natgillin/translations-raw huggingface dataset:
Noxafil concentrate for solution for infusion will be diluted to the correct concentration by your pharmacist or nurse.
Zdravilo Noxafil koncentrat za raztopino za infundiranje bosta farmacevt ali medicinska sestra razredčila na ustrezno koncentracijo.
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 uporabi posakonazola in rifabutina se je treba izogibati, razen če korist za bolnika odtehta tveganje (glejte zgoraj za učinke rifabutina na plazemsko koncentracijo posakonazola).
Posaconazole may substantially increase plasma levels of HMG-CoA reductase inhibitors that are metabolised by CYP3A4.
Posakonazol lahko bistveno poveča plazemsko koncentracijo zaviralcev reduktaze HMG-CoA, ki se presnovijo s CYP3A4.
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).
Po uporabi 300 mg posakonazola v koncentratu za raztopino za infundiranje v 90 minutah je bila povprečna največja koncentracija na koncu infundiranja 3.280 ng/ml (74 % KV).
If posaconazole is used concomitantly with CYP3A4 substrates that are administered orally, and for which an increase in plasma concentrations may be associated with unacceptable adverse reactions, plasma concentrations of the CYP3A4 substrate and/or adverse reactions should be closely monitored and the dose adjusted as needed.
Med sočasno uporabo posakonazola in peroralnih substratov CYP3A4, pri katerih lahko povečanje plazemske koncentracije spremljajo nesprejemljivi neželeni učinki, je treba skrbno spremljati plazemske koncentracije substrata CYP3A4 in/ali neželene učinke in po potrebi prilagoditi odmerek zdravila.
Due to the variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough fungal infections (see section 4.2).
Zaradi variabilne izpostavljenosti je treba bolnike s hudo okvaro ledvic skrbno spremljati glede prebijajočih glivnih okužb (glejte poglavje 4.2).
• patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS)
• pri bolnikih z oslabljenim imunskim sistemom zaradi kemoterapije, potrebne za zdravljenje akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS);
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 zmanjšal Cmax (največjo plazemsko koncentracijo) posakonazola na 57 %, AUC posakonazola (površino pod krivuljo plazemske koncentracije v odvisnosti od časa) pa na 51 %.
Treatment of azole-susceptible Oropharyngeal Candidiasis (OPC) A randomised, evaluator-blind, controlled study was completed in HIV-infected patients with azolesusceptible oropharyngeal candidiasis (most patients studied had C. albicans isolated at baseline).
Zdravljenje orofaringealne kandidoze, občutljive na azole Randomizirana, s "slepim ocenjevalcem" kontrolirana študija je bila opravljena pri bolnikih, okuženih z virusom HIV, ki so imeli na azole občutljivo orofaringealno kandidozo (pri večini bolnikov v tej študiji so na začetku študije izolirali C. albicans).
Cav quartile analyses of pivotal patient studies with posaconazole tablet and oral suspension Posaconazole tablet
Analiza kvartilov Cav ključnih študij pri bolnikih z uporabo tablet in peroralne suspenzije posakonazola
All drug interactions with posaconazole oral suspension, except for those that affect the absorption of posaconazole (via gastric pH and motility) are considered relevant to posaconazole concentrate for solution for infusion as well.
Vsa medsebojna delovanja s posakonazolom v peroralni suspenziji razen tistih, ki vplivajo na absorpcijo posakonazola (zaradi pH v želodcu ali motilitete želodca), so pomembna tudi za posakonazol v koncentratu za raztopino za infundiranje.
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 ni potrebno (glejte poglavje 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
Pri bolnikih z akutno mieloično levkemijo ali mielodisplastičnimi sindromi 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
The subject population for Cohorts 1 and 2 included subjects with AML or MDS who had recently received chemotherapy and had developed or were anticipated to develop significant neutropenia.
Populacija preiskovancev za kohorti 1 in 2 je obsegala 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.
Caution should be used when prescribing Noxafil to patients with hypersensitivity to other azoles.
Pri predpisovanju zdravila Noxafil bolnikom, preobčutljivim na druge azole, je potrebna previdnost.
Noxafil can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as:
Zdravilo Noxafil se lahko uporabi tudi za preprečevanje glivnih okužb pri odraslih, ki imajo veliko tveganje za takšne okužbe, na primer:
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 s posakonazolom, naj bodo rezervirani za bolnike, ki prejemajo alkaloid vinke, vključno z vinkristinom, in ki nimajo alternativnih možnosti protiglivnega zdravljenja (glejte poglavje 4.5).
• 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.
Do not take Noxafil if you are taking any of the following:
Ne jemljite zdravila Noxafil, če jemljete katero od naslednjih zdravil:
Accidental overdose was noted in one patient who took posaconazole oral suspension 1,200 mg twice a day for 3 days.
Nenamerno preveliko odmerjanje je bilo zabeleženo pri enem bolniku, ki je 3 dni jemal peroralno suspenzijo posakonazola v odmerku 1.200 mg dvakrat na dan.
• pimozide (used to treat symptoms of Tourette's disorder)
• pimozid (za zdravljenje simptomov Tourettovega sindroma)
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.
Zaporedne farmakokinetične vzorce so vzeli 1. dan in v stanju dinamičnega ravnovesja 14. dan vsem preiskovancem v kohorti 1 in 2 ter 10. dan podskupini preiskovancev v kohorti 3.
Excipient with known effect: Each vial contains 462 mg (20 mmol) sodium.
Pomožna snov z znanim učinkom: Ena viala vsebuje 462 mg (20 mmol) natrija.
Alternatively, patients who can tolerate food or a nutritional supplement may take 400 mg (10 mL) twice a day during or immediately following a meal or nutritional supplement.
200 mg (5 ml) štirikrat na dan. Bolniki, ki prenašajo hrano ali prehranske dodatke, lahko vzamejo 400 mg (10 ml) dvakrat na dan med ali takoj po jedi ali prehranskem dodatku.
• heart rhythm problems
• težave s srčnim ritmom
You should not take this medicine if you have a condition called glucose-galactose malabsorption and should take note of this amount of glucose if you need to watch your sugar intake for any reason.
To količino glukoze upoštevajte, če morate iz kakršnega koli razloga paziti na vnos sladkorja.
A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomisation.
Ključni sekundarni opazovani dogodek je bila pojavnost dokazanih oziroma verjetnih invazivnih glivnih okužb 100 dni po randomizaciji.
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:
Po isti intravenski liniji (ali kanili) kot zdravilo Noxafil koncentrat za raztopino za infundiranje je hkrati mogoče infundirati naslednja zdravila:
Common: the following may affect up to 1 in 10 people
Pogosti: pojavijo se lahko pri največ 1 od 10 oseb
• “pancytopenia” low level of all blood cells (red and white blood cells and platelets) shown in blood tests
• pancitopenija - nizko število vseh krvnih celic (rdečih in belih krvnih celic ter trombocitov)
• Do not crush, chew, break or dissolve the tablet.
• Tablete ne smete zdrobiti, žvečiti, prelomiti ali raztopiti.
Noxafil 40 mg/mL oral suspension posaconazole
Noxafil 40 mg/ml peroralna suspenzija posakonazol
b: In 1899 this was the period from randomisation to last dose of study medicinal product plus 7 days; in 316 it was the period from first dose to last dose of study medicinal product plus 7 days.
V študiji 1899 je bilo to obdobje od randomizacije do zadnjega odmerka preučevanega zdravila plus 7 dni, v študiji 316 pa je bilo to obdobje od prvega odmerka do zadnjega odmerka preučevanega zdravila plus 7 dni.
• 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.
• high level of “eosinophils” a type of white blood cell (eosinophilia) - this can happen if you have inflammation
• visoko število eozinofilcev - vrste belih krvnih celic (eozinofilija) - pojavi se lahko, če imate kakšno vnetje
Noxafil is also available as 40 mg/mL oral suspension and 300 mg concentrate for solution for infusion.
Zdravilo Noxafil je na voljo tudi kot peroralna suspenzija 40 mg/ml in 300 mg koncentrat za raztopino za infundiranje.
An increase in Cmax (26 %) and AUC (29 %) was observed in elderly subjects (24 subjects  65 years of age) relative to younger subjects (24 subjects 18 - 45 years of age).
Pri starostnikih (24 preiskovancev, starih  65 let) so opažali povečanje Cmax (26 %) in vrednosti AUC (29 %) v primerjavi z mlajšimi preiskovanci (24 preiskovancev, starih od 18 do 45 let).
Administration instructions for Noxafil concentrate for solution for infusion
Navodila za dajanje zdravila Noxafil koncentrat za raztopino za infundiranje
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 po enkratnem in večkratnem dajanju odmerkov do 800 mg, zaužitih z zelo mastno hrano.
The safety profile in these patients < 18 years of age appears similar to the safety profile observed in adults.
Varnostni profil zdravila je pri teh bolnikih, mlajših od 18 let, videti podoben kot pri odraslih.
The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose of posaconazole oral suspension.
V urinu in blatu izločeni presnovki zajemajo približno 17 % uporabljenega radioaktivno označenega odmerka posakonazola v peroralni suspenziji.
Stevens Johnson syndrome, vesicular rash
Stevens-Johnsonov sindrom, vezikularen izpuščaj
• midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants)
• midazolam, triazolam, alprazolam in drugi benzodiazepini (uporabljajo se kot pomirjevala ali zdravila za sprostitev mišic),
The length of treatment may depend on the type of infection that you have or the length of time your immune system is not working properly and may be individually adapted for you by your doctor.
Trajanje zdravljenja je lahko odvisno od vrste okužbe, ki jo imate, ali od tega, koliko časa vaš imunski sistem ne deluje pravilno.
If concomitant administration is required, close monitoring for breakthrough fungal infections is recommended.
Če je potrebna sočasna uporaba, je bolnike priporočljivo skrbno spremljati glede prebijajočih glivnih okužb.
Noxafil 100 mg gastro-resistant tablets
Noxafil 100 mg gastrorezistentne tablete
Of the circulating metabolites, the majority are glucuronide conjugates of posaconazole with only minor amounts of oxidative (CYP450 mediated) metabolites observed.
Od presnovkov v obtoku je večina glukuronidnih konjugatov posakonazola, opazili pa so le majhne količine oksidativnih presnovkov (presnova s CYP450).
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).].
Ta zaporedna farmakokinetična analiza je pokazala, da je 94 % preiskovancev, zdravljenih z odmerkom 300 mg enkrat na dan, v stanju dinamičnega ravnovesja doseglo Cav od 500 do 2.500 ng/ml [Cav je bila povprečna koncentracija posakonazola v stanju dinamičnega ravnovesja, izračunana kot AUC/odmerni interval (24 ur).].
• quinidine (used to treat abnormal heart rhythms).
• kinidin (za zdravljenje motenj srčnega ritma).
• terfenadine (used to treat allergies)
• terfenadin (za zdravljenje alergij)
The safety and efficacy of Noxafil in children aged below 18 years have not been established.
Varnost in učinkovitost zdravila Noxafil pri otrocih, mlajših od 18 let, nista ugotovljeni.
Whenever possible you should take posaconazole during or immediately after food or a nutritional drink.
Če je le mogoče, posakonazol vzemite med ali takoj po jedi ali zaužitju prehranskega dopolnila v obliki napitka.
Subjects who received 300 mg once daily achieved a mean Cav at steady state of 1500 ng/mL.
Preiskovanci, ki so dobivali 300 mg enkrat na dan, so v stanju dinamičnega ravnovesja dosegli povprečno Cav 1.500 ng/ml.
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).
Druge sestavine zdravila so: hipromeloza acetat sukcinat, mikrokristalna celuloza, hidroksipropilceluloza (E463), silicijev dioksid dentalnega tipa, premreženi natrijev karmelozat, magnezijev stearat, polivinilalkohol, makrogol 3350, titanov dioksid (E171), smukec, rumeni železov oksid (E172).
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.
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 je peroralna suspenzija posakonazola (200 mg ali 400 mg) med sočasno uporabo podaljšala povprečni terminalni razpolovni čas midazolama s približno 3 do 4 ure na 8 do 10 ur.
• medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir,
• zdravila za zdravljenje HIV, imenovana zaviralci proteaz (vključno z lopinavirjem in atazanavirjem, ki se dajeta skupaj z ritonavirjem),
This medicinal product contains approximately 1.75 g of glucose per 5 mL of suspension.
To zdravilo vsebuje približno 1,75 g glukoze v 5 ml suspenzije.
Dose adjustment of benzodiazepines metabolised by CYP3A4 should be considered (see section 4.5).
Razmisliti je treba o prilagoditvi odmerka benzodiazepinov, ki se presnavljajo s CYP3A4 (glejte poglavje 4.5).
Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Študija 316 je bila randomizirano, dvojno slepo preskušanje s peroralno suspenzijo posakonazola (200 mg trikrat na dan) v primerjavi s kapsulami flukonazola (400 mg enkrat na dan) pri bolnikih po alogenski transplantaciji hematopoetskih matičnih celic z reakcijo presadka proti gostitelju (GVHDgraft-versus-host disease).
• blood clots in your lungs (pulmonary embolism) - signs include feeling short of breath or pain while breathing
• krvni strdki v pljučih (pljučna embolija) - med znaki so kratka sapa ali bolečine med dihanjem
White suspension
peroralna suspenzija bela suspenzija
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 (glejte poglavje 4.3).
What you need to know before you use Noxafil
Kaj morate vedeti, preden boste uporabili zdravilo Noxafil
• signs of liver problems, these include yellowing of your skin or whites of the eyes, unusually dark urine or pale faeces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests
• znaki težav z jetri; med njimi so porumenelost kože ali očesnih beločnic, nenavadno temen urin ali svetlo blato, slabost v želodcu brez razloga, težave z želodcem, izguba apetita ali nenavadna utrujenost ali šibkost, zvišanje jetrnih encimov (pokaže se na preiskavah krvi)
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.
Plazemske koncentracije posakonazola so se po uporabi enkratnega odmerka posakonazola v koncentratu za raztopino za infundiranje v območju 50-200 mg povečale več kot sorazmerno z odmerkom, medtem ko so bila v območju 200-300 mg povečanja odvisna od odmerka.
Summary of posaconazole concentrate for solution for infusion bridging study Study 5520 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole concentrate for solution for infusion.
Povzetek premostitvene študije s posakonazolom v koncentratu za raztopino za infundiranje Študija 5520 je bila neprimerjalna, multicentrična študija za oceno farmakokinetičnih lastnosti, varnosti in prenašanja posakonazola v koncentratu za raztopino za infundiranje.
If a central venous catheter is not available, a single infusion may be administered through a peripheral venous catheter.
Če centralni venski kateter ni na voljo, je mogoče enkratno intravensko infuzijo dati po perifernem venskem katetru.
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 receptorjev H2 in zaviralci protonske črpalke Med sočasno uporabo posakonazola s cimetidinom (400 mg dvakrat na dan), so se plazemske koncentracije posakonazola (Cmax in AUC) znižale za 39 % zaradi zmanjšane absorpcije verjetno zaradi zmanjšanega nastajanja želodčne kisline.
Co-administration with the HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin (see section 4.5).
Sočasna uporaba z zaviralci reduktaze HMG-CoA simvastatinom, lovastatinom in atorvastatinom (glejte poglavje 4.5).
• inflammation of the pancreas (pancreatitis) - this may cause severe stomach pain
• vnetje trebušne slinavke (pankreatitis) - povzroči lahko hude bolečine v trebuhu
Posaconazole was shown to be non-inferior to fluconazole for clinical success rates at Day 14 as well as 4 weeks after the end of treatment.
Za posakonazol so pokazali, da po klinični uspešnosti, ugotovljeni na 14. dan in 4 tedne po koncu zdravljenja, ni nič slabši od flukonazola.
• stroke - signs include pain, weakness, numbness, or tingling in the limbs
• možganska kap - med znaki so bolečina, šibkost, omrtvičenost ali mravljinčenje v udih
The safety and efficacy of Noxafil concentrate for solution for infusion in children aged below 18 years have not been established.
Varnost in učinkovitost zdravila Noxafil koncentrat za raztopino za infundiranje pri otrocih, mlajših od 18 let, nista ugotovljeni.
C-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).
C-posakonazola se je radioaktivnost pojavila predvsem v blatu (77 % radioaktivno označenega odmerka); glavni del tega je bila matična spojina (66 % radioaktivno označenega odmerka).
altered medicine levels, blood phosphorus decreased, chest x-ray abnormal
spremenjene koncentracije zdravila, znižanje fosforja v krvi, nenormalen rentgenogram prsnega koša
The solution of Noxafil ranges from colourless to pale yellow.
Barva raztopine zdravila Noxafil je v območju od brezbarvne do bledo rumene.
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.
Po uporabi tablet je izločanje posakonazola počasno; povprečni razpolovni čas (t1/2) je 29 ur (razpon od 26 do 31 ur) in povprečni navidezni očistek sega od 7,5 do 11 l/uro.
Noxafil can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm.
Zdravilo Noxafil lahko poveča koncentracijo naslednjih zdravil v krvi, to pa lahko povzroči zelo resne motnje srčnega ritma.
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 presnovi z glukuronidacijo UDP (encimi 2. faze) in je in vitro substrat iztoka s p-glikoproteinom (P-gp).
• Administer via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow intravenous infusion over approximately 90 minutes.
• Zdravilo dajte po centralni venski liniji, ki vključuje centralni venski kateter ali periferno vstavljen centralni kateter (PICC), v počasni intravenski infuziji približno 90 minut.
Loading dose of 200 mg (5 mL) once a day on the first day, then 100 mg (2.5 mL) once a day for 13 days.
Začetni odmerek 200 mg (5 ml) enkrat na dan prvi dan, potem pa 100 mg (2,5 ml) enkrat na dan še 13 dni.
- The other ingredients in the suspension are polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), artificial cherry flavour containing benzyl alcohol and propylene glycol, and purified water.
- Pomožne snovi v suspenziji so polisorbat 80, simetikon, natrijev benzoat (E211), natrijev citrat dihidrat, citronska kislina monohidrat, glicerol, ksantanski gumi, tekoča glukoza, titanov dioksid (E171), umetna aroma češnje, ki vsebuje benzilni alkohol in propilenglikol, in prečiščena voda.
Each vial of Noxafil contains 462 mg (20 mmol) of sodium.
Ena viala zdravila Noxafil vsebuje 462 mg (20 mmol) natrija.
Similar recommendations apply to posaconazole concentrate for solution for infusion; however, a specific study has not been conducted with posaconazole concentrate for solution for infusion.
Podobna priporočila veljajo za posakonazol v koncentratu za raztopino za infundiranje, vendar pa specifične študije s posakonazolom v koncentratu za raztopino za infundiranje niso bile izvedene.
Study 5615 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole tablet.
Povzetek premostitvene študije s tabletami posakonazola Študija 5615 je bila neprimerjalna, multicentrična študija za oceno farmakokinetičnih lastnosti, varnosti in prenašanja tablet posakonazola.