FrancophonIA/ELRC3.0 huggingface dataset:
English: The company applied for a change (variation) to the marketing authorisation to add a new indication to be recognised by Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Maltese: Il'kumpanija applikat għal bidla (varjazzjoni) fl'awtorizzazzjoni għat'tqegħid fis'suq sabiex tiżdied indikazzjoni ġdida biex tiġi rikonoxxuta mill'Awstrija, il'Belġju, il'Bulgarija, Ċipru, ir'Repubblika Ċeka, id'Danimarka, l'Estonja, il'Finlandja, Franza, il'Greċja, l'Ungerija, l'Iżlanda, l'Irlanda, l'Italja, il'Latvja, il'Litwanja, il'Lussemburgu, in'Netherlands, in'Norveġja, il'Polonja, il'Portugall, ir'Rumanija, is'Slovakkja, is'Slovenja, Spanja, l'Iżvezja u r'Renju Unit (l'”Istati Membri kkonċernati”).
English: Seresto is an antiparasitic collar containing 10% imidacloprid and 4.5% flumethrin.
Maltese: Seresto huwa kullar antiparassitiku li fih 10 % imidakloprid u 4.5 % flumethrin.
English: What are the conclusions of the CVMP?
Maltese: X'inhuma l'konklużjonijiet tas'CVMP?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25 May 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom25 ta' Mejju 2018 EMA/468944/2018
English: Outcome of a procedure under Article 13 of Regulation (EC) No 1234/2008
Maltese: Riżultat ta' proċedura skont l'Artikolu 13 tar'Regolament (KE) Nru 1234/2008
English: What is Seresto?
Maltese: X'inhu Seresto?
English: The company that markets the product is Bayer Vital GmbH.
Maltese: Il'kumpanija li tqiegħed il'prodott fis'suq hija Bayer Vital GmbH.
English: On 15 February 2018, the European Medicines Agency (the Agency) completed an arbitration procedure for Seresto and its associated name Foresto.
Maltese: Fil'15 ta' Frar 2018, l'Aġenzija Ewropea għall'Mediċini (l'Aġenzija) temmet proċedura ta' arbitraġġ għal Seresto u l'isem assoċjat tiegħu Foresto.
English: The proposed new indication was against the disease leishmaniosis, which is caused by the parasite Leishmania infantum and transmitted to dogs by sand flies.
Maltese: L'indikazzjoni ġdida proposta kienet kontra l'marda lexmanjożi, li tiġi kkawżata mill'parassita Leishmania infantum u tiġi trażmessa lill'klieb mis'sand flies.
English: The European Commission issued an EU-wide legally binding decision to implement the CVMP recommendations on Seresto on 25 May 2018.
Maltese: Il'Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti madwar l'UE sabiex timplimenta r'rakkomandazzjonijiet tas'CVMP dwar Seresto fil'25 ta' Mejju 2018.
English: Seresto is authorised in the European Union (EU) under the decentralised procedure with Germany as the reference Member State.
Maltese: Seresto huwa awtorizzat fl'Unjoni Ewropea (UE) skont il'proċedura deċentralizzata bil'Ġermanja bħala l'Istat Membru ta' referenza.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the efficacy of Seresto in the reduction of the risk of infection with Leishmania infantum via transmission by sand flies for up to 8 months had been sufficiently demonstrated and therefore the variation to the marketing authorisation can be approved in all concerned Member States.
Maltese: Abbażi tal'evalwazzjoni tad'data disponibbli attwalment u d'diskussjoni xjentifika fi ħdan il'Kumitat, is'CVMP ikkonkluda li l'effikaċja ta' Seresto fit'tnaqqis tar'riskju ta' infezzjoni b'Leishmania infantum permezz tat'trażmissjoni minn sand flies sa 8 xhur kienet intweriet biżżejjed u għalhekk il'varjazzjoni għall'awtorizzazzjoni għat'tqegħid fis'suq tista' tiġi approvata fl'Istati Membri kkonċernati kollha.
English: Because these Member States were not able to reach an agreement, the German Federal Office of Consumer Protection and Food Safety (BVL) referred the matter to the CVMP for arbitration on 18 August 2017.
Maltese: Minħabba li dawn l'Istati Membri ma kinux kapaċi jaslu għal ftehim, l'Uffiċċju Federali Ġermaniż għall'Protezzjoni tal'Konsumatur u s'Sikurezza Alimentari (BVL) irrefera l'kwistjoni lis'CVMP għal arbitraġġ fit'18 ta' Awwissu 2017.
English: It is indicated for the treatment and prevention of infestations with fleas, ticks and lice in dogs and cats, and provides indirect protection against the diseases babesiosis and ehrlichiosis, which can be transmitted to dogs by ticks.
Maltese: Dan huwa indikat għall'kura u l'prevenzjoni ta' infestazzjonijiet bi briegħed, qurdien u qamel fil'klieb u l'qtates, u jipprovdi protezzjoni indiretta kontra l'mard babeżjożi u erlikjożi, li jistgħu jiġu trażmessi lill'klieb mill'qurdien.
English: However, the CVMP recommended inclusion of the statement, in the product information of Seresto, that the demonstrated repellent efficacy against sand flies was variable.
Maltese: Madankollu, is'CVMP irrakkomanda l'inklużjoni tad'dikjarazzjoni, fl'informazzjoni dwar il'prodott ta' Seresto, li l'effikaċja repellenti kontra sand flies li ntweriet kienet varjabbli.
English: Why was Seresto reviewed?
Maltese: Għaliex ġie rieżaminat Seresto?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the change to the marketing authorisation for Seresto to add a new indication can be granted.
Maltese: Il'Kumitat għall'Prodotti Mediċinali għall'Użu Veterinarju (CVMP) tal'Aġenzija kkonkluda li tista' tingħata l'bidla għall'awtorizzazzjoni għat'tqegħid fis'suq għal Seresto sabiex tiżdied indikazzjoni ġdida.
English: 10 ml (3.5 mg/ml) 5 (5 x 1) vial (multipack)
Maltese: 5 (5 x 1) kunjetti (pakkett multiplu)
English: Pack size bottle (HDPE)
Maltese: Daqs tal-pakkett flixkun (HDPE)
English: blister (aclar/alu) 56 tablets blister (aclar/alu);card
Maltese: folja (aclar/alu);kard 28 pillola
English: 4 (1x4) vials
Maltese: 4 (1x4) kunjetti
English: 150 mg/ml Solution for injection
Maltese: 150 mg/ml
English: EMA/379048/2013 EMEA/H/C/002349
Maltese: 27 ta' Ġunju 2013 EMA/442983/2013 EMEA/H/C/002349
English: What is IXinity?
Maltese: X'inhu IXinity?
English: It was expected to be available as a powder and solvent to make up a solution for injection (500, 1,000 and 1,500 units).
Maltese: Kien mistenni li jkun disponibbli bħala trab u solvent biex jagħmlu soluzzjoni għal injezzjoni (500, 1,000 u 1,500 unità).
English: Withdrawal of the marketing authorisation application for IXinity (trenonacog alfa) EMA/379048/2013
Maltese: (trenonacog alfa) EMA/442983/2013
English: IXinity is a medicine that contains the active substance trenonacog alfa (recombinant human factor IX).
Maltese: IXinity huwa mediċina li fiha s-sustanza attiva trenonacog alfa (fattur IX rikombinanti uman).
English: The active substance in IXinity is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce the clotting factor.
Maltese: Is-sustanza attiva f'IXinity hija prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': issir minn ċelloli li fihom ġie introdott ġene (DNA) li jagħmilhom kapaċi jirriproduċu l-fattur ta' tagħqid.
English: The active substance in IXinity, trenonacog alfa, is a form of human factor IX that replaces the missing factor IX in the blood, temporarily controlling the bleeding disorder.
Maltese: Is-sustanza attiva f'IXinity, trenonacog alfa, hija forma tal-fattur IX uman li tissostitwixxi l-fattur IX nieqes fid-demm, li temporanjament tikkontrolla d-disturb ta' fsada.
English: On 13 June 2013, Cangene Europe Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IXinity, for the treatment and prevention of bleeding in patients with haemophilia B.
Maltese: Fit-13 ta' Ġunju 2013, Cangene Europe Ltd. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għattqegħid fis-suq għal IXinity, għall-kura u l-prevenzjoni ta' fsada f'pazjenti bl-emofilja B.
English: IXinity was expected to be used to prevent and treat bleeding episodes in patients at least 12 years of age with haemophilia B (an inherited bleeding disorder caused by lack of factor IX).
Maltese: IXinity kien mistenni li jintuża fil-prevenzjoni u l-kura ta' episodji ta' fsada f'pazjenti ta' mill-inqas 12-il sena li jbatu minn emofilja B (disturb ta' fsada li jintiret ikkawżat minn nuqqas tal-fattur IX ).
English: Withdrawal of the marketing authorisation application for IXinity (trenonacog alfa)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal IXinity (trenonacog alfa)
English: This causes problems with blood clotting, leading to bleeding into the joints, muscles and internal organs.
Maltese: Dan jikkawża problemi fit-tagħqid tad-demm, li jwassal għal fsada fil-ġogi, fil-muskoli u fl-organi interni.
English: What was IXinity expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża IXinity?
English: The company presented the results of studies involving 42 patients with moderate or severe haemophilia B who were given IXinity for treatment or prevention of bleeding, including some patients undergoing surgery.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studji li fihom ħadu sehem 42 pazjent bl-emofilja B moderata jew severa li ngħataw IXinity għall-kura jew il-prevenzjoni ta' fsada, inkluż xi pazjenti li kienu għaddejjin minn kirurġija.
English: The company refined the manufacturing process for IXinity to remove these proteins, but it was not clear if the refined medicine would act in the same way as the original product in the studies, and the CHMP recommended further study in patients.
Maltese: Il-kumpanija rfinat il-proċess tal-manifattura għal IXinity biex jitneħħew dawn il-proteini, iżda ma kienx ċar jekk il-mediċina rfinuta kinitx se taġixxi bl-istess mod bħall-prodott oriġinali fl-istudji, u s-CHMP irrakkomanda studju ulterjuri fuq pazjenti.
English: Patients with haemophilia B do not have sufficient levels of factor IX, a protein in the blood that helps it to clot normally.
Maltese: Pazjenti bl-emofilja B m'għandhomx livelli biżżejjed tal-fattur IX, proteina fid-demm li tgħinu jagħqad b'mod normali.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that IXinity could not have been approved for the prevention and treatment of bleeding episodes in patients with haemophilia B.
Maltese: Abbażi tar-reviżjoni tad-dejta u t-tweġibiet tal-kumpanija għal-listi ta' mistoqsijiet tas-CHMP, fiż-żmien tal-irtirar is-CHMP kellu xi tħassib u kien tal-fehma provviżorja li IXinity ma setax jiġi approvat għallprevenzjoni u l-kura ta' episodji ta' fsada f'pazjenti bl-emofilja B.
English: The company informed the CHMP that patients currently included in clinical trials would continue to receive IXinity and would be switched to the refined product once revised rules for the conduct of the trials had been approved.
Maltese: Jekk inti qed tieħu sehem fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li jkun qed jagħtik il-kura.
English: Although the studies had shown evidence of the effectiveness of IXinity, they had also revealed that patients developed an unexpectedly high level of antibodies against proteins from the cells used to make IXinity, which were also present in the medicine.
Maltese: Għalkemm l-istudji kienu wrew evidenza tal-effikaċja ta' IXinity, kienu wrew ukoll li l-pazjenti żviluppaw livell għoli mhux mistenni ta' antikorpi kontra l-proteini miċ-ċelluli użati biex jagħmlu IXinity, li kienu wkoll jinsabu fil-mediċina.
English: Activity in vivo
Maltese: Attivita in vivo
English: Activity in vitro
Maltese: Attivita in vitro
English: Apache II score ≤ 20 Apache II score  20
Maltese: Skor Apache II ≤ 20 Skor Apache II  20
English: 2870 Puurs
Maltese: BE-2870 Puurs
English: In a single-dose clinical study, radiolabeled (
Maltese: Fi studju kliniku b'doża waħda, anidulafungin (~88 mg) radjutikkettat (
English: Mortality Anidulafungin Fluconazole
Maltese: Mortalità Anidulafungin Fluconazole
English: Between group difference ( 95% CI)
Maltese: Differenza bejn il-gruppi ( 95% CI)
English: EXP {MM/YYYY}
Maltese: EXP {XAHAR-SENA}
English: Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Other Candida spp.
Maltese: Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis
English: Anidulafungin is extensively bound (>99%) to human plasma proteins.
Maltese: Anidulafungin jeħel b'mod estensiv (>99%) mal-proteini tal-plasma umana.
English: Excipients: fructose, mannitol, polysorbate 80, tartaric acid, NaOH and/or HCl.
Maltese: Eċċipjenti: fructose, mannitol, polysorbate 80, tartaric acid, NaOH u/jew HCl.
English: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Maltese: Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Il-Belġju
English: The mean APACHE II score was 14.9 (range, 2 - 44).
Maltese: Ir-riżultat medju APACHE II kien ta' 14.9 (medda, 2 - 44).
English: 3 or WBC ≤ 500 cells/mm
Maltese: 3 jew WBC ≤ 500 ċellola/mm
English: Treatment of invasive candidiasis in adult patients (see sections 4.4 and 5.1).
Maltese: Kura ta' candidiasis invażiva f'pazjenti adulti (ara sezzjonijiet 4.4 u 5.1).
English: Date of first authorisation: 20 September 2007 Date of latest renewal: 28 August 2017
Maltese: Data tal-ewwel awtorizzazjoni: 20 ta' Settembru 2007 Data tal-aħħar tiġdid: 28 ta' Awwissu 2017
English: Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
Maltese: Anidulafungin mhux sottostrat, induttur, jew inibitur klinikament rilevanti ta' l-isoenzimi taċċitokromu P450 (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
English: Anidulafungin exhibited in-vitro activity against C. albicans, C. glabrata, C. parapsilosis, C. krusei and C. tropicalis.
Maltese: Anidulafungin wera attività in-vitro kontra C. albicans, C. glabrata, C. parapsilosis, C. krusei u C.
English: - The active substance is anidulafungin.
Maltese: - Is-sustanza attiva hija anidulafungin.
English: Nervous System Disorders
Maltese: Disturbi fisSistema Nervuża
English: The most common pathogens isolated at baseline were C. tropicalis (4 anidulafungin, 0 caspofungin), C. parapsilosis (2 anidulafungin, 1 caspofungin), C. krusei (2 anidulafungin, 1 caspofungin), and C. ciferrii (2 anidulafungin, 0 caspofungin).
Maltese: Il-patoġeni l-iżjed komuni iżolati fil-linja bażi kienu C. tropicalis (4 anidulafungin, 0 caspofungin), C. parapsilosis (2 anidulafungin, 1 caspofungin), C. krusei (2 anidulafungin, 1 caspofungin), u C. ciferrii (2 anidulafungin, 0 caspofungin).
English: ECALTA contains fructose
Maltese: ECALTA fih fructose
English: The majority of patients had candidemia only (84.8%; 39/46).
Maltese: Il-maġġoranza tal-pazjenti kellhom candidemia biss (84.8%; 39/46).
English: Infusion solution concentration is 0.77 mg/mL
Maltese: Konċentrazzjoni tas-soluzzjoni ta' l-Infużjoni hija 0.77 mg/mL
English: Excipient with known effect: Fructose 102.5 mg per vial
Maltese: Eċċipjenti b'effett magħruf : Fructose 102.5 mg kull kunjett
English: Anidulafungin has negligible renal clearance (<1%).
Maltese: Anidulafungin għandu tneħħija renali negliġibbli (<1%).
English: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Maltese: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Il-Belġju
English: Non-neutropenic (ANC, cells/mm
Maltese: Newtropeniċi(ANC, ċelluli/mm
English: The clinical relevance of this is unknown.
Maltese: Ir-rilevanza klinika ta' dan mhux magħrufa.
English: Polysorbate 80
Maltese: Fructose Mannitol Polysorbate 80
English: The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to very common (≥1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and from spontaneous reports with frequency not known (cannot be estimated from the available data).
Maltese: It-tabella li ġejja tinkludi r-reazzjonijiet avversi mill-kawżalità kollha (termini MedDRA) minn 840 suġġett li qed jirċievu 100 mg ta' anidulafungin bi frekwenza li tikkorrispondi għal komuni (1/100 to <1/10) jew mhux komuni (1/1,000 to <1/100) u mir-rapporti spontanji bil-frekwenza mhux magħrufa (frekwenza ma tistax tkun ikkalkulata mid-data disponibbli).
English: Each vial contains 100 mg anidulafungin.
Maltese: Kull kunjett fih 100 mg anidulafungin.
English: MIC breakpoint (mg/L) ≤S (Susceptible) >R (Resistant)
Maltese: Punt kritiku tal-MIC (mg/L) ≤S (Suxxettibbli)
English: Immune System Disorders
Maltese: Disturbi fisSistema Immuni
English: For the clinical relevance of these findings see “Clinical efficacy and safety.”
Maltese: Għar-rilevanza klinika ta' dawn is-sejbiet ara “Effikaċja klinika u sigurtà”.
English: It is unlikely that anidulafungin will have clinically relevant effects on the metabolism of drugs metabolised by cytochrome P450 isoenzymes.
Maltese: Mhux probabbli li anidulafungin ikollu effetti klinikament rilevanti fuq il-metaboliżmu ta' mediċini metabolizzati b'isoenzimi taċċitokromu P450.
English: Anidulafungin is a semi-synthetic echinocandin, a lipopeptide synthesised from a fermentation product of Aspergillus nidulans.
Maltese: Anidulafungin huwa echinocandin semi-sintetiku, lipopeptide sintetizzat minn prodott ta' fermentazzjoni ta' l-Aspergillus nidulans.
English: 3 at baseline) with invasive candidiasis was assessed in a prospective, double-blind, randomized, controlled trial.
Maltese: 3 fil-linja bażi) b'candidiasis invażiva kienet ivvalutata fi prova kontrollata, aleatorja, prospettiva, bi proċedura double-blind.
English: Hepatic metabolism of anidulafungin has not been observed.
Maltese: Ma ġiex osservat metaboliżmu epatiku ta' anidulafungin.
English: Ethnicity Anidulafungin pharmacokinetics were similar among Caucasians, Blacks, Asians, and Hispanics.
Maltese: Etniċità Il-farmakokinetiċi ta' anidulafungin kienu simili f'persuni Kawkasi, Suwed, Asjatiċi, u Ispaniċi.
English: Alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholestasis
Maltese: Żieda fl-alanine aminotransfera se, żieda flalkaline phosphatase fid-demm, żieda flaspartate aminotransfera se, żieda ta' bilirubin fiddemm, kolestasi
English: Convulsion, headache
Maltese: Konvulżjoni, uġigħ ta' ras
English: Fructose content
Maltese: Kontenut ta' fructose
English: The pharmacokinetics of anidulafungin are characterised by a rapid distribution half-life (0.5-1 hour) and a volume of distribution, 30-50 l, which is similar to total body fluid volume.
Maltese: Il-farmakokinetiċi ta' anidulafungin huma kkaratterizzati minn half-life rapida tad-distribuzzjoni (0.51 siegħa) u volum ta' distribuzzjoni, 30-50 l, li huwa simili għall-volum ta' fluwidu totali fil-ġisem.
English: The successful global response rate at the End of Intravenous Treatment (primary endpoint) was 18/35 (51.4%) and 16/35 (45.7%) at the End of All Treatment.
Maltese: Ir-rata ta' rispons globali ta' suċċess fit-Tmiem tat-Trattament ġol-Vina (punt tat-tmiem primarju) kienet ta' 18/35 (51.4%) u 16/35 (45.7%) fit-Tmiem tat-Trattament Kollu.
English: 90 min
Maltese: 90 min mg
English: Anidulafungin selectively inhibits 1,3-β-D glucan synthase, an enzyme present in fungal, but not mammalian cells.
Maltese: Anidulafungin jinibixxi b'mod selettiv il-glucan synthase 1,3-β-D, enzima preżenti fiċ-ċelloli fungali, iżda mhux mammiferi.
English: Urticaria
Maltese: Urtikaria
English: ECALTA belongs to a group of medicines called echinocandins.
Maltese: ECALTA jappartjeni għal grupp ta' mediċini msejjħa echinocandins.
English: Gastrointestinal Disorders
Maltese: Disturbi Gastro Intestinali
English: The pharmacokinetics of anidulafungin after at least 5 daily doses were investigated in 24 immunocompromised paediatric (2 to 11 years old) and adolescent (12 to 17 years old) patients with neutropenia.
Maltese: Il-farmakokinetiċi ta' anidulafungin wara mill-anqas 5 dożi li ngħataw darba kuljum ġew studjati f'24 pazjent pedjatriku (2 sa 11-il sena) u adoloxxenti (12 sa 17-il sena) immunokompromessi b'newtropenja.
English: Anidulafungin displays linear pharmacokinetics across a wide range of once daily doses (15-130 mg).
Maltese: Anidulafungin juri farmakokinetiċi lineari matul firxa wiesgħa ta' dożi mogħtija darba kuljum (15-130 mg).
English: The most common pathogens isolated at baseline were C. tropicalis (12 patients), C. albicans (7 patients), C. glabrata (7 patients), C. krusei (7 patients), and C. parapsilosis (6 patients).
Maltese: Il-patoġeni l-iżjed komuni iżolati fil-linja bażi kienu C. tropicalis (12-il pazjent), C. albicans (7 pazjenti), C. glabrata (7 pazjenti), C. krusei (7 pazjenti), u C. parapsilosis (6 pazjenti).
English: A risk to the suckling child cannot be excluded.
Maltese: Ir-riskju għat-tarbija li tkun qed titredda' mhux eskluż.
English: The in vitro degradation half-life of anidulafungin under physiologic conditions is approximately 24 hours.
Maltese: Il-half life tad-degradazzjoni in vitro ta' anidulafungin taħt kondizzjonijiet fiżjoloġiċi hija madwar 24 siegħa.
English: HIV positivity
Maltese: Pożittività għall-HIV
English: All-cause mortality by Day 28 was 10/35 (28.6%).
Maltese: Il-mortalità mill-kawżalità kollha sat-28 Ġurnata kienet ta' 10/35 (28.6%).
English: The reconstituted solution has a pH of 3.5 to 5.5.
Maltese: Is-soluzzjoni rikostitwita għandha pH ta' 3.5 sa 5.5.
English: Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ringopened peptide that lacks antifungal activity.
Maltese: Anidulafungin jiġi sottopost għal degradazzjoni kimika bil-mod f'temperatura fiżjoloġika u pH għal ring-opened peptide nieqsa minn attività antifungali.
English: C. albicans Non-albicans species
Maltese: C. albicans Speċi mhux albicans
English: The most common pathogens isolated at baseline were C. tropicalis (34.8%; 16/46), C. krusei (19.6%; 9/46), C. parapsilosis (17.4%; 8/46), C. albicans (15.2%; 7/46), and C. glabrata (15.2%; 7/46).
Maltese: Il-patoġeni l-iżjed komuni iżolati fil-linja bażi kienu C. tropicalis (34.8%; 16/46), C. krusei (19.6%; 9/46), C. parapsilosis (17.4%; 8/46), C. albicans (15.
English: Anidulafungin treatment prolonged survival and also reduced the organ burden of Candida species, when determined at intervals from 24 to 96 hours after the last treatment.
Maltese: Trattament b'anidulafungin tawwal is sopravvivenza u naqqas it-tgħabija ta' speċi ta' Candida fuq l-organi, meta dan ġie ddeterminatf'intervalli bejn 24 u 96 siegħa wara l-aħħar trattament.
English: Anidulafungin pharmacokinetics were examined in subjects with Child-Pugh class A, B or C hepatic insufficiency.
Maltese: Il-farmakokinetiċi ta' anidulafungin kienu studjati f'suġġetti li kellhom insuffiċjenza tal-fwied tal-klassi Child-Pugh A, B jew C.
English: Metabolism and Nutrition Disorders
Maltese: Disturbi filMetaboliżmu u nNutrizzjoni
English: Either 9 mg/mL (0.9%) sodium chloride for infusion or 50 mg/mL (5%) glucose for infusion.
Maltese: Jew 9 mg/mL (0.9%) sodium chloride għal infużjoni jew 50 mg/mL (5%) glukożju għal infużjoni.
English: 98.3% confidence intervals, adjusted post hoc for multiple comparisons of secondary time points.
Maltese: Informazzjoni ppreżentata għal pazjenti b'patoġenu wieħed fil-linja bażi. 98.3% intervalli ta' kunfidenza, aġġustati post hoc għal paraguni multipli ta' time points sekondarji.
English: Not known (frequency cannot be estimated from the available data) are:
Maltese: Mhux magħruf (frekwenza ma tistax tkun stimata mid-dejta disponibbli) huma