FrancophonIA/ELRC3.0 huggingface dataset:
English: On the efficacy side for the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”, the efficacy data were mainly provided from study publications conducted in patients with dementia (Alzheimer disease, multi-infarct dementia, vascular dementia, Parkinson disease, etc), while dementia is excluded from the scope of this referral procedure.
Maltese: Fir-rigward tal-effikaċja għall-indikazzjoni “kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja)”, id-dejta dwar l-effikaċja kienet ipprovduta prinċipalment minn pubblikazzjonijiet ta' studji li saru fuq pazjenti bid-dimenzja (marda ta' Alzheimer, multi-infarct dementia, dimenzja vaskulari, marda ta' Parkinson, eċċ,), filwaqt li d-dimenzja hija eskluża mill-kamp ta' applikazzjoni ta' din ilproċedura ta' riferiment.
English: Overall, the varying affinity for serotoninergic receptors with the different ergot derivatives and the therapeutic doses used may explain the differences observed for notification rates for the fibrotic reactions.
Maltese: B'mod ġenerali, l-affinità varjabbli għar-riċetturi serotoninerġiċi bid-derivati differenti tal-ergotina u d-dożi terapewtiċi użati jistgħu jispjegaw id-differenzi osservati fir-rati ta' notifika għar-reazzjonijiet fibrotiċi.
English: The improvement, when documented, was observed between 3 and 10 months after nicergoline discontinuation, without corticoid treatment in four cases.
Maltese: It-titjib, meta dokumentat, kien osservat bejn 3 u 10 xhur wara t-twaqqif ta' nicergoline, f'erba' każijiet mingħajr kura b'kortikojdi.
English: Therefore, even if it is highly pharmacologically plausible that ergot derivatives acting as 5HT2B receptor agonists may induce "serotonergic" valve disease similar to that induced by carcinoid tumours or fibrotic lesions of other tissues, it must be remembered that some ergot derivatives are not 5-HT2B receptor agonists.
Maltese: Għalhekk, anke jekk farmakoloġikament huwa plawsibbli ħafna li dderivati tal-ergotina li jaġixxu bħala agonisti tar-riċettur ta' 5-HT2B jistgħu jinduċu mard “serotonerġiku" tal-valvi simili għal dak ikkawżat minn tumuri karċinojdi jew leżjonijiet fibrotiċi ta' tessuti oħra, wieħed għandu jiftakar li xi derivati tal-ergotina mhumiex agonisti tar-riċettur ta' 5-HT2B.
English: Regarding ergotism, there were no cases identified in the MAH's safety database reporting the preferred term ergotism associated with nicergoline.
Maltese: Fir-rigward tal-ergotiżmu, ma kienx hemm każijiet identifikati fid-dejtabejż tas-sigurtà tal-MAH li rrapportaw it-terminu preferut ergotiżmu assoċjat ma' nicergoline.
English: Therefore, other mechanisms inducing fibrosis cannot be excluded, which suggests a causal link between fibrosis and agonism of 5-HT2A and 5-HT1B receptors and also plausible effect on serotonin transporter.
Maltese: Għalhekk, ma jistgħux jiġu esklużi mekkaniżmi oħra li jinduċi l-fibrożi, li jissuġġerixxi rabta kawżali bejn il-fibrożi u l-agoniżmu tar-riċetturi ta' 5-HT2A u 5-HT1B u anke effett plawsibbli fuq it-trasportatur tas-serotonin.
English: − Is not favourable for ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II).
Maltese: − Mhuwiex favorevoli għall-kura anċillari ta' klawdikazzjoni intermittenti f'mard okklużiv sintomatiku tal-arterji periferali (PAOD ta' Stadju II).
English: − Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Maltese: − Mhuwiex favorevoli għall-kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja).
English: In these cases, the event occurred after 5 months to 30 years of nicergoline treatment and in patients aged between 59 and 90 years.
Maltese: F'dawn il-każijiet, l-avveniment seħħ wara 5 xhur sa 30 sena ta' kura b'nicergoline u f'pazjenti b'età ta' bejn id-59 u d-90 sena.
English: For the indication “ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II)” no data were submitted and as a result was considered as unsupported by the CHMP.
Maltese: Għall-indikazzjoni “kura anċillari ta' klawdikazzjoni intermittenti f'mard okklużiv sintomatiku tal-arterji periferali (PAOD ta' Stadju II)” ma ġiet ippreżentata l-ebda dejta u għalhekk is-CHMP qies li din ma kinitx appoġġjata.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Maltese: Ġew issottolinjati s-serjetà ta' dawn l-effetti avversi u l-eżitu fatali possibbli tagħhom.
English: For the indication “ancillary treatment of Raynaud's syndrome”, the submitted studies did not really assess nicergoline in patients with this specific indication, but were rather conducted in patients with peripheral arteriopathy.
Maltese: Għall-indikazzjoni “kura anċillari tas-sindromu ta' Raynaud”, l-istudji ppreżentati ma evalwawx nicergoline f'pazjenti b'din l-indikazzjoni speċifika, imma pjuttost twettqu fuq pazjenti b'arterjopatija periferali.
English: The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) ippreżentaw id-dejta kollha disponibbli dwar l-effikaċja minn provi kliniċi u studji ta' osservazzjoni, inkluża dejta li saret disponibbli wara lgħoti tal-awtorizzazzjoni inizjali għat-tqegħid fis-suq.
English: Therefore, the CHMP was of the opinion that it is not possible to rule out the possibility that these actually correspond to the development of ergotism.
Maltese: Għalhekk, is-CHMP kien tal-fehma li mhuwiex possibbli li tiġi eskluża l-possibbiltà li dawn effettivament jikkorrispondu mal-iżvilupp talergotiżmu.
English: • The Committee considered that the benefit-risk balance of nicergoline containing products:
Maltese: • Il-Kumitat ħass li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti li fihom nicergoline:
English: − Is not favourable for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Maltese: − Mhuwiex favorevoli għall-kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-vista preżumibbilment ta' oriġini vaskulari.
English: Overall summary of the scientific evaluation of nicergoline containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali li fihom nicergoline (ara Anness I)
English: For the indication “prophylaxis of migraine headache” the available data in migraine headache are from open label studies in a small number of patients (40 and 17 patients).
Maltese: Għall-indikazzjoni “profilassi tal-uġigħ ta' ras tal-emigranja” id-dejta disponibbli fl-uġigħ ta' ras talemigranja hija minn studji b'tikketta miftuħa fuq għadd żgħir ta' pazjenti (40 u 17-il pazjent).
English: These data were considered insufficient by the CHMP to conclude on a beneficial efficacy of nicergoline in the prophylaxis of migraine headache.
Maltese: Din id-dejta ma kinitx meqjusa bħala suffiċjenti mis-CHMP għal konklużjoni dwar l-effikaċja benefika ta' nicergoline filprofilassi tal-uġigħ ta' ras tal-emigranja.
English: The full EPAR for Myfenax 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: Myfenax is a ‘generic medicine'.
Maltese: Myfenax huwa ‘mediċina ġenerika'.
English: Myfenax mycophenolate mofetil
Maltese: Myfenax mikofonelat mofetil (mycophenolate mofetil)
English: The active substance in Myfenax, mycophenolate mofetil, is an immunosuppressive medicine.
Maltese: Is-sustanza attiva f'Myfenax, mikofonelat mofetil , hija mediċina immunosoppressiva.
English: Other information about Myfenax
Maltese: Aktar Informazzjoni dwar Myfenax
English: This is a summary of the European public assessment report (EPAR) for Myfenax.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Myfenax.
English: For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Myfenax twice a day as soon as it can be tolerated.
Maltese: F'każ ta' trapjanti tal-fwied fl-adulti, mikofonelat mofetil għandu jingħata bħala infużjoni (dripp fil-vina) għall-ewwel erbat ijiem wara t-trapjant, qabel ma l-pazjent tinbidillu d-doża għal 1.5 g ta' Myfenax darbtejn kuljum hekk kif tiġi aċċettata mill-pazjent.
English: Because Myfenax is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, CellCept.
Maltese: Billi Myfenax huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet li jiddeterminaw il-bijoekwivalenza tiegħu għall-mediċina ta' referenza, CellCept.
English: The European Commission granted a marketing authorisation valid throughout the EU for Myfenax on 21 February 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Myfenax fil-21 ta' Frar 2008.
English: Why has Myfenax been approved?
Maltese: Għaliex ġie approvat Myfenax?
English: Myfenax is a medicine containing the active substance mycophenolate mofetil.
Maltese: Myfenax huwa mediċina li fiha s-sustanza attiva mikofonelat mofetil.
English: This means that Myfenax is similar to a ‘reference medicine' already authorised in the European Union (EU) called CellCept.
Maltese: Dan ifisser li Myfenax jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala CellCept.
English: The CHMP concluded that, in accordance with EU requirements, Myfenax has been shown to have comparable quality and to be bioequivalent to CellCept.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Myfenax għandu kwalità li tixbah lill-prodott mediċinali bijoekwivalenti ma' CellCept.
English: What is Myfenax?
Maltese: Għal xiex jintuża Myfenax?
English: Because Myfenax is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Myfenax huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu huma meqjusa li huma l-istess bħall dawk tal-mediċina ta' referenza.
English: This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Maltese: Din l-enzima hija importanti għall-formazzjoni tad-DNA fiċċelloli, partikolarment fil-linfoċiti (tip ta' ċelloli tad-demm bojod li għandhom x'jaqsmu mar-riġettar talorgani trapjantati).
English: By preventing the production of new DNA, Myfenax reduces the rate at which the lymphocytes multiply.
Maltese: Bil-prevenzjoni tal-produzzjoni ta' DNA ġdid, Myfenax inaqqas ir-rata li biha jimmultiplikaw ruħhom il-linfoċiti.
English: What are the benefits and risks of Myfenax?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Myfenax?
English: The way that Myfenax should be given and the dose depend on the type of organ transplant and the patient's age and size.
Maltese: Il-mod ta' kif Myfenax għandu jingħata u d-doża jiddependu mit-tip ta' organu li jiġi trapjantat, l-età u d-daqs tal-pazjent.
English: Therefore, the CHMP's view was that, as for CellCept, the benefit outweighs the identified risk.
Maltese: Għalhekk, l-opinjoni tas-CHMP hija li, bħal fil-każ ta' CellCept, il-benefiċċji jegħlbu r-riskju identifikat.
English: How has Myfenax been studied?
Maltese: Kif ġie studjat Myfenax?
English: The Committee appointed C. Muñoz Madero as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Maltese: Muñoz Madero bħala relatur u lil M.
English: On 22 April 2013, Spain presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products.
Maltese: Fit-22 ta' April 2013, Spanja ppreżentat notifika ta' riferiment lill-Aġenzija skont l-Artikolu 35 tadDirettiva 2001/82/KE għal Baytril 2.5% injettabbli, Baytril 5% injettabbli, Baytril 10% injettabbli u ismijiet assoċjati, u l-prodotti mediċinali veterinarji relatati.
English: Opinion following an Article 351 referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products
Maltese: Opinjoni wara riferiment skont l-Artikolu 351 għal Baytril 2.5% injettabbli, Baytril 5% injettabbli u Baytril 10%
English: Written explanations were provided by some of the applicants and marketing authorisation holders by 30 September 2013 and 3 February 2014.
Maltese: Ġew ipprovduti spjegazzjonijiet bil-miktub minn xi applikanti u detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq sat-30 ta' Settembru 2013 u t-3 ta' Frar
English: Opinion following an Article 350F referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products
Maltese: Opinjoni wara riferiment skont l-Artikolu 350F għal Baytril 2.5% injettabbli, Baytril 5%
English: The referral started on 15 May 2013.
Maltese: Il-proċedura ta' riferiment bdiet fil-15 ta' Mejju 2013.
English: Therefore, on 9 April 2014 the Committee adopted by majority a positive opinion, recommending variations to the terms of the marketing authorisations for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products.
Maltese: Għalhekk, fid-9 ta' April 2014, il-Kumitat adotta opinjoni pożittiva b'maġġoranza, u rrakkomanda varjazzjonijiet għall-awtorizzazzjonijiet għat-tqegħid fis-suq għal Baytril 2.5% injettabbli, Baytril 5% injettabbli u Baytril 10% injettabbli u l-ismijiet assoċjati tagħhom, u prodotti mediċinali veterinarji relatati.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Maltese: Skont evalwazzjoni tad-dejta disponibbli fil-preżent, is-CVMP ikkunsidra li l-profil benefiċċju-riskju ġenerali għal dawn il-prodotti jibqa' pożittiv soġġett għal emendi fl-informazzjoni dwar il-prodott.
English: The CVMP was requested to consider what indications, dosage regimens and durations of treatments should be applied for the products concerned in order to ensure efficacy and target animal safety and to minimise the development of antimicrobial resistance, taking into account the available data.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għallUżu Veterinarju (CVMP) intalab iqis liema indikazzjonijiet, skedi tad-dożaġġ, perjodu tal-kuri għandhom jiġu applikati għall-prodotti kkonċernati sabiex tkun żgurata l-effikaċja u s-sigurtà tal-annimali u sabiex jitnaqqas ir-riskju ta' żvilupp ta' reżistenza antimikrobika għal enrofloxacin filwaqt li titqies id-dejta disponibbli.
English: 8 May 2018
Maltese: 8 ta' Mejju 2018
English: Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/122)
Maltese: Riżultat ta' proċedura skont l-Artikolu 34 tad-Direttiva 2001/82/KE (EMEA/V/A/122)
English: Girolan (and its associated name Apralan) is marketed in Denmark, France, Germany, Ireland, Italy, The Netherlands, Portugal, Spain and the United Kingdom.
Maltese: Girolan (u l-isem assoċjat tiegħu Apralan) huwa kkummerċjalizzat fid-Danimarka, fi Franza, filĠermanja, fl-Irlanda, fl-Italja, fin-Netherlands, fil-Portugall, fi Spanja u fir-Renju Unit.
English: Apramycin is a broad-spectrum aminocyclitol antibiotic produced by a strain of Streptomyces tenebrarius.
Maltese: Apramycin hija antibijotiku aminoċiklitol ta' spettru wiesa' prodott minn razza ta' Streptomyces tenebrarius.
English: Girolan is authorised in the EU via national procedures.
Maltese: Girolan huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: enterica serovar Dublin (Salmonella Dublin) in pre-ruminant calves; treatment of colibacillosis caused by Escherichia coli in chickens and treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli in rabbits.
Maltese: Girolan huwa indikat għat-trattament ta' enterite batterjali kkawżata minn Escherichia coli fil-ħnieżer; trattament ta' enterite batterjali kkawżata minn Escherichia coli u tifqigħat kliniċi minħabba Salmonella enterica subsp. enterica serovar Dublin (Salmonella Dublin) f'għoġġiela pre-ruminanti; trattament ta' kolibaċillożi kkawżata minn Escherichia coli fit-tiġieġ u trattament u metafilassi ta' enterite batterjali kkawżata minn Escherichia coli fil-fniek.
English: On 24 June 2016, Spain referred the matter to the CVMP in order to harmonise the product information for Girolan (and its associated name Apralan) in the EU.
Maltese: Fl-24 ta' Ġunju 2016, Spanja rreferiet il-kwistjoni lis-CVMP sabiex l-informazzjoni dwar il-prodott għal Girolan tiġi armonizzata (u l-isem assoċjat tiegħu Apralan) fl-UE.
English: Girolan is a veterinary medicinal product available as a powder for use in drinking water/milk containing apramycin sulfate as the active substance.
Maltese: Girolan huwa prodott mediċinali veterinarju disponibbli bħala trab għall-użu f'ilma tax-xorb/ħalib li fih is-sulfat tal-apramiċina bħala sustanza attiva.
English: On 15 February 2018, the European Medicines Agency (the Agency) completed a review of Girolan and its associated name, Apralan.
Maltese: Fil-15 ta' Frar 2018, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet rieżami ta' Girolan u l-isem assoċjat tiegħu, Apralan.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for the aforementioned product in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni dwar il-prodott [sommarju talkaratteristiċi tal-prodott (SPC), tat-tikkettar u tal-fuljett ta' tagħrif], għall-prodott imsemmi qabel flUnjoni Ewropea (UE).
English: What is Girolan and its associated name Apralan?
Maltese: X'inhu Girolan u l-isem assoċjat tiegħu Apralan?
English: The European Commission issued a decision on 8 May 2018.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fit-8 ta' Mejju 2018.
English: Spain noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Girolan (and its associated name Apralan) is marketed.
Maltese: Spanja osservat li hemm xi diverġenzi fost l-Istati Membri fil-mod kif il-prodott mediċinali veterinarju jista' jintuża, kif jidher mid-differenzi flinformazzjoni dwar il-prodott fil-pajjiżi fejn Girolan (u l-isem assoċjat tiegħu Apralan) jitpoġġa fis-suq.
English: PASI 50 14 58* 70 74* 77 9
Maltese: PASI 50 14 58* 70 74* 77 9 PASI 75
English: 79 (75%)a sPGA “clear” or “minimal”, n (%)
Maltese: 79 (75%)a sPGA “ċara” jew “minima”, n (%)
English: Educational materials
Maltese: Materjal Edukattiv
English: Hepatitis B reactivation, listeria
Maltese: Riattivazzjoni talepatite B, listeria,
English: Etanercept N = 103 to 105*
Maltese: Etanercept N = 103 sa 105*
English: A-6336 Langkampfen Austria
Maltese: A-6336 Langkampfen L-Awstrija
English: Date of first authorisation: 23 June 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Ġunju 2017
English: INSTRUCTIONS ON USE ‘QR code to be included' + www.erelzi.eu
Maltese: ‘Kodiċi QR se tiġi inkluża' + www.erelzi.eu
English: Citric acid anhydrous Sodium citrate dihydrate Sodium chloride
Maltese: Citric acid anhydrous Sodium citrate dihydrate Sodium chloride Sucrose
English: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: (≥ 1/10); 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); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: c: Remission is defined as DAS < 1.6.
Maltese: ċ: Tnaqqis fil-mard hu definit bħala DAS < 1.6
English: Double-Blind Clinical Responses at Week 12
Maltese: Risponsi kliniċi double-blind fil-Ġimgħa 12
English: Abbreviation: sPGA-static Physician Global Assessment a. p < 0.0001 compared with placebo
Maltese: Taqsira: sPGA-static Physician Global Assessment a.p < 0.0001 meta mqabbel mal-plaċebo
English: Serious allergic/ anaphylactic reactions (including angioedema, bronchospasm), sarcoidosis
Maltese: Reazzjonijiet allerġiċi/anafilattiċi serji (inklużi anġjoedema, bronkospażmu), sarkojdożi
English: 28b a: p < 0.001, etanercept vs. placebo b: p = 0.002, etanercept vs. placebo
Maltese: 28b a: p< 0.001, etanercept vs. plaċebo b: p = 0.002, etanercept vs. plaċebo
English: Erelzi contains sodium
Maltese: Erelzi fih sodium
English: Placebo n = 104
Maltese: Plaċebo n = 104
English: • Information that Erelzi can increase risk for getting serious infection:
Maltese: • Informazzjoni li Erelzi jista' jżid ir-riskju ta' infezzjoni serja:
English: This appearance is normal for Erelzi.
Maltese: Din id-dehra hi normali għal Erelzi.
English: Responses of patients with psoriasis in studies 2, 3 and 4
Maltese: Risponsi ta' PAZJENTI bi PSORIJASI fi STUDJI 2, 3 u 4
English: The active substance is etanercept.
Maltese: Is-sustanza attiva hi etanercept.
English: Merkel cell carcinoma (see section 4.4)
Maltese: Karċinoma taċ ċelluli Merkel (ara sezzjoni 4.4)
English: Worsening of cardiac failure congestive (see section 4.4)
Maltese: insuffiċjenza kardijaka konġestiva (ara sezzjoni 4.4).
English: ACR 20 and 50 responses were higher in patients treated with etanercept at 3 and 6 months than in patients treated with placebo (ACR 20: etanercept 62% and 59%, placebo 23% and 11% at 3 and 6 months, respectively: ACR 50: etanercept 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p < 0.01 etanercept vs. placebo at all timepoints for both ACR 20 and ACR 50 responses).
Maltese: Ir-risponsi tal-ACR 20 u 50 kienu ogħla f'pazjenti li ġew ikkurati b'etanercept għal 3 xhur u 6 xhur milli minn f'pazjenti kkurati bil-plaċebo (ACR 20: etanercept 62% u 59%, plaċebo 23% u 11% wara 3 u 6 xhur rispettivament; ACR 50: etanercept 41% u 40%, plaċebo 8% u 5% wara 3 u 6 xhur rispettivament;
English: Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of etanercept (see section 4.8).
Maltese: Infezzjonijiet serji, sepsis, tuberkulosi, u infezzjonijiet opportunistiċi, li jinkludu infezzjonijiet fungali invażivi, listeriosis u legionellosis, kienu rrappurtati bl-użu ta' etanercept (ara sezzjoni 4.8).
English: In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Maltese: Fi studju open-label, single-dose, two-treatment, crossover, f'voluntiera f'saħħithom, etanercept mogħti bħala injezzjoni waħda ta' 50 mg/ml, instab li kien bijoekwivalenti għal żewġ injezzjonijiet simultanji ta' 25 mg/ml.
English: 70b a: 25 mg etanercept SC twice weekly b: p < 0.001, etanercept vs. placebo c: p < 0.01, etanercept vs. placebo
Maltese: 70b a: 25 mg ta' etanercept taħt il-ġilda darbtejn f'ġimgħa b: p < 0.001, etanercept vs. plaċebo c: p < 0.01, etanercept vs. plaċebo