FrancophonIA/ELRC3.0 huggingface dataset:
English: No specific tissue distribution studies of anidulafungin have been done in humans.
Slovenian: Specifična preskušanja tkivne porazdelitve anidulafungina pri ljudeh niso bila izvedena.
English: 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.
Slovenian: 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.
English: Rats in the high dose group experienced infusion-related reactions that were exacerbated by anaesthesia.
Slovenian: Pri podganah v visokoodmerni skupini so se pojavile z infundiranjem povezane reakcije, ki jih je anestezija poslabšala.
English: No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis.
Slovenian: Prilagoditev odmerjanja prav tako ni potrebna pri bolnikih z okvaro ledvic, ne glede na stopnjo okvare, vključno z bolniki na dializi.
English: In case of overdose, adverse reactions may occur as mentioned in section 4.8.
Slovenian: V primeru prevelikega odmerjanja se lahko pojavijo neželeni učinki, omenjeni v poglavju
English: Convulsion, headache
Slovenian: Bolezni živčevja konvulzije, glavobol
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Z mikrobiološkega vidika in v skladu z dobro aseptično prakso je rekonstituirana raztopina lahko uporabna do 24 ur, če jo hranimo pri 25 °C.
English: 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).
Slovenian: 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).
English: Chemical and physical in-use stability of the infusion solution has been demonstrated for 48 hours at 25ºC.
Slovenian: Kemična in fizikalna stabilnost raztopine za infundiranje med uporabo sta dokazani za 48 ur pri temperaturi 25 ºC.
English: In vitro and in vivo genotoxicity studies with anidulafungin provided no evidence of genotoxic potential.
Slovenian: Študije genotoksičnosti z anidulafunginom in vitro in in vivo niso odkrile znakov genotoksičnega potenciala.
English: No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment.
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvaro jeter odmerjanja ni treba prilagoditi.
English: 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.
Slovenian: 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.
English: - The other ingredients are: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide
Slovenian: - Druge sestavine zdravila so: fruktoza, manitol, polisorbat 80, vinska kislina, natrijev hidroksid
English: Anidulafungin did not produce any drug-related developmental toxicity in rats at the highest dose tested.
Slovenian: Anidulafungin v največjem testiranem odmerku pri podganah ni povzročil z zdravilom povezanih razvojnih toksičnih učinkov.
English: 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.
Slovenian: 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.
English: Nevertheless, care should be taken when co-administering anidulafungin and anaesthetic agents.
Slovenian: Kljub temu je med sočasno uporabo anidulafungina in anestetikov potrebna previdnost.
English: During clinical trials, a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose.
Slovenian: Med kliničnimi preskušanji je bil kot polnilni odmerek pomotoma uporabljen enkratni 400-mg odmerek anidulafungina.
English: If you stop using ECALTA You should not experience any effects from ECALTA if your doctor stops ECALTA treatment.
Slovenian: Če ste prenehali uporabljati zdravilo ECALTA Če zdravnik prekine zdravljenje z zdravilom ECALTA, ne bi smeli občutiti nobenih posledic.
English: Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25ºC.
Slovenian: Kemična in fizikalna stabilnost rekonstituirane raztopine med uporabo sta dokazani za 24 ur pri temperaturi 25 ºC.
English: Cases of significant hepatic dysfunction, hepatitis, and hepatic failure were uncommon in clinical trials.
Slovenian: Primeri zelo motenega delovanja jeter, hepatitisa in odpovedi jeter so bili v kliničnih preskušanjih občasni.
English: The effect of ECALTA in pregnant women is not known.
Slovenian: Učinek zdravila ECALTA pri nosečnicah ni znan.
English: 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
Slovenian: 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
English: Specimens for fungal culture should be obtained prior to therapy.
Slovenian: Pred zdravljenjem je treba vzeti vzorce za kulturo glivic.
English: Therefore ECALTA is not recommended during pregnancy.
Slovenian: Uporaba zdravila ECALTA med nosečnostjo ni priporočljiva.
English: For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Slovenian: Pri anidulafunginu v študijah na samcih in samicah podgan niso opazili vpliva na plodnost (glejte poglavje 5.3).
English: Fructose content
Slovenian: Vsebnost fruktoze
English: Global success in the MITT population: primary and secondary endpoints Anidulafungin Fluconazole
Slovenian: Globalen uspeh v populaciji MITT: primarni in sekundarni opazovani dogodki anidulafungin flukonazol razlika med skupinama (95 % IZ)
English: 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).
Slovenian: 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).
English: Anidulafungin concentrations were not increased in subjects with any degree of hepatic insufficiency.
Slovenian: Koncentracije anidulafungina se pri preskušancih niso zvišale pri nobeni stopnji okvare jeter.
English: Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes.
Slovenian: Anidulafungin ni klinično pomemben substrat, induktor ali zaviralec izoencimov citokroma P450.
English: 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).
Slovenian: 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).
English: The efficacy of anidulafungin in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm
Slovenian: Učinkovitost anidulafungina pri odraslih nevtropeničnih bolnikih (opredeljenih z absolutnim številom nevtrofilcev ≤ 500 celic/mm
English: How to use ECALTA
Slovenian: Kako uporabljati zdravilo ECALTA
English: Alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholestasis
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišanje alaninaminotransferaz e, zvišanje alkalne fosfataze v krvi, zvišanje aspartataminotransferaz e, zvišanje bilirubina v krvi, holestaza zvišanje gamaglutamil transferaze
English: 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).
Slovenian: 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).
English: Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were specifically excluded from the study.
Slovenian: Iz preskušanja so bili specifično izključeni bolniki z endokarditisom, osteomielitisom ali meningitisom, povzročenim s Candido, in bolniki z okužbo s C. krusei.
English: Each vial of powder contains 100 mg anidulafungin.
Slovenian: Ena viala s praškom vsebuje 100 mg anidulafungina.
English: Neutropenic (ANC, cells/mm At Other Endpoints End of All Therapy e
Slovenian: Nenevtropenični (ANC, celic/mm Nevtropenični (ANC, celic/mm Sekundarni opazovani dogodki Konec celotnega zdravljenja e
English: Blood and Lymphatic System Disorders
Slovenian: Bolezni krvi in limfatičnega sistema koagulopati ja
English: ECALTA is supplied as a box containing 1 vial of 100 mg powder for concentrate for solution for infusion.
Slovenian: Zdravilo ECALTA je na voljo v škatli, ki vsebuje 1 vialo s 100 mg praška za koncentrat za raztopino za infundiranje.
English: e
Slovenian: A
English: Uncommon side effects (may affect up to 1 in 100 people) are:
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) so:
English: The effect of ECALTA in breast-feeding women is not known.
Slovenian: Učinek zdravila ECALTA pri doječih ženskah ni znan.
English: 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).
Slovenian: 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).
English: Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and faeces 8 weeks post-dose.
Slovenian: Osem tednov po odmerku so v krvi, urinu in blatu ugotovili zanemarljive količine radioaktivnosti zaradi zdravila.
English: It is unlikely that anidulafungin will have clinically relevant effects on the metabolism of drugs metabolised by cytochrome P450 isoenzymes.
Slovenian: Ni verjetno, da bi anidulafungin klinično pomembno vplival na presnovo zdravil, ki se presnavljajo z izoencimi citokroma P450.
English: Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm and hypotension.
Slovenian: Pri uporabi anidulafungina so poročali o neželenih učinkih, povezanih z infundiranjem, ki so vključevali izpuščaj, urtikarijo, pordevanje, pruritus, dispnejo, bronhospazem in hipotenzijo.
English: [Justification for not including Braille accepted.]
Slovenian: Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: Vial label
Slovenian: nalepka na viali
English: 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.
Slovenian: 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 %).
English: 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).
Slovenian: 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).
English: The infusion solution may be stored at 25ºC for 48 hours or stored frozen for at least 72 hours.
Slovenian: Raztopino za infundiranje lahko hranite do 48 ur pri temperaturi 25 °C ali pa jo hranite zamrznjeno najmanj 72 ur.
English: 3 in 22 patients or classified by the investigator as neutropenic at baseline in 13 patients.
Slovenian: 3, in pri 13 bolnikih, ki jih je raziskovalec ob izhodišču razvrstil kot nevtropenične.
English: 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.
Slovenian: 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.
English: Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.4).
Slovenian: Z infundiranjem povezane reakcije so redke, če hitrost infundiranja anidulafungina ne preseže 1,1 mg/minuto (glejte poglavje 4.4).
English: 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).
Slovenian: 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).
English: End of IV Therapy (1º endpoint) Candidaemia only Other sterile sites Peritoneal fluid/IA c abscess
Slovenian: Konec intravenskega zdravljenja (primarni opazovani dogodek) Samo kandidemija Druga sterilna mesta Peritonealna tekočina/IA
English: EUCAST has not determined non-species related breakpoints for anidulafungin
Slovenian: Odbor EUCAST ni določil mejnih vrednosti za anidulafungin, neodvisnih od vrste.
English: The concentration of anidulafungin in the brain was low (brain to plasma ratio of approximately 0.2) in uninfected adult and neonatal rats after a single dose.
Slovenian: Koncentracija anidulafungina v možganih pri neokuženih odraslih in novorojenih podganah je bila po enkratnem odmerku nizka (razmerje možgani/plazma približno 0,2).
English: Infusion-related adverse events are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.8).
Slovenian: Z infundiranjem povezani neželeni učinku so redki, če hitrost infundiranja anidulafungina ne preseže 1,1 mg/minuto (glejte poglavje 4.8).
English: Anaphylactic reactions, including shock, were reported with the use of anidulafungin.
Slovenian: Pri uporabi anidulafungina so poročali o anafilaktičnih reakcijah, vključno s šokom.
English: The rate of infusion should not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions).
Slovenian: Hitrost infuzije ne sme presegati 1,1 mg/min (kar ustreza 1,4 ml/min po rekonstituciji in ustreznem redčenju).
English: ECALTA contains fructose
Slovenian: Zdravilo ECALTA vsebuje fruktozo
English: Dilution requirements for ECALTA administration
Slovenian: Razredčenji za aplikacijo zdravila ECALTA
English: - Low blood potassium (hypokalaemia) - Diarrhoea - Nausea
Slovenian: - nizka raven kalija v krvi (hipokaliemija) - driska - slabost s siljenjem na bruhanje
English: Infusion volume
Slovenian: Infuzijski volumen A
English: - The active substance is anidulafungin.
Slovenian: - Učinkovina je anidulafungin.
English: Excipients: fructose, mannitol, polysorbate 80, tartaric acid, NaOH and/or HCl.
Slovenian: Pomožne snovi: fruktoza, manitol, polisorbat 80, vinska kislina, natrijev hidroksid in/ali klorovodikova kislina.
English: The infusion solution may be stored at 25°C (room temperature) for 48 hours or stored frozen for at least 72 hours, and should be administered at 25C (room temperature) within 48 hours.
Slovenian: Raztopino za infundiranje lahko hranite do 48 ur pri temperaturi 25 C (sobna temperatura) ali pa jo hranite zamrznjeno najmanj 72 ur.
English: If either particulate matter or discolouration are identified, discard the solution.
Slovenian: Če ugotovite prisotnost delcev ali obarvanje, morate raztopino zavreči.
English: The most common pathogens isolated from a deep tissue site at baseline were C. albicans (64.3%; 83 of 129), C. glabrata (31.0%; 40 of 129), C. tropicalis (11.6%; 15 of 129), and C. krusei (5.4%; 7 of 129).
Slovenian: Najpogosteje izolirani patogeni iz globokega tkiva ob izhodišču so bili C. albicans (64,3 %; 83 od 129), C. glabrata (31,0 %; 40 od 129), C. tropicalis (11,6 %; 15 od 129) in C. krusei (5,4 %; 7 od 129).
English: Either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion.
Slovenian: Bodisi natrijev klorid 9 mg/ml (0,9 %) za infundiranje bodisi glukoza 50 mg/ml (5 %) za infundiranje.
English: Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion obtaining an anidulafungin concentration of 0.77 mg/mL.
Slovenian: Aseptično prenesite vsebino rekonstituirane viale/rekonstituiranih vial v intravensko vrečko (ali steklenico), ki vsebuje bodisi natrijev klorid 9 mg/ml (0,9 %) za infundiranje bodisi glukozo 50 mg/ml (5 %) za infundiranje, da boste dobili koncentracijo anidulafungina 0,77 mg/ml.
English: Hypotension, hypertension
Slovenian: Žilne bolezni hipotenzija, hipertenzija pordevanje, vročinski oblivi
English: The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 18/35 (51.4%) and 16/35 (45.7%) at the End of All Treatment.
Slovenian: 18/35 (51,4 %), na koncu celotnega zdravljenja pa 16/35 (45,7 %).
English: ECALTA is not dialysable.
Slovenian: Zdravila ECALTA z dializo ni mogoče odstraniti.
English: What ECALTA contains
Slovenian: Kaj vsebuje zdravilo ECALTA
English: In clinically stable patients, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Slovenian: Klinično stabilni bolniki so lahko po vsaj 5 do 10 dneh zdravljenja z anidulafunginom prešli na peroralno zdravljenje z azoli.
English: The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) was assessed in 35 adult neutropenic patients defined as absolute neutrophil count ≤ 500 cells/mm
Slovenian: Učinkovitost anidulafungina (200 mg intravenski polnilni odmerek, ki mu je sledila aplikacija 100 mg intravensko na dan) so ocenili pri 35 odraslih nevtropeničnih bolnikih, opredeljenih z absolutnim številom nevtrofilcev ≤ 500 celic/mm
English: Life-threatening allergic reactions that might include difficulty breathing with wheezing or worsening of an existing rash have been rarely reported during administration of ECALTA.
Slovenian: Pri uporabi zdravila ECALTA so redko poročali o življenjsko ogrožajočih alergijskih reakcijah, ki lahko vključujejo oteženo dihanje s piskanjem ali poslabšanje že obstoječega izpuščaja.
English: Anidulafungin is not hepatically metabolised.
Slovenian: Anidulafungin se ne presnavlja v jetrih.
English: ECALTA can be given without regard to the timing of haemodialysis (see section 5.2).
Slovenian: Zdravilo ECALTA lahko apliciramo ne glede na čas hemodialize (glejte poglavje
English: The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm
Slovenian: Učinkovitost anidulafungina (200 mg intravenski polnilni odmerek, ki mu je sledila aplikacija 100 mg intravensko na dan) pri odraslih nevtropeničnih bolnikih (opredeljenih z absolutnim številom nevtrofilcev ≤ 500 celic/mm
English: It is recommended that ECALTA be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions).
Slovenian: Priporočljivo je, da hitrost infundiranja zdravila ECALTA ne preseže 1,1 mg/minuto (kar ustreza 1,4 ml/minuto po rekonstituciji in ustreznem redčenju).
English: The compatibility of reconstituted ECALTA with intravenous substances, additives, or medicines other than 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion has not been established.
Slovenian: Združljivost rekonstituiranega zdravila ECALTA z intravenskimi snovmi, aditivi ali zdravili razen 9 mg/ml (0,9 %) natrijevega klorida za infundiranje ali 50 mg/ml (5 %) glukoze za infundiranje ni ugotovljena.
English: In the 4 open-label studies, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Slovenian: V 4 odprtih preskušanjih so lahko klinično stabilni bolniki po vsaj 5 do 10 dneh zdravljenja z anidulafunginom prešli na peroralno zdravljenje z azoli.
English: Patients with renal and hepatic impairment
Slovenian: Bolniki z okvaro ledvic ali jeter
English: In clinically stable patients, a switch to oral azole therapy was permitted after at least 10 days of study treatment.
Slovenian: Klinično stabilni bolniki so lahko po vsaj 10 dneh zdravljenja s preskušanim zdravilom prešli na peroralno zdravljenje z azoli.
English: Anaphylacti c shock, anaphylactic reaction*
Slovenian: Bolezni imunskega sistema anafilaktičn i šok, anafilaktičn a reakcija*
English: Common side effects (may affect up to 1 in 10 people) are:
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) so:
English: ECALTA 100 mg powder for concentrate for solution for infusion
Slovenian: ECALTA 100 mg prašek za koncentrat za raztopino za infundiranje