FrancophonIA/ELRC3.0 huggingface dataset:
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: Do not take a double dose to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
Danish: Dette var imidlertid ikke et prospektivt randomiseret kontrolleret studie, og alle sammenligninger med den eksterne kontrolgruppe skal vurderes med forsigtighed.
English: 08039 Barcelona, Spain
Danish: 08039 Barcelona Spanien
English: After first opening the container: 30 days
Danish: Efter første åbning af beholderen: 30 dage
English: The elimination half-life (t1/2) was prolonged from approximately 27 hours up to ~43 hours in respective groups.
Danish: Eliminationshalveringstiden (t1/2) blev forlænget fra ca. 27 timer op til ~43 timer i de respektive grupper.
English: - if you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.
Danish: - hvis du udvikler alvorlig diarré eller kaster op, da disse forhold kan begrænse virkningen af dette lægemiddel.
English: Bottles showing any visible settling should be vigorously shaken for a minimum of 10 seconds.
Danish: Flasker, der viser nogen synlig sedimentering, skal omrystes kraftigt i mindst 10 sekunder.
English: Effects of posaconazole on other medicinal products
Danish: Virkning af posaconazol på andre lægemidler
English: Recommended dose according to indication.
Danish: Anbefalet dosering efter indikation Indikation
English: H-1045 Budapest Hungary
Danish: H-1045 Budapest UNGARN
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: Tabulated list of adverse reactions 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.
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.
English: Children Posaconazole AHCL should not be used in children (17 years of age and younger).
Danish: Brug til børn Posaconazole AHCL må ikke anvendes til børn (17 år eller yngre).
English: fluconazole, itraconazole or voriconazole.
Danish: fluconazol, itaconazol eller voriconazol.
English: Do not adapt your dose yourself before consulting your doctor or change your treatment regime.
Danish: Du må ikke selv tilpasse din dosis eller ændre din behandling, før du har talt med din læge.
English: Chromoblastomycosis/Mycetoma
Danish: Chromoblastomykose/Mycetoma
English: Pharmacokinetic modeling 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: d: All randomized e: All treated
Danish: d: Alle randomiserede patienter e:
English: - If you have any suspension left in a bottle more than 30 days after it was first opened, you should not use this medicine.
Danish: Hvis du 30 dage efter åbning af flasken har en rest af suspensionen tilbage, må du ikke anvende denne medicinrest.
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: Epidemiological Cut-off (ECOFF) Values for Aspergillus spp.
Danish: Epidemiologiske cut-off (ECOFF) -værdier for Aspergillus-arter.
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: EXP Discard after 30 days of opening.
Danish: EXP Kasseres 30 dage efter åbning.
English: H-1045 Budapest HUNGARY
Danish: H-1045 Budapest
English: In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
Danish: I begge de profylaksiske studier var udbrud af aspergillose den hyppigste infektion.
English: Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomization, 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-relateret (P=0,0209).
English: Your doctor will monitor your response and condition to determine how long Posaconazole AHCL 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 Posaconazole AHCL skal tages, og om det er nødvendigt at ændre din daglige dosis.
English: Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1st line therapy
Danish: Refraktære invasive svampeinfektioner (IFI)/patienter med IFI som er intolerante over for førstevalgsbehandling
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: Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Danish: Samlet respons Virkning per art Alle mykologisk bekræftet Aspergillus arter1
English: LIST OF EXCIPIENTS Contains glucose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder glukose.
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: 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 fuldstændigt blodtælling og bivirkninger relateret til forhøjede niveaue af rifabutin (f.eks. uveitis).
English: Pharmacokinetic / Pharmacodynamic relationships A correlation between total medicinal product exposure divided by MIC (AUC/MIC) and clinical outcome was observed.
Danish: Der er fundet korrelation imellem den totale eksponering af lægemiddel divideret med MIC (AUC/MIC) og den kliniske virkning.
English: You may feel dizzy, sleepy, or have blurred vision while taking Posaconazole AHCL, 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 Posaconazole AHCL, hvilket kan påvirke din evne til at køre bil, bruge værktøj eller betjene maskiner.
English: Do not take Posaconazole AHCL - if you are allergic to posaconazole or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Posaconazole AHCL: - hvis du er allergisk over for posaconazol eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: EUCAST ECOFF values: - Aspergillus flavus: 0.5 mg/L - Aspergillus fumigatus: 0.25 mg/L - Aspergillus nidulans: 0.5 mg/L - Aspergillus niger: 0.5 mg/L - Aspergillus terreus: 0.25 mg/L
Danish: EUCAST ECOFF-værdier: - Aspergillus flavus: 0,5 mg/l - Aspergillus fumigatus: 0,25 mg/l - Aspergillus nidulans: 0,5 mg/l - Aspergillus niger: 0,5 mg/l - Aspergillus terreus: 0,25 mg/l
English: Posaconazole tablets are the preferred formulation to optimize plasma concentrations and generally provide higher plasma drug exposures than posaconazole oral suspension.
Danish: Posaconazol-tabletter er den foretrukne formulering til optimering af plasmakoncentrationer, og de giver generelt højere lægemiddeleksponering i plasma end posaconazol oral suspension.
English: c: In 1899, this was the period from randomization to 100 days post-randomization; in 316 it was the period from the baseline day to 111 days post-baseline.
Danish: I 1899, var det perioden fra randomisering til 100 dage efter randomisering; i 316 var det perioden fra baseline-dagen til 111 dage efter baseline.
English: 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 (> 98 %).
English: - efavirenz and fosamprenavir used to treat HIV infection.
Danish: - efavirenz og fosamprenavir, der anvendes til behandling af hiv-infektion.
English: The filled and sealed bottle is packed into a carton along with a graduated polystyrene spoon (2.5 mL and 5 mL) for dispensing and administration of the suspension.
Danish: Den fyldte og forseglede flaske er pakket i karton med en måleske af polystyren (2,5 ml og 5 ml) til opmåling og indgivelse af suspensionen.
English: The effect of posaconazole on fosamprenavir levels when fosamprenavir is given with ritonavir is unknown.
Danish: Posaconazols indvirkning på niveauet af fosamprenavir, når fosamprenavir gives sammen med ritonavir, er ikke kendt.
English: Do not take Posaconazole AHCL if any of the above apply to you.
Danish: Du må ikke tage Posaconazole AHCL, hvis noget af ovenstående gælder for dig.
English: The safety and efficacy of posaconazole in children aged below 18 years have not been established.
Danish: Posaconazols sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Proportion (%) of patients with proven/probable IFIs On-treatment periodb
Danish: P-Værdi Andel af patienter (%) med verificeret/sandsynlig IFI On-treatment periodeb
English: There is no clinical experience assessing the impact of posaconazole on fertility in humans.
Danish: Der er ingen klinisk erfaring som vurderer posaconazols indflydelse på fertiliteten hos mennesker.
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 svampeinfektionen.
English: Do not switch between taking Posaconazole tablets and posaconazole 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 posaconazol-tabletter og posaconazol oral suspension uden først at tale med lægen eller apotekspersonalet, da dette kan medføre manglende virkning eller øge risikoen for bivirkninger.
English: The following medicines may decrease the effectiveness of Posaconazole AHCL by decreasing the amount of Posaconazole AHCL in the blood: - rifabutin and rifampicin (used to treat certain infections).
Danish: Følgende lægemidler kan nedsætte virkningen af Posaconazole AHCL ved at nedsætte mængden af Posaconazole AHCL i blodet: - rifabutin og rifampicin (anvendes til behandling af visse infektioner).
English: Therefore, posaconazole may increase plasma concentration of digoxin and digoxin levels need to be monitored when initiating or discontinuing posaconazole treatment.
Danish: Derfor kan posaconazol øge plasmakoncentrationen af digoxin så det er nødvendigt at monitorere digoxinniveauerne ved påbegyndelse eller seponering af behandling med posaconazol.
English: Elderly (≥ 65 years) 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: Adverse reactions by body system and frequency* Blood and lymphatic system disorders Common:
Danish: Bivirkninger anført efter systemorganklasse og hyppighed* Blod og lymfesystem
English: Macrogolglycerol hydroxystearate
Danish: Macrogolglycerolhydroxystearat
English: Talk to your doctor or pharmacist before taking Posaconazole AHCL - if you have had an allergic reaction to another antifungal medicine such as ketoconazole,
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Posaconazole AHCL: - hvis du har haft en allergisk reaktion over for et andet svampemiddel såsom ketoconazol,
English: Posaconazole is also available as 100 mg gastro-resistant tablet and 300 mg concentrate for solution for infusion.
Danish: Posaconazol findes også som 100 mg gastroresistente tabletter og 300 mg koncentrat til infusionsvæske, opløsning.
English: Results from clinical studies in prophylaxis of Invasive Fungal Infections Study
Danish: Resultater fra kliniske studier til forebyggelse af invasive svampeinfektioner.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Do not take Posaconazole AHCL if you are pregnant unless you are told to by your doctor.
Danish: Brug ikke Posaconazole AHCL under graviditet, medmindre det er foreskrevet af din læge.
English: A key secondary endpoint was the incidence of proven/probable IFIs during the on-treatment period (first dose to last dose of study medicinal product + 7 days).
Danish: Et centralt sekundært endepunkt var forekomsten af verificeret/sandsynlig IFI i ontreatment perioden (fra første til sidste dosis studiemedicin + 7 dage).
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: - 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: World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, Spain
Danish: World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona
English: This medicine contains less than 1 mmol sodium (23 mg) per 5 mL of suspension, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. 5 ml suspension, dvs. det er i det væsentlige natriumfrit.
English: A measuring spoon is provided with each bottle for measuring 2.5 and 5 mL doses of the oral suspension.
Danish: Der er vedlagt en måleske hver flaske til afmåling af 2,5 ml og 5 ml doser af den orale suspension.
English: Discard after 30 days of opening.
Danish: Kasseres 30 dage efter åbning.
English: There is no information on the effect of alcohol on posaconazole."
Danish: Der er ingen information om alkohols effekt på posaconazol.
English: Posaconazole has been shown in vitro to be active against the following microorganisms: Aspergillus species (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida species (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, and species of Fusarium, Rhizomucor, Mucor, and Rhizopus.
Danish: Det er blevet påvist in vitro, at posaconazol har virkning på følgende mikroorganismer: Aspergillusarter (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida-arter (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, og arter af Fusarium, Rhizomucor, Mucor og Rhizopus.
English: - Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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 AHCL.
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 Posaconazole AHCL.
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
English: Each dose of Posaconazole AHCL 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 Posaconazole AHCL 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: For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole AHCL should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
Danish: For patienter med akut myeloid leukæmi eller myelodysplastisk syndrom, bør forebyggelse med Posaconazole AHCL påbegyndes flere dage før den forventede optræden af neutropeni og fortsætte i 7 dage efter det neutrofile antal i il
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, Clcr < 20 ml/min/1,73 m2) var AUC for posaconazol meget variabel [> 96 % CV (varianskoefficient)] sammenlignet med andre grupper med nyrelidelse [< 40 % CV].
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: Efter administration af 14C-posaconazol blev radioaktiviteten hovedsagelig genfundet i fæces (77 % af den radioaktivt mærkede dosis) heraf hovedparten som uforandret lægemiddel (66 % af den radioaktivt mærkede dosis).
English: Posaconazole AHCL contains approximately 1.75g of glucose per 5mLof suspension.
Danish: Posaconazole AHCL indeholder cirka 1,75 g glucose pr. 5 ml suspension.
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 Posaconazole AHCL”).
Danish: Brug af Posaconazole AHCL sammen med mad og drikke For at forbedre absorptionen af posaconazol skal det så vidt muligt tages med eller umiddelbart efter et måltid eller et ernæringstilskud (se punkt 3 ”Sådan skal du tage Posaconazole AHCL”).
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 forhøjede plasmakoncentrationer af disse lægemidler, som kan medføre QTc-forlængelse og sjældne forekomster af torsades de pointes (se pkt.
English: Posaconazole AHCL may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Danish: Posaconazole AHCL kan muligvis øge risikoen for bivirkninger af nogle andre lægemidler ved at forhøje mængden af disse lægemidler i blodet.
English: White to off-white free flowing suspension.
Danish: Hvid til råhvid letflydende suspension
English: Patients who develop abnormal liver function tests during Posaconazole AHCLtherapy must be routinely monitored for the development of more severe hepatic injury.
Danish: Patienter, som får anormale leverfunktionsværdier under behandling med Posaconazole AHCL, skal rutinemæssigt monitoreres for at undgå udvikling af mere alvorlig leverskade.
English: Certain medicines may increase the risk of side effects of Posaconazole AHCL by increasing the amount of Posaconazole AHCL in the blood.
Danish: Visse lægemidler kan muligvis øge risikoen for bivirkninger af Posaconazole AHCL ved at øge mængden af Posaconazole AHCL i blodet.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Posaconazole oral suspension and posaconazole tablets are NOT interchangeable.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Posaconazole oral suspension og posaconazol-tabletter er IKKE indbyrdes ombyttelige.
English: Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz and cimetidine
Danish: Rifamycin antibakterielle midler (rifampicin, rifabutin), visse antiepileptika (phenytoin, carbamazepin, phenobarbital, primidon), efavirenz og cimetidin
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 administration af posaconazol.
English: Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group
Danish: Samlet virkning af posaconazol oral suspension efter endt behandling af invasiv aspergillose sammenlignet med en ekstern kontrolgruppe Posaconazol oral suspension
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: - patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS) - patients having “high- dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).
Danish: Dette lægemiddel kan også anvendes til at forebygge svampeinfektioner hos voksne, som har en høj risiko for at få en svampeinfektion, f.eks.: - patienter, som har et svækket immunforsvar som følge af behandling med kemoterapi for ”akut myleoid leukæmi” (AML) eller ”myelodysplastisk syndrom” (MDS) - patienter, som får ”højdosis-immunundertrykkende behandling” efter ”stamcelletransplantation af hæmopoietiske (bloddannende) stamceller” (HSCT).