natgillin/translations-raw huggingface dataset:
If this happens, do not drive or use any tools or machines and contact your doctor.
Če se to zgodi, ne upravljajte vozil in strojev ter se posvetujte z zdravnikom.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known.
V okviru organskih sistemov so neželeni učinki navedeni z naslednjimi kategorijami pogostnosti: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost.
Dose and duration of therapy (See section 5.2)
Odmerek in trajanje zdravljenja (glejte poglavje 5.2)
Epidemiological Cut-off (ECOFF) Values for Aspergillus spp.
Epidemiološke mejne vrednosti (ECOFF) za Aspergillus spp.
Prophylaxis in AML and HSCT Study 5615
Profilaksapri AML in HSCT Študija 5615
There are currently insufficient data to set clinical breakpoints for other Candida species.
Trenutno ni dovolj podatkov za določitev kliničnih mejnih vrednosti za druge vrste Candide.
This belongs to a group of medicines called “antifungals”.
Ta učinkovina spada v skupino zdravil, imenovanih "antimikotiki" (protiglivna zdravila).
Dose adjustment of calcium channel blockers may be required.
Morda bo potrebna prilagoditev odmerkazaviralcev kalcijevih kanalčkov.
The tablets should be swallowed whole with water and should not be crushed, chewed, or broken.
Tablete je treba pogoltniti cele, z nekaj vode in se jih ne sme drobiti, žvečiti ali lomiti.
Recommended dose according to indication.
Priporočeno odmerjanje glede na indikacijo
The pharmacokinetics and safety data from Study 5615 were bridged to the existing data (including efficacy data) with the oral suspension.
Spodatki o farmakokinetiki in varnosti iz študije 5615 je bila opravljena premostitev na obstoječe podatke (vključno s podatki o učinkovitosti), pridobljene s peroralno suspenzijo.
§ See section 4.4.
§ Glejte poglavje 4.4.
Budapest, 1045, Hungary
Budimpešta, 1045, Madžarska
Budapest, 1045, HUNGARY
Budimpešta, 1045, MADŽARSKA
Overall Response Success by Species All mycologically confirmed Aspergillus spp.1
Skupni odziv Uspešnost po vrstah Vse mikološko potrjene Aspergillusspp.1
- if you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of this medicine.
- če se pojavita huda driska ali bruhanje, kajti lahko zmanjšata učinkovitost tega zdravila.
- efavirenz and fosamprenavir used to treat HIV infection.
- efavirenz in fosamprenavir, ki se uporabljata za zdravljenje okužbe s HIV.
Other medicines
Druga zdravila
Therefore, follow the specific dosage recommendations for each formulation.
Za vsako obliko je treba upoštevati posebna priporočila za odmerjanje.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalnicenter za poročanje, ki je naveden v Prilogi V.
Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy.
Zvišanevrednostitestov delovanja jeter so bile običajno reverzibilne po prenehanju zdravljenja, v nekaterih primerih pa so se normalizirale že brez prekinitve zdravljenja.
EUCAST MIC breakpoints for posaconazole [susceptible (S); resistant (R)]:
Mejne vrednosti EUCAST MIC za posakonazol [občutljivi (S - susceptible); odporni (R - resistant)]:
d: All randomized e: All treated
Vsi randomizirani e:
Clinical outcomes were compared with those in an external control group derived from a retrospective review of medical records.
Klinične izide so primerjali z izidi zunanje kontrolneskupine, ki so jih dobili na osnovi retrospektivnega pregleda zdravstvene dokumentacije.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Vplivi drugih zdravil na posakonazol
Most of the cases of aspergillosis were considered to be refractory to prior therapy in both the posaconazole group (88%) and in the external control group (79%).
Večina primerov aspergiloze je veljala za odporne na predhodno zdravljenje tako v skupini, ki je prejemala posakonazol(88 %), kot v zunanji kontrolni skupini (79 %).
Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. That expiry date refers to the last day of that month.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden napretisnem omotu ali škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dannavedenega meseca.
was comparable among ten adolescents (13-17 years of age) to Cav achieved in adults (≥ 18 years of age).
(Cav) pri desetih mladostnikih (starih od 13 do 17 let) primerljiva Cav, doseženi pri odraslih(starih
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.
Similar recommendations apply to posaconazole tablets; however, a specific study has not been conducted with the posaconazole tablets.
Podobna priporočila veljajo za posakonazol v tabletah, vendar pa specifične študije s tabletami posakonazola niso bile izvedene.
See Section 4 for more information
Za več informacij glejte poglavje 4.
Posaconazole Accord may be taken with or without food (see section 5.2).
Zdravilo Posakonazol Accord je mogoče jemati s hrano ali brez nje (glejte poglavje 5.2).
Unbound concentrations were not determined and it cannot be excluded that there is a larger increase in unbound posaconazole exposure than the observed 60% increase in total AUC.
Koncentracije nevezanega posakonazola niso bile določene in ni mogoče izključiti možnosti, da pride do večjega povečanja izpostavljenosti nevezanemu posakonazolu od opaženega 60 % povečanjacelokupneAUC.
Duration of therapy is based on recovery from neutropenia or immunosuppression.
Trajanje zdravljenja je odvisno od okrevanja po nevtropeniji ali imunosupresiji.
The use of combination antifungal therapies should not decrease the efficacy of either posaconazole or the other therapies; however, there is currently no clinical evidence that combination therapy will provide an added benefit.
Uporaba kombiniranih antimikotičnih zdravljenj naj ne bi zmanjšala učinkovitosti posakonazola ali drugih zdravil, vendar doslej ni kliničnih dokazov, da kombinirano zdravljenje dodatno koristi.
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).
Ledvični očistek je manjpomembna pot izločanja; v urinu se izloči 14 % radioaktivno označenega odmerka (<0,2 % radioaktivno označenega odmerka predstavlja matična spojina).
The excretion of posaconazole in human breast milk has not been investigated.
Izločanje posakonazola v materino mleko pri človeku ni raziskano.
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).
Ključni sekundarni opazovani dogodek je bila pojavnost dokazanih oziroma verjetnih invazivnih glivnih okužb med obdobjem zdravljenja (odprvega odmerka do zadnjega odmerka proučevanega zdravila + 7 dni).
Combination with other antifungal agents
Kombinacije z drugimi antimikotiki
Midazolam and other benzodiazepines
Midazolam in drugi benzodiazepini
Safety and efficacy in paediatric patients below the age of 18 years have not been established.
Varnost in učinkovitost zdravila pri pediatričnih bolnikih, mlajših od 18 let,nista ugotovljeni.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni, da je »brez natrija«.
Posaconazole is excreted into the milk of lactating rats (see section 5.3).
Posakonazol se izloča v mleko doječih podgan (glejte poglavje 5.3).
Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group
Skupna učinkovitost peroralne suspenzije posakonazola ob koncu zdravljenja invazivneaspergiloze v primerjavi z zunanjokontrolnoskupino Peroralna suspenzija posakonazola
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale vpliv nasposobnost razmnoževanja (glejte poglavje 5.3).
diplopia, scotoma
diplopija, skotom
New diagnosis of acute myelogenous leukaemia was the most common underlying condition (435/602, [72%]).
Najpogostejša osnovna bolezen je bila na novo diagnosticirana akutna mieloična levkemija (435/602, [72 %]).
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.
Ne preidite na jemanje tablet Posakonazol Accord, če jemljete peroralno suspenzijo posakonazola, in obratno, ne da bi se posvetovali z zdravnikom ali farmacevtom, saj lahko pride do pomanjkanja učinkovitosti ali povečanega tveganja za neželene učinke.
The following medicines may decrease the effectiveness of Posaconazole Accord by decreasing the amount of Posaconazole Accord in the blood: - rifabutin and rifampicin (used to treat certain infections).
Naslednja zdravila lahko zmanjšajo učinkovitost zdravila Posakonazol Accord, ker zmanjšajo njegovo količino v krvi: - rifabutin in rifampicin (uporabljata se za zdravljenje določenih okužb).
The microbiological data suggest that posaconazole is active against Rhizomucor, Mucor, and Rhizopus; however the clinical data are currently too limited to assess the efficacy of posaconazole against these causative agents.
Mikrobiološki podatki kažejo, da jeposakonazolučinkovitprotivrstam Rhizomucor, Mucor in Rhizopus;vendar je kliničnih podatkovtrenutno premalo, da bi lahko ocenili učinkovitost posakonazola proti tem povzročiteljem okužb.
The majority (377/600, [63%]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/600, [32.5%])
Večina (377/600, [63 %]) vštudijo vključenih bolnikov je imela na začetku študije akutno GVHD stadija 2 ali 3 ali kronično obsežno GVHD (195/600, [32,5 %]).
Prophylaxis in GVHD Study 316
Profilaksapri GVHD Študija 316
Effects of posaconazole on other medicinal products
Vplivi posakonazola na druga zdravila
In Study 316, overall mortality was similar (POS, 25%; FLU, 28%); however, the proportion of IFI- related deaths was significantly lower in the POS group (4/301) compared with the FLU group (12/299; P= 0.0413).
V študiji 316 je bila celokupna umrljivost podobna (POS 25 %, FLU 28%),vendar je bil odstotek zinvazivno glivno okužbo povezanih smrti v skupini s POS značilno manjši (4/301) kot v skupini sFLU (12/299, p = 0,0413).
If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine.
Če ste ženska v rodni dobi, morate med jemanjem tega zdravila uporabljati učinkovito kontracepcijo.
Reproduction, peri- and postnatal development studies were conducted in rats.
Pri podganah so bile opravljene študije razmnoževanja ter peri-in post-natalnega razvoja.
See “Other medicines and Posaconazole Accord” below for more information including information on other medicines which may interact with Posaconazole Accord.
Glejte "Druga zdravila in zdravilo Posakonazol Accord" (spodaj) za več informacij, vključno z informacijami o drugih zdravilih, ki lahko medsebojno delujejo z zdravilom Posakonazol Accord.
No data are available for the tablet formulation.
Podatkov za zdravilo v obliki tablet ni na voljo.
No pharmacokinetic data are available from paediatric patients less than 8 years of age.
Farmakokinetičnih podatkov za pediatrične bolnike, mlajše od 8let, ni na voljo.
Five of these patients had chromoblastomycosis due to Fonsecaea pedrosoi and 4 had mycetoma, mostly due to Madurella species.
Pet od teh bolnikov je imelo kromoblastomikozo zaradi okužbe sFonsecaea pedrosoi, 4 pasoimelimicetom, večinoma zaradi okužbe zMadurella spp.
Endocrine disorders Rare:
Bolezni endokrinega sistema Redki:
pulmonary hypertension, interstitial pneumonia, pneumonitis
pljučna hipertenzija, intersticijska pljučnica, pnevmonitis
The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical trials.
Varnost tablet posakonazola so ocenili pri 336 bolnikih in zdravih prostovoljcih, vključenih v klinična preskušanja.
For patients with acute myelogenous leukemia or myelodysplastic syndromes, prophylaxis with Posaconazole Accord should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3.
Pri bolnikih z akutno mieloično levkemijo ali mielodisplastičnimi sindromi je treba profilakso z zdravilom Posakonazol Accord začeti več dni pred pričakovanim pojavom nevtropenije in naj traja še 7 dni po zvečanjuštevila nevtrofilcev nad 500 celic/mm3.
Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed).
Zdravniku morate zato povedati za vsa zdravila, ki jih jemljete (tako za zdravila, ki ste jih dobili na recept, kot za takšna, ki ste jih dobili brez recepta).
Posaconazole must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Posakonazola sene sme uporabljatipri nosečnicah, razen če korist za mater očitno odtehta možno tveganje za plod.
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 prenašaliamfotericina B ali itrakonazola ali ki so imeli okužbe, odporne na amfotericin B ali itrakonazol, so jih sedem uvrstili med odzivne na zdravljenje.
Prophylaxis of Invasive Fungal Infections (IFIs) (Studies 316 and 1899) Two randomised, controlled prophylaxis studies were conducted among patients at high risk for developing invasive fungal infections.
Profilaksa invazivnih glivnih okužb (študiji 316 in 1899) Opravljeni sta bili dve randomizirani, kontrolirani študiji profilakse pri bolnikih z velikim tveganjem za pojav invazivnih glivnih okužb.
You may need to have blood tests while you are taking this medicine.
Morda vam bodo morali med jemanjem tega zdravilaopravljati preiskave krvi.
There is insufficient information on the use of posaconazole in pregnant women.
O uporabi posakonazola pri nosečnicah ni dovolj podatkov.
Triplex (PVC/PE/PVdC) white opaque-aluminium blister or perforated unit dose blister in cartons of 24 or 96 tablets.
Bel neprozoren-aluminijev pretisni omot tripleks (PVC/PE/PVdC) ali perforiran pretisni omot v škatlah, ki vsebujejo po 24 ali 96 tablet.
Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain
Laboratori Fundació Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Španija
Most of the vinca alkaloids (e.g., vincristine and vinblastine) are substrates of CYP3A4.
Večina alkaloidov vinke (npr. vinkristin in vinblastin) je substratov CYP3A4.
Clinical isolates with decreased susceptibility to posaconazole have been identified.
Našli so klinične izolate z zmanjšano občutljivostjo za posakonazol.
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.
Učinek posakonazola na substrate CYP3A4 je lahkopri bolnikih nekoliko manjši kot pri zdravih prostovoljcih in mogoče je pričakovati, da se od bolnika do bolnika razlikuje zaradi različne stopnje izpostavljenosti posakonazolu.
The subject population included: 1) patients with AML or MDS who had recently received chemotherapy and had developed or were anticipated to develop significant neutropenia, or 2) patients who had undergone a HSCT and were receiving immunosuppressive therapy for prevention or treatment of GVHD.
Populacija preiskovancev je vključevala: 1) bolnike z AML ali MDS, ki so nedavno prejemali kemoterapijo in se jim je pojavila, ali je bilo pričakovano, da se jim bo pojavila pomembna nevtropenija, oziroma 2) bolnike, ki so imeli opravljeno presaditev hematopoetskih matičnih celic (HSCT) in so prejemali imunosupresivno zdravljenje za preprečevanje ali zdravljenje GVHD.
It is recommended to exercise caution due to the potential for higher plasma exposure.
Priporočljiva je previdnostzaradi možne večje plazemske izpostavljenosti.
TreatmentInvasive Aspergillosis Study 0041
Zdravljenjeinvazivnaasp ergiloza Študija 0041
Results from clinical studies in prophylaxis of Invasive Fungal Infections Study
Preglednica 5.Izsledki kliničnih študij profilakse invazivnih glivnih okužb Študija
If you are already taking rifabutin, you will need a blood test and you will need to look out for some possible side effects of rifabutin.
boste morali opraviti preiskavo krvi in biti pozorni na nekatere možne neželene učinke rifabutina.
liver function tests raised (ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, GGT increased)
zvišane vrednosti jetrnih testov (zvišanje ALT, zvišanje AST, zvišanje bilirubina, zvišanje alkalne fosfataze, zvišanje GGT)
This medicine works by killing or stopping the growth of some types of fungi that can cause infections.
To zdravilo deluje tako, da uniči nekatere vrste gliv, ki lahko povzročajo okužbe, ali ustavi njihovo rast.
Administration of other azoles has been associated with increases in digoxin levels.
Uporaba drugih azolov je bila povezana s povečanjem koncentracij digoksina.
Do not adapt your dose yourself before consulting your doctor or change your treatment regimen.
Ne prilagajajte odmerka in ne spreminjajte sheme svojega zdravljenja, ne da bi se prej posvetovali z zdravnikom.
Posaconazole tablets are the preferred formulation to optimize plasma concentrations and generally provide higher plasma drug exposures than posaconazole oral suspension.
Posakonazol v obliki tablet je primernejša oblika za optimiziranje plazemske koncentracije in na splošno zagotavlja večjo plazemsko izpostavljenost zdravilu kot peroralna suspenzija posakonazola.
Cav Range (ng/mL)
Razpon Cav(ng/m
The safety of posaconazole tablets has been assessed in 230 patients enrolled in the pivotal clinical study.
Varnost tablet posakonazola so ocenili pri 230 bolnikih, vključenih v ključno klinično študijo.
There is no information regarding cross-sensitivity between posaconazole and other azole antifungal agents.
O navzkrižni občutljivosti med posakonazolom in drugimi azolskimi antimikotiki ni podatkov.
Based on pharmacokinetic data in 10 of these paediatric patients, the pharmacokinetic profile appears to be similar to patients ≥ 18 years of age.
Na podlagi farmakokinetičnih podatkov pri 10 od teh pediatričnih bolnikovjefarmakokinetičniprofil videtipodoben kot pri bolnikih, starih ≥18 let.
In Study 1899, a significant decrease in all cause mortality in favour of posaconazole was observed [POS 49/304 (16%) vs. FLU/ITZ 67/298 (22%) p= 0.048].
V študiji 1899 so značilno manjšo celokupno umrljivost zaradi vseh vzrokovopazili v skupini, ki je prejemala posakonazol [POS 49/304 (16 %) v primerjavi s FLU/ITZ67/298 (22 %), p = 0,048].
The effect of posaconazole on fosamprenavir levels when fosamprenavir is given with ritonavir is unknown.
Vpliv posakonazola na koncentracijo fosamprenavirja v primeru uporabe fosamprenavirja z ritonavirjem ni znan.
HIV Protease inhibitors
Zaviralci proteaze HIV
abnormal dreams, confusional state, sleep disorder
nenormalne sanje, zmedenost, motnje spanja
Posaconazole Accord can increase the amount of these medicines in the blood which may lead to a severe decrease in blood flow to your fingers or toes and could cause damage to them.
Zdravilo Posakonazol Accord lahko poveča koncentracijo teh zdravil v krvi; to lahko zelo zmanjša dotok krvi v prste rok in nog in lahko povzroči njihovo okvaro.
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.
V 12-mesečnih študijahnevrotoksičnosti na psih in opicah niso opažali funkcionalnih učinkov na osrednje ali periferno živčevje pri sistemskih izpostavljenostih, ki so bile večje od terapevtsko doseženih izpostavljenosti.
During post-marketing surveillance of posaconazole oral suspension, severe hepatic injury with fatal outcome has been reported (see section 4.4).
Med spremljanjem v obdobju trženja peroralne suspenzije posakonazola so poročali o hudi okvari jeter s smrtnim izidom (glejte poglavje 4.4).
Prophylaxis in Neutropenia Study 1899
Profilaksapri nevtropeniji Študija 1899
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.
Dokazanoje,daposakonazol invitro delujeprotinaslednjimmikroorganizmom:vrstiAspergillus(Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), vrstiCandida (Candidaalbicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaeapedrosoi, in vrstamFusarium, Rhizomucor, Mucor in Rhizopus.
- some medicines used to treat or prevent fits including; phenytoin, carbamazepine, phenobarbital or primidone).
- nekatera zdravila, ki se uporabljajo za zdravljenje ali preprečevanje epileptičnih napadov, med njimi fenitoin, karbamazepin, fenobarbital ali primidon.
200 mg three times daily
200 mg trikrat nadan
acute renal failure, renal failure, blood creatinine increased
akutna odpoved ledvic, odpoved ledvic, zvišanje ravni kreatinina v krvi
There is no clinical experience assessing the impact of posaconazole on fertility in humans.
Kliničnih izkušenj glede vpliva posakonazola na plodnost pri človeku ni.
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).
Sočasna uporaba lahko povzroči povečanje koncentracije teh zdravilv plazmi, kar vodi do podaljšanja intervala QTc in v redkih primerih povzročitorsades de pointes(glejte poglavje 4.3).
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.
Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 2.1-fold and 8.5-fold greater, respectively, than those achieved with the human therapeutic doses.
Zvišan sistolični in arterijski krvni tlak (do 29 mmHg) so opažali pri podganah oz. opicah pri sistemskih izpostavljenostih, ki so bile 2,1-krat oz. 8,5-krat večje od izpostavljenosti,
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 majhnotelesno maso (< 60 kg), imajo večjo verjetnost za povečane koncentracije posakonazola vplazmi injihjetreba skrbno spremljati glede neželenih učinkov.