FrancophonIA/ELRC3.0 huggingface dataset:
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 Cubicin and comparator regimens.
Danish: Bivirkninger (dvs. af investigator antaget at være muligvis, sandsynligvis eller definitivt relateret til lægemidlet) blev rapporteret med sammenlignelige frekvenser for Cubicin og komparative regimer.
English: This medicinal product must not be mixed with other medicinal products except those mentioned above.
Danish: Dette lægemiddel må ikke blandes med andre end de ovenfor nævnte lægemidler.
English: Cubicin 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: Cubicin må ikke bruges til børn under 1 år, da dyrestudier har vist, at denne aldergruppe kan få alvorlige bivirkninger.
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.
Danish: Beslutningen om at anvende daptomycin bør tage højde for organismens antibakterielle følsomhed og bør være baseret på ekspert-rådgivning.
English: There is a possibility that your blood levels of Cubicin 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 niveauerne af Cubicin i dit blod er højere end de niveauer, der findes hos personer med gennemsnitlig vægt, og det kan være nødvendigt at du overvåges nøje i tilfælde af bivirkninger.
English: However, from a microbiological point of view the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør præparatet dog anvendes med det samme.
English: Cubicin should not be used during pregnancy unless clearly necessary i.e., only if the expected benefit outweighs the possible risk.
Danish: Cubicin bør ikke anvendes under graviditet, medmindre det er klart nødvendigt, dvs. kun hvis den forventede fordel opvejer den mulige risiko.
English: Cubicin may interfere with laboratory tests that measure how well your blood is clotting.
Danish: Cubicin kan have indflydelse på resultaterne af visse laboratorieprøver, der måler, hvor godt dit blod størkner.
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 kaldet eosinofil pneumoni.
English: Pharmacotherapeutic group: Antibacterials for systemic use, Other antibacterials, ATC code: J01XX09
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, Andre Antibakterielle, ATC-kode: J01XX09
English: EXP Read the leaflet for the shelf life of the reconstituted product
Danish: EXP Læs indlægssedlen angående opbevaringstid af det rekonstituerede produkt.
English: In addition, there is a potential for a pharmacodynamic interaction to occur during coadministration 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: • 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, hvis CK-værdi overstiger 5 gange den øvre grænse for normalværdi ved baseline, kan have større risiko for yderligere stigninger under behandlingen med daptomycin.
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 Cubicin.
Danish: Det er muligt, at risikoen for bivirkninger, der har indvirkning på musklerne, er større, hvis du tager nogle af disse lægemidler (og nogle andre lægemidler, der kan have indvirkning på musklerne) samtidig med behandlingen med Cubicin.
English: For Reconstitution:
Danish: Til rekonstitution:
English: Modified intent-to-treat Clinically evaluable Microbiologically evaluable (ME)
Danish: Intent-to-treat Modificeret intent-to-treat Klinisk evaluerbar Mikrobiologisk evaluerbar (ME)
English: The interaction between daptomycin and tobramycin with an approved dose of Cubicin is unknown.
Danish: Interaktionen mellem daptomycin og tobramycin med en godkendt dosis Cubicin er ukendt.
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 inficerede med methicillin-følsom og 8 med methicillin-resistent Staphylococcus aureus.
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 CYP-isoformer: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 og 3A4.
English: Commonly Susceptible Species
Danish: Sædvanligvis følsomme arter
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: Other side effects which may occur following Cubicin treatment are described below:
Danish: Andre bivirkninger, som kan forekomme under behandling med Cubicin, er beskrevet nedenfor:
English: The recommended dosage regimens for paediatric patients based on age and indication are shown below.
Danish: De anbefalede doseringsregimer for pædiatriske patienter baseret på alder og indikation er vist nedenfor.
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.
Danish: Hvis samtidig administration ikke kan undgås, bør CK-værdier måles regelmæssigt mere end en gang om ugen, og patienterne bør overvåges tæt for ethvert tegn eller symptom, som kan tyde på myopati.
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 bliver forværret eller er vedvarende.
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: Cubicin should be discontinued immediately and treatment with systemic steroids should be initiated when appropriate.
Danish: Cubicin skal straks seponeres, og behandling med systemiske steroider skal påbegyndes, hvis det skønnes hensigtsmæssigt.
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 skal undersøges nøje for at sikre, at præparatet er opløst og inspiceres visuelt for partikler før brug.
English: If you are receiving dialysis, and your next dose of Cubicin is due on a dialysis day, you will be usually given Cubicin after the dialysis session.
Danish: Hvis du er i dialyse, og hvis din næste Cubicin-dosis skal indgives på en dag, hvor du får dialysebehandling, vil du normalt få Cubicin efter dialysebehandlingen.
English: Secondary objectives included: Clinical outcome based on the blinded Evaluator's assessment of clinical response (success [cure, improved], failure, or nonevaluable) 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: Therefore it is important that your doctor takes into account that you are receiving Cubicin.
Danish: Det er derfor vigtigt, at din læge tager i betragtning, at du behandles med Cubicin.
English: If a focus of infection other than cSSTI or RIE is identified after initiation of Cubicin 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 Cubicin-behandling, bør det overvejes om der skal startes alternativ antibakteriel behandling, som har vist effekt i behandlingen af den specifikke tilstedeværende type infektion(er).
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 Cubicin.
Danish: Fortæl det til din læge med det samme, hvis du udvikler et eller flere af følgende symptomer: - Alvorlige, akutte allergiske reaktioner er set hos patienter i behandling med stort set alle antibiotika inklusive Cubicin.
English: You should not be given Cubicin
Danish: Du må ikke få Cubicin
English: A rare but potentially serious lung disorder called eosinophilic pneumonia has been reported in patients given Cubicin, mostly after more than 2 weeks of treatment.
Danish: En sjælden, men eventuel alvorlig lungesygdom, kaldet eosinofil pneumoni, er blevet indberettet hos patienter i behandling med Cubicin, for det meste efter mere end 2 ugers behandling.
English: Do not breast-feed if you are receiving Cubicin, because it may pass into your breast milk and could affect the baby.
Danish: Du må ikke amme, hvis du er i behandling med Cubicin, da det kan udskilles i mælken og påvirke barnet.
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 dybt-siddende infektioner bør få foretaget ethvert nødvendigt kirurgisk indgreb (f.eks. oprensning, fjernelse af proteser, kirurgisk udskiftning af hjerteklappen) uden forsinkelse.
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 og symptomer, der kan tyde på myopati.
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 enkelt- og multiple doser.
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: 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 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 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: Resultater fra in vitro- og nogle in vivo-studier designet til at undersøge mekanismen for daptomycins myotoksicitet indikerer, at plasmamembranen af differentierede spontant sammentrækkende skeletmuskelceller er målet for toksicitet.
English: Your doctor may decide not to give you Cubicin or to stop the other medicine for a while.
Danish: Din læge kan beslutte ikke at ordinere Cubicin til dig eller, at du i et stykke tid skal holde op med at tage de andre lægemidler.
English: If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk over for daptomycin eller natriumhydroxid eller et af de øvrige indholdsstoffer i Cubicin (angivet i punkt 6).
English: (2) The same dose adjustments, which are based on pharmacokinetic 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: • 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 overvåget CK-værdierne hver anden dag.
English: 2 (increased alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP))
Danish: 2 (øget alaninaminotransferase (ALAT), aspartat-aminotransferase (ASAT) og basisk fosfatase (ALP))
English: Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution.
Danish: Til slut skal hætteglasset roteres forsigtigt i et par minutter, så der opnås en klar rekonstitueret opløsning.
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 præparatet anvendes med det samme efter rekonstitution (se pkt.
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 lavt (<1/10.000).
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 til at undgå afstødning af organer, eller ved andre tilstande som fx reumatoid artrit eller atopisk dermatitis).
English: Daptomycin pharmacokinetics in patients in this study are summarized in Table 2.
Danish: Daptomycins farmakokinetik hos patienter i dette studie er opsummeret i tabel 2.
English: The symptoms generally go away within a few days of stopping Cubicin.
Danish: Symptomerne forsvinder som regel i løbet af et par dage, når behandlingen med Cubicin er ophørt.
English: There is insufficient evidence to be able to draw any conclusions regarding the possible clinical efficacy of Cubicin against infections due to enterococci, including Enterococcus faecalis and Enterococcus faecium.
Danish: Der er utilstrækkeligt bevis for at kunne drage konklusioner vedrørende Cubicins mulige kliniske effekt over for infektioner forårsaget af enterokokker, inklusive Enterococcus faecalis og Enterococcus faecium.
English: Whenever possible, Cubicin should be administered following the completion of dialysis on dialysis days (see section 5.2).
Danish: Når det er muligt, bør Cubicin administreres på dialysedagene efter afsluttet dialyse (se pkt.
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 fremkommer uforklarlige abnormaliteter af PT/INR hos patienter, der behandles med daptomycin, bør en mulig in vitro-interaktion med laboratorieundersøgelsen tages i betragtning.
English: If your kidneys do not work well, you may receive Cubicin less often, e.g. once every other day.
Danish: Hvis dine nyrer ikke fungerer tilfredsstillende, kan du få Cubicin mindre hyppigt, fx hver anden dag.
English: Anxiety, insomnia
Danish: Almindelig: Angst, insomni
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Hvis der opstår en superinfektion, skal der træffes passende foranstaltninger.
English: 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).
Danish: 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.
English: - Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting.
Danish: - orale blodfortyndende lægemidler (fx warfarin), som er medicin, der forhindrer blodet i at størkne.
English: Regular monitoring of renal function is advised (see also section 5.2).
Danish: Regelmæssig overvågning af nyrefunktionen tilrådes (se også pkt.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: • 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.
Danish: • Cubicin bør ikke administreres til patienter, som tager andre lægemidler associeret med myopati, medmindre fordelen for patienten anses for at opveje risikoen.
English: Cubicin is therefore not indicated for the treatment of pneumonia.
Danish: Cubicin er derfor ikke indiceret til behandling af pneumoni.
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 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).
English: The lyophilised product takes approximately 15 minutes to dissolve.
Danish: Det tager ca. 15 minutter at opløse det lyofiliserede produkt.
English: Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Cubicin.
Danish: 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.
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 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.
English: Therefore, caution is advised when daptomycin is coadministered with any other medicinal product known to reduce renal filtration.
Danish: Der rådes derfor til forsigtighed, når daptomycin administreres samtidig med ethvert andet lægemiddel, som er kendt for at reducere den renale filtration.
English: These could interfere with the effects of Cubicin in the kidney.
Danish: Disse har muligvis en indvirkning på Cubicins virkning i nyrerne.
English: The same dose is recommended in people aged over 65 years provided their kidneys are working well.
Danish: Den samme dosis anbefales til patienter over 65 år, forudsat at deres nyrer fungerer tilfredsstillende.
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 aktiv imod grampositive bakterier.
English: 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).
Danish: I to kliniske studier med voksne med komplicerede hud- og bløddelsinfektioner opfyldte 36% af patienterne behandlet med Cubicin kriteriet for systemisk inflammatorisk responssyndrom (SIRS).
English: In healthy adult volunteers and adult patients treated with daptomycin, protein binding averaged about 90% including subjects with renal impairment.
Danish: Hos voksne frivillige og hos voksne patienter, som blev behandlet med daptomycin, var gennemsnitlig proteinbinding ca. 90% inklusive patienter med nedsat nyrefunktion.
English: - 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).
Danish: - Doseringskortet skal indeholde en passende algoritme til at udregne den Cubicindosis, der skal rekonstitueres, for at minimere risikoen for medicineringsfejl (høj osmolaritet, overdosering).
English: The most serious side effects are described below:
Danish: De alvorligste bivirkninger er beskrevet nedenfor:
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 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.
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 risikoen for komplikationer hos den individuelle patient.