natgillin/translations-raw huggingface dataset:
6. 6 ang. vejledninger til rekonstitution.
For reconstitution instructions see section 6.6.
4. 3 Kontraindikationer 3 Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance or to any of the excipients.
For at mindske risikoen for adaptiv regenerering og mulig dannelse af levertumorer anbefales der tidlig seponering ved signifikante og vedvarende forhøjede værdier af ALAT/ ASAT.
To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/ AST is recommended.
Micafunginbehandling bør først gives efter nøje vurdering af risk/ benefit - forholdet, især af patienter med svært nedsat leverfunktion eller kroniske leversygdomme med præneoplastiske tilstande, som f. eks, fremskreden leverfibrose, cirrose, viral hepatit, neonatal leversygdom eller medfødte enzymdefekter eller hos patienter, som samtidig får behandling, som har hepatotoksiske og/ eller genotoksiske egenskaber.
Micafungin treatment should be conducted on a careful risk/ benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/ or genotoxic properties.
Micafunginbehandling var forbundet med signifikant forværring af leverfunktion (forhøjet ALAT, ASAT eller total bilirubin > 3 gange ULN) både hos raske frivillige og hos patienter.
Micafungin treatment was associated with significant impairment of liver function (increase of ALT, AST or total bilirubin > 3 times ULN) in both healthy volunteers and patients.
I enkelte tilfælde er det blevet indberettet, at patienterne fik mere alvorligt nedsat leverfunktion, hepatit eller leversvigt, herunder dødsfald.
In some patients more severe hepatic dysfunction, hepatitis, or hepatic failure including fatal cases have been reported.
4. 8).
Paediatric patients < 1 year of age might be more prone to liver injury (see section 4.8).
5. 2).
There are insufficient data on the pharmacokinetics of micafungin in patients with severe hepatic impairment (see section 5.2).
Under behandling med micafungin kan anafylaktoide reaktioner forekomme, herunder anafylaktisk chok.
During administration of micafungin, anaphylactoid reactions including shock may occur.
Patienter, som udvikler kliniske symptomer eller har laboratorieprøver, som viser hæmolyse under behandling med micafungin, bør overvåges nøje, for at man kan følge en mulig forværring af disse tilstande, og vurdere risk/ benefit - forholdet med henblik på at fortsætte behandlingen.
Patients who develop clinical or laboratory evidence of haemolysis during micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/ benefit of continuing micafungin therapy.
4. 8).
The incidence of some adverse reactions was higher in paediatric patients than in adult patients (see section 4.8).
Dette lægemiddel til intravenøs brug indeholder laktose.
This medicinal product for intravenous use contains lactose.
Patienter med sjældne arvelige sygdomme som galaktose- intolerance, lapp- laktasemangel eller glukose- galaktose malabsorption bør ikke tage dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Micafungin har et lavt interaktionspotentiale med lægemidler, som omdannes via CYP3A - medierede nedbrydningsveje.
Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways.
Der er udført interaktionsforsøg hos raske frivillige for at undersøge interaktionspotentialet mellem micafungin og mykofenolatmofetil, ciklosporin, takrolimus, prednisolon, sirolimus, nifedipin, flukonazol, ritonavir, rifampicin, itrakonazol, vorikonazol og amfotericin B.
Drug interaction studies in healthy human subjects were conducted to evaluate the potential for interaction between micafungin and mycophenolate mofetil, ciclosporin, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole, voriconazole and amphotericin B.
I disse forsøg blev der ikke fundet bevis for, at farmakokinetikken af micafungin blev påvirket.
In these studies, no evidence of altered pharmacokinetics of micafungin was observed.
Eksponering (AUC) for
No micafungin dose adjustments are necessary when these medicines are administered concomitantly.
4 itrakonazol, sirolimus og nifedipin viste en let øgning i forbindelse med micafungin (henholdsvis 22%, 21% og 18%).
4 Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
Patienter, som får sirolimus, nifedipin eller itrakonzol i kombination med Mycamine, bør overvåges for forgiftning med sirolimus, nifedipin eller itrakonazol, og dosis for sirolimus, nifedipine eller itrakonazol bør reduceres om nødvendigt.
Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary.
I dyreforsøg passerede micafungin placentabarrieren, og der blev observeret reproduktionstoksicitet (se pkt.
In animal studies micafungin crossed the placental barrier and reproductive toxicity was seen (see section 5.3).
Det vides ikke, om micafungin udskilles i modermælken hos mennesker.
It is not known whether micafungin is excreted in human breast milk.
Dyreforsøg har vist, at micafungin udskilles i modermælken hos dyr.
Animal studies have shown excretion of micafungin in breast milk.
Fordele og ulemper ved amning af barnet afvejes med fordelene for moderen ved at forsætte med behandlingen.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with Mycamine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mycamine therapy to the mother.
Testikeltoksicitet blev observeret i dyreforsøg (se pkt.
Testicular toxicity was observed in animal studies (see section 5.3).
Micafungin kan have påvirke fertiliteten hos mænd.
Micafungin may have the potential to affect male fertility in humans.
4. 8).
However, adverse reactions may occur, which may influence the ability to drive and use machines (see section 4.8).
Sikkerhedsprofilen for micafungin er baseret på data fra 3. 028 patienter, der blev behandlet med micafungin i kliniske forsøg:
The safety profile of micafungin is based on 3028 patients treated with micafungin in clinical studies:
2. 002 patienter havde Candida- infektioner (inklusive candidæmi, invasiv candidiasis og candidiasis i øsofagus), 375 patienter havde invasiv aspergillose (primært refraktære infektioner), og 651 blev behandlet profylaktisk mod systemisk svampeinfektion.
2.002 patients with Candida infections (including candidaemia, invasive candidiasis and oesophageal candidiasis), 375 with invasive aspergillosis (primarily refractory infections) and 651 for prophylaxis of systemic fungal infections.
Patienter, der behandles med micafungin i kliniske forsøg, repræsenterer en kritisk syg patientgruppe, som kræver behandling med mange lægemidler, bl. a. antineoplastisk kemoterapi, potente systemiske immunosuppressiva og bredspektret antibiotika.
The patients treated with micafungin in clinical studies represent a critically ill patient population that requires multiple medicinal products including antineoplastic chemotherapy, potent systemic immunosuppressants and broad spectrum antibiotics.
Disse patienter havde mange forskellige komplekse underliggende sygdomme, såsom maligne hæmatologiske sygdomme og HIV- infektion, eller var transplanterede og/ eller fik intensiv behandling.
These patients had a wide variety of complex underlying conditions such as haematological malignancies and HIV-infection or were transplant recipients and/ or treated in intensive care.
I alt 32, 2% af patienterne oplevede bivirkninger.
Overall 32.2% of the patients experienced adverse drug reactions.
De hyppigst indberettede bivirkninger var kvalme (2, 8%), forhøjet alkalisk fosfatase i blodet (2, 7%), flebit (2, 5%, hovedsageligt hos HIV- inficerede patienter med perifert venekateter), opkast (2, 5%) og forhøjet aspartataminotransferase (ASTA) (2, 3%).
The most frequently reported adverse reactions were nausea (2.8%), blood alkaline phosphatase increased (2.7%), phlebitis (2.5%, primarily in HIV infected patients with peripheral lines), vomiting (2.5%), and aspartate aminotransferase increased (2.3%).
5 Systemorgan -
System Organ
≥1/ 100 til < 1/ 10
≥ 1/ 100 to < 1/ 10
≥1/ 1. 000 til < 1/ 100
≥ 1/ 1,000 to < 1/ 100
≥1/ 10. 000 til
≥
(kan ikke
Not known
< 1/ 1. 000
≥ 1/100 to < 1/10
estimeres ud fra forhåndenværen de data)
≥ 1/1,000 to < 1/100
Blod og lymfesystem Immunsystemet
1/10,000 to < 1/1,000
leukopeni, neutropeni, anæmi
(frequency cannot be
pancytopeni thrombocytopeni, eosinofili, hypoalbuminæmi anafylaktisk / anafylaktoid reaktion (se pkt.
estimated from available data) Blood and lymphatic system disorders
4. 4), hypersensitivitet
leukopenia, neutropenia, anaemia
4. 4)
haemolytic anaemia, haemolysis (see section 4.4)
hyperhidrose
anaphylactic / anaphylactoid reaction (see section 4.4), hypersensitivity
Metabolisme og ernæring
Endocrine disorders
hypokaliæmi, hypomagnesæmi, hypokalcæmi
hyperhidrosis
hyponatremi, hyperkaliæmi, hypofosfatæmi, anoreksi
Metabolism and nutritional disorders
Psykiske forstyrrelser
hypokalaemia, hypomagnesaemia, hypocalcaemia
insomni, angst, forvirring
hyponatraemia, hyperkalaemia, hypophosphataemia, anorexia
hovedpine
insomnia, anxiety, confusion
somnolens, tremor, svimmelhed, ændret smagssans
Nervous system disorders Cardiac disorders
Hjerte
headache
takykardi, palpitationer, bradykardi
somnolence, tremor, dizziness, dysgeusia tachycardia, palpitations, bradycardia
flebit
phlebitis
hypotension, hypertension, rødmen
hypotension, hypertension, flushing
shock
shock
kvalme, opkastning, diarré, abdominalsmerter
nausea, vomiting, diarrhoea, abdominal pain
forhøjet alkalisk fosfatase i blodet, forhøjet aspartataminotrans - ferase (ASAT), forhøjet alaninaminotransferase (ALAT), forhøjet blodbilirubin (inklusive hyperbilirubinæmi) unormal leverfunktionstest
blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased (including hyperbilirubinaemia), liver function test abnormal
4. 4), forhøjet gamma - glutamyltransferase, icterus, kolestase, hepatomegali, hepatitis
hepatic failure (see section 4.4), gamma- glutamyltransferase increased, jaundice, cholestasis, hepatomegaly, hepatitis
4. 4)
hepatocellular damage including fatal cases (see section 4.4)
udslæt
rash
nældefeber, pruritus, erytem
urticaria, pruritus, erythema
Systemorgan -
6 System Organ
≥1/ 100 til < 1/ 10
≥ 1/100 to < 1/10
≥1/ 1. 000 til < 1/ 100
≥ 1/1,000 to < 1/100
(kan ikke
1/10,000 to < 1/1,000
< 1/ 1. 000
(frequency cannot be
estimeres ud fra forhåndenværen de data)
blood creatinine increased, blood urea increased, renal failure aggravated
reaktioner på administrations - stedet
renal impairment (see section 4.4), acute renal failure
inflammation på injektionsstedet, smerte på injektionsstedet, perifert ødem
General disorders and administration site conditions
Undersøgelser
pyrexia, rigors
forhøjet laktatdehydrogena - se i blodet
injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema
Mulige allergilignende symptomer
blood lactate dehydrogenase increased
Symptomer såsom udslæt og rigor er indberettet i kliniske forsøg.
Possible allergic-like symptoms Symptoms such as rash and rigors have been reported in clinical studies.
Alvorlige reaktioner (f. eks. anafylaktoide reaktioner 0, 2%, 6/ 3028) blev indberettet som sjældne ved behandling med micafungin og kun hos patienter med alvorlige underliggende sygdomme, (f. eks. fremskreden AIDS og maligne tilstande), som kræver samtidig behandling med flere lægemidler.
Serious reactions (e.g. anaphylactoid reaction 0.2%, 6/3028) were uncommonly reported during therapy with micafungin and only in patients with serious underlying conditions (e.g. advanced AIDS, malignancies) requiring multiple co-medications.
Bivirkninger i leveren I de kliniske forsøg med micafungin var den totale incidens af bivirkninger i leveren 8, 6% (260/ 3028) hos patienter, som blev behandlet med micafungin.
Hepatic adverse reactions The overall incidence of hepatic adverse reactions in the patients treated with micafungin in clinical studies was 8.6% (260/3028).
Størstedelen af disse bivirkningerne var milde eller moderate.
The majority of hepatic adverse reactions were mild and moderate.
De hyppigste var forhøjet ALP (2, 7%), ASAT (2, 3%), ALAT (2, 0%), blodbilirubin (1, 6%) og unormale leverfunktionstests (1, 5%).
Most frequent reactions were increase in AP (2.7%), AST (2.3%), ALT (2.0%), blood bilirubin (1.6%) and liver function test abnormal (1.5%).
Få patienter (1, 1%; 0, 4% alvorlige) afbrød behandlingen pga. en hepatisk hændelse.
Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event.
4. 4).
Cases of serious hepatic dysfunction occurred uncommonly (see section 4.4).
Børn Hyppigheden af visse bivirkninger (angivet i nedenstående tabel) var større hos børn end hos voksne patienter.
Paediatric patients The incidence of some adverse reactions (listed in the table below) was higher in paediatric patients than in adult patients.
Den mest sandsynlige årsag var forskelle i de underliggende sygdomme hos børn < 1 år i forhold til voksne eller ældre børn i de kliniske undersøgelser.
The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies.
Det samme gjaldt for allogen SCT (29, 4% og 13,. 4%, henholdsvis) og hæmatologiske malignitet (henholdsvis 29, 1% og 8, 7%,).
At the time of entering the study, the proportion of paediatric patients with neutropenia was several-fold higher than in adult patients (40.2% and 7.3% of children and adults, respectively), as well as allogeneic HSCT (29.4% and 13.4%, respectively) and haematological malignancy (29.1% and 8.7%, respectively).
Blod og lymfesystem almindelig
Blood and lymphatic system disorders common
trombocytopeni
thrombocytopenia
takykardi
tachycardia
Vaskulære sygdomme almindelig
Vascular disorders common
hypertension, hypotension
hypertension, hypotension
7
7 Renal and urinary disorders common
Gentagne daglige doser op til 8
acute renal failure, blood urea increased
mg/ kg (maksimal total dosis 896 mg) er blevet administreret til voksne
4.9 Overdose
patienter i kliniske forsøg uden indberetning af dosisbegrænsende toksicitet.
Repeated daily doses up to 8 mg/kg (maximum total dose 896 mg) in adult patients have been administered in clinical trials with no reported dose-limiting toxicity.
Der er indberettet et tilfælde af fejldosering med 7, 8 mg/ kg/ dag i 7 dage hos en nyfødt patient.
One case of mis-dosage of 7.8 mg/kg/day for 7 days was reported in a newborn patient.
I tilfælde af overdosering bør der sættes ind med generelle støtteforanstaltninger og symptomatisk behandling. Micafungin er stærkt proteinbundet og kan ikke dialyseres.
Micafungin is highly protein-bound and not dialysable.
Virkningsmekanisme Micafungin hæmmer ikke- kompetitivt syntesen af 1, 3- β- D- glucan, der er en essentiel komponent i svampens cellevæg.
Mode of action Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall.
1, 3- β- D- glucan findes ikke i pattedyrs celler.
1,3-β-D-glucan is not present in mammalian cells.
Micafungin udviser fungicid effekt på de fleste Candida- arter og hæmmer kraftigt aktivt voksende hyfer af Aspergillus- arter.
Micafungin exhibits fungicidal activity against most Candida species and prominently inhibits actively growing hyphae of Aspergillus species.
Farmakokinetiske/ farmakodynamiske (PK/ PD) forhold Der blev fundet en additiv eller synergistisk farmakodynamisk interaktion mellem micafungin og amfotericin B i en musemodel med pulmonal aspergillose (immunsuppression med hydrokortison, intranasal infektion med Aspergillus fumigatus).
PK/PD relationship An additive or synergistic pharmacodynamic interaction of micafungin and amphotericin B was found in a mouse model of pulmonary aspergillosis (immunosuppression with hydrocortisone, intranasal infection with Aspergillus fumigatus).
Resistensmekanisme( r) Som med alle antimikrobielle midler er der indberettet tilfælde af reduceret følsomhed, og resistens og krydsresistens med andre echinocandiner kan ikke udelukkes.
Mechanism(s) of resistance As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded.
Reduceret følsomhed over for echinocandiner har været associeret med mutationer i Fks1- genet, som koder for en større subunit i glukansyntase.
Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 gene coding for a major subunit of glucan synthase.
Breakpoints Følsomhedstestning blev foretaget med modifikationer i henhold til Clinical and Laboratory Standards Institute (CLSI) - metoder, henholdsvis M27- A2 (Candida- arter) og M38- A (Aspergillus- arter).
Breakpoints Susceptibility testing was performed with modifications according to the Clinical and Laboratory Standards Institute (CLSI) methods M27-A2 (Candida species) and M38-A (Aspergillus species), respectively.
På nuværende tidspunkt er der ikke etableret standardiserede metoder for følsomhedstestning af 1, 3- β- D - glykansyntesehæmmere, og resultaterne fra følsomhedstestning stemmer derfor ikke nødvendigvis overens med de kliniske resultater.
To date, standardised techniques for susceptibility testing for 1,3-β-D-glucan synthesis inhibitors have not been established and results of susceptibility testing do not necessarily correlate with clinical outcome.
Infektioner opstået pga.
Although no MIC breakpoints for echinocandins have been established, a MIC of < 2 mg/l encompasses > 99% of all clinical isolates of Candida spp. without bisecting any species group and represents a concentration that is easily maintained throughout the dosing interval.
Candida- arter i dette MIC- område responderer sandsynligvis på behandling.
Infections due to Candida spp. in this MIC range are likely to respond to therapy.
Lokal viden om resistens er ønskeligt, især ved behandling af alvorlige infektioner.
The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Denne information er kun en vejledning i sandsynligheden af, at mikro- organismer vil være følsomme over for micafungin.
This information is only a guide to the probabilities of whether micro-organisms will be susceptible to micafungin or not.
Hvor det er relevant, angives det europæiske område for opnået resistens.
Where applicable the information on the European range of acquired resistance for the individual micro-organisms is indicated in brackets.
Dette er angivet for de individuelle mikroorganismer i parentes.
Commonly susceptible species [MIC ranges in Europe, mg/l]
Almindeligvis modtagelige arter [MIC områder i Europa, mg/ l] Candida albicans [0. 007- 0, 25] Candida glabrata [0, 007- 0, 12] Candida tropicalis [0, 007- 0, 12] Candida krusei [0, 015- 0, 12] 8 Candida kefyr [0, 03- 0, 06] Candida parapsilosis [0, 12- 2] Candida guilliermondii [0, 5] Candida lusitaniae [0, 12- 0, 25] Candida spp.
8 Candida albicans [0.007 - 0.25] Candida glabrata [0.007 - 0.12] Candida tropicalis [0.007 - 0.12] Candida krusei [0.015 - 0.12] Candida kefyr [0.03 - 0.06] Candida parapsilosis [0.12 - 2] Candida guilliermondii [0.5] Candida lusitaniae [0.12 - 0.25] Candida spp.
[0, 015- 0, 5] (inkl.
[0.015 - 0.5] (incl.
C. famata, C. dubliniensis, C. lipolytica, C. pelliculosa, C. rugosa, C. stellatoidea og C. zeylanoides)
C. famata, C. dubliniensis, C. lipolytica, C. pelliculosa, C. rugosa, C. stellatoidea and C. zeylanoides)
Aspergillus fumigatus Aspergillus flavus Aspergillus. niger Aspergillus terreus Aspergillus nidulans Aspergillus versicolor
Aspergillus fumigatus Aspergillus flavus Aspergillus niger Aspergillus terreus Aspergillus nidulans Aspergillus versicolor
Den mycelie form for dimorfe svampe (f. eks.
The mycelial form of dimorphic fungi (e.g.
Histoplasma capsulatum, Blastomyces dermatitidis, Cocciodiodes immitis)
Histoplasma capsulatum, Blastomyces dermatitidis, Coccidioides immitis)
Arter for hvilke erhvervet resistens kan være et problem Ingen
Species for which acquired resistance may be a problem None
Organismer med medfødt resistens Cryptococcus spp.
Inherently resistant organisms Cryptococcus spp.
Information fra kliniske undersøgelser Candidæmi og invasiv Candidiasis:
Information from clinical studies Candidaemia and Invasive Candidiasis:
Micafungin (100 mg/ dag eller 2 mg/ kg/ dag) var lige så effektive og bedre tolererede end liposomalt amphotericin B (3 mg/ kg) som førstevalgsbehandling af candidæmi og invasiv candidiasis i en randomiseret, dobbeltblind, multinational non- inferioritetsundersøgelse.
Micafungin (100 mg/day or 2 mg/kg/day) was as effective as and better tolerated than liposomal amphotericin B (3 mg/kg) as first-line treatment of candidaemia and invasive candidiasis in a randomised, double-blind, multinational non-inferiority study.
Non- inferioritet blev vist for voksne patienter, og lignende resultater sås for de pædiatriske undergrupper (herunder nyfødte og præmature spædbørn).
Non-inferiority was proven for adult patients, and similar findings were demonstrated for the paediatric subpopulations (including neonates and premature infants).
Virkningerne var konsistente, uafhængigt af Candida- arten, det primære infektionsområde og den neutropene status (se tabel).
Efficacy findings were consistent, independent of the infective Candida species, primary site of infection and neutropenic status (see Table).
Micafungin viste en mindre middelværdisreduktion i den estimerede glomerulære filtrationshastighed under behandlingen (P < 0, 001) og en lavere forekomst af infusionsrelaterede reaktioner (P=0, 001) sammenlignet med liposomalt amphotericin B.
Micafungin demonstrated a smaller mean peak decrease in estimated glomerular filtration rate during treatment (p < 0.001) and a lower incidence of infusion-related reactions (p=0.001) than liposomal amphotericin B.
Total behandlingssucces i per- protokol- sæt, forsøg med invasiv candidiasis
Overall Treatment Success in the Per Protocol Set, Invasive Candidiasis Study
Voksne patienter
Micafungin
Micafungin N n (%)
% Difference
Liposomalt Amphotericin B N n (%)
Amphotericin B
% Afvigelse [95% KI]
Adult Patie nts
202 181 (89, 6) 190 170 (89, 5) 0, 1 [- 5, 9 - 6, 1] †
181 (89.6) 190
18 (75, 0) 15
15
0, 7 [- 5, 3 - 6, 7] ‡
0.7 [-5.3, 6.7] ‡
178 163 (91, 6) 175 158 (90, 3)
158 (90.3)
Børn
Paediatric Patients
Total behandlingssucces Alder < 2 år For tidligt fødte
Overall Treatment Success < 2 years old Premature Infants Neonates (0 days to < 4 weeks)
48 26 10
48 26 10 7
35 (72, 9) 21 (80, 8) 7 (70, 0) 9
35 (72.9) 21 (80.8) 7 (70.0) 7 (100)
50 31 9
50 31 9 5
38 (76, 0) 24 (77, 4) 6 (66, 7)
38 (76.0) 24 (77.4) 6 (66.7) 4 (80)
- 2, 7 [- 17, 3- 11, 9] §
-2.7 [-17.3, 11.9] §
Alder 2- 15 år
2 to 15 years old
Voksne og børn kombineret, total behandlingssuccess med Candida arter
Adults and Children Combined, Overall Treatment Success by Candida Species
Candida albicans
Candida albicans Non-albicans species ¶: all C. tropicalis C. parapsilosis C. glabrata C. krusei
102 91 (89,. 2) 98
102 151 59 48 23 9
89 (90, 8)
91 (89.2) 133 (88.1) 54 (91.5) 41 (85.4) 19 (82.6) 8 (88.9)
Non- albicans species ¶: alle C. tropicalis C. parapsilosis C. glabrata C. krusei
98 140 51 44 17 7