FrancophonIA/ELRC3.0 huggingface dataset:
English: Exfoliative dermatitis, Stevens-Johnson syndrome, Lyell's syndrome, Linear IgA bullous dermatosis
Danish: Exfoliativ dermatitis, Stevens-Johnson's syndrom, Lyell's syndrom, Lineær IgA bulløs dermatose
English: Appropriate consideration should be given to the concomitant administration of medicinal products that may reduce vancomycin clearance and/or potentiate its undesirable effects (see section 4.4).
Danish: Der bør tages passende hensyn til samtidig administration af lægemidler, der kan reducere vancomycinclearance og/eller forstærke dets bivirkninger (se pkt.
English: Intravenous administration of vancomycin is not effective for the treatment of Clostridium difficile infection.
Danish: Intravenøs administration af vancomycin er ikke effektiv til behandling af Clostridium difficileinfektion.
English: To achieve this target when MICs are ≥ 1.0 mg/l, dosing in the upper range and high trough serum concentrations (15-20 mg/l) are required (see section 4.2).
Danish: For at nå dette mål, når MIC er ≥ 1,0 mg/l, er dosering i det øvre område og høj dal-koncentration i serum (15-20 mg/l) påkrævet (se punkt 4.2).
English: In some cases, your doctor may decide to give a higher daily dose of up to 500 mg every 6 hours.
Danish: I visse tilfælde kan lægen beslutte at give en højere daglig dosis på op til 500 mg hver 6 time.
English: In non-inflamed meninges, vancomycin passes the blood-brain barrier only to a low extent.
Danish: Hos ikke-betændte meninges passerer vancomycin kun blod-hjerne-barrieren i ringe grad. Biotransformation
English: Intermittent therapy: the recommended dose is 15-30 mg/kg in the long-dwell, every 5-7 days.
Danish: Intermitterende terapi: Den anbefalede dosis er 15-30 mg/kg i ”long-dwell” hver 5.-7. dag.
English: Renal dysfunction delays the excretion of vancomycin.
Danish: Nedsat nyrefunktion forsinker udskillelsen af vancomycin.
English: Van genes have rarely been found in Staphylococcus aureus, where changes in cell wall structure result in “intermediate” susceptibility, which is most commonly heterogeneous.
Danish: Van-gener er sjældent blevet fundet i Staphylococcus aureus, hvor ændringer i cellevægstruktur resulterer i ”intermediær” følsomhed, som almindeligvis er heterogen.
English: The drug is bactericidal for dividing microorganisms.
Danish: Lægemidlet er baktericidt for delende mikroorganismer.
English: In some cases, your doctor may decide to give an initial dose of up to 30 mg for each kg of body weight.
Danish: I visse tilfælde kan lægen beslutte at give en indledende dosis på op til 30 mg pr. kg legemsvægt.
English: The recommended dose is 15 to 20 mg/kg of body weight every 8 to 12 h (not to exceed 2 g per dose).
Danish: Den anbefalede dosis er 15 til 20 mg/kg legemsvægt hver 8. til 12. time (må ikke overstige 2 g pr. dosis).
English: One possible way of dosing vancomycin in neonates is illustrated in the following table: (see section 4.4)
Danish: En mulig måde for dosering af vancomycin hos nyfødte er illustreret i følgende tabel: (se pkt.
English: No blood concentrations were detected and urinary recovery did not exceed
Danish: Der blev ikke påvist nogen blodkoncentrationer, og uringenvindingen oversteg ikke 0,76%.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Danish: MIC-breakpoints fastlagt af European Committee on Antimicrobial Susceptibility Testing (EUCAST) er som følger:
English: Renal insufficiency manifested primarily by increased serum creatinine and serum urea
Danish: Nyreinsufficiens primært manifesteret af forhøjet serumkreatinin og serumurinstof
English: If a bullous disorder is suspected, the drug should be discontinued and specialised dermatological assessment should be carried out.
Danish: Hvis der er mistanke om en bulløs lidelse, skal behandlingen afbrydes, og der bør foretages specialiseret dermatologisk vurdering.
English: However, use of high-flux membranes and continuous renal replacement therapy (CRRT) increases vancomycin clearance and generally requires replacement dosing (usually after the haemodialysis session in case of intermittent haemodialysis).
Danish: Anvendelse af højfluxmembraner og kontinuerlig nyreerstatningsbehandling (CRRT) øger dog vancomycin-clearance og kræver normalt erstatningsdosering (normalt efter hæmodialysesessionen i tilfælde af intermitterende hæmodialyse).
English: In anephric patients, the mean half-life is 7.5 days.
Danish: Hos patienter uden egen nyrefunktion er den gennemsnitlige halveringstid 7,5 dage.
English: The recommended vancomycin dose is 10 mg/kg orally every 6 hours for 10 days.
Danish: Den anbefalede vancomycindosis er 10 mg/kg oralt hver 6. time i 10 dage.
English: Vancomycin shall only be administered as slow intravenous infusion of at least one hour duration or at a maximum rate of 10 mg/min (whichever is longer) which is sufficiently diluted (at least 100 ml per 500 mg or at least 200 ml per 1000 mg) (see section 4.4).
Danish: Vancomycin må kun indgives som langsom intravenøs infusion af mindst en times varighed eller ved en maksimal hastighed på 10 mg/min (alt efter, hvad der tager længst tid) i en tilstrækkeligt tynd opløsning (mindst 100 ml pr 500 mg eller mindst 200 ml pr 1000 mg) (se punkt 4.4).
English: In adult and paediatric patients with renal impairment, consideration should be given to an initial starting dose followed by serum vancomycin trough levels rather than to a scheduled dosing regimen, particularly in patients with severe renal impairment or those who undergo renal replacement therapy (RRT) due to the many varying factors that may affect vancomycin levels in them.
Danish: Hos voksne og pædiatriske patienter med nedsat nyrefunktion bør en indledende startdosis efterfølges af doser vejledt af dal-serumkoncentrationer af vancomycin i stedet for en planlagt dosering overvejes, især hos patienter med svær nyreinsufficiens eller dem, der får nyreerstatningsbehandling (RRT), grundet de mange forskellige faktorer, der kan påvirke vancomycinniveauerne hos disse patienter.
English: Term neonates (from birth to 27 days of post-natal age) and preterm neonates (from birth to the expected date of delivery plus 27 days)
Danish: Fuldbårne nyfødte (fra fødsel til 27 dage efter fødsel) og for tidligt fødte (fra fødsel til forventet fødselsdato plus 27 dage)
English: 24 hourly
Danish: 24 timer
English: Use in the elderly
Danish: Anvendelse til ældre
English: Immune system disorders: Rare
Danish: Immunsystemet: Sjælden
English: The dose given to you will depend on: - your age, - your weight, - the infection you have, - how well your kidneys are working,
Danish: Den dosis, du får, afhænger af: - din alder - din vægt
English: Vancomycin should be used with care in patients with renal insufficiency, including anuria, as the possibility of developing toxic effects is much higher in the presence of prolonged high blood concentrations.
Danish: Vancomycin bør anvendes med forsigtighed til patienter med nyreinsufficiens, inklusive anuri, da muligheden for at udvikle toksiske virkninger er meget højere ved tilstedeværelse af længerevarende høje blodkoncentrationer.
English: Also, methicillinresistant staphylococcus strains (MRSA) with reduced susceptibility for vancomycin were reported.
Danish: Også methicillinresistente Staphylococcus -stammer (MRSA) med nedsat følsomhed for vancomycin er rapporteret.
English: For the intraperitoneal treatment of peritoneal dialysis-associated peritonitis (PDP) in children with residual renal function, intermittent therapy should only be indicated provided that vancomycin serum levels can be monitored in a timely manner.
Danish: Til intraperitoneal behandling af peritonealdialyse-associeret peritonitis (PDP) hos børn med resterende nyrefunktion er intermitterende behandling udelukkende indikeret, hvis serumniveauerne af vancomycin kan overvåges rettidigt.
English: These patients may be at risk for the development of adverse reactions, especially if there is a concomitant renal impairment.
Danish: Disse patienter kan have risiko for udvikling af bivirkninger, især hvis der er en ledsagende nedsat nyrefunktion.
English: The recommended vancomycin dose is 125 mg every 6 hours for 10 days for the first episode of nonsevere CDI.
Danish: Den anbefalede vancomycindosis er 125 mg hver 6. time i 10 dage til den første episode af ikkealvorlig CDI.
English: After parenteral administration it is excreted almost completely as microbiologically active substance (approx. 75-90% within 24 hours) through glomerular filtration via the kidneys.
Danish: Efter parenteral administration udskilles det renalt via glomerulær filtration, næsten fuldstændigt som det mikrobiologisk aktive stof (ca. 75-90% inden for 24 timer).
English: 12 hourly
Danish: 12 timer
English: Vancomycin should be infused slowly in a dilute solution (2.5 to 5.0 mg/ml) at a rate no greater than 10 mg/min and over a period not less than 60 minutes to avoid rapid infusion-related reactions.
Danish: Vancomycin bør infunderes langsomt som en fortyndet opløsning (2,5 til 5,0 mg/ml) ved en hastighed på højst 10 mg/min og over en periode på mindst 60 minutter for at undgå hurtige infusionsrelaterede reaktioner.
English: Preterm and term newborn infants (from 0 to 27 days) The dosage will be calculated according to post-menstrual age (time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (post-natal age).
Danish: For tidligt fødte og fuldbårne nyfødte (fra 0 til 27 dage) Doseringen vil blive beregnet i henhold til den postmenstruelle alder (tidsrummet mellem sidste menstruations første dag og fødsel (gestationsalder) plus tiden efter fødslen (postnatal alder)).
English: [This section should read as follows:]
Danish: [Dette afsnit skal læses som følgende:]
English: Rapid bolus administration (i.e. over several minutes) may be associated with exaggerated hypotension (including shock and, rarely, cardiac arrest), histamine like responses and maculopapular or erythematous rash (“red man's syndrome” or “red neck syndrome”).
Danish: Hurtig bolusadministration (dvs. over flere minutter) kan være forbundet med forværret hypotension (herunder shock og, sjældent; hjertestop), histaminlignende respons og makulopapuløst eller erytematøst udslæt (”red man syndrome” eller ”red man syndrome”).
English: There is very little metabolism of the drug.
Danish: Lægemidlet metaboliseres kun i lille omfang.
English: In neonates, after intravenous administration, vancomycin volume of distribution varies between 0.38 and 0.97 L/kg, similar to adult values, while clearance varies between 0.63 and 1.4 ml/kg/min.
Danish: Hos nyfødte varierer vancomycins fordelingsvolumen efter intravenøs administration mellem 0,38 og 0,97 l/kg, svarende til værdierne hos voksne, mens clearance varierer mellem 0,63 og 1,4 ml/kg/min.
English: Vancomycin is administered intravenously for the treatment of systemic infections.
Danish: Vancomycin indgives intravenøst til behandling af systemiske infektioner.
English: Regular monitoring of the blood levels of vancomycin is indicated in high dose therapy and longer-term use, particularly in patients with renal dysfunction or impaired faculty of hearing as well as in concurrent administration of nephrotoxic or ototoxic substances, respectively (see section 4.2).
Danish: Regelmæssig overvågning af blodniveauet af vancomycin er indiceret ved højdosisbehandling og længere tids anvendelse, især hos patienter med renal dysfunktion eller nedsat hørelse samt ved samtidig administration af nefrotoksiske eller ototoksiske stoffer (se punkt 4.2).
English: Vancomycin should be used with caution in patients with allergic reactions to teicoplanin, since cross hypersensitivity, including fatal anaphylactic shock, may occur.
Danish: Vancomycin bør anvendes med forsigtighed til patienter med allergiske reaktioner på teicoplanin, idet krydsallergi, herunder dødeligt anafylaktisk shock, kan forekomme.
English: Anaerobic species Clostridium innocuum
Danish: Anaerobe arter Clostridium innocuum
English: Concomitant administration of vancomycin and anaesthetic agents has been associated with erythema and histamine-like flushing in children.
Danish: Samtidig administration af vancomycin og anæstetika er blevet forbundet med erytem og histamin-lignende rødme hos børn.
English: Nephrotoxicity has been described in children, usually in association with other nephrotoxic agents such as aminoglycosides.
Danish: Nefrotoksicitet er beskrevet hos børn, sædvanligvis i forbindelse med andre nefrotoksiske lægemidler såsom aminoglykosider.
English: If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for vancomycin eller et af de øvrige indholdsstoffer i <X> (angivet i afsnit 6).
English: Adequate replacement of fluid and electrolytes should be instituted.
Danish: Passende væske- og elektrolyterstatning bør iværksættes.
English: Interstitial nephritis, acute renal failure.
Danish: Interstitiel nefritis, akut nyresvigt.
English: Ototoxicity, which may be transitory or permanent (see section 4.8) has been reported in patients with prior deafness, who have received excessive intravenous doses, or who receive concomitant treatment with another ototoxic active substance such as an aminoglycoside.
Danish: Ototoksicitet, som kan være midlertidig eller permanent (se punkt 4.8) er blevet rapporteret hos patienter med døvhed, der har modtaget store intravenøse doser, eller som modtager samtidig behandling med et andet ototoksisk aktivt stof, fx et aminoglykosid.
English: Oral vancomycin use increases the chance of vancomycin-resistant Enterococci populations in the gastrointestinal tract.
Danish: Oral vancomycin anvendelse øger risikoen for vancomycinresistente Enterococci populationer i mavetarm-kanalen.
English: - your hearing ability, - any other medicines you may be taking.
Danish: - den infektion, du har - hvor godt dine nyrer fungerer - din hørelse - anden medicin, du eventuelt tager.
English: Intermittent therapy: initial dose of 30 mg/kg in the long-dwell, followed by 15 mg/kg every 3-5 days during the long-dwell (the second dose should be time-based on a blood level obtained 2-4 days after the initial dose, see section 4.4).
Danish: Intermitterende terapi: indledende dosis på 30 mg/kg i ”long-dwell”, efterfulgt af 15 mg/kg hver 3.-5. dag under ”long-dwell” (den anden dosis skal være tidsbaseret på et blodniveau opnået 2-4 dage efter den indledende dosis, se pkt.
English: Pseudomembranous enterocolitis
Danish: Pseudomembranøs enterocolitis
English: Similarly, concomitant use with nephrotoxic agents such as aminoglycoside antibiotics, NSAIDs (e.g., ibuprofen for closure of patent ductus arteriosus) or amphotericin B is associated with an increased risk of nephrotoxicity (see section 4.5) and therefore more frequent monitoring of vancomycin serum levels and renal function is indicated.
Danish: Ligeledes er samtidig anvendelse af nefrotoksiske lægemidler, såsom aminoglykosidantibiotika, NSAID (fx ibuprofen til lukning af åben ductus arteriosus) eller amphotericin B forbundet med en øget risiko for nefrotoksicitet (se punkt 4.5), og derfor er hyppigere kontrol af serumniveauerne af vancomycin og af nyrefunktionen indikeret.
English: Capsules
Danish: Kapsler
English: Hospital-acquired pneumonia, including ventilator-associated pneumonia
Danish: Hospitalserhvervet pneumoni (HAP), herunder ventilatorrelateret pneumoni (VAP)
English: Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered.
Danish: Antipropulsiva bør undgås, og anvendelse af protonpumpehæmmer bør genovervejes.
English: During or shortly after rapid infusion anaphylactic/anaphylactoid reactions including wheezing may occur.
Danish: Under eller kort tid efter hurtig infusion kan anafylaktiske/anafylaktoide reaktioner inklusive hvæsen forekomme.
English: Development of Drug-Resistant Bacteria
Danish: Udvikling af lægemiddelresistente bakterier
English: In patients with multiple recurrences, consideration may be given to treat the current episode of CDI with vancomycin, 125 mg four times daily for 10 days followed by either tapering the dose, i.e., gradually decreasing it until 125 mg per day or a pulse regimen, i.e., 125-500 mg/day every 2-3 days for at least 3 weeks.
Danish: Hos patienter med flere tilbagefald kan man overveje at behandle den nuværende episode af CDI med vancomycin 125 mg fire gang dagligt i 10 dage efterfulgt af enten nedsat dosis, dvs. gradvis nedsættelse til 125 mg dagligt, eller et pulsregime, dvs. 125-500 mg/dag hver 2.-3. dag i mindst 3 uger.
English: Continuous infusion: loading dose of 30 mg/kg followed by a maintenance dose of 1.5 mg/kg/bag in all exchanges.
Danish: Kontinuerlig infusion: Ladningsdosis på 30 mg/kg efterfulgt af en vedligeholdelsesdosis på 1,5 mg/kg/pose ved alle skift.
English: Anaerobic species Clostridium spp.
Danish: Anaerobe arter Clostridium spp.
English: In the case of patients with normal renal function, intravenous infusion of multiple doses of 1g vancomycin (15 mg/kg) for 60 minutes produces approximate average plasma concentrations of 50-60 mg/L, 20-25 mg/L and 5-10 mg/L, immediately, 2 hours and 11 hours after completing the infusion, respectively.
Danish: Hos patienter med normal nyrefunktion giver intravenøs infusion af flere doser af 1 g vancomycin (15 mg/kg) i 60 minutter omtrentlige gennemsnitlige plasmakoncentrationer på 50-60 mg/l, 20-25 mg/l og 5-10 mg/l, henholdsvis med det samme, 2 timer og 11 timer efter afslutning af infusionen.
English: Flushing of the upper body (“red man syndrome”), exanthema and mucosal inflammation, pruritus, urticaria
Danish: Rødme af overkroppen (”red man-syndrome”), eksantem og mucosal inflammation, pruritus, urticaria
English: Vancomycin is poorly dialyzable by intermittent hemodialysis.
Danish: Vancomycin er dårligt dialyserbar ved intermitterende hæmodialyse.
English: Vancomycin pharmacokinetics is not altered in patients with hepatic impairment.
Danish: Vancomycins farmakokinetiske forhold er ikke ændret hos patienter med nedsat leverfunktion.
English: Concomitant administration of vancomycin and anaesthetic agents has been associated with skin redness (erythema) and allergic reactions in children.
Danish: Samtidig administration af vancomycin og bedøvelsesmidler er blevet forbundet med hudrødme (erythem) og allergiske reaktioner hos børn.
English: Treatment duration
Danish: Behandlingsvarighed
English: Adults and adolescents aged 12 to less than 18 years old
Danish: Voksne og unge i alderen 12 til 18 år
English: [For parenteral formulations authorised for oral use:] If given for treatment of gastric disorders (so called Pseudomembranous colitis), the medicinal product must be administrated as a solution for oral use (you will take the medicine by mouth).
Danish: [For parenterale formuleringer godkendt til oral anvendelse:] Hvis lægemidlet gives som behandling for lidelser i mave-tarm-kanalen (såkaldt pseudomembranøs colitis), skal det indgives som en opløsning til oral anvendelse (du skal tage medicinen gennem munden).
English: Men: [Weight (kg) x 140 - age (years)]/ 72 x serum creatinine (mg/dl) Women: 0.85 x value calculated by the above formula.
Danish: Mænd: [Vægt (kg) x 140 - alder (år)]/72 x serumkreatinin (mg/dl)
English: General disorders and administration site conditions: Common
Danish: Almene symptomer og reaktioner på administrationsstedet: Almindelig
English: *The appropriate timing and amount of subsequent doses largely depends on the modality of RRT and should be based on serum vancomycin levels obtained prior to dosing and on residual renal function.
Danish: Re-dosering baseret på niveauer* * Den korrekte timing og mængde af efterfølgende doser afhænger i vid udstrækning af RRT's modalitet og bør baseres på serum-vancomycinniveauer opnået før dosering og på residual nyrefunktion.
English: The most common adverse reactions are phlebitis, pseudo-allergic reactions and flushing of the upper body (“red-neck syndrome”) in connection with too rapid intravenous infusion of vancomycin.
Danish: De mest almindelige bivirkninger er flebitis, pseudo-allergiske reaktioner og rødme på overkroppen (”red-neck-syndrome”) i forbindelse med for hurtig intravenøs infusion af vancomycin.
English: Children Vancomycin will be used with particular care in premature infants and young infants, because their kidneys are not fully developed and they may accumulare vancomycin in the blood.
Danish: Vancomycin skal anvendes med særlig forsigtighed hos for tidligt fødte spædbørn og spædbørn, fordi deres nyrer ikke er fuldt udviklede, og de kan ophobe vancomycin i blodet.
English: Respiratory, thoracic and mediastinal disorders: Common
Danish: Luftveje, thorax og mediastinum: Almindelig
English: Inherently resistant All Gram negative bacteria
Danish: Naturligt resistente organismer Alle Gramnegative bakterier
English: The combination of vancomycin with an aminoglycoside antibiotic has a synergistic effect against many strains of Staphylococcus aureus, non-enterococcal group D-streptococci, enterococci and streptococci of the Viridans group.
Danish: Kombinationen af vancomycin med et aminoglykosidantibiotikum har en synergistisk virkning mod mange stammer af Staphylococcus aureus, ikke-enterococcale gruppe D-streptokokker, enterokokker og streptokokker af Viridansgruppen.
English: Pain and thrombophlebitis may occur in many patients receiving intravenous vancomycin and are occasionally severe.
Danish: Smerte og tromboflebitis, nogle gange alvorlige, kan forekomme hos mange patienter, der får intravenøs vancomycin.
English: 5.1 Pharmacodynamic properties [This section should read as follows:] [the following paragraphs should be reflected in this section:]
Danish: FARMAKOLOGISKE EGENSKABER 5.1 Farmakodynamiske egenskaber [Dette afsnit skal lyde som følger:] [Følgende afsnit skal afspejles i dette afsnit:]
English: Dose adjustments in paediatric patients aged 1 year and older could be based on glomerular filtration rate estimated (eGFR) by the revised Schwartz formula: eGFR (mL/min/1.73m2 ) = (height cm x 0.413)/ serum creatinine (mg/dl) eGFR (mL/min/1.73m2)= (height cm x 36.2/serum creatinine (µmol/L) For neonates and infants below 1 year of age, expert advice should be sought as the revised Schwartz formula is not applicable to them.
Danish: Dosisjusteringer hos pædiatriske patienter fra 1 år og opefter kan baseres på estimeret glomerulær filtreringshastighed (eGFR) ved den reviderede Schwartz formel: eGFR (ml/min/1,73 m2) = (højde cm x 0,413)/serumkreatinin (mg/dl)
English: After oral administration, monitoring vancomycin serum concentrations in patients with inflammatory intestinal disorders should be performed (see section 4.4).
Danish: Efter oral administration bør serumkoncentrationerne af vancomycin hos patienter med inflammatoriske tarmlidelser monitoreres (se punkt 4.4).
English: The duration of the therapy may be different depending on the individual response to treatment for every patient.
Danish: Varigheden af behandlingen kan variere, alt efter hvor godt den enkelte patient reagerer på behandlingen.
English: Acquired resistance to glycopeptides is most common in enterococci and is based on acquisition of various van gene complexes which modifies the D-alanyl-D-alanine target to D-alanyl-D-lactate or Dalanyl-D-serine which bind vancomycin poorly.
Danish: Erhvervet resistens over for glykopeptider er mest almindelig i enterokokker og er baseret på erhvervelse af forskellige van-genkomplekser, som modificerer D-alanyl-D-alanin målet til D-alanyl-Dlactat eller D-alanyl-D-serin, som binder vancomycin dårligt.
English: - Necrotizing
Danish: - Nekrotiserende