natgillin/translations-raw huggingface dataset:
Den samme dosis anbefales til personer 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.
Der er ikke tilsat konserveringsmiddel eller bakteriostatisk middel i dette præparat.
No preservative or bacteriostatic agent is present in this product.
Patienter med høj risiko for at udvikle myopati bør få lavet hyppigere CK-målinger.
Patients at higher risk of developing myopathy should have more frequent CPK measurements.
Daptomycins farmakokinetik hos patienter i dette studie er opsummeret i tabel 2.
Daptomycin pharmacokinetics in patients in this study are summarised in Table 2.
- Enhver usædvanlig prikkende fornemmelse eller følelsesløs fornemmelse i hænder eller fødder, tab af følesans eller bevægelsesproblemer.
- Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements.
Andre bivirkninger, som kan forekomme efter behandling med Daptomycin Hospira, er beskrevet nedenfor:
Other side effects which may occur following daptomycin treatment are described below:
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.
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).
Resultaterne kan vise, at dit blod størkner dårligt, også selv om der ikke er noget i vejen.
The results can suggest poor blood clotting when, in fact, there is no problem.
Daptomycin Hospira kan have indflydelse på resultaterne af visse laboratorieprøver, der måler, hvor godt dit blod størkner.
Daptomycin Hospira may interfere with laboratory tests that measure how well your blood is clotting.
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.
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.
En dosisjustering baseret på alder er ikke nødvendig.
No dose adjustment is necessary based on age alone.
Vævsdistributionsforsøg i rotter viste, at daptomycin kun synes at penetrere blodhjernebarrieren og placentabarrieren minimalt efter enkeltdosis og multiple doser.
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.
Daptomycin Hospira bør ikke anvendes oftere end en gang dagligt.
Daptomycin Hospira should not be used more frequently than once a day.
De hyppigst indberettede bivirkninger er beskrevet nedenfor:
The most frequently reported side effects are described below:
Interaktionen mellem daptomycin og tobramycin med en godkendt dosis af daptomycin er ukendt.
The interaction between daptomycin and tobramycin with an approved dose of daptomycin is unknown.
Regelmæssig kontrol af nyrefunktionen tilrådes (se pkt.
Regular monitoring of renal function is advised (see section 5.2).
Clostridium difficile-associeret diarré**
Clostridium difficile-associated diarrhoea
Det kan være nødvendigt, at behandlingen varer længere end 14 dage i overensstemmelse med den forventede risiko 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.
Den rekonstituerede opløsning bør kontrolleres nøje for at sikre, at produktet er opløst og bør inspiceres visuelt for partikler før brug.
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.
Rater (95% KI)
Rates (95% CI)
Efter rensning må gummiproppen ikke berøres eller komme i kontakt med noget andet.
After cleaning, do not touch the rubber stopper or allow it to touch any other surface.
Den præcise hyppighed af eosinofil pneumoni associeret med daptomycin er ukendt på nuværende tidspunkt; antallet af spontane indrapporteringer er meget lav (< 1/10.000).
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).
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).
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.
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).
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.
Daptomycin Hospira skal straks seponeres, og behandling med systemiske steroider skal påbegyndes, hvis det skønnes hensigtsmæssigt.
Daptomycin should be discontinued immediately and treatment with systemic steroids should be initiated when appropriate.
I in vitro studier blev daptomycin ikke metaboliseret af humane levermikrosomer.
In in vitro studies, daptomycin was not metabolised by human liver microsomes.
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.
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.
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.
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.
Der er ikke udført langtidsstudier af karcinogenicitet hos gnavere.
Long-term carcinogenicity studies in rodents were not conducted.
Virkningsmekanisme Daptomycin er et naturligt cyklisk lipopeptid, som kun er aktivt imod grampositive bakterier.
Mechanism of action Daptomycin is a cyclic lipopeptide natural product that is active against Gram positive bacteria only.
Det bruges også til behandling af infektioner i blodet, som er forårsaget af samme type bakterie i forbindelse med infektion i hjertet.
It is also used to treat infections in the blood caused by the same type of bacteria when associated with heart infection.
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.
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.
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.
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).
(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).
(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).
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.
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.
Farmakokinetikken af daptomycin blev ikke signifikant ændret af aztreonam.
The pharmacokinetics of daptomycin were not significantly altered by aztreonam.
KARTON TIL 5 HÆTTEGLAS
CARTON FOR 1 VIAL CARTON FOR 5 VIALS
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.
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.
Svært nedsat nyrefunktion kan i sig selv prædisponere for øgede daptomycinniveauer, som kan øge risikoen for udvikling af 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).
Opbevaringsforhold efter rekonstitution og 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.
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).
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).
Doseringsregime
Dosage Regimen
Anafylaksi/overfølsomhedsreaktioner
Anaphylaxis/hypersensitivity reactions
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.
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.
Det primære mål med studie DAP-PEDBAC-11-02 var at vurdere sikkerheden af intravenøst daptomycin versus SOC-antibiotika.
The primary objective of Study DAP-PEDBAC-11-02 was to assess the safety of intravenous daptomycin versus SOC antibiotics.
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.
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.
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.
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.
Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår fertilitet (se pkt.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Vigtige virkningsendepunkter var det sponsordefinerede kliniske udfald af test-of-cure (TOC), som blev defineret af en blindet medicinsk direktør.
The key efficacy endpoint was the sponsor-defined clinical outcome at test-of-cure (TOC), which was defined by a blinded medical director.
De fleste tilfælde opstod efter mere end 2 ugers behandling med daptomycin og blev bedret, når daptomycin blev seponeret og steroidbehandling påbegyndt.
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.
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.
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.
Der rådes derfor til forsigtighed, når daptomycin administreres samtidigt med ethvert andet lægemiddel, som er kendt for at reducere den renale filtration.
Therefore, caution is advised when daptomycin is co-administered with any other medicinal product known to reduce renal filtration.
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).
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).
Daptomycins fordelingsvolumen ved steady state hos raske, voksne personer var ca. 0,1 l/kg og var uafhængig af dosis.
The volume of distribution at steady state of daptomycin in healthy adult subjects was approximately 0.1 l/kg and was independent of dose.
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.
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.
Hypertension, hypotension Ikke almindelig: Hedeture
Hypertension, hypotension Uncommon: Flushes
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).
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).
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.
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.
Daptomycin undergår ringe eller ingen cytokrom-P450 (CYP450)-medieret metabolisme.
Daptomycin undergoes little to no Cytochrome P450 (CYP450)-mediated metabolism.
Du må ikke amme, hvis du er i behandling med Daptomycin Hospira, da det udskilles i modermælken og kan påvirke barnet.
Do not breast-feed if you are receiving Daptomycin Hospira, because it may pass into your breast milk and could affect the baby.
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 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:
Omkring 5% af det indgivne radioaktivt mærkede materiale blev udskilt i fæces.
About 5% of the administered radiolabel was excreted in the faeces.
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.
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.
Derudover tilrådes regelmæssig kontrol af nyrefunktionen ved samtidig administration af potentielt nefrotoksiske lægemidler, uanset hvordan patientens allerede eksisterende nyrefunktion er (se 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 section 4.5).
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.
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.
- smertestillende lægemidler kaldet NSAID-præparater (non-steroide antiinflammatoriske lægemidler) eller COX-2-hæmmere (f.eks. celecoxib).
- Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib).
I de fleste rapporterede tilfælde associeret med daptomycin udviklede patienterne feber, dyspnø med hypoksisk respirationsinsufficiens og diffuse lungeinfiltrater eller organiserende pneumoni.
In most reported cases associated with daptomycin, patients developed fever, dyspnoea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates or organising pneumonia.
Det sekundære mål inkluderede en vurdering af virkningen af aldersrelaterede intravenøse doser af daptomycin sammenlignet med standardbehandling.
Secondary objectives included an assessment of efficacy of age-dependent doses of intravenous daptomycin in comparison with standard-of-care therapy.
- Doseringskortet skal indeholde en passende algoritme til at udregne den Daptomycin Hospiradosis, der skal rekonstitueres, for at minimere risikoen for medicineringsfejl (høj osmolaritet, overdosering).
- 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).
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).
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).
Beslutningen om at anvende daptomycin bør tage højde for organismens antibakterielle følsomhed, og bør være baseret på ekspert-rådgivning (se pkt.
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).
- orale blodfortyndende lægemidler (f.eks. warfarin), som er medicin, der forhindrer blodet i at størkne.
- Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting.
Hos raske 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.
Dosisjustering hos voksne patienter med nedsat nyrefunktion afhængigt af indikation og kreatininclearance
Dose adjustments in adult patients with renal impairment by indication and creatinine clearance
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.
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.
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.
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).
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).
I to kliniske studier med voksne med komplicerede hud- og bløddelsinfektioner opfyldte 36% af patienterne behandlet med daptomycin kriteriet for systemisk inflammatorisk responssyndrom (SIRS).
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).
I alt blev 81 forsøgspersoner behandlet i studiet, inklusive 55 forsøgspersoner, som fik daptomycin og 26 forsøgspersoner, som fik standardbehandling.
A total of 81 subjects were treated in the study, including 55 subjects who received daptomycin and 26 subjects who received standard-of-care.
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.
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.
1 til < 2 år
1 to < 2 years
Studier med daptomycin og antikoagulantia udover warfarin er ikke udført.
Studies of daptomycin with anticoagulants other than warfarin have not been conducted.
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.
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.
• Alle patienter, der udvikler uforklarlige muskelsmerter, -ømhed, -svaghed eller -kramper, bør have målt CK-værdierne hver anden dag.
- Any patient that develops unexplained muscle pain, tenderness, weakness or cramps should have CPK levels monitored every 2 days.