FrancophonIA/ELRC3.0 huggingface dataset:
English: It kills these bacteria by interfering with the formation of bacterial cell walls.
Danish: Den dræber bakterier ved at forstyrre dannelse af bakteriernes cellevæg.
English: The symptoms may become severe or may not go away and the stools may contain blood or mucus.
Danish: Symptomerne kan blive værre og forsvinder ikke, og afføringen kan indeholde blod eller slim.
English: These infusion reactions were transient (resolved within 1 hour post-dosing) and were attributed to histamine release.
Danish: Disse infusionsreaktioner var forbigående (ophørte inden for en time efter dosering) og kunne tilskrives histaminfrigivelse.
English: Other side effects reported with Xydalba are listed below.
Danish: Andre bivirkninger rapporteret med Xydalba er anført nedenunder.
English: • The active substance is dalbavancin.
Danish: • Aktivt stof: dalbavancin.
English: There are no data from the use of dalbavancin in pregnant women.
Danish: Der er ingen data fra anvendelse af dalbavancin til gravide kvinder.
English: Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA United Kingdom
Danish: Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA Storbritanien
English: If you also have other bacteria that cause your infection, your doctor may decide to treat you with other antibiotics in addition to Xydalba.
Danish: Hvis der også er andre bakterier, som er skyld i din infektion, skal din læge beslutte, om du skal behandles med andre antibiotika udover Xydalba.
English: Discard any portion of the reconstituted solution that remains unused.
Danish: Kasser den del af den rekonstituerede opløsning der ikke er anvendt.
English: Aseptic technique must be used for reconstitution and dilution of Xydalba.
Danish: Aseptisk teknik skal bruges til rekonstitution og fortynding af Xydalba.
English: Dalbavancin toxicity profile in juvenile rats was consistent with that previously observed in adult rats at the same dose (mg/kg /day) levels.
Danish: Dalbavancins toksicitetsprofil hos unge rotter var konsistent med det som tidligere blev observeret hos voksne rotter ved samme dosisniveauer (mg/kg/dag).
English: It is available in packs containing 1 vial.
Danish: Det er tilgængeligt i pakker med 1 hætteglas.
English: Day 1: 281 (52)
Danish: Dag 1: 281 (52)
English: Xydalba is not recommended during pregnancy unless clearly necessary.
Danish: Xydalba anbefales ikke under graviditet, medmindre det er strengt nødvendigt.
English: Results from an in vitro receptor screening study do not indicate a likely interaction with other therapeutic targets or a potential for clinically relevant pharmacodynamic interactions (see section 5.1).
Danish: Resultater fra et in vitro screeningsstudie på receptorniveau indikerer ikke en sandsynlig interaktion med andre terapeutiske angrebspunkter eller potentiale for klinisk relevante farmakodynamiske interaktioner (se pkt.
English: Increased exposure to transporter substrates sensitive for inhibited transporter activity, such as statins and digoxin, cannot be excluded if combined with dalbavancin.
Danish: Øget eksponering for transportørsubstrater, som er følsomme for hæmmet transportøraktivitet, såsom statiner og digoxin, kan ikke udelukkes, hvis de gives i kombination med dalbavancin.
English: Day 8: 141 (26)
Danish: Dag 8: 141 (26)
English: Antibacterial-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life threatening.
Danish: Antibiotika-associeret colitis og pseudomembranøs colitis er blevet rapporteret ved brug af næsten alle antibiotika og kan variere i sværhedsgrad fra let til livstruende.
English: Day 1: 411 (86)
Danish: Dag 1: 411 (86)
English: In vivo PK/PD relationship of dalbavancin for S. aureus was investigated using a neutropenic model of animal infection that showed that net reduction in the log10 of colony-forming units (CFU) was greatest when larger doses were given less frequently.
Danish: Dalbavancins in vivo PK/PD-forhold for S. aureus blev undersøgt i en neutropenisk model af en dyreinfektion, som viste, at nettoreduktionen i log10 i kolonidannende enheder (CFU) var størst, når større doser blev givet mindre hyppigt.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before being given Xydalba:
Danish: Advarsler og forsigtighedsregler Tal med din læge, apotekspersonalet eller sundhedspersonalet, før du får Xydalba:
English: The cause and the clinical significance of the decreased exposure in subjects with moderate and severe hepatic function are unknown.
Danish: Årsagen og den kliniske betydning af nedsat eksponering hos personer med moderat og svært nedsat leverfunktion er ukendt.
English: Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
Danish: Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Irland
English: If you experience these types of reactions your doctor may decide to stop or slow the infusion.
Danish: Hvis du oplever denne type reaktioner, kan din læge beslutte at stoppe infusionen eller nedsætte infusionshastigheden.
English: Patients with chronic kidney problems
Danish: Patienter med kroniske nyreproblemer
English: This is because it is not known what effect it might have on an unborn baby.
Danish: Det skyldes, at det er ukendt, hvilken effekt Xydalba kan have på det ufødte barn.
English: Pharmacotherapeutic group: antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA04.
Danish: Farmakoterapeutisk klassifikation: antibakterielle midler til systematisk brug, glykopeptidantibiotika, ATC kode: J01XA04.
English: Xydalba is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimise the risk of infusion-related reactions.
Danish: Xydalba skal gives som intravenøs infusion med en samlet infusionstid på 30 minutter for at minimere risikoen for infusionsrelaterede reaktioner.
English: is mediated by VanA, a genotype that results in modification of the target peptide in nascent cell wall.
Danish: forårsages af VanA, en genotype, som medfører en modifikation i målpeptidet i den nye cellevæg.
English: Each pack contains 1 vial.
Danish: Hver karton indeholder 1 hætteglas.
English: The metabolites hydroxy-dalbavancin and mannosyl aglycone have been detected in urine (< 25 % of administered dose).
Danish: Metabolitterne hydroxydalbavancin og mannosylaglykon er blevet fundet i urinen (< 25 % af administreret dosis).
English: In rabbits, abortion occurred in conjunction with maternal toxicity at exposures below the human therapeutic range.
Danish: Hos kaniner forekom abort sammen med maternel toksicitet ved eksponeringer, der var lavere end det humane terapeutiske interval.
English: The plasma protein binding of dalbavancin is 93 % and is not altered as a function of drug concentration, renal insufficiency, or hepatic insufficiency.
Danish: Dalbavancins plasmaproteinbinding er 93 % og ændres ikke som en funktion af lægemiddelskoncentration, nyreinsufficiens eller leverinsufficiens.
English: Tabulated list of adverse reactions (Table 1)
Danish: Tabel med bivirkninger (Tabel 1)
English: The pharmacokinetics of dalbavancin are best described using a three-compartment model (α and β distributional phases followed by a terminal elimination phase).
Danish: Dalbavancins farmakokinetiske egenskaber beskrives bedst af en trekompartmentsmodel (α- and β-distributionsfaser efterfulgt af en terminal eliminationsfase).
English: Although no information is available specifically regarding the use of haemodialysis to treat overdose, it should be noted that in a Phase 1 study in patients with renal impairment, less than 6 % of the recommended dalbavancin dose was removed after 3 hours of haemodialysis.
Danish: Selv om ingen data er tilgængelige præcist om brugen af hæmodialyse til behandling af overdosering, bør det noteres, at i et fase 1-studie med patienter med nedsat nyrefunktion var mindre end 6 % af den anbefalede dalbavancindosis fjernet efter 3 timers hæmodialyse.
English: Methicillin resistance has no impact on dalbavancin activity.
Danish: Methicillinresistens har ikke nogen indvirkning på dalbavancins aktivitet.
English: Thus, the distributional half-life (t1/2β), which constitutes most of the clinically-relevant concentration-time profile, ranged from 5 to 7 days and is consistent with once-weekly dosing.
Danish: Distributionshalveringstiden (t1/2β), som bidrager mest til den klinisk relevante koncentration-tidsprofil, spænder således fra 5 til 7 dage og er forenelig med dosering en gang om ugen.
English: • An increase in alkaline phosphatase (an enzyme found in the body)
Danish: • Forhøjet basisk fosfatase (et enzym i kroppen)
English: General disorders and administration site conditions infusion-related reactions
Danish: Almene symptomer og reaktioner på administrationsstedet infusionsrelaterede reaktioner
English: The pharmacokinetics of dalbavancin were not significantly altered with age; therefore, dose adjustment is not necessary based on age (see section 4.2).
Danish: Dalbavancins farmakokinetiske egenskaber ændres ikke signifikant på grund af alder; derfor er dosisjustering ikke nødvendig på grund af alder (se pkt.
English: Do not use Xydalba if you are allergic to dalbavancin or any of the other ingredients of this medicine (listed in section 6).
Danish: Du må ikke få Xydalba, hvis du er allergisk over for dalbavancin eller et af de andre indholdsstoffer i Xydalba (anført i punkt 6) .
English: The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin.
Danish: Følgende bivirkninger er blevet identificeret i kliniske fase 2/3-studier med dalbavancin.
English: Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Danish: Du må ikke tage nogen former for medicin mod din diarré, før du har talt med din læge.
English: There is no experience with dalbavancin in the treatment of severely immunocompromised patients.
Danish: Der er ingen erfaring med dalbavancin til behandling af svært immunsvækkede patienter.
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk,
Danish: Almac Pharma Services (Irland) Limited Finnabair Industrial Estate, Dundalk,
English: No specific information is available on the treatment of overdose with dalbavancin, as dose-limiting toxicity has not been observed in clinical studies.
Danish: Der foreligger ingen specifik information om behandling af overdosering med dalbavancin, da dosisbegrænsende toksicitet ikke er blevet observeret i kliniske studier.
English: Rare - may affect up to 1 in 1,000 people: • Difficulty breathing (bronchospasm)
Danish: Sjældne - kan ramme op til 1 ud af 1.000 behandlede • Vejrtrækningsproblemer (bronkospasme)
English: If an allergic reaction to dalbavancin occurs, administration should be discontinued and appropriate therapy for the allergic reaction should be instituted.
Danish: Hvis der opstår en allergisk reaktion over for dalbavancin, skal infusionen afbrydes og passende behandling af den allergiske reaktion iværksættes.
English: A decision must be made whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Xydalba taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Xydalba skal fortsættes/ophøre, idet der tages hensyn til fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: If the isolates with higher dalbavancin MICs represent stable phenotypes and are correlated with resistance to the other glycopeptides, then the likely mechanism would be an increase in the number of glycopeptide targets in nascent peptidoglycan.
Danish: Hvis isolater med højere dalbavancin-MIC repræsenterer stabile fænotyper og er korreleret med resistens over for andre glykopeptider, vil den sandsynlige mekanisme være en stigning i antallet af glykopeptidtargets i det voksende peptidoglykan.
English: Based on in vitro studies the activity of dalbavancin is not affected by other classes of vancomycin resistance genes.
Danish: På basis af in vitro studier påvirkes dalbavancins aktivitet ikke af andre klasser af vancomycin-resistensgener.
English: Xydalba must not be mixed with other medicinal products or intravenous solutions.
Danish: Xydalba må ikke blandes med andre lægemidler eller intravenøse opløsninger.
English: Dalbavancin was not mutagenic or clastogenic in a battery of in vitro and in vivo genotoxicity tests.
Danish: Dalbavancin var ikke mutagent eller klastogent i et batteri af in vitro og in vivo genotoksicitetstest.
English: The pharmacokinetics of dalbavancin have been characterised in healthy subjects, patients, and special populations.
Danish: Dalbavancins farmakokinetiske egenskaber er blevet karakteriseret hos raske personer, patienter og specielle befolkningsgrupper.
English: Xydalba contains sodium
Danish: Xydalba indeholder natrium
English: The most common adverse reactions occurring in ≥ 1 % of patients treated with dalbavancin were nausea (2.4 %), diarrhoea (1.9 %), and headache (1.3 %) and were generally of mild or moderate severity.
Danish: De hyppigste bivirkninger hos ≥ 1 % af patienterne behandlet med dalbavancin var kvalme (2,4 %), diarré (1,9 %) og hovedpine (1,3 %).
English: If you suffer from chronic kidney problems, your doctor may decide to reduce your dose.
Danish: Hvis du lider af kroniske nyreproblemer, kan din læge beslutte at reducere din dosis.
English: If particulate matter or discoloration is identified, the solution must be discarded.
Danish: Hvis der observeres partikler eller misfarvning, skal opløsningen kasseres.
English: In the major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only.
Danish: I de vigtigste ABSSSI-studier var de behandlede infektionstyper begrænset til cellulitis/erysipelas, abscesser og sårinfektioner.
English: Xydalba contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group.
Danish: Xydalba indeholder det aktive stof dalbavancin, som er et antibiotikum fra glykopeptid-gruppen
English: Cross-resistance between dalbavancin and other classes of antibiotics was not seen in in vitro studies.
Danish: Krydsresistens mellem dalbavancin og andre antibiotikaklasser blev ikke observeret i in vitro studier.
English: Resistance to dalbavancin in Staphylococcus spp.
Danish: Resistens over for dalbavancin hos Staphylococcus spp.
English: Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xydalba.
Danish: Fortæl øjeblikkeligt din læge eller sundhedspersonalet, hvis du er bekymret for, at du kan have fået for meget Xydalba
English: In Phase 3 studies, patients have been administered single doses of up to 1,500 mg.
Danish: I fase 3-studier har patienter fået enkeltdoser på op til 1.500 mg.
English: Co-administration with inhibitors of these transporters may increase the exposure to dalbavancin.
Danish: Samtidig administration af hæmmere af disse transportører kan øge eksponeringen for dalbavancin.
English: In mixed infections in which Gram-negative bacteria are suspected patients should also be treated with an appropriate antibacterial agent(s) against Gram-negative bacteria (see section 5.1).
Danish: Ved blandede infektioner, hvor der er mistanke om gramnegative bakterier, bør patienten også behandles med passende antibiotikum/antibiotika mod gramnegative bakterier (se pkt.
English: Bactericidal activity against staphylococci in vitro is time-dependent at serum concentrations of dalbavancin similar to those obtained at the recommended dose in humans.
Danish: Bakteriel aktivitet mod stafylokokker in vitro er tidsafhængig ved serumkoncentrationer af dalbavancin, der svarer til dem, man opnår ved den anbefalede dosis hos mennesker.
English: Infections and infestations vulvovaginal mycotic infection, urinary tract infection, fungal infection, Clostridioides (formerly Clostridium) difficile colitis, oral candidiasis
Danish: Infektioner og parasitære sygdomme vulvovaginal svampeinfektion, urinvejsinfektion, svampeinfektion, Clostridioides (tidligere Clostridium) difficile colitis, oral candidiasis
English: Dalbavancin MICs are higher for vancomycin-intermediate staphylococci (VISA) than for fully vancomycin susceptible strains.
Danish: MIC af dalbavancin er højere for vancomycin intermediært resistente stafylokokker (VISA) end for stammer, der er fuldt følsomme for vancomycin.
English: In in vitro studies, no antagonism has been observed between dalbavancin and other commonly used antibiotics (i.e. cefepime, ceftazidime, ceftriaxone, imipenem, meropenem, amikacin, aztreonam, ciprofloxacin, piperacillin/tazobactam and trimethoprim/sulfamethoxazole), when tested against 12 species of Gram-negative pathogens (see section 4.5).
Danish: I in vitro studier er der ikke blevet observeret antagonisme mellem dalbavancin og andre almindeligt anvendt antibiotika (fx. cefepim, ceftazidim, ceftriaxon, imipenem, meropenem, amikacin, aztreonam, ciprofloxacin, piperacillin/tazobactam og trimethoprim/sulfamethoxazol) ved test mod 12 arter af gramnegative patogener (se pkt.
English: There are no data on dalbavancin as an inhibitor of CYP2C8.
Danish: Der foreligger ingen oplysninger om dalbavancin som hæmmer af CYP2C8.
English: The metabolic pathways responsible for producing these metabolites have not been identified; however, due to the relatively minor contribution of metabolism to the overall elimination of dalbavancin, drug-drug interactions via inhibition or induction of metabolism of dalbavancin are not anticipated.
Danish: De metaboliseringsveje, hvor disse metabolitter dannes, er ikke blevet identificeret; men på grund af det relativt lille bidrag, som metabolisering yder til den samlede elimination af dalbavancin, forventes der ikke lægemiddelinteraktioner via hæmning eller induktion af dalbavancins metabolisme.
English: • Abnormal liver function test
Danish: • Unormale prøver for leverfunktion
English: The use of Xydalba in children under 18 has not yet been studied.
Danish: Xydalba er endnu ikke blevet undersøgt hos børn under 18 år.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the treatment with dalbavancin (see section 4.8).
Danish: Det er derfor vigtigt at overveje denne diagnose hos patienter, som får diarré under eller efter dalbavancinbehandling (se pkt.
English: To avoid foaming, alternate between gentle swirling and inversion of the vial, until its contents are completely dissolved.
Danish: For at undgå skumdannelse, skift mellem en forsigtig svingende bevægelse og vending af hætteglasset, indtil indholdet er fuldstændig opløst.
English: Studies in animals have shown reduced fertility (see section 5.3).
Danish: Dyrestudier har vist reduceret fertilitet (se pkt.
English: White to off-white to pale yellow powder.
Danish: Hvidt til off-white til lysegult pulver
English: Systemic exposures to dalbavancin are dose proportional following single doses over a range of 140 to 1120 mg, indicating linear pharmacokinetics of dalbavancin.
Danish: Den systemiske eksponering for dalbavancin er proportional med dosis efter en enkelt dosis i et dosisinterval mellem 140 og 1.120 mg, hvilket indikerer lineær farmakokinetik af dalbavancin.
English: The content of each vial must be reconstituted by slowly adding 25 ml of water for injections.
Danish: Indholdet af hvert hætteglas skal rekonstitueres ved langsomt at tilsætte 25 ml vand til injektioner.
English: Its mechanism of action in susceptible Gram-positive bacteria involves interruption of cell wall synthesis by binding to the terminal D-alanyl-D-alanine of the stem peptide in nascent cell wall peptidoglycan, preventing cross-linking (transpeptidation and transglycosylation) of disaccharide subunits resulting in bacterial cell death.
Danish: Dets virkningsmekanisme i følsomme grampositive bakterier omfatter blokering af cellevægssyntese ved binding til det terminale D-alanyl-D-alanin i peptidet i tværbroer i den voksende peptidoglykankæde i cellevæggen, hvilket forhindrer krydsbinding (transpeptidering og transglykosylering) af disaccharid-underenheder og medfører bakteriecelledød.
English: Reproductive system and breast disorders vulvovaginal pruritus
Danish: Det reproduktive system og mammae vulvovaginal pruritus
English: Examples of such transporter inhibitors are boosted protease inhibitors, verapamil, quinidine, itraconazole, clarithromycin and cyclosporine.
Danish: Eksempler på sådanne transportørhæmmere er boostede proteasehæmmere, verapamil, kinidin, itraconazol, clarithromycin og ciclosporin.
English: It is not known if dalbavancin is a substrate for hepatic uptake and efflux transporters.
Danish: Det vides ikke, om dalbavancin er substrat for hepatiske optagelses- og efflukstransportører.
English: Dalbavancin is a bactericidal lipoglycopeptide.
Danish: Dalbavancin er et baktericidt lipoglykopeptid.
English: Mixed infections
Danish: Blandede infektioner
English: Following administration of a single 1,000 mg dose in healthy subjects, an average of 19 % to 33 % of the administered dalbavancin dose was excreted in urine as dalbavancin and 8 % to 12 % as the metabolite hydroxy-dalbavancin.
Danish: Efter administration af en enkelt dosis på 1.000 mg til raske personer blev i gennemsnit 19-33 % af den administrerede dalbavancindosis udskilt i urinen som dalbavancin og 8-12 % som metabolitten hydroxy-dalbavancin.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xydalba in one or more subsets of the paediatric population in ABSSSI (see sections 4.2 and 5.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Xydalba i en eller flere undergrupper af den pædiatriske population ved ABSSSI (se pkt.
English: Mean (SD) dalbavancin pharmacokinetic parameters using population PK analysis1 Parameter
Danish: Gennemsnitlige (SD) farmakokinetiske parametre for dalbavancin ved anvendelse af populationfarmakokinetisk analyse1
English: Increase in blood levels of gamma-glutamyl transferase (an enzyme produced by the liver and other body tissues)
Danish: • Forhøjede blodniveauer af gamma-glutamyltransferase (et enzym, der produceres af leveren og andre kropsvæv)
English: Caution should be exercised when prescribing dalbavancin to patients with moderate or severe hepatic impairment (Child-Pugh B & C) as no data are available to determine appropriate dosing (see sections 5.2).
Danish: Der skal udvises forsigtighed, når dalbavancin ordineres til patienter med moderat til svært nedsat leverfunktion (Child-Pugh B & C), da der ikke foreligger data til at fastlægge en passende dosering (se pkt.
English: Xydalba is given in a single dose of 1,500 mg or in two doses a week apart: 1,000 mg on Day 1 and 500 mg on Day 8.
Danish: Xydalba bliver givet i en enkelt dosis på 1.500 mg eller i to doser med en uges mellemrum: 1.000 mg på dag 1 og 500 mg på dag 8.
English: Xydalba must be reconstituted and then further diluted prior to administration by intravenous infusion over a 30 - minute period.
Danish: Xydalba skal rekonstitueres og fortyndes yderligere før administration via intravenøs infusion over 30 minutter.
English: You and your doctor will decide if you will be given Xydalba.
Danish: Du vil sammen med din læge beslutte, om du skal have Xydalba.
English: (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
Danish: Frekvenskategorierne bygger på følgende konventioner: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000).