FrancophonIA/ELRC3.0 huggingface dataset:
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: Pharmacokinetic / Pharmacodynamic relationships
Maltese: .2 Tagħrif farmakokinetiku Relazzjonijiet farmakokinetiċi / farmakodinamiċi
English: In subjects with severe renal impairment (n=6, Clcr< 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'pazjenti b'indeboliment sever tal-kliewi (n=6, Cl cr < 20 mL/min/1.73 m2), l-AUC ta' posaconazole kien varjabbli ħafna [> 96 % CV (koeffiċjent ta' varjanza)] meta mqabbel ma' gruppi renali oħra [< 40 % CV]. Madankollu, billi posaconazole ma jiġix eliminat b'mod sinifikanti mill-kliewi, mhux mistenni effett tal-indeboliment sever tal-kliewi fuq il-farmakokinetika ta' posaconazole u ma huwa rakkomandat l-ebda aġġustament fid-doża.
English: tongue oedema, face oedema
Maltese: FULJETT TA' TAGĦRIF
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) għal kull pillola, jiġifieri hija essenzjalment “mingħajr sodium”.
English: Each tablet contains 100 mg of posaconazole.
Maltese: Kull pillola gastro-reżistenti fiha 100 mg of posaconazole.
English: Effects of posaconazole on other medicinal products
Maltese: Effetti ta' posaconazole fuq prodotti mediċinali oħra
English: Q1
Maltese: L-M
English: Therefore, inhibitors (e.g. verapamil, ciclosporin, quinidine, clarithromycin, erythromycin, etc.) or inducers (e.g. rifampicin, rifabutin, certain anticonvulsants, etc.) of these clearance pathways may increase or decrease posaconazole plasma concentrations, respectively.
Maltese: clarithromycin, erythromycin, eċċ.) jew l-indutturi (eż. rifampicin, rifabutin, ċerti antikonsulvanti, eċċ.) ta' dawn il-mogħdijiet ta' tneħħija jistgħu jżidu jew inaqqsu l- konċentrazzjonijiet ta' posaconazole fil-plażma,
English: In a study in healthy volunteers posaconazole oral suspension (200 mg once daily for 10 days) increased the exposure (AUC) of intravenous midazolam (0.05 mg/kg) by 83%.
Maltese: żiedet l-esponiment (AUC) ta' midazolam mogħti fil-vini (0.05 mg/kg) bi 83%.
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 studju aleatorju, blinded għall-evalwatur, tas-suspensjoni orali ta' posaconazole (200 mg tliet darbiet kuljum) kontra s-suspensjoni ta' fluconazole (400 mg darba kuljum) jew is- suspensjoni orali ta'
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: 0.4 mg) b'medja ta' 1.3 u 4.6 darbiet (medda 1.7 sa 6.4 darbiet), rispettivament; 400 mg darbtejn kuljum tassuspensjoni orali ta' posaconazole għal 7 ijiem żiedu s-Cmax u l-AUC ta' midazolam mogħti fil-vini b'1.6 u 6.2
English: Study 5615 was a non-comparative multi-center study performed to evaluate the pharmacokinetic properties, safety, and tolerability of posaconazole tablet.
Maltese: L-Istudju 5615 kien studju multiċentri mhux komparattiv li twettaq sabiex jiġu evalwati l-proprjetajiet farmakokinetiċi, is-sigurtà, u t-tollerabbiltà tal-pillola ta' posaconazole.
English: Vinca alkaloids
Maltese: Candida albicans:
English: which are given with ritonavir) - midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants) - diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure) - digoxin (used to treat heart failure) - Glipizide or other “sulfonylureas” (used to treat high blood sugar).
Maltese: diltiazem, verapamil, nifedipine, nisoldipine jew “imblokkaturi tal-kanali tal-kalċju” oħrajn (jintużaw għall-kura tal-pressjoni għolja tad-demm)
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 s- suspensjoni orali ta' posaconazole b'dożi terapewtiċi fil-pazjenti deskritti bħala analiżi tal-quartile.
English: nausea
Maltese: UŻATI
English: Tablet coating
Maltese: Kollha kkurati
English: torsade de pointes, sudden death, ventricular tachycardia, cardio-respiratory arrest, cardiac failure, myocardial infarction
Maltese: sindrome ta' titwil tal-QT§, elettrokardjogramma anormali§, palpitazzjonijiet, bradikardija, sistoli supraventrikulari żejda, takikardija torsade de pointes, mewt f'daqqa, takikardija ventrikulari, arrest kardjo-respiratorju, insuffiċjenza kardijaka, infart majokardijaku
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: Co-administration with ergot alkaloids (see section 4.5).
Maltese: L-għoti fl-istess ħin ma' alkalojdi tal-ergotina (ara sezzjoni 4.5).
English: Renal impairment
Maltese: Cav imbassra
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: During post-marketing surveillance of posaconazole oral suspension, severe hepatic injury with fatal outcome has been reported (see section 4.4).
Maltese: Matul is-sorveljanza ta' wara t-tqegħid fis-suq tas-suspensjoni orali ta' posaconazole, ġie rrappurtat korriment epatiku sever b'eżitu fatali (ara sezzjoni 4.4).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 2.1-fold and 8.5-fold greater, respectively, than those achieved with the human therapeutic doses.
Maltese: 29 mm-Hg) fil-firien u x-xadini b'esponimenti sistemiċi ta' 2.1 darbiet u 8.5 darbiet akbar, rispettivament, minn dawk miksuba bid-dożi terapewtiċi fil- bnedmin.
English: No adverse reactions were noted by the investigator.
Maltese: L-investigatur ma ra l-ebda reazzjonijiet avversi.
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: Fl-Istudju 1899, dan kien il-perjodu mill-għażla aleatorja sa 100 jum wara l-għażla aleatorja; fl-Istudju 316 dan kien il- perjodu mill-jum fil-linja bażi sa 111-il jum wara l-linja bażi.
English: Dose adjustment of calcium channel blockers may be required.
Maltese: Jista' jkun meħtieġ aġġustament fid-doża tal imblokkaturi tal-kanali tal-kalċju.
English: Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with neurotoxicity and other serious adverse reactions, including seizures, peripheral neuropathy, syndrome of inappropriate antidiuretic hormone secretion, and paralytic ileus.
Maltese: Tossiċità b'vincristine L-għoti fl-istess ħin ta' antifungali azole, inkluż posaconazole b'vincristine ġie assoċjat ma' newrotossiċità u reazzjonijiet avversi serji oħra, inkluż attakki ta' puplesija, newropatija periferali, sindrome ta' sekrezzjoni talormon antidijuretika mhux xierqa, u ileus paralitiku.
English: - Do not crush, chew, break or dissolve the tablet.
Maltese: (eż. simvastatin, lovastatin, u atorvastatin)
English: Metabolism and nutrition disorders Common:
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
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 sottostrati ta' CYP3A4 meta dawn jingħataw fl-istess ħin ma' posaconazole.
English: See Table 5 and 6 for results from both studies.
Maltese: Ara Tabella 5 u 6
English: Patients were immunocompromised with underlying conditions including haematological malignancy, neutropenia post-chemotherapy, GVHD, and post HSCT.
Maltese: Il-pazjenti kienu immunokompromessi b'kundizzjonijiet sottostanti li kienu jinkludu tumuri malinni ematoloġiċi, newropenija wara kimoterapija, GVHD, u wara HSCT.
English: hypotension, vasculitis
Maltese: tenerezza tal-fwied, asteriksis
English: rash, pruritis
Maltese: U L- UŻU
English: Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin).
Maltese: Il-ġestjoni tal-pazjenti għandha tinkludi evalwazzjoni fil-laboratorju tal-funzjoni epatika (b'mod partikolari testijiet tal-funzjoni tal-fwied u lbilirubin).
English: No data are available for the tablet formulation.
Maltese: Dejta mhux disponibbli għall-formulazzjoni tal-pillola.
English: Efavirenz
Maltese: Ċipru
English: Posaconazole tablets are absorbed with a median Tmax of 4 to 5 hours and exhibits dose proportional pharmacokinetics after single and multiple dosing up to 300 mg.
Maltese: Il-pilloli ta' posaconazole jiġu assorbiti b'ħin medjan Tmax ta' 4 sa 5 sigħat u juri farmakokinetiċi proporzjonali mad-doża wara li jingħataw doża waħda jew ħafna dożi sa 300 mg.
English: Liver function tests should be evaluated at the start of and during the course of posaconazole therapy.
Maltese: It-testijiet tal-funzjoni tal-fwied għandhom jiġu evalwati fil-bidu u waqt it-terapija b'posaconazole.
English: 11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole oral suspension 800 mg/day in divided doses for a median of 296 days and up to 460 days.
Maltese: 11 minn 16-il pazjent kienu kkurati b'suċċess (fi tmiem il-kura kellhom fejqan sħiħ jew parzjali mis- sinjali u s-sintomi li kien hemm fil-linja bażi) bi 800 mg/jum tas-suspensjoni orali ta' posaconazole f'dożi maqsumin għal perjodu medjan ta' 296 jum u sa 460 jum.
English: For oral use.
Maltese: “antifungali”.
English: See “Other medicines and Posaconazole Accord” below for more information including information on other medicines which may interact with Posaconazole Accord.
Maltese: Ara “Mediċini oħra u Posaconazole Accord” hawn isfel għal aktar informazzjoni, inkluża informazzjoni dwar mediċini oħra li jistgħu jinteraġixxu ma' Posaconazole Accord.
English: The most frequently reported serious related adverse reactions included nausea, vomiting, diarrhoea, pyrexia, and increased bilirubin.
Maltese: L-aktar reazzjonijiet avversi serji rrappurtati b'mod frekwenti kienu jinkludu dardir, rimettar, dijarea, deni, u żieda fil-bilirubin.
English: Posaconazole tablet and oral suspension safety
Maltese: Is-sigurtà tal-pillola u s-suspensjoni orali ta' posaconazole
English: HMG-CoA reductase inhibitors metabolised through CYP3A4 (e.g. simvastatin, lovastatin, and atorvastatin)
Maltese: Inibituri ta' HMG-CoA reductase metabolizzati permezz ta' CYP3A4
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: TreatmentInvasive Aspergillosis Study 0041
Maltese: Studju 0041
English: Co-administration of posaconazole with CYP3A4 substrates may result in large increases in exposure to CYP3A4 substrates as exemplified by the effects on tacrolimus, sirolimus, atazanavir and midazolam below.
Maltese: L-għoti fl-istess ħin ta' posaconazole ma' sottostrati ta' CYP3A4 jista' jwassal għal żidiet kbar fl-esponiment għas-sottostrati ta' CYP3A4 kif muri mill- effetti fuq tacrolimus, sirolimus, atazanavir u midazolam aktar 'l isfel.
English: The microbiological data suggest that posaconazole is active against Rhizomucor, Mucor, and Rhizopus; however the clinical data are currently too limited to assess the efficacy of posaconazole against these causative agents.
Maltese: It-tagħrif mikrobijoloġiku jissuġġerixxi li posaconazole huwa attiv kontra Rhizomucor, Mucor, u Rhizopus; madankollu t-tagħrif kliniku għadu limitat wisq biex tiġi valutata l effikaċja ta' posaconazole kontra dawn l-aġenti kawżattivi.
English: Ear and labyrinth disorder Rare:
Maltese: Mhux komuni: Rari:
English: high or low blood pressure - low blood pressure - inflammation of the pancreas (pancreatitis) - this may cause severe stomach pain - oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain - severe kidney problems - signs include passing more or less urine, that is a different colour than usual - high blood levels of creatinine - shown in blood tests - cough, hiccups - nose bleeds - severe sharp chest pain when breathing in (pleurritic pain) - swelling of lymph glands (lymphadenopathy) - reduced feeling of sensitivity especially on the skin - tremor - high or low blood sugar levels - blurred vision, sensitivity to light - hair loss (alopecia) - mouth ulcers - shivering, feeling generally unwell - pain, back or neck pain, pain in arms or legs - water retention (oedema) - menstrual problems (abnormal vaginal bleeding)
Maltese: - pressjoni tad-demm baxxa - infjammazzjoni tal-frixa (pankreatite) - dan jista' jikkawża wġigħ sever fl-istonku - interruzzjoni fil-provvista tal-ossiġnu għall-milsa (infart tal-milsa) - dan jista' jikkawża uġigħ qawwi fl-istonku - problemi severi fil-kliewi - is-sinjali jinkludu li tgħaddi aktar jew anqas awrina, li tkun ta' kulur differenti mis-soltu - livelli għoljin ta' krejatinina fid-demm - murija f'testijiet tad-demm
English: - Keep this leaflet.
Maltese: reazzjonijiet avversi.
English: Q3
Maltese: ANNESS III
English: electrolyte imbalance, anorexia, decreased appetite, hypokalaemia, hypomagnesaemia
Maltese: skwilibriju fl-elettroliti, anoressija, nuqqas ta' aptit, ipokalemija, ipomanjesimja ipergliċemija, ipogliċemija
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)
English: Coccidioidomycosis
Maltese: Dawn il-mediċini jinkludu:
English: Effects of other medicinal products on posaconazole
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Effetti ta' prodotti mediċinali oħra fuq posaconazole
English: Posaconazole after administration of the tablets, is slowly eliminated with a mean half-life (t½) of 29 hours (range 26 to 31 hours) and a mean apparent clearance ranging from 7.5 to 11 L/hr.
Maltese: Eliminazzjoni Wara l-għoti tal-pilloli, posaconazole jitneħħa bil-mod b'half-life (t½) medja ta' 29 siegħa (medda 26 sa 31
English: No dosage adjustment of posaconazole tablets is required when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Maltese: M'hemmx bżonn ta' aġġustament fid-doża tal-pilloli ta' posaconazole meta l-pilloli ta' posaconazole jintużaw fl-istess ħin ma' antaċidi, antagonisti tar-riċetturi H2 u inibituri tal-pompa tal-proton.
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 tas-suspensjoni orali ta' posaconazole f'individwi Suwed meta mqabbel ma' individwi Kawkasi.
English: Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group
Maltese: Effikaċja globali tas-suspensjoni orali ta' posaconazole fi tmiem il-kura għall-asperġillożi invażiva meta mqabbla ma' grupp ta' kontroll estern Suspensjoni orali ta' posaconazole
English: Rare: the following may affect up to 1 in 1,000 people - pneumonia - signs include feeling short of breath and producing discoloured phlegm - high blood pressure in the blood vessels in the lungs (pulmonary hypertension) this can cause serious damage to your lungs and heart - blood problems such as unusual blood clotting or prolonged bleeding - severe allergic reactions, including widespread blistering rash and skin peeling - mental problems such as hearing voices or seeing things that are not there - fainting - having problems thinking or talking, having jerking movements, especially in your hands that you cannot control - stroke - signs include pain, weakness, numbness, or tingling in the limbs - having a blind or dark spot in your field of vision - heart failure or heart attack which could lead to the heart stopping beating and death, heart rhythm problems, with sudden death - blood clots in your legs (deep vein thrombosis) - signs include intense pain or swelling of the legs - blood clots in your lungs (pulmonary embolism) - signs include feeling short of breath or pain while breathing - bleeding into your stomach or gut - signs include vomiting blood or passing blood in your stool - a blockage in your gut (intestinal obstruction) especially in the “ileum”.
Maltese: nawsja jew rimettar (tkun imdardar jew tirremetti), dijarea sinjali ta' problemi fil-fwied - dawn jinkludu sfura fil-ġilda jew fl-abjad tal-għajnejn, awrina skura jew ippurgar ċar mhux normali, tħossok ma tiflaħx għall-ebda raġuni, problemi fl-istonku, telf tal-aptit jew għeja jew dgħufija mhux tas-soltu, żieda fl-enzimi tal-fwied li tidher fit-testijiet tad-demm reazzjoni allerġika
English: The excreted metabolites in urine and faeces account for approximately 17% of the administered radiolabelled dose.
Maltese: Il-metaboliti li jitneħħew fl-awrina u fl- ippurgar jammontaw għal madwar 17 % tad-doża radjutikkettata li tingħata.
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 metaboliti prinċipali li jiċċirkolaw u l-konċentrazzjonijiet tiegħu mhumiex probabbli li jiġu mibdula minn inibituri tal-enzimi CYP450.
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: Doża ta' tagħbija ta' 300 mg (tliet pilloli ta' 100 mg) darbtejn filġurnata fl-ewwel jum, imbagħad 300 mg (tliet pilloli ta' 100 mg)
English: paresthesia, dizziness, somnolence, headache, dysgeusia
Maltese: (eż. diltiazem, verapamil, nifedipine,
English: Posaconazole Accord can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them: - 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; - 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; - infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped; - infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole 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; - infezzjonijiet ikkawżati minn fungi tal-familja Fusarium li ma jkunux tjiebu waqt kura b'amphotericin B jew meta amphotericin B kellu jitwaqqaf;
English: There is insufficient data among different races with posaconazole tablets.
Maltese: M'hemmx dejta suffiċjenti bejn razez differenti bil-pilloli ta' posaconazole.
English: mouth ulceration, alopecia, dermatitis, erythema, petechiae
Maltese: raxx, prurite ulċeri fil-ħalq, alopeċja, dermatite, eritema, petekje sindrome ta' Stevens Johnson, raxx vessikulari
English: This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as: - patients who have a weak immune system due to having chemotherapy for “acute myelogenous leukemia” (AML) or “myelodysplastic syndromes” (MDS) - patients having “high- dose immunosuppressive therapy” after “hematopoietic stem cell transplant” (HSCT).
Maltese: Din il-mediċina tista' tintuża wkoll għall-prevenzjoni ta' infezzjonijiet fungali f'adulti li jkunu f'riskju għoli ta' infezzjoni fungali, bħal: - pazjenti li jkollhom sistema immunitarja dgħajfa minħabba kimoterapija għal “lewkimja majeloġenuża akuta” (AML) jew “sindromi “majelodisplastiċi” (MDS) - pazjenti li jkunu qegħdin jieħdu “terapija immunosoppressiva f'doża għolja” wara “trapjant ta' ċelloli staminali ematopojetiċi” (HSCT).
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 fl-elettroliti, speċjalment dawk li jinvolvu l-livelli tal-potassju, manjeżju jew kalċju, għandhom jiġu mmonitorjati u korretti kif meħtieġ qabel u waqt it-terapija b'posaconazole.
English: In twelve-month neurotoxicity studies in dogs and monkeys, no functional effects were observed on the central or peripheral nervous systems at systemic exposures greater than those achieved therapeutically.
Maltese: Fi studji ta' tnax-il xahar dwar in-newrotossiċità fil-klieb u x-xadini, ma kinux osservati effetti funzjonali fuq is-sistemi nervużi ċentrali jew periferali b'esponimenti sistemiċi akbar minn dawk miksuba b'mod terapewtiku.
English: 200 mg three times daily
Maltese: imbagħad 400 mg darbtejn kuljum
English: - some medicines used to treat or prevent fits including; phenytoin, carbamazepine, phenobarbital or primidone).
Maltese: carbamazepine, phenobarbital, primidone), u efavirenz.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 100 mg of posaconazole.
Maltese: Kull pillola gastro-reżistenti fiha 100 mg ta' posaconazole.
English: Fixed-time periodc
Maltese: Tqala u treddigħ