FrancophonIA/ELRC3.0 huggingface dataset:
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 ogħla tal-bidu ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg adalimumab f'ġimgħa 2 tilħaq konċentrazzjonijiet minimi ta' adalimumab fis-serum ta' bejn wieħed u ieħor 12 µg/mL matul il-perjodu ta' induzzjoni.
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental
Maltese: Huwa importanti li inti tgħid lit-tabib tiegħek jekk għandek sintomi ta' infezzjoni, eż. deni, feriti, tħossok għajjien, problemi tas-snien.
English: • Merkel cell carcinoma (a type of skin cancer);
Maltese: • karċinoma taċ-ċelluli Merkel (tip ta' kanċer tal-ġilda);
English: Total Sharp
Maltese: Mhux komuni
English: Cyltezo dose for paediatric patients with Crohn's disease
Maltese: Doża ta' Cyltezo għal pazjenti pedjatriċi bil-marda Crohn (Crohn's Disease) Piż tal
English: The mean steady-state trough concentration at week 12 through week 36 were approximately 8 to 10 µg/mL during adalimumab 40 mg every week treatment.
Maltese: Konċentrazzjoni minima medja fi stat fiss f'ġimgħa 12 sa ġimgħa 36 kienet bejn wieħed u ieħor 8 sa 10 μg/mL matul trattament b'adalimumab 40 mg kull ġimgħa.
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 ogħla tal-bidu ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg adalimumab f'ġimgħa 2 tilħaq konċentrazzjonijiet minimi ta' adalimumab fis-serum ta' bejn wieħed u ieħor 12 µg/mL matul il-perjodu ta' induzzjoni.
English: Analysis Treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: Lupus-like syndrome
Maltese: Sindrome bħal ta' lupus
English: Hospitalisation rates
Maltese: Rispons radjografiku
English: Among those, 109 subjects (63.7 %) were reported to be in remission at 10 years.
Maltese: Fost dawn, 109 individwi (63.7%) kienu rrappurtati li kienu f'remissjoni wara 10 snin.
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 ilprovi, 11.9 % tal-pazjenti ttrattati b'adalimumab u 8.1 % tal-pazjenti ttrattati bil-plaċebo u bis-sustanza attiva użata bħala kontroll, li bdew b'livelli ta' anti-korpi anti-nukleari negattivi, irrappurtaw livelli pożittivi f'ġimgħa 24.
English: Time to Treatment Failure At or After Week 6 in Study UV I Primary analysis (ITT) Placebo Adalimumab 110 60 (54.5) 5.6
Maltese: Żmien għall-Falliment tat-Trattament fi jew wara ġimgħa 6 fi Studju UV I Analiżi Primarja (ITT) Plaċebo Adalimumab
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients.
Maltese: Fil-provi kkontrollati ta' Fażi 3 ta' adalimumab f'pazjenti b'artrite rewmatika u artrite psorjatika fejn il-pazjenti ngħataw kontroll għal perjodu ta' bejn 4 u 104 ġimgħat, kien hemm żidiet fl-ALT ta' ≥ 3 x ULN fi 3.7 % tal-pazjenti ttrattati b'adalimumab u f'1.6 % tal-pazjenti ttrattati bil-kontroll.
English: The recommended Cyltezo induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Maltese: Il-kors ta' dożaġġ ta' induzzjoni ta' Cyltezo rakkomandat għall-pazjenti adulti b'kolite ulċerattiva minn moderata sa severa, huwa ta' 160 mg mogħtija f'ġimgħa 0 (mogħtija bħala erba' injezzjonijiet ta' 40 mg f'ġurnata waħda jew bħala żewġ injezzjonijiet ta' 40 mg kull ġurnata għal jumejn wara xulxin) u 80 mg f'ġimgħa 2 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: • shortness of breath;
Maltese: • perforazzjoni tal-intestini;
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Maltese: Seħħet riattivazzjoni ta' epatite B f'pazjenti li kienu qed jirċievu antagonist ta' TNF, inkluż adalimumab, u li kienu jġorru dan il-virus b'mod kroniku (jiġifieri pożittivi għas-surface antigen).
English: Asthma, dyspnoea, cough
Maltese: Pankreatite, disfaġja, edima fil-wiċċ
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Maltese: Id-doża li s-soltu tingħata għall-adulti b'artrite rewmatika, ankylosing spondylitis, axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis u għal pazjenti b'artrite psorjatika hija 40 mg adalimumab bħala doża waħda ġimgħa iva u ġimgħa le.
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 studji RA I-IV, pazjenti ttrattati b'adalimumab laħqu risponsi statistikament sinifikanti tal-ACR 20 u 50 sa minn ġimgħa jew tnejn wara li nbeda t-trattament, meta pparagunati mal-plaċebo.
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'pazjenti pedjatriċi li għandhom CD moderata sa severa, d-doża ta' induzzjoni ta' adalimumab openlabel kienet 160/80 mg jew 80/40 mg f'ġimgħa 0 u 2, rispettivament, li kienet tiddeppendi fuq il-punt ta' qtugħ tal-piż tal-ġisem ta' 40 kg.
English: 6 months 12 months
Maltese: Minn 4 sa 7 snin
English: Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Maltese: Tabella 28: Rispons, Remissjoni u Fejqan tal-Mukoża fi Studju UC-II (Persentaġġ ta' Pazjenti) Plaċebo
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more The recommended dose of Cyltezo is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Maltese: Adolexxenti b'hidradenitis suppurativa ta' età minn 12 sa 17-il sena, li jiżnu 30 kg jew aktar) Id-doża rakkomandata ta' Cyltezo hija doża inizjali ta' 80 mg (bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda), segwita b'40 mg ġimgħa iva u ġimgħa le li jibdew ġimgħa wara.
English: System Organ Class Frequency
Maltese: KG organizačná zložka
English: • If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
Maltese: • Jekk għandhek infezzjoni severa, inkluż tuberkulosi (ara “Twissijiet u prekawzjonijiet”).
English: Cyltezo 40 mg solution for injection in pre-filled syringe Each 0.8 mL single dose pre-filled syringe contains 40 mg of adalimumab.
Maltese: Cyltezo 40 mg soluzzjoni għall-injezzjoni (injezzjoni) f'pinna mimlija għal-lest huwa fornut bħala soluzzjoni sterili ta' 0.8 mL, ċara sa ftit opalexxenti ta' 40 mg adalimumab.
English: A. Prepare to administer dose
Maltese: Metodu u rotta ta' amministrazzjoni
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' kanċers tal-ġilda li mhumiex melanoma u limfomi, huma bejn wieħed u ieħor 0.2 u 0.3 kull 1,000 sena ta' trattament ta' pazjenti, rispettivament (ara sezzjoni 4.4).
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab.
Maltese: Minkejja trattament profilattiku għat-tuberkulosi, kien hemm każijiet ta' riattivazzjoni tat-tuberkulosi f'pazjenti ttrattati b'adalimumab.
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 ta' żewġ korsijiet ta' dożaġġ ta' manteniment irranġati skont il-piż tal-ġisem wara terapija ta' induzzjoni li wkoll kienet irranġata skont il-piż tal-ġisem sa 52 ġimgħa ta' trattament, kien hemm żidiet fl-ALT ta' ≥ 3 x ULN fi 2.6 % (5/192) tal-pazjenti li minnhom 4 kienu qed jirċievu immunosoppressanti konkomitanti fil-linja bażi.
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 l-għoti ta' adalimumab 40 mg taħt il-ġilda ġimgħa iva u ġimgħa le f'pazjenti adulti li jbatu minn artrite rewmatika (AR - rheumatoid arthritis), il-konċentrazzjonijiet minimi medji fi stat fiss kienu ta' bejn wieħed u ieħor 5µg/mL (mingħajr t-teħid konkomitanti ta' methotrexate) u minn 8 sa 9 µg/mL (bit-teħid konkomitanti ta'methotrexate), rispettivament.
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Maltese: Żewġ pazjenti minn 3,441 li kienu ttrattati b'adalimumab fl-istudji kollha talartrite rewmatika u artrite psorjatika żviluppaw sinjali kliniċi li jindikaw bidu ta' sindrome li jixbaħ lillupus.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Maltese: Adalimumab huwa anti-korp rikombinanti monoklonali uman magħmul fiċ-ċelluli tal-Ovarji talĦamster Ċiniż.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Cyltezo, and in accordance with local recommendations.
Maltese: Jekk ikun hemm dijanjosi ta' tuberkulosi rieqda, għandha tinbeda kura bi trattament profilattiku għal kontra t-tuberkulosi qabel ma jinbeda Cyltezo, u skont rakkomandazzjonijiet lokali.
English: • pulmonary fibrosis (scarring of the lung);
Maltese: • fibrożi fil-pulmun (ċikatriċi fil-pulmun)
English: RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Maltese: Studju RA V evalwa 799 pazjent adult li jbatu minn artrite rewmatika attiva minn moderata sa severa li għada fil-bidu (il-medja ta' kemm kien ilha li bdiet il-marda kien ta' 9 xhur) li qatt ma kienu ħadu methotrexate qabel.
English: Psoriasis Study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Maltese: L-Istudju tal-Psorjasi II (CHAMPION) qabbel l-effikaċja u s-sigurtà ta' adalimumab kontra dawk ta' methotrexate u tal-plaċebo f'271 pazjent.
English: Following the administration of 24 mg/m² (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/mL with concomitant methotrexate.
Maltese: Wara l-ammistrazzjoni ta' 24 mg/m2 (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lillpazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, il-konċentrazzjonijiet minimi medji fi stat fiss (valuri mkejla f'ġimgħa 24) ta' adalimumab fis-serum kienu 8.8 ± 6.6 μg/mL meta adalimumab ma kienx użat flimkien ma' methotrexate u 11.8 ± 4.3 μg/mL meta adalimumab kien użat flimkien ma' methotrexate
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo
Maltese: *** p < 0.001 għall-paraguni kollha bejn adalimumab u l-plaċebo * p < 0.05 f għall-paraguni kollha bejn adalimumab u l-plaċebo N/A Mhux applikabbli
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 48).
Maltese: It-trattament b'adalimumab naqqas ir-rata li biha tipprogressa l-ħsara fil-ġogi periferali meta mqabbla ma' trattament bil-plaċebo, kif imkejjel mit-tibdil li kien hemm mil-linja bażi f'mTSS (medja ± SD) 0.8 ± 2.5 fil-grupp tal-plaċebo (f'ġimgħa 24) meta mqabbel ma' 0.0 ± 1.9 (p < 0.001) fil-grupp ta' adalimumab (f'ġimgħa 48).
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 individwu pedjatriku li għandhom bejn 6 u 17-il sena (inklużi), bil-marda ta' Crohn (CD - Crohn's disease) moderata sa severa definita bħala punteġġ tal-Indiċi tal-Attività tal-marda ta' Crohn fit-tfal (PCDAI - Paediatric
English: Cyltezo is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Maltese: Cyltezo jintuża għat-trattament ta' ankylosing spondylitis u axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis fl-adulti.
English: • There have been cases of cancers other than lymphoma in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Maltese: • Kien hemm każijiet ta' tipi ta' kanċer oħra, minbarra limfoma, f'pazjenti li jbatu minn mard speċifiku tal-pulmun, li jissejjaħ mard kroniku ostruttiv tal-pulmun (COPD - chronic obstructive pulmonary disease), u li jirċievu trattament b'mediċina oħra li timblokka TNFα.
English: Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Maltese: Pazjenti minn studji UC-I u UC-II kellhom l-għażla li jaqilbu għal studju ta' estensjoni open-label fuq tul ta' żmien (UC III).
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Maltese: Ma ġewx osservati l-ebda tumuri malinni f'249 pazjent pedjatriku b'espożizzjoni ta' 655.6 sena ta' pazjent waqt provi b'adalimumab f'pazjenti b'artrite idjopatika taż-żagħżagħ (artrite idjopatika poliartikulari taż-żagħżagħ u artrite relatata mal-entesite).
English: In RA study III, where adalimumab treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score.
Maltese: Fi studju RA III, fejn pazjenti ttrattati b'adalimumab kienu ilhom ibatu mill-artrite rewmatika għal medja ta' madwar 11-il sena, il-ħsara strutturali fil-ġogi kienet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (TSS - Total Sharp Score) modifikat u l-komponenti tiegħu, il-punteġġ ta' erożjoni u l-punteġġ ta' tnaqqis fl-ispazju bejn il-ġogi.
English: In the pivotal controlled trials in adults and children, 12.9 % of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2 % of patients receiving placebo or active control.
Maltese: Fil-provi pivitali kkontrollati li saru fl-adulti u fit-tfal, 12.9 % tal-pazjenti ttrattati b'adalimumab żviluppaw reazzjonijiet fil-post tal-injezzjoni (eritema u/jew ħakk, emorraġija, uġigħ jew nefħa), ipparagunat ma' 7.2 % tal-pazjenti li kienu qegħdin jirċievu l-plaċebo jew sustanza attiva użata bħala kontroll.
English: The recommended Cyltezo 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: Il-kors tad-doża ta' Cyltezo rakkomandat għall-pazjenti adulti b'hidradenitis suppurativa (HS) huwa 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), segwit minn 80 mg żewġ ġimgħat wara f'Jum 15 (mogħtija bħala żewġ injezzjonijiet ta' 40 mg f'ġurnata waħda).
English: Nocturia
Maltese: Treddigħ
English: Treatment with Cyltezo may result in the formation of autoimmune antibodies.
Maltese: It-trattament b'Cyltezo jista' jirriżulta fil-formazzjoni ta' anti-korpi awtoimmuni.
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 eow or MTX.
Maltese: F'ġimgħa 16, aktar pazjenti randomised għal adalimumab 0.8 mg/kg kellhom risponsi pożittivi tal-effikaċja (eż., PASI 75) minn dawk randomised għal 0.4 mg/kg eow jew MTX.
English: Some of these hepatosplenic T-cell lymphomas with adalimumab have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease.
Maltese: Xi wħud minn dawn il-hepatosplenic T-cell lymphomas b'adalimumab ġew osservati f'pazjenti adulti żgħażagħ meta kienu qed jiġu trattati wkoll b'azathioprine jew 6-mercaptopurine li jintuzaw għat-trattament ta' mard infjammatorju fil-musrana.
English: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64 %.
Maltese: Ilbiodisponibiltà medja assoluta ta' adalimumab stmata minn tliet studji wara t-teħid ta' doża waħda ta' 40 mg taħt il-ġilda kienet ta' 64 %.
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: Fi studju UC-II, minn dawk il-pazjenti ttrattati b'adalimumab u li kienu f'remissjoni f'ġimgħa 8, 21/41 (51%) kienu wkoll f'remissjoni f'ġimgħa 52.
English: Patients were randomised to receive either 24 mg/m² body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Maltese: Ilpazjenti kienu randomised biex jirċievu 24 mg/m2 tal-erja tal-wiċċ tal-ġisem (BSA - body surface area) ta' adalimumab sa massimu ta' 40 mg, jew plaċebo ġimgħa iva u ġimgħa le għal 12-il ġimgħa.
English: • It is normal to see one or more bubbles in the medication.
Maltese: • Huwa normali li tara bużżieqa waħda jew aktar fil-mediċina.
English: The highest frequency seen among the various indications has been included.
Maltese: Ġiet inkluża l-ogħla frekwenza osservata fost id-diversi indikazzjonijiet.
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Cyltezo should be considered prior to initiating therapy (see Other opportunistic infections).
Maltese: F'pazjenti li kienu diġa esposti għat-tuberkulosi u pazjenti li vvjaġġaw f'żoni ta' riskju għoli ta' tuberkulosi jew mikożi endemiċi bħal histoplasmosis, coccidioidomycosis, jew blastomycosis, ir-riskji u l-benefiċċji ta' trattament b'Cyltezo għandhom jiġu kkunsidrati qabel ma tinbeda t-terapija (ara Infezzjonijiet opportunistiċi oħra).
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with
Maltese: Fi studji tal-marda ta' Crohn fl-adulti, kien hemm inċidenzi aktar għoljin ta' avvenimenti avversi malinni u serji relatati mall-infezjoni meta adalimumab kien ikkombinat ma' azathioprine/6-mercaptopurine meta mqabbel ma' adalimumab waħdu.
English: At 8 years, 81 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Maltese: Wara 8 snin, 81 minn 207 pazjenti li oriġinarjament kienu ttrattati b'40 mg adalimumab ġimgħa iva u ġimgħa le ġew evalwati radjografikament.
English: In controlled Phase 3 trials of adalimumab in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8 % of adalimumab-treated patients
Maltese: Fil-provi kkontrollati ta' Fażi 3 ta' adalimumab f'pazjenti bi Psorjasi tal-plakka b'tul ta' perjodu kkontrollat li jvarja minn 12 sa 24 ġimgħa, żidiet fl-ALT ta' ≥ 3 x ULN seħħew f'1.8 % tal-pazjenti ttrattati b'adalimumab u 1.8 % tal-pazjenti ttrattati bil-kontroll.
English: The syringe inside the pen is made from type I glass with a plunger stopper (butyl rubber) and a needle with a cap (outer part made of plastic material and inner part made of elastomer containing latex).
Maltese: Is-siringa ġewwa l-pinna hija magħmula minn ħġieġ tip I b'tapp tal-planġer (lastku tal-butyl) u bl-labra b'għatu (il-parti ta' barra magħmula minn materjal talplastik u l-parti ta' ġewwa magħmula mil-latex li fih l-elastomer).
English: Pancytopenia
Maltese: FARMAĊEWTIKU
English: Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section 5.2).
Maltese: Sigurtà tad-doża rakkomandata ta' adalimumab fil-popolazzjoni adolexxenti b'HS hija bbażata fuq ilprofil tas-sigurtà ta' cross-indication ta' adalimumab kemm f'adulti kif ukoll f'pazjenti pedjatriċi b'dożi simili jew iżjed frekwenti (ara sezzjoni 5.2).
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: L-individwi kollha ngħataw terapija ta' induzzjoni open-label b'doża fuq bażi tal-piż tal-ġisem tagħhom fil-linja bażi: 160 mg f'ġimgħa 0 u 80 mg f'ġimgħa 2 għal individwi ≥ 40 kg, u 80 mg u 40 mg, rispettivament, għal individwi < 40 kg.
English: Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
Maltese: Infezzjonijiet fis-sistema respiratorja (li jinkludu infezzjoni fin-naħa ta' isfel u fin-naħa ta' fuq tas-sistema respiratorja, pnewmonja, sinożite, farinġite, nażofarinġite u pnewmonja kkawżata mill-virus tal-herpes)
English: Blood and the lymphatic system disorders*
Maltese: Disturbi fis-sistema nervuża*
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 trattament qabel b'anti-TNF u li ma ħadimx.