FrancophonIA/ELRC3.0 huggingface dataset:
English: Allergic reactions were reported more commonly in healthy, conscious volunteers
Maltese: Reazzjonijiet allerġiċi ġew irrappurtati f'voluntiera b'saħħithom u konxji.
English: In a pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Maltese: Fi studji ieħor importanti ħafna, il-pazjenti kienu assenjati b'mod fortuwitu għall-grupp ta' rocuronium jew vecuronium.
English: Re-administration of rocuronium or vecuronium after sugammadex: For waiting times for re-administration of rocuronium or vecuronium after reversal with sugammadex, see section 4.4.
Maltese: F'każ li tkun osservata l-okkorrenza mill-ġdid tal-imblokk newromuskolari, il-pazjent jista' jkollu bżonn ta' ventilazzjoni mekkanika u l-għoti mill-ġdid ta' sugammadex (ara sezzjoni 4.2).
English: The effects with sugammadex on human fertility have not been investigated.
Maltese: L-effetti ta' sugammadex fuq il-fertilità tal-bniedem ma kienux investigati.
English: Pharmacokinetic parameters as clearance and volume of distribution are assumed to be the same for non-complex-bound and complex-bound sugammadex in anaesthetised subjects.
Maltese: Il-parametri farmakokinetiċi ta' sugammadex kienu kkalkulati mis-somma totali ta' konċentrazzjonijiet mhux marbutin-kumplessivamenti ta' sugammadex u ta' konċentrazzjonijiet marbutin-kumplessivament ta' sugammadex.
English: CV=coefficient of variation
Maltese: .8 Effetti mhux mixtieqa
English: If such a situation is observed, the clinician is advised to consider the re-administration of the medicinal product, the administration of a therapeutically equivalent medicinal product (preferably from a different chemical class) and/or nonpharmacological interventions as appropriate.
Maltese: Jekk tkun osservata sitwazzjoni bħal din, hu rrakkomandat li t-tabib kliniku jikkunsidra l-għoti mill-ġdid tal-prodott mediċinali, l-għoti ta' prodott mediċinali li jkun terapewtikament ekwivalenti (preferibbilment minn klassi differenti ta' kimiċi) u/jew interventi mhux farmakoloġiċi, kif ikun xieraq.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, iż-żmien tal-ħażna waqt l-użu u l-kundizzjonijiet ta' qabel l-użu huma r-responsabbiltà ta' dak li jużah, u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2°C sa 8°C, għajr meta d-dilwizzjoni tkun saret f'kundizzjonijiet asettiċi kkontrollati u vverifikati.
English: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tel/Tél: +32(0)27766211 dpoc_belux@merck.com
Maltese: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tel/Tél:
English: A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade.
Maltese: Doża ta' 2 mg/kg ta' sugammadex hi rrakkomandata jekk irkuprar spontanju jkun seħħ sa mill-inqas sad-dehra mill-ġdid ta' T2 wara imblokk ikkaġunat minn rocuronium jew vecuronium.
English: Even though the recovery times in elderly tend to be slower, the same dose recommendation as for adults should be followed (see section 4.4).
Maltese: Għalkemm il-ħinijiet ta' l-irkuprar fl-anzjani għandhom tendenza li jkunu aktar bil-mod, l-istess rakkomandazzjoni tad-doża bħal dik ta' l-adulti għandha tkun segwita (ara sezzjoni 4.4).
English: When neuromuscular blockade was reversed intentionally in the middle of anaesthesia in clinical trials, signs of light anaesthesia were noted occasionally (movement, coughing, grimacing and suckling of the tracheal tube).
Maltese: Meta l-imblokk newromuskolari kien imreġġa' lura intenzjonalment f'nofs l-għoti tal-loppju fil-provi kliniċi, sinjali ta' loppju ħafif kienu osservati kultant (ċaqliq, sogħla, tkerrih tal-wiċċ u sefsif tat-tubu trakeali).
English: EU/1/07/393/001
Maltese: EU/1/07/393/001 Soliris
English: 30 ml (10 mg/ml)
Maltese: 300mg Konċentrat għal soluzzjoni għall-infużjoni Użu għal ġol-vini Kunjett (ħġieġ) 30ml (10mg/ml)
English: Content (concentration) Package size
Maltese: Kontenut (konċentrazzjoni)
English: Invented name Strength Pharmaceutical Form
Maltese: Qawwa Għamla Farmaċewtika
English: Intravenous use Vial (glass)
Maltese: Mnejn jingħata Il-pakkett
English: Packaging
Maltese: Daqs tal pakkett
English: 13 July 2011
Maltese: 13 ta' Lulju 2011
English: International non-proprietary name (inn): doxycycline hyclate
Maltese: Isem Ġeneriku Internazzjonali (inn): doxycycline hyclate
English: Opinion following an Article referral for Doxycycline 50% WSP and associated names EMA/507899/2011
Maltese: Opinjoni wara riferiment tal-Artikolu għal Doxycycline 50% WSP u l-ismijiet assoċjati EMA/507899/2011
English: Doxycycline is a semi-synthetic tetracycline antibiotic.
Maltese: Doxycycline huwa antibijotiku semi-sintetiku derivat mit-tetraciclina.
English: The Committee appointed Mrs Ruth Kearsley as rapporteur and Dr Jiří Bureš as co-rapporteur.
Maltese: Il-Kumitat ħatar lis-Sinjura Ruth Kearsley bħala rapporteur u lil Dr Jiří Bureš bħala ko-rapporteur.
English: Tetracyclines have broad spectrum activity inhibiting Gram-positive and Gram-negative bacteria, mycoplasmas, chlamydiae, rickettsias and some protozoa.
Maltese: It-tetraciclini għandhom spettru ta' attività wiesa' li jinibixxi batterji Gram-pożittivi u Gram-negattivi, mikoplasmi, klamidji, rickettsias u xi protożoj.
English: Written explanations were provided by the applicant/marketing authorisation holder on 29 October 2010 and 8 March 2011.
Maltese: Ingħataw spjegazzjonijiet bil-miktub mill-applikant/detentur tal-awtorizzazzjoni għattqegħid fis-suq fid-29 ta' Ottubru 2010 u fit-8 ta' Marzu 2011.
English: Opinion following an Article 34 referral for Doxycycline 50% WSP and associated names
Maltese: Opinjoni wara riferiment tal-Artikolu 34 għal Doxycycline 50% WSP u l-ismijiet assoċjati
English: Doxycycline 50% WSP and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g.
Maltese: Doxycycline 50% WSP u l-ismijiet assoċjati huwa trab sabiex jintuża fl-ilma tax-xorb, li fih is-sustanza attiva doxycycline hyclate 500 mg/g.
English: Due to divergent national decisions taken by Member States regarding the target species, indications, amounts to be administered and withdrawal periods concerning the authorisation of Doxycycline 50% WSP and associated names, on 18 June 2010 the United Kingdom referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised summary of product characteristics across the European Union.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri dwar l-ispeċi mira, lindikazzjonijiet, l-ammonti li għandhom jingħataw u l-perjodi ta' tiżmim dwar l-awtorizzazzjoni ta' Doxycycline 50% WSP u l-ismijiet assoċjati, fit-18 ta' Ġunju 2010, ir-Renju Unit irrefera l-kwistjoni lisCVMP skont l-Artikolu 34(1) tad-Direttiva 2001/82/KE, sabiex jiġu solvuti diverġenzi fost ilkaratteristiċi tal-prodott fil-qosor awtorizzati fuq livell nazzjonali fl-Unjoni Ewropea kollha.
English: Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the rapporteurship.
Maltese: Wara r-riżenja tas-Sinjura Ruth Kearsley bħala membru tas-CVMP, is-Sinjura Helen Jukes inħatret biex tissostitwixxiha u biex tieħu ħsieb irrapporteurship.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit/risk profile for Doxycycline 50% WSP and associated names remains positive subject to variation of the marketing authorisations in accordance with the summary of product characteristics, and therefore adopted a positive opinion on 4 May 2011.
Maltese: Fuq il-bażi tal-valutazzjoni tar-rapporteurs tad-dejta disponibbli attwalment, is-CVMP qies li l-profil ta' benefiċċju/riskju għal Doxycycline 50% WSP u l-ismijiet assoċjati jibqa' pożittiv, bil-kundizzjoni li jiġu rraportati l-modifiki fl-awtorizzazzjonijiet għat-tqegħid fis-suq skont il-karatteristiċi tal-prodott filqosor, u għaldaqstant adottaw opinjoni pożittiva fl-4 ta' Mejju 2011.
English: In pigs and pre-ruminant calves the product is indicated for the treatment of certain infections of the respiratory tract.
Maltese: Fil-majjali u fl-għoġġiela preruminanti, il-prodott huwa indikat għall-kura ta' ċerti infezzjonijiet tal-passaġġ respiratorju.
English: In chickens the product is indicated for named infections of the respiratory tract and the alimentary tract.
Maltese: Fit-tiġieġ, il-prodott huwa indikat għal infezzjonijiet imsemmija tal-passaġġ respiratorju u tal-passaġġ alimentari.
English: ANNEX II
Maltese: Anness II
English: [“Switch” indication]
Maltese: [Indikazzjoni ta' “Tibdil”]
English: The
Maltese: Jew
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION
Maltese: Konklużjonijiet xjentifiċi u raġunijiet għal opinjoni pożittiva
English: The leading global expert respiratory group (ATS/ERS) has recently proposed standardised definitions of clinically relevant exacerbations for use in future trials.
Maltese: Il-grupp ewlieni ta' esperti globali dwar in-nifs (ATS/ERS) dan l-aħħar ippropona definizzjonijiet standardizzati ta' attakki gravi klinikament rilevanti għall-użu fi provi futuri.
English: Iffeza 50/5, 125/5 and 250/10 microgram pressurised inhalation, suspension is a new fixed-dose combination of two well-known active drug substances fluticasone propionate and formoterol fumarate.
Maltese: Iffeza 50/5, 125/5 u 250/10 mikgrogrammi sospensjoni ta' inalazzjoni taħt pressjoni huwa taħlita ġdida f'doża fissa ta' żewġ sustanzi mediċinali attivi magħrufin sew, fluticasone propionate u formoterol fumarate.
English: Formoterol fumarate is a selective long-acting ß2 adrenergic agonist and exerts a preferential effect on ß2 adrenergic receptors on bronchial smooth muscle to produce relaxation and bronchodilatation.
Maltese: Formoterol fumarate huwa agonista adrenerġiku ß2 selettiv li jaġixxi fit-tul u jeżerċita effett preferenzjali fuq riċetturi adrenerġiċi ß2 fuq il-muskoli lixxi tal-bronki sabiex jipproduċi rilassament u bronkodilatazzjoni.
English: Pharmacokinetic (PK) data
Maltese: Konklużjonijiet xjentifiċi
English: agonist.
Maltese: (pMDI).
English: The data presented in respect of exacerbations demonstrate an increased protective benefit of Iffeza compared with GSK fluticasone propionate administered alone - the odds of any exacerbation occurring were 33% higher and the annual exacerbation rate was 49% higher in patients receiving GSK fluticasone propionate than in patients receiving Iffeza, p=0.019 and p=0.004, respectively.
Maltese: Id-dejta ppreżentata rigward lattakki gravi turi benefiċċju protettiv akbar ta' Iffeza meta mqabbel ma' GSK fluticasone propionate mogħti waħdu - il-probabbiltajiet li jseħħ xi attakk gravi kienu 33% ogħla u r-rata annwali ta' aggravar kienet 49% ogħla f'pazjenti li ngħataw GSK fluticasone propionate milli f'pazjenti li ngħataw Iffeza, p=0.019 u p=0.004, rispettivament.
English: These include two published studies which specifically recruited patients with a history of recent exacerbations and which were conducted over 6 to 12 months (Ind 2003; Verona 2003).
Maltese: Dawn jinkludu żewġ studji ppubblikati li speċifikament użaw pazjenti b'passat ta' attakki gravi reċenti u li saru fuq sitta sa 12-il xahar (Ind 2003; Verona 2003).
English: • In the pharmacokinetic data presented systemic exposure of fluticasone was lower (67%) following Iffeza inhalation than following the concurrent inhalation of fluticasone and formoterol from monoproduct pMDIs.
Maltese: • Fid-dejta farmakokinetika ppreżentata l-espożizzjoni sistemika ta' fluticasone kienet aktar baxxa (67%) wara l-inalazzjoni ta' Iffeza milli wara l-inalazzjoni fl-istess waqt ta' fluticasone u formoterol minn pMDIs ta' prodott wieħed.
English: The PK data in Study FLT1501 were compared with a corresponding pharmacodynamic (PD) dataset from Study FLT3503.
Maltese: Id-dejta PK fl-Istudju FLT1501 tqabblet ma' sett ta' dejta farmakodinamika (PD) korrispondenti mill
English: This provides further support for the clinical relevance of the effects seen with Iffeza.
Maltese: Dan jipprovdi aktar appoġġ għar-rilevanza klinika tal-effetti li dehru bi Iffeza.
English: The CHMP noted that the differences of the magnitude observed between Iffeza and GSK fluticasone propionate in Study FLT1501 (67% relative bioavailability) are within the same range of variance as observed within patients (from inhalation to inhalation), between different batches of the same product and between different inhalers containing the same or more than one of the same active substances and are without adverse clinical consequences, and therefore are likely to be clinically irrelevant.
Maltese: Is-CHMP innota li d-differenzi kbar osservati bejn Iffeza u GSK fluticasone propionate fl-Istudju FLT1501 (bijodisponibbiltà relattiva ta' 67%) huma fl-istess medda ta' varjazzjoni li ġiet osservata fil pazjenti (bejn inalazzjoni u oħra), bejn lottijiet differenti tal-istess prodott u bejn inalaturi differenti li fihom l-istess sustanza jew aktar minn waħda mill-istess sustanza attiva u m'għandhomx konsegwenzi kliniċi avversi, u għaldaqstant aktarx li m'humiex klinikament rilevanti.
English: An annual exacerbation rate ratio of 0.98, i.e. very close to unity for the comparison of Iffeza 500µg/20µg versus fluticasone propionate 500µg + formoterol fumarate 24µg was therefore suggestive of non-inferiority but was not statistically definitive.
Maltese: Proporzjon ta' rata ta' attakki gravi annwali ta' 0.98, jiġifieri qrib ħafna ta' xulxin għat-tqabbil ta' Iffeza 500µg/20µg meta mqabbel ma' fluticasone propionate 500µg + formoterol fumarate 24µg għaldaqstant jindika n-nuqqas ta' inferjorità iżda ma kienx statistikament definittiv.
English: With regard to the “Switch” indication, the proportion of patients experiencing exacerbations in the pivotal “Switch” study (Study FLT3503) was similar in Iffeza and fluticasone propionate + formoterol fumarate treated patients (36.4% and 35.3%, respectively) although this analysis lacked discriminative capacity as the proportion of fluticasone propionate monotherapy-treated patients experiencing exacerbations was similar (37.4%).
Maltese: Rigward l-indikazzjoni ta' “Tibdil”, il-proporzjon ta' pazjenti li kellhom attakki gravi fl-istudju ewlieni ta' “Tibdil” (Studju FLT3503) kien simili fil-pazjenti kkurati bi Iffeza u bi fluticasone propionate + formoterol fumarate (36.4% u 35.3%, rispettivament) għalkemm din l-analiżi ma kellhiex kapaċità diskriminatorja minħabba li l-proporzjon ta' pazjenti kkurati bi fluticasone propionate bħala monoterapija li kellhom attakki gravi kien simili (37.4%).
English: The question posed by CHMP implied that the 67% relative bioavailability of the fluticasone propionate component of Iffeza compared with GSK fluticasone propionate pMDI may translate to a lesser inhaled corticosteroid effect and that this lesser effect would be best evaluated in a 6- to 12-month exacerbations study.
Maltese: Il-mistoqsija li staqsa s-CHMP kienet timplika li l-bijodisponibbiltà relattiva ta' 67% tal-komponent ta' fluticasone propionate fi Iffeza meta mqabbel ma' GSK fluticasone propionate pMDI tista' tfisser effett inqas tal-kortikosterojde li jittieħed man-nifs u li dan in-nuqqas fl-effett ikun evalwat l-aħjar fi studju ta' sitta sa 12-il xahar dwar l-aggravar.
English: Overall summary of the scientific evaluation of Iffeza and associated names (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Iffeza u ismijiet assoċjati (ara Anness I)
English: The inclusion of a second, lower dose of Iffeza (100µg/10µg) in the PD study was also instructive.
Maltese: L-inklużjoni ta' doża oħra, aktar baxxa ta' Iffeza (100µg/10µg) fl-istudju PD kienet ukoll istruttiva.
English: Predictive value of the FEV1 data
Maltese: Valur ta' tbassir tad-dejta dwar l-FEV1
English: Turning to the available data in the Applicant's studies, for the “Step-up” comparison the odds of “any” exacerbation were 33% higher in fluticasone propionate- than Iffeza-treated patients (p=0.019) whilst the annual exacerbation rate was 49% higher in fluticasone propionate- than Iffeza-treated patients (p=0.004).
Maltese: Rigward id-dejta disponibbli fl-istudji tal-Applikant, fil-każ tat-tqabbil taż-“Żieda”, il-probabbiltajiet ta' “kwalunkwe” attakk gravi kienu 33% ogħla f'pazjenti kkurati bi fluticasone propionate milli f'pazjenti kkurati bi Iffeza (p=0.019) filwaqt li r-rata annwali ta' attakki gravi kienet 49% ogħla filpazjenti kkurati bi fluticasone propionate milli f'pazjenti kkurati bi Iffeza (p=0.004).
English: Data submitted by the Applicant demonstrated that asthma control with Iffeza is superior to that with fluticasone propionate pMDI alone and that asthma control with Iffeza is similar to that with fluticasone propionate pMDI + formoterol fumarate pMDI.
Maltese: Id-dejta ppreżentata mill-Applikant uriet li l-kontroll tal-ażżma bi Iffeza huwa aqwa minn dak bi fluticasone propionate pMDI waħdu u li l-kontroll tal-ażżma bi Iffeza huwa simili għal dak bi fluticasone propionate pMDI + formoterol fumarate pMDI.
English: Literature data indicate that even if the PK data accurately reflect comparative pulmonary drug deposition for Iffeza versus GSK fluticasone propionate pMDI, such differences are not of clinical relevance.
Maltese: Id-dejta mir-riċensjoni tindika li anki kieku d-dejta PK tirrifletti b'mod preċiż depożizzjoni komparattiva tal-mediċina fil-pulmun għal Iffeza meta mqabbel ma' GSK fluticasone propionate pMDI, dawn id-differenzi m'humiex ta' rilevanza klinika.
English: However, an analysis of annualised exacerbation rates in this study was able to differentiate the effects of high dose ICS-LABA (inhaled corticosteroid - long-acting β2 agonist) treatments (Iffeza 500µg/20µg and fluticasone propionate 500µg + formoterol fumarate 24µg) from low dose ICS-LABA treatment (fluticasone propionate 100µg/10µg) and fluticasone propionate 500µg monotherapy.
Maltese: ICS-LABA (kortikosterojde li jittieħed man-nifs - agonista β2 li jaġixxi fit-tul) (Iffeza 500µg/20µg u fluticasone propionate 500µg + formoterol fumarate 24µg) u l-kura b'ICS-LABA f'dożi baxxi (fluticasone propionate 100µg/10µg) u fluticasone propionate 500µg bħala monoterapija.
English: The Applicant presented some reasons which could potentially explain such discordance: this could be a function of the deviation of orally inhaled product (OIP) pulmonary PK from standard PK principles, i.e. unlike conventional PK analysis (e.g. for tablets) blood concentrations of OIPs are a “post-event” (rather than “pre-event”) surrogate for efficacy and standard PK analysis does not necessarily define drug residence at the pulmonary site of action.
Maltese: L-Applikant ippreżenta xi raġunijiet li jistgħu potenzjalment jispjegaw din id-diskrepanza: din tista' tkun funzjoni tad devjazzjoni tal-PK pulmonari tal-prodott li jittieħed man-nifs oralment (OIP) mill-prinċipji standard tal-PK, jiġifieri għall-kuntrarju tal-analiżi konvenzjonali tal-PK (eż. għall-pilloli) il-konċentrazzjonijiet fid-demm tal-OIPs huma sostitut ta' “wara l-avveniment” (aktar milli “qabel l-avveniment”) għaliex l analiżi tal-effikaċja u l-PK standard mhux neċessarjament tiddefinixxi l-permanenza tal-mediċina fis sit pulmonari tal-azzjoni.
English: Following oral inhalation of formoterol the onset of bronchodilatation is rapid, within 1 - 3 minutes, and bronchodilatation following a single dose lasts for 12 hours.
Maltese: Wara t-teħid man-nifs mill-ħalq ta' formoterol il-bronkodilatazzjoni tibda malajr, fi żmien minuta sa tliet minuti, u l-bronkodilatazzjoni wara doża waħda ddum għal 12-il siegħa.
English: The Applicant stated that the choice of this endpoint is consistent with the Note for Guidance on Clinical Investigation of Medicinal Products for Treatment of Asthma - CPMP/EWP/2922/01); it is accepted as an appropriate endpoint to measure inhaled corticosteroid effect as per the CHMP OIP Guideline (CPMP/EWP/4151/00 Rev.1); and it is advocated as an essential endpoint in asthma studies by a joint expert committee of the American Thoracic Society and European Respiratory Society (ATS/ERS).
Maltese: Investigazzjoni Klinika ta' Prodotti Mediċinali għall-Kura tal-Ażżma - CPMP/EWP/2922/01); huwa aċċettat bħala punt aħħari xieraq għall-kejl tal-effett tal-kortikosterojde li jittieħed man-nifs skont ilLinja Gwida tas-CHMP dwar l-OIP (CPMP/EWP/4151/00
English: The apparent lower systemic availability of fluticasone propionate in Iffeza compared with GSK fluticasone propionate pMDI would not appear to result in a lesser clinical effect.
Maltese: Id-disponibbiltà sistemika aktar baxxa apparenti ta' fluticasone propionate fi Iffeza meta mqabblel ma' GSK fluticasone propionate pMDI ma tidhirx li toħloq effett kliniku iżgħar.
English: Furthermore, the CHMP noted that the need to demonstrate either pharmacokinetic equivalence or therapeutic equivalence to a reference product is not a requirement for this development, which was submitted according to Directive 2001/83/EC, Article 10b fixed combination application - requiring complete administrative and complete quality, non-clinical and clinical data on the combination only; the specific combination of these two well known active substances, fluticasone propionate and formorerol fumarate, is new, and therefore equivalence/therapeutic equivalence does not have to be proven.
Maltese: Barra minn hekk, is-CHMP innota li l-ħtieġa li tintwera l-ekwivalenza farmakokinetika jew l ekwivalenza terapewtika għal prodott ta' referenza m'hijiex rekwiżit għal dan l-iżvilupp, li ġie ppreżentat skont l-applikazzjoni ta' kombinazzjoni fissa tal-Artikolu 10b tad-Direttiva 2001/83/KE - li teħtieġ dejta klinika u mhux klinika amministrattiva sħiħa u ta' kwalità sħiħa fuq it-taħlita biss; ittaħlita speċifika ta' dawn iż-żewġ sustanzi attivi magħrufin, fluticasone propionate u formorerol fumarate, hija ġdida, u għaldaqstant l-ekwivalenza/l-ekwivalenza terapewtika m'għandhiex għalfejn tkun ippruvata.
English: With regard to the “Switch” therapy, the CHMP accepted the discussions presented by the Applicant and was of the view that the clinical effects of Iffeza in respect of asthma control and exacerbation risk are comparable with/similar to the clinical effects of GSK fluticasone propionate and Novartis formoterol fumarate given concomitantly.
Maltese: Rigward il-kura ta' “Tibdil”, is-CHMP aċċetta d-diskussjonijiet ippreżentati mill-Applikant u kien talfehma li l-effetti kliniċi ta' Iffeza fir-rigward tal-kontroll tal-ażżma u r-riskju ta' aggravar huma komparabbli ma'/simili għall-effetti kliniċi ta' GSK fluticasone propionate u Novartis formoterol fumarate mogħtija flimkien.
English: The clinical findings suggest that fluticasone propionate in Iffeza is non-inferior in respect of clinical effects to GSK fluticasone propionate.
Maltese: Is-sejbiet kliniċi jissuġġerixxu li fluticasone propionate fi Iffeza m'huwiex inferjuri għal GSK fluticasone propionate fir-rigward tal-effetti kliniċi.
English: It is a multidimensional concept incorporating symptoms, night time awakenings, use of rescue medication, lung function and activity limitation.
Maltese: Dan huwa kunċett multidimensjonali li jinkorpora s-sintomi, ilqawmien matul il-lejl, l-użu ta' mediċini ta' salvataġġ, il-funzjoni tal-pulmun u t-tnaqqis tal-attività.
English: Moreover it was proposed that “severe” exacerbations are the most discriminative exacerbations variable.
Maltese: Barra minn hekk kien propost li laggravar “sever” huwa l-aktar varjabbli tal-aggravar diskriminatorju.
English: These PK and PD studies both included the same strengths/doses of Iffeza, GSK fluticasone propionate pMDI and Novartis formoterol fumarate pMDI, and all products in both studies were administered via the same spacing device, so allowing a valid comparison of PK and PD data.
Maltese: fluticasone propionate pMDI u Novartis formoterol fumarate pMDI, u l-prodotti kollha fiż-żewġ studji ngħataw permezz tal-istess apparat ta' spazjar, biex b'hekk seta' jsir tqabbil validu tad-dejta PK u PD.