natgillin/translations-raw huggingface dataset:
The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/itraconazole.
Zdravljenje s posakonazolom jetrajalopovprečno29 dni in s flukonazolom/itrakonazolom 25 dni.
Limited data on the effect of hepatic impairment (including Child-Pugh C classification of chronic liver disease) on the pharmacokinetics of posaconazole demonstrate an increase in plasma exposure compared to subjects with normal hepatic function, but do not suggest that dose adjustment is necessary (see sections 4.4 and 5.2).
Majhno število podatkov o vplivu okvare jeter (vključno s kronično boleznijo jeter razreda C po klasifikacijiChild-Pugh) na farmakokinetiko posakonazola kaže na povečanje plazemskeizpostavljenosti temu zdravilu v primerjavi s preiskovanci z normalnim delovanjem jeter, vendar nenakazuje, da bi bilo treba prilagoditiodmerek (glejte poglavji 4.4 in 5.2).
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.
Rumena obložena tableta v obliki kapsule, dolga približno 17,5mm in široka približno 6,7 mm, z vtisnjeno oznako "100P" na eni strani in brez oznake na drugi strani.
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).
Po uporabi14C-posakonazolase jeradioaktivnost pojavila predvsem v blatu (77 %radioaktivno označenega odmerka);glavnideltega jebilamatična spojina (66 % radioaktivno označenega odmerka).
Patients who have severe diarrhoea or vomiting should be monitored closely for breakthrough fungal infections.
Bolnike, ki imajo hudo drisko ali bruhajo, je treba skrbno spremljati gledeprebijajočih(breakthrough) glivnih okužb.
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.
Zdravljenje mora uvesti zdravnik z izkušnjami pri zdravljenju glivnih okužb ali podporni oskrbi bolnikov z velikim tveganjem, pri katerih je posakonazol indiciran za profilakso.
Supportive care may be considered.
V poštev pride podporno zdravljenje.
Gender The pharmacokinetics of posaconazole tablets are comparable in men and women.
Spol Farmakokinetika tablet posakonazola je pri moških in ženskah primerljiva.
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.
Tableteposakonazola se absorbirajo s srednjo vrednostjo tmaxod 4 do 5 ur in imajopo enkratnem invečkratnih odmerkih do 300 mg odmerku sorazmerno farmakokinetiko.
adrenal insufficiency, blood gonadotropin decreased
insuficienca nadledvične žleze, znižana raven gonadotropinov v krvi
300 mg once daily (Day 1 300 mg twice daily)*
300 mg enkrat na dan (1. dan300mg dvakrat na dan)*
- a “statin” such as simvastatin, atorvastatin or lovastatin used to treat high cholesterol.
- katerega od statinov, na primer simvastatina, atorvastatina ali lovastatina, ki se uporabljajo za zdravljenje visokega holesterola.
Pharmacokinetic modeling with an oral tablet formulation suggests that patients weighing greater than 120 kg may have lower posaconazole exposure.
Farmakokinetično modeliranje z obliko peroralnih tablet kaže, da je lahko izpostavljenost posakonazolumanjša pri bolnikih, ki tehtajo več kot 120 kg.
electrolyte imbalance, anorexia, decreased appetite, hypokalaemia, hypomagnesaemia
neravnovesje elektrolitov, anoreksija, zmanjšanje apetita, hipokaliemija, hipomagneziemija
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).
da pri bolnikih, okuženih zAspergillusom,dosežemonajvečje plazemske koncentracije (glejte poglavji 4.2 in 5.2 o priporočenih režimih odmerjanja).
Sulfonylureas
Sulfonilsečnine
An effect of renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended (see section 5.2).
Vpliva okvare ledvic na farmakokinetiko posakonazola ni pričakovati, zato prilagajanje odmerkov nipotrebno (glejte poglavje 5.2).
Therefore, posaconazole may increase plasma concentration of digoxin and digoxin levels need to be monitored when initiating or discontinuing posaconazole treatment.
Posakonazol torej lahko poveča plazemsko koncentracijo digoksina, zato je treba ob uvedbi in po prenehanju zdravljenja s posakonazolom spremljati koncentracijo digoksina.
No clinically relevant changes in the mean QTc (Fridericia) interval from baseline were observed.
V primerjavi z izhodiščem niso opazili kliničnopomembnih sprememb povprečnega intervala QTc (Fridericia).
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).
Poleg tega je dvanajst bolnikov, starih od 13 do 17 let, prejemalo peroralno suspenzijo posakonazola v odmerku 600mg/danzaprofilaksoinvazivnihglivnihokužb(študiji316in1899).
Posaconazole Accord must not be administered with medicinal products that are substrates for CYP3A4 and are known to prolong the QTc interval (see sections 4.3 and 4.5).
Zdravila Posakonazol Accord se ne sme uporabljati skupaj z zdravili, ki so substrati CYP3A4 in za katere je znano, da podaljšajo interval QTc (glejte poglavji 4.3 in 4.5).
Posaconazole increased the Cmax and AUC of rifabutin by 31% and 72%, respectively.
Posakonazolje povečal Cmaxrifabutina za 31% in AUC rifabutina za 72%.
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.
V primeru sočasne uporabe je priporočljivo skrbno spremljanje celotne krvne slike in neželenih učinkov, povezanih s povečanokoncentracijo rifabutina (npr. uveitisa).
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.
Če ste pozabili vzeti zdravilo Posakonazol Accord - Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
200 mg four times daily (hospitalized) then 400 mg twice daily
200 mg štirikratnadan(h ospitalizirani), nato 400 mg dvakrat na dan
The safety profile in these patients < 18 years of age appears similar to the safety profile observed in adults.
Varnostniprofilzdravila je pri teh bolnikih, mlajših od 18 let, videti podoben kot pri odraslih.
Concomitant use of posaconazole and rifabutin should be avoided unless the benefit to the patient outweighs the risk (see also above regarding the effect of rifabutin on plasma levels of posaconazole).
Sočasni uporabiposakonazola in rifabutina se je treba izogibati, razen če korist za bolnika odtehta tveganje (glejtezgoraj za učinke rifabutina na plazemsko koncentracijo posakonazola).
INFORMATION IN BRAILLE Posaconazole Accord 100 mg
PODATKI V BRAILLOVI PISAVI Posakonazol Accord 100 mg
Midazolam and other benzodiazepines metabolised by CYP3A4
Midazolam in drugi benzodiazepini, ki se presnovijo s CYP3A4
In heart transplant patients on stable doses of ciclosporin, posaconazole oral suspension 200 mg once daily increased ciclosporin concentrations requiring dose reductions.
Pri bolnikih s presajenim srcem, ki prejemajo stabilne odmerke ciklosporina, je peroralna suspenzija posakonazola v odmerku 200 mg enkrat na dan povečala koncentracijo ciklosporina, tako da je bilopotrebno zmanjšanje njegovega odmerka.
The safety profile of tablets was similar to that of the oral suspension.
Varnostni profil tablet je podoben varnostnemu profilu peroralne suspenzije.
Co-administration with ergot alkaloids (see section 4.5).
Sočasna uporaba z alkaloidi ergot (glejte poglavje 4.5).
Patients who develop abnormal liver function tests during Posaconazole Accord therapy must be routinely monitored for the development of more severe hepatic injury.
Bolnike, pri katerih se med zdravljenjem z zdravilom Posakonazol Accord pojavijo nenormalni izvidi jetrnihtestov, je treba rutinsko spremljati glede nastanka hujše poškodbe jeter.
Combining fosamprenavir with posaconazole may lead to decreased posaconazole plasma concentrations.
Sočasna uporaba fosamprenavirja in posakonazola lahko zmanjša koncentracijo posakonazola vplazmi.
Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Varnost in učinkovitost posakonazola pri otrocih, mlajših od 18 let, nistaugotovljeni.Trenutnorazpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
Look at the list of medicines given above that must not be taken while you are taking Posaconazole Accord.
Preberite zgornji seznam zdravil, ki jih ne smete jemati med zdravljenjem z zdravilom Posakonazol 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.
Poleg zgoraj navedenih zdravil so s tveganjem za motnje srčnega ritma povezana še druga zdravila in tveganje je lahko večje, če takšna zdravila jemljete skupaj z zdravilom Posakonazol
Posaconazole Accord may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Zdravilo Posakonazol Accord morda lahko poveča tveganje za pojav neželenih učinkov nekaterih drugih zdravil, ker poveča njihovo količino v krvi.
blurred vision, photophobia, visual acuity reduced
zamegljen vid, fotofobija, zmanjšanje ostrine vida
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).
Pri bolnikih z okvaro jeter je treba posakonazol uporabljati previdno, ker jekliničnih izkušenj malo inker obstaja možnost, da je koncentracija posakonazola v plazmi pri teh bolnikih višja (glejte poglavji 4.2 in 5.2).
Controla Proportion (%) of patients with proven/probable Aspergillosis On-treatment period b
Kontrolnaskupinaa Odstotek (%) bolnikov zdokazano oziroma verjetno aspergilozo Obdobjezdravljenjab
Monitoring of glucose concentrations is recommended in diabetic patients.
Pri sladkornih bolnikih je priporočljivo spremljati koncentracije glukoze.
At exposures lower than those obtained at therapeutic doses in humans, posaconazole caused skeletal variations and malformations, dystocia, increased length of gestation, reduced mean litter size and postnatal viability.
Priizpostavljenostih, manjših od izpostavljenosti, doseženih s terapevtskimi odmerki pri človeku, je posakonazol povzročil spremembe skeleta in malformacije, distocijo, podaljšanje gestacije,
Posaconazole inhibits the enzyme lanosterol 14α-demethylase (CYP51), which catalyses an essential step in ergosterol biosynthesis.
Posakonazolzaviraencimlanosterol-14α-demetilazo (CYP51), ki katalizira eno od ključnih stopenj vbiosinteziergosterola.
Several of the interaction studies were conducted in healthy volunteers in whom a higher exposure to posaconazole occurs compared to patients administered the same dose.
Pri zdravih prostovoljcih je bilo opravljenih več študij medsebojnega delovanjaposakonazola z drugimi zdravili, pri katerih je bila izpostavljenost posakonazolu večja kot pri bolnikih, ki so prejemali enak odmerek.
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.
klaritromicin,eritromicin, itd.) ali induktorji (npr. rifampicin, rifabutin, določeni antikonvulzivi, itd.) teh poti izločanja povečajo ali zmanjšajo koncentracije posakonazola vplazmi.
mouth ulceration, alopecia, dermatitis, erythema, petechiae
razjede v ustih, alopecija, dermatitis, eritem, petehije
Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for pglycoprotein (P-gp) efflux in vitro.
Posakonazol se presnovi z glukuronidacijo UDP (encimi 2. faze) in je invitro substrat iztoka s p-glikoproteinom (P-gp).
Posaconazole after administration of the tablets, is slowly eliminated with a mean half-life (t½) of 29 hours (range 26 to 31 hours) and a mean apparent clearance ranging from 7.5 to 11 L/hr.
Pouporabi tablet se posakonazol počasi izločas povprečnimrazpolovnim časom(t1/2) 29 ur (razponod26 do 31 ur) in povprečnim navideznim očistkom od 7,5 do11 l/uro.
long QT syndrome§, electrocardiogram abnormal§, palpitations, bradycardia, supraventricular extrasystoles, tachycardia
sindrom dolgega QT§, nenormalen elektrokardiogram§, palpitacije, bradikardija, supraventrikularne ekstrasistole, tahikardija
Rifabutin (300 mg once a day) decreased the Cmax (maximum plasma concentration) and AUC (area under the plasma concentration time curve) of posaconazole to 57% and 51%, respectively.
Rifabutin(300 mg enkrat na dan)je zmanjšalCmax(največjo plazemskokoncentracijo) posakonazolana 57 %, AUC posakonazola (površino pod krivuljo plazemske koncentracije v odvisnosti od časa) pa na 51 %.
Therefore, reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
Azolskiantimikotiki,vključno s posakonazolom, naj bodo zato rezerviraniza bolnike, ki prejemajo alkaloid vinke, vključnoz vinkristinom, in ki nimajo alternativnih možnosti protiglivnega zdravljenja.
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.
Zdravilo v obliki tablet so raziskali pri bolnikih z AML ali MDS in pri bolnikih po presaditvi hematopoetskih matičnih celic (HSCT), vendar le pri tistih, ki so imeli bolezen presadka proti gostitelju (GvHD) ali tveganje zanjo.
The pharmacokinetics of posaconazole tablets are comparable in young and elderly subjects.
Starostniki Farmakokinetika tablet posakonazola je pri mlajših in pri starejših bolnikih primerljiva.
The other ingredients are: Methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505), xylitol (E967), hydroxypropyl cellulose (E463), propyl gallate (E310), cellulose microcrystalline (E460), silica colloidal anhydrous, croscarmellose sodium, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), iron oxide yellow (E172).
Druge sestavine zdravila so: kopolimer metakrilne kisline in etilakrilata (1 : 1), trietil citrat (E1505), ksilitol (E967), hidroksipropilceluloza (E463), propil galat (E310), mikrokristalna celuloza (E460), brezvodni koloidni silicijev dioksid, premreženi natrijev karmelozat, natrijev stearilfumarat, polivinilalkohol, titanov dioksid (E171), makrogol, smukec (E553b), rumeni železov oksid (E172).
Some patients have also reported feeling confused after taking Posaconazole Accord, the frequency of this is not known.
Nekateri bolniki so po jemanju zdravila Posakonazol Accord poročali tudi o občutkuzmedenosti;pogostnosttegani znana.
- if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin
- čejemljete:terfenadin, astemizol, cisaprid, pimozid, halofantrin, kinidin,katerokolizdravilo,ki vsebuje alkaloide ergot (na primer ergotamin ali dihidroergotamin) ali kakšen statin, na primer simvastatin, atorvastatin ali lovastatin.
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.
Preglednica 3 prikazuje primerjavo izpostavljenosti (Cav) po uporabi tablet posakonazola in peroralnesuspenzije posakonazola v terapevtskih odmerkih pri bolnikih, predstavljeno z analizo kvartilov.
Quartile pCav Range (ng/mL)
Razpon pCav(ng/
During clinical trials, patients who received posaconazole oral suspension doses up to 1,600 mg/day experienced no different adverse reactions from those reported with patients at the lower doses.
Med kliničnimi preskušanji niso bili neželeni učinki pri bolnikih, ki so dobili peroralno suspenzijo posakonazola v odmerkih do 1.600 mg/dan, nič drugačni odneželenihučinkov, o katerih so poročalipri bolnikih, ki so dobivali manjše odmerke.
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.
11 od 16 bolnikov so uspešno zdravili (ob koncu zdravljenja popolno ali delno izginotje izhodiščnih znakov in simptomov) s peroralno suspenzijo posakonazola 800 mg/dan v deljenihodmerkih.Srednjavrednosttrajanjazdravljenjajebila296 dni,zdravljenjepajelahkotrajalodo460 dni.
Adrenal suppressive effects were observed in toxicity studies in rats and dogs at exposures equal to or greater than those obtained at therapeutic doses in humans.
V študijah toksičnosti na podganah in psih so opažali supresivne učinke na nadledvično žlezo pri izpostavljenostih, ki so bile enake ali večje od izpostavljenosti, dosežene s terapevtskimi odmerki pri človeku.
Treatment with these HMG-CoA reductase inhibitors should be discontinued during treatment with posaconazole as increased levels have been associated with rhabdomyolysis (see section 4.3).
Med zdravljenjem s posakonazolom je treba zdravljenje z zaviralci reduktaze HMG-CoA prekiniti, ker so bile povečane koncentracije povezane z rabdomiolizo (glejtepoglavje 4.3).
Following administration of 800 mg per day of posaconazole oral suspension as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8-17 years of age (776 ng/mL) were similar to concentrations from 194 patients 18-64 years of age (817 ng/mL).
Po uporabi peroralne suspenzije posakonazola 800 mg na dan v deljenih odmerkih za zdravljenje invazivnihglivnih okužb je bila povprečna najmanjša plazemska koncentracija pri 12 bolnikih, starih od 8 do 17 let (776 ng/ml), podobna kot pri 194 bolnikih, starih od 18 do 64 let (817 ng/ml).
Contents of the pack and other information
Shranjevanje zdravila Posakonazol Accord Vsebina pakiranja in dodatne informacije
Posaconazole was not genotoxic in in vitro and in vivo studies.
Posakonazol v študijah invitro in invivo ni bil genotoksičen.
In subjects with severe renal impairment (n=6, Clcr< 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [> 96% CV (coefficient of variance)] compared to other renal groups [< 40% CV].
Pri preiskovancih s hudo okvaro ledvic (n = 6,očistek kreatinina<20 ml/min/1,73 m2)jebilaAUCposakonazolamočnospremenljiva[koeficientvariacije(KV)> 96 %] v primerjavi z drugimi kategorijami delovanja ledvic [KV< 40 %].
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.
Med jemanjem zdravila Posakonazol Accord ste lahko omotični, zaspani ali imate zamegljen vid, kar lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
c: In 1899, this was the period from randomization to 100 days post-randomization; in 316 it was the period from the baseline day to 111 days post-baseline.
Vštudiji 1899 je bilo to obdobje od randomizacije do 100. dne po randomizaciji, v študiji 316 pa od začetka študije do 111.dne po začetku študije.
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).
Posakonazol je zaviralec CYP3A4, zato ga je le v posebnih primerih dovoljeno uporabljati sočasno z drugimi zdravili, ki se presnovijo s CYP3A4 (glejte poglavje 4.5).
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
EUCAST ECOFF vrednosti: - Aspergillusflavus: 0,5 mg/l - Aspergillus fumigatus: 0,25 mg/l
In addition, posaconazole oral suspension (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 8-10 hours during co-administration.
Poleg tega jeperoralna suspenzija posakonazola (200 mg ali 400 mg) med sočasno uporabo podaljšala povprečni terminalnirazpolovničasmidazolama s približno 3 do 4ure na 8 do 10 ur.
What Posaconazole Accord looks like and contents of the pack Posaconazole Accord gastro-resistant tablets are 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, packaged in a blister or in perforated unit dose blister in cartons of 24 or 96 tablets.
Izgled zdravila Posakonazol Accord in vsebina pakiranja Posakonazol Accord gastrorezistentne tablete so rumene obložene tablete v obliki kapsule, dolge približno 17,5 mm in široke približno 6,7 mm, z vtisnjeno oznako "100P" na eni strani in brez oznake na drugi strani; pakirane so v pretisnih omotih ali v perforiranih pretisnih omotih za enkratni odmerek v škatlah, ki vsebujejo po 24 ali 96 tablet.
Calcium channel blockers metabolised through CYP3A4 (e.g. diltiazem, verapamil, nifedipine, nisoldipine)
Zaviralci kalcijevih kanalčkov, ki se presnovijo s CYP3A4 (npr. diltiazem, verapamil, nifedipin,
Plasma exposure
Plazemska izpostavljenost
haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
hemolitično-uremični sindrom, trombotična trombocitopenična purpura, pancitopenija, koagulopatija,
Children (< 18 years)
Farmakokinetika pri posebnih skupinah bolnikov Otroci (< 18let)
However, as posaconazole is not significantly renally eliminated, an effect of severe renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended.
Ker pa seposakonazol skozi ledvice ne izloča v pomembni meri, ni pričakovati, da bi huda okvara ledvicvplivalanafarmakokinetikoposakonazola;prilagajanje odmerka tako ni potrebno.
Reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options (see section 4.5).
Azolski antimikotiki, vključno sposakonazolom, naj bodo rezerviraniza bolnike, ki prejemajoalkaloid vinke, vključno z vinkristinom, in ki nimajo alternativnih možnosti protiglivnega zdravljenja (glejte poglavje 4.5).
Hepatic toxicity
Jetrna toksičnost
Proportion (%) of patients with proven/probable IFIs On-treatment periodb d
Vrednost p Odstotek (%) bolnikov z dokazanimi oziroma verjetnimi invazivnimi glivnimi okužbami Obdobjezdravljenjab