FrancophonIA/ELRC3.0 huggingface dataset:
English: This followed a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not be used for these purposes.
Maltese: Dan segwa rieżami li kkonkludiet li ma hemmx data robusta li turi li dawn il-mediċini huma effettivi fil-kura ta' infezzjonijiet respiratorji eżistenti, jew għallprevenzjoni tal-pulmonite, u għalhekk m'għandhomx jintużaw għal dawn l-iskopijiet.
English: Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system to recognise and fight infections.
Maltese: Ma għandhomx jiġu preskritti mediċini bil-liżati batteriċi għall-kura ta' infezzjonijiet respiratorji eżistenti jew għal profilassi ta' pulmonite minħabba nuqqas ta' data dwar l-effikaċja.
English: Bacterial lysate medicines have been authorised via national procedures.
Maltese: Il-mediċini bil-liżati batteriċi ġew awtorizzati permezz ta' proċeduri nazzjonali.
English: The CHMP therefore recommended that use of the medicines for prevention can continue, but the companies must provide further data on safety and effectiveness from new clinical studies by 2026.
Maltese: Is-CHMP għalhekk irrakkomanda li l-użu tal-mediċini għall-prevenzjoni jista' jkompli, iżda l-kumpaniji jridu jipprovdu aktar data dwar is-sigurtà u l-effikaċja minn studji kliniċi ġodda sal-2026.
English: 1 x 2 tablets (unit dose)
Maltese: 1 X 2 pilloli (doża unika)
English: Oral use blister (alu/PVC/PCT FE)
Maltese: Folja (alu/PVC/PCTFE)i
English: 90 mg Film-coated tablet
Maltese: 90 mg Pillola miksija b'rita Użu orali
English: Further information on Leucofeligen FeLV/RCP can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Leucofeligen FeLV/RCP tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Leucofeligen FeLV/RCP (Feline calicivirosis, feline viral rhinotracheitis, feline panleucopenia (live attenuated) and feline leukaemia (inactivated) vaccine)
Maltese: Leucofeligen FeLV/RCP (Vaċċin ta' kaliċivirożi felina, rinotrakeite virali felina, palewkopenija felina (ħaj attenwat) u lewkimja felina (inattivat)
English: Other information about Leucofeligen FeLV/RCP
Maltese: Informazzjoni oħra dwar Leucofeligen FeLV/RCP
English: It also contains a protein of feline leukaemia virus (FeLV).
Maltese: Dan fih ukoll proteina tal-virus tal-lewkimja felina (FeLV).
English: The vaccine contains live feline viruses that have been attenuated (weakened) so they do not cause disease: feline calicivirus (strain F9), viral rhinotracheitis virus (strain F2) and feline panleucopenia virus (strain LR 72).
Maltese: Il-vaċċin fih ħames virusijiet felini li ġew attenwati (imdgħajfa) sabiex ma jikkawżawx il-mard: kaliċivirus felin (razza F9), virus tar-rinotrakeite virali (razza F2) u virus tal-panlewkopenija felina (razza LR 72).
English: The most common side effects with Leucofeligen FeLV/RCP (which may affect up to 1 in 10 cats) are a moderate and short-lived local reaction (<2 cm) after the first injection which resolves without treatment within 3 to 4 weeks, raised body temperature (lasting 1 to 4 days), apathy (listlessness) and digestive disturbances.
Maltese: L-effetti sekondarji l-aktar komuni b'Leucofeligen FeLV/RCP (li jistgħu jaffettwaw sa qattus 1 minn kull 10 iqtates) huma reazzjoni lokali moderata u li ma ddumx (<2 cm) wara l-ewwel injezzjoni li tmur mingħajr kura fi żmien 3 sa 4 ġimgħat, żieda fit-temperatura tal-ġisem (li ddum minn jum sa 4 ijiem), apatija (nuqqas ta' enerġija) u disturbi diġestivi.
English: Leucofeligen FeLV/RCP is a vaccine.
Maltese: Leucofeligen FeLV/RCP huwa vaċċin.
English: Leucofeligen FeLV/RCP is a vaccine used to protect cats from eight weeks of age against the following diseases: feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus); feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus); feline panleucopenia (a serious illness causing bloody diarrhoea and a fall in white blood cell counts caused by a parvovirus); feline leukaemia (an illness affecting the immune system causing loss of appetite, weight loss, poor fur condition, fever, pale gums and diarrhoea caused by a retrovirus).
Maltese: Għalhekk, qtates ikbar fl-età jeħtieġu tilqim mill-ġdid b'Leucofeligen FeLV/RCP wara biss 3 snin, b'tilqim mill-ġdid annwali fis-snin ta' intervent bil-vaċċin Feligen RCP biex jipproteġi kontra l-kaliċivirożi, ir-rinotrakeite u l-panlewkopenija. Leucofeligen FeLV/RCP jiġi bħala żewġ kunjetti, wieħed li fih pelit ta' trab abjad u wieħed li fih likwidu.
English: It also prevents feline panleucopenia and persistent viraemia for feline leukaemia (the presence of feline leukaemia virus in the blood).
Maltese: Dan jipprevjeni wkoll panlewkopenija felina u viremija persistenti għal lewkimja felina (il-preżenza ta' virus tal-lewkimja felina fid-demm).
English: How is Leucofeligen FeLV/RCP used?
Maltese: Kif jintuża Leucofeligen FeLV/RCP?
English: Leucofeligen FeLV/RCP received a marketing authorisation valid throughout the EU on <date of issue of the Marketing Authorisation>.
Maltese: Leucofeligen FeLV/RCP ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil25 ta' Ġunju 2009.
English: For the full list of side effects and restrictions with Leucofeligen FeLV/RCP, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Leucofeligen FeLV/RCP, ara l-fuljett ta' tagħrif.
English: What are the risks associated with Leucofeligen FeLV/RCP?
Maltese: Kif jaħdem Leucofeligen FeLV/RCP?
English: A laboratory study in which cats were exposed to feline leukaemia virus confirmed that following the first annual booster vaccination cats were protected for a three year period against leukaemia.
Maltese: Studju fil-laboratorju li fih qtates kienu esposti għall-virus tal-lewkimja tal-qtates ikkonferma li wara lewwel tilqima booster annwali, il-qtates kienu protetti għal perjodu ta' tliet snin kontra l-lewkimja.
English: The vaccine starts to protect against panleucopenia and leukaemia 3 weeks after the second injection and protection against calicivirosis and viral rhinotracheitis starts 4 weeks after the second injection.
Maltese: Il-vaċċin jibda jipproteġi kontra l-panlewkopenja u l-lewkimja 3 ġimgħat wara t-tieni injezzjoni u lprotezzjoni kontra l-kaliċivirożi u r-rinotrakeite virali tibda 4 ġimgħat wara t-tieni injezzjoni.
English: How does Leucofeligen FeLV/RCP work?
Maltese: Għaliex Leucofeligen FeLV/RCP huwa awtorizzat fl-UE?
English: 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland
Maltese: Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland
English: Edvard Thomsens Vej 14 DK-2300 København S Denmark
Maltese: Edvard Thomsens Vej 14 DK-2300 Köpenhamn S Denmark
English: Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
Maltese: Ir-Renju Unit Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
English: Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Maltese: Actavis Group PTC ehf Reykjavikurvegi 76-78 220
English: Belgium Sandoz N.V. Telecom Gardens Medialaan 40
Maltese: Telecom Gardens Medialaan 40
English: Velvian Germany GmbH Carl-Zeiss-Ring 9
Maltese: Il-Ġermanja VELVIAN Germany GmbH Carl-Zeiss-Ring 9
English: Perryment Ltd 42-46 High street Esher, KT10 9QY Surrey United Kingdom
Maltese: High street Esher, KT10 9QY Surrey United Kingdom
English: Maksimirska 120 Zagreb 10000 Croatia
Maltese: Sandoz d.o.o. Maksimirska 120 Zagreb 10090 Croatia
English: Sandoz d.o.o.
Maltese: Sandoz N.V.
English: Levonorgestrel-containing emergency contraceptive medicinal products Member State (in EEA)
Maltese: Prodotti mediċinali kontraċettivi ta' emerġenza li fihom Levonorgestrel Stat Membru
English: UAB „Orivas“ J. Jasinskio g. 16B LT- 01112 Vilnius Lithuania
Maltese: Jasinskio g. 16B LT- 01112 Vilnius Lithuania
English: Laboratorios Leon Farma, SA Poligono Industrial Navatejera C/La Vallina s/n
Maltese: Il-Ġermanja Laboratorios Leon Farma, SA Poligono Industrial Navatejera C/La Vallina s/n
English: Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n,
Maltese: Il-Bulgarija Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n,
English: NorLevo, tabletten 0,75 mg
Maltese: NorLevo, tabletten 0,75 mg 0,75 mg Pillola
English: 83607 Holzkirchen Germany unofem HEXAL 1,5 mg Tabletten
Maltese: Germany unofem HEXAL 1,5 mg Tabletten
English: Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain
Maltese: Laboratorios León Farma S.A. Calle La Vallina s/n Polígono Industrial Navatejera 24008 - Navatejera - León Spain
English: Gedeon Richter Romania S.A. Str. Cuza-Vodă nr. 99-105 Târgu Mureş 540306
Maltese: Ir-Rumanija Gedeon Richter Romania S.A. Str. Cuza-Vodă nr.
English: Norlevo 1500 microgramos comprimido
Maltese: Norlevo 1500 microgramos comprimidos
English: Navela 0,75 mg Tabletten 0.75 mg
Maltese: Navela 0,75 mg Tabletten 0,75 mg Pillola
English: Czech Republic Gedeon Richter Plc.
Maltese: Ir-Rumanija Gedeon Richter Plc.
English: Luxembourg Medimpex UK Limited 127 Shirland Road
Maltese: Il-Lussemburgu Medimpex UK Limited 127 Shirland Road
English: Postinor 1500 microgramos comprimido
Maltese: Postinor 1500 microgramos comprimidos
English: Belgium Medimpex UK Limited 127 Shirland Road
Maltese: In-Norveġja Medimpex UK Limited 127 Shirland Road
English: Navela 1,5 mg Tabletten 1.5 mg
Maltese: Navela 1,5 mg Tabletten
English: Belgium Laboratoire HRA Pharma 15, rue Béranger
Maltese: Il-Finlandja Laboratoire HRA Pharma 15, rue Béranger
English: POSTINOR-2 750 micrograme
Maltese: POSTINOR-2 750 micrograme 0,75 mg Pillola
English: Postinor 1500 Mikrogramm-Tablette
Maltese: Postinor 1500 MikrogrammTablette
English: Czech Republic Laboratorios León Farma S.A. Calle La Vallina s/n
Maltese: Ir-Renju Unit Laboratorios Leon Farma SA Calle La Vallina S/N
English: Belgium Laboratoire HRA Pharma 15. rue Béranger
Maltese: Id-Danimarka Laboratoire HRA Pharma 15, rue Béranger
English: Polígono Industrial Navatejera 24008 - Navatejera - León Spain
Maltese: Poligono Industrial Navatejera Navatejera, Leon E-24008
English: Isteranda 1.5mg Tablets 1.5 mg
Maltese: Isteranda 1.5mg Tablets
English: Ramonna 1,5 mg tableta 1.5 mg
Maltese: Ramonna 1,5 mg tableta
English: EGIANTI 0,75 mg tablety 0.75 mg
Maltese: EGIANTI 0,75 mg tablety
English: Nopregy 1,5 mg tablety 1.5 mg
Maltese: Nopregy 1,5 mg tablety
English: Empil 0,75 mg tabletta 0.75 mg
Maltese: Empil 0,75 mg tabletta
English: Escapelle 1,5 mg tablets 1.5 mg
Maltese: Escapelle 1,5 mg tablets
English: Escapelle 1,5 mg tableta 1.5 mg
Maltese: Escapelle 1,5 mg tableta
English: NORLEVO 1.5 mg tablet 1.5 mg
Maltese: NORLEVO 1.5 mg tablet
English: NORLEVO 1,5 mg, comprimé
Maltese: NORLEVO 1,5 mg, comprimé 1,5 mg
English: PiDaNa 1,5 mg Tablette 1.5 mg
Maltese: PiDaNa 1,5 mg Tablette
English: Luxembourg Laboratoire HRA Pharma 15, rue Béranger
Maltese: Il-Lussemburgu Laboratoire HRA France 15, rue Béranger
English: NORLEVO 1,5 mg tableta 1.5 mg
Maltese: NORLEVO 1,5 mg tableta
English: Cinqaero EMA/450050/2016
Maltese: Cinqaero EMA/450050/2016x
English: The full EPAR for Cinqaero 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: Flare-ups were seen in 32% of patients (151 out of 477) given Cinqaero compared with 50% (237 out of 476) of those given placebo.
Maltese: Ir-rikaduti dehru fi 32 % talpazjenti (151 minn 477) li ngħataw Cinqaero meta mqabbla ma' 50 % (237 minn 476) ta' dawk li ngħataw plaċebo.
English: EMA/450050/2016 EMEA/H/C/003912
Maltese: EMEA/H/C/003912
English: Other information about Cinqaero
Maltese: Informazzjoni oħra dwar Cinqaero
English: This is a summary of the European public assessment report (EPAR) for Cinqaero.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cinqaero.
English: Cinqaero reslizumab
Maltese: Is-sustanza attiva f'Cinqaero, reslizumab,
English: The medicine contains the active substance reslizumab.
Maltese: Il-mediċina fiha s-sustanza attiva reslizumab.
English: What are the risks associated with Cinqaero?
Maltese: X'inhuma r-riskji assoċjati ma' Cinqaero?
English: Why is Cinqaero approved?
Maltese: Għaliex ġiet approvata Cinqaero?
English: Anaphylactic (severe allergic) reactions may affect less than 1 person in 100.
Maltese: Reazzjonijiet (severi allerġiċi) anafilattiċi jistgħu jaffettwaw inqas minn persuna waħda minn kull 100.
English: The most common side effect with Cinqaero (which may affect about 2 people in 100) is an increase in levels of the enzyme creatine phosphokinase in the blood (a measure of possible damage to muscles).
Maltese: L-effett sekondarju l-aktar komuni Cinqaero (li jista' jaffettwa 2 minn kull 100) huwa żieda fil-livelli talenżima creatine phosphokinase fid-demm (kejl tal-possibbiltà ta' ħsara lill-muskoli).
English: The active substance in Cinqaero, reslizumab, is a monoclonal antibody designed to attach to a substance called interleukin-5, which
Maltese: hija antikorp monoklonali maħsub biex jingħaqad ma' sustanza msejħa interleukin-5, li tistimola ttkabbir u l-attività tal-esinofilji.
English: How does Cinqaero work?
Maltese: Kif jaħdem Cinqaero?
English: For the full list of all side effects and restrictions with Cinqaero, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Cinqaero, ara l-fuljett ta' tagħrif.
English: It is available as a concentrate for making a solution for infusion (drip) into a vein.
Maltese: Huwa disponibbli bħala konċentrat sabiex isir soluzzjoni għall-infużjoni (dripp) ġolvina.
English: The recommended dose is 3 mg for each kg of bodyweight.
Maltese: Id-doża rrakkomandata hija ta' 3 mg għal kull kg ta' piż tal-ġisem.
English: The reduction in flare-ups and improvement in lung function seen with Cinqaero were considered clinically relevant, particularly for patients who cannot be adequately controlled with high doses of inhaled corticosteroids and another medicine used for the prevention of asthma.
Maltese: It-tnaqqis fir-rikaduti u t-titjib fil-funzjoni tal-pulmun li dehru b'Cinqaero tqiesu bħala klinikament rilevanti, b'mod partikolari għall-pazjenti li ma jistgħux jiġu kkontrollati b'mod adegwat b'dożi għolja ta' kortikosterojdi li jittieħdu man-nifs u b'mediċina oħra li tintuża għall-prevenzjoni tal-ażma.
English: It is used as an additional treatment in adults with severe asthma that is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma.
Maltese: Hija tintuża bħala trattament addizzjonali fl-adulti li jbatu minn ażma severa li mhijiex ikkontrollata kif suppost b'taħlita ta' kortikosterojdi b'doża għolja li jittieħdu man-nifs flimkien ma' mediċina oħra li tintuża għall-prevenzjoni tal-ażma.
English: Cinqaero is an asthma medicine that is used to treat adults with a particular type of asthma called eosinophilic asthma.
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tiegħu fl-UE u l-kondizzjonijiet ta' użu tiegħu.
English: By attaching to interleukin-5 and blocking its activity, Cinquaero reduces the number of eosinophils in the blood and lungs.
Maltese: Billi tingħaqad ma' interleukin-5 u twaqqaf l-attività tagħha, Cinqaero jnaqqas in-numru ta' esinofilji fid-demm u fil-pulmun.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku reslizumab
English: The benefits of Cinqaero have been shown in two main studies involving 953 patients with eosinophilic asthma that was not well controlled by inhaled corticosteroids and other asthma medication used for the prevention of the disease.
Maltese: Il-benefiċċji ta' Cinqaero ntwerew f'żewġ studji ewlenin li jinvolvu 953 pazjent li jbatu minn ażma esinofilika li ma kinitx ikkontrollata kif suppost mill-kortikosterojdi li jittieħdu man-nifs u minn mediċina oħra kontra l-ażma li tintuża għall-prevenzjoni tal-marda.
English: Annex A
Maltese: Annss A
English: pipettes
Maltese: Amministrazzjoni
English: Not applicable
Maltese: Mod ta' Amministrazzjoni
English: Supraventricular extrasystoles Palpitations
Maltese: Extrasistoli supraventrikulari Palpitazzjonijiet
English: LAVENTAIR ELLIPTA (N = 413) versus
Maltese: LAVENTAIR ELLIPTA (N = 413) kontra
English: LAVENTAIR ELLIPTA (N = 454) versus tiotropium 18 mcg (N = 451) (Study ZEP117115)
Maltese: LAVENTAIR ELLIPTA (N = 454) kontra tiotropium 18 mcg (N = 451) (Studju ZEP117115)
English: Placebo (N = 280) LAVENTAIR ELLIPTA (N = 413) versus
Maltese: Plaċebo (N = 280) LAVENTAIR ELLIPTA (N = 413) kontra
English: FAES FARMA, S.A. Tel: + 34 900 460 153 aweber@faes.es
Maltese: Tel: + 34 900 460 153 aweber@faes.es
English: The other ingredients are lactose monohydrate (see section 2 under ‘LAVENTAIR ELLIPTA contains lactose') and magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate (ara sezzjoni 2 taħt “LAVENTAIR ELLIPTA fih il-lactose”) u magnesium stearate.
English: Date of first authorisation: 08 May 2014 Date of latest renewal: 11 January 2019
Maltese: Data ta' l-ewwel awtorizzazzjoni: 8 ta' Mejju 2014
English: LAVENTAIR ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol
Maltese: LAVENTAIR ELLIPTA 55/22 mcg trab li jittieħed man-nifs umeclidinium/vilanterol
English: Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (beta2-adrenergic agonist).
Maltese: Vilanterol huwa agonist li jaħdem fit-tul, tar-riċetturi beta2-adrenerġiċi (agonist beta2-adrenerġiku).
English: In the second study, the treatment difference in EET between LAVENTAIR ELLIPTA 55/22 micrograms and placebo was 21.9 seconds (p=0.234) at Week 12.
Maltese: Fit-tieni studju, id differenzi bejn il-kuri fl-EET bejn LAVENTAIR ELLIPTA 55/22 mikrogramma u l-plaċebo kienu ta' 21.9 sekondi (p=0.234) f'Ġimgħa 12.
English: In the other two studies, the risk of a moderate/severe COPD exacerbation was increased by 20% and 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 and HR 1.9; 95% CI: 1.0, 3.6; p=0.062 respectively).
Maltese: Fiż-żewġ studji l-oħra, ir-riskju ta' taħrix tas-COPD moderat/sever żdied b'20% u 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 u HR 1.9; 95% CI: 1.0, 3.6; p=0.062 rispettivament).
English: LAVENTAIR ELLIPTA (N = 207) versus tiotropium 18 mcg (N = 203) (Study DB2113360)
Maltese: LAVENTAIR ELLIPTA (N = 207) kontra tiotropium 18 mcg (N = 203) (Studju DB2113360) LAVENTAIR ELLIPTA (N = 217) kontra tiotropium 18 mcg (N = 215) (Studju DB2113374)
English: EU/1/14/899/001 1 inhaler of 7 doses EU/1/14/899/002 1 inhaler of 30 doses
Maltese: EU/1/14/899/002 1 inalatur ta' 30 doża
English: The safety profile of LAVENTAIR ELLIPTA is based on safety experience with umeclidinium/vilanterol and the individual components from the clinical development program comprising of 6,855 patients with COPD and from spontaneous reporting.
Maltese: Il-profil tas-sigurtà ta' LAVENTAIR ELLIPTA huwa bbażat fuq l-esperjenza tas-sigurtà b'umeclidinium/vilanterol u l-komponenti individwali mill-programm ta' żvilupp kliniku li fih ħadu sehem 6,855 pazjent b'COPD u minn rapportar spontanju.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: MENARINI France Tél: + 33 (0)1 45 60 77 20
Maltese: Tél: + 33 (0)1 45607720
English: In a 24-week placebo-controlled study in patients with symptomatic COPD, LAVENTAIR ELLIPTA reduced the risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis of time to first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121).
Maltese: Fi studju ta' 24 ġimgħa kkontrollat bil-plaċebo f'pazjenti b'COPD sintomatiku, LAVENTAIR ELLIPTA naqqas ir-riskju ta' taħrix tas-COPD moderat/sever b'50% meta mqabbel ma' plaċebo (abbażi tal-analiżi tas żmien għall-ewwel taħrix: Proporzjon ta' Periklu (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); b'20% meta mqabbel ma' umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); u b'30% meta mqabbel ma' vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121).
English: In the first study, LAVENTAIR ELLIPTA 55/22 micrograms demonstrated a statistically significant and clinically relevant improvement (based on a minimal clinically important difference (MCID) between 45 to 85 seconds) over placebo in exercise endurance time (EET) obtained 3 hours after dosing at Week 12 (69.4 seconds [p=0.003]).
Maltese: 55/22 mikrogramma wera titjib statistikament sinifikanti u t-titjib klinikament rilevanti (abbażi ta' differenza minima klinikament importanti (MCID) bejn 45 għal 85 sekonda) fuq plaċebo fil-ħin ta' felħan għall eżerċizzju (EET) miksub 3 sigħat dwar l-għoti tad-doża f'Ġimgħa 12 (69.4 sekondi [p=0.003]).
English: LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Maltese: LAVENTAIR ELLIPTA jintuża għall-kura ta' mard kroniku ostruttiv tal-pulmuni (COPD) fl-adulti.
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 24 was greater for LAVENTAIR ELLIPTA (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Maltese: Il-proporzjon ta' pazjenti li mill-anqas irrispondew bil-MCID fil-punteġġ tal-SGRQ (definit bħala tnaqqis ta' 4 unitajiet mil-linja bażi) f'Ġimgħa 24 kien akbar għal LAVENTAIR ELLIPTA (49%) meta mqabbel mal plaċebo (34%) u kull komponent ta' monoterapija (44% għal umeclidinium u 48% għal vilanterol).
English: The clinical efficacy of umeclidinium/vilanterol administered once daily was evaluated in eight Phase III clinical studies in 6,835 adult patients with a clinical diagnosis of COPD; 5,618 patients from five 6-month studies (two placebo-controlled and three active [tiotropium]-comparator controlled), 655 patients from two 3-month exercise endurance/lung function studies and 562 patients from a 12-month supportive study.
Maltese: fuq 6,835 pazjent adult b'dijanjosi klinika ta' COPD; 5,618 pazjent minn ħames studji ta' sitt xhur (żewġ provi kkontrollati bi plaċebo u tliet provi kkontrollati b'sustanza attiva [tiotropium] ta' tqabbil), 655 pazjent minn żewġ studji ta' 3 xhur dwar il-felħan għall-eżerċizzju/funzjoni tal-pulmuni u 562 pazjent minn studju ta' appoġġ ta' 12-il xahar.
English: LAVENTAIR ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) compared with placebo (see Table 1).
Maltese: LAVENTAIR ELLIPTA wera tnaqqis statistikament sinifikanti u klinikament importanti fil-qtugħ ta' nifs kif evalwat minn żieda fil-punteġġ fokali TDI f'Ġimgħa 24 (end-point sekondarju prinċipali) meta mqabbel mal-plaċebo ara Tabella 1).
English: LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol.
Maltese: LAVENTAIR ELLIPTA fih żewġ sustanzi attivi umeclidinium bromide u vilanterol.
English: • taste disturbance
Maltese: • disturb fit-togħma • ħanqa.