natgillin/translations-raw huggingface dataset:
This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as: - patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS) - patients having “high- dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).
Tozdravilo se lahko uporabitudiza preprečevanje glivnih okužb priodraslih, ki imajo velikotveganje za takšne okužbe, na primer: - pri bolnikih z oslabljenim imunskim sistemom zaradi kemoterapije, potrebne za zdravljenje akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS);
Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy.
Bolnika jetreba spremljati, da bi ugotovilimorebitne motnje ravnovesja elektrolitov, zlastimotnjekoncentracijekalija, magnezija ali kalcija, in jih po potrebi odpravitipred ali med zdravljenjem sposakonazolom.
Simeticone emulsion (containing polydimethylsiloxane, polyethylene glycol sorbitan tristearate, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid (E200), benzoic acid (E210) and sulfuric acid (E513))
6.1 Seznam pomožnih snovi makrogolglicerol hidroksistearat natrijevcitratdihidrat citronska kislina monohidrat emulzija simetikona (vsebuje polidimetilsiloksan, polietilenglikol sorbitan tristearat, metilcelulozo, silikagel, polietilenglikol stearat, sorbinsko kislino (E200), benzojsko kislino (E210) in žveplovo kislino (E513)) ksantanski gumi(E415) natrijev benzoat (E211)
However, the safety profile of posaconazole between the Black and Caucasian subjects was similar.
Vendar pa jebilvarnostniprofilposakonazola pri preiskovancih črne in bele rase podoben.
- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.
ter pri bolnikih, ki ne prenašajo teh zdravil, - orofaringealne kandidoze: kot terapija prve izbire pri bolnikih s hudo okužbo ali pri tistih z imunsko pomanjkljivostjo, pri katerih pričakujemo, da bo odziv na topikalno terapijo slab.
Do not take Posaconazole AHCL if you are pregnant unless you are told to by your doctor.
Če ste noseči, ne jemljite zdravila Posakonazol AHCL, razen če vam to naroči zdravnik.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Posvetujte se tudi, če opazite neželeneučinke,kinisonavedeni v temnavodilu.Oneželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden vPrilogi V. S tem,koporočate o neželenihučinkih,lahkoprispevate k zagotovitvivečinformacij ovarnostitegazdravila.
Due to the risk of prolonged sedation and possible respiratory depression co-administration of posaconazole with any benzodiazepines metabolised by CYP3A4 (e.g. midazolam, triazolam, alprazolam) should only be considered if clearly necessary.
Zaradi tveganja pojava dolgotrajne sedacije in morebitne depresije dihanja lahko sočasna uporaba posakonazola in katerega koli benzodiazepina, ki se presnavlja s CYP3A4 (npr. midazolam, triazolam,
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Posaconazole AHCL.
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden začnete jemati zdravilo Posakonazol AHCL.
The absorption of posaconazole was significantly increased when posaconazole 400 mg (once daily) was administered during and immediately after the consumption of a high fat meal (~ 50 grams fat) compared to administration before a meal, with Cmax and AUC increasing by approximately 330 % and 360 %, respectively.
Absorpcija posakonazola se je bistveno povečala, če so bolniki zaužili posakonazol v odmerku 400 mg(enkratnadan)obobroku z velikokoličinomaščob(~ 50 gramov maščobe) oziroma takoj potakšnem obroku, v primerjavi z jemanjemzdravila predobrokom.Pritemseje vrednostCmaxpovečalaza približno 330 %, vrednost AUC pa za približno 360%.
Other medicines and Posaconazole AHCL
Druga zdravila in zdravilo Posakonazol AHCL
Titanium dioxide (E171)
tekoča glukoza glicerol (E422) titanov dioksid (E171) aroma jagode (vsebuje propilenglikol)
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 intravensko danih substratov CYP3A4 jepotrebna previdnost in po potrebi zmanjšanje odmerka substrata CYP3A4.Med sočasno uporabo posakonazola in peroralnih substratovCYP3A4, pri katerih lahko povečanjeplazemske koncentracijespremljajo nesprejemljivi neželeni učinki, jetreba skrbno spremljatiplazemske koncentracije substrata CYP3A4 in/ali neželene učinke in po potrebi prilagoditi odmerek zdravila.
What Posaconazole AHCL is and what it is used for
Kaj je zdravilo Posakonazol AHCL in za kaj ga uporabljamo
Therefore, posaconazole may increase plasma concentration of digoxin and digoxin levels need to be monitored when initiating or discontinuing posaconazole treatment.
Posakonazol torej lahko povečaplazemskokoncentracijodigoksina, zato je treba obuvedbi inpoprenehanju zdravljenjas posakonazolom spremljatikoncentracijo digoksina.
Co-administration of posaconazole with proton pump inhibitors should be avoided if possible.
Sočasni uporabi posakonazola in zaviralcev protonske črpalke se jetreba izogibati, če je le mogoče.
Glucose concentrations decreased in some healthy volunteers when glipizide was co-administered with posaconazole.
Med sočasno uporabo glipizida in posakonazola se je pri nekaterih zdravih prostovoljcih znižalakoncentracija glukoze.
Do not take Posaconazole AHCL if you are taking any of the following: - terfenadine (used to treat allergies) - astemizole (used to treat allergies) - cisapride (used to treat stomach problems) - pimozide (used to treat symptoms of Tourette's and mental illness) - halofantrine (used to treat malaria) - quinidine (used to treat abnormal heart rhythms).
- terfenadin (za zdravljenje alergij) - astemizol (za zdravljenje alergij) - cisaprid (za zdravljenje težav z želodcem) - pimozid (za zdravljenje simptomov Tourettovega sindroma in duševnih bolezni) - halofantrin (za zdravljenje malarije)
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Posaconazole AHCL.
Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom,preden začnete jemati zdravilo Posakonazol AHCL.
If you are not sure, talk to your doctor or pharmacist before taking Posaconazole AHCL.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdraviloPosakonazol AHCL.
Posaconazole AHCL can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them: - infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped; - infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped; - infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped; - infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped.
- okužb,kijihpovzročajogliveiz družine Fusariumin ki se niso izboljšale med zdravljenjem zamfotericinom B, ali čejebilotreba amfotericin B ukiniti; - okužbzglivami,kipovzročajobolezni, imenovani"kromoblastomikoza"in "micetom",kiseniso izboljšale med zdravljenjem z itrakonazolom ali če jebilotreba zdravljenje zitrakonazolomukiniti; - okužb, ki jih povzročajo glive Coccidioides, ki se niso izboljšale med zdravljenjem z enim aliveč od naslednjih zdravil: amfotericinomB,itrakonazolomali flukonazolom,aliče jebilotrebazdravljenje s temi zdravilikončati;
In the fasting state, AUC increased less than in proportion to dose above 200 mg.
Na tešče se je vrednost AUC povečalamanjkotbibilosorazmernoodmerkunad200 mg.
Each millilitre of oral suspension contains 40 milligrams of posaconazole.
En ml peroralne suspenzije vsebuje 40 mg posakonazola.
During post-marketing surveillance of posaconazole oral suspension, severe hepatic injury with fatal outcome has been reported (see section 4.4).
Bolezni jeter, žolčnika in žolčevodov Med spremljanjem v obdobju trženja peroralne suspenzije posakonazola so poročali o hudi okvari jeter s smrtnim izidom (glejte poglavje 4.4).
200 mg (5 mL) three times a day.
Jemljite200 mg(eno polno 5 ml žličko) trikrat na dan.
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.
Med sočasno uporabo posakonazola s cimetidinom(400 mg dvakrat na dan), so se plazemskekoncentracijeposakonazola (Cmaxin AUC)znižale za 39 % zaradi zmanjšaneabsorpcije verjetnozaradi zmanjšanega nastajanja želodčne kisline.
Posaconazole was not genotoxic in in vitro and in vivo studies.
Posakonazol vštudijah invitro in invivo ni bil genotoksičen.
What Posaconazole AHCL looks like and contents of the pack Posaconazole AHCL is a white to off-white free flowing suspension, packaged in amber glass bottle.
Posakonazol AHCLjebela do belkasta dobro tekoča suspenzija, pakirana v steklenički iz rjavega stekla.
11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole oral suspension 800 mg/day in divided doses for a median of 296 days and up to 460 days.
11 od 16 bolnikov so uspešno zdravili(ob koncu zdravljenja popolno alidelno izginotje izhodiščnihznakov in simptomov) s peroralno suspenzijo posakonazola 800 mg/dan v deljenih odmerkih.
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.
Kot prikazuje preglednica 3,jebil uspešen odziv(popolno alidelno izginotje) ob koncu zdravljenjaopazen pri 42 % bolnikov,zdravljenih s posakonazolom, in pri26 % bolnikov izzunanjeskupine.Vendarto ni bila prospektvina, randomizirana in kontrolirana študija,zatojetreba vse primerjave zzunanjo kontrolno skupino previdnoobravnavati.
- bleeding into your stomach or gut - signs include vomiting blood or passing blood in your stool - a blockage in your gut (intestinal obstruction) especially in the “ileum”.
- krvavitev v želodec ali črevo - med znaki so bruhanje krvi ali kri v blatu
Elderly (≥ 65 years) 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).
Starostniki(≥65 let) Pristarostnikih (24 preiskovancev, starih ≥65let) so opažali povečanje Cmax(26 %)in vrednosti AUC(29
Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz and cimetidine
Rifamicinski antibiotiki (rifampicin, rifabutin), določeni antikonvulzivi (fenitoin,
If concomitant administration is required, close monitoring for breakthrough fungal infections is recommended.
Čejepotrebnasočasnauporaba,je bolnike priporočljivo skrbno spremljatigledeprebijajočihglivnih okužb.
Thereafter blood levels of ciclosporin should be monitored carefully during co-administration, and upon discontinuation of posaconazole treatment, and the dose of ciclosporin should be adjusted as necessary.
Potem je treba natančno spremljati koncentracije ciklosporina v krvi, in sicermed sočasno uporabo inpoprenehanju zdravljenja s posakonazolom;odmerekciklosporina jetrebaprilagoditi,kotjepotrebno.
Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment: - nausea or vomit (feeling or being sick), diarrhoea - 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 - allergic reaction.
- znakitežav z jetri;mednjimi so porumenelost kože ali očesnih beločnic, nenavadno temen urinali 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) - alergijska reakcija
Tell your doctor if you are or think you are pregnant before you start to take Posaconazole AHCL.
Če ste noseči ali menite, da bi lahko bili noseči, se posvetujte z zdravnikom, preden vzamete zdravilo Posakonazol AHCL.
The recommended dose is 200 mg (one 5 mL spoonful) taken four times daily.
Priporočeniodmerek je 200 mg (ena polna 5 ml žlička)štirikratna dan.
Pulmonary phospholipidosis resulting in dilatation and obstruction of the alveoli was observed in the 2-year study in rats.
V2-letništudijina podganah so opažali pljučno fosfolipidozo, ki je povzročila dilatacijo inobstrukcijo alveolov.
If you get any side effects, talk to your doctor, pharmacist or nurse.
Če opazite kateregakoliizmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom alimedicinsko sestro.
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.
Podobno staseprijemanju 400 mg posakonazola z esomeprazolom (40 mg na dan) v primerjavi zjemanjemsamega posakonazola v odmerku 400 mgzmanjšalisrednja vrednost Cmaxoz.
If it is considered that co-administration is unavoidable, then it is recommended that the dose of sirolimus should be greatly reduced at the time of initiation of posaconazole therapy and that there should be very frequent monitoring of trough concentrations of sirolimus in whole blood.
Če se sočasniuporabi ni mogoče izogniti, je ob uvedbi zdravljenja s posakonazolompriporočljivo zelozmanjšatiodmereksirolimusainzelopogosto preverjatinajnižjo koncentracijo sirolimusa v polnikrvi.
Uncommon: the following may affect up to 1 in 100 people - anaemia - signs include headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests - low level of platelets (thrombocytopenia) shown in blood tests - this may lead to bleeding - low level of “leukocytes” a type of white blood cell (leukopenia) shown in blood tests - this can make you more likely to get infections - high level of “eosinophils” a type of white blood cell (eosinophilia) - this can happen if you have inflammation - inflammation of the blood vessels - heart rhythm problems
- anemija - med znaki so glavoboli, utrujenost ali omotičnost, kratka sapa ali bledica ter nizka koncentracija hemoglobina, ki se pokaže na preiskavah krvi - nizko število trombocitov (trombocitopenija), ki se pokaže na preiskavah krvi - povzroči lahko krvavitve - nizko število levkocitov - belih krvnih celic (levkopenija) - pokaže se na preiskavah krvi;
Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir and ritonavir (300/100 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 1.5-fold and 2.5-fold (range 0.9 to 4.1-fold), respectively.
Po 7-dnevnisočasni uporabi peroralne suspenzije posakonazola(400 mgdvakrat na dan) z atazanavirjem in ritonavirjem (300/100 mg enkrat na dan) seje pri zdravihpreiskovancih Cmaxatazanavirjapovečala v povprečju za1,5-krat,njegovaAUC paza 2,5-krat (razponod 0,9-kratdo 4,1-krat).
Monitoring of glucose concentrations is recommended in diabetic patients.
Pri sladkornih bolnikih jepriporočljivospremljatikoncentracije glukoze.
Neuronal phospholipidosis occurred in dogs dosed for ≥ 3 months at lower systemic exposures than those obtained at therapeutic doses in humans.
Pri psih, ki so ≥3 mesecedobivaliodmerke zdravila za manjšo sistemsko izpostavljenost od tiste,dosežene med uporabo terapevtskih odmerkov pri človeku, se je pojavila fosfolipidoza nevronov.
If you become pregnant while you are taking Posaconazole AHCL, contact your doctor straight away.
Če med jemanjem zdravila Posakonazol AHCL zanosite, se nemudoma posvetujte z zdravnikom.
Frequent monitoring for adverse reactions and toxicity related to calcium channel blockers is recommended during co-administration with posaconazole.
Medsočasnouporabo s posakonazolom jepriporočljivo pogosto spremljanje gledeneželenih učinkovin toksičnosti, povezanih z zaviralci kalcijevih kanalčkov.
In general, exposures tended to be higher in the older patients (7 to <18 years) than in younger patients (2 to <7 years).
dan med 500 ng/mlin 2.500 ng/ml).Nasplošnoso bile izpostavljenosti večinoma višjepristarejšihbolnikih(7 do < 18 let) kot pri mlajših bolnikih (2 do < 7 let).
- fits (convulsions) - nerve damage (neuropathy) - abnormal heart rhythm - shown up on a heart trace (ECG), palpitations, slow or fast heartbeat,
- motnje srčnega ritma - pokažejo se na zapisu električnega delovanja srca (EKG), razbijanje srca
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.
Po enkratnem peroralnem odmerku 400 mg peroralne suspenzije posakonazola pri bolnikih z blago (razred A po Child-Pughu), zmerno (razred B po Child-Pughu) ali hudo okvaro jeter (razred C po
Due to the risk of prolonged sedation it is recommended that dose adjustments should be considered when posaconazole is administered concomitantly with any benzodiazepine that is metabolised by CYP3A4 (e.g. midazolam, triazolam, alprazolam) (see section 4.4).
Zaradi tveganja zadolgotrajnejšosedacijo je v primeru sočasne uporabe posakonazolainkateregakolibenzodiazepina, ki se presnovis CYP3A4 (npr. midazolama, triazolama ali alprazolama), priporočljivo razmisliti o prilagoditviodmerka (glejte poglavje 4.4).
b: In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316
Vštudiji1899jebilotoobdobje od randomizacije do zadnjega odmerka preučevanega zdravilaplus7 dni, v študiji316 pa je bilo to obdobje od prvega odmerka do zadnjega odmerka preučevanega zdravila plus 7dni.
Repeat dose administration of posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Uporabavečkratnih odmerkovposakonazola vobliki peroralne suspenzije (400 mg dvakrat na dan16 dni) jepri zdravihosebah (kiso dobile enkraten odmerek2 mgsirolimusa) povečala Cmaxsirolimusa v povprečjuza 6,7-kratin AUCsirolimusa v povprečju za 8,9-krat (razpon od 3,1-kratdo17,5-krat).
After administration of 14C-posaconazole, radioactivity was predominantly recovered in the faeces (77 % of the radiolabelled dose) with the major component being parent compound (66 % of the radiolabelled dose).
Posakonazolse izloča počasi, s srednjo razpolovno dobo (t½) 35 ur (razpon od 20 do 66 ur).Pouporabi 14C-posakonazola se jeradioaktivnost pojavila predvsem v blatu(77 % radioaktivnooznačenega odmerka);glavnidel tega jebila matična spojina (66% radioaktivnooznačenegaodmerka).
Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26-fold), respectively.
Po 7-dnevnisočasni uporabi peroralne suspenzijeposakonazola(400 mg dvakrat na dan) z atazanavirjem (300 mg enkrat na dan) seje pri zdravihpreiskovancih Cmaxatazanavirjapovečala v povprečju za2,6-krat,njegovaAUC paza 3,7-krat (razponod 1,2-kratdo 26-krat).
• If you get any side effects, talk to your doctor or pharmacist.
• Če opazite katerikoli neželeni učinek, seposvetujte z zdravnikom alifarmacevtom.
Talk to your doctor or pharmacist before taking Posaconazole AHCL - if you have had an allergic reaction to another antifungal medicine such as ketoconazole,
- če ste imeli alergijsko reakcijo na kakšno drugo protiglivno zdravilo, npr. na ketokonazol,
Phenytoin (200 mg once a day) decreased the Cmax and AUC of posaconazole by 41 % and 50 %, respectively.
Fenitoin(200 mg enkrat na dan) je zmanjšalCmaxposakonazola za 41 %, njegovoAUC paza 50 %.Sočasni uporabi posakonazola in fenitoina ter podobnih induktorjev (npr.
In subjects with severe renal impairment (n=6, Cl cr< 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [> 96 % CV (coefficient of variance)] compared to other renal groups [< 40 % CV].
Pripreiskovancih s hudookvaro ledvic (n = 6, očistek kreatinina< 20 ml/min/1,73 m2) je bila AUC posakonazola močno spremenljiva
Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during co-administration with posaconazole.
Medsočasno uporabo posakonazola je priporočljivo pogosto spremljanje glede neželenih učinkovintoksičnosti, povezanih s protiretrovirusnimizdravili, ki so substrati CYP3A4.
STATEMENT OF ACTIVE SUBSTANCE(S) Each mL contains 40 mg of posaconazole.
En ml vsebuje 40 mg posakonazola.
Stevens Johnson syndrome, vesicular rash Musculoskeletal and connective tissue disorders Uncommon:
Stevens-Johnsonov sindrom, vezikularen izpuščaj
How to take Posaconazole AHCL
Kako jemati zdravilo Posakonazol AHCL
In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
V obeh študijah profilaktične uporabe zdravila je bila aspergiloza najpogostejša prebijajočaokužba.Za izsledke obeh študij glejte preglednici 5 in 6.
No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at systemic exposures 4.6-fold greater than the concentrations obtained at therapeutic doses in humans.
Vfarmakološki študijivarnosti ponavljajočihse odmerkov na opicah pri sistemskih izpostavljenostih,ki so bile 4,6-krat večje od koncentracij, doseženih med uporabo terapevtskihodmerkovpričloveku,na elektrokardiogramih (vključno z intervaloma QT in QTc) niso opazili nobenih učinkov.
NAME OF THE MEDICINAL PRODUCT Posaconazole AHCL 40 mg/mL oral suspension posaconazole
Navodilo za uporabo Posakonazol AHCL 40 mg/ml peroralna suspenzija posakonazol
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 dogodekučinkovitosti je bila pojavnostdokazanih oziroma verjetnih invazivnihglivnihokužb,kijihje ugotavljala neodvisna skupina zunanjih strokovnjakov na slep način medobdobjemzdravljenja.Ključnisekundarni opazovani dogodekjebila pojavnostdokazanihoziromaverjetnih invazivnihglivnihokužb 100 dni po randomizaciji.