natgillin/translations-raw huggingface dataset:
Klinisk data om anvendelsen af Cubicin til behandling af RIE som følge af Staphylococcus aureus er begrænset til 19 voksne patienter (se ”Information fra kliniske studier” i pkt.
Clinical data on the use of Cubicin to treat RIE due to Staphylococcus aureus are limited to 19 adult patients (see “Information from clinical trials” in section 5.1).
- orale blodfortyndende lægemidler (fx warfarin), som er medicin, der forhindrer blodet i at størkne.
- Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting.
Regelmæssig overvågning af nyrefunktionen tilrådes (se også pkt.
Regular monitoring of renal function is advised (see also section 5.2).
I et enkelt humant studie blev Cubicin 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.
In a single human case study, Cubicin 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 24hour period on day 27.
Det anbefales, at andre lægemidler, der associeres med myopati, seponeres midlertidigt under behandlingen med Cubicin, hvis det er muligt, medmindre fordelen ved samtidig administration opvejer risikoen.
It is recommended that other medicinal products associated with myopathy should if possible be temporarily discontinued during treatment with Cubicin unless the benefits of concomitant administration outweigh the risk.
• Cubicin bør ikke administreres til patienter, som tager andre lægemidler associeret med myopati, medmindre fordelen for patienten anses for at opveje risikoen.
• Cubicin 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.
Cubicin er derfor ikke indiceret til behandling af pneumoni.
Cubicin is therefore not indicated for the treatment of pneumonia.
Under overvågningen efter markedføring er der blevet rapporteret tilfælde med interferens mellem daptomycin og særlige reagenser, som bruges i visse analyser af protombintid/international normalised ratio (PT/INR).
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.
Det tager ca. 15 minutter at opløse det lyofiliserede produkt.
The lyophilised product takes approximately 15 minutes to dissolve.
Afhængig af hvilken infektion eller hvilke infektioner du har, vil din læge muligvis også ordinere andre antibakterielle midler, mens du er i behandling med Cubicin.
Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Cubicin.
Et studie i hunde viste, at skeletal myopati blev reduceret efter en gang dagligt administration sammenlignet med delte doseringer med samme totale dagsdosis, hvilket indikerer, at myopatieffekter i dyr primært er relateret til tid mellem dosis.
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.
Der rådes derfor til forsigtighed, når daptomycin administreres samtidig med ethvert andet lægemiddel, som er kendt for at reducere den renale filtration.
Therefore, caution is advised when daptomycin is coadministered with any other medicinal product known to reduce renal filtration.
Disse har muligvis en indvirkning på Cubicins virkning i nyrerne.
These could interfere with the effects of Cubicin in the kidney.
Den samme dosis anbefales til patienter over 65 år, forudsat at deres nyrer fungerer tilfredsstillende.
The same dose is recommended in people aged over 65 years provided their kidneys are working well.
Virkningsmekanisme Daptomycin er et naturligt cyklisk lipopeptid, som kun er aktiv imod grampositive bakterier.
Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
I to kliniske studier med voksne med komplicerede hud- og bløddelsinfektioner opfyldte 36% af patienterne behandlet med Cubicin kriteriet for systemisk inflammatorisk responssyndrom (SIRS).
In two adult clinical trials in complicated skin and soft tissues infections, 36% of patients treated with Cubicin met the criteria for systemic inflammatory response syndrome (SIRS).
Hos voksne frivillige og hos voksne patienter, som blev behandlet med daptomycin, var gennemsnitlig proteinbinding ca. 90% inklusive patienter med nedsat nyrefunktion.
In healthy adult volunteers and adult patients treated with daptomycin, protein binding averaged about 90% including subjects with renal impairment.
- Doseringskortet skal indeholde en passende algoritme til at udregne den Cubicindosis, der skal rekonstitueres, for at minimere risikoen for medicineringsfejl (høj osmolaritet, overdosering).
- The dosage card should contain the appropriate algorithms for calculating the Cubicin dose for reconstitution, to help minimise the risk of medication errors (high osmolarity, overdose).
De alvorligste bivirkninger er beskrevet nedenfor:
The most serious side effects are described below:
Den normale dosis for voksne er 4 mg for hvert kilo (kg) kropsvægt en gang dagligt ved hudinfektioner eller 6 mg for hvert kg kropsvægt en gang dagligt ved infektion i hjertet eller infektion i blodet forbundet med hud- eller hjerteinfektion.
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.
Det kan være nødvendigt, at behandlingen varer længere end 14 dage i overensstemmelse med risikoen for komplikationer hos den individuelle patient.
The duration of therapy may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.
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.
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.
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.
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.
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.
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.
I de fleste rapporterede tilfælde associeret med Cubicin udviklede patienterne feber, dyspnø med hypoksisk respirationsinsufficiens og diffuse lungeinfiltrater eller organiserende pneumoni.
In most reported cases associated with Cubicin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
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.
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.
Din læge vil sørge for, at du får taget en blodprøve og vil rådgive dig, om du skal fortsætte med Cubicin eller ej.
Your doctor will make sure you have a blood test and will advise whether or not to continue with Cubicin.
7 til 11 år
7 to 11 years
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).
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).
Svært nedsat nyrefunktion kan i sig selv prædisponere for øgede daptomycinniveauer, som kan øge risikoen for, at der udvikles myopati (se ovenfor).
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).
Cubicin bør seponeres, hvis der foreligger uforklarlige muskelsymptomer, og CK-værdien bliver større end 5 gange den øvre grænse for normalværdi.
Cubicin should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal.
- Enhver usædvanlig prikkende eller følelsesløs fornemmelse i hænder eller fødder, følelsestab eller bevægelsesproblemer.
- Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements.
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.
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.
4.4, 4.8 og 5.3.
See sections 4.4, 4.8 and 5.3.
Erfaringerne med samtidig brug af Cubicin og warfarin er begrænsede.
Experience with the concomitant administration of Cubicin and warfarin is limited.
Fortæl din læge, at du er i behandling med Cubicin.
Please inform your doctor that you are on treatment with Cubicin.
De fleste tilfælde opstod efter mere end 2 ugers behandling med Cubicin og blev bedret, når Cubicin blev seponeret og steoridbehandling påbegyndt.
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.
Der er udført interaktionsstudier med Cubicin og aztreonam, tobramycin, warfarin og probenecid.
Interaction studies for Cubicin were performed with aztreonam, tobramycin, warfarin and probenecid.
Vigtigt: læs produktresuméet før ordinering.
Important: Please refer to the Summary of Product Characteristics before prescribing.
Derudover tilrådes regelmæssig overvågning af nyrefunktionen ved samtidig administration af potentielt nefrotoksiske lægemidler, uanset hvordan patientens allerede eksisterende nyrefunktion er (se også pkt.
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).
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.
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.
Dette bør tages i betragtning, når behandling med daptomycin initieres, og sådanne patienter bør overvåges mere end en gang om ugen, hvis daptomycin administreres.
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.
- smertestillende lægemidler, som kaldes non-steroide anti-inflammatoriske lægemidler (NSAID'er) eller COX-2 hæmmere (fx celecoxib).
- Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
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.
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.
Vand må ikke anvendes til rekonstitution af Cubicin til intravenøs injektion.
Water should not be used for reconstitution of Cubicin for intravenous injection.
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.
In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be coadministered with appropriate antibacterial agent(s).
Studier med Cubicin og antikoagulatia udover warfarin er ikke udført.
Studies of Cubicin with anticoagulants other than warfarin have not been conducted.
RIE eller cSSTI associeret med SAB
RIE or cSSTI associated with SAB
Brug til ældre Patienter over 65 år kan få den samme dosis som andre voksne, forudsat deres nyrer fungerer normalt.
People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
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.
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.
Pædiatriske patienter (i alderen 1 til 17 år)
Paediatric patients (1 to 17 years of age)
Sikkerhedsdata for administration af daptomycin som 2 minutters intravenøs injektion stammer fra to farmakokinetikstudier i raske voksne frivillige.
The safety data for the administration of daptomycin via 2-minute intravenous injection are derived from two pharmacokinetic studies in healthy adult volunteers.
Patienterne blev randomiseret i forholdet 2:1 til følgende aldersgrupper og fik en aldersafhængig dosis en gang om dagen i op til 42 dage:
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:
Cubicin indeholder: - Aktivt stof: daptomycin.
What Cubicin contains - The active substance is daptomycin.
Desuden er der ikke blevet fastlagt nogen dosisregimer for daptomycin, som vil være passende til behandlingen af enterokok-infektioner med eller uden bakteriæmi.
In addition, dose regimens of daptomycin that might be appropriate for the treatment of enterococcal infections, with or without bacteraemia, have not been identified.
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.
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.
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.
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.
12 til 17 år
12 to 17 years
Forsigtighed er påkrævet, når Cubicin administreres i kombination med tobramycin.
Caution is warranted when Cubicin is co-administered with tobramycin.
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.
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.
Opbevaringsforhold efter rekonstitution eller rekonstitution og fortynding af lægemidlet, se pkt.
For storage conditions after reconstitution and after reconstitution and dilution of the medicinal product see section 6.3.
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.
Most patients who failed due to persisting or relapsing Staphylococcus aureus infection had deep-seated infection and did not receive necessary surgical intervention.
Symptomerne kan omfatte vejrtrækningsproblemer, hoste/forværret hoste eller feber/højere feber.
The symptoms can include difficulty breathing, new or worsening cough, or new or worsening fever.
Indtil yderligere erfaring er opnået, skal amning ophøre, når Cubicin administreres til ammende kvinder.
Therefore, until more experience is gained, breastfeeding should be discontinued when Cubicin is administered to nursing women.
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.
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.
Der er blevet rappoteret om tilbagefald af eosinofil pneumoni ved reeksponering.
Recurrence of eosinophilic pneumonia upon reexposure has been reported.
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%).
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%).
Naturligt resistente organismer
Inherently resistant organisms
Patienterne blev opdelt og inkluderet i veldefinerede aldersgrupper og fik en aldersafhængig dosis en gang om dagen i op til 14 dage:
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:
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.
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.
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.
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.
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.
The duration of Cubicin may need to be longer than 14 days in accordance with the perceived risk of complications in the individual patient.
Mikrobiologisk modificeret intent-to-treat (mMITT)
Modified intent-to-treat (MITT) Microbiologically modified intent-to-treat (mMITT)
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.
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.
Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som forventes at udskrive/bruge Cubicin, får: - Produktresumé - Doseringskort
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
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.
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.
Fremstilling af infusionsvæske kræver et ekstra trin til fortynding, som beskrevet herunder.
Preparation of the solution for infusion requires an additional dilution step as detailed below.
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.
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).
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).
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).
I alt blev 389 patienter behandlet i studiet, 256 patienter fik daptomycin, og 133 patienter fik standardbehandling.
A total of 389 subjects were treated in the study, including 256 subjects who received daptomycin and 133 subjects who received standard-of-care.