FrancophonIA/ELRC3.0 huggingface dataset:
English: In a randomised controlled open-label study in 235 adult patients with Staphylococcus aureus bacteraemia (i.e. at least one positive blood culture of Staphylococcus aureus prior to receiving the first dose) 19 of 120 patients treated with Cubicin met the criteria for RIE.
Danish: I et randomiseret, kontrolleret, åbent studie med 235 voksne patienter med Staphylococcus aureus bakteriæmi (dvs. mindst en positiv blodkultur af Staphylococcus aureus før modtagelsen af første dosis), opfyldte 19 ud af 120 patienter behandlet med Cubicin kriteriet for RIE.
English: Strains with decreased susceptibility to daptomycin have been reported especially during the treatment of patients with difficult-to-treat infections and/or following administration for prolonged periods.
Danish: Der er rapporteret om stammer med nedsat følsomhed over for daptomycin specielt under behandlingen af patienter med infektioner, der er vanskelige at behandle, og/eller efter administration i forlængede perioder.
English: Minimum inhibitory concentration (MIC) breakpoint established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for Staphylococci and Streptococci (except S. pneumoniae) are Susceptible ≤ 1 mg/l and Resistant > 1 mg/l.
Danish: Mindste hæmmede koncentration (MIC), følsomhedsgrænser, fastlagt af EUCAST (European Committee on Antimicrobial Susceptibility Testing) for stafylokokker og streptokokker (undtagen S. pneumoniae) er: følsom ≤ 1 mg/l og resistent > 1 mg/l.
English: In most reported cases associated with Cubicin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
Danish: I de fleste rapporterede tilfælde associeret med Cubicin udviklede patienterne feber, dyspnø med hypoksisk respirationsinsufficiens og diffuse lungeinfiltrater eller organiserende pneumoni.
English: In very rare cases (reported in less than 1 in every 10,000 patients), muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.
Danish: I meget sjældne tilfælde (forekommer hos færre end 1 ud af 10.000 patienter) kan muskelproblemer være alvorlige, herunder muskelnedbrydning (rabdomyolyse), som kan medføre nyreskade.
English: Your doctor will make sure you have a blood test and will advise whether or not to continue with Cubicin.
Danish: Din læge vil sørge for, at du får taget en blodprøve og vil rådgive dig, om du skal fortsætte med Cubicin eller ej.
English: 7 to 11 years
Danish: 7 til 11 år
English: In paediatric studies, 372 patients received Cubicin, of whom 61 received a single dose and 311 received a therapeutic regimen for cSSTI or SAB (daily doses ranged from 4 mg/kg to 12 mg/kg).
Danish: I pædiatriske studier fik 372 patienter Cubicin, heraf fik 61 en enkeltdosis og 311 fik et terapeutisk regime for cSSTI eller SAB (daglige doser lå i intervallet 4 mg/kg til 12 mg/kg).
English: Severe renal impairment may in itself also pre-dispose to elevations in daptomycin levels which may increase the risk of development of myopathy (see above).
Danish: Svært nedsat nyrefunktion kan i sig selv prædisponere for øgede daptomycinniveauer, som kan øge risikoen for, at der udvikles myopati (se ovenfor).
English: Cubicin should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal.
Danish: Cubicin bør seponeres, hvis der foreligger uforklarlige muskelsymptomer, og CK-værdien bliver større end 5 gange den øvre grænse for normalværdi.
English: - Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements.
Danish: - Enhver usædvanlig prikkende eller følelsesløs fornemmelse i hænder eller fødder, følelsestab eller bevægelsesproblemer.
English: Based on these study results, both methods of daptomycin administration, the 2-minute intravenous injection and the 30-minute intravenous infusion, had a similar safety and tolerability profile.
Danish: Resultaterne fra disse studier viste, at begge metoder til administration af daptomycin, 2 minutters intravenøs injektion og 30 minutters intravenøs infusion, havde sammenlignelig sikkerheds- og tolerabilitetsprofil.
English: See sections 4.4, 4.8 and 5.3.
Danish: 4.4, 4.8 og 5.3.
English: Experience with the concomitant administration of Cubicin and warfarin is limited.
Danish: Erfaringerne med samtidig brug af Cubicin og warfarin er begrænsede.
English: Please inform your doctor that you are on treatment with Cubicin.
Danish: Fortæl din læge, at du er i behandling med Cubicin.
English: The majority of cases occurred after more than 2 weeks of treatment with Cubicin and improved when Cubicin was discontinued and steroid therapy was initiated.
Danish: De fleste tilfælde opstod efter mere end 2 ugers behandling med Cubicin og blev bedret, når Cubicin blev seponeret og steoridbehandling påbegyndt.
English: Interaction studies for Cubicin were performed with aztreonam, tobramycin, warfarin and probenecid.
Danish: Der er udført interaktionsstudier med Cubicin og aztreonam, tobramycin, warfarin og probenecid.
English: Important: Please refer to the Summary of Product Characteristics before prescribing.
Danish: Vigtigt: læs produktresuméet før ordinering.
English: In addition, regular monitoring of renal function is advised during concomitant administration of potentially nephrotoxic agents, regardless of the patient's pre-existing renal function (see also section 4.5).
Danish: Derudover tilrådes regelmæssig overvågning af nyrefunktionen ved samtidig administration af potentielt nefrotoksiske lægemidler, uanset hvordan patientens allerede eksisterende nyrefunktion er (se også pkt.
English: The mechanism of action involves binding (in the presence of calcium ions) to bacterial membranes of both growing and stationary phase cells causing depolarisation and leading to a rapid inhibition of protein, DNA, and RNA synthesis.
Danish: Virkemekanismen involverer binding (under tilstedeværelse af kalciumioner) til bakteriemembraner på celler både i vækst- og i stationærfase, hvilket forårsager en depolarisering og fører til hurtig hæmning af protein, DNA, og RNA-syntese.
English: This should be taken into account when initiating daptomycin therapy and, if daptomycin is given, these patients should be monitored more frequently than once weekly.
Danish: Dette bør tages i betragtning, når behandling med daptomycin initieres, og sådanne patienter bør overvåges mere end en gang om ugen, hvis daptomycin administreres.
English: - Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
Danish: - smertestillende lægemidler, som kaldes non-steroide anti-inflammatoriske lægemidler (NSAID'er) eller COX-2 hæmmere (fx celecoxib).
English: Cubicin is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a type of bacteria called Staphylococcus aureus.
Danish: Cubicin bruges også hos voksne til behandling af infektioner i vævene på indersiden af hjertet (herunder hjerteklapperne), som er forårsaget af en type bakterie kaldet Staphylococcus aureus.
English: Water should not be used for reconstitution of Cubicin for intravenous injection.
Danish: Vand må ikke anvendes til rekonstitution af Cubicin til intravenøs injektion.
English: In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be coadministered with appropriate antibacterial agent(s).
Danish: I blandede infektioner, hvor der er mistanke om både gramnegative og/eller visse typer anaerobe bakterier, bør Cubicin administreres sammen med et eller flere hensigtsmæssige antibakterielle lægemidler.
English: Studies of Cubicin with anticoagulants other than warfarin have not been conducted.
Danish: Studier med Cubicin og antikoagulatia udover warfarin er ikke udført.
English: RIE or cSSTI associated with SAB
Danish: RIE eller cSSTI associeret med SAB
English: People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Danish: Brug til ældre Patienter over 65 år kan få den samme dosis som andre voksne, forudsat deres nyrer fungerer normalt.
English: Failure of treatment due to persisting or relapsing Staphylococcus aureus infections was observed in 19/120 (15.8%) patients treated with Cubicin, 9/53 (16.7%) patients treated with vancomycin and 2/62 (3.2%) patients treated with an anti-staphylococcal semi-synthetic penicillin.
Danish: Fejlslagen behandling på grund af vedvarende eller tilbagevendende Staphylococcus aureus infektioner blev set hos 19/120 (15,8%) af patienterne, der blev behandlet med Cubicin, 9/53 (16,7%) af patienterne, der blev behandlet med vancomycin og 2/62 (3,2%) af patienterne, der blev behandlet med anti-staphylococcus semi-syntetisk penicillin.
English: Paediatric patients (1 to 17 years of age)
Danish: Pædiatriske patienter (i alderen 1 til 17 år)
English: The safety data for the administration of daptomycin via 2-minute intravenous injection are derived from two pharmacokinetic studies in healthy adult volunteers.
Danish: Sikkerhedsdata for administration af daptomycin som 2 minutters intravenøs injektion stammer fra to farmakokinetikstudier i raske voksne frivillige.
English: Patients were randomized in a 2:1 ratio into the following age groups and given age-dependent doses once daily for up to 42 days, as follows:
Danish: Patienterne blev randomiseret i forholdet 2:1 til følgende aldersgrupper og fik en aldersafhængig dosis en gang om dagen i op til 42 dage:
English: What Cubicin contains - The active substance is daptomycin.
Danish: Cubicin indeholder: - Aktivt stof: daptomycin.
English: In addition, dose regimens of daptomycin that might be appropriate for the treatment of enterococcal infections, with or without bacteraemia, have not been identified.
Danish: Desuden er der ikke blevet fastlagt nogen dosisregimer for daptomycin, som vil være passende til behandlingen af enterokok-infektioner med eller uden bakteriæmi.
English: The overall therapeutic response rate also was similar for the daptomycin and SOC treatment arms for infections caused by MRSA, MSSA and Streptococcus pyogenes (see table below; ME population); response rates were > 94% for both treatment arms across these common pathogens.
Danish: Den samlede terapeutiske responsrate var sammenlignelig i daptomycin-armen og SOC-armen for infektioner forårsaget af MRSA, MSSA og Streptococcus pyogenes (se nedenstående tabel; MEpopulationer); responsraterne var > 94% for begge behandlingsarme for disse almindelige patogener.
English: Following intravenous administration, plasma clearance of daptomycin is approximately 7 to 9 ml/h/kg and its renal clearance is 4 to 7 ml/h/kg.
Danish: Efter intravenøs administration, er plasma clearance af daptomycin ca. 7 til 9 ml/t/kg og renal clearance er 4 til 7 ml/t/kg.
English: 12 to 17 years
Danish: 12 til 17 år
English: Caution is warranted when Cubicin is co-administered with tobramycin.
Danish: Forsigtighed er påkrævet, når Cubicin administreres i kombination med tobramycin.
English: Due to limited clinical experience (see table and footnotes below) Cubicin should only be used in adult patients with any degree of renal impairment (CrCl < 80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk.
Danish: Da der er begrænset klinisk erfaring (se tabel og fodnoter nedenfor), bør Cubicin kun anvendes til voksne patienter med nedsat nyrefunktion af enhver grad (kreatininclearance < 80 ml/min), når den forventede kliniske fordel opvejer den potentielle risiko.
English: For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution eller rekonstitution og fortynding af lægemidlet, se pkt.
English: Most patients who failed due to persisting or relapsing Staphylococcus aureus infection had deep-seated infection and did not receive necessary surgical intervention.
Danish: De fleste patienter, hvor behandlingen slog fejl på grund af vedvarende eller tilbagevendende Staphylococcus aureus infektioner, havde dybtsiddende infektion og fik ikke det nødvendige kirurgiske indgreb.
English: The symptoms can include difficulty breathing, new or worsening cough, or new or worsening fever.
Danish: Symptomerne kan omfatte vejrtrækningsproblemer, hoste/forværret hoste eller feber/højere feber.
English: Therefore, until more experience is gained, breastfeeding should be discontinued when Cubicin is administered to nursing women.
Danish: Indtil yderligere erfaring er opnået, skal amning ophøre, når Cubicin administreres til ammende kvinder.
English: Although small changes in the pharmacokinetics of daptomycin and tobramycin were observed during coadministration by intravenous infusion over a 30-minute period using a Cubicin dose of 2 mg/kg, the changes were not statistically significant.
Danish: Selvom der blev observeret små ændringer i farmakokinetikken af daptomycin og tobramycin ved samtidig intravenøs infusion over 30 minutter (Cubicin i en dosis på 2 mg/kg), var ændringerne ikke statistisk signifikante.
English: Recurrence of eosinophilic pneumonia upon reexposure has been reported.
Danish: Der er blevet rappoteret om tilbagefald af eosinofil pneumoni ved reeksponering.
English: In clinical studies, marked increases in plasma CPK to > 5x Upper Limit of Normal (ULN) without muscle symptoms occurred more commonly in Cubicin-treated patients (1.9%) than in those that received comparators (0.5%).
Danish: I kliniske studier forekom markante stigninger i plasma-CK til > 5 x den øvre grænse for normalværdi (Upper Limit of Normal, ULN) uden muskelsymptomer hyppigere hos patienter, der blev behandlet med Cubicin, (1,9%) end hos dem, der blev behandlet med sammenligningspræparater (0,5%).
English: Inherently resistant organisms
Danish: Naturligt resistente organismer
English: Patients were enrolled in a stepwise approach into well-defined age groups and given age-dependent doses once daily for up to 14 days, as follows:
Danish: Patienterne blev opdelt og inkluderet i veldefinerede aldersgrupper og fik en aldersafhængig dosis en gang om dagen i op til 14 dage:
English: Caution is advised when administering Cubicin to patients who already have some degree of renal impairment (creatinine clearance < 80 ml/min) before commencing therapy with Cubicin.
Danish: Der bør udvises forsigtighed, når Cubicin administreres til patienter, som allerede har en vis grad af nedsat nyrefunktion (kreatininclearance < 80 ml/min), før behandlingen med Cubicin indledes.
English: The following have been shown to be compatible when added to Cubicin containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.
Danish: Følgende virkestoffer har vist sig at være kompatible, når de tilsættes infusionsopløsninger, der indeholder Cubicin: aztreonam, ceftazidim, ceftriaxon, gentamycin, fluconazol, levofloxacin, dopamin, heparin og lidocain.
English: The duration of Cubicin may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.
Danish: Det kan være nødvendigt, at behandlingen med Cubicin varer længere end 14 dage i overensstemmelse med den opfattede risiko for komplikationer hos den enkelte patient.
English: Modified intent-to-treat (MITT) Microbiologically modified intent-to-treat (mMITT)
Danish: Mikrobiologisk modificeret intent-to-treat (mMITT)
English: 12 mg/kg once every 24 hours infused over 60 minutes cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; (1) Minimum duration of Cubicin for paediatric SAB should be in accordance with the perceived risk of complications in the individual patient.
Danish: 12 mg/kg en gang hver 24. time som infusion over 60 minutter cSSTI = komplicerede hud- og bløddelsinfektioner; SAB = S. aureus bakteriæmi; (1) Minimumsvarighed af behandling med Cubicin for SAB hos pædiatriske patienter skal være i overensstemmelse med den opfattede risiko for komplikationer hos den enkelte patient.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe/use Cubicin are provided with: - Summary of Product Characteristics - Dosage card
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som forventes at udskrive/bruge Cubicin, får: - Produktresumé - Doseringskort
English: In particular, there have been reports of treatment failures in patients infected with Staphylococcus aureus, Enterococcus faecalis or Enterococcus faecium, including bacteraemic patients, that have been associated with the selection of organisms with reduced susceptibility or frank resistance to daptomycin during therapy.
Danish: Der er i særdeleshed blevet rapporteret om manglende effekt af behandling hos patienter, der er inficeret med Staphylococcus aureus, Enterococcus faecalis eller Enterococcus faecium, inklusive patienter med bakteriæmi, som er forbundet med valget af organismer med nedsat modtagelighed eller direkte resistens over for daptomycin under behandling.
English: Preparation of the solution for infusion requires an additional dilution step as detailed below.
Danish: Fremstilling af infusionsvæske kræver et ekstra trin til fortynding, som beskrevet herunder.
English: Adults - cSSTI without concurrent SAB: Cubicin 4 mg/kg is administered once every 24 hours for 7-14 days or until the infection is resolved (see section 5.1).
Danish: Voksne - cSSTI uden samtidig SAB: Cubicin 4 mg/kg administreres en gang i døgnet i 7-14 dage, eller indtil infektionen er forsvundet (se pkt.
English: Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during coadministration with medicinal products that reduce renal filtration (e.g. NSAIDs and COX-2 inhibitors).
Danish: Daptomycin elimineres primært ved renal filtration, og derfor kan plasmaniveauer være forhøjede ved samtidig administration af lægemidler, som reducerer renal filtration (f.eks. NSAID'er og COX-2 hæmmere).
English: A total of 389 subjects were treated in the study, including 256 subjects who received daptomycin and 133 subjects who received standard-of-care.
Danish: I alt blev 389 patienter behandlet i studiet, 256 patienter fik daptomycin, og 133 patienter fik standardbehandling.
English: Pharmacokinetic parameter values estimated by noncompartmental analysis Individual values reported as only two patients in this age group provided pharmacokinetic samples to enable pharmacokinetic analysis; AUC, apparent t1/2 and CL/wt could be determined for only one of the two patients Pharmacokinetic analysis conducted on the pooled pharmacokinetic profile with mean concentrations across subjects at each time point
Danish: Farmakokinetiske parameterværdier estimeret ud fra nonkompartmental analyse Individuelle værdier, som blev rapporteret, da kun to patienter i denne aldersgruppe indleverede de nødvendige prøver til farmakokinetisk analyse; AUC, tilsyneladende t1/2 og CL/vægt kunne kun bestemmes for en af de to patienter Farmakokinetisk analyse udført på poolet farmakokinetisk profil med gennemsnitlige koncentrationer på tværs af forsøgspersoner på hvert tidspunkt
English: 6 mg/kg every 48 hours cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia (1) The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is based on pharmacokinetic studies and modelling results (see sections 4.4 and 5.2).
Danish: 6 mg/kg hver 48. time cSSTI = komplicerede hud- og bløddelsinfektioner; SAB = S. aureus bakteriæmi (1) Sikkerhed og virkning ved justering af dosisintervallet er ikke blevet evalueret i kontrollerede kliniske forsøg, og anbefalingen er baseret på farmakokinetiske studier og modelleringsresultater (se pkt.
English: No data are available in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Der foreligger ingen data for patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry.
Danish: Tør toppen af gummiproppen af med en spritserviet eller et andet desinfektionsmiddel og lad den tørre.
English: • Plasma CPK should be measured at baseline and at regular intervals (at least once weekly) during therapy in all patients.
Danish: • Plasma-CK bør måles ved baseline og i regelmæssige intervaller (mindst en gang om ugen) under hele behandlingen hos alle patienter.
English: Not known*: Acute generalised exanthematous pustulosis
Danish: Ikke kendt*: Akut generaliseret eksantematøs pustulose
English: Prothrombin time (PT) prolonged Thrombocytopaenia
Danish: Forlænget protrombintid (PT) Trombocytopeni
English: In some instances treatment failure has been associated with the selection of organisms with reduced susceptibility or frank resistance to daptomycin (see section 5.1).
Danish: I nogle tilfælde har manglende effekt af behandlingen været forbundet med selektion af organismer med nedsat følsomhed eller direkte resistens over for daptomycin (se pkt.
English: - New or worsening fever, cough or difficulty breathing.
Danish: - Feber eller højere feber, hoste eller vanskeligheder med at trække vejret.
English: 2 to 6 years
Danish: 2 til 6 år
English: Daptomycin exhibits rapid, concentration dependent bactericidal activity against Gram positive organisms in vitro and in in vivo animal models.
Danish: Daptomycin udviser hurtig, koncentrationsafhængig bakteriedræbende aktivitet mod grampositive organismer i in vitro og in vivo dyremodeller.
English: If CDAD is suspected or confirmed, Cubicin may need to be discontinued and appropriate treatment instituted as clinically indicated.
Danish: Hvis CDAD er under mistanke eller allerede er bekræftet, kan det være nødvendigt at seponere behandlingen med Cubicin og iværksætte passende kliniske tiltag.
English: Anticoagulant activity in patients receiving Cubicin and warfarin should be monitored for the first several days after therapy with Cubicin is initiated.
Danish: Hos patienter, der behandles med Cubicin og warfarin, bør den antikoagulerende aktivitet monitoreres i adskillige dage, efter behandling med Cubicin er initieret.
English: Dizziness, headache
Danish: Træthed, smerter
English: To minimise this risk, physicians should be advised that for coagulation levels testing it is recommended to draw blood samples near the time of Cubicin trough plasma concentration.
Danish: For at minimire risikoen skal lægerne anbefales at tage blodprøven, som skal bruges til koagulationstest, når cubicin-plasmakoncentrationen er på sit laveste niveau.
English: - The other ingredient is sodium hydroxide.
Danish: - Øvrige indholdsstoffer: natriumhydroxid.
English: The pharmacokinetics of daptomycin is not altered in subjects with moderate hepatic impairment (Child-Pugh B classification of hepatic impairment) compared with healthy volunteers matched for gender, age and weight following a single 4 mg/kg dose.
Danish: Daptomycins farmakokinetik ændres ikke hos patienter med moderat nedsat leverfunktion (Child-Pugh nedsat leverfunktion klasse B) sammenlignet med raske frivillige, matchede mht. køn, alder og vægt, efter administration af en enkeltdosis på 4 mg/kg.
English: Uncommon: Thrombocythaemia, eosinophilia, international normalised ratio (INR) increased, leukocytosis
Danish: Trombocytæmi, eosinofili, forhøjet international normalised ratio (INR), leukocytose
English: Patients who develop these signs and symptoms while receiving Cubicin should undergo prompt medical evaluation, including, if appropriate, bronchoalveolar lavage, to exclude other causes (e.g. bacterial infection, fungal infection, parasites, other medicinal products).
Danish: Patienter, som udvikler disse tegn og symptomer under behandling med Cubicin, skal øjeblikkeligt have foretaget en klinisk vurdering, inkluderende bronkoalveolær udskylning, hvis det skønnes relevant, for at udelukke andre årsager (f.eks. bakterieinfektion,