FrancophonIA/ELRC3.0 huggingface dataset:
English: diplopia, scotoma
Danish: Dobbeltsyn, scotoma
English: In Table 3 a comparison is shown of exposure (Cav) after administration of posaconazole tablet and posaconazole oral suspension at therapeutic doses in patients depicted as quartile analysis.
Danish: I tabel 3 er der vist en sammenligning af eksponering (Cav) efter administration af posaconazol tablet og posaconazol oral suspension ved terapeutiske doser til patienter vist som en kvartilanalyse.
English: 200 mg three times daily
Danish: 200 mgtre gange dagligt
English: Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Danish: Utilstrækkelig behandling defineres som progression af en infektion eller mangel på bedring efter mindst 7 dagesterapeutiskedoserafeffektivbehandlingmedantimykotika.
English: There was a slight decrease (16%) in the AUC and Cmax of posaconazole oral suspension in Black subjects relative to Caucasian subjects.
Danish: Dervar en svag reduktion (16 %) iAUC og Cmaxfor posaconazol oral suspensionhos negroide iforhold til kaukasiske personer.
English: Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections.
Danish: Seksten patienter i alderen 8-17 år blev behandlet med posaconazol oral suspension 800 mg/dag i etstudie med invasive svampeinfektioner.
English: Therefore, posaconazole may increase plasma concentration of digoxin and digoxin levels need to be monitored when initiating or discontinuing posaconazole treatment.
Danish: Derfor kan posaconazol øge plasmakoncentrationen af digoxin, så det er nødvendigt at monitorere digoxinniveauerne ved påbegyndelse ellerseponering af behandling med posaconazol.
English: General disorders and administration site conditions Common:
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig
English: There is no clinical experience assessing the impact of posaconazole on fertility in humans.
Danish: Der er ingen klinisk erfaring, som vurderer posaconazols indvirkning på fertiliteten hos mennesker.
English: Cav = the average concentration when measured at steady state *20 patients received 200 mg once daily (Day 1 200 mg twice daily)
Danish: Cav = den gennemsnitlige koncentration målt vedsteady-state *20 patienter fik 200mg en gang dagligt (på dag 1 200mg to gange dagligt)
English: Posaconazole is also available as 40 mg/mL oral suspension and 300 mg concentrate for solution for infusion.
Danish: Posaconazol findes også som 40 mg/ml oral suspension og300mg koncentrat til infusionsvæske,opløsning.
English: If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine.
Danish: Hvisduerenkvinde,som kan blive gravid, skal du anvende sikker prævention, mens du tager
English: Gender The pharmacokinetics of posaconazole tablets are comparable in men and women.
Danish: Køn Farmakokinetikken for posaconazol tabletter er sammenlignelig hos mænd og kvinder.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Danish: Er du i tvivl, så spørg lægen ellerapotekspersonalet, før du tager dette lægemiddel.
English: The safety profile of tablets was similar to that of the oral suspension.
Danish: Sikkerhedsprofilen for tabletterne var lig sikkerhedsprofilen for den orale suspension.
English: Additionally, twelve patients 13-17 years of age received posaconazole oral suspension 600 mg/day for prophylaxis of invasive fungal infections (Studies 316 and 1899).
Danish: Derudover fik tolv patienter i alderen 13-17 år posaconazol oral suspension 600 mg/dag tilforebyggelse af invasive svampeinfektioner (studie 316 og1899).
English: However, the safety profile of posaconazole between the Black and Caucasian subjects was similar.
Danish: Sikkerhedsprofilen for posaconazol var imidlertid den samme hos negroideogkaukasiskepersoner.
English: Two different dosing groups were evaluated: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Part IA) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Part 1B and Part 2).
Danish: To forskellige doseringsgrupper blev vurderet: 200mg to gange dagligt pådag 1, herefter efterfulgt af 200 mg en gang dagligt (del IA) og 300 mg to gange dagligt på dag 1,herefterefterfulgtaf300 mg en gang dagligt (del 1B og del 2).
English: Posaconazole tablets are absorbed with a median Tmax of 4 to 5 hours and exhibits dose proportional pharmacokinetics after single and multiple dosing up to 300 mg.
Danish: Posaconazoltabletter absorberes med en medianTmaxpå 4 til 5 timerog udviser dosisproportionalfarmakokinetik efter enkeltdosis og flergangsdosering på op til 300 mg.
English: It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens).
Danish: Det er især vigtigt at forsøge at sikre, at de maksimale plasmaniveauer opnås hos patienter, der er inficeret med Aspergillus (se pkt.
English: Other medicines
Danish: Anden medicin
English: Cav quartile analyses of pivotal patient studies with posaconazole tablet and oral suspension Posaconazole tablet
Danish: Cav kvartilanalyser af pivotale patientstudier med posaconazol tablet og oral suspension Posaconazol tablet
English: Do not switch between taking Posaconazole Accord tablets and posaconazole oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.
Danish: Dumåikke skifte mellem Posaconazole Accord tabletter og posaconazol oral suspension uden først at tale med lægeneller apotekspersonalet, da dette kan medføre manglende virkning eller øge risikoen for bivirkninger.
English: If these medicinal products are co-administered, careful monitoring of full blood counts and adverse reactions related to increased rifabutin levels (e.g. uveitis) is recommended.
Danish: Hvisdisselægemidleradministreressamtidigt,anbefalesomhyggeligmonitorering af fuldstændigblodtælling og bivirkninger relateret til forhøjede niveauer af rifabutin (f.eks. uveitis).
English: Posaconazole is highly protein bound (> 98%), predominantly to serum albumin.
Danish: Posaconazol har en høj proteinbinding (>98 %)hovedsageligtilserumalbumin.
English: If posaconazole is used concomitantly with CYP3A4 substrates that are administered orally, and for which an increase in plasma concentrations may be associated with unacceptable adverse reactions, plasma concentrations of the CYP3A4 substrate and/or adverse reactions should be closely monitored and the dose adjusted as needed.
Danish: Hvis posaconazol anvendes sammenmedCYP3A4-substrater, som administreres oralt, og for hvilke en stigning i plasmakoncentrationernekan være forbundet med uacceptable bivirkninger, bør plasmakoncentrationerne af CYP3A4-substratog/eller bivirkninger følges nøje, og dosis justeres efter behov.
English: In twelve-month neurotoxicity studies in dogs and monkeys, no functional effects were observed on the central or peripheral nervous systems at systemic exposures greater than those achieved therapeutically.
Danish: I tolv måneders neurotoksicitetsstudier med hunde og aber blev der ikke konstateret påvirkning af det centrale eller perifere nervesystem ved systemisk eksponering, der var større end den, derblev opnået terapeutisk.
English: There is no special treatment available in the case of overdose with posaconazole.
Danish: Der er ingen særlig behandling tilgængelig i tilfælde af overdosering med posaconazol.
English: Dose and duration of therapy (See section 5.2)
Danish: Dosis og varighed af behandling (Sepkt.
English: The effect of co-administration with posaconazole on plasma levels of CYP3A4 substrates may also be variable within a patient.
Danish: Virkningen af samtidig administration af posaconazol på plasmaniveauer for CYP3A4-substrat kan også variere hos den enkelte patient.
English: Plasma exposure resulting from the tablet formulation was higher than observed with the oral suspension.
Danish: Plasmaeksponeringen fra tabletformuleringen var højere end den plasmaeksponering, som blev set ved den orale suspension.
English: Terfenadine, astemizole, cisapride, pimozide, halofantrine and quinidine (CYP3A4 substrates) Co-administration of posaconazole and terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine is contraindicated.
Danish: Terfenadin, astemizol, cisaprid, pimozid, halofantrin og quinidin (CYP3A4-substrater) Samtidig administration af posaconazol og terfenadin, astemizol, cisaprid, pimozid, halofantrin eller quinidin er kontraindiceret.
English: Hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.
Danish: Der er rapporteret hepatiske reaktioner (f.eks. lettil moderate forhøjelser af ALAT, ASAT, alkalisk fosfatase og total bilirubin og/eller klinisk hepatitis) under behandling med posaconazol.
English: long QT syndrome§, electrocardiogram abnormal§, palpitations, bradycardia, supraventricular extrasystoles, tachycardia
Danish: Langt QT-syndrom§, unormalt elektrokardiogram§, palpitationer, bradykardi, supraventrikulære ekstrasystoler, takykardi
English: Exposures after tablet administration are generally higher than, but overlapping with, exposures after administration of posaconazole oral suspension.
Danish: Eksponering efter administration af tabletter er generelt højere, men overlapper med eksponering efteradministration af posaconazol oral suspension.
English: Posaconazole increased Cmax and AUC of tacrolimus (0.05 mg/kg body weight single dose) by 121% and 358%, respectively.
Danish: Posaconazol øgedeCmaxogAUCfor tacrolimus(0,05 mg/kg kropsvægt somenkeltdosis) medhenholdsvis 121 % og 358%.
English: blurred vision, photophobia, visual acuity reduced
Danish: Sløret syn, fotofobi, nedsat synsstyrke
English: In a study in healthy volunteers posaconazole oral suspension (200 mg once daily for 10 days) increased the exposure (AUC) of intravenous midazolam (0.05 mg/kg) by 83%.
Danish: I et studie med raske frivillige øgede posaconazol oral suspension (200 mg en gang dagligt i 10 dage)eksponeringen(AUC)forintravenøstmidazolam(0,05 mg/kg)med 83 %.
English: Limited data on the effect of hepatic impairment (including Child-Pugh C classification of chronic liver disease) on the pharmacokinetics of posaconazole demonstrate an increase in plasma exposure compared to subjects with normal hepatic function, but do not suggest that dose adjustment is necessary (see sections 4.4 and 5.2).
Danish: Begrænsede data vedrørende indvirkningen af nedsat leverfunktion (inklusive Child-Pugh Cklassificering af kronisk leversygdom) på farmakokinetikken for posaconazol viser en stigning ieksponeringen i plasma sammenlignet med forsøgspersoner med normal leverfunktion, men tyder ikkepå, at dosisjustering er nødvendig (se pkt.
English: Concomitant use of posaconazole and rifabutin should be avoided unless the benefit to the patient outweighs the risk (see also above regarding the effect of rifabutin on plasma levels of posaconazole).
Danish: Samtidigadministration af posaconazol og rifabutin bør undgås, medmindre fordelen for patienten opvejer risikoen (se også ovenfor vedrørende indvirkningen af rifabutin på plasmaniveauer af posaconazol).
English: Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole tablets when given as antifungal prophylaxis.
Danish: Patienterne blev inkluderet i et ikke-sammenlignende farmakokinetisksikkerhedsstudie med posaconazol tabletter indgivet som profylaktisk antimykotisk behandling.
English: In addition, posaconazole oral suspension (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 8-10 hours during co-administration.
Danish: Posaconazol oral suspension (200 mg eller400 mg) forlængede ydermere middelterminalhalveringstiden af midazolam fra omkring 3-4timer til8-10 timer under samtidig administration.
English: The other ingredients are: Methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505), xylitol (E967), hydroxypropyl cellulose (E463), propyl gallate (E310), cellulose microcrystalline (E460), silica colloidal anhydrous, croscarmellose sodium, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), iron oxide yellow (E172).
Danish: - Øvrige indholdsstoffer: Metacrylsyre-ethylacrylatcopolymer (1:1), triethylcitrat (E1505), xylitol (E967), hydroxypropylcellulose (E463), propylgallat (E310), mikrokrystallinsk cellulose (E460), silica kolloid vandfri, croscarmellosenatrium, natriumstearylfumerat, polyvinylalkohol, titandioxid(E171), macrogol, talcum (E553b), gul jernoxid (E172)
English: The microbiological data suggest that posaconazole is active against Rhizomucor, Mucor, and Rhizopus; however the clinical data are currently too limited to assess the efficacy of posaconazole against these causative agents.
Danish: Demikrobiologiskedataantyder,atposaconazol er aktiv mod Rhizomucor, Mucor og Rhizopus;de aktuelle kliniske data er imidlertid forbegrænsede til at vurdere virkningen af posaconazol over for disse sygdomsfremkaldende arter.
English: Vincristine toxicity
Danish: Vincristin-toksicitet
English: Safety and efficacy in paediatric patients below the age of 18 years have not been established.
Danish: Sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.1-fold greater than that achieved therapeutically.
Danish: Ekkokardiografi viste ingen tegn på hjerteinsufficiens i et sikkerhedsfarmakologisk studie med gentagne doser til rotter ved en systemisk eksponering, der var 2,1 gange større end den, der blev opnået terapeutisk.
English: Do not take Posaconazole Accord - if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for posaconazol eller et af de øvrige indholdsstoffer i dette lægemiddel(angivet i punkt 6).
English: Glucose concentrations decreased in some healthy volunteers when glipizide was co-administered with posaconazole.
Danish: Glucosekoncentrationerne faldt hos nogle raske forsøgspersoner, da glipizid blev administreret samtidig med posaconazol.
English: Following single-dose administration of posaconazole oral suspension, there was no effect of mild and moderate renal impairment (n=18, Cl cr ≥ 20 mL/min/1.73 m2) on posaconazole pharmacokinetics; therefore, no dose adjustment is required.
Danish: Efter administration af en enkeltdosis af posaconazol oral suspension sås ingen påvirkning af posaconazols farmakokinetikvedletogmoderatnedsatnyrefunktion(n=18Clcr≥ 20 ml/min/1,73 m2); dosisjustering er således ikke nødvendig.
English: Subjects achieved a mean predicted Cav at steady state of 1,970 ng/mL.
Danish: ForsøgspersonerneopnåedeengennemsnitligformodetCavvedsteady-state på 1.970 ng/ml.
English: Liver function tests should be evaluated at the start of and during the course of posaconazole therapy.
Danish: Leverfunktionstest skal vurderes i starten af og i løbet af behandlingen med posaconazol.
English: During clinical trials, patients who received posaconazole oral suspension doses up to 1,600 mg/day experienced no different adverse reactions from those reported with patients at the lower doses.
Danish: Ikliniske studier havde patienter, som fik posaconazol oral suspension idoser op til 1.600 mg/dag,ikke oplevet andre bivirkninger end dem, der blev observeret hos patienter på lavere doser.
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 2.1-fold and 8.5-fold greater, respectively, than those achieved with the human therapeutic doses.
Danish: Forhøjet systolisk og arterielt blodtryk (op til 29 mmHg) blev målt hos rotter ogabervedsystemiskeksponering,dervarhenholdsvis2,1 gangeog 8,5 gange større end den, der blevopnået med terapeutiske doser hos mennesker.
English: For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole Accord should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
Danish: Behandlingensvarighedafhængeraf bedring efter neutropeni ellerimmunsuppression.Forpatientermedakutmyeloidleukæmiellermy elodysplastisk syndrom bør forebyggelse med Posaconazole Accord påbegyndes flere dage før den forventede optræden af neutropeni og fortsætte i 7 dage, efter at neutrofiltallet stiger til over 500celler pr. mm3.
English: Each tablet contains 100 mg of posaconazole.
Danish: Hver tablet indeholder 100 mg posaconazol.
English: Neuronal phospholipidosis occurred in dogs dosed for ≥ 3 months at lower systemic exposures than those obtained at therapeutic doses in humans.
Danish: Neuronal fosfolipidose forekom hos hunde behandlet i 3 måneder ved lavere systemisk eksponeringend den eksponering, der opnås ved terapeutiske doser hos mennesker.
English: Nervous system disorders Common:
Danish: Nervesystemet Almindelig
English: OTHER SPECIAL WARNING(S), IF NECESSARY Posaconazole oral suspension and tablets are NOT interchangeable.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Posaconazole oral suspension og tabletter er IKKE indbyrdes ombyttelige.
English: Posaconazole Accord may be taken with or without food (see section 5.2).
Danish: Posaconazole Accord gastroresistente tabletter kan tages med eller uden mad (se pkt.
English: However, as posaconazole is not significantly renally eliminated, an effect of severe renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended.
Danish: Da posaconazol imidlertid ikke i signifikant grad udskilles renalt, forventes ingen påvirkning af posaconazols farmakokinetik ved svært nedsat nyrefunktion, og der anbefales ingen dosisjustering.
English: Proportion (%) of patients with proven/probable IFIs On-treatment periodb d
Danish: Andel af patienter (%)med verificeret/sandsynlig IFI
English: Q1
Danish: K1
English: Steady-state plasma concentrations are attained by Day 6 at the 300 mg dose (once daily after twice daily loading dose at Day 1).
Danish: Plasmakoncentrationer ved steady-state opnås på dag 6 ved en dosis på 300 mg (en gang dagligt efter en initialdosis på to gange dagligt på dag 1).
English: b: In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316
Danish: b: I 1899 var det perioden fra randomisering til sidste dosis studiemedicin plus 7dage; i 316 var det perioden fra førstedosis til sidste dosis studiemedicin plus 7dage.
English: FLU = fluconazole; ITZ = itraconazole; POS = posaconazole.
Danish: FLU = fluconazol; ITZ = itraconazol; POS = posaconazol.
English: haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Danish: Hæmolytisk uræmisk syndrom, thrombotisk trombocytopenisk purpura, pancytopeni, koagulopati
English: Methacrylic acid-Ethyl acrylate copolymer (1:1) Triethyl citrate (E1505)
Danish: Metacrylsyre-ethylacrylatcopolymer (1:1) Triethylcitrat (E1505) Xylitol (E967)
English: Adrenal suppressive effects were observed in toxicity studies in rats and dogs at exposures equal to or greater than those obtained at therapeutic doses in humans.
Danish: Binyrebarkhæmmendevirkning blev observeret i toksicitetsstudier med rotter og hunde ved eksponering svarende tilellerstørre end den eksponering, der opnås ved terapeutiske doser hos mennesker.
English: INFORMATION IN BRAILLE Posaconazole Accord 100 mg
Danish: INFORMATION I BRAILLESKRIFT Posaconazole Accord 100 mg
English: Based on pharmacokinetic data in 10 of these paediatric patients, the pharmacokinetic profile appears to be similar to patients ≥ 18 years of age.
Danish: 10af disse pædiatriske patienter synes den farmakokinetiske profil at være tilsvarende for patienter≥18
English: Do not breast-feed while taking Posaconazole Accord.
Danish: Undlad at amme, mens du tager Posaconazole Accord.
English: Monitoring of hepatic function
Danish: Monitorering af leverfunktion
English: Cellulose, microcrystalline (E460) Silica, colloidal anhydrous Croscarmellose sodium
Danish: Mikrokrystallinsk cellulose (E460) Silica, kolloid vandfri Croscarmellosenatrium Natriumstearylfumerat
English: Effects of other medicinal products on posaconazole
Danish: Andre lægemidlers virkning på posaconazol
English: Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Danish: Posaconazole Accord er også indiceret til forebyggelse af invasive svampeinfektioner hos følgende patienter: - Patienter, der får kemoterapi til remissionsinduktion for akut myeloid leukæmi (AML) ellermyelodysplastiske syndromer (MDS), der forventes at resultere i langvarig neutropeni og som har høj risiko for at udvikle invasive svampeinfektioner; - Modtagere af hematopoietisk stamcelletransplantation (HSCT), der gennemgårhøjdosisimmunsuppressivbehandlingfor graft versus host-sygdom og som har høj risiko for at udvikleinvasivesvampeinfektioner.
English: The ECOFF values for posaconazole, which distinguish the wild type population from isolates with acquired resistance, have been determined by EUCAST methodology.
Danish: Epidemiologiske cut-off (ECOFF)-værdier for Aspergillus-arter ECOFF-værdierne for posaconazol, som adskiller vildtype-populationen fra isolater med erhvervetresistens, er blevet bestemt vha. EUCAST (European Committee on Antimicrobial SusceptibilityTesting)-metoden.
English: The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Danish: Resistens Kliniskeisolatermednedsatfølsomhedforposaconazolerset.Hovedvirkningsmekanismenvedresistensudvikl ing er substitutioner i target-proteinet CYP51.
English: Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (3.4 times the 300 mg tablet based on steady-state plasma concentrations in patients) or female rats at a dose up to 45 mg/kg (2.6 times the 300 mg tablet based on steady-state plasma concentrations in patients).
Danish: Posaconazolhavdeingenindvirkning på hanrotters fertilitet ved doser på op til 180 mg/kg(3,4gange300 mg tabletten baseret på plasmakoncentrationer ved steady-state hos patienter) eller hunrotter ved en dosis på op til 45 mg/kg(2,6gange 300 mg tabletten baseret på plasmakoncentrationer vedsteady-state hos patienter).
English: It is, therefore, suggested to closely monitor for breakthrough fungal infections in patients weighing more than 120 kg.
Danish: Det foreslås derfor at følge patienter, som vejer mere end 120 kg, nøje for tilbagevendende svampeinfektioner.
English: - if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin
Danish: • hvis du tager terfenadin, astemizol, cisaprid, pimozid, halofantrin, quinidin, et hvilket som helstlægemiddel, som indeholder “sekalealkaloider” (anvendes til behandling af migræne) såsom ergotamin eller dihydroergotamin, eller et “statin” (kolesterolsænkende lægemiddel) såsom simvastatin, atorvastatin eller lovastatin.
English: There is insufficient data among different races with posaconazole tablets.
Danish: Race Der foreligger ikke tilstrækkelige data blandt forskellige racer med posaconazol tabletter.