både i C1t (Dag 4 geometrisk gennemsnit 11,73 µg/ml, spænd 2,63 til 22,05 µg/ml) og C24t (Dag 4 geometrisk gennemsnit 3,55 µg/ml, spænd 0,13 til 7,17 µg/ml).
English: The overall success rates in the MITT analysis results, adjusted by risk strata, were as follows: 46.6 % (26/56) for caspofungin and 32.2 % (8/25) for liposomal amphotericin B.
Danish: Overordnet var succesraten i MITT-analyseresultaterne, justeret i henhold til risikostrata, følgende: 46,6% (26/56 for caspofungin og 32,2% (8/25) for liposomal amphotericin B.
English: An overall favourable response required meeting each of 5 criteria: (1) successful treatment of any baseline fungal infection (caspofungin 51.9 % [14/27], liposomal amphotericin B 25.9 % [7/27]), (2) no breakthrough fungal infections during administration of study drug or within 7 days after completion of treatment (caspofungin 94.8 % [527/556], liposomal amphotericin B 95.5 % [515/539]), (3) survival for 7 days after completion of study therapy (caspofungin 92.6 % [515/556], liposomal amphotericin B 89.2 % [481/539]), (4) no discontinuation from the study drug because of drug-related toxicity or lack of efficacy (caspofungin 89.7 % [499/556], liposomal amphotericin B 85.5 % [461/539]), and (5) resolution of fever during the period of neutropaenia (caspofungin 41.2 % [229/556], liposomal amphotericin B 41.4 % [223/539]).
Danish: Et samlet fordelagtigt respons krævede at alle 5 kriterier var opfyldt: (1) succesfuld behandling af enhver baseline svampeinfektion (caspofungin 51,9% [14/27], liposomal amphotericin B 25,9% [7/27]), (2) ingen ny- eller genopstået svampeinfektion under administration af studiemedicinen og i op til 7 dage efter endt behandling (caspofungin 94,8% [527/556], liposomal amphotericin B 95,5% [515/539]), (3) overlevelse i 7 dage efter afsluttet behandling med studiemedicin (caspofungin 92,6% [515/556], liposomal amphotericin B 89,2% [481/539]), (4) ingen afbrydelse af behandling med studiemedicinen på grund af lægemiddelrelateret toksicitet eller manglende effekt caspofungin 89,7% [499/556], liposomal amphotericin B 85,5% [461/539]), og (5) resolution af feber i perioden med neutropeni (caspofungin 41,2% [229/556], liposomal amphotericin B 41,4% [223/539]).
English: Caspofungin Accord will always be prepared and given to you by a healthcare professional.
Danish: Det er altid sundhedspersonalet, der vil tilberede og give Dem Caspofungin Accord.
English: Race: Patient pharmacokinetic data indicated that no clinically significant differences in the pharmacokinetics of caspofungin were seen among Caucasians, Blacks, Hispanics, and Mestizos.
Danish: Race: Patientfarmakokinetiske data indikerer at der ikke er set klinisk signifikante forskelle i caspofungins farmakokinetik hos patienter af europæisk, negroid, sydamerikansk og sydamerikansk/indiansk afstamning.
English: The mean duration of intravenous therapy was 11.9 days, with a range of 1 to 28 days.
Danish: Gennemsnitsvarigheden af intravenøs behandling var 11,9 dage, med et variationsområde på 128 dage.
English: Stability data have shown that the concentrate for solution for infusion can be stored for up to 24 hours when the vial is stored at 25°C or less and reconstituted with water for injections.
Danish: Holdbarhedsundersøgelser har vist, at koncentratet til infusionsvæske kan opbevares i op til 24 timer, hvis det opbevares ved 25C eller mindre og rekonstitueres med vand til injektionsvæsker.
English: • Abnormal skin tissue, generalised itching, hives, rash of varying appearance, abnormal skin, red often itchy spots on your arms and legs and sometimes on the face and the rest of the body
Danish: • Unormalt hudvæv, udbredt kløe, nældefeber, forskellige former for udslæt, unormal hud, røde og ofte kløende pletter på arme og ben og af og til i ansigtet og på resten af kroppen
English: • Decreased flow of bile, enlarged liver, yellowing of the skin and/or whites of the eyes, liver injury caused by a drug or chemical, liver disorder
Danish: • Nedsat mængde galde, forstørret lever, gulfarvning af huden og/eller det hvide i øjnene, leverskader forårsaget af et lægemiddel eller kemikalier, leversygdom
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan berøre op til 1 ud af 10 personer):
English: Data from 5 clinical studies completed in 171 paediatric patients suggest that the overall incidence of clinical adverse experiences (26.3%; 95% CI -19.9, 33.6) is not worse than reported for adults treated with caspofungin (43.1%; 95% CI -40.0, 46.2).
Danish: Data fra 5 kliniske studier hos 171 børn indikerer, at den overordnede incidens af kliniske bivirkninger (26,3%; 95%CI-19,9, 33,6) ikke er værre end for voksne i behandling med caspofungin (43,1%; 95% CI-40,0, 46,2).
English: * 10.5 mL should be used for reconstitution of all vials.
Danish: * der skal anvendes 10,5 ml ved rekonstitution af alle hætteglas.
English: EUCAST breakpoints have not yet been established for caspofungin, due to significant inter-laboratory variation in MIC ranges for caspofungin.
Danish: EUCASTgrænseværdier er endnu ikke fastlagt for caspofungin på grund af en betydelig variation mellem laboratorierne i grænseværdier for den mindste hæmmende koncentration (MIC-værdier).
English: Caspofungin Accord contains a medicine called caspofungin.
Danish: Caspofungin Accord indeholder et aktivt stof, der hedder caspofungin.
English: In adult patients with mild and moderate hepatic impairment, the AUC is increased about 20% and 75 %, respectively.
Danish: Hos voksne patienter med let til moderat nedsat leverfunktion øgedes AUC med hhv. ca. 20% og 75%.
English: • The active substance is caspofungin.
Danish: Aktivt stof: caspofungin.
English: • rash, itching, feeling warm, swelling of your face, lips or throat or difficulty breathing - you may be having a histamine reaction to the medicine.
Danish: • udslæt, kløe, varmefølelse, hævelse af ansigt, læber eller svælg eller vejrtrækningsbesvær - De kan have fået en histaminreaktion på medicinen.
English: • -if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for caspofungin eller et af de øvrige indholdsstoffer i Caspofungin
English: Repeated dose toxicity studies in rats and monkeys using doses up to 7-8 mg/kg given intravenously showed injection site reactions in rats and monkeys, signs of histamine release in rats, and evidence of adverse effects directed at the liver in monkeys.
Danish: Undersøgelser vedrørende toksicitet ved gentagne doser udført med rotter og aber, hvor der anvendtes doser på op til 7-8 mg/kg givet intravenøst, viste reaktioner fra injektionsstedet hos rotter og aber, tegn på histaminfrigørelse hos rotter, samt tegn på leverbivirkninger hos aber.
English: Limited data from population pharmacokinetics studies indicate that concomitant use of caspofungin with the inducers efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, or carbamazepine may result in a decrease in caspofungin AUC.
Danish: Begrænsede data fra populations-farmakokinetiske undersøgelser indikerer, at samtidig administration af caspofungin og induktorerne efavirenz, nevirapin, rifampicin, dexamethason, fenytoin eller carbamazepin kan resultere i et fald i caspofungins AUC.
English: • Changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood cells and white blood cells)
Danish: • Ændringer i nogle blodprøver (herunder blodplader, røde og hvide blodlegemer samt forstyrrelser i blodets størkningsevne)
English: The study compared caspofungin at 50 mg daily (following a 70-mg loading dose on Day 1) versus 150 mg daily in the treatment of invasive candidiasis.
Danish: Undersøgelsen sammenlignede caspofungin 50 mg dagligt (efter en startdosis på 70 mg på dag 1) versus 150 mg dagligt i behandlingen af invasiv candidiasis.
English: Of note, the efficacy and safety of caspofungin have not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age.
Danish: Bemærk at caspofungins effekt og sikkerhed ikke er blevet undersøgt i prospektive kliniske undersøgelser med nyfødte og spædbørn under 3 måneder.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial .
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: 564 febrile neutropaenic patients (empirical therapy study), 382 patients with invasive candidiasis, 228 patients with invasive aspergillosis, 297 patients with localised Candida infections, and 394 individuals enrolled in Phase I studies.
Danish: I alt 1.865 voksne personer modtog i kliniske undersøgelser enkeltdoser eller gentagne doser caspofungi: 564 patienter med febril neutropeni (undersøgelse med empirisk behandling), 382 patienter med invasiv candidiasis, 228 patienter med invasiv aspergillose, 297 patienter med lokaliserede Candida infektioner og 394 personer blev inkluderet i fase I undersøgelser.
English: There is limited treatment experience in patients 65 years of age and older (see section 5.2).
Danish: Erfaring med behandling af patienter ≥65 år er begrænset (se pkt.
English: • Sensation of fast or irregular heart beats, rapid heart beat, irregular heart beat, abnormal heart rhythm, heart failure
Danish: • Fornemmelse af hurtige og uregelmæssige hjerteslag, hurtigt hjerteslag, uregelmæssigt hjerteslag, unormal hjerterytme, hjertesvigt
English: This infection is caused by fungal (yeast) cells called Candida.
Danish: Denne infektion forårsages af en gærsvamp, som kaldes Candida.
English: In a multiple-dose study, a dose reduction of the daily dose to 35 mg in adult patients with moderate hepatic impairment has been shown to provide an AUC similar to that obtained in adult subjects with normal hepatic function receiving the standard regimen (see section 4.2).
Danish: Det er i en undersøgelse med gentagne doser vist, at en dosisreduktion af daglig dosis til 35 mg til voksne patienter med moderat nedsat leverfunktion giver et AUC svarende til det, der ses hos voksne forsøgspersoner med normal leverfunktion, der modtog standardbehandling (se pkt.
English: Moderate (creatinine clearance 31 to 49 mL/min), advanced (creatinine clearance 5 to 30 mL/min), and end-stage (creatinine clearance <10 mL/min and dialysis dependent) renal impairment moderately increased caspofungin plasma concentrations after single-dose administration (range: 30 to 49 % for AUC).
Danish: Moderat nedsat nyrefunktion (creatininclearance 3149 ml/min), fremskreden nyreinsufficiens (creatininclearance 5-30 ml/min) samt nedsat nyrefunktion i slutstadiet (creatininclearance <10 ml/min og dialyseafhængig) øgede i moderat grad plasmakoncentrationer af caspofungin efter administration af enkeltdosis (30 - 49% for AUC).
English: Limited data suggest that caspofungin at 25 mg/m2 daily in neonates and infants (less than 3 months of age) and 50 mg/m2 daily in young children (3 to 11 months of age) can be considered (see section 5.2).
Danish: Begrænsede data tyder på, at caspofungin 25 mg/m2 dagligt til nyfødte og spædbørn (under 3 måneder) og 50 mg/m2 dagligt til små børn (3-11 måneder) kan overvejes (se pkt.
English: In two clinical studies performed in healthy adult subjects, cyclosporin A (one 4 mg/kg dose or two 3 mg/kg doses 12 hours apart) increased the AUC of caspofungin by approximately 35 %.
Danish: I to kliniske undersøgelser med raske voksne frivillige, øgede ciclosporin A (en dosis a 4 mg/kg eller to doser a 3 mg/kg administreret med 12 timers mellemrum) caspofungins AUC med ca. 35%.
English: However, caspofungin has been shown to interact with other medicinal products in pharmacological and clinical studies (see below).
Danish: Der er dog i farmakologiske, og i kliniske, undersøgelser vist interaktion mellem caspofungin og andre lægemidler (se nedenfor).
English: When caspofungin is co-administered to paediatric patients (12 months to 17 years of age) with inducers of drug clearance, such as rifampicin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a caspofungin dose of 70-mg/m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
Danish: Når caspofungin administreres til børn (12 måneder til 17 år) sammen med induktorer af lægemiddelelimination, som rifampicin, efavirenz, neviparin, phenytoin, dexamethason eller carbamazepin, bør en caspofungindosis på 70 mg/m2 dagligt overvejes (må ikke overstige en faktisk daglig dosis på 70 mg).
English: In elderly patients (65 years of age or more), the area under the curve (AUC) is increased by approximately 30 %.
Danish: Arealet under kurven (AUC) øges med ca. 30% hos ældre patienter (≥65 år).
English: • Feeling dizzy, decreased feeling or sensitivity (especially in the skin), shaking, feeling sleepy, change in the way things taste, tingling or numbness
Danish: • Svimmelhed, nedsat følelse eller følsomhed (specielt i huden), rysten, søvnighed, smagsændring, snurrende eller sovende fornemmelse
English: Caspofungin has been shown to cross the placental barrier in animal studies.
Danish: Caspofungin er vist at passere placentabarrieren i dyreforsøg.
English: In a retrospective study of 40 patients treated during marketed use with caspofungin and cyclosporin for 1 to 290 days (median 17.5 days), no serious hepatic adverse reactions were noted.
Danish: I en retrospektiv undersøgelse af 40 patienter, som blev behandlet med caspofungin efter markedsføringen og ciclosporin i 1-290 dage (median 17,5 dage), blev der ikke observeret nogen alvorlige hepatiske bivirkninger.
English: Stability data have shown that the product can be used within 24 hours when stored at 25°C or less, or within 48 hours when the intravenous infusion bag (bottle) is stored refrigerated (2 to 8°C) and diluted with sodium chloride solution 9 mg/mL (0.9 %), 4.5 mg/mL (0.45 %), or 2.25 mg/mL (0.225 %) for infusion, or lactated Ringer's solution.
Danish: Holdbarhedsundersøgelser har vist at produktet kan anvendes inden for 24 timer hvis det opbevares ved 25C eller mindre, eller inden for 48 timer hvis den intravenøse infusionspose (flaske) opbevares i køleskab (2-8 C) og fortyndet med natrium chlorid 9 mg/ml (0,9%), 4,5 mg/ml (0,45%) eller 2,25 mg/ml (0,225%) infusionsvæske eller Ringer-lactat Infusionsvæske.
English: Store in a refrigerator (2C to 8C).
Danish: Opbevares i køleskab ved 2-8 C.
English: For all indications, a single 70-mg/m2 loading dose (not to exceed an actual dose of 70 mg) should be administered on Day 1, followed by 50 mg/m2 daily thereafter (not to exceed an actual dose of 70 mg daily).
Danish: For alle indikationer bør en enkelt mætningsdosis på 70 mg/m2 (som ikke må overstige en faktisk dosis på 70 mg) administreres på Dag 1 efterfulgt af 50 mg/m2 dagligt (som ikke må overstige en egentlig dosis på 70 mg dagligt).
English: Some healthy adult volunteers who received two 3 mg/kg doses of cyclosporin with caspofungin showed transient increases in alanine transaminase (ALT) and aspartate transaminase (AST) of less than or equal to 3-fold the upper limit of normal (ULN) that resolved with discontinuation of the treatment.
Danish: Nogle raske voksne frivillige, der fik ciclosporin 2 doser a 3 mg/kg sammen med caspofungin, viste forbigående stigninger i alanin transaminase (ALAT) og aspartat transaminase (ASAT) på op til 3 gange den øvre grænse i normalområdet, som svandt ved seponering.
English: Caution should apply in patients with history of allergic skin reaction (see section 4.8).
Danish: Der skal udvises forsigtighed hos patienter med allergiske hudreaktioner i anamnesen (se pkt.
English: Toxic epidermal necrolysis and StevensJohnson syndrome (see section 4.4)
Danish: Toksisk epidermal nekrolyse og Stevens-Johnsons syndrom (se pkt.
English: There is no clinical experience in adult patients with severe hepatic impairment (Child-Pugh score greater than 9) and in paediatric patients with any degree of hepatic impairment (see section 4.4).
Danish: Der er ingen klinisk erfaring hos voksne patienter med svært nedsat leverfunktion (Child-Pugh score større end 9) og hos børn med alle grader af nedsat leverfunktion (se pkt.
English: • If you get any side effects, talk to your doctor, nurse or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: * 10.5 mL should be used for reconstitution of all vials
Danish: * der skal anvendes 10,5 ml ved rekonstitution af alle hætteglas
English: Reduced volume infusion (reconstituted Caspofungin Accord added to 100 mL) final concentration
Danish: Reduceret infusionsvolumen (rekonstitueret Caspofungin Accord overført til 100 ml) endelig koncentration
English: DO NOT MIX OR CO-INFUSE CASPOFUNGIN ACCORD WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of Caspofungin Accord with other intravenous substances, additives, or medicinal products.
Danish: CASPOFUNGIN ACCORD MÅ IKKE BLANDES ELLER INFUNDERES SAMMEN MED ANDEN MEDICIN, da der ikke findes data vedrørende forligelighed mellem Caspofungin Accord og andre intravenøse substanser, tilsætningsstoffer eller lægemidler.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige (kan berøre op til 1 ud af 100 personer):
English: An initial 70 mg loading dose should be administered on Day-1.
Danish: Initial mætnings dosis på 70 mg bør administreres på Dag 1.
English: DO NOT MIX OR CO-INFUSE Caspofungin Accord WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of Caspofungin Accord with other intravenous substances, additives, or medicinal products.
Danish: CASPOFUNGIN ACCORD MÅ IKKE BLANDES ELLER INFUNDERES SAMMEN MED ANDEN MEDICIN, da der ikke findes data vedrørende forligelighed mellem Caspofungin Accord og andre intravenøse substanser, tilsætningsstoffer eller medicin.
English: Caspofungin Accord makes fungal cells fragile and stops the fungus from growing properly.
Danish: Caspofungin Accord svækker svampecellerne og forhindrer dermed svampen i at vokse.
English: Hepatic impairment: In adult patients with mild and moderate hepatic impairment, the AUC is increased about 20 and 75 %, respectively.
Danish: Nedsat leverfunktion: Hos voksne patienter med let til moderat nedsat leverfunktion øgedes AUC med hhv. ca. 20 og 75%.
English: It should be used in pregnancy only if the potential benefit justifies the potential risk to the unborn baby.
Danish: Caspofungin Accord, hvis det skønnes, at fordelene opvejer den mulige risiko for det ufødte barn.
English: Standard preparation (reconstituted Caspofungin Accord added to 250 mL) final concentration
Danish: Standard fremstilling (rekonstitueret Caspofungin Accord overført til 250 ml) endelig koncentration
English: The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 mL infusion bag or bottle.
Danish: Infusionsopløsningen tilberedes ved aseptisk at tilsætte den foreskrevne mængde af rekonstitueret koncentrat (som vist i tabellen nedenfor) til en 250 ml infusionspose eller -flaske.
English: • Decreased haemoglobin (decreased oxygen carrying substance in the blood), decreased white blood cells
Danish: • Nedsat indhold af hæmoglobin i blodet (det stof, der fører ilt rundt i blodet), nedsat antal hvide blodlegemer
English: Unopened vials: store in a refrigerator 2°C - 8°C).
Danish: Uåbnede hætteglas: Opbevares i køleskab (2 - 8°C).
English: • Changes in some laboratory blood tests (increased values of some liver tests)
Danish: • Ændringer i nogle blodprøver (forhøjede værdier af visse levertal)
English: Candida species (Candida albicans [N = 1,032], Candida dubliniensis [N = 100], Candida glabrata [N = 151], Candida guilliermondii [N = 67], Candida kefyr [N = 62], Candida krusei [N = 147], Candida lipolytica [N = 20], Candida lusitaniae [N = 80], Candida parapsilosis [N = 215], Candida rugosa [N = 1], and Candida tropicalis [N = 258]), including isolates with multiple resistance transport mutations and those with acquired or intrinsic resistance to fluconazole, amphotericin B, and 5-flucytosine.
Danish: Caspofungin virker in vitro også mod Candidaarter (Candida albicans N = 1032, Candida dubliensis N = 100, Candida glabrata N = 151, Candida guilliermondii N = 67, Candida kefyr N = 62, Candida krusei N = 147, Candida lipolytica N = 20, Candida lusitaniae N = 80, Candida parapsilosis N = 215, Candida rugosa N = 1 og Candida tropicalis
English: For caspofungin, there were no effects on fertility in studies conducted in male and female rats up to 5 mg/kg/day.
Danish: I studier udført med han- og hunrotter var der ingen virkning på fertiliteten med caspofungin op til 5 mg/kg/dag.