FrancophonIA/ELRC3.0 huggingface dataset:
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 erhovedpartenglucuronidkonjugaterafposaconazol,ogkunmindremængderafoxidative(CYP450medierede) metabolitter er set.
English: Posaconazole Accord may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Danish: Posaconazole Accord kan øge mængden af disse lægemidler i blodet.
English: hearing impairment
Danish: Forringet hørelse
English: 1899d
Danish: Fixed-time periodec 1899d
English: Therefore, reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
Danish: Derfor bør azolantimykotika,inklusive posaconazol, kun anvendes til patienter, der får vinkaalkaloider, inklusive vincristin, og somikke har andre muligheder for behandlingmed antimykotika.
English: 9 of 11 patients were successfully treated with posaconazole oral suspension 800 mg/day in divided doses for a median of 268 days and up to 377 days.
Danish: 9 ud af 11 patienter blev tilfredsstillende behandlet med posaconazol oral suspension 800 mgdagligtfordeltpåfleredoserioptil377 dage med en median på 268 dage.
English: Stevens Johnson syndrome, vesicular rash Musculoskeletal and connective tissue disorders Uncommon:
Danish: Stevens Johnsons-syndrom, vesikulært udslæt Knogler, led, muskler og bindevæv Ikke almindelig
English: Rarely, more severe hepatic reactions with fatal outcomes have been reported.
Danish: Mere alvorlige hepatiske reaktioner medletaltudfaldersjældentset.
English: If you are not sure, talk to your doctor or pharmacist before taking Posaconazole Accord.
Danish: Kontakt lægen,apotekspersonalet eller sundhedspersonalet, før du tager Posaconazole Accord:
English: Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients.
Danish: Efter administration af posaconazol tabletter kan plasmakoncentrationen afposaconazol øges over tidhos nogle patienter.
English: As observed with other azole antifungal agents, these effects on reproduction were considered to be due to a treatment-related effect on steroidogenesis.
Danish: Som det er blevet set ved andre antimykotiskeazolderivater,ansåsindvirkningen på reproduktionen for at være en følge af denterapeutiske hæmning af steroidhormon-syntesen.
English: There is no experience with overdose of posaconazole tablets.
Danish: Der er ingen erfaring med overdosering af posaconazol tabletter.
English: Sirolimus concentrations should be measured upon initiation, during co-administration, and at discontinuation of posaconazole treatment, with sirolimus doses adjusted accordingly.
Danish: Koncentrationer af sirolimus bør måles ved initieringaf behandling, under samtidig administration og ved seponering af behandling med posaconazol.
English: Adverse reactions by body system and frequency* Blood and lymphatic system disorders Common:
Danish: Bivirkningeranførteftersystemorganklasseoghyppighed* Blod og lymfesystem
English: In another study in healthy volunteers, repeat dose administration of posaconazole oral suspension (200 mg twice daily for 7 days) increased the Cmax and AUC of intravenous midazolam (0.4 mg single dose) by an average of 1.3- and 4.6-fold (range 1.7 to 6.4-fold), respectively; Posaconazole oral suspension 400 mg twice daily for 7 days increased the intravenous midazolam Cmax and AUC by 1.6 and 6.2-fold (range 1.6 to 7.6-fold), respectively.
Danish: I et andet studie med raskefrivillige øgede gentagen administration af posaconazol oral suspension (200 mg to gange dagligt i 7dage) Cmaxog AUC forintravenøst midazolam (0,4 mg enkeltdosis) medet gennemsnit påhenholdsvis1,3og4,6gange (interval1,7 til6,4 gange);posaconazol oral suspension 400 mgtogangedagligt i7 dage øgede intravenøst midazolam Cmaxog AUC med henholdsvis 1,6og 6,2 gange(interval 1,6 til7,6 gange).
English: The usual dose is 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day, thereafter.
Danish: Den almindelige dosis er 300 mg (tre 100 mg tabletter) to gange dagligt på den første dag, herefter 300 mg(tre100mgtabletter)en gang dagligt.
English: As observed with other azole antifungal agents, effects related to inhibition of steroid hormone synthesis were seen in repeated-dose toxicity studies with posaconazole.
Danish: Som for andre antimykotiske azolderivater blev der i toksicitetsstudier med gentagne doser afposaconazol set virkning som følge af hæmningen af steroidhormonsyntesen.
English: The pharmacokinetics and safety data from Study 5615 were bridged to the existing data (including efficacy data) with the oral suspension.
Danish: Studie 5615 blev udført med en patientpopulation, der lignede den patientpopulation, som blev undersøgt i detpivotalekliniskeprogrammedposaconazoloralsuspension.Dataforfarmakokinetikogsikkerhedfrastudie 5615 blev overført til de allerede eksisterende data (inklusive data for virkning) med den oralesuspension.
English: Concomitant use of posaconazole and rifabutin and similar inducers (e.g. rifampicin) should be avoided unless the benefit to the patient outweighs the risk.
Danish: Samtidig administration af posaconazol og rifabutin og lignende induktorer (f.eks. rifampicin) bør undgås, medmindre fordelen for patienten opvejer risikoen.
English: Phenytoin (200 mg once a day) decreased the Cmax and AUC of posaconazole by 41% and 50%, respectively.
Danish: Phenytoin (200 mgengangdagligt)nedsatte Cmaxog AUC for posaconazol med henholdsvis41 % og50 %.
English: There are currently insufficient data to set clinical breakpoints for Aspergillus spp.
Danish: Der er for tiden utilstrækkelige data til at fastsætte kliniske grænseværdier for Aspergillus-arter.ECOFFværdierne er ikke sidestillet med de kliniske grænseværdier.
English: Vinca alkaloids
Danish: Vinkaalkaloider
English: thrombocytopenia, leukopenia, anaemia, eosinophilia, lymphadenopathy, splenic infarction
Danish: Trombocytopeni, leukopeni, anæmi, eosinofili, lymfadenopati, miltinfarkt
English: rash, pruritis
Danish: Udslæt, pruritis
English: If you forget to take Posaconazole Accord - If you forget a dose, take it as soon as you remember it. - 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: Thereafter blood levels of tacrolimus should be monitored carefully during co-administration, and upon discontinuation of posaconazole, and the dose of tacrolimus should be adjusted as necessary.
Danish: Derefter bør blodniveaueraftacrolimusmonitoreresomhyggeligtundersamtidigadministrationogvedseponeringaf posaconazol, og doseringen af tacrolimus bør justeres som nødvendigt.
English: Posaconazole oral suspension
Danish: Posaconazol oral suspension
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each gastro-resistant tablet contains 100 mg of posaconazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver gastroresistent tablet indeholder 100 mg posaconazol.
English: The effect of posaconazole on CYP3A4 substrates in patients might be somewhat lower than that observed in healthy volunteers, and is expected to be variable between patients due to the variable posaconazole exposure in patients.
Danish: Adskillige af interaktionsstudierne blev udført med raske frivillige forsøgspersoner, hos hvem der forekommer en højere eksponering for posaconazolsammenlignetmedpatienter,derfikdensammedosis.Virkningenafposaconazol påCYP3A4substrater hos patienter kan være noget lavere end den observeret hos raske frivillige, og den forventes at variere mellem patienter som følge af den varierende eksponering for posaconazol hos patienterne.
English: Renal and urinary disorders Uncommon:
Danish: Nyrer og urinveje Ikke almindelig
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (sebilagI:Produktresumé,pkt.4.2).
English: After a single oral dose of 400 mg posaconazole oral suspension to patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment (six per group), the mean AUC was 1.3 to 1.6-fold higher compared to that for matched control subjects with normal hepatic function.
Danish: Efter en enkelt oral dosis på 400 mg posaconazol oral suspension til patienter medlet(Child-Pughklasse A), moderat (Child-Pugh klasse B) eller svær (Child-Pugh klasse C) nedsat leverfunktion (sekspr.
English: The tablet formulation was investigated in AML and MDS patients and those after HSCT with or at risk for Graft versus Host Disease (GvHD) only.
Danish: Tabletformuleringen er udelukkende blevet undersøgt hos patienter med AML og patienter med MDSsamt hos patienter efter HSCTmed eller uden risiko for graft versus hostsygdom(GVHD).Denmaksimale varighed af eksponering for tabletformuleringen var kortere end eksponeringen for denorale suspension.
English: Tell your doctor or pharmacist or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment: - nausea or vomit (feeling or being sick), diarrhoea - signs of liver problems - these include yellowing of your skin or whites of the eyes, unusually dark urine or pale faeces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests - allergic reaction.
Danish: Dette kan være gulfarvning af huden eller det hvide i øjnene,usædvanlig mørk urin eller lys afføring, føler dig utilpas uden grund, maveproblemer, appetitløshed eller usædvanlig træthed eller svaghed, en stigning i leverenzymer fremgår afdine blodprøver
English: What you need to know before you take Posaconazole Accord
Danish: Det skal du vide, før du begynder at tagePosaconazole Accord
English: How to take Posaconazole Accord
Danish: Sådan skal du tage Posaconazole Accord
English: What Posaconazole Accord is and what it is used for What you need to know before you take Posaconazole Accord How to take Posaconazole Accord Possible side effects
Danish: Det skal du vide, før du begynder at tage Posaconazole Accord Sådan skal du tage Posaconazole Accord Bivirkninger
English: pancreatitis, abdominal distension, enteritis, epigastric discomfort, eructation, gastrooesophageal reflux disease, oedema mouth
Danish: Pankreatitis, oppustethed, enteritis, epigastriske gener, opstød, gastroøsofageal reflukssygdom, ødem i munden
English: which are given with ritonavir) - midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants) - diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure) - digoxin (used to treat heart failure) - Glipizide or other “sulfonylureas” (used to treat high blood sugar).
Danish: • diltiazem, verapamil, nifedipin, nisoldipin eller andre “calciumblokkere” (anvendes til behandling af højt blodtryk)
English: was comparable among ten adolescents (13-17 years of age) to Cav achieved in adults (≥ 18 years of age).
Danish: I forebyggelsesstudiernevarmiddelværdien ved steady-state for den gennemsnitlige koncentration af posaconazol (Cav) blandt tiunge (13-17år)ligeledessammenlignelig med Cav opnået hos voksne (≥18 år).
English: PHARMACEUTICAL PARTICULARS
Danish: FARMACEUTISKEOPLYSNINGER
English: Polyvinyl alcohol-part hydrolyzed Titanium dioxide (E171) Macrogol
Danish: Titandioxid(E171)
English: Non-Interchangeability between Posaconazole Accord tablets and posaconazole oral suspension
Danish: Posaconazole Accord tabletter og Posaconazole Accord oral suspension kan ikke udskiftes med hinanden
English: Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
Danish: Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis du opdager en eller flere af følgende bivirkninger:
English: Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Danish: Studie 316 var et randomiseret, dobbeltblindet studie af posaconazol oral suspension (200 mgtregange dagligt) versus fluconazolkapsler (400 mg en gang dagligt) til patienter medgraft versus hostsygdom(GVHD), der havde gennemgået allogen HSCT.Detprimærevirkningsendepunkt varforekomstafverificeret/sandsynligIFI16ugerefterrandomiseringbestemtafetuafhængigt,blindeteksternt ekspertpanel.
English: Repeat dose administration of posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Danish: Gentagen administration af posaconazol oral suspension (400 mg to gange dagligt i 16 dage) øgedeCmaxogAUCforsirolimus(2mgenkeltdosis) med henholdsvis et gennemsnit på6,7 gangeog 8,9 gange (interval 3,1 til 17,5 gange) hos raske forsøgspersoner.
English: Coccidioidomycosis
Danish: Coccidioidomykose
English: Co-administration with ergot alkaloids (see section 4.5).
Danish: Samtidig administration med sekalealkaloider (se pkt.
English: Twenty patients received 200 mg daily dose and 210 patients received 300 mg daily dose (following twice daily dosing on Day 1 in each cohort).
Danish: Behandling med posaconazol blev givet med en medianvarighed på 28 dage.20 patienter fik en daglig dosis på 200 mg, og 210 patienterfik en daglig dosis på 300 mg (efter dosering,to gange dagligt på dag 1i hver kohorte).
English: NAME OF THE MEDICINAL PRODUCT Posaconazole Accord 100 mg gastro-resistant tablets
Danish: LÆGEMIDLETS NAVN Posaconazole Accord 100 mg gastroresistente tabletter
English: Not all pack sizes may be marketed.
Danish: Ikkeallepakningsstørrelserernødvendigvismarkedsført.
English: Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the 1st day, 200 mg twice daily on the 2nd day, then 400 mg twice daily x 8 Days) by 21% and 23%,
Danish: Hvis samtidig administration er nødvendig, tilrådes nøje monitorering for tilbagevendendesvampeinfektioner.Gentagnedoseraffosamprenavir(700mgto gange dagligt i 10dage)nedsatte Cmaxog AUC for posaconazoloral suspension (200 mgengang dagligtpå dag 1, 200 mgto gangedagligtpådag2,derefter400 mgto gange dagligt i8 dage) med henholdsvis 21 %og 23 %.
English: Posaconazole may increase the plasma concentration of ergot alkaloids (ergotamine and dihydroergotamine), which may lead to ergotism.
Danish: Posaconazol kan øge plasmakoncentrationen af sekalealkaloider (ergotamin og dihydroergotamin), somkanmedføreergotisme.Samtidigadministrationafposaconazologsekalealkaloidererkontraindiceret (se pkt.
English: H2 receptor antagonists and proton pump inhibitors No clinically relevant effects were observed when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Danish: Ingenkliniskrelevantvirkningblevobserveret,daposaconazoltabletterblevanvendtsammenmedsyreneutralis erendemidler, H2-receptorantagonisterogprotonpumpehæmmere.Dosisjusteringerafposaconazol tabletter er ikke nødvendige, når posaconazol tabletter anvendes sammen syreneutraliserendemidler, H2receptorantagonisterogprotonpumpehæmmere.
English: hepatocellular damage, hepatitis, jaundice, hepatomegaly, cholestasis, hepatic toxicity, hepatic function abnormal
Danish: Hepatocellulær ødelæggelse, hepatitis, gulsot, hepatomegali, kolestase, levertoksicitet, unormal leverfunktion
English: Talk to your doctor or pharmacist before taking Posaconazole Accord - if you have had an allergic reaction to another antifungal medicine such as ketoconazole,
Danish: • hvis du har haft en allergisk reaktion over for et andet svampemiddel såsom ketoconazol,
English: Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
Danish: Initialdosis på 300 mg (tre 100 mgtabletter)togangedagligtpåden første dag, herefter 300 mg (tre 100 mg tabletter) en gangdagligt.
English: Co-administration of posaconazole with CYP3A4 substrates may result in large increases in exposure to CYP3A4 substrates as exemplified by the effects on tacrolimus, sirolimus, atazanavir and midazolam below.
Danish: PosaconazolerenpotenthæmmerafCYP3A4.SamtidigadministrationafposaconazologCYP3A4-substrater kan resultere i en stor stigning i eksponering for CYP3A4-substrater som eksemplificeretnedenfor ved virkningenpåtacrolimus,sirolimus,atazanavirogmidazolam.Forsigtighedbørudvisesunder samtidig administration af posaconazol og CYP3A4-substrater administreret intravenøst, og derkanværebehovfor,atdosisafCYP3A4-substratet reduceres.
English: Oral posaconazole suspension 800 mg/day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a noncomparative salvage therapy trial (Study 0041).
Danish: Iet ikke-sammenlignende studie med salvage-behandling (studie 0041) blev posaconazol oralsuspension 800 mg dagligt fordelt på flere doser vurderet som behandling af invasiv aspergillose hos patienter,somvarsygdomsrefraktæreoverforbehandlingmedamphotericin B (inklusiveliposomformuleringer) eller itraconazol eller hos patienter, der havde intolerans over for disse lægemidler.
English: vomiting, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence, constipation, anorectal discomfort
Danish: Opkastning, abdominalsmerte, diarré, dyspepsi, mundtørhed, flatulens, obstipation, anorektale gener
English: Due to the risk of prolonged sedation and possible respiratory depression co-administration of posaconazole with any benzodiazepines metabolised by CYP3A4 (e.g. midazolam, triazolam, alprazolam) should only be considered if clearly necessary.
Danish: Som følge af risikoen for forlænget sedering og mulig respirationsdepression bør samtidig administrationafposaconazologbenzodiazepiner,sommetaboliseresafCYP3A4(f.eks.midazolam,triazolam,
English: Posaconazole plasma concentrations following administration of posaconazole tablets are generally higher than those obtained with posaconazole oral suspension.
Danish: Plasmakoncentrationen af posaconazolergenerelthøjereefteradministration af posaconazol tabletterend efter posaconazol oral suspension.
English: Therefore, inhibitors (e.g. verapamil, ciclosporin, quinidine, clarithromycin, erythromycin, etc.) or inducers (e.g. rifampicin, rifabutin, certain anticonvulsants, etc.) of these clearance pathways may increase or decrease posaconazole plasma concentrations, respectively.
Danish: Hæmmere (f.eks. verapamil, ciclosporin, quinidin,chlarithromycin,erythromycin osv.)eller induktorer (f.eks. rifampicin, rifabutin, visse antiepileptikaosv.)
English: Reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options (see section 4.5).
Danish: Azolantimykotika, inklusive posaconazol, bør kun anvendes til patienter,der fårvinkaalkaloider,inklusivevincristin, ogsom ikke har andre muligheder for behandling med antimykotika (se pkt.
English: In heart transplant patients on stable doses of ciclosporin, posaconazole oral suspension 200 mg once daily increased ciclosporin concentrations requiring dose reductions.
Danish: Posaconazol oral suspension 200 mg en gang dagligt øgede koncentrationerne af ciclosporin hos hjertetransplanteredepatienterpåenstabildosisafciclosporin, hvilketmedførtebehovfordosisnedsættelser.
English: Gastro-resistant tablet
Danish: Gastroresistenttablet
English: No overall differences in safety were observed between the geriatric patients and younger patients; therefore, no dosage adjustment is recommended for geriatric patients.
Danish: Farmakokinetikkenforposaconazoltabletterersammenlignelighosungeogældreforsøgspersoner.Der blev ikke observeret nogen generelle forskelle i sikkerheden hos de ældre patienter og de yngrepatienter.
English: Do not pass it on to others.
Danish: Lad derfor være med at give medicinentilandre.
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26-fold respectively.
Danish: Efter samtidig administration af posaconazol oral suspension (400 mg to gange dagligt) og atazanavir (300 mg en gang dagligt) i 7 dage hos raske forsøgspersoner øgedesCmaxogAUCforatazanavirmedetgennemsnit påhenholdsvis2,6gange og 3,7gange(interval 1,2til26 gange).
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir and ritonavir (300/100 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 1.5-fold and 2.5-fold (range 0.9 to 4.1-fold), respectively.
Danish: Efter samtidig administration af posaconazol oral suspension (400 mgtogangedagligt) ogatazanavirog ritonavir (300/100 mg en gangdagligt) i 7 dage hos raskeforsøgspersoner øgedes CmaxogAUCforatazanavirmedetgennemsnitpåhenholdsvis1,5gange og 2,5gange (interval 0,9til 4,1 gange).
English: Breast-feeding must be stopped on initiation of treatment with posaconazole.
Danish: Amning skal ophøre ved påbegyndelse af behandling medposaconazol.
English: Invasive aspergillosis
Danish: Invasivaspergillose
English: See also below regarding the effect of posaconazole on rifabutin plasma levels.
Danish: Se også nedenfor vedrørende virkningenafposaconazolpåplasmaniveauerafrifabutin.
English: Posaconazole Accord 100 mg gastro-resistant tablets posaconazole
Danish: Posaconazole Accord 100 mg gastroresistente tabletter posaconazol
English: Calcium channel blockers metabolised through CYP3A4 (e.g. diltiazem, verapamil, nifedipine, nisoldipine)
Danish: Calciumantagonister metaboliseret via CYP3A4 (f.eks. diltiazem, verapamil, nifedipin, nisoldipin) Der anbefales hyppig monitorering for bivirkninger og toksicitet relateret til calciumantagonister ved administration sammen med posaconazol.
English: If you take more Posaconazole Accord than you should If you think that you may have taken too much Posaconazole Accord, talk to a doctor or go to the hospital straight away.
Danish: Hvis du har taget for meget Posaconazole Accord Kontakt lægen, skadestuen eller apoteket, hvis du har tagetmere af Posaconazole Accord, end der står i denne information, eller mere end lægen har foreskrevet (og du føler dig utilpas).
English: Posaconazole was not genotoxic in in vitro and in vivo studies.
Danish: Posaconazol var ikke genotoksisk iinvitro-og invivo-studier.Karcinogenicitetsstudier viste ingenspeciel risiko for mennesker.
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 tabletterne elimineres posaconazol langsomt med en gennemsnitlighalveringstid(t½) på 29 timer (26-31 timer) og en gennemsnitlig tilsyneladende udskillelsei intervallet7,5 til 11 l/time.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).