FrancophonIA/ELRC3.0 huggingface dataset:
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with Humira compared to placebo (Table 14).
Maltese: Ir-riżultati ta' ġimgħa 12 wrew titjib statistikament sinifikanti tas-sinjali u ssintomi ta' nr-axSpA attiv f'pazjenti kkurati bi Humira meta mqabbla mal-plaċebo (Tabella 14).
English: A loading dose of 160 mg Humira on Week 0 followed by 80 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 12 g/ml during the induction period.
Maltese: Doża kbira ta' 160 mg Humira f'Ġimgħa 0 segwita b'80 mg Humira f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 12 g/ml matul il-perijodu tal-bidu.
English: Table 4 ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Maltese: Tabella 4 Risponsi għall-ACR fi Provi kontrollati bil-Plaċebo (Persentaġġ ta' Pazjenti)
English: Tel: +386 (1)32 08 060
Maltese: AbbVie Biofarmacevtska družba d.o.o. Tel: +386 (1)32 08 060
English: Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of Humira/MTX was administered every other week up to 10 years.
Maltese: Wara li għaddew l-ewwel 52 ġimgħa, 457 pazjent ħadu sehem fil-fazi ta' estenzjoni ta' l-istudju open-label fejn ingħataw 40 mg Humira/MTX ġimgħa iva u ġimgħa le sa 10 snin.
English: Patients remained on stable doses of NSAIDs and or prednisone ( 0.2 mg /kg/day or 10 mg/day maximum).
Maltese: Il-pazjenti nżammu fuq dożi stabbli ta' NSAIDs u jew prednisolone ( 0.2 mg /kg/ġurnata jew massimu ta' 10 mg/ġurnata).
English: One 0.8 ml vial contains 40 mg adalimumab.
Maltese: Kunjett wieħed ta' 0.8 ml li fih 40 mg adalimumab.
English: Humira 80 mg injection adalimumab SC
Maltese: U MNEJN GĦANDU JINGĦATA Humira 80 mg injezzjoni adalimumab
English: White Needle Sleeve
Maltese: Biex tinjetta lilek innifsek
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo (See Table 24).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar-riskju tal-falliment tat-trattament f'pazjenti ttrattati b'Humira kontra pazjenti li ngħataw plaċebo (Ara t-Tabella 24).
English: • abnormal muscle breakdown
Maltese: • deterjorazzjoni anormali tal-muskoli
English: 3) Injecting Humira
Maltese: 3) Biex tinjetta Humira
English: There are no clinical trials with Humira in adolescent patients with HS.
Maltese: M'hemm l-ebda provi kliniċi b'Humira f'pazjenti adolexxenti bi HS.
English: Humira 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: • ċerti tipi ta' aġenti anti-rewmatiċi li jaffetwaw il-proċess tal-mard (pereżempju sulfasalazine, hydroxychloroquine, leflunomide u preparazzjonijiet tad-deheb li jingħata b' injezzjoni), sterojdi jew medikazzjonijiet għall-uġigħ, li jinkludu mediċini anti-infjammatorji mhux sterojdi (NSAIDs).
English: UNIQUE INDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Table 26 Paediatric CD Study PCDAI Clinical Remission and Response Standard Dose 40/20 mg eow N = 93
Maltese: Tabella 26 Studju ta' CD fit-Tfal Qlib għall-aħjar fl-istat Kliniku u Rispons Kliniku tal-PCDAI Doża Standard 40/20 mg eow N = 93
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during a Humira trial in paediatric patients with uveitis.
Maltese: L-ebda tumuri malinni ma ġew osservati f'60 pazjent pedjatriku b'espożizzjoni ta' 58.4 snin ta' pazjenti waqt prova ta' Humira f'pazjenti pedjatriċi b'uveite.
English: Table 17 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission Standard Dose 40/20 mg eow
Maltese: Tabella 17 Studju ta' CD fit-Tfal Twaqqif tal-Kortikosterojdi jew Immunomodulaturi u Fejqan tal-Fistla Doża Standard 40/20 mg eow
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through Week 156.
Maltese: Titjib fil-kwalità tal-ħajja rrelatata mas-saħħa u funzjoni fiżika nżamm matul l-estensjoni open-label sa Ġimgħa 156.
English: Table 27 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission Standard Dose 40/20 mg eow
Maltese: Tabella 27 Studju ta' CD fit-Tfal Twaqqif tal-Kortikosterojdi jew Immunomodulaturi u Fejqan tal-Fistla Doża Standard 40/20 mg eow
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: 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); and not known (cannot be estimated from the available data).
Maltese: Il-lista li jmiss ta' reazzjonijiet avversi hija bbażata fuq esperjenza li ġejja minn studji kliniċi u minn esperjenza ta' wara t-tqegħid fis-suq, u hija mniżżla skont il-klassi tas-sistema ta' l-organu u l frekwenza f'Tabella 6 hawn taħt: 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); u mhux magħrufa (li ma jistgħux jiġu kkalkulati mill-informazzjoni eżistenti).
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 7).
Maltese: Fi Studju RA V, il-ħsara strutturali fil-ġogi ġiet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (ara Tabella 7).
English: Table 18 Paediatric CD Study PCDAI Clinical Remission and Response Standard Dose 40/20 mg eow N = 93
Maltese: Tabella 18 Studju ta' CD fit-Tfal Qlib għall-aħjar fl-istat Kliniku u Rispons Kliniku tal-PCDAI Doża Standard 40/20 mg eow N = 93
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomologous monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Maltese: Sar studju fuq l-effett tat-tossiċità waqt l-iżvilupp embrijo-fetali/l-iżvilupp fiż-żmien immedjatament qabel jew wara t-twelid, fuq xadini ċinomologi li b' 0, 30 u 100mk/kg (9-17 -il xadina/grupp) u dan ma wera l-ebda evidenza ta' dannu kkaġunat b'adalimumab fuq il-feti.
English: Deafness, tinnitus
Maltese: Kif tinjetta Humira
English: In controlled Phase 3 trials of Humira in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of Humira-treated patients and 1.3% of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kontrollati ta' Humira f'pazjenti b'artrite idjopatika poliartikulari taż-żagħżagħ li kellhom minn 4 sa 17-il sena u pazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, kien hemm żidiet f'ALT ta' ≥ 3 x ULN f'6.1% tal-pazjenti trattati bi Humira u 1.3% tal-pazjenti trattati bil-kontroll.
English: Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), or analgesics can be continued during treatment with Humira.
Maltese: Il-glukortikojdi, is-saliċilati u l-mediċini antiinfjammatorji mhux sterojdi (NSAIDs), jew analġeżiċi jistgħu jitkomplew waqt il-kura b'Humira.
English: The safety and efficacy of Humira were studied in adult patients with chronic plaque psoriasis ( 10% BSA involvement and PASI  12 or  10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Maltese: Is-sigurtà u l-effikaċja ta' Humira ġew studjati f'pazjenti adulti bi psorjasi tal-plakka kronika ( 10% involviment BSA u PASI  12 jew  10) li kienu kandidati għal terapija sistemika jew fototerapija fi studji każwali, double-blind. 73% tal-pazjenti rreġistrati fl-Studji Psorajisi I u II kienu rċevew minn qabel terapija sistemika jew fototerapija.
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
Maltese: HS hija bbażata fuq cross-indication tal-profil tas-sigurtà tal-adalimumab kemm f'adulti u f'pazjenti pedjatriċi b'dożi simili jew iżjed frekwenti (ara sezzjoni 5.2).
English: Humira Dose for Paediatric Patients with Plaque Psoriasis
Maltese: Tfal u adoloxxenti bi psorjasi tal-plakka
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 tal-bidu ta' adalimumab open-label 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: Humira is used to treat psoriatic arthritis in adults.
Maltese: Humira jintuża għall-kura ta' artrite psorjatika fl-adulti.
English: Total Sharp Score Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) < 0.001 0.0082 < 0.001 JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) < 0.001 0.0037 0.151 a p-value is from the pairwise comparison of methotrexate monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test. p-value is from the pairwise comparison of Humira monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: Fi provi kkontrollati ta' Humira (dożi inizjali ta' 80 mg f'Ġimgħa 0 segwita b'40 mg ġimgħa iva u ġimgħa le li tibda f'Ġimgħa 1) f'pazjenti adulti b'uveite sa 80 ġimgħa b'esponiment medjan ta' 166.5 ġurnata u 105.0 ġranet ttrattati b'Humira u pazjenti ttrattati b'kontroll, rispettivament, elevazzjonijiet ta' ALT ≥ 3 x ULN seħħew f'2.4% ta' pazjenti ttrattati b'Humira u 2.4% ta' pazjenti ttrattati b'kontroll.
English: 6 pre-filled pens 6 alcohol pads
Maltese: 6 pinen mimlijin għal-lest 6 kuxxinetti bl-alkoħol
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.
English: Amongst those who responded at Week 16 (n=144), the Pediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received Humira 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: In patients with Crohn's disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5.5 g/ml during the induction period.
Maltese: F'pazjenti li jbatu mill-marda Crohn (Crohn's disease), id-doża kbira ta' 80 mg Humira f'Ġimgħa 0 segwita b'40 mg Humira f'Ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas-serum f'adalimumab ta' bejn wieħed u ieħor 5.5 g/ml matul il-perijodu tal-bidu.
English: 2 pre-filled pens 2 alcohol pads
Maltese: 2 kuxxinetti bl-alkoħol
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus
Maltese: Reazzjoni Avversa tbejnġil (li tinkludi l-purpura), dermatite (li tinkludi l-ekżema), onikoklasi, iperidrożisi, alopeċja ħakk
English: • gallbladder inflammation, gallbladder stones
Maltese: • likwidu jkun imdardar, bla kulur, jew għandu biċċiet jew frak fiha
English: Humira 20 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).
Maltese: Humira 20mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest tintuża' darba (ħġieġ tat-tip I) b'tapp tal-planġer (lastku tal-bromobutyl) u labra bi protezzjoni tal-labra (elastomer termoplastiku).
English: In controlled Phase 3 trials of Humira 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 Humira-treated patients and 1.8% of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kontrollati ta' Humira f'pazjenti bi Psorjasi tal-plakka bi durazzjoni ta' perjodu kkontrollat tvarja minn 12 sa 24 ġimgħa, ALT ≥ 3 x ULN seħħew f'1.8% tal-pazjenti ttrattati b'Humira u 1.8% tal-pazjenti ttrattati kkontrollati.
English: The mean (±SD) serum adalimumab trough concentrations achieved at Week 4 were 15.7 ± 6.6 g/ml for patients  40 kg (160/80 mg) and 10.6 ± 6.1 g/ml for patients < 40 kg (80/40 mg).
Maltese: 7±6.6 g/ml għall-pazjenti  40 kg (160/80 mg) u 10.
English: Table 13 Efficacy Responses in Placebo-Controlled AS Study - Study I Reduction of Signs and Symptoms
Maltese: Tabella 13 Risponsi ta' l-Effikaċja fi Studju AS kontrollat bil-Plaċebo Effikaċja- Studju I Tnaqqis fisSinjali u s-Sintomi
English: Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira'.
Maltese: Istruzzjonijiet dettaljati kif tinjetta il-Humira huma pprovduti fit-taqsima 7 ‘Injettar talHumira'.
English: Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine.
Maltese: Fost il-pazjenti b'eżaminazzjoni ta' linja ta' bażi relatata mal-uġigħ tal-ġilda HS ≥ 3, ibbażata fuq Skala tal-Klassifikazzjoni Numerika 0 - 10; 0 = l-ebda uġigħ tal-ġilda, 10 = uġigħ ħafna tal-ġilda daqs kemm tista' timmaġina.
English: • pulmonary embolism (bloackage in an artery of the lung);
Maltese: • infjammazzjoni vaskulari (infjammazzjoni tal-vini u l-arterji);
English: • tingling;
Maltese: • Tnemnim;
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
Maltese: • disturbi fl-immunità li jistgħu jeffetwaw il-pulmun, ġilda u in-nodi tal-limfa (ippreżentata l-aktar komuni bħala sarcoidosis)
English: Table 16 Paediatric CD Study PCDAI Clinical Remission and Response Standard Dose 40/20 mg eow N = 93
Maltese: Tabella 16 Studju ta' CD fit-Tfal Qlib għall-aħjar fl-istat Kliniku u Rispons Kliniku tal-PCDAI Doża Standard 40/20 mg eow N = 93
English: • Paediatric plaque psoriasis
Maltese: • Psorijasi tal-plakka pedjatrika
English: Polyarticular juvenile idiopathic arthritis Age or body weight
Maltese: Humira jintuża biex jittratta • hidradenitis suppurativa moderata sa severa fl-adulti u
English: • intestinal perforation;
Maltese: • infezzjonijiet tal-fungu;
English: Humira 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Maltese: Humira 40 mg soluzzjoni għall-injezzjoni f'kunjett li jintuża għal darba waħda biss (ħġieġ tip I), komplut bis-siġilli tal-lastku, magħluq bil-pressa bl-aluminju u bis-siġilli flip-off.
English: Humira Dose for Paediatric Patients with Crohn's disease
Maltese: Doża ta' Humira għal pazjenti pedjatriċi bil-marda Crohn (Crohn's Disease)
English: Results from the overall UC-II study population are shown in Table 18.
Maltese: Riżultati ġenerali li ħarġu mill-popolazzjoni tal-istudju UC-II huma preżentati f'Tabella 18.
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I − V. In these trials, 11.9% of patients treated with Humira 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'Humira u 8.1% tal-pazjenti kkurati bil-plaċebo u bis-sustanza attivaużata bħala kontroll, li bdew bl-livelli tal-anti-korpi anti-nukleari negattivi, irrappurtaw livelli pożittivi f' Ġimgħa 24.
English: Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg
Maltese: Tfal u adolexxenti minn 6 snin 'il fuq li jiżnu minn 15 kg sa inqas minn 30 kg
English: • gastrointestinal bleeding;
Maltese: • tregħid;
English: Humira is available in other strengths and presentations.
Maltese: Humira huwa disponibbli f'qawwiet u preżentazzjonijiet oħra.
English: • If your child has active tuberculosis or other severe infections (see “Warnings and precautions”).
Maltese: • Jekk għandhek tuberkulosi attiva jew infezzjoni severa oħra, (ara “Twissijiet u prekawzjonijiet”).
English: Press the plum activator button and count slowly for 10 seconds.
Maltese: Agħfas l-buttuna tal-attivatur kulur l-għanbaqra u għodd bilmod għal 10 sekondi.
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 għall-ACR 20 f'Ġimgħa 24 jew 26.
English: • severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Maltese: • psorjasi kronika tal-plakka severa fit-tfal u adoloxxenti b'età minn 4 sa 17-il sena li għalihom terapija topika u fototerapiji jew ma ħadmux tajjeb ħafna jew mhumiex adattati.
English: АбВи ЕООД Тел.
Maltese: Aħsel idejk sewwa.
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 11).
Maltese: F'Ġimgħa 12, proporzjon ogħla b'mod sinifikanti ta' pazjenti fi Studju HS-II esperjenzaw tnaqqis klinikament rilevanti fl-uġigħ fil-ġilda relatati ma' HS (ara t-Tabella 11).
English: The combination of Humira and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Maltese: L-oftalmologi huma avżati biex jikkonsultaw ma' speċjalista xierqa qabel ma jinbeda t-trattament b'Humira (ara sezzjoni 4.4).
English: Table 19 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission Standard Dose 40/20 mg eow
Maltese: Tabella 19 Studju ta' CD fit-Tfal Twaqqif tal-Kortikosterojdi jew Immunomodulaturi u Fejqan tal-Fistla Doża Standard 40/20 mg eow
English: Table 21 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission Standard Dose 40/20 mg eow
Maltese: Tabella 21 Studju ta' CD fit-Tfal Twaqqif tal-Kortikosterojdi jew Immunomodulaturi u Fejqan tal-Fistla Doża Standard 40/20 mg eow
English: In controlled Phase 3 trials of Humira 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 Humira-treated patients and 1.8% of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kontrollati ta' Humira f'pazjenti bi psorjasi tal-plakka bi durazzjoni ta' perjodu kkontrollat tvarja minn 12 sa 24 ġimgħa, ALT ≥ 3 x ULN seħħew f'1.8 % tal-pazjenti ttrattati b'Humira u 1.8 % tal-pazjenti kkurati kkontrollati.
English: First dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later.
Maltese: segwita minn 80 mg (bħala 2 injezzjonijiet ta' 40 mg f'ġurnata waħda) ġimgħatejn wara.
English: Humira is used to treat rheumatoid arthritis in adults.
Maltese: Humira jintuża biex jittratta artrite rewmatika fl-adulti.
English: • neuropathy;
Maltese: • newropatija;
English: Your doctor should test you for HBV. Humira can cause reactivation of HBV in people who carry this virus.
Maltese: F'pazjenti li jġorru l-HBV, Humira jista' jikkaġuna riattivazzjoni ta' dan il-virus.
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 60mg/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: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo (See Table 19).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar-riskju tal-falliment tat-trattament f'pazjenti ttrattati b'Humira kontra pazjenti li ngħataw plaċebo (Ara t-Tabella 19).
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 TNF blocker.
Maltese: • Kien hemm każijiet ta' tipi ta' kanċer oħra, minbarra limfoma, f'pazjenti li jbatu minn marda speċifika tal-pulmun, li tissejjaħ mard kroniku assoċjat ma' imblukkar fis-sistema respiratorja (COPD), u li jirċievu l-kura b'mediċina oħra li timblokka t-TNF.
English: Humira 40 mg injection adalimumab SC
Maltese: U MNEJN GĦANDU JINGĦATA Humira 40 mg injezzjoni adalimumab
English: 1 sterile injection syringe 1 sterile needle
Maltese: Siringa sterili għall-injezzjoni
English: The recommended Humira 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: Id-dożaġġ irrakkomandat biex tinbeda l-kura b'Humira fuq 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: In RA study III, where Humira 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 kkurati b'Humira kienu ilhom ibatu mill-artrite rewmatika għal medja ta' 11 -il sena, il-ħsara strutturali fil-ġogi kienet stimata radjografikament u ġiet espressa bħala bidla fil-Punteġġ Totali Sharp (TSS) u l-komponenti tiegħu, il-punteġġ relatat ma' erożjoni u tnaqqis flispazju fil- ġogi.
English: Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira.
Maltese: Mediċini glukokortikojdi, saliċilati u mediċini anti-infjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt il-kura b'Humira.
English: Humira 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 Humira group (at Week 48).
Maltese: Il-kura b'Humira naqqset ir-rata li biha tipprogressa l-ħsara fil-ġogi periferali meta mqabbla mal-kura bil-plaċebo, kif imkejla mit-tibdil li kien hemm mil-linja bażi fil-punteġġ 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' Humira (f'Ġimgħa 48).
English: Choose an injection site:
Maltese: Jekk it-tifel jew tifla tiegħek tieqaf tuża Humira:
English: The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above.By attaching to TNFα, Humira decreases the process of inflammation in these diseases.
Maltese: Il-mira ta' adalimumab hija proteina msejħa fattur tan-nekrosi tat-tumur (TNFα), li hija involuta fissistema immuni (difiża) u hija preżenti f'livelli ogħla fil-mard infjammatorju elenkat hawn fuq.