FrancophonIA/ELRC3.0 huggingface dataset:
English: Concurrent administration of TNF-antagonists and anakinra Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit.
Maltese: L-għoti fl-istess ħin ta' antagonisti tat-TNF u anakinra Infezzjonijiet serji u newtropenija dehru fi studji kliniċi bl-użu fl-istess ħin ta' anakinra u sustanza oħra li timblokka t-TNF, etanercept, mingħajr ma kien hemm żieda fil-benefiċċju kliniku.
English: Simponi 50 mg solution for injection in pre-filled syringe 0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex).
Maltese: Simponi 50 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 0.5 mL ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ Tip 1) b'labra fissa (stainless steel) u għatu tal-labra (latex li fih il-gomma).
English: EU/1/09/546/003 1 pre-filled syringe EU/1/09/546/004 3 pre-filled syringes
Maltese: EU/1/09/546/003 siringa 1 mimlija għal-lest EU/1/09/546/004 3 siringi mimlijin għal-lest
English: Simponi 100 mg solution for injection in pre-filled syringe 1 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex).
Maltese: Simponi 100 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 1 mL ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ Tip 1) b'labra fissa (stainless steel) u għatu tallabra (latex li fih il-gomma).
English: Liver enzyme elevations
Maltese: Anemija aplastika, agranuloċitożi
English: Missed dose
Maltese: Tqala u tilqim
English: In a fertility and general reproductive function study in mouse, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, the number of pregnant mice was reduced.
Maltese: Fi studju dwar il-fertilità u funzjoni riproduttiva ġenerali fil-ġrieden, permezz ta' antikorp analogu li jinibixxi b'mod selettiv l-attività funzjonali tat-TNF-α tal-ġrieden, in-numru ta' ġrieden li ħarġu tqal naqas.
English: Patients receiving placebo + MTX were switched to Simponi 50 mg + MTX after week 24.
Maltese: Pazjenti li kienu qed jirċievu plaċebo + MTX inqalbu għal Simponi 50 mg + MTX wara ġimgħa 24.
English: Uncommon: Visual disorders (such as blurred vision and decreased visual acuity), conjunctivitis, eye allergy (such as pruritis and irritation)
Maltese: Mhux komuni: Disturbi fil-vista (bħal vista mċajpra u tnaqqis fl-akutezza tal-vista), konġunktivite, allerġija fl-għajnejn (bħal prurite u irritazzjoni)
English: EU/1/09/546/002 (3 packs, each containing 1 pre-filled pen)
Maltese: EU/1/09/546/002 (3 pakketti, li kull wieħed fih pinna 1 mimlija għal-lest)
English: Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Maltese: Simponi flimkien ma' methotrexate (MTX) huwa indikat għat-trattament ta' artrite poliartikulari idjopatika tat-tfal u ż-żgħażagħ fi tfal b'età ta' sentejn u akbar, li kellhom rispons mhux adegwat għal terapija preċedenti b'MTX.
English: • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.
Maltese: • kura ta' artrite rewmatojde severa, attiva u progressiva f'adulti li qabel ma kienux ikkurati b'MTX.
English: Physicians global assessment of disease (VAS
Maltese: Valutazzjoni globali tal-marda minn tabib (VAS
English: Inject within 5 minutes of removing the cap.
Maltese: Injetta fi żmien 5 minuti minn meta tneħħi l-għatu.
English: • blood cancer (leukaemia) (rare).
Maltese: • kanċer fid-demm (lewkimja) (rari).
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including golimumab (see section 4.8).
Maltese: Melanoma u karċinoma taċ-ċellula ta' Merkel kienu rrappurtati f'pazjenti kkurati b'sustanzi li jimblukkaw TNF, inkluż golimumab.
English: Patients treated with Simponi experienced significantly more improvements in health-related quality of life as assessed by ASQoL, EQ-5D, and physical and mental components of SF-36, and experienced significantly more improvements in productivity as assessed by greater reductions in overall work impairment and in activity impairment as assessed by the WPAI questionnaire than patients receiving placebo.
Maltese: Pazjenti ttrattati b'Simponi kellhom b'mod sinifikanti aktar titjib fil-kwalità tal-ħajja marbuta mas-saħħa kif stmat permezz ta' ASQoL, EQ-5D, u komponenti fiżiċi u mentali ta' SF-36, u kellhom b'mod sinifikanti aktar titjib filproduttività kif stmat minn tnaqqis ikbar fl-indeboliment globali tax-xogħol u fl-indeboliment ta' attività kif stmat permezz tal-kwestjonarju WPAI minn pazjenti li kienu qed jirċievu plaċebo.
English: Simponi is registered in 50 mg and 100 mg strengths for subcutaneous administration.
Maltese: Simponi huwa reġistrat f'qawwiet ta' 50 mg u 100 mg għall-għoti taħt il-ġilda.
English: Change from baseline JSN Score Baseline
Maltese: Jekk tinsa tuża Simponi
English: Children and adolescents Simponi 100 mg is not recommended for children and adolescents (younger than 18 years).
Maltese: Tfal u adolexxenti Simponi 100 mg mhuwiex rakkomandat għat-tfal u adolexxenti (taħt it-18-il sena).
English: Children with polyarticular course JIA (rheumatoid factor positive or negative polyarthritis, extended oligoarthritis, juvenile psoriatic arthritis or systemic JIA with no current systemic symptoms) were included in the study.
Maltese: Tfal b'JIA bi żvilupp poliartikulari (poliartrite b'fattur rewmatojde pożittiv jew negattiv, oligoartrite estiża, artrite psorjatika tat-tfal u ż-żgħażagħ jew JIA sistemika li attwalment m'għandhiex sintomi sistemiċi) ġew inklużi fl-istudju.
English: EU/1/09/546/009 1 pre-filled pen
Maltese: EU/1/09/546/009 pinna 1 mimlija għal-lest
English: The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4).
Maltese: Il-kombinazzjoni ta' golimumab ma' sustanzi bijoloġiċi terapewtiċi oħrajn li jintużaw biex jikkuraw listess kundizzjonijiet bħal golimumab, inkluż anakinra u abatacept mhix irrakkomandata (ara sezzjoni 4.4).
English: With concomitant use of MTX, treatment with 50 mg golimumab subcutaneously every 4 weeks resulted in a mean ( standard deviation) steady-state trough serum concentration of approximately 0.6  0.4 g/mL in RA patients with active RA despite MTX therapy, and approximately 0.5  0.4 g/mL in patients with active PsA and approximately 0.8  0.4 g/mL in patients with AS. Steady-state trough mean serum golimumab concentrations in patients with nr-Axial SpA were similar to those observed in patients with AS following subcutaneous administration of 50 mg golimumab every 4 weeks.
Maltese: Bl-użu fl-istess ħin ta' MTX, kura b'50 mg ta' golimumab taħt il-ġilda kull 4 ġimgħat wasslet għall-medja (± devjazzjoni standard) talaktar konċentrazzjoni baxxa fl-istat fiss fis-serum ta' madwar 0.6 ± 0.4 μg/mL f'pazjenti li għandhom RA attiva minkejja terapija b'MTX, u madwar 0.5 ± 0.4 μg/mL f'pazjenti li għandhom PsA attiva u madwar 0.8 ± 0.4 μg/mL f'pazjenti li għandhom AS.
English: Symptoms of an infection can include fever, tiredness, (persistent) cough, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, dental problems and a burning feeling when urinating.
Maltese: Sintomi ta' infezzjoni jinkludu deni, sogħla, qtugħ ta' nifs, sintomi bħal tal-influwenza, dijarea, ġrieħi, problemi fis-snien jew ikollok ħruq meta tgħaddi l-awrina.
English: Other information
Maltese: Informazzjoni oħra
English: EU/1/09/546/005 1 pre-filled pen EU/1/09/546/006 3 pre-filled pens
Maltese: EU/1/09/546/005 pinna 1 mimlija għal-lest EU/1/09/546/006 3 pinen mimlijin għal-lest
English: EU/1/09/546/006 (3 packs, each containing 1 pre-filled pen)
Maltese: EU/1/09/546/006 (3 pakketti, li kull wieħed fih pinna 1 mimlija għal-lest)
English: Patients with body weight greater than or equal to 80 kg Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2, then 100 mg every 4 weeks, thereafter (see section 5.1).
Maltese: Pazjenti b'piż tal-ġisem aktar minn jew ugwali għal 80 kg Simponi jingħata bħala doża inizjali ta' 200 mg, segwita minn 100 mg f'ġimgħa 2, u minn hemm 'il quddiem 100 mg kull 4 ġimgħat (ara sezzjoni 5.1).
English: The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-AHEAD) in 197 adult patients with severe active nr-Axial SpA (defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS).
Maltese: Is-sigurtà u l-effikaċja ta' Simponi ġew ivvalutati fi studju b'ħafna ċentri, ikkontrollat bi plaċebo li fih la l-pazjenti li ntagħżlu b'mod każwali u lanqas l-investigatur ma kienu jafu liema sustanza qed tingħata (GO-AHEAD) f'197 pazjent adult b'nr-Axial SpA attiva severa (definiti bħala dawk ilpazjenti li ssodisfaw il-kriterji tal-klassifika ta' ASAS ta' spondiloartrite tal-assi iżda ma ssodisfawx il-kriterji modifikati ta' New York għal AS).
English: Patients who developed anti-golimumab antibodies generally had low trough steady-state serum concentrations of golimumab (see section 5.1).
Maltese: Pazjenti li żviluppaw antikorpi kontra golimumab b'mod ġenerali kellhom il-konċentrazzjonijiet laktar baxxi ta' golimumab fl-istat fiss fis-serum baxxi (ara sezzjoni 5.1).
English: Sorbitol intolerance This medicine contains 20.5 mg sorbitol (E420) in each pre-filled pen.
Maltese: Intolleranza għas-sorbitol Din il-mediċina fiha 20.5 mg sorbitol (E420) f'kull pinna mimlija għal-lest.
English: • That treatment with Simponi may increase the risks of serious infection, opportunistic infections, tuberculosis, hepatitis B reactivation and breakthrough infection after administration of live vaccines in infants exposed to golimumab in utero; and when to seek attention from a
Maltese: • Li t-trattament b'Simponi jista' jżid ir-riskji ta' infezzjoni serja, infezzjonijiet opportunistiċi, tuberkulożi, riattivazzjoni tal-epatite B u infezzjoni li toħroġ wara l-għoti ta' tilqim ħaj lil tfal li jkunu ġew esposti għal golimumab in utero; u meta għandek tfittex l-għajnuna mingħand professjonist fil-qasam tal-kura tas-saħħa.
English: 0.25 mL 0.3 mL
Maltese: 0.25 mL
English: The significance of this finding is unknown.
Maltese: Hija taqfel, u inti ma tirċivix id-doża.
English: • reactivation of hepatitis B virus if you are a carrier or have had hepatitis B before (rare).
Maltese: • attivazzjoni mill-ġdid tal-virus tal-epatite B jekk inti persuna li ġġorr il-marda jew kellek l-epatite B qabel (rari).
English: Orange Priming Band
Maltese: Protezzjoni Oranġjo tal-Labra
English: • Tell your doctor if you think you might be at risk of contracting HBV
Maltese: • Għid lit-tabib tiegħek jekk taħseb li jista' jkollok riskju li taqbdek l-HBV
English: Simponi 50 mg administered once a month, on the same date each month, for children with a body weight of at least 40 kg. A 45 mg/0.45 mL pre-filled pen is available for administration to children with polyarticular juvenile idiopathic arthritis weighing less than 40 kg.
Maltese: Hija disponibbli pinna mimlija għal-lest ta' 45 mg/0.45 mL għal għoti lil tfal b'artrite poliartikulari idjopatka tat-tfl u ż-żgħażagħ li jiżnu inqas minn 40 kg.
English: In the controlled periods of pivotal trials and through approximately 4 years of follow-up, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the golimumab and the control groups.
Maltese: Fil-perjodi kkontrollati tal-provi pivitali u matul segwitu sa madwar 4 snin, l-inċidenza ta' tumuri malinni li ma kinux limfoma (minbarra kanċer tal-ġilda mhux melanoma) kienet simili bejn il-gruppi ta' golimumab u l-gruppi ta' kontroll.
English: Common: Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess
Maltese: Infezzjonijiet ikkawżati minn batterja (bħal ċellulitis), infezzjoni fil-passaġġ respiratorju ta' isfel (bħal pnewmonja), infezzjonijiet virali (bħal influwenza u herpes), bronkite, sinużite, infezzjonijiet superfiċjali kkawżati minn fungi, axxess
English: Sorbitol intolerance This medicine contains 20.5 mg sorbitol (E420) in each pre-filled syringe.
Maltese: Intolleranza għas-sorbitol Din il-mediċina fiha 20.5 mg sorbitol (E420) f'kull siringa mimlija għal-lest.
English: Remove the needle cover (see figure 5)
Maltese: Neħħi l-għatu (figura 5)
English: • Breast disorders
Maltese: • Fejqan imxekkel
English: Analyses were performed on both the All Treated (AT, N = 197) and Objective Signs of Inflammation (OSI, N = 158, defined by elevated CRP and/or evidence of sacroiliitis on MRI at baseline) populations.
Maltese: L-analiżi saru kemm fuq il-popolazzjonijiet Ittrattati Kollha (AT - All Treated, N = 197) kif ukoll fuq dawk b'Sinjali Oġġettivi ta' Infjammazzjoni (OSIObjective Signs of Inflammation, N = 158, definiti permezz ta' CRP għoli u/jew xhieda ta' sarkolite fuq MRI fil-linja bażi).
English: Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers, including golimumab.
Maltese: Każijiet ta' insuffiċjenza konġestiva tal-qalb (CHF) u CHF li dehret għall-ewwel darba kienu rrappurtati b'imblukkaturi ta' TNF, inkluż golimumab.
English: Golimumab exhibited approximately dose-proportional pharmacokinetics in patients with RA over the dose range of 0.1 to 10.0 mg/kg following a single intravenous dose.
Maltese: Golimumab wera farmakokinetika li kienet bejn wieħed u ieħor fi proporzjon mad-doża f'pazjenti li kellhom RA fuq il-medda ta' doża minn 0.1 sa 10.
English: • Taste disturbances
Maltese: Disturbi vaskulari
English: One 0.5 mL pre-filled pen contains 50 mg golimumab
Maltese: Pinna mimlija għal-lest waħda tal-0.5 mL fiha 50 mg golimumab
English: Uncommon: Arrhythmia, ischemic coronary artery disorders Rare: Congestive heart failure (new onset or worsening)
Maltese: Mhux komuni: Arritmija, disturbi fl-arterja koronarja iskemika Rari:
English: • Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Maltese: • Għid lit-tabib jew lill-ispiżjar tiegħek jekk qed tuża, użajt dan l-aħħar jew tista' tuża xi mediċini oħra, inkluż kwalunkwe mediċina oħra biex tikkura l-artrite rewmatojde, l-artrite poliartikulari idjopatika tat-tfal u ż-żgħażagħ, l-artrite psorjatika, ankylosing spondylitis, spondiloartrite assijali mhux radjugrafika, jew kolite bl-ulċeri.
English: A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility (see section 5.3).
Maltese: Studju dwar il-fertilità fil-ġrieden, bl-użu ta' antikorp analogu li jinibixxi b'mod selettiv l-attività funzjonali tat-TNF tal-ġrieden, ma wera lebda effett rilevanti fuq il-fertilità (ara sezzjoni 5.3).
English: Common: Asthma and related symptoms (such as wheezing and bronchial hyperactivity) Uncommon: Interstitial lung disease Gastrointestinal disorders
Maltese: Komuni: Ażma u sintomi relatati (bħal tħarħir u attività eċċessiva tal-bronki)
English: Simponi 50 mg solution for injection in pre-filled syringe One 0.5 mL pre-filled syringe contains 50 mg of golimumab*.
Maltese: Simponi 50 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Siringa waħda mimlija għal-lest tal-0.5 mL fiha 50 mg golimumab*.
English: Each pre-filled pen contains 20.5 mg sorbitol per 50 mg dose.
Maltese: Kull pinna mimlija għal-lest fiha 20.5 mg sorbitol għal kull doża ta' 50 mg.
English: The results of the maintenance study (PURSUIT-Maintenance) were based on evaluation of 456 patients who achieved clinical response from previous induction with Simponi.
Maltese: Ir-riżultati tal-istudju ta' manteniment (PURSUIT-Manteniment) kienu bbażati fuq valutazzjoni ta' 456 pazjent li kisbu rispons kliniku minn induzzjoni preċedenti b'Simponi.
English: 0.35 mL 0.4 mL
Maltese: 0.35 mL
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g. BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Maltese: Użu ieħor ta' sustanzi terapewtiċi infettivi bħal batterji ħajjin attenwati (eż. l-instillazzjoni ta' BCG fil-bużżieqa tal-awrina għall-kura tal-kanċer) jista' jwassal għal infezzjonijiet kliniċi, inkluż infezzjonijiet mifruxa.
English: Uncommon: Neoplasms (such as skin cancer, squamous cell carcinoma and melanocytic naevus) Rare: Lymphoma, leukaemia, melanoma, Merkel cell carcinoma Not known: Hepatosplenic T-cell lymphoma* Blood and lymphatic system disorders
Maltese: Mhux komuni: Neoplażmi (bħal kanċer tal-ġilda, karċinoma taċ-ċelluli squamous u nevus melanoċitiku) Rari:
English: Rare: Lupus-like syndrome
Maltese: Possibbiltà ta' żbalji fl-għoti tal-mediċina
English: • On rare occasions, a specific and severe type of lymphoma called hepatosplenic T-cell lymphoma has been observed in patients taking other TNF-blockers.
Maltese: • It-tabella taħt turi kif inti normalment se tuża din il-mediċina.
English: What Simponi looks like and contents of the pack Simponi is supplied as solution for injection in a single-use pre-filled syringe Simponi is available in packs containing 1 pre-filled syringe and multipacks containing 3 (3 packs of 1) pre-filled syringes.
Maltese: Simponi huwa disponibbli f'pakketti li jkun fihom siringa 1 mimlija għal-lest u pakketti b'ħafna li jkun fihom 3 (3 pakketti ta'1) siringi mimlijin għal-lest.
English: The safety of golimumab has been studied in a phase III study of 173 pJIA patients from 2 to 17 years of age.
Maltese: III ta' 173 pazjent b'pJIA b'età minn sentejn sa 17-il sena.
English: Simponi 50 mg solution for injection in pre-filled pen One 0.5 mL pre-filled pen contains 50 mg of golimumab*.
Maltese: Simponi 50 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Pinna waħda mimlija għal-lest tal-0.5 mL fiha 50 mg golimumab*.
English: Placebo-controlled efficacy data were collected and analysed through week 24.
Maltese: Dejta dwar l-effikaċja ikkontrollata mill-plaċebo kienet miġbura u analizzata sa' ġimgħa 24.
English: A drug-tolerant EIA method was used in the pJIA study for the detection of antibodies to golimumab.
Maltese: Intuża metodu ta' EIA li jittollera l-mediċina fl-istudju dwar pJIA biex jinstabu antikorpi għal golimumab.
English: EU/1/09/546/001 1 pre-filled pen EU/1/09/546/002 3 pre-filled pens
Maltese: EU/1/09/546/001 pinna 1 mimlija għal-lest EU/1/09/546/002 3 pinen mimlijin għal-lest
English: Appropriate screening tests, i.e. tuberculin skin or blood test and chest X-ray, should be performed in all patients (local recommendations may apply).
Maltese: Testijiet ta' stħarriġ adattati, jiġifieri test tal-ġilda jew tad-demm bit-tuberkulin u X-ray tas-sider, għandhom isiru fuq il-pazjenti kollha (rakkomandazzjonijiet lokali jistgħu jkunu applikati).
English: 0.15 mL 0.2 mL
Maltese: 0.15 mL
English: Golimumab has not been studied in patients with CHF.
Maltese: Golimumab ma ġiex studjat f'pazjenti b'CHF.
English: (maximum 50 mg) subcutaneously every 4 weeks and MTX.
Maltese: (massimu 50 mg) taħt il-ġilda kull 4 ġimgħat u MTX.
English: Among patients remaining in the study and treated with Simponi, DAS28 responses were similar from week 104 through week 256.
Maltese: Fost pazjenti li baqgħu fl-istudju u li kienu kkurati b'Simponi, risponsi DAS28 kienu simili minn ġimgħa 104 sa ġimgħa 256.
English: In addition to the primary endpoint(s), additional assessments of the impact of Simponi treatment on the signs and symptoms of arthritis, radiographic response, physical function and health-related quality of life were performed.
Maltese: Minbarra l-mira finali (miri finali), saru wkoll evalwazzjonijiet addizzjonali tal-impatt tal-kura b'Simponi fuq is-sinjali u sintomi tal-artrite, rispons radjugrafiku, funzjoni fiżika u kwalità tal-ħajja relatata mas-saħħa.
English: Patients were randomly assigned to placebo, Simponi 50 mg, or Simponi 100 mg.
Maltese: Il-pazjenti kienu randomised biex jirċievu plaċebo, Simponi 50 mg, jew Simponi 100 mg.
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents (see section 4.8).
Maltese: Każijiet rari wara t-tqegħid fis-suq ta' limfoma epatosplenika taċ-ċellula T (HSTCL - hepatosplenic T-cell lymphoma) kienu rrappurtati f'pazjenti kkurati b'sustanzi oħra li jimblukkaw TNF (ara sezzjoni 4.8).
English: • Bacterial infections (such as cellulitis)
Maltese: • Infezzjonijiet ikkawżati minn batterja (bħal ċellulite)
English: Among patients remaining in the study and treated with Simponi, improvement of the SF-36 physical component was similar from week 104 through week 256.
Maltese: Fost pazjenti li baqgħu fl-istudju u li kienu kkurati b'Simponi, titjib fil-komponent fiżiku ta' SF-36 kien simili minn ġimgħa 104 sa ġimgħa 256.
English: Solution for injection in pre-filled pen (SmartJect) Multipack: 3 (3 packs of 1) pre-filled pens
Maltese: Soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest (SmartJect) Pakkett b'ħafna: 3 (3 pakketti b'1) pinen mimlija għal-lest
English: In the controlled period of RA and AS pivotal trials, ALT elevations ≥ 5 x ULN were uncommon and seen in more golimumab-treated patients (0.4% to 0.9%) than control patients (0.0%).
Maltese: Fil-perjodu kkontrollat tal-provi pivitali ta' RA u AS, iż-żidiet fl-ALT ta' ≥ 5 x ULN ma kienux komuni u dehru aktar fil-pazjenti ikkurati b'golimumab (0.4% sa' 0.9%) milli fil-pazjenti fuq kontroll (0.0%).
English: PRE-FILLED PEN CARTON
Maltese: ĠEWWA TAL-KARTUNA
English: Merck Sharp & Dohme Cyprus Limited Τηλ.
Maltese: Merck Sharp & Dohme Limited Tel: +44
English: Among patients remaining in the study and treated with Simponi, similar rates of ACR 20/50/70 response were observed from week 104 through week 256.
Maltese: Fost pazjenti li baqgħu fl-istudju u li kienu kkurati b'Simponi, kienu osservati rati simili ta' rispons ACR 20/50/70 minn ġimgħa 104 sa ġimgħa 256.
English: The presence of antibodies to golimumab may increase the risk of injection site reactions (see section 4.4).
Maltese: Kura addizzjonali b'golimumab m'għandhiex tingħata jekk pazjent jiżviluppa infezzjoni serja jew sepsi (ara sezzjoni 4.3).
English: Non-radiographic axial spondyloarthritis
Maltese: • Infafet fil-ġilda
English: The majority of cases have occurred in adolescent and young adult males with nearly all on concomitant treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) for inflammatory bowel disease.
Maltese: Il-biċċa l-kbira tal-każijiet seħħew f'irġiel adolexxenti u adulti żgħażagħ li kważi kollha kienu fuq kura fl-istess ħin b'azathioprine (AZA) jew 6-mercaptopurine (6-MP) għallmarda infjammatorja tal-musrana.
English: In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Maltese: Fi prova klinika esploratorja biex jiġi evalwat l-użu ta' sustanza oħra kontra t-TNF, infliximab, f'pazjenti b'mard ostruttiv kroniku tal-pulmun (COPD) minn moderat sa sever, kien hemm aktar tumuri malinni, l-aktar fil-pulmun jew fir-ras u l-għonq, irrappurtati f'pazjenti ikkurati b'infliximab meta mqabbla ma' pazjenti ikkurati b'kontroll.