FrancophonIA/ELRC3.0 huggingface dataset:
English: • having a blind or dark spot in your field of vision
Danish: • en blind eller mørk plet i synsfeltet
English: • if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for posaconazol eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: The tablets should be swallowed whole with water and should not be crushed, chewed, or broken.
Danish: Tabletterne skal sluges hele med vand og må ikke knuses, tygges eller knækkes.
English: • Swallow the tablet whole with some water.
Danish: • Slug tabletten hel med vand.
English: This belongs to a group of medicines called “antifungals”.
Danish: Det hører til en gruppe af lægemidler, som kaldes ”svampemidler”.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Danish: Da du får dette lægemiddel under tæt medicinsk opsyn, er det usandsynligt, at sygeplejersken glemmer at give dig en dosis.
English: Five of these patients had chromoblastomycosis due to Fonsecaea pedrosoi and 4 had mycetoma, mostly due to Madurella species.
Danish: 5 af disse patienter havde chromoblastomykose forårsaget af Fonsecaea pedrosoi og 4 havde mycetoma, hovedsagelig forårsaget af Madurella-arter.
English: EXP Any product remaining four weeks after opening the bottle should be discarded.
Danish: EXP Eventuelt resterende lægemiddel skal kasseres 4 uger efter åbning af flasken.
English: • Noxafil is for single use.
Danish: • Noxafil er til engangsbrug.
English: Noxafil with food and drink
Danish: Brug af Noxafil sammen med mad og drikke
English: Steady-state is attained following 7 to 10 days of multiple-dose administration.
Danish: Steady-state opnås efter 7 til 10 dages flergangsdosering.
English: In general, exposures tended to be higher in the older patients (7 to <18 years) than in younger patients (2 to <7 years).
Danish: Generelt syntes eksponeringen at være højre hos ældre patienter (7 til < 18 år) end hos yngre patienter (2 til < 7 år).
English: Clinical outcomes were compared with those in an external control group derived from a retrospective review of medical records.
Danish: De kliniske resultater blev sammenlignet med resultater fra en ekstern kontrolgruppe udledt fra en retrospektiv gennemgang af medicinske journaler.
English: An increased effect on the QTc interval cannot be ruled out.
Danish: En øget effekt på QTc-intervallet kan ikke udelukkes.
English: See Table 4 and 5 for results from both studies.
Danish: Se tabel 4 og 5 for resultater fra begge studier.
English: White suspension
Danish: Hvid suspension
English: The pharmacokinetics and safety data from Study 5615 were bridged to the existing data (including efficacy data) with the oral suspension.
Danish: Data for farmakokinetik og sikkerhed fra studie 5615 blev overført til de allerede eksisterende data (inklusive data for virkning) med den orale suspension.
English: This medicinal product must not be mixed with other medicinal products except those mentioned below:
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført nedenfor:
English: Recommended dose is shown in Table 1.
Danish: Anbefalet dosering er vist i tabel 1.
English: EU/1/05/320/002 24 tablets EU/1/05/320/003 96 tablets
Danish: EU/1/05/320/002 24 tabletter EU/1/05/320/003 96 tabletter
English: No difference in the incidence of brain ventricle enlargement between control and treated animals was observed following the subsequent 5-month treatment-free period.
Danish: Der blev ikke observeret nogen forskel i forekomsten af forstørrelse af hjerneventrikler mellem kontroldyrene og de behandlede dyr efter den efterfølgende behandlingsfrie periode på 5 måneder.
English: See Table 5 and 6 for results from both studies.
Danish: Se tabel 5 og 6 for resultater fra begge studier.
English: Any products not listed in the table above should not be coadministered with Noxafil through the same intravenous line (or cannula).
Danish: Alle produkter, som ikke er anført i tabellen ovenfor, må ikke administreres sammen med Noxafil gennem den samme intravenøse slange (eller kanyle).
English: It is used to prevent and treat many different fungal infections.
Danish: Det anvendes til at forebygge og behandle mange forskellige svampeinfektioner.
English: Recommended dose and length of treatment
Danish: Anbefalet dosis og behandlingsvarighed
English: The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Danish: Hovedvirkningsmekanismen ved resistensudvikling er substitutioner i target-proteinet CYP51.
English: However, tell your doctor or pharmacist if you think that a dose has been forgotten.
Danish: Du skal dog fortælle lægen eller apotekspersonalet, hvis du tror, at en dosis er blevet glemt.
English: • reduced feeling of sensitivity especially on the skin
Danish: • nedsat følefornemmelse især på huden
English: • If you forget a dose, take it as soon as you remember it.
Danish: • Hvis du har glemt en dosis, så tag den, så snart du husker det.
English: Your doctor will monitor your response and condition to determine how long Noxafil needs to be given and whether any change is needed to your daily dose.
Danish: Din læge vil følge virkningen og din tilstand for at bestemme, hvor længe Noxafil skal tages, og om det er nødvendigt at ændre din daglige dosis.
English: Reproduction, peri- and postnatal development studies were conducted in rats.
Danish: Der er blevet udført studier af reproduktion samt peri- og postnatal udvikling hos rotter.
English: Clear, colourless to yellow liquid.
Danish: Klar, farveløs til gul væske.
English: The following information was derived from data with posaconazole oral suspension or early tablet formulation.
Danish: Følgende oplysninger er udledt fra data med posaconazol oral suspension eller den tidlige tabletformulering.
English: The primary efficacy variable was the clinical success rate (defined as cure or improvement) after 14 days of treatment.
Danish: Den primære virkningsvariabel var den kliniske succesrate (defineret som helbredelse eller forbedring) efter 14 dages behandling.
English: • have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole,
Danish: • har haft en allergisk reaktion over for et andet svampemiddel såsom ketoconazol, fluconazol,
English: This medicine works by killing or stopping the growth of some types of fungi that can cause infections.
Danish: Lægemidlet virker ved at dræbe eller stoppe væksten af nogle typer svampe, som kan forårsage infektioner.
English: • inflammation or pain at injection site
Danish: • betændelse eller smerter ved injektionsstedet.
English: Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy.
Danish: Forhøjede leverfunktionsværdier var generelt reversible ved afbrydelse af behandlingen, og i nogle tilfælde normaliseredes disse værdier uden afbrydelse af behandling.
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning hos patienter på en kontrolleret natriumdiæt.
English: Prophylaxis in AML and HSCT Study 5615
Danish: Profylakse for AML og HSCT Studie 5615
English: This finding was not seen in monkeys dosed for one year.
Danish: Denne virkning blev ikke set hos aber, der blev behandlet i et år.
English: • Do not crush, chew, break or dissolve the tablet.
Danish: • Du må ikke knuse, tygge, knække eller opløse tabletten.
English: • However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule.
Danish: • Hvis det imidlertid næsten er tid for din næste dosis, så spring den glemte dosis over og vend tilbage til dit sædvanlige dosisskema.
English: Recommended dose according to indication Indication
Danish: Anbefalet dosering efter indikation Indikation
English: It is recommended to exercise caution due to the potential for higher plasma exposure.
Danish: Det anbefales at udvise forsigtighed pga. muligheden for højere plasmaeksponering.
English: The study treated 155 (65 %) subjects with AML or MDS, and 82 (35 %) subjects with HSCT, as the primary diseases at study entry.
Danish: Studiet behandlede 155 (65 %) forsøgspersoner med AML eller MDS og 82 (35 %) forsøgspersoner med HSCT som de primære sygdomme ved inklusion i studiet.
English: • Congenital or acquired QTc prolongation
Danish: • Kongenital eller erhvervet QTc-forlængelse
English: Posaconazole has a distribution volume of 261 L, indicating extravascular distribution.
Danish: Posaconazol har en fordelingsvolumen på 261 l, hvilket indikerer ekstravaskulær fordeling.
English: The total subject population had a mean age of 51 years (range = 18-82 years), 95 % were White, the major ethnicity was not Hispanic or Latino (92 %), and 55 % were male.
Danish: Den samlede population af forsøgspersoner havde en gennemsnitsalder på 51 år (interval = 18-82 år), 95 % var hvide, den største etniske gruppe var ikke af latinamerikansk oprindelse (92 %) og 55 % var mænd.
English: If you have missed a dose, take it as soon as you remember and then carry on as before.
Danish: • Hvis du har glemt en dosis, så tag den, så snart du husker det og fortsæt som før.
English: Oral formulations of Noxafil should be used in these patients unless an assessment of the benefit/risk to the patient justifies the use of Noxafil concentrate for solution for infusion.
Danish: Orale formuleringer af Noxafil bør anvendes til disse patienter, medmindre en vurdering af benefit/risk-forholdet for patienten berettiger, at der anvendes Noxafil koncentrat til infusionsvæske, opløsning.
English: Prophylaxis in Neutropenia Study 1899
Danish: Profylakse for neutropeni Studie 1899
English: Noxafil can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them:
Danish: Noxafil kan anvendes hos voksne til behandling af følgende svampeinfektioner, når andre svampemidler ikke har virket, eller du var nødt til at stoppe med at tage dem:
English: • have any problem with potassium, magnesium or calcium levels in your blood
Danish: • har et problem med indholdet af kalium, magnesium eller calcium i dit blod.
English: Particular caution is advised in such cases where posaconazole is administered peripherally, as the recommended infusion time of 30 minutes may further increase Cmax.
Danish: Der bør udvises særlig forsigtighed i tilfælde, hvor posaconazol administreres perifert, da den anbefalede infusionstid på 30 minutter kan forøge Cmax yderligere.
English: Contains sodium.
Danish: Indeholder natrium.
English: Each dose of Noxafil should be administered during or immediately after a meal, or a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure.
Danish: Hver Noxafil dosis bør gives sammen med eller umiddelbart efter et måltid, eller et ernæringstilskud hos patienter, som ikke kan tåle fødeindtagelse, for at øge den orale absorption og for at sikre tilstrækkelig optagelse.
English: Clinical success rates in Oropharyngeal Candidiasis Endpoint
Danish: Kliniske succesrater i Oropharyngeal Candidiasis Endepunkt
English: Pharmacokinetic modelling with an oral tablet formulation suggests that patients weighing greater than 120 kg may have lower posaconazole exposure.
Danish: Farmakokinetiske modeller med en oral tabletformulering tyder på, at patienter, der vejer mere end 120 kg, kan have lavere eksponering for posaconazol.
English: Noxafil must not be diluted with:
Danish: Noxafil må ikke fortyndes med:
English: • Cardiomyopathy, especially in the presence of cardiac failure
Danish: • Kardiomyopati, især hvis hjerteinsufficiens er til stede
English: • Store in a refrigerator (2C-8C).
Danish: • Opbevares i køleskab (2-8 C).
English: Posaconazole was shown to be non-inferior to fluconazole for clinical success rates at Day 14 as well as 4 weeks after the end of treatment.
Danish: Posaconazol blev påvist til at være ikke-underlegen i forhold til fluconazol for klinisk succesrate på dag 14 samt 4 uger efter endt behandling.
English: Whenever possible you should take posaconazole during or immediately after food or a nutritional drink.
Danish: Posaconazol skal så vidt muligt tages med eller lige efter et måltid eller en ernæringsdrik.
English: No clinically relevant changes in the mean QTc (Fridericia) interval from baseline were observed.
Danish: Der blev ikke observeret klinisk relevante forandringer i det gennemsnitlige QTc (Fridericia)-interval i forhold til baseline.
English: If you are already taking rifabutin, you will need a blood test and you will need to look out for some possible side effects of rifabutin.
Danish: Hvis du allerede tager rifabutin, skal du have taget en blodprøve, og du skal være opmærksom på mulige bivirkninger af rifabutin.
English: • hair loss (alopecia)
Danish: • hårtab (alopeci)
English: Noxafil oral suspension and tablets are NOT interchangeable.
Danish: Noxafil oral suspension og tabletter er IKKE indbyrdes ombyttelige.
English: The critical ratio for subjects with Aspergillus infections was ~200.
Danish: Det kritiske forhold for patienter med Aspergillus infektioner var ~ 200.
English: Clinical success rate at Day 14 Clinical success rate 4 weeks after end of treatment
Danish: Klinisk succesrate på dag 14 Klinisk succesrate 4 uger efter endt behandling
English: • through a plastic tube placed in your vein (intravenous infusion)
Danish: • gennem en plastikslange, der er indsat i din blodåre (intravenøs infusion)
English: EUCAST MIC breakpoints for posaconazole [susceptible (S); resistant (R)]:
Danish: EUCAST-MIC-grænseværdier for posaconazol [følsomme (S); resistente (R)]:
English: • If you have any suspension left in a bottle more than four weeks after it was first opened, you should not use this medicine.
Danish: • Hvis du fire uger efter åbning af flasken har en rest af suspensionen tilbage, må du ikke anvende denne medicinrest.
English: • Sinus bradycardia
Danish: • Sinusbradykardi
English: itraconazole or voriconazole.
Danish: itraconazol eller voriconazol.
English: Noxafil tablets are the preferred formulation to optimize plasma concentrations and generally provide higher plasma drug exposures than Noxafil oral suspension.
Danish: Noxafil tabletter er den foretrukne formulering til optimering af plasmakoncentrationer, og de giver generelt højere lægemiddeleksponering i plasma end Noxafil oral suspension.
English: Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Danish: Utilstrækkelig behandling defineres som progression af en infektion eller mangel på bedring efter mindst 7 dages terapeutiske doser af effektiv behandling med antimykotika.
English: However, if it is almost time for your next dose, take your dose when it is due.
Danish: • Hvis det imidlertid næsten er tid for din næste dosis, så tag din dosis til tiden.
English: • blood problems such as unusual blood clotting or prolonged bleeding
Danish: • blodproblemer såsom unormal størkning af blodet eller forlænget blødning
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Inden for systemorganklasserne er bivirkningerne anført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not switch between taking Noxafil tablets and Noxafil oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.
Danish: Du må ikke skifte mellem Noxafil tabletter og Noxafil oral suspension uden først at tale med lægen eller apotekspersonalet, da dette kan medføre manglende virkning eller øge risikoen for bivirkninger.
English: When Noxafil treatment is stopped by your doctor you should not experience any effects.
Danish: Når din læge har stoppet behandlingen med Noxafil, bør du ikke opleve nogen bivirkninger.
English: ECOFF values do not equate to clinical breakpoints.
Danish: ECOFF-værdierne er ikke sidestillet med de kliniske grænseværdier.
English: noxafil tablets
Danish: noxafil tabletter
English: If not used immediately, the solution can be stored up to 24 hours at 2°C-8°C (in a refrigerator).
Danish: Hvis det ikke anvendes med det samme, kan opløsningen opbevares i op til 24 timer ved 2-8 °C (i køleskab).
English: No further increases in exposure were observed when doses above 800 mg daily were administered to patients and healthy volunteers.
Danish: Der ses ingen yderligere stigning i eksponering ved administration af doser over 800 mg dagligt til patienter og raske forsøgspersoner.
English: Prophylaxis in GVHD Study 316
Danish: Profylakse for GVHD Studie 316
English: The safety profile in these patients < 18 years of age appears similar to the safety profile observed in adults.
Danish: Sikkerhedsprofilen for disse patienter < 18 år synes at ligne den sikkerhedsprofil, som blev observeret hos voksne.
English: • swelling of the face or tongue
Danish: • hævelser i ansigt eller af tunge
English: An increase in Cmax (26 %) and AUC (29 %) was observed in elderly subjects (24 subjects  65 years of age) relative to younger subjects (24 subjects 18 - 45 years of age).
Danish: En stigning i Cmax (26 %) og AUC (29 %) kunne påvises i ældre (24 personer  65 år) i forhold til yngre (24 personer 18 - 45 år).
English: • swelling, redness, and tenderness along the vein in which Noxafil was given
Danish: • hævelse, rødme og ømhed langs den blodåre, hvor Noxafil blev givet
English: • have a weakness of the heart muscle or heart failure
Danish: • har en svaghed i hjertemusklen eller hjertesvigt.
English: Unbound concentrations were not determined and it cannot be excluded that there is a larger increase in unbound posaconazole exposure than the observed 60 % increase in total AUC.
Danish: Ubundne koncentrationer blev ikke bestemt, og det kan ikke udelukkes, at der er en større stigning i eksponeringen for ubundet posaconazol end den observerede 60 % øgning i totalt AUC.
English: Clinical success rate was defined as the number of cases assessed as having a clinical response (cure or improvement) divided by the total number of cases eligible for analysis.
Danish: Klinisk succesrate blev defineret som antal forsøgspersoner vurderet som havende et klinisk respons (helbredelse eller forbedring) delt med det totale antal forsøgspersoner kvalificeret til analyse.
English: Noxafil should be administered with caution to patients with pro-arrhythmic conditions such as:
Danish: Noxafil bør administreres med forsigtighed til patienter med proarytmiske tilstande såsom:
English: To improve absorption of posaconazole, whenever possible it should be taken during or immediately after food or a nutritional drink (see section 3 “How to take Noxafil”).
Danish: For at forbedre absorptionen af posaconazol skal det så vidt muligt tages sammen med eller umiddelbart efter et måltid eller et ernæringstilskud (se punkt 3 ”Sådan skal du tage Noxafil”).
English: Treatment should be initiated by a physician experienced in the management of fungal infections or in the supportive care in the high risk patients for which posaconazole is indicated as prophylaxis.
Danish: Behandling bør initieres af en læge med erfaring i behandling af svampeinfektioner eller i den understøttende behandling hos høj-risiko patienter, for hvem posaconazol er indiceret som profylakse.
English: 24 gastro-resistant tablets 96 gastro-resistant tablets
Danish: 24 gastroresistente tabletter 96 gastroresistente tabletter
English: From a microbiological point of view, once admixed, the product should be used immediately.
Danish: Efter opblanding skal produktet anvendes straks set ud fra et mikrobiologisk synspunkt.
English: Moreover, sparse PK samples were collected at several days during steady state before the next dose (Cmin) for a larger subject population.
Danish: Derudover blev der udtaget spredte farmakokinetiske prøver på flere dage under steady-state før den næste dosis (Cmin) for en større population af forsøgspersoner.
English: You will be given Noxafil:
Danish: Du får Noxafil:
English: The elimination half-life (t
Danish: Eliminationshalveringstiden (t
English: Noxafil gastro-resistant tablets may be taken with or without food (see section 5.2).
Danish: Noxafil gastroresistente tabletter kan tages med eller uden mad (se pkt.
English: Alternatively, if recommended by your doctor, you may take 400 mg (two 5 mL spoonfuls) twice a day provided that you are able to take both doses during or after food or a nutritional drink.
Danish: Alternativt, hvis din læge har anbefalet det, kan du tage 400 mg (to 5 ml måleskeer) to gange dagligt, forudsat at du er i stand til at tage begge doser sammen med eller lige efter et måltid eller en ernæringsdrik.
English: Store in a refrigerator at 2°C-8°C.
Danish: Opbevares i køleskab ved 2 -8 °C.
English: This exposure was selected based on pharmacokinetic/pharmacodymanic considerations with posaconazole oral suspension.
Danish: Denne eksponering blev valgt på basis af farmakokinetiske/farmakodynamiske overvejelser med posaconazol oral suspension.
English: Ear and labyrinth disorder Rare:
Danish: Øre og labyrint Sjælden:
English: Prophylaxis of Invasive Fungal Infections (IFIs) (Studies 316 and 1899) Two randomised, controlled prophylaxis studies were conducted among patients at high risk for developing invasive fungal infections.
Danish: Forebyggelse af invasive svampeinfektioner (IFI'er) (studie 316 og 1899) To randomiserede, kontrollerede forebyggelsesstudier blev udført blandt patienter med høj risiko for at udvikle invasive svampeinfektioner.
English: Thrombophlebitis was observed in clinical trials.
Danish: Tromboflebitis er set i kliniske studier.
English: In the fasting state, AUC increased less than in proportion to dose above 200 mg.
Danish: Under faste steg AUC mindre end i forhold til doser over 200 mg.
English: There were no neurologic, behavioural or developmental abnormalities in the dogs with this finding, and a similar brain finding was not seen with oral posaconazole administration to juvenile dogs (4 days to 9 months of age).
Danish: Der var ingen neurologiske, adfærdsmæssige eller udviklingsmæssige anormaliteter hos hundene i forbindelse med dette fund, og der blev ikke konstateret et tilsvarende hjernefund med administration af oral dosis af posaconazol til unghunde (4 dage til 9 måneders alderen).
English: 5 % dextrose in water 0.9 % sodium chloride 0.45 % sodium chloride 5 % dextrose and 0.45 % sodium chloride 5 % dextrose and 0.9 % sodium chloride 5 % dextrose and 20 mEq KCl
Danish: 0,9 % natriumchlorid 0,45 % natriumchlorid 5 % glucose og 0,45 % natriumchlorid 5 % glucose og 0,9 % natriumchlorid 5 % glucose og 20 mEq KCl
English: Patients were immunocompromised with underlying conditions including haematological malignancy, neutropenia post-chemotherapy, GVHD, and post HSCT.
Danish: Patienterne var immunkompromitteret med tilgrundliggende tilstande, herunder hæmatologisk malignitet, neutropeni efter kemoterapi, GVHD og efter HSCT.
English: New diagnosis of acute myelogenous leukaemia was the most common underlying condition (435/602, [72 %]).
Danish: Nydiagnosticeret AML var den hyppigste underliggende sygdom (435/602, [72 %]).
English: • Concomitant use with medicinal products known to prolong the QTc interval (other than those mentioned in section 4.3).
Danish: • Samtidig behandling med lægemidler, som er kendt for at forlænge QTc-intervallet (ud over dem, der er nævnt under pkt.