FrancophonIA/ELRC3.0 huggingface dataset:
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/mL (without concomitant methotrexate) and 8 to 9 μg/mL (with concomitant methotrexate), respectively.
Maltese: Wara t-teħid ta' adalimumab 40 mg taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti adulti li jbatu minn artrite rewmatika (AR), il-konċentrazzjoni minimali medja fissa kienet ta' bejn wieħed u ieħor 5 µg/mL (mingħajr t-teħid konkomitanti ta' methotrexate) u minn 8 sa 9 µg/mL (bit-teħid konkomitanti ta'methotrexate), rispettivament.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION AMGEVITA 20 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 20 mg of adalimumab in 0.4 mL (50 mg/mL) solution.
Maltese: AMGEVITA 20 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest b'doża waħda fiha 20 mg ta' adalimumab f'0.4 mL (50 mg/mL) ta' soluzzjoni.
English: 0.4 mL of solution or 40 mg of adalimumab in 0.8 mL of solution.
Maltese: Kull pinna mimlija għal-lest fiha 40 mg ta' adalimumab f'0.8 mL of solution.
English: ACR responses were maintained in the open-label extension study for up to 136 weeks.
Maltese: Fl-istudju ta' estensjoni open-label, ir-risponsi ACR ġew mantenuti sa 136 ġimgħa.
English: EU/1/16/1164/004 4 pack
Maltese: EU/1/16/1164/004 4 pakketti
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Maltese: L-iskop primarju fi studji RA I, II u III u l-iskop sekondarju fi Studju RA IV kien il-persentaġġ ta' pazjenti li laħqu rispons ACR 20 f'Ġimgħa 24 jew 26.
English: Children, adolescents and adults with enthesitis-related arthritis Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg The recommended dose of AMGEVITA is 20 mg every other week.
Maltese: Tfal, adolexxenti u adulti b'artrite relatata mal-entesite Tfal u adolexxenti minn 6 snin 'il fuq li jiżnu minn 15-il kg sa inqas minn 30 kg Id-doża rakkomandata ta' AMGEVITA hija 20 mg ġimgħa iva u ġimgħa le.
English: The safety and efficacy of adalimumab were assessed in two randomised, double-blind placebocontrolled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew evalwati f'żewġ studji randomised, double-blind u kkontrollati bil-plaċebo f'pazjenti b'axial spondyloarthritis mhux radjugrafika (nr-axSpAnon-radiographic axial spondyloarthritis).
English: Step 1: Prepare
Maltese: Figura 1: Kurvi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/009
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1164/009
English: 2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion
Maltese: 2 Kura bl-immunosuppressanti setgħat tkun mwaqqfa biss f'Ġimgħa 26 jew wara skont id-diskrezzjoni talinvestigatur jekk is-suġġett leħaq il-kriterji tar-rispons kliniku.
English: EU/1/16/1164/007 2 pack
Maltese: EU/1/16/1164/007 2 pakketti
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 g/ml.
Maltese: Wara għoti ta' adalimumab 40 mg taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti adulti li jbatu minn axial spondyloarthritis mhux radjugrafika, l-inqas konċentrazzjoni medja (±SD) fi stat fiss f'Ġimgħa 68 kienet 8.0 ± 4.6 μg/mL.
English: The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex) (see section 4.4).
Maltese: L-għatu tal-labra tal-pinna mimlija għal-lest huwa magħmul minn lastku naturali niexef (derivattiv tal-latex) (ara sezzjoni 4.4).
English: In psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see tables 17 and 18).
Maltese: Fl-istudji tal-Psorjasi I u II, l-iskop primarju kien il-proporzjon ta' pazjenti li rnexxielhom jilħqu rispons tal-PASI ta' 75 mil-linja bażi f'Ġimgħa 16 (ara tabelli 17 u 18).
English: Label expiration date
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of AMGEVITA is an initial dose of 40 mg, followed by 40 mg one week later.
Maltese: Tfal u adolexxenti minn 4 snin sa 17-il sena li jiżnu 30 kg jew aktar Id-doża rakkomandata ta' AMGEVITA hija doża inizjali ta' 40 mg, segwita b'40 mg ġimgħa wara.
English: Children and adolescents with plaque psoriasis
Maltese: Tfal u adolexxenti bi psorjasi tal-plakka
English: Available adalimumab data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Maltese: Id-dejta disponibbli dwar adalimumab tissuġġerixxi li r-rispons kliniku huwa normalment milħuq fi żmien 12-il ġimgħa ta' trattament.
English: A loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/mL during the induction period.
Maltese: Doża kbira ta' 160 mg adalimumab f'Ġimgħa 0 segwita b'80 mg adalimumab f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 12 µg/mL matul il-perjodu tal-bidu.
English: In the phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Maltese: Fil-prova ta' Fażi 3 ta' adalimumab fi tfal bil-marda ta' Crohn li evalwat l-effikaċja u s-sigurtà f'żewġ reġimi ta' dożaġġ ta' manteniment irranġati skont il-piż tal-ġisem wara terapija tal-bidu li wkoll kienet irranġata skont il-piż tal-ġisem sa 52 ġimgħa ta' trattament, kien hemm żidiet fl-ALT ta' ≥ 3 x ULN f'2.6% (5/192) tal-pazjenti li li minnhom 4 kienu qed jirċievu immunosuppressanti konkomitanti fillinja bażi.
English: All patients received a 2 week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Maltese: Il-pazjenti kollha rċevew doża standardizzat ta' ġimgħatejn ta' prednisone 60 mg/jum meta ddaħlu fl-istudju segwit minn skeda obbligatorja li d-doża tiġi mnaqqsa ftit ftit, bi twaqqif komplut tal-kortikosterojdi sa Ġimgħa 15.
English: AMGEVITA is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Maltese: AMGEVITA huwa indikat għat-trattament ta' artrite attiva relatata mal-entesite f'pazjenti, ta' 6 snin jew akbar, li kellhom rispons inadegwat għal, jew li ma jitollerawx, terapija konvenzjonali (ara sezzjoni 5.1).
English: Cerebrovascular accident1), Tremor,
Maltese: Aċċident ċerebrovaskulari1), Tregħid,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/005
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1164/005
English: SPARCCh MRI Sacroiliac Jointsd,i
Maltese: Tieqa safra (l-injezzjoni lesta)
English: The recommended AMGEVITA dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 mg injections in one day).
Maltese: Ir-reġimen tad-doża ta' AMGEVITA rakamondata għal pazjenti adulti bi suppurativa hidradenitis (HS) hija 160 mg inizjalment f'Jum 1 (mogħtija bħala erba' injezzjonijiet ta' 40 mg f'ġurnata waħda jew bħala żewġ injezzjonijiet ta' 40 mg kuljum għal jumejn konsekuttivi), segwiti minn 80 mg żewġ ġimgħat wara f'Jum 15 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 μg/mL during the induction period.
Maltese: F'pazjenti li jbatu mill-marda ta' Crohn , id-doża kbira ta' 80 mg adalimumab f'Ġimgħa 0 segwita b'40 mg adalimumab f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 5.5 µg/mL matul il-perjodu tal-bidu.
English: These trials included rheumatoid arthritis patients with short term and longstanding disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Maltese: Dawn il-provi inkludew pazjenti li jbatu minn artrite rewmatika, kemm f'dawk li ma jkunux ilhom u dawk li jkunu ilhom bil-marda, f'artrite idjopatika taż-żagħżagħ (artrite idjopatika poliartikulari taż-żagħżagħ jew artrite relatata mal-entesite) kif ukoll pazjenti li jbatu minn axial spondyloarthritis (infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis) u axial spondyloarthritis mingħajr evidenza radjografika ta' AS), minn artrite psorjatika, mill-marda ta' Crohn , mill-kolite ulċerattiva, mill-psorjasi, minn hidradenitis suppurativa u minn uveite.
English: Amongst those who responded at week 16 (n = 144), the paediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Maltese: Fost dawk li rrispondu f'Ġimgħa 16 (n=144), ir-rispons pedjatriku ACR 30/50/70/90 kien miżmum sa sitt snin fil-fażi
English: Paediatric Crohn's disease
Maltese: Titjib kliniku
English: In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Maltese: Fi Studi RA minn I-IV, pazjenti kkurati b'adalimumab laħqu risponsi statistikament sinifikanti ACR 20 u 50 sa minn ġimgħa jew tnejn wara li nbdiet il-kura, meta pparagunati mal-plaċebo.
English: Week 2 Week 12 Week 24 BASDAIb 50
Maltese: Ġimgħa 2 Ġimgħa 12 Ġimgħa 24
English: Yellow safety guard
Maltese: Protezzjoni tas-sigurtà safra
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Maltese: Dawn linfezzjonijiet jistgħu jkunu serji u jinkludu tuberkulosi, infezzjonijiet ikkawżati minn virus, fungus, parassiti jew batterji jew infezzjonijiet opportunistiċi u sepsis oħra li, f'każi rari, jistgħu ipoġġu l-ħajja fil-periklu.
English: Children, adolescents and adults with enthesitis-related arthritis Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of AMGEVITA is 40 mg every other week.
Maltese: Tfal, adolexxenti u adulti b'artrite relatata mal-entesite Tfal, adolexxenti u adulti minn 6 snin 'il fuq li jiżnu 30 kg jew aktar Id-doża rakkomandata ta' AMGEVITA hija 40 mg ġimgħa iva u ġimgħa le.
English: ≥30% Reduction in Skin Painb
Maltese: ≥ 30% Tnaqqis fl-uġigħ fil-ġildab
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI
English: ASDAS Inactive Disease hs-CRPd,f,g
Maltese: Pressjoni għolja b'mod anormali, Fwawar,
English: EU/1/16/1164/008 4 pack
Maltese: EU/1/16/1164/008 4 pakketti
English: Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Maltese: Huwa maħsub li Psorajisi tiġi kkawżata minn problema fis- sistema immuni tal-ġisem li twassal għal produzzjoni akbar ta' ċelluli tal-ġilda.
English: AMGEVITA single use SureClick pre-filled pen For subcutaneous use
Maltese: Tumuri malinni u disturbi fit-tkattir taċ-ċelluli fil-limfa
English: Erosion score
Maltese: Indeboliment fil-fejqan
English: Your injection could take about 10 seconds.
Maltese: L-injezzjoni tiegħek tista' tieħu madwar 10 sekondi.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (jistgħu jaffetwaw sa persuna waħda minn kull 100)
English: Paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission
Maltese: Studju ta' CD fit-tfal twaqqif tal-kortikosterojdi jew immunomodulaturi u fejqan talfistla
English: AMGEVITA Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Maltese: Relazzjoni bejn espożizzjoni u rispons fil-popolazzjoni pedjatrika
English: In these trials, 11.9% of patients treated with adalimumab and 8.1% of placebo and active control-treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Maltese: F'dawn il-provi, 11.9% tal-pazjenti kkurati b'adalimumab u 8.1% tal-pazjenti kkurati bil-plaċebo u bis-sustanza attiva użata bħala kontroll, li bdew bl-livelli tal-anti-korpi anti-nukleari negattivi, irrappurtaw livelli pożittivi f' Ġimgħa 24.
English: Each pack contains 1, 2, 4 or 6 single-use 40 mg pre-filled syringes (with blue plunger rod).
Maltese: Kull pakkett ikun fih 1, 2, 4 jew 6 siringi mimlija għal-lest ta' 40 mg għall-użu ta' darba (b'bastun li jimbotta l-mediċina blu).
English: 14 weeks a Paediatric ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015
Maltese: > 32 ġimgħa 14-il ġimgħa a Rispons Pedjatriku ACR 30/50/70 f'Ġimgħa 48 kien wisq akbar minn dak ta' pazjenti kkurati bil-plaċebo b p = 0.
English: Muscle spasms (including blood creatine phosphokinase increased)
Maltese: Spażmi fil-muskoli (li jinkludu żieda fil-livell talcreatine phosphokinase fid-demm)
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week (eow).
Maltese: Wara li tlestew iż-żewġ studji, 383 pazjent inkiteb għal studju ta' estensjoni open-label, li fih ingħatat doża ta' 40 mg adalimumab ġimgħa iva u ġimgħa le (eow - every other week).
English: Adalimumab has not been studied in patients with hepatic or renal impairment.
Maltese: Adalimumab ma kienx studjat f' pazjenti b' indeboliment epatiku jew renali.
English: Radiographic mean changes over 12 months in RA study III
Maltese: Tibdil Medju Radjografiku fuq perjodu ta' 12-il xahar fi Studju RA III
English: In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/mL during the induction period.
Maltese: F'pazjenti li għandhom kolite ulċerattiva, d-doża kbira ta' 160 mg adalimumab f'Ġimgħa 0 segwita b'80 mg adalimumab f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 12 µg/mL matul il-perjodu tal-bidu.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Maltese: Adalimumab huwa anti-korp monoklonali rikombinanti uman magħmul fiċ-ċelluli tal-Ovarju talĦamster Ċiniż.
English: Adalimumab Δ Censored
Maltese: Plaċebo Adalimumab
English: Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
Maltese: B'kollox 19-il suġġett, li 11 minnhom mill-grupp tal-linja bażi tal-età ta' bejn l-4 u 12-il sena u 8 mill-grupp tal-linja bażi taletà ta' bejn it-13 u 17-il sena kienu kkurati għal sitt snin jew aktar.
English: In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
Maltese: F'reġistru ta' koorti prospettiv, ġew irreklutati 257 mara b'artrite rewmatojde (RA, rheumatoid arthritis) jew bil-marda ta' Crohn (CD, Crohn's disease) ikkurati b'adalimumab għallinqas matul l-ewwel trimestru u 120 mara b'RA jew CD mhux ikkurati b'adalimumab.
English: Adverse Reaction unspecified (including cysts and polyps)*
Maltese: Neoplażmi beninni, malinni u mhux speċifikati (inklużi ċesti u polipi)*
English: For patients who dose escalated from every other week to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg/mL (40/20 mg, weekly) and 6.7 ± 3.5 μg/mL (20/10 mg, weekly).
Maltese: 3±11.4 μg/mL (40/20 mg, kull ġimgħa) u 6.7±3.5 μg/mL (20/10 mg, kull ġimgħa).
English: Figure 2: Kaplan-Meier curves summarising time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Maltese: UV I) jew ġimgħa 2 (studju UV II)
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Maltese: Waqt trattament ta' manutenzjoni kortikosterojdi jistgħu jiġu mnaqqsa bil-mod skont il-linji gwida tal-prattika klinika.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post-marketing setting.
Maltese: Ġew irrapurtati wkoll xi tumuri malinni oħra, xi wħud fatali, fit-tfal, adolexxenti, u adulti żgħar (sa 22 sena) ittrattati b'xi antagonisti tat-TNF (bidu tat-terapija ≤ 18-il sena), li jinkludu adalimumab wara li tqiegħed fuq is-suq.
English: EU/1/16/1164/003 2 pack
Maltese: EU/1/16/1164/003 2 pakketti
English: Important: Needle is inside
Maltese: It-Tielet Pass: Injetta
English: OTHER
Maltese: NA
English: Concomitant administration of AMGEVITA with other biologic DMARDS (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section 4.5).
Maltese: L-għoti flimkien ta' AMGEVITA ma' DMARDS bijoloġiċi oħra (e.ż. anakinra u abatacept) jew antagonisti ta' TNF oħra, mhux rakkomandat fuq bażi ta' żieda possibli fir-riskju ta' infezzjonijiet, inkluż infezzjonijiet serji u interazzjonijiet oħra ta' potenzjal farmakoloġiku.
English: It is normal to see a drop of liquid at the end of the needle.
Maltese: Huwa normali li tara taqtira likwidu fit-tarf tal-labra.
English: Solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), Melanoma**
Maltese: Neoplażmi fl-organi solidi (li jinkludu kanċer tassider, neoplażma fil-pulmun u neoplażma fittirojde),
English: Belly
Maltese: Fażi
English: AMGEVITA can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: AMGEVITA jista' jittieħed flimkien ma' methotrexate jew ċerti tipi ta' aġenti anti-rewmatiċi li jaffetwaw il-proċess tal-mard (sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet taddeheb li jingħata b' injezzjoni), sterojdi jew medikazzjonijiet għall-uġigħ, li jinkludu mediċini antiinfjammatorji mhux sterojdi (NSAIDs).
English: In Period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0 and 80 mg at week 2 and 40 mg every week starting at week 4 to week 11.
Maltese: F'Perjodu A, pazjenti rċevew plaċebo jew adalimumab b'doża inizjali ta' 160 mg f'Ġimgħa 0, 80 mg f'Ġimgħa 2, u 40 mg kull ġimgħa li tibda f'Ġimgħa 4 sa Ġimgħa 11.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1164/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1164/001
English: Mucosal healing
Maltese: Rispons kliniku
English: Nerve root compression
Maltese: Effetti mhux Mixtieqa
English: Adalimumab was studied in 9,506 patients in pivotal controlled and open-label trials for up to 60 months or more.
Maltese: Adalimumab ġie studjat f'9,506 pazjent fi provi pivitali kontrollati u open-label li damu sejrin sa 60 xahar jew aktar.
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (psoriasis study III).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati wkoll f'pazjenti adulti li jbatu minn Psorjasi kronika li tikkawża qoxra mhux normali fuq il-ġilda u psorjasi fl-idejn u/jew fis-saqajn fl-istess ħin li kienu kandidati għat-terapija sistemika fl-istudju double-blind magħżula b'ordni addoċċ (Studju tal-Psorjasi III).
English: Phase
Maltese: Punt Finali
English: Regarding combination with disease-modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Maltese: Rigward it-teħid flimkien ta' AMGEVITA ma' mediċini anti-rewmatiċi li jaffetwaw il-proċess tal-mard, minbarra methotrexate, ara sezzjoni 4.4 u 5
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (table 14).
Maltese: Ir-riżultati ta' ġimgħa 12 wrew titjib statistikament sinifikanti tas-sinjali u ssintomi ta' nr-axSpA attiva f'pazjenti kkurati b'adalimumab meta mqabbla mal-plaċebo (tabella 14).
English: • muscle spasms;
Maltese: • uġigħ fis-sider;
English: PsA study II with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Maltese: Studju PsA II li dam 12 -il ġimgħa, tratta 100 pazjent li kellhom rispons mhux adegwat għat-terapija DMARD.
English: In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Maltese: Fl-istudju UC-II, trattament b'adalimumab irriżulta f'titjib fil-punteġġ tal-Kwestjonarju tal-Marda talInfjzammazzjoni tal-Musrana (IBDQ).
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Maltese: Fost pazjenti li kellhom mill-inqas rispons parzjali f'Ġimgħa 12, u li rċevew terapija kontinwa b'adalimumab kull ġimgħa, ir-rata ta' HiSCR f'Ġimgħa 48 kienet 68.3% u f'Ġimgħa 96 kienet 65.1%.
English: At week 16, more patients randomised to adalimumab 0.8 mg/kg had positive efficacy responses (e.g. PASI 75) than those randomised to 0.4 mg/kg every other week or MTX.
Maltese: F'ġimgħa 16, aktar pazjenti magħżula b'mod każwali u li ngħataw adalimumab 0.8 mg/kg kellhom rispons pożittivi taleffikaċja (eż, PASI 75) milli dawk każwali għal 0.4 mg/kg ġimgħa iva u ġimgħa le jew MTX.
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);
Maltese: • sindromu Stevens-Johnson (is-sintomi bikrija jinkludu sensazzjoni fejn ma tħossokx tajjeb mingħajr ma jkollok l-ebda sintomi ta' mard, deni, uġigħ ta' ras u raxx);
English: Plaque psoriasis in adults and children
Maltese: Psorjasi fl-adulti u fit-tfal
English: All subjects received open-label induction therapy at a dose based on their baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Maltese: Is-suġġetti kollha ngħataw kura tal-bidu open-label b'doża fuq bażi tal-linja bażi tal-piż tal-ġisem tagħhom: 160 mg f'Ġimgħa 0 u 80 mg f'Ġimgħa 2 għal suġġetti ≥ 40 kg, u 80 mg u 40 mg, rispettivament, għal suġġetti < 40 kg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK CARTON PRE-FILLED SYRINGE (with blue box)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' PAKKETT MULTIPLU TA' SIRINGA MIMLIJA GĦAL-LEST (b'kaxxa blu)