FrancophonIA/ELRC3.0 huggingface dataset:
English: The product is used in the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Maltese: Il-prodott jintuża għall-kura ta' infezzjonijiet respiratorji kkawżati minn Pasteurella multocida u Mannheimia haemolytica fl-ifrat u għall-kura ta' infezzjonijiet respiratorji dovuti għal Pasteurella multocida fil-majjali.
English: The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain and the United Kingdom.
Maltese: L-Istat Membru ta' Riferiment kien Franza u l-Istati Membri Konċernati kienu l-Belġju, ir-Repubblika Ċeka, il-Ġermanja, l-Italja, Spanja u r-Renju Unit.
English: In both species the product is administered intramuscularly at a dose of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice with a 48 hour interval between doses.
Maltese: Fiż-żewġ speċi, il-prodott jingħata fil-muskolu b'rata ta' 15 mg amoxicillin/kg piż tal-ġisem (ekwivalenti għal 1 ml ta' Suramox 15% LA/10 kg piż tal-ġisem) darbtejn b'48 siegħa bejn kull doża.
English: The arbitration procedure started on 8 September 2005 with the adoption of a list of questions.
Maltese: Il-proċedura ta' arbitraġġ bdiet fit-8 ta' Settembru 2005 permezz ta' l-adozzjoni ta' lista ta' mistoqsijiet.
English: Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic belonging to the penicillin group.
Maltese: Suramox 15% LA huwa sospensjoni għall-injezzjoni li fiha amoxicillin, li huwa antibijotiku betalactam, li jagħmel parti mill-grupp ta' peniċillini.
English: A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S.A. in France on 6 July 2004 based on an abridged application citing Duphamox LA as reference medicinal product.
Maltese: Awtorizzazzjoni għat-tqegħid fis-suq għal Suramox 15% LA kienet ingħatat preċedentement lil Virbac S.A. fi Franza fis-6 ta' Lulju 2004 abbażi ta' applikazzjoni mqassra li fiha Duphamox LA kien imsemmi bħala prodott mediċinali ta'riferiment.
English: The Marketing Authorisation Holder (MAH) subsequently provided written explanations to the Committee on 16 January 2006.
Maltese: Id-Detentur ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq (MAH) sussegwentement ippreżenta spjegazzjonijiet bil-miktub lill-Kumitat fis-16 ta' Jannar 2006.
English: The Marketing Authorisation Holder submitted further new residue studies to the CVMP on 14 April 2008.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-suq ippreżenta aktar studji ġodda ta' residwi lisCVMP fl-14 ta' April 2008.
English: During its May 2006 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion recommending the suspension of the marketing authorisations for Suramox 15% LA and the Stabox 15% LA, for cattle and pigs.
Maltese: Matul il-laqgħa tiegħu ta' Mejju 2006, is-CVMP, fid-dawl tad-data ġenerali ppreżentata u fid-dawl taddiskussjoni xjentifika fi ħdan il-Kumitat, adotta b'kunsens opinjoni li tirrakkomanda s-sospensjoni ta' lawtorizzazzjonijiet għat-tqegħid fis-suq għal Suramox 15% LA u Stabox 15% LA, għallifrat u l-majjali.
English: • it was not possible to establish a withdrawal period for cattle and pigs based on the data available;
Maltese: • ma kienx possibbli li jiġi ffissat perjodu ta' rtirar għallifrat u l-majjali abbażi tad-data disponibbli;
English: A mutual recognition procedure was started on 28 April 2005.
Maltese: Fit-28 ta' April 2005 nbdiet proċedura ta' rikonoxximent reċiproku.
English: On 13 June 2007 the European Commission adopted a Commission Decision suspending the national marketing authorisations for Suramox 15% LA and Stabox 15% LA, but providing an opportunity for the decision to be reviewed further to a new opinion formulated by the CVMP on the basis of the assessment of new residue depletion studies.
Maltese: Fit-13 ta' Ġunju 2007, il-Kummissjoni Ewropea adottat Deċiżjoni tal-Kummissjoni li ssospendiet lawtorizzazzjonijiet nazzjonali għat-tqegħid fis-suq għal Suramox 15% LA u Stabox 15% LA, iżda li tipprovdi l-opportunità għal reviżjoni tad-deċiżjoni wara opinjoni ġdida mis-CVMP abbażi talvalutazzjoni ta' studji ġodda dwar it-tnaqqis ta' residwi.
English: Belgium referred the issue to the EMEA on 28 July 2005.
Maltese: Il-Belġju rrefera l-kwistjoni lill-EMEA fit-28 ta' Lulju 2005.
English: On 14 March 2007 the CVMP, having considered the new residue studies, concluded that it was not possible to set a withdrawal period for Suramox 15% LA and Stabox 15% LA, for either cattle or pig meat and offal and therefore recommended by consensus the suspension of the above marketing authorisations for the above-mentioned products.
Maltese: Fl-14 ta' Marzu 2007 s-CVMP, wara li kien ikkunsidra l-istudji l-ġodda tar-residwi, ikkonkluda li ma kienx possibbli li jiġi ffissat perjodu ta' rtirar għal Suramox 15% LA u Stabox 15% LA, għall-laħam u lġewwieni ta' l-ifrat u l-majjali u għalhekk irrakkomanda b'kunsens is-sospensjoni ta' lawtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti msemmija hawn fuq.
English: During its June 2006 meeting, the CVMP appointed Dr. R. Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Maltese: Dr. R. Breathnach bħala rapporteur għall-valutazzjoni tar-raġunijiet għat-talba ta' eżami mill-ġdid ta' lopinjoni.
English: During its June 2008 meeting the CVMP considered the new residue studies submitted with regard to Suramox 15% LA and concluded that withdrawal periods can now be set for both cattle and pigs for Suramox 15% LA and Stabox 15% LA.
Maltese: Matul il-laqgħa tiegħu ta' Ġunju 2008, is-CVMP ikkunsidra l-istudji ġodda dwar ir-residwi ppreżentati fir-rigward ta' Suramox 15% LA u kkonkluda li l-perjodi ta' rtirar issa jistgħu jiġu ffissati għall- ifrat kif ukoll għall-majjali għal Suramox 15% LA u Stabox 15% LA.
English: On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Maltese: Fl-14 ta' Novembru 2006, il-Kummissjoni Ewropea ssospendiet il-proċedura bil-miktub u fis-16 ta' Novembru 2006, talbet lis-CVMP sabiex jikkunsidra l-istudji ġodda dwar ir-residwi fil-valutazzjoni tarriferiment u sabiex jirrevedi kif xieraq l-opinjoni tat-13 ta' Settembru 2006.
English: The withdrawal periods established for Suramox 15% LA were 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Maltese: Il-perjodi ta' irtirar iffissati għal Suramox 15% LA kienu ta' 58 jum fl-ifrat għall-laħam u l-ġewwieni u 35 jum f'majjali għall-laħam u l-ġewwieni.
English: The product was accepted by the Czech Republic, Italy and Spain.
Maltese: Il-prodott ġie aċċettat mir-Repubblika Ċeka, mill-Italja u minn Spanja.
English: The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ippreżenta l-istudji l-ġodda dwar ir-residwi lisCVMP fid-9 ta' Jannar 2007 u fit-13 ta' Marzu 2007 ppreżenta spjegazzjonijiet bil-fomm lill-Kumitat.
English: (95% confidence interval)
Maltese: (95% Intervall ta' Konfidenzab)
English: Tuberculosis:
Maltese: Tuberkulosi:
English: Rare (< 1/1000)
Maltese: Rari (< 1/1000)
English: V.J.Salomone Pharma Limited 79, Simpson Street, Marsa HMR 14, Malta.
Maltese: V.J.Salomone Pharma Limited 79, Simpson Street, Marsa
English: • vision disturbances;
Maltese: • disturbi tal-vista;
English: **p < 0.01, Trudexa versus placebo
Maltese: **p < 0.01, Trudexa kontra l-plaċebo
English: Other opportunistic infections:
Maltese: Infezzjonijiet opportunistiċi oħra:
English: • protein in urine.
Maltese: • proteina fl-awrina.
English: INFORMATION IN BRAILLE Trudexa 40 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Trudexa 40 mg
English: Placebo/ MTXa
Maltese: Plaċebo/ MTXa
English: I-04010 Campoverde di Aprilia (Latina)
Maltese: Campoverde di Aprilia (Latina)
English: Study IIIa**
Maltese: Studju IIIa**
English: Placebo/MTXTRUDEXA/MTX (95% Confidence Intervalb)
Maltese: Plaċebo/MTXTRUDEXA/MTX (95% Intervall ta' Konfidenzab)
English: Study IIa**
Maltese: Studju IIa**
English: 59.2 Barceloneta
Maltese: Road No. 2, Km. 59.2 Barceloneta
English: Common (≥ 1/100 and < 1/10 patients):
Maltese: Komuni (≥ 1/100 u < 1/10 pazjent):
English: Česká republika Abbott Laboratories s. r. o. Hadovka Office Park Evropská 2590/33d CZ-160 00 Praha 6
Maltese: Hadovka Office Park Evropská 2590/33d CZ-160 00 Praha 6
English: SI-1000 Ljubljana Tel: + 386 (1) 43 22 322
Maltese: Ljubljana Tel: + 386 (1) 43 22 322
English: Ltd Θεοτόκη 4Β
Maltese: Lifepharma (Z.A.M.) Ltd Θεοτόκη 4Β
English: Patient's Name: _____________________ Doctor's Name: _____________________ Doctor's Phone: _____________________
Maltese: Isem il-pazjent: _____________________ Isem it-tabib: _____________________
English: Among those, 86, 72, and 41 patients had ACR 20/50/70 response, respectively at month 60.
Maltese: Fost dawn, 86, 72 u 41 pazjent kellhom rispons għall-ACR 20/50/70, rispettivament f'xahar 60.
English: EU/1/03/257/007 EU/1/03/257/008 EU/1/03/257/009 EU/1/03/257/010
Maltese: EU/1/03/257/008 EU/1/03/257/009 EU/1/03/257/010
English: ASASa 20 Week 2
Maltese: ASASa 20
English: In the pivotal trials, anti-adalimumab antibodies were identified in 58/1053 (5.5%) patients treated with adalimumab, compared to 2/370 (0.5%) on placebo.
Maltese: Fil-provi pivotali, anti-korpi kontra adalimumab kienu identifikati fi 58/1053 (5.5%) pazjent ikkurati b'adalimumab, imqabbla ma' 2/370 (0.5%) fuq il-plaċebo.
English: (Percent of Patients)
Maltese: (Persentaġġ ta' Pazjenti)
English: Clinical remission Clinical response (CR
Maltese: Titjib kliniku Rispons kliniku (CR
English: IS-210 Garðabær Tel: + 354 535 7000
Maltese: Garðabær Tel: + 354 535 7000
English: Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom
Maltese: Abbott Laboratories Ltd Queenborough Kent ME11 5EL Renju Unit
English: EU/1/03/257/002 EU/1/03/257/003 EU/1/03/257/004 EU/1/03/257/005
Maltese: EU/1/03/257/002 EU/1/03/257/003 EU/1/03/257/004
English: Total Sharp score
Maltese: Punteġġ totali Sharp
English: Study VI
Maltese: Studju VI
English: In CHARM, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Maltese: F'CHARM, f'ġimgħa 4, 58% (499/854) tal-pazjenti kellhom rispons kliniku u ġew assessjati fl-analiżi primarja.
English: Side effects may occur at least up to 5 months after the last treatment.
Maltese: L-effetti sekondarji jistgħu ifeġġu sa mill-inqas 5 xhur wara l-aħħar trattament.
English: • allergic reactions;
Maltese: • reazzjonijiet allerġiċi;
English: Study Ia**
Maltese: Studju Ia**
English: Абот Лабораторис С.А.
Maltese: Т.П. Абот Лабораторис С.А. ул.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/0.8 ml
Maltese: INDIVIDWALI 40 mg/0.8 ml
English: Hepatitis B Reactivation
Maltese: Riattivazzjoni ta' Epatite B
English: Adverse events at least possibly causally-related to adalimumab for Studies I − IX, CLASSIC I, GAIN and CHARM, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common≥ 1/100 < 1/10; uncommon≥ 1/1000 to ≤ 1/100) and rare < 1/1000 in Table 1 below.
Maltese: I-IX, CLASSIC I, GAIN u CHARM, kemm kliniċi u tal-laboratorju, li millinqas huma relatati każwalment ma'adalimumab, huma mniżżla skond il-klassi tas-sistema ta' lorganu u l-frekwenza (komuni ħafna ≥ 1/10; komuni ≥ 1/100 < 1/10; mhux komuni ≥ 1/1000 sa ≤ 1/100) u rari < 1/1000 f'Tabella 1 hawn taħt.
English: Placebo/ MTXc n=200
Maltese: Plaċebo/ MTXc n=200
English: • You should be screened for tuberculosis.
Maltese: • Int għandek tkun ittestjat għat-tuberkulosi.
English: 80/40 mg N = 75
Maltese: Trudexa 80/40 mg N = 75
English: Serious infections, sepsis, tuberculosis and other opportunistic infections, including fatalities, have been reported with Trudexa.
Maltese: Infezzjonijiet serji, sepsis, tuberkulosi u infezzjonijiet opportunistiċi oħra, li jinkludu fatalitajiet, ġew rapportati b'Trudexa.
English: Please record the dates of the last screening for tuberculosis below: Tuberculin test: _______________ Chest X-ray:
Maltese: Test tat-tuberkolina: _______________ X-ray tas-sider: _______________
English: In patients with Crohn's disease, adalimumab antibodies were identified in 7/269 subjects (2.6%) treated with adalimumab.
Maltese: F'pazjenti li jbatu mill-marda Crohn (Crohn's disease), anti-korpi ta' kontra adalimumab ġew identifikati f'7/269 suġġett (2.6%) ikkurati b'adalimumab.
English: D-65205 Wiesbaden
Maltese: D-65205
English: Uncommon (≥ 1/1000 and< 1/100 patients):
Maltese: Mhux komuni (≥ 1/1000 u < 1/100 pazjent):
English: In CHARM, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Maltese: F'CHARM, 854 pazjent irċevew 80 mg f'ġimgħa 0 u 40 mg f'ġimgħa 2, open label.
English: Table 1 Undesirable Effects in Clinical Studies
Maltese: Tabella 1 Effetti mhux Mixtieqa fi Studji Kliniċi
English: In patients with psoriatic arthritis, adalimumab antibodies were identified in 38/376 subjects (10%) treated with adalimumab.
Maltese: F'pazjenti li jbatu minn artrite psorjatika, anti-korpi ta' adalimumab ġew identifikati fi 38/376 suġġett (10%) ikkurati b'adalimumab.
English: Respiratory, thoracic and mediastinal disorders interstitial lung disease, including pulmonary fibrosis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali mard tal-pulmun ta' l-interstizju, inkluża fibrożi tal-pulmun
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Trudexa administration.
Maltese: Il-livelli fisserum ta' metalloproteinases fil-matriċi (MMP-1 u MMP-3) li jipproduċu tibdil fit-tessuti li hu responsabbli għall-qerda tal-qarquċa, naqsu ukoll wara li ngħata Trudexa.
English: Table 4: ACR Responses in Study V (percent of patients)
Maltese: Tabella 4: Risponsi għall-ACR fi Studju V (persentaġġ ta' pazjenti)
English: The percent of Trudexa-treated patients achieving ACR 20, 50 and 70 responses was consistent across trials I, II and III.
Maltese: Il-persentaġġ ta' pazjenti kkurati b'Trudexa li jilħqu risponsi għall-ACR 20, 50 u 70 kien konsistenti fil-provi I, II u III.
English: • lower respiratory tract infections (such as bronchitis, pneumonia);
Maltese: • infezzjonijiet fin-naħa t'isfel tas-sistema respiratorja (bħal bronkite, pnewmonja);
English: Study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Maltese: IV evalwa primarjament is-sigurtà tal-prodott f'636 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18 -il sena.
English: In patients not given concomitant methotrexate, the incidence was 16/185 (8.6%), compared to 1/19 (5.3%) when adalimumab was used as add-on to methotrexate.
Maltese: F'pazjenti li ma ngħatawx ukoll methotrexate flimkien ma' adalimumab, l-inċidenza kienet ta' 16/185 (8.6%), meta pparagunat ma' 1/19 (5.3%) meta adalimumab kien użat addizzjonalment ma' methotrexate.
English: DATE OF FIRST AU`THORISATION/RENEWAL OF THE AUTHORISATION 1 September 2003
Maltese: 1 ta' Settembru 2003
English: In controlled and open label studies with Trudexa, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated histoplasmosis, pneumocystis carinii pneumonia, aspergillosis and listeriosis).
Maltese: Fi studji kontrollati u open-label b'Trudexa, ġew irrappurtati infezzjonijiet serji (inklużi infezzjonijiet fatali, li ġraw rarament), li jinkludu rapporti ta' tuberkulosi (inklużi tuberkulosi b'ħafna għoqod tuberkulari mal-ġisem kollu u tuberkulosi f'postijiet barra mill-pulmun) u infezzjonijiet opportunistiċi li jinvadu (eż. histoplasmosis mifruxa, pnewmonja pneumocystis carinii, aspergillosis u listeriosis).
English: Placebo/ MTXc n=60
Maltese: Plaċebo/ MTXc n=60
English: LV-1004 Riia Läti
Maltese: LV-1004
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10 M).
Maltese: Adalimumab jimmodula ukoll ir-risponsi bijoloġiċi li jiġu kkawżati jew regolati mit-TNF, inkluż tibdil fil-livelli tal-molekuli li jeħlu li huma risponsabbli għall-migrazzjoni tal-lewkoċite (ELAM-1, VCAM1, u ICAM-1 ma' xi IC50 minn 1-2 X 10-10 M).
English: • nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances;
Maltese: • disturbi fin-nervituri (bħal sklerosi multipla u infjammazzjoni fin-nervituri ta' l-għajnejn),
English: Trudexa N=51
Maltese: Humira N=51
English: In patients not given concomitant methotrexate, the incidence was 12.4%, compared to 0.6% when adalimumab was used as add-on to methotrexate.
Maltese: F'pazjenti li ma ngħatawx methotrexate flimkien ma' adalimumab, l-inċidenza kienet ta' 12.4%, imqabbla ma' 0.6% meta adalimumab kien użat addizzjonalment ma' methotrexate.
English: The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells.
Maltese: Is-sustanza attiva, adalimumab, hija anti-korp uman monoklonali magħmul minn ċelluli kkulturati.
English: • If you have a severe infection, including active tuberculosis (see “Take special care with Trudexa”).
Maltese: • Jekk għandek infezzjoni severa, inkluż tuberkulosi attiva (ara “Oqgħod attent ħafna b'Trudexa”).
English: In Study III, improvement in physical function was maintained through week 260 (60 months) of open-label treatment.
Maltese: Fi Studju III, titjib fil-funzjoni fiżika ġie mantenut matul ġimgħa 260 (60 xahar) tal-kura open-label.
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
Maltese: Tuberkulosi attiva jew infezzjonijiet oħra severi bħal sepsis, u infezzjonijiet opportunistiċi (ara sezzjoni 4.4).
English: Impaired renal and/or hepatic function
Maltese: Indeboliment tal-funzjoni renali u/jew tal-fwied
English: Rare necrotising fasciitis, viral meningitis, diverticulitis
Maltese: faxxite bin-nekrosi, meninġite virali, infjammazzjoni tad-divertikulu
English: • dizziness, including vertigo, headache;
Maltese: • sturdament, li jinkludi vertigo, uġigħ ta' ras;
English: Adverse events of the haematologic system, including medically significant cytopoenia (e.g. thrombocytopaenia, leucopaenia) have been infrequently reported with Trudexa.
Maltese: Effetti avversi tas-sistema ematoloġika, li jinkludu ċitopenja li hi medikament sinifikanti (eż thrombocytopaenia, lewkopenja) ma ġewx irrappurtati frekwentament b'Trudexa.
English: In CLASSIC I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg Trudexa at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Maltese: Fi CLASSIC I, 299 pazjent li qatt ma ħadu antagonist ta' TNF ġew imqassma bl-addoċċ f'wieħed minn erbgħa gruppi ta' nies li kienu qegħdin jieħdu l-kura; plaċebo f'ġimgħat 0 u 2, 160 mg Trudexa f'ġimgħa 0 u 80 mg f'ġimgħa 2, 80 mg f'ġimgħa 0 u 40 mg f'ġimgħa 2, u 40 mg f'ġimgħa 0 u 20 mg f'ġimgħa 2.
English: After treatment with Trudexa, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed compared to baseline in patients with rheumatoid arthritis.
Maltese: Wara l-kura b'Trudexa, ġie osservat tnaqqis rapidu fil-livelli ta' sustanzi li jirreaġixxu fil-fażi akuta ta' l-infjammazzjoni (proteina C-reactive (CRP) u r-rata ta' tagħqid ta' l-eritroċit (ESR)) u cytokines fisserum (IL-6), meta pparagunat ma' linja bażi f'pazjenti li jbatu minn artrite rewmatika.
English: LV-1004 Rīga Tel: + 371 7605580
Maltese: Rīga Tel: + 371 7605580
English: Trudexa is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: Trudexa huwa kontro-indikat f'pazjenti li jbatu minn insuffiċjenza tal-qalb minn moderata sa severa (ara sezzjoni 4.3).
English: Table 3: ACR Responses in Placebo-Controlled Trials
Maltese: Tabella 3: Risponsi għall-ACR fi Provi kontrollati bil-Plaċebo
English: REMINDER STICKERS TEXT (included in pack)
Maltese: Neoplażmi beninni u malinni (inklużi ċesti u polipi)
English: There have been reports of tuberculosis in patients receiving Trudexa.
Maltese: Kien hemm rapporti ta' tuberkulosi f'pazenti li jierċievu Trudexa.
English: Trudexa was studied in 5293 patients in controlled and open label trials for up to 60 months.
Maltese: Trudexa ġie studjat f'5293 pazjent fi provi kontrollati u open-label li damu sejrin sa 60 xahar.
English: Hepatobiliary Disorders reactivation of hepatitis B
Maltese: Disturbi fil-fwied u fil-marrara reattivazzjoni ta' epatite B
English: 3) Injecting Trudexa
Maltese: 3) Biex tinjetta Trudexa
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskolu-skeletrali, tal-connective tissue u ta' lgħadam
English: • lung disease.
Maltese: Dan jinkludi t-tuberkulosi.
English: Т.П.
Maltese: B.
English: Manufacturer:
Maltese: GAIN:
English: Crohn's disease
Maltese: Il-marda Crohn (Crohn's disease)
English: Usually, Trudexa is used with methotrexate.
Maltese: Ġeneralment, Trudexa jintuża ma' methotrexate.
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified total Sharp score ≤ 0.5) was significantly higher with Trudexa/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Trudexa monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Maltese: Wara kura ta' 52 ġimgħa u ta' 104 ġimgħat, il-persentaġġ ta' pazjenti li ma avvanzatilhomx il-marda (bidla mil-linja bażi fit-tibdil tal-puteġġ totali Sharp ≤ 0.5) kien sinifikament ogħla bit-terapija kombinata ta' Trudexa/methotrexate (63.8% u 61.2% rispettivament) meta pparagunat ma' kura b' methotrexate waħdu (37.4% u 33.5% rispettivament, p<0.001) u kura b'Trudexa waħdu (50.7%, p < 0.002 u 44.5%, p < 0.001 rispettivament).
English: Λεωφόρος Βουλιαγµένης 512 GR-174 56 Άλιµος, Αθήνα Τηλ: + 30 21 0 9985-222
Maltese: Άλιµος, Αθήνα Τηλ: + 30 21 0 9985-222
English: • The needle cover of the syringe contains natural rubber (latex).
Maltese: • L-għatu tal-labra tas-siringa fih lastku naturali (latex).
English: ATC code: L04AA17 Mechanism of action
Maltese: L04AA17
English: ASAS 70 Week 2
Maltese: ASAS 70
English: • glaucoma;
Maltese: • glawkoma;
English: D - 65205 Wiesbaden Germany
Maltese: D - 65205
English: Study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Maltese: Studju II evalwa 544 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18 -il sena u li ma kinux irrispondew għal kura b'mill-inqas mediċina waħda anti-rewmatika li taffetwa l-proċess tal-mard.
English: Uncommon opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, wound infection, skin infection (including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot)
Maltese: Rari sepsis, infezzjonijiet opportunistiċi (li jinkludu ttuberkulosi, histoplasmosis), axxess, infezzjoni tal-ġogi, infezzjoni tal-ferita, infezzjoni tal-ġilda (inklużi infjammazzjoni tas-tessuti ċellulari u impetiġini), infezzjonijiet tal-fungu superfiċjali (li jinkludu l-ġilda, id-difer u s-sieq)
English: Bucureşti-Ploieşti 1A
Maltese: Pihatörmä 1A/Gårdsbrinken 1B
English: Trudexa N=151
Maltese: Humira N=151