FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited clinical data from a separate randomized, Phase 3, controlled trial, suggest that efficacy data (overall survival, progression free survival) for pemetrexed are similar between patients previously pre-treated with docetaxel (n = 41) and patients who did not receive previous docetaxel treatment (n = 540).
Maltese: Informazzjoni klinika limitata, minn studju separat, kkontrollat u, randomised ta' Fażi 3, tissuġġerixxi li l-informazzjoni dwar l-effikaċja (sopravivenza totali, sopravivenza mingħajr progressjoni) għal pemetrexed huma simili bejn il-pazjenti li kienu ġew ikkurati qabel b'docetaxel(n=41) u pazjenti li ma rċevewx kura b'docetaxel qabel (n=540).
English: Pharyngitis
Maltese: granuloċiti
English: Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Armisarte treatment.
Maltese: Kortikosterojdi: it-tabib tiegħek jordnalek pilloli ta' l-isterojdi (ekwivalenti għal 4 milligrammi ta' dexamethasone darbtejn kuljum) li jkollok bżonn tieħu l-ġurnata ta' qabel, dakinhar u l-ġurnata ta'
English: Table 1 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Haematologic toxicities
Maltese: TABELLA 1 - Tabella għall-modifikazzjoni fid-doża ta' pemetrexed ( bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin - Tossiċitajiet ematoloġiċi
English: Common ALT (SGPT) elevation
Maltese: Sopravivenza mingħajr progressjoni (xhur)
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated patients
Maltese: Effikaċja ta' pemetrexed ma' cisplatin vs. cisplatin f'mesoteljoma plewrali malinna
English: One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid) One vial of 20 ml concentrate contains 500 mg pemetrexed (as pemetrexed diacid) One vial of 34 ml concentrate contains 850 mg pemetrexed (as pemetrexed diacid) One vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid)
Maltese: Daqsijiet tal-pakketti 1 x 4 ml kunjett (100 mg/4 ml) 1 x 20 ml kunjett (500 mg/20 ml) 1 x 34 ml kunjett (850 mg/34 ml) 1 x 40 ml kunjett (1000 mg/40 ml)
English: One vial of 40 ml concentrate contains 1000 mg pemetrexed (as pemetrexed diacid).
Maltese: Kull kunjett ta' 40 ml konċentrat fih 1000 mg pemetrexed (bħala pemetrexed diacid).
English: Your doctor will discuss with you the potential risk of taking Armisarte during pregnancy.
Maltese: It-tabib tiegħek jiddiskuti miegħek dwar ir-riskju potenzjali li tieħu Armisarte waqt it-tqala.
English: Armisarte contains trometamol as an excipient.
Maltese: Armisarte fih trometamol bħala sustanza mhux attiva .
English: Statistically significant differences in pulmonary function tests were also observed.
Maltese: Symptom Scale.Differenzi statistikament sinifikanti kienu osservati wkoll fit-testijiet tal-funzjoni tal pulmun.
English: One vial of 4 ml contains 100 mg pemetrexed (as pemetrexed diacid).
Maltese: Kull kunjett ta' 4 ml konċentrat fih 100 mg pemetrexed (bħala pemetrexed diacid).
English: Cisplatin (N=222)
Maltese: (N = 222)
English: NeuropathySensory
Maltese: Il-Monitoraġġ
English: PARAMOUNT:Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed 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 bi pemetrexed kontra plaċebo f'pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous ( kkwantifikat permezz ta' għażla b'mod arbitrarju)
English: Infusion Solution: Chemical and physical in-use stability of infusion solution of pemetrexed was demonstrated for 3 days at room temperature and 21 days at refrigerated temperature.
Maltese: L-istabbilità kimika u fiżika ta' waqt l-użu, tas-soluzzjonijiet rikostitwiti u ta' infużjoni ta' pemetrexed ġiet ippruvata għal 3 ijiem f'temperatura ta' l-ambjent u 21 ġurnata f'temperatura ta' friġġ.
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed 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' pemetrexed u ta' 14.0 xhur għall-fergħa ta' plaċebo (hazard ratio= 0.78, 95% CI= 0.64-0.96).
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 pretreatment 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: 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, newtropenja bid-deni, insuffiċjenza renali, deni, diżidratazzjoni, konġuntivite u tnaqqis fit-tneħħija ta'
English: This suggests that pemetrexed may impair male fertility.
Maltese: Ir riskju jikber f'persuni li jkunu diġà immunosoppressi minħabba l-marda li jkollhom.
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: All Grades toxicity
Maltese: GĦAMLA FARMAĊEWTIKA
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 (v 2.0; NCI 1998) ta' l-Istitut Nazzjonali tal-Kanċer, l-alopeċja għandha tiġi rrapportata biss bħala Grad 1 jew 2.
English: Table 2 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin- Non-haematologic toxicitiesa,b
Maltese: TABELLA 2 - Tabella għall-modifikazzjoni fid-doża ta' pemetrexed (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin- Tossiċitajiet li mhumiex ematoloġiċia,b
English: Armisarte is provided in a colourless glass vial with rubber stopper and an aluminium cap with polypropylene disk.
Maltese: (bromobutyl) u kappa tal-aluminium b'diska tal polypropylene.
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: (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' tkomplija ta' manteniment bi pemetrexed flimkien ma' BSC (n=359) ma' dik ta' plaċebo flimkien ma' BSC (n=180) f'pazjenti li għandhom kanċer talpulmun 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: Survival Time (months) Median (m) 95 % CI for median HR 95 % CI for HR Non-inferiority p-value (HR)
Maltese: Medjan (m) 95 % CI għal medjan
English: For the full list of excipients see section 6.1.
Maltese: Eċċipjent(i) b'effett magħruf Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Pemetrexed has a steady-state volume of distribution of 9 l/m2.
Maltese: pemetrexed lil pazjenti b'funzjoni tal-kliewi normali (tneħħija tal-krejatinina ≥ 80 ml/min).
English: Cytotoxic
Maltese: Citotossiku
English: Use an inactivated vaccine where it exists (poliomyelitis) (see section 4.4).
Maltese: Uża vaċċininattivat jekk ikun jeżisti (poljomajelite) (ara sezzjoni 4.4).
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed 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 ċ ċelluli huma l-iżjed tat-tip squamous kien ta' 18.6 xhur għall-fergħa ta' pemetrexed u ta' 13.6 xhur għall-fergħa tal-plaċebo (hazard ratio =0.71, 95% CI = 0.56-0.88, p = 0.002).
English: One vial of 20 ml contains 500 mg pemetrexed (as pemetrexed diacid).
Maltese: Kull kunjett ta' 20 ml konċentrat fih 500 mg pemetrexed (bħala pemetrexed diacid).
English: Package leaflet: Information for the user Armisarte 25 mg/ml concentrate for solution for infusion pemetrexed
Maltese: Informazzjoni għall-utent Armisarte 25 mg/ml konċentrat għal soluzzjoni għall-infużjoni pemetrexed
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: F'pazjenti kkurati għall-kanċer tal-pulmun mhux b'ċelluli żgħar wara kimoterapija preċedenti, id-doża rakkomandata ta' pemetrexed hi ta' 500 mg/m2 BSA mogħtija b'infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Between patient variability in clearance is moderate at 19.3%.
Maltese: Il-varjabilità fit-tneħħija bejn il-pazjenti hija moderata f'perċentwali ta' 19.3%.
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (n=441) with that of placebo plus BSC (n=222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first line doublet therapy containing Cisplatin or Carboplatin in combination with Gemcitabine, Paclitaxel, or Docetaxel.
Maltese: (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' manteniment bi pemetrexed flimkien mal-aħjar kura ta' sosteniment (AKS) (n = 441) ma' dik ta' plaċebo flimkien ma' AKS (n = 222) f'pazjenti b'Kanċer tal-Pulmun Mhux b'Ċelluli Żgħar (NSCLC) lokalment avanzat (Stadju IIIB) jew metastatiku (Stadju
English: One vial of 34 ml contains 850 mg pemetrexed (as pemetrexed diacid).
Maltese: Kull kunjett ta' 34 ml fih 850mg ta' pemetrexed (bħala pemetrexed diacid)
English: Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent pemetrexed studies (n=164) and the Phase 3 single agent pemetrexed study described above, with the exception of neutropenia (12.8 % versus 5.3 %, respectively) and alanine aminotransferase elevation (15.2 % versus 1.9 %, respectively).
Maltese: Tossiċitajiet ta' laboratorju klinikament rilevanti ta' Grad 3 u Grad 4 kienu simili bejn ir-riżultati integrati ta' Fażi 2 minn tliet studji ta' pemetrexed bħala mediċina weħidha (n = 164) u l-istudju ta' Fażi 3 ta' pemetrexed bħala mediċina weħidha deskritta hawn fuq bl-eċċezzjoni ta' newtropenja (12.8%
English: One vial of 40 ml contains 1000 mg pemetrexed (as pemetrexed diacid).
Maltese: Kull kunjett ta' 40 ml fih 1000mg ta' pemetrexed (bħala pemetrexed diacid)
English: The pemetrexed maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Maltese: Il-profili ta' sigurtà dwar il-manteniment b'P kienu simili għaż-żewġ studji JMEN u PARAMOUNT.
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: 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 a
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Trometamol (għal aġġustament tal- pH)
English: A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n=862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n=863) in overall survival (adjusted hazard ratio 0.94; 95 % CI=0.84-1.05).
Maltese: Dan l-effett fil-kura bi pemetrexed kien konsistenti internament fis-sottogruppi varji (inklużi stadju tal marda, rispons fil-bidu, ECOG PS, stat ta' tipjip, sess, istoloġija u età) u simili għal dak osservat flanaliżi mhux aġġustati ta' OS u PFS.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: Of the 939 patients treated with pemetrexed plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Maltese: Mid-939 pazjent li bdew il-kura bi pemetrexed flimkien ma' cisplatin, 539 pazjent ġew magħżula b'mod arbitrarju biex jieħdu kura ta' manteniment b'pemetrexed jew plaċebo.
English: The use of Armisarte should be avoided during pregnancy.
Maltese: L-użu ta' Armisarte għandu jiġi evitat waqt it-tqala.
English: Median overall survival (months) (95% CI) Log Rank p-value* Median time to tumour progression (months) (95% CI) Log Rank p-value* Time to treatment failure (months) (95% CI) Log Rank p-value* Overall response rate** (95% CI) Fisher's exact p-value* Abbreviation: CI = confidence interval *p-value refers to comparison between arms.
Maltese: din it-tabella, ġie użat livell minimu ta' 5% biex jiġu inklużi dawk l-avvenimenti kollha li l-awtur ħaseb li setgħu kellhom relazzjoni ma' pemetrexed. ** Irriferi għall-Kriterji NCI CTCAE (Verżjoni 3.0; NCI 2003) għal kull grad ta' tossiċità.
English: Uncommon (may affect up to 1 in 100 people) - Acute renal failure - Fast or irregular heart rate - Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed/
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna) - Insuffiċjenza tal-kliewi akuta - Tħabbit tal-qalb b'rata mgħaġġla jew irregolari
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: Chemical and physical in-use stability of infusion solution of pemetrexed was demonstrated for 3 days at room temperature and 21 days at refrigerated temperature.
Maltese: L-istabbilità kimika u fiżika ta' waqt l-użu tas-soluzzjonijiet għall-infużjoni ta' pemetrexed ġiet ippruvata għal 3 ijiem f'temperatura ta' l-ambjent u 21 ġurnata f'temperatura ta' friġġ.
English: Creatinine clearance decreased**
Maltese: Disturbi filkliewi****
English: Common SGPT (ALT) elevation
Maltese: Għall-iskop ta'
English: Median overall survival in months (95% CI)
Maltese: Ir-rata ta' rispons globali** (95 % CI)
English: A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the pemetrexed /cisplatin arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the Lung Cancer Symptom Scale.
Maltese: meta kkomparat mal-fergħa ta' cisplatin waħdu (218-il pazjent) meta ġie użat il-Lung Cancer
English: Nadir platelets <50,000/mm 3 with bleedinga, regardless of nadir ANC
Maltese: /mm3 u lgħadd l-iktar baxx ta' plejtlits ≥ 50,000 /mm3
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Armisarte 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' Armisarte.
English: Each pack of Armisarte contains one vial.
Maltese: Kull pakkett ta' Armisarte fih kunjett wieħed.
English: 14 May 2013
Maltese: 14 ta' Mejju 2013
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Estonia) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Norway, Poland, Slovakia, Slovenia and Sweden).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ l-Estonja) jevalwa mediċina bil-għan li tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-‘Istati Membri kkonċernati', f'dan il-każ ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, l-Ungerija, il-Latvja, ilLitwanja, in-Norveġja, il-Polonja, is-Slovakkja, is-Slovenja u l-Isvezja).
English: • cirrhosis of the liver (a type of liver disease) and renal disease, including nephrotic syndrome;
Maltese: • ċirrożi tal-fwied (tip ta' marda tal-fwied) u mard renali, inkluż is-sindromu nefrotiku;
English: What is Furosemide Vitabalans?
Maltese: X'inhu Furosemide Vitabalans?
English: Vitabalans Oy submitted an application for Furosemide Vitabalans to the Estonian medicines regulatory agency for a decentralised procedure.
Maltese: Vitabalans Oy ippreżentat applikazzjoni għal Furosemide Vitabalans lil-aġenzija regolatorja tal-mediċini Estonjana għal proċedura deċentralizzata.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Furosemide Vitabalans do not outweigh its risks, and the marketing authorisation cannot be granted in Estonia and in the following Member States of the EU: Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Poland, Slovakia, Slovenia and Sweden, as well as Norway.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Furosemide Vitabalans ma jegħlbux ir-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fis-suq ma tistax tingħata fl-Estonja u fl-Istati Membri tal-UE li ġejjin: ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, l-Ungerija, il-Latvja, il-Litwanja, il-Polonja, is-Slovakkja, is-Slovenja u lIsvezja, kif ukoll in-Norveġja.
English: It was to be available as tablets (40 mg).
Maltese: (pillola, 40 mg)
English: • mild to moderate hypertension (high blood pressure).
Maltese: • ipertensjoni ħafifa għal moderata (pressjoni għolja tad-demm).
English: On 18 October 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Furosemide Vitabalans.
Maltese: Fit-18 ta' Ottubru 2012, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Furosemide Vitabalans.
English: Questions and answers on Furosemide Vitabalans (tablet, 40 mg)
Maltese: Mistoqsijiet u tweġibiet dwar Furosemide Vitabalans (pillola, 40 mg)
English: Furosemide Vitabalans is a medicine that contains the active substance furosemide.
Maltese: Furosemide Vitabalans hija mediċina li fiha s-sustanza attiva furosemide.
English: The active substance in Furosemide Vitabalans, furosemide, belongs to a group of medicines known as diuretics.
Maltese: Is-sustanza attiva fi Furosemide Vitabalans, furosemide, tagħmel parti minn grupp ta' mediċini magħrufa bħala dijuretiċi.
English: The application was supported by published literature rather than studies carried out with Furosemide Vitabalans, because furosemide has a history of well-established use in the EU for at least 10 years.
Maltese: L-applikazzjoni kienet appoġġjata minn letteratura ppubblikata minflok studji mwettqa bi Furosemide Vitabalans, minħabba li furosemide għandu storja ta' użu stabbilit sew fl-UE għal mill-inqas 10 snin.
English: The grounds for the referral were that the data from the literature submitted to support this application could not be applied to Furosemide Vitabalans and the bridging data provided were not considered adequate to conclude on the benefit-risk profile of Furosemide Vitabalans.
Maltese: Ir-raġunijiet għar-riferiment kienu li d-dejta mil-letteratura sottomessa b'appoġġ għal din l-applikazzjoni ma setgħetx tiġi applikata għal Furosemide Vitabalans u d-dejta ta' tqarrib ipprovduta ma kienitx meqjusa adegwata biex jikkonkludi dwar il-profil tal-benefiċċju-riskju ta' Furosemide Vitabalans .
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the data submitted were not sufficient to show that Furosemide Vitabalans could be used safely and effectively based on the well established use of furosemide.
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCHMP ikkonkluda li d-dejta sottomessa ma kienitx biżżejjed biex turi li Furosemide Vitabalans jista' jintuża b'mod sigur u effettiv abbażi tal-użu stabbilit sew ta' furosemide.
English: However, the Member States were not able to reach an agreement and the Polish medicines regulatory agency referred the matter to the CHMP for arbitration on 30 May 2011.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini Pollakka rriferiet il-kwistjoni lis-CHMP għall-arbitraġġ fit-30 ta' Mejju 2011.
English: Questions and answers on Furosemide Vitabalans (tablet, 40 mg) EMA/423459/2013
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fl-14 ta' Mejju 2013.
English: Furosemide Vitabalans was intended to be used to treat the following conditions:
Maltese: Furosemide Vitabalans kien maħsub li jintuża fil-kura tal-kondizzjonijiet li ġejjin:
English: Further information on Olumiant can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/olumiant.
Maltese: Aktar informazzjoni dwar Olumiant tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/en/medicines/human/EPAR/olumiant.
English: In one study involving 584 patients, Olumiant was more effective than methotrexate.
Maltese: Fi studju wieħed li involva 584 pazjent, Olumiant kien aktar effettiv minn methotrexate.
English: Olumiant contains the active substance baricitinib.
Maltese: Olumiant fih is-sustanza attiva baricitinib.
English: Other information about Olumiant
Maltese: Informazzjoni oħra dwar Olumiant
English: The active substance in Olumiant, baricitinib, is an immunosuppressant (a medicine that reduces the activity of the immune system).
Maltese: Is-sustanza attiva f'Olumiant, il-baricitinib, hija immunosoppressant (mediċina li tnaqqas l-attività tassistema immunitarja).