FrancophonIA/ELRC3.0 huggingface dataset:
English: This results in bacterial cell death with negligible cell lysis.
Danish: Dette resulterer i bakteriel celledød med kun ubetydelig cellelysis.
English: In a separate study, no metabolites were observed in plasma, and minor amounts of three oxidative metabolites and one unidentified compound were detected in urine.
Danish: I et særskilt studie blev ingen metabolitter detekteret i plasma, og mindre mængder af tre oxidative metabolitter og et uidentificeret stof blev målt i urinen.
English: The results of these studies show that exposures (AUC) in paediatric patients across all doses are generally lower than those in adults at comparable doses.
Danish: Resultaterne fra disse studier viste, at eksponeringen (AUC) hos pædiatriske patienter på tværs af alle doser generelt lå lavere end eksponeringen hos voksne ved sammenlignelige doser.
English: Mitochondrial loss/damage was also observed; however the role and significance of this finding in the overall pathology are unknown.
Danish: Tab af eller skade på mitokondrier blev også observeret, men betydningen og signifikansen af dette fund i den samlede patologi er ukendt.
English: These limitations of the patients population treated should be taken into account when deciding to use daptomycin.
Danish: Disse begrænsninger i patientpopulationerne bør tages i betragtning, når der træffes afgørelse om brug af daptomycin.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Hvis der opstår en superinfektion under behandlingen, skal der træffes passende foranstaltninger.
English: The primary objective of Study DAP-PEDS-07-03 was to assess the safety of treatment.
Danish: Det primære mål med studie DAP-PEDS-07-03 var at vurdere sikkerheden af behandlingen.
English: From a microbiological point of view, the product should be used immediately after reconstitution (see section 6.3).
Danish: Ud fra et mikrobiologisk synspunkt skal produktet anvendes straks efter rekonstitution (se pkt.
English: Inactive metabolites were detected in urine, as determined by the difference in total radioactive concentrations and microbiologically active concentrations.
Danish: Inaktive metabolitter blev detekteret i urinen, målt som forskellen i total radioaktiv koncentration og mikrobiologisk aktiv koncentration.
English: In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.
Danish: Hos voksne skal anvendelse ved bakteriæmi være associeret med RIE eller med cSSTI, mens anvendelse ved bakteriæmi hos pædiatriske patienter skal være associeret med cSSTI.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Other antibacterials, ATC code: J01XX09
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, Andre antibakterica, ATC-kode: J01XX09
English: - It cannot be ruled out that those patients with CPK greater than 5 times upper limit of normal at baseline may be at increased risk of further increases during daptomycin therapy.
Danish: • Det kan ikke udelukkes, at patienter med CK over 5 gange den øvre normalgrænse ved baseline kan have større risiko for yderligere stigninger under behandling med daptomycin.
English: These may be signs of a rare but serious lung disorder called eosinophilic pneumonia.
Danish: Dette kan være tegn på en sjælden, men alvorlig lungesygdom, som kaldes eosinofil pneumoni.
English: Animal studies showed that daptomycin is not absorbed to any significant extent after oral administration.
Danish: Dyrestudier viste, at daptomycin ikke absorberes i nogen særlig udstrækning efter oral administration.
English: In addition, there is a potential for a pharmacodynamic interaction to occur during co-administration due to additive renal effects.
Danish: Derudover er der en potentiel mulighed for, at der opstår en farmakodynamisk interaktion ved samtidig administration pga. additiv renal effekt.
English: Daptomycin Hospira is not usually given to pregnant women.
Danish: Daptomycin Hospira gives normalt ikke til gravide kvinder.
English: Of these 19 patients 11 were infected with methicillin-susceptible and 8 with methicillin-resistant Staphylococcus aureus.
Danish: Af disse 19 patienter var 11 inficeret med methicillin-følsom og 8 med methicillin-resistent Staphylococcus aureus.
English: The highest measured concentration of daptomycin in the breast milk was 0.045 mcg/ml, which is a low concentration.
Danish: Den højeste målte koncentration af daptomycin i mælken var 0,045 mikrogram/ml, hvilket er en lav koncentration.
English: This medicinal product must not be mixed with other medicinal products except those mentioned above.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført ovenfor.
English: The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is mainly based on pharmacokinetic modelling data.
Danish: Sikkerhed og virkning ved justering af dosisintervallet er ikke evalueret i kontrollerede, kliniske forsøg, og anbefalingen er hovedsageligt baseret på data fra farmakokinetisk modellering.
English: In vitro studies with human hepatocytes indicate that daptomycin does not inhibit or induce the activities of the following human cytochrome P450 isoforms: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 and 3A4.
Danish: In vitro studier med humane hepatocytter indikerer, at daptomycin ikke hæmmer eller inducerer aktiviteten af følgende humane cytokrom P450-isoformer: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 og 3A4.
English: - Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent.
Danish: - Diarré, særligt hvis du bemærker blod eller slim, eller hvis diarréen forværres eller er vedvarende.
English: However, renal function should be assessed and the dose should be reduced if there is evidence of severe renal impairment.
Danish: Nyrefunktionen bør dog bestemmes og dosis bør reduceres, hvis der er tegn på svært nedsat nyrefunktion.
English: Secondary objectives included: Clinical outcome based on the blinded Evaluator's assessment of clinical response (success [cure, improved], failure, or non-evaluable) at the TOC Visit; and Microbiological response (success, failure, or non-evaluable) based on evaluation of Baseline infecting pathogen at TOC.
Danish: Sekundære mål inkluderede: Klinisk udfald baseret på den blindede evaluators vurdering af klinisk respons (succes [helbredelse, forbedret], failure eller ikkeevaluerbar) ved TOC-besøget; og mikrobiologisk respons (succes, failure eller ikke-evaluerbar) baseret på vurdering af infektiøst patogen ved baseline i TOC.
English: No functional or pathological changes in smooth or cardiac muscle were observed.
Danish: Der blev ikke observeret funktionelle eller patologiske forandringer i glatte muskler eller hjertemuskulatur.
English: - That Daptomycin Hospira can interfere with coagulation tests (PT/INR) and this might lead to false results.
Danish: - At Daptomycin Hospira kan interferere med koagulationstest (PT/INR), hvilket kan medføre falske resultater.
English: The success rates in RIE patients are shown in the table below.
Danish: Succesraten for RIE-patienterne er vist i nedenstående tabel.
English: Uncommon: Vertigo
Danish: Ikke almindelig: Vertigo
English: Adverse reactions (i.e. considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported at similar frequencies for daptomycin and comparator regimens.
Danish: Bivirkninger (dvs. af investigator antaget at være muligvis, sandsynligvis eller definitivt relateret til lægemidlet) blev rapporteret med sammenlignelige frekvenser for daptomycin og komparative regimer.
English: Prothrombin time (PT) prolonged Not known*: Thrombocytopaenia
Danish: Forlænget protrombintid (PT) Ikke kendt* Thrombocytopeni
English: Daptomycin administration was associated with minimal to mild degenerative/regenerative changes in skeletal muscle in the rat and dog.
Danish: Administration af daptomycin blev associeret med minimale til lette degenerative/regenerative forandringer i skeletmuskulaturen hos rotter og hunde.
English: Reproductive toxicity testing showed no evidence of effects on fertility, embryofoetal, or postnatal development.
Danish: Toksicitetstest i forbindelse med reproduktion viste ingen tegn på effekt på fertilitet, embryoføtal eller postnatal udvikling.
English: 2 (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP))
Danish: 2 (øget alaninaminotransferase (ALAT), aspartat-aminotransferase (ASAT) eller basisk fosfatase (ALP))
English: The following adverse reactions were reported during therapy and during follow-up with frequencies corresponding to very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data):
Danish: Hyppigheden svarer til meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data):
English: There is a possibility that your blood levels of Daptomycin Hospira could be higher than those found in persons of average weight and you may need careful monitoring in case of side effects.
Danish: Det er muligt, at indholdet af Daptomycin Hospira i dit blod er højere end hos personer med en gennemsnitlig vægt, og det kan være nødvendigt at du overvåges nøje i tilfælde af bivirkninger.
English: It is also used to treat infections in the blood when associated with skin infection.
Danish: Det bruges også til behandling af infektioner i blodet i forbindelse med infektion i huden.
English: Subjects achieving clinical success (Clinical Response of “Cure” or “Improved”) and microbiological success (pathogen-level response of “Eradicated” or “Presumed Eradicated”) are classified as overall therapeutic success.
Danish: Patienter, som opnår klinisk succes (klinisk respons “helbredt” eller “forbedret”) og mikrobiologisk succes (niveau af patogen “udryddet” eller “formodet udryddet”) er klassificeret som overordnet terapeutisk succes.
English: Daptomycin Hospira should not be used during pregnancy unless clearly necessary i.e., only if the expected benefit outweighs the possible risk.
Danish: Daptomycin Hospira bør ikke anvendes under graviditet, medmindre det er klart nødvendigt, dvs. kun hvis den forventede fordel opvejer den mulige risiko.
English: Any unused portion remaining in the vial should be discarded.
Danish: Enhver ubrugt rest i hætteglasset skal kasseres.
English: The majority of transaminase elevations were of Grade 1-3 toxicity and resolved upon discontinuation of treatment.
Danish: Størstedelen af de forhøjede aminotransferaser havde en toksicitetsgrad på 1-3 og forsvandt efter seponering af behandlingen.
English: - Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy.
Danish: • Patienterne bør undersøges regelmæssigt under behandlingen for alle tegn eller symptomer, der kan tyde på myopati.
English: The findings of in vitro and some in vivo studies designed to investigate the mechanism of daptomycin myotoxicity indicate that the plasma membrane of differentiated spontaneously contracting muscle cells is the target of toxicity.
Danish: Resultaterne fra in vitro- og nogle in vivo-studier designet til at undersøge mekanismen for daptomycins myotoksicitet indikerer, at plasmamembranen af differentierede spontant sammentrækkende muskelceller er målet for toksicitet.
English: In clinical studies, 2,011 adult subjects received daptomycin.
Danish: I kliniske studier er 2.011 voksne forsøgspersoner blevet behandlet med daptomycin.
English: Table 1 Adverse reactions from clinical studies and post-marketing reports
Danish: Tabel 1 Bivirkninger rapporteret fra kliniske studier og post-marketing rapporter Systemorganklasse
English: People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Danish: Personer over 65 år kan få den samme dosis som andre voksne, forudsat at deres nyrer fungerer normalt.
English: Gram negative organisms * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Danish: * betegner arter, hvor aktivitet anses for at være påvist på tilfredsstillende måde i kliniske studier.
English: Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness.
Danish: Fortæl det straks til lægen, hvis du oplever uforklarlige muskelsmerter, -ømhed eller -svaghed.
English: Patients with deep-seated infections should receive any required surgical interventions (e.g. debridement, removal of prosthetic devices, valve replacement surgery) without delay.
Danish: Patienter med dybtsiddende infektioner bør få foretaget ethvert nødvendigt kirurgisk indgreb (f.eks. oprensning, fjernelse af proteser, kirurgisk udskiftning af hjerteklappen) uden forsinkelse.
English: The same dose is recommended in people aged over 65 years provided their kidneys are working well.
Danish: Den samme dosis anbefales til personer over 65 år, forudsat at deres nyrer fungerer tilfredsstillende.
English: No preservative or bacteriostatic agent is present in this product.
Danish: Der er ikke tilsat konserveringsmiddel eller bakteriostatisk middel i dette præparat.
English: Patients at higher risk of developing myopathy should have more frequent CPK measurements.
Danish: Patienter med høj risiko for at udvikle myopati bør få lavet hyppigere CK-målinger.
English: Daptomycin pharmacokinetics in patients in this study are summarised in Table 2.
Danish: Daptomycins farmakokinetik hos patienter i dette studie er opsummeret i tabel 2.
English: - Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements.
Danish: - Enhver usædvanlig prikkende fornemmelse eller følelsesløs fornemmelse i hænder eller fødder, tab af følesans eller bevægelsesproblemer.
English: Other side effects which may occur following daptomycin treatment are described below:
Danish: Andre bivirkninger, som kan forekomme efter behandling med Daptomycin Hospira, er beskrevet nedenfor:
English: On this basis, it is recommended that adult patients on HD or CAPD receive daptomycin once every 48 hours at the dose recommended for the type of infection being treated (see section 4.2).
Danish: På basis heraf anbefales det, at voksne patienter, som får i HD eller CAPD, får daptomycin en gang hver 48. time i den anbefalede dosis for den type infektion, som skal behandles (se pkt.
English: The results can suggest poor blood clotting when, in fact, there is no problem.
Danish: Resultaterne kan vise, at dit blod størkner dårligt, også selv om der ikke er noget i vejen.
English: Daptomycin Hospira may interfere with laboratory tests that measure how well your blood is clotting.
Danish: Daptomycin Hospira kan have indflydelse på resultaterne af visse laboratorieprøver, der måler, hvor godt dit blod størkner.
English: Tell your doctor straight away if you develop any of the following symptoms: - Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including Daptomycin Hospira.
Danish: Fortæl det straks til lægen, hvis du får nogen af følgende symptomer: - Alvorlige, akutte allergiske reaktioner er set hos patienter i behandling med stort set alle antibiotika inklusive Daptomycin Hospira.
English: No dose adjustment is necessary based on age alone.
Danish: En dosisjustering baseret på alder er ikke nødvendig.
English: Tissue distribution studies in rats showed that daptomycin appears to only minimally penetrate the blood-brain barrier and the placental barrier following single and multiple doses.
Danish: Vævsdistributionsforsøg i rotter viste, at daptomycin kun synes at penetrere blodhjernebarrieren og placentabarrieren minimalt efter enkeltdosis og multiple doser.
English: Daptomycin Hospira should not be used more frequently than once a day.
Danish: Daptomycin Hospira bør ikke anvendes oftere end en gang dagligt.
English: The most frequently reported side effects are described below:
Danish: De hyppigst indberettede bivirkninger er beskrevet nedenfor:
English: The interaction between daptomycin and tobramycin with an approved dose of daptomycin is unknown.
Danish: Interaktionen mellem daptomycin og tobramycin med en godkendt dosis af daptomycin er ukendt.
English: Regular monitoring of renal function is advised (see section 5.2).
Danish: Regelmæssig kontrol af nyrefunktionen tilrådes (se pkt.
English: Clostridium difficile-associated diarrhoea
Danish: Clostridium difficile-associeret diarré**
English: The duration of therapy 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 varer længere end 14 dage i overensstemmelse med den forventede risiko for komplikationer hos den individuelle patient.
English: The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use.
Danish: Den rekonstituerede opløsning bør kontrolleres nøje for at sikre, at produktet er opløst og bør inspiceres visuelt for partikler før brug.
English: Rates (95% CI)
Danish: Rater (95% KI)
English: After cleaning, do not touch the rubber stopper or allow it to touch any other surface.
Danish: Efter rensning må gummiproppen ikke berøres eller komme i kontakt med noget andet.
English: While the exact incidence of eosinophilic pneumonia associated with daptomycin is unknown, to date the reporting rate of spontaneous reports is very low (< 1/10,000).
Danish: Den præcise hyppighed af eosinofil pneumoni associeret med daptomycin er ukendt på nuværende tidspunkt; antallet af spontane indrapporteringer er meget lav (< 1/10.000).
English: If a focus of infection other than cSSTI or RIE is identified after initiation of daptomycin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Danish: Hvis et infektionsfokus udover cSSTI eller RIE identificeres efter initieringen af behandling med Daptomycin Hospira, bør det overvejes, om der skal startes alternativ antibakteriel behandling, som har vist effekt i behandlingen af den specifikke tilstedeværende type infektion(er).
English: During post-marketing surveillance, cases of interference between daptomycin and particular reagents used in some assays of prothrombin time/international normalised ratio (PT/INR) have been reported.
Danish: Under overvågningen efter markedsføring er der blevet rapporteret tilfælde af interferens mellem daptomycin og særlige reagenser, som bruges i visse analyser af protrombintid/international normalised ratio (PT/INR).
English: Daptomycin should be discontinued immediately and treatment with systemic steroids should be initiated when appropriate.
Danish: Daptomycin Hospira skal straks seponeres, og behandling med systemiske steroider skal påbegyndes, hvis det skønnes hensigtsmæssigt.
English: In in vitro studies, daptomycin was not metabolised by human liver microsomes.
Danish: I in vitro studier blev daptomycin ikke metaboliseret af humane levermikrosomer.
English: A study in dogs demonstrated that skeletal myopathy was reduced upon once daily administration as compared to fractionated dosing at same total daily dose, suggesting that myopathic effects in animals were primarily related to time between doses.
Danish: Et studie i hunde viste, at skeletal myopati blev reduceret efter administration en gang dagligt sammenlignet med delte doseringer med samme totale dagsdosis, hvilket tyder på, at myopati-effekter i dyr primært er relateret til tid mellem dosis.
English: It is possible that the risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Daptomycin Hospira.
Danish: Det er muligt, at risikoen for bivirkninger i musklerne er større, hvis du tager et af disse lægemidler (og nogle andre lægemidler, som påvirker musklerne) samtidig med behandlingen med Daptomycin Hospira.
English: Long-term carcinogenicity studies in rodents were not conducted.
Danish: Der er ikke udført langtidsstudier af karcinogenicitet hos gnavere.
English: Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Danish: Virkningsmekanisme Daptomycin er et naturligt cyklisk lipopeptid, som kun er aktivt imod grampositive bakterier.
English: It is also used to treat infections in the blood caused by the same type of bacteria when associated with heart infection.
Danish: Det bruges også til behandling af infektioner i blodet, som er forårsaget af samme type bakterie i forbindelse med infektion i hjertet.
English: There is insufficient evidence to be able to draw any conclusions regarding the possible clinical efficacy of daptomycin against infections due to enterococci, including Enterococcus faecalis and Enterococcus faecium.
Danish: Der er utilstrækkeligt bevis for at kunne drage konklusioner vedrørende daptomycins mulige, kliniske effekt over for infektioner forårsaget af enterokokker, inclusive Enterococcus faecalis og Enterococcus faecium.
English: Clinical data on the use of daptomycin to treat RIE due to Staphylococcus aureus are limited to 19 adult patients (see “Information from clinical trials” in section 5.1).
Danish: Kliniske data om anvendelsen af daptomycin til behandling af RIE som følge af Staphylococcus aureus er begrænset til 19 voksne patienter (se “Information fra kliniske studier” i pkt.
English: (2) The same dose adjustments, which are based on PK data in volunteers including PK modelling results, are recommended for adult patients on haemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).
Danish: (2) De samme dosisjusteringer, som er baseret på farmakokinetiske data i frivillige, inklusive resultater fra farmakokinetisk modellering, anbefales hos voksne patienter, der får hæmodialyse (HD) eller kontinuerlig ambulant peritonealdialyse (CAPD).
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 resistens >1 mg/l.
English: The pharmacokinetics of daptomycin were not significantly altered by aztreonam.
Danish: Farmakokinetikken af daptomycin blev ikke signifikant ændret af aztreonam.
English: CARTON FOR 1 VIAL CARTON FOR 5 VIALS
Danish: KARTON TIL 5 HÆTTEGLAS
English: If you are receiving dialysis, and your next dose of Daptomycin Hospira is due on a dialysis day, you will be usually given Daptomycin Hospira after the dialysis session.
Danish: Hvis du er i dialyse, og hvis din næste dosis af Daptomycin Hospira skal indgives på en dag, hvor du er i dialysebehandling, vil du normalt få Daptomycin Hospira efter dialysebehandlingen.
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 udvikling af myopati (se ovenfor).
English: For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution og rekonstitution og fortynding af lægemidlet, se pkt.