FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic / Pharmacodynamic relationships:
Maltese: Relazzjonijiet Farmakokinetiċi / Farmakodinamiċi
English: Tacrolimus: Posaconazole increased Cmax and AUC of tacrolimus (0.05 mg/kg body weight single dose) by 121 % and 358 %, respectively.
Maltese: Posaconazole żied is-Cmax u l-AUC ta' tacrolimus (0.05 mg/kg piż tal-ġisem doża waħda) b'121% u 358%, rispettivament.
English: • An abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
Maltese: • Traċċat tar-ritmu tal-qalb anormali (ECG) li jindika problema li tissajjaħ interval QTc imtawwal.
English: Rifabutin: Posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Maltese: Posaconazole żied is-Cmax u l-AUC ta' rifabutin b'31 % u 72 %, rispettivament.
English: • pimozide (used to treat symptoms of Tourette's disorder)
Maltese: • pimozide (jintuża għall-kura ta' sintomi ta' disturbi ta' Tourette)
English: New diagnosis of acute myelogenous leukemia was the most common underlying condition (435/602, [72 %]).
Maltese: Lewkimja majeloġenuża li tkun għada kif ġiet dijanjostikata hija l-aktar kundizzjoni komuni (435/602, [72%]).
English: Proportion (%) of patients with proven/probable Aspergillosis On-treatment periodb d e
Maltese: Proporzjon (%) ta' pazjenti b'Asperġillożi ppruvata/probabbli Perijodu fuq il-kura b d
English: • Tacrolimus and sirolimus (used in transplant surgery)
Maltese: • Tacrolimus u sirolimus (jintużaw meta issir kirurġija ta' trapjant)
English: Fixed-time periodc d d
Maltese: Għid lit-tabib tiegħek:
English: A correlation between total medicinal product exposure divided by MIC (AUC/MIC) and clinical outcome was observed.
Maltese: Korrelazzjoni bejn l-esponiment totali tal-prodott mediċinali diviż bl-MIC (AUC/MIC) u r-riżultat kliniku kienet osservata.
English: 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).
Maltese: 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).
English: • halofantrine (used to treat malaria)
Maltese: • halofantrine (jintuża għall-kura ta' malarja)
English: This medicinal product contains approximately 1.75 g of glucose per 5 ml of suspension.
Maltese: Dan il-prodott mediċinali fih madwar 1.75 g ta' glucose għal kull 5 ml ta' sospensjoni.
English: Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for pglycoprotein (P-gp) efflux in vitro.
Maltese: Posaconazole jiġi metabolizzat permezz ta' glukoronidazzjoni UDP (enzimi ta' fażi 2) u huwa sottostrat għall-effluss ta' glikoproteina-p (P-gp) in vitro.
English: Name and address of the manufacturer responsible for batch release Schering-Plough S.A., 2, rue Louis Pasteur; 14200 Hérouville St Clair, France
Maltese: Schering-Plough S.A., 2, rue Louis Pasteur; 14200
English: thrombocytopenia, leukopenia, anaemia, eosinophilia, lymphadenopathy haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Maltese: newtropenja tromboċitopenia, lewkopenja, anemija, eżinofilja, limfadenopatija sindrome ħemolitika uremika, purpura trombotika tromboċitopenika, panċitopenja, koagulopatija, emorraġġija
English: 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.
Maltese: 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.
English: Proportion (%) of patients with proven/probable IFIs On-treatment period b
Maltese: Proporzjon (%) ta' pazjenti b'IFIs pruvati/probabbli Perjodu fuq il-kurab
English: § See section 4.4.
Maltese: (ara sezzjoni 4.5).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 25 October 2005
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI 25 October 2005
English: • Vincristine, vinblastine and other vinca alkaloids (used to treat cancer)
Maltese: • Vincristine, vinblastine u alkalojdi vinka oħrajn (jintużaw għall-kura tal-kanċer)
English: 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.
Maltese: Ilmaġġoranza (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.
English: Posaconazole SP 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 SP m'għandux jingħata ma' prodotti mediċinali li huma sottostrati għal CYP3A4 u magħrufin li jtawlu l-intervall QTc (ara sezzjonijiet 4.3 u 4.5).
English: These include ketoconazole, fluconazole, itraconazole and voriconazole.
Maltese: Dawn jinkludu ketoconazole, fluconazole, itraconazole u voriconazole. - jekk għandek jew kellek problemi tal-fwied.
English: The active substance in Posaconazole SP oral suspension is posaconazole.
Maltese: Is-sustanza attiva fis-suspensjoni orali ta'Posaconazole SP hija posaconazole.
English: c: 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.
Maltese: 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.
English: Rifabutin (300 mg once a day) decreased the Cmax (maximum plasma concentration) and AUC (area under the plasma concentration time curve) of posaconazole to 57 % and 51 %, respectively.
Maltese: Rifabutin (300 mg darbtejn kuljum) inaqqas is-Cmax (l-ogħla konċentrazzjoni fil-plażma) u l-AUC (erja taħt il-kurva tal-konċentrazzjoni fil-plażma mal-ħin) ta' posaconzole għal 57 % u 51 % rispettivament.
English: Phenytoin (200 mg once a day) decreased the Cmax and AUC of posaconazole by 41 % and 50 %, respectively.
Maltese: Phenytoin (200 mg darba kuljum) jnaqqas is-Cmax u l-AUC ta' posaconazole b'41 % u 50 % rispettivament.
English: 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].
Maltese: F'individwi li jkollhom insuffiċjenza renali severa (n=6, Cl cr < 20 ml/min/1.73 m2), lAUC ta' posaconazole varja ħafna [> 96 % CV (koeffiċjenti tal-varjanza)] imqabbel mal-gruppi renali l-oħrajn [< 40 % CV].
English: • Midazolam, triazolam, alprazolam and some similar medicines called benzodiazepines (used as sedatives or muscle relaxants)
Maltese: • Midazolam, triazolam, alprazolam u mediċini simili li jissejħu benżodijażepini (jintużaw bħala sedattivi jew rilassanti tal-muskoli)
English: 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).
Maltese: 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).
English: Prophylaxis of Invasive Fungal Infections
Maltese: Profilassi ta' Infezzjonijiet Invażivi tal- Fungu
English: Electrocardiogram evaluation
Maltese: Evalwazzjoni ta' l-elettrokardjogramma
English: Clinical success rates in Oropharyngeal Candidiasis Endpoint
Maltese: Rati ta' suċċess kliniku f'Kandidijażi Orofarinġali Endpoint
English: • Ciclosporin (used in transplant surgery)
Maltese: • Ciclosporin (jintuża meta issir kirurġija ta' trapjant)
English: 200 mg (5 ml) three times a day.
Maltese: 200 mg (5 ml) tliet darbiet kuljum.
English: • Diltiazem, verapamil, nifedipine, nisoldipine and some of the other medicines called calcium channel blockers (used to treat high blood pressure)
Maltese: • Diltiazem, verapamil, nifedipine, nisoldipine u xi ftit mill-mediċini l-oħrajn li jissejħu imblukkaturi tal-kanali ta' calcium (jintużaw għal kura ta' pressjoni tad-demm għolja)
English: NAME OF THE MEDICINAL PRODUCT Posaconazole SP 40 mg/ml oral suspension
Maltese: TAL-PRODOTT MEDIĊINALI Posaconazole SP 40 mg/ml suspensjoni orali
English: Effects of other medicinal products on posaconazole:
Maltese: Effetti ta' prodotti mediċinali oħrajn fuq posaconazole:
English: B-1180 Bruxelles, Belgium
Maltese: B-1180 Bruxelles, Il-Belġju
English: Posaconazole SP 40 mg/ml oral suspension posaconazole
Maltese: Posaconazole SP 40 mg/ml suspensjoni orali posaconazole
English: Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini I-20090 Segrate (Milano) Tel: + 39-02 21018.1
Maltese: Via fratelli Cervi snc, Centro Direzionale Milano Due Palazzo Borromini
English: INFORMATION IN BRAILLE Posaconazole SP
Maltese: INFORMAZZJONI BIL-BRAILLE Posaconazole SP
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 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).
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: 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).
Maltese: Fi studju b'numru żgħir ta' pazjenti (n=12) li kellhom insuffiċjenza epatika, kien hemm żieda flesponiment 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).
English: 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.
Maltese: 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.
English: Posaconazole SP is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):
Maltese: Posaconazole SP jintuża għall-kura ta' infezzjonijiet tal-fungu f'adulti (ara sezzjoni 5.1):
English: Αγίου Δημητρίου 63
Maltese: Tqala u treddigħ
English: Hepatic toxicity: 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: Reazzjonijiet epatiċi (eż. żiediet ħfief għal moderati fl-ALT, AST, alkaline phosphatase, bilirubin totali u/jew epatite klinika) kienu rrappurtati waqt kura b'posaconazole.
English: 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).
Maltese: 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 817-il sena (776 ng/ml) kienu simili għall-konċentrazzjonijiet minn 194 pazjent ta' etajiet bejn 1864-il sena (817 ng/ml).
English: Additionally, twelve patients 13-17 years of age received 600 mg/day for prophylaxis of invasive fungal infections (Studies 316 and 1899).
Maltese: 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).
English: Midazolam and other benzodiazepines metabolised by CYP3A4: In a study in healthy volunteers posaconazole (200 mg once daily for 10 days) increased the exposure (AUC) of IV midazolam (0.05 mg/kg) by 83 %.
Maltese: Fi studju b'voluntiera b'saħħithom posaconazole (200 mg darba kuljum għal 10 ijiem) żied l-esponiment (AUC) ta' midazolam mogħti minn ġol-vina (0.05 mg/kg) bi 83 %.
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 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.
English: This leaflet was last approved on
Maltese: DATA TA' META ĠIET RIVEDUTA
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 exposures 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-esponimenti li jinkisbu b'dożi terapewtiċi fil-bnedmin.
English: A measuring spoon is provided with each bottle for measuring 2.5 and 5 ml doses of the oral suspension.
Maltese: Hemm ukoll kuċċarina għal kejl ma' kull flixkun biex tkejjel dożi ta' 2.5 u 5 ml ta'suspensjoni orali.
English: If you have ever had an allergic reaction to other medicines of the azole or triazole family.
Maltese: - Jekk qatt kellek reazzjoni allerġika għal mediċini oħrajn mill-familja azole jew triazole.
English: Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;
Maltese: Fusarjożi f'pazjenti b'mard li hu refrattarju għal amphotericin B jew f'pazjenti intolleranti għal amphotericin B;
English: Recommended dose according to indication
Maltese: Doża rakkomandata skond l-indikazzjoni
English: In Study 316, overall mortality was similar (POS, 25 %; FLU, 28 %); however, the proportion of IFIrelated deaths was significantly lower in the POS group (4/301) compared with the FLU group (12/299; P= 0.0413).
Maltese: FLU, 28 %); iżda l-proporzjon ta' mwiet relatati ma' IFI kienet aktar baxxa b'mod sinifikanti fil-grupp ta' POS (4/301) meta mqabbla malgrupp ta' FLU (12/299; P= 0.
English: Ul.
Maltese: A.
English: Marketing Authorisation Holder: SP Europe
Maltese: SP Europe
English: High blood levels of glucose
Maltese: Livelli għoljin ta' glucose
English: • Rifabutin (used to treat certain infections)
Maltese: • Rifabutin (jintuża għall-kura ta' ċerti infezzjonijiet)
English: • astemizole (used to treat allergies)
Maltese: • astemizole (jintuża għall-kura ta' allerġiji)
English: vomiting, nausea, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence pancreatitis gastrointestinal haemorrhage, ileus
Maltese: rimettar, tqallih, uġigħ addominali, dijarea, dispepsja, ħalq pankrejatite emorraġġija gastro-intestinali, iljus
English: HIV Protease Inhibitors: 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: LIST OF EXCIPIENTS Contains also liquid glucose.
Maltese: 3. LISTA TA' SUSTANZI MHUX ATTIVI Fih ukoll glucose likwidu.
English: In another study in healthy volunteers, repeat dose administration of oral posaconazole (200 mg twice daily for 7 days) increased the Cmax and AUC of IV midazolam (0.4 mg single dose) by an average of 1.3- and 4.6-fold (range 1.7 to 6.4-fold), respectively; Posaconazole 400 mg twice daily for 7 days increased the IV midazolam Cmax and AUC by 1.6 and 6.2-fold (range 1.6 to 7.6-fold), respectively.
Maltese: Fi studju ieħor b'voluntiera b'saħħithom, l-għotja ta' dożi ripetuti ta' posaconazole mill-ħalq (200 mg darbtejn kuljum għal 7 ijiem) żdied is-Cmax u l-AUC ta' midazolam mogħti minn ġol-vina (0.4 mg doża waħda) b'medja ta'1.3 u 4.6-il darba (medda 1.7 sa 6.4-il darba), rispettivament;
English: 105 ml of oral suspension in a 123 ml bottle (glass amber type IV) closed with a plastic child-resistant cap (polypropylene) and a measuring spoon (polystyrene) with 2 graduations: 2.5 ml and 5 ml.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 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 u 5 ml.
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-għotja flimkien ma' sustrati ta' CYP3A4 terfenadine, astemizole, cisapride, pimozide, halofantrine jew quinidine peress li dan jista' jwassal għal żieda tal-konċentrazzjonijiet fil-plażma ta' dawn ilprodotti mediċinali, li jwasslu sabiex il-QTc jitwal u jkun hemm każijiet rari ta' torsades de pointes (ara sezzjonijiet 4.4 u 4.5).
English: allergic reaction hypersensitivity reaction
Maltese: reazzjoni allerġika reazzjoni ta' sensittività eċċessiva
English: NAME OF THE MEDICINAL PRODUCT Posaconazole SP 40 mg/ml oral suspension posaconazole
Maltese: TAL-PRODOTT MEDIĊINALI Posaconazole SP 40 mg/ml suspensjoni orali posaconazole
English: • Efavirenz, which is used to treat HIV infection.
Maltese: • Efavirenz, li jintuża għall-kura ta' infezzjoni b'HIV.
English: In the small number of subjects studied who had hepatic impairment, there was an increase in exposure and half-life with a decrease in hepatic function (see sections 4.4 and 5.2).
Maltese: Fin-numru żgħir ta' pazjenti li kellhom indeboliment epatiku, kien hemm żieda fl-esponiment u l-half-life ma' tnaqqis fil-funzjoni epatika (ara sezzjonijiet 4.4 u 5.2).
English: Each millilitre of oral suspension contains 40 milligrams of posaconazole.
Maltese: Kull millilitru ta'suspensjoni orali fih 40 milligramma ta' posaconazole.
English: Oropharyngeal Candidiasis 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: Posaconazole SP is also indicated for prophylaxis of invasive fungal infections in the following patients:
Maltese: Posaconazole SP huwa indikat ukoll għal profilassi ta' infezzjonijiet tal-fungu invasiva fil-pazjenti li ġejjin:
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 ingħataw kif ġej: 100 mg darbtejn kuljum għal ġurnata 1 segwita b'100 mg darba kuljum għal 13-il gurnata).
English: HMG-CoA reductase inhibitors metabolised through CYP3A4 (e.g. simvastatin, lovastatin, and atorvastatin): Posaconazole may substantially increase plasma levels of HMG-CoA reductase inhibitors that are metabolised by CYP3A4.
Maltese: (eż. simvastatin, lovastatin u atorvastatin): Posaconazole jista' jżid b'mod sostanzjali l-livelli fil-plażma ta' impedituri ta' HMGCoA reductase li huma metabolizzati minn CYP3A4.
English: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;
Maltese: Asperġillożi invażiva f'pazjenti b'mard li hu refrattarju għal amphotericin B jew itraconazole jew f'pazjenti intolleranti għal dawn il-prodotti mediċinali;
English: No clinically relevant changes in the mean QTc (Fridericia) interval from baseline were observed.
Maltese: Ma dehrux bidliet ta' rilevanza klinika fil-medja ta' l-interval tal-QTc (Fridericia) mil-linja bażi.
English: Effects of posaconazole on other medicinal products:
Maltese: L-effetti ta' posaconazole fu prodotti mediċinali oħrajn:
English: Sirolimus: Repeat dose administration of oral posaconazole (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-għotja ta' dożi ripetuti ta' posaconazole mill-ħalq (400 mg darbtejn kuljum għal 16-il jum) żiedet is-Cmax u l-AUC ta'sirolimus (2 mg doża waħda) b'medja ta' 6.7-il darba u 8.9-il darba (medda 3.1 sa 17.5-il darba), rispettivament, f'voluntiera b'saħħithom.
English: Ergot alkaloids: Posaconazole may increase the plasma concentration of ergot alkaloids (ergotamine and dihydroergotamine), which may lead to ergotism.
Maltese: Posaconzole jista' jżid il-konċentrazzjoni fil-plażma ta' alkalojdi ergot (ergotamine u dihydroergotamine), li jista' jwassal għal ergotiżmu.
English: long QT syndrome§, electrocardiogram abnormal§, palpitations torsade de pointes, sudden death, ventricular tachycardia, cardio-respiratory arrest, cardiac failure, myocardial infarction
Maltese: sindrome ta' titwil tal-QT§, elettrokardjogramma anormali§, palpitazzjonijiet torsade de pointes, mewt f'daqqa, takikardija ventrikulari, arrest kardjo-respiratorju, insuffiċjenza kardijaka, infart majokardijaku
English: Vascular disorders Uncommon:
Maltese: Disturbi vaskulari Mhux komuni: Rari:
English: 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.
Maltese: 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.
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 essenzjali sekondarju kien l-inċidenza ta' IFI's li probabbli/ġew pruvati li seħħew waqt ilperijodu tal-kura (l-ewwel doża sa l-aħħar doża tal-prodott mediċinali li qed jiġi studjat+ 7 ijiem).
English: Chromoblastomycosis/Mycetoma: 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.
Maltese: Kromoblastomikożi/Miċetoma: 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.
English: Inflammation of the pancreas
Maltese: Infjammazzjoni tal-pankrejas