FrancophonIA/ELRC3.0 huggingface dataset:
English: There are insufficient data to evaluate the potential effect of race on trametinib pharmacokinetics as clinical experience is limited to Caucasians.
Maltese: M'hemmx dejta suffiċenti biex jiġi evalwat l-effett potenzjali tar-razza fuq il-farmakokinetika ta' trametinib minħabba li esperjenza klinika hija limitata għall-Kawkażjatiċi.
English: In clinical trials, central testing for BRAF V600 mutation using a BRAF mutation assay was conducted on the most recent tumour sample available.
Maltese: Fi provi kliniċi, sar ittestjar ċentrali għall-mutazzjoni BRAF V600 bl-użu ta' prova tal-mutazzjoni BRAF fuq il-kampjun tat-tumuri disponibbli l-aktar reċenti.
English: The efficacy and safety of trametinib in combination with dabrafenib in patients with BRAF mutant-positive melanoma that has metastasised to the brain was studied in a non-randomised, open-label, multicentre, Phase II study (COMBI-MB study).
Maltese: Is-sigurtà u l-effikaċja ta' meta trametinib u dabrafenib jingħataw flimkien lil pazjenti b'melanoma pożittiva għall-mutazzjoni BRAF V600 li kellha metatesi fil-moħħ ġew studjati waqt studju mhux randomizzat, open-label, multiċentriku f'Fażi II (studju COMBI-MB).
English: The primary endpoint of the study was to evaluate the efficacy of trametinib compared to chemotherapy with respect to PFS in patients with advanced/metastatic BRAF V600E/K mutation-positive melanoma without a prior history of brain metastases (N=273) which is considered the primary efficacy population.
Maltese: L-endpoint primarju tal-istudju kien li jevalwa l-effikaċja ta' trametinib meta mqabbel ma' kimoterapija fir-rigward ta' PFS f'pazjenti b'melanoma pożittiva għall-mutazzjoni V600E/K BRAF avvanzata/metastatika mingħajr storja preċedenti ta' metastasi fil-moħħ (N = 273), li hija meqjusa bħala l-popolazzjoni tal-effikaċja primarja.
English: The mean trametinib concentrations observed following repeat dose administration of 2 mg once daily exceeds the preclinical target concentration over the 24-hr dosing interval, thereby providing sustained inhibition of the MEK pathway.
Maltese: Il-konċentrazzjonijiet medji ta' trametinib osservati wara doża ripetuta ta' 2 mg darba kuljumjaqbżu lkonċentrazzjoni immirata preklinika fuq l-intervall tad-dożaġġ ta' 24 siegħa, u b'hekk jipprovdu inibizzjoni sostnuta tal-mogħdija MEK.
English: Serious skin reactions
Maltese: Reazzjonijiet gravi fil-ġilda
English: In mice, lower heart rate, heart weight and left ventricular function were observed without cardiac histopathology after 3 weeks at ≥0.25 mg/kg/day trametinib (approximately 3 times human clinical exposure based on AUC) for up to 3 weeks.
Maltese: Fil-ġrieden, rata tat-taħbit tal-qalb baxxa, piż tal-qalb aktar baxx u l-funzjoni indebolita tal-ventrikulari tax-xellug kienu osservati mingħajr istopatoloġija kardijaka wara 3 ġimgħat fi ≥ trametinib 0.25 mg/kg/jum (madwar 3 darbiet l-esponiment kliniku uman ibbażat fuq l-AUC) għal sa 3 ġimgħat.
English: Patients with brain metastases
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: Side effects when Mekinist and dabrafenib are taken together
Maltese: Effetti sekondarji meta Mekinist u dabrafenib jittieħdu flimkien
English: By Investigator
Maltese: Mill-Investigatur
English: Additionally, in juvenile rats given trametinib, decreased ovarian weights, slight delays in hallmarks of female sexual maturation (vaginal opening and increased incidence of prominent terminal end buds within the mammary gland) and slight hypertrophy of the surface epithelium of the uterus were observed.
Maltese: Barra minn hekk, fil-firien li għadhom qed jikbru mogħtija trametinib, ġew osservati tnaqqis fil-piż tal-ovarji, dewmien żgħir fil-karatteristiċi tal-maturazzjoni sesswali femminili (ftuħ vaġinali u inċidenza akbar ta' blanzuni terminali prominenti fil-glandola mammarja) u ipertrofija żgħira talepitelju tal-wiċċ tal-utru.
English: Manufacturer SP Labo N.V.
Maltese: SP Labo N.V.
English: diplopia, scotoma
Maltese: diplopja, skotoma
English: gastrointestinal haemorrhage, ileus
Maltese: emorraġija gastrointestinali, ileus
English: Unopened container: 3 years
Maltese: Kontenitur mhux miftuħ: 3 snin
English: itraconazole or voriconazole.
Maltese: itraconazole jew voriconazole.
English: Gentamicin sulfate
Maltese: Gentamicin sulphate
English: Xanthan gum
Maltese: Glycerol Xanthan gum
English: noxafil tablets
Maltese: pilloli noxafil
English: Posaconazole has a distribution volume of 261 L, indicating extravascular distribution.
Maltese: Posaconazole għandu volum ta' distribuzzjoni ta' 261 L, li tindika distibuzzjoni extravaskulari.
English: See Section 4 for more information.
Maltese: Ara sezzjoni 4 għal aktar informazzjoni.
English: Children (< 18 years)
Maltese: Tfal (< 18-il sena)
English: 5 % dextrose in water 0.9 % sodium chloride 0.45 % sodium chloride 5 % dextrose and 0.45 % sodium chloride 5 % dextrose and 0.9 % sodium chloride 5 % dextrose and 20 mEq KCl
Maltese: 5 % dextrose fl-ilma 0.9 % sodium chloride 0.45 % sodium chloride 5 % dextrose u 0.45 % sodium chloride 5 % dextrose u 0.9 % sodium chloride
English: Safety data in the elderly are limited.
Maltese: Id-dejta tas-sigurtà fl-anzjani hija limitata.
English: Liquid glucose
Maltese: Glucose likwidu
English: Noxafil 40 mg/mL oral suspension
Maltese: Noxafil 40 mg/mL suspensjoni orali
English: Dose and duration of therapy (See section 5.2)
Maltese: Doża u tul tat-terapija (ara sezzjoni 5.2)
English: Danmark MSD Danmark ApS Tlf: + 45 44 82 4000 dkmail@merck.com
Maltese: MSD Danmark ApS Tlf: + 45 44 82 4000 dkmail@merck.com
English: • Sinus bradycardia
Maltese: • Sinus bradikardja
English: Tablet coat polyvinyl alcohol macrogol 3350 titanium dioxide (E171) talc iron oxide yellow (E172)
Maltese: Magnesium stearate Kisja tal-pillola polyvinyl alcohol macrogol 3350 titanium dioxide (E171)
English: The total subject population had a mean age of 51 years (range = 18-82 years), 95 % were White, the major ethnicity was not Hispanic or Latino (92 %), and 55 % were male.
Maltese: Il-popolazzjoni totali ta' individwi kellha età medja ta' 51 sena (medda = 18-82 sena), 95 % kienu Bojod, l-akbar etniċità ma kinitx Ispanika jew Latina (92 %), u 55 % kienu rġiel.
English: • Store in a refrigerator (2C-8C).
Maltese: • Aħżen fi friġġ (2°C-8°C).
English: Noxafil contains sodium
Maltese: Noxafil fih sodium
English: EU/1/05/320/001
Maltese: EU/1/05/320/003 96 pillola
English: Store in a refrigerator at 2°C-8°C.
Maltese: Aħżen fi friġġ f'temperatura ta' 2°C-8°C.
English: Gentamicin sulfate Hydromorphone hydrochloride Levofloxacin
Maltese: Hydromorphone hydrochloride Levofloxacin
English: The other ingredients are: hypromellose acetate succinate; cellulose, microcrystalline; hydroxypropylcellulose (E463); silica dental type; croscarmellose sodium; magnesium stearate, polyvinyl alcohol, macrogol 3350 , titanium dioxide (E171), talc, iron oxide yellow (E172).
Maltese: Is-sustanzi l-oħra huma: hypromellose acetate succinate; cellulose, microcrystalline; hydroxypropylcellulose (E463); silica dental type; croscarmellose sodium; magnesium stearate, polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, iron oxide yellow (E172).
English: Posaconazole has been shown in vitro to be active against the following microorganisms: Aspergillus species (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), Candida species (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, and species of Fusarium, Rhizomucor, Mucor, and Rhizopus.
Maltese: Posaconazole ntwera li huwa effettiv in vitro kontra l-mikroorganiżmi li ġejjin: speċi ta' Aspergillus (Aspergillus fumigatus, A. flavus, A. terreus, A. nidulans, A. niger, A. ustus), speċi ta' Candida (Candida albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, C. dubliniensis, C. famata, C. inconspicua, C. lipolytica, C. norvegensis, C. pseudotropicalis), Coccidioides immitis, Fonsecaea pedrosoi, u l-ispeċi ta' Fusarium, Rhizomucor, Mucor, u Rhizopus.
English: such as simvastatin, atorvastatin or lovastatin.
Maltese: (eż. simvastatin, lovastatin, u atorvastatin)
English: The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Maltese: Il-mekkaniżmu prinċipali ta' reżistenza huwa l-akkwiżizzjoni ta' sostituzzjonijiet fil-proteina fil-mira, CYP51.
English: Epidemiological Cut-off (ECOFF) values for Aspergillus spp.
Maltese: Valuri ta' limitu Epidemjoloġiku (ECOFF - Epidemiological Cut-off) għal Aspergillus spp.
English: EUCAST MIC breakpoints for posaconazole [susceptible (S); resistant (R)]:
Maltese: Breakpoints Breakpoints MIC tal-EUCAST għal posaconazole [suxxettibbli (S); reżistenti (R)]:
English: Posaconazole tablets
Maltese: Pillola ta' posaconazole
English: EUCAST ECOFF values:
Maltese: Valuri ECOFF ta' EUCAST:
English: Elderly ( 65 years)
Maltese: Anzjani (≥ 65 sena)
English: Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Maltese: Ir-refrattorjetà hija definita bħala l-progressjoni tal-infezzjoni jew in-nuqqas ta' titjib wara minimu ta' 7 ijiem ta' dożi terapewtiċi preċedenti ta' terapija antifungali effettiva.
English: Posaconazole is highly protein bound (> 98 %), predominantly to serum albumin.
Maltese: Posaconazole jeħel ħafna mal-proteini (> 98 %), l-aktar mal-albumina tas-serum.
English: • Candida parapsilosis: S ≤0.06 mg/L, R >0.06 mg/L
Maltese: S ≤0.06 mg/L, R >0.06 mg/L
English: Control
Maltese: Kontrolla
English: Non-Interchangeability between Noxafil Tablets and Noxafil Oral Suspension
Maltese: In-non-interkambjalità bejn Noxafil Pilloli u Noxafil Suspensjoni
English: Filgrastim
Maltese: Famotidine Filgrastim
English: - The other ingredients in the suspension are polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), artificial cherry flavour containing benzyl alcohol and propylene glycol, and purified water.
Maltese: - Is-sustanzi l-oħra -huma polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, glucose likwidu, titanium dioxide (E171), togħma artifiċjali taċ-ċirasa li fiha benzyl alcohol u propylene glycol, u ilma purifikat.
English: Noxafil 100 mg gastro-resistant tablets
Maltese: Noxafil 100 mg pilloli gastro-reżistenti
English: Prophylaxis of invasive fungal infections
Maltese: Profilassi ta' infezzjonijiet fungali infettivi
English: Rifamycin antibacterials (rifampicin, rifabutin), certain anticonvulsants (phenytoin, carbamazepine, phenobarbital, primidone), and efavirenz.
Maltese: Antibatteriċi ta' Rifamycin (rifampicin, rifabutin), ċerti mediċini kontra l-konvulżjonijiet (phenytoin, carbamazepine, phenobarbital, primidone), u efavirenz.
English: Posaconazole oral suspension
Maltese: Posaconazole suspensjoni orali
English: Artificial cherry flavour containing benzyl alcohol and propylene glycol Purified water
Maltese: Togħma artifiċjali ta' ċirasa li fiha benzyl alcohol u propylene glycol Ilma purifikat
English: • rifabutin and rifampicin (used to treat certain infections).
Maltese: • rifabutin u rifampicin (jintużaw għall-kura ta' ċerti infezzjonijiet).
English: Noxafil 40 mg/mL oral suspension posaconazole
Maltese: Noxafil 40 mg/mL suspensjoni orali posaconazole
English: The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/itraconazole.
Maltese: Itterapija damet medja ta' 29 jum għal posaconazole u 25 jum għal fluconazole/itraconazole.
English: • menstrual problems (abnormal vaginal bleeding)
Maltese: • problemi mestrwali (fsada abnormali mill-vaġina)
English: Subjects achieved a mean predicted Cav at steady state of 1,970 ng/mL.
Maltese: Il-pazjenti kisbu Cav medja mbassra fi stat fiss ta' 1,970 ng/mL.
English: Posaconazole, after administration of the tablet, has a mean apparent volume of distribution of 394 L (42 %), ranging between 294-583 L among the studies in healthy volunteers.
Maltese: Posaconazole, wara l-għoti tal-pillola, għandu volum apparenti medju ta' distribuzzjoni ta' 394 L (42%), li jvarja bejn 294-583 L fl-istudji fuq voluntiera b'saħħithom.
English: White suspension
Maltese: Suspensjoni bajda
English: 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: Hypromellose acetate succinate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Silica dental type Croscarmellose sodium Magnesium stearate
Maltese: Hypromellose acetate succinate Cellulose, microcrystalline Hydroxypropylcellulose (E463)
English: 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: • have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole,
Maltese: • kellek reazzjoni allerġika għal xi mediċina antifungali oħra bħal ketoconazole, fluconazole,
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Stevens Johnson syndrome, vesicular rash
Maltese: sindrome ta' Stevens Johnson, raxx bl-infafet
English: • halofantrine (used to treat malaria)
Maltese: • halofantrine (użat għall-kura tal-malarja)
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: Il-maġġoranza (377/600, [63 %]) talpazjenti inklużi kellhom GVHD Akut ta' Grad 2 jew 3 jew kroniku estensiv (195/600, [32.5 %]) filbidu tal-istudju.
English: Electrocardiogram evaluation
Maltese: Evalwazzjoni tal-elettrokardjogramma
English: • diltiazem, verapamil, nifedipine, nisoldipine or other “calcium channel blockers” (used to treat high blood pressure)
Maltese: • diltiazem, verapamil, nifedipine, nisoldipine jew “imblokkaturi tal-kanali tal-kalċju” oħrajn
English: • quinidine (used to treat abnormal heart rhythms).
Maltese: • quinidine (użat għall-kura ta' ritmi tal-qalb abnormali).
English: • midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants)
Maltese: • midazolam, triazolam, alprazolam jew “benzodiazepines” oħra (jintużaw bħala sedattivi jew rilassanti tal-muskoli)
English: Posaconazole inhibits the enzyme lanosterol 14α-demethylase (CYP51), which catalyses an essential step in ergosterol biosynthesis.
Maltese: Posaconazole jinibixxi l-enzima lanosterol 14α-demethylase (CYP51), li tikkatalizza pass essenzjali fil-bijosintesi ta' ergosterol.
English: HIV Protease inhibitors
Maltese: Impedituri tal-HIV protease
English: Each vial of Noxafil contains 462 mg (20 mmol) of sodium.
Maltese: Kull kunjett ta' Noxafil fih 462 mg (20 mmol) ta' sodium.
English: See “Other medicines and Noxafil” below for more information including information on other medicines which may interact with Noxafil.
Maltese: Ara “Mediċini oħra u Noxafil” hawn isfel għal aktar informazzjoni, inkluża informazzjoni dwar mediċini oħra li jistgħu jinteraġixxu ma' Noxafil.
English: Date of first authorisation: 25 October 2005 Date of latest renewal: 25 October 2010
Maltese: Data tal-aħħar tiġdid: 25 ta' Ottubru 2010
English: mouth ulceration, alopecia, dermatitis, erythema, petechiae
Maltese: ulċerazzjoni fil-ħalq, alopeċja, dermatite, eritema, petekje
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: Noxafil is also available for oral administration (Noxafil 100 mg gastro-resistant tablets and 40 mg/mL oral suspension).
Maltese: Noxafil huwa disponibbli wkoll għal għoti orali (Noxafil 100 mg pilloli gastroreżistenti u 40 mg/mL suspensjoni orali).
English: Noxafil gastro-resistant tablets are packaged in a blister in cartons of 24 (2x12) or 96 (8x12) tablets.
Maltese: Noxafil pilloli gastro-reżistenti huma ppakkjati f'folja f'pakketti ta' 24 (2x12) jew 96 (8x12) pillola.
English: Effects of other medicinal products on posaconazole Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for p-glycoprotein (P-gp) efflux in vitro.
Maltese: Effetti ta' prodotti mediċinali oħra fuq posaconazole Posaconazole jiġi metabolizzat permezz ta' glukoronidazzjoni tal-UDP (enzimi ta' fażi 2) u huwa substrat għall-effluss tal-glikoproteina-p (P-gp) in vitro.
English: • mild to severe nausea, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain
Maltese: • nawsja ħafifa sa severa, rimettar, bugħawwieġ u dijarea, normalment ikkawżati minn virus,
English: Gastro-resistant tablet (tablet) Yellow-coated, capsule-shaped tablet of 17.5 mm length debossed with “100” on one side.
Maltese: Pillola forma ta' kapsula, miksija bl-isfar, b'tul ta' 17.5 mm u mnaqqxa “100” fuq naħa waħda.
English: • astemizole (used to treat allergies)
Maltese: • astemizole (użat għall-kura tal-allerġiji)
English: Posaconazole may increase the plasma concentration of ergot alkaloids (ergotamine and dihydroergotamine), which may lead to ergotism.
Maltese: Posaconazole jista' jżid il-konċentrazzjonijiet fil-plażma tal-alkalojdi tal-ergotina (ergotamine u dihydroergotamine), li jista' jwassal għal ergotiżmu.
English: Study 5615 was conducted in a similar patient population to that previously studied in the pivotal posaconazole oral suspension clinical program.
Maltese: L-Istudju 5615 twettaq f'popolazzjoni ta' pazjenti simili għal dik studjata qabel fil-programm kliniku pivitali dwar issuspensjoni orali ta' posaconazole.
English: Most of the vinca alkaloids (e.g., vincristine and vinblastine) are substrates of CYP3A4.
Maltese: Ħafna mill-alkalojdi vinka (eż., vincristine u vinblastine) huma sottostrati ta' CYP3A4.
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Maltese: Peress li sejjer tingħata din il-mediċina taħt superviżjoni medika mill-viċin, huwa improbabbli li taqbeż doża.
English: New diagnosis of acute myelogenous leukaemia was the most common underlying condition (435/602, [72 %]).
Maltese: Id-dijanjosi ġdida ta' lewkimja majeloġenuża akuta kienet l-aktar kundizzjoni sottostanti komuni (435/602, [72 %]).
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 mal-albumina tas-serum.
English: • rectal discomfort
Maltese: • skonfort rettali
English: 24 gastro-resistant tablets 96 gastro-resistant tablets
Maltese: 24 pillola gastro-reżistenti
English: haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Maltese: sindrome uremiku emolitiku, purpura tromboċitopenika trombotika, panċitopenija, koagulopatija, emorraġija
English: • Equilibrate the refrigerated vial of Noxafil to room temperature.
Maltese: • Ekwilibra l-kunjett iffriżat ta' Noxafil għat-temperatura ambjentali.
English: 2, rue Louis Pasteur F-14200 Hérouville St Clair France
Maltese: 2, rue Louis Pasteur
English: Noxafil 100 mg gastro-resistant tablets are packaged in a PVC/ polychlorotrifluoroethylene laminate blister with push-through aluminium lidding.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Noxafil 100 mg pilloli gastro-reżistenti huma ppakkjati f'folja laminata talPVC/polychlorotrifluoroethylene b'għatu tal-aluminju tat-tip ‘push-through'.
English: blurred vision, photophobia, visual acuity reduced
Maltese: vista mċajpra, fotofobija, tnaqqis fl-akutezza tal-vista
English: One bottle of 105 mL of oral suspension.
Maltese: Flixkun ta' 105 mL ta' suspensjoni orali.
English: Pharmacokinetic / Pharmacodynamic relationships A correlation between total medicinal product exposure divided by MIC (AUC/MIC) and clinical outcome was observed.
Maltese: Kienet osservata korrelazzjoni bejn l-esponiment totali għall-prodott mediċinali diviż bil-MIC (AUC/MIC) u r-riżultat kliniku.
English: Invasive aspergillosis
Maltese: Aspergillożi invażiva
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) naqqas is-Cmax u l-AUC ta' posaconazole b'41 % u 50 %, rispettivament.
English: • water retention (oedema)
Maltese: • żamma tal-ilma (edima)
English: Study 5520 enrolled a total of 279 subjects, including 268 receiving at least one dose of posaconazole concentrate for solution for infusion.
Maltese: L-istudju 5520 irreġistra total ta' 279 individwu, inkluż 268 li rċevew tal-anqas doża waħda ta' posaconazole konċentrat għal soluzzjoni għall-infużjoni.
English: Recommended dose is shown in Table 1.
Maltese: Id-doża rakkomandata tidher f'Tabella 1.
English: Noxafil 100 mg gastro-resistant tablets posaconazole
Maltese: Noxafil 100 mg pilloli gastro-reżistenti posaconazole
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 darba kuljum) naqqas is-Cmax (konċentrazzjoni massima fil-plażma) u l-AUC (erja taħt il-kurva tal-konċentrazzjoni fil-plażma mal-ħin) ta' posaconazole għal 57 % u 51 %, rispettivament.
English: • vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)
Maltese: • vincristine, vinblastine “alkalojdi vinca” (jintużaw għall-kura tal-kanċer)
English: torsade de pointes, sudden death, ventricular tachycardia, cardio-respiratory arrest, cardiac failure, myocardial infarction
Maltese: torsade de pointes, mewt f'daqqa, takikardija ventrikolari, arrest kardjo-respiratorju, insuffiċjenza tal-qalb, infart mijokardijaku
English: Treatment of refractory Fungal Infections (Invasive aspergillosis, Fusariosis,
Maltese: (Asperġillożi invażiva, Fusarjożi,
English: Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections (Study 0041).
Maltese: Sittax il-pazjent f'etajiet ta' bejn 8-17-il sena kienu kkurati bi posaconazole suspensjoni orali 800 mg/jum fi studju dwar infezzjonijiet invażivi tal-fungu (Studju 0041).
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'pazjenti b'indeboliment sever tal-kliewi (n=6, Clcr < 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].
English: • terfenadine (used to treat allergies)
Maltese: • terfenadine (użat għall-kura tal-allerġiji)
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: Fi studju b'voluntiera b'saħħithom, is-suspensjoni orali ta' posaconazole (200 mg darba kuljum għal 10 ijiem) żiedet l-esponiment (AUC) ta' midazolam mogħti fil-vini (0.05 mg/kg) bi 83 %.