FrancophonIA/ELRC3.0 huggingface dataset:
English: Anidulafungin has a predominant elimination half-life of approximately 24 hours that characterizes the majority of the plasma concentration-time profile, and a terminal half-life of 40-50 hours that characterises the terminal elimination phase of the profile.
Maltese: Anidulafungin għandu half-life predominanti ta' l-eliminazzjoni ta' madwar 24 siegħa li tikkaratterizza l-biċċa l-kbira tal-profil talkonċentrazzjoni fil-plasma mal-ħin, u half-life terminali ta' 40-50 siegħa li tikkaratterizza l-fażi finali ta' l-eliminazzjoni tal-profil.
English: A total of 14 neutropenic patients with microbiologically confirmed invasive candidiasis (MITT population) were enrolled in the study (11 anidulafungin; 3 caspofungin).
Maltese: Total ta' 14-il pazjent newtropeniku b'candidiasis invażiva kkonfermata b'mod mikrobijoloġiku (popolazzjoni MITT) ġew irreġistrati fl-istudju (11 anidulafungin; 3 caspofungin).
English: Global success in the MITT population: primary and secondary endpoints Anidulafungin Fluconazole
Maltese: MITT: punti tat-tmiem primarji u sekondarji Anidulafungin Fluconazole
English: A total of 46 patients were included in the analysis.
Maltese: Total ta' 46 pazjent ġew inklużi fl-analiżi.
English: The most common pathogens isolated from a deep tissue site at baseline were C. albicans (64.3%; 83 of 129), C. glabrata (31.0%; 40 of 129), C. tropicalis (11.6%; 15 of 129), and C. krusei (5.4%; 7 of 129).
Maltese: Il-patoġeni l-iżjed komuni iżolati minn post ta' tessuti fondi ta' taħt il-ġilda fil-linja bażi kienu C. albicans (64.3%; 83 minn 129), C. glabrata (31.0%; 40 minn 129), C. tropicalis (11.6%; 15 minn 129), u C. krusei (5.4%; 7 minn 129).
English: Pharmacotherapeutic group: - Antimycotics for systemic use, other antimycotics for systemic use.ATC code: JO2AX06
Maltese: Antimikotiċi għal użu sistemiku, antimikotiċi oħra għal użu sistemiku Kodiċi ATC:
English: Anidulafungin has shown fungicidal activity against Candida species and activity against regions of active cell growth of the hyphae of Aspergillus fumigatus.
Maltese: Anidulafungin wera attività fungiċida kontra speċi ta' Candida u attività kontra reġjuni ta' tkabbir attiv taċ-ċelloli tal-filament fil-miċelju ta' l-Aspergillus fumigatus.
English: The successful global response rate at End of Intravenous Treatment (primary endpoint) was 26/46 (56.5%) and End of All Treatment was 24/46 (52.2%).
Maltese: Ir-rata ta' rispons globali ta' suċċess fit-Tmiem tat-Trattament ġol-Vina (punt tat-tmiem primarju) kienet 26/46 (56.5%) u fit-Tmiem tat-Trattament Kollu kienet 24/46 (52.2%).
English: Pfizer Manufacturing Belgium NV Rijksweg 12
Maltese: Pfizer Manufacturing Belgium N.V.
English: Exacerbation of infusion-related reactions by co-administration of anaesthetics has been seen in a nonclinical (rat) study (see section 5.3).
Maltese: Aggravament ta' reazzjonijiet relatati ma' l-infużjoni bl-għoti ta' anestetiċi ma' anidulafungin intwera fi studju mhux kliniku (fuq il-firien) (ara sezzjoni 5.3).
English: A total of 129 patients were included in the analysis.
Maltese: Total ta' 129 pazjent kienu inklużi fl-analiżi.
English: EUCAST Breakpoints
Maltese: Punti kritiċi tal-EUCAST
English: Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm and hypotension.
Maltese: Reazzjonijiet avversi relatati mal-infużjoni ta' anidulafungin, inkluż raxx, urtikarja, fwawar, prurite, qtugħ ta' nifs, bronkospażmu, u pressjoni baxxa, kienu rrapurtati.
English: The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3); the successful global response rate at the End of All Treatment was 8/11 (72.7%) for anidulafungin and 3/3 (100.0%) for caspofungin (difference -27.3, 95% CI -80.9, 40.3).
Maltese: 0%) għal caspofungin (differenza -27.3, 95% CI -80.9, 40.3); ir-rata ta' rispons globali ta' suċċess fit-Tmiem tat-Trattament Kollu kienet ta' 8/11 (72.7%) għal anidulafungin u 3/3 (100.
English: Tel: +44 (0)1304 616161
Maltese: Pfizer Limited Tel: + 44 (0)1304 616161
English: A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
Maltese: F-Jum 1għandha tingħata loading dose waħda ta' 200 mg, segwita suċċessivament minn 100 mg kuljum.
English: - The other ingredients are: fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide
Maltese: - Is-sustanzi l-oħra huma fructose, mannitol, polysorbate 80, tartaric acid, sodium hydroxide (għal aġġustament tal-pH), hydrochloric acid (għal aġġustament tal-pH)
English: In a clinical study of subjects with mild, moderate, severe or end stage (dialysis-dependent) renal insufficiency, anidulafungin pharmacokinetics were similar to those observed in subjects with normal renal function.
Maltese: Fi studju kliniku ta' suġġetti b'insuffiċjenza renali ħafifa, moderata, severa jew ta' l-aħħar stadju (dipendenti fuq id-dijalisi), ilfarmakokinetiċi ta' anidulafungin kienu simili għal dawk osservati f'suġġetti b'funzjoni tal-kliewi normali.
English: All-cause mortality up to the 6 Week FollowUp visit for anidulafungin (MITT population) was 4/11 (36.4%) and 2/3 (66.7%) for caspofungin.
Maltese: Il-mortalità mill-kawżalità kollha saż-żjara ta' Segwitu ta' 6 Ġimgħat għal anidulafungin (popolazzjoni MITT) kienet ta' 4/11 (36.4%) u 2/3 (66.7%) għal caspofungin.
English: The most common sites of infection included the peritoneal cavity (54.3%; 70 of 129), hepatobiliary tract (7.0%; 9 of 129), pleural cavity (5.4%; 7 of 129) and kidney (3.1%; 4 of 129).
Maltese: L-iżjed postijiet komuni tal-infezzjoni kienu jinkludu l-kavità peritonali (54.3%; 70 minn 129), is-sistema tal-fwied u tal-marrara (7.0%; 9 minn 129), il-kavità plewrali (5.4%; 7 minn 129) u l-kliewi (3.1%; 4 minn 129).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini: http://www.ema.europa.eu/
English: - Convulsion (seizure) - Headache - Vomiting - Changes in blood tests of liver function - Rash, pruritis (itching) - Changes in blood tests of kidney function - Abnormal flow of bile from the gallbladder into the intestine (cholestasis) - High blood sugar - High blood pressure - Low blood pressure - Sudden contraction of the muscles around the airways resulting in wheezing or coughing - Difficulty of breathing
Maltese: - Konvulżjoni (aċċessjoni) - Uġigħ ta' ras - Rimettar - Bidliet fit-testijiet tad-demm dwar il-funzjoni tal-fwied - Raxx, prurite (ħakk) - Bidliet fit-testijiet tad-demm dwar il-funzjoni tal-kliewi - Fluss abnormali ta' bili mill-bużżieqa tal-marrara għal ġol-imsaren (kolestażi) - Zokkor għoli fid-demm - Pressjoni tad-demm għolja - Pressjoni tad-demm baxxa - Kontrazzjoni f'daqqa tal-muskoli madwar il-passaġġi tal-arja li jirriżulta fi tħarħir jew sogħla - Diffikultà biex tieħu n-nifs
English: Parenterally administered anidulafungin was effective against Candida species in immunocompetent and immunocompromised mouse and rabbit models.
Maltese: Anidalfungin mogħti b'mod parenterali, kien effettiv kontra speċi ta' Candida f'mudelli ta' ġrieden u fniek immunokompetenti u immunokompromessi.
English: Anidulafungin crossed the placental barrier in rats and was detected in foetal plasma.
Maltese: Anidulafungin għadda minn ġol-barrier plaċentali u kien rilevat fil-plasma tal-fetu.
English: ECALTA 100 mg powder for concentrate for solution for infusion anidulafungin
Maltese: ECALTA 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Anidulafungin
English: The rate of infusion should not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions) (see sections 4.2, 4.4 and 4.8).
Maltese: Ir-rata ta' infużjoni ma għandiex tkun iktar minn 1.1mg/min (li hija ekwivalenti għal 1.4mL/min meta rikostitwita u dilwita skont l-istruzzjonijiet) (ara sezzzjonijiet 4.2, 4.4 u 4.8).
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Maltese: Billi inti se tingħata din il-mediċina taħt sorveljanza medika mill-qrib, mhux probabbli li tista' tintesa doża.
English: Systemic exposure following daily maintenance dose of 0.75 and 1.5 mg/kg/day in this population were comparable to those observed in adults following 50 and 100 mg/day, respectively.
Maltese: L-espożizzjoni sistemiku wara doża ta' manutenzjoni kuljum ta' 0.75 u 1.5 mg/kg/ġurnata f'din il-popolazzjoni kien paragunabbli ma' dak osservat f'persuni adulti wara 50 u 100 mg/ġurnata, rispettivament.
English: In vivo, the ring-opened product is subsequently converted to peptidic degradants and eliminated mainly through biliary excretion.
Maltese: In vivo, il-prodott ring-opened jiġi suċċessivament konvertit f'degradanti peptidiċi u mneħħi prinċipalment permezz ta' eskrezzjoni biljari.
English: No dose limiting toxicity was observed in a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (3 x Upper Limit of Normal (ULN)).
Maltese: L-ebda tossiċità li tillimita d-doża ma kienet osservata fi studju ta' għaxar suġġetti b'saħħithom li ngħataw loading dose ta' 260 mg segwita b'130 mg kuljum; 3 mill-10 suġġetti esperjenzaw żidiet momentanji bla sintomi fit-transaminases (3 x Limitu ta' Fuq tan-Normal (ULN - Upper Limit of Normal)).
English: Eligible patients received either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or caspofungin (70 mg intravenous loading dose followed by 50 mg intravenous daily) (2:1 randomization).
Maltese: Il-pazjenti eliġibbli rċevew jew anidulafungin (loading dose ta' 200 mg ġol-vina segwita minn 100 mg ġol-vina kuljum) jew caspofungin (loading dose ta' 70 mg ġolvina segwita minn 50 mg ġol-vina kuljum) (każwalità ta' 2:1).
English: Uncommon to
Maltese: Komuni Ħafna
English: Infusion-related adverse events are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.8).
Maltese: Reazzjonijiet avversi relatati malinfużjoni ma kienux frekwenti meta r-rata tal-infużjoni ta' anidulafungin ma kinitx aktar minn 1.1 mg/minuta (ara sezzjoni 4.8).
English: Patients were randomised to receive either anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) or fluconazole (800 mg intravenous loading dose followed by 400 mg intravenous daily), and were stratified by APACHE II score (≤20 and >20) and the presence or absence of neutropaenia.
Maltese: Il-pazjenti kienu magħżula b'mod każwali biex jirċievu jew anidulafungin (loading dose ta' 200 mg ġol-vina segwita minn 100 mg ġol-vina kuljum) jew fluconazole (loading dose ta' 800 mg ġol-vina segwita minn 400 mg ġol-vina kuljum), u ġew stratifikati skont l-iskor APACHE II (≤20 and >20) u l-preżenza jew nuqqas ta' neutropenia.
English: A low intersubject variability in systemic exposure (coefficient of variation ~25%) was observed.
Maltese: Kienet osservata varjabilità baxxa bejn is-suġġetti f'espożizzjoni sistemika (koeffiċjent ta' varjazzjoni~25%).
English: Minimum duration of infusion
Maltese: Ħin minimu ta' Infużjoni
English: With the 200/100 mg daily dose regimen at an infusion rate of 1.1 mg/min, the steady state Cmax and trough concentrations (Cmin) could reach approximately 7 and 3 mg/l, respectively, with an average steady state AUC of approximately 110 mgh/l.
Maltese: Bir-reġim ta' dożaġġ ta' 200/100 mg kuljum b'rata ta' infużjoni ta' 1.1 mg/min, il-Cmax stabbli u lkonċentrazzjonijiet minimi (Cmin) jistgħu jilħqu madwar 7 u 3 mg/l, rispettivament, b'medja ta' AUC stabbli ta' madwar 110 mgh/l.
English: Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.4).
Maltese: Reazzjonijiet assoċjati malinfużjonijiet huma rari meta r-rata tal-infużjoni ta' anidulafungin ma taqbiżx 1.1 mg/minuta (ara sezzjoni 4.4).
English: In 3 month studies, evidence of liver toxicity, including elevated enzymes and morphologic alterations, was observed in both rats and monkeys at doses 4- to 6-fold higher than the anticipated clinical therapeutic exposure.
Maltese: Fi studji ta' 3 xhur, evidenza ta' tossiċità tal-fwied, fosthom enzimi elevati u bidliet morfoloġiċi, ġiet osservata kemm fil-firien kif ukoll fix-xadini b'dożi 4 sa 6 darbiet ogħla mill-espożizzjoni terapewtika klinika mistennija.
English: cells/mm or classified by the investigator as neutropenic at baseline) with microbiologically confirmed invasive candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative versus caspofungin and 4 open-label, non-comparative).
Maltese: WBC ≤ 500 ċellola/mm jew klassifikati mill-investigatur bħala newtropeniċi fil-linja bażi) b'candidiasis invażiva kkonfermata b'mod mikrobijoloġiku kienet ivvalutata f'analiżi ta' informazzjoni miġbura minn 5 studji prospettivi (1 komparattiv vs caspofungin u 4 open-label, mhux komparattivi).
English: Store in a refrigerator (2C - 8C).
Maltese: Żomm fi friġġ (2 oC- 8
English: In clinically stable patients, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Maltese: F'pazjenti klinikament stabbli, ilbidla għal terapija ta' azole orali kienet permessa wara mill-inqas 5 sa 10 ġranet ta' trattament blanidulafungin.
English: The reconstituted solution contains 3.33 mg/mL anidulafungin and the diluted solution contains 0.77 mg/mL anidulafungin.
Maltese: Is-soluzzjoni rikostitwita fiha 3.33 mg/mL anidulafungin u s-soluzzjoni dilwita fiha 0.77 mg/mL anidulafungin.
English: Patients with microbiologically confirmed invasive candidiasis (MITT population) and neutropenia were identified in an analysis of pooled data from 4 similarly designed prospective, open-label, noncomparative studies.
Maltese: Pazjenti b'candidiasis invażiva kkonfermata b'mod mikrobijoloġiku (popolazzjoni MITT) u newtropenja ġew identifikati f'analiżi ta' informazzjoni miġbura minn 4 studji prospettivi ddisinjati b'mod simili, mhux komparattivi u open-label.
English: Pfizer Pharma PFE GmbH
Maltese: PFE GmbH
English: C. albicans (63.8% anidulafungin, 59.3% fluconazole), followed by C. glabrata (15.7%, 25.4%), C. parapsilosis (10.2%, 13.6%) and C. tropicalis (11.8%, 9.3%) - with 20, 13 and 15 isolates of the last 3 species, respectively, in the anidulafungin group.
Maltese: 2%, 13.6%) u C. tropicalis (11.8%, 9.3%) - b'20, 13 u 50 isolati ta' laħħar 3 speċi rispettivament, fil-grupp ta' anidulafungin.
English: White to off-white solid.
Maltese: Il-ħin tar-rikostituzzjoni jista' jieħu sa 5 minuti.
English: Pfizer Luxembourg SARL filialas Lietuvoje
Maltese: Pfizer Luxembourg SARL filialas Lietuvoje Tel.
English: Other medicines and ECALTA
Maltese: Mediċini oħra u ECALTA
English: In the 4 open-label studies, a switch to oral azole therapy was permitted after at least 5 to 10 days of treatment with anidulafungin.
Maltese: Fl-4 studji openlabel, il-bidla għal terapija ta' azole orali kienet permessa wara mill-inqas 5 sa 10 ġranet ta' trattament bl-anidulafungin.
English: This medicine contains fructose (a type of sugar).
Maltese: Din il-mediċina fiha l-fructose (tip ta' zokkor).
English: Coagulopathy
Maltese: Koagulopati ja
English: [Justification for not including Braille accepted.]
Maltese: [Il-Ġustifikazzjoni biex ma' jkunx inkluż il-Braille hija aċċettata]
English: - Low blood potassium (hypokalaemia) - Diarrhoea - Nausea
Maltese: - Potassju baxx fid-demm (ipokalimja) - Dijarea - Dardir
English: The efficacy of anidulafungin in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm
Maltese: L-effikaċja tal-anidulafungin f'pazjenti newtropeniċi adulti (definiti bħala l-għadd assolut ta' newtrofil ≤ 500 ċellola/mm
English: This results in inhibition of the formation of 1,3--D-glucan, an essential component of the fungal cell wall.
Maltese: Dan jirriżulta f'inibizzjoni tal-ħolqien ta' 1,3--D-glucan, komponent essenzjali tal-ħajt taċ-ċelloli fungali.
English: The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult patients with microbiologically confirmed deep tissue candidiasis was assessed in an analysis of pooled data from 5 prospective studies (1 comparative and 4 open-label).
Maltese: L-effikaċja tal-anidulafungin (loading dose ta' 200 mg ġol-vina segwita minn 100 mg ġol-vina kuljum) f'pazjenti adulti b'candidiasis f'tessuti fondi ta' taħt il-ġilda kkonfermata b'mod mikrobijoloġiku kienet ivvalutata f'analiżi ta' informazzjoni miġbura minn 5 studji prospettivi (1 komparattiv u 4 open-label).
English: Very Common
Maltese: Komuni sa
English: Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided that they were able to tolerate oral medicinal products and were afebrile for at least 24 hours, and that the most recent blood cultures were negative for Candida species.
Maltese: Ilpazjenti fiż-żewġ gruppi ta' studju kienu permessi li jaqilbu għal fluconazole orali wara talanqas 10 ijiem ta' terapija ġol-vina, bil-kondizzjoni li kienu kapaċi jittolleraw prodotti mediċinali orali u ma kellhomx deni għal mill-anqas 24 siegħa, u li l-aktar kolturi riċenti tad-demm kienu negattivi għal speċi Candida.
English: ECALTA can be given without regard to the timing of haemodialysis (see section 5.2).
Maltese: ECALTA jista' jingħata mingħajr rigward għall-ħin talħemodijalisi (ara sezzjoni 5.2).
English: Most clinical cases involve caspofungin treatment.
Maltese: Il-kampjuni għal koltura fungali għandhom jinkisbu qabel it-terapija.
English: This will be followed by a daily dose of 100 mg (maintenance dose).
Maltese: Din se tkun segwita minn doża ta' kuljum ta' 100 mg (doża ta' manutenzjoni).
English: Dosage adjustments are not required based on HIV positivity, irrespective of concomitant antiretroviral therapy.
Maltese: M'hemmx bżonn ta' aġġustament fid-doża bbażat fuq pożittività għall-HIV, irrispettivament mitterapija antiretrovirali konkomitanti.
English: It is recommended that ECALTA be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions).
Maltese: Huwa rrakkomandat li ECALTA jingħata b'rata ta' infużjoni li ma taqbiżx 1.1 mg/minuta (ekwivalenti għal 1.4 ml/minuta meta jkun rikostitwit u dilwit skont l-istruzzjonijiet).
English: The majority of patients had Apache II scores ≤ 20 and very few were neutropenic.
Maltese: Il-maġġoranza tal-pazjenti kellhom punteġġi Apache II ta' ≤ 20 u ftit biss kienu newtropeniċi.
English: Renal and Urinary Disorders
Maltese: Disturbi filKliewi u fisSistema Urinarja
English: Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes.
Maltese: Anidulafungin mhux sottostrat, induttur, jew inibitur klinikament rilevanti ta' isoenzimi taċ-ċitokromu P450.
English: Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and faeces 8 weeks post-dose.
Maltese: Ammonti negliġibbli ta' radjuattività derivata mill-mediċina kienu rkuprata fid-demm, fl-awrina, u fl-ippurgar 8 ijiem wara d-doża.
English: Candida Species
Maltese: Speċi ta' Candida
English: During clinical trials, a single 400 mg dose of anidulafungin was inadvertently administered as a loading dose.
Maltese: Waqt provi kliniċi, doża waħda ta' 400 mg anidulafungin ġiet mogħtija bi żball bħala loading dose.
English: The population pharmacokinetic analysis showed that median clearance differed slightly between the elderly group (patients ≥ 65, median CL = 1.07 l/h) and the non-elderly group (patients < 65, median CL = 1.22 l/h), however the range of clearance was similar.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni wriet li t-tneħħija medjana varjat daqsxejn bejn il-grupp anzjan (pazjenti ≥ 65, CL medjana = 1.07 l/siegħa) u l-grupp mhux anzjan (pazjenti < 65, CL medjana = 1.22 l/siegħa), madankollu l-medda tat-tneħħija kienet simili.
English: Gammaglutamyltrans ferase increased
Maltese: Żieda filgammaglutamyltran sferase
English: Approximately 30% of the administered radioactive dose was eliminated in the faeces over 9 days, of which less than 10% was intact drug.
Maltese: Madwar 30% tad-doża radjuattiva amministrata ġiet eliminata fl-ippurgar fuq 9 ijiem, li minnhom anqas minn 10% kienet mediċina intatta.
English: Experimental infections included disseminated C. albicans infection in neutropenic rabbits, oesophageal/oropharyngeal infection of neutropenic rabbits with fluconazole-resistant C. albicans and disseminated infection of neutropenic mice with fluconazole-resistant C. glabrata.
Maltese: Infezzjonijiet ta' prova kienu jinkludu tixrid ta' infezzjoni C. albicans fi fniek newtropeniċi, infezzjonijiet fl-esofagu jew fil-ħalq u l-farinġi ta' fniek newtropeniċi b'C. albicans reżistenti għal fluconazole, u infezzjoni imxerrrda fi ġrieden newtropeniċi bi C. glabrata reżistenti għal fluconazole.
English: End of IV Therapy (1º endpoint) Candidaemia only Other sterile sites Peritoneal fluid/IA c abscess
Maltese: Tmiem tar-IV Terapija (l-Ewwel punt tat-tmiem) Candidemia biss Siti sterili oħrajn Fluwidu peritonali/Axxess IA Oħrajn
English: Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion obtaining an anidulafungin concentration of 0.77 mg/mL.
Maltese: Ittrasferixxi b'mod asettiku l-kontenut tal-kunjett(i) rikostitwit(i) ġo borża (jew flixkun) għal ġol-vini li jkun fiha 9 mg/mL (0.9%) sodium chloride għal infużjoni jew 50 mg/mL (5%) glukożju għal infużjoni biex tinkiseb konċentrazzjoni ta' anidulafungin ta' 0.77 mg/mL.
English: The efficacy of anidulafungin (200 mg intravenous loading dose followed by 100 mg intravenous daily) in adult neutropenic patients (defined as absolute neutrophil count ≤ 500 cells/mm
Maltese: L-effikaċja tal-anidulafungin (loading dose ta' 200 mg ġol-vina segwita minn 100 mg ġol-vina kuljum) f'pazjenti newtropeniċi adulti (definiti bħala l-għadd assolut tan-newtrofili ≤ 500 ċellola/mm
English: ECALTA will always be prepared and given to you by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only).
Maltese: ECALTA dejjem se jiġi ppreparat u mogħti lilek minn tabib jew professjonist fil-kura tas-saħħa (hemm aktar tagħrif dwar il-metodu ta' preparazzjoni fl-aħħar ta' dan il-fuljett fit-taqsima għal professjonisti mediċi u tal-kura tas-saħħa biss).
English: A successful global response required clinical improvement and microbiological eradication.
Maltese: Rispons globali ta' suċċess kien jeħtieġ titjib kliniku u qerda totali mikrobijoloġika.
English: ECALTA contains the active substance anidulafungin and is prescribed in adults to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis.
Maltese: ECALTA fih is-sustanza attiva anidulafungin u jingħata fl-adulti sabiex tiġi kkurata tip ta' infezzjoni fungali fid-demm jew organi interni oħra msejjħa kandidjasi invażiva.
English: Peritoneal cavity
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: In case of overdose, adverse reactions may occur as mentioned in section 4.8.
Maltese: F'każ ta' doża eċċessiva, jista' jkun hemm reazzjonijiet avversi kif imsemmi f'sezzjoni 4.8.
English: The pharmacokinetics of anidulafungin in patients with fungal infections are similar to those observed in healthy subjects based on population pharmacokinetic analyses.
Maltese: Il-farmakokinetiċi ta' anidulafungin f'pazjenti b'infezzjonijiet fungali huma simili għal dawk osservati f'suġġetti b'saħħithom ibbażati fuq analiżi farmakokinetiċi tal-popolazzjoni.
English: Duration of treatment In general, antifungal therapy should continue for at least 14 days after the last positive culture.
Maltese: B'mod ġenerali, it-terapija antifungali għandha tkompli għal mill-anqas 14-il jum wara l-aħħar koltura pożittiva.