FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study 316, overall mortality was similar (POS, 25%; FLU, 28%); however, the proportion of IFI- related 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 %);andelenafdødsfald med relation til IFI var derimod signifikant lavere i POS-gruppen (4/301) sammenlignet medFLUgruppen (12/299; P=0,0413).
English: Electrocardiogram evaluation
Danish: Elektrokardiogramundersøgelser
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Lægerogsundhedspersonaleanmodesomatindberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Prophylaxis in Neutropenia Study 1899
Danish: Profylaksefor neutropeni Studie 1899
English: The addition of posaconazole to therapy with atazanavir or with atazanavir plus ritonavir was associated with increases in plasma bilirubin levels.
Danish: Tilføjelsen af posaconazol til behandling med atazanavir eller med atazanavir plus ritonavir blev associeret med forhøjede bilirubinniveauer i plasma.
English: Prophylaxis in GVHD Study 316
Danish: Profylaksefor GVHD Studie 316
English: Ear and labyrinth disorder Rare:
Danish: Øre og labyrint Sjælden
English: As a result, sirolimus trough concentrations that fall within the usual therapeutic range may result in sub-therapeutic levels.
Danish: Som resultat heraf kan dalkoncentrationer af sirolimus, der ligger inden for det sædvanlige terapeutiske indeks, resultere i subterapeutiske niveauer.
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 atudvikleinvasivesvampeinfektioner.
English: menstrual disorder
Danish: Menstruationsforstyrrelser
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 forfostret.
English: Do not take Posaconazole Accord if any of the above apply to you.
Danish: Dumå ikke tage Posaconazole Accord, hvis noget af ovenstående gælder for dig.
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 sammenmed ritonavir, er ikke kendt.
English: - efavirenz and fosamprenavir used to treat HIV infection.
Danish: • efavirenz og fosamprenavir, der anvendes til behandling af hiv-infektion.
English: pulmonary hypertension, interstitial pneumonia, pneumonitis
Danish: Pulmonal hypertension, interstitiel pneumoni, pneumonitis
English: Most of the vinca alkaloids (e.g., vincristine and vinblastine) are substrates of CYP3A4.
Danish: De fleste vinkaalkaloider (f.eks. vincristin og vinblastin) er substrater af CYP3A4.
English: Plasma exposure
Danish: Plasmaeksponering
English: Hydroxypropyl cellulose (E463) Propyl gallate (E310)
Danish: Hydroxypropylcellulose (E463) Propylgallat (E310)
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, som ikke er medtaget i denneindlægsseddel.
English: Metabolism and nutrition disorders Common:
Danish: Metabolisme og ernæring Almindelig
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 foreliggende datafra 16 af disse pædiatriske patienter synes sikkerhedsprofilen at være tilsvarende for patienter ≥18 år.
English: The subject population included: 1) patients with AML or MDS who had recently received chemotherapy and had developed or were anticipated to develop significant neutropenia, or 2) patients who had undergone a HSCT and were receiving immunosuppressive therapy for prevention or treatment of GVHD.
Danish: Populationen af forsøgspersoner omfattede: 1) patienter med AML eller MDS, som fornyligt havde fået kemoterapi, og som havde udviklet eller forventedes at udvikle signifikant neutropeni, eller 2) patienter, som havde gennemført en HSCT, og som fik immunsuppressiv behandling til forebyggelseeller behandling af GVHD.
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 somprofylakse.
English: Combination with other antifungal agents
Danish: Kombination med andre antimykotika
English: There is insufficient information on the use of posaconazole in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af posaconazol til gravide kvinder.
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/ITZ67/298 (22 %) p=0,048].
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 plasmaniveaueraf disse antiretrovirale midler.
English: Dose adjustment of calcium channel blockers may be required.
Danish: Dosisjustering af calciumantagonister kan være nødvendigt.
English: You may feel dizzy, sleepy, or have blurred vision while taking Posaconazole Accord, 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 Accord, hvilket kan påvirke dinevne til at køre bil, bruge værktøj eller betjene maskiner.
English: This finding was not seen in monkeys dosed for one year.
Danish: Denne virkning blev ikke sethos aber, der blev behandlet i et år.
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: Indvirkningen af posaconazol påsirolimus hos patienter er ukendt, men forventes at være varierende som følge af den varierende eksponering for posaconazol hos patienterne.
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 havdechromoblastomykoseforårsagetaf Fonsecaea pedrosoiog4 havde mycetoma, hovedsageligforårsaget af Madurella-arter.
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 grundliggende sygdom, bedring efter immunsuppression og kliniskrespons.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturshjemmeside http://www.ema.europa.eu
English: Effects of posaconazole on other medicinal products
Danish: Virkningen af posaconazol på andre lægemidler
English: abnormal dreams, confusional state, sleep disorder
Danish: Unormale drømme, konfus tilstand, søvnforstyrrelser
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 forhøjetkolesterol.
English: The primary efficacy endpoint was the incidence of proven/probable IFIs as determined by an independent, blinded external expert panel during the on-treatment period.
Danish: Det primærevirkningsendepunktvarforekomst afverificeret/sandsynlig IFI bestemt af et uafhængigt, blindet eksternt ekspertpanel i on-treatment perioden.
English: Controla
Danish: Kontrola
English: ● At the request of the European Medicines Agency;
Danish: • påanmodningfraDetEuropæiskeLægemiddelagentur
English: The safety of posaconazole tablets has been assessed in 230 patients enrolled in the pivotal clinical study.
Danish: Sikkerheden af posaconazol tabletter er blevet vurderet hos 230 patienter, som var inkluderet i det pivotale kliniske studie.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudierhar påvist reproduktionstoksicitet (se pkt.
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: 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 aspergillosesammenlignet med en ekstern kontrolgruppe
English: Safety data at higher exposure levels achieved with posaconazole tablets are at present limited.
Danish: Sikkerhedsdata ved højereeksponeringsniveauer med posaconazol tabletter er på nuværende tidspunkt begrænset.
English: Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1st line therapy
Danish: Refraktære invasive svampeinfektioner(IFI)/pati enter med IFI, som erintolerante over for førstevalgsbehandling
English: Co-administration of posaconazole with sirolimus is not recommended and should be avoided whenever possible.
Danish: Samtidig administration af posaconazol og sirolimusanbefales ikke og bør undgås, når det er muligt.
English: Posaconazole is excreted into the milk of lactating rats (see section 5.3).
Danish: Posaconazol udskilles i mælken hos diegivende rotter (se pkt.5.3).
English: Patients who have severe diarrhoea or vomiting should be monitored closely for breakthrough fungal infections.
Danish: Patienter, der har alvorlig diarré eller kaster op, bør følges nøje fortilbagevendende svampeinfektioner.
English: 96 gastro-resistant tablets
Danish: 96 gastroresistente tabletter
English: Quartile pCav Range (ng/mL)
Danish: Kvartil pCavområde(ng/m
English: The pharmacokinetics of posaconazole oral suspension have been evaluated in paediatric patients.
Danish: Farmakokinetikken for posaconazol oral suspension er blevet vurderet hos pædiatriske patienter.
English: liver function tests raised (ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, GGT increased)
Danish: Forhøjede leverfunktionstest (forhøjet ALAT, forhøjet ASAT, forhøjet bilirubin, forhøjet alkalisk fosfatase, forhøjet GGT)
English: World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona,
Danish: World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona
English: pyrexia (fever), asthenia, fatigue
Danish: Pyreksi (feber), asteni, træthed
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain
Danish: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040
English: hyperglycaemia, hypoglycaemia
Danish: Hyperglykæmi, hypoglykæmi
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 spredtefarmakokinetiske prøver på flere dage understeady-state før den næste dosis (Cmin)for enstørrepopulation af forsøgspersoner.
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 kan ikke udskiftes med hinanden på grund af forskelle idoseringshyppighed, administration sammen med mad og opnået lægemiddelkoncentrationi plasmamellem de to formuleringer.
English: 300 mg once daily (Day 1 300 mg twice daily)*
Danish: 300 mg en gang dagligt (dag 1 300 mg to gange dagligt)*
English: Midazolam and other benzodiazepines metabolised by CYP3A4
Danish: Midazolam og andre benzodiazepiner, som metaboliseres af CYP3A4
English: Posaconazole does not have any major circulating metabolites and its concentrations are unlikely to be altered by inhibitors of CYP450 enzymes.
Danish: Posaconazol har ingen væsentlige cirkulerende metabolitter, og det er ikke sandsynligt, at koncentrationen vil blive påvirket af CYP450-enzymhæmmere.
English: Investigations Uncommon:
Danish: Undersøgelser Ikke almindelig
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02AC04
Danish: Farmakoterapeutisk klassifikation:Antimykotikatilsystemiskanvendelse, triazolderivater,ATCkode:J02AC04.
English: Accidental overdose was noted in one patient who took posaconazole oral suspension 1,200 mg twice a day for 3 days.
Danish: Uforsætlig overdosering sås hos en patient, som tog posaconazol oral suspension 1.200 mg to gange dagligt i 3 dage.
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 forekomst af verificeret/sandsynlig IFI iontreatmentperioden (fra første til sidste dosis studiemedicin + 7 dage).
English: Controla Proportion (%) of patients with proven/probable Aspergillosis On-treatment period b
Danish: Andel af patienter (%)med verificeret/sandsynlig Aspergillosis
English: Taking this medicine - Swallow the tablet whole with some water.
Danish: • Synk tabletten hel med vand.
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 associeretmed neurotoksicitet ogandre alvorlige bivirkninger, inklusive krampeanfald, perifer neuropati,syndrommed uhensigtsmæssig sekretion af antidiuretisk hormon og paralytiskileus.
English: Recommended dose according to indication.
Danish: Tabel 1.Anbefalet dosering efter indikation
English: No dose adjustment is recommended for patients with mild to severe hepatic impairment but caution is advised due to the potential for higher plasma exposure.
Danish: Dosisjustering anbefales ikke hos patienter med let til svær nedsat leverfunktion,menderbørudvises forsigtighed på grund afpotentialet for højere plasmaeksponering.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AFTILLADELSEN
English: Look at the list of medicines given above that must not be taken while you are taking Posaconazole Accord.
Danish: Se de ovenfor nævnte typer medicin, som ikke må anvendes, mens du tager Posaconazole Accord.
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: - Aspergillusflavus: 0,5 mg/l - Aspergillus fumigatus: 0,25 mg/l - Aspergillus nidulans: 0,5 mg/l - Aspergillus niger: 0,5 mg/l - Aspergillusterreus: 0,25 mg/l
English: renal tubular acidosis, interstitial nephritis Reproductive system and breast disorders Uncommon:
Danish: Renal tubulær acidose, interstitiel nefritis Det reproduktive system og mammae Ikke almindelig
English: Posaconazole should be used with caution in patients with hepatic impairment due to limited clinical experience and the possibility that posaconazole plasma levels may be higher in these patients (see sections 4.2 and 5.2).
Danish: Posaconazol bør anvendes med forsigtighed hos patienter med nedsat leverfunktion grundet begrænset klinisk erfaring og muligheden for, at posaconazols plasmaniveau kan være højere hos disse patienter(se pkt.
English: Patients who develop abnormal liver function tests during Posaconazole Accord therapy must be routinely monitored for the development of more severe hepatic injury.
Danish: Patienter, som får anormale leverfunktionsværdier under behandling med Posaconazole Accord, skal rutinemæssigt monitoreres for at undgå udvikling af mere alvorlig leverskade.
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 iergosterolbiosyntesen.
English: It is recommended to exercise caution due to the potential for higher plasma exposure.
Danish: Det anbefales at udviseforsigtighedpga.muligheden for højere plasmaeksponering.
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 får ciclosporin, bør dosis af ciclosporin nedsættes (f.eks. til omkring tre fjerdedele af den aktuelle dosis).
English: Do not adapt your dose yourself before consulting your doctor or change your treatment regimen.
Danish: Du må ikke selv tilpasse din dosis eller ændre din behandling, før duhartaltmed dinlæge.
English: altered medicine levels, blood phosphorus decreased, chest x-ray abnormal * Based on adverse reactions observed with the oral suspension, gastro-resistant tablets, and concentrate for solution for infusion.
Danish: Ændret lægemiddelkoncentration, nedsat fosforkoncentration i blodet, unormal røntgen af thorax * Baseret på bivirkninger, som blev observeret med den orale suspension, gastroresistente tabletter og koncentratet tilinfusionsvæske, opløsning.
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 behovførogunderbehandlingmedposaconazol.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER MED ENHEDSDOSERING
English: Yellow coated, capsule shaped tablet of approximate 17.5 mm length and 6.7 mm width, debossed with “100P” on one side and plain on the other side.
Danish: Kapselformet tablet med gult overtræk, der er ca. 17,5 mmlang og 6,7 mm bred,prægetmed “100P” på den ene side og glat på den anden side.
English: Renal clearance is a minor elimination pathway, with 14% of the radiolabelled dose excreted in urine (< 0.2% of the radiolabelled dose is parent compound).
Danish: Den renale udskillelse er begrænsetmed 14 %af den radioaktivt mærkede dosis udskilt i urinen (<0,2 % af den radioaktivt mærkede dosis er uforandret lægemiddel).
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 vedsamtidig administration af posaconazol.
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 aftacrolimus nedsættes (f.eks. til ca. en tredjedel af den aktuelle dosis).
English: Caution should be used when prescribing Posaconazole Accord to patients with hypersensitivity to other azoles.
Danish: Derbør udvises forsigtighed, når Posaconazole Accord ordineres til patienter, som er overfølsomme over for andre azoler.
English: In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
Danish: Ibegge deprofylaktiske studier var udbrud af aspergillose den hyppigste infektion.
English: If it is considered that co-administration is unavoidable, then it is recommended that the dose of sirolimus should be greatly reduced at the time of initiation of posaconazole therapy and that there should be very frequent monitoring of trough concentrations of sirolimus in whole blood.
Danish: Såfremt det vurderes, at samtidig administration ikke kan undgås, anbefales det, at dosis af sirolimus reduceres væsentligt ved initieringaf behandling medposaconazol, og at der bør ske meget hyppige målinger af dalkoncentrationer af sirolimus i fuldblod.
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, ogde giver generelt højere lægemiddeleksponering i plasma end posaconazole oral suspension.
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 årerikke klarlagt.
English: Triplex (PVC/PE/PVdC) white opaque-aluminium blister or perforated unit dose blister in cartons of 24 or 96 tablets.
Danish: 6.5 Emballagetype og pakningsstørrelser Triplex (PVC/PE/PVDC) hvid uigennemsigtig aluminiumsblister eller perforeret blister med enhedsdosering i kartoner med 24 eller 96 tabletter.
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 invitro, atposaconazolharvirkningpåfølgendemikroorganismer: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, Fonsecaeapedrosoi og arter af Fusarium, Rhizomucor, Mucor og Rhizopus.
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-glukuronidering (fase 2 enzymer) og er etsubstratforp-glykoprotein (P-gp) efflux invitro.
English: Posaconazole, after administration of the tablet, has a mean apparent volume of distribution of 394 L (42%), ranging between 294-583 L among the studies in healthy volunteers.
Danish: Efter administration af tabletten har posaconazol en gennemsnitlig tilsyneladende fordelingsvolumen på 394 l (42 %) i intervallet 294-583 l blandt studierne med raske forsøgspersoner.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • nårrisikostyringssystemetændres,særligsomfølgeaf, at der er modtaget nye oplysninger, derkan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtigmilepæl