FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory tract infections may be differentiated in upper and lower respiratory tract infections.
Maltese: Infezzjonijiet fl-apparat respiratorju jistgħu jkunu differenzjati f'infezzjonijiet fl-apparat respiratorju ta' fuq u t'isfel.
English: Limited data provides some evidence of efficacy in the prophylaxis of respiratory infections to different extents depending on products and on age groups.
Maltese: Iddata limitata tipprovdi xi evidenza tal-effikaċja fil-profilassi ta' infezzjonijiet respiratorji rikorrenti b'mod differenti skont il-prodotti u l-gruppi tal-età.
English: Conflicting results were observed in all double-blind, placebo-controlled, RCT which were associated with methodological limitations.
Maltese: Ġew osservati riżultati konfliġġenti fl-RCT double-blind, ikkontrollati bi plaċebo kollha li ġew assoċjati ma' limitazzjonijiet metodoloġiċi.
English: Luivac is indicated for the prophylaxis of recurrent respiratory tract infections (RRTI) in adults and children from 4 years of age.
Maltese: Luivac huwa indikat għall-profilassi ta' infezzjonijiet rikorrenti fl-apparat respiratorju (RRTI) fl-adulti u fit-tfal mill-età ta' 4 snin.
English: • The CHMP considered the totality of the data submitted for bacterial lysates based medicinal products for use in respiratory conditions.
Maltese: • Is-CHMP ikkunsidra d-data kollha sottomessa għal prodotti mediċinali bbażati fuq liżati batteriċi għall-użu f'kundizzjonijiet respiratorji.
English: Favourable effects of Lantigen B in the prophylaxis of RTI were observed in adults and children in a number of old studies, with methodological limitations.
Maltese: L-effetti favorevoli ta' Lantigen B fil-profilassi tal-RTI ġew osservati fl-adulti u fit-tfal f'għadd ta' studji antiki, b'limitazzjonijiet metodoloġiċi.
English: Of note, the Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases does not recommend oral bacterial lysates for the management of adult LRTI (Woodhead, 2011).
Maltese: Ta' min jinnota, it-Taskforce tas-Soċjetà Respiratorja Ewropea u s-Soċjetà Ewropea għall-Mikrobijoloġija Klinika u l-Mard li Jittieħed ma tirrakkomandax liżati batteriċi orali għall-ġestjoni ta' LRTI fl-adulti (Woodhead, 2011).
English: Finally the CHMP noted that Polyvaccinum-containing products contain phenol, an excipient that should be avoided.
Maltese: Finalment is-CHMP innota li l-prodotti li fihom Polyvaccinum fihom fenol, eċċipjent li għandu jiġi evitat.
English: In one MS, the paediatric indication is restricted to recurrent upper RTI (RURTI).
Maltese: Fi SM wieħed, l-indikazzjoni pedjatrika hija ristretta għal RTI ta' fuq rikorrenti (RURTI).
English: It remains unknown whether these differences translate into different clinical effects of the medicinal products; this conclusion was also supported by the scientific advisory group expert group meeting on antiinfectives (SAG AI).
Maltese: Jibqa' mhux magħruf jekk dawn iddifferenzi jirriżultawx f'effetti kliniċi differenti tal-prodotti mediċinali; din il-konklużjoni ġiet appoġġjata wkoll mil-laqgħa tal-grupp ta' esperti ta' grupp konsultattiv xjentifiku dwar l-antiinfettivi (SAG AI).
English: More recent studies with more robust design report conflicting results as one study failed to show a statistically significant effect over placebo in adults and in children whilst the statistically significant results of the other study conducted in adults only should be interpreted with caution in view of the noted methodological deficiencies (Braido, 2014).
Maltese: Studji aktar riċenti b'disinn aktar robust jirrappurtaw riżultati konfliġġenti peress li studju wieħed naqas milli juri effett statistikament sinifikanti fuq ilplaċebo fl-adulti u fit-tfal, filwaqt li r-riżultati statistikament sinifikanti tal-istudju l-ieħor li sar fl-adulti biss għandhom jiġu interpretati b'kawtela minħabba n-nuqqasijiet metodoloġiċi nnutati (Braido, 2014).
English: The review of the safety profile of Ismigen confirmed the known risk serious hypersensitivity reactions.
Maltese: Ir-reviżjoni tal-profil tas-sigurtà ta' Ismigen ikkonfermat ir-reazzjonijiet ta' sensittività eċċessiva serji ta' riskju magħruf.
English: Upper respiratory tract infection (URTI) is a non-specific term used to describe acute infections involving the nose, paranasal sinuses, pharynx, and larynx.
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq (URTI) hija terminu mhux speċifiku użat biex jiddeskrivi infezzjonijiet akuti li jinvolvu l-imnieħer, is-sinus paranażali, il-farinġi, u l-larinġi.
English: Having reviewed the appropriateness of the formulations and pharmaceutical forms for use in the authorised paediatric populations up to 5 years of age, the CHMP considered that acceptability studies in children below the age of 5 years should be performed for Respivax, Buccalin, Ismigen, Polyvaccinum suspension for injection.
Maltese: Wara li eżamina mill-ġdid kemm huma xierqa l-formulazzjonijiet u l-għamliet farmaċewtiċi għall-użu filpopolazzjonijiet pedjatriċi awtorizzati sal-età ta' 5 snin, is-CHMP ikkunsidra li għandhom isiru studji ta' aċċettabilità fi tfal taħt l-età ta' 5 snin għal Respivax, Buccalin, Ismigen, Polyvaccinum sospensjoni għall-injezzjoni.
English: A recent RCT provided limited evidence for some positive effects in the prophylaxis of RTIs in adults (statistically significant improvement in the number of days with RTI); the clinical relevance of these results is questionable considering that no superiority over placebo was observed for important secondary endpoints.
Maltese: RCT riċenti pprovda evidenza limitata għal xi effetti pożittivi fil-profilassi ta' RTIs fl-adulti (titjib statistikament sinifikanti fin-numru ta' jiem b'RTI); ir-rilevanza klinika ta' dawn ir-riżultati hija dubjuża meta jiġi kkunsidrat li ma ġiet osservata l-ebda superjorità fuq il-plaċebo għal punti tat-tmiem sekondarji importanti.
English: The CHMP noted that underreporting is probable.
Maltese: IsCHMP innota li n-nuqqas ta' rappurtar huwa probabbli.
English: On 8 June 2018 the Italian National Competent Authority (AIFA) therefore triggered a referral under Article 31 of Directive 2001/83/EC and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of bacterial lysates-containing medicinal products for respiratory conditions and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Għalhekk, fit-8 ta' Ġunju 2018, l-Awtorità Nazzjonali Kompetenti Taljana (AIFA) tat bidu għal riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE u talbet lis-CHMP biex jivvaluta l-impatt tattħassib imsemmi hawn fuq il-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti mediċinali li fihom liżati batteriċi għal kundizzjonijiet respiratorji u biex joħroġ opinjoni dwar jekk l-awtorizzazzjonijiet għattqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew jiġu revokati.
English: No robust study was conducted for Polyvaccinum and no data in adults was identified.
Maltese: Ma sar l-ebda studju robust għal Polyvaccinum u ma ġiet identifikata l-ebda data fl-adulti.
English: Buccalin is indicated for the prophylaxis of RRTI in adults and of bacterial RURTI in children older than 6 months or for the prophylaxis of bacterial RTI without age limits.
Maltese: Buccalin huwa indikat għall-profilassi ta' RRTI fl-adulti u ta' RURTI batterika fit-tfal ta' aktar minn 6 xhur jew għall-profilassi ta' RTI batterika mingħajr limiti tal-età.
English: It is noted that the authors of a review article on immunomodulators for the prevention of RTI in children (Cardinale, 2015) concluded that no sufficient evidence for the efficacy of Luivac in the paediatric field was available.
Maltese: Ta' min jinnota li l-awturi ta' artikolu ta' reviżjoni dwar limmunomodulaturi għall-prevenzjoni ta' RTI fit-tfal (Cardinale, 2015) ikkonkludew li ma kienx hemm disponibbli evidenza biżżejjed għall-effikaċja ta' Luivac fil-qasam pedjatriku.
English: • The CHMP considered that the safety data reviewed was in accordance with the known profile of the products.
Maltese: • Is-CHMP ikkunsidra li d-data dwar is-sigurtà riveduta kienet skont il-profil magħruf tal-prodotti.
English: Bacterial lysates-based medicinal products contain several strains of inactivated whole bacteria/bacterial lysates/bacterial fractions claimed to stimulate the immune system to recognise and fight infections.
Maltese: Il-prodotti mediċinali bbażati fuq liżati batteriċi fihom diversi razez ta' batterji sħaħ inattivati/liżati batteriċi/frazzjonijiet batteriċi li huma ddikjarati li jistimulaw is-sistema immuni biex tirrikonoxxi u tiġġieled l-infezzjonijiet.
English: The review of the safety profile of Broncho-Vaxom confirmed the known risk serious hypersensitivity reactions, in particular two life-threatening cases of anaphylactic reactions and one report of toxic epidermal necrolysis in a 5 year old for which the causality remains uncertain were noted.
Maltese: Ir-reviżjoni tal-profil tas-sigurtà ta' Broncho-Vaxom ikkonfermat ir-reazzjonijiet ta' sensittività eċċessiva serji ta' riskju magħruf, b'mod partikolari ġew innutati żewġ każijiet ta' periklu għall-ħajja ta' reazzjonijiet anafilattiċi u rapport wieħed ta' nekroliżi epidermali tossika f'tifel/tifla ta' 5 snin li lkawżalità tagħha għadha inċerta.
English: Bacterial lysates-based medicinal products are authorised in various indications including the prevention and/or treatment of different types of respiratory infections.
Maltese: Prodotti mediċinali li huma bbażati fuq liżati batteriċi huma awtorizzati f'diversi indikazzjonijiet inkluż ilprevenzjoni u/jew il-kura ta' tipi differenti ta' infezzjonijiet respiratorji.
English: Conflicting results were obtained from two double-blind, placebo-controlled RCT evaluating Ismigen in the prophylaxis of LRTI in adults.
Maltese: Inkisbu riżultati konfliġġenti minn żewġ RCT double-blind, ikkontrollati bi plaċebo li jevalwaw Ismigen fil-profilassi ta' LRTI fl-adulti.
English: Lower respiratory tract infection (LRTI) is a broad description of a group of disease entities, encompassing acute bronchitis, pneumonia and exacerbations of chronic lung disease.
Maltese: Infezzjoni fl-apparat respiratorju t'isfel (LRTI) hija deskrizzjoni wiesgħa ta' grupp ta' entitajiet tal-marda, li tinkludi bronkite akuta, pulmonite u aggravar ta' mard kroniku talpulmun.
English: More recent well designed RCTs (e.g. AIACE, ACASP, CLEARI) failed to demonstrate efficacy of Ismigen in adults with COPD, Luivac in adults mainly with URTI and Ribomunyl in children with URTI, albeit in some these studies the background infection rate was very low, thus complicating the interpretation of the results.
Maltese: RCTs aktar riċenti mfassla tajjeb (eż. AIACE, ACASP, CLEARI) naqsu milli juru l-effikaċja ta' Ismigen fladulti b'COPD, Luivac fl-adulti priniċipalment b'URTI u Ribomunyl fit-tfal b'URTI, għalkemm f'xi wħud minn dawn l-istudji r-rata ta' infezzjoni fl-isfond kienet baxxa ħafna, u b'hekk tikkomplika linterpretazzjoni tar-riżultati.
English: • The CHMP considered the lack of evidence in the treatment settings and that the treatment wording was not reflective of the intended clinical use for this indication.
Maltese: • Is-CHMP ikkunsidra n-nuqqas ta' evidenza fl-ambjenti tal-kura u li l-formulazzjoni tal-kura ma kinitx tirrifletti l-użu kliniku maħsub għal din l-indikazzjoni.
English: Limited evidence of efficacy in the prophylaxis of RTIs in children is mainly based on a retrospective study.
Maltese: L-evidenza limitata tal-effikaċja fil-profilassi ta' RTIs fit-tfal hija bbażata prinċipalment fuq studju retrospettiv.
English: Three double-blind RCTs conducted in children and adults showed the statistically significant superiority of Luivac over placebo with regards to a non-validated severity score used as primary endpoint, thus precluding conclusions as to the clinical relevance of the results.
Maltese: Tliet RCTs double-blind li saru fit-tfal u fl-adulti wrew superjorità statistikament sinifikanti ta' Luivac fuq il-plaċebo fir-rigward ta' punteġġ ta' severità mhux ivvalidat użat bħala punt tat-tmiem primarju, u b'hekk jipprekludu l-konklużjonijiet dwar ir-rilevanza klinika tar-riżultati.
English: Polyvaccinum nasal drops are indicated for the prophylaxis and treatment of RURTI in adults and children from 6 months old and suspension for injections are indicated for prophylactic and therapeutic use or adjunctive treatment in case of long-lasting, chronic and recurrent RTI in adults and children from 2 years of age.
Maltese: It-taqtir għall-imnieħer Polyvaccinum huwa indikat għall-profilassi u l-kura ta' RURTI fl-adulti u fit-tfal minn 6 xhur u s-sospensjoni għall-injezzjonijiet huma indikati għall-użu profilattiku u terapewtiku jew għal kura miżjuda fil-każ ta' RTI fit-tul, kronika u rikorrenti fl-adulti u fit-tfal mill-età ta' sentejn.
English: A small doubleblind placebo-controlled RCT and some supportive studies with methodological limitations provide some evidence of efficacy of Ismigen in the prophylaxis of URTIs in adults.
Maltese: RCT żgħir double-blind ikkontrollat bi plaċebo u xi studji ta' sostenn b'limitazzjonijiet metodoloġiċi jipprovdu xi evidenza tal-effikaċja ta' Ismigen filprofilassi tal' URTIs fl-adulti.
English: Favourable effects were reported from a small placebo controlled study and 8 observation uncontrolled studies, all suffering from serious methodological issues.
Maltese: Ġew irrappurtati effetti favorevoli minn studju żgħir ikkontrollat bi plaċebo u 8 studji ta' osservazzjoni mhux ikkontrollati, li kollha kellhom kwistjonijiet metodoloġiċi serji.
English: Lantigen B is indicated for the prophylaxis and treatment of RURTI or bacterial URTI in adults and children, as prophylaxis of RRTI in adults and URTIs in children or for the prevention of RRTI in adults and children from 3 years of age.
Maltese: Lantigen B huwa indikat għall-profilassi u l-kura ta' RURTI jew URTI batterika fl-adulti u fit-tfal, bħala profilassi ta' RRTI fl-adulti u URTIs fit-tfal jew għall-prevenzjoni ta' RRTI fl-adulti u fit-tfal mill-età ta' 3 snin.
English: Bacterial lysates are approved in EU member states under a broad spectrum of indications that can generally be categorised as prophylaxis and treatment of URTIs and LRTIs in adults and children.
Maltese: Il-liżati batteriċi huma approvati fl-Istati Membri tal-UE taħt firxa wiesgħa ta' indikazzjonijiet li ġeneralment jistgħu jiġu kkategorizzati bħala profilassi u kura ta' URTIs u LRTIs fl-adulti u fit-tfal.
English: The minimal age group for which Luivac can be used (from 4 years of age) should be explicitly stated across all EU MS PIs.
Maltese: Il-grupp ta' età minimu li Luivac jista' jintuża għalih (mill-età ta' 4 snin) għandu jiġi ddikjarat b'mod espliċitu fil-PIs kollha tal-iSM tal-UE.
English: Whilst most double-blind, placebo controlled, RCTs and supportive studies reported positive effects of Broncho-Vaxom these are not considered to provide robust evidence of efficacy in adults of children, in view of the methodological limitations noted.
Maltese: Filwaqt li l-biċċa l-kbira tal-RCTs double-blind, ikkontrollati bi plaċebo u studji ta' sostenn irrappurtaw effetti pożittivi ta' Broncho-Vaxom dawn mhumiex meqjusa li jipprovdu evidenza robusta tal-effikaċja fl-adulti tat-tfal, fid-dawl tal-limitazzjonijiet metodoloġiċi nnutati.
English: The safety information from both clinical trials and pharmacovigilance data was in line with the known safety profile, as described in the product information; rare hypersensitivity/allergic reactions have been reported.
Maltese: L-informazzjoni dwar is-sigurtà kemm mill-provi kliniċi kif ukoll mid-data ta' farmakoviġilanza kienet konformi mal-profil tas-sigurtà magħruf, kif deskritt fl-informazzjoni dwar il-prodott; ġew irrappurtati sensittività eċċessiva/reazzjonijiet allerġiċi rari.
English: The scope of this procedure is limited to respiratory tract conditions.
Maltese: Il-kamp ta' applikazzjoni ta' din il-proċedura huwa limitat għal kundizzjonijiet fl-apparat respiratorju.
English: A recent well-designed, double-blind, placebo-controlled, RCT in children failed to demonstrate any significant effect of Ribomunyl in the primary (i.e. number of URTI) and most secondary endpoints.
Maltese: RCT riċenti, imfassla tajjeb, double-blind, ikkontrollata bi plaċebo fit-tfal naqset milli turi kwalunkwe effett sinifikanti ta' Ribomunyl fil-punti tat-tmiem primarji (jiġifieri n-numru ta' URTI) u filbiċċa l-kbira tal-punti tat-tmiem sekondarji.
English: Depending on MS, the paediatric indication covers children from 1 year, 6 months, or without restrictions.
Maltese: Skont l-iSM, l-indikazzjoni pedjatrika tkopri tfal minn sena, 6 xhur, jew mingħajr restrizzjonijiet.
English: Respivax is indicated for the prophylaxis and treatment of chronic and recurrent RTI in adults and children from 3 years of age.
Maltese: Respivax huwa indikat għall-profilassi u l-kura ta' RTI kronika u rikorrenti fl-adulti u fit-tfal mill-età ta' 3 snin.
English: • The CHMP also considered the lack of evidence from clinical studies in the use of these products for the prevention of pneumonia, a severe infection, and therefore was of the view that it should not be recommended.
Maltese: • Is-CHMP ikkunsidra wkoll in-nuqqas ta' evidenza mill-istudji kliniċi fl-użu ta' dawn il-prodotti għall-prevenzjoni tal-pulmonite, infezzjoni severa, u għalhekk kien tal-fehma li m'għandux jiġi rakkomandat.
English: Ismigen is indicated in for the prophylaxis of RRTI in adults and in some MS for the treatment of acute, subacute recurrent or chronic RTI as well as in one MS in children from 3 years of age.
Maltese: Ismigen huwa indikat għall-profilassi ta' RRTI fl-adulti u f'xi SM għall-kura ta' RTI akuta, subakuta jew kronika kif ukoll fi SM wieħed fi tfal mill-età ta' 3 snin.
English: Ribomunyl is indicated for the prophylaxis of RURTI in children above 2 or 6 years old depending on the presentation, and of recurrent surinfections in chronic bronchitis in adults.
Maltese: Ribomunyl huwa indikat għall-profilassi ta' RURTI fi tfal ta' aktar minn sentejn jew 6 snin skont ilpreżentazzjoni, u ta' surinfezzjonijiet rikorrenti fil-bronkite kronika fl-adulti.
English: Further, considering the severity of pneumonia, the CHMP considered that a warning should be added in the SmPC of all products with the unspecified RTI indication to recommend against the use in the prevention of pneumonia in view of the absence of data demonstrating the efficacy for the prophylaxis of this type of infection.
Maltese: Barra minn hekk, meta tiġi kkunsidrata s-severità tal-pulmonite, isCHMP ikkunsidra li għandha tiżdied twissija fl-SmPC tal-prodotti kollha bl-indikazzjoni RTI mhux speċifikata sabiex ma jiġix irrakkomandat l-użu fil-prevenzjoni ta' pulmonite fid-dawl tan-nuqqas ta' data li turi l-effikaċja għall-profilassi ta' din it-tip ta' infezzjoni.
English: Only a few ADRs have been collected over the last 12 year which may indicate serious under-reporting.
Maltese: Ġew miġbura biss ftit ADRs matul l-aħħar 12-il sena li jistgħu jindikaw nuqqas serju ta' rappurtar.
English: Post-marketing reports concerned mostly injection site reactions for one presentation and “flu like” signs and symptoms for the other one.
Maltese: Ir-rapporti ta' wara t-tqegħid fis-suq kienu jikkonċernaw l-aktar reazzjonijiet fis-sit tal-injezzjoni għal preżentazzjoni waħda u sinjali u sintomi “bħal tal-influwenza” għall-oħra.
English: However considering the lack of robust evidence, the conduct of phase IV placebo-controlled, double-blind, multicentre, RCTs according to agreed protocols in order to further characterise the efficacy and safety in their authorised indication(s) should be imposed on the MAs of these products.
Maltese: IV, ikkontrollati bi plaċebo, double-blind, multiċentriċi, skont il-protokolli miftiehma sabiex jiġu kkaratterizzati aktar l-effikaċja u ssigurtà fl-indikazzjoni(jiet) awtorizzata(i) tagħhom għandu jiġi impost fuq l-MAs ta' dawn il-prodotti.
English: No robust study was conducted in the prophylaxis of RTIs children; however, a retrospective cohort study and two small RCT provide some limited evidence of efficacy.
Maltese: Ma sar l-ebda studju robust fil-profilassi ta' RTIs fit-tfal; madankollu, studju ta' koorti retrospettiv u żewġ RCT żgħar jipprovdu xi evidenza limitata tal-effikaċja.
English: The CHMP also noted that whilst some studies suggest that the positive effects observed were mainly related to URTIs, for the majority of studies it was not possible to differentiate between the effects related to the prophylaxis of URTIs and that related to the prophylaxis of LRTIs.
Maltese: Is-CHMP innota wkoll li filwaqt li xi studji jissuġġerixxu li l-effetti pożittivi osservati kienu prinċipalment relatati ma' URTIs, għall-maġġoranza tal-istudji ma kienx possibbli li ssir distinzjoni bejn l-effetti relatati mal-profilassi tal-URTIs u dik relatata mal-profilassi ta' LRTIs.
English: • Therefore, the CHMP considered that the benefit-risk balance of bacterial lysates based medicinal products for use in respiratory conditions is unchanged in the prophylaxis setting provided the efficacy and safety of the products are further characterised through the conduct of appropriate phase IV double-blind, multicentre, RCT(s).
Maltese: • Is-CHMP ikkunsidra li b'mod ġenerali d-data disponibbli tippreżenta limitazzjonijiet serji u ma tipprovdix evidenza robusta tal-effikaċja tal-prodotti fl-indikazzjonijiet awtorizzati tagħhom.
English: The CHMP noted that whilst serious LRTI can be clearly distinguished from URTI (e.g. exacerbation of asthma, pneumonia), numerous URTI may lead to involvement of the bronchi.
Maltese: Is-CHMP innota li filwaqt li LRTI serja tista' tiġi distinta b'mod ċar minn URTI (eż. aggravar tal-ażma, pulmonite), diversi
English: CHMP opinion The CHMP, as a consequence, considers that the benefit-risk balance of bacterial lysates based medicinal products for use in respiratory conditions remains favourable subject to the amendments to the product information and to the conditions described above.
Maltese: Konsegwentement, is-CHMP jikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti mediċinali bbażati fuq liżati batteriċi għall-użu f'kundizzjonijiet respiratorji jibqa' favorevoli soġġett għall-emendi fl-informazzjoni dwar il-prodott u fil-kundizzjonijiet deskritti hawn fuq.
English: EMA/477972/2014 EMEA/H/C/000788
Maltese: EMEA/H/C/000788
English: Ecalta anidulafungin
Maltese: Ecalta anidulafunġina
English: The full EPAR for Ecalta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance anidulafungin.
Maltese: Fih is-sustanza attiva anidulafunġina.
English: Ecalta was compared with fluconazole (another antifungal medicine).
Maltese: Ecalta tqabbel ma' fluconazole (mediċina antifungali oħra).
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom treatment should continue for at least two weeks after the last day that fungus is found in the patient's blood.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: At the end of the treatment course, 76% of the patients receiving Ecalta had responded to treatment (96 out of 127), compared with 60% of the patients receiving fluconazole (71 out of 118).
Maltese: Fi tmiem il-kura, 76% tal-pazjenti kkurati b'Ecalta rrispondew għall-kura (96 minn 127), meta mqabbla ma' 60% tal-pazjenti kkurati bi fluconazole (71 minn 118).
English: This is a summary of the European public assessment report (EPAR) for Ecalta.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ecalta.
English: Both medicines were given by infusion, for between 14 and 42 days.
Maltese: Iż-żewġ mediċini ngħataw permezz ta' infużjoni għal perjodu bejn 14 u 42 ġurnata.
English: Other information about Ecalta
Maltese: Aktar informazzjoni dwar Ecalta
English: Ecalta is given as an initial dose of 200 mg on day one, followed by 100 mg each day from day two.
Maltese: Ecalta jingħata bħala doża inizjali ta' 200 mg fl-ewwel ġurnata, segwit minn 100 mg kuljum mit-tieni ġurnata.