FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), and 4.8 (side effects).
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħrajn tal-SmPC inklużi s-sezzjonijiet 4.4 (twissijiet speċjali u prekawzjonijiet għall-użu), 4.6 (fertilità, tqala u treddigħ) u 4.8 (effetti sekondarji).
English: In some countries it is available under the trade names Amoxicilline Biogaran and Clamoxyl.
Maltese: F'xi pajjiżi huwa disponibbli bl-ismijiet kummerċjali Amoxicilline Biogaran u Clamoxyl.
English: Amoxil has been authorised in the EU via national procedures.
Maltese: Amoxil huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: • Acute cystitis;
Maltese: • Ċistite akuta;
English: • Community acquired pneumonia;
Maltese: • Pulmonite akkwiżita mill-komunità;
English: On 25 June 2015, the European Medicines Agency completed a review of Amoxil.
Maltese: Fil-25 ta' Ġunju 2015, l-Aġenzija Ewropea għall-Mediċini temmet rieżami ta' Amoxil.
English: The injectable formulations can also be used for the treatment and prevention of endocarditis.
Maltese: Il-formulazzjonijiet injettabbli jistgħu jintużaw ukoll għall-kura u l-prevenzjoni ta' endokardite.
English: • Acute exacerbations of chronic bronchitis;
Maltese: • Aggravar akut (rikaduti) ta' bronkite kronika (infjammazzjoni tal-passaġġi tal-arja fil-pulmuni);
English: Oral Amoxil can also be used for the prevention of endocarditis (infection of the inner lining of the heart).
Maltese: Amoxil orali jista' jintuża wkoll għall-prevenzjoni ta' endokardite (infezzjoni tal-inforra ta' ġewwa talqalb).
English: • Acute streptococcal tonsillitis and pharyngitis (infections of the tonsils and throat);
Maltese: • Tonsillite u farinġite streptokokkali akuta (infezzjonijiet tat-tunsilli u tal-ġriżmejn);
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there was a need to harmonise the prescribing information for Amoxil in the European Union (EU).
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni fl-informazzjoni dwar il-preskrizzjoni għal Amoxil fl-Unjoni Ewropea (UE).
English: On 22 July 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Amoxil in the EU.
Maltese: Fit-22 ta' Lulju 2013, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Amoxil fl-UE.
English: • Acute bacterial sinusitis (infection of the sinuses);
Maltese: • Sinużite batterjali akuta (infezzjoni tas-sinus);
English: • Acute pyelonephritis (kidney infection);
Maltese: • Pajelonefrite akuta (infezzjoni tal-kliewi);
English: Amoxil was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Amoxil ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċedura tarRikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: The CHMP agreed that the oral (to be taken by mouth) formulations of Amoxil (such as capsules, tablets and suspensions) can be used in adults and children for the treatment of the following bacterial infections:
Maltese: Is-CHMP qabel li l-formulazzjonijiet orali (li jittieħdu mill-ħalq) ta' Amoxil (bħal kapsuli, pilloli u sospensjonijiet) jistgħu jintużaw f'adulti u tfal għall-kura tal-infezzjonijiet batteriċi li ġejjin:
English: • Acute otitis media (infection of the middle ear);
Maltese: • Otite medja akuta (infezzjoni fil-widna tan-nofs);
English: • Acute cystitis (infection of the bladder);
Maltese: • Ċistite akuta (infezzjoni tal-bużżieqa tal-awrina);
English: Amoxil is an antibiotic used to treat a wide range of bacterial infections.
Maltese: Amoxil huwa antibijotiku li jintuża għall-kura ta' firxa wiesgħa ta' infezzjonijiet batteriċi.
English: • Typhoid and paratyphoid fever;
Maltese: • Deni tat-tifojde u paratifojde;
English: • Dental abscess with spreading cellulitis (inflammation of the deep skin tissue);
Maltese: • Axxessi dentali b'ċellulite li qiegħda tinfirex (infjammazzjoni tat-tessut tal-ġilda fonda);
English: The CHMP also agreed that Amoxil should no longer be used to treat female genital infections, because not enough clinical data are available to support this indication.
Maltese: Is-CHMP qabel ukoll li Amoxil m'għandux jibqa' jintuża għall-kura ta' infezzjonijiet ġenitali fin-nisa, minħabba li m'hemmx biżżejjed data klinika disponibbli biex tappoġġja din l-indikazzjoni.
English: EU/2/02/035/007 SevoFlo 100% Inhalation vapour, liquid
Maltese: EU/2/02/035/007 SevoFlo 100% Fwar li jittieħed man-nifs, likwidu
English: 1 bottle Not applicable.
Maltese: 1 flixkun Mhux applikabbli.
English: Inhalation use Bottle (polyethylene naphthalate) with Quik-Fil (II) closure
Maltese: Għal biex jinġibed man-nifs
English: Target species
Maltese: Flixkun
English: Dogs and cats.
Maltese: Klieb u qtates.
English: Further information on Giapreza can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/giapreza
Maltese: Aktar informazzjoni dwar Giapreza tinstab fis-sit web talAġenzija: https://www.ema.europa.eu/en/medicines/human/EPAR/giapreza
English: It is given as a continuous infusion (‘drip') into a vein.
Maltese: Jingħata bħala infużjoni (“dripp”) kontinwa ġol-vina.
English: After 3 hours, 70% of patients treated with Giapreza in addition to standard treatments had their average arterial blood pressure rise to above 75 mmHg (an acceptable level) or by at least 10 mmHg, compared with 23% of patients treated with placebo (a dummy treatment) and standard treatments.
Maltese: Wara 3 sigħat, il-pressjoni tad-demm arterjali medja ta' 70 % tal-pazjenti kkurati b'Giapreza flimkien mal-kuri standard għoliet għal aktar minn 75 mmHg (livell aċċettabbli) jew b'tal-inqas 10 mmHg, meta mqabbla ma' dik ta' 23 % tal-pazjenti kkurati bi plaċebo (kura finta) u kuri standard.
English: This overview was last updated in 08-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'08 2019.
English: Other information about Giapreza
Maltese: Informazzjoni oħra dwar Giapreza
English: Giapreza (angiotensin II) EMA/370784/2019
Maltese: EMA/370784/2019
English: As for all medicines, data on the use of Giapreza are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Giapreza hija ssorveljata kontinwament.
English: Giapreza (angiotensin II)
Maltese: Is-sustanza attiva f'Giapreza, l-anġjotensina
English: How is Giapreza used?
Maltese: Giapreza?
English: The side effects of Giapreza were similar to those of standard treatments and were considered manageable.
Maltese: L-effetti sekondarji ta' Giapreza kienu simili għal dawk f'kuri standard u kienu kkunsidrati maniġġabbli.
English: For the full list of side effects and restrictions with Giapreza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Giapeza, ara l-fuljett ta' tagħrif.
English: What are the risks associated with Giapreza?
Maltese: X'inhuma r-riskji assoċjati ma' Giapreza?
English: Giapreza is a medicine used in adults with dangerously low blood pressure (a condition known as shock).
Maltese: Giapreza huwa mediċina li tintuża fl-adulti bi pressjoni tad-demm baxxa b'mod perikoluż (kundizzjoni magħrufa bħala xokk).
English: The most common side effects with Giapreza (which may affect more than 1 in 10 people) are thromboembolic events (problems due to clots in blood vessels) and short-lived high blood pressure.
Maltese: L-effetti sekondarji l-aktar komuni b'Giapreza (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma avvenimenti tromboemboliċi (problemi minħabba emboli fil-vażijiet) u pressjoni tad-demm għolja għal żmien qasir.
English: Angiotensin II increases blood pressure by narrowing blood vessels and releasing another hormone (aldosterone) that increases the volume of blood circulating in the body.
Maltese: Il-kumpanija li tqiegħed Giapreza fis-suq se twettaq studju biex tkompli tinvestiga l-effettività u ssikurezza ta' Giapreza, inkluż jekk il-mediċina tistax tipprevjeni ħsara fl-organi u taffettwa kemm idumu ħajjin il-pazjenti.
English: Side effects reported with Giapreza are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Giapreza huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: A main study involving 344 patients in shock has shown that Giapreza is effective at raising blood pressure when other treatments have not worked.
Maltese: Studju ewlieni li fih ħadu sehem 344 pazjent f'xokk wera li Giapreza huwa effettiv biex jgħolli lpressjoni tad-demm meta kuri oħrajn ma jkunux ħadmu.
English: How does Giapreza work?
Maltese: Kif jintuża Giapreza?
English: respectively.
Maltese: rispettivament.
English: § See section 4.4.
Maltese: §Ara sezzjoni 4.4.
English: fluconazole, itraconazole or voriconazole.
Maltese: fluconazole, itraconazole jew voriconazole.
English: Endocrine disorders Rare:
Maltese: Disturbi fis-sistema endokrinarja Rari:
English: Prophylaxis in AML and HSCT Study 5615
Maltese: Profilassi fl-AML u l-HSCT Studju 5615
English: Controla
Maltese: Kontrolla
English: Polyvinyl alcohol-part hydrolyzed Titanium dioxide (E171) Macrogol
Maltese: Titanium dioxide (E171) Macrogol
English: 24x1 gastro-resistant tablet 96x1 gastro-resistant tablet
Maltese: 24 x 1 pillola gastro-reżistenti 96 x 1 pillola gastro-reżistenti
English: The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Maltese: reżistenza huwa l-akkwiżizzjoni ta' sostituzzjonijiet fil-proteina fil-mira, CYP51.
English: EUCAST ECOFF values: - Aspergillus flavus: 0.5 mg/L - Aspergillus fumigatus: 0.25 mg/L - Aspergillus nidulans: 0.5 mg/L - Aspergillus niger: 0.5 mg/L - Aspergillus terreus: 0.25 mg/L
Maltese: Aspergillus flavus: 0.5 mg/L Aspergillus fumigatus: 0.25 mg/L Aspergillus nidulans: 0.5 mg/L Aspergillus niger: 0.5 mg/L Aspergillus terreus: 0.25 mg/L
English: Epidemiological Cut-off (ECOFF) Values for Aspergillus spp.
Maltese: Valuri ta' limitu Epidemjoloġiku (ECOFF - Epidemiological Cut-off) għal Aspergillus spp.
English: Dose and duration of therapy (See section 5.2)
Maltese: Doża u tul tat-terapija (Ara sezzjoni 5.2)
English: Electrocardiogram evaluation
Maltese: Evalwazzjoni tal-elettrokardjogrammi
English: EUCAST MIC breakpoints for posaconazole [susceptible (S); resistant (R)]:
Maltese: Breakpoints MIC tal-EUCAST għal posaconazole [suxxettibbli (S); reżistenti (R)]:
English: The other ingredients are: Methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505), xylitol (E967), hydroxypropyl cellulose (E463), propyl gallate (E310), cellulose microcrystalline (E460), silica colloidal anhydrous, croscarmellose sodium, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), iron oxide yellow (E172).
Maltese: Is-sustanzi l-oħra mhux attivi huma: Methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505), xylitol (E967), hydroxypropyl cellulose (E463), propyl gallate (E310), cellulose microcrystalline (E460), silica colloidal anhydrous, croscarmellose sodium, sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), iron oxide yellow (E172).
English: Budapest, 1045, HUNGARY
Maltese: Budapest, 1045, L-UNGERIJA
English: Budapest, 1045, Hungary
Maltese: Budapest, 1045, L-Ungerija
English: World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona,
Maltese: World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona,
English: Prophylaxis in Neutropenia Study 1899
Maltese: Profilassi finNewtropenija Studju 1899
English: Sodium stearyl fumarate
Maltese: Sodium stearyl fumarate Kisja tal-pillola
English: Chromoblastomycosis/Mycetoma
Maltese: Kromoblastomikożi/Miċetoma
English: 08039 Barcelona, Spain
Maltese: Zona Franca 08040 Barcelona SPANJA
English: Iron oxide yellow (E172)
Maltese: Talc (E553b) Iron oxide yellow (E172)
English: Plasma exposure
Maltese: Espożizzjoni tal-plasma
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: Prophylaxis of invasive fungal infections
Maltese: Profilassi ta' infezzjonijiet fungali invażivi
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'
English: Posaconazole tablets
Maltese: Pilloli ta' posaconazole
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: Ergot alkaloids
Maltese: Alkalojdi ergot
English: Subjects achieved a mean predicted Cav at steady state of 1,970 ng/mL.
Maltese: Ilpazjenti kisbu Cav medja mbassra fi stat fiss ta' 1,970 ng/mL.
English: The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole/itraconazole.
Maltese: It-terapija damet medja ta' 29 jum għal posaconazole u 25 jum għal fluconazole/itraconazole.
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: Recommended dose according to indication.
Maltese: Doża rakkomandata skont l-indikazzjoni.
English: 300 mg once daily (Day 1 300 mg twice daily)*
Maltese: 300 mg darba kuljum (Jum 1 300 mg darbtejn kuljum)*
English: Marketing Authorisation Holder Accord Healthcare S.L.U.
Maltese: Accord Healthcare S.L.U.
English: There are limited pharmacokinetic data in patients with severe gastrointestinal dysfunction (such as severe diarrhoea).
Maltese: Hemm dejta farmakokinetika limitata f'pazjenti li jkollhom disfunzjoni gastro-intestinali severa (bħal dijarea severa).
English: Posaconazole Accord contain sodium
Maltese: Posaconazole Accord fih sodium
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: 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 (doża waħda ta' 0.05 mg/kg tal-piż tal-ġisem) b'121% u 358%, rispettivament.
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 filbijosintesi ta' ergosterol.
English: Cav Range (ng/mL)
Maltese: Medda tas-Cav (ng/mL)
English: Controla Proportion (%) of patients with proven/probable Aspergillosis On-treatment period b
Maltese: Kontrolla Proporzjon (%) ta' pazjenti b'Asperġillożi ppruvata/probabbli Perjodu fuq il-kurab
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1379/001-004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1379/001-004
English: Midazolam and other benzodiazepines metabolised by CYP3A4
Maltese: Midazolam u benzodiazepines oħra metabolizzati permezz ta' CYP3A4
English: Midazolam and other benzodiazepines
Maltese: Midazolam u benzodiazepines oħra
English: Quartile pCav Range (ng/mL)
Maltese: Medda tal-pCav (ng/mL)
English: Phenytoin (200 mg once a day) decreased the Cmax and AUC of posaconazole by 41% and 50%, respectively.
Maltese: Phenytoin Phenytoin (200 mg darba kuljum) naqqas is-Cmax u l-AUC ta' posaconazole b'41% u 50%, rispettivament.
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 ilkurva tal-konċentrazzjoni fil-plażma mal-ħin) ta' posaconazole għal 57% u 51%, rispettivament.
English: There are currently insufficient data to set clinical breakpoints for Aspergillus spp.
Maltese: Attwalment m'hemmx dejta suffiċjenti biex jiġu stabbiliti breakpoints kliniċi għal Aspergillus spp.
English: The safety profile of tablets was similar to that of the oral suspension.
Maltese: Il-profil tas-sigurtà tal-pilloli kien simili għal dak tas-suspensjoni orali.
English: Some azoles have been associated with prolongation of the QTc interval.
Maltese: Xi azoles ġew assoċjati ma' titwil tal-intervall QTc.
English: HIV Protease inhibitors
Maltese: Inibituri tal-protease tal-HIV
English: 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 rriżultat kliniku.
English: Dose adjustment of benzodiazepines metabolised by CYP3A4 should be considered (see section 4.5).
Maltese: benzodiazepines metabolizzati minn CYP3A4 (ara sezzjoni 4.5).
English: The majority (377/600, [63%]) of patients included had Acute Grade 2 or 3 or chronic extensive (195/600, [32.5%])
Maltese: Il-maġġoranza (377/600, [63 %]) tal-pazjenti inklużi kellhom GVHD Akut ta' Grad 2 jew 3 jew kroniku estensiv (195/600, [32.5%]) fil- bidu tal-istudju.
English: ECOFF values do not equate to clinical breakpoints.
Maltese: ECOFF mhumiex daqs il-breakpoints kliniċi.
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02AC04
Maltese: Antimikotiċi għall-użu sistemiku, derivattivi tat-triazole, Kodiċi ATC:
English: Recommended dose is shown in Table 1.
Maltese: Id-doża rakkomandata hija murija f'Tabella 1.
English: The mean duration of therapy was 80 days for posaconazole and 77 days for fluconazole.
Maltese: It-terapija damet medja ta' 80 jum għal posaconazole u 77 jum għal fluconazole.
English: There is no information regarding cross-sensitivity between posaconazole and other azole antifungal agents.
Maltese: M'hemmx informazzjoni dwar sensittività trasversali bejn posaconazole u sustanzi antifungali azole oħra.
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 ergot (ergotamine u dihydroergotamine),
English: Posaconazole is also available as 40 mg/mL oral suspension and 300 mg concentrate for solution for infusion.
Maltese: Posaconazole huwa disponibbli wkoll bħala 40 mg/mL suspensjoni orali u 300 mg ta' konċentrat għal soluzzjoni għall-infużjoni.
English: Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for pglycoprotein (P-gp) efflux in vitro.
Maltese: Posaconazole jiġi metabolizzat permezz ta' glukoronidazzjoni tal-UDP (enzimi ta' fażi 2) u huwa sottostrat għall-effluss tal-glikoproteina-p (P-gp) in vitro.
English: A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomization.
Maltese: Endpoint sekondarju importanti kienet l-inċidenza ta' IFIs ippruvati/probabbli 100 jum wara l-għażla aleatorja.
English: Hepatic toxicity
Maltese: Tossiċità epatika
English: Prophylaxis in GVHD Study 316
Maltese: Profilassi filGVHD Studju 316
English: The pharmacokinetics of posaconazole oral suspension have been evaluated in paediatric patients.
Maltese: Il-farmakokinetika tas-suspensjoni orali ta' posaconazole ġiet evalwata f'pazjenti pedjatriċi.
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 8-17 years of age (776 ng/mL) were similar to concentrations from 194 patients 18-64 years of age (817 ng/mL).
Maltese: 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: 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: posaconazole għall-profilassi ta' infezzjonijiet fungali invażivi (Studji 316 u 1899).
English: Posaconazole may substantially increase plasma levels of HMG-CoA reductase inhibitors that are metabolised by CYP3A4.
Maltese: Posaconazole jista' jżid il-konċentrazzjonijiet fil-plażma tal-inibituri ta' HMG-CoA reductase li jiġu metabolizzati permezz ta' CYP3A4.
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 1st day, 200 mg twice daily on the 2nd day, then 400 mg twice daily x 8 Days) by 21% and 23%,
Maltese: L-għoti ta' dożi ripetuti ta' fosamprenavir (700 mg darbtejn kuljum x 10 ijiem) naqqas is-Cmax u l-AUC tas-suspensjoni orali ta' posaconazole (200 mg darba kuljum fl-1wel jum, 200 mg darbtejn kuljum fit-2ni jum, imbagħad 400 mg darbtejn kuljum x 8
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: Gastrointestinal dysfunction
Maltese: Disfunzjoni gastro-intestinali
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 8.5-fold greater than the concentrations obtained at therapeutic doses in humans.
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' 8.5 darbiet akbar millkonċentrazzjonijiet miksuba b'dożi terapewtiċi fil-bnedmin.
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 tal- fwied ħafif (Child-Pugh Klassi A), moderat (Child-Pugh Klassi B) jew sever (Child-Pugh Klassi C) (sitta għal kull grupp), lAUC medja kienet 1.3 sa 1.6 darbiet ogħla meta mqabbla ma' dik għall- individwi ta' kontroll imqabbla b'funzjoni tal-fwied normali.
English: FLU = fluconazole; ITZ = itraconazole; POS = posaconazole.
Maltese: FLU = fluconazole;