FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Maltese: Studju 316 kien prova double-blind, aleatorja tas-suspensjoni orali ta' posaconazole (200 mg tliet darbiet kuljum) kontra l-kapsuli ta' fluconazole (400 mg darba kuljum) f'riċevituri ta' trapjant ta' ċelloli staminali ematopojetiċi alloġeniċi li kellhom mard tal-impjant kontra l-host (GVHD).
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona
Maltese: Laboratori Fundacio Dau C/ C, 12-14
English: Posaconazole Accord 100 mg gastro-resistant tablets posaconazole
Maltese: Posaconazole Accord 100 mg pilloli gastro-reżistenti posaconazole
English: Study 5615 was conducted in a similar patient population to that previously studied in the pivotal posaconazole oral suspension clinical program.
Maltese: L-Istudju 5615 twettaq f'popolazzjoni ta' pazjenti simili għal dik studjata qabel fil-programm kliniku pivitali dwar is- suspensjoni orali ta' posaconazole.
English: Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), and efavirenz
Maltese: Antibatteriċi ta' Rifamycin (rifampicin, rifabutin), ċerti mediċini kontra l-konvulżjonijiet (phenytoin,
English: Posaconazole oral suspension
Maltese: Suspensjoni orali ta' posaconazole
English: haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Maltese: limfadenopatija, infart fil-milsa sindromu ħemolitiku uremiku, purpura trombotika tromboċitopenika, panċitopenja, koagulopatija, emorraġġija
English: Posaconazole Accord must not be administered with medicinal products that are substrates for CYP3A4 and are known to prolong the QTc interval (see sections 4.3 and 4.5).
Maltese: Posaconazole Accord m'għandux jingħata ma' prodotti mediċinali li huma sottostrati għas-CYP3A4 u magħrufin li jtawlu l-intervall QTc (ara sezzjonijiet 4.3 u 4.5).
English: Efavirenz (400 mg once a day) decreased the Cmax and AUC of posaconazole by 45% and 50%, respectively.
Maltese: Efavirenz Efavirenz (400 mg darba kuljum) naqqas is-Cmax u l-AUC ta' posaconazole b'45% u 50%, rispettivament.
English: Yellow coated, capsule shaped tablet of approximate 17.5 mm length and 6.7 mm width, debossed with “100P” on one side and plain on the other side.
Maltese: Pillola gastro-reżistenti Pillola forma ta' kapsula, miksija bl-isfar, b'tul ta' madwar 17.5 mm u wisa' ta' 6.7 mm, imnaqqxa “100P” fuq naħa waħda u b'xejn fuq in-naħa l-oħra.
English: Proportion (%) of patients with proven/probable IFIs On-treatment periodb d
Maltese: Proporzjon (%) ta' pazjenti b'IFIs ippruvati/probabbli Perjodu fuq il-kurab
English: Posaconazole tablets are the preferred formulation to optimize plasma concentrations and generally provide higher plasma drug exposures than posaconazole oral suspension.
Maltese: Il-pilloli Posaconazole huma l-formulazzjoni preferita sabiex jiġu ottimizzati l konċentrazzjonijiet fil-plażma u ġeneralment jipprovdu esponiment ogħla tal-mediċina fil-plażma minn posaconazole suspensjoni orali.
English: - Candida albicans: S ≤0.06 mg/L, R >0.06 mg/L - Candida tropicalis: S ≤0.06 mg/L, R >0.06 mg/L - Candida parapsilosis: S ≤0.06 mg/L, R >0.06 mg/L
Maltese: S ≤0.06 mg/L, R >0.06 mg/L Candida parapsilosis:
English: Posaconazole Accord contains a medicine called posaconazole.
Maltese: Posaconazole Accord fih mediċina msejħa posaconazole.
English: 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).
Maltese: Huwa partikolarment importanti li wieħed jipprova jassigura li jinkisbu konċentrazzjonijiet massimi fil-plażma fil pazjenti infettati bl-Aspergillus (ara sezzjonijiet 4.2 u 5.2 dwar ir-reġimi ta' dożaġġ rakkomandati).
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 tal kolesterol.
English: cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope
Maltese: insomnija inċident ċerebrovaskulari, enċefalopatija, newropatija periferali, sinkope
English: The safety of posaconazole oral suspension has been assessed in > 2,400 patients and healthy volunteers enrolled in clinical trials and from post-marketing experience.
Maltese: Is-sigurtà tas-suspensjoni orali ta' posaconazole ġiet valutata f'> 2,400 pazjent u voluntiera b'saħħithom li kienu rreġistrati fi provi kliniċi u mill-esperjenza ta' wara t-tqegħid fis-suq.
English: 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).
Maltese: Wara l-għoti ta' 14C- posaconazole, ir radjuattività kienet irkuprata prinċipalment fl-ippurgar (77 % tad-doża radjutikkettata) bl-akbar komponent ikun il-kompost oriġinali (66 % tad-doża radjutikkettata).
English: thrombocytopenia, leukopenia, anaemia, eosinophilia, lymphadenopathy, splenic infarction
Maltese: newtropenja tromboċitopenia, lewkopenja, anemija, eżinofilja,
English: Co-administration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes (see sections 4.4 and 4.5).
Maltese: L-għoti fl-istess ħin mas-sottostrati ta' CYP3A4 terfenadine, astemizole, cisapride, pimozide, halofantrine jew quinidine billi dan jista' jwassal għal żieda fil-konċentrazzjonijiet fil-plażma ta' dawn il-prodotti mediċinali, li twassal għal titwil tal-QTc u inċidenzi rari ta' torsades de pointes (ara sezzjonijiet 4.4 u 4.5).
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: midazolam orali (doża orali waħda ta' 2 mg) bi 2.2 u 4.5 darbiet, 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 primarju taleffikaċja kienet l-inċidenza ta' IFIs ippruvati/probabbli kif determinati minn bord ta' esperti esterni indipendenti, blinded matul il-perjodu tal-kura.
English: The elimination half-life (t1/2) was prolonged from approximately 27 hours up to ~43 hours in respective groups.
Maltese: Ilhalf-life tal-eliminazzjoni (t1/2) kien imtawwal minn madwar 27 siegħa sa ~43 siegħa fil-grupp rispettivi.
English: Hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole.
Maltese: Kienu rrappurtati reazzjonijiet epatiċi (eż. żidiet ħfief sa moderati fl-ALT, AST, alkaline phosphatase, bilirubin totali u/jew epatite klinika) waqt il-kura b'posaconazole.
English: The addition of posaconazole to therapy with atazanavir or with atazanavir plus ritonavir was associated with increases in plasma bilirubin levels.
Maltese: Iż-żieda ta' posaconazole mat-terapija b'atazanavir jew b'atazanavir u ritonavir kienet assoċjata ma' żidiet fil-livelli ta' bilirubin fil plażma.
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: Most of the vinca alkaloids (e.g., vincristine and vinblastine) are substrates of CYP3A4.
Maltese: Alkalojdi vinka Ħafna mill-alkalojdi vinka (eż., vincristine u vinblastine) huma sottostrati ta' CYP3A4.
English: Cav quartile analyses of pivotal patient studies with posaconazole tablet and oral suspension Posaconazole tablet
Maltese: Tabella 3. Analiżi tal-quartile tas-Cav tal-istudji pivitali fuq pazjenti bil-pillola u s-suspensjoni orali ta' posaconazole
English: 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).
Maltese: FLU, 28%); madankollu, il-proporzjon ta' mwiet relatati ma' IFI kien konsiderevolment aktar baxx fil-grupp li ħa POS (4/301) meta mqabbel mal-grupp li ħa FLU (12/299; P= 0.
English: Terfenadine, astemizole, cisapride, pimozide, halofantrine and quinidine (CYP3A4 substrates) Co-administration of posaconazole and terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine is contraindicated.
Maltese: Terfenadine, astemizole, cisapride, pimozide, halofantrine u quinidine (sottostrati ta' CYP3A4)
English: P-Value
Maltese: Valur-P
English: Triplex (PVC/PE/PVdC) white opaque-aluminium blister or perforated unit dose blister in cartons of 24 or 96 tablets.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folja tal-aluminju opaka bajda triplex (PVC/PE/PVdC) jew folja ta' unità tad-doża mtaqqba f'pakketti ta' 24 jew 96 pillola.
English: Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with serious adverse reactions (see section 4.4).
Maltese: antifungali azole, inkluż posaconazole b'vincristine ġie assoċjat ma' reazzjonijiet avversi serji (ara sezzjoni 4.4).
English: Oral posaconazole suspension 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 noncomparative salvage therapy trial (Study 0041).
Maltese: 800 mg/jum tas-suspensjoni orali ta' posaconazole f'dożi maqsuma ġew evalwati għall-kura ta' asperġillożi invażiva f'pazjenti b'mard li kien refrattorju għal amphotericin B (inklużi formulazzjonijiet liposomali) jew itraconazole jew f'pazjenti li kienu intolleranti għal dawn il-prodotti mediċinali fi prova mhux komparattiva b'terapija ta' salvataġġ (Studju 0041).
English: Following single-dose administration of posaconazole oral suspension, 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.
Maltese: Wara l-għoti ta' doża waħda tas-suspensjoni orali ta' posaconazole, ma kien hemm l-ebda effett ta' indeboliment ħafif u moderat tal-kliewi (n=18, Cl cr ≥ 20 mL/min/1.73 m2) fuq il-farmakokinetika ta' posaconazole; għalhekk, m'hemmx bżonn ta' aġġustament fid-doża.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Accord
Maltese: KONDIZZJONIJIET U REKWIŻITI
English: The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical trials.
Maltese: Is-sigurtà tal-pillola ta' posaconazole ġiet valutata fi 336 pazjent u voluntiera b'saħħithom irreġistrati fi provi kliniċi.
English: Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole tablets when given as antifungal prophylaxis.
Maltese: Il-pazjenti kienu rreġistrati fi prova mhux komparattiva tal-farmakokinetika u s-sigurtà tal-pilloli ta' posaconazole meta mogħtija bħala profilassi antifungali.
English: diplopia, scotoma
Maltese: Kull doża tista'
English: What Posaconazole Accord looks like and contents of the pack Posaconazole Accord gastro-resistant tablets are yellow coated, capsule shaped tablet of approximate 17.5 mm length and 6.7 mm width, debossed with “100P” on one side and plain on the other side, packaged in a blister or in perforated unit dose blister in cartons of 24 or 96 tablets.
Maltese: Posaconazole Accord pilloli gastro-reżistenti huma miksijin bl-isfar u għandhom għamla ta' kapsula ta' tul ta' madwar 17. mm u wisa' ta' 6.7 mm, għandhom imnaqqax fuqhom “100P” fuq naħa waħda u b'xejn fuq in-naħa l-oħra, u huma ppakkjati f'folja jew f'folja ta' unità tad-doża mtaqqba f'pakketti ta' 24 jew 96 pillola.
English: 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.
Maltese: L- endpoint primarju tal-effikaċja kienet l-inċidenza ta' IFIs ippruvati/probabbli 16-il ġimgħa wara l- għażla aleatorja kif determinati minn bord ta' esperti esterni indipendenti, blinded.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: Posaconazole was not genotoxic in in vitro and in vivo studies.
Maltese: Posaconazole ma kellux effett tossiku fuq il-ġeni fi studji in vitro u in vivo.
English: 96 gastro-resistant tablets
Maltese: 24 pillola gastro-reżistenti 96 pillola gastro-reżistenti
English: NAME OF THE MEDICINAL PRODUCT Posaconazole Accord 100 mg gastro-resistant tablets
Maltese: Posaconazole Accord 100 mg pilloli gastro-reżistenti
English: Maximum duration of exposure to the tablet formulation was shorter than with the oral suspension.
Maltese: Id-durata massima tal-esponiment għall- formulazzjoni tal-pillola kienet iqsar minn dik bis-suspensjoni orali.
English: Limited data on the effect of hepatic impairment (including Child-Pugh C classification of chronic liver disease) on the pharmacokinetics of posaconazole demonstrate an increase in plasma exposure compared to subjects with normal hepatic function, but do not suggest that dose adjustment is necessary (see sections 4.4 and 5.2).
Maltese: Dejta limitata dwar l-effett ta' indeboliment tal-fwied (inkluża klassifikazzjoni Child-Pugh C ta' mard kroniku tal-fwied) fuq il-farmakokinetika ta' posaconazole turi żieda fl-esponiment tal-plażma meta mqabbla ma' individwi b'funzjoni tal-fwied normali, iżda ma tindikax li hemm bżonn aġġustament fid-doża (ara sezzjonijiet 4.4 u 5.2).
English: Other medicines and Posaconazole Accord
Maltese: Mediċini oħra u Posaconazole Accord
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: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad- Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The tablet formulation was investigated in AML and MDS patients and those after HSCT with or at risk for Graft versus Host Disease (GvHD) only.
Maltese: Il-formulazzjoni tal-pillola ġiet investigata f'pazjenti b'AML u MDS u dawk wara HSCT bi jew f'riskju ta' Mard tal-Impjant kontra l-Host (GvHD) biss.
English: Of the circulating metabolites, the majority are glucuronide conjugates of posaconazole with only minor amounts of oxidative (CYP450 mediated) metabolites observed.
Maltese: Mill-metaboliti li jiċċirkolaw, il- maġġoranza huma konjugati tal-glucuronide ta' posaconazole filwaqt li kienu osservati biss ammonti żgħar ta' metaboliti ossidattivi (medjati minn CYP450).
English: No clinically relevant changes in the mean QTc (Fridericia) interval from baseline were observed.
Maltese: Ma kinux osservati bidliet klinikament rilevanti fl-intervall QTc medju (Fridericia) mil-linja bażi.
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: As HIV protease inhibitors are CYP3A4 substrates, it is expected that posaconazole will increase plasma levels of these antiretroviral agents.
Maltese: Billi l-inibituri tal-protease tal-HIV huma sottostrati ta' CYP3A4, huwa mistenni li posaconazole jżid il-livelli ta' dawn is-sustanzi antiretrovirali fil-plażma.
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.1-fold greater than that achieved therapeutically.
Maltese: dikumpens tal-qalb fi studju ta' sigurtà farmakoloġika b'dożi ripetuti fil-firien b'esponiment sistemiku ta' 2.1
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: Wara l-għoti fl-istess ħin tas-suspensjoni orali ta' 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: 9 of 11 patients were successfully treated with posaconazole oral suspension 800 mg/day in divided doses for a median of 268 days and up to 377 days.
Maltese: 9 minn 11-il pazjent kienu kkurati b'suċċess bi 800 mg/jum tas-suspensjoni orali ta' posaconazole f'dożi maqsumin għal perjodu medjan ta' 268 jum u sa 377 jum.
English: Co-administration of posaconazole and ergot alkaloids is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess ħin ta' posaconazole u alkalojdi ergot huwa kontraindikat (ara sezzjoni 4.3).
English: Invasive aspergillosis
Maltese: Asperġillożi invażiva
English: Serial PK samples were collected on Day 1 and at steady-state on Day 8 for all Part 1 subjects and a subset of Part 2 subjects.
Maltese: Inġabru kampjuni farmakokinetiċi serjali f'Jum 1 u fl-istat fiss f'Jum 8 għall-pazjenti kollha ta' Parti 1 u subsett ta' pazjenti ta' Parti 2.
English: Combination with other antifungal agents
Maltese: Kombinazzjoni ma' sustanzi antifungali oħra
English: Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1st line therapy
Maltese: Infezzjonijiet fungali invażivi li jkunu refrattorji (IFI)/pazjenti b'IFI li jkunu intolleranti għat- terapija talewwel għażla
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 tassuspensjoni orali ta' posaconazole f'dożi maqsuma għal perjodu medjan ta' 124 jum u sa 212-il jum.
English: Pharmacokinetic modeling with an oral tablet formulation suggests that patients weighing greater than 120 kg may have lower posaconazole exposure.
Maltese: Immudellar farmakokinetiku bil-formulazzjoni tal-pillola orali jissuġġerixxi li pazjenti li jiżnu aktar minn 120 kg jista' jkollhom esponiment aktar baxx għal posaconazole.
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 fil- pazjenti).
English: Two different dosing groups were evaluated: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Part IA) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Part 1B and Part 2).
Maltese: IA) u 300 mg darbtejn kuljum f'Jum 1, segwiti bi 300 mg darba kuljum fil-jiem ta' wara (Parti 1B u Parti 2).
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: Antagonisti tar-riċetturi H2 u inibituri tal-pompa tal-proton Ma kinux osservati effetti klinikament rilevanti meta l-pilloli ta' posaconazole ntużaw fl-istess ħin ma' antaċidi,
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known.
Maltese: <1/100); rari (≥ 1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf.
English: 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).
Maltese: Endpoint sekondarju importanti kienet l-inċidenza ta' IFIs ippruvati/probabbli matul il-perjodu tal-kura (l-ewwel doża sal-aħħar doża tal-prodott mediċinali studjat + 7
English: Results from clinical studies in prophylaxis of Invasive Fungal Infections Study
Maltese: Riżultati mill-istudji kliniċi dwar il-profilassi ta' Infezzjonijiet Fungali Invażivi Studju
English: Summary of posaconazole tablet bridging study
Maltese: Esperjenza klinika Sommarju tal-bridging study dwar il-pillola ta' posaconazole
English: Repeat dose administration of 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: 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: Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: It-tagħrif attwalment disponibbli huwa deskritt f'sezzjonijiet 5.1 u 5.2, iżda ma tista' tingħata l-ebda rakkomandazzjoni dwar pożoloġija.
English: The critical ratio for subjects with Aspergillus infections was ~200.
Maltese: Il-proporzjon kritiku għall-pazjenti b'infezzjonijiet tal-Aspergillus kien ta' ~200.
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain
Maltese: Zona Franca, Barcelona, 08040, Spanja
English: The safety of posaconazole tablets has been assessed in 230 patients enrolled in the pivotal clinical study.
Maltese: Is-sigurtà tal-pilloli ta' posaconazole kienet valutata f'230 pazjent irreġistrati fl-istudju kliniku pivitali.
English: pancreatitis, abdominal distension, enteritis, epigastric discomfort, eructation, gastrooesophageal reflux disease, oedema mouth
Maltese: sogħla, epistassi, sulluzzu, konġestjoni nażali, uġigħ plewritiku, takipnea ipertensjoni pulmonari, pulmonite fl-interstizzju, infezzjoni filpulmun