natgillin/translations-raw huggingface dataset:
Indvirkningen af posaconazol påsirolimus hos patienter er ukendt, men forventes at være varierende som følge af den varierende eksponering for posaconazol hos patienterne.
The effect of posaconazole on sirolimus in patients is unknown, but is expected to be variable due to the variable posaconazole exposure in patients.
5 af disse patienter havdechromoblastomykoseforårsagetaf Fonsecaea pedrosoiog4 havde mycetoma, hovedsageligforårsaget af Madurella-arter.
Five of these patients had chromoblastomycosis due to Fonsecaea pedrosoi and 4 had mycetoma, mostly due to Madurella species.
Behandlingens varighed afhænger af sværhedsgraden af den grundliggende sygdom, bedring efter immunsuppression og kliniskrespons.
Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturshjemmeside http://www.ema.europa.eu
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Virkningen af posaconazol på andre lægemidler
Effects of posaconazole on other medicinal products
Unormale drømme, konfus tilstand, søvnforstyrrelser
abnormal dreams, confusional state, sleep disorder
• et “statin” såsom simvastatin, atorvastatin eller lovastatin, der anvendes til behandling af forhøjetkolesterol.
- a “statin” such as simvastatin, atorvastatin or lovastatin used to treat high cholesterol.
Det primærevirkningsendepunktvarforekomst afverificeret/sandsynlig IFI bestemt af et uafhængigt, blindet eksternt ekspertpanel i on-treatment perioden.
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.
Kontrola
Controla
• påanmodningfraDetEuropæiskeLægemiddelagentur
● At the request of the European Medicines Agency;
Sikkerheden af posaconazol tabletter er blevet vurderet hos 230 patienter, som var inkluderet i det pivotale kliniske studie.
The safety of posaconazole tablets has been assessed in 230 patients enrolled in the pivotal clinical study.
Dyrestudierhar påvist reproduktionstoksicitet (se pkt.
Studies in animals have shown reproductive toxicity (see section 5.3).
• nogle lægemidler, der anvendes til at behandle eller forebygge krampeanfald, herunder phenytoin,carbamazepin, phenobarbital eller primidon.
- some medicines used to treat or prevent fits including; phenytoin, carbamazepine, phenobarbital or primidone).
Samlet virkning af posaconazol oral suspension efter endt behandling af invasiv aspergillosesammenlignet med en ekstern kontrolgruppe
Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group
Sikkerhedsdata ved højereeksponeringsniveauer med posaconazol tabletter er på nuværende tidspunkt begrænset.
Safety data at higher exposure levels achieved with posaconazole tablets are at present limited.
Refraktære invasive svampeinfektioner(IFI)/pati enter med IFI, som erintolerante over for førstevalgsbehandling
Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1st line therapy
Samtidig administration af posaconazol og sirolimusanbefales ikke og bør undgås, når det er muligt.
Co-administration of posaconazole with sirolimus is not recommended and should be avoided whenever possible.
Posaconazol udskilles i mælken hos diegivende rotter (se pkt.5.3).
Posaconazole is excreted into the milk of lactating rats (see section 5.3).
Patienter, der har alvorlig diarré eller kaster op, bør følges nøje fortilbagevendende svampeinfektioner.
Patients who have severe diarrhoea or vomiting should be monitored closely for breakthrough fungal infections.
96 gastroresistente tabletter
96 gastro-resistant tablets
Kvartil pCavområde(ng/m
Quartile pCav Range (ng/mL)
Farmakokinetikken for posaconazol oral suspension er blevet vurderet hos pædiatriske patienter.
The pharmacokinetics of posaconazole oral suspension have been evaluated in paediatric patients.
Forhøjede leverfunktionstest (forhøjet ALAT, forhøjet ASAT, forhøjet bilirubin, forhøjet alkalisk fosfatase, forhøjet GGT)
liver function tests raised (ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, GGT increased)
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona,
Pyreksi (feber), asteni, træthed
pyrexia (fever), asthenia, fatigue
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain
Hyperglykæmi, hypoglykæmi
hyperglycaemia, hypoglycaemia
Derudover blev der udtaget spredtefarmakokinetiske prøver på flere dage understeady-state før den næste dosis (Cmin)for enstørrepopulation af forsøgspersoner.
Moreover, sparse PK samples were collected at several days during steady state before the next dose (Cmin) for a larger subject population.
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.
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.
300 mg en gang dagligt (dag 1 300 mg to gange dagligt)*
300 mg once daily (Day 1 300 mg twice daily)*
Midazolam og andre benzodiazepiner, som metaboliseres af CYP3A4
Midazolam and other benzodiazepines metabolised by CYP3A4
Posaconazol har ingen væsentlige cirkulerende metabolitter, og det er ikke sandsynligt, at koncentrationen vil blive påvirket af CYP450-enzymhæmmere.
Posaconazole does not have any major circulating metabolites and its concentrations are unlikely to be altered by inhibitors of CYP450 enzymes.
Undersøgelser Ikke almindelig
Investigations Uncommon:
Farmakoterapeutisk klassifikation:Antimykotikatilsystemiskanvendelse, triazolderivater,ATCkode:J02AC04.
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02AC04
Uforsætlig overdosering sås hos en patient, som tog posaconazol oral suspension 1.200 mg to gange dagligt i 3 dage.
Accidental overdose was noted in one patient who took posaconazole oral suspension 1,200 mg twice a day for 3 days.
Et centralt sekundært endepunkt var forekomst af verificeret/sandsynlig IFI iontreatmentperioden (fra første til sidste dosis studiemedicin + 7 dage).
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).
Andel af patienter (%)med verificeret/sandsynlig Aspergillosis
Controla Proportion (%) of patients with proven/probable Aspergillosis On-treatment period b
• Synk tabletten hel med vand.
Taking this medicine - Swallow the tablet whole with some water.
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.
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.
Tabel 1.Anbefalet dosering efter indikation
Recommended dose according to indication.
Dosisjustering anbefales ikke hos patienter med let til svær nedsat leverfunktion,menderbørudvises forsigtighed på grund afpotentialet for højere plasmaeksponering.
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.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AFTILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Se de ovenfor nævnte typer medicin, som ikke må anvendes, mens du tager Posaconazole Accord.
Look at the list of medicines given above that must not be taken while you are taking Posaconazole Accord.
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
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
Renal tubulær acidose, interstitiel nefritis Det reproduktive system og mammae Ikke almindelig
renal tubular acidosis, interstitial nephritis Reproductive system and breast disorders Uncommon:
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.
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).
Patienter, som får anormale leverfunktionsværdier under behandling med Posaconazole Accord, skal rutinemæssigt monitoreres for at undgå udvikling af mere alvorlig leverskade.
Patients who develop abnormal liver function tests during Posaconazole Accord therapy must be routinely monitored for the development of more severe hepatic injury.
Posaconazol hæmmer enzymet lanosterol 14α-demetylase (CYP51), som katalyserer et essentielt trin iergosterolbiosyntesen.
Posaconazole inhibits the enzyme lanosterol 14α-demethylase (CYP51), which catalyses an essential step in ergosterol biosynthesis.
Det anbefales at udviseforsigtighedpga.muligheden for højere plasmaeksponering.
It is recommended to exercise caution due to the potential for higher plasma exposure.
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).
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).
Du må ikke selv tilpasse din dosis eller ændre din behandling, før duhartaltmed dinlæge.
Do not adapt your dose yourself before consulting your doctor or change your treatment regimen.
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.
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.
Elektrolytforstyrrelser, især dem som er forbundet med kalium-, magnesium-eller calciumniveauer,bør monitoreres og korrigeres efter behovførogunderbehandlingmedposaconazol.
Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET BLISTER MED ENHEDSDOSERING
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTER
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.
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.
Den renale udskillelse er begrænsetmed 14 %af den radioaktivt mærkede dosis udskilt i urinen (<0,2 % af den radioaktivt mærkede dosis er uforandret lægemiddel).
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).
Det bør bemærkes, at forholdet mellem dalkoncentrationen af sirolimus og AUC ændres vedsamtidig administration af posaconazol.
It should be noted that the relationship between sirolimus trough concentration and AUC is changed during co-administration with posaconazole.
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).
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).
Derbør udvises forsigtighed, når Posaconazole Accord ordineres til patienter, som er overfølsomme over for andre azoler.
Caution should be used when prescribing Posaconazole Accord to patients with hypersensitivity to other azoles.
Ibegge deprofylaktiske studier var udbrud af aspergillose den hyppigste infektion.
In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
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.
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.
Posaconazol-tabletter er den foretrukne formulering til optimering af plasmakoncentrationer, ogde giver generelt højere lægemiddeleksponering i plasma end posaconazole oral suspension.
Posaconazole tablets are the preferred formulation to optimize plasma concentrations and generally provide higher plasma drug exposures than posaconazole oral suspension.
Posaconazols sikkerhed og virkning hos børn under 18 årerikke klarlagt.
The safety and efficacy of posaconazole in children aged below 18 years have not been established.
6.5 Emballagetype og pakningsstørrelser Triplex (PVC/PE/PVDC) hvid uigennemsigtig aluminiumsblister eller perforeret blister med enhedsdosering i kartoner med 24 eller 96 tabletter.
Triplex (PVC/PE/PVdC) white opaque-aluminium blister or perforated unit dose blister in cartons of 24 or 96 tablets.
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.
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.
Posaconazol metaboliseres via UDP-glukuronidering (fase 2 enzymer) og er etsubstratforp-glykoprotein (P-gp) efflux invitro.
Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for pglycoprotein (P-gp) efflux in vitro.
Efter administration af tabletten har posaconazol en gennemsnitlig tilsyneladende fordelingsvolumen på 394 l (42 %) i intervallet 294-583 l blandt studierne med raske forsøgspersoner.
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.
• nårrisikostyringssystemetændres,særligsomfølgeaf, at der er modtaget nye oplysninger, derkan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtigmilepæl
● 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.
Dobbeltsyn, scotoma
diplopia, scotoma
I tabel 3 er der vist en sammenligning af eksponering (Cav) efter administration af posaconazol tablet og posaconazol oral suspension ved terapeutiske doser til patienter vist som en kvartilanalyse.
In Table 3 a comparison is shown of exposure (Cav) after administration of posaconazole tablet and posaconazole oral suspension at therapeutic doses in patients depicted as quartile analysis.
200 mgtre gange dagligt
200 mg three times daily
Utilstrækkelig behandling defineres som progression af en infektion eller mangel på bedring efter mindst 7 dagesterapeutiskedoserafeffektivbehandlingmedantimykotika.
Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Dervar en svag reduktion (16 %) iAUC og Cmaxfor posaconazol oral suspensionhos negroide iforhold til kaukasiske personer.
There was a slight decrease (16%) in the AUC and Cmax of posaconazole oral suspension in Black subjects relative to Caucasian subjects.
Seksten patienter i alderen 8-17 år blev behandlet med posaconazol oral suspension 800 mg/dag i etstudie med invasive svampeinfektioner.
Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections.
Derfor kan posaconazol øge plasmakoncentrationen af digoxin, så det er nødvendigt at monitorere digoxinniveauerne ved påbegyndelse ellerseponering af behandling med posaconazol.
Therefore, posaconazole may increase plasma concentration of digoxin and digoxin levels need to be monitored when initiating or discontinuing posaconazole treatment.
Almene symptomer og reaktioner på administrationsstedet Almindelig
General disorders and administration site conditions Common:
Der er ingen klinisk erfaring, som vurderer posaconazols indvirkning på fertiliteten hos mennesker.
There is no clinical experience assessing the impact of posaconazole on fertility in humans.
Cav = den gennemsnitlige koncentration målt vedsteady-state *20 patienter fik 200mg en gang dagligt (på dag 1 200mg to gange dagligt)
Cav = the average concentration when measured at steady state *20 patients received 200 mg once daily (Day 1 200 mg twice daily)
Posaconazol findes også som 40 mg/ml oral suspension og300mg koncentrat til infusionsvæske,opløsning.
Posaconazole is also available as 40 mg/mL oral suspension and 300 mg concentrate for solution for infusion.
Hvisduerenkvinde,som kan blive gravid, skal du anvende sikker prævention, mens du tager
If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine.
Køn Farmakokinetikken for posaconazol tabletter er sammenlignelig hos mænd og kvinder.
Gender The pharmacokinetics of posaconazole tablets are comparable in men and women.
Er du i tvivl, så spørg lægen ellerapotekspersonalet, før du tager dette lægemiddel.
If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Sikkerhedsprofilen for tabletterne var lig sikkerhedsprofilen for den orale suspension.
The safety profile of tablets was similar to that of the oral suspension.
Derudover fik tolv patienter i alderen 13-17 år posaconazol oral suspension 600 mg/dag tilforebyggelse af invasive svampeinfektioner (studie 316 og1899).
Additionally, twelve patients 13-17 years of age received posaconazole oral suspension 600 mg/day for prophylaxis of invasive fungal infections (Studies 316 and 1899).
Sikkerhedsprofilen for posaconazol var imidlertid den samme hos negroideogkaukasiskepersoner.
However, the safety profile of posaconazole between the Black and Caucasian subjects was similar.
To forskellige doseringsgrupper blev vurderet: 200mg to gange dagligt pådag 1, herefter efterfulgt af 200 mg en gang dagligt (del IA) og 300 mg to gange dagligt på dag 1,herefterefterfulgtaf300 mg en gang dagligt (del 1B og del 2).
Two different dosing groups were evaluated: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Part IA) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Part 1B and Part 2).
Posaconazoltabletter absorberes med en medianTmaxpå 4 til 5 timerog udviser dosisproportionalfarmakokinetik efter enkeltdosis og flergangsdosering på op til 300 mg.
Posaconazole tablets are absorbed with a median Tmax of 4 to 5 hours and exhibits dose proportional pharmacokinetics after single and multiple dosing up to 300 mg.
Det er især vigtigt at forsøge at sikre, at de maksimale plasmaniveauer opnås hos patienter, der er inficeret med Aspergillus (se pkt.
It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens).
Anden medicin
Other medicines
Cav kvartilanalyser af pivotale patientstudier med posaconazol tablet og oral suspension Posaconazol tablet
Cav quartile analyses of pivotal patient studies with posaconazole tablet and oral suspension Posaconazole tablet
Dumåikke skifte mellem Posaconazole Accord tabletter og posaconazol oral suspension uden først at tale med lægeneller apotekspersonalet, da dette kan medføre manglende virkning eller øge risikoen for bivirkninger.
Do not switch between taking Posaconazole Accord tablets and posaconazole oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.
Hvisdisselægemidleradministreressamtidigt,anbefalesomhyggeligmonitorering af fuldstændigblodtælling og bivirkninger relateret til forhøjede niveauer af rifabutin (f.eks. uveitis).
If these medicinal products are co-administered, careful monitoring of full blood counts and adverse reactions related to increased rifabutin levels (e.g. uveitis) is recommended.
Posaconazol har en høj proteinbinding (>98 %)hovedsageligtilserumalbumin.
Posaconazole is highly protein bound (> 98%), predominantly to serum albumin.
Hvis posaconazol anvendes sammenmedCYP3A4-substrater, som administreres oralt, og for hvilke en stigning i plasmakoncentrationernekan være forbundet med uacceptable bivirkninger, bør plasmakoncentrationerne af CYP3A4-substratog/eller bivirkninger følges nøje, og dosis justeres efter behov.
If posaconazole is used concomitantly with CYP3A4 substrates that are administered orally, and for which an increase in plasma concentrations may be associated with unacceptable adverse reactions, plasma concentrations of the CYP3A4 substrate and/or adverse reactions should be closely monitored and the dose adjusted as needed.
I tolv måneders neurotoksicitetsstudier med hunde og aber blev der ikke konstateret påvirkning af det centrale eller perifere nervesystem ved systemisk eksponering, der var større end den, derblev opnået terapeutisk.
In twelve-month neurotoxicity studies in dogs and monkeys, no functional effects were observed on the central or peripheral nervous systems at systemic exposures greater than those achieved therapeutically.
Der er ingen særlig behandling tilgængelig i tilfælde af overdosering med posaconazol.
There is no special treatment available in the case of overdose with posaconazole.
Dosis og varighed af behandling (Sepkt.
Dose and duration of therapy (See section 5.2)
Virkningen af samtidig administration af posaconazol på plasmaniveauer for CYP3A4-substrat kan også variere hos den enkelte patient.
The effect of co-administration with posaconazole on plasma levels of CYP3A4 substrates may also be variable within a patient.