natgillin/translations-raw huggingface dataset:
Følgende lægemidler kan nedsætte virkningen af Posaconazole Accord ved at nedsætte mængden af Posaconazole Accord i blodet:
Certain medicines may increase the risk of side effects of Posaconazole Accord by increasing the amount of Posaconazole Accord in the blood.
Der anbefales hyppig monitorering for bivirkninger og toksicitet relateret til antiretrovirale midler, der er CYP3A4-substrater, vedadministration samtidig med posaconazol.
Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during coadministration with posaconazole.
Kombination af fosamprenavir og posaconazol kan medføre lavere plasmakoncentration af posaconazol.
Combining fosamprenavir with posaconazole may lead to decreased posaconazole plasma concentrations.
K3
Q3
96x1 gastroresistente tabletter
24x1 gastro-resistant tablet 96x1 gastro-resistant tablet
Hjerneblødning, encefalopati, perifer neuropati, synkope
cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope
11 ud af 24 patienter med påvist eller sandsynlig fusariose blev tilfredsstillende behandlet med posaconazol oral suspension 800 mg dagligt fordelt på flere doser i op til 212 dage med en median på124 dage.
11 of 24 patients who had proven or probable fusariosis were successfully treated with posaconazole oral suspension 800 mg/day in divided doses for a median of 124 days and up to 212 days.
Et centralt sekundært endepunkt var forekomstaf verificeret/sandsynligIFI100 dage efterrandomisering.
A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomization.
Patienternevarimmunkompromitteretmedtilgrundliggendetilstande,herunderhæmatologiskmalignitet, neutropeni efter kemoterapi, GVHD og efter HSCT.
Patients were immunocompromised with underlying conditions including haematological malignancy, neutropenia post-chemotherapy, GVHD, and post HSCT.
Efavirenz(400 mg en gang dagligt) nedsatte Cmaxog AUC for posaconazol med henholdsvis45 % og50 %.
Efavirenz (400 mg once a day) decreased the Cmax and AUC of posaconazole by 45% and 50%, respectively.
Samtidig administration med HMG-CoAreduktasehæmmerne simvastatin, lovastatin og atorvastatin(se pkt.
Co-administration with the HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin (see section 4.5).
Samtidig anvendelse af posaconazol og efavirenz bør undgås, medmindre fordelen for patienten opvejer risikoen.
Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient outweighs the risk.
11 ud af 16 patienter blev tilfredsstillende behandlet (efter endt behandling fuldstændig eller delvis bedring af alle tegn og symptomer på infektion, der var til stede ved behandlingsstart (baseline)) medposaconazol oral suspension 800 mg dagligt fordelt på flere doser i op til 460 dage med en median på296 dage.
11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole oral suspension 800 mg/day in divided doses for a median of 296 days and up to 460 days.
Posaconazol oral suspension Ekstern kontrolgruppe
Posaconazole oral suspension External control group
Forebyggelse af invasivesvampeinfektioner
Prophylaxis of invasive fungal infections
Seriellefarmakokinetiskeprøverblevudtagetpådag 1 ogvedsteady-state på dag 8 for alleforsøgspersoner i del 1 og en delgruppe af forsøgspersonerne i del2.
Serial PK samples were collected on Day 1 and at steady-state on Day 8 for all Part 1 subjects and a subset of Part 2 subjects.
200 mgfiregange dagligt (indlagt), herefter400 mg to gange dagligt
200 mg four times daily (hospitalized) then 400 mg twice daily
Sørg for at fortælle din lægeomalledelægemidler,dutager(bådereceptpligtigeogikke-receptpligtige).
Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed).
Kramper, neuropati, hypoesthesi, tremor, afasi, insomni
convulsions, neuropathy, hypoaesthesia, tremor, aphasia, insomnia
Torsades de pointes, pludselig død, ventrikulær takykardi, hjertestop/respirationsstop, nedsat hjertefunktion, myokardieinfarkt
torsade de pointes, sudden death, ventricular tachycardia, cardio-respiratory arrest, cardiac failure, myocardial infarction
Der var færre udbrud afAspergillus-infektion hos patienter, der fik posaconazol forebyggende,sammenlignetmedpatienter i kontrolgruppen.
There were fewer breakthrough Aspergillus infections in patients receiving posaconazole prophylaxis when compared to control patients.
I kliniske effektstudier blev der rapporteret klinisk signifikanteinteraktioner, som resulterede i hospitalsindlæggelse og/eller afbrydelse af behandling med posaconazol.
Clinically significant interactions resulting in hospitalisation and/or posaconazole discontinuation were reported in clinical efficacy studies.
Akut nyresvigt, nyresvigt, forhøjet kreatininkoncentration i blodet
acute renal failure, renal failure, blood creatinine increased
• brystsmerter
breast pain
Isærpatienter,derfår posaconazol efter HSCT og som haren lav kropsvægt (<60kg), harstørresandsynlighed for at opleve højere plasmakoncentration af posaconazologbørmonitoreresnøjeforbivirkninger.
Patients, in particular those receiving posaconazole after HSCT, who have a low body weight (< 60 kg) are more likely to experience higher plasma concentrations of posaconazole and should be closely monitored for adverse events.
Niveauet af ciclosporin i blodet bør derefter følges omhyggeligt under samtidig administrationog efter afbrydelse af behandling med posaconazol, og dosis af ciclosporin bør om nødvendigt justeres.
Thereafter blood levels of ciclosporin should be monitored carefully during co-administration, and upon discontinuation of posaconazole treatment, and the dose of ciclosporin should be adjusted as necessary.
Den eksterne kontrolgruppe bestod af 86patienterbehandletmedtilgængeligterapi(somovennævnt)påomtrentsammetidspunktogpådesamme afdelinger, som patienterne behandlet med posaconazol.
The external control group included 86 patients treated with available therapy (as above) mostly at the same time and at the same sites as the patients treated with posaconazole.
Posaconazol er en hæmmer af CYP3A4 og bør kun anvendes under særlige omstændigheder vedbehandlingmedandrelægemidler,sommetaboliseresafCYP3A4(sepkt.
Posaconazole is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4 (see section 4.5).
5.1): - Invasiv aspergillose hos patienter med sygdom, hvor behandling med amphotericin B elleritraconazol har været utilstrækkelig, eller hos patienter med intolerans over for disse lægemidler; - Fusariose hos patienter med sygdom, hvor behandling med amphotericin B har væretutilstrækkelig, eller hos patienter med intolerans over for amphotericin B; - Chromoblastomykoseog mycetoma hos patienter med sygdom, hvor behandling meditraconazol har været utilstrækkelig, eller hos patienter med intolerans over for itraconazol; - Coccidioidomykose hos patienter med sygdom, hvor behandlingmedamphotericinB,itraconazol eller fluconazol har været utilstrækkelig, eller hos patienter med intolerans over for disse lægemidler.
Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Samlet respons Virkning per art Alle mykotisk bekræftet Aspergillus-arter.2 A. fumigatus
Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Sammendrag af bridging-studiet med posaconazol tabletten Studie5615varetikke-sammenlignende multicenterstudie, som blev udført for at vurdere defarmakokinetiske egenskaber, sikkerheden og tolerabiliteten af posaconazol tabletten.
Study 5615 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole tablet.
Samtidig administration kan resultere i forhøjede plasmakoncentrationer afdisselægemidler,somkanmedføreQTc-forlængelse og sjældne forekomster af torsades de pointes(se pkt.
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).
Studie 1899 var et randomiseret, evaluator-blindet studie af posaconazol oral suspension (200 mgtregange dagligt) versus fluconazol suspension (400 mg en gang dagligt) eller itraconazol oral opløsning(200 mg to gange dagligt) hos patienter medneutropeni,derfikcytotoksiskkemoterapiforakutmyeloid leukemi eller myelodysplastisk syndrom.
Study 1899 was a randomised, evaluator-blinded study of posaconazole oral suspension (200 mg three times a day) versus fluconazole suspension (400 mg once daily) or itraconazole oral solution (200 mg twice a day) in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukaemia or myelodysplastic syndromes.
Cavområde(ng
Cav Range (ng/mL)
Parestesi, svimmelhed, døsighed, hovedpine, dysgeusi
paresthesia, dizziness, somnolence, headache, dysgeusia
Posaconazol øgedeCmaxog AUC forrifabutin med henholdsvis 31% og72%.
Posaconazole increased the Cmax and AUC of rifabutin by 31% and 72%, respectively.
Samtidig administration af posaconazol ogphenytoin og lignende induktorer (f.eks.carbamazepin, phenobarbital, primidon) bør undgås, medmindre fordelen for patienten opvejerrisikoen.
Concomitant use of posaconazole and phenytoin and similar inducers (e.g. carbamazepine, phenobarbital, primidone) should be avoided unless the benefit to the patient outweighs the risk.
Hiv-proteasehæmmere
HIV Protease inhibitors
Som følge af risikoen for forlænget sedering, anbefales det at dosisjustering bør overvejes, nårposaconazolgivessamtidigmedethvilkensomhelstbenzodiazepin,dermetaboliseresafCYP3A4(f.eks. midazolam, triazolam, alprazolam) (se pkt.
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) (see section 4.4).
Posaconazole Accord indeholder natrium
Posaconazole Accord contain sodium
Posaconazoltabletter
Posaconazole tablets
I kliniske effektstudier blev der rapporteret tilfælde af stigning i ciclosporinniveauer med alvorlige bivirkninger til følge, inklusive nefrotoksicitet samt et letalt tilfælde af leukoencephalopati.
Cases of elevated ciclosporin levels resulting in serious adverse reactions, including nephrotoxicity and one fatal case of leukoencephalopathy, were reported in clinical efficacy studies.
Sammendrag af studier med posaconazol oral suspension
Summary of posaconazole oral suspension studies
Efter administration af en enkeltdosis af 300 mg posaconazol-tabletter efter et måltid med højt fedtindhold tilraskeforsøgspersoner var AUC0-72timerogCmaxhøjeresammenlignetmed administrationunderfaste(henholdsvis51 %og16 %for AUC0-72timerog Cmax).
Following a single dose administration of 300 mg posaconazole tablets after a high fat meal to healthy volunteers, the AUC0-72 hours and Cmax were higher compared to administration under fasted condition (51% and 16% for AUC0-72 hours and Cmax respectively).
Indehaver af markedsføringstilladelsen Accord Healthcare S.L.U.
MARKETING AUTHORISATION HOLDER Accord Healthcare S.L.U.
Posaconazol kan øge plasmakoncentrationen af vinkaalkaloider,hvilket kan føretilneurotoksicitetogandrealvorligebivirkninger.
Posaconazole may increase the plasma concentrations of vinca alkaloids which may lead to neurotoxicity and other serious adverse reactions.
Påbasis af gennemsnitlige Cmin-koncentrationer kunnederudregnes en formodet gennemsnitlig koncentration (Cav) for 186 forsøgspersoner, som havde fået endosis på 300 mg.FarmakokinetiskanalysehospatientermedCavkonstaterede,at81%afforsøgspersonerne behandlet med en dosis på 300 mg en gang dagligt opnåede en formodet Cav vedsteady-state på mellem 5002.500ng/ml.Enforsøgsperson(<1 %) havde en formodet Cav på under500 ng/l, og 19 % af forsøgspersonerne havde en formodet Cav på over 2.500 ng/ml.
Based on average Cmin concentrations, a predicted average concentration (Cav) could be calculated for 186 subjects dosed with 300 mg. PK analysis in patients of Cav found that 81% of the subjects treated with the 300 mg once daily dose attained steady state predicted Cav between 500-2,500 ng/mL.
I tillæg tildenmedicin,somernævntovenfor,erderandenmedicin,somindebæreren risiko forhjerterytmeproblemer, som kan være større, når de tages med Posaconazole Accord.
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 Accord.
Samtidig administration af azol-antimykotika, inklusive posaconazol, og vincristin er blevet associeret medalvorligebivirkninger (se pkt.
Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with serious adverse reactions (see section 4.4).
Farmakokinetikken for posaconazol formodes ikke at blive påvirket af nedsat nyrefunktion, og deranbefales ikke dosisjustering (se pkt.
An effect of renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended (see section 5.2).
Af de cirkulerende metabolitter erhovedpartenglucuronidkonjugaterafposaconazol,ogkunmindremængderafoxidative(CYP450medierede) metabolitter er set.
Of the circulating metabolites, the majority are glucuronide conjugates of posaconazole with only minor amounts of oxidative (CYP450 mediated) metabolites observed.
Posaconazole Accord kan øge mængden af disse lægemidler i blodet.
Posaconazole Accord may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Forringet hørelse
hearing impairment
Fixed-time periodec 1899d
1899d
Derfor bør azolantimykotika,inklusive posaconazol, kun anvendes til patienter, der får vinkaalkaloider, inklusive vincristin, og somikke har andre muligheder for behandlingmed antimykotika.
Therefore, reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
9 ud af 11 patienter blev tilfredsstillende behandlet med posaconazol oral suspension 800 mgdagligtfordeltpåfleredoserioptil377 dage med en median på 268 dage.
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.
Stevens Johnsons-syndrom, vesikulært udslæt Knogler, led, muskler og bindevæv Ikke almindelig
Stevens Johnson syndrome, vesicular rash Musculoskeletal and connective tissue disorders Uncommon:
Mere alvorlige hepatiske reaktioner medletaltudfaldersjældentset.
Rarely, more severe hepatic reactions with fatal outcomes have been reported.
Kontakt lægen,apotekspersonalet eller sundhedspersonalet, før du tager Posaconazole Accord:
If you are not sure, talk to your doctor or pharmacist before taking Posaconazole Accord.
Efter administration af posaconazol tabletter kan plasmakoncentrationen afposaconazol øges over tidhos nogle patienter.
Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients.
Som det er blevet set ved andre antimykotiskeazolderivater,ansåsindvirkningen på reproduktionen for at være en følge af denterapeutiske hæmning af steroidhormon-syntesen.
As observed with other azole antifungal agents, these effects on reproduction were considered to be due to a treatment-related effect on steroidogenesis.
Der er ingen erfaring med overdosering af posaconazol tabletter.
There is no experience with overdose of posaconazole tablets.
Koncentrationer af sirolimus bør måles ved initieringaf behandling, under samtidig administration og ved seponering af behandling med posaconazol.
Sirolimus concentrations should be measured upon initiation, during co-administration, and at discontinuation of posaconazole treatment, with sirolimus doses adjusted accordingly.
Bivirkningeranførteftersystemorganklasseoghyppighed* Blod og lymfesystem
Adverse reactions by body system and frequency* Blood and lymphatic system disorders Common:
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).
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.
Den almindelige dosis er 300 mg (tre 100 mg tabletter) to gange dagligt på den første dag, herefter 300 mg(tre100mgtabletter)en gang dagligt.
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.
Som for andre antimykotiske azolderivater blev der i toksicitetsstudier med gentagne doser afposaconazol set virkning som følge af hæmningen af steroidhormonsyntesen.
As observed with other azole antifungal agents, effects related to inhibition of steroid hormone synthesis were seen in repeated-dose toxicity studies with posaconazole.
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.
The pharmacokinetics and safety data from Study 5615 were bridged to the existing data (including efficacy data) with the oral suspension.
Samtidig administration af posaconazol og rifabutin og lignende induktorer (f.eks. rifampicin) bør undgås, medmindre fordelen for patienten opvejer risikoen.
Concomitant use of posaconazole and rifabutin and similar inducers (e.g. rifampicin) should be avoided unless the benefit to the patient outweighs the risk.
Phenytoin (200 mgengangdagligt)nedsatte Cmaxog AUC for posaconazol med henholdsvis41 % og50 %.
Phenytoin (200 mg once a day) decreased the Cmax and AUC of posaconazole by 41% and 50%, respectively.
Der er for tiden utilstrækkelige data til at fastsætte kliniske grænseværdier for Aspergillus-arter.ECOFFværdierne er ikke sidestillet med de kliniske grænseværdier.
There are currently insufficient data to set clinical breakpoints for Aspergillus spp.
Vinkaalkaloider
Vinca alkaloids
Trombocytopeni, leukopeni, anæmi, eosinofili, lymfadenopati, miltinfarkt
thrombocytopenia, leukopenia, anaemia, eosinophilia, lymphadenopathy, splenic infarction
Udslæt, pruritis
rash, pruritis
• Hvis det imidlertid næsten er tid for din næste dosis, så spring den glemte dosis over og vend tilbage til dit sædvanlige dosisskema.
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.
Derefter bør blodniveaueraftacrolimusmonitoreresomhyggeligtundersamtidigadministrationogvedseponeringaf posaconazol, og doseringen af tacrolimus bør justeres som nødvendigt.
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.
Posaconazol oral suspension
Posaconazole oral suspension
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver gastroresistent tablet indeholder 100 mg posaconazol.
STATEMENT OF ACTIVE SUBSTANCE(S) Each gastro-resistant tablet contains 100 mg of posaconazole.
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.
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.
Nyrer og urinveje Ikke almindelig
Renal and urinary disorders Uncommon:
Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (sebilagI:Produktresumé,pkt.4.2).
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).
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.
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.
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.
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.
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
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.
Det skal du vide, før du begynder at tagePosaconazole Accord
What you need to know before you take Posaconazole Accord
Sådan skal du tage Posaconazole Accord
How to take Posaconazole Accord
Det skal du vide, før du begynder at tage Posaconazole Accord Sådan skal du tage Posaconazole Accord Bivirkninger
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
Pankreatitis, oppustethed, enteritis, epigastriske gener, opstød, gastroøsofageal reflukssygdom, ødem i munden
pancreatitis, abdominal distension, enteritis, epigastric discomfort, eructation, gastrooesophageal reflux disease, oedema mouth