FrancophonIA/ELRC3.0 huggingface dataset:
English: ALIMTA 100 mg powder for concentrate for solution for infusion ALIMTA 500 mg powder for concentrate for solution for infusion
Maltese: ALIMTA 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni ALIMTA 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
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 ALIMTA and cisplatin is documented in Table 3.
Maltese: 100 % tad-doża ta' qabel a Kriterji ta' Tossiċità Komuni ta' l-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998) b Minbarra n-newrotossiċità
English: From the start of ALIMTA plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the ALIMTA arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Maltese: medjan tal-pazjenti kien ta' 16.9 xhur għall-fergħa ta' ALIMTA u ta' 14.0 xhur għall-fergħa ta' plaċebo (hazard ratio= 0.78, 95% CI= 0.64-0.96).
English: Grade toxicity
Maltese: tossiċità
English: After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Maltese: sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
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: When prepared as directed, reconstituted and infusion solutions of ALIMTA contain no antimicrobial preservatives.
Maltese: Meta ppreparati kif suppost, is-soluzzjonijiet rikostitwiti u ta' infużjoni ta' ALIMTA ma jkun fihom ebda preservattiv antimikrobiku.
English: The recommended dose of cisplatin is 75 mg/m2 BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Maltese: Id-doża rakkomandata ta' cisplatin hi ta' 75 mg/m2 BSA infuża fuq perijodu ta' sagħtejn madwar 30 minuta wara li tkun saret l-infużjoni ta' pemetrexed fl-ewwel ġurnata ta' kull ċiklu ta' 21
English: The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a 10-minute period.
Maltese: Wara l-għoti ta' pemetrexed bħala mediċina weħidha, il-proprjetajiet farmakokinetiċi ta' pemetrexed ġew evalwati f'dożi li jvarjaw bejn 0.2 sa 838 mg/m2 infużi fuq perijodu ta' għaxar minuti f'426
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1500 cells/mm3 and platelet count returns to ≥ 100,000 cells/mm3.
Maltese: newtrofili (ANC) ma jerġa' jkun ≥ 1500 ċellula/mm3 u l-għadd ta' plejtlits ma jerġa' jkun ≥ 100,000 ċellula/mm3.
English: A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the ALIMTA/cisplatin arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the Lung Cancer Symptom Scale.
Maltese: mesoteljoma plewrali malinna kien dimonstrat fil-fergħa ta' ALIMTA/cisplatin (212-il pazjent) meta kkomparat mal-fergħa ta' cisplatin waħdu (218-il pazjent) meta ġie użat il-Lung Cancer Symptom Scale.Differenzi statistikament sinifikanti kienu osservati wkoll fit-testijiet tal-funzjoni tal pulmun.
English: Large cell (N=153)
Maltese: (N=153)
English: No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified.
Maltese: Pazjenti b'indeboliment tal-fwied Ma kienet identifikata l-ebda relazzjoni bejn l-AST (SGOT), l-ALT (SGPT), jew it-total ta' bilirubina u l-farmakokinetika ta' pemetrexed.
English: Neuropathysensory
Maltese: Il-Monitoraġġ
English: Less toxicity and reduction in Grade 3/4 haematologic and non-haematologic toxicities such as neutropenia, febrile neutropenia and infection with Grade 3/4 neutropenia were reported when pre-treatment with folic acid and vitamin B12 was administered.
Maltese: grad 3/4 kif ukoll f'dawk mhux ematoloġiċi bħan-newtropenja, newtropenja bid-deni, u infezzjoni b'newtropenja ta' Grad 3/4, f'pazjenti li ngħataw folic acid u vitamina
English: Table 2 - Dose modification table for ALIMTA (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b Dose of ALIMTA (mg/m2)
Maltese: TABELLA 1 - Tabella għall-modifikazzjoni fid-doża ta' ALIMTA ( bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Tossiċitajiet ematoloġiċi
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: QUALITATIVE AND QUANTITATIVE COMPOSITION ALIMTA 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Maltese: ALIMTA 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 100 mg ta' pemetrexed (bħala pemexetred disodium).
English: Your doctor will discuss with you the potential risk of taking ALIMTA during pregnancy.
Maltese: It-tabib tiegħek jiddiskuti miegħek dwar ir-riskju potenzjali li tieħu ALIMTA waqt it-tqala.
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with ALIMTA 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 ALIMTA in combination with cisplatin.
Maltese: (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' tkomplija ta' manteniment b' ALIMTA 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' ALIMTA flimkien ma' cisplatin.
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, dermatite).
English: This suggests that pemetrexed may impair male fertility.
Maltese: Pemetrexed jista' jkollu effetti li jagħmlu ħsara fuq livell ġenetiku.
English: A hospital pharmacist, nurse or doctor will have mixed the ALIMTA 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' ALIMTA jiġi mħallat ma' soluzzjoni għall-injezzjoni ta' 9 mg/ml(0.9 %) sodium chloride, mill-ispiżjar ta' l-isptar, infermier jew tabib.
English: Common Neuropathysensory
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: DATE OF REVISION OF THE TEXT Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq il-website tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: During post marketing surveillance, the following adverse reactions have been reported in patients treated with pemetrexed:
Maltese: Waqt sorveljanza ta' wara t-tqegħid fis-suq, ġew irrapportati dawn ir-reazzjonijiet avversi f'pazjenti kkurati b'pemetrexed:
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' 9mg/ml(0.9%)sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the ALIMTA 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' ALIMTA u ta' 10.3 xhur għall-fergħa tal-plaċebo (hazard ratio = 0.70, 95% CI = 0.56-0.88, p=0.002).
English: ALIMTA 100 mg powder for concentrate for solution for infusion Type I glass vial with rubber stopper containing 100 mg of pemetrexed.
Maltese: ALIMTA 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni pemetrexed Għall-użu għal ġol-vini.
English: When using ALIMTA in combination with cisplatin:
Maltese: Meta tuża ALIMTA flimkien ma' cisplatin:
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 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,
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the ALIMTA arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Maltese: Meta tinkludi l fażi tal-induzzjoni l-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċċelluli huma l-iżjed tat-tip squamous kien ta' 18.6 xhur għall-fergħa ta' ALIMTA u ta' 13.6 xhur għall-fergħa tal-plaċebo (hazard ratio =0.71, 95% CI = 0.56-0.88, p = 0.002).
English: Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia and anaemia.
Maltese: Komplikazzjonijiet mistennija ta' doża eċċessiva jinkludu: soppressjoni tal-mudullun kif jixhdu n-newtropenja, t-tromboċitopenja u l-anemija.
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 <.001).
English: Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: ALIMTA 500 mg Irrikostitwixxi kunjetti ta' 500 mg b'20 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%)
English: Pemetrexed is not a vesicant.
Maltese: Pemetrexed mhuwiex visikant.
English: For instructions on reconstitution and dilution of ALIMTA before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwizzjoni ta' ALIMTA qabel l amministrazzjoni, ara sezzjoni 6.6. 4.3 Kontraindikazzjonijiet
English: PARAMOUNT:Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation ALIMTA maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Maltese: Dijagrammi Kaplan Meier ta' sopravivenza mingħajr progressjoni (PFS) u Sopravivenza Totali (OS) għat-tkomplija ta' manteniment b'ALIMTA kontra plaċebo f'pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous
English: You must continue taking the folic acid for 21 days after the last dose of ALIMTA.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' ALIMTA.
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: Acute renal failure
Maltese: Komuni Ħafna
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: All patients were diagnosed with Stage IIIB or IV NSCLC and had received prior platinum-based chemotherapy.
Maltese: Il-pazjenti kollha kienu ddijanjostikati li kellhom NSCLC fi Stadju IIIB je IV u li diġà kienu rċevew kemoterapija bbażata fuq il-platinum.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/290/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/290/002
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: Hyperpigmentation has been commonly reported.
Maltese: B'mod komuni ġiet irrapportata l-iperpigmentazzjoni.
English: Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: ALIMTA 100 mg Irrikostitwixxi kunjetti ta' 100 mg b'4.2 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%)
English: Neutrophils decreased
Maltese: Disturbi filfwied u filmarrara
English: MARKETING AUTHORISATION NUMBER EU/1/04/290/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/290/001
English: Each vial contains approximately 11 mg sodium.
Maltese: Kull kunjett fih madwar 11 mg ta' sodium.
English: Unopened vial 3 years.
Maltese: Ġeneralment l-infużjoni tingħatalek darba kull 3 ġimgħat.
English: Common SGPT (ALT) elevation
Maltese: GĦAMLA KWALITATTIVA
English: Taking into account the PRAC Assessment Report on the PSUR(s) for pemetrexed, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal pemetrexed, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Upset stomach
Maltese: Disturbi gastro-intestinali
English: *Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** which is derived from the term “renal/genitourinary other”.
Maltese: *Irreferi għal verżjoni 2 tas- CTC ta' l-Istitut Nazzjonali tal-Kanċer għal kull grad ta' tossiċità ħlief għat-terminu “tnaqqis fit-tneħħija tal-krejatinina”
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' > 1% u < 5% (komuni) tal-pazjenti li ntgħażlu bl-addoċċ biex jirċievu pemetrexed jinkludu: infezzjoni mingħajr newtropenja newtropenja bid-deni, reazzjoni allerġika/sensittivita aċċessiva, żieda fil-krejatinina, newropatija motorja,
English: Abbreviations: CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
Maltese: ITT = intenzjoni li tikkura; n = daqs tal-popolazzjoni kollha
English: ALIMTA 100 mg contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'
Maltese: ALIMTA 100 mg fih inqas minn mmol 1 (23 mg) ta' sodium, jiġifieri tista' tgħid li huwa ‘nieqes mis sodium'.
English: Diarrhoea without colostomy
Maltese: Dijarrea mingħajr kolostomija
English: Dose adjustments
Maltese: Sopravivenza Mingħajr Progressjoni
English: The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anticancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
Maltese: Minħabba il-varjabilità intra-individwali għolja ta' l-istat ta' koagulazzjoni waqt il-mard u l-possibilità ta' interazzjoni bejn antikoagulanti li jittieħdu b'mod orali u l-kimoterapija kontra l-kanċer ikun hemm bżonn ta' monitoraġġ ta' l-INR (International Normalised Ratio) aktar spiss, jekk ikun deċiż li lpazjent għandu jingħatalu kura b'antikoagulanti orali.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/304459/2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Settembru 2016 EMA/304459/2016
English: Hop strobile EMA/304459/2016
Maltese: Fjura tal-Lupulu EMA/304459/2016
English: Hop strobile
Maltese: Struzzjonijiet
English: Hop strobile is the common name for the flowers of the plant Humulus lupulus L.
Maltese: Fjura tal-lupulu huwa l-isem komuni għall-frotta tal-pjanta Humulus lupulus L.
English: Hop strobile medicines should only be used in adults and adolescents over the age of 12 years.
Maltese: Il-mediċini li fihom il-fjura tal-lupulu għandhom jintużaw biss fl-adulti u fl-adolexxenti li għandhom ‘il fuq minn 12-il sena.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini talħxejjex hija plawżibbli u hemm evidenza li ilhom jintużaw b'mod sigur b'dan il-mod mill-inqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: The HMPC also considered clinical studies but since these studies used combinations of hop strobile and valerian root preparations to aid sleep, firm conclusions on the effects of hop strobile could not be drawn.
Maltese: L-HMPC ikkunsidra wkoll studji kliniċi imma minħabba li dawn l-istudji jużaw kombinazzjonijiet ta' preparazzjonijiet tal-fjura tal-lupulu u tal-għerq tal-valerjana, ma jistgħux isiru konklużjonijiet sodi dwar l-effetti tal-fjura tal-lupulu.
English: What are the risks associated with hop strobile medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-fjura tal-lupulu?
English: Other information about hop strobile medicines
Maltese: Aktar informazzjoni dwar il-mediċini tal-fjura tal-lupulu
English: Further information on the HMPC assessment of hop strobile medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: What is hop strobile?
Maltese: X'inhi l-fjura tal-lupulu?
English: Further information on the risks associated with these hop strobile medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini tal-fjura tal-lupulu, inklużi d-dettalji talkonklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' (All Documents') fis-sit elettroniku tal-Aġenzija:
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of hop strobile.
Maltese: Dan huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għall-Prodotti tal-Ħxejjex Mediċinali (HMPC) dwar l-użu mediċinali tal-fjura tal-lupulu.
English: The solvent is then partially or completely evaporated to obtain a dry extract.
Maltese: Is-solvent imbagħad jiġi evaporat parzjalment jew kompletament biex jinkiseb estratt niexef.
English: Any applications for the licensing of medicines containing hop strobile have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom il-fjura tal-lupulu għandha titressaq lillawtoritajiet nazzjonali responsabbli għall-prodotti mediċinali, li ser jivvalutaw l-applikazzjoni għallmediċina tal-ħxejjex u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Further information on Rolufta Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Rolufta Ellipta tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Each inhalation provides 65 micrograms of umeclidinium bromide equivalent to 55 micrograms of umeclidinium.
Maltese: Kull inalazzjoni tipprovdi 65 mikrogramma ta' umeclidinium bromide ekwivalenti għal 55 mikrogramma ta' umeclidinium.
English: This overview was last updated in 09-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'09-2018.
English: Rolufta Ellipta received a marketing authorisation valid throughout the EU on 20 March 2017.
Maltese: Rolufta Ellipta rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-20 ta' Marzu 2017.
English: The most common side effects with Rolufta Ellipta (which may affect up to 1 in 10 people) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), cough, urinary tract infection (infection of the structures that carry urine), and tachycardia (increased heart rate).
Maltese: L-effetti sekondarji l-aktar komuni b'Rolufta Ellipta (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma uġigħ ta' ras, nażofarinġite (infjammazzjoni tal-imnieħer u l-griżmejn), infezzjoni fl-apparat respiratorju ta' fuq (infezzjoni tal-imnieħer u tal-griżmejn), sinusite (infjammazzjoni tas-sinusis), sogħla, infezzjoni fl-apparat tal-awrina (infezzjoni tal-istrutturi li jġorru l-awrina), u takkikardija (żieda fir-rata tal-qalb).
English: The active substance in Rolufta Ellipta, umeclidinium bromide, is a muscarinic receptor antagonist.
Maltese: Is-sustanza attiva f'Rolufta Ellipta, l-umeclidinium bromide, hija antagonista tar-riċettur muskariniku.
English: Rolufta Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Rolufta Ellipta huwa mediċina użata biex ittaffi s-sintomi tal-mard pulmonari ostruttiv kroniku (COPD) fl-adulti.
English: Rolufta Ellipta contains the active substance umeclidinium bromide.
Maltese: Rolufta Ellipta fih is-sustanza attiva umeclidinium bromide.
English: Results showed that Rolufta Ellipta improved lung function by an average FEV1 by 127 ml more than placebo after 12 weeks of treatment and by 115 ml after 24 weeks of treatment.
Maltese: Ir-riżultati wrew li Rolufta Ellipta tejjeb il-funzjoni tal-pulmun b'FEV1 medju b'127 ml aktar minn plaċebo wara 12-il ġimgħa ta' kura u b'115-il ml wara 24 ġimgħa ta' kura.
English: Rolufta Ellipta was investigated in four main studies involving over 4,000 patients.
Maltese: Rolufta Ellipta ġie investigat f'erba' studji ewlenin li involvew aktar minn 4,000 pazjent.