FrancophonIA/ELRC3.0 huggingface dataset:
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: Binyrebarkhæmmende virkning blev observeret i toksicitetsstudier med rotter og hunde ved eksponering svarende til eller større end den eksponering, der opnås ved terapeutiske doser hos mennesker.
English: Look at the list of medicines given above that must not be taken while you are taking Noxafil.
Danish: Se de ovenfor nævnte typer medicin, som ikke må anvendes, mens du tager Noxafil.
English: Multiple doses of posaconazole administered via a peripheral venous catheter were associated with thrombophlebitis (60 % incidence).
Danish: Flere doser af posaconazol, som blev administreret via et perifert venekateter, blev associeret med tromboflebitis (forekomst på 60 %).
English: This medicinal product contains 462 mg (20 mmol) sodium per dose.
Danish: Dette lægemiddel indeholder 462 mg (20 mmol) natrium pr. dosis.
English: Dose and duration of therapy (See section 5.2)
Danish: Dosis og varighed af behandling (Se pkt.
English: Thromboembolic events have been identified as a potential risk for posaconazole intravenous concentrate for solution for infusion but were not observed in the clinical studies.
Danish: Tromboemboliske hændelser er blevet identificeret som en potentiel risiko ved posaconazol intravenøs koncentrat til infusionsvæske, men er ikke set i kliniske studier.
English: • efavirenz and fosamprenavir used to treat HIV infection.
Danish: • efavirenz og fosamprenavir, der anvendes til behandling af hiv-infektion.
English: allergic reaction
Danish: allergisk reaktion
English: The length of treatment may depend on the type of infection that you have or the length of time your immune system is not working properly and may be individually adapted for you by your doctor.
Danish: Varigheden af behandlingen kan afhænge af, hvilken type infektion du har, eller af hvor længe dit immunsystem ikke har fungeret korrekt, og din læge kan tilpasse behandlingen personligt til dig.
English: The following medicines may decrease the effectiveness of Noxafil by decreasing the amount of Noxafil in the blood:
Danish: Følgende lægemidler kan nedsætte virkningen af Noxafil ved at nedsætte mængden af Noxafil i blodet:
English: Amikacin sulfate Caspofungin
Danish: Amikacinsulfat Caspofungin
English: Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1
Danish: Refraktære invasive svampeinfektioner (IFI)/patienter med IFI som er intolerante over for førstevalgsbehandling
English: liver function tests raised (ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, GGT increased)
Danish: forhøjede leverfunktionstest (forhøjet ALAT, forhøjet ASAT, forhøjet bilirubin, forhøjet alkalisk fosfatase, forhøjet GGT)
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: Baseret på farmakokinetiske data fra 10 af disse pædiatriske patienter synes den farmakokinetiske profil at være tilsvarende for patienter ≥ 18 år.
English: Cav Range (ng/mL)
Danish: Cav-område (ng/ml)
English: The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/itraconazole.
Danish: Den gennemsnitlige behandlingsvarighed var 29 dage for posaconazol og 25 dage for fluconazol/itraconazol.
English: • blurred vision, sensitivity to light
Danish: • sløret syn, lysfølsomhed
English: • rifabutin and rifampicin (used to treat certain infections).
Danish: • rifabutin og rifampicin (anvendes til behandling af visse infektioner).
English: The table below shows the recommended dose and length of treatment which depend on the type of infection that you have and may be individually adapted for you by your doctor.
Danish: Tabellen nedenfor viser den anbefalede dosis og behandlingsvarighed, som afhænger af den type infektion, du har og kan blive justeret af din læge, så den passer til dig.
English: • nerve damage (neuropathy)
Danish: • nerveskader (neuropati)
English: Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Danish: Behandlingens varighed afhænger af sværhedsgraden af den grundliggende sygdom, bedring efter immunsuppression og klinisk respons.
English: Subjects achieved a mean predicted Cav at steady state of 1,970 ng/mL.
Danish: Forsøgspersonerne opnåede en gennemsnitlig formodet Cav ved steady-state på 1.970 ng/ml.
English: If it is considered that co-administration is unavoidable, then it is recommended that the dose of sirolimus should be greatly reduced at the time of initiation of posaconazole therapy and that there should be very frequent monitoring of trough concentrations of sirolimus in whole blood.
Danish: Såfremt det vurderes, at samtidig administration ikke kan undgås, anbefales det, at dosis af sirolimus reduceres væsentligt ved initiering af behandling med posaconazol, og at der bør ske meget hyppige målinger af dalkoncentrationer af sirolimus i fuldblod.
English: Noxafil gastro-resistant tablets are packaged in a blister in cartons of 24 (2x12) or 96 (8x12) tablets.
Danish: Noxafil gastroresistente tabletter er pakket i blisterkort i kartoner med 24 (2x12) eller 96 (8x12) tabletter.
English: It should be noted that the relationship between sirolimus trough concentration and AUC is changed during coadministration with posaconazole.
Danish: Det bør bemærkes, at forholdet mellem dalkoncentrationen af sirolimus og AUC ændres ved samtidig administration af posaconazol.
English: However, the safety profile of posaconazole between the Black and Caucasian subjects was similar.
Danish: Sikkerhedsprofilen for posaconazol var imidlertid den samme hos negroide og kaukasiske personer.
English: • cisapride (used to treat stomach problems)
Danish: • cisaprid (anvendes til behandling af maveproblemer)
English: • pseudoaldosteronism, which results in high blood pressure with a low potassium level (shown in blood test)
Danish: • pseudoaldosteronisme som medfører højt blodtryk med et lavt indhold af kalium i blodet (ses i blodprøve)
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: Hvis disse lægemidler administreres samtidigt, anbefales omhyggelig monitorering af fuldstændig blodtælling og bivirkninger relateret til forhøjede niveauer af rifabutin (f.eks. uveitis).
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: I kliniske studier havde patienter, som fik posaconazol oral suspension i doser op til 1.600 mg/dag, ikke oplevet andre bivirkninger end dem, der blev observeret hos patienter på lavere doser.
English: Renal clearance is a minor elimination pathway, with 14 % of the radiolabelled dose excreted in urine (< 0.2 % of the radiolabelled dose is parent compound).
Danish: Den renale udskillelse er begrænset med 14 % af den radioaktivt mærkede dosis udskilt i urinen (< 0,2 % af den radioaktivt mærkede dosis er uforandret lægemiddel).
English: Cohort 0 was designed to evaluate the tolerability of a single dose of posaconazole concentrate for solution for infusion when administered via a central line.
Danish: Kohorte 0 blev designet til at vurdere tolerabiliteten af en enkelt dosis posaconazol koncentrat til infusionsvæske, opløsning ved administration via et centralt venekateter.
English: In subjects with severe renal impairment (n=6, Cl cr < 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [> 96 % CV (coefficient of variance)] compared to other renal groups [< 40 % CV].
Danish: Hos patienter med svært nedsat nyrefunktion (n=6, Cl cr < 20 ml/min/1,73 m2) var AUC for posaconazol meget variabel [> 96 % CV (varianskoefficient)] sammenlignet med andre grupper med nyrelidelse [< 40 % CV].
English: Do not adapt your dose yourself before consulting your doctor or change your treatment regimen.
Danish: Du må ikke selv tilpasse din dosis eller ændre din behandling, før du har talt med din læge.
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 ved steady-state *20 patienter fik 200 mg en gang dagligt (på dag 1 200 mg to gange dagligt)
English: §, electrocardiogram abnormal palpitations, bradycardia, supraventricular extrasystoles, tachycardia
Danish: §, unormalt elektrokardiogram palpitationer, bradykardi, supraventrikulære ekstrasystoler, takykardi
English: Pharmacokinetic / Pharmacodynamic relationships A correlation between total medicinal product exposure divided by MIC (AUC/MIC) and clinical outcome was observed.
Danish: Der blev observeret en sammenhæng mellem den samlede lægemiddeleksponering divideret med MIC (AUC/MIC) og det kliniske resultat.
English: • medicines used to decrease stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines that are called proton pump inhibitors.
Danish: • lægemidler, der anvendes til at nedsætte mavesyre, herunder cimetidin og ranitidin eller omeprazol og lignende lægemidler, kaldet protonpumpehæmmere.
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 sammen med CYP3A4-substrater, som administreres oralt, og for hvilke en stigning i plasmakoncentrationerne kan være forbundet med uacceptable bivirkninger, bør plasmakoncentrationerne af CYP3A4-substrat og/eller bivirkninger følges nøje, og dosis justeres efter behov.
English: abnormal dreams, confusional state, sleep disorder psychotic disorder, depression
Danish: unormale drømme, konfus tilstand, søvnforstyrrelser psykotiske tilstande, depression
English: If a central venous catheter was not readily available, patients could receive a single infusion over 30 minutes via a peripheral venous catheter.
Danish: Hvis et centralt venekateter ikke var muligt, kunne patienterne få en enkelt infusion over 30 minutter via et perifert venekateter.
English: Epidemiological Cut-off (ECOFF) values for Aspergillus spp.
Danish: Epidemiologiske cut-off (ECOFF) -værdier for Aspergillus-arter.
English: Posaconazole should be used with caution in patients with hepatic impairment due to limited clinical experience and the possibility that posaconazole plasma levels may be higher in these patients (see sections 4.2 and 5.2).
Danish: Posaconazol bør anvendes med forsigtighed hos patienter med nedsat leverfunktion grundet begrænset klinisk erfaring og muligheden for, at posaconazols plasmaniveau kan være højere hos disse patienter (se pkt.
English: • quinidine (used to treat abnormal heart rhythms).
Danish: • quinidin (anvendes til behandling af unormal hjerterytme).
English: Posaconazole is slowly eliminated with a mean half-life (t½) of 35 hours (range 20 to 66 hours).
Danish: Posaconazol udskilles langsomt med en gennemsnitlig halveringstid (t½) på 35 timer (20 - 66 timer).
English: • heartburn (a burning sensation in the chest rising up to the throat)
Danish: • halsbrand (svidende eller brændende fornemmelse bag brystbenet, som stråler op mod halsen)
English: Race There is insufficient data among different races with posaconazole tablets.
Danish: Race Der foreligger ikke tilstrækkelige data blandt forskellige racer med posaconazol tabletter.
English: Safety data at higher exposure levels achieved with posaconazole tablets are at present limited.
Danish: Sikkerhedsdata ved højere eksponeringsniveauer med posaconazol tabletter er på nuværende tidspunkt begrænset.
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, der blev opnået terapeutisk.
English: Uncommon: the following may affect up to 1 in 100 people
Danish: Ikke almindelige: følgende tilstande kan berøre op til 1 ud af 100 personer
English: Clinical isolates with decreased susceptibility to posaconazole have been identified.
Danish: Kliniske isolater med nedsat følsomhed for posaconazol er set.
English: If concomitant administration is required, close monitoring for breakthrough fungal infections is recommended.
Danish: Hvis samtidig administration er nødvendig, tilrådes nøje monitorering for tilbagevendende svampeinfektioner.
English: Posaconazole is slowly absorbed and slowly eliminated with a large apparent volume of distribution (1,774 litres) and is highly protein bound (> 98 %), predominantly to serum albumin.
Danish: Posaconazol absorberes langsomt og elimineres langsomt med et stort tilsyneladende fordelingsvolumen (1.774 liter), og proteinbindingen, hovedsagelig til serum albumin, er høj
English: Effects of other medicinal products on posaconazole Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for p-glycoprotein (P-gp) efflux in vitro.
Danish: Posaconazol metaboliseres via UDP-glukuronidering (fase 2 enzymer) og er et substrat for pglykoprotein (P-gp) efflux in vitro.
English: Noxafil contains glucose
Danish: Noxafil indeholder glucose
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 C klassificering af kronisk leversygdom) på farmakokinetikken for posaconazol viser en stigning i eksponeringen i plasma sammenlignet med forsøgspersoner med normal leverfunktion, men tyder ikke på, at dosisjustering er nødvendig (se pkt.
English: • pimozide (used to treat symptoms of Tourette's and mental illness)
Danish: • pimozid (anvendes til behandling af symptomer ved Tourettes syndrom og psykiske sygdomme)
English: Artificial cherry flavour containing benzyl alcohol and propylene glycol Purified water
Danish: Kunstig kirsebæraroma indeholdende benzylalkohol og propylenglycol Renset vand
English: There are currently insufficient data to set clinical breakpoints for Aspergillus spp.
Danish: Der er for tiden utilstrækkelige data til at fastsætte kliniske grænseværdier for Aspergillus-arter.
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 eksponering end den eksponering, der opnås ved terapeutiske doser hos mennesker.
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 posaconazole.
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 posaconazol.
English: • large purple discolourations on the skin (thrombotic thrombocytopenic purpura)
Danish: • store blålige misfarvninger af huden (trombotisk trombocytopenisk purpura)
English: Therefore, in subsequent studies posaconazole was administered via central venous catheter.
Danish: Derfor blev posaconazol administreret via et centralt venekateter i efterfølgende studier.
English: Posaconazole, after administration of the tablet, has a mean apparent volume of distribution of 394 L (42 %), ranging between 294-583 L among the studies in healthy volunteers.
Danish: Efter administration af tabletten har posaconazol en gennemsnitlig tilsyneladende fordelingsvolumen på 394 l (42 %) i intervallet 294-583 l blandt studierne med raske forsøgspersoner.
English: When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes.
Danish: Ved administration via et perifert venekateter skal infusionen administreres over ca. 30 minutter.
English: The most frequently reported adverse reaction (>25 %) with an onset during the posaconazole intravenous phase of dosing with 300 mg once daily was diarrhoea (32 %).
Danish: Den hyppigst rapporterede bivirkning (>25 %) med start under den intravenøse fase af doseringen med posaconazol 300 mg en gang dagligt var diarré (32 %).
English: The effect of posaconazole on fosamprenavir levels when fosamprenavir is given with ritonavir is unknown.
Danish: Posaconazols virkning på fosamprenavir-niveauet, når fosamprenavir gives sammen med ritonavir, er ikke kendt.
English: • having problems thinking or talking, having jerking movements, especially in your hands that you cannot control
Danish: • problemer med at tænke eller tale, ufrivillige spjæt af især hænderne
English: • Do not use this medicine after the expiry date which is stated on the blister after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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 til forebyggelse af invasive svampeinfektioner (studie 316 og 1899).
English: • “pancytopenia” low level of all blood cells (red and white blood cells and platelets) shown in blood tests
Danish: • “pancytopeni” et lavt niveau af alle blodlegemer (røde og hvide blodlegemer samt blodplader)
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) for intravenøst midazolam (0,05 mg/kg) med 83 %.
English: The primary efficacy endpoint was the incidence of proven/probable IFIs at 16 weeks post-randomisation as determined by an independent, blinded external expert panel.
Danish: Det primære virkningsendepunkt var forekomst af verificeret/sandsynlig IFI 16 uger efter randomisering bestemt af et uafhængigt, blindet eksternt ekspertpanel.
English: No dose adjustment is recommended for patients with mild to severe hepatic impairment but caution is advised due to the potential for higher plasma exposure.
Danish: Dosisjustering anbefales ikke hos patienter med let til svær nedsat leverfunktion, men der bør udvises forsigtighed på grund af potentialet for højere plasmaeksponering.
English: The most frequently reported serious related adverse reactions included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.
Danish: De hyppigst rapporterede alvorlige bivirkninger er kvalme, opkastning, diarré, pyreksi og øget bilirubinniveau.
English: The duration of therapy is based on recovery from neutropenia or immunosuppression.
Danish: Behandlingens varighed afhænger af bedring efter neutropeni eller immunsuppression.
English: Co-administration of posaconazole with H2 receptor antagonists should be avoided if possible.
Danish: Samtidig administration af posaconazol og H2-receptorantagonister bør om muligt undgås.
English: During post-marketing surveillance of posaconazole oral suspension, severe hepatic injury with fatal outcome has been reported (see section 4.4).
Danish: Efter markedsføring af posaconazol oral suspension er der set alvorlige hepatiske skader med letalt udfald (se pkt.
English: The primary efficacy endpoint was the incidence of proven/probable IFIs as determined by an independent, blinded external expert panel during the on-treatment period.
Danish: Det primære virkningsendepunkt var forekomst af verificeret/sandsynlig IFI bestemt af et uafhængigt, blindet eksternt ekspertpanel i on-treatment perioden.
English: Noxafil may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Danish: Noxafil kan muligvis øge risikoen for bivirkninger af nogle andre lægemidler ved at forhøje mængden af disse lægemidler i blodet.
English: The safety of posaconazole oral suspension has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Danish: Sikkerheden af posaconazol oral suspension er vurderet hos > 2.400 patienter og frivillige raske forsøgspersoner i kliniske studier og på baggrund af erfaring efter markedsføring.
English: • halofantrine (used to treat malaria)
Danish: • halofantrin (anvendes til behandling af malaria)
English: Patients who have severe diarrhoea or vomiting should be monitored closely for breakthrough fungal infections.
Danish: Patienter, der har alvorlig diarré eller kaster op, bør følges nøje for tilbagevendende svampeinfektioner.
English: Patients, in particular those receiving posaconazole after HSCT, who have a low body weight (< 60 kg) are more likely to experience higher plasma concentrations of posaconazole and should be closely monitored for adverse events.
Danish: Især patienter, der får posaconazol efter HSCT og som har en lav kropsvægt (< 60 kg), har større sandsynlighed for at opleve højere plasmakoncentration af posaconazol og bør monitoreres nøje for bivirkninger.
English: • severe kidney problems - signs include passing more or less urine that is a different colour than usual
Danish: • alvorlige nyreproblemer - tegn på dette kan være øget eller nedsat urinmængde, som har en anden farve end normalt
English: • a change in the salt level in your blood shown in blood tests - signs include feeling confused or weak
Danish: • en ændring i saltniveauet i dit blod (fremgår af dine blodprøver) - tegn på dette kan være en følelse af forvirring eller svaghed
English: • some medicines used to treat or prevent fits including: phenytoin, carbamazepine, phenobarbital or primidone.
Danish: • nogle lægemidler, der anvendes til at behandle eller forebygge krampeanfald, herunder phenytoin, carbamazepin, phenobarbital eller primidon.
English: Posaconazole increased Cmax and AUC of tacrolimus (0.05 mg/kg body weight single dose) by 121 % and 358 %, respectively.
Danish: Posaconazol øgede Cmax og AUC for tacrolimus (0,05 mg/kg kropsvægt som enkeltdosis) med henholdsvis 121 % og 358 %.
English: Noxafil 100 mg gastro-resistant tablets are packaged in a PVC/ polychlorotrifluoroethylene laminate blister with push-through aluminium lidding.
Danish: Noxafil 100 mg gastroresistente tabletter er pakket i et blisterkort af polyvinylchlorid (PVC)/polychlorotrifluoroethylen (PCTFE) med aluminiumsfolie, som tabletterne kan trykkes ud igennem.
English: • hearing problems
Danish: • høreproblemer.
English: The effect of co-administration with posaconazole on plasma levels of CYP3A4 substrates may also be variable within a patient, unless posaconazole is administered in a strictly standardised way with food, given the large food effect on posaconazole exposure (see section 5.2).
Danish: Virkningen af samtidig administration af posaconazol på plasmaniveauer for CYP3A4-substrat kan også variere hos den enkelte patient, medmindre posaconazol administreres på en strengt standardiseret måde sammen med føde på grund af den store virkning af føde på posaconazol-eksponering (se pkt.