natgillin/translations-raw huggingface dataset:
Klinisk erfaring Invasiv aspergillose I en ikke- sammenlignende klinisk undersøgelse blev oral posaconazol 800 mg dagligt fordelt på flere doser vurderet som behandling af invasiv aspergillose hos patienter, som var sygdomsrefraktære for behandling med amphotericin B (inklusive liposomformuleringer) eller itraconazol eller hos patienter, der havde intolerans overfor disse lægemidler.
Clinical experience Invasive aspergillosis Oral posaconazole 800 mg/ day in divided doses was evaluated for the treatment of invasive aspergillosis in patients with disease refractory to amphotericin B (including liposomal formulations) or itraconazole or in patients who were intolerant of these medicinal products in a non-comparative salvage therapy trial.
De fleste tilfælde af aspergillose blev vurderet som værende refraktære for tidligere terapi både i posaconazolgruppen (88%) og i den eksterne kontrolgruppe (79%).
Most of the cases of aspergillosis were considered to be refractory to prior therapy in both the posaconazole group (88%) and in the external control group (79%).
Som vist i tabel 3 sås et tilfredsstillende respons (fuldstændig eller delvis bedring) efter endt behandling hos 42% af de posaconazolbehandlede patienter sammenlignet med 26% i den eksterne gruppe.
As shown in Table 3, a successful response (complete or partial resolution) at the end of treatment was seen in 42% of posaconazole-treated patients compared to 26% of the external group.
Samlet effekt af posaconazol efter endt behandling af invasiv aspergillose sammenlignet med en ekstern kontrolgruppe
Overall efficacy of posaconazole at the end of treatment for invasive aspergillosis in comparison to an external control group Overall Response Success by Species All mycologically confirmed
Aspergillus arter. 1 A. fumigatus A. flavus A. terreus A. niger
Aspergillus spp.1 A. fumigatus A. flavus A. terreus A. niger
Fusarium arter.:
10 Fusarium spp.:
11 ud af 24 patienter med kendt eller sandsynlig fusariose var tilfredsstillende behandlet med posaconazol 800 mg dagligt fordelt på flere doser i op til 212 dage med en median på 124 dage.
11 of 24 patients who had proven or probable fusariosis were successfully treated with posaconazole 800 mg/ day in divided doses for a median of 124 days and up to 212 days.
Chromoblastomykose/ Mycetoma:
Chromoblastomycosis/ Mycetoma:
9 ud af 11 patienter var tilfredsstillende behandlet med posaconazol 800 mg dagligt fordelt på flere doser i op til 377 dage med en median på 268 dage.
9 of 11 patients were successfully treated with posaconazole 800 mg/ day in divided doses for a median of 268 days and up to 377 days.
Coccidioidomykose:
Coccidioidomycosis:
10 behandlingsstart) med posaconazol 800 mg dagligt fordelt på flere doser i op til 460 dage med en median på 296 dage.
11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole 800 mg/ day in divided doses for a median of 296 days and up to 460 days.
Albicans isoleret ved baseline).
Treatment of azole-susceptible Oropharyngeal Candidiasis (OPC) A randomised, evaluator-blind, controlled study was completed in HIV-infected patients with azole- susceptible oropharyngeal candidiasis (most patients studied had C. albicans isolated at baseline).
Patienterne blev behandlet med posaconazol eller fluconazol oral suspension (både posaconazol og fluconazol blev givet som følger:
Patients were treated with posaconazole or fluconazole oral suspension (both posaconazole and fluconazole were given as follows:
100 mg to gange dagligt i 1 dag efterfulgt af 100 mg en gang dagligt i 13 dage).
100 mg twice a day for 1 day followed by 100 mg once a day for 13 days).
Posaconazol blev påvist til at være ikke- underlegen i forhold til fluconazol for klinisk succesrate på dag 14 samt 4 uger efter endt behandling.
Posaconazole was shown to be non-inferior to fluconazole for clinical success rates at Day 14 as well as 4 weeks after the end of treatment.
Undersøgelse 316 var en randomiseret, dobbeltblindet undersøgelse af posaconazol oral suspension (200 mg tre gange dagligt) versus fluconazol kapsler (400 mg en gang dagligt) til allogeneisk HSCT modtagere med graft- versus vært sygdom (GVHD).
Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Det primære effekt endpoint var forekomsten af bevist/ sandsynlig IFIs 16 uger efter randomisering bestemt af et uafhængigt, blindet eksternt ekspert panel.
The primary efficacy endpoint was the incidence of proven/ probable IFIs at 16 weeks post-randomization as determined by an independent, blinded external expert panel.
Et andet vigtigt endpoint var tilfældet af bevist/ sandsynlig IFIs under on- treatment perioden (første dosis til sidste dosis af undersøgelsens lægemiddel + 7 dage).
A key secondary endpoint was the incidence of proven/ probable IFIs during the on-treatment period (first dose to last dose of study medicinal product + 7 days).
Størstedelen (377/ 600, [63%]) af de inkluderede patienter havde Akut Grad 2 eller 3 eller kronisk ekstensiv (195/ 600, [32, 5%]) GVHD ved undersøgelsens start.
The majority (377/ 600, [63%]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/ 600, [32.5%]) GVHD at study start.
Undersøgelse 1899 var en randomiseret, evaluator- blindet undersøgelse af posaconazol oral suspension (200 mg tre gange dagligt) versus fluconazol suspension (400 mg en gang dagligt) eller itraconazol oral opløsning (200 mg to gange dagligt) i neutropeniske patienter, der modtog cytotoksisk kemoterapi for akut myeloid leukemi eller myelodysplastisk syndrom.
Study 1899 was a randomised, evaluator-blinded study of posaconazole oral suspension (200 mg three times a day) versus fluconazole suspension (400 mg once daily) or itraconazole oral solution (200 mg twice a day) in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes.
Det primære effekt endpoint var forekomsten af bevist/ sandsynlig IFIs bestemt af et uafhængigt, blindet eksternt panel under on - treatment perioden.
The primary efficacy endpoint was the incidence of proven/ probable IFIs as determined by an independent, blinded external expert panel during the on-treatment period.
Et andet vigtigt endpoint var forekomsten af bevist/ sandsynlig IFIs ved 100 dages post- randomisering.
A key secondary endpoint was the incidence of proven/ probable IFIs at 100 days post-randomization.
Ny diagnose af AML var de mest almindelige underliggende vilkår (435/ 602, [72%]).
New diagnosis of acute myelogenous leukemia was the most common underlying condition (435/ 602, [72%]).
Gennemsnitlig varighed af behandling var 29 dage for posaconazol og 25 dage for fluconazol/ itraconazol.
The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/ itraconazole.
I begge forebyggende undersøgelser var aspergillose den mest almindelige gennembrydende infektion.
11 In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
P- Værdi
P-Value
Patientandel (%) med bevist/ sandsynlig IFIs On- treatment periodeb 1899d
Proportion (%) of patients with proven/ probable IFIs On-treatment periodb 1899d 316e
7/ 304 (2)
7/ 304 (2) 7/ 291 (2)
25/ 298 (8)
25/ 298 (8) 22/ 288 (8)
0, 0009
0.0009 0.0038
11
33/ 298 (11) 27/ 299 (9)
FLU = fluconazol; ITZ = itraconazol; POS = posaconazol. a:
FLU = fluconazole; ITZ = itraconazole; POS = posaconazole. a:
I 1899 var dette perioden fra randomisering til sidste dosis af undersøgelsens lægemiddel plus 7 dage; i 316 var det perioden fra første dosis til sidste dosis af undersøgelsens lægemiddel plus 7 dage. c:
In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316 it was the period from first dose to last dose of study medicinal product plus 7 days. c:
I 1899, var dette perioden fra randomisering til 100 dage efter randomisering; i 316 var det perioden fra baseline dagen til 111 dage efter baseline. d:
In 1899, this was the period from randomization to 100 days post-randomization; in 316 it was the period from the baseline day to 111 days post-baseline. d:
Alle randomiseret e:
All randomized e:
Alle behandlet
All treated
Patientandel (%) med bevist/ sandsynlig Aspergillosis On- treatment periodeb 1899d 316e
Proportion (%) of patients with proven/ probable Aspergillosis On-treatment periodb 1899d 316e
Fixed- time periodec 1899d 316 d FLU = fluconazol; ITZ = itraconazol; POS a:
Fixed-time periodc 1899d 316 d
4/ 304 (1) 7/ 301 (2) = posaconazol.
4/ 304 (1) 7/ 301 (2)
26 / 298 (9) 21/ 299 (7)
26/ 298 (9) 21/ 299 (7)
b:
FLU/ ITZ (1899); FLU (316). b:
I undersøgelse 1899 blev et signifikant fald i alle årsager til dødelighed til fordel for posaconazol observeret [POS 49/ 304 (16%) vs.
In Study 1899, a significant decrease in all cause mortality in favour of posaconazole was observed [POS 49/ 304 (16%) vs.
FLU/ ITZ 67/ 298 (22%) p=0, 048].
FLU/ ITZ 67/ 298 (22%) p= 0.048].
Baseret på Kaplan- Meier estimater, var sandsynligheden for at overleve frem til dag 100 efter randomisering signifikant højere for modtagere af posaconazol; denne overlevelsesbenefit blev demonstreret da analysen betragtede alle dødsårsager (P=0, 0354) såvel som IFI- relateret død (P=0, 0209).
Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomization, was significantly higher for posaconazole recipients; this survival benefit was demonstrated when the analysis considered all causes of death (P= 0.0354) as well as IFI-related deaths (P = 0.0209).
I undersøgelse 316, var den overordnede dødelighed tilsvarende (POS, 25%; FLU, 28%); andelen af IFI relateret død var derimod signifikant lavere i POS gruppen (4/ 301) sammenlignet med FLU gruppen (12/ 299; P=0, 0413).
In Study 316, overall mortality was similar (POS, 25%; FLU, 28%); however, the proportion of IFI- related deaths was significantly lower in the POS group (4/ 301) compared with the FLU group (12/ 299; P= 0.0413).
Erfaring med pædiatriske patienter Seksten patienter fra 8- 17 år blev behandlet med 800 mg/ dag i en undersøgelse for invasive svampeinfektioner.
12 Use in paediatric patients Sixteen patients 8-17 years of age were treated with 800 mg/ day in a study for invasive fungal infections.
Derudover modtog tolv patienter fra 13- 17 år 600 mg/ dag for forebyggelse af invasive svampeinfektioner (Undersøgelserne 316 og 1899).
Additionally, twelve patients 13-17 years of age received 600 mg/ day for prophylaxis of invasive fungal infections (Studies 316 and 1899).
Elektrokardiogramundersøgelser Fra 173 raske forsøgspersoner, mænd og kvinder mellem 18 og 85 år, blev der før og efter indgift af posaconazol (400 mg to gange dagligt med et fedtrigt måltid) indsamlet flere tidsmæssigt
Electrocardiogram evaluation Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years.
Absorption Posaconazol absorberes med en median tmax på 3 timer (patienter, der har indtaget føde).
Absorption Posaconazole is absorbed with a median tmax of 3 hours (fed patients).
I fastende raske forsøgspersoner gav en opdeling af den totale daglige dosis (800 mg) på 200 mg fire gange dagligt sammenlignet med 400 mg to gange dagligt en 58% øget eksponering for posaconazol over 48 timer.
In healthy volunteers under fasting conditions, dividing the total daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 58% over 48 hours.
2, 6 gange større ved indgift sammen med et ikke fedtrigt måltid eller sammen med ernæringstilskud (14 gram fedt) og 4 gange større ved indgift med et fedtrigt måltid (~ 50 gram fedt) i forhold til faste.
Effect of food on oral absorption in healthy volunteers The AUC of posaconazole is about 2.6 times greater when administered with a non-fat meal or nutritional supplement (14 grams fat) and 4 times greater when administered with a high-fat meal (~ 50 grams fat) relative to the fasted state.
4. 2).
Posaconazole should be administered with food or a nutritional supplement (see section 4.2).
Fordeling Posaconazol absorberes langsomt og elimineres langsomt med et stort tilsyneladende fordelingsvolumen (1. 774 liter), og proteinbindingen, hovedsagelig til serum albumin, er høj (> 98%).
Distribution Posaconazole is slowly absorbed and slowly eliminated with a large apparent volume of distribution (1,774 litres) and is highly protein bound (> 98%), predominantly to serum albumin.
Metabolisme Posaconazol har ingen væsentlige cirkulerende metabolitter, og det er ikke sandsynligt, at koncentrationen vil blive påvirket af CYP450 enzymhæmmere.
Metabolism Posaconazole does not have any major circulating metabolites and its concentrations are unlikely to be altered by inhibitors of CYP450 enzymes.
17% af en indgivet radioaktivt mærket dosis.
The excreted metabolites in urine and faeces account for approximately 17% of the administered radiolabelled dose.
Elimination Posaconazol udskilles langsomt med en gennemsnitlig halveringstid (t½) på 35 timer (20 - 66 timer).
Excretion Posaconazole is slowly eliminated with a mean half-life (t½) of 35 hours (range 20 to 66 hours).
Efter indgift af 14C- posaconazol, genfandtes radioaktiviteten hovedsagelig i fæces (77% af den radioaktivt mærkede dosis) heraf hovedparten som uforandret lægemiddel (66% af den radioaktivt mærkede dosis).
After administration of 14C-posaconazole, radioactivity was predominantly recovered in the faeces (77% of the radiolabelled dose) with the major component being parent compound (66% of the radiolabelled dose).
Den renale udskillelse er begrænset med 14% af den radioaktivt mærkede dosis udskilt i urinen (< 0, 2% af den radioaktivt mærkede dosis er uforandret lægemiddel).
Renal clearance is a minor elimination pathway, with 14% of the radiolabelled dose excreted in urine (< 0.2% of the radiolabelled dose is parent compound).
Steady- state opnås efter 7 til 10 dages flergangsdosering.
Steady-state is attained following 7 to 10 days of multiple-dose administration.
Farmakokinetik i specielle patientgrupper Børn (< 18 år) Efter indgift af 800 mg posaconazol dagligt fordelt på flere doser til behandling af invasive svampeinfektioner, svarede de gennemsnitlige dalplasmakoncentrationer fra 12 patienter i alderen 8 - 17 år (776 ng/ ml) til koncentrationerne fra 194 patienter i alderen 18 - 64 år (817 ng/ ml).
13 Following administration of 800 mg per day of posaconazole as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8 - 17 years of age (776 ng/ ml) were similar to concentrations from 194 patients 18 - 64 years of age (817 ng/ ml).
I undersøgelserne for forebyggelse var steady- state middelværdien for den gennemsnitlige posaconazol koncentration (Cav) blandt ti unge (13- 17 år) tilsvarende sammenlignelig med Cav opnået hos voksne (≥ 18 år).
Similarly, in the prophylaxis studies, the mean steady-state posaconazole average concentration (Cav) was comparable among ten adolescents (13-17 years of age) to Cav achieved in adults (≥ 18 years of age).
Ældre (≥ 65 år) En stigning i Cmax (26%) og AUC (29%) kunne påvises i ældre (24 personer ≥ 65 år) i forhold til yngre (24 personer 18 - 45 år).
Elderly (≥ 65 years) An increase in Cmax (26%) and AUC (29%) was observed in elderly subjects (24 subjects ≥ 65 years of age) relative to younger subjects (24 subjects 18 - 45 years of age).
13 Der var en svag reduktion (16%) i AUC og Cmax for posaconazol hos negroide i forhold til kaukasiske personer.
Race There was a slight decrease (16%) in the AUC and Cmax of posaconazole in Black subjects relative to Caucasian subjects.
Nedsat nyrefunktion Efter indgift af enkeltdosis, sås ingen påvirkning af posaconazols farmakokinetik ved let og moderat nedsat nyrefunktion (n=18 Cl cr ≥ 20 ml/ min/ 1, 73 m2); dosisjustering er således ikke nødvendig.
Renal impairment Following single-dose administration, there was no effect of mild and moderate renal impairment (n=18, Cl cr ≥ 20 ml/ min/ 1.73 m2) on posaconazole pharmacokinetics; therefore, no dose adjustment is required.
Hos patienter med svært nedsat nyrefunktion (n=6, Cl cr < 20 ml/ min/ 1, 73 m2) var AUC for posaconazol meget variabel [> 96% CV (varianskoefficient)] sammenlignet med andre grupper med nyrelidelse [< 40% CV].
In subjects with severe renal impairment (n=6, Cl cr < 20 ml/min/1.73 m2), the AUC of posaconazole was highly variable [> 96% CV (coefficient of variance)] compared to other renal groups [< 40% CV].
Nedsat leverfunktion I en undersøgelse med få patienter (n=12) med nedsat leverfunktion var der en øget eksponering forbundet med en forlænget halveringstid hos patienter med nedsat leverfunktion (26, 6, 35, 3, og 46, 1 timer for henholdsvis let, moderat og alvorligt nedsat leverfunktion sammenlignet med 22, 1 timer for personer med normal leverfunktion).
Hepatic impairment In a study with small number of subjects (n=12) who had hepatic impairment, there was an increase in exposure associated with prolongation of half-life in hepatic impaired patients (26.6, 35.3, and 46.1 hours for the mild, moderate and severe groups, respectively compared to 22.1 hours in subjects with normal hepatic function).
2 gange stigning i steady- state AUC hos patienter med alvorligt nedsat leverfunktion.
An approximately 2-fold increase in steady-state AUC is estimated in patients with severe hepatic impairment.
Der blev ikke konstateret effekt på elektrokardiogram, inklusive QT og QTc intervaller, i en sikkerhedsfarmakologisk undersøgelse med gentagen dosering til aber ved 4, 6 gange større systemisk eksponering end den, der opnås ved terapeutiske doser i mennesker.
14 No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at systemic exposures 4.6-fold greater than the exposures obtained at therapeutic doses in humans.
Ekkokardiografi viste ingen tegn på hjerteinsufficiens i en sikkerhedsfarmakologisk undersøgelse med gentagen dosering til rotter ved en systemisk eksponering 1, 4 gange større end den, der opnås terapeutisk.
Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 1.4-fold greater than that achieved therapeutically.
Forhøjet systolisk og arterielt blodtryk (op til 29 mmHg) blev målt hos rotter og aber ved systemisk eksponering på henholdsvis 1, 4 gange og 4, 6 gange den, der opnås med terapeutiske doser.
Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 1.4-fold and 4.6-fold greater, respectively, than those achieved with therapeutic doses.
Der er udført undersøgelser af reproduktion samt peri - og postnatal udvikling hos rotter.
Reproduction, peri- and postnatal development studies were conducted in rats.
Som det ses ved andre antimykotiske azolderivater, menes effekten på reproduktionen at være en følge af den terapeutiske hæmning af steroidhormon - syntesen.
As observed with other azole antifungal agents, these effects on reproduction were considered to be due to a treatment-related effect on steroidogenesis.
Polysorbat 80 Simeticon Natriumbenzoat (E211) Natriumcitratdihydrat Citronsyremonohydrat Glycerol Xanthangummi Flydende glucose Titandioxid (E171) Kunstig kirsebæraroma indeholdende benzylalcohol og propylenglycol Renset vand
Polysorbate 80 Simeticone Sodium benzoate (E211) Sodium citrate dihydrate Citric acid monohydrate Glycerol Xanthan gum Liquid glucose Titanium dioxide (E171) Artificial cherry flavour containing benzyl alcohol and propylene glycol Purified water
Uåbnet beholder:
Unopened container:
Efter første åbning af beholderen:
After first opening the container:
4 uger.
4 weeks.
105 ml oral suspension i en 123 ml flaske (brunt glas type IV) lukket med børnesikret plastlåg (polypropylen) samt en måleske (polystyren) med 2 inddelinger:
105 ml of oral suspension in a 123 ml bottle (glass amber type IV) closed with a plastic child-resistant cap (polypropylene) and a measuring spoon (polystyrene) with 2 graduations:
2, 5 ml og 5 ml.
2.5 ml and 5 ml.
6. 6 Særlige forholdsregler ved bortskaffelse
15 6.6 Special precautions for disposal
15 25. oktober 2005
25 October 2005
Yderligere information om dette lægemiddel er tilgængelig på det europæiske lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
FREMSTILLER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
17 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Schering- Plough S. A., 2, rue Louis Pasteur; 14200 Hérouville St Clair, Frankrig
Schering-Plough S. A., 2, rue Louis Pasteur; 14200 Hérouville St Clair, France
Noxafil 40 mg/ ml oral suspension posaconazol
Noxafil 40 mg/ ml oral suspension posaconazole
Oral anvendelse Omrystes godt før brug.
Oral use Shake well before use.
Udløbsdato Eventuelt resterende lægemiddel skal kasseres 4 uger efter åbning af flasken.
EXP Any product remaining four weeks after opening the bottle should be discarded.
SP Europe Rue de Stalle, 73 B- 1180 Bruxelles Belgien
SP Europe Rue de Stalle, 73 B-1180 Bruxelles, Belgium
22 MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
22 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
EXP Eventuel medicinrest fire uger efter åbning af flasken skal kasseres.
EXP Any product remaining four weeks after opening the bottle should be discarded.
- Lægen har ordineret Noxafil til Dem personligt.
- This medicine has been prescribed for you.
Virkning og anvendelse 2.
What Noxafil is and what it is used for 2.
Det skal De vide, før De begynder at tage Noxafil 3.
Before you take Noxafil 3.
Sådan skal De tage Noxafil 4.
How to take Noxafil 4.
Opbevaring 6.
How to store Noxafil 6.
VIRKNING OG ANVENDELSE
WHAT NOXAFIL IS AND WHAT IT IS USED FOR
Noxafil hører til en gruppe af lægemidler, som kaldes triazolsvampemidler.
Noxafil belongs to a group of medicines called triazole antifungal agents.
Noxafil virker ved at dræbe eller stoppe væksten af nogle af de typer svampe, som kan forårsage infektioner i mennesker.
Noxafil works by killing or stopping the growth of some types of fungi that can cause infections in humans.
Noxafil kan anvendes til behandling af følgende svampeinfektioner hos voksne:
Noxafil can be used to treat the following types of fungal infections in adults:
- Infektioner fremkaldt af svampe af Aspergillus arten, hvis infektionen ikke er behandlet
- Infections caused by fungi of the Aspergillus family that have not improved during treatment
tilstrækkelig med et af anti- svampemidlerne amphotericin B eller itraconazol eller hvis De har måtte stoppe behandlingen med disse midler;
with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;
- Infektioner fremkaldt af svampe af Fusarium arten hvis infektionen ikke er behandlet
- Infections caused by fungi of the Fusarium family that have not improved during treatment with
tilstrækkelig med amphotericin B eller hvis De har måtte stoppe behandlingen med dette middel;
amphotericin B or when amphotericin B has had to be stopped;
- Infektioner fremkaldt af svampe som medfører en tilstand der kaldes chromoblastomykose
- Infections caused by fungi that cause the conditions known as chromoblastomycosis and
og/ eller mycetoma, hvis infektionen ikke er behandlet tilstrækkelig med itraconazol eller hvis De har måtte stoppe behandlingen med dette middel;
mycetoma that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;
- Infektioner fremkaldt af svampe der kaldes Coccidioides, hvis infektionen ikke er behandlet
- Infections due to fungi called Coccidioides that have not improved during treatment with one or