FrancophonIA/ELRC3.0 huggingface dataset:
English: It is particularly important that you mention the following: - Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis).
Danish: Det er særligt vigtigt, at du nævner følgende: - lægemidler, der kaldes statiner eller fibrater (til at sænke kolesteroltallet) eller ciclosporin (et lægemiddel, der bruges ved transplantation for at undgå afstødning af organer, eller ved andre tilstande, f.eks. leddegigt eller astmaeksem).
English: Dosage Regimen
Danish: Doseringsregime
English: Anaphylaxis/hypersensitivity reactions
Danish: Anafylaksi/overfølsomhedsreaktioner
English: If unexplained abnormalities of PT/INR are observed in patients taking daptomycin, consideration should be given to a possible in vitro interaction with the laboratory test.
Danish: Hvis der observeres uforklarlige abnormaliteter af PT/INR hos patienter, der behandles med daptomycin, bør en mulig in vitro-interaktion med laboratorietesten tages i betragtning.
English: The primary objective of Study DAP-PEDBAC-11-02 was to assess the safety of intravenous daptomycin versus SOC antibiotics.
Danish: Det primære mål med studie DAP-PEDBAC-11-02 var at vurdere sikkerheden af intravenøst daptomycin versus SOC-antibiotika.
English: When clinical information on the patients was available to make a judgement, approximately 50% of the cases occurred in patients with pre-existing renal impairment, or in those receiving concomitant medicinal products known to cause rhabdomyolysis.
Danish: Når klinisk information omkring patienterne var tilgængelig til at foretage en bedømmelse, kunne det ses, at omkring 50% af tilfældene opstod hos patienter med allerede eksisterende nedsat nyrefunktion eller hos patienter, der var i samtidig behandling med lægemidler, der er kendt for at forårsage rabdomyolyse.
English: In a mass balance study using radiolabelled material, 78% of the administered dose was recovered from the urine based on total radioactivity, whilst urinary recovery of unchanged daptomycin was approximately 50% of the dose.
Danish: I en undersøgelse af massebalance med radioaktivt mærket materiale blev 78% af administreret dosis genfundet i urin, baseret på total radioaktiv mærkning, mens ca. 50% af dosis blev genfundet i urin som uomdannet daptomycin.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår fertilitet (se pkt.
English: The key efficacy endpoint was the sponsor-defined clinical outcome at test-of-cure (TOC), which was defined by a blinded medical director.
Danish: Vigtige virkningsendepunkter var det sponsordefinerede kliniske udfald af test-of-cure (TOC), som blev defineret af en blindet medicinsk direktør.
English: The majority of cases occurred after more than 2 weeks of treatment with daptomycin and improved when daptomycin was discontinued and steroid therapy was initiated.
Danish: De fleste tilfælde opstod efter mere end 2 ugers behandling med daptomycin og blev bedret, når daptomycin blev seponeret og steroidbehandling påbegyndt.
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: Virkningsmekanismen 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: Therefore, caution is advised when daptomycin is co-administered with any other medicinal product known to reduce renal filtration.
Danish: Der rådes derfor til forsigtighed, når daptomycin administreres samtidigt med ethvert andet lægemiddel, som er kendt for at reducere den renale filtration.
English: Patients who develop these signs and symptoms while receiving daptomycin 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 daptomycin, skal øjeblikkeligt have foretaget en klinisk vurdering, inkluderende bronkoalveolær udskylning, hvis det skønnes relevant, for at udelukke andre årsager (f.eks. bakterieinfektion, svampeinfektion, parasitter, andre lægemidler).
English: The volume of distribution at steady state of daptomycin in healthy adult subjects was approximately 0.1 l/kg and was independent of dose.
Danish: Daptomycins fordelingsvolumen ved steady state hos raske, voksne personer var ca. 0,1 l/kg og var uafhængig af dosis.
English: The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection.
Danish: Den normale dosis til voksne er 4 mg pr. kg legemsvægt en gang dagligt ved hudinfektioner, eller 6 mg pr. kg legemsvægt en gang dagligt for infektioner i hjertet eller infektion i blodet forbundet med hud- eller hjerteinfektion.
English: Hypertension, hypotension Uncommon: Flushes
Danish: Hypertension, hypotension Ikke almindelig: Hedeture
English: In paediatric studies, 372 patients received daptomycin, 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 daptomycin, 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: 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 behandling af patienter med infektioner, der er vanskelige at behandle, og/eller efter administration i forlængede perioder.
English: Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism.
Danish: Daptomycin undergår ringe eller ingen cytokrom-P450 (CYP450)-medieret metabolisme.
English: Do not breast-feed if you are receiving Daptomycin Hospira, because it may pass into your breast milk and could affect the baby.
Danish: Du må ikke amme, hvis du er i behandling med Daptomycin Hospira, da det udskilles i modermælken og kan påvirke barnet.
English: Patients were randomised 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: About 5% of the administered radiolabel was excreted in the faeces.
Danish: Omkring 5% af det indgivne radioaktivt mærkede materiale blev udskilt i fæces.
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 daptomycin 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 ved en dosis af daptomycin på 2 mg/kg, var ændringerne ikke statistisk signifikante.
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 section 4.5).
Danish: Derudover tilrådes regelmæssig kontrol af nyrefunktionen ved samtidig administration af potentielt nefrotoksiske lægemidler, uanset hvordan patientens allerede eksisterende nyrefunktion er (se pkt.
English: In a single human case study, daptomycin was intravenously administered daily for 28 days to a nursing mother at a dose of 500 mg/day, and samples of the patient's breast milk were collected over a 24-hour period on day 27.
Danish: I et enkelt humant studie blev daptomycin administreret intravenøst dagligt i 28 dage til en ammende mor i en dosis på 500 mg/dag, og prøver af patientens mælk blev samlet over en 24-timers periode på dag 27.
English: - Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
Danish: - smertestillende lægemidler kaldet NSAID-præparater (non-steroide antiinflammatoriske lægemidler) eller COX-2-hæmmere (f.eks. celecoxib).
English: In most reported cases associated with daptomycin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
Danish: I de fleste rapporterede tilfælde associeret med daptomycin udviklede patienterne feber, dyspnø med hypoksisk respirationsinsufficiens og diffuse lungeinfiltrater eller organiserende pneumoni.
English: Secondary objectives included an assessment of efficacy of age-dependent doses of intravenous daptomycin in comparison with standard-of-care therapy.
Danish: Det sekundære mål inkluderede en vurdering af virkningen af aldersrelaterede intravenøse doser af daptomycin sammenlignet med standardbehandling.
English: - The dosage card should contain the appropriate algorithms for calculating the Daptomycin Hospira dose for reconstitution, to help minimise the risk of medication errors (high osmolarity, overdose).
Danish: - Doseringskortet skal indeholde en passende algoritme til at udregne den Daptomycin Hospiradosis, der skal rekonstitueres, for at minimere risikoen for medicineringsfejl (høj osmolaritet, overdosering).
English: Daptomycin is slowly cleared from the body by haemodialysis (approximately 15% of the administered dose is removed over 4 hours) or by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours).
Danish: Daptomycin fjernes langsomt fra kroppen ved hæmodialyse (ca. 15% af den administrerede dosis fjernes i løbet af 4 timer) eller ved peritonealdialyse (ca. 11% af den administrerede dosis fjernes i løbet af 48 timer).
English: It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice (see sections 4.4 and 5.1).
Danish: Beslutningen om at anvende daptomycin bør tage højde for organismens antibakterielle følsomhed, og bør være baseret på ekspert-rådgivning (se pkt.
English: - Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting.
Danish: - orale blodfortyndende lægemidler (f.eks. warfarin), som er medicin, der forhindrer blodet i at størkne.
English: In healthy adult volunteers and adult patients treated with daptomycin, protein binding averaged about 90% including subjects with renal impairment.
Danish: Hos raske voksne frivillige og hos voksne patienter, som blev behandlet med daptomycin, var gennemsnitlig proteinbinding ca. 90% inklusive patienter med nedsat nyrefunktion.
English: Dose adjustments in adult patients with renal impairment by indication and creatinine clearance
Danish: Dosisjustering hos voksne patienter med nedsat nyrefunktion afhængigt af indikation og kreatininclearance
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: 60 minutes cSSTI = complicated skin and soft-tissue infections; SAB = S. aureus bacteraemia; (1) Minimum duration of Daptomycin Hospira for paediatric SAB should be in accordance with the perceived risk of complications in the individual patient.
Danish: 60 minutter cSSTI = komplicerede hud- og bløddelsinfektioner; SAB = S. aureus bakteriæmi; (1) Minimumsvarighed af behandling med Daptomycin Hospira for SAB hos pædiatriske patienter skal være i overensstemmelse med den opfattede risiko for komplikationer hos den enkelte patient.
English: The microbiological outcome at TOC for the daptomycin and SOC treatment arms for infections caused by MRSA and MSSA are presented in the table below (mMITT population).
Danish: Det mikrobiologiske udfald af TOC for daptomycin-armen og SOC-armen for infektioner, der er forårsaget af MRSA og MSSA, er vist i tabellen nedenfor (mMITT-population).
English: In two adult clinical trials in complicated skin and soft tissues infections, 36% of patients treated with daptomycin met the criteria for systemic inflammatory response syndrome (SIRS).
Danish: I to kliniske studier med voksne med komplicerede hud- og bløddelsinfektioner opfyldte 36% af patienterne behandlet med daptomycin kriteriet for systemisk inflammatorisk responssyndrom (SIRS).
English: A total of 81 subjects were treated in the study, including 55 subjects who received daptomycin and 26 subjects who received standard-of-care.
Danish: I alt blev 81 forsøgspersoner behandlet i studiet, inklusive 55 forsøgspersoner, som fik daptomycin og 26 forsøgspersoner, som fik standardbehandling.
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 nedbrydning af musklerne (rabdomyolyse), som kan medføre nyreskade.
English: 1 to < 2 years
Danish: 1 til < 2 år
English: Studies of daptomycin with anticoagulants other than warfarin have not been conducted.
Danish: Studier med daptomycin og antikoagulantia udover warfarin er ikke udført.
English: It is recommended that other medicinal products associated with myopathy should if possible be temporarily discontinued during treatment with daptomycin unless the benefits of concomitant administration outweigh the risk.
Danish: Det anbefales, at andre lægemidler, der associeres med myopati, seponeres midlertidigt under behandlingen med Daptomycin Hospira, hvis det er muligt, medmindre fordelen ved samtidig administration opvejer risikoen.
English: - Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.
Danish: • Alle patienter, der udvikler uforklarlige muskelsmerter, -ømhed, -svaghed eller -kramper, bør have målt CK-værdierne hver anden dag.
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 med raske voksne frivillige.
English: - Do not store above 30°C.
Danish: - Må ikke opbevares ved temperaturer over 30°C.
English: 12 to 17 years
Danish: 12-17 år
English: Daptomycin Hospira should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.
Danish: Daptomycin Hospira bør ikke gives til børn under 1 år, da dyreforsøg har vist, at denne aldersgruppe kan få alvorlige bivirkninger.
English: Paediatric patients with SAB
Danish: Pædiatriske patienter med SAB
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 dagligt i op til 14 dage:
English: Your doctor may decide not to give you Daptomycin Hospira or to stop the other medicine for a while.
Danish: Din læge kan beslutte, at du ikke skal have Daptomycin Hospira, eller at du i et stykke tid skal stoppe behandlingen med de andre lægemidler.
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 daptomycin met the criteria for RIE.
Danish: I et randomiseret, kontrolleret, åbent studie med 235 voksne patienter med Staphylococcus aureus bakteriæmi (dvs. mindst en positiv bloddyrkning af Staphylococcus aureus før indgivelse af første dosis), opfyldte 19 ud af 120 patienter behandlet med daptomycin kriteriet for RIE.
English: - Daptomycin Hospira should not be administered to patients who are taking other medicinal products associated with myopathy unless it is considered that the benefit to the patient outweighs the risk.
Danish: • Daptomycin Hospira bør ikke administreres til patienter, som tager andre lægemidler associeret med myopati, medmindre det vurderes, at fordelen for patienten opvejer risikoen.
English: Enterococcal infections
Danish: Enterokok-infektioner
English: 7 to 11 years
Danish: 7-11 år
English: Daptomycin Hospira 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: Daptomycin Hospira bruges også hos voksne til behandling af infektioner i vævene på indersiden af hjertet (herunder hjerteklapperne), som er forårsaget af en type bakterie kaldet Staphyloccocus aureus.
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 foretaget det nødvendige kirurgiske indgreb.
English: The most serious side effects are described below:
Danish: De alvorligste bivirkninger er beskrevet herunder:
English: In neonatal dogs, daptomycin caused marked clinical signs of twitching, muscle rigidity in the limbs, and impaired use of limbs, which resulted in decreases in body weight and overall body condition at doses ≥50 mg/kg/day and necessitated early discontinuation of treatment in these dose groups.
Danish: Hos neonatale hunde forårsagede daptomycin udtalte kliniske tegn på muskelsitren, muskelrigiditet i lemmerne samt hæmmet brug af lemmerne, hvilket resulterede i nedsat legemsvægt og generelt nedsat almentilstand ved doser ≥50 mg/kg/dag og nødvendiggjorde tidlig seponering i disse dosisgrupper.
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; MEpopulation); responsraterne var >94% i begge behandlingsarme for disse almindelige patogener.
English: At lower dose levels (25 mg/kg/day), mild and reversible clinical signs of twitching and one incidence of muscle rigidity were observed without any effects on body weight.
Danish: Ved lavere doser (25 mg/kg/dag) blev der observeret lette og reversible kliniske tegn på muskelsitren samt et tilfælde af muskelrigiditet uden påvirkning af legemsvægten.
English: Children and adolescents (1 to 17 years of age)
Danish: Børn og unge (i alderen 1-17 år)
English: Whenever possible, Daptomycin Hospira should be administered following the completion of dialysis on dialysis days (see section 5.2).
Danish: Når det er muligt, bør Daptomycin Hospira administreres på dialysedagene efter afsluttet dialyse (se pkt.
English: It is unlikely that daptomycin will inhibit or induce the metabolism of medicinal products metabolised by the P450 system.
Danish: Det er ikke sandsynligt, at daptomycin vil hæmme eller inducere metabolismen af lægemidler, der metaboliseres af P450systemet.
English: Daptomycin Hospira should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal.
Danish: Daptomycin Hospira bør seponeres, hvis der foreligger uforklarlige muskelsymptomer, og hvis CK-værdien bliver større end 5 gange den øvre grænse for normalværdi.
English: Failure of treatment due to persisting or relapsing Staphylococcus aureus infections was observed in 19/120 (15.8%) patients treated with daptomycin, 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 aureusinfektioner blev set hos 19/120 (15,8%) af patienterne, der blev behandlet med daptomycin, 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: Clinical efficacy in paediatric patients
Danish: Klinisk virkning hos pædiatriske patienter
English: In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).
Danish: Ved blandede infektioner, hvor der er mistanke om gramnegative og/eller visse typer anærobe bakterier, bør daptomycin administreres sammen med et eller flere hensigtsmæssige antibakterielle lægemidler.
English: This dose is given directly into the blood stream (into a vein), as an infusion lasting about 30-60 minutes.
Danish: Denne dosis gives direkte ind i blodbanen (i en blodåre) som en infusion, der tager omkring 30-60 minutter.
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 doseringsregimer for daptomycin, som vil være passende til behandling af enterokok-infektioner med eller uden bakteriæmi.
English: Water should not be used for reconstitution of Daptomycin Hospira for intravenous injection.
Danish: Vand må ikke anvendes til rekonstitution af Daptomycin Hospira til intravenøs injektion.
English: Experience with the concomitant administration of daptomycin and warfarin is limited.
Danish: Erfaringerne med samtidig brug af daptomycin og warfarin er begrænsede.
English: After infusion of 14C-daptomycin in healthy adults, the plasma radioactivity was similar to the concentration determined by microbiological assay.
Danish: Efter infusion af 14C-daptomycin hos raske voksne var plasmaradioaktiviteten sammenlignelig med koncentrationen målt ved mikrobiologisk analyse.
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 følsomhed eller direkte resistens over for daptomycin under behandling.
English: Uncommon: Supraventricular tachycardia, extrasystole
Danish: Ikke almindelig: Supraventrikulær takykardi, ekstrasystole
English: Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during co-administration 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-2hæmmere).