FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of intravenous colistimethate sodium with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.
Danish: Anvendelse af intravenøs colistimethatnatrium sammen med andre lægemidler, der er potentielt nefrotoksiske eller neurotoksiske, bør ske med stor forsigtighed.
English: fAUC/ MIC is considered to be correlated with clinical efficacy.
Danish: fAUC/MIC formodes at korrelere med klinisk virkning.
English: There are indications that pharmacokinetics in critically ill patients differ from those in patients with less severe physiological derangement and from those in healthy volunteers.
Danish: Der er noget, der tyder på, at farmakokinetikken hos kritisk syge patienter er forskellig fra farmakokinetikken hos patienter med mindre svær fysiologisk forstyrrelse og hos raske frivillige.
English: Peak plasma concentrations of colistin have been shown to occur with a delay of up to 7 hours after administration of colistimethate sodium in critically ill patients.
Danish: Maksimale plasmakoncentrationer af colistin er vist at komme med en forsinkelse på op til 7 timer efter administration af colistimethatnatrium hos kritisk syge patienter.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent, in at least some types of infections, is questionable.
Danish: Der skal om nødvendigt søges ekspertrådgivning, når lokal forekomst af resistens er sådan, at anvendeligheden af lægemidlet i det mindste ved visse infektionstyper kan diskuteres.
English: The mechanism of colistin clearance, including renal handling, is equally unknown.
Danish: Mekanismen ved colistinclearance, herunder renal clearance, er ligeledes ukendt.
English: The information on the pharmacokinetics of colistimethate sodium (CMS) and colistin is limited.
Danish: Oplysninger om farmakokinetikken for colistimethatnatrium (CMS) og colistin er begrænsede.
English: Annex III Amendments to relevant sections of the summary of product characteristics and the package leaflets
Danish: Bilag III Ændringer til relevante afsnit i produktresuméet og indlægssedlen
English: There are no data regarding the use or magnitude of a loading dose in critically ill children.
Danish: Der er ingen data vedrørende brug eller størrelsen af en inialdosis til kritisk syge børn.
English: Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose.
Danish: Resistente bakterier er kendetegnet ved en modificering af phosphatgrupperne på lipopolysaccharid, der bliver substitueret med ethanolamin eller aminoarabinose.
English: What you need to know before you <take> <use> [Product name]
Danish: Det skal De vide, før De begynder at <tage> <bruge> [Produktnavn]
English: Colistimethate sodium should be used with extreme caution in patients with porphyria.
Danish: Colistimethatnatrium bør anvendes med den yderste forsigtighed til patienter med porfyri.
English: Half-life of colistin in healthy subjects and those with cystic fibrosis is reported to be around 3h and 4h, respectively, with a total clearance of around 3L/h.
Danish: Det er rapporteret, at halveringstiden for colistin hos raske personer og personer med cystisk fibrose er henholdsvis ca. 3 og 4 timer med en total-clearance på ca. 3 l/time.
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents and may occur with colistimethate sodium.
Danish: Antibiotika-associeret colitis og pseudomembranøs colitis er blevet rapporteret i forbindelse med næsten alle antibakterielle midler og kan muligvis forekomme med colistimethatnatrium.
English: CVVHF/ CVVHDF As in patients with normal renal function.
Danish: CVVHF/ CVVHDF Som hos patienter med normal nyrefunktion.
English: R>4 mg/L a Breakpoints apply to dosage of 2-3 MIU x 3.
Danish: R > 4 mg/l a Grænseværdier gælder for en dosis på 2-3 MIE x 3 dagligt.
English: The usual daily dose in children weighing up to 40 kg is 75.000 to 150.000 units per kilogram body weight, divided into three doses.
Danish: Den sædvanlige daglige dosis til børn, der vejer op til 40 kg, er 75.000 til 150.000 enheder pr. kg kropsvægt fordelt på tre doser.
English: There are limited clinical data on the efficacy and safety of intravenous colistimethate sodium.
Danish: Der er begrænsede kliniske data vedrørende virkningen af og sikkerheden ved intravenøs colistimethatnatrium.
English: The usual daily dose in adults is 9 million units, divided into two or three doses.
Danish: Den sædvanlige dosis til voksne er 9 millioner enheder, der deles i to eller tre doser.
English: The dosage can be adjusted depending on the severity of the condition and clinical response.
Danish: Dosen kan justeres afhængigt af tilstandens sværhedsgrad og den kliniske respons.
English: The potential for drug-drug interactions should be borne in mind when [Product name] is coadministered with drugs known to inhibit or induce drug metabolising enzymes or drugs known to be substrates for renal carrier mechanisms.
Danish: Man skal huske på risikoen for lægemiddelinteraktioner, når [Produktnavn] administreres sammen med lægemidler, der er kendt for at hæmme eller inducere lægemiddelmetaboliserende enzymer, eller lægemidler, der er kendt for at være substrater for renale transportmekanismer.
English: It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium (see section 4.8).
Danish: Det er vigtigt at overveje denne diagnose hos patienter, der udvikler diarré under eller efter behandling med colistimethatnatrium (se pkt.
English: Colistin clearance is decreased in renal impairment, possibly due to increased conversion of CMS.
Danish: Colistinclearance er reduceret ved nedsat nyrefunktion, muligvis pga. øget omdannelse af CMS.
English: Note: If intrathecal administration is included in the SmPC of your product, the following should also be included:
Danish: Bemærk: Hvis intratekal administration er inkluderet i produktresuméet for dit produkt, skal følgende også inkluderes:
English: Caution should be taken with concomitant use with other formulations of colistimethate sodium as there is little experience and there is a possibility of summative toxicity.
Danish: Der skal udvises forsigtighed ved anvendelse sammen med andre formuleringer af colistimethatnatrium, da der kun er ringe erfaring hermed og risiko for additiv toksicitet.
English: Talk to your doctor, pharmacist or nurse before using [Product name] - If you have or have had kidney problems.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De bruger [Produktnavn] - hvis De har eller har haft nyreproblemer.
English: Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium.
Danish: Polymyxiner virker ved at beskadige cellemembranen, og de resulterende fysiologiske virkninger er dræbende for bakterien.
English: Older people No dose adjustments in older patients with normal renal function are considered necessary.
Danish: Ældre Det vurderes, at dosisjustering ikke er nødvendig til ældre patienter med normal nyrefunktion.
English: Colistimethate sodium is known to reduce the presynaptic release of acetyl-choline at the neuromuscular junction and should be used in patients with myasthenia gravis with the greatest caution and only if clearly needed.
Danish: Colistimethatnatrium er kendt for at reducere den præsynaptiske frigivelse af acetylcholin i den neuromuskulære overgang og bør derfor anvendes til patienter med myasthenia gravis med den største forsigtighed og kun, hvis det er klart nødvendigt.
English: Impaired renal function increases the possibility of apnoea and neuromuscular blockade following administration of colistimethate sodium.
Danish: Nedsat nyrefunktion øger risikoen for apnø og neuromuskulær blokade efter administration af colistimethatnatrium.
English: Both CMS and colistin display linear PK in the clinically relevant dose range.
Danish: Både CMS og colistin fremviser lineær farmakokinetik i det klinisk relevante dosisområde.
English: Dose reductions are recommended for patients with creatinine clearance < 50 ml/min: Twice daily dosing is recommended.
Danish: Det anbefales, at dosis reduceres hos patienter med kreatininclearance < 50 ml/min: Det anbefales, at døgndosis fordeles på 2 doser.
English: Stenotrophomonas maltophilia Achromobacter xylosoxidans (formerly Alcaligenes xylosoxidans)
Danish: Arter, for hvilke erhvervet resistens kan være et problem Stenotrophomonas maltophilia Achromobacter xylosoxidans (formerly Alcaligenes xylosoxidans)
English: Firm dose recommendations cannot be made.
Danish: Der kan ikke gives faste dosisanbefalinger.
English: High serum concentrations of colistimethate sodium, which may be associated with overdosage or failure to reduce the dosage in patients with renal impairment, have been reported to lead to neurotoxic effects such as facial paraesthesia, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea.
Danish: Det er blevet rapporteret, at høje serumkoncentrationer af colistimethatnatrium, fx i forbindelse med overdosering eller manglende dosisreduktion til patienter med nedsat nyrefunktion, har medført neurotoksiske virkninger, såsom facialisparese, muskelsvaghed, vertigo, sløret tale, vasomotorisk ustabilitet, synsforstyrrelser, konfusion, psykose og apnø.
English: Recommended dose range:
Danish: Anbefalet dosisinterval:
English: [Product name] is given as an inhalation to treat chronic chest infections in patients with cystic fibrosis.
Danish: [Produktnavn] gives som en inhalation til behandling af kroniske infektioner i lungerne hos patienter med cystisk fibrose.
English: Monitoring should be performed for perioral paraesthesia and paraesthesia in the extremities, which are signs of overdose (see section
Danish: Patienterne bør overvåges for perioral paræstesi og paræstesi i ekstermiteterne, som er tegn på overdosering (se pkt.
English: The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response.
Danish: Den administrerede dosis og behandlingsvarigheden skal fastsættes under hensyntagen til infektionens sværhedsgrad samt den kliniske respons.
English: A tabulated presentation of the posology could be considered acceptable.
Danish: Et skema, der viser doseringen, kunne være acceptabelt.
English: As the development of resistance to intravenous colistin has been reported in particular when it is used as a monotherapy, co- administration with other antibacterial should also be considered in order to prevent the emergence of resistance.
Danish: Da der især er rapporteret om resistensudvikling over for intravenøs colistin, når det anvendes som monoterapi, bør samtidig administration af andre antibakterielle midler også overvejes for at undgå resistensudvikling.
English: The usual dose for children less than 2 years old is 0.5-1 million units twice daily (maximum 2 million units per day).
Danish: Den sædvanlige dosis til børn under 2 år er 0,5-1 million enheder to gange dagligt (maksimalt 2 millioner enheder dagligt).
English: The data supporting the dose regimen in paediatric patients are very limited.
Danish: Data, der understøtter dosisregimet til pædiatriske patienter, er meget begrænsede.
English: Nephrotoxicity has been reported to be associated with cumulative dose and treatment duration in some studies.
Danish: Nefrotoksicitet er i nogle studier blevet rapporteret at være forbundet med kumulativ dosis og behandingsvarighed.
English: Changes agreed by the CHMP to the product information of CMS-containing products for injection or infusion
Danish: Ændringer, der er godkendt af CHMP, til produktinformationen for CMS-holdige produkter til injektion og infusion
English: Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation.
Danish: Colistin gennemgår omfattende renal tubulær reabsorption og cleares muligvis enten non-renalt eller gennemgår renal metabolisme med mulighed for renal akkumulering.
English: Caution is advised when administering colistimethate sodium in these patients.
Danish: Der bør udvises forsigtighed ved administrering af colistimethatnatrium til disse patienter.
English: The dose is expressed in international units (IU) of colistimethate sodium (CMS).
Danish: Dosis udtrykkes i internationale enheder (IE) af colistimethatnatrium (CMS).
English: 125.000 IU/day Intrathecally administered doses should not exceed those recommended for intraventricular use.
Danish: Intratekalt administrerede doser bør ikke overstige de doser, der anbefales til intraventrikulær brug.
English: Polymyxins have been reported to have a concentration-dependent bactericidal effect on susceptible bacteria.
Danish: Det er rapporteret, at polymyxiner har en koncentrationsafhængig baktericid virkning på følsomme bakterier.
English: The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity (mg CBA).
Danish: Dosen angives i USA og andre dele af verden som milligram colistin-basisaktivitet (mg CBA).
English: In patients who are critically ill, a loading dose of 9 MIU should be administered.
Danish: Patienter, der er kritisk syge, skal have administreret en initialdosis på 9 MIE.
English: Do not <take><use> [Product name] - If you are allergic (hypersensitive) to colistimethate sodium, colistin or to other polymyxins.
Danish: <Tag><Brug> ikke [Produktnavn] - hvis De er allergisk (overfølsom) over for colistimethatnatrium, colistin eller over for andre polymyxiner.
English: Section 4.1 Therapeutic indication
Danish: Afsnit 4.1 Terapeutisk indikation
English: Section 4.2 Posology and method of administration
Danish: Afsnit 4.2 Dosering og administration
English: There are extremely limited data from population PK studies from very small numbers of patients on renal replacement therapy.
Danish: Der er yderst begrænsede data fra populationsfarmakokinetiske studier fra et meget lille antal patienter i nyreerstatningsbehandling.
English: Due to the effects of colistin on the release of acetylcholine, non-depolarising muscle relaxants should be used with caution in patients receiving colistimethate sodium as their effects could be prolonged (see section 4.4).
Danish: På grund af colistins virkninger på frigivelsen af acetylcholin bør ikke-depolariserende muskelrelaksantia anvendes med forsigtighed til patienter, der får colistimethatnatrium, da virkningen kan blive forlænget (se pkt.
English: Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group.
Danish: Colistin er et antibakterielt middel og et cyklisk polypeptid, der tilhører polymyxingruppen.
English: Haemodialysis and continuous haemo(dia)filtration Colistin appears to be dialyzable through conventional haemodialysis and continuous venovenous haemo(dia)filtration (CVVHF, CVVHDF).
Danish: Colistin ser ud til at kunne dialyseres ved traditionel hæmodialyse og kontinuerlig venovenøs hæmo(dia)filtrering (CVVHF, CVVHDF).
English: Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.
Danish: Hos naturligt resistente gramnegative bakterier, såsom Proteus mirabilis og Burkholderia cepacia, er lipidphosphat fuldstændigt substitueret med ethanolamin eller aminoarabinose.
English: Section 5.2 Pharmacokinetic properties
Danish: Afsnit 5.2 Farmakokinetiske egenskaber
English: Maintenance dose 9MIU/day in 2-3 divided doses
Danish: Vedligeholdelsesdosis 9 MIE/døgn fordelt på 2-3 doser.
English: The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid (ECF).
Danish: Fordeling Fordelingsvolumenet af colistin hos raske personer er lavt og svarer omtrent til ekstracellulærvæsken
English: Respiratory arrest has been reported following intramuscular administration of colistimethate sodium.
Danish: Respirationsstop er blevet rapporter efter intramuskulær administration af colistimethatnatrium.
English: Consideration should be given to co-administering intravenous colistimethate sodium with another antibacterial agent whenever this is possible, taking into account the remaining susceptibilities of the pathogen(s) under treatment.
Danish: Det bør overvejes at administrere intravenøs colistimethatnatrium sammen med et andet antibakterielt middel, når dette er muligt, idet der skal tages hensyn til den resterende følsomhed hos patogenet/patogenerne, der behandles.
English: The usual dose for adults, adolescents and children aged 2 years or older is 1-2 million units two to three times per day (maximum 6 million units per day).
Danish: Den sædvanlige dosis til voksne, unge og børn på 2 år og derover er 1-2 millioner enheder to til tre gange dagligt (maksimalt 6 millioner enheder dagligt).
English: Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer membrane.
Danish: Polymyxiner er selektive for aerobe, gramnegative bakterier med en hydrofob ydre membran.
English: In the EU, the dose of colistimethate sodium (CMS) must be prescribed and administered only as International Units (IU).
Danish: I EU må dosen af colistimethatnatrium (CMS) ved ordinering og til administration kun angives i internationale enheder (IE).
English: For dose preparation, particularly where combination of multiple vials is needed, reconstitution of the required dose must be performed using strict aseptic technique (see section 6.6).
Danish: Ved dosisklargøring skal rekonstitution af den nødvendige dosis foregå ved en strengt aseptisk teknik (se pkt.
English: Changes agreed by the CHMP to the Product Information of CMS-containing products for solution for inhalation or nebulisation
Danish: Ændringer, der er godkendt af CHMP, til produktinformationen for CMS-holdige produkter til opløsning til inhalation eller til nebulisator
English: The loading dose applies to patients with normal and impaired renal functions including those on renal replacement therapy.
Danish: Initialdosen er passende til patienter med normal og nedsat nyrefunktion, herunder patienter, der er i nyreerstatningsbehandling.
English: The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients (see section 4.4):
Danish: Følgende dosisanbefalinger er baseret på begrænsede populationsfarmakokinetiske data hos kritisk syge patienter (se pkt.
English: After infusion of colistimethate sodium the inactive pro-drug is converted to the active colistin.
Danish: Efter infusion af colistimethatnatrium omdannes det inaktive prodrug til det aktive colistin.
English: The dose of colistimethate sodium should be adjusted according to creatinine clearance (see section 4.2).
Danish: Dosis af colistimethatnatrium skal justeres i henhold til kreatininclearance (se pkt.
English: They may range from mild to lifethreatening in severity.
Danish: Sværhedsgraden kan være fra let til livstruende.
English: [Product name] is given to you by your doctor as an infusion into a vein over 30 - 60 minutes.
Danish: De får [Produktnavn] af en læge som drop (infusion i en vene) i løbet af 30-60 minutter.
English: Note: If present, any contraindication in myasthenia gravis should be deleted, to be replaced with a warning in section 4.4, as indicated below.
Danish: Bemærk: Hvis myasthenia gravis på nogen måde er angivet som kontraindikation, skal det slettes og erstattes med en advarsel i afsnit 4.4 som anført nedenfor.
English: Further, the effect of immature renal and metabolic function on the conversion of colistimethate sodium to colistin is not known.
Danish: Endvidere er det ikke kendt, hvordan en umoden nyrefunktion og metabolisk funktion påvirker omdannelsen af colistimethatnatrium til colistin.
English: If you suffer from myasthenia gravis and are also taking other antibiotics called macrolides (such as azithromycin, clarithromycin or erythromycin) or antibiotics called fluoroquinolones (such as ofloxacin, norfloxacin and ciprofloxacin), taking [Product name] further increases the risk of muscle weakness and breathing difficulties.
Danish: Hvis De lider af myasthenia gravis og også tager andre typer af antibiotika, der kaldes makrolider (som f.eks. azithromycin, clarithromycin eller erythromycin) eller fluorquinoloner (som f.eks. ofloxacin, norfloxacin og ciprofloxacin), kan det betyde, at risikoen for muskelsvaghed og vejrtrækningsproblemer øges yderligere, hvis De tager [Produktnavn].
English: No dose recommendations have been established in children with impaired renal function.
Danish: Der er ikke fastlagt dosisanbefalinger til børn med nedsat nyrefunktion.
English: If you have a general anaesthetic, let your anaesthetist know that you are having [Product name]
Danish: Hvis De skal i fuld bedøvelse, skal De fortælle narkoselægen, at De er i behandling med [Produktnavn]
English: Dose adjustments in renal impairment are necessary, but pharmacokinetic data available for patients with impaired renal function is very limited.
Danish: Dosisjustering er nødvendig ved nedsat nyrefunktion, men der foreligger kun meget begrænsede farmakokinetiske data fra patienter med nedsat nyrefunktion.
English: Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis (see section 4.4).
Danish: Samtidig behandling med colistimethatnatrium og makrolider, såsom azithromycin og clarithromycin, eller fluorquinoloner, såsom norfloxacin og ciprofloxacin, skal ske med forsigtighed til patienter med myasthenia gravis (se pkt.
English: A conversion table from CMS in IU to mg of CMS as well as to mg of colistin base activity (CBA) is included at the end of this section.
Danish: I slutningen af afsnittet findes en omregningstabel fra CMS i IE til mg CMS samt til mg colistinbase-aktivitet (CBA).
English: The dose should be based on lean body weight.
Danish: Dosen bør baseres på fedtfri kropsvægt (LBM).
English: Section 5.1 Pharmacodynamic properties
Danish: Afsnit 5.1 Farmakodynamiske egenskaber
English: Data supporting the posology are very limited.
Danish: Data til understøtning af doseringen er meget begrænsede.
English: Children ≤ 40kg 75.000-150.000 IU/kg/day divided into 3 doses.
Danish: 75.000-150.000 IE/kg/døgn fordelt på 3 doser.
English: Other medicines and [Product name] - medicines which can affect how your kidneys function.
Danish: Brug af anden medicin sammen med [Produktnavn] - lægemidler, der kan påvirke, hvordan nyrerne fungerer.
English: Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin (see sections 4.5 and 4.8).
Danish: Hypovolæmiske patienter og patienter, der får andre potentielt nefrotoksiske lægemidler, har øget risiko for nefrotoksicitet ved brug af colistin (se pkt.
English: There are no data in patients with hepatic impairment.
Danish: Der foreligger ingen data fra patienter med nedsat leverfunktion.
English: Since the mechanism of action of the polymyxins is different from that of other antibacterial agents, resistance to colistin and polymyxin by the above mechanism alone would not be expected to result in resistance to other drug classes.
Danish: Der forventes krydsresistens mellem colistin (polymyxin E) og polymyxin B. Da virkningsmekanismen for polymyxinerne er forskellig fra virkningsmekanismen for andre antibakterielle midler, forventes det ikke, at resistens over for colistin og polymyxin udelukkende ved ovennævne mekanisme vil resultere i resistens over for andre lægemiddelklasser.
English: If present, any contraindication in myasthenia gravis should be deleted, to be replaced with a warning, as indicated below.
Danish: Hvis der er angivet en kontraindikation ved myasthenia gravis, skal den slettes og erstattes med en advarsel som anført nedenfor.