FrancophonIA/ELRC3.0 huggingface dataset:
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Maltese: F'Ġimgħa 52, 42.9% tal-pazjenti li rċevew it-terapija kombinata ta' adalimumab/methotrexate laħqu titjib kliniku (DAS28 < 2.6) meta pparagunati ma' 20.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 13).
Maltese: Valutazzjonijiet tal-psorjasi tad-dwiefer jinkludu l-Indiċi Modifikata tas-Severità talPsorjasi tad-Dwiefer (mNAPSI), l-Evalwazzjoni Globali tat-Tobba tal-Psorjasi tad-dwiefer (PGA-F) u l-Indiċi tas-Severità tal-Psorjasi tad-Dwiefer (NAPSI) (ara Tabella 13).
English: Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, enthesitis-related arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and non-infectious uveitis affecting the back of the eye.
Maltese: Adalimumab jeħel ma' proteina speċifika (fattur tan-nekrosi tat-tumur jew TNFα), li tinsab f'livelli aktar għolja f'mard infjammatorju bħal artrite rewmatika, artrite relatata mal-entesite, infjammazzjoni tal-vertebri li twassal għal twaħħil tal-vertebri flimkien (ankylosing spondylitis), axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis, artrite psorjatika, psorjasi, hidradenitis suppurativa, il-marda ta' Crohn , kolite ulċerattiva u uveite mhux infettiva li taffettwa n-naħa ta' wara tal-għajn.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffetwaw sa persuna waħda minn kull 100):
English: Pancytopaenia
Maltese: Pożoloġija
English: Hypertension,
Maltese: Ipokalimja,
English: SOLYMBIC 40 mg syringe
Maltese: SOLYMBIC 40 mg siringa
English: Adalimumab 40 mg weekly
Maltese: Adalimumab 40 mg
English: If you are over 65 years you may be more susceptible to infections while taking SOLYMBIC.
Maltese: - Jekk għandek aktar minn 65 sena, jistgħu jaqbduk infezzjonijiet b'mod aktar faċli waqt li qed tieħu SOLYMBIC.
English: Vertigo and visual impairment may occur following administration of SOLYMBIC (see section 4.8).
Maltese: Jista jkun hemm vertigo u ndeboliment fil-vista wara li jingħata SOLYMBIC (ara sezzjoni 4.8).
English: SOLYMBIC 20 mg solution for injection in pre-filled syringe EU/1/16/1163/001 - 1 pack
Maltese: SOLYMBIC 20 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/16/1163/001 - pakkett wieħed
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see table 7).
Maltese: Fi Studju RA V, il-ħsara strutturali fil-ġogi ġiet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (ara tabella 7).
English: Table 21 Paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission
Maltese: Tabella 21 Studju ta' CD fit-Tfal Twaqqif tal-Kortikosterojdi jew Immunomodulaturi u Fejqan tal-Fistla
English: Table 4 ACR responses in placebo-controlled trials (percent of patients)
Maltese: Tabella 4 Risponsi għall-ACR fi Provi kontrollati bil-plaċebo (persentaġġ ta' pazjenti)
English: Adalimumab 40 mg every other week was assessed in 185 patients in one randomised, 12 week double-blind, placebo-controlled study in patients with active non-radiographic axial spondyloarthritis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Maltese: Dawn il-pazjenti għandhom axial spondyloarthritis attiva mhux radjografika (punteġġ medju mil-linja bażi tal-attività tal-marda [Indiċi tal-Attività tal-Mard Bath Ankylosing Spondylitis (BASDAI)] kien 6.4 għal pazjenti kkurati b'adalimumab u 6.5 għal dawk li qed jieħdu l-plaċebo) li ma kellhomx rispons adegwat jew ma kienux tolleranti għal ≥ 1 NSAIDs, jew NSAIDs huma kontraindikati.
English: Hypokalaemia, Uric acid increased, Blood sodium abnormal, Hypocalcaemia, Hyperglycaemia, Hypophosphataemia, Dehydration
Maltese: Żieda fl-aċidu uriku, Sodium fid-demm ikun anormali, Ipokalċimija,
English: SOLYMBIC 40 mg solution for injection in pre-filled syringe 0.8 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Maltese: SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 0.8 mL ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ tip I) b'tapp tal-bastun li jimbotta l-mediċina (bromobutyl rubber) u labra tal-azzar li ma jissaddadx b'għatu ta' protezzjoni tal-labra (thermoplastic elastomer).
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a
Maltese: * p < 0.001 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab kontra l-plaċebo ** p < 0.02 għall-paraguni magħmula bejn kull par ta' proporzjonijiet għal adalimumab kontra l-plaċebo a
English: SOLYMBIC 40 mg solution for injection in pre-filled syringe EU/1/16/1163/002 - 1 pack
Maltese: SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/16/1163/002 - pakkett wieħed
English: 6 SureClick pre-filled pens.
Maltese: 6 pinen mimlija għal-lest SureClick.
English: Table 17 Induction of clinical remission and response (percent of patients)
Maltese: Tabella 17 Qlib għall-Aħjar fl-Istat Kliniku u Rispons (Persentaġġ ta' Pazjenti)
English: SOLYMBIC 20 mg solution for injection in pre-filled syringe 0.4 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Maltese: SOLYMBIC 20 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 0.4 mL ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ tip I) b'tapp tal-bastun li jimbotta l-mediċina (bromobutyl rubber) u labra tal-azzar li ma jissaddadx b'għatu ta' protezzjoni tal-labra (thermoplastic elastomer).
English: EU/1/16/1163/009 - 6 pack
Maltese: EU/1/16/1163/009 - 6 pakketti
English: Muscle spasms (including blood creatine phosphokinase
Maltese: Uġigħ muskolu-skeletriku Spażmi fil-muskoli (li jinkludu żieda fil-livell talcreatine phosphokinase fid-demm)
English: A single SOLYMBIC pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Maltese: Pinna waħda mimlija għal-lest ta' SOLYMBIC tista' tkun maħżuna f'temperaturi sa massimu ta' 25°C għal-perjodu sa 14-il ġurnata.
English: Results from the overall UC-II study population are shown in table 22.
Maltese: Riżultati ġenerali li ħarġu mill-popolazzjoni tal-istudju UC-II huma preżentati f'tabella 22.
English: Cutaneous vasculitis
Maltese: Piż tal-pazjent
English: EU/1/16/1163/007 - 2 pack
Maltese: EU/1/16/1163/007 - 2 pakketti
English: EU/1/16/1163/005 - 6 pack
Maltese: EU/1/16/1163/005 - 6 pakketti
English: (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 µg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 µg/mL with concomitant methotrexate.
Maltese: (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lillpazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, il-konċentrazzjonijiet minimi u massimi medji fi stat fiss (valuri mkejla f'Ġimgħa 24) ta' adalimumab fis-serum kienu 8.8 ± 6.6 μg/mL għal adalimumab mingħajr użu ta' methotrexate fl-istess waqt u 11.8 ± 4.3 μg/mL flimkien ma' methotrexate
English: Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with SOLYMBIC.
Maltese: Mediċini glukokortikojdi, saliċilati u mediċini anti-infjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt it-trattament b'SOLYMBIC.
English: • gallbladder inflammation, gallbladder stones;
Maltese: • zokkor għoli fid-demm;
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of SOLYMBIC, and in accordance with local recommendations.
Maltese: Jekk ikun hemm dijanjosi ta' tuberkulosi rieqda, għandha tinbeda kura bi trattament profilattiku għal kontra t-tuberkulosi qabel ma jinbeda SOLYMBIC, u skont rakkomandazzjonijiet lokali.
English: SOLYMBIC 20 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 20 mg of adalimumab in 0.4 mL (50 mg/mL) solution.
Maltese: U KWANTITATTIVA SOLYMBIC 20 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest b'doża waħda fiha 20 mg ta' adalimumab f'0.4 mL (50 mg/mL) ta' soluzzjoni.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See table 23).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar-riskju tal-falliment tat-trattament f'pazjenti ttrattati b'adalimumab kontra pazjenti li ngħataw plaċebo (Ara Tabella 23).
English: Telecomlaan 5-7
Maltese: VFQ-25.
English: SOLYMBIC is used to treat rheumatoid arthritis in adults.
Maltese: SOLYMBIC jintuża biex jittratta artrite rewmatika fl-adulti.
English: SOLYMBIC 40 mg solution for injection in pre-filled pen EU/1/16/1163/006 - 1 pack
Maltese: SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/16/1163/006 - pakkett wieħed
English: The safety and efficacy of adalimumab in children aged 12-17 years have not yet been established for hidradenitis suppurativa.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab fit-tfal b'età ta' 12-17-il sena għadhom ma ġewx determinati għal hidradenitis suppurativa.
English: Placebo N = 94
Maltese: Plaċebo N=74
English: Total body weight (kg)
Maltese: Piż totali tal-ġisem (kg)
English: Syringe barrel
Maltese: Sindrome sikka
English: SOLYMBIC is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Maltese: SOLYMBIC huwa intenzjonat għat-trattament ta' ankylosing spondylitis u axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis fl-adulti.
English: System Organ Class Frequency Adverse Reaction Common
Maltese: Klassi tas-Sistemi u tal-Organi
English: EU/1/16/1163/004 - 4 pack
Maltese: EU/1/16/1163/004 - 4 pakketti
English: Some patients who experience decrease in their response may benefit from an increase in dosing frequency to 40 mg SOLYMBIC every week.
Maltese: Xi pazjenti li jesperjenzaw tnaqqis fir-rispons jistgħu jibbenifikaw minn żieda fil-frekwenza tad-doża sa 40 mg SOLYMBIC kull ġimgħa.
English: EU/1/16/1163/008 - 4 pack
Maltese: EU/1/16/1163/008 - 4 pakketti
English: ACR response
Maltese: ACR 50
English: EU/1/16/1163/003 - 2 pack
Maltese: EU/1/16/1163/003 - 2 pakketti
English: Angioedema
Maltese: Anafilassi
English: SOLYMBIC is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Maltese: SOLYMBIC huwa indikat għat-trattament tal-marda ta' Crohn attiva minn moderata sa severa fit-tfal (minn 6 snin il-fuq) li ma kellhomx rispons kif mistenni għal trattament konvenzjonali inkluż terapija ta' nutrizzjoni primarja, kortikosterojde, u immunomodulatur, jew ma jittollerawx jew għandhom kontraindikazzjonijiet għal dawn it-terapiji.
English: Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine
Maltese: Fost pazjenti b'linja bażi ta' evalwazzjoni fl-uġigħ fil-ġilda relatati ma' HS ≥ 3, ibbażat fuq Klassifikazzjoni ta' Skala Numerika 0 - 10; 0 = l-ebda uġigħ fil-ġilda, 10 = uġigħ kbir fil-ġilda daqs kemm tista' timmaġina.
English: Paediatric psoriasis dose
Maltese: Popolazzjoni pedjatrika
English: SOLYMBIC is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Maltese: SOLYMBIC huwa indikat għat-trattament ta' artrite attiva relatata mal-entesite f'pazjenti, ta' 6 snin jew akbar, li kellhom rispons inadegwat għal, jew li ma jitollerawx, terapija konvenzjonali (ara sezzjoni 5.1).
English: Figure 1: Kaplan-Meier curves summarising time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Maltese: Kaplan-Meier li Jiġbru fil-Qosor iż-Żmien għall-Falliment tat-Trattament fi jew wara Ġimgħa 6 (Studji UV I) jew Ġimgħa 2 (Studju UV II)
English: Vascular disorders
Maltese: Disfunzjoni erettili
English: In patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/mL at week 2 and week 4.
Maltese: F'pazjenti bi hidradenitis suppurativa, doża ta' 160 mg adalimumab f'Ġimgħa 0 segwit b'80 mg f'Ġimgħa 2 kisbu konċentrazzjonijiet baxxi t'adalimumab fis-serum ta' madwar 7-8 μg/mL f'Ġimgħa 2 u Ġimgħa 4.
English: Leucocytosis, Thrombocytopaenia Uncommon Idiopathic thrombocytopaenic purpura Rare
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata.
English: Before initiation of therapy with SOLYMBIC, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Maltese: Qabel jinbeda t-trattament b'SOLYMBIC, il-pazjenti kollha għandhom jiġu evalwati għall-infezzjoni tat-tuberkulosi kemm attiva kif ukoll mhux attiva (“rieqda”).
English: Uncommon Pancreatitis, Dysphagia,
Maltese: Emorraġija gastrointestinali, Dispepsja,
English: SOLYMBIC 40 mg solution for injection in pre-filled pen (SureClick) Solution for injection.
Maltese: SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest (SureClick) Soluzzjoni għall-injezzjoni.
English: Vascular arterial occlusion, Thrombophlebitis
Maltese: Tubu ċilindriku tas-siringa
English: LABEL PRE-FILLED PEN
Maltese: Żieda fil-lipidi
English: SOLYMBIC 40 mg solution for injection in pre-filled pen Each single dose pre-filled pen contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution.
Maltese: SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Kull pinna mimlija għal-lest b'doża waħda fiha 40 mg ta' adalimumab f'0.8 mL (50 mg/mL) ta' soluzzjoni.
English: SOLYMBIC can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Maltese: SOLYMBIC jista' ukoll jintuża għat-trattament tal-artrite rewmatika attiva u progressiva severa, mingħajr ma tkun ingħatat trattament b'methotrexate qabel.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Maltese: L-iskop primarju fi studji RA I, II u III u l-iskop sekondarju fi Studju RA IV kien il-persentaġġ ta' pazjenti li laħqu rispons għall-ACR 20 f'Ġimgħa 24 jew 26.
English: The recommended SOLYMBIC dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 mg injections in one day).
Maltese: Ir-reġimen tad-doża ta' SOLYMBIC rakamondata għal pazjenti adulti bi suppurativa hidradenitis (HS) hija 160 mg inizjalment f'Jum 1 (mogħtija bħala erba' injezzjonijiet ta' 40 mg f'ġurnata waħda jew bħala żewġ injezzjonijiet ta' 40 mg kuljum għal jumejn konsekuttivi), segwiti minn 80 mg żewġ ġimgħat wara f'Jum 15 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: GI haemorrhage, Dyspepsia,
Maltese: Ażżma, Dispneja, Sogħla
English: At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 15).
Maltese: F'Ġimgħa 12, proporzjon ogħla b'mod sinifikanti ta' pazjenti fi Studju HS-II esperjenzaw tnaqqis klinikament rilevanti fl-uġigħ fil-ġilda relatati ma' HS (ara tabella 15).
English: Use a new SOLYMBIC pre-filled pen.
Maltese: Żomm SOLYMBIC fil-pakett ta' barra sabiex tilqa' mid-dawl.
English: Inspect the SOLYMBIC pre-filled syringe.
Maltese: Fil-każijiet kollha uża siringa ġdida.
English: A 40 mg pen, and a 20 mg and 40 mg pre-filled syringes are available for patients to administer a full 20 mg or 40 mg dose.
Maltese: Pinna ta' 40 mg u siringi mimlija għal-lest ta' 20 mg u 40 mg huma disponibbli għal pazjenti biex tingħata doża sħiħa ta' 20 mg jew 40 mg.
English: Following the administration of 24 mg/m
Maltese: Wara l-ammistrazzjoni ta' 24 mg/m
English: SOLYMBIC is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Maltese: SOLYMBIC huwa indikat għat-trattament ta' adulti li jbatu minn axial spondyloarthritis mingħajr evidenza radjografika ta' AS imma b'sinjali oġġettivi għoljin ta' infjammazzjoni minn CRP u/jew MRI, li ma kellhomx rispons adegwat jew ma jittolerawx il-mediċini kontra l-infjammazzjoni li mhumiex sterojdi.
English: Table 23 Time to treatment failure in studies UV I and UV II
Maltese: Tabella 23 Żmien għall-falliment tat-trattament fi studji
English: Not applicable, SOLYMBIC is only available as 20 mg and 40 mg pre-filled syringe and 40 mg pre-filled pen.
Maltese: Mhux applikabbli, SOLYMBIC huwa disponibbli biss bħala siringa mimlija għal-lest ta' 20 mg u 40 mg u pinna mimlija għal-lest ta' 40 mg.
English: Inhibition of inflammation
Maltese: Infezzjonijiet u infestazzjonijiet*
English: SOLYMBIC is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Maltese: SOLYMBIC huwa indikat għat-trattament ta' psorjasi tat-tip li tikkawża qoxra mhux normali fuq ilġilda, li hi minn moderata sa severa, f'pazjenti adulti li li huma kandidati għal terapija sistemika.
English: SOLYMBIC can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: SOLYMBIC jista' jittieħed flimkien ma' methotrexate jew ċerti tipi ta' aġenti anti-rewmatiċi li jaffetwaw il-proċess tal-mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet taddeheb li jingħata b' injezzjoni), sterojdi jew medikazzjonijiet għall-uġigħ, li jinkludu mediċini antiinfjammatorji mhux sterojdi (NSAIDs).
English: Adalimumab b n = 113
Maltese: Adalimumabb n=113
English: Prior to launch of Solymbic in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Solymbic f'kull Stat Membru id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel dwar il-kontenut u d-disinn tal-programm edukattiv, inkluż mezzi ta' komunikazzjoni, modalitajiet ta' distribuzzjoni, u kull aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Two weeks later (day 29) continue with a dose of 40 mg every week.
Maltese: Ġimagħtejn wara (Jum 29) kompli ma' doża ta' 40 mg kull ġimgħa.
English: SOLYMBIC 40 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution.
Maltese: SOLYMBIC 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest b'doża waħda fiha 40 mg ta' adalimumab f'0.8 mL (50 mg/mL) ta' soluzzjoni.
English: Table 8 Efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms
Maltese: Tabella 8 Risponsi tal-Effikaċja fi Studju AS kontrollat bil-Plaċebo Effikaċja - Studju I Tnaqqis fis-Sinjali u s-Sintomi
English: In psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see tables 11 and 12).
Maltese: Fl-istudji tal-Psorjasi I u II, l-iskop primarju kien il-proporzjon ta' pazjenti li rnexxielhom jilħqu rispons tal-PASI ta' 75 mil-linja bażi f'Ġimgħa 16 (ara tabelli 11 u 12).
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with SOLYMBIC and is positive for antibodies against double-stranded DNA, further treatment with SOLYMBIC should not be given (see section 4.8).
Maltese: Jekk pazjent jiżviluppa sintomi li jindikaw sindromu li jixbaħ lis-sindromu tal-lupus wara li tkun ingħatat kura b'SOLYMBIC, u jkun pożittiv għall-anti-korpi kontra DNA li hi double stranded, m'għandhiex tingħata aktar kura b'SOLYMBIC (ara sezzjoni 4.8).
English: In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/mL during the induction period.
Maltese: F'pazjenti li għandhom kolite ulċerattiva, d-doża kbira ta' 160 mg adalimumab f'Ġimgħa 0 segwita b'80 mg adalimumab f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 12 µg/mL matul il-perjodu tal-bidu .
English: Very common Elevated liver enzymes Uncommon Cholecystitis and cholelithiasis, Hepatic steatosis, Bilirubin increased
Maltese: Żieda fl-enzimi tal-fwied Koleċistite u kolelitijasi, Stejatożi tal-fwied, Żieda fil-bilirubina Epatite
English: When combining controlled portions of these trials and ongoing and completed open-label extension studies of adalimumab, with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient-years.
Maltese: Meta wieħed jgħaqqad il-porzjonijiet kontrollati ta' dawn il-provi u l-istudji extension open-label ta' adalimumab li ġew kompluti u dawk li għadhom sejrin bħalissa ma' durazzjoni medja ta' bejn wieħed u ieħor 3.3 snin, li jinkludu 6,427 pazjent u aktar minn 26,439 sena ta' pazjent ta' terapija, ir-rata ta' tumuri malinni osservati, minbarra limfoma u kanċer tal-ġilda li m'humiex melanoma, hija ta' bejn wieħed u ieħor 8.5 kull 1,000 sena ta' pazjent.
English: Patients were randomised to receive either 24 mg/m body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Maltese: Il-pazjenti kienu magħżula b'mod każwali biex jirċievu 24 mg/m tal-erja tal-wiċċ tal-ġisem (BSA - body surface area) ta' adalimumab sa massimu ta' 40 mg, jew plaċebo ġimgħa iva u ġimgħa le għal 12-il ġimgħa.
English: Children with enthesitis-related arthritis
Maltese: Artrite relata mal-entesite
English: P Value b
Maltese: Valur-p b