qanastek/EMEA-V3 huggingface dataset:
Accidental overdose was noted in one patient who took 1,200 mg twice a day for 3 days.
Doża eċċessiva bi żball kienet rappurtata f’ pazjent wieħed li ħa 1, 200 mg darbtejn kuljum għal 3 ijiem.
No adverse reactions were noted by the investigator.
L- investigatur ma ra l- ebda reazzjonijiet avversi.
Posaconazole is not removed by haemodialysis.
Posaconazole ma jitneħħiex bid- dijaliżi tad- demm.
Antimycotics for systemic use-triazole derivatives, ATC code:
Mediċini kontra l- fungu għall- użu sistemiku – derivati triazole, Kodiċi ATC:
Mechanism of action Posaconazole inhibits the enzyme lanosterol 14α -demethylase (CYP51), which catalyses an essential step in ergosterol biosynthesis.
Mod kif jaħdem Posoconazole jinibixxi l- enzima lanosterol 14α- demethylase (CYP51), li tikkatalizza pass essenzjali fil- biosintesi ta ’ ergosterol.
Aspergillus species (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida species (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, and species of Fusarium, Rhizomucor, Mucor, and Rhizopus.
9 Mikrobijoloġija Intwera li posaconazole huwa effettiv in vitro kontra l- mikro- organiżmi li ġejjin: Speċi ta ’ Aspergillus (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), speċi ta ’ Candida (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, u speċi ta ’ Fusarium, Rhizomucor, Mucor, u Rhizopus.
The microbiological data suggest that posaconazole is active against Rhizomucor, Mucor, and Rhizopus, however the clinical data are currently too limited to assess the efficacy of posaconazole against these causative agents.
It- tagħrif mikrobijoloġiku jindika li posaconazole huwa attiv kontra Rhizomucor, Mucor, u Rhizopus, iżda it- tagħrif kliniku għadu limitat wisq sabiex tkun evalwata l- effikaċja ta ’ posaconazole kontra dawn l- aġenti kawżattivi.
Resistance Clinical isolates with decreased susceptibility to posaconazole have been identified.
Reżistenza Iżolati kliniċi li kienu anqas suxxettibli għal posaconazole kienu identifikati.
The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Il- mekkaniżmu prinċipali ta ’ reżitsenza huwa l’ akkwist ta ’ sostituzzjonijiet fil- proteina li tkun immirata, CYP51.
Combination with other antifungal agents The use of combination antifungal therapies should not decrease the efficacy of either posaconazole or the other therapies; however, there is currently no clinical evidence that combination therapy will provide an added benefit.
L- użu ma ’ aġenti oħrajn kontra l- fungu L- użu ma ’ terapiji kontra l - fungu m’ għandux inaqqas l- effikaċja la ta ’ posaconazole u l- anqas tat - terapiji l- oħra; iżda bħalissa m’ hemmx evidenza klinika li terapija kombinata tipprovdi xi benefiċċju addizzjonali.
A correlation between total medicinal product exposure divided by MIC (AUC/ MIC) and clinical outcome was observed.
Relazzjonijiet Farmakokinetiċi / Farmakodinamiċi Korrelazzjoni bejn l- esponiment totali tal- prodott mediċinali diviż bl- MIC (AUC/ MIC) u r- riżultat kliniku kienet osservata.
The critical ratio for subjects with Aspergillus infections was ~200.
Il- proporzjon kritiku għall- individwi b’ infezzjonijiet ta ’ Aspergillus kienet ~200.
It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens and the effects of food on absorption).
Huwa importanti b’ mod partikolari li tipprova taċċerta ruħek li jinkisbu l- ogħla livelli fil- plażma f’ pazjenti infettati b’ Aspergillus (ara sezzjonijiet 4. 2 u 5. 2 dwar il- korsijiet tad- dożi rakkomandati u l - effetti ta ’ l- ikel fuq l- assorbiment).
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.
Esperjenza klinika Aspergillożi invażiva Posaconazole orali 800 mg/ jum mogħti f’ dożi maqsuma kien evalwata għall- kura ta ’ asperġillożi invażiva f’ pazjenti b’ mard li kien refrattarju għal amphotericin B (inklużi formulazzjonijiet liposomali) jew itraconazole jew f’ pazjenti li kienu intolleranti għal dawn il- prodotti mediċinali fi prova mhux kumparattiva b’ terapija ta ’ salvataġġ.
Clinical outcomes were compared with those in an external control group derived from a retrospective review of medical records.
Ir- riżultati kliniċi kienu mqabbla ma ’ grupp ta ’ kontroll minn barra li nkiseb minn reviżjoni retrospettiva tad- dokumenti mediċi.
The external control group included 86 patients treated with available therapy (as above) mostly at the same time and at the same sites as the patients treated with posaconazole.
Il- krupp ta ’ kontroll minn barra kien jinkludi 86 pazjent kurati bil- kura disponibbli (bħal hawn fuq) fil- parti l- kbira fl- istess ħin u fl- istess postijiet bħall- pazjenti ikkurati b’ posaconazole.
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%).
Il- parti l- kbira tal- każijiet ta ’ asperġillożi kienu meqjusa refrattorji għat- terapija li ngħatat qabel kemm fil- grupp ta ’ posaconazole (88%) kif ukoll fil- grupp ta ’ kontroll minn barra (79%).
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.
Kif jidher f’ Tabella 3, rispons b’ suċċess (fejqan komplet jew parzjali) fi tmiem il- kura deher f’ 42% tal- pazjenti kkurati b’ posaconazole meta mqabbel ma’ 26% tal- grupp ta ’ barra.
However, this was not a prospective, randomised controlled study and so all comparisons with the external control group should be viewed with caution.
Madankollu dan ma kienx studju prospettiv, randomised u b’ kontroll u għalhekk it- tqabbil mal- gruppi ta ’ kontroll minn barra għandhom jitqiesu b’ attenzjoni.
Table 3.
Tabella 3 L- effikaċja globali ta ’ posaconazole fl- aħħar tal- kura għal asperġillożi invażiva imqabbla mal- grupp ta ’ kontroll minn barra.
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
Rispons globali Suċċess skond l- ispeċi Kollha konfermati b’ mod mikoloġiku
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.
11 minn 24 pazjent li wrew li probabbli kellhom fusarjożi kienu ikkurati b’ suċċess b’ posaconazole 800 mg/ jum b’ dożi maqsumin għal medjan ta ’ 124 jum u sa 212 jum.
Among eighteen patients who were intolerant or had infections refractory to amphotericin B or itraconazole, seven patients were classed as responders.
Fost 18- il pazjent li ma kienux tolleranti għal jew kellhom infezzjonijiet li kienu refrattorji għal amphotericin B jew itraconazole, seba ’ pazjenti kienu meqjusa bħala li wrew rispons.
Chromoblastomycosis/ Mycetoma:
Kromoblastomikożi/ Miċetoma:
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.
9 mill- 11- il pazjent li kienu kkurati b’ suċċess b’ posaconazole 800 mg/ jum f’ dożi maqsumin għal medjan ta ’ 268 jum u sa 377 jum.
Five of these patients had chromoblastomycosis due to Fonsecaea pedrosoi and 4 had mycetoma, mostly due to Madurella species.
Ħames minn dawn il- pazjenti kellhom kromoblastomikożi minħabba Fonsecaea pedrosoi u erbgħa kellhom miċetoma, l- aktar minħabba speċi ta ’ Madurella.
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.
Kokkidajojdomikożi: 11 mis- 16- il pazjent kienu kkurati b’ suċċess (fi tmiem il- kura kellhom fejqan komplet jew parzjali mis- sinjali u s- sintomi li kien hemm mal- linja bażi) b’ posaconazole 800 mg/ jum b’ dożi maqsuma għal medjan ta ’ 296 jum u sa 460 jum.
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).
Albicans mal- linja bażi).
The primary efficacy variable was the clinical success rate (defined as cure or improvement) after 14 days of treatment.
Il- varjant ta ’ l- effikaċja ewlienija kienet ir- rata ta ’ suċċess kliniku (definita bħala fejqan jew titjib) wara 14- il jum ta ’ kura.
Patients were treated with posaconazole or fluconazole oral suspension (both posaconazole and fluconazole were given as follows:
Il- pazjenti kienu kkurati b’ suspensjoni orali ta ’ posaconazole jew fluconazole (kemm posaconazole kif ukoll fluconazole ingħataw kif ġej:
100 mg twice a day for 1 day followed by 100 mg once a day for 13 days).
100 mg darbtejn kuljum għal ġurnata 1 segwita b’ 100 mg darba kuljum għal 13- il gurnata).
The clinical response rates from the above study are shown in the Table 4 below.
Ir- rati ta ’ rispons kliniku mill- istudju t’ hawn fuq qed jidhru f’ Tabella 4 hawn taħt.
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.
Intwera li posaconazole ma kienx inferjuri għal fluconazole għar- rati ta ’ suċċess kliniku ma ’ Jum 14 kif ukoll wara 4 ġimgħat minn meta ntemmet il- kura.
Clinical success rates in Oropharyngeal Candidiasis Endpoint
Rati ta ’ suċċess kliniku f’ Kandidijażi Orofarinġali Endpoint
Clinical success rate at Day 14 Clinical success rate 4 weeks after end of treatment
Rata ta ’ suċċess kliniku ma ’ Jum 14 Rata ta ’ suċċess kliniku 4 ġimgħat wara li ntemmet il- kura Rata ta ’ suċċess kliniku kienet definita bħala n- numru ta ’ każijiet meqjusa li diviż man- numru totali ta ’ każijiet eliġibbli għall- analiżi.
91.7% (155/ 169) 68.5% (98/ 143)
91. 7% (155/ 169) 68. 5% (98/ 143) għandhom rispons kliniku
92.5% (148/ 160) 61.8% (84/ 136)
92. 5% (148/ 160) 61. 8% (84/ 136) (fejqan jew titjib)
Clinical success rate was defined as the number of cases assessed as having a clinical response (cure or improvement) divided by the total number of cases eligible for analysis.
Profilassi ta ’ Infezzjonijiet Invażivi tal- Fungu (IFIs) (Studji 316 u 1899)
Prophylaxis of Invasive Fungal Infections (IFIs) (Studies 316 and 1899) Two randomised, controlled prophylaxis studies were conducted among patients at high risk for developing invasive fungal infections.
Żewġ studji ta ’ profilassi randomised bil- kontroll saru b’ pazjenti li għandhom jiżviluppaw infezzjonijiet invażivi tal- fungu.
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).
Studju 316 kien prova randomised, double- blind b’ suspensjoni orali ta ’ posaconazole (200 mg tliet darbiet kuljum) kontra kapsuli ta ’ fluconazole (400 mg darba kuljum) f’ riċevituri ta ’ trapjanti ta ’ ċelluli stem ħematopejetiċi alloġeniċi, b’ mard tal- graft kontra l- host (GVHD).
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.
L- endpoint ewlieni ta ’ l- effikaċja kien l- inċidenza ta ’ IFI’ s li probabbli/ ġew pruvati li seħħew wara 16- il ġimgħa li tkun seħħet ir- randomisation, hekk kif ikun deċiż minn pannell estern ta ’ esperti indipendenti blinded.
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).
Endpoint essenzjali sekondarju kien l- inċidenza ta ’ IFI’ s li probabbli/ ġew pruvati li seħħew waqt il - perijodu tal- kura (l- ewwel doża sa l- aħħar doża tal- prodott mediċinali li qed jiġi studjat+ 7 ijiem).
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.
Il - maġġoranza (377/ 600, [63%]) tal- pazjenti li kienu nklużi kellhom GVHD Akut ta ’ Grad 2 jew 3 jew kroniku estensiv (195/ 600, [32. 5%]) mal- bidu ta ’ l- istudju.
The mean duration of therapy was 80 days for posaconazole and 77 days for fluconazole.
Bħala medja t- terapija damet 80 jum għal posaconazole u 77 jum għal fluconazole.
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.
Studju 1899 kien wieħed randomised, blinded għall- evalwatur ta ’ suspensjoni orali ta ’ posaconazole (200 mg tliet darbiet kuljum) kontra suspensjoni ta ’ fluconazole (400 mg darba kuljum) jew soluzzjoni orali ta ’ itraconazole (200 mg darbtejn kuljum) f’ pazjenti newtropeniċi li kienu qed jirċievu kimoterapija ċitotossika għall- lewkimja majeloġenuża jew sindromi majelodisplastiċi.
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.
L- endpoint ta ’ l- effikaċja ewlieni kien l- inċidenza ta ’ IFI’ s li probabbli/ ġew pruvati li seħħew minn pannell estern ta ’ esperti indipendenti blinded waqt il- perijodu tal- kura.
A key secondary endpoint was the incidence of proven/ probable IFIs at 100 days post-randomization.
Lewkimja
New diagnosis of acute myelogenous leukemia was the most common underlying condition (435/ 602, [72%]).
11 majeloġenuża li tkun għada kif ġiet dijanjostikata hija l- aktar kundizzjoni komuni (435/ 602, [72%]).
The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/ itraconazole.
It- terapija damet medja ta ’ 29 jum għal posaconazole u 25 jum għal fluconazole/ itraconazole.
11 In both prophylaxis studies, aspergillosis was the most common breakthrough infection.
Fiż- żewġ studji ta ’ profilassi, asperġillożi kienet l- aktar infezzjoni mifruxa komuni li kien hemm.
See Table 5 and 6 for results from both studies.
Ara Tabella 5 u 6 għar- riżultati miż- żewġ studji.
There were fewer breakthrough Aspergillus infections in patients receiving posaconazole prophylaxis when compared to control patients.
Kien hemm anqas infezzjonijiet mifruxa ta ’ Aspergillus f’ pazjenti li ngħataw profilassi b’ posaconazole meta mqabbla mal- pazjenti tal- kontroll.
Results from clinical studies in prophylaxis of Invasive Fungal Infections.
Kontroll ª
P-Value
Valur- P
Proportion (%) of patients with proven/ probable IFIs On-treatment periodb 1899d 316e
Proporzjon (%) ta ’ pazjenti b’ IFIs pruvati/ probabbli Perjodu fuq il- kurab d 1899 316e
0.0009 0.0038
0. 0009 0. 0038
Fixed-time periodc 1899d 316 d
Perijodu b’ ħin- fissc 1899d 316 d
0.0031 0.0740
0. 0031 0. 0740
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:
FLU/ ITZ (1899); FLU (316). b: f’ 1899 dan kien il- perijodu minn meta kienu randomized sa l- aħħar doża tal- prodott mediċinali li qed jiġi studjat u 7 ijiem aktar; f’ 316 kien il- perijodu mill- ewwel doża sa l- aħħar doża tal- prodott mediċinali li qed jiġi studjat u 7 ijiem aktar. c: f’ 1899 dan kien il- perijodu minn meta kienu randomized sa 100 jum wara li kienu randomized; f’ 316 dan kien il - perijodu mil- jum tal- linja bażi għal 111- il jum wara l- linja bażi. d:
All randomized e:
Kollha randomized e:
All treated
Kullha kkurati
Table 6.
12 Tabella 6.
Proportion (%) of patients with proven/ probable Aspergillosis On-treatment periodb 1899d 316e
Proporzjon (%) ta ’ pazjenti b’ Asperġillożi ppruvata/ probabbli Perijodu fuq il- kurab 1899d 316e
In Study 1899, a significant decrease in all cause mortality in favour of posaconazole was observed [POS 49/ 304 (16%) vs.
Fi studju 1899, deher tnaqqis sinifikanti fil- kawżi kollha ta ’ mwiet favur posaconazole [POS 49/ 304 (16%) vs.
FLU/ ITZ 67/ 298 (22%) p= 0.048].
FLU/ ITZ 67/ 298 (22%) p= 0. 048].
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).
Minn stimi Kaplan- Meier, il- probabilità ta ’ sopravivenza sa ’ jum 100 wara li kienu randomized, kienet ogħla b’ mod sinifikanti għar- riċevituri ta ’ posaconazole; dan il- benefiċċju ta ’ sopravivenza intwera meta l- analiżi qieset il- kawżi kollha ta ’ mwiet (P= 0. 0354) kif ukoll imwiet relatati ma ’ IFI’ s (P= 0. 0209).
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).
Fi studju 316, il- mortalità globali kienet simili (POS, 25%; FLU, 28%); iżda l- proporzjon ta ’ mwiet relatati ma ’ IFI kienet aktar baxxa b’ mod sinifikanti fil- grupp ta ’ POS (4/ 301) meta mqabbla mal - grupp ta ’ FLU (12/ 299; P= 0. 0413).
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.
L- użu f’ pazjenti pedjatriċi Sittax il- pazjent f’ etajiet ta ’ bejn 8- 17- il sena kienu kkurati b’ 800 mg/ jum fi studju dwar infezzjonijiet invażivi tal- fungu.
Based on the available data in 16 of these paediatric patients, the safety profile appears to be similar to patients ≥ 18 years of age.
Ibbażat mit- tgħarif li nkiseb minn dawn is- 16- il pazjent, il- profil ta ’ sigurtà jidher li huwa simili għal dak f’ pazjenti li għandhom ≥18- il sena.
Additionally, twelve patients 13-17 years of age received 600 mg/ day for prophylaxis of invasive fungal infections (Studies 316 and 1899).
Minbarra hekk, tnax- il pazjent ta ’ etajiet bejn 13- 17- il sena rċevew 600 mg/ jum għal profilassi ta ’ infezjonijiet invażivi tal- fungu (Studji 316 u 1899).
The safety profile in these patients < 18 years of age appears similar to the safety profile observed in adults.
Il- profil ta ’ sigurtà f’ dawn il- pazjenti < 18- il sena jidher li huwa simili għal profil ta ’ sigurtà li jidher fl- adulti.
Based on pharmacokinetic data in 10 of these paediatric patients, the pharmacokinetic profile appears to be similar to patients ≥ 18 years of age.
Minn tagħrif farmakokinetiku miksub minn 10 minn dawn il- pazjenti pedjatriċi, il- profil farmakokinetiku jidher simili għal dak f’ pazjenti ≥ 18- il sena.
Safety and efficacy in paediatric patients below the age of 18 years have not been established.
Is- sigurtà u l- effikaċja f’ pazjenti pedjatriċi taħt it- 18- il sena ma ġewx stabbiliti.
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.
Evalwazzjoni ta ’ l- elettrokardjogramma Ħafna ECG’ s imqabbla bil- ħin li nġabru fuq perijodu ta ’ 12- il siegħa inkisbu qabel u wara li ngħata posaconazole (400 mg darbtejn kuljum ma ’ ikel b’ ħafna xaħam) minn 173 irġiel u nisa b’ saħħithom ta ’ etajiet bejn 18 u 85 sena.
No clinically relevant changes in the mean QTc (Fridericia) interval from baseline were observed.
Ma dehrux bidliet ta ’ rilevanza klinika fil- medja ta ’ l- interval tal- QTc (Fridericia) mil- linja bażi.
Absorption Posaconazole is absorbed with a median tmax of 3 hours (fed patients).
Assorbiment Posaconazole jiġi assorbit b’ medjan ta ’ tmax ta ’ 3 sigħat (pazjenti li kielu).
The pharmacokinetics of posaconazole are linear following single and multiple dose administration of up to 800 mg when taken with a high fat meal.
Il- farmakokinetiċi ta ’ posaconazole isegwu linja dritta wara li jingħataw doża waħda jew ħafna dożi li jilħqu 800 mg li jittieħdu ma ’ ikla b’ ħafna xaħam.
No further increases in exposure were observed when doses above 800 mg daily were administered to patients and healthy volunteers.
Ma dehrux aktar żiediet fl- esponiment meta dożi ’ l fuq minn 800 mg ingħataw kuljum lill- pazjenti u lil voluntiera b’ saħħithom.
In the fasting state, AUC increased less than in proportion to dose above 200 mg.
Fl- istat sajjem, l- AUC żdiedet anqas milli fil- proporzjon mad- doża ’ l fuq minn 200 mg.
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.
13 tal- jum (800 mg) kienet maqsuma f’ 200 mg erba ’ darbiet kuljum imqabbel ma ’ 400 mg darbtejn kuljum, intwera li l- esponiment ta ’ posconazole żdied b’ 58% fuq 48 siegħa.
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.
L- effett ta ’ l- ikel fuq l- assorbiment orali f’ voluntiera b’ saħħithom L- AUC ta ’ posaconazole huwa madwar 2. 6- il darba akbar meta jingħata ma ’ ikla mingħajr xaħam jew suppliment nutrizzjonali (14- il gramma xaħam) u 4 darbiet akbar meta jingħata ma ’ ikla għolja fix - xaħam (~ 50 gramma xaħam) relattiv ma ’ l- istat sajjem.
Posaconazole should be administered with food or a nutritional supplement (see section 4.2).
Posaconazole għandu jingħata ma ’ l- ikel jew ma ’ suppliment nutrizzjonali (ara sezzjoni 4. 2).
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.
Distribuzzjoni Posaconazole jiġi assorbit bil- mod u jiġi eliminat bil- mod b’ volum ta ’ distribuzzjoni apparent kbir (1, 774 litru) u jintrabat ħafna mal- proteini (> 98%), l- aktar ma ’ l- albumina tas- serum.
Metabolism Posaconazole does not have any major circulating metabolites and its concentrations are unlikely to be altered by inhibitors of CYP450 enzymes.
Metaboliżmu Posaconazole m’ għandux metaboli ewlenin li jiċċurkulaw u l- konċentrazzjonijiet tiegħu mhux probabbli li jinbidlu b’ impedituri ta ’ enzimi CYP450.
Of the circulating metabolites, the majority are glucuronide conjugates of posaconazole with only minor amounts of oxidative (CYP450 mediated) metabolites observed.
Mill- metaboli li jkunu qed jiċċirkulaw, il - maġġoranza huma konjugati ta ’ glukuronajd ta ’ posaconazole u jidhru ammonti żgħar ta ’ metaboli ossidattivi (medjati b’ CYP450).
The excreted metabolites in urine and faeces account for approximately 17% of the administered radiolabelled dose.
Il- metaboli li jiġu eskretati fl- awrina u l- ippurgar jgħoddu għal madwar 17% tad- doża radjutikkettata li tingħata.
Excretion Posaconazole is slowly eliminated with a mean half-life (t½) of 35 hours (range 20 to 66 hours).
Eskrezzjoni Posaconazole jitneħħa bil- mod b’ medja ta ’ half- life (t1/ 2) ta ’ 35 siegħa (medda bejn 20 u 66 siegħa).
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).
Wara li jingħata 14C- posaconazole, ir- radjuattività inġabret fil- parti l- kbira mill- ippurgar (77% tad - doża radjutikkettata) bl- akbar komponent ikun il- mediċina oriġinali (66% tad- doża radjutikkettata).
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).
It - tneħħija mill- kliewi hija mezz ta ’ eliminazzjoni minuri, b’ 14% tad- doża radjutikkettata imneħħija mill- awrina (< 0. 2% tad- doża radjutikkettata tkun il- mediċina oriġinali).
Steady-state is attained following 7 to 10 days of multiple-dose administration.
L- istat fiss jinkiseb wara li jkunu ingħataw dożi multipli għal 7 sa 10 ijiem.
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).
Farmakokinetiċi f’ popolazzjonijiet speċjali Tfal (< 18- il sena) Wara li jingħataw 800 mg posaconazole kuljum bħala dożi maqsuma għall- kura ta ’ infezzjonijiet invażivi tal- fungu, il- medja tal- konċentrazzjonijiet fil- plażma minn 12- il pazjent ta ’ etajiet bejn 8 – 17- il sena (776 ng/ ml) kienu simili għall- konċentrazzjonijiet minn 194 pazjent ta ’ etajiet bejn 18 – 64- il sena (817 ng/ ml).
No pharmacokinetic data are available from paediatric patients less than 8 years of age.
Ma kienx hemm tagħrif farmakokinetiku għal pazjenti taħt it- 8 snin.
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).
Bl- istess mod, fi studji dwar profilassi, il- medja tal- konċentrazzjoni (Cav) ta ’ posaconazole fi stat fiss kien kumparabbli fost għaxar adolexxenti (13- 17- il sena) mas- Cav li nkiseb fl- adulti (≥ 18- il sena).
Gender The pharmacokinetics of posaconazole are comparable in men and women.
Sess Il- farmakokinetiċi ta ’ posaconazole fl- irġiel u n- nisa kienu kumparabbli.
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).
Anzjani (≥ 65 sena) Żieda fis- Cmax (26%) u l- AUC (29%) dehret f’ individwi anzjani (24 individwu ≥ 65 sena) relattiv ma ’ individwi aktar żgħar (24 individwu ta ’ bejn 18 – 45 sena).
However, in clinical efficacy trials, the safety profile of posaconazole between the young and elderly patients was similar.
Madankollu, fi provi dwar l- effikaċja klinika, il- profil ta ’ sigurtà ta ’ posaconazole bejn il- pazjenti żgħażagħ u dawk anzjani kien simili.
Race There was a slight decrease (16%) in the AUC and Cmax of posaconazole in Black subjects relative to Caucasian subjects.
Razza Kien hemm tnaqqis żgħir (16%) fl- AUC u s- Cmax ta ’ posaconazole f’ individwi Suwed relattivi ma ’ individwi Kawkażi.
However, the safety profile of posaconazole between the Black and Caucasian subjects was similar.
Madankollu, il- profil ta ’ sigurtà ta ’ posaconazole bejn individwi Suwed u dawk Kawkażi kien simili.
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.
Insuffiċjenza renali Wara li tingħata doża waħda, ma kienx hemm effett minn insuffiċjenza renali ħafifa u moderata (n=18, Cl cr ≥ 20 ml/ min/ 1. 73 m2) fuq il- farmakokinetiċi ta ’ posaconazole, għalhekk m’ hemmx bżonn tibdil fid- doża.
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].
F’ individwi li jkollhom insuffiċjenza renali severa (n=6, Cl cr < 20 ml/ min/ 1. 73 m2), l - AUC ta ’ posaconazole varja ħafna [> 96% CV (koeffiċjenti tal- varjanza)] imqabbel mal- gruppi renali l- oħrajn [< 40% CV].
However, as posaconazole is not significantly renally eliminated, an effect of severe renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended.
14 sinifikanti, mhux mistenni li jkun hemm effett ta ’ insuffiċjenza renali severa fuq il- farmakokinetiċi ta ’ posaconazole u mhux rakkomandat li tinbidel id- doża.
Posaconazole is not removed by haemodialysis.
Posaconazole ma jitneħħiex bid- dijaliżi tad - demm.
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).
Insuffiċjenza epatika Fi studju b’ numru żgħir ta ’ pazjenti (n=12) li kellhom insuffiċjenza epatika, kien hemm żieda fl - esponiment assoċjat ma ’ titwil tal- half- life f’ pazjenti b’ insuffiċjenza epatika (26. 6, 35. 3, u 46. 1 siegħa għal gruppi ħafif, moderat u sever rispettivament imqabbel ma ’ 22. 1 siegħa f’ individwi b’ funzjoni epatika normali).
An approximately 2-fold increase in steady-state AUC is estimated in patients with severe hepatic impairment.
Żieda ta ’ madwar darbtejn fl- istat fiss ta ’ l- AUC hija stmata f’ pazjenti li jkollhom insuffiċjenza epatika severa.
Due to the limited pharmacokinetic data in patients with hepatic impairment, posaconazole should be used with caution in patients with severe hepatic impairment since the prolonged half-life that may occur will lead to increased exposure.
Minħabba t- tagħrif farmakokinetiku limitat li hemm f’ pazjenti b’ insuffiċjenza epatika, posaconazole għandu jintuża b’ attenzjoni f’ pazjenti b’ insuffiċjenza epatika severa peress li t- titwil tal - half- life li jista ’ jseħħ iwassal għal esponiment akbar.
As observed with other azole antifungal agents, effects related to inhibition of steroid hormone synthesis were seen in repeated-dose toxicity studies with posaconazole.
Kif deher b’ aġenti kontra l- fungu oħrajn, l- effetti relatati ma ’ l- impediment tas- sintesi ta ’ l- ormon sterojdali dehru fi studji dwar it- tossiċità b’ dożi ripetuti b’ posaconazole.
Adrenal suppressive effects were observed in toxicity studies in rats and dogs at exposures equal to or greater than those obtained at therapeutic doses in humans.
Effetti ta ’ soppressjoni ta ’ l - adreni dehru fi studji dwar it- tossiċita f’ firien u klieb b’ esponimenti daqs jew akbar minn dawk li jinkisbu b’ dożi terapewtiċi fil- bnedmin.
Neuronal phospholipidosis occurred in dogs dosed for ≥ 3 months at lower systemic exposures than those obtained at therapeutic doses in humans.
Fosfolipidożi newronali seħħet fi klieb li ngħataw dożi għal ≥ 3 xhur b’ esponimenti aktar baxxi minn dawk li jinkisbu b’ dożi terapewtiċi fil- bnedmin.
This finding was not seen in monkeys dosed for one year.
Din is- sejba ma dehrietx fix- xadini li ngħataw l- istess doża għal sena.
In twelve-month neurotoxicity studies in dogs and monkeys, no functional effects were observed on the central or peripheral nervous systems at systemic exposures greater than those achieved therapeutically.
Fi studji ta ’ tnax- il xahar ta ’ newrotossiċità fi klieb u xadini, ma kienx hemm effetti funzjonali fuq is- sistemi nervużi ċentrali jew periferali b’ esponimenti akbar minn dawk miksuba b’ mod terapewtiku.
Pulmonary phospholipidosis resulting in dilatation and obstruction of the alveoli was observed in the 2-year study in rats.
Fosfolipidożi pulmonari li tirriżulta f’ dilatazzjoni u ostruzzjoni ta ’ alvejoli dehret fl- istudju ta ’ sentejn fil- firien.
These findings are not necessarily indicative of a potential for functional changes in humans.
Dawn is- sejbiet mhux neċessarjament jindikaw li jista ’ jkun hemm xi tibdil funzjonali fil - bnedmin.
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.
Ma dehrux bidliet fl- elettrokardjogrammi, inklużi l- intervalli QT u QTc, fi studju farmakoloġiku dwar is- sigurtà b’ dożi ripetuti f’ xadini b’ esponimenti sistemiċi 4. 6- il darba ogħla mill- esponimenti li jinkisbu b’ dożi terapewtiċi fil- bnedmin.
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.
L- ekokardjografija ma wriet l- ebda indikazzjoni ta ’ dikumpens kardijaku fi studju farmakoloġiku dwar dożi ripetuti dwar is- sigurtà f’ firien b’ esponimenti sistemiċi 1. 4- il darba ogħla minn dawk li jinkisbu bit- terapija.
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.
Żiediet fil- pressjonijiet sistoliċi u arterjali (sa 29 mm- Hg) dehru f’ firien u xadini b’ esponimenti sistemiċi 1. 4- il darba u 4. 6- il darba ogħla rispettivament, minn dawk li jinkisbu b’ dożi terapewtiċi.
Reproduction, peri- and postnatal development studies were conducted in rats.
Studji ta ’ riproduzzjoni, u ta ’ zvilupp madwar u wara t- twelid saru f’ firien.
At exposures lower than those obtained at therapeutic doses in humans, posaconazole caused skeletal variations and malformations, dystocia, increased length of gestation, reduced mean litter size and postnatal viability.
B’ esponiment aktar baxxi minn dawk li jinkisbu b’ dożi terapewtiċi fil- bnedmin, posaconazole ikkawża bidliet skeletrali u malformazzjonijiet, distoċja, żmien ta ’ ġestazzjoni itwal, tnaqqis fil- medja tad- daqs tal- botom u tas - soppravivenza ta ’ wara t- twelid.
In rabbits, posaconazole was embryotoxic at exposures greater than those obtained at therapeutic doses.
Fil- fniek, posaconazole kien embrijutossiku f’ esponimenti akbar minn dawk miksuba b’ dożi terapewtiċi.
As observed with other azole antifungal agents, these effects on reproduction were considered to be due to a treatment-related effect on steroidogenesis.
Kif deher b’ agenti kontra l- fungu azole oħrajn, dawn l- effetti fuq ir- riproduzzjoni kienu meqjusa bħala effetti relatati mal- kura fuq il- ġenesi ta ’ l- isterojdi.
Posaconazole was not genotoxic in in vitro and in vivo studies.
Posaconazole ma kienx ġenotossiku fi studji in vitro u in vivo.
Carcinogenicity studies did not reveal special hazards for humans.
Studji dwar ir- riskju ta ’ kanċer ma indikawx xi perikli speċjali għall- bnedmin.
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
Polysorbate 80 Simeticone Sodium benzoate (E211) Sodium citrate dihydrate
6.2 Incompatibilities
15 Citric acid monohydrate Glycerol Xanthan gum Glucose likwidu Titanium dioxide (E171) Togħma artifiċjali ta ’ ċirasa li fiha benzyl alcohol u propylene glycol Ilma purifikat
After first opening the container:
Wara li l- kontenitur jinfetaħ l- ewwel darba:
4 weeks.
4 ġimgħat.
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:
105 ml ta ’ suspensjoni fi flixkun ta ’ 123 ml (ħġieġ kannella jagħti fl- oranġjo tat- tip IV) magħluq b’ ghatu tal- plastik reżistenti għat- tfal (polypropylene) u kuċċarina għal kejl (polystyrene) b’ 2 marki tal- kejl:
2.5 ml and 5 ml.
2. 5 ml u 5 ml.
15 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
25 October 2005
25 October 2005
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
17 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Schering-Plough S. A., 2, rue Louis Pasteur; 14200 Hérouville St Clair, France
Schering- Plough S. A., 2, rue Louis Pasteur; 14200 Hérouville St Clair, Franza
(See Annex I:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (ara Anness I:
BOTTLE (Outer Carton)
FLIXKUN (Kartuna ta ’ barra)
Noxafil 40 mg/ ml oral suspension posaconazole
Noxafil 40 mg/ ml suspensjoni orali posaconazole
Each ml of oral suspension contains 40 mg of posaconazole.
Kull ml tas- suspensjoni orali fiha 40 mg ta ’ posaconazole.
Contains also liquid glucose.
Fih ukoll glucose likwidu.
One bottle of 105 ml of oral suspension Measuring spoon
Flixkun ta ’ 105 ml ta ’ suspensjoni orali Magħrfa tal- kejl
Oral use Shake well before use.
Użu orali Ħawwad sew qabel l- użu.
EXP Any product remaining four weeks after opening the bottle should be discarded.
JIS Kull prodott li jibqa erba ’ ġimgħat wara li jinfetaħ il- flixkun għandu jintrema.
SP Europe Rue de Stalle, 73 B-1180 Bruxelles, Belgium
SP Europe Rue de Stalle, 73 B- 1180 Bruxelles, Il- Belġju
BOTTLE (Bottle label)
FLIXKUN (Tikketta tal- flixkun)
What Noxafil is and what it is used for 2.
X’ inhu Noxafil u għalxiex jintuża 2.
Before you take Noxafil 3.
Qabel ma tieħu Noxafil 3.
How to take Noxafil 4.
Kif għandek tieħu Noxafil 4.
How to store Noxafil 6.
Kif taħżen Noxafil 6.
WHAT NOXAFIL IS AND WHAT IT IS USED FOR
X’ INHU NOXAFIL U GĦALXIEX JINTUŻA
Noxafil belongs to a group of medicines called triazole antifungal agents.
Noxafil jgħamel parti minn grupp ta ’ mediċini li jissejjħu aġenti triazole kontra l- fungu.
These medicines are used to prevent and treat a wide variety of fungal infections.
Dawn il - mediċini jintużaw biex jiġu evitati u kkurati varjetà wiesa ’ ta ’ infezzjonijiet tal- fungu.
Noxafil works by killing or stopping the growth of some types of fungi that can cause infections in humans.
Noxafil jaħdem billi joqtol jew iwaqqaf it- tkabbir ta ’ ċerti tipi ta ’ fungu li jistgħu jikkawżaw infezzjonijiet fil- bnedmin.
Noxafil can be used to treat the following types of fungal infections in adults:
Noxafil jista ’ jintuża biex jikkura dawn it- tipi ta ’ infezzjonijiet tal- fungu fl- adulti:
- Infections caused by fungi of the Aspergillus family that have not improved during treatment
- Infezzjonijiet ikkawżati minn fungu tal- familja ta ’ l- Aspergillus li ma jkunux tjiebu meta jkunu
with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;
ġew ikkurati bil- mediċini kontra l- fungu amphotericin B jew itraconazole jew meta dawn il - mediċini kellhom jitwaqqfu;
- Infections caused by fungi of the Fusarium family that have not improved during treatment with
- Infezzjonijiet ikkawżati minn fungu tal- familja Fusarium li ma jkunux tjiebu meta jkunu ġew
amphotericin B or when amphotericin B has had to be stopped;
ikkurati b’ amphotericin B jew meta amphotericin B kellu jitwaqqaf;
- Infections caused by fungi that cause the conditions known as chromoblastomycosis and
- Infezzjonijiet ikkawżati minn fungu li jikkawża kondizzjonijiet imsejħin kromoblastomikożi u
mycetoma that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;
miċetoma li ma jkunux tjiebu meta jkunu ġew ikkurati b’ itraconazole jew meta itraconazole kellu jitwaqqaf;
- Infections due to fungi called Coccidioides that have not improved during treatment with one or
- Infezzjonijiet minħabba fungu imsejjaħ Coccidioides li ma jkunux tjiebu meta jkunu ġew ikkurati
more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped;
b’ wieħed jew aktar minn amphotericin B, itraconazole jew fluconazole jew meta dawn il- mediċini kellhom jitwaqqfu;
- Infections in the mouth or throat area (known as “ thrush”) caused by fungi called Candida,
- Infezzjonijiet tal- ħalq jew tad- dawra tal- grieżem (mgħarufin bħala “ traxx ”) ikkawżati minn fungu
which are initial infections.
imsejjaħ Candida, li huma nfezzjonijiet tal- bidu.
Noxafil can be used to prevent fungal infections in patients whose immune systems may be weakened due to other medicines or diseases.
Noxafil jista ’ jintuża biex jevita infezzjonijiet tal- fungu f’ pazjenti li jkollhom is- sistema immuni dgħajfa minħabba mediċini oħra jew mard.
BEFORE YOU TAKE NOXAFIL
QABEL MA TIEĦU NOXAFIL
Do not take Noxafil
Tieħux Noxafil
- If you are allergic (hypersensitive) to posaconazole or to any of the other ingredients of Noxafil.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal posaconazole jew sustanzi oħra ta ’
- If you are taking medicines that contain ergot alkaloids (used to treat migraines).
- jekk qed tieħu xi mediċini li fihom alkalojdi ergot (jintużaw għall- kura ta ’ migranji).
can increase the blood levels of these medicines, which can lead to severe reductions in blood flow to some parts of the body and damage tissues.
jista ’ jżid il- livelli fid- demm ta ’ dawn il- mediċini, li jista ’ jwassal għal tnaqqis sever fil- fluss ta ’ demm f’ xi partijiet tal- ġisem u jikkawża ħsara lit- tessuti.
- If you are taking any of the following medicines.
- Jekk qed tieħu xi wieħed minn dawn il- mediċini.
Posaconazole can increase the blood levels of
Posaconazole jista ’ jżid il- livelli fid- demm ta ’
these medicines, which can lead to very serious disturbances in heart rhythm:
dawn il- mediċini, li jista ’ jwassal għal disturbi serji ħafna fir- ritmu li bih tħabbat il- qalb:
26 • terfenadine (used to treat allergies) • astemizole (used to treat allergies) • cisapride (used to treat stomach problems) • pimozide (used to treat symptoms of Tourette's disorder) • halofantrine (used to treat malaria) • quinidine (used to treat abnormal heart rhythms).
26 • terfenadine (jintuża għall- kura ta ’ allerġiji) • astemizole (jintuża għall- kura ta ’ allerġiji) • cisapride (jintuża għall- kura ta ’ problemi fl- istonku) • pimozide (jintuża għall- kura ta ’ sintomi ta ’ disturbi ta ’ Tourette) • halofantrine (jintuża għall- kura ta ’ malarja) • quinidine (jintuża għall- kura ta ’ meta l- qalb tkun qed tħabbat b’ ritmu anormali).
- If you are taking simvastatin, lovastatin, atorvastatin and some similar medicines (called HMG-
- Jekk qed tieħu simvastatin, lovastatin, atorvastatin u xi mediċini simili (li jissejħu impedituri ta ’
CoA reductase inhibitors or statins) that are used to treat high cholesterol levels in the blood.
HMG- CoA reductase jew statini) li jintużaw għall- kura ta ’ livelli għoljin ta ’ kolesterol fid- demm.
Please see the section “ Taking other medicines ” for information on other medicines which may interact with Noxafil.
Jekk jogħġbok irreferi għas- sezzjoni “ Meta tieħu mediċini oħra ” għal tagħrif fuq mediċini oħra li jistgħu jinteraġixxu ma ’ Noxafil.
Take special care with Noxafil Ask your doctor or pharmacist for advice before taking any medicine.
Oqgħod attent ħafna b’ Noxafil Saqsi lit- tabib jew lill- ispiżjar tiegħek għal parir qabel ma tibda tieħu xi mediċina.
In addition to the medicines named above that must not be taken with posaconazole because of the risk of heart rhythm disturbances, there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with posaconazole.
Minbarra l- mediċini msemmija hawn fuq li m’ għandhomx jittieħdu ma ’ posaconazole minħabba r- riskju ta ’ disturbi fuq ir - ritmu li bih tħabbat il- qalb, hemm mediċini oħrajn li għandhom riskju ta ’ problemi fuq ir- ritmu li jistgħu ikunu akbar meta tieħodhom ma ’ posaconazole.
Please make sure you tell your doctor about all the medicines you are taking (prescribed or non prescribed).
Jekk jogħġbok aċċerta ruħek li tgħid lit- tabib tiegħek dwar il- mediċini kollha li qed tieħu (bir- riċetta jew mingħajr riċetta).
- If you have ever had an allergic reaction to other medicines of the azole or triazole family.
Dawn
These include ketoconazole, fluconazole, itraconazole and voriconazole.
jinkludu ketoconazole, fluconazole, itraconazole u voriconazole.
- If you have or have had liver problems.
- jekk għandek jew kellek problemi tal- fwied.
You may need special blood tests to be done while you
Jista ’ jkollok bżonn li jsirulek testijiet tad- demm
are taking Noxafil.
speċjali meta tkun qed tieħu Noxafil.
- If you have kidney problems and are taking medicines that affect the kidney.
- Jekk għandek problemi tal- kliewi u qed tieħu xi mediċini li jaffettwaw il- kilwa.
- If you develop severe diarrhoea or vomiting, as these conditions may limit the effectiveness of
- Jekk taqbdek dijarea jew tibda tirremetti, għax dawn il- kundizzjonijiet jillimitaw kemm ikun
Noxafil.
effettiv Noxafil.
- If you have ever been told that you have any of the following conditions:
- Jekk qatt xi darba qalulek li għandek xi wieħed minn dawn il- kundizzjonijiet:
An abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval A weakness of the heart muscle or heart failure A very slow heartbeat Any heart rhythm disturbance Any problem with amounts of potassium, magnesium or calcium in your blood.
• Traċċat tar- ritmu tal- qalb anormali (ECG) li jindika problema li tissajjaħ interval QTc imtawwal. • Indeboliment tal- muskolu tal- qalb jew insuffiċjenza tal- qalb • Qalb tħabbat bil- mod ħafna • Kwalunkwe disturb fir- ritmu tal- qalb • Kwalunkwe problema fl- ammonti ta ’ potassium, magnesium jew calcium fid- demm tiegħek.
Please note that Noxafil is only for use in adults (older than 18 years of age).
Jekk jogħġbok innota li Noxafil jintuża biss f’ adulti (akbar minn 18- il sena).
Please look at the list of medicines that must not be taken while you are taking Noxafil that is given above.
Jekk jogħġbok ara l- lista ta ’ mediċini li m’ għandhomx jittieħdu meta tkun qed tieħu Noxafil li tidher hawn fuq.
There are other medicines that can sometimes be given while you are taking Noxafil but special care may be needed.
Hemm mediċini oħrajn li jistgħu jingħataw jekk qed tieħu Noxafil iżda jista ’ jkun hemm bżonn ta ’ kawtela speċjali.
Certain medicines may increase (possibly increasing the risk of side effects) or decrease (possibly causing lack of effectiveness) the blood levels of posaconazole.
Ċerti mediċini jistgħu iżidu (possibilment iżidu r- riskju ta ’ effetti sekondarji) jew inaqsu (possibilment jikkawżaw tnaqqis fl- effettività) tal- livelli ta ’ posaconazole fid- demm.
Medicines that can decrease blood levels of posaconazole include: • Rifabutin and rifampicin (used to treat certain infections).
Mediċini li jistgħu jnaqqsu il- livelli ta ’ posaconazole fid- demm jinkludu: • Rifabutin u rifampicin (jintużaw għall- kura ta ’ ċerti infezzjonijiet).
If you are already being treated with rifabutin, your blood counts and some possible side effects to rifabutin will need to be monitored. • Some medicines used to treat or prevent fits, such as phenytoin, carbamazepine, phenobarbital, primidone. • Efavirenz, which is used to treat HIV infection. • Medicines used to decrease stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines that are called proton pump inhibitors.
Jekk qed tiġi kkurat b’ rifabutin, l- għadd tad- demm u xi effetti sekondarji ta ’ rifabutin jkollhom bżonn jiġu monitorati. • Xi mediċini li jintużaw biex jevitaw aċċessjonijiet, bħal phenytoin, carbamazepine, phenobarbital, primidone. • Efavirenz, li jintuża għall- kura ta ’ infezzjoni b’ HIV. • Mediċini li jintużaw biex inaqqsu l- aċidu fl- istonku bħal cimetidine u ranitidine jew omeprazole u mediċini simili li jissejħu impedituri tal- pompi tal- protoni.
27 Noxafil may increase (possibly increasing the risk of side effects) the blood levels of some other medicines.
27 Noxafil jista ’ jżid (possibilment jżid ir- riskju ta ’ effetti sekondarji) fil- livelli ta ’ mediċini oħrajn fid - demm.