FrancophonIA/ELRC3.0 huggingface dataset:
English: Daptomycin Hospira is therefore not indicated for the treatment of pneumonia.
Danish: Daptomycin Hospira er derfor ikke indiceret til behandling af pneumoni.
English: These transaminase increases were likely to be related to the skeletal muscle effects.
Danish: Disse forhøjede aminotransferaser blev formodet at være relateret til effekten på skeletmuskulaturen.
English: The symptoms generally go away within a few days of stopping Daptomycin Hospira.
Danish: Symptomerne forsvinder som regel i løbet af et par dage, når behandlingen med Daptomycin Hospira er ophørt.
English: The duration of Daptomycin Hospira 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 Daptomycin Hospira varer længere end 14 dage i overensstemmelse med den opfattede risiko for komplikationer hos den enkelte patient.
English: Gender No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
Danish: Der er ikke observeret nogen klinisk signifikante kønsrelaterede forskelle i daptomycins farmakokinetik.
English: No data are available in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Der foreligger ingen data fra patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: Eosinophilic pneumonia
Danish: Eosinofil pneumoni
English: In clinical studies, marked increases in plasma CPK to >5x Upper Limit of Normal (ULN) without muscle symptoms occurred more commonly in daptomycin -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 daptomycin (1,9%) end hos dem, der blev behandlet med sammenligningspræparater (0,5%).
English: If your kidneys do not work well, you may receive Daptomycin Hospira less often, e.g. once every other day.
Danish: Hvis dine nyrer ikke fungerer tilfredsstillende, skal du måske have Daptomycin Hospira mindre hyppigt, f.eks. hver anden dag.
English: These could interfere with the effects of Daptomycin Hospira in the kidney.
Danish: Disse har muligvis en virkning på virkningen af Daptomycin Hospira i nyrerne.
English: In contrast to adult dogs, juvenile dogs appeared to be more sensitive to peripheral nerve lesions as compared to skeletal myopathy.
Danish: Til forskel fra voksne hunde syntes unge hunde at være mere følsomme for perifere nervelæsioner end for myopati i skeletmuskulaturen.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger for graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Dose Infusion Time
Danish: Dosis Infusionstid
English: Paediatric patients with cSSTI
Danish: Pædiatriske patienter med cSSTI
English: Daptomycin pharmacokinetics are generally linear and time-independent at doses of 4 to 12 mg/kg administered as a single daily dose by 30-minute intravenous infusion for up to 14 days in healthy adult volunteers.
Danish: Daptomycins farmakokinetik er generelt lineær og uafhængig af tid ved doser på 4 til 12 mg/kg administreret en gang dagligt som intravenøs infusion over 30 minutter i op til 14 dage i raske voksne frivillige.
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: Daptomycin had no effect on the pharmacokinetics of warfarin or probenecid, nor did these medicinal products alter the pharmacokinetics of daptomycin.
Danish: Daptomycin havde ingen effekt på farmakokinetikken af warfarin og probenecid, og disse lægemidler havde heller ingen effekt på farmakokinetikken af daptomycin.
English: Concomitant administration of probenecid and daptomycin has no effect on daptomycin pharmacokinetics in humans suggesting minimal to no active tubular secretion of daptomycin.
Danish: Samtidig administration af probenecid og daptomycin har ingen effekt på daptomycins farmakokinetik hos mennesker, hvilket tyder på minimal eller ingen aktiv tubulær sekretion af daptomycin.
English: AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg) 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: (g×timer/ml) Cmax (g/ml) Tilsyneladende t1/2 (timer) Clearance (CL)/vægt (ml/timer/kg) 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: The site of metabolism has not been identified.
Danish: Det er ikke blevet identificeret, hvor metabolismen finder sted.
English: There is limited information on the safety and efficacy of daptomycin in the very obese and so caution is recommended.
Danish: Der er kun begrænsede data om sikkerhed og virkning af daptomycin hos meget adipøse patienter, og derfor tilrådes forsigtighed.
English: Interaction studies for daptomycin were performed with aztreonam, tobramycin, warfarin and probenecid.
Danish: Der er udført interaktionsstudier med daptomycin og aztreonam, tobramycin, warfarin og probenecid.
English: Expelair, large bubbles, and any excess solution in order to obtain the required dose.
Danish: Fjern luft, store luftbobler og eventuel overskydende opløsning for at få den korrekte dosis.
English: In some cases of myopathy involving raised CPK and muscle symptoms, the patients also presented with elevated transaminases.
Danish: I nogle tilfælde med myopati med forhøjede CK-værdier og muskelsymptomer havde patienterne ligeledes forhøjede aminotransferaser.
English: cSSTI associated with SAB
Danish: cSSTI associeret med SAB
English: It may be necessary for your doctor to monitor your blood clotting times.
Danish: Det kan være nødvendigt, at din læge måler dit blods størkningshastighed.
English: Depending on the study duration, all muscle effects, including microscopic changes, were fully reversible within 1-3 months following cessation of dosing.
Danish: Alle muskelforandringer, inklusive mikroskopiske forandringer, var fuldt reversible inden for 1-3 måneder efter seponering af dosis afhængig af studiets varighed.
English: Among these failures six patients treated with daptomycin and one patient treated with vancomycin were infected with Staphylococcus aureus that developed increasing MICs of daptomycin on or following therapy (see “Mechanisms of resistance” above).
Danish: Blandt disse fejlslagne behandlinger var 6 daptomycin-behandlede patienter og 1 vancomycin-behandlet patient inficeret med Staphylococcus aureus, som udviklede tiltagende MIC-værdier på eller efter behandling (se ”Resistensmekanisme” ovenfor).
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. 7-9 ml/t/kg, og renal clearance er 4-7 ml/t/kg.
English: Juvenile dogs developed peripheral and spinal nerve lesions at doses lower than those associated with skeletal muscle toxicity.
Danish: Unge hunde udviklede perifere og spinale nervelæsioner ved doser, der var lavere end dem, der blev associeret med skeletmuskulaturtoksicitet.
English: Uncommon: Renal impairment, including renal failure and renal insufficiency, serum creatinine increased
Danish: Ikke almindelig: Nedsat nyrefunktion, inklusive nyresvigt og nyreinsufficiens, øget serum-kreatinin
English: Sodium hydroxide (for pH adjustment) Citric acid (solubiliser/stabiliser)
Danish: Natriumhydroxid (til justering af pH-værdien) Citronsyre (opløselighedsfremmer/stabilisator)
English: The possibility of erroneous results may be minimised by drawing samples for PT or INR testing near the time of trough plasma concentrations of daptomycin (see section
Danish: Muligheden for fejlagtige resultater kan minimeres ved at tage prøverne til PT- eller INR-analysen nær tidspunktet for laveste daptomycin-plasmakoncentration (se pkt.
English: In all populations the clinical success rates were comparable in the daptomycin versus the SOC treatment arm.
Danish: I alle populationer var de kliniske succesrater sammenlignelige i daptomycin-armen versus SOC-armen.
English: The dosage card should contain the following key messages: - That there is a risk of severe skeletal muscle toxicity and so measuring the CPK at treatment initiation and at regular intervals is important.
Danish: Doseringskortet skal indeholde følgende vigtige informationer: - At der er risiko for alvorlig skeletmuskeltoksicitet, og at det derfor er vigtigt at måle kreatinkinase (CK), før behandlingen startes og regelmæssigt derefter.
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 personer med moderat nedsat leverfunktion (Child-Pugh nedsat leverfunktion klasse B) sammenlignet med raske frivillige af samme køn, alder og vægt efter administration af en enkeltdosis på 4 mg/kg.
English: Daptomycin Hospira is not physically or chemically compatible with glucose-containing solutions.
Danish: Daptomycin Hospira er ikke fysisk eller kemisk forligelig med opløsninger, der indeholder glucose.
English: In the paediatric SAB study, the mean duration of IV Daptomycin Hospira was 12 days, with a range of 1 to 44 days.
Danish: I SAB-studiet med pædiatriske patienter var den gennemsnitlige varighed af intravenøst Daptomycin Hospira 12 dage med et interval på 1-44 dage.
English: Important: Please refer to the Summary of Product Characteristics before prescribing.
Danish: Vigtigt: Læs produktresuméet inden ordination.
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 den manglende effekt af behandlingen været forbundet med selektion af organismer med nedsat følsomhed eller direkte resistens over for daptomycin (se pkt.
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: Your doctor will make sure you have a blood test and will advise whether or not to continue with Daptomycin Hospira.
Danish: Din læge vil sørge for, at du får taget en blodprøve og vil rådgive dig, om du skal fortsætte med Daptomycin Hospira eller ej.
English: Adults - cSSTI without concurrent SAB: daptomycin 4mg/kg is administered once every 24hours for 7-14 days or until the infection is resolved (see section 5.1).
Danish: Voksne - cSSTI uden samtidig SAB: daptomycin 4 mg/kg administreres en gang i døgnet i 7-14 dage, eller indtil infektionen er forsvundet (se pkt.
English: If co-administration cannot be avoided, CPK levels should be measured more frequently than once weekly and patients should be closely monitored for any signs or symptoms that might represent myopathy (see sections 4.4, 4.8 and
Danish: Hvis samtidig administration ikke kan undgås, bør CK-værdier måles hyppigere end en gang om ugen, og patienterne bør kontrolleres tæt for ethvert tegn eller symptom, som kan tyde på myopati (se pkt.
English: The recommended doses should be used in elderly patients except those with severe renal impairment (see above and section 4.4).
Danish: De anbefalede doseringer bør anvendes til ældre patienter, medmindre der foreligger svært nedsat nyrefunktion (se ovenfor og pkt.
English: In all populations the clinical success rates were comparable between the daptomycin and SOC treatment arms, supporting the primary efficacy analysis in the ITT population.
Danish: I alle populationer var de kliniske succesrater sammenlignelige mellem daptomycin-armen og SOC-armen, hvilket understøtter den primære virkningsanalyse i ITTpopulationen.
English: However, some cases of marked rises in CPK levels and cases of rhabdomyolysis occurred in adult patients taking one of these medicinal products at the same time as daptomycin.
Danish: Der opstod dog nogle tilfælde med markante stigninger i CK-værdier og tilfælde af rabdomyolyse hos voksne patienter, som indtog et sådant lægemiddel samtidig med Daptomycin Hospira.
English: However, when compared with the same doses given as intravenous infusions over 30 minutes there were no clinically important differences in the pharmacokinetics and safety profile of daptomycin (see sections 4.8 and 5.2).
Danish: Ved sammenligning med den samme dosis givet som intravenøs infusion over 30 minutter er der dog ingen klinisk relevant forskel i farmakokinetikken og sikkerhedsprofilen af daptomycin (se pkt.
English: Preparation of the solution for infusion requires an additional dilution step as detailed below.
Danish: Fremstilling af opløsning til infusion kræver et ekstra trin til fortynding som beskrevet herunder.
English: What Daptomycin Hospira contains - The active substance is daptomycin.
Danish: Daptomycin Hospira indeholder: - Aktivt stof: daptomycin.
English: In animal models AUC/MIC and Cmax/MIC correlate with efficacy and predicted bacterial kill in vivo at single doses equivalent to human adult doses of 4 mg/kg and 6 mg/kg once daily.
Danish: I dyrestudier korrelerer AUC/MIC og Cmax/MIC med virkning og forventet bakteriedrab in-vivo ved enkeltdoser, der er ækvivalente til humane voksendoser på 4 mg/kg og 6 mg/kg en gang dagligt.
English: There is limited experience regarding concomitant administration of daptomycin with other medicinal products that may trigger myopathy (e.g. HMG-CoA reductase inhibitors).
Danish: Der er begrænset erfaring med samtidig administration af daptomycin og andre lægemidler, som kan udløse myopati (f.eks. HMG-CoA reduktasehæmmere).
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Ekspertvejledning bør indhentes, hvis den lokale resistensprævalens er af en sådan beskaffenhed, at der må stilles spørgsmål ved virkestoffets nytte i det mindste i nogle af infektionstyperne.
English: An updated RMP should be submitted: - At the request of the European Medicines Agency; - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: There is no clinical experience in patients with the administration of daptomycin as an injection over 2 minutes.
Danish: Der er ingen klinisk erfaring fra patienter med administration af daptomycin som injektion over 2 minutter.
English: Daptomycin Hospira is available in packs containing 1 vial or 5 vials.
Danish: Daptomycin Hospira fås i pakninger, der indeholder 1 hætteglas eller 5 hætteglas.
English: Daptomycin is reversibly bound to human plasma proteins in a concentration independent manner.
Danish: Daptomycin bindes på en koncentrationsuafhængig måde, reversibelt til humane plasmaproteiner.
English: Therefore it is important that your doctor takes into account that you are receiving Daptomycin Hospira.
Danish: Der er derfor vigtigt, at din læge tager i betragtning, at du behandles med Daptomycin Hospira.
English: - Do not use this medicine after the expiry date which is stated on the carton and label after EXP.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK.
Danish: De mikroskopiske forandringer i skeletmuskulatur var minimale (ca. 0,05% af myofibre blev påvirket), og var ved højere doser ledsaget af stigninger i CK. Der blev ikke observeret fibrose eller rabdomyolyse.
English: Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 30-minute intravenous infusion of 6 mg/kg once daily in patients with normal renal function.
Danish: Sikkerhedsmarginer for perifere nervevirkninger i rotter og hunde er henholdsvis 8 og 6 gange større, baseret på sammenligning af Cmax-værdier ved NOEL (No Observed Effect Level) med Cmax opnået ved dosering med 30 minutters infusion af 6 mg/kg en gang dagligt hos patienter med normal nyrefunktion.
English: Daptomycin administered as a 2-minute intravenous injection also exhibited dose proportional pharmacokinetics in the approved therapeutic dose range of 4 to 6 mg/kg.
Danish: Administration af daptomycin som en 2 minutters intravenøs injektion viste også dosis-proportional farmakokinetik i det godkendte doseringsinterval på 4 til 6 mg/kg.
English: The pharmacokinetics of daptomycin in paediatric subjects was evaluated in 3 single-dose pharmacokinetic studies.
Danish: Daptomycins farmakokinetik hos pædiatriske patienter blev vurderet i 3 farmakokinetiske enkeltdosisstudier.
English: Comparator
Danish: Komparator
English: False prolongation of prothrombin time (PT) and elevation of international normalised ratio (INR) have been observed when certain recombinant thromboplastin reagents are utilised for the assay (see section
Danish: Interaktioner mellem lægemiddel og laboratorietest Falsk forlængelse af protrombintid (PT) og stigning i international normaliseret ratio (INR) er blevet observeret, når visse rekombinante thromboplastinreagenser er anvendt til analysen (se pkt.
English: - Occasionally, patients receiving Daptomycin Hospira may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information).
Danish: - Patienter, som behandles med Daptomycin Hospira, kan af og til få ømme, smertende eller svage muskler (se under afsnit 4 i denne indlægsseddel for yderligere information).
English: The laboratory susceptibility testing leaflet should contain the following key messages: - That susceptibility testing minimises the risk of treatment failure by identifying strains with potential resistance to daptomycin.
Danish: Informationen om antibiotisk følsomhedsbestemmelse skal indeholde følgende vigtige informationer: - At antibiotisk følsomhedsbestemmelse minimerer risikoen for fejl i behandlingen ved at identificere de stammer, som potentielt kan være resistente for daptomycin.
English: 6 mg/kg every 48 hours cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; RIE = right-sided infective endocarditis (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 (PK) 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: - Known or suspected RIE due to Staphylococcus aureus: daptomycin 6mg/kg is administered once every 24 hours.
Danish: - Kendt eller formodet RIE som følge af Staphylococcus aureus: daptomycin 6 mg/kg administreres en gang i døgnet.
English: Comparable exposure (AUC and Cmax) was demonstrated in healthy adult subjects following administration of daptomycin as a 30-minute intravenous infusion or as a 2-minute intravenous injection.
Danish: Sammenlignelig eksponering (AUC og Cmax) blev vist i raske voksne frivillige efter administration af daptomycin som 30 minutters infusion eller som 2 minutters intravenøs injektion.
English: Daptomycin Hospira given as 2-minute intravenous injection (adult patients only) Water should not be used for reconstitution of Daptomycin Hospira for intravenous injection.
Danish: Daptomycin Hospira givet som 2 minutters intravenøs injektion (kun voksne patienter) Vand må ikke anvendes til rekonstitution af Daptomycin Hospira til intravenøs injektion.
English: Simulation using a population pharmacokinetic model demonstrated that the AUCss (area under the concentration-time curve at steady state) of daptomycin in paediatric patients 1 to <2 years of age receiving12 mg/kg once daily would be comparable to that in adult patients receiving 6 mg/kg once daily.
Danish: Simulering ved hjælp af en farmakokinetisk populationsmodel viste, at AUCss (areal under kurven for koncentration over tid ved steady state) for daptomycin hos pædiatriske patienter i alderen 1 til <2 år, der fik 12 mg/kg en gang dagligt, kunne sammenlignes med AUCss hos voksne patienter, der fik 6 mg/kg en gang dagligt.
English: Daptomycin was not mutagenic or clastogenic in a battery of in vivo and in vitro genotoxicity tests.
Danish: Daptomycin viste ingen mutagen eller klastogen effekt i en række in vivo og in vitro genotoksicitetstest.
English: The mechanism(s) of daptomycin resistance is (are) not fully understood.
Danish: Mekanismen/mekanismerne for daptomycinresistens er ikke fuldstændig kendt.
English: - Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus.
Danish: - Voksne patienter med højresidig infektiøs endocarditis (RIE) som følge af Staphylococcus aureus.
English: 4 mg/kg every 48 hours
Danish: 4 mg/kg hver 48. time
English: However, no dose adjustment is considered to be necessary based on obesity alone.
Danish: En dosisjustering udelukkende baseret på adipositas anses dog ikke for at være nødvendig.
English: Uncommon: Thrombocythaemia, eosinophilia, international normalised ratio (INR) increased, leukocytosis
Danish: Ikke almindelig: Trombocytæmi, eosinofili, stigning i internaltional normalised ratio (INR), leukocytose
English: Comparator n/N (%)
Danish: Komparator n/N (%)
English: If you experience these symptoms, tell your doctor or nurse straight away.
Danish: Hvis du får disse symptomer, skal du straks fortælle det til lægen eller sundhedspersonalet.
English: The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) at 25°C must not exceed 12 hours (24 hours if refrigerated).
Danish: Den samlede opbevaringstid (rekonstitueret opløsning i hætteglas og fortyndet opløsning i infusionspose) ved 25°C må ikke overstige 12 timer (24 timer ved opbevaring i køleskab).