natgillin/translations-raw huggingface dataset:
Posaconazole may increase the plasma concentrations of vinca alkaloids which may lead to neurotoxicity and other serious adverse reactions.
Posakonazol lahko zviša plazemsko koncentracijo alkaloidov vinke kar lahko vodi do nevrotoksičnosti in drugih resnih neželenih učinkov.
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 peroralne suspenzije posakonazola v terapevtskih odmerkih pri bolnikih, predstavljeno z analizo kvartilov.
• a change in the salt level in your blood shown in blood tests - signs include feeling confused or weak
• sprememba koncentracije soli v krvi, ki se pokaže na preiskavah krvi - med znaki sta občutek zmedenosti ali šibkost
The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose.
V urinu in blatu izločeni presnovki zajemajo približno 17 % uporabljenega radioaktivno označenega odmerka.
The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/itraconazole.
Zdravljenje s posakonazolom je trajalo povprečno 29 dni in s flukonazolom/itrakonazolom 25 dni.
Non-Interchangeability between Noxafil Tablets and Noxafil Oral Suspension
Medsebojna nezamenljivost Noxafil tablet in Noxafil peroralne suspenzije
When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes (see section 4.8 and 6.6).
Če je zdravilo dano po perifernem venskem katetru, mora infundiranje trajati približno 30 minut (glejte poglavji 4.8 in 6.6).
Noxafil is a white, cherry flavoured, 105 mL oral suspension packaged in amber glass bottles.
Noxafil je bela 105 ml peroralna suspenzija z okusom češnje, pakirana v stekleničke iz rjavega stekla.
Co-administration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes (see sections 4.4 and 4.5).
Sočasna uporaba s substrati CYP3A4 terfenadinom, astemizolom, cisapridom, pimozidom, halofantrinom ali kinidinom, ker lahko poveča plazemske koncentracije teh zdravil, kar pa lahko povzroči podaljšanje intervala QTc in redko tudi torsades de pointes (glejte poglavji 4.4 in 4.5).
See “Other medicines and Noxafil” below for information on other medicines which may interact with Noxafil.
Glejte "Druga zdravila in zdravilo Noxafil" (spodaj) za več informacij o drugih zdravilih, ki lahko medsebojno delujejo z zdravilom Noxafil.
• a blockage in your gut (intestinal obstruction) especially in the “ileum”.
• zapora črevesa (intestinalna obstrukcija), zlasti v delu, imenovanem "ileum".
Therefore, reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
Azolski antimikotiki, vključno s posakonazolom, naj bodo zato rezervirani za bolnike, ki prejemajo alkaloid vinke, vključno z vinkristinom, in ki nimajo alternativnih možnosti protiglivnega zdravljenja.
• severe sharp chest pain when breathing in (pleurritic pain)
• hude, ostre bolečine v prsih pri vdihu (plevritične bolečine)
• menstrual problems (abnormal vaginal bleeding)
• težave z menstruacijo (nenormalna krvavitev iz nožnice)
• shivering, feeling generally unwell
• drgetanje, splošno slabo počutje
Co-administration of posaconazole and ergot alkaloids is contraindicated (see section 4.3).
Sočasna uporaba posakonazola in alkaloidov ergot je kontraindicirana (glejte poglavje 4.3).
If a central venous catheter was not readily available, patients could receive a single infusion over 30 minutes via a peripheral venous catheter.
Če centralni venski kateter ni bil na voljo, so bolniki lahko dobili enkratno 30-minutno infuzijo po perifernem venskem katetru.
Adverse reactions by body system and frequency reported in clinical trials and/or postmarketing use*
Neželeni učinki, razvrščeni po organskih sistemih in pogostnosti, o katerih so poročali v kliničnih preskušanjih in/ali v obdobju trženja*
No further increases in exposure were observed when doses above 800 mg daily were administered to patients and healthy volunteers.
Pri dajanju odmerkov nad 800 mg na dan bolnikom in zdravim prostovoljcem niso opažali nobenega nadaljnjega povečanja izpostavljenosti zdravilu.
200 mg four times daily (hospitalized) then 400 mg twice daily
200 mg štirikrat na dan (hospitalizirani), nato 400 mg dvakrat na dan
Co-administration of posaconazole with H2 receptor antagonists should be avoided if possible.
Sočasni uporabi posakonazola in antagonistov receptorjev H2 se je treba izogibati, če je le mogoče.
Following single-dose administration of posaconazole oral suspension, there was no effect of mild and moderate renal impairment (n=18, Cl cr ≥ 20 mL/min/1.73 m2) on posaconazole pharmacokinetics; therefore, no dose adjustment is required.
Po enkratnem odmerku peroralne suspenzije posakonazola blaga in zmerna okvara ledvic (n = 18, očistek kreatinina ≥ 20 ml/min/1,73 m2) nista vplivali na farmakokinetiko posakonazola, zato prilagoditev odmerka ni potrebna.
Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Trajanje zdravljenja je odvisno od resnosti bolnikove osnovne bolezni, okrevanja po imunosupresiji in bolnikovega kliničnega odziva.
• have a very slow heartbeat
• če imate zelo počasno bitje srca.
Type I glass vial closed with bromobutyl rubber stopper and aluminium seal containing 16.7 mL of solution.
Viala iz stekla tipa I, zaprta z zamaškom iz brombutilne gume in aluminijasto zaporo; viala vsebuje 16,7 ml raztopine.
• some patients have also reported feeling confused after taking Noxafil.
• nekateri bolniki so po jemanju zdravila Noxafil poročali tudi o občutku zmedenosti.
You may feel dizzy, sleepy, or have blurred vision while taking Noxafil, which may affect your ability to drive or use tools or machines.
Med uporabo zdravila Noxafil ste lahko omotični, zaspani ali imate zamegljen vid, kar lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
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 glede prebijajočih (breakthrough) glivnih okužb.
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.
Sočasna uporaba azolskih antimikotikov, vključno s posakonazolom, in vinkristina je bila povezana z nevrotoksičnostjo in drugimi resnimi neželenimi učinki, vključno z epileptičnimi napadi, periferno nevropatijo, sindromom neustreznega izločanja antidiuretskega hormona in paralitičnim ileusom.
In a nonclinical study using intravenous administration of posaconazole in very young dogs (dosed from 2-8 weeks of age) an increase in the incidence of brain ventricle enlargement was observed in treated animals as compared with concurrent control animals.
V predklinični študiji intravenske uporabe posakonazola pri zelo mladih psih (ki so zdravilo prejemali v starosti od 2 do 8 tednov) so pri živalih, ki so dobivale zdravilo, opazili večjo pojavnost povečanja možganskih prekatov kot pri sočasnih kontrolnih živalih.
Alternatively, if recommended by your doctor, you may take 400 mg (two 5 mL spoonfuls) twice a day provided that you are able to take both doses during or after food or a nutritional drink.
Druga možnost je, če vam tako svetuje zdravnik, da zaužijete po 400 mg (dve polni 5 ml žlički) suspenzije dvakrat na dan, če imate možnost, da ta dva odmerka vzamete med ali takoj po jedi ali zaužitju prehranskega dopolnila v obliki napitka.
• Congenital or acquired QTc prolongation
• kongenitalno ali pridobljeno podaljšanje intervala QTc,
Patients with a low body weight (< 60 kg) are more likely to experience higher plasma concentrations of posaconazole and should be closely monitored for adverse events.
Bolniki z majhno telesno maso (< 60 kg) imajo večjo verjetnost za povečane koncentracije posakonazola v plazmi in jih je treba skrbno spremljati glede neželenih učinkov.
What Noxafil looks like and contents of the pack
Izgled zdravila Noxafil in vsebina pakiranja
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.
Po uporabi tablet je povprečni navidezni volumen porazdelitve posakonazola 394 l (42 %) in v študijah pri zdravih prostovoljcih sega od 294 do 583 l.
Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole concentrate for solution for infusion when given as antifungal prophylaxis (Study 5520).
Bolnike so vključili v neprimerjalno preskušanje farmakokinetike in varnosti posakonazola v koncentratu za raztopino za infundiranje, uporabljenega za antimikotično profilakso (študija 5520).
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.
Bolniki, zlasti tisti, ki prejemajo posakonazol po presaditvi hematopoetskih celic in imajo majhno telesno maso (< 60 kg), imajo večjo verjetnost za povečane koncentracije posakonazola v plazmi in jih je treba skrbno spremljati glede neželenih učinkov.
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 bilo potrebno zmanjšanje njegovega odmerka.
Noxafil concentrate for solution for infusion requires dilution (see section 6.6) prior to administration.
Zdravilo Noxafil koncentrat za raztopino za infundiranje je treba pred uporabo razredčiti (glejte poglavje 6.6).
As HIV protease inhibitors are CYP3A4 substrates, it is expected that posaconazole will increase plasma levels of these antiretroviral agents.
Zaviralci proteaze HIV so substrati CYP3A4, zato se pričakuje, da bo posakonazol povečal plazemsko koncentracijo teh protiretrovirusnih zdravil.
Serum creatinine levels should be closely monitored in these patients (see section 4.4).
Pri teh bolnikih je treba natančno kontrolirati koncentracijo kreatinina v serumu (glejte poglavje 4.4).
In healthy volunteers under fasting conditions, dividing the total daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 2.6-fold.
Pri zdravih prostovoljcih na tešče so pokazali, da razdelitev celotnega dnevnega odmerka (800 mg) na 200 mg štirikrat na dan v primerjavi s 400 mg dvakrat na dan poveča izpostavljenost posakonazolu za 2,6-krat.
Thromboembolic events have been identified as a potential risk for posaconazole intravenous concentrate for solution for infusion but were not observed in the clinical studies.
Obstaja potencialno tveganje tromboemboličnih dogodkov pri uporabi posakonazola v obliki intravenskega koncentrata za raztopino za infundiranje, vendar ga v kliničnih študijah niso opazili.
• astemizole (used to treat allergies)
• astemizol (za zdravljenje alergij)
Noxafil is also available for oral administration (Noxafil 100 mg gastro-resistant tablets and 40 mg/mL oral suspension).
Zdravilo Noxafil je na voljo tudi za peroralno uporabo (Noxafil 100 mg gastrorezistentne tablete in 40 mg/ml peroralna suspenzija).
• Glipizide or other “sulfonylureas” (used to treat high blood sugar).
• glipizid ali druge sulfonilsečnine (uporabljajo se za zdravljenje zvišanega sladkorja v krvi).
Among eighteen patients who were intolerant or had infections refractory to amphotericin B or itraconazole, seven patients were classed as responders.
Med osemnajstimi bolniki, ki niso prenašali amfotericina B ali itrakonazola ali ki so imeli okužbe, odporne na amfotericin B ali itrakonazol, so jih sedem uvrstili med odzivne na zdravljenje.
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).
Ob uvedbi zdravljenja s posakonazolom je treba bolnikom, ki že prejemajo takrolimus, odmerek takrolimusa zmanjšati (npr. na približno tretjino trenutnega odmerka).
Investigations Uncommon:
Preiskave Občasni:
Since certain adverse reactions (e.g. dizziness, somnolence, etc.) have been reported with posaconazole use, which potentially may affect driving/operating machinery, caution needs to be used.
Ker so med uporabo posakonazola poročali o nekaterih neželenih učinkih (npr. omotici, zaspanosti, itd.), ki lahko poslabšajo sposobnost vožnje in upravljanja s stroji, je potrebna previdnost.
200 mg three times daily
200 mg trikrat na dan
When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes.
Če je zdravilo uporabljeno po perifernem venskem katetru, mora infundiranje trajati približno 30 minut.
Calcium channel blockers metabolised through CYP3A4 (e.g. diltiazem, verapamil, nifedipine, nisoldipine)
Zaviralci kalcijevih kanalčkov, ki se presnovijo s CYP3A4 (npr. diltiazem, verapamil, nifedipin, nizoldipin)
HMG-CoA reductase inhibitors metabolised through CYP3A4 (e.g. simvastatin, lovastatin, and atorvastatin)
Zaviralci reduktaze HMG-CoA, ki se presnovijo s CYP3A4 (npr. simvastatin, lovastatin in atorvastatin)
Noxafil gastro-resistant tablets are yellow-coated and capsule-shaped, debossed “100” on one side packaged in a blister in cartons of 24 (2x12) or 96 (8x12) tablets.
Noxafil gastrorezistentne tablete so rumene, obložene tablete v obliki kapsule ter imajo na eni strani vtisnjeno oznako "100"; pakirane so v pretisnih omotih v škatlah, ki vsebujejo po 24 (2 x 12) ali 96 (8 x 12) tablet.
For patients with AML or MDS, prophylaxis with Noxafil should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm
Pri bolnikih z AML ali MDS je treba profilakso z zdravilom Noxafil začeti več dni pred pričakovanim pojavom nevtropenije in naj traja še 7 dni po zvečanju števila nevtrofilcev nad 500 celic/mm
Combining fosamprenavir with posaconazole may lead to decreased posaconazole plasma concentrations.
Sočasna uporaba fosamprenavirja in posakonazola lahko zmanjša koncentracijo posakonazola v plazmi.
• tacrolimus and sirolimus (used during or after transplant surgery)
• takrolimus in sirolimus (uporabljata se med ali po presaditvah),
When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes to reduce the likelihood of infusion site reactions (see section 4.8).
Če je zdravilo dano po perifernem venskem katetru, mora infundiranje trajati približno 30 minut, da se zmanjša verjetnost reakcij na mestu infundiranja (glejte poglavje 4.8).
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.
Dokazano je, da posakonazol in vitro deluje proti naslednjim mikroorganizmom: vrsti Aspergillus (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), vrsti Candida (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, in vrstam Fusarium, Rhizomucor, Mucor in Rhizopus.
• ciclosporin (used during or after transplant surgery)
• ciklosporin (uporablja se med ali po presaditvah),
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 povečano koncentracijo rifabutina (npr. uveitisa).
The effect of co-administration with posaconazole on plasma levels of CYP3A4 substrates may also be variable within a patient.
Učinek sočasne uporabe posakonazola na plazemske koncentracije substratov CYP3A4 se lahko razlikuje tudi pri posameznem bolniku.
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.
Tablete posakonazola se absorbirajo s srednjo vrednostjo tmax od 4 do 5 ur in imajo po enkratnem in večkratnih odmerkih do 300 mg odmerku sorazmerno farmakokinetiko.
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.
Primarni opazovani dogodek učinkovitosti je bila pojavnost dokazanih oziroma verjetnih invazivnih glivnih okužb, ki jih je ugotavljala neodvisna skupina zunanjih strokovnjakov na slep način med obdobjem zdravljenja.
• rifabutin (used to treat certain infections)
• rifabutin (uporablja se za zdravljenje določenih okužb),
The primary efficacy endpoint was the incidence of proven/probable IFIs at 16 weeks post-randomisation as determined by an independent, blinded external expert panel.
Primarni opazovani dogodek učinkovitosti je bila pojavnost dokazanih oziroma verjetnih invazivnih glivnih okužb 16 tednov po randomizaciji, ki jih je ugotavljala neodvisna skupina zunanjih strokovnjakov na slep način.
Noxafil contains glucose
Zdravilo Noxafil vsebuje glukozo
The most frequently reported adverse reaction (>25 %) with an onset during the posaconazole intravenous phase of dosing with 300 mg once daily was diarrhoea (32 %).
Najpogosteje poročani neželeni učinek (> 25 %), ki se je pojavil med intravensko fazo uporabe posakonazola v odmerku 300 mg enkrat na dan, je bila driska (32 %).
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 delovanja posakonazola z drugimi zdravili, pri katerih je bila izpostavljenost posakonazolu večja kot pri bolnikih, ki so prejemali enak odmerek.
If you develop severe diarrhoea or vomiting (being sick) while taking Noxafil, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly.
Če se med jemanjem zdravila Noxafil pojavita huda driska ali bruhanje (slabost), se takoj posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, kajti lahko preprečita pravilno delovanje zdravila.
Terfenadine, astemizole, cisapride, pimozide, halofantrine and quinidine (CYP3A4 substrates) Co-administration of posaconazole and terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine is contraindicated.
Terfenadin, astemizol, cisaprid, pimozid, halofantrin in kinidin (substrati CYP3A4) Sočasna uporaba posakonazola in terfenadina, astemizola, cisaprida, pimozida, halofantrina ali kinidina je kontraindicirana.
The most common adverse reaction (>1 %) leading to discontinuation of posaconazole concentrate for solution for infusion 300 mg once daily was AML (1 %).
Najpogostejši neželeni učinek (> 1 %), ki je povzročil prekinitev uporabe posakonazola v koncentratu za raztopino za infundiranje v odmerku 300 mg enkrat na dan, je bila AML (1 %).
Excipient with known effect: This medicinal product contains approximately 1.75 g of glucose per 5 mL of suspension.
Pomožna snov z znanim učinkom: To zdravilo vsebuje približno 1,75 g glukoze v 5 ml suspenzije.
Posaconazole does not have any major circulating metabolites and its concentrations are unlikely to be altered by inhibitors of CYP450 enzymes.
Posakonazol v obtoku nima nobenega glavnega presnovka in ni verjetno, da bi zaviralci encimov CYP450 vplivali na njegovo koncentracijo.
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.
Sočasna uporaba posakonazola in substratov CYP3A4 lahko zelo poveča izpostavljenost tem substratom, kot kažejo spodaj opisani učinki na takrolimus, sirolimus, atazanavir in midazolam.
The study treated 155 (65 %) subjects with AML or MDS, and 82 (35 %) subjects with HSCT, as the primary diseases at study entry.
Primarni razlog zdravljenja v študiji sta bila ob vstopu v študijo AML ali MDS pri 155 (65 %) preiskovancih in HSCT pri 82 (35 %) preiskovancih.
The mean duration of therapy was 80 days for posaconazole and 77 days for fluconazole.
Zdravljenje s posakonazolom je trajalo povprečno 80 dni in s flukonazolom 77 dni.
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).
Po enkratnem odmerku 300 mg posakonazola v tabletah po zelo mastnem obroku sta bili pri zdravih prostovoljcih AUC0-72 ur in Cmax večji kot po uporabi na tešče (AUC0-72 ur 51 % in Cmax 16 %).
adrenal insufficiency, blood gonadotropin decreased pseudoaldosteronism
insuficienca nadledvične žleze, znižana raven gonadotropinov v krvi psevdoaldosteronizem
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 je kliničnih izkušenj malo in ker obstaja možnost, da je koncentracija posakonazola v plazmi pri teh bolnikih višja (glejte poglavji 4.2 in 5.2).
The AUC of posaconazole is: 4 times greater when administered with a highfat meal (~ 50 grams fat) and about 2.6 times greater when administered during a non-fat meal or nutritional supplement (14 grams fat) relative to the fasted state (see sections 4.2 and 4.5).
Vrednost AUC za posakonazol je 4-krat večja, če ga bolnik zaužije skupaj z zelo mastnim obrokom (~ 50 gramov maščobe) in približno 2,6-krat večja pri zaužitju z nemastnim obrokom ali s prehranskim dodatkom (14 gramov maščobe) v primerjavi s stanjem na tešče (glejte poglavji 4.2 in 4.5).
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 od neželenih učinkov, o katerih so poročali pri bolnikih, ki so dobivali manjše odmerke.
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.
Bolnikom z blago do hudo okvaro jeter odmerka sicer ni treba prilagoditi, a je zaradi možne večje plazemske izpostavljenosti priporočljiva previdnost.
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 se posakonazol skozi ledvice ne izloča v pomembni meri, ni pričakovati, da bi huda okvara ledvic vplivala na farmakokinetiko posakonazola; prilagajanje odmerka tako ni potrebno.