FrancophonIA/ELRC3.0 huggingface dataset:
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: De mikrobiologiske data antyder, at posaconazol er aktiv mod Rhizomucor, Mucor og Rhizopus; de aktuelle kliniske data er imidlertid for begrænsede til at vurdere virkningen af posaconazol over for disse sygdomsfremkaldende arter.
English: 105 mL of oral suspension in a bottle (glass amber type IV) closed with a plastic child-resistant cap (polypropylene) and a measuring spoon (polystyrene) with 2 graduations: 2.5 mL and 5 mL.
Danish: 105 ml oral suspension i en flaske (brunt glas type IV) lukket med børnesikret plastlåg (polypropylen) samt en måleske (polystyren) med 2 inddelinger: 2,5 ml og 5 ml.
English: There was a slight decrease (16 %) in the AUC and Cmax of posaconazole oral suspension in Black subjects relative to Caucasian subjects.
Danish: Der var en svag reduktion (16 %) i AUC og Cmax for posaconazol oral suspension hos negroide i forhold til kaukasiske personer.
English: Posaconazole must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Danish: Posaconazol må ikke anvendes under graviditet, medmindre fordelen for moderen klart opvejer den potentielle risiko for fostret.
English: • severe allergic reactions, including widespread blistering rash and skin peeling
Danish: • alvorlige allergiske reaktioner, inklusive udbredt blæredannende udslæt og afskallende hud
English: adrenal insufficiency, blood gonadotropin decreased pseudoaldosteronism
Danish: adrenal insufficiens, nedsat blod gonadotropin pseudoaldosteronisme
English: At exposures lower than those obtained at therapeutic doses in humans, posaconazole caused skeletal variations and malformations, dystocia, increased length of gestation, reduced mean litter size and postnatal viability.
Danish: Ved lavere eksponering end den, der blev opnået ved terapeutiske doser hos mennesker, forårsagede posaconazol skeletforandringer og misdannelser, dystoki, forlænget drægtighedsperiode, reduceret gennemsnitlig kuldstørrelse og postnatal overlevelse.
English: In rabbits, posaconazole was embryotoxic at exposures greater than those obtained at therapeutic doses.
Danish: Hos kaniner var posaconazol embryotoksisk ved eksponering, der var større end den, der blev opnået med terapeutiske doser.
English: Schering-Plough Labo N.V., Industriepark 30, Zone A, BE-2220 Heist-op-den-Berg, Belgium
Danish: Schering-Plough Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgien
English: You may feel dizzy, sleepy, or have blurred vision while taking Noxafil, which may affect your ability to drive or use tools or machines.
Danish: Du kan føle dig svimmel, søvnig eller få sløret syn, mens du tager Noxafil, hvilket kan påvirke din evne til at køre bil, bruge værktøj eller betjene maskiner.
English: Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy.
Danish: Elektrolytforstyrrelser, især dem som er forbundet med kalium-, magnesium- eller calciumniveauer, bør monitoreres og korrigeres efter behov før og under behandling med posaconazol.
English: Posaconazole was not genotoxic in in vitro and in vivo studies.
Danish: Posaconazol var ikke genotoksisk i in vitro- og in vivo-studier.
English: Endocrine disorders Rare:
Danish: Det endokrine system Sjælden:
English: • abnormal dreams, or difficulty sleeping
Danish: • unormale drømme eller søvnbesvær
English: menstrual disorder
Danish: menstruationsforstyrrelser
English: As HIV protease inhibitors are CYP3A4 substrates, it is expected that posaconazole will increase plasma levels of these antiretroviral agents.
Danish: Da hiv-proteasehæmmere er CYP3A4-substrater forventes det, at posaconazol vil øge plasmaniveauer af disse antiretrovirale midler.
English: Noxafil is also available for oral administration (Noxafil 100 mg gastro-resistant tablets and 40 mg/mL oral suspension).
Danish: Noxafil fås også til oral administration (Noxafil 100 mg gastroresistente tabletter og 40 mg/ml oral suspension).
English: 2, rue Louis Pasteur F-14200 Hérouville St Clair France
Danish: 2, rue Louis Pasteur F-14200 Hérouville St Clair Frankrig
English: Contains also liquid glucose.
Danish: Indeholder også flydende glucose.
English: Treatment of azole-susceptible Oropharyngeal Candidiasis (OPC) A randomised, evaluator-blind, controlled study was completed in HIV-infected patients with azolesusceptible oropharyngeal candidiasis (most patients studied had C. albicans isolated at baseline).
Danish: Behandling af azol-følsom Oropharyngeal Candidiasis (OPC) Et randomiseret, evaluator-blindet, kontrolleret studie hos hiv-inficerede patienter med azol-følsom oropharyngeal candidiasis blev afsluttet (de fleste undersøgte patienter havde C. Albicans isoleret ved baseline).
English: Alternatively, patients who can tolerate food or a nutritional supplement may take 400 mg (10 mL) twice a day during or immediately following a meal or nutritional supplement.
Danish: Alternativt kan patienter, der tåler mad eller ernæringstilskud, tage 400 mg (10 ml) to gange dagligt sammen med eller umiddelbart efter et måltid eller et ernæringstilskud.
English: * Based on adverse reactions observed with the oral suspension, gastro-resistant tablets, and concentrate for solution for infusion.
Danish: * Baseret på bivirkninger, som blev observeret med den orale suspension, gastroresistente tabletter og koncentratet til infusionsvæske, opløsning.
English: • tacrolimus and sirolimus (used during or after transplant surgery)
Danish: • tacrolimus og sirolimus (anvendes under og efter transplantationskirurgi)
English: Peripheral infusion time longer than 30 minutes, leads to a higher incidence of infusion site reactions and thrombophlebitis.
Danish: Infusionstider i perifere venekatetre, der overstiger 30 minutter, fører til en højere forekomst af reaktioner på infusionsstedet og tromboflebitis.
English: Safety data in the elderly are limited.
Danish: Der er begrænsede sikkerhedsdata fra ældre patienter.
English: Note: In clinical trials, multiple peripheral infusions given through the same vein resulted in infusion site reactions (see section 4.8).
Danish: Bemærk: I kliniske studier resulterede flere perifere infusioner indgivet gennem den samme vene i reaktioner på infusionsstedet (se pkt.
English: No pharmacokinetic data are available from paediatric patients less than 8 years of age.
Danish: Der foreligger ingen farmakokinetiske data fra børn under 8 år.
English: In Study 1899, a significant decrease in all cause mortality in favour of posaconazole was observed [POS 49/304 (16 %) vs. FLU/ITZ 67/298 (22 %) p= 0.048].
Danish: I studie 1899 blev der observeret et signifikant fald i død af alle årsager (all cause mortality) til fordel for posaconazol [POS 49/304 (16 %) versus FLU/ITZ 67/298 (22 %) p=0,048].
English: Coadministration of posaconazole with sirolimus is not recommended and should be avoided whenever possible.
Danish: Samtidig administration af posaconazol og sirolimus anbefales ikke og bør undgås, når det er muligt.
English: • If a central venous catheter is not available, a single infusion may be administered through a peripheral venous catheter with a volume to achieve a dilution of approximately 2 mg/mL.
Danish: • Hvis der ikke er lagt et centralt venekateter, kan der administreres en enkelt infusion gennem et perifert venekateter med et volumen til at opnå en fortynding på cirka 2 mg/ml.
English: Study 5520 enrolled a total of 279 subjects, including 268 receiving at least one dose of posaconazole concentrate for solution for infusion.
Danish: I studie 5520 blev der inkluderet i alt 279 forsøgspersoner, herunder 268 forsøgspersoner, som fik mindst en dosis posaconazol koncentrat til infusionsvæske, opløsning.
English: • difficulty breathing
Danish: • svært ved at trække vejret
English: Cenexi HSC, 2, rue Louis Pasteur; 14200 Hérouville St Clair, France
Danish: Cenexi HSC, 2, rue Louis Pasteur; 14200 Hérouville St Clair, Frankrig
English: Rare: the following may affect up to 1 in 1,000 people
Danish: Sjældne: følgende tilstande kan berøre op til 1 ud af 1.000 personer
English: • ciclosporin (used during or after transplant surgery)
Danish: • ciclosporin (anvendes under og efter transplantationskirurgi)
English: • heart failure or heart attack which could lead to the heart stopping beating and death, heart rhythm problems, with sudden death
Danish: • hjertesvigt eller hjerteanfald, som kan medføre hjertestop og død og hjerterytmeproblemer med pludselig død
English: Caution should be used when prescribing Noxafil to patients with hypersensitivity to other azoles.
Danish: Der bør udvises forsigtighed, når Noxafil ordineres til patienter, som er overfølsomme over for andre azoler.
English: Pulmonary phospholipidosis resulting in dilatation and obstruction of the alveoli was observed in the 2-year study in rats.
Danish: Pulmonal fosfolipidose, der resulterede i dilatation og obstruktion af alveolerne, blev observeret i et 2 års studie med rotter.
English: Similarly, in the prophylaxis studies, the mean steady-state posaconazole average concentration (Cav) was comparable among ten adolescents (13-17 years of age) to Cav achieved in adults (≥ 18 years of age).
Danish: I forebyggelsesstudierne var middelværdien ved steady-state for den gennemsnitlige koncentration af posaconazol (Cav) blandt ti unge (13-17 år) ligeledes sammenlignelig med Cav opnået hos voksne (≥ 18 år).
English: The following medicinal products can be infused at the same time through the same intravenous line (or cannula) as Noxafil concentrate for solution for infusion:
Danish: Følgende lægemidler må indgives samtidig gennem den samme intravenøse slange (eller kanyle) som Noxafil koncentrat til infusionsvæske, opløsning:
English: A measuring spoon is provided with each bottle for measuring 2.5 and 5 mL doses of the oral suspension.
Danish: En måleske leveres med hver flaske til afmåling af 2,5 ml og 5 ml doser af den orale suspension.
English: If you forget to take Noxafil
Danish: Hvis du har glemt at tage Noxafil
English: Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with neurotoxicity and other serious adverse reactions, including seizures, peripheral neuropathy, syndrome of inappropriate antidiuretic hormone secretion, and paralytic ileus.
Danish: Samtidig administration af azol-antimykotika, inklusive posaconazol, og vincristin er blevet associeret med neurotoksicitet og andre alvorlige bivirkninger, inklusive krampeanfald, perifer neuropati, syndrom med uhensigtsmæssig sekretion af antidiuretisk hormon og paralytisk ileus.
English: Most of the cases of aspergillosis were considered to be refractory to prior therapy in both the posaconazole group (88 %) and in the external control group (79 %).
Danish: De fleste tilfælde af aspergillose blev vurderet som værende refraktære over for tidligere terapi både i posaconazolgruppen (88 %) og i den eksterne kontrolgruppe (79 %).
English: The external control group included 86 patients treated with available therapy (as above) mostly at the same time and at the same sites as the patients treated with posaconazole.
Danish: Den eksterne kontrolgruppe bestod af 86 patienter behandlet med tilgængelig terapi (som ovennævnt) på omtrent samme tidspunkt og på de samme afdelinger, som patienterne behandlet med posaconazol.
English: No data are available.
Danish: Der foreligger inden data.
English: Prevention of serious Fungal Infections
Danish: Forhindring af alvorlige svampeinfektioner
English: Therefore, trough concentrations that fall in the upper part of the usual therapeutic range should be targeted and careful attention should be paid to clinical signs and symptoms, laboratory parameters and tissue biopsies.
Danish: Dalkoncentrationer af sirolimus, der ligger i den øvre del af det sædvanlige terapeutiske indeks, bør derfor tilstræbes, og der bør rettes særlig opmærksomhed mod kliniske tegn og symptomer, laboratorieparametre og vævsbiopsier.
English: Common: the following may affect up to 1 in 10 people
Danish: Almindelige: følgende tilstande kan berøre op til 1 ud af 10 personer
English: The majority (377/600, [63 %]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/600, [32.5 %]) GVHD at study start.
Danish: Størstedelen (377/600, [63 %]) af de inkluderede patienter havde akut grad 2 eller 3 eller kronisk ekstensiv GVHD (195/600, [32,5 %]) ved studiestart.
English: In Study 316, overall mortality was similar (POS, 25 %; FLU, 28 %); however, the proportion of IFIrelated deaths was significantly lower in the POS group (4/301) compared with the FLU group (12/299; P= 0.0413).
Danish: I studie 316, var den overordnede dødelighed tilsvarende (POS, 25 %; FLU, 28 %); andelen af dødsfald med relation til IFI var derimod signifikant lavere i POS gruppen (4/301) sammenlignet med FLU gruppen (12/299; P=0,0413).
English: • have a very slow heartbeat
Danish: • har meget langsomme hjerteslag.
English: Patients were treated with posaconazole or fluconazole oral suspension (both posaconazole and fluconazole were given as follows: 100 mg twice a day for 1 day followed by 100 mg once a day for 13 days).
Danish: Patienterne blev behandlet med posaconazol eller fluconazol oral suspension (både posaconazol og fluconazol blev givet som følger: 100 mg to gange dagligt i 1 dag efterfulgt af 100 mg en gang dagligt i 13 dage).
English: pyrexia (fever), asthenia, fatigue
Danish: pyreksi (feber), asteni, træthed
English: Posaconazole is highly protein bound (> 98 %), predominantly to serum albumin.
Danish: Posaconazol har en høj proteinbinding (> 98 %) hovedsagelig til serumalbumin.
English: • a “statin” such as simvastatin, atorvastatin or lovastatin used to treat high cholesterol.
Danish: • et “statin” såsom simvastatin, atorvastatin eller lovastatin, der anvendes til behandling af forhøjet kolesterol.
English: Noxafil is a white, cherry flavoured, 105 mL oral suspension packaged in amber glass bottles.
Danish: Noxafil er en hvid, 105 ml oral suspension med kirsebæraroma, der er pakket i brune glasflasker.
English: This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as:
Danish: Dette lægemiddel kan også anvendes til at forebygge svampeinfektioner hos voksne, som har en høj risiko for at få en svampeinfektion, f.eks.:
English: • mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain
Danish: • let til svær kvalme, opkastning, kramper og diarré, normalt forårsaget af et virus, mavesmerter
English: There is no information on the effect of alcohol on posaconazole.
Danish: Der er ingen information om alkohols effekt på posaconazol.
English: Quartile pCav Range (ng/mL)
Danish: Kvartil pCav-område (ng/ml)
English: Several of the interaction studies were conducted in healthy volunteers in whom a higher exposure to posaconazole occurs compared to patients administered the same dose.
Danish: Adskillige af interaktionsstudierne blev udført med raske frivillige forsøgspersoner, hos hvem der forekommer en højere eksponering for posaconazol sammenlignet med patienter, der fik den samme dosis.
English: renal tubular acidosis, interstitial nephritis
Danish: renal tubulær acidose, interstitiel nefritis
English: In a nonclinical study using intravenous administration of posaconazole in very young dogs (dosed from 2-8 weeks of age) an increase in the incidence of brain ventricle enlargement was observed in treated animals as compared with concurrent control animals.
Danish: I et ikke-klinisk studie med intravenøs administration af posaconazol til meget unge hunde (fik dosis fra 2-8 ugers alderen) blev der observeret en stigning i forekomsten af forstørrelse af hjerneventrikler hos de behandlede dyr sammenlignet med sideløbende kontroldyr.
English: • Infections in the mouth or throat area (known as “thrush”) caused by fungi called Candida, which were not previously treated.
Danish: • infektioner i munden eller svælget (kendt som trøske) forårsaget af svampe kaldet Candida, som ikke er behandlet tidligere.
English: In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
Danish: I begge de profylaktiske studier var udbrud af aspergillose den hyppigste infektion.
English: Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.
Danish: Se produktresuméet for Noxafil oral suspension for oplysninger om brug til oropharyngeal candidiasis.
English: Rarely, more severe hepatic reactions with fatal outcomes have been reported.
Danish: Mere alvorlige hepatiske reaktioner med letalt udfald er sjældent set.
English: This medicine is available in a single use glass vial closed with bromobutyl rubber stopper and aluminium seal.
Danish: Dette lægemiddel fås i et hætteglas til engangsbrug lukket med en bromobutyl-gummiprop og en aluminiumshætte.
English: Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomisation, was significantly higher for posaconazole recipients; this survival benefit was demonstrated when the analysis considered all causes of death (P= 0.0354) as well as IFI-related deaths (P = 0.0209).
Danish: Baseret på KaplanMeier-estimater var sandsynligheden for at overleve frem til dag 100 efter randomisering signifikant højere for modtagere af posaconazol; denne overlevelsesfordel blev påvist, da analysen betragtede død af alle årsager (P=0,0354) såvel som dødsfald med relation til IFI (P=0,0209).
English: Results from clinical studies in prophylaxis of Invasive Fungal Infections Study
Danish: Resultater fra kliniske studier til forebyggelse af invasive svampeinfektioner Studie
English: Posaconazole does not have any major circulating metabolites.
Danish: Posaconazol har ingen væsentlige cirkulerende metabolitter.
English: All drug interactions with posaconazole oral suspension, except for those that affect the absorption of posaconazole (via gastric pH and motility) are considered relevant to posaconazole concentrate for solution for infusion as well.
Danish: Alle interaktioner, som posaconazol oral suspension har med andre lægemidler, bortset fra de interaktioner, der påvirker posaconazols absorption (via gastrisk pH-værdi og motilitet), anses for også at være relevante for posaconazol koncentrat til infusionsvæske, opløsning.
English: If not used immediately, the solution can be stored up to 24 hours refrigerated 2°C-8°C.
Danish: Hvis det ikke anvendes straks, kan opløsningen opbevares i op til 24 timer i køleskab ved 2-8 °C.
English: When initiating posaconazole treatment in patients already receiving tacrolimus, the dose of tacrolimus should be reduced (e.g. to about one third of the current dose).
Danish: Når behandling med posaconazol initieres hos patienter, der allerede får tacrolimus, bør dosis af tacrolimus nedsættes (f.eks. til ca. en tredjedel af den aktuelle dosis).
English: diplopia, scotoma
Danish: dobbeltsyn, scotoma
English: These types of patients had been previously studied in a pivotal controlled trial of posaconazole oral suspension.
Danish: Disse typer patienter blev tidligere undersøgt i et pivotalt kontrolleret studie af posaconazol oral suspension.
English: Posaconazole is absorbed with a median tmax of 3 hours (fed patients).
Danish: Posaconazol absorberes med en median tmax på 3 timer (patienter, der har indtaget føde).
English: One subject (<1 %) had a predicted Cav below 500 ng/mL and 19 % of the subjects had a predicted Cav above 2,500 ng/mL.
Danish: En forsøgsperson (<1 %) havde en formodet Cav på under 500 ng/l, og 19 % af forsøgspersonerne havde en formodet Cav på over 2.500 ng/ml.
English: See also below regarding the effect of posaconazole on rifabutin plasma levels.
Danish: Se også nedenfor vedrørende virkningen af posaconazol på plasmaniveauer af rifabutin.
English: One bottle of 105 mL of oral suspension.
Danish: 1 flaske med 105 ml oral suspension.
English: Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group Posaconazole oral suspension
Danish: Samlet virkning af posaconazol oral suspension efter endt behandling af invasiv aspergillose sammenlignet med en ekstern kontrolgruppe Posaconazol oral suspension
English: Type I glass vial closed with bromobutyl rubber stopper and aluminium seal containing 16.7 mL of solution.
Danish: Type I-hætteglas lukket med en brombutyl-gummiprop og en aluminiumshætte indeholdende 16,7 ml koncentrat.
English: Patients with glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med arvelig fructoseintolerans bør ikke tage denne medicin.
English: Gastro-resistant tablet (tablet) Yellow-coated, capsule-shaped tablet of 17.5 mm length debossed with “100” on one side.
Danish: Gastroresistent tablet (tablet) Gul, kapselformet tablet, der er 17,5 mm lang, mærket med “100” på den ene side.
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 en hæmmer af CYP3A4 og bør kun anvendes under særlige omstændigheder ved behandling med andre lægemidler, som metaboliseres af CYP3A4 (se pkt.
English: • Aseptically transfer 16.7 mL of posaconazole to an intravenous bag (or bottle) containing a compatible admixture diluent (see below for list of diluents) using the volume ranging from 150 mL to 283 mL depending on the final concentration to be achieved (not less than 1 mg/mL and not greater than 2 mg/mL).
Danish: • Overfør aseptisk 16,7 ml posaconazol til en intravenøs pose (eller flaske) indeholdende en kompatibel infusionsvæske (se nedenfor for en liste over infusionsvæsker) i et volumen, der ligger i intervallet 150 ml til 283 ml, afhængigt af den slutkoncentration, der skal opnås (mindst 1 mg/ml og ikke højere end 2 mg/ml).
English: The tablet and oral suspension are not to be used interchangeably due to the differences between these two formulations in frequency of dosing, administration with food and plasma drug concentration achieved.
Danish: Tabletterne og den orale suspension er ikke indbyrdes ombyttelige på grund af forskelle i doseringshyppighed, administration sammen med mad og opnået lægemiddelkoncentration i plasma mellem de to formuleringer.
English: Treatment with these HMG-CoA reductase inhibitors should be discontinued during treatment with posaconazole as increased levels have been associated with rhabdomyolysis (see section 4.3).
Danish: Behandling med disse HMG-CoA reduktasehæmmere bør seponeres under behandling med posaconazol, da forhøjede niveauer har været forbundet med rhabdomyolyse (se pkt.
English: Patients with 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: Patienter med en lav kropsvægt (< 60 kg) har større sandsynlighed for at opleve højere plasmakoncentration af posaconazol og bør monitoreres nøje for bivirkninger.
English: Posaconazole inhibits the enzyme lanosterol 14α-demethylase (CYP51), which catalyses an essential step in ergosterol biosynthesis.
Danish: Posaconazol hæmmer enzymet lanosterol 14α-demetylase (CYP51), som katalyserer et essentielt trin i ergosterolbiosyntesen.
English: Patients who develop abnormal liver function tests during Noxafil therapy must be routinely monitored for the development of more severe hepatic injury.
Danish: Patienter, som får anormale leverfunktionsværdier under behandling med Noxafil, skal rutinemæssigt monitoreres for at undgå udvikling af mere alvorlig leverskade.
English: If a dose of Noxafil has been forgotten
Danish: Hvis du har glemt en Noxafil dosis