FrancophonIA/ELRC3.0 huggingface dataset:
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 (cannot be estimated from the available data).
Maltese: Fost is-sistema tal-klassifika tal-organi, l-effetti avversi huma mniżżla skont il-frekwenza permezz tal-kategoriji li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥ 1/10,000 sa <1/1,000); rari ħafna (<1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Noxafil gastro-resistant tablets are yellow-coated and capsule-shaped, debossed “100” on one side packaged in a blister in cartons of 24 (2x12) or 96 (8x12) tablets.
Maltese: Noxafil pilloli gastro-reżistenti huma miksijin bl-isfar u għandhom għamla ta' kapsula, għandhom imnaqqax fuqhom “100” fuq naħa waħda u huma ppakkjati f'folja f'pakketti ta' 24 (2x12) jew 96 (8x12) pillola.
English: Some azoles have been associated with prolongation of the QTc interval.
Maltese: Xi azoles kienu assoċjati ma' titwil tal-intervall QTc.
English: Co-administration with the HMG-CoA reductase inhibitors simvastatin, lovastatin and atorvastatin (see section 4.5).
Maltese: L-għotja flimkien ma' impedituri ta' HMG-CoA reductase simvastatin, lovastatin u atorvastatin (ara sezzjoni 4.5).
English: Each mL contains 18 mg of posaconazole.
Maltese: Kull mL fih 18 mg ta' posaconazale.
English: Amikacin sulfate Caspofungin
Maltese: Amikacin sulphate Caspofungin Ciprofloxacin
English: Thrombophlebitis was observed in clinical trials.
Maltese: Fil-provi kliniċi kienet osservata tromboflebite.
English: Lactated Ringer's solution 5 % dextrose with Lactated Ringer's solution 4.2 % sodium bicarbonate
Maltese: soluzzjoni ta' Lactated Ringer 5 % dextrose ma' soluzzjoni ta' Lactated Ringer
English: Efavirenz (400 mg once a day) decreased the Cmax and AUC of posaconazole by 45 % and 50 %, respectively.
Maltese: Efavirenz (400 mg darba kuljum) naqqas is-Cmax u l-AUC ta' posaconazole b'45 % u 50 %, rispettivament.
English: The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical trials.
Maltese: Is-sigurtà ta' posaconazole pillola ġiet ivvalutat fi 336 pazent u voluntiera b'saħħithom irreġistrati filprovi kliniċi.
English: Posaconazole exhibits dose proportional pharmacokinetics after single and multiple dosing in the therapeutic dose range (200-300 mg).
Maltese: Posaconazole juri farmakokinetika proporzjonali mad-doża wara li jingħataw doża waħda jew ħafna dożi fil-medda tad-dożi terapewiċi (200-300 mg).
English: Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomisation, 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 (IFIs) (Studies 316 and 1899) Two randomised, controlled prophylaxis studies were conducted among patients at high risk for developing invasive fungal infections.
Maltese: Profilassi ta' Infezzjonijiet Fungali Invażivi (IFIs) (Studji 316 u 1899) Saru żewġ studji aleatorji, ikkontrollati ta' profilassi fost pazjenti li kellhom riskju għoli li jiżviluppaw infezzjonijiet fungali invażivi.
English: In another study in healthy volunteers, repeat dose administration of posaconazole oral suspension (200 mg twice daily for 7 days) increased the Cmax and AUC of intravenous 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 oral suspension 400 mg twice daily for 7 days increased the intravenous 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-għoti ta' dożi ripetuti tas-suspensjoni orali ta' posaconazole (200 mg darbtejn kuljum għal 7 ijiem) żied is-Cmax u l-AUC ta' midazolam mogħti fil-vini (doża waħda ta' 0.4 mg) b'medja ta' 1.3 u 4.6 darbiet (medda 1.7 sa 6.4 darbiet), rispettivament; 400 mg darbtejn kuljum tas-suspensjoni orali ta' posaconazole għal 7 ijiem żiedu s-Cmax u l-AUC ta' midazolam mogħti fil-vini b'1.6 u 6.2 darbiet (medda 1.6 sa 7.6 darbiet), rispettivament.
English: • pimozide (used to treat symptoms of Tourette's and mental illness)
Maltese: • pimozide (użat għall-kura tas-sintomi ta' Tourette u mard mentali)
English: Excipients: Betadex Sulfobutyl Ether Sodium (SBECD), disodium edetate, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
Maltese: Betadex Sulfobutyl Ether Sodium (SBECD), disodium edetate, hydrochloric acid u sodium hydroxide (għall-aġġustament tal-pH), ilma għall-injezzjonijiet.
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: The other ingredients are: Betadex Sulfobutyl Ether Sodium (SBECD), disodium edetate, hydrochloric acid (concentrated), sodium hydroxide, water for injections.
Maltese: Betadex Sulfobutyl Ether Sodium (SBECD), disodium edetate, hydrochloric acid (konċentrat), sodium hydroxide, ilma għall-injezzjonijiet.
English: cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope
Maltese: inċident ċerebrovaskulari, enċefalopatija, newropatija periferali, sinkope
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: When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes (see section 4.8 and 6.6).
Maltese: Meta jingħata permezz ta' kateter venuż periferali, l-infużjoni għandha tingħata fuq perjodu ta' 30 minuta (ara sezzjoni 4.8 u 6.6).
English: • swelling of lymph glands (lymphadenopathy)
Maltese: • nefħa tal-glandoli limfatiċi (limfadenopatija)
English: Summary of posaconazole tablet bridging study
Maltese: Sommarju tal-bridging study dwar il-pillola ta' posaconazole
English: Additionally, twelve patients 13-17 years of age received posaconazole oral suspension 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 posaconazole suspensjoni orali 600 mg/jum għal profilassi ta' infezjonijiet invażivi tal-fungu (Studji 316 u 1899).
English: Multiple doses of posaconazole administered via a peripheral venous catheter were associated with thrombophlebitis (60 % incidence).
Maltese: Dożi multipli ta' posaconazole mogħtija permezz ta' kateter venuż periferali kienu assoċjati ma' tromboflebite (inċidenza ta' 60%).
English: One subject (<1 %) had a predicted Cav below 500 ng/mL and 19 % of the subjects had a predicted Cav above 2,500 ng/mL.
Maltese: Pazjent wieħed (<1 %) kellu Cav imbassra taħt 500 ng/mL u 19 % tal-pazjenti kellhom Cav imbassra 'l fuq minn 2,500 ng/mL.
English: Cenexi HSC, 2, rue Louis Pasteur; 14200 Hérouville St Clair, France
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Cenexi HSC, 2, rue Louis Pasteur; 14200
English: In a study (Study 03579) of 136 neutropenic paediatric patients 11 months - 17 years treated with posaconazole oral suspension at doses up to 18 mg/kg/day divided TID, approximately 50% met the pre-specified target (Day 7 Cav between 500 ng/mL-2,500 ng/mL) (see section 5.2).
Maltese: Fi studju (Studju 03579) ta' 136 pazjent newtropeniku pedjatriku ta' 11-il xahar - 17-il sena kkurati b'posaconazole suspensjoni orali f'dożi sa 18 mg/kg/ġurnata b'TID maqsuma, madwar 50% ssodisfaw il-mira speċifikata minn qabel (Ġurnata 7 Cav bejn 500 ng/mL-2,500 ng/mL) (ara sezzjoni 5.2).
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: A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomisation.
Maltese: Endpoint sekondarju importanti kienet l-inċidenza ta' IFIs ippruvati/probabbli 100 jum wara l-għażla aleatorja.
English: After a single oral dose of 400 mg posaconazole oral suspension to patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment (six per group), the mean AUC was 1.3 to 1.6-fold higher compared to that for matched control subjects with normal hepatic function.
Maltese: Wara doża orali waħda ta' 400 mg suspensjoni orali ta' posaconazole lil pazjenti b'indeboliment talfwied ħafif (Child-Pugh Klassi A), moderat (Child-Pugh Klassi B) jew sever (Child-Pugh Klassi C) (sitta għal kull grupp), l-AUC medja kienet 1.3 sa 1.6 darbiet ogħla meta mqabbla ma' dik għallindividwi ta' kontroll imqabbla b'funzjoni tal-fwied normali.
English: Following administration of 300 mg posaconazole concentrate for solution for infusion over 90 minutes, mean peak plasma concentration at the end of infusion was 3280 ng/mL (74 % CV).
Maltese: Wara l-għoti ta' 300 mg ta' konċentrat għal soluzzjoni għall-infużjoni ta' posaconazole fuq perjodu ta' 90 minuta, il-medja tal-ogħla konċentrazzjoni fil-plażma fi tmiem l-infużjoni kienet 3280 ng/mL (74 % CV).
English: §, electrocardiogram abnormal palpitations, bradycardia, supraventricular extrasystoles, tachycardia
Maltese: palpitazzjonijiet, bradikardija, sistoli supraventrikulari żejda,
English: Contains also liquid glucose.
Maltese: TA' EĊĊIPJENTI Fih ukoll glucose likwidu.
English: Rarely, more severe hepatic reactions with fatal outcomes have been reported.
Maltese: Rarament, kienu rrappurtati reazzjonijiet epatiċi aktar severi b'eżiti fatali.
English: The study treated 155 (65 %) subjects with AML or MDS, and 82 (35 %) subjects with HSCT, as the primary diseases at study entry.
Maltese: L-istudju kkura 155 155 (65 %) individwu b'AML jew MDS, u 82 (35 %) individwu b'HSCT, bħala l-mard primarju fillivell ta' dħul tal-istudju.
English: This medicinal product contains 462 mg (20 mmol) sodium per dose.
Maltese: Dan il-prodott mediċinali fih 462 mg (20 mmol) ta' sodium f'kull doża.
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' suspensjoni.
English: Noxafil contains approximately 1.75 g of glucose per 5 mL of suspension.
Maltese: Noxafil fih madwar 1.75 g ta' glucose għal kull 5 mL ta' suspensjoni.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletrici u tattessuti konnettivi
English: Cav = the average concentration when measured at steady state *20 patients received 200 mg once daily (Day 1 200 mg twice daily)
Maltese: Cav = il-konċentrazzjoni medja meta mkejla fl-istat fiss *20 pazjent irċevew 200 mg darba kuljum (Jum 1 200 mg darbtejn kuljum)
English: 200 mg (5 mL) four times a day.
Maltese: 200 mg (5 mL) erba' darbiet kuljum.
English: • Existing symptomatic arrhythmias
Maltese: • Preżenza ta' arritmiji sintomatiċi
English: Noxafil 300 mg sterile concentrate posaconazole
Maltese: U MNEJN GĦANDU JINGĦATA Noxafil 300 mg konċentrat sterili posaconazole
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 ijiem).
English: Betadex Sulfobutyl Ether Sodium (SBECD) Disodium edetate
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Betadex Sulfobutyl Ether Sodium (SBECD)
English: • Aseptically transfer 16.7 mL of posaconazole to an intravenous bag (or bottle) containing a compatible admixture diluent (see below for list of diluents) using the volume ranging from 150 mL to 283 mL depending on the final concentration to be achieved (not less than 1 mg/mL and not greater than 2 mg/mL).
Maltese: • Ittrasferixxi b'mod asettiku 16.7 mL ta' posaconazole f'borża (jew flixkun) għal għoti fil-vina li fiha taħlita ta' dilwent kompatibbli (ara hawn taħt għal lista ta' dilwenti) billi tuża l-volum li jvarja minn 150 mL sa 283 mL skont il-konċentrazzjoni finali li trid tinkiseb (mhux anqas minn 1 mg/mL u mhux akbar minn 2 mg/mL).
English: Recommended dose according to indication Indication
Maltese: Doża rakkomandata skont l-indikazzjoni
English: Two different dosing groups were evaluated in Cohorts 1 and 2: 200 mg twice daily on Day 1, followed by 200 mg once daily thereafter (Cohort 1) and 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter (Cohort 2).
Maltese: Ġew evalwati żewġ gruppi ta' dożaġġ differenti f'Koorti 1 u 2: 200 mg darbtejn kuljum flEwwel Jum, segwiti minn 200 mg darba kuljum minn hemm 'il quddiem (Koorti 1) u 300 mg darbtejn kuljum fl-Ewwel Jum, segwit minn 300 mg darba kuljum minn hemm 'il quddiem (Koorti 2).
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-substrati ta' CYP3A4 terfenadine, astemizole, cisapride, pimozide, halofantrine jew quinidine billi dan jista' jwassal għal żieda fil-konċentrazzjonijiet ta' dawn il-prodotti mediċinali fil-plażma, li twassal għal titwil tal-QTc u inċidenzi rari ta' torsades de pointes (ara sezzjonijiet 4.4 u 4.5).
English: Patients were enrolled in a non-comparative pharmacokinetic and safety trial of posaconazole concentrate for solution for infusion when given as antifungal prophylaxis (Study 5520).
Maltese: Il-pazjenti kienu rreġistrati fi prova klinika tal-farmakokinetika u s-sigurtà mhux komparattiva ta' posaconazole meta ngħata bħala profilassi antifungali (Studju 5520).
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02AC04.
Maltese: Antimikotiċi għall-użu sistemiku, derivattivi tat-triazole, Kodiċi ATC:
English: • have an abnormal heart rhythm tracing (ECG) that shows a problem called long QTc interval
Maltese: • għandek traċċat tar-ritmu tal-qalb abnormali (ECG) li juri problema msejħa intervall QTc twil
English: Caution is warranted on any sign or symptom of thromboembolic events (see sections 4.8 and 5.3).
Maltese: Hija meħtieġa kawtela f'każ ta' kwalunkwe sinjal jew sintomu ta' avvenimenti tromboemboliċi (ara sezzjonijiet 4.8 u 5.3).
English: Hydrochloric acid [for pH adjustment] Sodium hydroxide [for pH adjustment] Water for injections
Maltese: Hydrochloric acid [għall-aġġustament tal-pH] Sodium hydroxide [għall-aġġustament tal-pH]
English: Schering-Plough Labo N.V., Industriepark 30, Zone A, BE-2220 Heist-op-den-Berg, Belgium
Maltese: Hérouville St Clair, Franza Schering-Plough Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Il-Belġju Fuq il-fuljett ta' tagħrif tal-prodott mediċinali għandu jkun hemm l-isem u l-indirizz tal-manifattur responsabbli għall-ħruġ tal-lott konċernat.
English: EXPIRY DATE
Maltese: Profilassi fin
English: When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes to reduce the likelihood of infusion site reactions (see section 4.8).
Maltese: Meta tingħata permezz ta' kateter venuż periferali, l-infużjoni għandha tingħata fuq perjodu ta' madwar 30 minuta biex tnaqqas il-probabbiltà ta' reazzjonijiet fis-sit tal-infużjoni (ara sezzjoni 4.8).
English: Co-administration of posaconazole and ergot alkaloids is contraindicated (see section 4.3).
Maltese: L-użu fl-istess ħin ta' posaconazole u alkalojdi ergot huwa kontra-indikat (ara sezzjoni 4.3).
English: Vincristine toxicity
Maltese: Tossiċità b'Vincristine
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 %); 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: Noxafil 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: Noxafil 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: 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 leukaemia 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: 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 8 - 17il sena (776 ng/mL) kienu simili għall-konċentrazzjonijiet minn 194 pazjent ta' etajiet bejn 18 - 64il sena (817 ng/mL).
English: cough, epistaxis, hiccups, nasal congestion, pleuritic pain, tachypnoea pulmonary hypertension, interstitial pneumonia, pneumonitis
Maltese: sogħla, epistassi, sulluzzu, konġestjoni nażali, uġigħ plewritiku, takipnea ipertensjoni pulmonari, pulmonite fl-interstizzju, infezzjoni filpulmun
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 8.9-fold greater than the concentrations obtained at therapeutic doses in humans with 300 mg intravenous infusion administration.
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' 8.9 darbiet akbar mill-konċentrazzjonijiet miksuba b'dożi terapewtiċi fil-bnedmin b'għoti ta' infużjoni ġol-vina ta' 300 mg.
English: In patients with moderate or severe renal impairment (creatinine clearance <50 mL/min), accumulation of the intravenous vehicle, Betadex Sulfobutyl Ether Sodium (SBECD), is expected to occur.
Maltese: F'pazjenti b'indeboliment renali moderat jew sever (tneħħija ta' kreatinina <50 mL/min), huwa mistenni li jkun hemm akkumulazzjoni tal-mezz ta' trasport fil-vini, Betadex Sulfobutyl Ether Sodium (SBECD).
English: Dose adjustment of benzodiazepines metabolised by CYP3A4 should be considered (see section 4.5).
Maltese: Għandu jiġi kkunsidrat aġġustament fid-doża ta' benzodiazepines metabolizzati minn CYP3A4 (ara sezzjoni 4.5).
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: Reazzjonijiet epatiċi (eż. żidiet ħfief għal moderati fl-ALT, AST, alkaline phosphatase, bilirubin totali u/jew epatite klinika) kienu rrappurtati waqt kura b'posaconazole.
English: Chromoblastomycosis/Mycetoma, Coccidioidomycosis)
Maltese: Kromoblastomikożi/Miċetomja, Kokkojdomikożi)
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, ilmaġġoranza huma konjugati tal-glucuronide ta' posaconazole filwaqt li kienu osservati biss ammonti żgħar ta' metaboliti ossidattivi (medjati minn CYP450).
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 fuq l-effett tal-indeboliment epatiku (inkluża klassifika Child-Pugh C tal-marda kronika tal-fwied) fuq il-farmakokinetika ta' posaconazole turi żieda fl-esponiment tal-plażma meta mqabbla ma' individwi b'funzjoni epatika normali, iżda ma jindikawx li hemm bżonn tibdil tad-doża (ara sezzjonijiet 4.4 u 5.2).
English: • have heart rhythm disturbance
Maltese: Disturbi fis-sistema nervuża
English: abnormal dreams, confusional state, sleep disorder psychotic disorder, depression
Maltese: ħolm stramb, stat konfużjonali, disturb fl-irqad disturb psikotiku, depressjoni
English: Noxafil is also available as 40 mg/mL oral suspension and 300 mg concentrate for solution for infusion.
Maltese: Noxafil huwa disponibbli wkoll bħala 40 mg/mL suspensjoni orali u 300 mg ta' konċentrat għal soluzzjoni għall-infużjoni.
English: This belongs to a group of medicines called “antifungals”.
Maltese: Dan jappartjeni għal grupp ta' mediċini msejħa “antifungali”.
English: Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (1.7 times the 400-mg twice daily regimen based on steady-state plasma concentrations in healthy volunteers) or female rats at a dose up to 45 mg/kg (2.2 times the 400-mg twice daily regimen).
Maltese: Posaconazole ma kellux effett fuq il-fertilità ta' firien maskili b'dożi sa' 180 mg/kg (1.7-il darba talkors ta' 400 mg darbtejn kuljum ibbażat fuq il-konċentrazzjonijiet fil-plażma fi stat fiss f'voluntiera b'saħħithom) jew firien femminili b'doża sa 45 mg/kg (2.2-il darba tal-kors ta' 400 mgdarbtejn kuljum).
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: Posaconazole is slowly eliminated with a mean half-life (t½) of 35 hours (range 20 to 66 hours).
Maltese: Posaconazole jitneħħa bil-mod b'medja ta' half-life (t1/2) ta' 35 siegħa (medda bejn 20 u 66 siegħa).
English: rash, pruritis
Maltese: raxx, ħakk
English: After oral administration, posaconazole increased the Cmax and AUC of rifabutin by 31 % and 72 %, respectively.
Maltese: Wara l-għoti orali, posaconazole żied is-Cmax u l-AUC ta' rifabutin b'31 % u 72 %, rispettivament.
English: pCav: predicted Cav
Maltese: pCav: