FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the administration of 24 mg/m2 (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: Wara l-għoti ta' 24 mg/m² (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lil pazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, il-livell minimu medju fl-istat fiss ta' konċentrazzjoni ta' adalimumab fis-serum (valuri mkejla f'ġimgħa 24) kien 8.8 ±6.6 µg/mL meta adalimumab ma kienx użat flimkien ma' methotrexate u 11.8 ±4.3 µg/mL meta adalimumab kien użat flimkien ma' methotrexate
English: In the pivotal controlled trials in adults and children, 12.9% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
Maltese: Fil-provi pivitali kontrollati li saru fl-adulti u fit-tfal, 12.9% tal-pazjenti kkurati b'adalimumab żviluppaw reazzjonijiet fis-sit tal-injezzjoni (eritema u/jew ħakk, emorraġija, uġigħ jew nefħa), ipparagunati ma' 7.2% tal-pazjenti li kienu qegħdin jirċievu plaċebo jew sustanza attiva użata bħala kontroll.
English: However, the occurrence was rare.
Maltese: Dan huwa normali.
English: Improved physical function continued during the open label extension up to week 136.
Maltese: It-titjib fil-funzjoni fiżika kompla matul l-estensjoni open-label sa ġimgħa 136.
English: In controlled Phase 3 trials of adalimumab in patients with plaque psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of adalimumabtreated patients and 1.8% of control-treated patients.
Maltese: Fil-provi kkontrollati ta' Fażi 3 ta' adalimumab f'pazjenti bi Psorijasi tal-plakka b'perjodu ta' kontroll b'tul li jvarja minn 12 sa 24 ġimgħa, żidiet fil-livelli tal-ALT ≥3 × ULN seħħew f'1.8% tal-pazjenti kkurati b'adalimumab u 1.8% tal-pazjenti kkurati bil-kontroll.
English: • fatty liver (build-up of fat in liver cells);
Maltese: • ħakk, infjammazzjoni tal-ġilda (li tinkludi ekżema);
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Maltese: Seħħet attivazzjoni mill-ġdid ta' epatite B f'pazjenti li kienu qed jirċievu xi antagonist ta' TNF, inkluż adalimumab, u li kienu jġorru dan il-virus b'mod kroniku (jigifieri pozittivi għall-antiġen tal-wiċċ).
English: Table 11: Distribution of patients by age and adalimumab dose received during the OL LI
Maltese: Tabella 11: Tqassim tal-pazjenti skont l-età u d-doża ta' adalimumab li ngħataw waqt il-fażi OL-LI
English: Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9% (15 of 19 subjects) and PGA clear or minimal of 52.6% (10 of 19 subjects).
Maltese: PASI 75 rispons ta' 78.9% (15 minn 19-il individwu) u PGA xejn jew minimali ta' 52.6% (10 minn 19-il individwu).
English: Step 13 - Squeeze injection site
Maltese: Pass 13 - Oqros is-sit tal-injezzjoni
English: Asthma, dyspnoea, cough
Maltese: Indeboliment tal-kliewi, ematurja
English: The combination of Hulio and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Maltese: L-oftalmologi huma avżati jikkonsultaw ma' speċjalista xieraq qabel ma jinbeda t-trattament b'Hulio (ara sezzjoni 4.4).
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Maltese: Fost it-68 pazjent li marru għall-agħar fil-grupp allokat għall-irtirar tat-trattament, 65 lestew 12-il ġimgħa ta' terapija ta' salvataġġ b'adalimumab, li minnhom 37 (56.9%) reġgħu marru għall-aħjar (ASDAS <1.3) wara 12-il ġimgħa li reġgħu bdew it-trattament open-label.
English: • lichenoid skin reaction (itchy reddish-purple skin rash).
Maltese: • reazzjoni tal-lichenoid tal-ġilda (raxx tal-ġilda ħamrani-vjola bil-ħakk).
English: week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table 14).
Maltese: Ir-riżultati ta' ġimgħa 12 urew titjib statistikament sinifikanti tas-sinjali u s-sintomi ta' nr-axSpA attiva f'pazjenti kkurati b'adalimumab meta mqabbla mal-plaċebo (Tabella 14).
English: At week 16, more patients randomised to adalimumab 0.8 mg/kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg/kg eow or MTX.
Maltese: F'ġimgħa 16, aktar pazjenti magħżula b'mod każwali li ngħataw adalimumab 0.8 mg/kg kellhom risponsi pożittivi taleffikaċja (eż, PASI 75) milli dawk magħżula b'mod każwali għal 0.4 mg/kg ġimgħa iva u ġimgħa le jew MTX.
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I − V. In these trials, 11.9% of patients treated with adalimumab and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Maltese: F'dawn il-provi, 11.9% tal-pazjenti kkurati b'adalimumab u 8.1% tal-pazjenti kkurati bil-plaċebo u bis-sustanza attiva użata bħala kontroll, li bdew b'titri ta' antikorpi antinukleari fil-linja bażi negattivi, irrappurtaw titri pożittivi f'ġimgħa 24.
English: Step 8 - Pull plunger to draw dose + 0.1 ml Keep the plunger rod pressed down and turn the connected syringe and vial upside down.
Maltese: Pass 8 - Iġbed il-planġer biex tiġbed doża + 0.1 mL
English: Τηλ.
Maltese: Hulio.
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 rrispondew f'ġimgħa 16 (n=144), ir-risponsi Pedjatriċi ACR 30/50/70/90 inżammu sa sitt snin fil-fażi
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
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 Minn dawk li jirċievu l-kortikosterjdi fil-linja bażi
English: Score
Maltese: TIKKETTAR
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-kanċers tal-ġilda, kien hemm l-okkorrenza ta' karċinoma taċ-ċelluli tat-tip squamous b'rati (95% intervall ta' kunfidenza) 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 1000 sena ta' pazjent fost pazjenti mogħtija kura bis-sustanza ta' kontroll..
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at week 68 was 8.0 ± 4.6 µg/ml.
Maltese: Wara l-għoti ta' 40 mg ta' adalimumab ġimgħa iva u ġimgħa le f'pazjenti adulti bi spondyloarthritis axjali mhux radjografika, il-medja (± SD) tal-konċentrazzjoni fil-livell minimu fl-istat fiss f'ġimgħa 68 kienet ta' 8.0 ±4.6 g/mL.
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Maltese: Data disponibbli tindika li r-rispons kliniku normalment jintlaħaq fi żmien 12-il ġimgħa ta' kura.
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 sinusite), reazzjonijiet fil-post ta' l-injezzjoni (eritema, ħakk, emorraġija, uġigħ jew nefħa), uġigħ ta' ras u uġigħ muskolu-skeletrali.
English: Total Sharp Score
Maltese: Rispons għall-ACR
English: V.J.
Maltese: TAT-TREJ
English: Hulio contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Maltese: Hulio fih is-sustanza attiva adalimumab, mediċina li taġixxi fuq is-sistema immuni (ta' difiża) talġisem tiegħek.
English: Hulio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Maltese: Hulio huwa ndikat għall-kura ta' artrite psorijatika attiva u progressiva f'adulti meta r-rispons tagħhom għal terapija preċedenti b'mediċini antirewmatiċi li jaffettwaw il-proċess tal-mard ma jkunx adegwat.
English: Ankylosing spondylitis (AS)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Maltese: F'ġimgħa 4, il-pazjenti kienu magħżula b'mod każwali 1:1 jew għallgrupp ta' trattament ta' manteniment tad-Doża Standard (40/20 mg ġimgħa iva u ġimgħa le) jew għallgrupp tad-Doża Baxxa (20/10 mg ġimgħa iva u ġimgħa le) abbażi tal-piż tal-ġisem tagħhom.
English: In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Maltese: Fil-prova ta' Fażi 3 ta' adalimumab fit-tfal bil-marda ta' Crohn (Crohn's disease) li evalwat l-effikaċja u s-sigurtà f'żewġ korsijiet ta' dożaġġ ta' manteniment irranġati skont il-piż tal-ġisem wara terapija tal-bidu li wkoll kienet irranġata skont il-piż tal-ġisem sa 52 ġimgħa ta' trattament, kien hemm żidiet fil-livelli tal-ALT ta' ≥3 × ULN f'2.6% (5/192) tal-pazjenti li minnhom 4 kienu qed jirċievu immunosuppressanti konkomitanti fil-linja bażi.
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 tat-Trattament fl-Istudju Pedjatriku tal-Uveite
English: Of those in clinical response at week 4, 48% had been previously exposed to other TNF-antagonists.
Maltese: Minn dawk li kellhom rispons kliniku f'ġimgħa 4, 48% kienu ġew esposti għal kura oħra ta' antagonisti tat-TNF fil-passat.
English: c Ankylosing Spondylitis Disease Activity Score d Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Maltese: c Punteġġ tal-Attività tal-Marda Ankylosing Spondylitis d Flare Parzjali huwa ddefinit bhala ASDAS ≥1.3 izda <2.1 f'2 żjarat konsekuttivi. ***, ** Statistikament sinifikanti f'p<0.001 u <0.01, rispettivament, għall-paraguni kollha bejn adalimumab u plaċebo.
English: p-valuea pvalueb pvaluec
Maltese: Eċċipjenti b'effett magħruf
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Maltese: Tendenzi simili (mhux kollha statistikament sinifikanti) ġew osservati fl-iżgħar studju AS II doubleblind u kkontrollat bil-plaċebo li fih l-individwi ntgħażlu b'mod każwali ta' 82 pazjent adult li jbatu b'infjammazzjoni attiva tal-vertebri li tirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis).
English: Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Maltese: Minn dawn, 48 pazjent ma wrew l-ebda progress ta' ħsara strutturali definita mill-bidla mil-linja bażi fl-mTSS li kienet ta' 0.5 jew inqas.
English: No patients developed lupus nephritis or central nervous system symptoms.
Maltese: L-ebda pazjenti ma żviluppaw injamazzjoni filkliewi tat-tip lupus jew sintomi tas-sistema nervuża ċentrali.
English: Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Maltese: Il-pazjenti minn studji UC-I u UC-II kellhom l-għażla li jkomplu fi studju ta' estensjoni open-label fuq żmien twil (UC-III).
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Maltese: Żewġ pazjenti minn 3,441 li kienu kkurati b'adalimumab fl-istudji kollha tal-artrite rewmatika u artrite psorijatika żviluppaw sinjali kliniċi li jindikaw bidu ta' sindrome li jixbah lis-sindromu tal-lupus.
English: • symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
Maltese: • sintomi ta' problemi fin-nervituri bħal tingiż, tnemmin, tara doppju jew dgħufija fid-dirgħajn jew fir-riġlejn;
English: • There have been cases of cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Maltese: • Ġew irrappurtati każijiet ta' tipi ta' kanċer oħra, minbarra limfoma, f'pazjenti li jbatu minn marda speċifika tal-pulmun, li tissejjaħ marda kronika assoċjata ma' imblukkar fis-sistema respiratorja (COPD, Chronic Obstructive Pulmonary Disease), u li jirċievu l-kura b'mediċina oħra li timblokka t-TNFα.
English: Among those, 64 patients (79.0%) had ACR 20 responses;
Maltese: 4%) kellhom rispons għall-ACR 20;
English: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during adalimumab trials in paediatric patients with Crohn's disease.
Maltese: Barra minn hekk, ma ġewx osservati l-ebda tumuri malinni f'192 pazjent pedjatriku b'espożizzjoni ta' 498.1 sena ta' pazjent waqt provi b'adalimumab f'pazjenti pedjatriċi bil-marda ta' Crohn (Crohn's disease).
English: • 1 pre-filled syringe (with 2 alcohol pads)
Maltese: • 1 pinna mimlija għal-lest (b'2 tajjariet bl-alkoħol)
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, minn 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: Liver failure1)
Maltese: Insuffiċjenza tal-fwied1)
English: Crohn's disease in adults and children
Maltese: Il-marda ta' Crohn (Crohn's disease) fl-adulti u fit-tfal
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hulio.
Maltese: Mediċini glukokortikojdi, saliċilati u mediċini antiinfjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt il-kura b'Hulio.
English: Ελλάδα BGP ΠΡΟΪΟΝΤΑ Μ.Ε.Π.Ε.
Maltese: Nisa li jistgħu joħorġu tqal
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 μ g/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 (RA), il-medja tal-konċentrazzjoni fil-livell minimu fl-istat fiss kienet ta' madwar 5 µg/mL (mingħajr it-teħid konkomitanti ta' methotrexate) u minn 8 sa 9 µg/mL (bit-teħid konkomitanti ta' methotrexate), rispettivament.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)*
Maltese: Neoplażmi beninni, malinni u mhux speċifikati (li jinkludu ċesti u polipi)*
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Maltese: Riżultati talIstħarriġ tas-Saħħa fil-Forma l-Qasira (SF-36) għad-dożi/skedi kollha ta' adalimumab fl-erba' studji jikkonfermaw dan, b'punteġġi li huma statistikament sinifikanti tas-sommarju dwar il-komponent fiżiku (PCS, physical component summary), kif ukoll puntieġġi li huma statistikament sinifikanti fiddominju tal-uġigħ u l-vitalità għad-doża ta' 40 mg ġimgħa iva u ġimgħa le.
English: In RA study III, where adalimumab treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score.
Maltese: Fi Studju RA III, fejn pazjenti kkurati b'adalimumab kienu ilhom ibatu mill-artrite rewmatika għal medja ta' 11-il sena, il-ħsara strutturali fil-ġogi kienet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (TSS, Total Sharp Score) u l-komponenti tiegħu, il-punteġġ relatat ma' erożjoni u l-punteġġ tat-tnaqqis fl-ispazju fil-ġogi.
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati f'pazjenti adulti li jbatu minn psorjasi tal-plakka kronika (≥10% involviment tal-BSA u l-Indiċi tal-Parti Milquta mill-Psorijasi u s-Severità tagħha (PASI, Psoriasis Area and Severity Index) ≥12 jew ≥10) li kienu kandidati għat-terapija sistemika jew għall-fototerapija fi studji double-blind fejn l-individwi ntgħażlu b'mod każwali. 73% tal-pazjenti rreġistrati fl-Istudji tal-Psorijasi I u II kienu diġa rċivew terapija sistemika jew fototerapija qabel.
English: CLINICAL PARTICULARS
Maltese: Titjib kliniku
English: In period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0 and 80 mg at week 2 and 40 mg every week starting at week 4 to week 11.
Maltese: F'perjodu A, il-pazjenti rċivew plaċebo jew adalimumab b'doża inizjali ta' 160 mg f'ġimgħa 0, 80 mg f'ġimgħa 2, u 40 mg kull ġimgħa li tibda f'ġimgħa 4 sa ġimgħa 11.
English: Discontinuation of Immunomodulators2
Maltese: Twaqqif tal-Immunomodulaturi2
English: 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine.
Maltese: Skala tal-Klassifikazzjoni Numerika 0-10; 0 = l-ebda uġigħ tal-ġilda, 10 = uġigħ ħafna tal-ġilda daqs kemm tista' timmaġina.
English: Hulio is used to treat psoriatic arthritis in adults.
Maltese: Hulio huwa intenzjonat għall-kura ta' artrite psorijatika fl-adulti.
English: Paraesthesias (including hypoesthesia), migraine, nerve root compression
Maltese: Parasteżija (inkluża ipoestesija), emigranja, tagħfis fuq l-għerq tan-nerv
English: Erectile dysfunction
Maltese: Anormalità erettili
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Maltese: Titjib fil-kwalità tal-ħajja relatata mas-saħħa u l-funzjoni fiżika nżamm matul l-estensjoni open-label sa ġimgħa 156.
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Maltese: Fost pazjenti li kellhom mill-inqas rispons parzjali f'ġimgħa 12, u li rċivew terapija kontinwa b'adalimumab kull ġimgħa, ir-rata ta' HiSCR f'ġimgħa 48 kienet 68.3% u f'ġimgħa 96 kienet 65.1%.
English: When combining controlled portions of these trials and ongoing and completed open label extension studies 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 nonmelanoma skin cancers is approximately 8.5 per 1,000 patient years.
Maltese: Meta wieħed jgħaqqad il-porzjonijiet ikkontrollati ta' dawn il-provi u l-istudji ta' estensjoni open-label 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 kanċers tal-ġilda li mhumiex melanoma, hija ta' bejn wieħed u ieħor 8.5 kull 1,000 sena ta' pazjent.
English: Disease flares at the end of 32 weeksa (n/N)
Maltese: Il-marda tmur għallagħar fl-aħħar ta' 32 ġimgħaa (n/N)
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.
Maltese: Ankylosing spondylitis u spondiloartrite assjali mingħajr evidenza radjografika ta' ankylosing spondylitis huma mard infjammatorju tal-ispina.
English: Lipids increased
Maltese: Punteġġ talerożjoni
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: Ilkombinazzjoni ta' Hulio u anakinra jew abatacept mhijiex irrakkomandata abbażi tar-riskju miżjud possibbli għal infezzjonijiet, li jinkludu infezzjonijiet serji u interazzjonijiet potenzjali farmakoloġiċi oħrajn.
English: • ≥ 40 kg: 40 mg every week or 80 mg every other week.
Maltese: ±6.1 µg/mL f'pazjenti <40 kg (80/40 mg).
English: Viewing Window Fill Marker
Maltese: Żieda fil lipidi
English: Corticosteroid taper was permitted after week 8.
Maltese: It-tnaqqis tal-kortikosterojd ftit ftit sakemm jitwaqqaf totalment kien permess wara ġimgħa 8.
English: Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta/kartuna wara
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Maltese: Adalimumab huwa anti-korp uman monoklonali rikombinanti, prodott fiċ-ċelluli ta' l-ovarji talħamster ċiniż.
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to  2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Maltese: [BASDAI] kienet ta' 7.0) li kellhom rispons inadegwat għal ≥2 NSAIDs, jew intolleranza għal jew kontraindikazzjoni għal NSAIDs irreġistrati fil-perjodu open-label ta' Studju nr-axSpA II li matulu rċivew adalimumab 40 mg ġimgħa iva u ġimgħa le għal 28 ġimgħa.
English: Table 9: Radiographic Mean Changes Over 12 Months in RA Study III
Maltese: Tabella 9: Tibdil Medju Radjografiku fuq perjodu ta' 12-il xahar fi Studju RA III
English: - If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
Maltese: - Jekk it-tifel/tifla tiegħek għandhom infezzjoni severa, inkluż tuberkulożi (ara “Twissijiet u prekawzjonijiet”).