FrancophonIA/ELRC3.0 huggingface dataset:
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: (ara sezzjoni 4.5).
English: Following administration of 800 mg per day of posaconazole oral suspension as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 817 years of age (776 ng/mL) were similar to concentrations from 194 patients 18 - 64 years of age
Maltese: Wara lgħoti ta' 800 mg kuljum tas-suspensjoni orali ta' posaconazole bħala doża maqsuma għall-kura ta' infezzjonijiet fungali invażivi, il-medja tal-konċentrazzjonijiet minimi fil-plażma minn 12-il pazjent b'etajiet minn 8 - 17-il sena (776 ng/mL) kienu simili għall-konċentrazzjonijiet minn 194 pazjent b'etajiet minn 18 - 64 sena (817 ng/mL).
English: There is no paediatric experience with posaconazole concentrate for solution for infusion (see sections 4.2 and 5.3).
Maltese: M'hemmx esperjenza pedjatrika bil-konċentrat għal soluzzjoni għall-infużjoni ta' posaconazole (ara sezzjonijiet 4.2 u 5.3).
English: Renal clearance is a minor elimination pathway, with 14 % of the radiolabelled dose excreted in urine (< 0.2 % of the radiolabelled dose is parent compound).
Maltese: Ittneħħija mill-kliewi hija mezz ta' eliminazzjoni minuri, b'14 % tad-doża radjutikkettata imneħħija mill-awrina (< 0.2 % tad-doża radjutikkettata tkun il-mediċina oriġinali).
English: Do not take Noxafil
Maltese: Tiħux Noxafil
English: Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with serious adverse reactions (see section 4.4).
Maltese: L-għoti flistess ħin ta' antifungali azole, inkluż posaconazole b'vincristine ġie assoċjat ma' reazzjonijiet avversi serji (ara sezzjoni 4.4).
English: Treatment of azole-susceptible Oropharyngeal Candidiasis (OPC) A randomised, evaluator-blind, controlled study was completed in HIV-infected patients with azolesusceptible oropharyngeal candidiasis (most patients studied had C. albicans isolated at baseline).
Maltese: Kura ta' Kandidijażi Orofarinġali suxxettibli għal azole (OPC) Studju randomised, blind għall-evalwatur, bil-kontroll kien mitmum f'pazjenti infettati b'HIV b'kandidijażi orofarinġali suxxettibli għal azole (f'ħafna mill-pazjenti studjati kienet iżolata C.
English: Reserve azole antifungals, including posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options (see section 4.5).
Maltese: Ħalli l-antifungali azole, inkluż posaconazole, għal pazjenti li jirċievu alkalojdi vinka, inkluż vincristine li m'għandhom l-ebda għażla ta' kura antifungali alternattiva (ara sezzjoni 4.5).
English: st line therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: If a central venous catheter is not available, a single infusion may be administered through a peripheral venous catheter.
Maltese: Jekk ma jkunx disponibbli kateter venuż, tista' tingħata infużjoni waħda permezz ta' kateter venuż periferali.
English: Similarly, administration of 400 mg posaconazole with esomeprazole (40 mg daily) decreased mean Cmax and AUC by 46 % and 32 %, respectively, compared to dosing with 400 mg posaconazole alone.
Maltese: Bl-istess mod, l-għotja ta' 400 mg posaconazole ma' esomeprazole (40 mg kuljum) naqset il-medja tas-Cmax u l-AUC b'46 % u 32 %
English: neutropenia
Maltese: ipomanjesimja
English: There was a slight decrease (16 %) in the AUC and Cmax of posaconazole oral suspension in Black subjects relative to Caucasian subjects.
Maltese: Kien hemm tnaqqis żgħir (16 %) fl-AUC u s-Cmax ta' posaconazole suspensjoni orali f'individwi Suwed relattivi ma' individwi Kawkażi.
English: Noxafil is used to prevent and treat many different fungal infections.
Maltese: Noxafil jintuża għall-prevenzjoni u l-kura ta' bosta infezzjonijiet fungali differenti.
English: Other medicines and Noxafil
Maltese: Mediċini oħra u Noxafil
English: • tacrolimus and sirolimus (used during or after transplant surgery)
Maltese: • tacrolimus u sirolimus (jintużaw meta issir kirurġija ta' trapjant jew wara)
English: Food The absorption of posaconazole is significantly increased by food (see sections 4.2 and 5.2).
Maltese: L-assorbiment ta' posaconazole jiżdied b'mod sinifikanti bl-ikel (ara sezzjonijiet 4.2 u 5.2).
English: In Table 3 a comparison is shown of exposure (Cav) after administration of posaconazole tablet and posaconazole oral suspension at therapeutic doses in patients depicted as quartile analysis.
Maltese: F'Tabella 3 jidher tqabbil tal-esponiment (Cav) wara l-għoti tal-pillola ta' posaconazole u ssuspensjoni orali ta' posaconazole b'dożi terapewtiċi fil-pazjenti deskritti bħala analiżi tal-quartile.
English: Based on average Cmin concentrations, a predicted average concentration (Cav) could be calculated for 186 subjects dosed with 300 mg. PK analysis in patients of Cav found that 81 % of the subjects treated with the 300 mg once daily dose attained steady state predicted Cav between 500-2,500 ng/mL.
Maltese: L-analiżi farmakokinetika f'pazjenti ta' Cav sabet li 81 % tal-pazjenti kkurati bid-doża ta' 300 mg darba kuljum kisbu Cav imbassra fl-istat fiss bejn 500-2,500 ng/mL.
English: Thromboembolic events have been identified as a potential risk for posaconazole intravenous concentrate for solution for infusion but were not observed in the clinical studies.
Maltese: Ġew identifikati avvenimenti tromboemboliċi bħala riskju potenzjali tal-konċentrat għal soluzzjoni għall-infużjoni ġol-vina ta' posaconazole iżda ma ġewx osservati fl-istudji kliniċi.
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.
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.
English: hepatocellular damage, hepatitis, jaundice, hepatomegaly, cholestasis, hepatic toxicity, hepatic function abnormal
Maltese: ħsara epatoċellulari, epatite, suffejra, epatomegalija, kolestażi, tossiċità epatika, funzjoni epatika mhux normali
English: 105 mL of oral suspension in a 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 orali fi flixkun (ħġieġ kannella jagħti fl-oranġjo tat-tip IV) magħluq b'għatu tal-plastik reżistenti għat-tfal (polypropylene) u kuċċarina għal kejl (polystyrene) b'2 marki tal-kejl: 2.5 mL u 5 mL.
English: Subjects who received 300 mg once daily achieved a mean Cav at steady state of 1500 ng/mL.
Maltese: L-individwi li rċevew 300 mg darba kuljum kisbu Cav medja fi stat stabbli ta' 1500 ng/mL.
English: These types of patients had been previously studied in a pivotal controlled trial of posaconazole oral suspension.
Maltese: Dawn it-tipi ta' pazjenti kienu studjati qabel fi prova pivotali kkontrollata bi plaċebo ta' posaconazole suspensjoni orali.
English: • patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS)
Maltese: • pazjenti li jkollhom sistema immunitarja dgħajfa minħabba kimoterapija għal “lewkimja majeloġenuża akuta” (AML) jew “sindromi “majelodisplastiċi” (MDS)
English: Morphine sulphate Norepinephrine bitartrate Potassium chloride Vancomycin hydrochloride
Maltese: Lorazepam Meropenem Micafungin Morphine sulphate
English: pyrexia (fever), asthenia, fatigue
Maltese: piressija (deni), astenja, għeja
English: Proportion (%) of patients with proven/probable IFIs
Maltese: Proporzjon (%) ta' pazjenti b'IFIs pruvati/probabbli Perjodu fuq il-kurab
English: Most of the cases of aspergillosis were considered to be refractory to prior therapy in both the posaconazole group (88 %) and in the external control group (79 %).
Maltese: Il-biċċa lkbira tal-każijiet ta' asperġillożi kienu meqjusa li huma refrattorji għat-terapija preċedenti kemm filgrupp li ħa posaconazole (88 %) kif ukoll fil-grupp ta' kontroll estern (79 %).
English: Clinical isolates with decreased susceptibility to posaconazole have been identified.
Maltese: Iżolati kliniċi li kienu anqas suxxettibli għal posaconazole kienu identifikati.
English: Oropharyngeal candidiasis
Maltese: Kandidijażi Orofarinġali
English: Repeat dose administration of fosamprenavir (700 mg twice daily x 10 days) decreased the Cmax and AUC of posaconazole oral suspension (200 mg once daily on the st day, 200 mg twice daily on the 2
Maltese: Għoti ta' dożi ripetuti ta' fosamprenavir (700 mg darbtejn kuljum x 10 ijiem) naqqas is-Cmax u l-AUC ta' posaconazole suspensjoni orali (200 mg darba kuljum fl-ewwel jum, 200 mg darbtejn kuljum fit-tieni jum, imbagħad 400 mg darbtejn kuljum x 8 ijiem) b'21 % u 23 %, rispettivament.
English: Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
Maltese: Loading dose ta' 300 mg (tliet pilloli ta' 100 mg) darbtejn filġurnata fl-ewwel jum, imbagħad 300 mg (tliet pilloli ta' 100 mg) darba kuljum fil-jiem ta' wara.
English: Each vial contains 300 mg of posaconazole.
Maltese: Kull kunjett fih 300 mg ta' posaconazole.
English: Effect of food on oral absorption in healthy volunteers The absorption of posaconazole was significantly increased when posaconazole 400 mg (once daily) was administered during and immediately after the consumption of a high fat meal (~ 50 grams fat) compared to administration before a meal, with Cmax and AUC increasing by approximately 330 % and 360 %, respectively.
Maltese: L-effett tal-ikel fuq l-assorbiment orali f'voluntiera b'saħħithom L-assorbiment ta' posaconazole żdied b'mod sinifikanti meta posaconazole 400 mg (darba kuljum) ingħata waqt u eżattament wara l-konsum ta' ikla b'kontenut għoli ta' xaħam (~ 50 gramma xaħam) meta mqabbla mal-għoti qabel ikla, b'Cmax u AUC jiżdiedu b'madwar 330 % u 360 %, rispettivament.
English: Hyperglycaemia, hypoglycaemia
Maltese: Ipergliċemija, ipogliċemija
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 2.2-fold greater than that achieved therapeutically.
Maltese: L-ekokardjografija ma żvelat l-ebda indikazzjoni ta' dikumpens tal-qalb fi studju ta' sigurtà farmakoloġika b'dożi ripetuti fil-firien b'esponiment sistemiku ta' 2.2 darbiet akbar minn dak miksub b'mod terapewtiku.
English: Similarly, in the prophylaxis studies, the mean steady-state posaconazole average concentration (Cav) was comparable among ten adolescents (13-17 years of age) to Cav achieved in adults (≥ 18 years of age).
Maltese: Bl-istess mod, fi studji dwar profilassi, il-medja tal-konċentrazzjoni (Cav) ta' posaconazole fi stat fiss kien kumparabbli fost għaxar adolexxenti (13-17-il sena) mas-Cav li nkiseb fl-adulti (≥ 18-il sena).
English: Peripheral infusion time longer than 30 minutes, leads to a higher incidence of infusion site reactions and thrombophlebitis.
Maltese: Ħin tal-infużjoni periferali itwal minn 30 minuta, iwassal għal inċidenza ogħla ta' reazzjonijiet fis-sit tal-infużjoni u tromboflebite.
English: The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose.
Maltese: Il-metaboli li jiġu eskretati fl-awrina u l-ippurgar jgħoddu għal madwar 17 % tad-doża radjutikkettata li tingħata.
English: Each ml of oral suspension contains 40 mg of posaconazole.
Maltese: Kull mL ta' suspensjoni orali fih 40 mg ta' posaconazole.
English: • infections caused by fungi of the Aspergillus family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped;
Maltese: • infezzjonijiet ikkawżati minn fungi tal-familja Aspergillus li ma jkunux tjiebu waqt kura bilmediċini antifungali amphotericin B jew itraconazole jew meta dawn il-mediċini kellhom jitwaqqfu;
English: Summary of posaconazole concentrate for solution for infusion bridging study Study 5520 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole concentrate for solution for infusion.
Maltese: Sommarju tal-bridging study tal-konċentrat għal soluzzjoni għall-infużjoni ta' posaconazole L-Istudju 5520 kien studju multiċentri mhux komparattiv li twettaq sabiex jiġu evalwati l-proprjetajiet farmakokinetiċi, is-sigurtà, u t-tollerabbiltàta' posaconazole konċentrat għal soluzzjoni għall-infużjoni.
English: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.
Maltese: - Pazjenti li jkunu qegħdin jirċievu kimoterapija ta' remissjoni-induzzjoni għal lewkimja majeloġenuża akuta (AML) jew għal sindromi majelodisplastiċi (MDS) li jkunu mistennija li jikkawżaw newtropenija fit-tul u li jkunu f'riskju għoli li jiżviluppaw infezzjonijiet fungali invażivi;
English: Prophylaxis in AML and HSCT Study 5615
Maltese: Studju 5615
English: An effect of renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended (see section 5.2).
Maltese: Mhux mistenni li jkun hemm effett minn indeboliment renali fuq il-farmakokinetiċi ta' posaconazole u mhux rakkomandat li tinbidel id-doża (ara sezzjoni 5.2).
English: acute renal failure, renal failure, blood creatinine increased
Maltese: insuffiċjenza renali akuta, insuffiċjenza renali, żieda filkreatinina fid-demm
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: L-ekokardjografija ma żvelat lebda indikazzjoni ta' dikumpens tal-qalb fi studju ta' sigurtà farmakoloġika b'dożi ripetuti fil-firien b'esponiment sistemiku ta' 2.1 darbiet akbar minn dak miksub b'mod terapewtiku.
English: breast pain
Maltese: Kollha kkurati
English: Frequent monitoring for adverse reactions and toxicity related to antiretroviral agents that are substrates of CYP3A4 is recommended during coadministration with posaconazole.
Maltese: Huwa rakkomandat monitoraġġ frekwenti għar-reazzjonijiet avversi u t-tossiċità relatati mas-sustanzi antiretrovirali li huma substrati ta' CYP3A4 meta dawn jingħataw fl-istess ħin ma' posaconazole.
English: Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy.
Maltese: Disturbi ta' elettroliti, l-aktar dawk li jinvolvu potassium, magnesium jew livelli ta' calcium, għandhom ikunu monitorati u rranġati kif meħtieġ qabel u waqt terapija b'posaconazole.
English: b: In 1899 this was the period from randomisation to last dose of study medicinal product plus 7 days; in 316 it was the period from first dose to last dose of study medicinal product plus 7 days.
Maltese: b: Fl-istudju 1899 dan kien il-perjodu mill-għażla aleatorja sal-aħħar doża tal-prodott mediċinali studjat u 7 ijiem aktar; fl istudju 316 dan kien il-perjodu mill-ewwel doża sal-aħħar doża tal-prodott mediċinali studjat u 7 ijiem aktar.
English: Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.
Maltese: OĦRA, JEKK MEĦTIEĠA Noxafil suspensjoni orali u pilloli MHUMIEX interkambjabbli.
English: Single use vial.
Maltese: Mhux applikabbli.
English: • blurred vision, sensitivity to light
Maltese: • vista mċajpra, sensittività għad-dawl
English: • Do not use this medicine after the expiry date which is stated on the blister after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta.
English: Calcium channel blockers metabolised through CYP3A4 (e.g. diltiazem, verapamil, nifedipine, nisoldipine)
Maltese: (eż. diltiazem, verapamil, nifedipine, nisoldipine)
English: oedema, pain, chills, malaise, chest discomfort, drug intolerance, feeling jittery, infusion site pain, infusion site phlebitis, infusion site thrombosis, mucosal inflammation
Maltese: edima, uġigħ, kesħa, telqa, skumdità fis-sider, intolleranza għall-mediċini, tħossok nervuż, uġigħ fis-sit tal-infużjoni, flebite fis-sit tal-infużjoni, trombożi fis-sit talinfużjoni,infjammazzjoni tal-mukuża
English: In addition, posaconazole oral suspension (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 8-10 hours during co-administration.
Maltese: Minbarra hekk, posaconazole suspensjoni orali (200 mg jew 400 mg) tawwal il-medja tal-half-life terminali ta' midazolam minn madwar 3-4 sigħat għal 8-10 sigħat meta ngħataw flimkien.
English: Rare: the following may affect up to 1 in 1,000 people
Maltese: Rari: dawn li ġejjin jistgħu jaffettwaw sa 1 minn kull 1,000 persuna
English: Posaconazole should be used with caution in patients with hepatic impairment due to limited clinical experience and the possibility that posaconazole plasma levels may be higher in these patients (see sections 4.2 and 5.2).
Maltese: Posaconazole għandu jintuża b'attenzjoni f'pazjenti b'indeboliment epatiku minħabba esperjenza klinika limitata u l-possibilità li l-livelli fil-plażma jkunu ogħla f'dawn il-pazjenti (ara sezzjonijiet 4.2 u 5.2).
English: • problems with co-ordination or balance
Maltese: • problemi bil-koordinazzjoni jew il-bilanċ
English: As observed with other azole antifungal agents, effects related to inhibition of steroid hormone synthesis were seen in repeated-dose toxicity studies with posaconazole.
Maltese: Kif deher b'aġenti kontra l-fungu oħrajn, l-effetti relatati mal-impediment tas-sintesi tal-ormon sterojdali dehru fi studji dwar it-tossiċità b'dożi ripetuti b'posaconazole.
English: liver function tests raised (ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, GGT increased)
Maltese: testijiet tal-funzjoni tal-fwied jiġu għoljin (żieda fl-ALT, żieda fl-AST, żieda fil-bilirubin, żieda fl-alkaline phosphatase, żieda fil-GGT)
English: Amikacin sulfate
Maltese: Ikkurati kollha
English: • cough, hiccups
Maltese: • sogħla, sulluzzu
English: Take 200 mg (one 5 mL spoonful) three times a day.
Maltese: 200 mg (5 mL) tliet darbiet kuljum.
English: Posaconazole therapy was given for a median duration of 28 days.
Maltese: It-terapija b'posaconazole ngħatat għal perjodu medjan ta' 28 ġurnata.
English: The AUC of posaconazole is: 4 times greater when administered with a highfat meal (~ 50 grams fat) and about 2.6 times greater when administered during a non-fat meal or nutritional supplement (14 grams fat) relative to the fasted state (see sections 4.2 and 4.5).
Maltese: L-AUC ta' posaconazole huwa: 4 darbiet ogħla meta jingħata ma' ikla b'kontenut għoli ta' xaħam (~ 50 gramma xaħam) u madwar 2.6 darbiet ogħla meta jingħata ma' ikla b'kontenut mhux għoli ta' xaħam jew b'suppliment nutrizzjonali (14- gramma xaħam) imqabbel mal-istat sajjem (ara sezzjoni 4.2 u 4.5).
English: H2 receptor antagonists and proton pump inhibitors Posaconazole plasma concentrations (Cmax and AUC) were reduced by 39 % when posaconazole was administered with cimetidine (400 mg twice a day) due to reduced absorption possibly secondary to a decrease in gastric acid production.
Maltese: Il-konċentrazzjonijiet fil-plażma ta' posaconazole (Cmax u AUC) kienu mnaqqsa b'39% meta posaconazole ingħata ma' cimetidine (400 mg darbtejn kuljum) minħabba tnaqqis fl-assorbiment li jista' jkun effett sekondarju għal tnaqqis tal-aċidu gastriku.
English: • medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir,
Maltese: • mediċini li jintużaw għall-kura ta' HIV li jissejħu impedituri protease (jinkludu lopinavir u atazanavir, li jingħataw ma' ritonavir)
English: The safety of posaconazole concentrate for solution for infusion has been assessed in 268 patients in clinical trials.
Maltese: Is-sigurtà ta' posaconazole konċentrat għal soluzzjoni għall-infużjoni ġiet ivvalutata f'268 pazjent fi provi kliniċi.
English: Unbound concentrations were not determined and it cannot be excluded that there is a larger increase in unbound posaconazole exposure than the observed 60 % increase in total AUC.
Maltese: Ma kinux stabbiliti konċentrazzjonijiet mhux marbuta u ma jistax jiġi eskluż li hemm żieda akbar fl-esponiment għal posaconazole mhux marbut miż-żieda ta' 60 % osservata fl-AUC totali.
English: Posaconazole does not have any major circulating metabolites and its concentrations are unlikely to be altered by inhibitors of CYP450 enzymes.
Maltese: Posaconazole m'għandux metaboli ewlenin li jiċċurkulaw u l-konċentrazzjonijiet tiegħu mhux probabbli li jinbidlu b'impedituri ta' enzimi CYP450.
English: • infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped;
Maltese: • infezzjonijiet ikkawżati minn fungi tal-familja Fusarium li ma jkunux tjiebu waqt kura b'amphotericin B jew meta amphotericin B kellu jitwaqqaf;
English: Echocardiography revealed no indication of cardiac decompensation in a repeat dose safety pharmacology study in rats at a systemic exposure 1.4-fold greater than that achieved therapeutically.
Maltese: L-ekokardjografija ma wriet l-ebda indikazzjoni ta' dikumpens kardijaku fi studju farmakoloġiku dwar dożi ripetuti dwar is-sigurtà f'firien b'esponimenti sistemiċi 1.4-il darba ogħla minn dawk li jinkisbu bit-terapija.
English: Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group Posaconazole oral suspension
Maltese: Tabella 3. Effikaċja globali tas-suspensjoni orali ta' posaconazole fi tmiem il-kura għall-asperġillożi invażiva meta mqabbla ma' grupp ta' kontroll estern
English: In addition, posaconazole oral suspension (200 mg or 400 mg) prolonged the mean terminal half-life of midazolam from approximately 3-4 hours to 810 hours during co-administration.
Maltese: Minbarra hekk, posaconazole suspensjoni orali (200 mg jew 400 mg) tawwal il-medja tal-half-life terminali ta' midazolam minn madwar 3-4 sigħat għal 810 sigħat meta ngħataw flimkien.
English: • Glipizide or other “sulfonylureas” (used to treat high blood sugar).
Maltese: • Glipizide jew “sulfonylureas” oħrajn (jintużaw għall-kura ta' zokkor għoli fid-demm).
English: HMG-CoA reductase inhibitors metabolised through CYP3A4 (e.g. simvastatin, lovastatin, and atorvastatin)
Maltese: Impedituri ta' HMG-CoA reductase metabolizzati permezz ta' CYP3A4
English: Noxafil should be administered 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: Noxafil għandu jintgħata f'linja venuża ċentrali, inkluż kateter venuż ċentrali jew kateter ċentrali mdaħħal b'mod periferali (PICC) permezz ta' infużjoni bil-mod ġol-vina fuq perjodu ta' madwar 90 minuta.
English: The most frequently reported serious related adverse reactions included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.
Maltese: L-aktar reazzjonijiet avversi li kienu rrappurtati ta' spiss kienu jinkludu dardir, remettar, dijarea, deni u żieda fil-bilirubin.
English: • mucosal inflammation
Maltese: Disturbi gastro-intestinali
English: • fainting
Maltese: Endpoint