FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with neurotoxicity and other serious adverse reactions, including seizures, peripheral neuropathy, syndrome of inappropriate antidiuretic hormone secretion, and paralytic ileus.
Maltese: L-għoti fl-istess ħin ta' antifungali azole, inkluż posaconazole b'vincristine ġie assoċjat ma' newrotossiċità u reazzjonijiet avversi serji oħra, inkluż attakki ta' puplesija, newropatija periferali, sindrome ta' sekrezzjoni tal-ormon antidijuretika mhux xierqa, u ileus paralitiku.
English: This exposure was selected based on pharmacokinetic/pharmacodymanic considerations with posaconazole oral suspension.
Maltese: Dan l-esponiment kien magħżul abbażi ta' kunsiderazzjonijiet fuq farmakokinetiċi/farmakondinamiċi b'suspensjoni orali ta' posaconazole.
English: 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].
Maltese: Fi Studju 1899, kien osservat tnaqqis sinifikanti fil-mortalità mill-kawżi kollha favur posaconazole [POS 49/304 (16 %) vs.
English: Hydromorphone hydrochloride
Maltese: Vancomycin hydrochloride
English: * Based on adverse reactions observed with the oral suspension, gastro-resistant tablets, and concentrate for solution for infusion.
Maltese: * Abbażi tar-reazzjonijiet avversi osservati bis-suspensjoni orali, bil-pilloli gastroreżistenti u bil-konċentrat għal soluzzjoni għall-infużjoni.
English: H2 receptor antagonists and proton pump inhibitors No clinically relevant effects were observed when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Maltese: Ma kinux osservati effetti klinikament rilevanti meta l-pilloli ta' posaconazole ntużaw fl-istess ħin ma' antaċidi, antagonisti tar-riċetturi H2 u inibituri tal-pompa tal-proton.
English: • a “statin” such as simvastatin, atorvastatin or lovastatin used to treat high cholesterol.
Maltese: • “statin” bħal simvastatin, atorvastatin jew lovastatin li jintużaw għall-kura ta' livelli għoljin talkolesterol.
English: As HIV protease inhibitors are CYP3A4 substrates, it is expected that posaconazole will increase plasma levels of these antiretroviral agents.
Maltese: Peress li l-impedituri ta' HIV protease huma sottostrati ta' CYP3A4, huwa mistenni li posaconazole jżid il-livelli fil-plażma ta' dawn l-aġenti kontra r-retrovajrus.
English: Noxafil is also available as 100 mg gastro-resistant tablet and 300 mg concentrate for solution for infusion.
Maltese: Noxafil huwa disponibbli wkoll bħala 100 mg pilloli gastro-reżistenti u 300 mg ta' konċentrat għal soluzzjoni għall-infużjoni.
English: • Congenital or acquired QTc prolongation
Maltese: • Titwil konġenitali jew akkwiżit tal-QTc
English: Effects of posaconazole on other medicinal products Posaconazole is a potent inhibitor of CYP3A4.
Maltese: L-effetti ta' posaconazole fu prodotti mediċinali oħrajn Posaconzole huwa impeditur qawwi ta' CYP3A4.
English: Patients were treated with posaconazole or fluconazole oral suspension (both posaconazole and fluconazole were given as follows: 100 mg twice a day for 1 day followed by 100 mg once a day for 13 days).
Maltese: Il-pazjenti kienu kkurati b'suspensjoni orali ta' posaconazole jew fluconazole (kemm posaconazole kif ukoll fluconazole ngħataw kif ġej: 100 mg darbtejn kuljum għal ġurnata 1 segwita b'100 mg darba kuljum għal 13-il gurnata).
English: Posaconazole after administration of the tablets, is slowly eliminated with a mean half-life (t½) of 29 hours (range 26 to 31 hours) and a mean apparent clearance ranging from 7.5 to 11 L/hr.
Maltese: Wara l-għoti tal-pilloli, posaconazole jitneħħa bil-mod b'half-life (t½) medja ta' 29 siegħa (medda 26 sa 31 siegħa) u tneħħija apparenti medja li tvarja minn 7.5 sa 11 L/siegħa.
English: hepatic failure, hepatitis cholestatic, hepatosplenomegaly, liver tenderness, asterixis
Maltese: insuffiċjenza tal-fwied, epatite kolestatika, epatosplenomegalija, sensittività tal-fwied, asteriksis
English: Posaconazole is absorbed with a median tmax of 3 hours (fed patients).
Maltese: Posaconazole jiġi assorbit b'medjan ta' tmax ta' 3 sigħat (pazjenti li kielu).
English: • efavirenz and fosamprenavir used to treat HIV infection.
Maltese: • efavirenz u fosamprenavir li jintużaw għall-kura ta' infezzjoni tal-HIV.
English: Co-administration with ergot alkaloids (see section 4.5).
Maltese: L-għotja flimkien ma' ergot alkaloids (ara sezzjoni 4.5).
English: • nerve damage (neuropathy)
Maltese: • ħsara fin-nervituri (newropatija)
English: Based on pharmacokinetic data in 10 of these paediatric patients, the pharmacokinetic profile appears to be similar to patients ≥ 18 years of age.
Maltese: Minn tagħrif farmakokinetiku miksub minn 10 minn dawn il-pazjenti pedjatriċi, il-profil farmakokinetiku jidher simili għal dak f'pazjenti ≥ 18-il sena.
English: • Administer via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow intravenous infusion over approximately 90 minutes.
Maltese: • Agħti permezz ta' linja venuża ċentrali, inkluż kateter venuż ċentrali jew kateter ċentrali mdaħħal b'mod periferali (PICC) b'infużjoni bil-mod ġol-vina fuq perjodu ta' madwar 90 minuta.
English: Following a single dose administration of 300 mg posaconazole tablets after a high fat meal to healthy volunteers, the AUC0-72 hours and Cmax were higher compared to administration under fasted condition (51 % and 16 % for AUC0-72 hours and Cmax respectively).
Maltese: Wara l-għoti ta' doża waħda ta' 300 mg pilloli ta' posaconazole wara ikla b'kontenut għoli ta' xaħam lil voluntiera b'saħħithom, l-AUC0-72 hours u s-Cmax kienu ogħla meta mqabbla mal-għoti fl-istat ta' sawm (51% u 16 % għall-AUC0-72 hours u s-Cmax rispettivament).
English: Summary of posaconazole oral suspension studies
Maltese: Sommarju tal-istudji ta' posaconazole suspensjoni orali
English: Hepatic reactions (e.g. elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.
Maltese: Reazzjonijiet epatiċi (eż. żidiet fl-ALT, AST, alkaline phosphatase, bilirubin totali u/jew epatite klinika) kienu rrappurtati waqt kura b'posaconazole.
English: Each millilitre of oral suspension contains 40 milligrams of posaconazole.
Maltese: Kull millilitru ta' suspensjoni orali fih 40 milligramma ta' posaconazole.
English: The primary efficacy endpoint was the incidence of proven/probable IFIs at 16 weeks post-randomisation as determined by an independent, blinded external expert panel.
Maltese: Lendpoint primarju tal-effikaċja kienet l-inċidenza ta' IFIs ippruvati/probabbli 16-il ġimgħa wara lgħażla aleatorja kif determinati minn bord ta' esperti esterni indipendenti, blinded.
English: • patients having “high-dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).
Maltese: • pazjenti li jkunu għaddejjin minn “terapija immunosoppressiva ta' doża għolja” wara “trapjant ematopoetiku taċ-ċellula staminali” (HSCT).
English: electrolyte imbalance, anorexia, decreased appetite, hypokalaemia, hypomagnesaemia
Maltese: żbilanċ fl-elettroliti, anoressija, nuqqas ta' aptit, ipokalimja,
English: The most frequently reported adverse reaction (>25 %) with an onset during the posaconazole intravenous phase of dosing with 300 mg once daily was diarrhoea (32 %).
Maltese: Ir-reazzjoni avversa l-aktar frekwentement irrapportata (>25 %) li tibda matul il-fażi ta' għoti fil-vina ta' posaconazole ta' dożaġġ b'300 mg darba kuljum kienet id-dijarea (32 %).
English: Noxafil tablets are the preferred formulation to optimize plasma concentrations and generally provide higher plasma drug exposures than Noxafil oral suspension.
Maltese: Il-pilloli Noxafil huma l-formulazzjoni preferita sabiex jiġu ottimizzati lkonċentrazzjonijiet fil-plażma u ġeneralment jipprovdu esponiment ogħla tal-mediċina fil-plażma minn Noxafil suspensjoni orali.
English: Posaconazole was not genotoxic in in vitro and in vivo studies.
Maltese: Intwera li posaconazole huwa effettiv in vitro kontra l-mikro-organiżmi li ġejjin:
English: Posaconazole concentrate for solution for infusion safety In initial studies of healthy volunteers, administration of a single dose of posaconazole infused over 30 minutes via a peripheral venous catheter was associated with a 12 % incidence of infusion site reactions (4 % incidence of thrombophlebitis).
Maltese: Sigurtà tal-konċentrat għal soluzzjoni għall-infużjoni ta' posaconazole Fi studji inizjali fuq voluntiera b'saħħithom, l-għoti ta' doża unika ta' posaconazole li jingħata b'infużjoni għal perjodu ta' 30 minuta permezz ta' kateter venuż periferali kien assoċjat ma' inċidenza ta' 12% fir-reazzjonijiet tas-sit tal-infużjoni (4% inċidenza ta' tromboflebite).
English: Control Proportion (%) of patients with proven/probable Aspergillosis On-treatment period
Maltese: Kontrolla Proporzjon (%) ta' pazjenti b'Asperġillożi ppruvata/probabbli Perijodu fuq il-kurab
English: • Noxafil is for single use.
Maltese: • Noxafil huwa għal użu ta' darba.
English: No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at maximal plasma concentrations 8.5-fold greater than the concentrations obtained at therapeutic doses in humans.
Maltese: Ma dehrux effetti fuq l-elettrokardjogrammi, inklużi l-intervalli QT u QTc, fi studju dwar ta' sigurtà farmakoloġika b'dożi ripetuti fuq ix-xadini b'konċentrazzjonijiet massimi fil-plażma ta' 8.5 darbiet akbar mill-konċentrazzjonijiet miksuba b'dożi terapewtiċi fil-bnedmin.
English: Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following patients:
Maltese: Noxafil suspensjoni orali huwa indikat ukoll għal profilassi ta' infezzjonijiet tal-fungu invasiva filpazjenti li ġejjin:
English: Each gastro-resistant tablet contains 100 mg of posaconazole.
Maltese: Kull pillola gastro-reżistenti fiha 100 mg of posaconazole.
English: Loading dose of 200 mg (5 mL) once a day on the first day, then 100 mg (2.5 mL) once a day for 13 days.
Maltese: Doża ta' tagħbija ta' 200 mg (5 mL) darba kuljum fl-ewwel jum, imbagħad 100 mg (2.5 mL) darba kuljum għal 13-il ġurnata.
English: Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1
Maltese: Infezzjonijiet fungali invażivi refrattarji (IFI)/pazjenti b'IFI li ma jifilħux għat-terapija talewwel għażla
English: An increased effect on the QTc interval cannot be ruled out.
Maltese: Effett akbar fuq l-intervall QTc ma jistax jiġi eskluż.
English: ECOFF values do not equate to clinical breakpoints.
Maltese: Ilvaluri ECOFF ma jwasslux għal breakpoints kliniċi.
English: • Cardiomyopathy, especially in the presence of cardiac failure
Maltese: • Kardjomajopatija, l-aktar meta jkun hemm insuffiċjenza kardijaka
English: Prophylaxis in Neutropenia Study 1899
Maltese: Studju 1899
English: Eleven patients received a single dose of 200 mg posaconazole concentrate for solution for infusion, 21 patients received 200 mg daily dose for a median of 14 days, and 237 patients received 300 mg daily dose for a median of 9 days.
Maltese: Ħdax il-pazjent ingħataw doża unika ta' 200 mg konċentrat ta' posaconazole għal soluzzjoni għall-infużjoni, 21 pazjent irċevew doża ta' kuljum ta' 200 mg għal medja ta' 14-il jum, u 237 pazjent irċevew doża ta' kuljum ta' 300 mg għal medja ta' 9 ijiem.
English: • low levels of “neutrophils” a type of white blood cell (neutropenia) -this can make you more likely to get infections and be shown up in blood tests
Maltese: • livelli baxxi ta' “newtrofili” - tip ta' ċelloli bojod tad-demm (newtropenija) -dan jista' jagħmlek aktar probabbli li jaqbduk infezzjonijiet u jidhru fit-testijiet tad-demm
English: Pharmacokinetic modelling with an oral tablet formulation suggests that patients weighing greater than 120 kg may have lower posaconazole exposure.
Maltese: Immudellar farmakokinetiku b'formulazzjoni ta' pillola orali jissuġġerixxi li pazjenti li jiżnu aktar minn 120 kg jista' jkollhom esponiment aktar baxx għal posaconazole.
English: Both doses of posaconazole increased Cmax and AUC of oral midazolam (2 mg single oral dose) by 2.2 and 4.5-fold, respectively.
Maltese: Iżżewġ dożi ta' pozaconazole it-tnejn li huma żiedu s-Cmax u l-AUC ta' midazolam mill-ħalq (2 mg doża waħda mill-ħalq) b'2.2 u 4.5-il darba, rispettivament.
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir and ritonavir (300/100 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 1.5-fold and 2.5-fold (range 0.9 to 4.1-fold), respectively.
Maltese: Wara l-għoti fl-istess ħin tas-suspensjoni orali ta' posaconazole (400 mg darbtejn kuljum) ma' atazanavir u ritonavir (300/100 mg darba kuljum) għal 7 ijiem f'individwi b'saħħithom, is-Cmax u l-AUC ta' atazanavir żdiedu b'medja ta' 1.5 darbiet u 2.5 darbiet (medda 0.9 sa 4.1 darbiet), rispettivament.
English: Steady-state plasma concentrations are attained by Day 6 at the 300 mg dose (once daily after twice daily loading dose at Day 1).
Maltese: Ilkonċentrazzjonijiet fissi fil-plażma jinkisbu sa Jum 6 bid-doża ta' 300 mg (darba kuljum wara loading dose darbtejn kuljum f'Jum 1).
English: The most common adverse reaction (>1 %) leading to discontinuation of posaconazole concentrate for solution for infusion 300 mg once daily was AML (1 %).
Maltese: Ir-reazzjoni avversa l-aktar komuni (>1 %) li twassal għat-twaqqif tal-konċentrat ta' posaconazole għal soluzzjoni għall-infużjoni ta' 300 mg darba kuljum kienet AML (1 %).
English: Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz and cimetidine Posaconazole concentrations may be significantly lowered in combination; therefore, concomitant use with posaconazole should be avoided unless the benefit to the patient outweighs the risk (see section 4.5).
Maltese: Antibatteriċi ta' rifamycin (rifampicin, rifabutin), ċerti mediċini kontra l-aċċessjonijiet (phenytoin, carbamazepine, phenobarbital, primidone), efavirenz u cimetidine Il-konċentrazzjonijiet ta' posaconazole jistgħu jitbaxxew b'mod sinifikanti; għalhekk l-użu fl-istess ħin ma' posaconazole għandu jkun evitat sakemm il-benefiċċju għall-pazjent ma jegħlibx ir-riskju (ara sezzjoni 4.5).
English: Noxafil contains glucose
Maltese: Noxafil fih il-glucose
English: • rifabutin (used to treat certain infections)
Maltese: • rifabutin (jintuża għall-kura ta' ċerti infezzjonijiet)
English: Therefore, inhibitors (e.g. verapamil, ciclosporin, quinidine, clarithromycin, erythromycin, etc.) or inducers (e.g. rifampicin, rifabutin, certain anticonvulsants, etc.) of these clearance pathways may increase or decrease posaconazole plasma concentrations, respectively.
Maltese: Għalhekk, impedituri (eż. verapamil, ciclosporin, quinidine, clarithromycin, erythromycin, eċċ.) jew indutturi (eż. rifampicin, rifabutin, xi mediċini kontra l-aċċessjonijiet, eċċ.) ta' dawn il-mezzi ta' tneħħija jistgħu jżidu jew inaqqsu ilkonċentrazzjonijiet fil-plażma ta' posaconazole rispettivament.
English: 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.
Maltese: L-endpoint taleffikaċja 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.
English: renal tubular acidosis, interstitial nephritis
Maltese: aċidożi tat-tubi tal-kliewi, nefrite interstizjali
English: • large purple discolourations on the skin (thrombotic thrombocytopenic purpura)
Maltese: • tidnis vjola kbir fuq il-ġilda (purpura tromboċitopenika trombotika)
English: • pimozide (used to treat symptoms of Tourette's disorder)
Maltese: • pimozide (użat għall-kura tas-sintomi tal-marda ta' Tourette)
English: EU/1/05/320/002 24 tablets EU/1/05/320/003 96 tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/05/320/002 24 pillola
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 2.2-fold and 8.9-fold greater, respectively, than those achieved with the human therapeutic doses.
Maltese: Dehru żidiet fil-pressjonijiet tad-demm sistoliċi u arterjali (sa 29 mm-Hg) fil-firien u x-xadini b'esponimenti sistemiċi ta' 2.2 darbiet u 8.9 darbiet akbar, rispettivament, minn dawk miksuba bid-dożi terapewtiċi fil-bnedmin.
English: • heart rhythm problems
Maltese: • problemi fis-smigħ
English: Accidental overdose was noted in one patient who took posaconazole oral suspension 1,200 mg twice a day for 3 days.
Maltese: Doża eċċessiva bi żball kienet rappurtata f'pazjent wieħed li ħa posaconazole suspensjoni orali 1,200 mg darbtejn kuljum għal 3 ijiem.
English: Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (2.8 times the exposure achieved from a 300 mg intravenous dose in human) or female rats at a dose up to 45 mg/kg (3.4 times the exposure from a 300 mg intravenous dose in patients).
Maltese: Posaconazole ma kellux effett fuq il-fertilità ta' firien maskili b'dożi sa' 180 mg/kg (2.8 darbiet lesponiment milħuq minn doża ġol-vina ta' 300 mg fil-bnedmin) jew firien femminili b'doża sa 45 mg/kg (3.4-il darba l-esponiment minn doża ġol-vina ta' 300 mg fil-pazjenti).
English: Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (3.4 times the 300-mg tablet based on steady-state plasma concentrations in patients) or female rats at a dose up to 45 mg/kg (2.6 times the 300-mg tablet based on steady-state plasma concentrations in patients).
Maltese: Posaconazole ma kellux effett fuq il-fertilità tal-firien irġiel b'dożi sa 180 mg/kg (3.4 darbiet il-pillola ta' 300 mg fuq il-bażi tal-konċentrazzjonijiet fissi fil-plażma fil-pazjenti) jew tal-firien nisa b'doża sa 45 mg/kg (2.6 darbiet il-pillola ta' 300 mg fuq il-bażi tal-konċentrazzjonijiet fissi fil-plażma filpazjenti).
English: 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 the human therapeutic doses.
Maltese: Żidiet 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 umani.
English: 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 concentrations obtained at therapeutic doses in humans.
Maltese: 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-konċentrazzjonijiet li jinkisbu b'dożi terapewtiċi fil-bnedmin.
English: Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Maltese: Noxafil suspensjoni orali jintuża għall-kura ta' infezzjonijiet tal-fungu f'adulti (ara sezzjoni 5.1): - Asperġillożi invażiva f'pazjenti b'mard li hu refrattarju għal amphotericin B jew itraconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali; - Fusarjożi f'pazjenti b'mard li hu refrattarju għal amphotericin B jew f'pazjenti intolleranti għal amphotericin B; - Kromoblastomikożi u miċetoma f'pazjenti b'mard li hu refrattarju għal itraconazole jew f'pazjenti intolleranti għal itraconazole;
English: • breast pain
Maltese: • imnieħer miżdud
English: hearing impairment
Maltese: Disturbi vaskulari
English: C-posaconazole as oral suspension, radioactivity was predominantly recovered in the faeces (77 % of the radiolabelled dose) with the major component being parent compound (66 % of the radiolabelled dose).
Maltese: Wara l-għoti ta' 14Cposaconazole, ir-radjuattività kienet irkuprata prinċipalment fl-ippurgar (77 % tad-doża radjutikkettata) bl-akbar komponent ikun il-kompost oriġinali (66 % tad-doża radjutikkettata).
English: • if you are taking: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin.
Maltese: • jekk qed tieħu: terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, kwalunkwe mediċina li fiha “alkalojdi ergot” bħal ergotamine jew dihydroergotamine, jew “statin” bħal simvastatin, atorvastatin jew lovastatin.
English: This serial pharmacokinetic analysis demonstrated that 94 % of the subjects treated with the 300 mg once daily dose attained steady state Cav between 500-2500 ng/mL [Cav was the average concentration of posaconazole at steady state, calculated as AUC/dosing interval (24 hours).].
Maltese: Inġabru kampjuni farmakokinetiċi serjali fl-Ewwel Jum u fi stat fiss fil-Jum 14 għall-individwi kollha tal-Koorti 1 u 2 u fil-Jum 10 għas-sottosett tal-individwi tal-Koorti 3. Din l-analiżi tal-farmakokinetika serjali turi li 94% tal-individwi kkurati bid-doża ta' 300 mg darba kuljum kisbu Cav fi stat fiss bejn 500-2500 ng/Ml. [CAV kien il-konċentrazzjoni medja ta' posaconazole fi stat stabbli, ikkalkolat bħala l-AUC/intervall f'dożaġġ (24 siegħa).].
English: Repeat dose administration of oral posaconazole oral suspension (400 mg twice daily for 16 days) increased the Cmax and AUC of sirolimus (2 mg single dose) an average of 6.7-fold and 8.9-fold (range 3.1 to 17.5-fold), respectively, in healthy subjects.
Maltese: L-għoti ta' dożi ripetuti ta' suspensjoni orali ta' posaconazole (400 mg darbtejn kuljum għal 16-il jum) żied is-Cmax u l-AUC ta' sirolimus (doża waħda ta' 2 mg) b'medja ta' 6.7 darbiet u 8.9 darbiet (medda 3.1 sa 17.5-il darba), rispettivament, f'individwi b'saħħithom.
English: Posaconazole plasma concentrations following administration of posaconazole concentrate for solution for infusion single dose increased in a greater than dose proportional manner over the range of 50-200 mg; by comparison, dose-dependent increases were observed over a range of 200-300 mg.
Maltese: Il-konċentrazzjonijiet ta' posaconazole fil-plażma wara l-għoti ta' doża waħda ta' konċentrat għal soluzzjoni għall-infużjoni ta' posaconazole żdiedu b'mod aktar minn dak proporzjonali fuq il-medda ta' 50-200 mg; b'paragun, kienu osservati żidiet dipendenti fuq id-doża fuq medda ta' 200-300 mg.
English: Following co-administration of posaconazole oral suspension (400 mg twice daily) with atazanavir (300 mg once daily) for 7 days in healthy subjects Cmax and AUC of atazanavir increased by an average of 2.6-fold and 3.7-fold (range 1.2 to 26-fold), respectively.
Maltese: posaconazole (400 mg darbtejn kuljum) ma' atazanavir (300 mg darba kuljum) għal 7 ijiem f'individwi b'saħħithom, is-Cmax u l-AUC ta' atazanavir żdiedu b'medja ta' 2.6 darbiet u 3.7 darbiet (medda 1.2 sa 26 darba), rispettivament.
English: 11 of 24 patients who had proven or probable fusariosis were successfully treated with posaconazole oral suspension 800 mg/day in divided doses for a median of 124 days and up to 212 days.
Maltese: 11 minn 24 pazjent li kellhom fusarjożi ppruvata jew probabbli ġew ikkurati b'suċċess bi 800 mg/jum tas-suspensjoni orali ta' posaconazole f'dożi maqsuma għal perjodu medjan ta' 124 jum u sa 212-il jum.
English: Pack size: 1 vial
Maltese: Grupp ta' kontroll estern