FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor that you are receiving VIBATIV.
Danish: Fortæl din læge, at du er i behandling med VIBATIV.
English: Bolus injections must not be administered.
Danish: Bolusinjektioner må ikke administreres.
English: Human plasma protein binding is approximately 90%, primarily to serum albumin.
Danish: Human plasmaproteinbinding er ca. 90 %, primært til serumalbumin.
English: The potential risk for humans is unknown (see section 4.6).
Danish: Den potentielle risiko for mennesker kendes ikke (se pkt.
English: Telavancin must not be given to pregnant women.
Danish: Telavancin må ikke gives til gravide kvinder.
English: Tell your doctor that
Danish: Fortæl din læge,
English: Like all medicines, VIBATIV can cause side effects, although not everybody gets them.
Danish: VIBATIV kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: While antibiotics including VIBATIV fight certain bacteria, other bacteria and fungi may continue to grow.
Danish: Mens antibiotika, inklusive VIBATIV, bekæmper visse bakterier, kan andre bakterier og svampe fortsætte med at vokse.
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: Prævalensen af erhvervet resistens kan variere geografisk og over tid for udvalgte arter, og lokal information vedrørende resistens er ønskelig især ved behandling af alvorlige infektioner.
English: The solution should only be used if the solution is clear and free from particles.
Danish: Opløsningen bør kun anvendes, hvis den er klar og fri for partikler.
English: Vibativ should be used with caution with other nephrotoxic medicinal products.
Danish: Vibativ bør anvendes med forsigtighed sammen med andre nefrotoksiske medicinprodukter.
English: The AUC of the predominant metabolite accounted for approximately 2-3% of AUC of telavancin.
Danish: AUC for den dominerende metabolit svarede til ca. 2-3 % af telavancins AUC.
English: The first signs of a severe allergic reaction may include swelling of the skin, face and/or throat and/or difficulty breathing.
Danish: De første symptomer på en alvorlig allergisk reaktion kan omfatte hævelse af huden, i ansigtet og/eller halsen og/eller vejrtrækningsbesvær.
English: Stopping or slowing the infusion may result in cessation of these reactions.
Danish: Afbrudt infusion eller nedsat infusionshastighed kan medføre, at disse reaktioner ophører.
English: • That there is a risk of infusion related reactions including red man syndrome-like reactions.
Danish: • At der er en risiko for infusionsrelaterede reaktioner, herunder 'red man syndrome-lignende'
English: What you need to know before you use VIBATIV
Danish: Det skal du vide, før du begynder at bruge VIBATIV
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: Om nødvendigt bør der søges ekspertråd, når den lokale prævalens af resistens er således, at anvendeligheden af stoffet ved i det mindste nogle typer infektioner er tvivlsom.
English: • The existence and scope of the pregnancy register and details of how to enter patients into it.
Danish: • Eksistensen af og omfanget af graviditetsregisteret og detaljer om hvordan patienterne kommer
English: Final study results by 31 December
Danish: Endelige resultater af studiet senest 31. december
English: if you develop diarrhoea during or shortly after your treatment, tell your doctor immediately.
Danish: hvis du får diaré under eller umiddelbart efter din behandling, skal du straks fortælle det til din læge.
English: This dose is given as an infusion (drip into a vein) over a period of about 60 minutes.
Danish: Denne dosis gives som en infusion (drop i en vene) i en periode på ca. 60 minutter.
English: Degree of Renal Impairment Moderate
Danish: Grad af nedsat nyrefunktion Moderat
English: Exposure to telavancin increases with increase in BMI; for each 10-unit increase in BMI, it is estimated that plasma exposure will increase by up to 25%.
Danish: Eksponeringen for telavancin øges med stigende BMI, og for hver stigning i BMI på 10 enheder vurderes det, at plasmaeksponeringen øges med op til 25 %.
English: The tubular injury was reversible, but not all animals had yet reached full recovery 4 weeks after the end of treatment.
Danish: Den tubulære skade var reversibel, men ikke alle dyr havde opnået fuld restitution 4 uger efter endt behandling.
English: Renal excretion is the major route of elimination for telavancin in humans.
Danish: Renal udskillelse er den vigtigste eliminationsvej for telavancin hos mennesker.
English: Foaming may occur during reconstitution but will dissipate upon standing.
Danish: Skum kan forekomme under rekonstitution, men det vil opløses ved henstand.
English: Both studies consistently showed that the area under the curve (AUC) of telavancin, but not the maximum plasma concentration (Cmax) increases with decreasing renal function.
Danish: Begge studier viste konsistent, at arealet under kurven (AUC) for telavancin, men ikke den maksimale plasmakoncentration (Cmax), stiger med faldende nyrefunktion.
English: Your doctor may decide to adjust the rate of the infusion.
Danish: Din læge vil muligvis beslutte at ændre infusionshastigheden.
English: Higher concentrations were observed in alveolar macrophages with ratios varying between 0.360 (at 4 h) and 6.67 (at 24 h).
Danish: Der blev observeret højere koncentrationer i alveolære makrofager med ratioer, der varierede mellem 0,360 (ved 4 timer) og 6,67 (ved 24 timer).
English: Final results of the study and the re-evaluation of the benefit/risk ratio for Vibativ should be provided to CHMP no later than 31 December 2017.
Danish: Endelige resultater af studiet og reevaluering af risk/benefit-forholdet for Vibativ skal sendes til CHMP senest 31. december 2017
English: Systemic macrophage hypertrophy and hyperplasia occurred in rats and dogs, in many organ systems that normally contain macrophages.
Danish: Systemisk makrofag hypertrofi og hyperplasi forekom hos rotter og hunde i mange organsystemer, som normalt indeholder makrofager.
English: • Healthcare professionals should be aware that the administration of Vibativ may interfere with some coagulation laboratory tests and qualitative and quantitative urine protein tests.
Danish: • Sundhedspersonalet skal være opmærksom på, at anvendelse af Vibativ kan interferere med visse koagulations-laboratorieprøver og kvalitative og kvantitative urinproteinprøver.
English: Telavancin is not to be used in children or adolescents under 18 years of age.
Danish: Telavancin må ikke anvendes til børn eller unge under 18 år.
English: If this happens, the infusion of telavancin will be stopped and the doctor will check the functioning of your kidneys.
Danish: Hvis dette sker, vil infusionen med telavancin blive stoppet og lægen vil undersøge hvordan dine nyrer fungerer.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for
English: The liver, kidney, macrophages and testis were identified as target organs of toxicity in animals.
Danish: Lever, nyrer, makrofager og testikler blev identificeret som målorganer for toksicitet hos dyr.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officielle vejledninger vedrørende hensigtsmæssig brug af antibakterielle lægemidler bør tages i
English: Preparation of the reconstituted concentrate
Danish: Tilberedning af det rekonstituerede koncentrat
English: In healthy young adults, three hydroxylated metabolites were identified after infusion of telavancin.
Danish: I raske, unge voksne blev tre hydroxylerede metabolitter identificeret efter infusion af telavancin.
English: Vacuolisation is considered to represent a cytoprotective event and is expected to reverse with the same half-life as the turnover time of the proximal tubular cells.
Danish: Vakuolisering anses for at repræsentere en cellebeskyttende faktor og forventes at revertere med den samme halveringstid som turnovertiden af de proximale tubulære celler.
English: if you experience skin reactions to the product.
Danish: hvis du oplever hudreaktioner pga. produktet.
English: Your doctor will monitor you for any potential infections and treat you if necessary.
Danish: Din læge vil undersøge dig for alle mulige infektioner og behandle dig, hvis det er nødvendigt.
English: The final protocol for the PASS should be provided to the CHMP by 30 April 2014.
Danish: Endelig protokol for PASS skal sendes til CHMP senest 30. april 2014.
English: Infusion related reactions can be limited if the daily dose is infused over a 1 hour period.
Danish: Infusionsrelaterede reaktioner kan begrænses, hvis den daglige dosis bliver tilført
English: The recommended dosage regimen is 10 mg/kg, once every 24 hours, for 7 to 21 days.
Danish: Det anbefalede dosisregimen er 10 mg/kg, én gang i døgnet, i 7 til 21 dage.
English: If your kidneys do not work well or if you are overweight, the dose may be reduced.
Danish: Hvis dine nyrer ikke fungerer særlig godt, eller hvis du er overvægtig, vil dosis eventuelt blive nedsat.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with telavancin in one or more subsets of the paediatric population in nosocomial pneumonia.
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af studier med telavancin hos en eller flere undergrupper af den pædiatriske population ved nosokomiel pneumoni.
English: Your doctor may decide to reduce the dose of VIBATIV and monitor you more closely during treatment.
Danish: Din læge vil muligvis beslutte at nedsætte dosis af VIBATIV og følge dig mere tæt under behandlingen.
English: if you are suffering from heart disorders.
Danish: hvis du har en hjertelidelse.
English: Antibiotic-associated colitis and pseudomembranous colitis
Danish: Antibiotikaassocieret colitis og pseudomembranøs colitis
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne præsenteret i faldende rækkefølge af alvorlighed.
English: However, no information is available on the use of haemodialysis to treat an overdose.
Danish: Der er dog ingen tilgængelig information vedrørende anvendelse af hæmodialyse til at behandle en overdosis.
English: All-cause mortality was 32/73 (44%) in the telavancin group and 16/64 (25%) in the vancomycin group, whereas in patients without acute renal failure at baseline it was 118/678 (17%) and 124/688 (18%), respectively.
Danish: Samlet set var mortaliteten 32/73 (44 %) i telavancingruppen og 16/64 (25 %) i vancomycingruppen, hvorimod mortaliteten hos patienter uden akut nyresvigt ved baseline var henholdsvis 118/678 (17 %) og 124/688 (18 %).
English: In embryo-fetal development studies malformations of digits and limbs were observed in rats, rabbits and minipigs.
Danish: I embryo-føtale udviklingsstudier blev misdannelser af poter, klove og lemmer observeret hos rotter, kaniner og minigrise.
English: The use of VIBATIV is contraindicated during pregnancy (see section 4.3).
Danish: Brugen af VIBATIV er kontraindiceret under graviditeten (se pkt.
English: Vacuolisation is considered to be a cytoprotective event, which is not associated with functional impairment.
Danish: Vakuolisering anses for at være en cellebeskyttende faktor, som ikke er forbundet med funktionel forringelse.
English: In vitro experiments indicate that telavancin will not affect the clearance of medicinal products metabolised by CYP isoforms 1A2, 2C9, 2C19 and 2D6.
Danish: In vitroforsøg indikerer, at telavancin ikke vil påvirke clearance af lægemidler, som metaboliseres af CYP isoformer 1A2, 2C9, 2C19 og 2D6.
English: Your doctor may monitor your hearing during treatment.
Danish: Din læge vil muligvis undersøge din hørelse under behandlingen.
English: Male fertility was unaffected.
Danish: Fertiliteten var upåvirket.
English: The safety and efficacy of VIBATIV in children and adolescents aged below 18 years have not yet been established.
Danish: VIBATIVS sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Although telavancin does not interfere with coagulation, it interfered with certain tests used to monitor coagulation (see below), when tests are conducted using samples drawn between 0 to 18 hours after telavancin administration to patients being treated once every 24 hours.
Danish: På trods af at telavancin ikke interfererer med koagulation, interfererer det med bestemte tests, som anvendes til at monitorere koagulation (se nedenfor), når disse tests udføres ved at anvende prøver udtrukket mellem 0 til 18 timer efter administration af telavancin til patienter, som bliver behandlet én gang i døgnet.
English: • That there is an identified risk of ototoxicity and patients developing ototoxicity signs or symptoms or patients receiving other medicinal products with ototoxic potential should be
Danish: • At der er en identificeret risiko for ototoksicitet, og patienter, der udvikler tegn eller symptomer på ototoksicitet, eller patienter, der får andre medicinprodukter med ototoksisk potentiale, bør
English: This data indicate that telavancin is not extensively distributed.
Danish: Disse data antyder, at telavancin ikke distribueres i noget større omfang.
English: Furthermore, no evidence of hypercoagulability has been seen, as healthy subjects receiving telavancin have normal levels of D-dimer and fibrin degradation products.
Danish: Endvidere er der ikke set nogen tegn på hyperkoagulationevne, eftersom raske forsøgspersoner, som fik telavancin, har normale niveauer af D-dimer og fibrin nedbrydningsprodukter.
English: In vitro studies have shown that CYP1A1, 1A2, 2B6, 2C18, 2C19, 2D6, 2E1, 2J2, 3A4, 3A5 and 4F12 are able to metabolise telavancin, resulting in hydroxylation at the 7, 8 and 9 position of the 2-(decylamino) ethyl side chain of telavancin.
Danish: In vitro-forsøg har vist, at CYP1A1, 1A2, 2B6, 2C18, 2C19, 2D6, 2E1, 2J2, 3A4, 3A5 og 4F12 er i stand til at metabolisere telavancin, hvilket resulterer i en hydroxylation i position 7, 8 og 9 af 2(decylamino) ethylsidekæden af telavancin.
English: Analysis of patient population pharmacokinetic data did not show a relevant effect of age on pharmacokinetics.
Danish: Analyser af farmakokinetiske data for patientpopulationer viste ikke nogen relevant alderseffekt på farmakokinetikken.
English: Blood samples for coagulation tests should be collected as closely as possible prior to a patient's next dose of telavancin or consideration given to using a test unaffected by telavancin.
Danish: Blodprøver til koagulationstests bør samles så tæt som muligt forud for en patients næste telavancindosis, eller det bør overvejes at bruge en test, som ikke påvirkes af telavancin.
English: Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT United Kingdom
Danish: Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT Det Forenede Kongerige
English: If you also have other bacteria that cause your infection, your doctor may prescribe other antibiotics in
Danish: Hvis du også har andre bakterier, der forårsager din infektion, vil din læge muligvis også ordinere
English: Genotoxicity was addressed with a standard in vitro and in vivo test battery.
Danish: Genotoksicitet blev undersøgt med en standard in vitro og in vivo testrække.
English: Rare:
Danish: Almindelig:
English: Read all of this leaflet carefully before you are given this medicine because it contains important
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den
English: To ensure a comparable exposure in patients with moderate renal impairment, the dose should be lowered to 7.5 mg/kg/24 hr.
Danish: For at sikre en sammenlignelig eksponering hos patienter med moderat nedsat nyrefunktion bør dosis nedsættes til 7,5 mg/kg/døgn.
English: After 13 weeks of treatment, reversible seminiferous tubular degeneration was observed in the testis of rats.
Danish: Efter 13 ugers behandling blev der observeret reversibel seminiferus tubulær degeneration i testiklerne hos rotter.
English: In the clinical studies, patients with pre existing acute renal failure receiving telavancin had an increased risk of mortality.
Danish: I de kliniske studier havde patienter med eksisterende akut nyresvigt, der fik telavancin, en forøget risiko for mortalitet.
English: Telavancin is mainly excreted unchanged accounting for approximately 82% of the total amount recovered over 48 hours in urine.
Danish: Telavancin bliver hovedsagelig udskilt uomdannet, hvilket udgør ca. 82 % af den totale mængde, der genfindes i urinen i løbet af 48 timer.
English: In mixed infections where Gram-negative and/or certain types of anaerobic bacteria are suspected, VIBATIV should be co-administered with appropriate antibacterial agent(s).
Danish: Ved blandede infektioner, hvor der er mistanke om gramnegative og/eller visse typer af anaerobe bakterier, skal VIBATIV administreres sammen med passende antibakterielle
English: The tubular injury was characterised by degeneration and necrosis of proximal tubular cells, and was associated with increases in BUN and creatinine that reach a maximum of 2 times the control values at the highest doses.
Danish: Den tubulære skade var karakteriseret ved degenerering og nekrose af proximale tubulære celler og blev forbundet med stigninger i BUN og kreatinin, som når et maksimum på 2 gange kontrolværdierne ved de højeste doser.
English: • That patients' renal function should be assessed and monitored and initial dose and dosage adjustments should be calculated based on the creatinine clearance.
Danish: • At patienternes nyrefunktion bør vurderes og overvåges, og at initialdosis og dosistilpasning bør beregnes på baggrund af kreatininclearance.
English: In the event of overdose, telavancin should be discontinued and supportive care is advised with maintenance of glomerular filtration and careful monitoring of renal function.
Danish: I tilfælde af overdosering bør telavancin seponeres, og understøttende behandling tilrådes med opretholdelse af glomerulær filtration og omhyggelig monitorering af nyrefunktionen.
English: Since telavancin is primarily excreted unchanged by renal clearance and multiple CYP enzymes are able to metabolise telavancin, no relevant interactions are expected with inhibitors or inducers of the CYP450 system.
Danish: Eftersom telavancin primært udskilles uomdannet ved renal clearance, og adskillige CYP enzymer er i stand til at metabolisere telavancin, forventes der ingen relevante interaktioner med inhibitorer eller inducere af CYP450 systemet.
English: The test results can suggest poor blood clotting when, in fact, there is no problem.
Danish: Testresultaterne kan vise, at dit blod størkner dårligt, selv om der ikke er noget i vejen.
English: • The Healthcare Professional Guide
Danish: • Indlægsseddel • Vejledning til sundhedspersonale
English: Vacuolisation was not associated with renal function impairment, but was not reversible after 4 weeks of recovery.
Danish: Vakuolisering blev ikke forbundet med nedsat nyrefunktion men var ikke reversibel efter 4 ugers restitution.
English: Aseptic technique must be used to reconstitute VIBATIV.
Danish: Der bør anvendes aseptisk teknik til at rekonstituere VIBATIV.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Hvis der opstår en superinfektion under behandlingen, bør der tages passende forholdsregler.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE
English: Changes in AUC only become clinically relevant in patients with moderate and severe renal impairment.
Danish: Ændringerne i AUC bliver kun klinisk relevante hos patienter med moderat til svær nedsat nyrefunktion.
English: Therefore, the same dose of 10 mg/kg/24 hr can be used in patients with normal renal function or mild renal impairment.
Danish: Derfor kan den samme dosis på 10 mg/kg/døgn bruges til patienter med normal nyrefunktion eller let nedsat nyrefunktion.
English: Telavancin was cleared by CVVH and the clearance of telavancin increased with increasing ultrafiltration rate.
Danish: Telavancin blev renset med CVVH og clearance af telavancin blev forøget med stigende ultrafiltrationshastighed.
English: The presence of hydroxypropylbetadex in the formulation at a ratio of 1:10 reduces the incidence and severity of the changes due to telavancin and attenuates the glycopeptides-like toxicity of telavancin.
Danish: Tilstedeværelsen af hydroxypropylbetadex i formuleringen i forholdet 1:10 reducerer forekomsten og sværhedsgraden af de ændringer, der forårsages af telavancin, og svækker den glycopeptid-lignende toksisitet af
English: Telavancin may interfere with some laboratory tests that measure proteins in the urine.
Danish: Telavancin kan have indvirkning på nogle laboratorietests, der måler protein i urinen.
English: The excretion of telavancin in milk has not been studied in animals.
Danish: Udskillelsen af telavancin i mælk er ikke undersøgt hos dyr.
English: At higher doses or longer treatment durations, vacuolisation of the urothelium in the bladder also occurred.
Danish: Ved højere doser eller langvarige behandlinger forekom også vakuolisering af urinvejsepitel i blæren.
English: The dose for adults (18 years and older) is 10 milligrams (mg) for every kilogram (kg) of body weight, given once a day.
Danish: Dosis for voksne (18 år og ældre) er 10 milligram(mg) for hvert kilo(kg) legemsvægt, indgivet én gang om dagen.
English: In healthy young adults, after infusion of radiolabeled telavancin, approximately 76% of the administered dose was recovered from urine and less than 1% of the dose was recovered from faeces (collected for up to 9 days), based on total radioactivity.
Danish: Efter infusion af radioaktivt mærket telavancin hos raske, unge voksne genfandt man ca. 76 % af den indgivne dosis i urinen, og mindre end 1 % af dosis blev genfundet i fæces (opsamlet i op til 9 dage), baseret på total radioaktivitet.
English: In a mass balance study in male subjects using radiolabeled telavancin, 3 hydroxylated metabolites were identified with the predominant metabolite (THRX-651540) accounting for <10% of the radioactivity in urine and <2% of the radioactivity in plasma.
Danish: I et masseligevægtsforsøg hos mandlige forsøgspersoner med anvendelse af radioaktivt mærket telavancin blev 3 hydroxylerede metabolitter identificeret, hvor den dominerende metabolit (THRX651540) udgjorde <10 % af radioaktiviteten i urinen og <2 % af radioaktiviteten i plasma.
English: Patients with these conditions were not included in clinical trials of telavancin.
Danish: Patienter med disse tilstande blev ikke inkluderet i kliniske forsøg med telavancin.
English: Treatment was discontinued due to adverse reactions in 5.0% of patients who received telavancin.
Danish: Som følge af bivirkninger ophørte behandlingen hos 5,0 % af patienterne, som fik telavancin.
English: Microalbumin assays based on immunoassay utilizing nephelometric (turbidity) detection are not affected and can be used to monitor urinary protein excretion during telavancin treatment.
Danish: Mikroalbumintests baseret på immunoassays, som benytter nelefometrisk (turbidimetri) bestemmelse, bliver ikke påvirket og kan anvendes til at monitorere udskillelse af urinprotein under telavancin behandling.