natgillin/translations-raw huggingface dataset:
Steady state was achieved on the first day after a loading dose (twice the maintenance dose), and steady state Cmax and AUCss increase in a dose-proportional manner.
Stanje dinamičnega ravnovesja je bilo doseženo prvi dan po polnilnem odmerku (dvakratni vzdrževalni odmerek), Cmax in AUCss v stanju dinamičnega ravnovesja pa se povečujeta sorazmerno z odmerkom.
Anidulafungin pharmacokinetics were examined in subjects with Child-Pugh class A, B or C hepatic insufficiency.
Farmakokinetiko anidulafungina so raziskali pri preskušancih z okvaro jeter razredov A, B in C po Child-Pughu.
Anidulafungin crossed the placental barrier in rats and was detected in foetal plasma.
Anidulafungin je pri podganah prehajal skozi placentno pregrado in so ga našli v plazmi plodov.
Pack size of 1 vial.
Škatla z 1 vialo.
ECALTA belongs to a group of medicines called echinocandins.
Zdravilo ECALTA sodi v skupino zdravil, imenovanih ehinokandini.
The following information is intended for medical or healthcare professionals only and applies only to the single vial ECALTA 100 mg powder for concentrate for solution for infusion presentation:
Naslednje informacije so namenjene samo zdravstvenim delavcem in veljajo samo za pakiranje z eno vialo zdravila ECALTA 100 mg prašek za koncentrat za raztopino za infundiranje:
The successful global response rate at End of Intravenous Treatment (primary endpoint) was 26/46 (56.5%) and End of All Treatment was 24/46 (52.2%).
Delež uspešnega globalnega odziva na koncu intravenskega zdravljenja (primarni opazovani dogodek) je bil 26/46 (56,5 %) in na koncu celotnega zdravljenja 24/46 (52,2 %).
The reconstituted solution contains 3.33 mg/mL anidulafungin and the diluted solution contains 0.77 mg/mL anidulafungin.
Rekonstituirana raztopina vsebuje 3,33 mg/ml anidulafungina, razredčena raztopina pa 0,77 mg/ml anidulafungina.
Drug interaction studies were performed with anidulafungin and other medicinal products likely to be co-administered.
Študije medsebojnega delovanja so izvedli z anidulafunginom in drugimi zdravili, za katera je sočasna uporaba z njim verjetna.
What ECALTA looks like and contents of the pack
Izgled zdravila ECALTA in vsebina pakiranja
- Convulsion (seizure) - Headache - Vomiting - Changes in blood tests of liver function - Rash, pruritis (itching) - Changes in blood tests of kidney function - Abnormal flow of bile from the gallbladder into the intestine (cholestasis) - High blood sugar - High blood pressure - Low blood pressure - Sudden contraction of the muscles around the airways resulting in wheezing or coughing - Difficulty of breathing
- konvulzije (napadi krčev) - glavobol - bruhanje - spremembe v izvidih krvnih preiskav delovanja jeter - izpuščaj, pruritus (srbenje) - spremembe v izvidih krvnih preiskav delovanja ledvic - nenormalnosti pri iztekanju žolča iz žolčnika v črevo (holestaza) - visoka raven sladkorja v krvi - visok krvni tlak - nizek krvni tlak - nenadno skrčenje mišic okrog dihalnih poti, ki se kaže kot piskajoče dihanje ali kašljanje - oteženo dihanje
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Parenteralna zdravila je treba pred uporabo vizualno pregledati, da ne vsebujejo delcev in niso obarvana, kadarkoli raztopina in vsebnik dopuščata takšen pregled.
Excursions for 96 hours up to 25ºC are permitted, and the powder can be returned to refrigerated storage.
Odkloni temperature za 96 ur do temperature 25 ºC so dovoljeni, prašek pa lahko potem ponovno shranjujete v hladilniku.
Mortality rates in both the anidulafungin and fluconazole arms are presented below in Table 4:
Stopnje umrljivosti v krakih z anidulafunginom in flukonazolom so zajete v preglednici 4, spodaj:
Each vial contains 100 mg anidulafungin.
Ena viala vsebuje 100 mg anidulafungina.
Dilution and infusion
Razredčenje in infundiranje
Anidulafungin selectively inhibits 1,3-β-D glucan synthase, an enzyme present in fungal, but not mammalian cells.
Anidulafungin selektivno zavre 1,3--D-glukan-sintazo, encim, ki je prisoten v celicah gliv, ne pa tudi v celicah sesalcev.
All-cause mortality up to the end of the study (6 Week Follow-up Visit) was 21/46 (45.7%).
Umrljivost zaradi vseh vzrokov je bila do konca preskušanja (kontrolni obisk v 6. tednu) 21/46 (45,7 %).
For instructions on reconstitution of the medicinal product before administration (see section 6.6).
Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
The most common pathogens isolated at baseline were C. tropicalis (4 anidulafungin, 0 caspofungin), C. parapsilosis (2 anidulafungin, 1 caspofungin), C. krusei (2 anidulafungin, 1 caspofungin), and C. ciferrii (2 anidulafungin, 0 caspofungin).
Najpogosteje izolirani patogeni ob izhodišču so bili C. tropicalis (4 anidulafungin, 0 kaspofungin), C. parapsilosis (2 anidulafungin, 1 kaspofungin), C. krusei (2 anidulafungin, 1 kaspofungin) in C. ciferrii (2 anidulafungin, 0 kaspofungin).
- Disorder of blood clotting system - Flushing - Hot flush - Stomach pain - Hives - Pain at injection site
- motnje strjevanja krvi - pordevanje - vročinski oblivi - bolečine v želodcu - koprivnica - bolečina na mestu injiciranja
30 mL Type 1 glass vial with an elastomeric stopper (butyl rubber with an inert polymer coating on the product contact surface and lubricant on the top surface for easier machinability, or alternatively bromobutyl rubber with a lubricant) and aluminium seal with flip-off cap.
30 ml steklena viala iz stekla tipa I z elastomernim zamaškom (butilna guma prevlečena z inertno polimerno plastjo na stični površini zamaška in mazivom na zgornji površini za lažjo strojno obdelavo, ali alternativno bromobutilna guma z mazivom) in aluminijsko zaporo s snemljivo zaporko.
The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3); the successful global response rate at the End of All Treatment was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3).
Delež uspešnega globalnega odziva na koncu intravenskega zdravljenja (primarni opazovani dogodek) za anidulafungin je bil 8/11 (72,7 %), za kaspofungin pa 3/3 (100,0 %) (razlika -27,3, 95 % IZ -80,9, 40,3); delež uspešnega globalnega odziva na koncu celotnega zdravljenja za anidulafungin je bil 8/11 (72,7 %), za kaspofungin pa 3/3 (100,0 %) (razlika -27,3, 95 % IZ -80,9, 40,3).
Dose Number of vials of powder
Odmerek Število vial s praškom
The pharmacokinetics of anidulafungin in patients with fungal infections are similar to those observed in healthy subjects based on population pharmacokinetic analyses.
Pri bolnikih z glivičnimi okužbami je farmakokinetika anidulafungina podobna farmakokinetiki pri zdravih preskušancih, ugotovljeni na podlagi analiz populacijske farmakokinetike.
Patients with fungal infections
Bolniki z glivičnimi okužbami
From a microbiological point of view, following good aseptic practices, the infusion solution can be utilized for up to 48 hours from preparation when stored at 25ºC.
Z mikrobiološkega vidika in v skladu z dobro aseptično prakso je raztopina za infundiranje lahko uporabna do 48 ur od priprave, če jo hranimo pri 25 °C.
Candidaemia and other forms of Invasive Candidiasis The safety and efficacy of anidulafungin were evaluated in a pivotal Phase 3, randomised, doubleblind, multicentre, multinational study of primarily non-neutropenic patients with candidaemia and a limited number of patients with deep tissue Candida infections or with abscess-forming disease.
Varnost in učinkovitost anidulafungina so ocenili v ključnem, randomiziranem, dvojno slepem, multicentričnem, multinacionalnem preskušanju 3. faze s predvsem nenevtropeničnimi bolniki s kandidemijo ter omejenim številom bolnikov z okužbami globokih tkiv s Candido ali bolnikov z boleznijo, povezano z nastajanjem abscesov.
A total of 14 neutropenic patients with microbiologically confirmed invasive candidiasis (MITT population) were enrolled in the study (11 anidulafungin; 3 caspofungin).
V preskušanje so vključili skupno 14 nevtropeničnih bolnikov z mikrobiološko potrjeno invazivno kandidozo (populacija MITT) (11 jih je prejemalo anidulafungin, 3 pa kaspofungin).
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 diseminirana 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.
ECALTA has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis.
Zdravila ECALTA niso proučevali pri bolnikih z endokarditisom, osteomielitisom ali meningitisom, povzročenimi s Candido.
No specific tissue distribution studies of anidulafungin have been done in humans.
Specifična preskušanja tkivne porazdelitve anidulafungina pri ljudeh niso bila izvedena.
With the 200/100 mg daily dose regimen at an infusion rate of 1.1 mg/min, the steady state Cmax and trough concentrations (Cmin) could reach approximately 7 and 3 mg/l, respectively, with an average steady state AUC of approximately 110 mgh/l.
Z odmerno shemo 200/100 mg na dan in hitrostjo infundiranja 1,1 mg/min lahko v stanju dinamičnega ravnovesja Cmax doseže 7 mg/l, najnižja koncentracija (Cmin) pa 3 mg/l, povprečna AUC v stanju dinamičnega ravnovesja pa je približno 110 mg∙h/l.
Rats in the high dose group experienced infusion-related reactions that were exacerbated by anaesthesia.
Pri podganah v visokoodmerni skupini so se pojavile z infundiranjem povezane reakcije, ki jih je anestezija poslabšala.
No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis.
Prilagoditev odmerjanja prav tako ni potrebna pri bolnikih z okvaro ledvic, ne glede na stopnjo okvare, vključno z bolniki na dializi.
In case of overdose, adverse reactions may occur as mentioned in section 4.8.
V primeru prevelikega odmerjanja se lahko pojavijo neželeni učinki, omenjeni v poglavju
Convulsion, headache
Bolezni živčevja konvulzije, glavobol
The most common pathogens isolated at baseline were C. tropicalis (12 patients), C. albicans (7 patients), C. glabrata (7 patients), C. krusei (7 patients), and C. parapsilosis (6 patients).
Najpogosteje izolirani patogeni ob izhodišču so bili C. tropicalis (12 bolnikov), C. albicans (7 bolnikov), C. glabrata (7 bolnikov), C. krusei (7 bolnikov) in C. parapsilosis (6 bolnikov).
In multiple dose studies in rabbits with disseminated candidiasis and in mice with CNS candida infection, anidulafungin has been shown to reduce fungal burden in the brain.
V študijah večkratnih odmerkov pri kuncih z diseminirano kandidozo ter pri miših z okužbo centralnega živčnega sistema s kandido je bilo dokazano, da anidulafungin zmanjšuje glivično breme v možganih.
From a microbiological point of view, following good aseptic practices, the reconstituted solution can be utilized for up to 24 hours when stored at 25ºC.
Z mikrobiološkega vidika in v skladu z dobro aseptično prakso je rekonstituirana raztopina lahko uporabna do 24 ur, če jo hranimo pri 25 °C.
The rate of infusion should not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions) (see sections 4.2, 4.4 and 4.8).
Hitrost infuzije ne sme presegati 1,1 mg/min (kar ustreza 1,4 ml/min po rekonstituciji in ustreznem redčenju) (glejte poglavja 4.2, 4.4 in 4.8).
Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25ºC.
Kemična in fizikalna stabilnost raztopine za infundiranje med uporabo sta dokazani za 48 ur pri temperaturi 25 ºC.
In vitro and in vivo genotoxicity studies with anidulafungin provided no evidence of genotoxic potential.
Študije genotoksičnosti z anidulafunginom in vitro in in vivo niso odkrile znakov genotoksičnega potenciala.
No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment.
Pri bolnikih z blago, zmerno ali hudo okvaro jeter odmerjanja ni treba prilagoditi.
No dosage adjustment of either medicinal product is recommended when anidulafungin is co-administered with ciclosporin, voriconazole or tacrolimus, and no dosage adjustment for anidulafungin is recommended when co-administered with amphotericin B or rifampicin.
Odmerjanja niti enega niti drugega zdravila ni treba prilagoditi, če je anidulafungin uporabljen sočasno s ciklosporinom, vorikonazolom ali takrolimusom in odmerjanja anidulafungina ni treba prilagoditi, če je uporabljen sočasno z amfotericinom B ali rifampicinom.
- The other ingredients are: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide
- Druge sestavine zdravila so: fruktoza, manitol, polisorbat 80, vinska kislina, natrijev hidroksid
Anidulafungin did not produce any drug-related developmental toxicity in rats at the highest dose tested.
Anidulafungin v največjem testiranem odmerku pri podganah ni povzročil z zdravilom povezanih razvojnih toksičnih učinkov.
ECALTA should be reconstituted with water for injections to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL.
Zdravilo ECALTA je treba rekonstituirati z vodo za injekcije do koncentracije 3,33 mg/ml, nato pa ga pred uporabo razredčiti do koncentracije 0,77 mg/ml.
Nevertheless, care should be taken when co-administering anidulafungin and anaesthetic agents.
Kljub temu je med sočasno uporabo anidulafungina in anestetikov potrebna previdnost.
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 enkratni 400-mg odmerek anidulafungina.
If you stop using ECALTA You should not experience any effects from ECALTA if your doctor stops ECALTA treatment.
Če ste prenehali uporabljati zdravilo ECALTA Če zdravnik prekine zdravljenje z zdravilom ECALTA, ne bi smeli občutiti nobenih posledic.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25ºC.
Kemična in fizikalna stabilnost rekonstituirane raztopine med uporabo sta dokazani za 24 ur pri temperaturi 25 ºC.
Cases of significant hepatic dysfunction, hepatitis, and hepatic failure were uncommon in clinical trials.
Primeri zelo motenega delovanja jeter, hepatitisa in odpovedi jeter so bili v kliničnih preskušanjih občasni.
The effect of ECALTA in pregnant women is not known.
Učinek zdravila ECALTA pri nosečnicah ni znan.
Serious side effects - tell your doctor or another healthcare professional immediately should any of the following occur: - Convulsion (seizure) - Flushing - Rash, pruritis (itching) - Hot flush - Hives - Sudden contraction of the muscles around the airways resulting in wheezing or coughing - Difficulty of breathing
Resni neželeni učinki - če se pojavi karkoli od naslednjega, nemudoma obvestite zdravnika ali drugega zdravstvenega delavca: - konvulzije (napadi krčev) - pordevanje - izpuščaj, pruritis (srbenje) - vročinski oblivi - koprivnica - nenadno skrčenje mišic okrog dihalnih poti, ki se kaže kot piskajoče dihanje ali kašljanje - oteženo dihanje
Specimens for fungal culture should be obtained prior to therapy.
Pred zdravljenjem je treba vzeti vzorce za kulturo glivic.
Therefore ECALTA is not recommended during pregnancy.
Uporaba zdravila ECALTA med nosečnostjo ni priporočljiva.
For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Pri anidulafunginu v študijah na samcih in samicah podgan niso opazili vpliva na plodnost (glejte poglavje 5.3).
Fructose content
Vsebnost fruktoze
Global success in the MITT population: primary and secondary endpoints Anidulafungin Fluconazole
Globalen uspeh v populaciji MITT: primarni in sekundarni opazovani dogodki anidulafungin flukonazol razlika med skupinama (95 % IZ)
Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including rash, pruritus, dyspnoea, bronchospasm, hypotension (common events), flushing, hot flush, and urticaria (uncommon events), summarized in Table 1 (see section 4.4).
Pri uporabi anidulafungina v kliničnih preskušanjih so poročali o neželenih učinkih, povezanih z infundiranjem, ki so vključevali izpuščaj, pruritus, dispnejo, bronhospazem, hipotenzijo (pogosti neželeni učinki), pordevanje, vročinske oblive in urtikarijo (občasni neželeni učinki), ter so povzeti v preglednici 1 (glejte poglavje 4.4).
Anidulafungin concentrations were not increased in subjects with any degree of hepatic insufficiency.
Koncentracije anidulafungina se pri preskušancih niso zvišale pri nobeni stopnji okvare jeter.
Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes.
Anidulafungin ni klinično pomemben substrat, induktor ali zaviralec izoencimov citokroma P450.
The most common pathogens isolated at baseline were C. tropicalis (34.8%; 16/46), C. krusei (19.6%; 9/46), C. parapsilosis (17.4%; 8/46), C. albicans (15.2%; 7/46), and C. glabrata (15.2%; 7/46).
Najpogosteje izolirani patogeni ob izhodišču so bili C. tropicalis (34,8 %; 16/46), C. krusei (19,6 %; 9/46), C. parapsilosis (17,4 %; 8/46), C. albicans (15,2 %; 7/46) in C. glabrata (15,2 %; 7/46).
The efficacy of anidulafungin in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm
Učinkovitost anidulafungina pri odraslih nevtropeničnih bolnikih (opredeljenih z absolutnim številom nevtrofilcev ≤ 500 celic/mm
How to use ECALTA
Kako uporabljati zdravilo ECALTA
Alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholestasis
Bolezni jeter, žolčnika in žolčevodov zvišanje alaninaminotransferaz e, zvišanje alkalne fosfataze v krvi, zvišanje aspartataminotransferaz e, zvišanje bilirubina v krvi, holestaza zvišanje gamaglutamil transferaze
The most common sites of infection included the peritoneal cavity (54.3%; 70 of 129), hepatobiliary tract (7.0%; 9 of 129), pleural cavity (5.4%; 7 of 129) and kidney (3.1%; 4 of 129).
Najpogostejša mesta okužbe so bila peritonealna votlina (54,3 %; 70 od 129), hepatobiliarni trakt (7,0 %; 9 od 129), plevralna votlina (5,4 %; 7 od 129) in ledvice (3,1 %; 4 od 129).
Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were specifically excluded from the study.
Iz preskušanja so bili specifično izključeni bolniki z endokarditisom, osteomielitisom ali meningitisom, povzročenim s Candido, in bolniki z okužbo s C. krusei.
Each vial of powder contains 100 mg anidulafungin.
Ena viala s praškom vsebuje 100 mg anidulafungina.
Neutropenic (ANC, cells/mm At Other Endpoints End of All Therapy e
Nenevtropenični (ANC, celic/mm Nevtropenični (ANC, celic/mm Sekundarni opazovani dogodki Konec celotnega zdravljenja e
Blood and Lymphatic System Disorders
Bolezni krvi in limfatičnega sistema koagulopati ja
ECALTA is supplied as a box containing 1 vial of 100 mg powder for concentrate for solution for infusion.
Zdravilo ECALTA je na voljo v škatli, ki vsebuje 1 vialo s 100 mg praška za koncentrat za raztopino za infundiranje.
Uncommon side effects (may affect up to 1 in 100 people) are:
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) so:
The effect of ECALTA in breast-feeding women is not known.
Učinek zdravila ECALTA pri doječih ženskah ni znan.
The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult patients with microbiologically confirmed deep tissue candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative and 4 open-label).
Učinkovitost anidulafungina (200 mg intravenski polnilni odmerek, ki mu je sledila aplikacija 100 mg intravensko na dan) pri odraslih bolnikih z mikrobiološko potrjeno kandidozo globokega tkiva so ocenili v analizi združenih podatkov iz 5 prospektivnih preskušanj (1 primerjalnega in 4 odprtih).
Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and faeces 8 weeks post-dose.
Osem tednov po odmerku so v krvi, urinu in blatu ugotovili zanemarljive količine radioaktivnosti zaradi zdravila.
It is unlikely that anidulafungin will have clinically relevant effects on the metabolism of drugs metabolised by cytochrome P450 isoenzymes.
Ni verjetno, da bi anidulafungin klinično pomembno vplival na presnovo zdravil, ki se presnavljajo z izoencimi citokroma P450.
Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm and hypotension.
Pri uporabi anidulafungina so poročali o neželenih učinkih, povezanih z infundiranjem, ki so vključevali izpuščaj, urtikarijo, pordevanje, pruritus, dispnejo, bronhospazem in hipotenzijo.
[Justification for not including Braille accepted.]
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Vial label
nalepka na viali
The successful global response rate at End of Intravenous Treatment and End of All Treatment were both 7/13 (53.8%) in the 13 patients with neutropenia assessed by investigators at baseline.
Deleža uspešnega globalnega odziva na koncu intravenskega zdravljenja ter na koncu celotnega zdravljenja pri 13 bolnikih, ki jih je raziskovalec ob izhodišču razvrstil kot nevtropenične, sta bila oba 7/13 (53,8 %).
cells/mm or classified by the investigator as neutropenic at baseline) with microbiologically confirmed invasive candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative versus caspofungin and 4 open-label, non-comparative).
3, številom levkocitov ≤ 500 celic/mm ali ki jih je raziskovalec ob izhodišču razvrstil kot nevtropenične) z mikrobiološko potrjeno invazivno kandidozo so ocenili v analizi združenih podatkov iz 5 prospektivnih preskušanj (1 primerjalnega s kaspofunginom in 4 odprtih, neprimerjalnih).
The infusion solution may be stored at 25ºC for 48 hours or stored frozen for at least 72 hours.
Raztopino za infundiranje lahko hranite do 48 ur pri temperaturi 25 °C ali pa jo hranite zamrznjeno najmanj 72 ur.
3 in 22 patients or classified by the investigator as neutropenic at baseline in 13 patients.
3, in pri 13 bolnikih, ki jih je raziskovalec ob izhodišču razvrstil kot nevtropenične.
C. albicans (63.8% anidulafungin, 59.3% fluconazole), followed by C. glabrata (15.7%, 25.4%), C. parapsilosis (10.2%, 13.6%) and C. tropicalis (11.8%, 9.3%) - with 20, 13 and 15 isolates of the last 3 species, respectively, in the anidulafungin group.
Najpogosteje izolirane vrste ob izhodišču preskušanja so bile C. albicans (63,8 % anidulafungin, 59,3 % flukonazol), nato pa C. glabrata (15,7 %, 25,4 %), C. parapsilosis (10,2 %, 13,6 %) in C. tropicalis (11,8 %, 9,3 %) - od tega je bilo 20, 13 in 15 izolatov zadnjih treh naštetih vrst v skupini z anidulafunginom.
Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.4).
Z infundiranjem povezane reakcije so redke, če hitrost infundiranja anidulafungina ne preseže 1,1 mg/minuto (glejte poglavje 4.4).
Eligible patients received either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or caspofungin (70 mg intravenous loading dose followed by 50 mg intravenous daily) (2:1 randomization).
Primerni bolniki so prejemali anidulafungin (200 mg intravenski polnilni odmerek, ki mu je sledila aplikacija po 100 mg intravensko na dan) ali kaspofungin (70 mg intravenski polnilni odmerek, ki mu je sledila aplikacija 50 mg intravensko na dan) (randomizacija 2 : 1).
End of IV Therapy (1º endpoint) Candidaemia only Other sterile sites Peritoneal fluid/IA c abscess
Konec intravenskega zdravljenja (primarni opazovani dogodek) Samo kandidemija Druga sterilna mesta Peritonealna tekočina/IA