natgillin/translations-raw huggingface dataset:
The effects of ECALTA were compared with those of fluconazole (another antifungal medicine).
Učinke zdravila ECALTA so primerjali z učinki flukonazola (drugega protiglivičnega zdravila).
The main measure of effectiveness 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Obe zdravili sta bili dajani v obliki infuzije, pri čemer je zdravljenje trajalo 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged was the proportion of patients who had responded to treatment at the end of the treatment.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so se ob koncu zdravljenja nanj odzvali.
A response was defined as a significant or complete improvement of symptoms, with no need for further antifungal treatment and no Candida found in the specimens taken from the patient.
Odziv je bil opredeljen kot pomembno ali popolno izboljšanje simptomov, brez potrebe po nadaljnjem protiglivičnem zdravljenju, pri čemer v vzorcih, vzetih pri bolnikih, Candida ni bila več prisotna.
What benefit has ECALTA shown during the studies?
Kakšne koristi je zdravilo ECALTA izkazalo med raziskavami?
ECALTA was more effective than fluconazole in treating invasive candidiasis.
Zdravilo ECALTA je bilo učinkovitejše od flukonazola pri zdravljenju invazivne kandidoze.
At the end of intravenous therapy, 96 (76%) of the 127 patients receiving ECALTA had responded to treatment, compared with 71 (60%) of the 118 receiving fluconazole.
Ob koncu intravenskega zdravljenja se je na zdravljenje odzvalo 96 (76%) od 127 bolnikov, ki so prejemali zdravilo ECALTA, v primerjavi z 71 (60%) od 118 bolnikov, ki so prejemali flukonazol.
What is the risk associated with ECALTA?
Kakšna tveganja so povezana z zdravilom ECALTA?
The most common side effects with ECALTA (seen in between 1 and 10 patients in 100) are coagulopathy (problems with blood clotting), convulsion (fits), headache, diarrhoea, vomiting, nausea (feeling sick), increased blood creatinine levels (a marker of kidney problems), rash, pruritus (itching), hypokalaemia (low levels of potassium in the blood), flushing, and raised blood levels of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin and gamma- glutamyltransferase (markers of liver problems).
Najpogostejši neželeni učinki pri jemanju zdravila ECALTA (opaženi pri 1 do 10 bolnikih izmed 100) so koagulopatija (motnje strjevanja krvi), konvulzije (krči), glavobol, driska, bruhanje, navzeja (slabost), zvišanje kreatinina v krvi (znak težav z ledvicami), izpuščaji, pruritus (srbenje), hipokaliemija (znižana raven kalija v krvi), zardevanje ter povišane ravni alanin- aminotransferaze, alkalne fosfataze, aspartat- aminotransferaze, bilirubina in gama- glutamiltransferaze v krvi (znaki težav z jetri).
For the full list of all side effects reported with ECALTA, see the Package Leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila ECALTA, glejte Navodilo za uporabo.
ECALTA should not be used in people who may be hypersensitive (allergic) to anidulafungin or any of the other ingredients, or to any other medicines in the echinocandin class.
Zdravila ECALTA ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) anidulafungin ali katero koli drugo sestavino zdravila oziroma na katero koli zdravilo iz razreda ehinokandinov.
Once made up into an infusion, ECALTA contains alcohol in an amount that is comparable to a small glass of wine or beer.
Pripravljeno za infundiranje, vsebuje zdravilo ECALTA količino alkohola, ki je primerljiva z majhnim kozarcem vina ali piva.
This will need to be taken into consideration when it is given to some patients (such as pregnant women, alcoholic patients or those with liver disease).
Pri dajanju zdravila nekaterim bolnikom (npr. nosečnicam, alkoholikom ali bolnikom z boleznimi jeter) je to potrebno upoštevati.
Because ECALTA can affect liver function, patients who show signs of liver problems during treatment should be carefully monitored.
Ker lahko zdravilo ECALTA vpliva na delovanje jeter, je treba bolnike, ki kažejo znake težav z jetri, med zdravljenjem skrbno spremljati.
Why has ECALTA been approved?
Zakaj je bilo zdravilo ECALTA odobreno?
The Committee for Medicinal Products for Human Use (CHMP) concluded that ECALTA’ s benefits are greater than its risks in the treatment of invasive candidiasis in adult non-neutropenic patients.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila ECALTA pri zdravljenju invazivne kandidoze pri odraslih ne- nevtropeničnih bolnikih večje od z njim povezanih tveganj.
However, the Committee noted that the main study of ECALTA included an insufficient number of patients with neutropenia to demonstrate the medicine ’ s effectiveness in this group.
Vendar pa je Odbor opozoril, da je bilo v glavno študijo zdravila ECALTA vključeno premajhno število bolnikov z nevtropenijo, da bi bilo mogoče dokazati učinkovitost zdravila pri tej skupini.
In addition, it noted that ECALTA has been studied mainly in patients with candidaemia (Candida sp. in the blood), and only in a limited number of patients with deep tissue infections or abscesses.
Nadalje je opozoril, da je bilo zdravilo ECALTA preučevano predvsem pri bolnikih s kandidemijo (Candido sp. v krvi) in le pri omejenem številu bolnikov z okužbami globokih tkiv ali abscesi.
The Committee recommended that ECALTA be given marketing authorisation.
Odbor je priporočil, da se za zdravilo ECALTA odobri dovoljenje za promet.
Other information about ECALTA:
Druge informacije o zdravilu ECALTA:
The European Commission granted a marketing authorisation valid throughout the European Union for ECALTA to Pfizer Limited on 20 September 2007.
Evropska komisija je dovoljenje za promet z zdravilom ECALTA, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited dne 20. septembra 2007.
The full EPAR for ECALTA can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo ECALTA je na voljo tukaj.
Route of EU number
Velikost Številka EU
100 mg Solvent:
100 mg Vehikel:
ECALTA 100 mg powder and solvent for concentrate for solution for infusion.
ECALTA 100 mg prašek in vehikel za koncentrat za raztopino za infundiranje
The reconstituted solution contains 3.33 mg/ ml anidulafungin and the diluted solution contains 0.36 mg/ ml anidulafungin.
Rekonstituirana raztopina vsebuje 3, 33 mg/ ml anidulafungina, razredčena raztopina pa 0, 36 mg/ ml anidulafungina.
Fructose 102.5 mg per vial Ethanol 6 g per vial
Pomožne snovi: fruktoza, 102, 5 mg na vialo etanol, 6 g na vialo
White to off-white lyophilised solid.
Prašek: bel do kremast, liofiliziran čvrst prašek.
Clear colourless solution.
Vehikel: bistra, brezbarvna raztopina.
The reconstituted solution has a pH of 4.0 to 6.0.
Rekonstituirana raztopina ima pH od 4, 0 do 6, 0.
Treatment of invasive candidiasis in adult non-neutropenic patients.
Zdravljenje invazivne kandidoze pri odraslih nenevtropeničnih bolnikih.
ECALTA has been studied primarily in patients with candidaemia and only in a limited number of patients with deep tissue Candida infections or with abscess-forming disease (see section 4.4 and section 5.1).
Zdravilo ECALTA je raziskano predvsem pri bolnikih s kandidemijo in le pri omejenem številu bolnikov z okužbami globokih tkiv s Candido ali bolnikov z boleznijo, povezano z nastajanjem abscesov (glejte poglavji 4. 4 in 5. 1).
Duration of treatment should be based on the patient ’ s clinical response.
Trajanje zdravljenja mora temeljiti na kliničnem odzivu bolnika.
ECALTA should be reconstituted with the solvent to a concentration of 3.33 mg/ ml and subsequently diluted to a concentration of 0.36 mg/ ml before use according to the instructions given in section 6.6.
Zdravilo ECALTA je treba rekonstituirati z vehiklom do koncentracije 3, 33 mg/ ml, nato pa ga pred uporabo razredčiti do koncentracije 0, 36 mg/ ml po navodilih v poglavju 6. 6.
It is recommended that ECALTA be administered at a rate of infusion that does not exceed 1.1 mg/ minute (equivalent to 3.0 ml/ minute).
Priporočljivo je, da hitrost infundiranja zdravila ECALTA ne preseže 1, 1 mg/ minuto (kar ustreza 3, 0 ml/ minuto).
Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/ minute.
Z infundiranjem povezane reakcije so redke, če hitrost infundiranja anidulafungina ne preseže 1, 1 mg/ minuto.
ECALTA should not be administered as a bolus injection.
Zdravila ECALTA se ne sme aplicirati v bolusni injekciji.
2 No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment.
2 Okvara ledvic ali jeter Pri bolnikih z blago, zmerno ali hudo okvaro jeter odmerjanja ni treba prilagoditi.
ECALTA can be given without regard to the timing of haemodialysis (see section 5.2).
Zdravilo ECALTA lahko apliciramo ne glede na čas hemodialize (glejte poglavje 5. 2).
Duration of treatment There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
Trajanje zdravljenja Ni dovolj podatkov, ki bi podpirali več kot 35- dnevno zdravljenje z odmerkom 100 mg.
Other special populations No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or geriatric status (see section 5.2).
Druge posebne populacije Pri odraslih bolnikih odmerjanja ni treba prilagajati glede na spol, telesno maso, etnično pripadnost, HIV- pozitivnost ali geriatrično stanje (glejte poglavje 5. 2).
Children and adolescents ECALTA is not recommended for use in children below 18 due to insufficient data on safety and efficacy (see section 5.2).
Otroci in mladostniki Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila ECALTA pri otrocih pod 18 let ni priporočljiva (glejte poglavje 5. 2).
Hypersensitivity to the active substance, or to any of the excipients.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov.
Hypersensitivity to other medicinal products of the echinocandin class.
Preobčutljivost za druga zdravila iz skupine ehinokandinov.
The efficacy of ECALTA in neutropenic patients with candidaemia and in patients with deep tissue Candida infections or intra-abdominal abscess and peritonitis has not been established.
Učinkovitost zdravila ECALTA pri nevtropeničnih bolnikih s kandidemijo ter pri bolnikih z okužbami globokih tkiv s Candido ali intraabdominalnim abscesom in peritonitisom ni bila dokazana.
Clinical efficacy has been evaluated primarily in non-neutropenic patients with C. albicans infections and in a smaller number of patients infected with non-albicans, mainly C. glabrata, C. parapsilosis and C. tropicalis.
Klinično učinkovitost so ocenjevali predvsem pri nenevtropeničnih bolnikih z okužbami s C. albicans ter pri manjšem številu bolnikov, okuženih z drugimi vrstami Candide, predvsem C. glabrata, C. parapsilosis in C. tropicalis.
Patients with candida endocarditis, osteomyelitis or meningitis and known C. krusei infection have not been studied.
Bolnikov z endokarditisom, osteomielitisom ali meningitisom, povzročenimi s Candido, in bolnikov s potrjeno okužbo s C. krusei niso preučevali.
Hepatic effects Increased levels of hepatic enzymes have been seen in healthy subjects and patients treated with anidulafungin.
Učinki na jetra Pri zdravih preiskovancih in bolnikih, zdravljenih z anidulafunginom, so ugotavljali zvišane ravni jetrnih encimov.
Isolated cases of significant hepatic dysfunction, hepatitis, or worsening hepatic failure have been reported.
Poročali so o posameznih primerih zelo motenega delovanja jeter, hepatitisu in poslabšanju odpovedi jeter.
Patients with increased hepatic enzymes during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/ benefit of continuing anidulafungin therapy.
Bolnike, pri katerih se med zdravljenjem z anidulafunginom pojavi zvišana raven jetrnih encimov, je treba nadzirati glede znakov slabšanja delovanja jeter; oceniti je treba koristi in tveganja nadaljnjega zdravljenja z anidulafunginom.
Infusion-related reactions Exacerbation of infusion-related reactions by coadministration of anaesthetics has been seen in a non- clinical (rat) study (see section 5.3).
Z infundiranjem povezane reakcije V neklinični študiji (na podganah) so zabeležili poslabšanje z infundiranjem povezanih reakcij med sočasno uporabo anestetikov (glejte poglavje 5. 3).
Alcohol content This medicinal product contains 24 vol% ethanol (alcohol); this is equivalent to 6 g ethanol in the 100 mg maintenance dose (administered over a 1.5-hour period), and 12 g ethanol in the 200 mg loading dose (administered over a 3-hour period).
To ustreza 6 g etanola v 100 mg vzdrževalnem odmerku (apliciranem v 1, 5 ure) in 12 g etanola v 200 mg polnilnem odmerku (apliciranem v 3 urah).
Ethanol could be harmful for those suffering from alcoholism.
Etanol lahko škoduje osebam z alkoholizmom.
This should be taken into account in pregnant or breast-feeding women, children, and in high-risk groups such as those with liver disease or epilepsy.
Vsebnost alkohola je treba upoštevati pri nosečnicah in doječih ženskah, otrocih in zelo ogroženih skupinah, npr. bolnikih z boleznijo jeter ali epilepsijo.
The amount of alcohol in this medicinal product may impair the ability to drive or use machines.
Količina alkohola v tem zdravilu lahko okvari bolnikovo sposobnost upravljanja vozil in strojev.
3 Fructose content Patients with rare hereditary problems of fructose intolerance should not take this medicine.
3 Vsebnost fruktoze Bolniki z redko dedno intoleranco za fruktozo ne smejo dobiti tega zdravila.
Slight developmental effects have been observed in rabbits administered anidulafungin during pregnancy, in the presence of maternal toxicity (see section 5.3).
Pri kuncih, ki so dobivali anidulafungin med brejostjo, so opazili učinke na razvoj ter toksične učinke pri samici (glejte poglavje 5. 3).
A decision on whether to continue/ discontinue breast- feeding or therapy with anidulafungin should be made taking into account the benefit of breast-feeding to the child and the benefit of anidulafungin to the mother.
Pri odločitvi za nadaljevanje ali prekinitev dojenja oz. zdravljenja z anidulafunginom je treba upoštevati korist dojenja za otroka in korist zdravljenja z anidulafunginom za mater.
Nine hundred and twenty-nine (929) subjects received single or multiple doses of intravenous anidulafungin in clinical trials:
V kliničnih preskušanjih je posamične ali večkratne odmerke intravenskega anidulafungina dobilo 929 bolnikov:
672 in Phase 2/ 3 trials (287 patients with candidaemia/ invasive candidiasis, 355 patients with oral/ oesophageal candidiasis, 30 patients with invasive aspergillosis), and 257 in Phase I studies.
672 v preskušanjih 2. ali 3. faze (287 bolnikov s kandidemijo/ invazivno kandidozo, 355 bolnikov z oralno oz. ezofagealno kandidozo, 30 bolnikov z invazivno aspergilozo) in 257 v študijah 1. faze.
Three studies (one comparative vs fluconazole, two non-comparative) assessed the efficacy of anidulafungin in patients with candidaemia and a limited number of patients with deep tissue Candida infections.
Tri študije (ena primerjalna s flukonazolom, dve neprimerjalni) so ocenile učinkovitost anidulafungina pri bolnikih s kandidemijo in pri omejenem številu bolnikov z okužbami globokih tkiv s Candido.
A total of 204 patients received the recommended daily dose of 100 mg; the mean duration of intravenous treatment in these patients was 13.5 days (range, 1 to 38 days).
Priporočeni dnevni odmerek 100 mg so dobili skupaj 204 bolniki; intravensko zdravljenje teh bolnikov je v povprečju trajalo 13, 5 dneva (razpon: od 1 do 38 dni).
One hundred and nineteen patients received ≥ 14 days of anidulafungin.
Stodevetnajst bolnikov je dobivalo anidulafungin ≥ 14 dni.
Infusion-related adverse reactions have been reported with anidulafungin; in the pivotal ICC study, these included flushing/ hot flush (2.3%), pruritus (2.3%), rash (1.5%), and urticaria (0.8%).
Med uporabo anidulafungina so poročali o neželenih učinkih, povezanih z infundiranjem; v ključni študiji ICC so ti vključevali zardevanje/ valove vročine (2, 3%), srbenje (2, 3%), izpuščaj (1, 5%) in urtikarijo (0, 8%).
Other treatment-related adverse reactions that occurred in ≥ 1% of patients in the pivotal study included hypokalemia (3.1%), diarrhoea (3.1%), ALT increased (2.3%), hepatic enzyme increased (1.5%), blood alkaline phosphatase increased (1.5%), and blood bilirubin increased (1.5%).
Med drugimi z zdravljenjem povezanimi neželenimi učinki, ki so se pojavili pri ≥ 1% bolnikov v ključni študiji, so bili hipokaliemija (3, 1%), driska (3, 1%), zvišanje ALT (2, 3%), zvišanje jetrnih encimov (1, 5%), zvišanje alkalne fosfataze v krvi (1, 5%) in zvišanje bilirubina v krvi (1, 5%).
In the 100 mg ICC database (N = 204), the drug-related adverse reactions (MedDRA) listed below were reported with frequencies corresponding to Common (≥ 1/ 100 to < 1/ 10) or Uncommon (≥ 1/ 1,000
V podatkovni bazi za 100 mg ICC (n = 204) so bili spodaj našteti z zdravilom povezani neželeni učinki (MedDRA) zabeleženi s pogostnostima "pogosti" (≥ 1/ 100, < 1/ 10) ali "občasni" (≥ 1/ 1. 000, < 1/ 100).
Blood and lymphatic system disorders Common:
4 Bolezni krvi in limfatičnega sistema Pogosti:
Nervous system Common:
Bolezni živčevja Pogosti:
disorders Convulsion, headache
konvulzije, glavobol
Gastrointestinal disorders Common:
Bolezni prebavil Pogosti:
Diarrhoea, vomiting, nausea Abdominal pain upper
driska, bruhanje, navzea bolečine v zgornjem delu trebuha
Renal and urinary disorders Common:
Pogosti:
Rash, pruritus Urticaria
izpuščaj, srbenje urtikarija
Metabolism and Common:
Presnovne in prehranske motnje Pogosti:
nutrition disorders Hypokalaemia Hyperglycaemia
hipokaliemija hiperglikemija
Vascular disorders Common:
Pogosti:
Flushing Hypertension, hot flush
zardevanje hipertenzija, navali vročine
Infusion site pain
bolečine na mestu infundiranja
Hepatobiliary disorders Common:
Bolezni jeter, žolčnika in žolčevodov Pogosti:
Alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, gamma-glutamyltransferase increased
zvišanje alanin- aminotransferaze, zvišanje alkalne fosfataze v krvi, zvišanje aspartat - aminotransferaze, zvišanje bilirubina v krvi, zvišanje gama- glutamiltransferaze
In case of overdose, adverse reactions may occur as mentioned in section 4.8.
V primeru prevelikega odmerjanja se lahko pojavijo neželeni učinki, kot je omenjeno v poglavju 4. 8.
During clinical trials, a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose.
Med kliničnimi preskušanji je bil kot polnilni odmerek pomotoma uporabljen en 400- mg odmerek anidulafungina.
No dose limiting toxicity was observed in a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤ 3 x Upper Limit of Normal (ULN)).
Pri 3 od 10 preiskovancev se je pojavilo prehodno, asimptomatsko zvišanje transaminaz (≤ 3- kratna zgornja normalna meja (ZNM)).
Other antimycotics for systemic use, ATC code:
Splošne lastnosti Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, drugi antimikotiki; oznaka ATC:
Anidulafungin selectively inhibits 1,3-β -D glucan synthase, an enzyme present in fungal, but not mammalian cells.
Anidulafungin selektivno zavre 1, 3- β- D- glukan- sintazo, encim, ki je prisoten v celicah gliv, ne pa v celicah sesalcev.
This results in inhibition of the formation of 1,3-β -D-glucan, an essential component of the fungal cell wall.
Posledica je zavrtje nastajanja 1, 3- β- D- glukana, nujne sestavine celične stene glivic.
Activity in vitro Anidulafungin exhibited in-vitro activity against C. albicans, C. glabrata, C. parapsilosis, and C. tropicalis.
Delovanje in vitro Anidulafungin in vitro deluje proti C. albicans, C. glabrata, C. parapsilosis in C. tropicalis.
Susceptibility breakpoints for 1,3- β -D-glucan synthesis inhibitors have not been established.
Mejne vrednosti občutljivosti za zaviralce sinteze 1, 3- β- D- glukana niso bile določene.
For the clinical relevance of these findings see below under clinical studies.
Za klinični pomen teh izsledkov glejte spodaj pod naslovom Klinične študije.
Minimum inhibitory concentration (MIC) determinations were performed according to the Clinical and Laboratory Standards Institute methods M27 and M38.
Minimalne inhibitorne koncentracije (MIK) so bile določene v skladu z metodama M27 in M38 Clinical and Laboratory Standards Institute.
Candida isolates with reduced susceptibility to anidulafungin have not been isolated from treated patients.
Pri zdravljenih bolnikih niso osamili izolatov Candide z manjšo občutljivostjo za anidulafungin.
Among a number of isolates with elevated echinocandin MICs isolated from patients treated with other echinocandins, only two Candida isolates were reported to also have elevated anidulafungin MICs, suggesting the lack of complete cross resistance among echinocandins.
Med številnimi izolati z zvišanimi MIK za ehinokandin, izoliranimi pri bolnikih, zdravljenih z drugimi ehinokandini, sta imela le dva izolata Candide zvišane tudi MIK za anidulafungin, kar kaže, da navzkrižna odpornost med ehinokandini ni popolna.
Activity in vivo Parenterally administered anidulafungin was effective against Candida spp. in immunocompetent and immunocompromised mouse and rabbit models.
Delovanje in vivo Pri imunokompetentnih in imunsko oslabelih miših in kuncih je bil parenteralno aplicirani anidulafungin učinkovit proti Candidi spp.
Anidulafungin treatment prolonged survival and also reduced the organ burden of Candida spp., when determined at intervals from 24 to 96 hours after the last treatment.
Zdravljenje z anidulafunginom je podaljšalo preživetje in zmanjšalo obremenjenost organov s Candido spp., ugotavljano v intervalu od 24 do 96 ur po zadnji terapiji.
Experimental infections included disseminated C. albicans infection in neutropenic rabbits, oesophageal/ oropharyngeal infection of neutropenic rabbits with fluconazole-resistant C. albicans and disseminated infection of neutropenic mice with fluconazole-resistant C. glabrata.
Med eksperimentalnimi okužbami so bile okužba s C. albicans pri nevtropeničnih kuncih, okužba požiralnika/ orofarinksa s C. albicans, odporno proti flukonazolu, pri nevtropeničnih kuncih ter diseminirana okužba s C. glabrato, odporno proti flukonazolu, pri nevtropeničnih miših.
[Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were specifically excluded from the study].
[Iz študije so bili specifično izključeni bolniki, ki so imeli endokarditis, osteomielitis ali meningitis, povzročen s Candido, in bolniki, ki so imeli okužbo s C. krusei].
Patients were randomised to receive either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or fluconazole (800 mg intravenous loading dose followed by 400 mg intravenous daily), and were stratified by APACHE II score (≤ 20 and > 20) and the presence or absence of neutropenia.
Bolniki so bili stratificirani po seštevku APACHE II (≤ 20 in > 20) in prisotnosti ali odsotnosti nevtropenije.
6 to-treat (MITT) population.
6 Bolniki, ki so dobili vsaj en odmerek raziskovanega zdravila in so imeli pozitivno kulturo za Candida species z normalno sterilnega mesta pred vstopom v študijo, so bili vključeni v modificirano populacijo z- namenom- zdravljenja (MITT – Modified Intention To Treat).