natgillin/translations-raw huggingface dataset:
As shown in Table 4, a successful response (complete or partial resolution) at the end of treatment was seen in 42 % of posaconazole-treated patients compared to 26 % of the external group.
Kako je prikazano u Tablici 4, uspješan terapijski odgovor (potpuno ili djelomično povlačenje bolesti) na kraju liječenja opažen je u 42% bolesnika liječenih posakonazolom u odnosu na 26% ispitanika u vanjskoj kontrolnoj skupini.
Subjects who received 300 mg once daily achieved a mean Cav at steady state of 1500 ng/mL.
Ispitanici koji su primali 300 mg jedanput na dan postigli su srednju vrijednost Cav u stanju dinamičke ravnoteže od 1500 ng/ml.
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.
Stoga inhibitori tih puteva uklanjanja (npr. verapamil, ciklosporin, kinidin, klaritromicin, eritromicin, itd.) mogu povećati, a induktori (npr. rifampicin, rifabutin, neki antikonvulzivi, itd.) smanjiti koncentraciju posakonazola u plazmi.
In a study in healthy volunteers posaconazole oral suspension (200 mg once daily for 10 days) increased the exposure (AUC) of intravenous midazolam (0.05 mg/kg) by 83 %.
U jednom ispitivanju u zdravih dobrovoljaca, posakonazol oralna suspenzija (200 mg jedanput na dan tijekom 10 dana) povećala je bioraspoloživost (AUC) intravenski primijenjenog midazolama (0,05 mg/kg) za 83%.
• have a very slow heartbeat
• ako imate vrlo spore otkucaje srca;
• adrenal glands not working properly - this may cause weakness, tiredness, loss of appetite, skin discolouration
• neispravan rad nadbubrežnih žlijezdi - to može uzrokovati slabost, umor, gubitak apetita,
H2 receptor antagonists and proton pump inhibitors Posaconazole plasma concentrations (Cmax and AUC) were reduced by 39 % when posaconazole was administered with cimetidine (400 mg twice a day) due to reduced absorption possibly secondary to a decrease in gastric acid production.
Antagonisti H2-receptora i inhibitori protonske pumpe Koncentracije posakonazola u plazmi (Cmax i AUC) bile su 39% niže kada se primjenjivao s cimetidinom (400 mg dvaput na dan) zbog smanjenje apsorpcije koja može biti posljedica smanjenog lučenja želučane kiseline.
• pimozide (used to treat symptoms of Tourette's disorder)
• pimozid (primjenjuje se za liječenje simptoma Touretteovog poremećaja),
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.
Tablica 3 prikazuje usporedbu izloženosti (Cav) nakon primjene terapijskih doza posakonazol tableta i posakonazol oralne suspenzije u bolesnika odabranih za analizu kvartila.
As shown in Table 3, a successful response (complete or partial resolution) at the end of treatment was seen in 42 % of posaconazole-treated patients compared to 26 % of the external group.
Kako je prikazano u Tablici 3, uspješan terapijski odgovor (potpuno ili djelomično povlačenje bolesti) na kraju liječenja opažen je u 42% bolesnika liječenih posakonazolom u odnosu na 26% ispitanika u vanjskoj kontrolnoj skupini.
• midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants)
• midazolam, triazolam, alprazolam i drugi benzodiazepini (primjenjuju se kao sredstva za umirenje ili opuštanje mišića),
Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02AC04.
Farmakoterapijska skupina: antimikotici za sistemsku primjenu, derivati triazola, ATK oznaka: J02AC04.
These types of patients had been previously studied in a pivotal controlled trial of posaconazole oral suspension.
Ovi tipovi bolesnika prethodno su ispitivani u ključnim kontroliranim ispitivanjima posakonazol oralne suspenzije.
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
U bolesnika s AML-om ili MDS-om profilaksu lijekom Noxafil treba započeti nekoliko dana prije očekivanog nastupa neutropenije i nastaviti još 7 dana nakon što broj neutrofila poraste na više od 500 stanica po mm
Safety data at higher exposure levels achieved with posaconazole tablets are at present limited.
Trenutno dostupni podaci o sigurnosti pri izlaganju višim koncentracijama kod primjene posakonazol tableta su ograničeni.
Following administration of 300 mg posaconazole concentrate for solution for infusion over 90 minutes, mean peak plasma concentration at the end of infusion was 3280 ng/mL (74 % CV).
Nakon primjene 300 mg posakonazol koncentrata za otopinu za infuziju tijekom 90 minuta, srednja vrijednost vršne koncentracije u plazmi na kraju infuzije iznosila je 3280 ng/ml (74% CV).
Do not use Noxafil if any of the above apply to you.
Nemojte primjenjivati Noxafil ako se nešto od gore navedenog odnosi na Vas.
long QT syndrome
sindrom produljenog QT-intervala
The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose.
Izlučeni metaboliti u mokraći i stolici čine oko 17% primijenjene radioaktivno označene doze.
Noxafil is also available for oral administration (Noxafil 100 mg gastro-resistant tablets and 40 mg/mL oral suspension).
Dostupan je i Noxafil za peroralnu primjenu (Noxafil 100 mg želučanootporne tablete i 40 mg/ml oralna suspenzija).
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 %).
Najčešće prijavljena nuspojava (>25%) koja je nastupila tijekom intravenske faze primjene doze od 300 mg jedanput na dan bio je proljev (32%).
• rifabutin (used to treat certain infections)
• rifabutin (primjenjuje se za liječenje nekih infekcija),
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).
Osim toga, 12 bolesnika u dobi od 13-17 godina primalo je posakonazol oralnu suspenziju u dozi od 600 mg na dan za profilaksu invazivnih gljivičnih infekcija (ispitivanja 316 i 1899).
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).
Istodobna primjena može dovesti do povećanja koncentracije ovih lijekova u plazmi te time do produljenja QTc-intervala, a u rijetkim slučajevima i do pojave torsade de pointes (vidjeti dio 4.3).
• loss of appetite, stomach pain or upset stomach, passing wind, dry mouth, changes in your taste
• gubitak apetita, bol u želucu ili nadražen želudac, vjetrovi, suha usta, promjene osjeta okusa
c: In 1899, this was the period from randomisation to 100 days post-randomisation; in 316 it was the period from the baseline day to 111 days post-baseline.
c: U Ispitivanju 1899 to je bilo razdoblje od randomizacije do 100 dana nakon randomizacije; u ispitivanju 316 to je bilo razdoblje od dana početka ispitivanja do 111. dana nakon toga.
The most common adverse reaction (>1 %) leading to discontinuation of posaconazole concentrate for solution for infusion 300 mg once daily was AML (1 %).
Najčešća nuspojava (>1%) koja je dovela do prekida primjene posakonazol koncentrata za otopinu za infuziju u dozi od 300 mg jedanput na dan bio je AML (1%).
Thrombophlebitis was observed in clinical trials.
U kliničkim ispitivanjima zabilježen je tromboflebitis.
Posaconazole increased Cmax and AUC of tacrolimus (0.05 mg/kg body weight single dose) by 121 % and 358 %, respectively.
Posakonazol je povećao Cmax takrolimusa (primijenjenog u jednokratnoj dozi od 0,05 mg/kg tjelesne mase) za 121%, a AUC za 358%.
Co-administration of posaconazole with proton pump inhibitors should be avoided if possible.
Ako je moguće, istodobnu primjenu posakonazola i inhibitora protonske pumpe treba izbjegavati.
If a central venous catheter is not available, a single infusion may be administered through a peripheral venous catheter.
Ako nije dostupan centralni venski kateter, jednokratna infuzija može se primijeniti kroz periferni venski kateter.
This serial pharmacokinetic analysis demonstrated that 94 % of the subjects treated with the 300 mg once daily dose attained steady state Cav between 500-2500 ng/mL [Cav was the average concentration of posaconazole at steady state, calculated as AUC/dosing interval (24 hours).].
Ova serijska farmakokinetička analiza pokazala je da je 94% ispitanika liječenih dozom od 300 mg jedanput na dan postiglo prosječnu koncentraciju (Cav) u stanju dinamičke ravnoteže između 500 i 2500 ng/ml [Cav je bila prosječna koncentracija posakonazola u stanju dinamičke ravnoteže, izračunata kao AUC/interval doziranja (24 sata)].
Monitoring of patients with severe renal impairment Due to the variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough fungal infections (see sections 4.2 and 5.2).
Nadzor bolesnika s teškim oštećenjem bubrežne funkcije Zbog varijabilne izloženosti, bolesnike s teškim oštećenjem bubrežne funkcije mora se pomno nadzirati zbog mogućih probojnih gljivičnih infekcija (vidjeti dijelove 4.2 i 5.2).
For patients with acute myelogenous leukemia or myelodysplastic syndromes, 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
U bolesnika s akutnom mijeloičnom leukemijom ili mijelodisplastičnim sindromima profilaksu lijekom Noxafil treba započeti nekoliko dana prije očekivanog nastupa neutropenije i nastaviti još 7 dana nakon što broj neutrofila poraste na više od 500 stanica po mm
• have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
• ako imate promijenjen nalaz elektrokardiograma (EKG) koji pokazuje poremećaj koji se zove produljeni QTc-interval;
The effect of posaconazole on sirolimus in patients is unknown, but is expected to be variable due to the variable posaconazole exposure in patients.
Nije poznat učinak posakonazola na sirolimus u bolesnika, ali se očekuje da će biti promjenjiv uslijed razlika u izloženosti posakonazolu.
• astemizole (used to treat allergies)
• astemizol (primjenjuje se za liječenje alergija),
If you have missed a dose, take it as soon as you remember and then carry on as before.
Ako ste zaboravili uzeti dozu, uzmite ju čim se sjetite i zatim nastavite uzimati Noxafil prema uobičajenom rasporedu.
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).
Nakon jednokratne primjene posakonazol tableta u dozi od 300 mg nakon obroka bogatog mastima u zdravih dobrovoljaca, AUC0-72 h i Cmax bili su viši u usporedbi s primjenom natašte (51% za AUC0-72 h te 16% za Cmax).
Due to the variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough fungal infections (see section 4.2).
Zbog varijabilne izloženosti, bolesnici s teškim oštećenjem bubrežne funkcije moraju se pomno nadzirati zbog mogućih probojnih gljivičnih infekcija (vidjeti dio 4.2).
Similar recommendations apply to posaconazole tablets; however, a specific study has not been conducted with the posaconazole tablets.
Slične preporuke vrijede i za posakonazol tablete; međutim, nije provedeno posebno ispitivanje s posakonazol tabletama.
The following medicinal products can be infused at the same time through the same intravenous line (or cannula) as Noxafil concentrate for solution for infusion:
Sljedeći se lijekovi mogu primijeniti istodobno s Noxafil koncentratom za otopinu za infuziju kroz istu intravensku liniju (ili kanilu):
This medicinal product contains approximately 1.75 g of glucose per 5 mL of suspension.
Ovaj lijek sadrži približno 1,75 g glukoze u 5 ml suspenzije.
Noxafil concentrate for solution for infusion was investigated in AML and MDS patients and those after HSCT with or at risk for GVHD only.
Noxafil koncentrat za otopinu za infuziju ispitan je samo u bolesnika s AML-om i MDS-om te u bolesnika s HSCT-om koji su razvili ili u kojih je postojao rizik od GVHD-a.
• quinidine (used to treat abnormal heart rhythms).
• kinidin (primjenjuje se za liječenje poremećaja srčanog ritma).
After a single oral dose of 400 mg posaconazole oral suspension to patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment (six per group), the mean AUC was 1.3 to 1.6-fold higher compared to that for matched control subjects with normal hepatic function.
Nakon jednokratne doze od 400 mg posakonazol oralne suspenzije u bolesnika s blagim (Child-Pugh stadij A), umjerenim (Child-Pugh stadij B) ili teškim oštećenjem funkcije jetre (Child-Pugh stadij C) (6 po grupi), prosječan AUC bio je 1,3 do 1,6 puta veći u odnosu na odgovarajuće ispitanike iz kontrolne skupine s normalnom funkcijom jetre.
In heart transplant patients on stable doses of ciclosporin, posaconazole oral suspension 200 mg once daily increased ciclosporin concentrations requiring dose reductions.
U bolesnika koji su nakon transplantacije srca primali stabilne doze ciklosporina, posakonazol oralna suspenzija u dozi od 200 mg jedanput na dan povećala je koncentraciju ciklosporina, zbog čega se morala smanjiti doza toga lijeka.
Pharmacokinetic modelling with an oral tablet formulation suggests that patients weighing greater than 120 kg may have lower posaconazole exposure.
Prema farmakokinetičkom modeliranju s lijekom u obliku tableta za peroralnu primjenu, bolesnici s tjelesnom težinom većom od 120 kg mogu biti manje izloženi posakonazolu.
The pharmacokinetics of posaconazole are linear following single and multiple dose administration of up to 800 mg when taken with a high fat meal.
Farmakokinetika posakonazola je linearna nakon jednokratne i višekratne primjene u dozi do 800 mg kada se uzima uz obrok bogat mastima.
The solution of Noxafil ranges from colourless to pale yellow.
Otopina lijeka Noxafil može biti bezbojna do blijedo žute boje.
Administration instructions for Noxafil concentrate for solution for infusion
Upute za primjenu Noxafil koncentrata za otopinu za infuziju
Maximum duration of exposure to the tablet formulation was shorter than with the oral suspension.
Maksimalno trajanje izloženosti formulaciji tablete bilo je kraće nego formulaciji oralne suspenzije.
Noxafil 40 mg/mL oral suspension posaconazole
Noxafil 40 mg/ml oralna suspenzija posakonazol
Liver function tests should be evaluated at the start of and during the course of posaconazole therapy.
Pretrage jetrene funkcije treba procijeniti na početku i tijekom liječenja posakonazolom.
• severe sharp chest pain when breathing in (pleurritic pain)
• jaka, oštra bol u prsima pri udisanju (pleuralna bol)
If a dose of Noxafil has been forgotten
Ako ste zaboravili dozu lijeka Noxafil
Effects of other medicinal products on posaconazole Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for p-glycoprotein (P-gp) efflux in vitro.
Posakonazol se metabolizira UDP-glukuronidacijom (enzimima faze 2) i supstrat je efluksa preko P-glikoproteina (P-gp) in vitro.
Serial pharmacokinetic samples were collected on Day 1 and at steady-state on Day 14 for all Cohort 1 and 2 subjects and on Day 10 for a subset of Cohort 3 subjects.
Serijski uzorci za procjenu farmakokinetike prikupljeni su 1. dana i u stanju dinamičke ravnoteže 14. dana za sve ispitanike u Kohortama 1 i 2 te 10. dana za podskupinu ispitanika u Kohorti
Therefore, reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
Stoga, sačuvajte azolne antimikotike, uključujući posakonazol, za bolesnike koji primaju vinka alkaloide, uključujući vinkristin, a u kojih nema drugih opcija za antimikotičko liječenje.
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).
Bolesnici su uključeni u nekomparativno ispitivanje farmakokinetike i sigurnosti primjene posakonazol koncentrata za otopinu za infuziju kada se davao za profilaksu gljivičnih infekcija (Ispitivanje 5520).
a: FLU/ITZ (1899); FLU (316).
FLU = flukonazol; ITZ = itrakonazol; POS = posakonazol a: FLU/ITZ (1899); FLU (316).
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).
Posakonazol se manjim dijelom eliminira putem bubrega, uz 14% radioaktivno označene doze izlučene mokraćom (< 0,2% radioaktivno označene doze je izvorni spoj).
If you become pregnant while you are taking Noxafil, contact your doctor straight away.
Ako zatrudnite tijekom liječenja lijekom Noxafil, odmah se obratite svom liječniku.
§, electrocardiogram abnormal palpitations, bradycardia, supraventricular extrasystoles, tachycardia
§, palpitacije, bradikardija, supraventrikularne ekstrasistole, tahikardija
• some patients have also reported feeling confused after taking Noxafil.
• neki su bolesnici prijavili da su se nakon uzimanja lijeka Noxafil osjećali zbunjeno.
P-Value
Kontrolna skupina p-vrijednost
pulmonary embolism, deep vein thrombosis
plućna embolija, duboka venska tromboza
Co-administration with the HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin (see section 4.5).
Istodobna primjena inhibitora HMG-CoA reduktaze simvastatina, lovastatina i atorvastatina (vidjeti dio 4.5).
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).
AUC posakonazola je 4 puta veći kad se primjenjuje uz obrok bogat mastima (~50 g masti) te približno 2,6 puta veći kad se primjenjuje uz nemasni obrok ili nadomjestak prehrani (14 g masti) u odnosu na primjenu na prazan želudac (vidjeti dijelove 4.2 i 4.5).
During post-marketing surveillance of posaconazole oral suspension, severe hepatic injury with fatal outcome has been reported (see section 4.4).
Tijekom praćenja nakon stavljanja u promet posakonazol oralne suspenzije prijavljena su teška oštećenja jetre sa smrtnim ishodom (vidjeti dio 4.4).
There was a slight decrease (16 %) in the AUC and Cmax of posaconazole oral suspension in Black subjects relative to Caucasian subjects.
Zabilježen je lagani pad (16%) AUC-a i Cmax posakonazol oralne suspenzije u ispitanika crne rase u odnosu na ispitanike bijele rase.
* Based on adverse reactions observed with the oral suspension, gastro-resistant tablets, and concentrate for solution for infusion.
* Na temelju nuspojava primijećenih kod primjene oralne suspenzije, želučanootpornih tableta i koncentrata za otopinu za infuziju.
Accidental overdose was noted in one patient who took posaconazole oral suspension 1,200 mg twice a day for 3 days.
Slučajno predoziranje zabilježeno je u jednog bolesnika koji je tijekom 3 dana uzimao posakonazol oralnu suspenziju u dozi od 1200 mg dvaput na dan.
Based on pharmacokinetic data in 10 of these paediatric patients, the pharmacokinetic profile appears to be similar to patients ≥ 18 years of age.
Na temelju farmakokinetičkih podataka u 10 od tih pedijatrijskih bolesnika, čini se da je farmakokinetički profil lijeka sličan onomu u bolesnika u dobi od ≥ 18 godina.
Noxafil may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood.
Noxafil može povećati rizik od nuspojava nekih drugih lijekova jer može povećati količinu tih lijekova u krvi.
Pharmacokinetic / Pharmacodynamic relationships A correlation between total medicinal product exposure divided by MIC (AUC/MIC) and clinical outcome was observed.
Opažena je korelacija između ukupne izloženosti lijeku podijeljene s najmanjom inhibitornom koncentracijom (AUC/MIK) i kliničkog ishoda.
The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose of posaconazole oral suspension.
Izlučeni metaboliti u mokraći i stolici čine oko 17% primijenjene radioaktivno označene doze posakonazol oralne suspenzije.
The other ingredients are: hypromellose acetate succinate; cellulose, microcrystalline; hydroxypropylcellulose (E463); silica dental type; croscarmellose sodium; magnesium stearate, polyvinyl alcohol, macrogol 3350 , titanium dioxide (E171), talc, iron oxide yellow (E172).
Drugi sastojci su: hipromeloza acetat sukcinat; celuloza, mikrokristalična; hidroksipropilceluloza (E463); silicijev dioksid, dentalni tip; karmeloza natrij, umrežena; magnezijev stearat; poli(vinilni alkohol), makrogol 3350, titanijev dioksid (E171), talk, željezov oksid, žuti (E172).
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.
U zdravih dobrovoljaca koji su bili natašte pokazalo se da raspodjela ukupne dnevne doze (800 mg) na četiri doze od 200 mg povećava izloženost posakonazolu 2,6 puta u usporedbi s raspodjelom dnevne doze na dvije doze od 400 mg.
Metabolism and nutrition disorders Common:
Poremećaji metabolizma i prehrane
This should be taken into consideration by patients on a controlled sodium diet.
To trebaju uzeti u obzir bolesnici koji su na dijeti s kontroliranim unosom natrija.
The safety and efficacy of Noxafil in children aged below 18 years have not been established.
Sigurnost i djelotvornost lijeka Noxafil u djece mlađe od 18 godina nisu ustanovljene.
Posaconazole plasma concentrations following administration of posaconazole concentrate for solution for infusion single dose increased in a greater than dose proportional manner over the range of 50-200 mg; by comparison, dose-dependent increases were observed over a range of 200-300 mg.
Koncentracije posakonazola u plazmi nakon intravenske primjene jednokratne doze posakonazol koncentrata za otopinu za infuziju bile su povećane u rasponu većem od 50 do 200 mg kao što bi trebale biti povećane obzirom na dozu; usporedbe radi, povećanja ovisna o dozi bila su zamijećena u rasponu od 200 do 300 mg.
Monitoring of hepatic function
Nadzor jetrene funkcije
11 of 24 patients who had proven or probable fusariosis were successfully treated with posaconazole oral suspension 800 mg/day in divided doses for a median of 124 days and up to 212 days.
Jedanaest od 24 bolesnika koji su imali dokazanu ili vjerojatnu fuzariozu uspješno je liječeno posakonazol oralnom suspenzijom od 800 mg na dan u podijeljenim dozama tijekom medijana od 124 dana, a najdulje 212 dana.
• patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS)
• bolesnici čiji je imunološki sustav oslabljen zbog kemoterapije koju primaju za liječenje akutne mijeloične leukemije (AML) ili mijelodisplastičnog sindroma (MDS)
Similarly, administration of 400 mg posaconazole with esomeprazole (40 mg daily) decreased mean Cmax and AUC by 46 % and 32 %, respectively, compared to dosing with 400 mg posaconazole alone.
Slično tomu, primjena 400 mg posakonazola s esomeprazolom (40 mg na dan) snizila je prosječan Cmax za 46%, a AUC za 32% u usporedbi s primjenom samog posakonazola u dozi od 400 mg.
Reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options (see section 4.5).
Sačuvajte azolne antimikotike, uključujući posakonazol, za bolesnike koji primaju vinka alkaloide, uključujući vinkristin, a u kojih nema drugih opcija za antimikotičko liječenje (vidjeti dio 4.5).