FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition to the medicines named above that must not be taken with posaconazole because of the risk of heart rhythm disturbances, there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with posaconazole.
Danish: I tillæg til de lægemidler, som er nævnt ovenfor, som ikke må tages med posaconazol på grund af risiko for hjerterytmeforstyrrelser, er der andre lægemidler, som indebærer risiko for rytmeproblemer, som kan være større, når de tages med posaconazol.
English: pulmonary hypertension, interstitial pneumonia, pneumonitis
Danish: pulmonal hypertension, interstitiel pneumoni, pneumonitis
English: Important information about some of the ingredients of Posaconazole SP Posaconazole SP contains approximately 1.75 g of glucose per 5 ml of suspension.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Posaconazole SP Posaconazole SP indeholder cirka 1,75 g glucose per 5 ml suspension.
English: Gender The pharmacokinetics of posaconazole are comparable in men and women.
Danish: Køn Posaconazols farmakokinetik er sammenlignelig hos mænd og kvinder.
English: The duration of therapy is based on recovery from neutropenia or immunosuppression.
Danish: Behandlingens varighed afhænger af bedring efter neutropeni eller immunosuppression.
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-risisko patienter, for hvem posaconazol er indiceret som profylakse.
English: Overall efficacy of posaconazole at the end of treatment for invasive aspergillosis in comparison to an external control group
Danish: Samlet effekt af posaconazol efter endt behandling af invasiv aspergillose sammenlignet med en ekstern kontrolgruppe
English: In rabbits, posaconazole was embryotoxic at exposures greater than those obtained at therapeutic doses.
Danish: Hos kaniner var posaconazol embryotoksisk ved eksponering større end den, der opnås med terapeutiske doser.
English: Proportion (%) of patients with proven/probable Aspergillosis On-treatment periodb d e
Danish: Patientandel (%) med bevist/sandsynlig Aspergillosis On-treatment periode b d e
English: Please see the section “Taking other medicines” for information on other medicines which may interact with Posaconazole SP.
Danish: Læs afsnittet ”Brug af anden medicin” for information om andre lægemidler, som kan reagere med Posaconazole SP.
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 (IFIs) (Undersøgelserne 316 og 1899) To randomiserede, kontrollerede forebyggende undersøgelser blev udført blandt patienter med høj risiko for at udvikle invasive svampeinfektioner.
English: • A weakness of the heart muscle or heart failure
Danish: • En svaghed i hjertemusklen eller hjertesvigt.
English: There was a slight decrease (16 %) in the AUC and Cmax of posaconazole in Black subjects relative to Caucasian subjects.
Danish: Der var en svag reduktion (16 %) i AUC og Cmax for posaconazol hos negroide i forhold til kaukasiske personer.
English: Certain medicines may increase (possibly increasing the risk of side effects) or decrease (possibly causing lack of effectiveness) the blood levels of posaconazole.
Danish: Visse lægemidler kan øge (muligvis øge risikoen for bivirkninger) eller nedsætte (muligvis forårsage manglende effekt) koncentrationen af posaconazol i blodet.
English: • Sulfonylureas such as glipizide (used to treat high blood sugar).
Danish: • Sulfonylurinstoffer såsom glipizid (anvendt til behandling af højt blodsukker)
English: If you are taking medicines that contain ergot alkaloids (used to treat migraines).
Danish: hvis De anvender lægemidler, som indeholder sekalealkaloider (anvendes til behandling af migræne).
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 opnås ved terapeutiske doser hos mennesker, forårsagede posaconazol skeletforandringer og misdannelser, dystoki, forlænget drægtighedsperiode, reduceret gennemsnitlig kuldstørrelse og postnatal overlevelse.
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 andet vigtigt endpoint var tilfældet af bevist/sandsynlig IFIs under on-treatment perioden (første dosis til sidste dosis af undersøgelsens lægemiddel + 7 dage).
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 (andre end dem der er nævnt under pkt.
English: Artificial cherry flavour containing benzyl alcohol and propylene glycol Purified water
Danish: Kunstig kirsebæraroma indeholdende benzylalcohol og propylenglycol Renset vand
English: 105 ml of oral suspension in a 123 ml 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 123 ml flaske (brunt glas type IV) lukket med børnesikret plastlåg (polypropylen) samt en måleske (polystyren) med 2 inddelinger: 2,5 ml og 5 ml.
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) En randomiseret, evaluator-blindet, kontrolleret undersøgelse hos HIV-inficerede patienter med azolfølsom oropharyngeal candidiasis blev afsluttet (de fleste undersøgte patienter havde C. Albicans isoleret ved baseline).
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 undersøgelserne for forebyggelse var steady-state middelværdien for den gennemsnitlige posaconazol koncentration (Cav) blandt ti unge (13-17 år) tilsvarende sammenlignelig med Cav opnået hos voksne (≥ 18 år).
English: Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for pglycoprotein (P-gp) efflux in vitro.
Danish: Posaconazol metaboliseres via UDP glucuronidering (fase 2 enzymer) og er et substrat for pglycoprotein (P-gp) efflux in vitro.
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
Danish: De fleste tilfælde af aspergillose blev vurderet som værende refraktære for tidligere terapi både i posaconazolgruppen (88 %) og i den eksterne kontrolgruppe (79 %).
English: High blood levels of glucose
Danish: Højt indhold i blodet af glucose
English: Your doctor will monitor your response and condition to determine how long Posaconazole SP needs to be given and whether any change is needed to your daily dose.
Danish: Deres læge vil følge virkningen og Deres tilstand for at bestemme hvor længe Posaconazole SP skal tages og om det er nødvendigt at ændre Deres daglige dosis.
English: If these medicinal products are co-administered, careful monitoring of full blood counts and adverse events related to increased rifabutin levels (e.g. uveitis) is recommended.
Danish: Hvis disse lægemidler administreres samtidigt, anbefales omhyggelig monitorering af fuldt blodbillede og bivirkninger relateret til forhøjede rifabutinniveauer (f.eks. uveitis).
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 i raske frivillige, hos hvem der forekommer en højere eksponering for posaconazol sammenlignet med patienter, der fik den samme dosis.
English: The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/itraconazole.
Danish: Gennemsnitlig varighed af behandling var 29 dage for posaconazol og 25 dage for fluconazol/itraconazol.
English: Based on pharmacokinetic data in 10 of these paediatric patients, the pharmacokinetic profile appears to be similar to patients ≥ 18 years of age.
Danish: Baseret på farmakokinetiske data i 10 af disse pædiatriske patienter, synes den farmakokinetiske profil at være tilsvarende patienter ≥ 18 år.
English: As a result, sirolimus trough concentrations that fall within the usual therapeutic range may result in sub-therapeutic levels.
Danish: Som resultat heraf må dalkoncentrationer af sirolimus, der ligger inden for det sædvanlige terapeutiske indeks, resultere i sub-terapeutiske niveauer.
English: Gastrointestinal disorders Common:
Danish: Gastrointestinale sygdomme Almindelig:
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 initiering og afbrydelse af posaconazol behandling.
English: The mean duration of therapy was 80 days for posaconazole and 77 days for fluconazole.
Danish: Gennemsnitlig varighed af behandling var 80 dage for posaconazol og 77 dage for fluconazol.
English: Posaconazole SP works by killing or stopping the growth of some types of fungi that can cause infections in humans.
Danish: Posaconazole SP virker ved at dræbe eller stoppe væksten af nogle af de typer svampe, som kan forårsage infektioner i mennesker.
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 indgift af doser over 800 mg dagligt til patienter og raske forsøgspersoner.
English: You should not take this medicine if you have a condition called glucose-galactose malabsorption and should take note of this amount of glucose if you need to watch your sugar intake for any reason.
Danish: De bør ikke tage denne medicin hvis De lider af en tilstand der hedder glucose-galactoseintolerans eller hvis det er nødvendigt at De holder regnskab med denne mængde af glucose af enhver anden årsag.
English: Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Danish: Behandlingens varighed afhænger af sværhedsgraden af den grundlæggende sygdom, bedring efter immunosuppression og klinisk respons.
English: For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole SP should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm
Danish: For patienter med akut myeloid leukæmi eller myelodysplastisk syndrom, bør forebyggelse med Posaconazole SP påbegyndes flere dage før den forventede optræden af neutropeni og fortsætte i 7 dage efter det neutrofile antal stiger til over 500 celler per mm3.
English: Based on the available data in 16 of these paediatric patients, the safety profile appears to be similar to patients ≥ 18 years of age.
Danish: Baseret på tilgængelige data fra 16 af disse pædiatriske patienter, synes sikkerhedsprofilen at være tilsvarende til patienter ≥ 18 år.
English: In a study with small number of subjects (n=12) who had hepatic impairment, there was an increase in exposure associated with prolongation of half-life in hepatic impaired patients (26.6, 35.3, and 46.1 hours for the mild, moderate and severe groups, respectively compared to 22.1 hours in subjects with normal hepatic function).
Danish: I en undersøgelse med få patienter (n=12) med nedsat leverfunktion var der en øget eksponering forbundet med en forlænget halveringstid hos patienter med nedsat leverfunktion (26,6, 35,3, og 46,1 timer for henholdsvis let, moderat og alvorligt nedsat leverfunktion sammenlignet med 22,1 timer for personer med normal leverfunktion).
English: Clinical isolates with decreased susceptibility to posaconazole have been identified.
Danish: Kliniske isolater med nedsat følsomhed over for posaconazol er set.
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: During clinical trials, patients who received posaconazole doses up to 1,600 mg/day experienced no different adverse reactions from those reported with patients at the lower doses.
Danish: Under kliniske undersøgelser havde patienter, som fik posaconazol i doser op til 1.600 mg/dag, ikke oplevet andre bivirkninger end dem, der blev observeret hos patienter på lavere doser.
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 ergosterol biosyntesen.
English: If you are not able to take food or nutritional supplement, your doctor will tell you to take 200 mg (one 5 ml spoonful) four times a day.
Danish: Hvis De ikke er i stand til at indtage føde eller ernæringstilskud, vil Deres læge ordinere 200 mg (en 5 ml teskefuld) fire gange dagligt.
English: Posaconazole SP belongs to a group of medicines called triazole antifungal agents.
Danish: Posaconazole SP hører til en gruppe af lægemidler, som kaldes triazolsvampemidler.
English: adrenal insufficiency, blood gonadotropin decreased
Danish: adrenal insufficiens, nedsat blod gonadotropin
English: There were fewer breakthrough Aspergillus infections in patients receiving posaconazole prophylaxis when compared to control patients.
Danish: Der var færre gennembrydende Aspergillus infektioner hos patienter, der fik posaconazol forebyggende sammenlignet med kontrolpatienter.
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 1.4-fold and 4.6-fold greater, respectively, than those achieved with therapeutic doses.
Danish: Forhøjet systolisk og arterielt blodtryk (op til 29 mmHg) blev målt hos rotter og aber ved systemisk eksponering på henholdsvis 1,4 gange og 4,6 gange den, der opnås med terapeutiske doser.
English: Endocrine disorders Rare:
Danish: Endokrine sygdomme Sjælden:
English: Like all medicines, Posaconazole SP can cause side effects, although not everybody gets them.
Danish: Posaconazole SP kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Posaconazole SP is a white, cherry flavoured, 105 ml oral suspension packaged in amber glass bottles.
Danish: Posaconazole SP er en hvid, 105 ml oral suspension med kirsebæraroma, der er pakket i brune glasflasker.
English: Due to the limited pharmacokinetic data in patients with hepatic impairment, posaconazole should be used with caution in patients with severe hepatic impairment since the prolonged half-life that may occur will lead to increased exposure.
Danish: På grund af de begrænsede farmakokinetiske data fra patienter med nedsat leverfunktion bør posaconazol ordineres med forsigtighed til patienter med alvorligt nedsat leverfunktion, da den forlængede halveringstid kan føre til øget eksponering.
English: Medicines that can decrease blood levels of posaconazole include:
Danish: Lægemidler, der kan nedsætte koncentrationen af posaconazol i blodet, inkluderer:
English: • A very slow heartbeat
Danish: • Meget langsomme hjerteslag.
English: There is no information on the effect of Posaconazole SP on the ability to drive and use machines.
Danish: Der foreligger ingen oplysninger om virkningen af Posaconazole SP på evnen til at køre bil eller betjene maskiner.
English: Due to the risk of prolonged sedation it is recommended that dose adjustments should be considered when posaconazole is administered concomitantly with any benzodiazepine that is metabolised by CYP3A4 (e.g. midazolam, triazolam, alprazolam).
Danish: Som følge af risikoen for forlænget sedering, anbefales det at dosisjustering bør overvejes, når posaconazol gives samtidig med ethvert benzodiazepin, der metaboliseres af CYP3A4 (f.eks. midazolam, triazolam, alprazolam).
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: Posaconazol har in vitro vist effekt over for følgende mikroorganismer: Aspergillus arter (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: electrolyte imbalance, anorexia hyperglycaemia
Danish: elektrolytforstyrrelser, anoreksi hyperglykæmi
English: If co-administered, then it is recommended that dose adjustment of vinca alkaloids be considered.
Danish: Ved samtidig administration anbefales det at overveje dosisjustering af vincaalkaloider.
English: The effect of posaconazole on sirolimus in patients is unknown, but is expected to be variable due to the variable posaconazole exposure in patients.
Danish: Effekten af posaconazol på sirolimus i patienter er ukendt, men forventes at være variabel som følge af den variable posaconazol eksponering i patienter.
English: • Vincristine, vinblastine and other vinca alkaloids (used to treat cancer)
Danish: • Vincristin, vinblastin og andre vinca alkaloider (anvendt i cancerbehandling)
English: Monitoring of hepatic function: Patients who develop abnormal liver function tests during Posaconazole SP therapy must be routinely monitored for the development of more severe hepatic injury.
Danish: Monitorering af leverfunktion: Patienter, som får anormale leverfunktionsværdier under behandling med Posaconazole SP, skal rutinemæssigt monitoreres for at undgå udvikling af mere alvorlig leverskade.
English: Hypersensitivity: There is no information regarding cross-sensitivity between posaconazole and other azole antifungal agents.
Danish: Overfølsomhed: Der findes ingen data om krydsallergi mellem posaconazol og andre antimykotiske azolderivater.
English: Of the circulating metabolites, the majority are glucuronide conjugates of posaconazole with only minor amounts of oxidative (CYP450 mediated) metabolites observed.
Danish: Af de cirkulerende metabolitter er hovedparten glucuronidkonjugater af posaconazol, og kun mindre mængder af oxydative (CYP450 medierede) metabolitter er set.
English: • pimozide (used to treat symptoms of Tourette's disorder)
Danish: • pimozid (anvendes til behandling af symptomer ved Tourettes sygdom)
English: Effects of other medicinal products on posaconazole:
Danish: Andre lægemidlers virkning på posaconazol:
English: Proportion (%) of patients with proven/probable IFIs On-treatment period b
Danish: Patientandel (%) med bevist/sandsynlig IFIs On-treatment periode b d e
English: Pharmacokinetics in special populations
Danish: Farmakokinetik i specielle patientgrupper
English: Posaconazole SP may increase (possibly increasing the risk of side effects) the blood levels of some other medicines.
Danish: Posaconazole SP kan øge (muligvis øge risikoen for bivirkninger) koncentrationen i blodet af nogle andre lægemidler.
English: Adrenal suppressive effects were observed in toxicity studies in rats and dogs at exposures equal to or greater than those obtained at therapeutic doses in humans.
Danish: Binyrebarkhæmmende effekt blev observeret i toksicitetsundersøgelser hos rotter og hunde ved eksponering svarende til eller større end den, der opnås ved terapeutiske doser hos mennesker.
English: • Tacrolimus and sirolimus (used in transplant surgery)
Danish: • Tacrolimus og sirolimus (anvendt i transplanteringskirurgi)
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 De fire uger efter åbning af flasken har en rest af suspensionen tilbage, skal De ikke anvende denne medicinrest.
English: Posaconazole SP can be used to prevent fungal infections in patients whose immune systems may be weakened due to other medicines or diseases.
Danish: Posaconazole SP kan anvendes til at forhindre svampeinfektioner hos patienter, hvis immunforsvar kan være svækket som følge af anden medicin eller andre sygdomme.
English: Rarely, more severe hepatic reactions with fatal outcomes have been reported.
Danish: Mere alvorlige leverreaktioner med fatalt udfald er sjældent set.
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 afbrydes under behandling med posaconazol, da forhøjede niveauer har været forbundet med rhabdomyolyse (se pkt.
English: • Diltiazem, verapamil, nifedipine, nisoldipine and some of the other medicines called calcium channel blockers (used to treat high blood pressure)
Danish: • Diltiazem, verapamil, nifedipin, nisoldipin og nogle af de andre lægemidler kaldet calcium blokkere (anvendt til behandling af højt blodtryk)
English: The most frequently reported serious related adverse events included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.
Danish: De hyppigst rapporterede alvorlige bivirkninger er kvalme, opkastning, diarre, pyreksi og øget bilirubin.
English: In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
Danish: I begge forebyggende undersøgelser var aspergillose den mest almindelige gennembrydende infektion.
English: • Rifabutin and rifampicin (used to treat certain infections).
Danish: • Rifabutin og rifampicin (anvendt til behandling af visse infektioner).
English: However, the safety profile of posaconazole between the Black and Caucasian subjects was similar.
Danish: Sikkerhedsprofilen for posaconazol var imidlertid den samme hos negroide og kaukasiske
English: Any product remaining four weeks after opening the bottle should be discarded.
Danish: Eventuelt resterende lægemiddel skal kasseres 4 uger efter åbning af flasken.
English: You may need special blood tests to be done while you are taking Posaconazole SP.
Danish: Måske er det nødvendigt at De får taget særlige blodprøver mens De anvender Posaconazole SP.
English: When initiating treatment with posaconazole in patients already receiving ciclosporin, the dose of ciclosporin should be reduced (e.g. to about three quarters of the current dose).
Danish: Når behandling med posaconazol initieres hos patienter, der allerede modtager ciclosporin, bør ciclosporin dosis nedsættes (f.eks. til omkring tre fjerdedele af den aktuelle dosis).
English: HIV Protease Inhibitors: As HIV protease inhibitors are CYP3A4 substrates, it is expected that posaconazole will increase plasma levels of these antiretroviral agents.
Danish: HIV-Proteasehæmmere: Da HIV-proteasehæmmere er CYP3A4-substrater forventes det, at posaconazol vil øge plasmaniveauer af disse antiretrovirale midler.