FrancophonIA/ELRC3.0 huggingface dataset:
English: At a dose of 200 mg/kg, representing 11-fold a human exposure at 10 mg/kg based on AUC, limited changes in immune function (a 9-fold increase in the mean T-cell-dependent antibody response in female pups and inflammation of the thyroid of 1 female pup out of 10 male and 10 female pups evaluated at this dose) were observed.
Maltese: F'doża ta' 200 mg/kg, li tirrappreżenta 11-il darba l-espożizzjoni umana b'doża umana ta' 10 mg/kg ibbażata fuq AUC, ġie osservat tibdil limitat fil-funzjoni ta' l-immunità (żieda ta' 9 darbiet iktar fil-medja tar-rispons ta' antikorpi dipendenti fuq iċ-ċelluli-T fi frieħ nisa u infjammazzjoni tat-tirojde ta' ferħ mara (wieħed) minn 10 ifrieħ irġiel u 10 nisa evalwati b'din iddoża.
English: Studies in adult mice and monkeys have not demonstrated similar findings.
Maltese: Studji fuq ġrieden u xadini adulti ma wrewx sejbiet simili.
English: Uncommon Increased tendency to bruise, dry skin, alopecia, pruritus, urticaria, psoriasis, acne, erythema, hyperhidrosis
Maltese: Mhux komuni Żieda fit-tendenza għat-tbenġil, ġilda xotta, alopeċja, prurite, urtikarja, psorjażi, akne, eritema, iperidrosi
English: Placebo +MTX n = 253
Maltese: Plaċebo +MTX n = 253
English: EU/1/07/389/004-010 EU/1/07/389/013-014
Maltese: EU/1/07/389/013-014
English: In study VI, ACR responses were assessed at 2 years in 232 patients with 85% ACR 20 responses, 74% ACR 50 responses, and 54% ACR 70 responses.
Maltese: Fi studju VI, risponsi għal ACR kienu evalwati wara sentejn f'232 pazjent b'85% ta' risponsi għal ACR 20, 74% rispons għal ACR 50 u 54% rispons għal ACR 70.
English: Uncommon (may affect up to 1 in 100 people): tooth infection, nail fungal infection, infection in the muscles, blood stream infection, collection of pus under the skin, kidney infection, ear infection low white blood cells count skin cancer, skin warts low blood platelet count allergic reactions depression, anxiety, sleep disturbance migraine numbness dry eye, reduced vision eye inflammation palpitation, rapid heart rate, low heart rate low blood pressure, hot flush, blood vessels inflammation, flushing difficulty in breathing, wheezing, shortness of breath, acute worsening of a lung disease called chronic obstructive pulmonary disease (COPD) throat tightness rhinitis increased tendency to bruise, dry skin, psoriasis, skin redness, excessive sweating, acne hair loss, itching, hives painful joints pain in the extremities absence of menstruation, excessive menses flu-like illness, increased weight, infusion-related reactions
Maltese: Mhux komuni (jista' jaffettwa sa persuna 1 minn kull 100): infezzjoni tas-snien, infezzjoni tad-dwiefer b'fungus, infezzjoni fil-muskoli, infezzjoni fil-fluss tad-demm, ġbir ta' materja taħt il-ġilda, infezzjoni tal-kliewi, infezzjoni tal-widnejn għadd baxx ta' ċelloli tad-demm bojod kanċer tal-ġilda, felul fuq il-ġilda għadd baxx ta' plejtlits tad-demm reazzjonijiet allerġiċi dipressjoni, ansjetà, disturb fl-irqad emigranja tnemnim għajnejn xotti, tnaqqis fil-vista infjammazzjoni fl-għajnejn palpitazzjonijiet, rata rapida ta' tħabbit tal-qalb, rata baxxa ta' tħabbit tal-qalb pressjoni tad-demm baxxa, sensazzjoni ta' sħana kbira f'daqqa fil-ġisem, infjammazzjoni talvażi tad-demm, fwawar fil-wiċċ diffikultà fit-teħid tan-nifs, tħarħir, qtugħ ta' nifs, aggravar akut ta' mard tal-pulmun magħruf bħala mard pulmonari ostruttiv kroniku (COPD) għafis fil-griżmejn rinite tendenza akbar għat-tbenġil, ġilda xotta, psorijasi, ħmura tal-ġilda, għaraq eċċessiv, akne telf ta' xagħar, ħakk, ħorriqija uġigħ fil-ġogi uġigħ fl-estremitajiet nuqqas ta' mestruwazzjoni, mensi eċċessivi mard li jixbaħ l-influwenza, żieda fil-piż, reazzjonijiet relatati mal-infużjoni
English: Flare was defined as: ≥ 30% worsening in at least 3 of the 6 pJIA core set variables ≥ 30% improvement in not more than 1 of the 6 pJIA core set variables ≥ 2 cm (possible up to 10 cm) of worsening must have been present if the Physician or Parent Global Assessment was used to define flare worsening in ≥ 2 joints must have been present if the number of active joints or joints with limited range of motion was used to define flare
Maltese: Aggravament kien definit bħala: aggravament ta' ≥ 30% f'mill-inqas 3 mis-6 varjabbli tas-sett prinċipali ta' pJIA titjib ta' ≥ 30% f'mhux iktar minn 1 mis-6 varjabbli tas-sett prinċipali ta' pJIA aggravament ta' ≥ 2 ċm (possibbli sa 10 ċm) irid ikun preżenti jekk l-Evalwazzjoni Globali tatTabib jew tal-Ġenitur tkun intużat biex tiddefinixxi aggravament aggravament f'≥ 2 ġogi jrid ikun preżenti jekk in-numru ta' ġogi attivi jew ġogi b'medda limitata ta' moviment ikun intuża biex jiddefinixxi aggravament
English: Of the 190 patients enrolled, 170 completed Period A, 65% (123/190) achieved an ACR Pedi 30 response, and 122 were randomised to Period B. Responses were similar in all subtypes of pJIA studied and for patients with or without methotrexate use.
Maltese: Mill-190 pazjent irreġistrati, 170 temmew Perjodu A, 65 % (123/190) kisbu rispons għal ACR Pedi 30, u 122 ġew randomizzati għal Perjodu B.
English: Dose-dependent reductions were observed with abatacept in serum levels of soluble interleukin2 receptor, a marker of T lymphocyte activation; serum interleukin-6, a product of activated synovial macrophages and fibroblast-like synoviocytes in rheumatoid arthritis; rheumatoid factor, an autoantibody produced by plasma cells; and C-reactive protein, an acute phase reactant of inflammation.
Maltese: B'abatacept, ġie osservat tnaqqis fil-livelli fis-serum ta'riċetturi interleukin-2 solubuli, markatur ta' lattivazzjoni tal- limfoċiti-T; interleukin-6 fis-serum, prodott ta' makrofaġi sinovjali attivati u sinoviċite simili għal fibroblast f'artrite tar-rewmatiżmu; fattur ta' rewmatojde, awto-antikorp magħmul miċ-ċelluli tal-plasma; u proteina C-reattiva, li tirreaġġixxi fil-fażi akuta ta' infjammazjoni.
English: DAS28-Remission a Odds Ratio (95% CI) vs. MTX P value
Maltese: MTX fi 12-il Xahar (95% CI)* Punteġġ tal-Erożjoni tal-MRI
English: Uncommon Chronic obstructive pulmonary disease exacerbated, bronchospasm, wheezing, dyspnea, throat tightness
Maltese: Mhux komuni Aggravar ta' mard pulmonari ostruttiv kroniku, bronkospażmu, tħarħir, dispnea, għafis filgriżmejn
English: During the initial double blind 6 months period (short term period), the overall immunogenicity frequency to abatacept was 1.1% (8/725) and 2.3% (16/710)for the subcutaneous and intravenous groups, respectively.
Maltese: Matul il-perjodu double blind inizjali ta' 6 xhur (perjodu ta' żmien qasir), ilfrekwenza ġenerali ta' immunoġeniċità għal abatacept kienet 1.1% (8/725) u 2.3% (16/710) għallgruppi li ħaduh taħt il-ġilda u dawk li ħaduh fil-vini, rispettivament.
English: BATCH NUMBER
Maltese: Numru ta' Kunjettib
English: Unopened vial
Maltese: Doża rakkomandata
English: Most randomised Period B patients entered Period C (58/60 Period B abatacept recipients; 59/62 Period B placebo recipients), as did 36 of the 47 Period A non-responders (n=153 total patients).
Maltese: Ħafna mill-pazjenti randomizzati fil-Perjodu B daħlu fil-Perjodu Ċ (58/60 reċipjenti ta' abatacept talPerjodu B; 59/62 reċipjenti ta' plaċebo tal-Perjodu B), kif għamlu 36 mis-47 mhux reċipjenti talPerjodu A (n=153pazjenti totali).
English: ORENCIA 87.5 mg solution for injection in pre-filled syringe with light blue plunger pack of 4 pre-filled syringes with needle guard.
Maltese: ORENCIA 87.5 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bi planġer ċelesti pakkett ta' 4 siringi mimlijin għal-lest bi protezzjoni għal-labra.
English: This medicinal product contains 34.5 mg sodium per maximum dose of 4 vials (8.625 mg sodium per vial), equivalent to 1.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 34.5 mg ta' sodju għal kull doża massima ta' 4 kunjetti (8.625 mg ta' sodju f'kull kunjett), ekwivalenti għal 1.7% tat-teħid tal-ammont massimu rakkomandat mid-WHO ta' 2 g ta' sodju għal adult kuljum.
English: Patients were randomised to receive placebo or abatacept 3 mg/kg, 10 mg/kg, or two doses of 30 mg/kg followed by 10 mg/kg, without escape for 24 weeks, followed by open label abatacept 10 mg/kg monthly intravenous every month.
Maltese: Il-pazjenti ġew randomizzati biex jirċievu plaċebo jew abatacept 3 mg/kg, 10 mg/kg, jew żewġ dożi ta' 30 mg/kg segwit minn 10 mg/kg, mingħajr ma nqabżu għal 24 ġimgħa, segwit minn abatacept open-label 10 mg/kg fix-xahar ġol-vini kull xahar.
English: In study I, ACR responses were assessed at 7 years in 43 patients with 72% ACR 20 responses, 58% ACR 50 responses, and 44% ACR 70 responses.
Maltese: Fi studju I, risponsi ta' ACR ġew evalwati sa 7 snin fi 43 pazjent b'rispons ta' 72% għal ACR 20, rispons ta' 58% għal ACR 50, rispons ta' 44% għal ACR 70.
English: In the placebo-controlled clinical trials, the frequencies of malignancies in abatacept- and placebotreated patients were 1.2% and 0.9%, respectively (see section 4.8).
Maltese: Fi provi kliniċi kkontrollati bi plaċebo, il-frekwenza ta' tumuri malinni f'pazjenti ttrattati b'abatacept u bi plaċebo kienet 1.2% u 0.9% rispettivament (ara sezzjoni 4.8).
English: Co-administration of ORENCIA with biologic immunosuppressive or immunomodulatory agents could potentiate the effects of abatacept on the immune system (see section 4.5).
Maltese: M'hemmx evidenza biżejjed biex tiġi vvalutata s-sigurtà u l-effikaċja ta' abatacept fuq is-sistema immuni (ara sezzjoni 4.5).
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq ilpreparazzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: Concomitant MTX, NSAIDs, corticosteroids, and TNF-inhibitors did not influence abatacept apparent clearance.
Maltese: L-għoti konkomitanti ta' MTX, NSAIDs, kortikosterojdi u inibituri ta' TNF ma influwenzax l-eliminazzjoni apparenti ta' abatacept.
English: Uncommon Basal cell carcinoma, skin papilloma Rare
Maltese: Mhux komuni Karċinoma taċ-ċelloli bażiċi, papilloma tal-ġilda Rari
English: Intravenous
Maltese: INJETTA
English: Please refer to the ORENCIA powder for concentrate for solution for infusion 250 mg and ORENCIA solution for injection in prefilled syringe 125 mg, 87.5 mg and 50 mg SmPCs.
Maltese: Jekk jogħġbok irreferi għall-SmPC ta' ORENCIA trab għall-konċentrat għal soluzzjoni għall-infużjoni 250 mg u ORENCIA soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest 125 mg 87.5 mg u 50 mg.
English: The dose of abatacept was 500 mg for patients weighing less than 60 kg, 750 mg for patients weighing 60 to 100 kg, and 1,000 mg for patients weighing greater than 100 kg.
Maltese: Id-doża ta' abatacept kienet 500 mg għall-pazjenti li kienu jiżnu inqas minn 60 kg, 750 mg għall-pazjenti li kienu jiżnu 60 sa 100 kg, u 1,000 mg għall-pazjenti li kienu jiżnu iktar minn 100 kg.
English: During the first 4-month treatment period of intravenous and subcutaneous abatacept in 409 patients with pJIA, the most common adverse reactions were nasopharyngitis (3.7% patients) and upper respiratory tract infection (2.9% patients).
Maltese: Waqt l-ewwel perjodu ta' kura ta' 4 xhur ta' abatacept ġol-vini u taħt ilġilda f'409 pazjenti b'pJIA, ir-reazzjonijiet avversi l-aktar komuni kienu nażofarinġite (3.7 % talpazjenti) u infezzjoni fl-apparat respiratorju ta' fuq (2.9 % tal-pazjenti).
English: Abatacept/methotrexate reduced the rate of progression of structural damage compared to placebo/methotrexate after 12 months of treatment as shown in Table 5.
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 5.
English: ORENCIA 125 mg solution for injection in pre-filled syringe with orange plunger packs of 1, or 4 pre-filled syringes and multipack containing 12 pre-filled syringes (3 packs of packs of 1, 3, or 4 pre-filled syringes with needle guard and multipack containing 12 pre-filled syringes with needle guard (3 packs of 4).
Maltese: ORENCIA 125 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest bi planġer oranġjo pakketti ta' 1, jew 4 siringi mimlijin għal-lest u pakkett multiplu li fih 12-il siringa mimlijin għal-lest (3 pakketti ta' 4). pakketti ta' 1, 3, jew 4 siringi mimlijin għal-lest bi protezzjoni għal-labra u pakkett multiplu li fih 12-il siringa mimlijin għal-lest bi protezzjoni għal-labra (3 pakketti ta' 4).
English: 0.7 mL pre-filled syringe (type 1 glass) with an automatic needle safety guard and flange extenders (light blue plunger).
Maltese: Siringa mimlija għal-lest ta' 0.7 mL (ħġieġ ta' tip 1) bi protezzjoni awtomatika għal-labra u extenders tal-flanġ (planġer blu ċar).
English: A total of 404 patients 65 years of age and older, including 67 patients 75 years and older, received intravenous abatacept in placebo-controlled clinical trials.
Maltese: Total ta' 404 pazjenti ta' 65 sena jew ikbar, inklużi 67 pazjent ta' 75 sena jew ikbar, irċevew abatacept fi provi kliniċi kkontrollati bi plaċebo.
English: Overall antibodies against abatacept were generally transient and of low titer.
Maltese: L-antikorpi globali kontra abatacept kienu ġeneralment temporanji u ta' titer baxx.
English: In the placebo-controlled clinical trials with abatacept, infections at least possibly related to treatment were reported in 22.7% of abatacept-treated patients and 20.5% of placebo-treated patients.
Maltese: Fil-provi kliniċi kkontrollati bi plaċebo b'abatacept, infezzjonijiet li ta' l-inqas jista' jkollhom ilpossibbiltà li għandhom x'jaqsmu mat-trattament ġew irrapportati fi 22.7% tal-pazjenti ttrattati b'abatacept u f'20.5% tal-pazjenti ttrattati bi plaċebo.
English: Recommended dose in adults
Maltese: Doża rakkomandata fl-adulti
English: Patients entering the two PsA studies had mild to moderate psoriasis with median PASI scores of 8.6 in PsA-I and 4.5 in PsA-II.
Maltese: PsA kellhom psorjasi ħafifa sa moderata b'punteġġi ta' PASI medjani ta' 8.6 f'PsA-I u 4.5 f'PsA-II.
English: EU/1/07/389/001 1 vial and 1 silicone-free syringe
Maltese: EU/1/07/389/001 kunjett u siringa mingħajr silikon
English: In study PsA-II, the proportion of patients who achieved PASI 50 response was 26.7% with abatacept vs. 19.6% with placebo (7.3 [-2.2, 16.7], estimate of difference [95% CI]), and the proportion of patients who achieved PASI 75 response was 16.4% with abatacept vs. 10.1% with placebo (6.4 [-1.3, 14.1], estimate of difference [95% CI]).
Maltese: Fl-istudju PsA-II, ilproporzjon ta' pazjenti li ġabu rispons ta' PASI 50 kien ta' 26.7% b'abatacept vs. 19.6% bi placebo (7.3 [-2.2, 16.7], stima ta' differenza [95% CI]), u l-proporzjon ta' pazjenti li ġabu rispons ta' PASI 75 kien ta' 16.4% b'abatacept vs. 10.
English: The percent of patients achieving ACR 20, 50, or 70 responses at the recommended abatacept dose in studies PsA-I (10 mg/kg intravenous) and PsA-II (125 mg subcutaneous) are presented in Table 7 below.
Maltese: Il-perċentwali ta' pazjenti li ġabu ACR ta' 20, 50 jew 70 rispons bid-doża rakkomandata ta' abatacept fi studji PsA-I (10 mg/kg ġol-vini) u PsA-II (125 mg taħt il-ġilda) huma ppreżentati fit-Tabella 7 ta' hawn taħt.
English: Powder for concentrate for solution for infusion.
Maltese: a Ibbażat fuq analiżi mhux parametrika.
English: * p < 0.05 vs placebo, p values not assessed for ACR 50 and ACR 70. a 37% of patients were previously treated with TNF inhibitor.
Maltese: * p < 0.05 kontra plaċebo, il-valuri p ma ġewx ivvalutati għal ACR 50 u ACR 70.
English: In PsA-I, patients were randomised to receive intravenous placebo or abatacept 3 mg/kg (3/3 mg/kg), 10 mg/kg (10/10 mg/kg), or two doses of 30 mg/kg followed by 10 mg/kg (30/10 mg/kg), on day 1, 15, 29, and then every 28 days thereafter.
Maltese: F'PsA-I, il-pazjenti ġew randomizzati biex jirċievu plaċebo jew abatacept ġol-vini 3 mg/kg (3/3 mg/kg), 10 mg/kg (10/10 mg/kg), jew żewġ dożi ta' 30 mg/kg segwiti minn 10 mg/kg (30/10 mg/kg), f'jum 1, 15, 29, imbagħad kull 28 jum wara dan il-perjodu.
English: Twenty-two of 48 evaluable patients showed significant neutralizing activity.
Maltese: Tnejn u għoxrin minn fost 48 pazjent li seta' jiġi vvalutat urew attività newtralizzanti sinifikanti.
English: In study III, ACR responses were assessed at 5 years in 91 patients with 74% ACR 20 responses, 51% ACR 50 responses, and 23% ACR 70 responses.
Maltese: Fi studju III, risponsi ta' ACR ġew evalwati wara 5 snin f'91 pazjent b'rispons ta' 74% għal ACR 20, rispons ta' 51% għal ACR 50, u rispons ta' 23% għal ACR 70.
English: NAME OF THE MEDICINAL PRODUCT ORENCIA 250 mg powder for concentrate for solution for infusion 2.
Maltese: ORENCIA 250 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni 2.
English: Dose
Maltese: Stikk
English: In PsA-I, patients were randomised to receive intravenous placebo or abatacept 3 mg/kg (3/3 mg/kg), 10 mg/kg (10/10 mg/kg), or two doses of 30 mg/kg followed by 10 mg/kg (30/10 mg/kg), on day 1,
Maltese: F'PsA-I, il-pazjenti ġew randomizzati biex jirċievu plaċebo jew abatacept ġol-vini 3 mg/kg (3/3 mg/kg), 10 mg/kg (10/10 mg/kg), jew żewġ dożi ta' 30 mg/kg segwiti minn 10 mg/kg
English: Improvement from baseline as measured by HAQ-DI at 24 months and over time was also similar between abatacept SC and adalimumab SC.
Maltese: Titjib mil-linja bażi kif imkejjel minn HAQ-DI wara 24 xahar u maż-żmien kien simili wkoll bejn abatacept SC u adalimumab SC.
English: At 10 mg/kg, the mean terminal half-life was 13.1 days, ranging from 8 to 25 days.
Maltese: B'10 mg/kg, il-medja tal-half-life terminali kienet 13.1-il jum, fuq medda ta' 8 sa 25 jum.
English: Two patients (2/117, 1.7%) using the SC prefilled pen experienced local injection site reactions.
Maltese: Żewġ pazjenti (2/117, 1.7%) li użaw il-pinna mimlija għal-lest esperjenzaw reazzjonijiet lokali fis-sit tal-injezzjoni.
English: Dates of ORENCIA Treatment:
Maltese: Dati tat-Trattament b'ORENCIA:
English: In the 6 to 17 year age cohort, the overall rate of seropositivity during the cumulative period including post abatacept follow-up was 4.7% (8/172): 2.3% (4/172) on treatment and 13.6% (6/44) after discontinuation of abatacept (≥ 28 days after the last dose).
Maltese: Filkoorti ta' dawk bejn is-6 u s-17-il sena, ir-rata globali ta' seropożittività matul il-perjodu kumulattiv inkluż fil-perjodu ta' segwitu wara abatacept kienet ta' 4.7% (8/172): 2.3% (4/172) fuq il-kura u ta' 13.6% (6/44) wara t-twaqqif ta' abatacept (≥ 28 jum wara l-aħħar doża).
English: Anti-abatacept antibodies were generally transient and of low titer.
Maltese: Antikorpi anti-abatacept kienu ġeneralment temporanji u ta' titer baxx.
English: EU/1/07/389/006 12 pre-filled syringes (3 packs of 4)
Maltese: EU/1/07/389/006 12-il siringa mimlijin għal-lest (3 pakketti ta' 4)
English: During the first 4-month open-label period, the overall safety profile in these 409 pJIA patients was similar to that observed in the RA population with the following exceptions in the pJIA patients:
Maltese: Waqt l-ewwel perjodu open-label ta' 4 xhur, il-profil ta' sigurtà globali f'dawn l-409 pazjent b'pJIA kien simili għal dak osservat fil-popolazzjoni ta' RA bl-eċċezzjonijiet li ġejjin fil-pazjenti b'pJIA:
English: Patients were allowed to receive stable doses of concomitant methotrexate, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial.
Maltese: Il-pazjenti kienu permessi li jirċievu dożi stabbli ta' methotrexate konkomitranti, kortikosterojdi ta' doża baxxa (ekwivalenti għal ≤ 10 mg ta' prednisone) u/jew NSAIDs waqt il-prova.
English: A total of 270 patients 65 years of age and older, including 46 patients 75 years and older, received subcutaneous abatacept in controlled clinical trials.
Maltese: Total ta' 270 pazjent ta' 65 sena u aktar, inklużi 46 pazjent ta' 75 sena u aktar, irċevew abatacept taħt il-ġilda fi provi kliniċi kkontrollati.
English: In these studies, clinically and statistically significant improvement was observed in the abatacept group as compared with the placebo group in all 8 domains of the SF-36 (4 physical domains: physical function, role physical, bodily pain, general health; and 4 mental domains: vitality, social function, role emotional, mental health), as well as the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Maltese: F'dawn l-istudji, it-titjib klinikament u statistikament sinifikattiv ġie osservat fil-grupp ta' abatacept meta mqabbel mal-grupp tal-plaċebo fit-8 oqsma kollha tal-SF-36 (4 oqsma fiżiċi: funzjoni fiżika, rwol fiżiku, uġigħ fil-ġisem, saħħa b'mod ġenerali; u 4 oqsma mentali: vitalità, funzjoni soċjali, rwol emozzjonali, saħħa mentali), kif ukoll is-Sommarju tal-Komponent Fiżiku (Physical Component Summary - PCS) u s-Sommarju tal-Komponent Mentali (Mental Component Summary - MCS).
English: In the smaller study PsA-I, the ACR 20 responses with abatacept 10 mg/kg intravenous vs placebo in patients who were TNF inhibitor-naive were 55.6% vs 20.0%, respectively, and in patients who were TNF inhibitorexperienced were 30.8% vs 16.7%, respectively.
Maltese: 0%, rispettivament, u f'pazjenti li kellhom esperjenza ta' inibitur ta' TNF kienu ta' 30.8% vs 16.7%, rispettivament.
English: In study PsA-I, the proportions of patients achieving PASI 50 response was 28.6% with abatacept vs. 14.3% with placebo (14.3 [-15.3, 43.9], estimate of difference [95% CI]), and the proportion of patients who achieved PASI 75 response was 14.3% with abatacept vs. 4.8% with placebo (9.5 [-13.0, 32.0], estimate of difference [95% CI]).
Maltese: Fl-istudju PsA-I, il-proporzjon ta' pazjenti li ġabu rispons ta' PASI 50 kien ta' 28.6% b'abatacept vs. 14.3% bi placebo (14.3 [-15.3, 43.9], stima ta' differenza [95% CI]), u l-proporzjon ta' pazjenti li ġabu rispons ta' PASI 75 kien ta' 14.3% b'abatacept vs. 4.8% bi placebo (9.5
English: The percent of patients achieving ACR 20, 50, or 70 responses at the recommended abatacept dose in studies PsA-I (10 mg/kg intravenous ) and PsA-II (125 mg subcutaneous ) are presented in Table 8 below.
Maltese: Il-perċentwali ta' pazjenti li ġabu ACR ta' 20, 50 jew 70 rispons bid-doża rakkomandata ta' abatacept fi studji PsA-I (10 mg/kg ġol-vini) u PsA-II (125 mg taħt il-ġilda) huma ppreżentati fit-Tabella 8 ta' hawn taħt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled pen contains 125 mg abatacept in one mL.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Pinna mimlija għal-lest fiha 125 mg abatacept f'1 mL.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'2°C - 8°C.
English: As in study SC-I, there was no effect of immunogenicity on safety or efficacy.
Maltese: Bħal fi studju SC-I, ma kienx hemm effett tal-immunoġeniċità fuq is-sigurtà u l-effikaċja.
English: EU/1/07/389/009 12 pre-filled syringes with needle guard (3 packs of 4)
Maltese: EU/1/07/389/009 12-il siringa mimlijin għal-lest bi protezzjoni għal-labra (3 pakketti ta' 4)
English: When receiving ORENCIA, patients that require blood glucose monitoring should be advised to consider methods that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods.
Maltese: Meta jieħdu ORENCIA, pazjenti li għandhom bżonn monitoraġġ talglucose fid-demm iridu jiġu avżati biex jikkonsidraw metodi li ma jagħmlux reazzjoni ma' maltose, bħal metodi ta' testijiet ibbażati fuq glucose dehydrogenase nicotine adenine dinucleotide (GDHNAD), glucose oxidase jew glucose hexokinase.
English: Month 12
Maltese: Jum 15
English: Paediatric population Polyarticular juvenile idiopathic arthritis
Maltese: Popolazzjoni pedjatrika Artrite idjopatika ġovanili poliartikulari
English: Proceed to Step 5
Maltese: Pass 5:
English: Abatacept was also evaluated in an open-label study in rheumatoid arthritis patients administered the seasonal influenza trivalent virus vaccine.
Maltese: Abatacept ġie evalwat ukoll fi studju open-label f'pazjenti b'artrite rewmatojde li ngħataw it-tilqima b'virus trivalenti kontra l-influwenza staġjonali.
English: Window
Maltese: Stenna