FrancophonIA/ELRC3.0 huggingface dataset:
English: H2 receptor antagonists and proton pump inhibitors Posaconazole plasma concentrations (Cmax and AUC) were reduced by 39 % when posaconazole was administered with cimetidine (400 mg twice a day) due to reduced absorption possibly secondary to a decrease in gastric acid production.
Danish: H2-receptorantagonister og protonpumpehæmmere Posaconazolplasmakoncentrationer (Cmax og AUC) reduceredes med 39 %, da posaconazol blev administreret samtidig med cimetidin (400 mg 2 gange dagligt) på grund af reduceret absorption, som muligvis var sekundær til reduktion af mavesyreproduktionen.
English: Administration instructions for Noxafil concentrate for solution for infusion
Danish: Instruktioner vedrørende administration af Noxafil koncentrat til infusionsvæske, opløsning
English: Stevens Johnson syndrome, vesicular rash
Danish: Stevens Johnsons-syndrom, vesikulært udslæt
English: Posaconazole is excreted into the milk of lactating rats (see section 5.3).
Danish: Posaconazol udskilles i mælken hos diegivende rotter (se pkt.
English: HMG-CoA reductase inhibitors metabolised through CYP3A4 (e.g. simvastatin, lovastatin, and atorvastatin)
Danish: HMG-CoA reduktasehæmmere metaboliseret via CYP3A4 (f.eks. simvastatin, lovastatin og atorvastatin)
English: Do not use Noxafil if any of the above apply to you.
Danish: Du må ikke bruge Noxafil, hvis noget af ovenstående gælder for dig.
English: A key secondary endpoint was the incidence of proven/probable IFIs during the on-treatment period (first dose to last dose of study medicinal product + 7 days).
Danish: Et centralt sekundært endepunkt var forekomsten af verificeret/sandsynlig IFI i on-treatment perioden (fra første til sidste dosis studiemedicin + 7 dage).
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 eller seponering af behandling med posaconazol.
English: Subjects who received 300 mg once daily achieved a mean Cav at steady state of 1500 ng/mL.
Danish: Forsøgspersoner, som fik 300 mg en gang dagligt, opnåede en gennemsnitlig Cav ved steady-state på 1.500 ng/ml.
English: Do not take Noxafil if any of the above apply to you.
Danish: Du må ikke tage Noxafil, hvis noget af ovenstående gælder for dig.
English: Of the circulating metabolites, the majority are glucuronide conjugates of posaconazole with only minor amounts of oxidative (CYP450 mediated) metabolites observed.
Danish: Af de cirkulerende metabolitter er hovedparten glucuronidkonjugater af posaconazol, og kun mindre mængder af oxidative (CYP450 medierede) metabolitter er set.
English: Noxafil 40 mg/mL oral suspension posaconazole
Danish: Noxafil 40 mg/ml oral suspension posaconazol
English: Based on the pharmacokinetics and safety results of Cohorts 1 and 2, all subjects in Cohort 3 received 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter.
Danish: På basis af de farmakokinetiske resultater og sikkerhedsresultaterne fra kohorte 1 og 2 fik alle forsøgspersonerne i kohorte 3 300 mg to gange dagligt på dag 1, efterfulgt af 300 mg en gang dagligt.
English: • patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS)
Danish: • patienter, som har et svækket immunforsvar som følge af behandling med kemoterapi for ”akut myleoid leukæmi” (AML) eller ”myelodysplastisk syndrom” (MDS)
English: Following a single dose administration of 300 mg posaconazole tablets after a high fat meal to healthy volunteers, the AUC0-72 hours and Cmax were higher compared to administration under fasted condition (51 % and 16 % for AUC0-72 hours and Cmax respectively).
Danish: Efter administration af en enkeltdosis af 300 mg posaconazol tabletter efter et måltid med højt fedtindhold til raske forsøgspersoner var AUC0-72 timer og Cmax højere sammenlignet med administration under faste (henholdsvis 51 % og 16 % for AUC0-72 timer og Cmax).
English: Noxafil can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as:
Danish: Noxafil kan også anvendes til at forebygge svampeinfektioner hos voksne, som har en høj risiko for at få en svampeinfektion, f.eks.:
English: This serial pharmacokinetic analysis demonstrated that 94 % of the subjects treated with the 300 mg once daily dose attained steady state Cav between 500-2500 ng/mL [Cav was the average concentration of posaconazole at steady state, calculated as AUC/dosing interval (24 hours).].
Danish: Denne serielle farmakokinetiske analyse påviste, at 94 % af forsøgspersonerne, som blev behandlet med en dosis på 300 mg en gang dagligt opnåede Cav ved steady-state på mellem 500-2.500 ng/ml [Cav var den gennemsnitlige koncentration af posaconazol ved steady-state, beregnet som AUC/doseringsintervallet (24 timer)].
English: • “haemolytic uraemic syndrome” when red blood cells breakup (hemolysis) which may happen with or without kidney failure
Danish: • “hæmolytisk uræmisk syndrom”, når de røde blodlegemer nedbrydes (hæmolyse), hvilket kan forekomme med eller uden nyresvigt
English: Serial pharmacokinetic samples were collected on Day 1 and at steady-state on Day 14 for all Cohort 1 and 2 subjects and on Day 10 for a subset of Cohort 3 subjects.
Danish: Serielle farmakokinetiske prøver blev udtaget på dag 1 og ved steady-state på dag 14 for alle forsøgspersoner i kohorte 1 og 2 og på dag 10 for en delgruppe af forsøgspersonerne i kohorte 3.
English: In patients with moderate or severe renal impairment (creatinine clearance <50 mL/min), accumulation of the intravenous vehicle, Betadex Sulfobutyl Ether Sodium (SBECD), is expected to occur.
Danish: Hos patienter med moderat til svært nedsat nyrefunktion (creatinin-clearance <50 ml/min) kan det forventes, at der forekommer ophobning af det intravenøse vehikel, Sulfobutylether beta cyclodextrinnatrium (SBECD).
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02AC04.
Danish: Farmakoterapeutisk klassifikation: Antimykotika til systemisk anvendelse, triazolderivater, ATC-kode: J02AC04.
English: Noxafil concentrate for solution for infusion should not be used in children aged below 18 years because of pre-clinical safety concerns (see section 5.3).
Danish: Noxafil koncentrat til infusionsvæske, opløsning bør ikke anvendes til børn under 18 år på grund af prækliniske problemstillinger vedrørende sikkerhed (se pkt.
English: Eleven patients received a single dose of 200 mg posaconazole concentrate for solution for infusion, 21 patients received 200 mg daily dose for a median of 14 days, and 237 patients received 300 mg daily dose for a median of 9 days.
Danish: 11 patienter fik en enkelt dosis på 200 mg posaconazol koncentrat til infusionsvæske, opløsning, 21 patienter fik en daglig dosis på 200 mg med en medianvarighed på 14 dage og 237 patienter fik en daglig dosis på 300 mg med en medianvarighed på 9 dage.
English: The ECOFF values for posaconazole, which distinguish the wild type population from isolates with acquired resistance, have been determined by EUCAST methodology.
Danish: ECOFF-værdierne for posaconazol, som adskiller vildtype-populationen fra isolater med erhvervet resistens, er blevet bestemt vha. EUCAST (European Committee on Antimicrobial Susceptibility Testing)-metoden.
English: • nausea or vomit (feeling or being sick), diarrhoea
Danish: • kvalme eller opkastning (føler dig utilpas), diarré
English: Posaconazole has been shown in vitro to be active against the following microorganisms: Aspergillus species (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida species (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, and species of Fusarium, Rhizomucor, Mucor, and Rhizopus.
Danish: Det er blevet påvist in vitro, at posaconazol har virkning på følgende mikroorganismer: Aspergillusarter (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida-arter (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi og arter af Fusarium, Rhizomucor, Mucor og Rhizopus.
English: The mean duration of therapy was 80 days for posaconazole and 77 days for fluconazole.
Danish: Den gennemsnitlige behandlingsvarighed var 80 dage for posaconazol og 77 dage for fluconazol.
English: A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomisation.
Danish: Et centralt sekundært endepunkt var forekomst af verificeret/sandsynlig IFI 100 dage efter randomisering.
English: • menstrual problems (abnormal vaginal bleeding)
Danish: • menstruationsproblemer (unormal blødning fra skeden)
English: Noxafil 100 mg gastro-resistant tablets
Danish: Noxafil 100 mg gastroresistente tabletter
English: Caution is warranted on any sign or symptom of thromboembolic events (see sections 4.8 and 5.3).
Danish: Forsigtighed er påkrævet ved alle tegn eller symptomer på tromboemboliske hændelser (se pkt.
English: acute renal failure, renal failure, blood creatinine increased
Danish: akut nyresvigt, nyresvigt, forhøjet blod-kreatinin
English: Posaconazole therapy was given for a median duration of 28 days.
Danish: Behandling med posaconazol blev givet med en medianvarighed på 28 dage.
English: • have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
Danish: • har en unormal hjerterytme (ved ekg) i form af et såkaldt langt QTc-interval.
English: Noxafil concentrate for solution for infusion should be inspected visually for particulate matter prior to administration.
Danish: Noxafil koncentrat til infusionsvæske, opløsning skal inspiceres visuelt for partikler før administration.
English: There were fewer breakthrough Aspergillus infections in patients receiving posaconazole prophylaxis when compared to control patients.
Danish: Der var færre udbrud af Aspergillus-infektion hos patienter, der fik posaconazol forebyggende, sammenlignet med kontrolpatienter.
English: Posaconazole concentrate for solution for infusion safety In initial studies of healthy volunteers, administration of a single dose of posaconazole infused over 30 minutes via a peripheral venous catheter was associated with a 12 % incidence of infusion site reactions (4 % incidence of thrombophlebitis).
Danish: Sikkerheden af posaconazol koncentrat til infusionsvæske, opløsning I initiale studier med raske forsøgspersoner blev administration af en enkelt dosis posaconazol indgivet over 30 minutter via et perifert venekateter associeret med en forekomst af reaktioner på infusionsstedet på 12 % (forekomst af tromboflebitis på 4 %).
English: The effect of posaconazole on CYP3A4 substrates in patients might be somewhat lower than that observed in healthy volunteers, and is expected to be variable between patients due to the variable posaconazole exposure in patients.
Danish: Virkningen af posaconazol på CYP3A4-substrater hos patienter kan være noget lavere end den observeret hos raske frivillige, og den forventes at variere mellem patienter som følge af den varierende eksponering for posaconazol hos patienterne.
English: The safety of posaconazole concentrate for solution for infusion has been assessed in 268 patients in clinical trials.
Danish: Sikkerheden af posaconazol koncentrat til infusionsvæske, opløsning er vurderet hos 268 patienter i kliniske studier.
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: Posaconazol tabletter absorberes med en median Tmax på 4 til 5 timer og udviser dosisproportional farmakokinetik efter enkeltdosis og flergangsdosering på op til 300 mg.
English: In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with Noxafil.
Danish: I tillæg til den medicin, som er nævnt ovenfor, er der anden medicin, som indebærer en risiko for hjerterytmeproblemer, som kan være større, når de tages med Noxafil.
English: • rifabutin (used to treat certain infections)
Danish: • rifabutin (anvendes til behandling af visse infektioner)
English: In patients, mean maximum plasma concentrations (Cmax) after posaconazole concentrate for solution for infusion are 4-fold increased compared to administration of oral suspension.
Danish: Hos patienter stiger den gennemsnitlige maksimale plasmakoncentration (Cmax) efter administration af posaconazol koncentrat til infusionsvæske, opløsning 4 gange i forhold til efter administration af oral suspension.
English: Talk to your doctor, pharmacist or nurse before taking Noxafil if you:
Danish: Kontakt lægen, apotekspersonalet eller sygeplejersken, før du tager Noxafil, hvis du:
English: Liquid glucose
Danish: Flydende glucose
English: b: In 1899 this was the period from randomisation to last dose of study medicinal product plus 7 days; in 316 it was the period from first dose to last dose of study medicinal product plus 7 days.
Danish: b: I 1899 var det perioden fra randomisering til sidste dosis studiemedicin plus 7 dage; i 316 var det perioden fra første dosis til sidste dosis studiemedicin plus 7 dage.
English: Certain medicines may increase the risk of side effects of Noxafil by increasing the amount of Noxafil in the blood.
Danish: Visse lægemidler kan muligvis øge risikoen for bivirkninger af Noxafil ved at øge mængden af Noxafil i blodet.
English: The subject population for Cohorts 1 and 2 included subjects with AML or MDS who had recently received chemotherapy and had developed or were anticipated to develop significant neutropenia.
Danish: Populationen af forsøgspersoner i kohorte 1 og 2 omfattede forsøgspersoner med AML eller MDS, som fornyligt havde fået kemoterapi, og som havde udviklet eller forventedes at udvikle signifikant neutropeni.
English: Posaconazole may substantially increase plasma levels of HMG-CoA reductase inhibitors that are metabolised by CYP3A4.
Danish: Posaconazol kan øge plasmaniveauerne af HMG-CoA reduktasehæmmere, som metaboliseres af CYP3A4, betydeligt.
English: Therefore, inhibitors (e.g. verapamil, ciclosporin, quinidine, clarithromycin, erythromycin, etc.) or inducers (e.g. rifampicin, rifabutin, certain anticonvulsants, etc.) of these clearance pathways may increase or decrease posaconazole plasma concentrations, respectively.
Danish: Hæmmere (f.eks. verapamil, ciclosporin, quinidin, chlarithromycin, erythromycin osv.) eller induktorer (f.eks. rifampicin, rifabutin, visse antiepileptika osv.) af disse eliminationsveje kan således henholdsvis forhøje eller nedsætte plasmakoncentrationerne af posaconazol.
English: Study 5615 was conducted in a similar patient population to that previously studied in the pivotal posaconazole oral suspension clinical program.
Danish: Studie 5615 blev udført med en patientpopulation, der lignede den patientpopulation, som blev undersøgt i det pivotale kliniske program med posaconazol oral suspension.
English: The effect of posaconazole on sirolimus in patients is unknown, but is expected to be variable due to the variable posaconazole exposure in patients.
Danish: Indvirkningen af posaconazol på sirolimus hos patienter er ukendt, men forventes at være varierende som følge af den varierende eksponering for posaconazol hos patienter.
English: • any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraines.
Danish: • enhver type medicin som indeholder “sekalealkaloider” såsom ergotamin eller dihydroergotamin, der anvendes til behandling af migræne.
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 helst lægemiddel, som indeholder “sekalealkaloider” (anvendes til behandling af migræne) såsom ergotamin eller dihydroergotamin, eller et “statin” (kolesterolsænkende lægemiddel) såsom simvastatin, atorvastatin eller lovastatin.
English: Based on the available data in 16 of these paediatric patients, the safety profile appears to be similar to patients ≥ 18 years of age.
Danish: Baseret på foreliggende data fra 16 af disse pædiatriske patienter, synes sikkerhedsprofilen at være tilsvarende for patienter ≥ 18 år.
English: The tablet formulation was investigated in AML and MDS patients and those after HSCT with or at risk for Graft versus Host Disease (GvHD) only.
Danish: Tabletformuleringen er udelukkende blevet undersøgt hos patienter med AML og patienter med MDS samt hos patienter efter HSCT med eller uden risiko for graft versus host-sygdom (GVHD).
English: Do not use Noxafil
Danish: Brug ikke Noxafil
English: Similarly, administration of 400 mg posaconazole with esomeprazole (40 mg daily) decreased mean Cmax and AUC by 46 % and 32 %, respectively, compared to dosing with 400 mg posaconazole alone.
Danish: Ligeledes nedsatte administration af 400 mg posaconazol med esomeprazol (40 mg dagligt) middel Cmax og AUC med henholdsvis 46 % og 32 % sammenlignet med dosering med 400 mg posaconazol alene.
English: The most common adverse reaction (>1 %) leading to discontinuation of posaconazole concentrate for solution for infusion 300 mg once daily was AML (1 %).
Danish: Den mest almindelige bivirkning (>1 %), som førte til seponering af behandlingen med posaconazol koncentrat til infusionsvæske, opløsning 300 mg en gang dagligt, var AML (1 %).
English: Co-administration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes (see sections 4.4 and 4.5).
Danish: Samtidig administration med CYP3A4-substraterne terfenadin, astemizol, cisaprid, pimozid, halofantrin eller quinidin, da dette kan resultere i forhøjede plasmakoncentrationer af disse lægemidler med forlænget QTc og sjældne forekomster af torsades de pointes til følge (se pkt.
English: Twenty patients received 200 mg daily dose and 210 patients received 300 mg daily dose (following twice daily dosing on Day 1 in each cohort).
Danish: 20 patienter fik en daglig dosis på 200 mg, og 210 patienter fik en daglig dosis på 300 mg (efter dosering, to gange dagligt på dag 1 i hver kohorte).
English: Rifabutin (300 mg once a day) decreased the Cmax (maximum plasma concentration) and AUC (area under the plasma concentration time curve) of posaconazole to 57 % and 51 %, respectively.
Danish: Rifabutin (300 mg en gang dagligt) nedsatte Cmax (maksimal plasmakoncentration) og AUC (arealet under kurven for plasmakoncentration som funktion af tiden) for posaconazol til henholdsvis 57 % og 51 %.
English: Do not use Noxafil if you are pregnant unless you are told to by your doctor.
Danish: Brug ikke Noxafil under graviditet, medmindre det er foreskrevet af din læge.
English: Do not take Noxafil if you are pregnant unless you are told to by your doctor.
Danish: Tag ikke Noxafil under graviditet, medmindre det er foreskrevet af din læge.
English: If you are a woman who could become pregnant you should use effective contraception while you are using Noxafil.
Danish: Hvis du er en kvinde, som kan blive gravid, skal du anvende sikker prævention, mens du bruger Noxafil.
English: A switch to oral administration is recommended as soon as the patients' condition allows (see section 4.4).
Danish: Så snart patientens tilstand tillader det, anbefales det, at der skiftes til oral administration (se pkt.
English: • inability to sleep (insomnia)
Danish: • søvnproblemer (søvnmangel)
English: Noxafil must not be administered with medicinal products that are substrates for CYP3A4 and are known to prolong the QTc interval (see sections 4.3 and 4.5).
Danish: Noxafil må ikke administreres sammen med lægemidler, som er substrater for CYP3A4, og som er kendt for at forlænge QTcintervallet (se pkt.
English: After oral administration, posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Danish: Efter oral administration øgede posaconazol Cmax og AUC for rifabutin med henholdsvis 31 % og 72 %.
English: blurred vision, photophobia, visual acuity reduced
Danish: sløret syn, fotofobi, nedsat synsstyrke
English: As observed with other azole antifungal agents, these effects on reproduction were considered to be due to a treatment-related effect on steroidogenesis.
Danish: Som det er blevet set ved andre antimykotiske azolderivater, ansås indvirkningen på reproduktionen for at være en følge af den terapeutiske hæmning af steroidhormon-syntesen.
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 efter administration af posaconazol oral suspension.
English: mouth ulceration, alopecia, dermatitis, erythema, petechiae
Danish: mundsår, alopeci, dermatitis, erytem, petekkier
English: c: In 1899, this was the period from randomisation to 100 days post-randomisation; in 316 it was the period from the baseline day to 111 days post-baseline.
Danish: I 1899 var det perioden fra randomisering til 100 dage efter randomisering; i 316 var det perioden fra baseline-dagen til 111 dage efter baseline.
English: P-Value
Danish: P-Værdi
English: Posaconazole after administration of the tablets, is slowly eliminated with a mean half-life (t½) of 29 hours (range 26 to 31 hours) and a mean apparent clearance ranging from 7.5 to 11 L/hr.
Danish: Efter administration af tabletterne elimineres posaconazol langsomt med en gennemsnitlig halveringstid (t½) på 29 timer (26-31 timer) og en gennemsnitlig tilsyneladende udskillelse i intervallet 7,5 til 11 l/time.
English: Posaconazole may increase the plasma concentrations of vinca alkaloids which may lead to neurotoxicity and other serious adverse reactions.
Danish: Posaconazol kan øge plasmakoncentrationen af vinkaalkaloider, hvilket kan føre til neurotoksicitet og andre alvorlige bivirkninger.
English: • pimozide (used to treat symptoms of Tourette's disorder)
Danish: • pimozid (anvendes til behandling af symptomer ved Tourettes syndrom)
English: • diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure)
Danish: • diltiazem, verapamil, nifedipin, nisoldipin eller andre “calciumblokkere” (anvendes til behandling af højt blodtryk)
English: Do not breast-feed while using Noxafil.
Danish: Undlad at amme, mens du bruger Noxafil.
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 eller 400 mg) forlængede ydermere middelterminalhalveringstiden af midazolam fra omkring 3-4 timer til 8-10 timer under samtidig administration.
English: • astemizole (used to treat allergies)
Danish: • astemizol (anvendes til behandling af allergier)