FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more
Maltese: Tfal u żagħżagħ minn 6 sa 17-il sena li jiżnu inqas minn 40 kg
English: Among those, 86 patients (75.4 %) had ACR 20 responses; 72 patients (63.2 %) had ACR 50 responses; and 41 patients (36 %) had ACR 70 responses.
Maltese: 72 pazjent (63.2 %) kellhom rispons għal ACR 50; u 41 pazjent (36 %) kellhom rispons għal
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 6 snin jew aktar.
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 Hefiya f'ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-seru f'adalimumab ta' bejn wieħed u ieħor 12 µg / ml matul il-perijodu tal-bidu.
English: The safety and efficacy of adalimumab were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Maltese: (Crohn's disease) (CDAI) ≥ 220 u ≤ 450) fi studji double-blind, ikkontrollati bil-plaċebo, li saru b'ordni addoċċ.
English: The usual dose regimen is 40 mg adalimumab initially followed by 20 mg two weeks later.
Maltese: Id-doża ta' adalimumab normalment hija 20 mg ġimgħa iva u ġimgħa le b'methotrexate.
English: In Study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Maltese: Fi Studju UV II, kienu osservati differenzi statistikament sinifikanti għal akutezza viżiva biss, iżda l-komponenti l-oħra kienu numerikament favur adalimumab.
English: Table 11 distribution of patients by age and adalimumab dose received during the OL LI phase age group number of patients at baseline n (%) Minimum, median and maximum dose
Maltese: Tabella 11 L-ammont ta' pazjenti mqassma skont l-età u dożi minimi, medji u massimi li ngħataw waqt il-fażi OL LI
English: • leukaemia (cancer affecting the blood and bone marrow);
Maltese: • diverticulite (infjammazzjoni u infezzjoni tal-musrana l-kbira);
English: Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Maltese: Minn dawn, 40 pazjent ma wrew l-ebda progress ta' ħsara strutturali definita mil-linja bażi fl-mTSS li kienet ta' 0.5 jew inqas.
English: solution for injection Multipack: 6 (3 packs of 2) pre-filled pens (SensoReady)
Maltese: 6 (3 pakketti ta' 2) pinen mimlijin għal-lest (SensoReady)
English: Psychiatric disorders
Maltese: Disturbi psikjatriċi
English: Of those in clinical response at week 4, 48 % had been previously exposed to other TNF-antagonists.
Maltese: Minn dawk li kellhom rispons kliniku f'ġimgħa 4, 48% kienu ġew esposti għal kura oħra ta' antagonisti tat-TNF fil-passat.
English: Hefiya is supplied in a single-use clear type I glass syringe with a stainless steel needle with a needle guard with finger flange, rubber needle cap and plastic plunger rod, containing 0.8 ml of solution.
Maltese: Is-sirigna ġol-pinna hija magħmula minn ħġieġ tat-tip I b'labra talistainless steel, u protezzjoni tal-labra ta' ġewwa tal-gomma, u tapp tal-gomma li fiha 0.8 ml ta' soluzzjoni.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage 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-perċentwal ta' pazjenti li laħqu rispons għall-ACR 20 f'ġimgħa 24 jew 26.
English: Hefiya is used to treat psoriatic arthritis in adults.
Maltese: Hefiya jintuża biex jikkura artrite rewmatika fl-adulti.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTXtreated.
Maltese: Fil-fażi tal-bidu open-label (OL LI) il-pazjenti kienu imqassma f'żewġ gruppi, dawk ikkurati b'MTX (methotrexate) u dawk li mhux kkurati b'MTX (non-MTX).
English: Patients demonstrating a paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg / m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Maltese: Il-pazjenti li wrew rispons pedjatriku ACR 30 f'ġimgħa 16 kienu eliġibbli biex jiġu mqassma b'addoċċ fil-fazi double blind (DB) u jirċievu adalimumab 24 mg / m2 sa massimu ta' 40 mg, jew plaċebo ġimgħa iva u ġimgħa le għal 32 ġimgħa oħra jew sakemm il-marda tmur għall-agħar.
English: • vasculitis (inflammation of blood vessels);
Maltese: • tregħid; • newropatija (ħsara fin-nervituri);
English: Corticosteroid taper was permitted after week 8.
Maltese: kien permess wara ġimgħa 8.
English: PsA study II
Maltese: studju PsA II
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21 / 41 (51 %) were in remission at week 52.
Maltese: minn dawk il-pazjenti kkurati b'adalimumab u li kellhom titjib kliniku f'ġimgħa 8, 21 / 41 (51 %) kellhom ukoll titjib kliniku f'ġimgħa 52.
English: Concomitant stable doses of aminosalicylates, corticosteroids, and / or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of these medications.
Maltese: Dożi stabbli ta' aminosalicylates, kortikosterojdi, u / jew aġenti immunomodulatorji mittieħda fl-istess waqt, kienu permessi u 80 % tal-pazjenti komplew jirċievu mill-inqas waħda minn dawn il-mediċini.
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 għall-ACR ġew mantenuti sa 136 ġimgħa.
English: The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Maltese: L-aktar reazzjonijiet avversi li ġew irrappurtati b'mod komuni huma infezzjonijiet (bħal nasofarinġite, infezzjonijiet fin-naħa ta' fuq tas-sistema respiratorja u sinożite), reazzjonijiet fil-post tal-tal-injezzjoni (eritema, ħakk, emorraġija, uġigħ jew nefħa), uġigħ ta' ras u uġigħ muskolu-skeletriku.
English: adalimumabb n = 113
Maltese: adalimumab b n = 113
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: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg / ml at week 2 and week 4.
Maltese: F'pazjenti adulti bi hidradenitis suppurativa, doża ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg f'ġimgħa 2 kisbu konċentrazzjonijiet baxxi t'adalimumab fis-seru ta' madwar 7-8 μg / ml f'ġimgħa 2 u f'ġimgħa 4. Livelli minimali medji fissi tal-konċentrazzjoni f'ġimgħa 12 sa ġimgħa 36 kienu bejn wieħed u ieħor 8 sa 10 μg / ml matul kura b'adalimumab 40 mg kull ġimgħa.
English: Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Maltese: Minn dawn, 48 pazjent ma urew l-ebda progress ta' ħsara strutturali definita mill-bidla mill-linja bażi fl-mTSS li kienet ta' 0.5 jew inqas.
English: The safety and efficacy of adalimumab were assessed in two randomized, double-blind placebocontrolled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Maltese: Axial spondyloarthritis mingħajr evidenza radjografika ta' AS Is-sigurtà u l-effikaċja ta' adalimumab ġew ivvalutati f'żewġ studji randomised, double-blind ikkontrollati bil-plaċebo f'pazjenti b'spondyloarthrite axjali mhux radjografika (nr-axSpA).
English: • Gently pinch the skin at the injection site (see Figure H).
Maltese: • Bil-mod oqros il-ġilda fis-sit ta' injezzjoni (ara Figura H).
English: • difficulty in swallowing;
Maltese: • nawseja u rimettar;
English: Paediatric Uveitis
Maltese: Popolazzjoni pedjatrika Ara
English: Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn's disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Maltese: Din il-prova saret f'192 suġġetti pedjatriċi li għandhom bejn 6 u 17 (inkluż)-il sena, bil-marda Crohn (CD) moderata sa severa definita bħala riżultat tal-Indiċi tal
English: In the open-label extension of RA Study III, the reduction in rate of progression of structural damage is maintained for 8 and 10 years in a subset of patients.
Maltese: Fil-fażi ta' estensjoni open-label tal-istudju RA III, it-tnaqqis fir-rata ta' progress ta' ħsara strutturali jinżamm għal 8 u 10 snin.
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, id-doża kbira ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg adalimumab f'ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-seru f'adalimumab ta' bejn wieħed u ieħor 12 μg / ml matul il-perijodu tal-bidu.
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160 / 80 mg or 80 / 40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40 / 20 mg eow) or Low Dose (20 / 10 mg eow) maintenance treatment groups based on their body weight.
Maltese: F'ġimgħa 4, il-pazjenti kienu magħżula b'mod każwali 1:1 għal doża ta' manteniment Standard (40 / 20 mg eow) jew Baxxa (20 / 10 mg eow) fil-grupp ta' nies li qed jieħdu l-kura fuq bażi tal-piż tal-ġisem tagħhom.
English: for HR
Maltese: Ażma,
English: • Cotton ball or gauze
Maltese: • Kuxxinett tal-alkoħol
English: A total of 76.5 % (218 / 285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1 % [123 / 178] and 88.8 % [95 / 107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Maltese: Total ta' 76.5 % (218 / 285) tal-pazjenti li daħlu fil- perjodu li fih reġgħet inbdiet il-kura, kellhom PGA mingħajr rispons jew b' rispons minimu wara 16-il ġimgħa minn meta reġgħet inbdiet il-kura, irrispettivament minn jekk dawn il-pazjenti reġgħux esperjenzaw tfaċċar mill-ġdid ta' sintomi ta' Psorjasi matul il-perjodu li fih twaqqfet il-kura (69.1 % [123 / 178] u 88.8 % [95 / 107] għal dawk il-pazjenti li esperjenzaw tfaċċar mill-ġdid ta' sintomi tal-psorjasi u dawk li m'esperjenzawx tfaċċar mill-ġdid ta' sintomi tal-Psorjasi rispettivament,
English: Induction dose
Maltese: Viżjoni doppja
English: Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks.
Maltese: Is-suġġetti li ħarġu matul il-perjodu double-blind ingħataw terapija ta' salvataġġ ta' adalimumab 40 mg eow għal mill-inqas 12-il ġimgħa.
English: Approximately 40 % of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Maltese: Bejn wieħed u ieħor 40 % tal-pazjenti fi studju UC-II kellhom kura qabel b' anti-TNF u li ma ħadmitx.
English: Psoriasis Study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Maltese: IV ġew imqabbla l-effikaċja u s-sigurta ta' adalimumab ma' plaċebo f'217 pazjent adult b'psorjasi tad-dwiefer moderata għal severa.
English: Table 13 efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms response placebo N=107
Maltese: Risponsi tal-effikaċja fi studju AS ikkontrollat bil-plaċebo - studju I
English: Figure F: clean your injection site
Maltese: Figura F: naddaf is-sit ta' injezzjoni tiegħek
English: Figure I: hold the syringe
Maltese: Figura I: żomm is-siringa
English: Hefiya 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: Hefiya huwa indikat għall-kura ta' artrite attiva relatata mal-entesite f'pazjenti, ta' 6 snin jew akbar, li kellhom rispons inadegwat għal, jew li ma jittollerawx, terapija konvenzjonali (ara sezzjoni 5.1).
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Maltese: • disturbi fl-immunità li jistgħu jeffetwaw il-pulmun, ġilda u in-nodi tal-limfa (l-aktar komuni bħala kondizzjoni msejħa sarcoidosis);
English: • lichenoid skin reaction (itchy reddish-purple skin rash).
Maltese: • reazzjoni tal-lichenoid tal-ġilda (raxx tal-ġilda ħamrani bil-ħakk).
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Maltese: Ir-rati rrappurtati ta' kanċer tal-ġilda li mhumiex melanoma u limfomi, huma ta' bejn wieħed u ieħor 0.2 u 0.3 kull 1,000 sena ta' kura ta' pazjenti, rispettivament (ara sezzjoni 4.4).
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab.
Maltese: Infezzjonijiet opportunistiċi, li jinkludu infezzjonijiet fungali invażivi, ġew osservati f'pazjenti li kienu qed jirċievu adalimumab.
English: Exposure-response relationship in paediatric population
Maltese: Relazzjoni bejn espożizzjoni u rispons fil-popolazzjoni pedjatrika
English: At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo achieved HiSCR.
Maltese: F'ġimgħa 12, proporzjon ogħla b'mod sinifikanti ta' pazjenti kkurati b'Hefiya kontra l-plaċebo kisbu HiSCR.
English: Hefiya contains sodium
Maltese: Jekk tinsa tuża Hefiya
English: Hefiya is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: Hefiya huwa kontroaindikat f'pazjenti li jbatu minn insuffiċjenza tal-qalb minn moderata sa severa (ara sezzjoni 4.3).
English: • high blood measurements for lactate dehydrogenase;
Maltese: • ammont għoli ta' lactate dehydrogenase fid-demm;
English: Headache
Maltese: Tqala
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: Most side effects are mild to moderate.
Maltese: Ħafna mill-effetti sekondarji huma minn ħfief għal moderati.
English: Avoid areas with scars or stretch marks.
Maltese: Evita partijiet b'marki jew bi stretch marks.
English: One 0.8 ml pre-filled pen contains 40 mg adalimumab.
Maltese: Pinna waħda ta' 0.8 ml mimlija għal-lest fiha 40 mg adalimumab.
English: a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Maltese: HR ta' adalimumab vs plaċebo minn rigressjoni ta' perikli li huma proporzjonali mat-trattament bħala fattur.
English: Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus.
Maltese: Sintomi jistgħu jinkludu noduli ratba (nefħa) u axxessi (imsiemer fil-follikuli tax-xagħar) li jistgħu jnixxu materja.
English: Seventy-nine (20.1 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 37 (9.4 %) patients with glucocorticoids.
Maltese: Disgħa u sebgħin (20.1 %) pazjent ġew ikkurati flimkien ma' mediċini antirewmatiċi li li jaffettwaw il-proċess tal-marda, u 37 (9.4 %) pazjent flimkien ma' glukokortikojdi.
English: • muscle spasms;
Maltese: • spażmi fil-muskoli;
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 għall-ACR 20 u 50 sa minn ġimgħa jew tnejn wara li nbdiet il-kura, meta pparagunati mal-plaċebo.
English: After week 2, patients in both adalimumab arms received 40 mg eow.
Maltese: Wara ġimgħa 2, pazjenti fiż-żewġ gruppi ta' adalimumab irċevew 40 mg eow.
English: Hefiya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Maltese: Psorjasi tal-plakka pedjatrika Hefiya huwa indikat għall-kura ta' psorjasi tal-plakka severa u kronika fit-tfal u adolexxenti minn 4 snin 'ilfuq u li kellhom rispons inadegwat jew huma kandidati mhux xierqa għat-terapija topika u fototerapiji.
English: Hefiya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Maltese: Hefiya jista' ukoll jintuża għall-kura tal-artrite rewmatika attiva u progressiva severa, mingħajr ma tkun ingħatat kura b'methotrexate qabel.
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p < 0.001) in the adalimumab group (at week
Maltese: Adalimumab ittardja b'mod sinifikanti l-ħin għall-falliment tat-trattament, meta mqabbel mal-plaċebo (Ara Figura 3, P <0.0001 mit-test ta' log rank).
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
Maltese: antibody bi strand doppja), żieda fil-blood lactate dehydrogenase
English: >32 weeks
Maltese: >32 ġimgħa
English: The recommended Hefiya induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Maltese: Ir-reġimen tad-dożaġġ irrakkomandat biex tinbeda l-kura b'Hefiya għal pazjenti adulti li jbatu mill-marda Crohn (Crohn's disease) b'attività moderata sa severa, huwa ta' 80 mg f'ġimgħa 0 segwiti b'40 mg f'ġimgħa 2.
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 64.3 % 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 kien ta' 65.1 %.
English: Hefiya dose for paediatric patients with plaque psoriasis Patient weight
Maltese: Tabella 3. Doża ta' Hefiya għal pazjenti pedjatriċi bil-psorjasi tal-plakka
English: Haematologic reactions
Maltese: Reazzjoni allerġika
English: Posology
Maltese: TIKKETTAR
English: Following the administration of 24 mg / m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg / ml (102 % CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg / ml (47.7 % CV) with concomitant methotrexate.
Maltese: Wara t-teħid ta' 24 mg / m2 (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti b' artrite idjopatika poliartikulari taż-żgħażagħ (JIA) li kellhom 4 sa 17-il sena, trough steady-state medju ta' koncetrazzjoni ta' adalimumab fis-seru (valuri mkejla minn ġimgħa 20 sa 48)
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10 % BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew studjati f'pazjenti adulti li jbatu minn psorjasi kronika li tikkawża qoxra mhux normali fuq il-ġilda (≥ 10 % involviment tal-BSA u l-Indiċi tal-Parti milquta mill-Psorjasi u s-Severità tagħha (PASI) ≥ 12 jew ≥ 10) li kienu kandidati għat-terapija sistemika jew għall-fototerapija fi studji double-blind magħżula b'ordni addoċċ.73% tal-pazjenti miktuba fl-Istudji tal-Psorjasi I u II kienu diġà rċevew terapija sistemika jew fototerapija.
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji bilprodott mediċina ta' referenza adalimumab f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kolite ulċerattiva (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
Maltese: Tuberkulożi, inkluż riattivazzjoni u bidu ġdid ta' tuberkulożi, kienet irrappurtata f'pazenti li jirċievu adalimumab.
English: • Use your pen within 5 minutes of removing the cap.
Maltese: • Uża l-pinna tiegħek fi żmien 5 minuti minn meta tneħħi l protezzjoni.
English: Hefiya is intended for the treatment of the following inflammatory diseases:
Maltese: Hefiya huwa intenzjonat għall-kura ta' mard infjammatorju:
English: Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Hefiya for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (table 1).
Maltese: Artrite relatata mal-entesite Id-doża rrakomandata ta' Hefiya f'pazjenti b'artrite relatata mal-entesite mill-età ta' 6 snin jew aktar hija bbażata fuq il-piż tal-ġisem (tabella 2).
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: • symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
Maltese: • sintomi ta' problemi fin-nervituri bħal tingiż, tnemnim, tara doppju jew dgħufija fl-idejn jew fir-riġlejn;
English: Other medicines and Hefiya
Maltese: Kif taħżen Hefiya
English: • Do not store the syringes in extreme heat or cold.
Maltese: • Taħżinx is-siringi fi sħana jew kesħa estrema.