FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism of resistance identified is FKS1 and/or FKS2 (for C. glabrata) gene mutations.
Danish: Den resistensmekanisme, der blev identificeret, er FKS1- og/eller FKS2-genmutation (for C. glabrata).
English: Gender: Caspofungin plasma concentrations were on average 17-38 % higher in women than in men.
Danish: Køn: Plasmakoncentrationer af caspofungin var gennemsnitligt 17-38% højere hos kvinder end hos mænd.
English: • Caspofungin Accord has not been studied in pregnant women.
Danish: • Caspofungin Accord er ikke undersøgt hos gravide kvinder.
English: Children and adolescents The dose for children and adolescents may differ from the adult dose.
Danish: Brug til børn og unge Dosis til børn og unge kan være forskellig fra den dosis, der bruges til voksne.
English: In this study, the caspofungin dose was administered over 2 hours (instead of the routine 1-hour administration).
Danish: I denne undersøgelse blev caspofungindosen administreret over 2 timer (i stedet for standardadministrationen over 1 time).
English: AUC0-24 hr measurements were not performed in this study due to the sparse plasma sampling.
Danish: Målinger vedrørende AUC0-24t blev ikke udført i denne undersøgelse på grund af ringe mængde plasmaprøver.
English: Inadvertent administration of up to 400 mg of caspofungin in one day has been reported.
Danish: Der er rapporteret utilsigtet administration af op til 400 mg caspofungin i løbet af en dag.
English: Pharmacotherapeutic group: antimycotics for systemic use, ATC code: J02AX04
Danish: Farmakoterapeutisk klassifikation: Antimykotikum til systemisk anvendelse ATC-kode: J02AX04
English: Caspofungin is not dialysable.
Danish: Caspofungin er ikke dialyserbart.
English: It is unknown whether caspofungin is excreted in human milk.
Danish: Det er ukendt, om caspofungin udskilles i human mælk.
English: These data suggest that caspofungin can be used in patients receiving cyclosporin when the potential benefit outweighs the potential risk.
Danish: Disse data tyder på, at caspofungin kan anvendes hos patienter, der behandles med ciclosporin, hvis de potentielle fordele overstiger de potentielle risici.
English: Overall, the available pharmacokinetic, efficacy, and safety data are limited in patients 3 to 10 months of age.
Danish: Generelt er de data, der er tilgængelige vedrørende farmakokinetik, effekt og sikkerhed begrænsede hos patienter i alderen 3-10 måneder.
English: If you are pregnant or breast-feeding ,think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De får dette lægemiddel.
English: Caspofungin should be given as a single daily infusion.
Danish: Caspofungin bør gives som infusion en gang dagligt.
English: This medicinal product contains sucrose.
Danish: Dette lægemiddel indeholder saccharose.
English: Further metabolism involves peptide hydrolysis and N-acetylation.
Danish: Yderligere metabolisme involverer peptidhydrolyse og N-acetylering.
English: • rifampicin (an antibiotic).
Danish: • rifampicin (et antibiotikum).
English: The distribution into tissues peaked at 1.5 to 2 days after dosing when 92 % of the dose was distributed into tissues.
Danish: Distribution til væv toppede 1,5-2 dage efter dosering, hvor 92% af dosis var distribueret til vævet.
English: Caspofungin resistance in Candida has been observed but the incidence may differ by species or region.
Danish: Caspofungin-resistens hos Candida er observeret, men incidensen kan variere alt efter art og region.
English: The elimination of caspofungin from plasma is slow with a clearance of 10-12 mL/min.
Danish: Eliminationen af caspofungin fra plasma er langsom med en clearance på 10-12 ml/min.
English: There are no or limited data from the use of caspofungin in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af caspofungin hos gravide kvinder.
English: There are no clinical data for caspofungin to assess its impact on fertility.
Danish: Der er ingen kliniske data for caspofungin til vurdering af dets indvirkning på fertiliteten.
English: Excretion is slow and the terminal half-life of radioactivity was 12 to 15 days.
Danish: Udskillelsen er langsom, med en terminal halveringstid af radioaktivitet på 12-15 dage.
English: After reconstitution and dilution, the solution should be administered by slow intravenous infusion over approximately 1 hour.
Danish: Efter rekonstitution og fortynding skal opløsningen administreres ved langsom intravenøs infusion over ca. 1 time.
English: If you are worried that you may have been given too much Caspofungin Accord, tell your doctor or nurse straight away.
Danish: Hvis De er bekymret for, om De måske har fået for meget Caspofungin Accord, skal De fortælle det til lægen eller sundhedspersonalet med det samme.
English: Your doctor will determine the duration of your treatment and how much Caspofungin Accord you will be given each day.
Danish: Lægen bestemmer behandlingens varighed, og hvor meget Caspofungin Accord De skal have hver dag.
English: Sodium hydroxide (to adjust the pH)
Danish: Natriumhydroxid (til justering af pH)
English: • dexamethasone (a steroid)
Danish: • dexamethason (et steroid)
English: • by slow injection into a vein (intravenous infusion)
Danish: • ved langsom indgivelse i en blodåre (intravenøs infusion)
English: Tell your doctor or nurse straight away if you notice any of the following side effects - you may need urgent medical treatment:
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis De bemærker en eller flere af følgende bivirkninger - De kan have brug for omgående lægehjælp:
English: This is because Caspofungin Accord can affect the way some other medicines work.
Danish: Dette skyldes, at Caspofungin Accord kan påvirke måden, andre lægemidler virker på.
English: Therapy should be continued until up to 72 hours after resolution of neutropaenia (ANC≥500).
Danish: Behandlingen bør fortsættes op til 72 timer efter resolution af neutropeni (ANC≥500).
English: The unbound fraction of caspofungin in plasma varies from 3.5 % in healthy volunteers to 7.6 % in patients with invasive candidiasis.
Danish: Den ubundne fraktion af caspofungin i plasma varierer fra 3,5% i raske frivillige til 7,6% i patienter med invasiv candidiasis.
English: 70 mg (from two 50 mg vials)**
Danish: 70 mg (fra to 50 mg hætteglas)**
English: As this was a primary therapy study, patients who were refractory to prior antifungal agents were also excluded.
Danish: Da denne var en primær undersøgelse, blev patienter, som var refraktære over for tidligere antimykotisk behandling, også udelukket.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER ANDET
English: Supplied in packs of 1 vial.
Danish: Leveres i pakninger med 1 hætteglas.
English: The study design, diagnostic criteria, and criteria for efficacy assessment were similar to the corresponding studies in adult patients (see section 5.1).
Danish: Designet for undersøgelsen, diagnostiske kriterier og kriterierne for vurdering af effekten var de samme som i de tilsvarende undersøgelser for voksne patienter (se pkt.
English: Beta (1,3)-D-glucan is not present in mammalian cells.
Danish: Beta (1,3)-D-glucan findes ikke i pattedyrsceller.
English: • serious fungal infections in your tissues or organs (called ‘invasive candidiasis').
Danish: • alvorlige svampeinfektioner i væv eller organer (kaldet "invasiv candidiasis").
English: Other side effects in adults include
Danish: Andre bivirkninger hos voksne:
English: Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see below “Instructions of how to reconstitute and dilute Caspofungin Accord”).
Danish: Kun veluddannet sundhedspersonale, som har læst den fuldstændige vejledning, må tilberede medicinen (se nedenfor ”Brugsvejledning til rekonstitution og fortynding af Caspofungin Accord”).
English: • some HIV medicines such as efavirenz or nevirapine
Danish: • medicin mod hiv, f.eks. efavirenz eller nevirapin
English: In general, treatment should continue for at least 7 days after resolution of symptoms.
Danish: Generelt bør behandlingen fortsætte i mindst 7 dage efter symptomresolution.
English: However, available data suggest that caspofungin continues to be well tolerated with longer courses of therapy (up to 162 days in adult patients and up to 87 days in paediatric patients).
Danish: Tilgængelige data indikerer dog, at caspofungin fortsat er veltolereret ved længere behandlingsforløb (op til 162 dage hos voksne patienter og 87 dage hos pædiatriske patienter).
English: In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Danish: Generelt bør antimykotisk behandling fortsætte i mindst 14 dage efter sidste positive dyrkning.
English: It is likely that only a small fraction of the caspofungin taken up into tissues later returns to plasma as parent compound.
Danish: Det er sandsynligt, at kun en lille del af det caspofungin, der optages i vævene, senere vender tilbage til plasma som det oprindelige stof.
English: • Itching at the injection site.
Danish: • Kløe på injektionsstedet.
English: • phenytoin or carbamazepine (used for the treatment of seizures)
Danish: • phenytoin eller carbamazepin (anvendes til behandling af epilepsi)
English: Distribution plays the prominent role in caspofungin plasma pharmacokinetics and is the rate-controlling step in both the alpha- and beta-disposition phases.
Danish: Distributionen er hovedansvarlig for caspofungins plasmafarmakokinetik og er det hastighedskontrollerende trin i både alfa- og beta-dispositionsfasen.
English: Patients were to be treated until up to 72 hours after resolution of neutropaenia, with a maximum duration of 28 days.
Danish: Patienterne skulle behandles i op til 72 timer efter resolution af neutropeni, dog i højst 28 dage.
English: The mean duration of therapy was 33.7 days, with a range of 1 to 162 days.
Danish: Den gennemsnitlige varighed af behandlingen var 33,7 dage, inden for en ramme af 1-162 dage.
English: Susceptibility testing was performed according to a modification of both the Clinical and Laboratory Standards Institute (CLSI, formerly known as the National Committee for Clinical Laboratory Standards [NCCLS]) method M38-A2 (for Aspergillus species) and method M27-A3 (for Candida species).
Danish: Der blev udført følsomhedstest i overensstemmelse med en modifikation af såvel Clinical and Laboratory Standards Institute (CLSI tidligere kendt som National Committee for Clinical Laboratory Standards [NCCSL]) M38-A2-metoden (for Aspergillusarter) og M27-A3-metoden (for Candidaarter).
English: The study excluded patients with suspected Candida endocarditis, meningitis, or osteomyelitis.
Danish: Undersøgelsen udelukkede patienter, hvor der var mistanke om Candida endocarditis, meningitis eller osteomyelitis.
English: White to off-white, powder.
Danish: Hvidt til offwhite pulver.
English: PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS
Danish: TILBEREDNING AF INFUSIONSOPLØSNING TIL VOKSNE
English: Stringent definitions, modelled after the Mycoses Study Group Criteria, were used for diagnosis of invasive aspergillosis and for response to therapy (favourable response required clinically significant improvement in radiographs as well as in signs and symptoms).
Danish: Der anvendtes faste definitioner, fastsat efter ”Mycoses Study Group” kriterier, til at diagnosticere invasiv aspergillose og til behandlingsrespons (gunstigt respons krævede klinisk signifikant radiografisk forbedring såvel som forbedring i tegn og symptomer).
English: DOSE*
Danish: DOSIS*
English: However, patients found to have a documented fungal infection could be treated longer.
Danish: Patienter med påvist svampeinfektion kunne imidlertid behandles i længere tid.
English: Patients in the caspofungin group experienced breakthrough infections due to the following uncommon yeasts and moulds: Trichosporon species (1), Fusarium species (1), Mucor species (1), and Rhizopus species (1).
Danish: Patienter i caspofungingruppen oplevede gennembrudsinfektioner ved følgende ikke-almindelige gær- og skimmelsvampe: Trichosporon arter (1), Fusarium arter (1), Mucor arter (1) og Rhizopus arter (1).
English: Diluted patient infusion solution: should be used immediately.
Danish: Fortyndet infusionsvæske til patienten: Skal anvendes straks.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution have taken place in controlled validated aseptic conditions.
Danish: Hvis opløsningen ikke anvendes straks, er opbevaringstid og -forhold før anvendelse brugerens ansvar og bør normalt ikke være længere end 24 timer ved 2-8C, med mindre rekonstitution og fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: The incidence of resistance to caspofungin by various clinical isolates of Aspergillus is rare.
Danish: Incidensen af resistens over for caspofungin ved forskellige kliniske isolater af Aspergillus er sjælden.
English: Also some other medicines can affect the way Caspofungin Accord works.
Danish: Andre lægemidler kan også påvirke måden, Caspofungin Accord virker på.
English: • Treatment of invasive candidiasis in adult or paediatric patients.
Danish: • Behandling af invasiv candidiasis hos voksne patienter eller børn.
English: However, paediatric patients probably have a different adverse event profile compared to adult patients.
Danish: Dog har børn sandsynligvis en anden bivirkningsprofil i forhold til voksne patienter.
English: • fungal infections in your nose, nasal sinuses or lungs (called ‘invasive aspergillosis') if other anti-fungal treatments have not worked or have caused side effects.
Danish: • svampeinfektion i næse, bihuler eller lunger (kaldet "invasiv aspergillosis"), hvis andre behandlinger mod svamp ikke har virket eller har givet bivirkninger.
English: • Changes in some laboratory blood tests.
Danish: • Ændringer i nogle blodprøver.
English: This infection is caused by a mould called Aspergillus.
Danish: Denne infektion forårsages af en skimmelsvamp, som kaldes Aspergillus.
English: For those patients who received more than 7 days of therapy with caspofungin, 50 % (26/52) had a favourable response.
Danish: Af de patienter der fik mere end 7 dages behandling med caspofungin, havde 50% (26/52) gunstigt respons.
English: Patients with rare hereditary problems of fructose intolerance or sucrase-isomaltase insufficiency should not take this medicinal product (see section 2).
Danish: Patienter med sjælden, arvelig fructoseintolerance eller sucrase-isomaltasemangel bør ikke anvende dette lægemiddel (se pkt.
English: Patients who met the entry criteria and received one or more doses of caspofungin study therapy were included in the efficacy analysis.
Danish: De patienter, der opfyldte inklusionskriterierne og fik en eller flere doser caspofungin, blev inkluderet i effektanalysen.
English: Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour intravenous infusions.
Danish: Plasmakoncentrationen af caspofungin falder i et polyfasisk mønster efter enkelt 1-times intravenøs infusion.
English: Limited data suggest that less common non-Candida yeasts and non-Aspergillus moulds are not covered by caspofungin.
Danish: Begrænsede data tyder på at mindre almindelige ikke-Candida gærsvampe og ikke-Aspergillus skimmelsvampe ikke dækkes af caspofungin.
English: Caspofungin should be initiated by a physician experienced in the management of invasive fungal infections.
Danish: Caspofungin skal initieres af en læge, som har erfaring i at behandle invasive svampeinfektioner.
English: Of these, 37 had invasive candidiasis, 10 had invasive aspergillosis, and 1 patient had esophageal candidiasis.
Danish: Af disse patienter havde 37 invasiv candidiasis, 10 havde invasiv aspergillosis og 1 patient havde candidiasis i øsofagus.
English: Duration of empirical therapy should be based on the patient's clinical response.
Danish: Varigheden af empirisk behandling skal baseres på patientens kliniske respons.
English: All adolescents received doses >50 mg daily, and, in fact, 6 of 8 received the maximum dose of 70 mg/day.
Danish: Alle de unge fik doser >50 mg dagligt, og faktisk fik 6 ud af 8 den maksimale dosis på 70 mg/dag.
English: In adult patients with moderate liver impairment or in higher weight patients, a dosage adjustment may be necessary (see below).
Danish: Hos voksne patienter med moderat nedsat leverfunktion eller høj vægt kan en dosisjustering være nødvendig (se nedenfor).
English: These AUC increases are probably due to reduced uptake of caspofungin by the liver.
Danish: Disse øgninger i AUC hænger sandsynligvis sammen med reduceret hepatisk optagelse af caspofungin.
English: Step 1 Reconstitution of conventional vials
Danish: Trin 1 Rekonstitution af almindelige hætteglas
English: Caspofungin is extensively bound to albumin.
Danish: Caspofungin bindes i udstrakt grad til albumin.
English: • Diarrhoea, nausea or vomiting
Danish: • Diarré, kvalme eller opkastning
English: After two weeks' administration rifampicin had limited effect on AUC, but trough levels were 30 % lower than in adult subjects who received caspofungin alone.
Danish: Efter to ugers administration havde rifampicin begrænset effekt på AUC, mens det mindste målte niveau var 30% lavere end hos voksne patienter, som fik caspofungin alene.
English: Caspofungin reduced the trough concentration of tacrolimus by 26 % in healthy adult volunteers.
Danish: Caspofungin reducerede mindste målte koncentration af tacrolimus med 26% hos frivillige raske voksne.
English: Rifampicin caused a 60 % increase in AUC and 170 % increase in trough concentration of caspofungin on the first day of co-administration when both medicinal products were initiated together in healthy adult volunteers.
Danish: Rifampicin forårsagede en 60% øgning i AUC og 170% øgning i mindste målte koncentration af caspofungin på den første dag med co-administration når lægemidlerne blev initieret samtidigt hos raske voksne frivillige.
English: The efficacy of caspofungin against these fungal pathogens has not been established.
Danish: Effekten af caspofungin over for disse svampepatogener er ikke fastlagt.
English: On Day 1, C1 hr was comparable and C24 hr modestly elevated (36 %) in these neonates and infants relative to adults.
Danish: På Dag 1 var C1t den samme, og C24t var let forhøjet (36%) hos disse nyfødte og spædbørn i forhold til voksne.
English: The most frequent diagnoses were bloodstream infections (candidaemia) (77 %, n=186) and Candida peritonitis (8 %, n=19); patients with Candida endocarditis, osteomyelitis, or meningitis were excluded from this study.
Danish: Den hyppigste diagnose var blodforgiftning (candidaæmi) (77%, n=186) og Candida-peritonitis (8%, n=19); patienter med Candida endocarditis, osteomyelitis eller meningitis blev holdt ude af denne undersøgelse.
English: Volume of reconstituted Caspofungin Accord for transfer to intravenous bag or bottle
Danish: Volumen af rekonstitueret Caspofungin Accord til overførsel til intravenøs pose eller flaske
English: Reported clinical and laboratory abnormalities among all adults treated with caspofungin (total 1,780) were typically mild and rarely led to discontinuation.
Danish: Indberettede kliniske og laboratoriemæssige abnormaliteter blandt alle voksne, der er behandlet med caspofungin (i alt 1.780), var sædvanligvis milde og krævede sjældent seponering.
English: Patients who develop abnormal liver function tests during caspofungin therapy should be monitored for evidence of worsening hepatic function and the risk/benefit of continuing caspofungin therapy should be re-evaluated.
Danish: Patienter, som får unormale leverfunktionsprøver under behandling med caspofungin, skal monitoreres for tegn på forværring af leverfunktionen, og risiko/fordel ved fortsat caspofungin-behandling skal revurderes.
English: No dosage adjustment is necessary based on gender or race (see section 5.2).
Danish: Dosisjustering er ikke nødvendig på baggrund af køn og race (se pkt.
English: • cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.
Danish: • hoste, alvorlige vejrtrækningsproblemer - hvis De er voksen og har invasiv aspergillose, kan De få alvorlige vejrtrækningsproblemer, som kan medføre åndedrætssvigt.
English: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom
Danish: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Storbritannien
English: This includes medicines obtained without a prescription, including herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks naturlægemidler.
English: Two intermediate products, formed during the degradation of caspofungin to this open ring compound, form covalent adducts to plasma proteins resulting in a low-level, irreversible binding to plasma proteins.
Danish: To mellemprodukter, dannet under nedbrydningen af caspofungin ved ringåbning, danner kovalente adduktorer til plasmaproteiner, resulterende i irreversibel binding til plasmaproteiner i mindre grad.
English: Standardised techniques for susceptibility testing have been established for yeasts by EUCAST.
Danish: EUCAST har fastlagt standardiserede teknikker for følsomhedstest for gærsvampe.
English: Close monitoring of liver enzymes should be considered if caspofungin and cyclosporin are used concomitantly.
Danish: Tæt monitorering af leverenzymerne skal overvejes, hvis caspofungin og ciclosporin administreres samtidigt.
English: In vitro studies show that caspofungin is not an inhibitor of cytochrome P450 enzymes 1A2, 2A6, 2C9, 2C19, 2D6 or 3A4.
Danish: In vitro undersøgelser viser, at caspofungin ikke hæmmer CYP- enzymer 1A2, 2A6, 2C9, 2C19, 2D6 eller 3A4.
English: In paediatric patients (12 months to 17 years of age), dosing should be based on the patient's body surface area (see Instructions for Use in Paediatric Patients, Mosteller1 Formula).
Danish: Hos børn (i alderen 12 måneder til 17 år) skal dosis baseres på patientens legemsoverfladeareal (se Instructions for Use in Paediatric Patients, Mosteller Formula).
English: • Increased blood pressure and alterations in some laboratory blood tests (including kidney electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the immune system
Danish: • Forhøjet blodtryk og ændringer i nogle blodprøver (herunder elektrolytter i nyrerne og koagulationstest), forhøjet koncentration af de lægemidler, De tager, som svækker immunsystemet
English: • Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole.
Danish: • Behandling af invasiv aspergillose hos voksne patienter eller børn, der er refraktære eller intolerante over for amphotericin B, lipidformuleringer af amphotericin B og/eller itraconazol.
English: Women receiving caspofungin should not breast-feed.
Danish: Kvinder, der får caspofungin, bør ikke amme.
English: There is little excretion or biotransformation of caspofungin during the first 30 hours after administration.
Danish: Caspofungin udskilles og biotransformeres i ringe grad inden for de første 30 timer efter administration.
English: Hypersensitivity reactions (anaphylaxis and possibly histamine-mediated adverse reactions) have been reported (see section 4.4).
Danish: Der er rapporteret om overfølsomhedsreaktioner (anafylaksi og mulige histaminmedierede reaktioner) (se pkt.
English: There is no information to suggest that Caspofungin Accord affects your ability to drive or operate machinery.
Danish: Der findes ingen oplysninger om, at Caspofungin Accord påvirker evnen til at køre bil eller betjene maskiner.