FrancophonIA/ELRC3.0 huggingface dataset:
English: Cimzia all dosing regimens(a) N=218
Maltese: Cimzia kull dożaġġ(a) N=218
English: Response Placebo + MTX N=199
Maltese: Plaċebo + MTX N=199
English: Serious infections, including sepsis and tuberculosis (including miliary, disseminated and extrapulmonary disease), and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) have been reported in patients receiving Cimzia.
Maltese: Infezzjonijiet serji, inkluż sepsis u tuberkulożi (inkluż dik miliary, disseminata u extrapulmonarja) u infezzjonijiet opportunistiċi ( eż. histoplasmosis, nocardia, candidiasis), ġew rappurati f'pazjenti li kienu fuq Cimzia.
English: Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4, spinal pain ≥ 4 on a 0 to 10 Numerical Rating Scale (NRS) and increased CRP or current evidence of sacroiliitis on Magnetic Resonance Imaging (MRI).
Maltese: Pazjenti kellhom marda attiva kif definit mill-Indiċi ta' Attivita` tal-Marda Spondilite Ankilosing ta' Bath (BASDAI) ≥ 4, uġigħ fis-sinsla ≥ 4 fuq skala ta' 0 sa 10 Skala ta' Kejl Numerika (NRS) u CRP ogħla jew evidenza kurrenti ta' sakroiliite fuq Magnetic Resonance Imaging (MRI).
English: Severe infections and neutropaenia were reported in clinical trials with concurrent use of anakinra (an interleukin-1 antagonist) or abatacept (a CD28 modulator) and another TNF-antagonist, etanercept, with no added benefit compared to TNF-antagonist therapy alone.
Maltese: F'provi kliniċi, bl'użu flimkien ta' anakinra (antagonist ta' interleukin-1) jew abatacept (modulatur CD28) u mediċini ta' kontra TNF ieħor etanercept, ġew rappurtati infezzjonijiet severi u newtropenja, u ma kienx hemm benefiċji ogħla meta mqabbel ma' terapija b' mediċini ta' kontra TNF weħedha.
English: Cimzia 400 mg + MTX every 4 weeks N=69
Maltese: Cimzia 400 mg + MTX kull 4 ġimgħat N=69
English: In vitro functional studies of human vacuolated macrophages indicated all functions tested were retained.
Maltese: Studji funzjonali in vitro ta' makrofaġi vakwolati umani juru li l-funzjonijiet eżaminati kienu miżmumha.
English: There is no evidence of an increased risk of infections with continued exposure over time (see section 4.4).
Maltese: M'hemmx evidenza fiż-żieda fir-riskju ta' infezzjonijiet b'esponiment kontinwu maż-żmien (ara sezzjoni 4.4).
English: Rare gastrointestinal tumours, melanoma
Maltese: Rari tumuri gastrointestinali, melanoma,
English: Following subcutaneous administration, peak plasma concentrations of certolizumab pegol were attained between 54 and 171 hours post-injection.
Maltese: Wara li jingħata minn taħt il-ġilda, intlaħqu l'ogħla konċentrazzjonijiet fil-plażma ta' certolizumab pegol, bejn 54 u 171 siegħa wara l-injezzjoni.
English: In the placebo-controlled trial in patients with non-radiographic axial spondyloarthritis, using a more sensitive and drug tolerant assay than in previous trials, the overall incidence of patients who were antibody positive to certolizumab pegol was 97% (248/255 patients) after up to 52 weeks of treatment.
Maltese: Fil-prova kkontrollata bi plaċebo f'pazjenti bi spondiloartrite axjali mhux radjografika, permezz ta' assaġġ aktar sensittiv u tolleranti għall-mediċina milli fi provi preċedenti, l-inċidenza globali ta' pazjenti li kienu pożittivi għall-antikorp għal certolizumab pegol kienet 97% (248/255 pazjent) wara sa 52 ġimgħa ta' kura.
English: Serious infections also included invasive opportunistic infections (e.g. pneumocystosis, fungal oesophagitis, nocardiosis and herpes zoster disseminated).
Maltese: Infezzjonijiet serji inkludew ukoll infezzjonijiet opportunistiċi invażivi (eż. pnewmocistożi, esofagite fungali, nokardjożi u herpes zoster disseminat).
English: Pregnancy
Maltese: Emosiderożi
English: There is no evidence that Cimzia therapy has an effect on coagulation in vivo.
Maltese: M'hemmx evidenza li terapija b'Cimzia għandha effett fuq il-koagulazzjoni in vivo.
English: Cimzia 200 mg + MTX N = 528 Mean (SD)
Maltese: Cimzia 200 mg + MTX N = 528 Medja (SD)
English: Axial spondyloarthritis Overall Population
Maltese: Spondiloartrite axjali Popolazzjoni kollha
English: Clearance following subcutaneous dosing was estimated to be 21.0 ml/h in a rheumatoid arthritis population pharmacokinetic analysis, with an inter-subject variability of 30.8% (CV) and an interoccasion variability of 22.0%.
Maltese: It-tneħħija wara doża taħt il-ġilda kien smat li hu 21.0 ml/h/ f'analiżi tal-farmakokinetika filpopolazzjoni ta' pazjenti b'artrite rewmatika, b'varjabilita` bejn bnedmin differenti ta' 30.8% (CV) u varjabilita` bejn l-okkażjonijiet differenti ta' 22.0%.
English: Table 7 ACR response in DoseFlex clinical trial at week 34
Maltese: Tabella 7 Rispons ACR fil-prova klinika DoseFlex f'ġimgħa 34 Trattament ġimgħa 0 sa 16
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists including certolizumab pegol (see section 4.8).
Maltese: Melanoma u karċinoma taċ-ċelloli Merkels kienu rrappurtati f'pazjenti ttrattati b' antagonisti TNF li jinkludu certolizumab pegol (ara sezzjoni 4.8).
English: In the placebo-controlled rheumatoid arthritis clinical trials, 5.8% of patients treated with Cimzia developed injection site reactions such as erythema, itching, haematoma, pain, swelling or bruising, compared to 4.8% of patients receiving placebo.
Maltese: F'provi kliniċi dwar l-artrite rewmatika kkontrollati mill-plaċebo, 5.8% tal-pazjenti trattati b'Cimzia żvilluppaw reazzjonijiet fil-post ta' l-injezzjoni bħal eritema, ħakk, ematoma, uġigħ, nefħa jew tbenġil meta mqabbel ma' 4.8% tal-pazjenti fuq il-plaċebo.
English: Uncommo muscle disorders, blood creatine phosphokinase increased
Maltese: Mhux komuni disturbi tal-muskoli, żieda fil-creatinine phosphokinase tad-demm,
English: Uncommo anaemia, lymphadenopathy, thrombocytopaenia, thrombocytosis
Maltese: Mhux komuni enemija, limfadenopatija, tromboċitopenja, tromboċitożi
English: Reports of pancytopaenia, including aplastic anaemia, have been rare with TNF-antagonists.
Maltese: Rapporti ta' panċitopenja, inkluż anemija aplastika, kienu rari b'mediċini ta' kontra TNF.
English: • Periodic Safety Update Reports
Maltese: • infjammazzjoni perikardjali
English: Of the 135 patients randomised to Cimzia 400 mg every 4 weeks, 89, 62 and 41 patients had an ACR 20/50/70 response, respectively.
Maltese: Mill-135 pazjent randomizzat fuq Cimzia 400 mg kull 4 ġimgħat, 89, 62 u 41 pazjent kellhom rispons ACR 20/50/70, rispettivament.
English: The clinical significance of low levels certolizumab pegol for infants is unknown.
Maltese: Ir-rilevanza klinika tal-livelli baxxi ta' certolizumab pegol mhix magħrufa.
English: • severe rash, hives or other signs of allergic reaction (urticaria)
Maltese: • raxx sever, urtikarja jew sinjali oħra ta' reazzjoni allerġika (urtikarja)
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: Spondilite ankylosing u spondiloartrite axjali mingħajr evidenza radjografika ta' spondilite ankylosing
English: Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs.
Maltese: Adulti b' spondiartrite axjali mingħajr evidenza radjografika ta' AS attiva u severa imma b'sinjali oġġettivi ta' infjammazzjoni b' proteina C-reattiva (CPR) u/jew Magnetic Resonance Imaging (MRI) għoli, li ma kellhomx rispons tajjeb għal, jew huma intolleranti għal NSAIDs.
English: Table 4: C-EARLY trial: percent of patients in sustained remission and sustained low disease activity at Week 52
Maltese: Tabella 4: Prova C-EARLY: perċentaġġ tal-pazjenti f' rimissjoni sostenut u attivita` baxxa talmarda sostenuta f' Ġimgħa 52
English: JSN Score
Maltese: Punti JSN
English: The most common adverse reactions belonged to the system organ classes Infections and infestations, reported in 14.4% of patients on Cimzia and 8.0% of patients on placebo, General disorders and administration site conditions, reported in 8.8% of patients on Cimzia and 7.4% of patients on placebo, and Skin and subcutaneous tissue disorders, reported in 7.0% of patients on Cimzia and 2.4% of patients on placebo.
Maltese: Ir-reazzjonijiet avversi l-iżjed komuni kienu fis-sistema tal-klassifika tal-organi tal-Infezzjonijiet u infestazzjonijiet, irrappurtati f' 14.4% tal-pazjenti fuq Cimzia u 8.0% tal-pazjenti fuq plaċebo, Mard ġenerali u kundizzjonijiet fil-post tat-teħid, irrappurtati f' 8.8% tal-pazjenti fuq Cimzia u 7.4% talpazjenti fuq plaċebo, u Mard tal-ġilda u tat-tessut subkutanju, irrappurtati f' 7.0% f'pazjenti fuq Cimzia u 2.4% tal-pazjenti fuq plaċebo.
English: Patients had to fulfil ASAS criteria for nraxSpA (not including family history and good response to NSAIDs), and have had objective signs of inflammation indicated by C-reactive protein (CRP) levels above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging (MRI), indicative of inflammatory disease [positive CRP (> ULN) and/or positive MRI], but without definitive radiographic evidence of structural damage on sacroiliac joints.
Maltese: Il-pazjenti kellhom jissodisfaw il-kriterji ASAS għal nr- axSpA (li ma jinkludux storja fil-familja u rispons tajjeb għall-NSAIDs), u kellhom sinjali oġġettivi ta' infjammazzjoni indikati minn livelli ta' proteina reattiva C (CRP) ta' aktar mil-limitu ta' fuq tan-normal u/jew sakroiliite fuq magnetic resonance imaging (MRI), indikattivi ta' marda infjammatorja [CRP pożittiva (> ULN) u/jew MRI pożittiv], iżda mingħajr evidenza radjografika definittiva ta' ħsara strutturali fuq il-ġogi sakroiljiċi.
English: Uncommo sepsis (including multi-organ failure, septic shock), tuberculosis (including miliary, disseminated and extrapulmonary disease), fungal infections (includes opportunistic)
Maltese: Mhux komuni sepsis (li jinkludi insuffiċjenza ta' organi multipli, xokk settiku), tuberkulożi (inkluż dik miljari, disseminata u l-mard extrapulmonari), infezzjoni tal-fungu (jinkludi dawk opportunistiċi)
English: The frequency of creatine phosphokinase (CPK) elevations was generally higher in patients with axSpA as compared to the RA population.
Maltese: Il-frekwenza ta' elevazzjonijiet ta' creatinine phosphokinase (CPK) kienet ġeneralment ogħla f'pazjenti b' axSpA meta mqabbla ma' popolazzjonijiet b' RA.
English: Ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis) Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Maltese: Spondilite ankilosing (AS) (magħrufa wkoll bħala spondiartrite axjali radjografika) Adulti b' spondilite ankilosing severa u attiva li ma kellhomx rispons tajjeb għal, jew huma intolleranti għal mediċini mhux steroidjali ta' kontra l-infjammazzjoni (NSAIDs).
English: NA = not available *p≤0.05, Cimzia vs placebo **p<0.001, Cimzia vs placebo
Maltese: Sett Analiżi Komplut NA = mhux disponibbli * p≤ 0.05, Cimzia vs plaċebo ** p<0.001, Cimzia vs plaċebo
English: Among patients remaining in the study, who had both baseline values and week 204 values, inhibition of inflammatory signs in both the sacroiliac joints (n=72) and spine (n=82) was largely maintained through Week 204 in the overall axial spondyloarthritis population as well as in both the AS and the nr-axSpA subpopulations.
Maltese: Fost il-pazjenti li baqgħu fl-istudju, li kellhom iż-żewġt valuri tal-linja bażi u l-valuri ta' ġimgħa 204, l-inhibizzjoni ta' sinjali infjammatorji fiż-żewġt ġogi sakroiljiċi (n=72) u ssinsla (n=82) kienu mantenuti l-biċċa l-kbira f' Gimgħa 204 fil-popolazzjoni kollha ta' spondiloartrite axjali kif ukoll fis-sub-popolazzjonijiet AS u nr-axSpA.
English: Cimzia, which you will take in combination with methotrexate, is used to:
Maltese: Cimzia, li int ser tieħu flimkien ma' methotrexate, huwa użat biex:
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance Sandoz GmbH
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva Sandoz GmbH
English: Statistically significant improvements at Week 16 (CIMPASI-1 and CIMPASI-2) from baseline compared to placebo were demonstrated in the DLQI (Dermatology Life Quality Index).
Maltese: Titjib statistikament sinifikanti f'Ġimgħa 16 (CIMPASI-1 u CIMPASI-2) mil-linja bażi meta mqabbel mal-plaċebo ntwera mill-Indiċi tad-Dermatoloġija dwar il-Kwalità tal-Ħajja (DLQI, Dermatology Life Quality Index).
English: Accordingly, certolizumab pegol is an antibody Fab' fragment conjugated with PEG in order to extend the terminal plasma elimination half-life of the Fab' to a value comparable with a whole antibody product.
Maltese: Bl' istess mod, certolizumab pegol huwa antikorp Fab' framment konjugat b' PEG sabiex itawwal il-half life terminali ta' l-eliminazzjoni mill-plażma tal- Fab' għal valur komparabli ma' prodott tal-antikorp sħiħ.
English: Excluding non-melanoma skin cancer, 9 malignancies including 1 case of lymphoma were observed in the Cimzia psoriasis clinical trials in which a total of 1112 patients were treated, representing 1481 patient-years.
Maltese: Meta teskludi kanċer tal-ġilda li mhux melanoma, 9 tumuri malinni inkluż każ wieħed ta' limfoma kienu osservati fil-provi kliniċi ta' Cimzia bi psorjasi fejn total ta' 1112-il pazjent kienu ttrattati, li jirrappreżentaw 1481 sena ta' pazjent.
English: Week 12 Week 24 ASAS40(c,d)
Maltese: ASAS40(c,d)
English: The key results of CIMPASI-1 and CIMPASI-2 studies are presented in Table11.
Maltese: III (CIMPASI-1, CIMPASI-2 u CIMPACT).
English: Certolizumab pegol does not bind to the human neonatal Fc receptor (FcRn).
Maltese: Certolizumab pegol ma jeħilx mar riċettur neonatali uman Fc (FcRn, Fc receptor).
English: • axial spondyloarthritis (including ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis),
Maltese: • spondiloartrite axjali (li jinkludi spondilite ankilosing u spondiloartrite axjali mingħajr evidenza radjografika ta' spondilite ankilosing),
English: The efficacy and safety of 2 dose regimens (200 mg every 2 weeks and 400 mg every 4 weeks) of Cimzia versus placebo were assessed in an 18-week, open-label, run-in, and 16-week randomised, double-blind, placebo-controlled clinical trial in adult patients with active rheumatoid arthritis diagnosed according to the ACR criteria who had inadequate response to MTX.
Maltese: L-effikaċja u s-sigurta` ta' żewġt dożaġġi (200 mg kull ġimagħtejn u 400 mg kull 4 ġimgħat) ta' Cimzia versus il-plaċebo kienu mkejla f' run-in, open-label ta' 18-il ġimgħa u prova klinika ta' 16-il ġimgħa, randomizzat, double-blind, ikkontrollata minn plaċebo f'pazjenti adulti b' dijanjożi ta' artrite rewmatika attiva skond il-kriterji ACR li a kellhomx rispons tajjeb għal MTX.
English: • psoriatic arthritis
Maltese: • artrite psorijatika
English: Co-primary endpoints: ACR 20 at Week 24 and change from baseline in mTSS at Week 52
Maltese: ACR 20 f'ġimgħa 24 u tibdil mill-linja bażi f'mTSS f' Ġimgħa 52
English: • swollen lymph nodes
Maltese: • mard tad-demm
English: Certolizumab pegol plasma concentrations measured in 14 infants at birth were Below the Limit of Quantification (BLQ) in 13 samples; one was 0.042 µg/ml with an infant/mother plasma ratio at birth of 0.09%.
Maltese: Il-konċentrazzjonijiet fil-plażma ta' certolizumab pegol imkejla f'14-il tarbija fit-twelid kienu Taħt il-Limitu ta' Kwantifikazzjoni (BLQ, Below the Limit of Quantification) fi 13-il kampjun; wieħed kien 0.042 µg/ml bi proporzjon fil-plażma tat-tarbija/omm fit-twelid ta' 0,09 %.
English: Certolizumab pegol has a bioavailability (F) of approximately 80% (range 76% to 88%) following subcutaneous administration compared to intravenous administration.
Maltese: Certolizumab pegol għandu bijodisponibilta` (F) ta' bejn wieħed u ieħor 80% (medda ta' 76% sa 88%) wara li jingħata minn taħt il-ġilda meta mqabbel ma' ġol-vina.
English: Cimzia is contraindicated in moderate or severe heart failure (see section 4.3).
Maltese: Cimzia huwa kontra-indikat f'insuffiċjenza tal-qalb moderata u severa (ara sezzjoni 4.3).
English: For subjects who were anti-dsDNA antibody negative at baseline, 2.2% of those treated with Cimzia developed positive anti-dsDNA antibody titers, compared with 1.0% of subjects in the placebo group.
Maltese: Għal pazjenti li kienu negattivi għal antikorpi anti ds-DNA fil-linja bażi, 2.2% ta' dawk trattati b'Cimzia żvillupaw titers pożittivi ta' antikorpi anti-dsDNA, meta mqabbla ma' 1.0% talpazjenti fil-grupp tal-plaċebo.
English: The proportion of patients who discontinued treatment due to adverse events in the controlled clinical studies was 1.5% for patients treated with Cimzia and 1.4% for patients treated with placebo.
Maltese: Il-proporzjon ta' pazjenti li ma komplewx it-trattament minħabba avvenimenti avversi fl-istudji kliniċi kkontrollati kien ta' 1.5% għal pazjenti kkurati b'Cimzia u ta' 1.4% għal pazjenti kkurati bi plaċebo.
English: Week 52 p-values were < 0.001 for both mTSS and erosion score and ≤ 0.01 for JSN score.
Maltese: Valuri-p huma < 0.001 f' Ġimgħa 24 u 52 għaż-żewġt mTSS u l-punteġġ tal-erożjoni u ≤0.01 għallpunteġġ JSN.
English: The efficacy and safety of Cimzia were assessed in one multicenter, randomized, double-blind, placebo-controlled trial (AS001) in 325 patients ≥18 years of age with adult-onset active axial spondyloarthritis for at least 3 months as defined by the Assessment of Spondyloarthritis International Society (ASAS) Classification Criteria for axial spondyloarthritis.
Maltese: L-effikaċja u s-sigurta` ta' Cimzia kienet mkejjla f'prova waħda multi-ċentrali, randomizzata, doubleblind ikkontrollata mill-plaċebo (AS001) f'325 -l pazjent ≥18 tmintax -il sena t'eta` b' spondiloartrite axjali attiva li bdiet meta kienu adulti għal mill-inqas 3 xhur kif definit mill-Kriterja ta' Klassifikazzjoni tas-Soċjeta` Internazzjonali ta' Assessjar ta' Spondiloartrite (ASAS) għal spondiloartrite axjali.
English: Cimzia 200 mg + MTX every 2 weeks
Maltese: Cimzia 200 mg + MTX
English: Adverse reactions of the haematologic system, including medically significant cytopaenia (e.g. leukopaenia, pancytopaenia, thrombocytopaenia) have been reported with Cimzia (see section 4.8).
Maltese: Effetti mhux mixtieqa fis-sistema ematoloġoka, li tinkludi ċitopenja medikament sinifikanti (lewkopenja, komuni, panċitopenja, tromboċitopenja) kienu rapportati b' Cimzia (ara sezzjoni 4.8).
English: In the CIMPACT study, among PASI 75 responders at Week 16 who received Cimzia 400 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 2 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (98.0%, 80.0%, and 36.0%, respectively).
Maltese: Fl-istudju CIMPACT, fost dawk li wrew rispons għal PASI 75 f'Ġimgħa 16 li rċevew Cimzia 400 mg kull ġimagħtejn u li ġew magħżula mill-ġdid b'mod każwali jew għal Cimzia 400 mg kull ġimagħtejn, għal Cimzia 200 mg kull ġimagħtejn, jew għal plaċebo, kien hemm perċentwali ogħla ta' dawk li wrew rispons għal PASI 75 f'Ġimgħa 48 fil-gruppi ta' Cimzia meta mqabbel mal-plaċebo (98.0%, 80.0% u 36.0%, rispettivament).
English: The mean PASI score at baseline was 20 and ranged from 12 to 69.
Maltese: Il-medja tal-punteġġ PASI fil-linja bażi kienet ta' 20 u kienet tvarja minn 12 sa 69.
English: Cimzia was studied in 409 patients with psoriatic arthritis in the PsA001 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 168-week open-label treatment period.
Maltese: Cimzia kienet studjata f' 409 pazjent b' artrite psorijatika f'prova klinika PsA001 għal mhux iżjed minn 4 snin li inkuda fażi kkontrollata minn plaċebo segwita minn perjodu ta' 24-ġimgħa dose-blind u perjodu ta' 168-il ġimgħa ts' trattament open-label.
English: Patients were randomized to receive placebo, or Cimzia 200 mg every 2 weeks (following a loading dose of Cimzia 400 mg at Weeks 0, 2 and 4), or Cimzia 400 mg every 2 weeks up to Week 16, or etanercept 50 mg twice weekly, up to Week 12.
Maltese: Il-pazjenti ntgħażlu b'mod każwali biex jirċievu plaċebo, jew Cimzia 200 mg kull ġimagħtejn (wara doża inizjali qawwija ta' Cimzia 400 mg f'Ġimgħat 0, 2 u 4), jew Cimzia 400 mg kull ġimagħtejn sa Ġimgħa 16, jew etanercept 50 mg darbtejn fil-ġimgħa, sa Ġimgħa 12.
English: Medication body
Maltese: TAL-PRODOTT MEDIĊINALI
English: Overall, 16% of patients had prior TNF-antagonist exposure.
Maltese: B'kollox 16% tal-pazjenti kellhom esponiment għal antagonista ta' TNF.
English: The efficacy and safety of Cimzia were assessed in two placebo-controlled studies (CIMPASI-1 and CIMPASI-2) and one placebo- and active-controlled study (CIMPACT) in patients ≥18 years of age with moderate to severe chronic plaque psoriasis for at least 6 months.
Maltese: L-effikaċja u sigurtà ta' Cimzia kienu evalwati f'żewġ studji kkontrollati bil-plaċebo (CIMPASI-1 u CIMPASI-2) u fi studju attiv u kkontrollat bil-plaċebo (CIMPACT) f'pazjenti ta' ≥18-il sena bi psorjasi tal-plakka kronika minn moderata sa severa għal mill-inqas 6 xhur.
English: One Cimzia pack contains:
Maltese: Il-pakkett multiplu:
English: Certolizumab pegol is a recombinant, humanised antibody Fab' fragment against tumour necrosis factor alpha (TNFα) expressed in Escherichia coli and conjugated to polyethylene glycol (PEG).
Maltese: Kull siringa mimlija għal-lest fiha 200 mg ta' certolizumab pegol f' ml wieħed. Certolizumab pegol huwa framment Fab' ta' antikorp umanizzat u rikombinat kontra tumour necrosis factor alpha (TNFα) espress f' Escherichia coli, u wara jiġi purifikat u msieħeb ma' polyethylene glycol (PEG).
English: Evaluation for treatment of signs and symptoms and inhibition of structural damage in DMARD naïve patients.
Maltese: Evalwazzjoni għat-trattament għas-sinjali u s-sintomi u l-inibizzjoni ta' ħsara strutturali f' pazjenti DMARD naïve.
English: In C-EARLY, Cimzia+MTX-treated patients reported significant improvements at Week 52 compared to placebo+MTX in pain as assessed by the Patient Assessment of Arthritis Pain (PAAP) - 48,5 vs44,0 (least square mean) (p<0.05).
Maltese: F' C-EARLY, pazjenti ttrattati b' Cimzia+MTX-irrapurtaw titjib sinifikanti f' Ġimgħa 52 meta mqabbel ma' placebo+MTX fl-uġigħ kif mkejjel fil-Kejl mill-Pazjent tal-Uġigħ tal-Artrite (PAAP)48,5 vs - 44,0 (least square mean) (p<0.05).
English: The percentage of ACR 20 responders was clinically relevant for the Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks treatment groups compared to placebo group at every visit after baseline through Week 24 (nominal p≤0.001 at each visit).
Maltese: Il-perċentwali ta' rispons ACR 20 kienu klinikament relevanti għal gruppi tat-trattament Cimzia 200 mg kull ġimagħtejn u Cimzia 400 mg kull 4 ġimgħat meta mqabbla mal-grupp tal-plaċebo f'kull vista wara l-linja bażi sa Ġimgħa 24 (p≤0.001 nominali f'kull vista).
English: The terminal elimination phase half-life (t1/2) was approximately 14 days for all doses tested.
Maltese: Il-half life terminali ta' l-eliminazzjoni mill-plażma (t1/2) kien bejn wieħed u ieħor 14 il-ġurnata għal kull doża eżaminata.
English: Table12: Clinical response in CIMPACT study at Week 12 and Week 16 Week 12
Maltese: Tabella 12: Rispons kliniku fl-istudju CIMPACT f'Ġimgħa 12 u Ġimgħa 16 Ġimgħa 12
English: Uncommo asthma and related symptoms, pleural effusion and symptoms, respiratory tract congestion and inflammation, cough
Maltese: Mhux komuni ażma u sintomi relatati, efużżjoni plewrali u sintomi, konġestjoni tal-apparat respiratorju u infjammazzjoni, sogħla
English: The recommended starting dose of Cimzia for adult patients is 400 mg (given as 2 subcutaneous injections of 200 mg each) at weeks 0, 2 and 4.
Maltese: Id-doża tal-bidu rrikkmandata ta' Cimzia għal pazjenti adulti hija ta' 400 mg (mgħotija bħala żewġt injezzjonijiet sub-kutanji ta' 200 mg l-waħda) fil-ġimgħat 0, 2 u 4.