FrancophonIA/ELRC3.0 huggingface dataset:
English: The reduced susceptibility or resistance to vancomycin in Staphylococcus is not well understood.
Danish: Den reducerede følsomhed eller resistens over for vancomycin i Staphylococcus er ikke velforstået.
English: Vancomycin can cause allergic reactions, although serious allergic reactions (anaphylactic shock) are rare.
Danish: Vancomycin kan forårsage allergiske reaktioner, selvom alvorlige allergiske reaktioner (anafylaktisk chok) er sjældne.
English: However, absorption may occur after oral administration in patients with (pseudomembranous) colitis.
Danish: Imidlertid kan absorption forekomme efter oral administration til patienter med (pseudomembranøs) colitis.
English: The plasma levels obtained after multiple doses are similar to those achieved after a single dose.
Danish: Plasmaniveauerne opnået efter flere doser svarer til dem opnået efter en enkelt dosis.
English: If vancomycin is administered during a peritoneal dialysis intraperitoneally, approximately 30-65% reach the systemic cycle during the first 6 hours.
Danish: Hvis vancomycin administreres intraperitonealt under en peritonealdialyse, når ca. 30-65% det systemiske kredsløb i løbet af de første 6 timer.
English: This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.
Danish: Det kan være et tegn på betændelse i tarmen (pseudomembranøs colitis), som kan forekomme efter behandling med antibiotika.
English: Therefore, the below mentioned adverse reactions and frequencies related to parenteral vancomycin administration are included.
Danish: Derfor er nedenstående bivirkninger og frekvenser relateret til parenteral vancomycin administration inkluderet.
English: Vancomycin will be given into your vein for at least 60 minutes.
Danish: Vancomycin vil blive givet i en vene i mindst 60 minutter.
English: Vancomycin should be administered orally for this indication.
Danish: Vancomycin bør administreres oralt ved denne indikation.
English: Vancomycin displays concentration-independent activity with the area under the concentration curve (AUC) divided by the minimum inhibitory concentration (MIC) of the target organism as the primary predictive parameter for efficacy.
Danish: Vancomycin udviser koncentrationsuafhængig aktivitet med arealet under koncentrationskurven (AUC) divideret med den minimale inhiberende koncentration (MIC) af målorganismen som den primære prædiktive parameter for effektivitet.
English: Testing for Clostridium difficile colonization or toxin is not recommended in children younger than 1 year due to high rate of asymptomatic colonisation unless severe diarrhoea is present in infants with risk factors for stasis such as Hirschsprung disease, operated anal atresia or other severe motility disorders.
Danish: Testning for Clostridium difficile kolonisering eller toksin anbefales ikke til børn under 1 år på grund af en høj rate af asymptomatisk kolonisering, medmindre alvorlig diarré er til stede hos børn med risikofaktorer for stase såsom Hirschsprungs sygdom, opereret anal atresi eller andre alvorlige motilitetsygdomme.
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Forekomsten af erhvervet resistens kan variere geografisk og med tiden for udvalgte arter, og lokal information om resistens er ønskelig, især ved behandling af alvorlige infektioner.
English: Intravenous vancomycin is usually administered as an intermittent infusion and the dosing recommendations presented in this section for the intravenous route correspond to this type of administration.
Danish: Intravenøs vancomycin administreres sædvanligvis som en intermitterende infusion, og de doseringsanbefalinger, der præsenteres i dette afsnit, svarer til denne type administration.
English: Adequate replacement of fluid and electrolytes should be ensured.
Danish: Tilstrækkelig erstatning af væske og elektrolytter bør sikres.
English: What you need to know before you use Vancomycin Do not use Vancomycin
Danish: Det skal du vide, før du begynder at bruge Vancomycin
English: Vancomycin should be infused slowly (see sections 4.2 and 4.4).
Danish: Vancomycin skal indgives langsomt (se punkt 4.2 og 4.4).
English: Cross-resistance with other glycopeptide antibiotics, such as teicoplanin, does occur.
Danish: Krydsresistens med andre glykopeptidantibiotika, såsom teicoplanin, forekommer.
English: Vancomycin distribution may be altered in overweight patients due to increases in volume of distribution, in renal clearance and possible changes in plasma protein binding.
Danish: Vancomycinfordelingen kan være ændret for overvægtige patienter som følge af stigninger i distributionsvolumen, i renal clearance og eventuelle ændringer i plasmaproteinbinding.
English: Oral Use Only
Danish: Kun oral anvendelse
English: During anaesthesia, doses must be well diluted and administered slowly with close cardiac monitoring.
Danish: Under anæstesi skal doserne være godt fortyndede og indgives langsomt under tæt hjertemonitorering.
English: Patients whose fluid intake must be limited can also receive a solution of 500 mg/50 ml or 1000 mg/100 ml, although the risk of infusion-related undesirable effects can be increased with these higher concentrations.
Danish: Patienter hvis væskeindtag skal begrænses, kan også modtage en opløsning af 500 mg/50 ml eller 1000 mg/100 ml, selvom risikoen for infusionsrelaterede bivirkninger kan øges med disse højere koncentrationer.
English: In some countries, increasing cases of resistance are observed particularly in enterococci; multi-resistant strains of Enterococcus faecium are especially alarming.
Danish: I nogle lande observeres stigende tilfælde af resistens især i enterokokker; multi-resistente stammer af Enterococcus faecium er særligt alarmerende.
English: The natural decrement of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted (see section 4.2).
Danish: Den naturlige formindskelse af glomerulusfiltration med stigende alder kan føre til forhøjede serumkoncentrationer af vancomycin, hvis dosis ikke justeres (se punkt 4.2).
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Hvis superinfektion forekommer under behandlingen, skal der træffes passende foranstaltninger.
English: In patients with normal renal function, the serum concentration of vancomycin should be monitored on the second day of treatment immediately prior to the next dose.
Danish: Hos patienter med normal nyrefunktion skal serumkoncentrationen af vancomycin kontrolleres på den anden behandlingsdag umiddelbart inden næste dosis.
English: Resistant > 2 mg/L 1 The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility.
Danish: Resistent > 2 mg/l 1 breakpoints er baseret på epidemiologiske cut-off-værdier (ECOFFs), som adskiller vildtypeisolater fra dem med nedsat følsomhed.
English: Vancomycin PK has shown wide inter-individual variability in preterm and term neonates.
Danish: Vancomycin PK har udvist bred inter-individuel variation hos præmature og fuldbårne nyfødte.
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: Efter behov skal der søges ekspertrådgivning, når den lokale forekomst af resistens er sådan, at anvendelsen af midlet i mindst nogle typer infektioner er tvivlsom.
English: The frequency and severity of thrombophlebitis can be minimized by administering the medicinal product slowly as a dilute solution (see section 4.2) and by changing the sites of infusion regularly.
Danish: Hyppigheden og sværhedsgraden af tromboflebitis kan minimeres ved at indgive lægemidlet langsomt som en fortyndet opløsning (se punkt 4.2) og ved jævnligt at skifte infusionssted.
English: Vancomycin is primarily cleared by glomerular filtration.
Danish: Vancomycin elimineres primært ved glomerulær filtration.
English: At serum concentrations of vancomycin of 10 mg/l to 100 mg/l, the binding of the drug to plasma proteins is approximately 30-55%, measured by ultra-filtration.
Danish: Ved serumkoncentrationer af vancomycin på 10 mg/l til 100 mg/l er bindingen af lægemidlet til plasmaproteiner ca. 30-55%, målt ved ultrafiltrering.
English: Whenever possible the antibacterial suspected to have caused CDI should be discontinued.
Danish: Når det er muligt, skal antibakterielle stoffer, der mistænkes for at have forårsaget CDI, seponeres.
English: Vancomycin has a spectrum of antibacterial activity limited to Gram-positive organisms.
Danish: Vancomycin har et spektrum af antibakteriel aktivitet som er begrænset til Grampositive organismer.
English: Due to the very low systemic absorption, dose adjustment is unlikely, unless substantial oral absorption may occur in case of inflammatory intestinal disorders or Clostridium difficile-induced pseudomembranous colitis (see section 4.4).
Danish: På grund af den meget lave systemiske absorption, er dosisjustering ikke sandsynlig, medmindre der kan forekomme betydelig oral absorption i tilfælde af inflammatoriske tarmsygdomme eller Clostridium difficile-induceret pseudomembranøs colitis (se punkt 4.4).
English: Vancomycin should also be avoided in patients with previous hearing loss.
Danish: Vancomycin bør også undgås hos patienter med tidligere høretab.
English: The frequency of infusion-related reactions (hypotension, flushing, erythema, urticaria and pruritus) increases with the concomitant administration of anaesthetic agents (see section 4.5).
Danish: Hyppigheden af infusionsrelaterede reaktioner (hypotension, rødmen, erytem, urticaria og pruritus) stiger med samtidig administration af anæstetika (se punkt 4.5).
English: Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”.
Danish: Vancomycin er et antibiotikum, der tilhører en gruppe af antibiotika, som kaldes glykopeptider.
English: In case of severe persistent diarrhoea the possibility of pseudomembranous enterocolitis that might be life-threatening has to be taken into account (see section 4.8).
Danish: I tilfælde af alvorlig vedvarende diarré skal tages højde for muligheden for pseudomembranøs enterocolitis, der kan være livstruende (se punkt 4.8).
English: Complicated skin and soft tissue infections -Non necrotizing
Danish: Komplicerede hud- og bløddelsinfektioner - Ikke nekrotiserende
English: An oral dose is excreted almost exclusively in the faeces.
Danish: En oral dosis udskilles næsten udelukkende i fæces.
English: Supplemental doses may be needed for patients on Automated Peritoneal Dialysis (APD) because rapid exchanges in APD may lead to inadequate time to achieve therapeutic levels when vancomycin is given via intraperitoneal intermittently.
Danish: Supplerende doser kan være nødvendige for patienter i automatiseret peritonealdialyse (APD), fordi hurtige skift i APD kan føre til utilstrækkelig tid til at opnå terapeutiske niveauer, når vancomycin gives intraperitonealt intermitterende.
English: The maximum daily dose should not exceed 2 g. If you suffered other episodes (infection of the mucosa) before you may need different dose and different duration of the therapy.
Danish: Den maksimale daglige dosis bør ikke overstige 2 g. Hvis du tidligere har haft betændelse i slimhinden, er det muligt, at du skal have en anden dosis og en anden varighed af behandlingen.
English: The volume of distribution is about 60 L/1.73 m2 body surface.
Danish: Fordelingsvolumenet er ca. 60 l/1,73 m2 legemsoverflade.
English: Therapeutic trough (minimum) vancomycin blood levels should normally be 10-20 mg/l, depending on the site of infection and susceptibility of the pathogen.
Danish: Terapeutisk dal-koncentration (minimum) af vancomycin i blodet bør normalt være 10-20 mg/l, afhængigt af infektionsstedet og patogenets følsomhed.
English: Peritoneal dialysis-associated peritonitis
Danish: Peritoneal dialyseassocieret peritonitis
English: Reversible neutropenia usually starting one week or more after onset of intravenous therapy or after total dose of more than 25 g.
Danish: Reversibel neutropeni, der normalt starter en uge eller mere efter indtræden af intravenøs terapi eller efter total dosis på mere end 25 g.
English: The greater the renal impairment, the greater the risk of developing the adverse reactions associated with the parenteral administration of vancomycin.
Danish: Jo større nedsat nyrefunktion, jo større er risikoen for at udvikle bivirkningerne forbundet med parenteral administration af vancomycin.
English: Orally administered Vancomycin capsules are not effective for other types of infections.
Danish: Oralt administrerede Vancomycin kapsler er ikke effektive ved andre typer infektioner.
English: If symptoms or signs of SJS (e.g. progressive skin rash often with blisters or mucosal lesions) are present, vancomycin treatment should be discontinued immediately and specialised dermatological assessment be sought.
Danish: Hvis symptomer eller tegn på SJS (fx progressivt hududslæt ofte med blærer eller slimhindelæsioner) er til stede, bør behandlingen med vancomycin straks afbrydes, og der bør søges specialiseret dermatologisk vurdering.
English: Trough values of 15-20 mg/l are usually recommended by clinical laboratories to better cover susceptible-classified pathogens with MIC ≥1 mg/L (see sections 4.4 and 5.1).
Danish: Dal-værdier på 15-20 mg/l anbefales normalt af kliniske laboratorier til bedre dækning af patogener klassificerede som følsomme med MIC ≥1 mg/l (se punkt 4.4 og 5.1).
English: Vancomycin should not be administered intramuscularly due to the risk of necrosis at the site of administration.
Danish: Vancomycin bør ikke administreres intramuskulært på grund af risikoen for nekrose på administrationsstedet.
English: Administration site related reactions
Danish: Reaktioner på administrationsstedet
English: Phlebitis, redness of the upper body and face.
Danish: Phlebitis, rødme af overkroppen og ansigt.
English: All patients receiving vancomycin should have periodic haematologic studies, urine analysis, liver and renal function tests.
Danish: Alle patienter, der får vancomycin, bør gennemgå regelmæssige hæmatologiske undersøgelser, urinanalyser samt lever- og nyrefunktionsprøver.
English: PMA: 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: PMA: postmenstruel alder [( tiden mellem sidste menstruations første dag og fødsel (svangerskabsalder) plus tiden efter fødslen (postnatal alder)].
English: Pharmacokinetic/ Pharmacodynamic relationship
Danish: Farmakokinetiske/farmakodynamiske forhold
English: The usual duration of the therapy is 10 days but it may be different depending on the individual response to treatment for every patient.
Danish: Den sædvanlige behandlingsvarighed er 10 dage, men varigheden kan være en anden, afhængigt af hvordan den enkelte patient reagerer på behandlingen.
English: In obese patients, the initial dose should be individually adapted according to total body weight as in non-obese patients.
Danish: Adipøse patienter Hos adipøse patienter bør initialdosis tilpasses individuelt i forhold til total kropsvægt som hos ikkeovervægtige patienter.
English: Although the vancomycin is not eliminated efficiently by haemodialysis or peritoneal dialysis, there have been reports of an increase in vancomycin clearance with haemoperfusion and haemofiltration.
Danish: Selvom vancomycin ikke elimineres effektivt ved hæmodialyse eller peritonealdialyse, har der været rapporter om en stigning i vancomycinclearance med hæmoperfusion og hæmofiltration.
English: Due to ototoxicity of vancomycin therapy-adjuvant monitoring of the plasma concentrations is indicated in such cases.
Danish: På grund af ototoksicitet af vancomycin er terapi-adjuvant monitorering af plasmakoncentrationen indikeret i sådanne tilfælde.
English: Reversible neutropenia, agranulocytosis, eosinophilia, thrombocytopenia, pancytopenia.
Danish: Reversibel neutropeni, agranulocytose, eosinofili, trombocytopeni, pancytopeni.
English: aureus with vancomycin MIC values of 2 mg/L are on the border of the wild type distribution and there may be an impaired clinical response.
Danish: 1 S. aureus med vancomycin MIC-værdier på 2 mg/l er på grænsen af vildtypedistribution, og der kan være en forringet klinisk respons.
English: In addition, it impairs the permeability of the bacterial cell membrane and RNA synthesis.
Danish: Derudover påvirker det permeabiliteten af bakteriecellemembranen og RNA-syntesen.
English: *Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours **Longer courses of oral suppression treatment with suitable antibiotics should be considered for prosthetic joint infections ***Duration and need for combination therapy is based on valve-type and organism
Danish: * Fortsæt indtil yderligere debridering ikke er nødvendig, patienten er klinisk forbedret, og patienten er afebril i 48 til 72 timer ** Længere forløb med oral suppressionsbehandling med passende antibiotika bør overvejes i forbindelse med infektioner i ledproteser.
English: The adverse reactions listed below are defined using the following MedDRA convention and system organ class database:
Danish: Bivirkningerne angivet nedenfor er defineret ved hjælp af følgende MedDRA-konvention og systemorganklasse:
English: In patients receiving vancomycin over a longer-term period or concurrently with other medications which may cause neutropenia or agranulocytosis, the leukocyte count should be monitored at regular intervals.
Danish: Hos patienter i behandling med vancomycin over en længerevarende periode eller samtidig med andre lægemidler, som kan forårsage neutropeni eller agranulocytose, bør leukocyttallet monitoreres regelmæssigt.
English: Staphylococcus aureus Methicillin-resistant Staphylococcus aureus coagulase-negative Staphylococci Streptococcus spp.
Danish: Enterococcus faecalis Staphylococcus aureus Methicillinresistent Staphylococcus aureus Koagulase-negative Staphylococci Streptococcus spp.
English: Neonates, infants and children less than 12 years old
Danish: Nyfødte, spædbørn og børn under 12 år
English: Tinnitus, possibly preceding onset of deafness, should be regarded as an indication to discontinue treatment.
Danish: Tinnitus, muligvis forud for døvhed, bør betragtes som en indikation for at afbryde behandlingen.
English: The administration of vancomycin by intraperitoneal injection during continuous ambulatory peritoneal dialysis has been associated with a syndrome of chemical peritonitis.
Danish: Administration af vancomycin ved intraperitoneal injektion under kontinuerlig ambulant peritonealdialyse har været associeret med kemisk peritonitis.
English: Posology and method of administration.
Danish: Dosering og administration.
English: In these subpopulations vancomycin serum concentration were found higher than expected in male healthy adults (see section 4.2).
Danish: Hos denne befolkningsgruppe er det fundet, at vancomycinserumkoncentrationen er højere end forventet hos raske, mandlige voksne (se punkt 4.2).
English: Vancomycin diffuses readily across the placenta and is distributed into cord blood.
Danish: Vancomycin diffunderer let over placenta og fordeles i navlestrengsblodet.
English: In patients with impaired renal function the terminal elimination half- life of vancomycin is prolonged and the total body clearance is reduced.
Danish: Hos patienter med nedsat nyrefunktion er den terminale eliminationshalveringstid af vancomycin forlænget, og den totale clearance er reduceret.
English: Plasma clearance is about 0.058 L/kg/h and kidney clearance about 0.048 L/kg/h.
Danish: Plasmaclearance er ca. 0,058 l/kg/h og renal clearance ca. 0,048 l/kg /time.
English: Vancomycin is also indicated in all age groups for the perioperative antibacterial prophylaxis in patients that are at high risk of developing bacterial endocarditis when undergoing major surgical procedures.
Danish: Vancomycin er også indiceret til alle aldersgrupper som perioperativ antibakteriel profylakse hos patienter, der har stor risiko for at udvikle bakteriel endocarditis, når de undergår større kirurgiske indgreb.
English: In seriously ill patients, a loading dose of 25-30 mg/kg of body weight can be used to facilitate rapid attainment of target trough serum vancomycin concentration.
Danish: Hos alvorligt syge patienter kan en ladningsdosis på 25-30 mg/kg legemsvægt anvendes til at fremme hurtig opnåelse af den ønskede dal-koncentration af vancomycin.
English: Pregnant Women:
Danish: Gravide:
English: Plasma concentrations during multiple dose administration are similar to those after the administration of a single dose.
Danish: Plasmakoncentrationerne under indgivelse af flere doser er de samme som efter administration af en enkelt dosis.
English: Coagulase-negative staphylococci1 ≤ 4 mg/L
Danish: Koagulase-negative stafylokokker1 ≤ 4 mg/L
English: Vancomycin capsules are not appropriate for the treatment of children under the age of 12 years or for adolescents unable to swallow them.
Danish: Vancomycin kapsler er ikke egnede til behandling af børn under 12 år eller for unge, der ikke er i stand til at sluge dem.
English: The efficacy and safety of vancomycin has not been established for the intrathecal, intralumbar and intraventricular routes of administration.
Danish: Virkningen og sikkerheden af vancomycin til intrathekal, intralumbar og intraventrikulær administration er ikke fastslået.
English: Continuous vancomycin infusion may be considered, e.g., in patients with unstable vancomycin clearance.
Danish: Kontinuerlig infusion af vancomycin kan overvejes, for eksempel hos patienter med ustabil vancomycinclearance.
English: In infants and older children, the volume of distribution ranges between 0.26-1.05 L/kg while clearance varies between 0.33-1.87 ml/kg/min.
Danish: Hos spædbørn og ældre børn spænder fordelingsvolumen mellem 0,26-1,05 l/kg, mens clearance varierer mellem 0,33-1,87 ml/kg/min.
English: Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, redness on the upper part of the body, rash or itching.
Danish: Gå straks til lægen, hvis du pludselig får pibende vejrtrækning, åndedrætsbesvær, rødme på den øverste del af kroppen, udslæt eller kløe.
English: During multiple dosing of 250 mg every 8 hours for 7 doses, faecal concentrations of vancomycin, in volunteers, exceeded 100 mg/kg in the majority of samples.
Danish: I løbet af 7doser på 250 mg hver 8. time oversteg de fækale koncentrationer af vancomycin hos frivillige 100 mg/kg i de fleste prøver.
English: This information only provides approximate guidance on the chance whether micro-organisms are susceptible to vancomycin.
Danish: Her gives der kun en skønsmæssig vejledning om chancen for, at mikroorganismer er følsomme for vancomycin.
English: Treatment duration with vancomycin may need to be tailored to the clinical course of individual patients.
Danish: Behandlingsvarighed med vancomycin må muligvis skræddersys til de enkelte patienters kliniske forløb.
English: Decrease in blood pressure
Danish: Blodtryksfald
English: The usual starting dose for adult patients is 15 to 20 mg/kg that could be administered every 24 hours in patients with creatinine clearance between 20 to 49 ml/min.
Danish: Den sædvanlige startdosis for voksne patienter er 15 til 20 mg/kg, der kan administreres en gang i døgnet hos patienter med kreatininclearance mellem 20 og 49 ml/min.
English: Intraperitoneal antibiotics should be added to the dialysate using sterile technique.
Danish: Intraperitoneal administration Intraperitoneale antibiotika bør tilføjes til dialysatet ved hjælp af steril teknik.
English: Acute tubular necrosis
Danish: Akut tubulær nekrose
English: Significantly increased doses may be required to achieve therapeutic serum concentrations in pregnant women (see Section 4.6).
Danish: Markant øgede doser kan være nødvendige for at opnå terapeutiske serumkoncentrationer hos gravide (se punkt 4.6).