FrancophonIA/ELRC3.0 huggingface dataset:
English: Randomised, double-blind treatment regimen week 18 to 34
Maltese: Trattament randomizzat, double-blind f'ġimgħa 18 sa 34
English: Study RA-II Methotrexate combination (24 weeks)
Maltese: Kombinat ma' Methotrexate (24 ġimgħat)
English: Rare sexual dysfunction
Maltese: Rari disfunzjoni sesswali
English: Table 9: ASDAS-MI and ASAS 40 responses in AS0006 (percent of patients)
Maltese: Tabella 9: Risponsi ta' ASDAS-MI u ASAS 40 f'AS0006 (perċentwal ta' pazjenti)
English: (p<0.05) ** Cimzia vs Placebo p< 0.001.
Maltese: (p<0.05) ** Cimzia vs Plaċebo p< 0.001.
English: The efficacy and safety of Cimzia was assessed in DMARD-naïve adult patients with active RA in a randomized, placebo-controlled, double-blind clinical trial (C-EARLY).
Maltese: L'effikaċja u s-sigurta` ta' Cimzia kienet mkejjla f' pazjenti adulti DMARD-naïve b'RA attiv f'prova klinika randomizzata, ikkontrollata mill-plaċebo, double-blind (C-EARLY).
English: Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis
Maltese: Artrite rewmatika, artrite tal-psorjasi, spondiloartrite axjali, psorjasi tal-plakka
English: Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Maltese: Cimzia huwa indikat għat-trattament ta' psorjasi tal-plakka minn moderata sa severa f'pazjenti adulti li huma kandidati għal terapija sistemika.
English: At Week 52, the percentage of patients achieving ASDAS inactive disease (ASDAS < 1.3) was 36.4 % for the Cimzia group compared to 11.8 % for the placebo group.
Maltese: F'Ġimgħa 52, il-perċentwal ta' pazjenti li kisbu ASDAS marda inattiva (ASDAS < 1.3) kien 36.4 % għall-grupp ta' Cimzia meta mqabbel ma' 11.8 % għall-grupp ta' plaċebo.
English: Sodium acetate Sodium chloride Water for injections
Maltese: Sodium acetate Sodium chloride Ilma għall-injezzjoni
English: Erosion Score
Maltese: Punti erosion
English: Table 10 Key efficacy outcomes in PsA001 clinical trial (percent of patients) Response
Maltese: Tabella 10 Riżultati important dwar l-effikaċja f' prova klinika PsA001 clinical trial (perċentwali tal-pazjenti)
English: Cimzia has not been studied specifically in a lupus population (see section 4.8).
Maltese: Cimzia ma ġiex studjat speċifikament f'pazjenti b' lupus (ara sezzjoni 4.8).
English: ACR20 Week 12 Week 24 ACR50 Week 12 Week 24
Maltese: ACR20 Ġimgħa 12 Ġimgħa 24 ACR50 Ġimgħa 12 Ġimgħa 24
English: • kidney problems (including nephritis)
Maltese: • problemi fil-kliewi (inkluż nefrite)
English: Table 8 Key efficacy outcomes in AS001 clinical trial (percent of patients)
Maltese: Tabella 8 Riżultati importanti rigward l-effikaċja f' prova klinika AS001 (perċentwali ta' pazjenti)
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB05
Maltese: Kategorija farmakoterapewtika: immunosoppressanti, inhibituri (TNFα) ta' tumor necrosis factor alpha,
English: Assessments on remission (DAS28(ESR) <2.6), Low Disease Activity (DAS28(ESR) ≤3.2) status, ACR50 and ACR 70 by visit demonstrated that Cimzia+MTX treatment led to faster and greater responses than PBO+MTX treatment.
Maltese: L-assessjar fuq ir-rimissjoni (DAS28(ESR) <2.6), stat flAttivita`tal-Marda Baxxa (DAS28(ESR) ≤3.2), ACR50 u ACR 70 mill-vista wera li t-trattament Cimzia+MTX wassal għal risponsi iktar malajr u akbarmit-trattament PBO+MTX.
English: 2 years.
Maltese: 2 u 4.
English: • inflammatory skin rash (erythema multiforme)
Maltese: • raxx u infjammazzjoni fil-ġilda(erythema multiforme)
English: Uncommo cardiomyopathies (including heart failure), ischaemic coronary artery disorders, arrhythmias (including atrial fibrillation), palpitations
Maltese: Mhux komuni kardjomajopatiji (inkluż insuffiċjenza tal-qalb), mard iskemiku tal-arterja koronarja, arritmiji inkluż fibrillazzjoni atrijali), palpitazzjonijiet
English: Mean baseline BSA was 25% and ranged from 10% to 96%.
Maltese: Il-medja ta' BSA fil-linja bażi kienet ta' 25% u kienet tvarja minn 10% sa 96%.
English: In the placebo+MTX group, 49.7% of patients experienced no radiographic progression (change in mTSS ≤0.5) at Week 52 compared to 70.3% in the Cimzia+MTX group (p<0.001).
Maltese: Fil-grupp plaċebo+MTX, 49.7% tal-pazjenti ma esperjenzaw ebda progressjoni radjografika (tibdil fil- mTSS ≤0.5) f' Ġimgħa 52 meta mqabbel ma' 70.3% fil-grupp Cimzia+MTX (p<0.001).
English: The frequency was increased both in patients treated with placebo (2.8% vs 0.4% in axSpA and RA populations, respectively) as well as in patients treated with Cimzia (4.7% vs 0.8% in axSpA and RA populations, respectively).
Maltese: Il-frekwenza kienet ogħla kemm f'pazjenti trattati b'plaċebo (2.8% vs 0.4% f' popolazzjoni axSpA u RA, rispettivament) kif ukoll f'pazjenti trattati b'Cimzia (4.7% vs 0.8% f'popolazzjoni axSpA u RA, rispettivament).
English: Rare nephropathy (including nephritis)
Maltese: Rari nefropatija (inkluż nefrite)
English: The infections consisted primarily of upper respiratory tract infections, urinary tract infections, and lower respiratory tract infections and herpes viral infections (see sections 4.3 and 4.4).
Maltese: L-infezzjonijiet jikkonsistu primarjament f' infezzjonijiet tal-parti ta' fuq ta' l-apparat respiratorju, infezzjonijiet f'apparat urinarju u infezzjonijiet tal-parti t' isfel ta' l-apparat respiratorju u infezzjonijiet virali b' herpes (ara sezzjonijiet 4.3 u 4.4).
English: The C-EARLY trial met its primary and key secondary endpoints.
Maltese: Il-prova C-EARLY wasal għal punti ta' l-aħħar primarji u sekondarji kruċjali tiegħu.
English: Inhibition of inflammation in Magnetic Resonance Imaging (MRI) In an imaging sub-study including 153 patients, signs of inflammation were assessed by MRI at week 12 and expressed as change from baseline in SPARCC (Spondyloarthritis Research Consortium of Canada) score for sacroiliac joints and ASspiMRI-a score in the Berlin modifications for the spine.
Maltese: L-inhibizzjoni tal-infjammazzjoni f' Magnetic Resonance Imaging (MRI) F' sub-studju bl-immaġini li jinkludi 153 pazjent, sinjali ta' infjammazzjoni kienu mkejjla b' MRI f' ġimgħa 12 u espressi bħala bidla mill-linja bażi fil-punti tal-fl- SPARCC (Consorzju tal-Kanada tarRiċerka tal-iSpondiloartrite) għal ġogi sakroiljaċi u ASspiMRI-punti tal-modifikazzjoni Berlin tassinsla tad-dahar.
English: Other medicines and Cimzia
Maltese: Mediċini oħra u Cimzia
English: Cimzia was studied in 4,049 patients with rheumatoid arthritis in controlled and open label trials for up to 92 months.
Maltese: Cimzia kien studjat f'4,049 pazjent b'artrite rewmatika f'provi kkontrollati u open-label għal mhux iżjed minn 92 xahar.
English: Mean decreases (improvements) in DLQI from baseline ranged from -8.9 to -11.1 with Cimzia 200 mg every 2 weeks, from -9.6 to -10.0 with Cimzia 400 mg every 2 weeks, versus -2.9 to -3.3 for placebo at Week 16.
Maltese: It-tnaqqis medju (titjib) fid-DLQI mil-linja bażi kien bejn -8.9 u -11.1 għal Cimzia 200 mg kull ġimagħtejn, bejn -9.6 u -10.
English: In C-EARLY, Cimzia+ MTX inhibited the radiographic progression compared to placebo+MTX at Week 52 (see Table 6).
Maltese: F'C-EARLY, Cimzia+ MTX ihibixxew progressjoni radjografika meta mqabbla ma' plaċebo+MTX f' Ġimgħa 52 (ara Tabella 6).
English: Excipients: sodium acetate, sodium chloride and water for injections.
Maltese: Eċċipjenti: sodium acetate, sodium chloride u ilma għall-injezzjoni.
English: Partial remission(c,d)
Maltese: Remissjoni parzjali(c,d)
English: JSN score
Maltese: Punteġġ JSN
English: DoseFlex clinical trial
Maltese: Prova klinika DoseFlex:
English: Cimzia contains sodium acetate and sodium chloride This medicinal product contains less than 1 mmol sodium (23 mg) per 400 mg, i.e. essentially ‘sodium-free'.
Maltese: Cimzia fih sodium acetate u sodium chloride Dan il-prodott mediċinali fiħ inqas minn 1 mmol ta' sodju (23 mg) kull 400 mg, jiġifieri huwa prattikament ‘mingħajr-sodju'.
English: Improvements in ASAS5/6, Partial Remission and BASDAI-50 were statistically signficant at Week 12 and Week 24 and were sustained up to Week 48 in the overall popualtion as well as in the subpopulations.
Maltese: Titjib f' ASAS 5/6, Remissjoni Parzjali u BASDAI-50 kienu statistikament sinifikanti f'Ġimgħa 12 u Ġimgħa 24 u kienu miżmuma sa Ġimgħa 48 fil-popolazzjoni kollha kif ukoll fis-sub-popolazzjonijiet.
English: Primary endpoint: ACR 20 at Week 24.
Maltese: ACR 20 f'Ġimgħa 24.
English: Placebo N=158
Maltese: Plaċebo N= 158
English: Patients were predominantly men (64%) and Caucasian (94%), with a mean age of 45.7 years (18 to 80 years); of these, 7.2% were ≥ 65 years of age.
Maltese: Il-pazjenti kienu l-aktar irġiel (64%) u Kawkasi (94%), b'età medja ta' 45.7 sena (18 sa 80 sena); minn dawn, 7.2% kellhom ≥ 65 sena.
English: Placebo + MTX N=127
Maltese: Plaċebo + MTX N=127
English: Component of a multipack, cannot be sold separately
Maltese: Parti minn pakkett multiplu, ma jistgħux jinbigħu separatament
English: Cimzia all dosing regimens(a) N=121
Maltese: Cimzia kull dożaġġ(a) N=121
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis.
Maltese: Artrite psorijatika hija marda infjammatorja talġogi, normalment akkompanjata minn psorijażi.
English: N/A: Not Applicable *Wald p-values for Cimzia 200 mg vs. placebo and Cimzia 400 mg vs. placebo comparisons are estimated from a logistic regression model with factors for treatment
Maltese: Mhux applikabbli *Wald p-values għal Cimzia 200 mg vs. plaċebo u Cimzia 400 mg vs. plaċebo huma stmati minn mudell ta' regressjoni loġistika b'fatturi għat-trattament.
English: • the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate.
Maltese: • għat-trattament tal-artrite rewmatika attiva (RA) moderata u severa f'pazjenti adulti meta irrispons għal mediċini ta' kontra l-artrite rewmatika li jbiddlu il-marda (DMARDs) li jinkludi MTX ma kinitx adekwata.
English: Results are from the randomized set.Treatment Difference: Cimzia 200 mg-placebo, Cimzia 400 mgplacebo (and corresponding 95% CI and p-value) are estimated using a standard two-sided Wald asymptotic standard errors test. Non-responder Imputation (NRI) is used for patients who escaped therapy or had missing data.
Maltese: Cimzia 200 mg-plaċebo, Cimzia 400 mg-plaċebo (u 95% CI u p-value li jikkorrispondu) huma stmati bl-użu ta'test standard taliżbalji two-sided Waldtest standard tal-iżbalji asimptotiku.
English: Cimzia 200 mg + MTXPlacebo + MTX Mean Difference mTSS
Maltese: Cimzia 200 mg + MTX Plaċebo + MTX Medja tad-Differenza mTSS
English: Cimzia contains the active substance certolizumab pegol, a human antibody fragment.
Maltese: Cimzia fih is-sustanza attiva certolizumab pegol, framment ta' antikorp uman.
English: Placebo+MTX N= 213
Maltese: Plaċebo+MTX N= 213
English: mTSS: modified Total Sharp Score *Sustained remission at Week 52 is defined as DAS28[ESR] <2.6 at both Week 40 and Week 52.
Maltese: Total Sharp Score modifikat *rimissjoni sostenuta f'Ġimgħa 52 kienet definita bħala DAS28[ESR] <2.6 kemm f' Ġimgħa 40 u Ġimgħa 52.
English: Frequency Adverse reactions Common hypertension Uncommo haemorrhage or bleeding (any site), hypercoagulation (including thrombophlebitis, pulmonary embolism), syncope, oedema (including peripheral, facial), ecchymoses (including haematoma, petechiae)
Maltese: Mhux komuni emoraġġija jew fsad (f'kull sit), iperkoagulazzjoni (inkluż tromboflebite, emboliżmu pulmonari), sinkope, edima (inkluż periferali, tal-wiċċ), ekkimożi (inkluż ematoma, petechiae)
English: Rare pancytopaenia, splenomegaly, erythrocytosis, white blood cell morphology abnormal
Maltese: Rari pansitopenja, splenomegali, eritrositożi, morfoloġija abnormali taċ-ċelloli bojod tad-demm
English: In AS001 clinical trial, at Week 12 ASAS20 responses were achieved by 58% of patients receiving Cimzia 200 mg every 2 weeks and 64% of patients receiving Cimzia 400 mg every 4 weeks as compared to 38% of patients receiving placebo (p<0.01).
Maltese: Fil-prova klinika AS001, f'Ġimgħa 12 kien hemm risponsi ASAS20 f' 58% tal-pazjenti li rċievew Cimzia 200 mg kull ġimgħatejn u 64% tal-pazjenti li rċievew Cimzia 400 mg kull 4 ġimgħat, meta mqabbla ma' 38% tal-pazjenti li rċievew plaċebo (p < 0.01).
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age) in the post marketing setting.
Maltese: Tumuri, xi drabi fatali, kienu rrappurtati fit-tfal, addoloxxenti u adulti żgħar (sa eta` ta' 22 sena) trattati b'mediċini ta' kontra TNF (bidu tal-kura ≤ 18-il sena t'eta`) wara it-tqegħid fis-suq.
English: At week 12 and 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) were seen in the Cimzia-treated patients (nominal p-value p<0.01).
Maltese: F'Ġimgħa 12 u 24 kienu osservati ameljoramenti filparametri tal-attività periferali tipika ta'artrite psorijatika (eż. numru ta' ġogi minfuħin, numru ta' ġogi li juġgħu/ juġgħu ftit, daktilite u entesite) fil-pazjenti ttrattati b'Cimzia (p-value nominali p<0.01).
English: Injection
Maltese: Infezzjonijiet
English: Placebo N=51
Maltese: Plaċebo N=51
English: The mTSS Score was modified for psoriatic arthritis by addition of hand distal interphalangeal joints.
Maltese: Il-Punti mTSS kienu modifikati għal artrite psorijatika bl'addizzjoni ta' ġogi distali interfalangejali tal-id.
English: • gastrointestinal stenosis (narrowing of part of the digestive system).
Maltese: • stenożi gastro-intestinali (djuq ta' parti mis-sistema diġestiva)
English: The efficacy and safety of Cimzia have been assessed in 2 randomised, placebo-controlled, doubleblind clinical trials in patients ≥ 18 years of age with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria, RA-I (RAPID 1) and RA-II (RAPID 2).
Maltese: L-effikaċja u s-sigurta` ta' Cimzia kienu mkejla f'2 provi kliniċi double blind, randomised u kontrollat mill-plaċebo f'pazjenti t'eta` ≥ 18 il-sena b' artrite rewmatika attiva dijanjożizzata skont il-kriterji talKulleġġ Amerikan tar-Rewmatoloġija (ACR), RA-I (RAPID 1) u RA-II (RAPID 2),.
English: - Do not touch the area again before injecting.
Maltese: - Ċerti tilqim jistgħu jikkawżaw infezzjonijiet.
English: Cimzia treatment inhibited the radiographic progression compared with placebo treatment at Week 24 as measured by change from baseline in total mTSS Score (LS mean [±SE] score was 0.28 [±0.07] in the placebo group compared with 0.06 [±0.06] in the Cimzia all doses group; p=0.007).
Maltese: Trattament b'Cimzia waqqaf l-progressjoni radjografika meta mqabbel mattrattament bil-plaċebo f'Ġimgħa 24 kif mkejjla bil-bidla mill-linja bażi fl-iSkala mTSS totali (punti medji LS [±SE] kien 0.28 [±0.07] fil-grupp tal-plaċebo meta mqabbel ma' 0.06 [± 0.06] fil-gruppi taddożi kollha Cimzia; p=0.007).
English: • liver problems
Maltese: • problem fil-marrara
English: Cimzia was studied in 325 patients with active axial spondyloarthritis (including ankylosing spondylitis and non-radiopraphic axial spondyloarthritis) in the AS001 clinical study for up to 4 years, which includes a 24-week placebo-controlled phase followed by a 24-week dose-blind period and a 156-week open-label treatment period.
Maltese: Cimzia kien studjat f' 325 -il pazjent b' spondiloartrite axjali attiva (inkluż spondilite ankilosing u spondiartrite axjali mhux radjografika) f' studju kliniku fl-istudju kliniku AS001 għal mhux iżjed minn 4 snin, li jinkludi fażi ta' 24 ġimgħa ikkontrollata mil plaċebo segwita minn perjodu fejn id-doża ma kinitx magħrufa ta' 24 ġimgħa u perjodu ta' trattament open-label ta' 156 ġimgħa.
English: In the Phase III placebo- and active-controlled studies, the percentages of patients who were positive for antibodies to Cimzia on at least one occasion during treatment up to Week 48 were 8.3 % (22/265) and 19.2% (54/281) for the Cimzia 400 mg every 2 weeks and Cimzia 200 mg every 2 weeks respectively.
Maltese: III, il-perċentwali ta' pazjenti li kienu pożittivi għall-antikorpi għal Cimzia f'mill-inqas okkażjoni waħda matul it-trattament sa Ġimgħa 48 kienu 8.3% (22/265) u 19.2% (54/281) għal Cimzia 400 mg kull ġimagħtejn u Cimzia 200 mg kull ġimagħtejn rispettivament.
English: During controlled clinical trials through Week 16, the proportion of patients with serious adverse events was 3.5% for Cimzia and 3.7% for placebo.
Maltese: Waqt provi kliniċi kkontrollati sa Ġimgħa 16, il-proporzjon ta' pazjenti b'avvenimenti avversi serji kien ta' 3.5% għal Cimzia u ta' 3.7% għal plaċebo.
English: A dose of 400 mg every 2 weeks can be considered in patients with insufficient response (see section 5.1).
Maltese: Doża ta' 400 mg kull ġimagħtejn tista' tigi kkunsidrata f'pazjenti b'rispons insuffiċjenti (ara sezzjoni 5.1).
English: Placebo N=50
Maltese: Plaċebo N=50
English: Of the 850 patients, 14% had received at least one TNF-antagonist, 13% had received an anti-IL-17, and 5% had received an anti-IL 12/ 23.
Maltese: Mit850 pazjent, 14% kienu rċevew mill-inqas antagonista ta' TNF wieħed, 13% kienu rċevew anti-IL-17, u 5% kienu rċevew anti-IL 12/ 23.
English: Excluding non-melanoma of the skin, 121 malignancies including 5 cases of lymphoma were observed in the Cimzia RA clinical trials in which a total of 4,049 patients were treated, representing 9,277 patient-years.
Maltese: Meta teskludi tumuri tal-ġilda li mhux melanoma, 121 tumur li jinkludu 5 każi ta' limfoma kienu osservati fil-provi kliniċi ta' Cimzia RA fejn total ta' 4,049 pazjent kienu trattati, li jirripreżentaw 9,277 -il sena ta' pazjent.
English: In the placebo group, 52% of patients experienced no radiographic progression (mTSS ≤ 0.0) at Week 52 compared to 69% in the Cimzia 200 mg treatment group.
Maltese: Fil-grupp tal-plaċebo, 52% talpazjenti ma kellhomx progressjoni radjografika (mTSS ≤ 0.0) f' Ġimgħa 52 meta mqabbel ma' 69% fil-grupp trattament ta' Cimzia 200 mg.
English: In the clinical trials, there was an apparently higher incidence of infections among subjects ≥ 65 years of age, compared to younger subjects, although experience is limited.
Maltese: Fi provi kliniċi, kien hemm apparentament inċidenza ogħla ta' infezzjonijiet f'persuni ≥ minn 65 sena, meta mqabbel ma' persuni iżgħar, għalkemm l-esperjenza hi limitata.
English: • Guillain-Barré syndrome*
Maltese: • Sindromu ta' Guillain-Barré*
English: Metabolism and nutrition disorders
Maltese: Disturb fil-metaboliżmu u nnutrizzjoni
English: Utilization and dose adjustment of standard of care medication (SC) (e.g., NSAIDs, DMARDs, corticosteroids, analgesics) were permitted at any time.
Maltese: Utilizzazzjoni u aġġustament tad-doża tal-medikazzjoni tal-istandard tal-kura (SC) (eż., NSAIDs, DMARDs, kortikosterojdi, analġesiċi) ġew permessi fi kwalunkwe żmien.
English: Cimzia all dosing regimens(a) N=97
Maltese: Cimzia kull dożaġġ(a) N=97
English: At baseline, 37 % and 41% of patients had high disease activity (ASDAS ≥2.1, ≤3.5) and 62% and 58% of patient had very high disease activity (ASDAS >3.5) in the CIMZIA group and placebo group respectively.
Maltese: Fil-linja bażi, 37 % u 41 % tal-pazjenti kellhom attività tal-marda għolja (ASDAS ≥2.1, ≤3.5) u 62 % u 58 % tal-pazjenti kellhom attività tal-marda għolja ħafna (ASDAS >3.5) fil-grupp ta' CIMZIA u filgrupp ta' plaċebo rispettivament.
English: About 22% (54/248) of the patients who were anti-certolizumab pegol antibody positive at any time, had antibodies that were classified as neutralizing.
Maltese: Madwar 22 % (54/248) talpazjenti li kienu pożittivi għall-antikorp kontra certolizumab pegol fi kwalunkwe ħin, kellhom antikorpi li ġew ikklassifikati bħala newtralizzanti.
English: Concomitant treatment with methotrexate, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics showed no effect on the pharmacokinetics of certolizumab pegol based on a population pharmacokinetics analysis.
Maltese: Terapija flimkien ma' methotrexate, kortikosterojdi, mediċini anti-infjammatorji mhux sterojdi (NSAIDs) u mediċini kontra l-uġigħ, ma kellhom ebda effett fuq il-farmakokinetika ta' certolizumab pegol, meta bbażata fuq analiżi tal-farmakokinetika tal-popolazzjoni.
English: In PsA001 clinical trial, inhibition of progression of structural damage was assessed radiographically and expressed as the change in modified total Sharp score (mTSS) and its components, the Erosion Score (ES) and Joint Space Narrowing score (JSN) at Week 24, compared to baseline.
Maltese: Fil-prova klinika PsA001, l-inhibizzjoni tal-progressjoni tal-ħsara strutturali kienet mkejjla radjografikament u espressa bħala total tal-iskala Sharp modifikat (mTSS) u l-komponenti tiegħu, liSkala ta' Erosjoni (ES) u l-iskala tad-djuq tal-ispazzju bejn il-ġogi (JSN) f'Ġimgħa 24, ikkomparati mal-linja bażi.
English: Uncommo blood and lymphatic system malignancies (including lymphoma and leukaemia), solid organ tumours, nonmelanoma skin cancers, pre-cancerous lesions (including oral leukoplakia, melanocytic nevus), benign tumours and cysts (including skin papilloma)
Maltese: Mhux komuni mard malinn tad-demm u tas-sistema limfatika (inkluż limfoma u lukemja), tumuri tal-organi solidi, kanċer tal-ġilda mhux melanoma, leżjonijiet ta' qabel il-kanċer (inkluż lewkoplakia orali, melanocytic nevus) tumuri beninni u ċesti (inkluż papilloma tal-ġilda)
English: The most common adverse reactions reported through Week 16 belonged to the system organ classes Infections and infestations, reported in 6.1% of patients on Cimzia and 7% of patients on placebo, General disorders and administration site conditions, reported in 4.1% of patients on Cimzia and 2.3% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 3.5% of patients on Cimzia and 2.8% of patients on placebo.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni rrappurtati sa Ġimgħa 16 kienu jaqgħu taħt is-sistema talklassifika tal-organi Infezzjonijiet u infestazzjonijiet, irrappurtati f'6.1% tal-pazjenti fuq Cimzia u 7% tal-pazjenti fuq plaċebo, Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata, irrappurtati f'4.1% talpazjenti fuq Cimzia u 2.3% tal-pazjenti fuq plaċebo, u Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda, irrappurtati f'3.5% tal-pazjenti fuq Cimzia u 2.8% tal-pazjenti fuq plaċebo.
English: The needle shield is styrene butadiene rubber which contains a derivative of natural rubber latex (see section 4.4).
Maltese: L-għatu tal-labra huwa gomma stirene butadiene li fih derivattiv ta' latex ta' gomma naturali (ara sezzjoni 4.4).
English: The efficacy and safety of Cimzia were assessed in a multicentre, randomised, double-blind, placebo controlled clinical trial (PsA001) in 409 patients ≥ 18 years of age with adult-onset active psoriatic arthritis for at least 6 months as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
Maltese: L-effikaċja u s-sigurta`ta' Cimzia kienu mkejjla f'prova klinika (PsA001) multi-ċentrali, randomizzata, double-blind, ikkontrollata mil-plaċebo f' 409 pazjent ≥18 -il sena b'artrite psorijatika attiva li bdiet meta kienu adulti għal mill-inqas 6 xhurs kif definit mill-kriterja tal-Kriterja ta' Klassifikazzjoni għal-Artrite Psorijatika (CASPAR).
English: Cimzia 200 mg + MTX N=393 Mean (SD)
Maltese: Cimzia 200 mg + MTX N=393 Medja (SD)
English: Table 1 Adverse reactions in clinical trials and postmarketing System Organ Class
Maltese: Tabella 1 Reazzjonijiet avversi f' provi kliniċi u wara t-tqegħid fis-suq Sistema tal-Klassifika tal
English: Inhibition of radiographic progression was further maintained up to Week 216 for the patients who remained in the study.
Maltese: L-inhibizzjoni ta' progressjoni radjografika kompliet tiġi mantenuta sa Ġimgħa 216 fil-pazjenti li baqgħu fl-istudju.
English: Week 12 Week 24 BASDAI 50(c,d)
Maltese: BASDAI 50(c,d)
English: Cimzia was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 18 months.
Maltese: Cimzia ġie studjat f'1112-il pazjent bi psorjasi fi studji kkontrollati u open-label li damu sejrin sa 18-il xahar.