FrancophonIA/ELRC3.0 huggingface dataset:
English: In study SC-III, abatacept subcutaneous was evaluated in combination with methotrexate, or as abatacept monotherapy, and compared to MTX monotherapy in induction of remission following 12 months of treatment, and the possible maintenance of drug-free remission after complete drug withdrawal, in adult MTX-naive patients with highly active early rheumatoid arthritis (mean DAS28-CRP of 5.4; mean symptom duration less than 6.7 months) with poor prognostic factors for rapidly progressive disease (e.g. anti-citrullinated protein antibodies [ACPA+], as measured by anti-CCP2 assay, and/or RF+, baseline joint erosions).
Maltese: Fi studju SC-III, abatacept taħt il-ġilda ġie evalwat flimkien ma' methotrexate, jew bħala monoterapija ta' abatacept, u mqabbel ma' monoterapija ta' MTX fl-induzzjoni ta' remissjoni wara 12-il xahar ta' kura, u fl-induzzjoni tarremissjoni wara 12-il xahar ta' kura, u ż-żamma possibbli ta' remissjoni mingħajr mediċina wara rtirar sħiħ tal-mediċina, f'pazjenti adulti li qatt ma ġew ikkurati b'MTX qabel, b'artrite rewmatojde attiva ħafna, bikrija (DAS28-CRP medju ta' 5.4, durata tas-sintomi medja inqas minn 6.7 xhur) b'fatturi ta' tbassir dgħajfin għal marda li tipprogressa malajr (eż., antikorpi tal-proteina antiċitrullinati [ACPA+], kif imkejjel skont assaġġ kontra CCP2, u/jew RF+, erożjonijiet fil-ġog fil-linja bażi).
English: Clinical efficacy and safety in adult rheumatoid arthritis
Maltese: Effikaċja klinika u sigurtà f'adulti b'artrite rewmatojde
English: Over the 2 year study period, 3.8 % (12/318) and 1.5 % (5/328) patients treated with abatacept SC and adalimumab SC respectively reported autoimmune disorders mild to moderate in severity (e.g., psoriasis, Raynaud's phenomenon, erythema nodosum).
Maltese: Fuq il-perjodu tal-istudju ta' sentejn, 3.8% (12/318) u 1.5% (5/328) tal-pazjenti kkurati b'abatacept SC u adalimumab SC rispettivament, irrappurtataw disturbi awtoimmuni minn ħfief sa moderati fis-severità (eż., psorjażi, il-fenomenu ta' Raynaud, eritema nodosum).
English: The incidence rate of autoimmune disorders in abatacept-treated patients during the double-blind period was 8.8 (7.6, 10.1) per 100 person-years of exposure and for placebo-treated patients was 9.6 (7.9, 11.5) per 100 person-years of exposure.
Maltese: Ir-rata ta' inċidenza ta' disturbi awtoimmuni f'pazjenti li ngħataw kura b'abatacept matul il-perjodu ‘double blind' kienet ta' 8.8 (7.6, 10.1) għal kull 100 sena ta' pazjent ta' esponiment u għal pazjenti li ngħataw kura bi plaċebo din kienet ta' 9.6 (7.9, 11.5) għal kull 100 sena ta' pazjent ta' esponiment.
English: In study SC-III, abatacept subcutaneous was evaluated in combination with methotrexate (MTX), or as abatacept monotherapy, and compared to MTX monotherapy in induction of remission following 12 months of treatment, and the possible maintenance of drug-free remission after complete drug withdrawal, in adult MTX-naive patients with highly active early, rheumatoid arthritis (mean DAS28-CRP of 5.4; mean symptom duration less than 6.7 months) with poor prognostic factors for rapidly progressive disease (e.g., anti-citrullinated protein antibodies [ACPA+], as measured by antiCCP2 assay, and/or RF+, baseline joint erosions).
Maltese: Fi studju SC-III, abatacept taħt il-ġilda ġie evalwat flimkien ma' methotrexate (MTX), jew bħala monoterapija ta' abatacept, u mqabbel ma' monoterapija ta' MTX flinduzzjoni ta' remissjoni wara 12-il xahar ta' kura, u fl-induzzjoni tar-remissjoni wara 12-il xahar ta' kura, u ż-żamma possibbli ta' remissjoni mingħajr mediċina wara rtirar sħiħ tal-mediċina, f'pazjenti adulti li qatt ma ġew ikkurati b'MTX qabel, b'artrite rewmatojde attiva ħafna, bikrija (DAS28-CRP medju ta' 5.4, durata tas-sintomi medja inqas minn 6.7 xhur) b'fatturi ta' tbassir dgħajfin għal marda li tipprogressa malajr (eż., antikorpi tal-proteina antiċitrullinati [ACPA+], kif imkejjel skont assaġġ kontra CCP2, u/jew RF+, erożjonijiet fil-ġog fil-linja bażi).
English: In the 2 to 5 year age cohort, the overall rate of seropositivity during the cumulative period including post abatacept follow-up was 15.2% (7/46): 10.9% (5/46) on treatment and 37.5% (3/8) after discontinuation of abatacept (≥ 28 days after the last dose).
Maltese: 2% (7/46): 10.9% (5/46) fuq il-kura u ta' 37.5% (3/8) wara ttwaqqif ta' abatacept (≥ 28 jum wara l-aħħar doża).
English: ORENCIA 125 mg solution for injection in pre-filled syringe The active substance is abatacept.
Maltese: ORENCIA 125 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Is-sustanza attiva hija abatacept.
English: Determine the dose and the number of ORENCIA vials needed (see section 4.2).
Maltese: Stabbilixxi d-doża u n-numru ta' kunjetti ta' ORENCIA li hemm bżonn (ara sezzjoni 4.2).
English: The primary endpoint for both PsA-I and PsA-II was the proportion of patients achieving ACR 20 response at Week 24 (day 169).
Maltese: Il-punt aħħari primarju għal kemm PsA-I u PsA-II kien il-proporzjon ta' pazjenti li ġabu rispons ta' ACR 20 f'Ġimgħa 24 (jum 169).
English: Proceed to Step 6
Maltese: Pass 6:
English: Higher ACR 20 responses in study PsA-II were seen with abatacept 125 mg subcutaneous vs. placebo irrespective of concomitant non-biological DMARD treatment.
Maltese: Fi studju PsA-II, dehru risponsi ta' ACR 20 ogħla b'abatacept 125 mg taħt il-ġilda vs. plaċebo irrispettivament minn kura b'DMARD mhux bijoloġika konkomitanti.
English: 10 kg to less than 25 kg
Maltese: 10 kg sa anqas minn 25 kg
English: ORENCIA 50 mg solution for injection in pre-filled syringe The active substance is abatacept.
Maltese: ORENCIA 50 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Is-sustanza attiva hi abatacept.
English: Abatacept SC n = 116 Proportion of randomised patients with induction of remission after 12 months of treatment DAS28-Remissiona Odds Ratio (95% CI) vs. MTX P value
Maltese: Abatacept SC n = 116 Proporzjon ta' pazjenti li ntgħażlu b'mod każwali bl-induzzjoni ta' remissjoni wara 12-il xahar ta' kura
English: ORENCIA 50 mg solution for injection in pre-filled syringe with white plunger pack of 4 pre-filled syringes with needle guard.
Maltese: ORENCIA 50 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bi planġer abjad pakkett ta' 4 siringi mimlijin għal-lest bi protezzjoni għal-labra.
English: the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
Maltese: f'pazjenti adulti li ma rrispondewx b'mod xieraq għal terapija li ngħatat qabel b'mediċina jew mediċini oħra ta' kontra r-rewmatiżmu li jimmodifikaw l-marda (disease-modifying anti rheumatic drugs, DMARDs) li jinkludu methotrexate (MTX) jew impeditur ta' fattur ta' nekrożi tat-tumuri (TNF)-alfa.
English: Abatacept/methotrexate reduced the rate of progression of structural damage compared to placebo/methotrexate after 12 months of treatment as shown in Table 4.
Maltese: Abatacept/methotrexate naqqas ir-rata ta' progressjoni tal-ħsara strutturali meta mqabbel ma' plaċebo/methotrexate wara 12-il xahar ta' trattament hekk kif muri fitTabella 4.
English: ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults.
Maltese: ORENCIA jintuża biex jittratta l-artrite rewmatojde u l-artrite psorjatika fl-adulti.
English: In study II, ACR responses were assessed at 5 years in 270 patients with 84% ACR 20 responses, 61% ACR 50 responses, and 40% ACR 70 responses.
Maltese: Fi studju II, ir-risponsi ta' ACR ġew evalwati wara 5 snin f'270 pazjent b'rispons ta' 84% għal ACR 20, rispons ta' 61% għal ACR 50, rispons ta' 40% għal ACR 70.
English: Fatigue, asthenia Uncommon Influenza like illness, weight increased
Maltese: Mhux komuni Mard simili għall-influwenza, żieda fil-piż
English: In addition, serum levels of matrix metalloproteinase-3, which produces cartilage destruction and tissue remodelling, were decreased.
Maltese: Barra minn hekk, il-livelli fis-serum ta' matrix metalloproteinases-3, li jipproduċi l-qerda tal-qarquċa u rimudellar tat-tessut, naqsu.
English: Vial (15 mL Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium).
Maltese: Kunjett (15 mL ħġieġ ta' Tip 1) b'tapp (gomma halobutyl) u siġill li jinfetaħ b'daqqa ta' saba' (aluminju).
English: Summary of the safety profile in rheumatoid arthritis
Maltese: Sommarju tal-profil tas-sigurtà f'artrite rewmatojde
English: There have been reports of non-melanoma skin cancers in patients receiving ORENCIA (see section 4.8).
Maltese: Kien hemm rapporti ta' tuberkolożi f'pazjenti li kienu qegħdin jirċievu ORENCIA (ara sezzjoni 4.8).
English: Studies I, II, III, V, and VI required patients to have at least 12 tender and 10 swollen joints at randomisation.
Maltese: Studji I, II, III, V u VI ħtieġu pazjenti li kellhom tal-inqas 12-il ġog fi stat teneru u 10 ġogi minfuħin fuq bażi każwali.
English: Typical estimates for distribution volume and elimination half-life were 0.12 L/kg and 11.4 days, respectively, for a child weighing 40 kg. As a result of the higher body-weight normalised clearance and volume of distribution in pJIA patients, the predicted and observed systemic exposures of abatacept were lower than that observed in adults, such that the observed mean (range) peak and trough concentrations were 204 (66 to 595) mcg/mL and 10.6 (0.15 to 44.2) mcg/mL, respectively, in patients weighing less than 40 kg, and 229 (58 to 700) mcg/mL and 13.1 (0.34 to 44.6) mcg/mL, respectively, in patients weighing 40 kg or greater.
Maltese: B'riżultat ta' tneħħija normalizzata għal-linja bażi tal-piż tal-ġisem u volum tad-distribuzzjoni ogħla f'pazjenti b'pJIA, l-espożizzjonijiet sistemiċi mbassra u osservati ta' abatacept kienu iktar baxxi minn dawk osservati fl-adulti, b'tali mod li medja osservata (medda) tal-konċentrazzjonijiet massimi u minimi kienu ta' 204 (66 sa 595) mcg/mL u 10.6
English: During the open-label periods of studies I, II, III, and VI the improvement in physical function has been maintained through 7 years, 5 years, 5 years, and 2 years, respectively.
Maltese: Waqt il-perjodi open-label ta' studji I, II, III, u IV it-titjib fil-funzjoni fiżika nżamm sa 7 snin, 5 snin, 5 snin u sentejn, rispettivament.
English: ORENCIA 87.5 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 87.5 mg of abatacept in 0.7 mL.
Maltese: ORENCIA 87.5 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 87.5 mg ta' abatacept f'0.7 mL.
English: Greater improvement (p < 0.001) in DAS28 was observed with abatacept and with infliximab compared to placebo at six months in the placebo-controlled portion of the trial; the results between the abatacept and infliximab groups were similar.
Maltese: Titjib ikbar (p < 0.001) f'DAS28 ġie osservat b'abatacept u b'infliximab meta mqabbla ma' plaċebo wara 6 xhur fil-porzjon ta' l-istudju kkontrollat minn plaċebo; ir-riżultati bejn il-gruppi ta' abatacept u infliximab kienu simili.
English: Population pharmacokinetic analysis of abatacept serum concentration data from patients with pJIA 6 to 17 years of age following administration of intravenous abatacept 10 mg/kg revealed that the estimated clearance of abatacept, when normalised for baseline body weight, was higher in pJIA patients (0.4 mL/h/kg for a child weighing 40 kg) versus adult rheumatoid arthritis patients.
Maltese: Analiżi farmakokinetika tal-popolazzjoni ta' dejta dwar il-konċentrazzjoni fis-serum ta' abatacept minn pazjenti b'pJIA li kellhom bejn 6 snin sa 17-il sena wara l-għoti ta' abatacept ġol-vini 10 mg/kg, żvelat li t-tneħħija stmata ta' abatacept, meta normalizzata għal-linja bażi tal-piż tal-ġisem, kienet ogħla f'pazjenti b'pJIA (0.4 mL/siegħa/kg għal tifel jew tifla li jiżnu 40 kg) meta mqabbel ma' pazjenti adulti b'artrite rewmatojde.
English: ClickJect Pre-filled Pen
Maltese: Protezzjoni tal-labra klikk
English: In the cumulative period in clinical trials in 7,044 patients treated with abatacept during 20,510 patient-years, the incidence rate of serious infections was 2.4 per 100 patient-years, and the annualised incidence rate remained stable.
Maltese: Fil-perjodu kumulattiv fil-provi kliniċi li saru fuq 7,044 pazjent ittrattat b'abatacept waqt 20,510 sena ta' pazjenti, ir-rata ta' inċidenza ta' infezzjonijiet serji kienet ta' 2.4 għal kull 100 sena ta' pazjent, u rrata annwalizzata ta' inċidenza baqgħet stabbli.
English: The ACR responses in study V were consistent with the DAS28 score.
Maltese: Ir-risponsi ta' ACR fi studju V kienu konsistenti ma' l-iskor ta' DAS28.
English: Patients on controlled sodium diet
Maltese: Pazjenti fuq dieta li tikkontrolla t-teħid ta' sodium
English: Needle Cover (cap)
Maltese: Għatu tal-labra (kappa)
English: 125 mg/mL Pre-filled Syringe
Maltese: 125 mg/mL Siringa mimlija għal-Lest
English: Patients had active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with DMARD therapy and had one qualifying psoriatic skin lesion of at least 2 cm in diameter.
Maltese: Ilpazjenti kellhom PsA attiva (≥ 3 ġogi minfuħin u ≥ 3 ġogi teneri) minkejja kura preċedenti b'terapija b'DMARD u kellhom leżjoni tal-ġilda psorjatika waħda li kkwalifikat ta' dijametru ta' tal-inqas 2 cm.
English: Each pre-filled syringe contains 50 mg of abatacept in 0.4 mL.
Maltese: Siringa waħda mimlija għal-lest fiha 50 mg abatacept f'0.4 mL.
English: In study IV, there were 37 patients with COPD treated with intravenous abatacept and 17 treated with placebo.
Maltese: Fi studju IV, kien hemm 37 pazjent b'COPD ittrattati b'abatacept ġol-vini u 17 ittrattati bi plaċebo.
English: Combination with TNF-inhibitors
Maltese: Żomm nota tal-injezzjoni
English: Adult psoriatic arthritis
Maltese: Adulti b'artrite psorjatika
English: ORENCIA is available in packs of 1 vial and 1 silicone-free syringe, and in multipacks containing 2, or 3 vials and 2, or 3 silicone-free syringes (2 or 3 packs of 1).
Maltese: ORENCIA huwa disponibbli f'pakketti ta' 1 kunjett u 1 siringa mingħajr silikon, u f'pakketti multipli li fihom 2, jew 3 kunjetti u 2, jew 3 siringi mingħajr silikon (2 jew 3 pakketti ta' 1).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ORENCIA 125 mg injection abatacept
Maltese: U MNEJN GĦANDU JINGĦATA ORENCIA 125 mg injezzjoni abatacept
English: No major safety issues were identified with use of abatacept in combination with sulfasalazine, hydroxychloroquine, or leflunomide.
Maltese: Ma ġew identifikati punti sostanzjali ta' sigurtà bl-użu ta' abatacept meta mogħti flimkien ma' sulfasalazine, hydroxychloroquine jew leflunomide.
English: Remission rates at end of drug treatment and drug withdrawal phases in study SC-III
Maltese: Rati ta' remmissjoni fit-tmiem tal-kura bil-mediċina u fażijiet tal-irtirar tal-mediċina fi studju SC-III
English: The rate of progression of structural damage in year 2 was significantly lower than that in year 1 for patients randomised to abatacept (p < 0.0001).
Maltese: Ir-rata ta' progressjoni tal-ħsara strutturali fis-sena 2 kienet ferm inqas minn dik f'sena 1 għal pazjenti mogħtija abatacept fuq bażi każwali (p < 0.0001).
English: Pack of 1 vial and 1 silicone-free syringe (polyethylene), and multipacks containing 2, or 3 vials and 2, or 3 silicone-free syringes (2 or 3 packs of 1).
Maltese: Pakketti ta' 1 kunjett u 1 siringa mingħajr silikon (polyethylene), u pakketti multipli li fihom 2, jew 3 kunjetti u 2, jew 3 siringi mingħajr silikon (2 jew 3 pakketti ta' 1).
English: The syringe should not be shaken.
Maltese: Armi kull soluzzjoni mhux użata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 125 mg abatacept in one mL.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa mimlija għal-lest fiha 125 mg abatacept f'1 mL.
English: The overall frequency of injection site reactions was 2.6% (19/736) and 2.5% (18/721) for the subcutaneous abatacept group and the subcutaneous placebo group (intravenous abatacept), respectively.
Maltese: Il-frekwenza ġenerali tar-reazzjonijiet fis-sit tal-injezzjoni kienet 2.6% (19/736) u 2.5% (18/721) għall-grupp li ħa abatacept taħt il-ġilda u l-grupp li ħa plaċebo taħt il-ġilda (abatacept fil-vini), rispettivament.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ORENCIA 87.5 mg injection abatacept
Maltese: U MNEJN GĦANDU JINGĦATA ORENCIA 87.5 mg injezzjoni abatacept
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħżin wara rikostituzzjoni u dilwizzjoni tal-prodott mediċinali, ara ttaqsima 6.3.
English: The results from studies II, III, and VI are shown in Table 6.
Maltese: II, III u IV jidhru f'Tabella 6.
English: The results from studies II, III, and VI are shown in Table 7.
Maltese: II, III u IV jidhru f'Tabella 7.
English: Common (may affect up to 1 in 10 people): upper airway infection (including infections of nose, sinus and throat) fever
Maltese: Komuni (jista' jaffettwa sa persuna 1 minn kull 10): infezzjoni fil-passaġġ tal-arja ta' fuq (inkluż infezzjonijiet tal-imnieħer, tas-sinus u tal-gerżuma) deni
English: Co-administration of abatacept with biologic immunosuppressive or immunomodulatory agents could potentiate the effects of abatacept on the immune system.
Maltese: L-għoti fl-istess ħin ta' abatacept ma' sustanzi immunosuppressivi jew immunomodulatorji bijoloġiċi jista' jsaħħaħ l-effetti ta' abatacept is-sistema immuni.
English: Consequently, these infants may be at increased risk of infection.
Maltese: Għaldaqstant, dawn it-trabi jistgħu jkunu f'riskju ikbar ta' infezzjoni.
English: The efficacy and safety of intravenous abatacept were assessed in randomised, double-blind, placebocontrolled clinical trials in adult patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
Maltese: L-effikaċja u s-sigurtà ta' abatacept ġol-vini ġew ivvalutati fi provi kliniċi double-blind ikkontrollati bi plaċebo magħmulin fuq bażi każwali f'pazjenti adulti b'artrite tar-rewmatiżmu attiva ddijanjostikata skond il-kriterji tal-kulleġġ Amerikan tar-rewmatoloġija (ACR).
English: Proceed to Step 1
Maltese: Kompli għal Pass 1.
English: Inadequate response to MTX
Maltese: Qatt ma ħadu MTX
English: Each pre-filled pen contains 125 mg of abatacept in one mL.
Maltese: Pinna mimlija għal-lest fiha 125 mg abatacept f'1 mL.
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+ 49 (0)89 121 42 350)
Maltese: KGaA Tel: 0800 0752002 (+49 (0)89 121 42 350)
English: Uncommon Conjunctivitis, dry eye, visual acuity reduced
Maltese: Mhux komuni Konġuntivite, għajn xotta, tnaqqis fl-akutezza tal-vista
English: Air Bubble
Maltese: QABEL TIBDA
English: Flange extender
Maltese: Agħfas u Żomm
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ORENCIA 50 mg injection abatacept
Maltese: U MNEJN GĦANDU JINGĦATA ORENCIA 50 mg injezzjoni abatacept
English: The rate of seropositivity while patients were receiving abatacept therapy was 0.5% (1/189) during Period A; 13.0% (7/54) during Period B; and 12.8% (19/148) during Period C. For patients in Period B who were randomised to placebo (therefore withdrawn from therapy for up to 6 months) the rate of seropositivity was 40.7% (22/54).
Maltese: Irrata ta' seropożittività waqt li l-pazjenti kienu qed jirċievu t-terapija b'abatacept kienet ta' 0.5% (1/189) matul Perjodu A; 13.0% (7/54) matul Perjodu B; u 12.8% (19/148) matul Perjodu Ċ.
English: In study VI, the efficacy and safety of abatacept were assessed in methotrexate-naive, Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide 2 (Anti-CCP2)-positive patients with early, erosive rheumatoid arthritis (≤ 2 years disease duration) who were randomised to receive abatacept plus methotrexate or methotrexate plus placebo.
Maltese: Fi studju VI, l-effikaċja u s-sigurtà ta' abatacept kienu evalwati f'pazjenti li qatt ma kienu ħadu methotrexate u li kienu pożittivi għal Fattur tar-Rewmatojde (RF) u/jew anti-Cyclic Citrullinated Peptide 2 (Anti CCP2), b'artrite rewmatojde bikrija u li tmermer (marda li damet ≤ sentejn) u li ġew magħżula b'mod każwali biex jirċievu abatacept flimkien ma' methotrexate jew methotrexate flimkien ma' plaċebo.
English: Liquid
Maltese: Tieqa
English: Mean steady-state trough concentrations were approximately 25 mcg/mL, and mean Cmax concentrations were approximately 290 mcg/mL.
Maltese: Il-medja ta' l-inqas konċentrazzjonijiet fi stat stabbli kienet bejn wieħed u ieħor 25 mcg/mL, u l-medja tal-konċentrazzjonijiet Cmas kienet bejn wieħed u ieħor 290 mcg/mL.
English: Overall, 6.9% (15/218) of subjects (cohorts combined) had a positive immunogenicity response relative to baseline during the cumulative period, including the 4-month short-term treatment period, 20-month extension treatment period and the 6-month post abatacept follow-up period.
Maltese: B'mod ġenerali, 6.9% (15/218) tal-individwi (koorti kkombinati) kellhom rispons immunoġeniku pożittiv relattiv għal-linja bażi matul il-perjodu kumulattiv, inkluż il-perjodu qasir ta' kura ta' 4 xhur, il-perijodu ta' kura ta' estensjoni ta' 20 xahar u l-perjodu ta' segwitu ta' 6 xhur wara abatacept.
English: The symptoms described above can be signs of the side effects listed below, all of which have been observed with ORENCIA in adult clinical trials:
Maltese: Is-sintomi deskritti hawn fuq jistgħu jkunu sinjali ta' effetti sekondarji elenkati hawn isfel, li kollha ġew osservati b'ORENCIA fi provi kliniċi fuq adulti:
English: Package leaflet: Information for the patient ORENCIA 50 mg solution for injection in pre-filled syringe ORENCIA 87.5 mg solution for injection in pre-filled syringe ORENCIA 125 mg solution for injection in pre-filled syringe abatacept
Maltese: Informazzjoni għall-pazjent ORENCIA 50 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest ORENCIA 87.5 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest ORENCIA 125 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest abatacept
English: In rats and rabbits, abatacept exposure was up to 29-fold a human 10 mg/kg exposure based on AUC.
Maltese: Fil-firien u l-fniek, l-espożizzjoni għal abatacept kienet sa 29 darba iktar l-espożizzjoni mid-doża umana ta' 10 mg/kg ibbażata fuq AUC.
English: During the extension period of the pJIA studies (20 months in the pJIA ongoing SC study and 5 years in the pJIA IV study), the safety profile in the pJIA patients aged 6 to 17 years was comparable to that seen in adult patients.
Maltese: Waqt il-perjodu ta' estensjoni ta' studji ta' pJIA (20 xahar fl-istudju ta' pJIA SC u 5 snin fl-istudju ta' pJIA IV), il-profil ta' sigurtà fil-pazjenti b'pJIA li kellhom bejn 6 sa 17-il sena kien komparabbli ma' dak li ġie osservat fl-adulti.
English: After pneumococcal vaccination, 62 of 112 abatacept-treated patients were able to mount an adequate immune response of at least a 2-fold increase in antibody titers to pneumococcal polysaccharide vaccine.
Maltese: Wara t-tilqima pnewmokokkali, 62 mill-112-il pazjent ikkurati b'abatacept kienu kapaċi jipproduċu rispons immuni adegwat ta' mill-inqas żieda bid-doppju ta' titres ta' antikorpi għat-tilqima polysaccharide pnewmokokkali.
English: In SC-I, the ACR 20 response rates at day 169 for subcutaneous and intravenous abatacept were respectively 78.3% (472/603 SC) and 76.0% (456/600 IV) in patients < 65 years, versus 61.1% (55/90 SC) and 74.4% (58/78 IV) for patients ≥ 65 years.
Maltese: F'SC-I, ir-rati ta' rispons ta' ACR 20 f'jum 169 għal abatacept mogħti taħt il-ġilda u ġol-vini kienu rispettivament 78.3% (472/603 SC) u 76.0% (456/600
English: B. PACKAGE LEAFLET
Maltese: b Kif osservat
English: 0.7 mL Fill line
Maltese: 0.7 mL
English: walking, hygiene, reach, grip, and activities.
Maltese: qawmien, ikel, mixi, iġjene, ilħuq, qbid u attivitajiet.
English: For children and adolescents aged 6 to 17 years with polyarticular juvenile idiopathic arthritis who weigh less than 75 kg, the recommended dose of intravenous abatacept is 10 mg/kg.
Maltese: Għal tfal u adolexxenti li jkollhom minn 6 snin sa 17-il sena b'artrite idjopatika ġovanili poliartikulari li jiżnu inqas minn 75 kg, id-doża rakkomandata ta' abatacept ġol-vini hi ta' 10 mg/kg.