FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with normal renal function (creatinine clearance > 80 mL/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/day) and acetylsalicylic acid at higher dose (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Maltese: F'pazjenti li jkollhom il-kliewi jaħdmu normali (tneħħija tal-krejatinina ≥ 80 mL/min), dożi għolja ta' mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs, bħal ibuprofen > 1600 mg/kuljum) kif ukoll doża għolja ta' acetylsalicilyc acid (≥ 1.3 g kuljum) jistgħu jnaqqsu l-eliminazzjoni ta' pemetrexed u, b'hekk, tiżdied l-inċidenza ta' każijiet avversi ta' pemetrexed.
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95 % CI = 0.51-0.81, p = 0.0002).
Maltese: pemetrexed meta mqabbel mal-fergħa tal-plaċebo (n=472, popolazzjoni eżaminata b'mod indipendenti; medjan ta' 3.9 ta' xahar u 2.6 ta' xahar rispettivament) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
English: ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Maltese: *** Skont is-CTC (v 2.0; NCI 1998) ta' l-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u l alopeċja għandhom jiġu rrapportati bħala Grad 1 jew 2 biss.
English: For instructions on reconstitution and dilution of Pemetrexed Lilly before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwizzjoni ta' Pemetrexed Lilly qabel l-amministrazzjoni, ara sezzjoni 6.6. 4.3 Kontra-indikazzjonijiet
English: 100 % of previous dose
Maltese: 100% tad-doża ta' qabel
English: Hydrochloric acid (for pH adjustment)
Maltese: Hydrochloric acid (għall-aġġustament tal-pH) Sodium hydroxide (għall-aġġustament tal-pH) 6
English: Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion
Maltese: Pemetrexed Lilly 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Lilly 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: The active substance is pemetrexed.
Maltese: sigurtà ta' pemetrexed.
English: For precautions to be taken before handling or administering Pemetrexed Lilly, see section 6.6.
Maltese: Għal prekawzjonijiet li għandhom jittieħdu qabel ma tmiss jew tamministra Pemetrexed Lilly, ara sezzjoni 6.6.
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 micrograms) on a daily basis.
Maltese: Il-pazjenti għandhom jieħdu b'mod orali folic acid jew xi prodott multivitaminiku li jkun fih folic acid (minn 350 sa 1000 mikrogramma) kuljum.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Maltese: Pemetrexed Lilly 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 500 mg ta' pemetrexed (bħala pemexetred disodium).
English: Median time to tumour progression (months) (95 % CI)
Maltese: Log Rank p-value* Żmien medjan fil-progress tat-tumur (xhur) (95% CI)
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Maltese: Tossiċitajiet klinikament rilevanti li ġew irrapportati f' ≥ 1% u ≤5% (komuni) tal-pazjenti li ntgħażlu bl-addoċċ biex jirċievu cisplatin u pemetrexed jinkludu: żieda fl-AST, żieda fl-ALT, infezzjoni, newtropenja bid-deni, insuffiċjenza renali, deni, diżidratazzjoni, konġuntivite u tnaqqis fit-tneħħija ta'
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (n = 359) with that of placebo plus BSC (n = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first line doublet therapy of pemetrexed in combination with cisplatin.
Maltese: (PARAMOUNT), qabbel l-effikaċja u s-sigurtà ta' kura ta' tkomplija ta' manteniment b' pemetrexed flimkien ma' BSC (n=359) ma' dik ta' plaċebo flimkien ma' BSC (n=180) f'pazjenti li għandhom kanċer tal-pulmun mhux b'ċelluli żgħar u li jkun lokalment avanzat (Stadju IIIB) jew metastatiku (Stadju IV), ħlief meta l-istoloġija turi li fil-biċċa l-kbira ċ-ċelluli jkunu tat-tip squamous u li ma jwrew ebda progress wara 4 ċikli ta' kura primarja doppja ta' pemetrexed flimkien ma' cisplatin.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Lilly has finished.
Maltese: Cisplatin ukoll jingħata b'infużjoni f'waħda mill-vini tiegħek, u jingħata madwar 30 minuta wara li tkun spiċċat l-infużjoni ta' Pemetrexed Lilly.
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 mL with 9 mg/mL (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Maltese: soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
English: The median OS for the overall population (n = 663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI = 0.65-0.95, p = 0.01192).
Maltese: 13.6 xhur għall-fergħa tal-plaċebo, hazard ratio =0.71 (95% CI = 0.56-0.88, p = 0.002).
English: Large cell (N = 153)
Maltese: (N=153)
English: Pemetrexed Lilly is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Maltese: Pemetrexed Lilly tingħata flimkien ma' cisplatin, mediċina oħra kontra l-kanċer, bħala kura għal mesoteljoma plewrali malinna, tip ta' kanċer li jaffettwa r-rita tal-pulmun, lil pazjenti li jkunu għadhom ma ngħatawx kimoterapija.
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Lilly powder with 9 mg/mL (0.9 %) sodium chloride solution for injection before it is given to you.
Maltese: Qabel ma' jingħatalek, it-trab ta' Pemetrexed Lilly jiġi mħallat ma' soluzzjoni għall-injezzjoni ta' 9 mg/mL(0.9%) sodium chloride, mill-ispiżjar ta' l-isptar, infermier jew tabib.
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR = 0.78; 95 % CI = 0 .61-1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n = 172, 6.2 versus 7.4 months, adjusted HR = 1.56;
Maltese: Wara li bdiet il-kura b'pemetrexed flimkien ma' cisplatin (4 ċikli), il-kura b'pemetrexed kienet statistikament superjuri għal placebo għall-OS (medjan 13.9 xhur kontra 11.0 xhur, hazard ratio = 0.78, 95% CI=0.64-0.96, p=0.0195).Fil-ħin ta' din l-analiżi finali ta' sopravivenza, 28.7% tal-pazjenti kienu ħajjin jew ma baqgħux jiġu segwiti fuq il-fergħa ta' pemetrexed kontra 21.7% fuq il-fergħa ta' plaċebo.
English: The use of Pemetrexed Lilly should be avoided during pregnancy.
Maltese: L-użu ta' Pemetrexed Lilly għandu jiġi evitat waqt it-tqala.
English: Reconstitute each 100 mg vial with 4.2 mL of 9 mg/mL (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/mL pemetrexed.
Maltese: soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9 %)sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
English: EU/1/15/1034/001 EU/1/15/1034/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1034/002
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95 % CI = 0.47-0.74).
Maltese: kif mkejjel mill-bidu tal-kura primarja inizjali ta' pemetrexed flimkien ma' cisplatin, il-medjan talPFS evalwat mill-investigatur kien ta' 6.9 xhur għall-fergħa ta' pemetrexed u ta' 5.6 ta' xahar għall fergħa tal-plaċebo (hazard ratio = 0.59, 95% CI = 0.
English: Table 2 - Dose modification table for Pemetrexed Lilly (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b Dose of Pemetrexed Lilly (mg/m2)
Maltese: Tabella 2 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Lilly (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin- Tossiċitajiet li mhumiex ematoloġiċia,b
English: 50 % of previous dose (both Pemetrexed Lilly and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI
Maltese: a Dawn il-kriterji jissodisfaw id-definizzjoni ta' ≥ CTC Grad 2 ta' fsada tal-Kriterji ta' Tossiċità Komuni (CTC) ta' l-Istitut Nazzjonali tal-Kanċer (CTC v2.0; NCI 1998).
English: It is available in packs of:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-suq:
English: Interstitial pneumonitis (scarring of the air sacs of the lung)
Maltese: Pulmonite interstizjali (il-boroż ta' l-arja ġewwa 'l pulmun irabbu qoxra)
English: Alkaline phosphatase, AST and ALT ≤ 5 times upper limit of normal is acceptable if liver has tumour involvement.
Maltese: għandhom ikunu ≤ 3 darbiet il-limitu massimu tan-normal.Alkaline Phosphatase, AST u ALT ≤ 5 darbiet il-limitu massimu tan-normal hu aċċettabbli jekk il-fwied ikun sit ta' metastasi f'każ ta' tumur.
English: Pemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Maltese: X'inhu Pemetrexed Lilly u gћalxiex jintuża Pemetrexed Lilly hija mediċina li tintuża fil-kura tal-kanċer.
English: Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion This medicinal product contains approximately 54 mg of sodium per vial.
Maltese: Pemetrexed Lilly 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċinali fih madwar 54 mg ta' sodium f'kull kunjett.
English: The 1 year and 2 year survival rates for patients on pemetrexed were 58 % and 32 % respectively, compared to 45 % and 21 % for patients on placebo.
Maltese: Ir-rati ta' sopravivenza għall-ewwel sena u għat-tieni sena għal pazjenti fuq pemetrexed kienu ta' 58% u 32% rispettivament meta mqabbla ma' 45% u 21% għal pazjenti fuq plaċebo.
English: Your doctor will discuss with you the potential risk of taking Pemetrexed Lilly during pregnancy.
Maltese: It-tabib tiegħek jiddiskuti miegħek dwar ir-riskju potenzjali li tieħu Pemetrexed Lilly waqt it-tqala.
English: When using Pemetrexed Lilly in combination with cisplatin:
Maltese: Meta tuża Pemetrexed Lilly flimkien ma' cisplatin:
English: An insufficient number of patients has been studied with creatinine clearance of below 45 mL/min.
Maltese: Ġew studjati numru insuffiċjenti ta' pazjenti bi tneħħija tal- krejatinina ta' inqas minn 45 mL/min.
English: Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion
Maltese: Pemetrexed Lilly 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p < 0.001).
Maltese: ITT = intenzjoni li tikkura; N = daqs talpopolazzjoni kollha a Statistikament sinifikanti biex ma tkunx inferjuri, bl-intervall ta' kunfidenza għal HR kollu kemm hu ħafna taħt il-marġni ta' 1.17645 li turi li m'hemmx inferjorità (p < 0.001).
English: Creatinine clearance decreased**
Maltese: Tnaqqis fit tneħħija tal krejatinina**
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95 % CI = 0.64-0.96, p = 0.0195).
Maltese: medjan tal-pazjenti kien ta' 16.9 xhur għall-fergħa ta' pemetrexed u ta' 14.0 xhur għall-fergħa ta' plaċebo (hazard ratio= 0.78, 95% CI= 0.64-0.96).
English: - България тел.
Maltese: B12.
English: Table 1 - Dose modification table for Pemetrexed Lilly (as single agent or in combination) and cisplatin - Haematologic toxicities Nadir ANC < 500 /mm3 and nadir platelets ≥ 50,000 /mm3
Maltese: Tabella 1 - Tabella għall-modifikazzjoni fid-doża ta' Pemetrexed Lilly ( bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Tossiċitajiet ematoloġiċi
English: Superiority p-value
Maltese: GĦAMLA KWALITATTIVA
English: As a result there is sufficient evidence suggesting a causal relationship between the use of pemetrexed and infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue including acute bacterial dermo-hypodermitis, cellulitis, pseudocellulitis and dermatitis.
Maltese: B'frekwenza mhux magħrufa ġew irrapportati disturbi infettivi u mhux infettivi tad-dermis, lipodermis u/jew tat-tessut ta' taħt il-ġilda (eż. dermo-ipodermite batterjali akuta, psewdoċellulite,
English: NSCLC, maintenance treatment
Maltese: NSCLC, kura ta' manteniment JMEN
English: 100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed Lilly and cisplatin is documented in Table 3.
Maltese: 50% tad-doża ta' qabel a Kriterji ta' Tossiċità Komuni ta' l-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998) Il-kura b' Pemetrexed Lilly għandha titwaqqaf jekk il-pazjent ikollu xi tossiċità ematoloġika jew tossiċità li mhijiex ematoloġika ta' Grad 3 jew 4 wara li d-doza tkun tnaqqset darbtejnjew minnufih jekk tkun osservata newrotossiċità ta' Grad 3 jew 4.
English: Of the 939 patients treated with pemetrexed plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Maltese: Mid939 pazjent li bdew il-kura b'pemetrexed flimkien ma' cisplatin, 539 pazjent ġew magħżula b'mod arbitrarju biex jieħdu kura ta' manteniment b'pemetrexed jew plaċebo.
English: The incidence of adverse reactions was evaluated for patients who received ≤ 6 cycles of pemetrexed maintenance (N = 519), and compared to patients who received > 6 cycles of pemetrexed (N = 281).
Maltese: L-inċidenza ta' reazzjonijiet avversi ġiet analizzata f'pazjenti li rċevew ≤ 6 ċikli ta' manteniment b'pemetrexed (N=519), u mqabbla mal-pazjenti li rċevew > 6 ċikli ta' pemetrexed
English: **According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
Maltese: *** Skont is-CTC (v2.0; NCI 1998) ta' l-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u lalopeċja għandhom jiġu rrapportati biss bħala Grad 1 jew 2.
English: Immune-mediated haemolytic anaemia (antibody-mediated destruction of red blood cells) Hepatitis (inflammation of the liver)
Maltese: Anemija emolitika kkawżata mis-sistema immunitarja tiegħek stess (jinqerdu ċ-ċelluli ħomor tad demm minħabba l-antikorpi) Epatite (infjammazzjoni tal-fwied)
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritis/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' ≥ 1% u ≤ 5% (komuni) tal-pazjenti li ntgħażlu bl-addoċċ biex jirċievu cisplatin u pemetrexed jinkludu: insuffiċjenza renali, infezzjoni, deni,
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5 % of 800 patients randomly assigned to receive single agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N = 663) and continuation pemetrexed maintenance (PARAMOUNT: N = 539) studies.
Maltese: It-tabella hawn taħt tipprovdi l-frekwenza u s-severità tal-effetti mhux mixtieqa li huma maħsuba li jistgħu jkunu relatati mal-mediċina taħt studju u li ġew irrapportati f'> 5 % tat-800 pazjent li b'mod arbitrarju ġew magħżula biex jirċievu pemetrexed bħala sustanza waħidha u l-402 pazjenti li b'mod arbitrarju ġew magħżula biex jirċievu plaċebo fl-istudji ta' manteniment (JMEN: N=663) u tat tkomplija ta' manteniment b'pemetrexed (PARAMOUNT:
English: After reconstitution, the solution contains 25 mg/mL of pemetrexed.
Maltese: Wara r-rikostituzzjoni , kull kunjett fih 25 mg/mL ta' pemetrexed.
English: Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 100 mg of pemetrexed.
Maltese: U KWANTITATTIVA Pemetrexed Lilly 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Nadir platelets < 50,000 /mm3 with bleedinga, regardless of nadir ANC
Maltese: /mm3 u lgħadd l-iktar baxx ta' plejtlits ≥ 50,000 /mm3
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Maltese: Il-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous (n= 481) kien ta' 15.5 xhur għall-fergħa ta' pemetrexed u ta' 10.3 xhur għall-fergħa tal-plaċebo (hazard ratio = 0.70, 95% CI = 0.56-0.88, p=0.002).
English: Calculate the dose and the number of Pemetrexed Lilly vials needed.
Maltese: Ikkalkula d-doża u n-numru ta' kunjetti ta' Pemetrexed Lilly li hemm bżonn.
English: Further information on Relvar Ellipta 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: Vilanterol is a long-acting beta-2 agonist.
Maltese: Vilanterol huwa agonista beta-2 li jaħdem fit-tul.
English: Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms).
Maltese: Relvar Ellipta jiġi bħala inalatur f'żewġ qawwiet (92/22 mikrogramma u 184/22 mikrogramma).
English: Fluticasone furoate is a corticosteroid.
Maltese: Fluticasone furoate huwa kortikosterojde.
English: Relvar Ellipta received a marketing authorisation valid throughout the EU on 13 November 2013.
Maltese: Relvar Ellipta rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU fit-13 ta' Novembru 2013.
English: Relvar Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD).
Maltese: Relvar Ellipta huwa inalatur biex jikkura l-ażma u marda pulmonari ostruttiv kroniku (COPD, chronic obstructive pulmonary disease).
English: Other information about Relvar Ellipta
Maltese: Informazzjoni oħra dwar Relvar Ellipta
English: Relvar Ellipta contains the active substances fluticasone furoate and vilanterol.
Maltese: Relvar Ellipta fih is-sustanzi attivi fluticasone furoate u vilanterol.
English: Relvar Ellipta 184/22 also improved FEV1 by 193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
Maltese: Relvar Ellipta 184/22 tejjeb ukoll il-FEV1 b'193 ml aktar minn fluticasone furoate u b'210 ml aktar minn inalatur ieħor li fih fluticasone propionate.
English: A fourth study in 1,522 patients showed that Relvar Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol).
Maltese: Ir-raba' studju f'1,522 pazjent wera li Relvar Ellipta kien effettiv daqs mediċina oħra li fiha kortikosterojde (fluticasone propionate) u agonista beta-2 li jaġixxi fit-tul (salmeterol).
English: The first study showed that Relvar Ellipta 92/22 improved average FEV1 by 115 ml more than placebo, and a second study showed that Relvar Ellipta 184/22 improved average FEV1 by 131 ml more than placebo.
Maltese: L-ewwel studju wera li Relvar Ellipta 92/22 tejjeb il-FEV1 medju b'115 ml aktar mill-plaċebo, u t-tieni studju wera li Relvar Ellipta 184/22 tejjeb il-FEV1 medju b'131 ml aktar mill-plaċebo.
English: How is Relvar Ellipta used?
Maltese: Kif jaħdem Relvar Ellipta?
English: In two further studies, Relvar Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone.
Maltese: F'żewġ studji oħra, Relvar Ellipta naqqas in-numru ta' episodji ta' feġġa mill-ġdid b'bejn 13 u 34 % aktar minn vilanterol waħdu.
English: In two of the studies, Relvar Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment).
Maltese: Fi tnejn mill-istudji, Relvar Ellipta 92/22 żied il-volum tal-arja li pazjent seta' joħroġ man-nifs f'sekonda (FEV1) b'36 ml aktar minn fluticasone furoate waħdu u b'172 ml aktar mill-plaċebo (kura finta).
English: Four studies in over 5,500 patients showed that Relvar Ellipta improves breathing and reduces flareups of symptoms in patients with COPD.
Maltese: Erba' studji f'aktar minn 5,500 pazjent urew li Relvar Ellipta jtejjeb it-teħid tan-nifs u jnaqqas il-feġġa mill-ġdid tas-sintomi f'pazjenti bis-COPD.
English: In a third study, fewer patients taking Relvar Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).
Maltese: Fit-tielet studju, inqas pazjenti li kienu qed jieħdu Relvar Ellipta 92/22 kellhom tal-inqas feġġa mill-ġdid severa waħda wara sena ta' kura minn dawk li kienu qed jieħdu fluticasone furoate waħdu (13 % kontra 16 %).
English: As for all medicines, data on the use of Relvar Ellipta are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Relvar Ellipta hija ssorveljata kontinwament.
English: Side effects reported with Relvar Ellipta are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati b'Relvar Ellipta huma evalwati bir-reqqa u hija meħuda kull azzjoni meħtieġa biex tipproteġi lill-pazjenti.
English: It works on various types of immune cells, blocking the release of substances involved in inflammation.
Maltese: Dan jaħdem fuq diversi tipi ta' ċelloli immuni, jimblokka rrilaxx tas-sustanzi involuti fl-infjammazzjoni.
English: These patients were already well controlled with the comparator medicine and Relvar Ellipta treatment was able to maintain their FEV1.
Maltese: Dawn ilpazjenti diġà kienu kkontrollati tajjeb bil-mediċina komparatur u l-kura b'Relvar Ellipta setgħet iżżomm il-FEV1 tagħhom.