FrancophonIA/ELRC3.0 huggingface dataset:
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni ma kinitx tipika b'żieda moderata ta' inqas minn 14 mmol/L (250 mg/dL) biss fil-valuri tal-glukożju fid-demm.
English: Temporarily stop taking Vokanamet if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Maltese: Waqqaf b'mod temporanju it-teħid ta' Vokanamet jekk għandek kundizzjoni li tista' tkun assoċjata ma' deidratazzjoni (telf sinifikanti ta' fluwidi tal-ġisem) bħal rimettar sever, dijarea, deni, esponiment għal sħana jew jekk tixrob inqas fluwidu min-normal.
English: Placebo-controlled studies
Maltese: Studji kkontrollati bi plaċebo
English: Haematocrit increase was observed with canagliflozin treatment (see section 4.8); therefore, careful monitoring in patients with already elevated haematocrit is warranted.
Maltese: Kienet osservata żieda fl-ematokrit bi trattament b'canagliflozin (ara sezzjoni 4.8); għalhekk, huwa meħtieġ monitoraġġ b'attenzjoni f'pazjenti li diġà għandhom livelli għolja ta' ematokrit.
English: SK-821 08 Bratislava Tel: +421 2 6381 1611
Maltese: SK-821 08 Bratislava
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g., type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Maltese: Il-pazjenti li jistgħu jkunu f'riskju akbar għal DKA jinkludu pazjenti b'riserva baxxa ta' funzjoni taċċelluli beta (eż., pazjenti b'dijabete tat-tip 2 b'peptide C baxx jew dijabete awtoimmuni latenti fl-adulti (LADA - latent autoimmune diabetes in adults) jew pazjenti bi storja ta' pankreatite), pazjenti b'kundizzjonijiet li jwasslu għal ammont ristrett fl-ikel li jittiekel jew deidratazzjoni severa, pazjenti li għalihom id-dożi tal-insulina jiġu mnaqqsa u pazjenti b'żieda fil-ħtieġa għall-insulina minħabba mard mediku akut, operazzjoni jew abbuż tal-alkoħol.
English: Metformin is a biguanide with antihyperglycemic effects, lowering both basal and postprandial plasma glucose.
Maltese: Metformin huwa biguanide b'effetti kontra l-ipergliċemija, li jbaxxi kemm il-glukożju bażiku filplażma kif ukoll il-glukożju fil-plażma wara l-ikel.
English: From a starting value of RTG of approximately 13 mmol/L, maximal suppression of 24-hour mean RTG was seen with the 300 mg daily dose to approximately 4 mmol/L to 5 mmol/L in patients with type 2 diabetes in phase 1 studies, suggesting a low risk for treatment-induced hypoglycaemia.
Maltese: Mill-valur ta' RTG tal-bidu ta' madwar 13 mmol/L, l-akbar soppressjoni fil-medja ta' RTG f'24 siegħa dehret bid-doża ta' 300 mg kuljum għal madwar 4 mmol/L sa 5 mmol/L f'pazjenti b'dijabete tat-tip 2 fl-istudji ta' fażi 1, li jissuġġerixxu riskju baxx ta' ipogliċemija kkawżata mill-kura.
English: Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 150 mg ta' canagliflozin, u 850 mg ta' metformin hydrochloride.
English: Triple therapy with metformin and sitagliptin e (26 weeks)
Maltese: Terapija tripla b'metformin u sitagliptin e (26 ġimgħa) Canagliflozin + metformin u sitagliptin (N = 107)
English: • hives
Maltese: SN
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe
Maltese: 0.6 ml (10 mg/ml) Siringa 1 mimlija għal-lest
English: Subcutaneous use pre-filled syringe (glass)
Maltese: Siringa mimlija għal-lest (ħġieġ)
English: MA (EU) number
Maltese: Numru tal-MA (UE) Isem (Ivvintat)
English: Further information on Udenyca 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: Other information about Udenyca
Maltese: Informazzjoni oħra dwar Udenyca
English: Udenyca is a ‘biosimilar medicine'.
Maltese: Udenyca hija "mediċina bijosimili".
English: The active substance in Udenyca, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Udenyca, il-pegfilgrastim, hija magħmula minn filgrastim, li hija simili ħafna għal proteina tal-bniedem imsejħa fattur stimolanti tal-kolonja tal-granuloċiti (G-CSF).
English: The reference medicine for Udenyca is Neulasta.
Maltese: Il-mediċina ta' referenza għal Udenyca hija Neulasta.
English: Laboratory studies comparing Udenyca with Neulasta have shown that the active substance in Udenyca is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Udenyca ma' Neulasta wrew li s-sustanza attiva f'Udenyca hija simili ħafna għal dik f'Neulasta f'termini ta' struttura, purità u attività bijoloġika.
English: Filgrastim works by encouraging the
Maltese: Filgrastim jaħdem
English: What are the risks associated with Udenyca?
Maltese: X'inhuma r-riskji assoċjati ma' Udenyca?
English: Udenyca is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Maltese: Udenyca jingħata bħala doża waħda ta' 6 mg li tiġi injettata taħt il-ġilda mill-inqas 24 siegħa wara t-tmiem ta' kull ċiklu ta' kimoterapija (kura b'mediċini tal-kanċer).
English: In Udenyca, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'Udenyca, filgrastim ġie “pegilat” (twaħħal ma' kimika msejħa polietilenglikol).
English: How is Udenyca used?
Maltese: Kif jintuża Udenyca?
English: As for all medicines, data on the use of Udenyca are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Udenyca hija ssorveljata kontinwament.
English: All these data were considered sufficient to conclude that Udenyca will behave in the same way as Neulasta in terms of effectiveness and safety in its approved uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Udenyca ser jaġixxi bl-istess mod bħal Neulasta f'termini ta' effettività u sigurtà fl-użu approvat tiegħu.
English: This means that Udenyca is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Udenyca huwa simili ħafna għal mediċina bijoloġika oħra (il-"mediċina ta' referenza") li diġà hija awtorizzata fl-UE.
English: Udenyca is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in large numbers of abnormal blood cells are produced, , which can develop into leukaemia).
Maltese: Udenyca mhuwiex maħsub biex jintuża f'pazjenti bil-lewkimja majelojde kronika tal-kanċer tad-demm jew b'sindromi majelodisplastiċi (kundizzjonijiet li fihom jiġu prodotti għadd kbir ta' ċelloli tad-demm anormali, li jistgħu jiżviluppaw f'lewkimja).
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Udenyca has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Udenyca għandu struttura, purità u attività bijoloġika simili ħafna għal Neulasta u jiġi distribwit bl-istess mod fil-ġisem.
English: Because Udenyca is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Udenyca.
Maltese: Dan jingħata speċifikament biex jitnaqqas it-tul ta' żmien tan-newtropenija u biex tiġi evitata nnewtropenija bid-deni (meta n-newtropenija tkun akkumpanjata minn deni).
English: Side effects reported with Udenyca are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Udenyca huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Udenyca is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Maltese: Udenyca huwa mediċina li tintuża f'pazjenti bil-kanċer biex tgħin fin-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), li hija effett sekondarju komuni tal-kura tal-kanċer u tista' twassal biex il-pazjenti jsiru vulnerabbli għall-infezzjonijiet.
English: What measures are being taken to ensure the safe and effective use of Udenyca?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Udenyca?
English: Pharmacokinetic (PK) data
Maltese: Dejta farmakokinetika (PK)
English: Flutiform 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: Flutiform 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: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of Council Directive 2001/83/EC.
Maltese: Direttiva tal-Kunsill 2001/83/KE.
English: The relative bioavailability of fluticasone propionate at steady state was 67% following Flutiform administration compared with GSK fluticasone propionate pMDI.
Maltese: Il-bijodisponibbiltà relattiva ta' fluticasone propionate fi stat stabbli kienet 67% wara l-għoti ta' Flutiform meta mqabbel ma' GSK fluticasone propionate pMDI.
English: • In the pharmacokinetic data presented systemic exposure of fluticasone was lower (67%) following Flutiform 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' Flutiform milli wara l-inalazzjoni fl-istess waqt ta'
English: The data presented in respect of exacerbations demonstrate an increased protective benefit of Flutiform 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 Flutiform, p=0.019 and p=0.004, respectively.
Maltese: Id-dejta ppreżentata rigward lattakki gravi turi benefiċċju protettiv akbar ta' Flutiform 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 Flutiform, p=0.019 u p=0.004, rispettivament.
English: The CHMP noted that the differences of the magnitude observed between Flutiform 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 Flutiform 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: With regard to the “Switch” indication, the proportion of patients experiencing exacerbations in the pivotal “Switch” study (Study FLT3503) was similar in Flutiform 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 Flutiform 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: Approximately 20 subjects in each arm of this parallel group study were administered Flutiform 500/20 (fluticasone propionate 500µg and formoterol fumarate 20µg) or GSK fluticasone propionate 500µg pMDI + Novartis formoterol fumarate 24µg pMDI.
Maltese: Madwar 20 suġġett f'kull fergħa ta' dan l-istudju ta' grupp parallel ingħataw Flutiform 500/20 (fluticasone propionate 500µg u formoterol fumarate 20µg) jew GSK fluticasone propionate 500µg pMDI + Novartis formoterol fumarate 24µg pMDI.
English: agonist.
Maltese: Jew
English: The question posed by CHMP implied that the 67% relative bioavailability of the fluticasone propionate component of Flutiform 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 Flutiform 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: This provides further support for the clinical relevance of the effects seen with Flutiform.
Maltese: Dan jipprovdi aktar appoġġ għar-rilevanza klinika tal-effetti li dehru bi Flutiform.
English: The inclusion of a second, lower dose of Flutiform (100µg/10µg) in the PD study was also instructive.
Maltese: Linklużjoni ta' doża oħra, aktar baxxa ta' Flutiform (100µg/10µg) fl-istudju PD kienet ukoll istruttiva.
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: • Therefore the Committee concluded that the benefit-risk balance of Flutiform in the applied indications is favourable.
Maltese: • Għaldaqstant il-Kumitat ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju ta' Flutiform flindikazzjonijiet applikati huwa favorevoli.
English: An annual exacerbation rate ratio of 0.98, i.e. very close to unity for the comparison of Flutiform 500µg/20µg versus fluticasone propionate 500µg + formoterol fumarate 24µg was therefore suggestive of non-inferiority but was not statistically definitive.
Maltese: 500µg/20µg meta mqabbel ma' fluticasone propionate 500µg + formoterol fumarate 24µg għaldaqstant jindika n-nuqqas ta' inferjorità iżda ma kienx statistikament definittiv.
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 Flutiform-treated patients (p=0.019) whilst the annual exacerbation rate was 49% higher in fluticasone propionate- than Flutiform-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 Flutiform (p=0.019) filwaqt li r-rata annwali ta' attakki gravi kienet 49% ogħla fil-pazjenti kkurati bi fluticasone propionate milli f'pazjenti kkurati bi Flutiform (p=0.004).
English: Literature data indicate that even if the PK data accurately reflect comparative pulmonary drug deposition for Flutiform 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 Flutiform meta mqabbel ma' GSK fluticasone propionate pMDI, dawn id-differenzi m'humiex ta' rilevanza klinika.
English: These PK and PD studies both included the same strengths/doses of Flutiform, 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: GSK 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.
English: The apparent lower systemic availability of fluticasone propionate in Flutiform 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 Flutiform meta mqabblel ma' GSK fluticasone propionate pMDI ma tidhirx li toħloq effett kliniku iżgħar.
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 Flutiform 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' Flutiform 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: 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 (Flutiform 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: (kortikosterojde li jittieħed man-nifs - agonista β2 li jaġixxi fit-tul) (Flutiform 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: Effects with the low dose of Flutiform (100µg/10µg) upon pre-dose FEV1 were similar to those with the high dose of GSK fluticasone propionate 500µg (alone or in combination with formoterol fumarate 24µg).
Maltese: Flutiform (100µg/10µg) fuq l-FEV1 ta' qabel id-doża kienu simili għal dawk li dehru bid-doża għolja ta' GSK fluticasone propionate 500µg (mogħti kemm waħdu kif ukoll flimkien ma' formoterol fumarate 24µg).
English: The clinical findings suggest that fluticasone propionate in Flutiform is non-inferior in respect of clinical effects to GSK fluticasone propionate.
Maltese: Is-sejbiet kliniċi jissuġġerixxu li fluticasone propionate fi Flutiform m'huwiex inferjuri għal GSK fluticasone propionate fir-rigward tal-effetti kliniċi.
English: Masking of any lesser clinical corticosteroid effect by the long-acting ß2 agonist
Maltese: Għall-indikazzjoni ta' “Żieda” l-effetti fuq l-FEV1
English: The PK study (Study FLT1501) which has given rise to concerns was conducted to evaluate the comparative safety of Flutiform when compared with the marketed monoproduct pMDIs.
Maltese: L-istudju PK (Studju FLT1501) li ħoloq it-tħassib sar sabiex tkun evalwata s-sigurtà komparattiva ta' Flutiform meta mqabbel mal-pMDIs ta' prodott wieħed fis-suq.
English: These endpoints were demonstrably inhaled cortocosteroid-driven and/or inhaled corticosteroid dose-responsive and all provided rigorous statistical evidence that the inhaled corticosteroid effects of Flutiform were not less than those of fluticasone propionate + formoterol fumarate.
Maltese: Dawn il-punti aħħarin kienu biċ-ċar ikkawżati minn kortikosterojde li jittieħed man-nifs u/jew reattivi għad-doża tal-kortikosterojde li jittieħed man-nifs u kollha pprovdew evidenza statistika rigoruża li l-effetti tal-kortikosterojde li jittieħed man-nifs ta' Flutiform ma kinux iżgħar minn dawk ta' fluticasone propionate + formoterol fumarate.
English: These conclusions based on an indirect assessment of future exacerbation risk are consistent with and support those based on a direct observation of exacerbation rates during the clinical studies.
Maltese: Dawn il-konklużjonijiet ibbażati fuq evalwazzjoni indiretta tar-riskju ta' aggravar futur huma konsistenti ma' u jappoġġjaw dawk ibbażati fuq osservazzjoni diretta tar-rati ta' attakki gravi waqt l-istudji kliniċi.
English: This comparison showed that despite a lower relative fluticasone propionate bioavailability, the effect upon pre-dose FEV1 (which was demonstrably mediated by fluticasone propionate alone in Study FLT3503) was numerically greater with Flutiform 500µg/20µg than with GSK fluticasone propionate 500µg (either alone or in conjunction with Novartis formoterol fumarate 24µg).
Maltese: qabel id-doża (li biċ-ċar kien medjat minn fluticasone propionate waħdu fl-Istudju FLT3503) kien numerikament akbar bi Flutiform 500µg/20µg milli b'GSK fluticasone propionate 500µg (kemm waħdu kif ukoll flimkien ma' Novartis formoterol fumarate 24µg).
English: Moreover it was proposed that “severe” exacerbations are the most discriminative exacerbations variable.
Maltese: Barra minn hekk kien propost li l-aggravar “sever” huwa l-aktar varjabbli tal-aggravar diskriminatorju.
English: Turning to the data in the Applicant's clinical studies: For the “Step-up” indication both pre-dose and post-dose FEV1 effects at 8 to 12 weeks were significantly greater with Flutiform than with fluticasone propionate; for the “Switch” indication both pre-dose and post-dose FEV1 effects numerically favoured Flutiform over fluticasone propionate + formoterol fumarate (in both Per Protocol and Intention-to-Treat population comparisons).
Maltese: Flutiform milli bi fluticasone propionate; għall-indikazzjoni ta' “Tibdil” l-effetti fuq l-FEV1 kemm ta' qabel id-doża kif ukoll ta' wara d-doża numerikament jiffavorixxu lil Flutiform minflok fluticasone propionate + formoterol fumarate (kemm fit-tqabbil tal-popolazzjoni Skont il-Protokoll kif ukoll dik bl-Intenzjoni ta' Kura).