FrancophonIA/ELRC3.0 huggingface dataset:
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: Therefore posaconazole is not recommended for use in patients below 18 years of age (see sections 5.1 and 5.2).
Danish: Derfor kan posaconazol ikke anbefales til patienter under 18 år (se pkt.
English: Contact your doctor immediately if you become pregnant while being treated with Posaconazole SP.
Danish: Kontakt straks Deres læge, hvis De bliver gravid under behandling med Posaconazole SP.
English: In patients who cannot tolerate a meal or a nutritional supplement, Posaconazole SP should be administered at a dose of 200 mg (5 ml) four times a day.
Danish: For patienter, som ikke kan tåle et måltid eller ernæringstilskud, bør Posaconazole SP gives i doser á 200 mg (5 ml) fire gange dagligt.
English: The other ingredients in the suspension are polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), artificial cherry flavour containing benzyl alcohol and propylene glycol, and purified water.
Danish: Øvrige indholdsstoffer i suspensionen: polysorbat 80, simeticon, natriumbenzoat (E211), natriumcitratdihydrat, citronsyremonohydrat, glycerol, xanthangummi, flydende glucose, titandioxid (E171), kunstig kirsebæraroma med benzylalkohol og propylenglycol, og renset vand.
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 events, plasma concentrations of the CYP3A4 substrate and/or adverse events should be closely monitored and the dose adjusted as needed.
Danish: Hvis posaconazol anvendes sammen med CYP3A4 substrater, som indgives 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: Neuronal phospholipidosis occurred in dogs dosed for ≥ 3 months at lower systemic exposures than those obtained at therapeutic doses in humans.
Danish: Neuronal phospholipidose forekom hos hunde behandlet i ≥ 3 måneder ved lavere systemisk eksponering end den, der opnås ved terapeutiske doser hos mennesker.
English: Weakness, tiredness
Danish: Slaphed, træthed
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 neurotoksicitetsundersøgelser hos hunde og aber blev der ikke fundet påvirkning af det centrale eller perifere nervesystem ved systemisk eksponering større end den, der opnås terapeutisk.
English: Sudden behaviour changes, problems with thinking or speech Pain, weakness, numbness, or tingling in the arm or leg Depression
Danish: Pludselige ændringer i adfærd, problemer med at tænke og tale Smerte, slaphed, følelsesløshed eller snurren i armen eller benet Depression
English: Use in hepatic impairment: There are limited pharmacokinetic data in patients with hepatic impairment; therefore, no recommendation for dose adjustment can be made.
Danish: Brug hos patienter med nedsat leverfunktion: Der findes kun begrænsede farmakokinetiske data om patienter med nedsat leverfunktion, hvorfor det ikke er muligt at give anbefaling om dosisjustering.
English: Co-administration may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes (see section 4.3).
Danish: Samtidig administration kan resultere i stigning af disse lægemidlers plasmakoncentrationer, som kan medføre QTc-forlængelse og sjældne forekomster af torsades de pointes (se pkt.
English: Rifabutin: Posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Danish: Rifabutin: Posaconazol øgede Cmax og AUC af rifabutin med henholdsvis 31 % og 72 %.
English: Posaconazole can increase the blood levels of these medicines, which can lead to very serious disturbances in heart rhythm:
Danish: Posaconazol kan øge koncentrationen af disse lægemidler i blodet, hvilket kan føre til meget alvorlige forstyrrelser i hjerterytmen:
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 anvendt til at nedsætte mavesyre såsom cimetidin og ranitidin eller omeprazol og lignende lægemidler, kaldet protonpumpe hæmmere.
English: Posaconazole SP is also indicated for prophylaxis of invasive fungal infections in the following patients:
Danish: Posaconazole SP er også indiceret til forebyggelse af invasive svampeinfektioner hos følgende patienter:
English: Sulfonylureas: Glucose concentrations decreased in some healthy volunteers when glipizide was coadministered with posaconazole.
Danish: Sulfonylureas: Glucosekoncentrationerne faldt hos nogle raske forsøgspersoner, da glipizid administreredes samtidig med posaconazol.
English: Low numbers of all blood cells, blood clotting disorder, bleeding Severe allergic reactions, including widespread blistering rash and skin peeling Poor functioning of the adrenal gland
Danish: Lavt antal af alle blodlegemer, blodstørkningsforstyrrelser, blødning Alvorlige allergiske reaktioner, inklusive udbredt blæredannende udslæt og afskallende hud Nedsat funktion af binyrerne
English: In addition, oral posaconazole (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 810 hours during co-administration.
Danish: Oralt posaconazol (200 mg eller 400 mg) forlængede ydermere middelterminalhalveringstiden af midazolam fra omkring 3-4 timer til 8-10 timer under samtidig indtagelse.
English: No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at systemic exposures 4.6-fold greater than the exposures obtained at therapeutic doses in humans.
Danish: Der blev ikke konstateret effekt på elektrokardiogram, inklusive QT og QTc intervaller, i en sikkerhedsfarmakologisk undersøgelse med gentagen dosering til aber ved 4,6 gange større systemisk eksponering end den, der opnås ved terapeutiske doser i mennesker.
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: Effekten af posaconazol på CYP3A4 substrater hos patienter kan være noget lavere end den observeret hos raske frivillige, og den forventes at være variabel mellem patienter som følge af den variable posaconazol eksponering i patienter.
English: menstrual disorder breast pain
Danish: menstruationsforstyrrelser brystsmerte
English: Hepatic toxicity: 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: Levertoksicitet: Der har været set hepatiske reaktioner (f.eks. milde til moderate forhøjelser af ALT, AST, alkalisk phosphatase og total bilirubin og/eller klinisk hepatitis) under behandling med posaconazol.
English: It should be noted that the relationship between sirolimus trough concentration and AUC is changed during co-administration with posaconazole.
Danish: Det bør bemærkes, at forholdet mellem dalkoncentrationen af sirolimus og AUC ændres ved samtidig indtagelse af posaconazol.
English: Nervous system disorders Common:
Danish: Sygdomme i nervesystemet Almindelig:
English: Following administration of 800 mg per day of posaconazole as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8 - 17 years of age (776 ng/ml) were similar to concentrations from 194 patients 18 - 64 years of age (817 ng/ml).
Danish: Efter indgift af 800 mg posaconazol dagligt fordelt på flere doser til behandling af invasive svampeinfektioner, svarede de gennemsnitlige dalplasmakoncentrationer fra 12 patienter i alderen 817 år (776 ng/ml) til koncentrationerne fra 194 patienter i alderen 18 - 64 år (817 ng/ml).
English: Tacrolimus: Posaconazole increased Cmax and AUC of tacrolimus (0.05 mg/kg body weight single dose) by 121 % and 358 %, respectively.
Danish: Tacrolimus: Posaconazol øgede Cmax og AUC af tacrolimus (0,05 mg/kg kropsvægt som enkeltdosis) med henholdsvis 121 % og 358 %.
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 1.4-fold greater than that achieved therapeutically.
Danish: Ekkokardiografi viste ingen tegn på hjerteinsufficiens i en sikkerhedsfarmakologisk undersøgelse med gentagen dosering til rotter ved en systemisk eksponering 1,4 gange større end den, der opnås terapeutisk.
English: • Ciclosporin (used in transplant surgery)
Danish: • Ciclosporin (anvendt i transplanteringskirurgi)
English: Initial treatment of Thrush On the first day of treatment take 200 mg (one 5 ml spoonful) once.
Danish: Initial behandling af trøske Tag på den første behandlingsdag 200 mg (en 5 ml teskefuld) en gang.
English: A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomization.
Danish: Et andet vigtigt endpoint var forekomsten af bevist/sandsynlig IFIs ved 100 dages post-randomisering.
English: Both doses of posaconazole increased Cmax and AUC of oral midazolam (2 mg single oral dose) by 2.2 and 4.5-fold, respectively.
Danish: Begge doser af posaconazol øgede Cmax og AUC af oralt midazolam (2 mg enkelt oral dosis) med henholdsvis 2,2 og 4,5 gange.
English: Oropharyngeal Candidiasis Loading dose of 200 mg (5 ml) once a day on the first day, then 100 mg (2.5 ml) once a day for 13 days.
Danish: Initialdosis á 200 mg (5 ml) en gang dagligt den første dag, herefter 100 mg (2,5 ml) en gang dagligt i 13 dage.
English: Co-administration of posaconazole with CYP3A4 substrates may result in large increases in exposure to CYP3A4 substrates as exemplified by the effects on tacrolimus, sirolimus, atazanavir and midazolam below.
Danish: Samtidig indtagelse af posaconazol med CYP3A4 substrater kan resultere i en stor stigning i eksponering af CYP3A4 substrater som eksemplificeret nedenfor ved effekten på tacrolimus, sirolimus, atazanavir og midazolam.
English: Effects of posaconazole on other medicinal products:
Danish: Virkning af posaconazol på andre lægemidler
English: Following single-dose administration, 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 indgift af enkeltdosis, sås ingen påvirkning af posaconazols farmakokinetik ved let og moderat nedsat nyrefunktion (n=18 Cl cr ≥ 20 ml/min/1,73 m2); dosisjustering er således ikke nødvendig.
English: Chromoblastomycosis/Mycetoma: 9 of 11 patients were successfully treated with posaconazole 800 mg/day in divided doses for a median of 268 days and up to 377 days.
Danish: Chromoblastomykose/Mycetoma: 9 ud af 11 patienter var tilfredsstillende behandlet med posaconazol 800 mg dagligt fordelt på flere doser i op til 377 dage med en median på 268 dage.
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-receptor antagonister 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: 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 indtagelse ikke kan undgås, anbefales det, at sirolimusdosis bør reduceres væsentligt ved initiering af posaconazol behandling, og at der bør ske meget hyppige målinger af dalkoncentrationer af sirolimus i helblod.
English: The primary efficacy endpoint was the incidence of proven/probable IFIs at 16 weeks post-randomization as determined by an independent, blinded external expert panel.
Danish: Det primære effekt endpoint var forekomsten af bevist/sandsynlig IFIs 16 uger efter randomisering bestemt af et uafhængigt, blindet eksternt ekspert panel.
English: Posaconazole SP should be administered with caution to patients with pro-arrhythmic conditions such as:
Danish: Posaconazole SP bør administreres med forsigtighed til patienter med proarytmiske tilstande såsom:
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 chinidin (CYP3A4 substrater): Samtidig administration af posaconazol og terfenadin, astemizol, cisaprid, pimozid, halofantrin eller chinidin er kontraindiceret.
English: Abnormal liver function tests
Danish: Unormale leverfunktionstests
English: Posaconazole can increase the blood levels of these medicines, which can lead to severe reductions in blood flow to some parts of the body and damage tissues.
Danish: Posaconazol kan øge koncentrationen af disse lægemidler i blodet, hvilket kan føre til alvorlig nedsættelse af blodgennemstrømningen i dele af kroppen og dermed ødelæggelse af vævet.
English: • An abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
Danish: • Påvisning af en unormal hjerterytme (ved EKG) i form af et såkaldt forlænget QTc interval.
English: Vinca alkaloids: Posaconazole may increase the plasma concentration of vinca alkaloids (e.g. vincristine and vinblastine), which may lead to neurotoxicity.
Danish: Vincaalkaloider: Posaconazol kan øge plasmakoncentrationen af vincaalkaloider (f.eks. vincristin og vinblastin), hvilket kan føre til neurotoksicitet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 25 October 2005
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: 1899d d
Danish: 316 d
English: : 11 of 24 patients who had proven or probable fusariosis were successfully treated with posaconazole 800 mg/day in divided doses for a median of 124 days and up to 212 days.
Danish: : 11 ud af 24 patienter med kendt eller sandsynlig fusariose var tilfredsstillende behandlet med posaconazol 800 mg dagligt fordelt på flere doser i op til 212 dage med en median på 124 dage.
English: acute renal failure, renal failure, blood creatinine increased renal tubular acidosis, interstitial nephritis
Danish: akut nyresvigt, nyresvigt, øget blod kreatinin renal tubulær acidose, interstitiel nephritis
English: • Rifabutin (used to treat certain infections)
Danish: • Rifabutin (anvendt til behandling af visse infektioner)
English: Investigations
Danish: Undersøgelse
English: hypertension, hypotension pulmonary embolism, deep vein thrombosis
Danish: hypertension, hypotension pulmonal embolisme, dyb venøs trombose
English: Uncommon: Rare:
Danish: Almindelig: Usædvanlig: Sjælden:
English: Breast pain
Danish: Brystsmerte
English: HMG-CoA reductase inhibitors metabolised through CYP3A4 (e.g. simvastatin, lovastatin, and atorvastatin): Posaconazole may substantially increase plasma levels of HMG-CoA reductase inhibitors that are metabolised by CYP3A4.
Danish: HMG-CoA reduktasehæmmere metaboliseres via CYP3A4 (f.eks. simvastatin, lovastatin og atorvastatin): Posaconazol kan øge plasmaniveauerne af HMG-CoA reduktasehæmmere, som metaboliseres af CYP3A4, betydeligt.
English: Ergot alkaloids: Posaconazole may increase the plasma concentration of ergot alkaloids (ergotamine and dihydroergotamine), which may lead to ergotism.
Danish: Sekalealkaloider: Posaconazol kan øge plasmakoncentrationer af sekalealkaloider (ergotamin og dihydroergotamin), som kan medføre ergotisme.
English: Posaconazole is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4 (see section 4.5).
Danish: Posaconazol er hæmmer af CYP3A4 og bør kun anvendes undersærlige omstændigheder ved behandling med andre lægemidler, som metaboliseres af CYP3A4 (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Posaconazole SP 40 mg/ml oral suspension posaconazole
Danish: LÆGEMIDLETS NAVN Posaconazole SP 40 mg/ml oral suspension posaconazol
English: Caution is advised during coadministration of posaconazole with CYP3A4 substrates administered intravenously and the dose of the CYP3A4 substrate may need to be reduced.
Danish: Forsigtighed bør udvises under samtidig administration af posaconazol og CYP3A4 substrater indgivet intravenøst, og der kan være behov for at dosen af CYP3A4 substratet reduceres.
English: Ciclosporin: In heart transplant patients on stable doses of ciclosporin, posaconazole 200 mg once daily increased ciclosporin concentrations requiring dose reductions.
Danish: Ciclosporin: Posaconazol 200 mg en gang dagligt øgede ciclosporinkoncentrationerne hos hjertetransplanterede patienter på stabil dosis af ciclosporin, hvilket medførte behov for dosisnedsættelser.
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 1 gang dagligt) nedsatte Cmax (maksimal plasmakoncentration) og AUC (arealet under plasmakoncentrationstidskurven) af posaconazol til henholdsvis 57 % og 51 %.
English: The effect of coadministration 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: Effekten af samtidig indtagelse af posaconazol på plasmaniveauer for CYP3A4 substrat kan også være variable hos den enkelte patient, medmindre posaconazol indgives på en strengt standardiseret måde sammen med føde på grund af den store effekt af føde på posaconazol eksponering (se pkt.
English: If you have kidney problems and are taking medicines that affect the kidney.
Danish: Hvis De har eller har haft problemer med nyrerne og tager medicin, som virker på nyrerne.
English: blurred vision diplopia, scotoma
Danish: sløret syn dobbeltsyn, scotoma
English: Posaconazole is excreted into the milk of lactating rats (see section 5.3).
Danish: Posaconazol udskilles i mælk fra diegivende rotter (se pkt.
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 ses ved andre antimykotiske azolderivater, menes effekten på reproduktionen at være en følge af den terapeutiske hæmning af steroidhormonsyntesen.
English: Effect of food on oral absorption in healthy volunteers The AUC of posaconazole is about 2.6 times greater when administered with a non-fat meal or nutritional supplement (14 grams fat) and 4 times greater when administered with a high-fat meal (~ 50 grams fat) relative to the fasted state.
Danish: Virkning af føde på oral absorption hos raske forsøgspersoner AUC for posaconazol er ca. 2,6 gange større ved indgift sammen med et ikke fedtrigt måltid eller sammen med ernæringstilskud (14 gram fedt) og 4 gange større ved indgift med et fedtrigt måltid (~ 50 gram fedt) i forhold til faste.
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 effekt endpoint var forekomsten af bevist/sandsynlig IFIs bestemt af et uafhængigt, blindet eksternt panel under ontreatment perioden.
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, chinidin, chlarithromycin, erythromycin og andre) eller induktorer (f.eks. rifampicin, rifabutin, visse antiepileptika og andre) af disse eliminationsveje kan således henholdsvis forhøje eller nedsætte posaconazolplasmakoncentrationer.
English: PHARMACEUTICAL FORM AND CONTENTS One bottle of 105 ml of oral suspension Measuring spoon
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 flaske med 105 ml oral suspension
English: Please return the bottle containing any left over suspension to your pharmacist.
Danish: Aflevér venligst flasken med medicinresten på apoteket.
English: • Midazolam, triazolam, alprazolam and some similar medicines called benzodiazepines (used as sedatives or muscle relaxants)
Danish: • Midazolam, triazolam, alprazolam og nogle lignende lægemidler kaldet benzodiazepiner
English: primidone.
Danish: Tηλ.
English: Posaconazole SP can be used to treat the following types of fungal infections in adults: Infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;
Danish: Posaconazole SP kan anvendes til behandling af følgende svampeinfektioner hos voksne: Infektioner fremkaldt af svampe af Aspergillus arten, hvis infektionen ikke er behandlet tilstrækkelig med et af anti-svampemidlerne amphotericin B eller itraconazol eller hvis De har måtte stoppe behandlingen med disse midler;
English: Breast-feeding must be stopped on initiation of treatment with posaconazole.
Danish: Amning skal ophøre ved initiering af behandling med posaconazol.
English: After administration of 14C-posaconazole, radioactivity was predominantly recovered in the faeces (77 % of the radiolabelled dose) with the major component being parent compound (66 % of the radiolabelled dose).
Danish: C-posaconazol, genfandtes radioaktiviteten hovedsagelig i fæces (77 % af den radioaktivt mærkede dosis) heraf hovedparten som uforandret lægemiddel (66 % af den radioaktivt mærkede dosis).
English: • Digoxin (used to treat heart failure)
Danish: • Digoxin (anvendt til behandling af hjertesvigt)
English: What Posaconazole SP contains
Danish: Posaconazole SP indeholder
English: Safety and efficacy in paediatric patients below the age of 18 years have not been established.
Danish: Sikkerhed og effekt ved behandling af børn under 18 år er endnu ukendt.
English: Posaconazole should be used with caution in patients with severe hepatic impairment.
Danish: Posaconazol bør anvendes med forsigtighed hos patienter med svært nedsat leverfunktion.
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: Samtidig administration af posaconazol og rifabutin bør undgås, medmindre fordelen for patienten opvejer risikoen (se også ovenfor vedrørende virkningen af rifabutin på posaconazolplasmaniveauer).