natgillin/translations-raw huggingface dataset:
Den kliniske effekt er primært vurderet i non- neutropene patienter med C. albicans- infektioner og i et begrænset antal patienter inficeret med non- albicans, hovedsagelig C. glabrata, C. parapsilosis og C. tropicalis.
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.
Patienter med Candida endocarditis, osteomyelitis eller meningitis samt kendt C. krusei - infektion er ikke undersøgt.
Patients with candida endocarditis, osteomyelitis or meningitis and known C. krusei infection have not been studied.
Leverpåvirkning Hos raske forsøgspersoner og patienter, der er behandlet med anidulafungin, er der set en stigning i leverenzymer.
Hepatic effects Increased levels of hepatic enzymes have been seen in healthy subjects and patients treated with anidulafungin.
Der er rapporteret isolerede tilfælde af signifikant leverdysfunktion, hepatitis eller forværring af leversvigt.
Isolated cases of significant hepatic dysfunction, hepatitis, or worsening hepatic failure have been reported.
Patienter med stigning i leverenzymer under behandling med anidulafungin, bør monitoreres for tegn på forværring af leverfunktionen, og risk/ benefit- forholdet ved fortsat anidulafungin- behandling bør vurderes.
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.
5. 3).
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).
Dette svarer til 6 g ethanol i 100 mg vedligeholdelsesdosis (administreret over 1, 5 time) samt 12 g ethanol i 200 mg initialdosis (administreret over 3 timer).
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).
Ethanol er skadelig for alkoholikere.
Ethanol could be harmful for those suffering from alcoholism.
Der bør tages højde for alkoholindholdet, når behandling gives til gravide eller ammende kvinder, børn og patienter i højrisikogruppe som patienter med leversygsdomme eller epilepsi.
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.
Mængden af alkohol i denne medicin kan påvirke effekten af andre lægemidler.
The amount of alcohol in this medicinal product may alter the effects of other medicines.
Mængden af alkohol i denne medicin kan forringe evnen til at køre bil samt påvirke arbejdssikkerheden.
The amount of alcohol in this medicinal product may impair the ability to drive or use machines.
Fructoseindhold Denne medicin bør ikke anvendes til patienter med hereditær fructoseintolerans.
3 Fructose content Patients with rare hereditary problems of fructose intolerance should not take this medicine.
3 Anidulafungin er ikke et klinisk betydende substrat, en induktor eller hæmmer af cytochrom P450 - isoenzymerne (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
In vitro- forsøg udelukker ikke fuldt ud mulige in vivo- interaktioner.
Of note, in vitro studies do not fully exclude possible in vivo interactions.
5. 3).
Slight developmental effects have been observed in rabbits administered anidulafungin during pregnancy, in the presence of maternal toxicity (see section 5.3).
Dyreforsøg har vist, at anidulafungin udskilles hos diegivende dyr.
Animal studies have shown excretion of anidulafungin in breast milk.
Det vides ikke, om anidulafungin udskilles i modermælk hos mennesker.
It is not known whether anidulafungin is excreted in human breast milk.
Der skal tages beslutning om fortsættelse eller afbrydelse af amning eller behandling med anidulafungin afhængig af fordel af amning for barnet og fordel af anidulafunginbehandling for moderen.
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.
I kliniske forsøg har 929 forsøgspersoner fået enkeltdoser eller gentagne doser af intravenøst anidulafungin:
Nine hundred and twenty-nine (929) subjects received single or multiple doses of intravenous anidulafungin in clinical trials:
672 patienter i fase 2/ 3- forsøg (287 patienter med candidæmi/ invasiv candidiasis, 355 patienter med oral/ øsofageal candidiasis, 30 patienter med invasiv aspergillose) og 257 patienter i fase 1- forsøg.
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.
I tre kliniske forsøg (en komparativ vs. fluconazol, to non- komparative) blev effekten af anidulafungin vurderet hos patienter med candidæmi og et begrænset antal patienter med Candida- infektioner i dybtliggende væv.
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.
Behandlingsvarigheden af den intravenøse behandling var 13, 5 dage (spredning 1- 38 dage) hos disse patienter.
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).
119 patienter fik ≥14 dages behandling med anidulafungin.
One hundred and nineteen patients received ≥ 14 days of anidulafungin.
Bivirkningerne var sædvanligvis milde til moderate og førte sjældent til seponering af behandlingen.
Adverse reactions were typically mild to moderate and seldom led to discontinuation.
I det pivotale ICC- forsøg omfattede disse bivirkninger rødme/ hedeture (2, 3%), pruritus (2, 3%), udslæt (1, 5%) og urticaria (0, 8%).
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%).
Andre behandlingsrelaterede bivirkninger, som forekom hos ≥1% af patienterne i det pivotale forsøg, omfatter hypokaliæmi (3, 1%), diarré (3, 1%), stigning i ALAT (2, 3%), stigning i leverenzymer (1, 5%), stigning i serum- alkalisk fosfatase (1, 5%) og stigning i serum- bilirubin (1, 5%).
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%).
Nedenfor er lægemiddelrelaterede bivirkninger for 100 mg ICC- databasen (N=204) opført i henhold til MedDRA og opdelt i henhold til følgende frekvens: almindelig (≥1/ 100 og < 1/ 10) eller ikke almindelig (≥1/ 1000 og < 1/ 100).
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
4 Blod - og lymfesystem Almindelig:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Koagulopati
Blood and lymphatic system disorders Common:
Nervesystemet
Coagulopathy
Almindelige:
Nervous system Common:
Krampe, hovedpine
disorders Convulsion, headache
Diarré, opkastning, kvalme Øvre abdominalsmerter
Diarrhoea, vomiting, nausea Abdominal pain upper
Nyrer og urinveje
Renal and urinary disorders Common:
Stigning i serum- kreatinin
Blood creatinine increased
Udslæt, pruritus Urticaria
Rash, pruritus Urticaria
Metabolisme og ernæring Almindelig:
Metabolism and Common:
Hypokaliæmi Hyperglykæmi
nutrition disorders Hypokalaemia Hyperglycaemia
Vaskulære sygdomme
Vascular disorders Common:
Rødme Hypertension, hedeture
Flushing Hypertension, hot flush
Lever og galdeveje
Infusion site pain
Almindelige:
Hepatobiliary disorders Common:
Stigning i alanin aminotransferase, stigning i serum- alkalisk fosfatase, stigning i aspartat aminotransferase, stigning i serum- bilirubin, stigning i gamma - glutamyltransferase
Alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, gamma-glutamyltransferase increased
4. 8, forekomme.
In case of overdose, adverse reactions may occur as mentioned in section 4.8.
I kliniske forsøg er en enkeltdosis på 400 mg ved en fejltagelse blevet givet som initialdosis.
During clinical trials, a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose.
3 af de 10 forsøgspersoner oplevede forbigående, asymptomatisk transaminasestigning (≤3 gange den øvre referenceværdi).
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)).
Generelle egenskaber Farmakoterapeutisk klassifikation:
General properties Pharmacotherapeutic group:
Andre antimykotika til systemisk brug, ATC- kode:
Other antimycotics for systemic use, ATC code:
Anidulafungin hæmmer selektivt 1, 3- β- D- glucan- syntase, et enzym, der findes i svamp, men ikke i pattedyrceller.
Anidulafungin selectively inhibits 1,3-β -D glucan synthase, an enzyme present in fungal, but not mammalian cells.
Dette fører til hæmning af dannelsen af 1, 3- β- D- glucan, der er en essentiel bestanddel af svampens cellevæg.
This results in inhibition of the formation of 1,3-β -D-glucan, an essential component of the fungal cell wall.
Anidulafungin virker fungicidt over for Candida, mens det for Aspergillus ’ vedkommende hæmmer væksten af hyphae.
Anidulafungin has shown fungicidal activity against Candida species and activity against regions of active cell growth of the hyphae of Aspergillus fumigatus.
In vitro- aktivitet Anidulafungin udviser in vitro- aktivitet over for C. albicans, C. glabrata, C. parapsilosis, og C. tropicalis.
Activity in vitro Anidulafungin exhibited in-vitro activity against C. albicans, C. glabrata, C. parapsilosis, and C. tropicalis.
Breakpoints for 1, 3- β- glucansyntesehæmmeres følsomhed er ikke fastslået.
Susceptibility breakpoints for 1,3- β -D-glucan synthesis inhibitors have not been established.
Den kliniske relevans af disse fund kan ses under kliniske forsøg nedenfor.
For the clinical relevance of these findings see below under clinical studies.
Mindste hæmmende koncentration (MIC) bestemmelser blev udført i henhold til de standardiserede laboratoriemetoder M27 og M38, der er defineret af Clinical and Laboratory Standards Institute.
Minimum inhibitory concentration (MIC) determinations were performed according to the Clinical and Laboratory Standards Institute methods M27 and M38.
Candida- isolater med nedsat følsomhed over for anidulafungin er ikke isoleret fra behandlede patienter.
Candida isolates with reduced susceptibility to anidulafungin have not been isolated from treated patients.
Dette tyder ikke på fuldstændig krydsresistens blandt echinocandinerne.
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.
In vivo- aktivitet Parenteralt administreret anidulafungin var virksomt over for Candida spp. i immunkompetente og immunkompromitterede modeller med mus og kaniner.
Activity in vivo Parenterally administered anidulafungin was effective against Candida spp. in immunocompetent and immunocompromised mouse and rabbit models.
Behandling med anidulafungin forlængede overlevelsen og reducerede også organskaden af Candida spp., når den blev målt ved intervaller fra 24- 96 timer efter sidste behandling.
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.
Eksperimentelle infektioner omfattede dissemineret C. albicans- infektion i neutropene kaniner, øsofageal/ orofaryngeal- infektion af neutropene kaniner med fluconazol- resistente C. albicans og dissemineret infektion af neutropene mus med fluconazol- resistente C. glabrata.
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.
Information fra kliniske forsøg
Information from clinical studies
Sikkerhed og effekt af anidulafungin er vurderet i et pivotal fase 3, randomiseret, dobbeltblindt, multicenter, multinationalt forsøg hos primært non- neutropene patienter med candidæmi og et begrænset antal patienter med Candida- infektioner i dybtliggende væv eller med abscesdannende tilstande.
The safety and efficacy of anidulafungin were evaluated in a pivotal Phase 3, randomised, double- blind, 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.
[Patienter med Candida- endocarditis, osteomyelitis eller meningitis eller patienter inficeret med C. krusei blev specifikt ekskluderet af forsøget].
[Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were specifically excluded from the study].
Patienterne blev randomiseret til enten at få anidulafungin (200 mg intravenøs initialdosis efterfulgt af 100 mg intravenøst dagligt) eller fluconazol (800 mg intravenøs initialdosis efterfulgt af 400 mg intravenøst dagligt) og blev stratificeret ved APACHE II- score (≤20 og > 20) og tilstedeværelse eller fravær af neutropeni.
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.
Patienter i begge behandlingsgrupper fik tilladelse til at skifte til oral fluconazol efter mindst 10 dages intravenøs behandling på betingelse af, at de kunne tåle oral medicin, og at de var afebrile i mindst 24 timer, samt at den seneste bloddyrkning var negativ for Candida- arter.
Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided that they were able to tolerate oral medication and were afebrile for at least 24 hours, and that the most recent blood cultures were negative for Candida species.
De patienter, der fik mindst én dosis af forsøgsmedicin, og som havde en positiv dyrkning for Candida- arter fra et normalt sterilt sted, før de indgik i forsøget, blev inkluderet i den modificerede
Patients who received at least one dose of study medication and who had a positive culture for Candida species from a normally sterile site before study entry were included in the modified intent-
6 intent- to- treat (MITT) - population.
6 to-treat (MITT) population.
I den primære effektanalyse, blev det globale respons for anidulafungin sammenlignet med fluconazol i MITT- populationer ved afslutning af intravenøs behandling i en præ- specifik statistisk sammenligning i 2 trin (non- inferioritet efterfulgt af superioritet).
In the primary efficacy analysis, global response in the MITT populations at the end of intravenous therapy, anidulafungin was compared to fluconazole in a pre-specified two- step statistical comparison (non-inferiority followed by superiority).
256 patienter i alderen 16- 91 år blev randomiseret til behandling, og fik mindst én dosis af forsøgsmedicinen.
Two hundred and fifty-six patients, ranging from 16 to 91 years in age, were randomised to treatment and received at least one dose of study medication.
De hyppigste arter isoleret ved baseline var C. albicans (63, 8% anidulafungin, 59, 3% fluconazol) efterfulgt af C. glabrata (15, 7%, 25, 4%), C. parapsilosis (10, 2%, 13, 6%) og C. tropicalis (11, 8%, 9, 3%) med henholdsvis 20, 13 og 15 isolater af de 3 sidstnævnte arter i anidulafungingruppen.
The most frequent species isolated at baseline were 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.
Størstedelen af patienterne havde Apache II- score ≤20, og meget få var neutropene.
The majority of patients had Apache II scores ≤ 20 and very few were neutropenic.
Effektdata, både totalt og i forskellige undergrupper, ses i tabel 1 nedenfor.
Efficacy data, both overall and by various subgroups, are presented below in Table 1.
Global succes i MITT- populationen: primære og sekundære endemål
Global success in the MITT population: primary and secondary endpoints
Forskelle mellem grupper a (95% CI)
Between group difference a (95% CI)
Afslutning af i. v. - behandling (primære endemål)
96/ 127 (75.6%) 88/ 116 (75.9%) 8/ 11 (72.7%)
96/ 127 (75, 6%) 71/ 118 (60, 2%)
71/ 118 (60.2%) 63/ 103 (61.2%) 8/ 15 (53.3%)
15, 42 (3, 9; 27, 0)
15.42 (3.9, 27.0) 14.7 (2.5, 26.9) -
Kun candidæmi Andre sterile stederb Peritonealvæske/ IAc absces Andre
Peritoneal fluid/ IA abscess Other
88/ 116 (75, 9%) 63/ 103 (61, 2%) 8/ 11 (72, 7%) 8/ 15 (53, 3%) 6/ 8 5/ 8 2/ 3 3/ 7
6/ 8 2/ 3
14, 7 (2, 5; 26, 9) -
5/ 8 3/ 7
C. albicansd Non- albicans arterd
C. albicansd Non-albicans speciesd
60/ 74 (81, 1%) 32/ 45 (71, 1%)
60/ 74 (81.1%) 32/ 45 (71.1%)
Apache II score ≤20 Apache II score > 20
Apache II score ≤ 20 Apache II score > 20
Non- neutropene (ANC, celler/ mm3 > 500) Neutropene (ANC, celler/ mm3≤500) Ved andre endemål
Non-neutropenic (ANC, cells/ mm3 > 500) Neutropenic (ANC, cells/ mm3 ≤ 500) At Other Endpoints
94/ 124 (75, 8%) 2/ 3
94/ 124 (75.8%) 2/ 3
69/ 114 (60, 5%) 2/ 4
69/ 114 (60.5%) 2/ 4
Afslutning af al behandling 2 ugers opfølgning 6 ugers opfølgning a Kalkuleret som anidulafungin minus fluconazol b Med eller uden samtidig candidæmi c Intra- abdominal d
End of All Therapy 2 Week Follow-up 6 Week Follow-up a
94/ 127 (74, 0%) 82/ 127 (64, 6%) 71/ 127 (55, 9%)
94/ 127 (74.0%) 82/ 127 (64.6%) 71/ 127 (55.9%)
67/ 118 (56, 8%) 58/ 118 (49, 2%) 52/ 118 (44, 1%)
67/ 118 (56.8%) 58/ 118 (49.2%) 52/ 118 (44.1%)
17, 24 (2, 9; 31, 6) e 15, 41 (0, 4; 30, 4) e 11, 84 (- 3, 4; 27, 0) e
17.24 (2.9, 31.6)e 15.41 (0.4, 30.4)e 11.84 (-3.4, 27.0)e
Data for patienter med et enkelt patogen ved baseline. e 98. 3% konfidensinterval, justeret post- hoc for gentagne sammenligninger ved sekundære tidspunkter.
Calculated as anidulafungin minus fluconazole b With or without concurrent candidaemia c Intra-abdominal d Data presented for patients with a single baseline pathogen. e 98.3% confidence intervals, adjusted post hoc for multiple comparisons of secondary time points.
Mortalitetsrater i både anidulafungingruppen og fluconazolgruppen er anført i tabel 2 nedenfor.
Mortality rates in both the anidulafungin and fluconazole arms are presented below in Table 2:
Samlet mortalitet i forsøget Mortalitet under forsøgsbehandling Mortalitet tilskrevet Candida- infektion
Overall study mortality Mortality during study therapy Mortality attributed to Candida infection
29/ 127 (22, 8%) 10/ 127 (7, 9%) 2/ 127 (1, 6%)
29/ 127 (22.8%) 10/ 127 (7.9%) 2/ 127 (1.6%)
37/ 118 (31, 4%) 17/ 118 (14, 4%) 5/ 118 (4, 2%)
37/ 118 (31.4%) 17/ 118 (14.4%) 5/ 118 (4.2%)
5. 2 Farmakokinetiske egenskaber
7 5.2 Pharmacokinetic properties
7 Generelle farmakokinetiske karakteristika Anidulafungins farmakokinetik er beskrevet hos raske forsøgspersoner, i specielle populationer og hos patienter.
General pharmacokinetic characteristics The pharmacokinetics of anidulafungin have been characterised in healthy subjects, special populations and patients.
Der blev observeret en lav interindividuel variation i systemisk eksponering (variationskoefficient på omtrent 25%).
A low intersubject variability in systemic exposure (coefficient of variation ~25%) was observed.
Distribution Anidulafungins farmakokinetik er karakteriseret ved en hurtig distributionshalveringstid (0, 5- 1 time) og et fordelingsvolumen på 30- 50 l, svarende til kroppens totale væskevolumen.
Distribution The pharmacokinetics of anidulafungin are characterised by a rapid distribution half-life (0.5-1 hour) and a volume of distribution, 30-50 l, which is similar to total body fluid volume.
Anidulafungin er i udstrakt grad (> 99%) bundet til humane plasmaproteiner.
Anidulafungin is extensively bound (> 99%) to human plasma proteins.
Der er ikke udført specifikke vævsdistributionsforsøg med anidulafungin på mennesker, hvorfor der ikke findes information vedrørende anidulafungins penetration af cerebrospinalvæsken og/ eller over blod- hjernebarrieren.
Therefore, no information is available about the penetration of anidulafungin into the cerebrospinal fluid (CSF) and/ or across the blood-brain barrier.
Biotransformation Der er ikke observeret hepatisk metabolisme af anidulafungin.
Biotransformation Hepatic metabolism of anidulafungin has not been observed.
Anidulafungin er ikke et klinisk betydende substrat, en induktor eller hæmmer af cytochrom P450- isoenzymer.
Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes.
Det er ikke sandsynligt, at anidulafungin vil have klinisk betydende effekt på metabolismen af lægemidler, der metaboliseres via cytochrom P450- isoenzymer.
It is unlikely that anidulafungin will have clinically relevant effects on the metabolism of drugs metabolised by cytochrome P450 isoenzymes.
24 timer in vitro.
The in vitro degradation half-life of anidulafungin under physiologic conditions is approximately 24 hours.
In vivo omdannes det ring- åbnede peptid efterfølgende til petid- nedbrydningsprodukter, og bliver hovedsageligt elimineret ved udskillelse gennem galden.
In vivo, the ring-opened product is subsequently converted to peptidic degradants and eliminated mainly through biliary excretion.
Elimination Clearance af anidulafungin er ca 1 l/ time.
Elimination The clearance of anidulafungin is about 1 l/ h.
24 timer, som karakteriserer størstedelen af plasmakoncentrations- tidsprofilen, og har en halveringstid på 40- 50 timer, som karakteriserer eliminationsfasen.
Anidulafungin has a predominant elimination half-life of approximately 24 hours that characterizes the majority of the plasma concentration-time profile, and a terminal half-life of 40-50 hours that characterises the terminal elimination phase of the profile.
I et klinisk enkelt- dosisforsøg blev radioaktivt mærket (14C) anidulafungin (~88 mg) givet til raske forsøgspersoner.
In a single-dose clinical study, radiolabeled (14C) anidulafungin (~88 mg) was administered to healthy subjects.
30% af den indgivne radioaktive dosis blev udskilt i fæces over 9 dage, heraf mindre end 10% som intakt lægemiddelstof.
Approximately 30% of the administered radioactive dose was eliminated in the faeces over 9 days, of which less than 10% was intact drug.
Mindre end 1% af den indgivne radioaktive dosis blev udskilt i urinen, hvilket tyder på en ubetydelig renal clearance.
Less than 1% of the administered radioactive dose was excreted in the urine, indicating negligible renal clearance.
Linearitet Anidulafungin udviser lineær farmakokinetik over et bredt spektrum af doser givet 1 gang dagligt (15 - 130 mg).
Linearity Anidulafungin displays linear pharmacokinetics across a wide range of once daily doses (15-130 mg).