FrancophonIA/ELRC3.0 huggingface dataset:
English: * q2w = every 2 weeks ‡ Visual analogue scale †p-value <0.01 for difference from placebo ††p-value <0.001 for difference from placebo †††p-value <0.0001 for difference from placebo
Maltese: 001 għad-differenza mill-plaċebo †††valur p <0.0001 għad-differenza mill-plaċebo ‡
English: In the placebo-controlled population, 4.0%, 5.6%, and 2.0% of patients treated with Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs and placebo + DMARDs respectively, exhibited a positive response in the anti-drug antibody (ADA) assay.
Maltese: Fil-popolazzjoni kkontrollata bi plaċebo, 4.0%, 5.6%, u 2.0% tal-pazjenti ttrattati b'Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs u plaċebo + DMARDs rispettivament, urew rispons pożittiv fl-assaġġ tal-antikorp kontra l-mediċina (ADA, anti-drug antibody).
English: Injection site rash, rash, and urticaria were the most frequent hypersensitivity reactions.
Maltese: Raxx fil-post tal-injezzjoni, raxx u urtikarja kienu l-aktar reazzjonijiet frekwenti ta' sensittività eċċessiva.
English: kevzara 200 mg syringe
Maltese: kevzara 200 mg siringa
English: KEVZARA 200 mg injection sarilumab
Maltese: KEVZARA 200 mg injezzjoni sarilumab
English: When considering anti-tuberculosis therapy, consultation with a physician with expertise in tuberculosis may be appropriate.
Maltese: Meta titqies terapija kontra t-tuberkulożi, tista' tkun xierqa konsultazzjoni ma' tabib b'kompetenza fit-tuberkulożi.
English: TARGET demonstrated significant improvement in HAQ-DI scores at Week 12 compared to placebo (-0.49, -0.50, and -0.29 for Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs, and placebo + DMARDs, every two weeks, respectively).
Maltese: TARGET wera titjib sinifikanti fil-punteġġi HAQDI f'Ġimgħa 12 meta mqabbel mal-plaċebo (-0.49, -0.50, u -0.29 għal Kevzara 200 mg + DMARDs, Kevzara 150 mg + DMARDs, u plaċebo + DMARDs, kull ġimagħtejn, rispettivament).
English: kevzara 150 mg pen
Maltese: kevzara 150 mg pinna
English: Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., absolute neutrophil count (ANC) less than 2 x 109/L.
Maltese: għadd assolut ta' newtrofili (ANC, absolute neutrophil count) inqas minn 2 x 109/L.
English: In the Kevzara monotherapy population, observations were consistent with the Kevzara + DMARDs population.
Maltese: Fil-popolazzjoni ta' monoterapija b'Kevzara, l-osservazzjonijiet kienu konsistenti mal-popolazzjoni ta' Kevzara + DMARDs.
English: Treatment with Kevzara 200 mg and 150 mg + MTX inhibited the progression of structural damage by 91% and 68%, respectively, compared to placebo + MTX at Week 52.
Maltese: Trattament b'Kevzara 200 mg u 150 mg + MTX inibixxa l-progressjoni ta' ħsara strutturali b'91% u 68%, rispettivament, meta mqabbel ma' plaċebo + MTX f'Ġimgħa 52.
English: kevzara 150 mg syringe
Maltese: kevzara 150 mg siringa
English: Events of gastrointestinal perforation have been reported in clinical studies, primarily as complications of diverticulitis.
Maltese: Każijiet ta' perforazzjoni gastroinestinali ġew irrappurtati fi studji kliniċi, l-aktar bħala komplikazzjonijiet ta' divertikulite.
English: Most patients who developed gastrointestinal perforations were taking concomitant nonsteroidal anti-inflammatory medications (NSAIDs), corticosteroids, or methotrexate.
Maltese: Il-biċċa l-kbira tal-pazjenti li żviluppaw perforazzjonijiet gastrointestinali fl-istess waqt kienu qed jieħdu mediċini antiinfjammatorji mhux sterojdi (NSAIDs, nonsteroidal anti-inflammatory medications), kortikosterojdi, jew methotrexate.
English: Of these, 2170 patients received Kevzara for at least 24 weeks, 1546 for at least 48 weeks, 1020 for at least 96 weeks, and 624 for at least 144 weeks.
Maltese: Minn dawn, 2,170 pazjent irċivew Kevzara għal mill-inqas 24 ġimgħa, 1,546 għal millinqas 48 ġimgħa, 1,020 għal mill-inqas 96 ġimgħa, u 624 għal mill-inqas 144 ġimgħa.
English: • you have tuberculosis (TB), symptoms of TB (persistent cough, weight loss, listlessness, mild fever), or have been in close contact with someone with TB.
Maltese: • inti għandek it-tuberkulożi (TB, tuberculosis), sintomi ta' TB (sogħla persistenti, telf ta' piż,
English: Patients receiving Kevzara 200 mg + DMARDs reported greater improvement relative to placebo in the domains of Physical Functioning, Role Physical, Bodily Pain, General Health Perception, Vitality, Social Functioning, and Mental Health.
Maltese: Il-pazjenti li kienu qed jirċievu Kevzara 200 mg + DMARDs irrappurtaw titjib akbar meta mqabbel mal-plaċebo fl-oqsma ta' Funzjoni Fiżika, Rwol Fiżiku, Uġigħ fil-Ġisem, Perċezzjoni tas-Saħħa Ġenerali, Vitalità, Funzjoni Soċjali, u Saħħa Mentali.
English: Placebo + MTX (N =
Maltese: Plaċebo + MTX
English: The absolute bioavailability for sarilumab after SC injection was estimated to be 80% by population PK analysis.
Maltese: Il-bijodisponibbiltà assoluta għal sarilumab wara injezzjoni minn taħt il-ġilda (SC) ġiet stmata li kienet 80% permezz ta' analiżi PK tal-popolazzjoni.
English: • theophylline, used to treat asthma
Maltese: • theophylline, jintuża biex jittratta l-ażma
English: In MOBILITY, the improvement in physical functioning as measured by HAQ-DI was maintained up to Week 52 (-0.75, -0.71, and -0.46 for Kevzara 200 mg + MTX, Kevzara 150 mg + MTX, and placebo + MTX treatment groups, respectively).
Maltese: F'MOBILITY, it-titjib fil-funzjoni fiżika mkejjel permezz ta' HAQ-DI inżamm sa Ġimgħa 52 (-0.75, -0.71, u -0.46 għall-gruppi ta' trattament b'Kevzara 200 mg + MTX, Kevzara 150 mg + MTX, u plaċebo + MTX, rispettivament).
English: DAS28-ESR remission (< 2.6), n (%)
Maltese: Remissjoni DAS28-ESR (< 2.6), n valur p versus adalimumab
English: MOBILITY evaluated 1197 patients with RA who had inadequate clinical response to MTX.
Maltese: Studji kkontrollati bi plaċebo MOBILITY evalwa 1,197 pazjent b'RA li ma kellhomx rispons kliniku xieraq għal MTX.
English: • injection-site reactions (including redness and itching).
Maltese: • reazzjonjiet fil-post tal-injezzjoni (inkluż ħmura u ħakk).
English: Treatment with Kevzara + MTX was associated with significantly less radiographic progression of structural damage as compared with placebo.
Maltese: It-trattament b'Kevzara + MTX kien assoċjat ma' progressjoni radjografika ta' ħsara strutturali b'mod sinifikanti inqas meta mqabbel mal-plaċebo.
English: Decreases in neutrophil counts below 0.5 x 109/L occurred in 0.8% and 0.6% of patients in the 200 mg and 150 mg Kevzara+ DMARDs groups, respectively.
Maltese: Tnaqqis fl-għadd tan-newtrofili inqas minn 0.5 x 109/L seħħ f'0.8% u 0.6% talpazjenti fil-gruppi ta' 200 mg u 150 mg Kevzara+ DMARDs, rispettivament.
English: Elevated levels of interleukin-6 (IL-6) may down-regulate CYP activity such as in patients with RA and hence increase drug levels compared to subjects without RA.
Maltese: Livelli elevati ta' interleukin-6 (IL-6) jistgħu jirregolaw tnaqqis fl-attività ta' CYP bħal f'pazjenti b'RA u b'hekk iżidu l-livelli tal-mediċini meta mqabbla ma' individwi mingħajr RA.
English: DAS28-CRP remission (< 2.6) ACR20‡ ACR50
Maltese: remissjoni DAS28-CRP ACR20
English: Patients should be closely monitored for the development of signs and symptoms of infection during treatment with Kevzara (see sections 4.2 and 4.8).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għall-iżvilupp ta' sinjali u sintomi ta' infezzjoni waqt it-trattament b'Kevzara (ara sezzjonijiet 4.2 u 4.8).
English: The primary endpoints were the proportion of patients who achieved an ACR20 response at Week 24, changes from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Week 16, and change from baseline in van der Heijde-modified Total Sharp Score (mTSS) at Week
Maltese: (HAQ-DI, Health Assessment Questionnaire - Disability Index) f'Ġimgħa 16, u bidla mil-linja bażi fil-Punteġġ Totali ta' Sharp modifikat minn van der Heijde (mTSS, modified Total Sharp Score)
English: • if you have an active severe infection.
Maltese: • jekk inti għandek infezzjoni severa attiva.
English: The efficacy and safety of Kevzara were assessed in three randomised, double-blind, controlled multicentre studies (MOBILITY and TARGET were placebo-controlled studies and MONARCH was an active comparator-controlled study) in patients older than 18 years with moderately to severely active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
Maltese: (MOBILITY u TARGET kienu studji kkontrollati bi plaċebo u MONARCH kien studju ikkontrollat b'kumparatur attiv) li fihom la l-investigaturi u lanqas il-pazjenti kienu jafu liema sustanza qed tintuża f'pazjenti li kellhom aktar minn 18-il sena b'artrite rewmatojd attiva b'mod minn moderat sa sever iddijanjostikata skont il-kriterji tal-Kulleġġ Amerikan tar-Rewmatoloġija (ACR American College of Rheumatology).
English: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including Kevzara for RA.
Maltese: Infezzjonijiet serji u xi drabi fatali minħabba patoġeni batteriċi, mikobatteriċi, fungali invażivi, virali jew patoġeni opportunistiċi oħra ġew irrappurtati f'pazjenti li kienu qed jirċievu sustanzi immunosoppressivi inkluż Kevzara għal RA.
English: Placebo + MTX (N = 398)
Maltese: + MTX (N = 398)
English: Treatment with sarilumab resulted in decreases in fibrinogen and serum amyloid A, and increases in haemoglobin and serum albumin.
Maltese: It-trattament b'sarilumab wassal għal tnaqqis fil-fibrinoġin u l-amilojd A fis-serum, u żidiet fl-emoglobina u fl albumina fis-serum.
English: Kevzara should not be administered in patients with an active infection, including localised infections.
Maltese: Kevzara m'għandux jingħata lill-pazjenti b'infezzjoni attiva, inkluż infezzjonijet lokalizzati.
English: The most commonly reported infections (5% to 7% of patients) were upper respiratory tract infections, urinary tract infections, and nasopharyngitis.
Maltese: L-aktar infezzjonijiet irrappurtati b'mod komuni (5% sa 7% talpazjenti) kienu infezzjonijiet fin-naħa ta' fuq tal-apparat tan-nifs, infezzjonijiet fl-apparat tal-awrina, u nażofarinġite.
English: Recommendation
Maltese: LISTA
English: Physical function response
Maltese: Rispons tal-funzjoni fiżika
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kevzara (sarilumab) in one or more subsets of the paediatric population in chronic idiopathic arthritis (including rheumatoid arthritis, spondylarthritis, psoriatic arthritis and juvenile idiopathic arthritis) (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Kevzara (sarilumab) f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fl-artrite idjopatika kronika (inkluż artrite rewmatojd, spondilartrite, artrite psorjatika u artrite idjopatika tat-tfal u ż żgħażagħ) (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku). 5
English: • underlying conditions that may predispose them to infection;
Maltese: • diġà għandhom kundizzjonijiet li jistgħu jippredisponuhom għal infezzjoni;
English: Results at 24 weeks in TARGET were similar to the results at 52 weeks in MOBILITY (see Table 3).
Maltese: fil-ġimgħat 24 u 52 (ara Tabella 5).
English: Positive responses in the neutralizing antibody (NAb) assay were detected in 1.0%, 1.6%, and 0.2% of patients on Kevzara 200 mg, Kevzara 150 mg, and placebo respectively.
Maltese: Risponsi pożittivi fl-assaġġ talantikorp li jinnewtralizza (NAb, neutralizing antibody) setgħu jitkejlu f'1.0%, 1.6%, u 0.2% talpazjenti fuq Kevzara 200 mg, Kevzara 150 mg, u plaċebo rispettivament.
English: Two patients on Kevzara (0.2%) discontinued treatment due to injection site reactions.
Maltese: Żewġ pazjenti fuq Kevzara (0.2%) waqqfu t-trattament minħabba reazzjonijiet fil-post tal-injezzjoni.
English: * q2w=every two weeks † p-value <0.001 ††p-value <0.0001 ‡ Primary end point
Maltese: †valur p <0.01 għad-differenza mill-plaċebo ††valur p <0.
English: • There will be a “click” when the injection starts.
Maltese: • Se jkun hemm “klikk” meta tibda l-injezzjoni.
English: Patients treated with Kevzara + MTX (47.6% in the 200 mg treatment group and 47.0% in the 150 mg treatment group) achieved a clinically relevant improvement in HAQ-DI (change from baseline of
Maltese: Pazjenti ttrattati b'Kevzara + MTX (47.6% fil-grupp ta' trattament ta' 200 mg u 47.
English: CRP
Maltese: Tapp
English: At Week 4 the mean LDL increased by 14 mg/dL; mean triglycerides increased by 23 mg/dL; and mean HDL increased by 3 mg/dL. After Week 4 no additional increases were observed.
Maltese: F'Ġimgħa 4 il-medja tal-LDL żdiedet b'14-il mg/dL; il-medja tat-trigliċeridi żdiedet bi 23 mg/dL; u l-medja tal-HDL żdiedet bi 3 mg/dL.
English: Cases of herpes zoster were observed in clinical studies with Kevzara.
Maltese: Każijiet ta' erpete zoster kienu osservati fi studji kliniċi b'Kevzara.
English: Distribution In patients with RA, the apparent volume of distribution at steady state was 8.3 L.
Maltese: Distribuzzjoni F'pazjenti b'RA, il-volum apparenti ta' distribuzzjoni fl-istat fiss kien 8.3 L.
English: • Kevzara attaches to another protein called interleukin-6 (IL-6) receptor and blocks its action.
Maltese: • Kevzara jintrabat ma' proteina oħra msejħa riċettur ta' interleukin-6 (IL-6) u jimblokka lazzjoni tagħha.
English: Lipid abnormalities
Maltese: Bijotrasformazzjoni
English: Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.
Maltese: Żomm is-siringi mhux użati fil-kartuna oriġinali u aħżen fil-friġġ f'temperatura bejn 2ºC u 8ºC.
English: Sarilumab is a human monoclonal antibody selective for the interleukin-6 (IL-6) receptor, produced in Chinese Hamster Ovary cells by recombinant DNA technology.
Maltese: Sarilumab huwa antikorp monoklonali tal-bniedem selettiv għar-riċettur interleukin-6 (IL-6), magħmul f'ċelluli tal-Ovarju tal-Ħamster Ċiniż permezz ta' teknoloġija tad-DNA rikombinanti.
English: IL-6 is a pleiotropic cytokine that stimulates diverse cellular responses such as proliferation, differentiation, survival, and apoptosis and can activate hepatocytes to release acute-phase proteins, including C-reactive protein (CRP) and serum amyloid A. Elevated levels of IL-6 are found in the synovial fluid of patients with rheumatoid arthritis and play an important role in both the pathologic inflammation and joint destruction which are hallmarks of RA.
Maltese: divrenzjazzjoni, sopravivenza u apoptosi u jista' jattiva epatoċiti biex jirrilaxxaw proteini tal-istat akut, inkluż il-proteina C reattiva (CRP, C-reactive protein) u amilojd A tas-serum.
English: Hypersensitivity reactions have been reported in association with Kevzara (see section 4.8).
Maltese: Ġew irrappurtati reazzjonijiet ta' sensittività eċċessiva b'rabta ma' Kevzara (ara sezzjoni 4.8).
English: The pharmacokinetics of sarilumab were characterised in 2186 patients with RA treated with sarilumab which included 751 patients treated with 150 mg and 891 patients treated with 200 mg subcutaneous doses every two weeks for up to 52 weeks.
Maltese: Il-farmakokinetika ta' sarilumab ġiet deskritta f'2,186 pazjent b'RA trattati b'sarilumab li kienu jinkludu 751 pazjent itrattati bid-doża ta' 150 mg u 891 pazjent ittrattati bid-doża ta' 200 mg taħt il ġilda kull ġimagħtejn sa 52 ġimgħa.
English: In the placebo-controlled population, the rates of infections were 84.5, 81.0, and 75.1 events per 100 patient-years, in the 200 mg and 150 mg Kevzara + DMARDs and placebo + DMARDs groups respectively.
Maltese: Fil-popolazzjoni kkontrollata bil-plaċebo, ir-rati ta' infezzjonijiet kienu 84.5, 81.0, u 75.1 avveniment għal kull 100 sena ta' terapija tal-pazjenti, fil-gruppi ta' 200 mg u 150 mg Kevzara + DMARDs u plaċebo + DMARDs rispettivament.
English: Sarilumab is eliminated by parallel linear and non-linear pathways.
Maltese: Sarilumab jitneħħa permezz ta' sensiela ta' reazzjonijiet paralelli lineari u b'nuqqas ta' linearità.
English: • chronic or recurrent infection;
Maltese: • infezzjoni kronika jew rikurrenti;
English: Decrease in ANC was not associated with higher incidence of infections, including serious infections.
Maltese: Tnaqqis fl-ANC ma kienx assoċjat ma' inċidenza akbar ta' infezzjonijiet, inkluż infezzjonijiet serji.
English: • high cholesterol, high triglycerides shown by blood tests
Maltese: • kolesterol għoli, trigliċeridi għoljin li jidhru minn testijiet tad-demm
English: Sarilumab This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: TARGET evaluated 546 patients with RA who had an inadequate clinical response or were intolerant to one or more TNF-α antagonists.
Maltese: TARGET evalwa 546 pazjent b'RA li ma kellhomx rispons kliniku xieraq jew kienu intolleranti għal antagonist wieħed jew aktar ta' TNF-α.
English: • abnormal liver function tests
Maltese: • riżultati mhux normali għat-testijiet tal-funzjoni tal-fwied
English: Reduction in platelets was not associated with bleeding events (see section 4.8).
Maltese: It-tnaqqis fil plejtlits ma kienx assoċjat ma' avvenimenti ta' fsada (ara sezzjoni 4.8).
English: Kevzara 200 mg was superior to adalimumab 40 mg in reducing disease activity and improving physical function, with more patients achieving clinical remission over 24 weeks (see Table 6).
Maltese: Kevzara 200 mg kien superjuri għal adalimumab 40 mg fit-tnaqqis tal-attività tal-marda u t-tijib talfunzjoni fiżika, b'aktar pazjenti jiksbu remissjoni klinika fuq perjodu ta' 24 ġimgħa (ara Tabella 6).
English: Blockade of IL-6 signalling by IL-6Rα antagonists such as sarilumab might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to altered medicinal products concentrations.
Maltese: sinjali permezz ta' IL-6 minn antagonisti ta' IL-6Rα bħal sarilumab jista' jreġġa' lura l-effett inibitorju ta' IL-6 u jġib lura l-attività ta' CYP, li jwassal għal konċentrazzjonijiet mibdula ta' prodotti mediċinali.
English: ALT > 3 to 5 x ULN Treatment with Kevzara should be withheld until < 3 x ULN.
Maltese: It-trattament b'Kevzara għandu jitwaqqaf sakemm < 3 x ULN.
English: • Initiating treatment with Kevzara is not recommended in patients with a low neutrophil count, i.e., ANC less than 2 x 109/L.
Maltese: • Mhuwiex rrakkomandat li trattament b'Kevzara jinbeda f'pazjenti b'għadd baxx ta' newtrofili, i.e., ANC inqas minn 2 x 109/L.
English: In patients experiencing a decrease in absolute neutrophil count (ANC), modification of treatment regimen such as interruption of Kevzara or reduction in dose resulted in an increase or normalization of ANC (see section 4.2).
Maltese: F'pazjenti li kellhom tnaqqis fl-għadd assolut tan-newtrofili (ANC, absolute neutrophil count), modifikazzjoni fl-iskeda tat trattament bħal twaqqif temporanju ta' Kevzara jew tnaqqis fid-doża wassal għal żieda jew normalizzazzjoni ta' ANC (ara sezzjoni 4.2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON with the Blue Box - MULTIPACK OF 6 (3 PACKS OF 2) PRE-FILLED PENS
Maltese: KARTUNA TA' BARRA bil-Kaxxa l-Blu - PAKKETT MULTIPLU TA' 6 (3 PAKKETTI TA'
English: No formal study of the effect of renal impairment on the pharmacokinetics of sarilumab was conducted.
Maltese: Ma sar l-ebda studju formali dwar l-effet ta' indeboliment tal-kliewi fuq il-farmakokinetika ta' sarilumab.
English: Kevzara 150 mg solution for injection in pre-filled syringe Kevzara 150 mg solution for injection in pre-filled pen Kevzara 200 mg solution for injection in pre-filled syringe Kevzara 200 mg solution for injection in pre-filled pen
Maltese: Kevzara jista' imbagħad jitkompla bid-doża ta' 150 mg kull ġimagħtejn u jiżdied għal 200 mg kull ġimagħtejn skont kif ikun xieraq b'mod kliniku.
English: Rensselaer
Maltese: Planġer
English: Kevzara has not been studied in patients with severe renal impairment (see section 5.2).
Maltese: Kevzara ma ġiex studjat f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 5.2).
English: As a monoclonal antibody sarilumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Maltese: Bħala antikorp monoklonali sarilumab huwa mistenni li jitkisser f'peptidi żgħar u aċidi amminiċi permezz ta' sensiela ta' reazzjonijiet kataboliċi bl-istess mod ta' IgG endoġenuż.
English: In MOBILITY and TARGET, physical function and disability were assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI).
Maltese: F'MOBILITY u TARGET, il-funzjoni fiżika u d-diżabilità ġew stmati permezz tal-Indiċi ta' Diżabilità tal-Kwestjonarju ta' Valutazzjoni tas-Saħħa (HAQ-DI).
English: For further details on administration of this medicinal product see section 6.6.
Maltese: Għal aktar dettalji dwar l-għoti ta' dan il-prodott mediċinali ara sezzjoni 6.6.
English: In the Kevzara +DMARDs long-term safety population, the rates of infections and serious infection were 57.3 and 3.4 events per 100-patient years, respectively.
Maltese: Fil-popolazzjoni ta' sigurtà fit-tul ta' Kevzara +DMARDs, ir-rati ta' infezzjonijiet u infezzjoni serja kienu 57.3 u 3.4 avveniment għal kull 100 sena ta' terapija ta' pazjent, rispettivament.
English: The activity of sarilumab in reducing inflammation is associated with laboratory changes such as decrease in ANC and elevation in lipids (see section 4.4).
Maltese: L-attività ta' sarilumab fit-tnaqqis tal-infjammazzjoni hija assoċjata ma' tibdiliet tal-laboratorju bħal tnaqqis fl-ANC u żieda fil-lipidi (ara sezzjoni 4.4).
English: PHARMACEUTICAL FORM
Maltese: Regeneron Pharmaceuticals
English: There were no reports of gastrointestinal perforation in the Kevzara monotherapy population.
Maltese: Ma kien hemm l-ebda rapporti ta' perforazzjoni gastrointestinali fil-popolazzjoni ta' monoterapija b'Kevzara.
English: DAS28-CRP remission (< 2.6)
Maltese: remissjoni DAS28-CRP
English: Caution should be exercised in patients who start Kevzara treatment while on therapy with CYP3A4 substrates (e.g., oral contraceptives or statins), as Kevzara may reverse the inhibitory effect of IL-6 and restore CYP3A4 activity, leading to decreased exposure and activity of CYP3A4 substrate.
Maltese: (eż., kontraċettivi orali jew statins), minħabba li Kevzara jista' jreġġa' lura l effett inibitorju ta' IL-6 u jirritorna l-attività ta' CYP3A4, li jwassal għal tnaqqis fl-esponiment u flattività tas-sustrat ta' CYP3A4.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F-75008 Paris France
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq sanofi-aventis groupe 54, rue La Boétie F-75008 Paris Franza
English: *cDMARDs in TARGET included MTX, sulfasalazine, leflunomide and hydroxychloroquine p-value <0.01 for difference from placebo ††p-value <0.001 for difference from placebo †††p-value <0.0001 for difference from placebo ‡ Primary endpoint § NA=Not Applicable as TARGET was a 24-week study ¶ Major clinical response = ACR70 for at least 24 consecutive weeks during the 52-week period
Maltese: *cDMARDs f'TARGET kienu jinkludu MTX, sulfasalazine, leflunomide u hydroxychloroquine valur p <0.01 għad-differenza mill-plaċebo ††valur p <0.
English: Treatment with Kevzara should be withheld until >100 x 103/µL.
Maltese: It-trattament b'Kevzara għandu jitwaqqaf sakemm >100 x 103/µl.
English: • other biological medicines used in the treatment of rheumatoid arthritis.
Maltese: • mediċini bijoloġiċi oħra użati fit-trattament ta' artrite rewmatojd
English: In the placebo-controlled population, malignancies occurred at the same rate in patients receiving either Kevzara + DMARDs or placebo + DMARDs (1.0 events per 100 patient-years).
Maltese: Fil-popolazzjoni kkontrollata bi plaċebo, tumuri malinni seħħew bl-istess rata f'pazjenti li jew kienu qed jirċievu Kevzara + DMARDs jew plaċebo + DMARDs (avveniment 1.0 għal kull 100 sena ta' terapija ta' pazjent).
English: Kevzara should not be administered to patients with known hypersensitivity to sarilumab (see section 4.3).
Maltese: Kevzara m'għandux jingħata lill-pazjenti magħrufa li għandhom sensitttività eċċessiva għal sarilumab (ara sezzjoni 4.3).