FrancophonIA/ELRC3.0 huggingface dataset:
English: In combination with the small Vss, this results in a t1/2 of about 8 h.
Danish: Kombineret med det lille Vss resulterer dette i en t½ på ca. 8 timer.
English: Important information about some of the ingredients of VIBATIV This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i VIBATIV Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er stort set
English: Rare: may affect up to 1 in 1,000 people deafness
Danish: Sjælden: kan forekomme hos op til 1 ud af 1000 patienter døvhed
English: Store in a refrigerator (2-8°C).
Danish: Pulver i salgspakning: Opbevares i køleskab (2 °C-8 °C).
English: Mean (SD) AUC0-24 amounts to 780 (125) µg.h/ml.
Danish: Middel (SD) AUC0-24 er 780 (125) µg.time/ml.
English: The telavancin medicinal product, which contains the excipient hydroxypropylbetadex (HP-β-CD), induced adverse effects in animal studies at plasma concentrations that were in the same range as clinical exposure levels and with possible relevance to clinical use.
Danish: Lægemidler med telavancin, som indeholder hjælpestoffet hydroxypropylbetadex (HP-β-CD), inducerede bivirkninger i dyreforsøg ved plasmakoncentrationer, der var på samme niveau som niveauet ved klinisk eksposition og med mulig relevans for klinisk brug.
English: Telavancin has no effect on platelet aggregation.
Danish: Telavancin har ingen virkning på blodpladeaggregationen.
English: Patients receiving telavancin in conjunction with or sequentially with other medicinal products with known ototoxic potential should be carefully monitored and the benefit of telavancin evaluated if hearing deteriorates.
Danish: Patienter, der får telavancin samtidig eller sekventielt med andre medicinprodukter med kendt ototoksisk potentiale, bør monitoreres omhyggeligt, og fordelene ved telavancin skal vurderes, hvis hørelsen forringes.
English: Discard the vial if the vacuum does not pull the diluent into the vial.
Danish: Kassér hætteglasset, hvis et vakuum ikke trækker fortyndingsmidler op i hætteglasset.
English: CARTON AND VIAL
Danish: KARTON OG HÆTTEGLAS
English: However, the clearance of telavancin by CVVH has not been evaluated in a clinical study; thus, the clinical significance of this finding and use of CVVH to treat an overdose
Danish: Telavancin clearance ved CVVH er dog ikke vurderet i et klinisk studie, og således er den kliniske signifikans af dette fund og brug af CVVH til behandling af en overdosis ikke kendt.
English: S. aureus that exhibit high level resistance to glycopeptide antibacterial agents (GRSA) are not susceptible to telavancin.
Danish: S. aureus, som udviser høj resistens overfor glycopeptid-antibakterielle stoffer (GRSA), er ikke følsomme overfor telavancin.
English: Paediatric patients The pharmacokinetics of telavancin in patients below 18 years of age have not been established (see
Danish: Pædiatrisk population Farmakokinetikken af telavancin hos patienter under 18 år er ikke fastslået (se pkt.
English: Your doctor will treat you as necessary.
Danish: Din læge vil give dig den nødvendige behandling.
English: A reconstituted concentrate of VIBATIV is a clear, colourless to pale pink solution.
Danish: Et rekonstitueret koncentrat af VIBATIV er en klar, farveløs til svag lyserød opløsning.
English: For routine monitoring of renal function it is recommended to use serum creatinine concentration or estimated creatinine clearance.
Danish: Til rutinemonitorering af nyrefunktionen anbefales det at bruge serumkreatininkoncentration eller beregnet kreatininclearance.
English: Effects on the kidney occurred after a minimum of 4 weeks of dosing and were a combination of renal tubular injury and tubular epithelial vacuolisation.
Danish: Virkningerne på nyrerne forekom efter en behandlingsperiode på mindst 4 uger og var en kombination af tubulær skade og tubulær epitelial vakuolisering.
English: The clearance of telavancin by continuous venovenous haemofiltration (CVVH) was evaluated in an in vitro study.
Danish: Clearance af telavancin ved kontinuerlig venovenøs hæmofiltration (CVVH) blev vurderet i et in vitro forsøg.
English: Final study results by 31 May 2017
Danish: Endelige resultater af studiet senest 31. maj 2017
English: VIBATIV contains telavancin as active substance, which is an antibiotic of the glycopeptide group.
Danish: VIBATIV indeholder det aktive stof telavancin, som er et antibiotikum, der tilhører glycopeptidgruppen.
English: The minimum inhibitory concentration (MIC) breakpoints are as follows:
Danish: Grænseværdier for den mindste hæmmende koncentration (MIC) er som følger: MIC (µg/ml)
English: a ESRD= End-stage renal disease maintained on haemodialysis b Baseline mean creatinine clearance as calculated by Cockcroft-Gault equation
Danish: ESRDa a ESRD= End-Stage Renal Disease opretholdt med hæmodialyse b Baseline middel kreatininclearance beregnet efter Cockcroft-Gaults ligning
English: Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with telavancin should be carefully evaluated and monitored (see section 4.8).
Danish: De patienter, som udvikler tegn og symptomer på nedsat hørelse eller sygdomme i det indre øre under behandling med telavancin, bør vurderes omhyggeligt og monitoreres (se pkt.
English: It was demonstrated in a clinical study with intravenous midazolam that multiple doses of telavancin had no effect on the pharmacokinetics of midazolam, which is a sensitive substrate for CYP3A4.
Danish: I et klinisk studie med intravenøs midazolam blev det vist, at gentagne doser af telavancin ikke havde nogen effekt på farmakokinetikken af midazolam, som er et følsomt substrat for CYP3A4.
English: Telavancin exhibited linear pharmacokinetics at doses up to 15 mg/kg administered as a daily 60 minute intravenous infusion for 7 days in healthy volunteers.
Danish: Telavancin udviser lineær farmakokinetik i doser op til 15 mg/kg administreret som én daglig 60 minutters intravenøs infusion hos raske forsøgspersoner i 7 dage.
English: In rats and dogs vacuolisation of the epididymal tubular epithelium cells was also noted, and this finding did not show reversibility after a recovery period of 4 weeks.
Danish: Hos rotter og hunde blev vakuolisering af bitestiklernes tubulære epitel også bemærket, og dette fund viste ikke reversibilitet efter en restitutionsperiode på 4 uger.
English: Common: may affect up to 1 in 10 people kidney disorder, abnormal kidney function tests, foamy urine
Danish: Almindelig: kan forekomme hos op til 1 ud af 10 patienter nyrelidelse, unormale nyrefunktionstests, skummende urin
English: VIBATIV may cause side effects, such as dizziness, sleepiness, confusion or blurred vision that can have an influence on the ability to drive or operate machinery.
Danish: VIBATIV kan give bivirkninger, som svimmelhed, træthed, forvirring eller sløret syn, hvilket kan have indvirkning på evnen til at køre bil eller betjene maskiner.
English: • The need to counsel patients on important risks associated with Vibativ therapy and appropriate
Danish: • Nødvendigheden af at rådgive patienterne om vigtige risici ved behandling med Vibativ og passende forholdsregler ved brug af dette lægemiddel.
English: The apparent distribution volume of telavancin at steady-state in healthy adult subjects was
Danish: Det tilsyneladende steady-state fordelingsvolumen af telavancin hos raske, voksne forsøgspersoner var
English: The MAH shall continue to monitor the activity of telavancin and the microbiological resistance as compared to other agents, through the longitudinal resistance surveillance program.
Danish: Indehaveren af markedsføringstilladelsen skal fortsætte med at kontrollere telavancins aktivitet og mikrobiologiske resistens sammenlignet med andre præparater i langtidsresistens-overvågningsprogrammet.
English: For storage conditions of the reconstituted or diluted medicinal product, see section 6.3.
Danish: Opbevaringsforhold for det rekonstituerede eller fortyndede lægemiddel, se pkt.
English: Based on their pharmacokinetic properties, no interaction is expected with other beta-lactams, clindamycin, metronidazole, or
Danish: På grund af deres farmakokinetiske egenskaber forventes der ikke interaktion med andre betalaktamer, clindamycin, metronidazol eller fluoquinoloner.
English: if you are allergic (hypersensitive) to telavancin or any of the other ingredients of VIBATIV If you suffer from severe kidney problems, or receive haemodialysis
Danish: hvis du er overfølsom (allergisk) over for telavancin eller et af de øvrige indholdsstoffer i hvis du har alvorlige nyreproblemer eller er i hæmodialyse.
English: In studies on fertility in male rats, decreases in sperm motility and epididymal sperm counts as well as an increase in the frequency of abnormal sperm were demonstrated after 10 weeks of intravenous administration of telavancin.
Danish: Fertilitetsstudier hos hanrotter faldt sædmotiliteten og det epididymale sædtal, ligesom en øgning i frekvensen af abnorm sæd blev vist efter 10 uger intravenøs administration af telavancin.
English: In the rat embryo-fetal development study dilatation of lateral ventricles of the brain was observed in the high dose group.
Danish: I det embryo-føtale udviklingsstudie med rotter observeredes dilatation af de laterale ventrikler i hjernen hos højdosis-gruppen.
English: Detailed information on this medicine is available on the European Medicines Agency website:
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs
English: No data are available in subjects with severe hepatic impairment (Child-Pugh class C).
Danish: Der er ingen tilgængelige data for personer med svært nedsat leverfunktion (Child- Pugh klasse C).
English: VIBATIV must be reconstituted and then further diluted prior to administration by intravenous infusion through a dedicated line or through a Y-site over a 60 minute period.
Danish: VIBATIV skal rekonstitueres og derpå fortyndes yderligere forud for administration som intravenøs infusion gennem en til formålet indlagt dropslange eller gennem et sidedrop over 60 minutter.
English: In phase 3 clinical trials involving 1680 patients (751 and 929, NP and cSSTI, respectively) who received telavancin at a daily dose of 10 mg/kg, adverse reactions were reported in 47.3% of patients.
Danish: I kliniske fase 3 studier, der involverede 1680 patienter (751 og 929 i henholdsvis NP og cSSTI), som fik telavancin som en daglig dosis på 10 mg/kg, blev der rapporteret bivirkninger hos 47,3 % af patienterne.
English: Pharmacokinetic parameters (mean (SD)) following a single dose administration of 7.5 mg/kg telavancin in volunteers with varying degrees of renal function are provided below.
Danish: Farmakokinetiske parametre (middel (SD)) efter administration af en enkelt dosis telavancin på 7,5 mg/kg til frivillige med varierende grad af nyrefunktion er anført nedenfor.
English: During treatment dose adjustments according to the table should be made based on calculated or measured creatinine clearance in patients with clinically relevant changes in renal function.
Danish: Under behandlingen bør dosisjusteringer i henhold til tabellen baseres på beregnet eller målt kreatininclearance hos patienter med klinisk relevante ændringer i nyrefunktionen.
English: Telavancin inhibits cell wall biosynthesis by binding to late-stage peptidoglycan precursors, including lipid II, which prevents polymerisation of the precursor into peptidoglycan and subsequent cross-linking events.
Danish: Telavancin hæmmer cellevægsbiosyntesen ved at binde sig til senstadiepeptidoglycanprækursorer, herunder lipid II, hvilket forhindrer polymeriseringen af prækursoren til peptidoglycan samt efterfølgende tværgående virkninger.
English: • There is a risk of QTc prolongation and Vibativ should be used with caution in patients taking medicinal products known to prolong the QT interval.
Danish: • Der er en risiko for en forlængelse af QTc, og at Vibativ bør anvendes med forsigtighed til patienter, der tager medicinprodukter, som er kendt for at forlænge QT-intervallet.
English: Hydroxypropylbetadex; the ratio of telavancin to hydroxypropylbetadex is 1:10 (w/w).
Danish: Hydroxypropylbetadex: forholdet mellem telavancin og hydroxypropylbetadex er 1:10 (w/w) Mannitol (E421)
English: The other ingredients are hydroxypropylbetadex, mannitol (E421), sodium hydroxide (E524) (for pH adjustment) and hydrochloric acid (E507) (for pH adjustment).
Danish: De øvrige indholdsstoffer er hydroxypropylbetadex, mannitol (E421), natriumhydroxid (E524) (til pH justering) og saltsyre (E507) (til pH justering).
English: In the pooled clinical studies (NP and complicated skin and soft tissue infection (cSSTI)), renal adverse reactions were reported more frequently in patients receiving telavancin compared with vancomycin (3.8% vs. 2.2%, respectively).
Danish: I de poolede kliniske studier (NP og med komplicerede hud- og vævsinfektioner (cSSTI)) blev der hyppigere rapporteret nyrerelaterede bivirkninger hos patienter, der fik telavancin sammenlignet med vancomycin (henholdsvis 3,8 % vs. 2,2 %).
English: In a second study, 6 weeks of dosing was associated with sloughed testicular germ cells in the epididymis, indicative of testicular injury, and effects upon sperm quality and quantity were observed.
Danish: I et andet studie blev dosering over 6 uger forbundet med døde testikelkønsceller i epididymis, hvilket indikerer testikelskader og virkninger på sædkvalitet og -kvantitet blev observeret.
English: In vitro studies showed that telavancin retained full activity in the presence of pulmonary surfactant.
Danish: In vitro-forsøg viste, at telavancin ved tilstedeværelse af pulmonære overfladeaktive stoffer bevarede fuld aktivitet.
English: Also, the pharmacokinetics of aztreonam or piperacillin tazobactam were not altered by telavancin.
Danish: Tilsvarende blev farmakokinetikken af aztreonam eller piperacillintazobactam ikke ændret med telavancin.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with telavancin should be made taking into account the benefit of breastfeeding to the child and the benefit of telavancin therapy to the woman.
Danish: Det skal besluttes, om amning skal fortsætte/ophøre, eller om behandling med telavancin skal fortsætte/ophøre, idet der bør tages højde for fordelene for barnet ved amning i forhold til de terapeutiske fordele af telavancinbehandling for moderen.
English: Following administration of a single dose of telavancin 7.5 mg/kg to subjects with end-stage renal disease, approximately 5.9% of the administered dose of telavancin was recovered in the dialysate following 4 hours of haemodialysis.
Danish: Efter administration af en enkelt dosis telavancin 7,5 mg/kg til forsøgspersoner med nyresygdom i slutstadiet blev ca. 5,9 % af den administrerede dosis af telavancin genfundet i dialysatet efter 4 timers hæmodialyse.
English: 4.7 Effects on ability to drive and use machines Dizziness, somnolence, confusion and blurred vision may occur and VIBATIV may have an influence on the ability to drive and use machines (see section 4.8).
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Svimmelhed, søvnighed, forvirring og sløret syn kan forekomme, og VIBATIV kan influere på evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: angina pectoris, atrial fibrillation, bradycardia, cardiac failure congestive, electrocardiogram QT corrected interval prolonged, palpitations, sinus tachycardia, supraventricular extrasystoles, ventricular extrasystoles
Danish: Angina pectoris, atrieflimmer, bradykardi, medfødt hjerteinsufficiens, elektrokardiogram QT korrigeret interval forlænget, palpitationer, sinustakykardi, supraventrikulære ekstrasystoler, ventrikulære ekstrasystoler
English: Because renal excretion is the primary route of elimination, dosage adjustment is necessary in patients with a creatinine clearance of 30-50 ml/min (see section 4.2).
Danish: Eftersom renal udskillelse er den primære eliminationsvej, er det nødvendigt med dosisjustering hos patienter med kreatininclearance på 30-50 ml/min (se pkt.
English: In studies in healthy subjects, the pharmacokinetics of telavancin were not significantly altered by simultaneous administration of aztreonam or piperacillin-tazobactam.
Danish: I studier med raske forsøgspersoner blev telavancins farmakokinetik ikke signifikant forandret ved samtidig administration af aztreonam eller piperacillintazobactam.
English: At a dose of 10 mg/kg for 3 consecutive days to healthy volunteers subjected to bronchoalveolar lavage, the concentration ratio in pulmonary epithelial lining fluid/plasma ranged from 0.050 and 0.121 over a period of 4 to 24 hours after start of infusion.
Danish: Ved indgivelse af en dosis på 10 mg/kg i 3 på hinanden følgende dage til raske frivillige forsøgspersoner som fik udført bronkoalveolær lavage (BAL) lå koncentrationsratioen i lungeepitelvæskefilm/plasma i intervallet 0,050 til 0,121 over en periode på 4 til 24 timer efter infusionsstart.
English: No evidence of increased bleeding risk has been observed in clinical trials with telavancin.
Danish: Der er ikke observeret noget tegn på øget blødningsrisiko i kliniske forsøg med telavancin.
English: The studies did not provide any evidence for a genotoxic potential of telavancin.
Danish: Forsøgene viste ingen evidens for genotoksisk potentiale af telavancin.
English: A clinical QTc study with telavancin doses of 7.5 and 15 mg/kg versus vehicle and an active comparator (400 mg moxifloxacin) showed that once daily dosing for 3 days resulted in a mean vehicle corrected increase in QTcF by 4.1 and 4.5 millisecond, respectively, compared to a 9.2 millisecond increase observed with the comparator.
Danish: Et klinisk QTc studie med telavancindoser på 7,5 og 15 mg/kg over for hjælpestof og en aktiv komparator (400 mg moxifloxacin) viste, at dosering en gang dagligt i 3 dage resulterede i en gennemsnitlig hjælpestof-korrigeret stigning af QTcF på henholdsvis 4,1 og 4,5 millisekunder sammenlignet med en stigning på 9,2 millisekunder observeret med komparator.
English: Telavancin exerts concentration-dependent bactericidal activity against susceptible Gram-positive bacteria.
Danish: Telavancin udøver en koncentrationsafhængig baktericid aktivitet mod følsomme grampositive bakterier.
English: Following administration of a single 10 mg/kg dose of telavancin, the pharmacokinetics of telavancin in subjects with moderate hepatic impairment (Child-Pugh class B) were similar to that observed in subjects with normal hepatic function.
Danish: Efter administration af en enkelt dosis telavancin på 10 mg/kg var telavancins farmakokinetik hos forsøgspersoner med moderat nedsat leverfunktion (Child Pugh klasse B) den samme som den, der blev observeret hos forsøgspersoner med normal leverfunktion.
English: Vacuolisation of tubular epithelium was a common observation in animals treated with the telavancin medicinal product and with the vehicle (HP-β-CD).
Danish: Vakuolisering af tubulært epitel var en almindelig observation hos dyr, som blev behandlet med lægemidler indeholdende telavancin og med hjælpestoffet (HP-β-CD).
English: Discard any unused solution.
Danish: Ikke anvendt opløsning kasseres.
English: VIBATIV should be used only in situations where it is known or suspected that other alternatives are not suitable (see sections 4.3, 4.4, 4.8 and 5.1).
Danish: VIBATIV bør kun bruges i situationer, hvor det vides eller formodes, at andre alternativer ikke er egnede (se pkt.
English: Doses less than 150 mg or greater than 800 mg should be further diluted in a volume resulting in a final solution of 0.6 to 8 mg/ml.
Danish: Doser på mindre end 150 mg eller større end 800 mg bør fortyndes yderligere til et volumen, som giver en endelig opløsning på 0,6-8 mg/ml.
English: Studies in animals have shown reproductive toxicity
Danish: Dyreforsøg har påvist
English: Also patients with baseline QTc >500 msec, congenital long QT syndrome, uncompensated heart failure, or abnormal K+ or Mg2+ blood levels that could not be corrected, severely neutropenic (absolute neutrophil count <500/mm3) or anticipated to develop severe neutropenia due to prior or planned chemotherapy, or who had HIV with CD4 count <100/mm3 during the last 6 months were excluded.
Danish: Patienter med baseline QTc >500 msec, medfødt lang QT-syndrom, inkompenseret hjerteinsufficiens eller abnorme K+ eller Mg2+ blodniveauer, som ikke kunne korrigeres, svær neutropeni (absolut neutrofiltal <500/mm3) eller forventet udvikling af svær neutropeni på grund af tidligere eller planlagt kemoterapi, eller med HIV med CD4 tal <100/mm3 i løbet af de sidste 6 måneder blev også ekskluderet.
English: Type I clear glass vials with rubber stoppers and aluminium/plastic flip off cap.
Danish: Hætteglas af klart type 1 glas med gummiprop og aluminium/plastik flip-off låg.
English: The Marketing Authorisation Holder shall agree the format and content of the Healthcare Professional Guide with the National Competent Authority in the Member State.
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal forud for lancering I medlemsstaterne være enig med den national, kompetente myndighd om form og indhold af vejledningen til sundhedspersonale.
English: Pharmacotherapeutic group: Antibacterials for systemic use, glycopeptide antibacterials, ATC code:
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, glycopeptid antibiotikum,
English: Coagulation tests affected by telavancin
Danish: Koagulationstests påvirket af telavancin
English: The pregnancy status of women of childbearing potential has to be established prior to dosing with telavancin.
Danish: Graviditetsstatus af kvinder i den fertile alder skal bestemmes forud for dosering med telavancin.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Vibativ are provided with a healthcare professional educational pack containing the following:
Danish: Medlemsstaterne skal sikre, at MAH tildeler alle læger, som forventes at ordinere eller anvende Vibativ, en uddannelsespakke indeholdende:
English: If these symptoms occur you must inform your doctor or nurse immediately.
Danish: Hvis disse symptomer forekommer, skal du straks informere din læge.
English: No clinically significant gender-related differences in telavancin pharmacokinetics have been observed.
Danish: Der er ikke observeret klinisk signifikante kønsrelaterede forskelle i telavancins farmakokinetik.
English: Telavancin interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods (e.g. pyrogallol red molybdate).
Danish: Telavancin interfererer med såvel kvalitative urinstiks til proteintests som med kvantitative farvemetoder (f.eks. pyrogallolrødt molybdat).
English: The solution is to be inspected visually for particulate matter and discoloration prior to administration.
Danish: Opløsningen skal inspiceres visuelt for partikler og misfarvning før anvendelse.
English: Patients with renal impairment should receive an initial dose according to calculated or measured creatinine clearance as presented in the table below.
Danish: Patienter med nedsat nyrefunktion bør have en startdosis i henhold til den beregnede eller målte kreatininclearance som vist i tabellen nedenfor.
English: Telavancin also binds to bacterial membranes and causes depolarisation of membrane potential and an increase in membrane permeability that results in inhibition of protein,
Danish: Telavancin binder sig også til bakteriemembraner og forårsager depolarisering af membranpotentialet samt en øget membranpermeabilitet, som resulterer i hæmning af protein-, RNA- og lipidsyntesen.
English: The pregnancy status of women of childbearing potential must be established prior to dosing with telavancin and women of childbearing potential must use effective contraception during
Danish: Graviditetsstatus hos kvinder i den fødedygtige alder skal fastslås før dosering af telavancin, og at kvinder i den fødedygtige alder skal anvende effektiv antikonception under behandlingen.