FrancophonIA/ELRC3.0 huggingface dataset:
English: The calculated volume of the reconstituted solution should be added to the infusion bag to a target concentration of 0.3 mg/mL, within a range of 0.2 to 0.6 mg/mL.
Danish: Den beregnede mængde rekonstitueret opløsning bør tilsættes til infusionsposen, så der nås en målkoncentration på 0,3 mg/ml (inden for et interval på 0,2-0,6 mg/ml).
English: There is approximately a 45% accumulation following intravenous dosing of 1 mg/kg every 12 hours.
Danish: Der ses en akkumulation på ca. 45 % efter intravenøs indgift af 1 mg/kg hver 12. time.
English: Powder for concentrate for solution for infusion Multipack: 12 (12x1) vials
Danish: Pulver til koncentrat til infusionsvæske, opløsning Multipakning: 12 (12x1) hætteglas
English: • Feeling lightheaded or faint
Danish: • følelse af uklarhed eller besvimelse
English: The recommended dose for adults is based on body weight and is 1 mg/kg every 12 hours.
Danish: Den anbefalede dosis til voksne er baseret på legemsvægt og er 1 mg/kg hver 12. time.
English: Within the range of eravacycline multiple intravenous doses studied clinically, the pharmacokinetic parameters AUC and Cmax demonstrate linearity, but with increasing doses the increase in both AUC and Cmax are slightly less than dose-proportional.
Danish: Inden for de multidoser af intravenøst eravacyclin, der er undersøgt i kliniske studier, ses linearitet i de farmakokinetiske parametre AUC og Cmax, men med stigende doser er stigningen i såvel AUC som Cmax lidt mindre end dosisproportional.
English: Frequency categories are derived according to the following conventions: very common (≥1/10); common (≥1/100 to <1/10);
Danish: Hyppigheden defineres som følger: meget almindelig (≥ 1/10),
English: The C-7 and C-9 substitutions in eravacycline are not present in any naturally occurring or semisynthetic tetracyclines and the substitution pattern imparts microbiological activities including retention of in vitro potency against Gram-positive and Gram-negative strains expressing tetracycline-specific resistance mechanism(s) (i.e., efflux mediated by tet(A), tet(B), and tet(K); ribosomal protection as encoded by tet(M) and tet(Q)).
Danish: C-7- og C-9-substitutionerne i eravacyclin er ikke til stede i nogen naturligt forekommende eller semisyntetiske tetracycliner; substitutionsmønsteret formidler mikrobiologisk aktivitet, herunder retention af in vitro-styrke mod grampositive og gramnegative stammer, der udtrykker en eller flere tetracyclin-specifikke resistensmekanismer (dvs. efflux-medieret af tet(A), tet(B) og tet(K) og ribosomal beskyttelse som kodet af tet(M) og tet(Q)).
English: Xerava will be given to you in hospital by a doctor or nurse.
Danish: Du vil få Xerava indgivet på et hospital af en læge eller en sygeplejerske.
English: Tell your doctor or nurse if you notice any of the following at the site of infusion during or after your treatment: redness of the skin, rash, inflammation, or pain or tenderness.
Danish: Fortæl det til din læge eller sundhedspersonalet, hvis du bemærker noget af følgende på infusionsstedet under eller efter behandlingen: rødme, udslæt, betændelse, smerter eller ømhed.
English: It is unknown whether eravacycline and its metabolites are excreted in human breast milk.
Danish: Det er ukendt, om eravacyclin og dets metabolitter udskilles i human mælk.
English: Xerava must not be used in children below 8 years of age because it can cause permanent effects on their teeth such as discolouration.
Danish: Xerava må ikke anvendes hos børn under 8 år, da det kan medføre varige skader på deres tænder, f.eks. misfarvning.
English: Other side effects have been reported with other tetracycline antibiotics including minocycline and doxycycline.
Danish: Der er rapporteret om andre bivirkninger ved andre tetracyclin-holdige antibiotika, herunder minocyclin og doxycyclin.
English: Long term use of other tetracyclines during breast-feeding may result in significant absorption by the breast-fed infant and is not recommended because of the risk of dental discolouration and delay in ossification processes of the breast-fed infant.
Danish: Længere tids anvendelse af andre tetracycliner under amning kan resultere i signifikant absorption hos det ammede barn og anbefales ikke, da der kan være risiko for misfarvning af tænderne og forsinkede ossifikationsprocesser hos det ammede barn.
English: Findings on the male reproductive organs were also observed in rats in the repeated dose toxicity studies for 14 days or 13 weeks at exposures more than 10- or 5-fold the clinical exposure based on AUC.
Danish: Der blev også observeret fund i kønsorganerne hos hanrotter i toksicitetsstudierne med gentagne doser i 14 dage eller 13 uger ved eksponeringer, der var 10 eller 5 gange større end den kliniske eksponering baseret på AUC.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Xerava in one or more subsets of the paediatric population in cIAI (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Xerava i en eller flere undergrupper af den pædiatriske population ved komplicerede intraabdominale infektioner (se pkt.
English: The infusion solution should be inspected visually for particulate matter prior to administration.
Danish: Infusionsopløsningen skal kontrolleres for synlige partikler inden administration.
English: Potential for drug-drug interactions
Danish: Potentiale for lægemiddelinteraktioner
English: However, the resulting difference in exposure to eravacycline in terms of AUC does not warrant dose adjustments in the weight range studied.
Danish: Den deraf følgende forskel i AUC, hvad angår eravacyclineksponering, giver dog ikke anledning til dosisjustering inden for de undersøgte vægtintervaller.
English: From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra en mikrobiologisk betragtning bør præparatet anvendes med det samme, medmindre metoden til åbning/rekonstitution/fortynding udelukker risiko for kontaminering med mikroorganismer.
English: For single use only, any unused solution should be discarded.
Danish: Kun til engangsbrug; eventuelle rester af opløsningen skal bortskaffes.
English: Resistance to eravacycline has been observed in Enterococcus harbouring mutations in rpsJ.
Danish: Resistens over for eravacyclin er observeret hos Enterococcus med mutationer i rpsJ.
English: Shaking or rapid movement should be avoided as it may cause foaming.
Danish: Omrystning og hurtige bevægelser skal undgås, da der kan dannes skum.
English: Infusion site reactions can be mitigated by reducing the eravacycline infusion concentration or the infusion rate.
Danish: Reaktionerne på infusionsstedet kan mindskes ved at reducere eravacyclin-koncentrationen eller infusionshastigheden.
English: Table 2 Mean (%CV) plasma pharmacokinetic parameters of eravacycline after single and multiple intravenous and in healthy adults
Danish: Tabel 2 Gennemsnitlige (% CV) farmakokinetiske plasma-parametre for eravacyclin efter enkelte eller flere intravenøse infusioner hos raske voksne
English: Talk to your doctor or nurse before you receive Xerava if you are concerned about any of the following:
Danish: Tal med din læge eller sundhedspersonalet, før du får Xerava, hvis du er bekymret for noget af følgende:
English: Contents of the pack and other information What Xerava contains
Danish: Pakningsstørrelser og yderligere oplysninger Xerava indeholder:
English: Concomitant use of strong CYP3A4 inducers
Danish: Samtidig anvendelse af potente CYP3A4-inducere
English: The powder for concentrate for solution for infusion (powder for concentrate) will be reconstituted in the vial with 5 mL of water for injections.
Danish: Pulveret til koncentrat til infusionsvæske, opløsning (pulver til koncentrat), vil blive rekonstitueret i hætteglasset med 5 ml vand til injektionsvæsker.
English: The observations included degeneration of the seminiferous tubules, oligospermia, and cellular debris in the epididymides, spermatid retention in the seminiferous tubules, increase of spermatid head retention in Sertoli cells, and vacuolation of Sertoli cells and decreased sperm counts.
Danish: Observationerne omfattede degeneration af de sædførende kanaler, oligospermi og cellerester i bitestiklerne, spermatidretention i de sædførende kanaler, øget spermatidhovedretention i Sertoli-cellerne samt vakuolisering af Sertoli-celler og nedsat antal sædceller.
English: Reconstituted Xerava should be a clear, pale yellow to orange solution.
Danish: Den rekonstituerede Xerava-væske bør være klar og bleggul til orange.
English: Other medicines and Xerava
Danish: Brug af anden medicin sammen med Xerava
English: In fertility studies in male rats, eravacycline administered at about 5 times the clinical exposure (based on AUC), gave rise to a significantly reduced number of pregnancies.
Danish: I fertilitetsstudier af hanrotter gav eravacyclin administreret i doser, der gav ca. 5 gange den kliniske eksponering (baseret på AUC), anledning til et signifikant nedsat antal graviditeter.
English: Xerava is administered only by intravenous infusion over approximately 1 hour (see section 4.4).
Danish: Xerava administreres kun ved intravenøs infusion over ca. 1 time (se pkt.
English: The mean pharmacokinetic parameters of eravacycline after single and multiple intravenous infusions (60 minutes) of 1 mg/ kg administered to healthy adults every 12 hours are presented in Table 2.
Danish: De gennemsnitlige farmakokinetiske parametre for eravacyclin efter enkelte eller flere intravenøse infusioner (over 60 minutter) af 1 mg/kg til raske voksne hver 12. time er vist i tabel 2.
English: Anaphylactic (allergic) reactions have been reported with other tetracycline antibiotics.
Danish: Anafylaktiske (allergiske) reaktioner er rapporteret ved behandling med andre tetracyclin-holdige antibiotika.
English: Additional measures to reduce the occurrence and severity of infusion site reactions include decreasing the eravacycline infusion rate and/or concentration.
Danish: Yderligere foranstaltninger til at mindske forekomsten og sværhedsgraden af reaktioner på infusionsstedet kan være at nedsætte infusionshastigheden og/eller koncentrationen af eravacyclin.
English: No dose adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion eller hos patienter i hæmodialyse.
English: Potential for eravacycline to affect the pharmacokinetics of other medicinal products
Danish: Eravacyclins potentielle indvirkning på andre lægemidlers farmakokinetik
English: Eravacycline is metabolised primarily by CYP3A4- and FMO-mediated oxidation of the pyrrolidine ring to TP-6208, and by chemical epimerisation at C-4 to TP-498.
Danish: Eravacyclin metaboliseres fortrinsvis ved CYP3A4- og FMO-medieret oxidering af pyrrolidinringen til TP-6208 og ved kemisk epimerisering ved C-4 til TP-498.
English: PK parameters arithmetic mean (%CV)
Danish: Farmakokinetiske parametrearitmetisk gennemsnit (% CV)
English: Aseptic technique must be followed when preparing the infusion solution.
Danish: Der skal anvendes aseptisk teknik, når infusionsvæsken klargøres.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis produktet ikke anvendes med det samme, er det brugerens ansvar at sikre egnede opbevaringsforhold før ibrugtagning.
English: Antibiotic-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: Der er rapporteret om antibiotika-relateret kolitis og pseudomembranøs kolitis ved anvendelse af næsten alle antibiotika, og disse bivirkninger kan være lette til livstruende.
English: Table 1 Tabulated list of adverse reactions to eravacycline in clinical trials
Danish: Tabel 1 Oversigt over bivirkninger ved eravacyclin i kliniske studier
English: Doses more than 2- or 4-fold higher than the clinical exposure (based on AUC) were associated with maternal toxicity (clinical observations and reduced body weight gain and food consumption), and reduced foetal body weights and delays in skeletal ossification in both species and abortion in the rabbit.
Danish: Doser, der var 2 eller 4 gange højere end kliniske eksponering (baseret på AUC), var forbundet med maternel toksicitet (kliniske observationer og reduceret vækst og fødeindtag), reduceret fostervægt og forsinket knogledannelse hos begge arter samt abort hos kaniner.
English: Pancreatitis Diarrhoea
Danish: Pankreatitis Diarré
English: Xerava is therefore not indicated for the treatment of complicated urinary tract infections.
Danish: Xerava er derfor ikke indiceret til behandling af komplicerede urinvejsinfektioner.
English: Recommended infusion bag size
Danish: Anbefalet størrelse af infusionsposen
English: A drug-drug interaction in vivo cannot be excluded and co-administration of eravacycline and other medicinal products that inhibit these transporters (examples of OATP1B1/3 inhibitors; atazanavir, cyclosporine, lopinavir, and saquinavir) may increase the eravacycline plasma concentration.
Danish: En lægemiddelinteraktion in vivo kan ikke udelukkes, og samtidig administration af eravacyclin og andre lægemidler, der hæmmer disse transportere, kan øge plasmakoncentrationen af eravacyclin (eksempler på OATP1B1/3-hæmmere: atazanavir, cyclosporin, lopinavir og saquinavir).
English: mannitol (E421), sodium hydroxide, hydrochloric acid
Danish: mannitol (E421), natriumhydroxid, saltsyre
English: Concomitant administration of the strong CYP 3A4/3A5 inducer rifampicin altered the pharmacokinetics of eravacycline, decreasing exposure by approximately 32% and increasing clearance by approximately 54%.
Danish: Samtidig administration af den potente CYP3A4/3A5-inducer rifampicin ændrede eravacyclins farmakokinetik ved at reducere eksponeringen med ca. 32 % og øge clearance med ca. 54 %.
English: Your doctor may increase your dose (1.5 mg/kg every 12 hours) if you are taking other medicines including rifampicin, phenobarbital, carbamazepine, phenytoin, or St. John's Wort.
Danish: Din læge kan øge dosen (1,5 mg/kg hver 12. time), hvis du tager andre lægemidler som f.eks. rifampicin, phenobarbital, karbamazepin, phenytoin eller prikbladet perikon.
English: As for other tetracycline class antibiotics, eravacycline may induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses exposed in utero during the 2nd and 3rd trimester, due to accumulation in tissues with a high calcium turnover and formation of calcium chelate complexes (see sections 4.4 and 5.3).
Danish: Som for andre antibiotika i tetracyclin-klassen kan eravacyclin forårsage permanente tanddefekter (misfarvning og emaljedefekter) og forsinkede ossifikationsprocesser hos fostre, der eksponeres in utero i 2. og 3. trimester, på grund af akkumulering i væv med høj kalciumomsætning og dannelse af kalciumkelat-komplekser (se pkt.
English: In embryo-foetal studies, no adverse effects were observed in rats at exposures comparable to clinical exposure or in rabbits at exposures 1.9-fold higher than the clinical exposure (based on AUC) in rats and rabbits respectively.
Danish: I embryoføtale studier sås ingen bivirkninger hos rotter ved eksponeringer svarende til den kliniske eksponering eller hos kaniner ved eksponeringer, der var 1,9 gange større end den kliniske eksponering (baseret på AUC).
English: Tetracycline class adverse reactions include photosensitivity, pseudotumor cerebri, and anti-anabolic action which have led to increased BUN, azotaemia, acidosis, and hyperphosphataemia.
Danish: Klasseeffekter for tetracycliner omfatter lysfølsomhed, pseudotumor cerebri og anti-anabolisk indvirkning, der har ført til forhøjet karbamid, azotæmi, acidose og hyperfosfatæmi.
English: • Redness or swelling at the site of the injection
Danish: • rødme eller hævelse på injektionsstedet.
English: Keep the vial in the inner carton in order to protect from light.
Danish: Opbevar hætteglasset i den indre karton for at beskytte mod lys.
English: Chemical and physical in-use stability after dilution in the infusion bag has been demonstrated for 72 hours at refrigerated conditions (2-8°C) .
Danish: Der er påvist kemisk og fysisk brugsstabilitet efter fortynding i infusionsposen i 72 timer ved opbevaring i køleskab (2-8 °C) .
English: The adverse reactions identified with eravacycline are presented in Table 1.
Danish: Bivirkninger, der er set ved eravacyclin, er vist i tabel 1.
English: Serious and occasionally fatal hypersensitivity reactions are possible and have been reported with other tetracycline class antibiotics (see section 4.3).
Danish: Alvorlige og i nogle tilfælde fatale overfølsomhedsreaktioner kan opstå og er blevet indberettet ved anvendelse af andre antibiotika i tetracyclin-klassen (se pkt.
English: Eravacycline is a substrate for the transporters P-gp, OATP1B1 and OATP1B3 but not for BCRP.
Danish: Eravacyclin er et substrat for transporterne P-gp, OATP1B1 og OATP1B3, men ikke for BCRP.
English: Do not take any medicine to treat your diarrhoea without first checking with your doctor (see also section 4).
Danish: Du må ikke tage medicin mod diarré, før du har talt med lægen (se også pkt.
English: What Xerava is used for
Danish: Hvad anvendes Xerava til?
English: 10mL Type I glass vial with chlorobutyl rubber stopper and aluminium cap.
Danish: Type I-hætteglas (10 ml) af glas med klorobutylgummiprop og aluminiumshætte.
English: - The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Danish: - Øvrige indholdsstoffer: mannitol (E421), saltsyre (til justering af pH) og natriumhydroxid (til justering af pH).
English: Concomitant administration of the strong CYP3A inhibitor itraconazole altered the pharmacokinetics of eravacycline, increasing Cmax by approximately 5% and AUC0-24 by approximately 23%, and decreasing clearance.
Danish: Samtidig administration af den potente CYP3A-hæmmer itraconazol ændrede eravacyclins farmakokinetik ved at øge Cmax med ca. 5 % og AUC0-24 med ca. 23 % samt reducere clearance.
English: Intravenous administration of high doses of eravacycline has been associated with cutaneous responses (including hives, scratching, swelling, and/or skin erythema) in rat and dog studies.
Danish: Intravenøs administration af høje doser eravacyclin har været forbundet med hudreaktioner (herunder nældefeber, kløe, hævelse og/eller erytem) i studier af rotter og hunde.
English: Clinical trials have failed to demonstrate the efficacy of Xerava for the treatment of complicated urinary tract infections.
Danish: Kliniske studier har ikke påvist nogen effekt af Xerava til behandling af komplicerede urinvejsinfektioner.
English: Eravacycline may be administered without regard to the timing of haemodialysis (see section 5.2).
Danish: Eravacyclin kan administreres uden hensyn til tidspunkterne for hæmodialyse (se pkt.
English: However, patients receiving strong CYP3A inhibitors (for example ritonavir, itraconazole, clarithromycin) with a combination of factors that may increase the exposure, such as severe hepatic impairment and/or obesity should be monitored for adverse reactions (see sections 4.4 and 4.8).
Danish: Patienter, der får potente CYP3A-hæmmere (f.eks. ritonavir, itraconazol eller clarithromycin) med en kombination af faktorer, der kan øge eksponeringen, herunder svært nedsat leverfunktion og/eller overvægt, bør imidlertid overvåges for bivirkninger (se pkt.
English: In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in AUC by gender were observed for eravacycline.
Danish: I en farmakokinetisk populationsanalyse af eravacyclin sås ingen klinisk relevante forskelle mellem kønnene, hvad angår AUC.
English: Table 3 Example calculations for weights ranging from 40 kg to 200 kg
Danish: Tabel 3 Eksempler på beregninger for legemsvægt i intervallet 40-200 kg
English: It is not known if Xerava passes into breast milk.
Danish: Det er ukendt, om Xerava udskilles i human mælk.
English: Symptoms to look out for include rash, swelling of the face, feeling lightheaded or faint, tightness of the chest, breathing difficulties, fast heartbeat, or losing consciousness (see also section 4).
Danish: Symptomerne er udslæt, hævelse i ansigtet, ørhed eller svimmelhed, trykken for brystet, vejrtrækningsbesvær, hurtig hjerterytme eller bevidsthedstab (se også pkt.
English: In vitro, eravacycline was shown to be a substrate for the transporters P-gp, OATP1B1 and OATP1B3.
Danish: Det er påvist in vitro, at eravacyclin er et substrat for transporterne P-gp, OATP1B1 og OATP1B3.
English: Other tetracycline antibiotics
Danish: Andre tetracyclin-holdige antibiotika
English: Eravacycline and its metabolites are not inhibitors of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 in vitro.
Danish: Eravacyclin og dets metabolitter er ikke hæmmere af CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4 in vitro.
English: Tell your doctor or nurse straightaway if you develop diarrhoea during or after your treatment.
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du får diarré under eller efter behandlingen.
English: Xerava is available in packs containing 1 vial or multipacks comprising 12 cartons, each containing 1 vial.
Danish: Xerava fås i pakninger med 1 hætteglas eller multipakninger bestående af 12 kartoner med hver 1 hætteglas.
English: Xerava is used to treat adults with a complicated infection in the abdomen.
Danish: Xerava anvendes til at behandle voksne med en kompliceret maveinfektion.
English: • Inflammation of a vein causing pain and swelling (phlebitis)
Danish: • betændelse i en blodåre, der forårsager smerter og hævelse (flebitis)
English: In clinical trials, the most common adverse reactions in patients with cIAI treated with eravacycline (n=576) were nausea (3.0%), vomiting, infusion site phlebitis (each 1.9%), phlebitis (1.4%), infusion site thrombosis (0.9%), diarrhoea (0.7%), vessel puncture site erythema (0.5%), hyperhidrosis, thrombophlebitis, infusion site hypoaesthesia, and headache (each 0.3%), which were generally mild or moderate in severity.
Danish: De hyppigste bivirkninger i kliniske studier af patienter med komplicerede intraabdominale infektioner i behandling med eravacyclin (n = 576) var kvalme (3,0 %), opkastning, flebitis ved infusionsstedet (begge 1,9 %), flebitis (1,4 %), trombose ved infusionsstedet (0,9 %), diarré (0,7 %), erytem ved indstiksstedet (0,5 %), hyperhidrose, tromboflebitis, hypoæstesi ved infusionsstedet og hovedpine (hver 0,3 %), og de var typisk af let til moderat sværhedsgrad.
English: Pack sizes: 1 vial and multipacks containing 12 (12 packs of 1) vials.
Danish: Pakningsstørrelser: 1 hætteglas og multipakninger med 12 (12 pakker á 1) hætteglas.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Xerava should be made, 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 Xerava skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: MULTIPACK, CONTAINS BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON: MULTIPAKNING, INDEHOLDER BLUE BOX
English: The ready to use solution should be inspected visually for particulate matter prior to administration.
Danish: Den klargjorte opløsning skal kontrolleres for synlige partikler inden administration.
English: After further dilution 1 mL contains 0.3 mg eravacycline.
Danish: Efter yderligere fortynding indeholder 1 ml opløsning 0,3 mg eravacyclin.
English: Keep the vial in the carton in order to protect from light.
Danish: Opbevar hætteglasset i kartonen for at beskytte mod lys.