FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies I, II, III, IV, V, VI, SC-II, and SC-III evaluated 339, 638, 389, 1441, 431, 509, 646, and 351 adult patients, respectively.
Maltese: Studji I, II, III, IV, V, VI, SC-II u SC-III evalwaw 339, 638, 389, 1,441, 431, 509, 646 u 351 pazjent adult rispettivament.
English: Allow the syringe to rest at room temperature for 30 to 60 minutes before you inject.
Maltese: Ħalli s-siringa toqgħod fit-temperatura ambjentali għal 30 sa 60 minuta qabel ma tinjettaha.
English: Studies I, II, III, IV, V, VI, SC-I, SC-II, and SC-III evaluated 339, 638, 389, 1441, 431, 509, 1371, 646, and 351 adult patients, respectively.
Maltese: Studji I, II, III, IV, V, VI, SC-I, SC-II u SC-III evalwaw 339, 638, 389, 1,441, 431, 509, 1,371, 646 u 351 pazjent adult rispettivament.
English: ≥ 60 kg to ≤ 100 kg
Maltese: ≥ 60 kg sa ≤ 100 kg
English: This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.7 % tat-teħid fid-dieta massimu ta' kuljum rakkomandat ta' sodium għal adult.
English: Excipient with known effect sodium: 0.375 mmol (8.625 mg) per vial
Maltese: Eċċipjent b'effett magħruf sodium: 0.375 mmol (8.625 mg) f'kull kunjett
English: Parenteral medicinal products containing maltose can interfere with the readings of blood glucose monitors that use test strips with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ).
Maltese: Prodotti mediċinali parenterali li fihom maltose jistgħu jinterferixxu mar-riżultati ta' moniters talglucose fid-demm li jużaw strippi għat-testijiet bi glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ).
English: Tuberculosis, bacteraemia, gastrointestinal infection, pelvic inflammatory disease
Maltese: Tuberkolożi, batteremija, infezzjoni gastrointestinali, marda infjammatorja tal-pelvis
English: Adverse reactions in patients with chronic obstructive pulmonary disease (COPD)
Maltese: Reazzjonijiet avversi f'pazjenti b'mard pulmonari ostruttiv kroniku (COPD)
English: Abdomen, avoid 5 cm around navel
Maltese: L-addome, evita 5 cm madwar iż-żokra
English: * n = 119 for Abatacept SC + MTX; n = 116 for MTX
Maltese: * n = 119 għal Abatacept SC + MTX; n = 116 għall-MTX
English: Table 8:
Maltese: Tabella 8:
English: The systemic clearance was approximately 0.22 mL/h/kg.
Maltese: L-eliminazzjoni sistemika kienet bejn wieħed u ieħor 0.22 mL/h/kg.
English: DAS28CRP
Maltese: Remissjoni DAS28CRPe
English: Abatacept Abatacept Placebo Abatacept group in Period B
Maltese: Abatacept Abatacept Plaċebo Grupp ta' abatacept f'Perjodu B
English: * p < 0.05, abatacept vs. placebo.
Maltese: * p < 0.05, abatacept vs. plaċebo.
English: The mean distribution volume (Vss) was 0.07 L/kg and ranged from 0.02 to 0.13 L/kg.
Maltese: Il-volum medju tad-distribuzzjoni (Vss) kien 0.07 L/kg u varja bejn 0.02 u 0.13 L/kg.
English: responses, and 40% ACR 70 responses.
Maltese: 40% għal ACR 70.
English: 125 mg/mL orange plunger
Maltese: 125 mg/mL planġer oranġjo
English: Boolean Clinical Remission Estimate of Difference (95% CI) vs. MTX
Maltese: Remissjoni Klinika Boolean Stima ta' Differenza (95% CI) vs.
English: The most frequently reported event with abatacept (1-2%) was dizziness.
Maltese: L-aktar avvenimentli ġie rrapportat b'mod frekwenti b'abatacept (1-2%) kien sturdament.
English: Placebo +DMARDsb
Maltese: Plaċebo +DMARDsb
English: Placebo +DMARDsb n = 133
Maltese: Plaċebo +DMARDsb n = 133
English: * No active joints, physician's global assessment of disease severity ≤10 mm and CRP ≤0.6 mg/dL.
Maltese: * Ebda ġog attiv, valutazzjoni globali tat-tabib tas-severità tal-marda ≤10 mm u CRP ≤0.6 mg/dL.
English: The pJIA IV study included 190 patients in the 6 to 17 year age cohort.
Maltese: L-istudju ta' pJIA IV inkluda 190 pazjent fil-koorti tal-età ta' 6 sa 17-il sena.
English: For ITT; n=736, 721 for subcutaneous (SC) and intravenous (IV) abatacept,
Maltese: Għal ITT; n = 736, 721 għal abatacept mogħti taħt il-ġilda (SC) u ġol-vina (IV), rispettivament
English: *** p < 0.001, abatacept vs. placebo.
Maltese: *** p < 0.001, abatacept vs. plaċebo. †
English: Other medicines and ORENCIA
Maltese: Mediċini oħra u ORENCIA
English: The respective values for ACR 50 and ACR 70 at 12 months and 24 months were consistent and similar for abatacept and adalimumab.
Maltese: Il-valuri rispettivi għal ACR 50 u ACR 70 wara 12 u 24 xahar kienu konsistenti u simili għal abatacept u adalimumab.
English: Serious adverse reactions were reported in 3.5% (11/318) and 6.1% (20/328) of the respective group.
Maltese: Reazzjonijiet avversi serji ġew irrappurtati fi 3.5% (11/318) u 6.1% (20/328) tal-grupp rispettiv.
English: Liver function test abnormal (including transaminases increased)
Maltese: Test tal-funzjoni tal-fwied mhux normali (inkluż żieda fit-transaminases)
English: ORENCIA, in combination with methotrexate, is indicated for:
Maltese: ORENCIA, meta kkombinat ma' methotrexate, huwa indikat:
English: Placebo +MTX
Maltese: Plaċebo +MTX
English: Doctor's Name: ____________________
Maltese: Isem tal-Pazjent: ____________________
English: Uncommon Hypersensitivity
Maltese: Mhux komuni Sensittività eċċessiva
English: At 6 months, the incidence of AE of infections were 48.1% (75), 52.1% (86), and 51.8% (57) and the incidence of serious AE of infections were 1.3% (2), 4.2% (7), and 2.7% (3) for abatacept, infliximab and placebo groups, respectively.
Maltese: Wara 6 xhur, l-inċidenza ta' AE ta' infezzjonijiet kienu 48.1% (75), 52.1% (86), u 51.8% (57) u l-inċidenza ta' AE serja ta' infezzjonijiet kienet 1.3% (2), 4.2% (7), u 2.7% (3) għal abatacept, infliximab u gruppi ta' plaċebo rispettivament.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA24
Maltese: Immunosuppressanti, immunosuppressanti selettivi, Kodiċi ATC:
English: In Period A all patients received 10 mg/kg of abatacept on days 1, 15, 29, 57 and 85 and were assessed on day 113.
Maltese: F'Perjodu A, il-pazjenti kollha rċivew 10 mg/kg ta' abatacept f'jiem 1, 15, 29, 57 u 85 u kienu evalwati f'jum 113.
English: Alcohol swab
Maltese: Swab bl-alkoħol
English: Lymphoma, lung neoplasm malignant, squamous cell carcinoma
Maltese: Limfoma, neoplasmi malinni fil-pulmun, karċinoma taċ-ċelloli skwamużi
English: Formal studies of the potential effect of abatacept on human fertility have not been conducted.
Maltese: Ma sarux studji formali fuq l-effetti potenzjali ta' abatacept fuq il-fertilità umana.
English: Start:
Maltese: PASS:
English: ORENCIA increases the risk of getting infections.
Maltese: ORENCIA iżid ir-riskju li int tieħu infezzjoni.
English: Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic Tlymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1).
Maltese: Abatacept huwa proteina tal-fużjoni li tikkonsisti mid-domain ekstraċellulari ta' l-antiġen 4 assoċjat mal-limfoċite T ċitotossika (CTLA-4) uman mqabbad ma' porzjon Fc modifikat ta' immunoglobulina umana G1 (IgG1) umana.
English: c Major clinical response is defined as achieving an ACR 70 response for a continuous 6-month period.
Maltese: c Rispons kliniku maġġuri huwa definit bħala l-ilħuq ta' rispons ta' ACR 70 għal perijodu kontinwu ta' 6 xhur.
English: Tuberculosis (TB): You should be screened for TB prior to ORENCIA treatment.
Maltese: Tuberkolożi (TB): Għandek tiġi ċċekkjat/a għal TB qabel trattament b'ORENCIA.
English: The geometric mean (CV%) cmin at day 169 were 7.8 mcg/mL (56.3%) for the 3/3 mg/kg, 24.3 mcg/mL (40.8%) for 10/10 mg/kg, and 26.6 mcg/mL (39.0%) for the 30/10 mg/kg regimens.
Maltese: Il-medja ġeometrika (CV%) cmin f'jum 169 kien 8 mcg/mL (56.3%) għar-reġimen ta' 3/3 mg/kg, 24.3 mcg/mL (40.8%) għal 10/10 mg/kg, u 26.6 mcg/mL (39.0%) għar-reġimen ta' 30/10 mg/kg.
English: 0.4 mL Fill line
Maltese: 0.4 mL Linja tal-mili
English: Read carefully.
Maltese: Aqra b'attenzjoni.
English: EU/1/07/389/007 1 pre-filled syringe with needle guard EU/1/07/389/008 4 pre-filled syringes with needle guard EU/1/07/389/010 3 pre-filled syringes with needle guard
Maltese: EU/1/07/389/007 Siringa mimlija għal-lest bi protezzjoni għal-labra EU/1/07/389/008 4 siringi mimlijin għal-lest bi protezzjoni għal-labra EU/1/07/389/010 3 siringi mimlijin għal-lest bi protezzjoni għal-labra
English: Respiratory disorders occurred more frequently in abatacept-treated patients than in placebo-treated patients (10.8% vs. 5.9%, respectively); these included COPD exacerbation, and dyspnea.
Maltese: Disturbi respiratorji seħħew bi frekwenza ikbar f'pazjenti trattati b'abatacept milli f'dawk trattati bi plaċebo (10.8% vs. 5.9% rispettivament); dawn inkludew aggravar ta' COPD u dispneja.
English: EU/1/07/389/002 2 vials and 2 silicone-free syringes (2 packs of 1) EU/1/07/389/003 3 vials and 3 silicone-free syringes (3 packs of 1)
Maltese: EU/1/07/389/002 2 kunjetti u 2 siringi mingħajr silikon (2 pakketti ta' 1) EU/1/07/389/003 3 kunjetti u 3 siringi mingħajr silikon (3 pakketti ta' 1)
English: Pre-filled syringe with UltraSafe Passive Needle guard
Maltese: Siringa mimlija għal-lest bi Protezzjoni għal-Labra Passiva UltraSafe
English: Transparent Tip
Maltese: Tarf Trasparenti
English: Abatacept selectively inhibits this costimulatory pathway by specifically binding to CD80 and CD86.
Maltese: Abatacept selettivament jinibixxi din il-linja ta' ko-stimulazzjoni billi jaqbad speċifikament ma' CD80 u CD86.
English: Patients entered in the trial were a mean 10.6 years of age with mean disease duration of 2.4 years.
Maltese: Il-pazjenti li daħlu fil-prova kienu ta' medja ta' età ta' 10.6 snin b'durata medja tal-marda ta' 2.4 snin.
English: Placebo/MTX n = 195
Maltese: Plaċebo/MTX n = 195
English: The mean (range) trough concentration of abatacept at day 113 was 46.2 mcg/mL (13.4 to 96.2 mcg/mL), 48.0 mcg/mL (22.4 to 122.1 mcg/mL), and 38.5 mcg/mL (9.3 to 73.2 mcg/mL) in paediatric pJIA patients weighing 10 to <25 kg, 25 to <50 kg, and ≥50 kg, respectively.
Maltese: Il-konċentrazzjoni minima medja (medda) ta' abatacept f'jum 113 kienet 46.2 mcg/mL (13.4 sa 96.2 mcg/mL), 48.0 mcg/mL (22.4 sa 122.1 mcg/mL), u 38.5 mcg/mL (9.3 sa 73.2 mcg/mL) f'pazjenti ta' pJIA pedjatriċi li jiżnu 10 sa <25 kg, 25 sa <50 kg, u ≥50 kg, rispettivament.
English: Severe and uncontrolled infections such as sepsis and opportunistic infections (see section 4.4).
Maltese: Infezzjonijiet serji u mhux ikkontrollati bħal sepsis u infezzjonijiet opportunistiċi (ara sezzjoni 4.4).
English: 50 mg/0.4 mL: white Plunger
Maltese: 50 mg/0.4 mL: Planġer abjad
English: Each vial contains 250 mg of abatacept.
Maltese: Kull kunjett fih 250 mg ta' abatacept.
English: In SC-III the safety profiles of the three treatment groups (abatacept + MTX, abatacept monotherapy, MTX group) were overall similar.
Maltese: F'SC-III il-profili tas-sigurtà tat-tliet gruppi ta' kura (abatacept + MTX, monoterapij abatacept, grupp MTX) kienu simili b'mod ġenerali.
English: Psoriatic arthritis Adults
Maltese: Artrite Psorjatika Adulti
English: DAS28-CRP Remissione
Maltese: Remissjoni DAS28-CRPe
English: 5 How to store ORENCIA 6.
Maltese: Kif taħżen ORENCIA 6.
English: Abatacept has been studied in patients with active rheumatoid arthritis in placebo-controlled clinical trials (2,653 patients with abatacept, 1,485 with placebo).
Maltese: Abatacept ġie studjat f'pazjenti b'artrite tar-rewmatiżmu attiva fi provi kliniċi kkontrollati bi plaċebo (2,653 pazjent b'abatacept, 1,485 bi plaċebo).
English: Proportion (%) of polyarticular JIA patients with ACR responses or inactive disease
Maltese: Proporzjon (%) ta' pazjenti b'JIA poliartikulari b'risponsi ACR jew marda inattiva
English: In study SC-I, ACR responses were assessed at 5 years with 85% (356/421) ACR 20 responses, 66% (277/423) ACR 50 responses, and 45% (191/425) ACR 70 responses.
Maltese: Fl-istudju SC-I, ir-risponsi għal ACR ġew evalwati wara 5 snin b'rispons ta' 85% (356/421) għal ACR 20, rispons ta' 66% (277/423) għal ACR 50 u rispons ta' 45% (191/425) għal ACR 70.
English: Proportion (%) of polyarticular JIA patients with ACRP responses or inactive disease at end of short-term period (4 months) Ages 2 to 17 years n=219
Maltese: Proporzjon (%) ta' pazjenti ta' JIA poliartikulari b'risponsi ACRP jew marda inattiva fl-aħħar tal-perjodu ta' żmien qasir (4 xhur) Etajiet 2 sa 17-il sena n=219
English: Multipack: 2 vials and 2 silicone-free syringes (2 packs of 1) Multipack: 3 vials and 3 silicone-free syringes (3 packs of 1) 5.
Maltese: 2 kunjetti u 2 siringi mingħajr silikon (2 pakketti ta' 1) Pakkett multiplu: 3 kunjetti u 3 siringi mingħajr silikon (3 pakketti ta' 1) 5.
English: In study SC-III, similar immunogenicity rates were seen in patients on treatment for the abatacept+MTX, and abatacept monotherapy groups (2.9% (3/103) and 5.0% (5/101), respectively) during the double-blind 12 month period.
Maltese: Fi studju SC-III, f'pazjenti kkurati dehru rati simili tal-immunoġeniċità għall-gruppi ta' abatacept + MTX, u tal-monoterapija ta' abatacept (2.9% (3/103) u 5.0% (5/101), rispettivament) waqt il-perjodu double-blind ta' 12-il xahar.
English: The mean (range) for cmin and cmax at steady state observed after 85 days of treatment was 32.5 mcg/mL (6.6 to 113.8 mcg/mL) and 48.1 mcg/mL (9.8 to 132.4 mcg/mL), respectively.
Maltese: Ilmedja -(medda) għal cmin u cmax fi stat fiss osservata wara 85 jum ta' kura kienet ta' 32.5 mcg/mL (6.6 sa 113.8 mcg/mL) u 48.1 mcg/mL (9.8 sa 132.4 mcg/mL), rispettivament.
English: In vitro, abatacept attenuates human T lymphocyte activation as measured by decreased proliferation and cytokine production.
Maltese: In vitro, abatacept jattenwa l-attivazzjoni ta' limfociti-T umani kif ġie mkejjel bi tnaqqis fil-proliferazzjoni u produzzjoni ta' cytokines.
English: Having an infection could put you at risk of serious side effects from ORENCIA.
Maltese: Jekk ikollok infezzjoni, dan jista' jpoġġik f'riskju ta' effetti sekondarji serji ta' ORENCIA.
English: Most recent:
Maltese: NN:
English: RA is usually a chronic (long-term), progressive disease.
Maltese: L-RA hija ġeneralment marda progressiva kronika (perjodu ta' żmien twil).
English: In SC-III, increased rates of immunogenicity were observed in subjects tested during 6 months of complete drug withdrawal in the abatacept+MTX and abatacept monotherapy groups (37.7% [29/77] and 44.1% [27/59], respectively) with generally low titer antibody responses.
Maltese: F'SC-III, iż-żieda fir-rati tal-immunoġeniċità kienu osservati f'individwi ttestjati waqt 6 xhur ta' rtirar sħiħ tal-mediċina fil-gruppi ta' abatacept + MTX u tal-monoterapija ta' abatacept (37.7% [29/77] u 44.1% [27/59], rispettivament) b'risponsi ġeneralment baxxi ta' tajters u antikorpi.
English: MTX-Naive
Maltese: MTX
English: P-valuea
Maltese: Valur P
English: Similar inhibition was observed in both treatment groups up to 24 months (mTSS (mean ± standard deviation [SD] = 0.89 ± 4.13 vs 1.13 ±8.66), erosion score (0.41 ± 2.57 vs 0.41 ±5.04), and JSN score (0.48 ±2.18 vs 0.72 ±3.81)) for the abatacept (n=257) and adalimumab (n=260) groups, respectively.
Maltese: Inibizzjoni simili ġiet osservata fiż-żewġ grupp tal-kura għal sa 24 xahar (mTSS (± devjazzjoni standard [SD] medja = 0.89 ± 4.13 vs 1.13 ±8.66), punteġġ tal-erożjoni (0.41 ± 2.57 vs 0.41 ±5.04), u punteġġ JSN (0.48 ±2.18 vs 0.
English: Sodium dihydrogen phosphate monohydrate Disodium phosphate anhydrous Water for injections
Maltese: Sodium dihydrogen phosphate monohydrate Disodium phosphate anhydrous Ilma għall-injezzjonijiet
English: Listed in Table 1 are adverse reactions observed in clinical trials and post-marketing experience presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Maltese: Fit-Tabella 1 hemm elenkati r-reazzjonijiet avversi osservati fi provi kliniċi u l-esperjenza ta' wara ttqegħid fis-suq ippreżentati skont is-sistema tal-klassifika tal-organi u l-frekwenza, permezz ta' dawn il-kategoriji: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000).
English: *(e.g. pruritus, throat tightness, dyspnea)
Maltese: * (eż. prurite, għafis fil-gerżuma, dispnea)
English: Concomitant medication, such as methotrexate, corticosteroids, and NSAIDs, did not influence abatacept apparent clearance.
Maltese: Il-medikazzjoni konkomitanti, bħal methotrexate, kortikosterojdi, u NSAIDs, ma influwenzatx it-tneħħija apparenti ta' abatacept.
English: Their pJIA subtypes at disease onset were: oligoarticular (16%), polyarticular (64%; 20% of the total were rheumatoid factor positive), and systemic (20%).
Maltese: Is-sottotipi tagħhom ta' pJIA mal-bidu tal-marda kienu: oligoartikulari (16%), poliartikulari (64%; 20% tat-total kienu pożittivi għall-fattur tar-rewmatojde), u sistemiċi (20%).
English: At 12 months, the incidence of AE of infections were 59.6% (93), 68.5% (113), and the incidence of serious AE of infections were 1.9% (3) and 8.5% (14) for abatacept and infliximab groups, respectively.
Maltese: Wara 12-il xahar, l-inċidenza ta' AE ta' infezzjonijiet kienet 59.6% (93), 68.5% (113), u l-inċidenza ta' AE serja ta' infezzjonijiet kienet 1.9% (3) u 8.5% (14) għall-gruppi ta' abatacept u infliximab, rispettivament.
English: While transitioning from TNF-inhibitor therapy to ORENCIA therapy, patients should be monitored for signs of infection (see section 5.1, study VII).
Maltese: Waqt it-transizzjoni minn terapija b'inibituri ta' TNF għal terapija b'ORENCIA, il-pazjenti jeħtieġu jiġu mmonitorjati għal sinjali ta' infezzjoni (ara sezzjoni 5.1, studju VII).
English: 50 mg/0.4 mL Pre-filled Syringe
Maltese: 50 mg/0.4 mL
English: Summary of the safety profile in psoriatic arthritis
Maltese: Sommarju tal-profil ta' sigurtà f'artrite psorjatika
English: The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis (Table 2).
Maltese: Il-profil ta' sigurtà globali kien komparabbli bejn studji PsA-I u PsA-II u konsistenti mal-profil ta' sigurtà fl-artrite rewmatojde (Tabella 2).
English: respectively
Maltese: RESPONSABBLI
English: Listed in Table 2 are adverse reactions observed in clinical trials and post-marketing experience presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Maltese: Fit-Tabella 2 hemm elenkati r-reazzjonijiet avversi osservati fi provi kliniċi u l-esperjenza ta' wara ttqegħid fis-suq ippreżentati skont is-sistema tal-klassifika tal-organi u l-frekwenza, permezz ta' dawn il-kategoriji: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000).
English: Lower respiratory tract infection (including bronchitis), urinary tract infection, herpes infections (including herpes simplex, oral herpes, and herpes zoster), pneumonia, influenza Uncommon Tooth infection, onychomycosis, sepsis, muskuloskeletal infections, skin abscess, pyelonephritis, rhinitis, ear infection
Maltese: Infezzjoni fin-naħa t'isfel tal-apparat respiratorju (inkluż bronkite), infezzjoni fis-sistema talawrina, infezzjonijiet ta' herpes (li jinkludu herpes simplex, herpes orali u herpes zoster), pulmonite, influwenza
English: Paediatric pJIA population
Maltese: Popolazzjoni pedjatrika b'pJIA
English: They had active disease, with baseline mean active joint count of 16 and a mean number of joints with loss of motion of 16; and elevated C-reactive protein (CRP) levels (mean, 3.2 mg/dl) and ESRs (mean, 32 mm/h).
Maltese: Huma kellhom marda attiva, bil-medja fil-linja bażi tal-għadd ta' ġogi attivi ta' 16 u medja tan-numru ta' ġogi b'telf ta' moviment ta' 16; u livelli għolja ta' proteina reattiva-Ċ (CRP) (medja, 3.2 mg/dl) u ESRs (medja, 32 mm/siegħa).
English: Significantly more placebo recipients flared during Period B (33/62; 53%) than those maintained on abatacept (12/60; 20%; chi-square p<0.001).
Maltese: B'mod sinifikanti, iktar reċipjenti tal-plaċebo kellhom aggravament matul Perjodu B (33/62; 53%) minn dawk li baqgħu jieħdu abatacept (12/60; 20%; chi-square p<0.001).
English: DAS28 response
Maltese: Rispons DAS28
English: It's normal to see a drop of fluid leaving the needle.
Maltese: Huwa normali li tara' qatra fluwidu ħierġa mil-labra.
English: Uncommon Palpitations, tachycardia, bradycardia
Maltese: Mhux komuni Palpitazzjonijiet, takikardja, bradikardja
English: Serious infections, including sepsis and pneumonia, have been reported with abatacept (see section 4.8).
Maltese: Infezzjonijiet serji inklużi sepsi u pnewmonja ġew irrapportati b'abatacept (ara sezzjoni 4.8).
English: 87.5 mg/0.7 mL light blue plunger
Maltese: 87.5 mg/0.7 mL planġer blu ċar
English: Treatment with immunosuppressive therapy, such as ORENCIA, may be associated with progressive multifocal leukoencephalopathy (PML).
Maltese: Il-kura b'terapija immunosoppressiva bħal ORENCIA, tista' tkun assoċjata ma' lewkoenċefalopatija multifokali progressiva (PML).
English: A greater percentage of abatacept- than placebotreated patients with COPD developed a serious adverse reaction (5.4% vs. 0%), including COPD exacerbation (1 of 37 patients [2.7%]) and bronchitis (1 of 37 patients [2.7%]).
Maltese: Perċentwal ikbar ta' pazjenti b'COPD li ġew ttrattati b'abatacept milli minn dawk ttrattati bi plaċebo żviluppaw reazzjonijiet avversi serji (5.4% vs. 0%), inkluż aggravar ta' COPD (1 minn 37 pazjent [2.7%]) u bronkite (1 minn 37 pazjent [2.7%]).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Excipients: maltose, sodium dihydrogen phosphate monohydrate and sodium chloride 4.
Maltese: Eċċipjenti: maltose, sodium dihydrogen phosphate monohydrate u sodium chloride 4. GĦAMLA FARMAĊEWTIKA
English: The respective values for ACR 20 at 24 months were 59.7% (190/318) for the abatacept SC group and 60.1% (197/328) for the adalimumab SC group.
Maltese: Ilvaluri rispettivi għal ACR 20 wara 24 xahar kienu 59.7% (190/318) għall-grupp ta' abatacept SC u 60.1% (197/328) għall-grupp ta' adalimumab SC.
English: In the open-label extension of studies I, II, III, VI, and SC-I durable and sustained ACR 20, 50, and 70 responses have been observed through 7 years, 5 years, 5 years, 2 years, and 5 years, respectively, of abatacept treatment.
Maltese: Fl-estensjoni ta' studji I, II, III u VI open-label, ġew osservati risponsi sostenibbli u durabbli ta' ACR 20, 50 u 70 sa 7 snin, 5 snin, 5 snin, u sentejn rispettivament, ta' trattament b'abatacept.
English: The type of serious infections was similar between the abatacept and placebo treatment groups (see section 4.4).
Maltese: It-tip ta' infezzjonijiet serji kien simili bejn il-gruppi ta' kura b'abatacept u bi plaċebo (ara sezzjoni 4.4).
English: Clinical efficacy and safety in adult psoriatic arthritis
Maltese: Effikaċja klinika u sigurtà f'adulti b'artrite psorjatika
English: *Note: the figure shows the 50 mg pre-filled syringe Proceed to Step 3
Maltese: *Nota: il-figura turi l-50 mg siringa mimlija għal-lest Kompli għall-Pass 3.
English: The adjusted mean changes (standard error; SE) from baseline in DAS28-CRP were2.35 (SE 0.08) [95% CI: -2.51, -2.19] and -2.33 (SE 0.08) [95% CI: -2.50, -2.17] in the SC abatacept group and the adalimumab group, respectively, at 24 months, with similar changes over time.
Maltese: SE) mil-linja bażi f'DAS28-CRP kien -2.35 (SE 0.08) [95% CI: -2.51, -2.19] u -2.33 (SE 0.08) [95% CI: -2.50, -2.17] fil-grupp ta' abatacept SC u fil-grupp ta' adalimumab, rispettivament, wara 24 xahar, b'tibdil simili maż-żmien.