FrancophonIA/ELRC3.0 huggingface dataset:
English: PsA study II
Maltese: Studju PsA II
English: Table 27 Time to treatment failure in studies UV I and UV II
Maltese: Tabella 27 Żmien għall-falliment tat-trattament fi studji
English: Adalimumab N=51
Maltese: Plaċebo N=49 Adalimumab N=51
English: Paediatric plaque psoriasis
Maltese: Psorjazi tal-plakka pedjatrika
English: Kromeya 40 mg/0.8 mL solution for injection (injection) for paediatric use is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Maltese: Kromeya 40 mg soluzzjoni għall-injezzjoni (injezzjoni) f'pinna mimlija għal-lest hija fornuta bħala soluzzjoni sterili ta' 40 mg adalimumab imdewba f'soluzzjoni ta' 0.8 ml.
English: Adverse reaction flushing, haematoma
Maltese: Pressjoni għolja b'mod anormali, fwawar, ematoma
English: ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Maltese: < 40 kg • 40 mg f'ġimgħa 0 and 20 mg f'ġimgħa 2
English: In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
Maltese: F'reġistru ta' koorti prospettiv, ġew irreklutati 257 mara b'artrite rewmatojde (RA, rheumatoid arthritis) jew bil-marda ta' Crohn (CD, Crohn's disease) ikkurati b'adalimumab għallinqas matul lewwel trimestru u 120 mara b'RA jew CD mhux ikkurati b'adalimumab.
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Maltese: Fil-każi fejn hemm iżjed informazzjoni pprovduta f'partijiet oħra f'sezzjonijiet 4.3, 4.4 u 4.8, tidher asterisk (*) fil-kolonna tas-Sistema tal-Klassifika tal-Organi.
English: ▪ the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Maltese: ▪ kura ta' artrite rewmatika attiva minn moderata sa severa f'pazjenti adulti, meta r-rispons tagħhom għal mediċini anti-rewmatiċi li jaffetwaw il-proċess tal-mard, inkluż methotrexate, ma kienx adegwat.
English: Polyarticular juvenile idiopathic arthritis Age or body weight
Maltese: Artrite idjopatika ġovanili poliartikolari Età jew piż tal-ġisem Kemm tieħu u kemm ta'
English: Amongst those who responded at week 16 (n=144), the Pediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Maltese: Fost dawk li rrispondu f'ġimgħa 16 (n=144), ir-rispons pedjatriku ACR 30/50/70/90 kien miżmum sa sitt snin fil-fażi
English: Phase
Maltese: TIKKETTAR
English: The safety and efficacy of adalimumab was assessed in an open-label, multicenter study in 32 children (2 - < 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati fi studju tat-tip multiċentriku u “open-label” fi 32 tfal (2 - < 4 snin jew li għandhom min 4 snin il-fuq u li jiżnu < 15 kg) li għandhom artrite poliartikulari
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more
Maltese: Tfal u adolexxenti minn 4 snin sa 17-il sena ta' età u li jiżnu 30 kg jew aktar
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTXtreated.
Maltese: Fil-fażi tal-bidu open-label (OL LI) il-pazjenti kienu imqassma f'żewgt gruppi, dawk ikkurati b'MTX (methotrexate) u dawk li mhux trattati b'MTX (non-MTX).
English: Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Maltese: Minn dawn, 40 pazjent ma wrew l-ebda progress ta' ħsara strutturali definita mill-linja bażi fl-mTSS li kienet ta' 0.5 jew inqas.
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis study III).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati wkoll f'pazjenti adulti li jbatu minn Psorijasi kronika li tikkawża qoxra mhux normali fuq ilġilda u psorijasi fl-idejn u/jew fis-saqajn fl-istess ħin li kienu kandidati għat-terapija sistemika flistudju double-blind magħżula b'ordni addoċċ (Studju tal-Psorijasi III).
English: Clinical Response
Maltese: Kliniku
English: Concurrent administration of biologic DMARDs or TNF-antagonists
Maltese: L-għoti flimkien ta' DMARDS bijoloġiċi jew ta' antagonisti TNF
English: Needle cap Liquid-filled syringe Barrel (inside)
Maltese: Bidla perċentwal tattotal tad-dwiefer NAPSI (%)
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/mL (without concomitant methotrexate) and 8 to 9 µg/mL (with concomitant methotrexate), respectively.
Maltese: Wara t-teħid ta' adalimumab 40 mg taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti adulti li jbatu minn artrite rewmatika (AR), il-konċentrazzjoni minimali medja fissa kienet ta' bejn wieħed u ieħor 5 g/ml (mingħajr t-teħid konkomitanti ta' methotrexate) u minn 8 sa 9 g/mL (bit-teħid konkomitanti ta'methotrexate), rispettivament.
English: Blood and lymphatic system disorders*
Maltese: Disturbi tad-demm u tassistema limfatika*
English: All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001 ** p < 0.01
Maltese: Il-valuri-p kollha huma paraguni magħmula għal kull par ta' proporzjonijiet għal adalimumab kontra l-plaċebo p < 0.001 p < 0.01
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level.
Maltese: Informazzjoni limitata mil-litteratura ppubblikata tindika li adalimumab joħroġ mal-ħalib tas-sider talbniedem f'konċentrazzjonijiet baxxi ħafna bil-preżenza ta' adalimumab fil-ħalib tal-bniedem f'konċentrazzjonijiet ta' 0.1% sa 1% tal-livell tas-serum maternali.
English: Table 13 Efficacy responses in placebo-controlled AS Study - Study I reduction of signs and symptoms
Maltese: Tabella 13 Risponsi tal-effikaċja fi Studju AS bil-Plaċebo bħala kontroll - Studju I Tnaqqis f'sinjali u sintomi
English: NE
Maltese: JIS
English: Each pack contains 2 or 6 pre-filled pens with 2 or 6 alcohol pads.
Maltese: Kull pakkett fih 2 jew 6 pinen mimlijin għal-lest bi 2 jew 6 kuxxinetti tal-alkoħol.
English: For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 were 15.3±11.4 μg/mL (40/20 mg, weekly) and 6.7±3.5 μg/mL (20/10 mg, weekly).
Maltese: 3±11.4 μg/mL (40/20 mg, kull ġimgħa) u 6.7±3.5 μg/mL (20/10 mg, kull ġimgħa).
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double−blind, placebo−controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Maltese: It-teħid ta' 40 mg adalimumab ġimgħa iva u ġimgħa le kien stimat fi 393 pazjent f'żewġ studji doubleblind, kontrollati bil-plaċebo li ħadu 24 ġimgħa u li saru b'ordni addoċċ fuq pazjenti li jbatu minn infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) (il-punt medju tal-linja bażi ta' l-attività tal-mard [l-Indiċi ta' l-Attività tal-Mard Ankylosing Spondylitis (BASDAI)] kien 6.3 fil-gruppi kollha) li ma kellhomx rispons adegwata għat-terapija konvenzjonali.
English: Discontinued corticosteroids
Maltese: Twaqqif tal-kortikosterojdi
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Maltese: Ir-rati rrappurtati ta' kanċer tal-ġilda li m'humiex melanoma u limfomi, huma ta' bejn wieħed u ieħor 0.2 u 0.3 kull 1,000 sena ta' trattament ta' pazjenti, rispettivament (ara sezzjoni 4.4).
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage 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: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab- treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Maltese: Minn dawn il-kanċer tal-ġilda, kien hemm l-okkorrenza ta' karċinoma biċċelluli tat-tip squamous b'rati (95% intervall ta' konfidenza) ta' 2.7 (1.4, 5.4) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 0.6 (0.1, 4.5) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Maltese: HR ta' adalimumab vs plaċebo minn rigressjoni ta' perikli li huma proporzjonali mat-trattament bħala fattur.
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Maltese: Tnaqqis statistikament sinifikanti fl-għejja, kif inhi mkejla mill-istima funzjonali tatterapija tal-mard kroniku (FACIT) kien osservat fit-tliet studji li fihom saret l-istima (Studji RA I, III u IV).
English: Adverse reaction skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster),
Maltese: • lupus erythematosus sistemiku (disturb immuni li jinkludi infjammazzjoni tal ġilda, tal qalb, tal pulmun, tal ġogi u ta' sistemi ta' organi oħra);
English: Kromeya contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Maltese: Kromeya fih is-sustanza attiva adalimumab, mediċina li taġixxi fuq is-sistema immuni (difiża) ta‘ ġismek.
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Maltese: Fi studju li sar fuq 226 suġġetti adulti li jbatu minn artrite rewmatika u li kienu kkurati b'adalimumab jew bil-plaċebo, ġew osservati risponsi simili ta'anti-korpi għat-tilqima b'vaċċin stàndard 23-valent ta' newmokokku u t-tilqima tal-virus trivalenti ta' l-influwenza.
English: Percent of patients achieving PASI75 response was calculated as centeradjusted rate b p<0.001, adalimumab vs. placebo
Maltese: Perċentaġġ ta' pazjenti li kisbu rispons ta' PASI75 ġie kkalkulat bħala rrata aġġustata fiċ-ċentru b p<0.001, adalimumab vs. placebo
English: Figure 3: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Maltese: Figura 3: Kurvi ta' Kaplan-Meier li jiġbru fil-qosor iż-żmien għall-falliment fl-istudju pedjatriku tal-uveite
English: Low dose
Maltese: Viżjoni doppja
English: Kromeya is recommended for use in combination with methotrexate.
Maltese: Kromeya hu rakkomandat għall-użu f'kombinazzjoni ma' methotrexate.
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Maltese: Huwa importanti li inti tgħid lit-tabib tiegħek jekk għandek sintomi ta' infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas-snien (ara Twissijiet u prekawzjonijiet).
English: Step 3 Check the Pre-filled Pen
Maltese: Tagħmlux fil-friża.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffetwaw sa persuna 1 f'100)
English: pen containing a pre-filled syringe (type I glass) with a 29G Thin-Wall, ½ inch needle with latex-free needle cap and a plunger stopper (synthetic rubber).
Maltese: li fiha siringa mimlija għal-lest (ħġieġ ta' tip I) b'wiċċ 29G irqieq, labra tan-nofs pulzier u b'tapp tal-labra li huwa ħieles mill-latex, tapp tal-planġer (lastiku sintetiku).
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomized design.
Maltese: Linterpretazzjoni tad-data jista' jkollha impatt minħabba limitazzjonijiet metodoloġiċi tal-istudju, inkluż daqs tal-kampjun żgħir u disinn mhux randomizzat.
English: Table 22 Time to treatment failure in studies UV I and UV II
Maltese: Tabella 22 Żmien għall-falliment tat-trattament fi studji
English: One 0.8 mL pre-filled pen contains 40 mg adalimumab
Maltese: Kunjett wieħed ta' 0.8 ml li fih 40 mg adalimumab.
English: /MTX (N = 38)
Maltese: Adalimumab (N = 38)
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Maltese: Id-dejta disponibbli tissuġġerixxi li r-rispons kliniku huwa normalment milħuq fi żmien 12-il ġimgħa ta' trattament.
English: Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott mediċinali.
English: Concomitant administration of adalimumab with other biologic DMARDs (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Maltese: L-għoti flimkien ta' adalimumab ma' DMARDs bijoloġiċi oħra (e.ż. anakinra u abatacept) jew antagonisti ta' TNF oħra, mhux rakkomandat fuq bażi ta' żieda possibli fir-riskju ta' infezzjonijiet, inkluż infezzjonijiet serji u interazzjonijiet oħra ta' potenzjal farmakoloġiku.
English: Adalimumab was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Maltese: Adalimumab ġie studjat f'9,506 pazjent fi provi pivitali kontrollati u open-label li damu sejrin sa 60 xahar jew aktar.
English: Adalimumab, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Maltese: It-teħid ta' 40 mg adalimumab ġimgħa iva u ġimgħa le ġie studjat f'pazjenti li jbatu minn artrite psorjatika attiva minn moderata sa severa f'żewġ studji kontrollati bil-plaċebo, Studji PsA I u II.
English: Week 52 Fistula remission3
Maltese: Stadju 3 Ħejji s-Siriga
English: • There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Maltese: • Kien hemm każijiet ta' tipi ta' kanċer oħra, minbarra limfoma, f'pazjenti li jbatu minn marda speċifika tal-pulmun, li tissejjaħ mard kroniku ostruutiv tal-pulmun (COPD, chronic obstructive pulmonary disease), u li jirċievu l-kura b'mediċina oħra li timblokka t-TNFα.
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use
Maltese: Kromeya 40 mg/0.8mL soluzzjoni għall-injezzjoni għal użu pedjatriku
English: Adalimumab treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
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 t-Tabella 24).
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis,
Maltese: F'pazjenti li kienu diġa esposti għat-tuberkulożi u pazjenti li vvjaġġaw f'żoni ta' riskju għoli ta' tuberkulożi jew mikożji endemiċi bħal histoplasmosis, coccidioidomycosis, jew blastomycosis, ir-riskji u l-benefiċċji tat terapija bi Kromeya għandhom jiġu kkunsidrati qabel ma tinbeda l-kura (ara Infezzjonijietopportunistiċi oħra).
English: Myocardial infarction arrhythmia, congestive heart failure
Maltese: Infart mijokardiku tħabbit irregolari tal-qalb, insuffiċjenza tal-qalb konġestiva
English: Week 12 Week 24 BASDAI
Maltese: Ġimgħa 12 Ġimgħa 24
English: One 0.8 mL pre-filled syringe contains 40 mg adalimumab
Maltese: Siringa waħda ta' 0.8 ml mimlija għal-lest fiha 40 mg adalimumab.
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
Maltese: Fi studju UC-II, min dawk il-pazjenti ttrattati b' adalimumab u li kellhom titjib kliniku f'ġimgħa 8, 21/41 (51%) kellhom ukoll titjib kliniku f'ġimgħa 52.
English: Headache
Maltese: Għatu
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Maltese: Rigward it-teħid flimkien ta' ma' mediċini antirewmatiċi li jaffetwaw il-proċess tal-mard, minbarra methotrexate, ara sezzjoni 4.4 u 5
English: Your doctor will decide if your child should receive Kromeya.
Maltese: It-tabib jista' jirrakkomandalhom li jwaqqfu Kromeya.
English: N
Maltese: U
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9% for patients taking adalimumab and 5.4% for control treated patients.
Maltese: Il-proporzjon ta' pazjenti li waqt il-porzjoni kontrollata double-blind fl-istudji pivitali ma baqgħux jieħdu l-kura minħabba effetti avversi kien ta' 5.9% għall-pazjenti li kienu qegħdin jieħdu adalimumab u 5.4% għal pazjenti kkurati b'mod kontrollat.
English: The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Maltese: L-aktar reazzjonijiet avversi li gew irrapurtati b'mod komuni huma infezzjonijiet (bħal nasofarinġite, infezzjonijiet fin-naħa ta' fuq tas-sistema respiratorja u sinożite), reazzjonijiet fil-post ta' l-injezzjoni (eritema, ħakk, emorraġija, uġigħ jew nefħa), uġigħ ta' ras u uġigħ muskolu-skeletriku.
English: The patients improved following discontinuation of therapy.
Maltese: Il-pazjenti marru għall-aħjar meta twaqqfet it-terapija.
English: Figure 1: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Maltese: Figura 1: Kurvi ta' Kaplan-Meier li jiġbru fil-qosor iż-żmien għall-falliment fl-istudju pedjatriku tal-uveite
English: In Psoriasis study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5% continuing on adalimumab, p<0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Maltese: Fi Studju Psorajisi I, 28% tal-pazjenti li kienu rrispondew għal PASI 75 u reġgħu ġew magħżula b'ordni addoċċ għall-plaċebo f'ġimgħa 33 meta mqabbla ma' 5% li komplew jirċievu adalimumab, p <0.
English: Chest pain, oedema, pyrexia
Maltese: Uġigħ fis-sider, edima, deni
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti−rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Maltese: 1%) pazjent ġew ikkurati flimkien ma' mediċini anti-rewmatiċi li li jaffetwaw ilproċess tal-marda, u 37 (9.4%) pazjent flimkien ma' glukokortikojdi.
English: Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Maltese: M'hawnx informazzjoni adegwata minn trattament ta' pazjenti li jġorru l-HBV permezz ta' terapija anti-virali flimkien ma' terapija b'antagonist ta' TNF biex tiġi evitata r-riattivazzjoni ta' l-HBV.
English: Children, adolescents and adults from 2 years of age weighing 30 kg or more
Maltese: Tfal, adolexxenti u adulti minn età ta' sentejn 'il fuq u li jiżnu 30 kg jew aktar
English: Kromeya 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 and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Maltese: Kromeya huwa ndikat għall-kura tal-marda Crohn (Crohn's diease) attiva minn moderata sa severa fit-tfal (minn 6 snin il-fuq) li ma kellhomx rispons kif mistenni għall-kura konvenzjonali inkluż terapija ta' nutrizzjoni primarja u kortikosterojde u /jew immunomodulatur, jew ma jittollerawx jew għandhom kontraindikazzjonijiet għal dawn it-terapiji.
English: Kromeya contains sodium
Maltese: Dehra ta' Kromeya u l-kontenuti tal-pakkett
English: Table 20: Paediatric plaque psoriasis efficacy results at 16 weeks MTX
Maltese: Tabella 6 Effetti mhux mixtieqa
English: Step 1 Prepare for your injection
Maltese: Stadju 1 Ħejji għall-injezzjoni tiegħekPrepare for your injection
English: In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dl) values) improved at 24 or 26 weeks compared to placebo.
Maltese: Fl-istudji RA minn I-IV, il-komponenti kollha tal-kriterji tar-rispons għall-ACR (numru ta' ġogi bluġigħ u minfuħa, l-istima ta' l-attività tal-mard u ta' l-uġigħ magħmula mit-tabib u mill-pazjent, ilpunti ta' l-indiċi ta' diżabilità (HAQ) u valuri tas-CRP (mg/dl)) marru għall-aħjar fir-24 u fis-26 ġimgħa meta pparagunati mal-plaċebo.
English: 6.2 With a quick, short motion, push the needle into the skin at an angle of 45°.
Maltese: 6.2 B'moviment qasir, u ta' malajr, imbotta l-labra kollha 'l isfel ġol-ġilda f'angolu ta' 45°.
English: Kromeya is used to treat:
Maltese: Jekk it-tifel jew tifla tiegħek tieqaf tuża Kromeya:
English: 4.3 Pull the needle packaging off.
Maltese: 4.3 Neħħi l-ippakkjar tal-labra minnha.
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p< 0.001) in the adalimumab group (at week 48).
Maltese: Adalimumab ittardja b'mod sinifikanti l-ħin għall-falliment tat-trattament, meta mqabbel mal-plaċebo (Ara Figura 1, P <0.0001 mit-test ta' log rank).
English: Table 19 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission
Maltese: Tabella 19 Studju ta' CD fit-Tfal Twaqqif tal-kortikosterojdi jew immunomodulaturi u fejqan tal-fistla Doża standard 40/20 mg eow
English: joints and other organ systems);
Maltese: tal-pulmun, tal-ġogi u ta' sistemi ta' organi oħra);
English: If your doctor considers that methotrexate is inappropriate, Kromeya can be given alone.
Maltese: Jekk it-tabib tiegħek jiddeċiedi li methotrexate m'huwiex adattat, Kromeya jista' jingħata waħdu.