FrancophonIA/ELRC3.0 huggingface dataset:
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 tad­doża rrakkomandata ta' adalimumab fil­popolazzjoni adolexxenti bi HS hija bbażata fuq cross­indication tal­profil tas­sigurtà tal­adalimumab kemm f'adulti u f'pazjenti pedjatriċi b'dożi simili jew iżjed frekwenti (ara sezzjoni 5.2).
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 20.
Maltese: Ir­rati tal­qlib għall­aħjar fl­istat kliniku u r­rispons kliniku (definit bħala tnaqqis fir­riżultat tal­ PCDAI ta' mill­inqas 15­il punt mill­linja bażi) huma preżentati f'Tabella 20.
English: Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease.
Maltese: Studju UV II evalwa 226 pazjent b'uveite inattiv li jeħtieġu trattament kroniku ta' kortikosterojdi (prednisone orali 10 sa 35 mg/kuljum) fil­linja bażi għall­kontroll tal­marda tagħhom.
English: The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Maltese: Il­każijiet l­oħra kienu tumuri malinni oħra u inkludew malinni rari li normalment jiġu assocjati ma' immunosoppressjoni.
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 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 eow jew MTX.
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Maltese: Fi studju UC­I, 390 pazjent li ma kienux ħadu antagonisti tat­TNF kienu randomizzati biex jew jirċievu l­plaċebo f'ġimgħat 0 u 2, 160 mg adalimumab f'ġimgħa 0 u wara 80 mg f'ġimgħa 2, jew 80 mg adalimumab f'ġimgħa 0 u wara 40 mg f'ġimgħa 2.
English: 1.7 Leave the pre-filled pen at room temperature for at least 30 minutes to allow the medicine to warm up (Figure F).
Maltese: 1.7 Ħalli l­pinna mimlija għal­lest fit­temperatura tal­kamra għal mill­inqas 30 minuta biex tippermetti l­mediċina tisħon (Stampa F).
English: How to store Idacio
Maltese: Tużax Idacio
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 adalimumabtreated patients and 1.8% of control-treated patients.
Maltese: Fil­Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti bi Psorjasi tal­plakka bi durazzjoni ta' perjodu kkontrollat tvarja minn 12 sa 24 ġimgħa, ALT ≥ 3 x ULN seħħew f'1.8% tal­pazjenti ttrattati b'adalimumab u 1.8% tal-pazjenti ttrattati kkontrollati.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Maltese: Artrite idjopatika poliartikulari taż­żagħżagħ u l­artrite relatata mal­entesite
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti monitoraġġ kontinwu tal­bilanċ bejn il­benefiċċju u r­riskju tal­prodott mediċinali.
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Maltese: Fil­gruppi kollha ta' kura, il­linja bażi medja tar­riżultat tal­PASI kienet ta' 18.9 u l­linja bażi ta' l­Istima Ġenerali tat­Tabib (PGA) varjat minn “moderat” (53% tas­ suġġetti li ġew inklużi) għal “sever” (41%) għal “sever ħafna” (6%).
English: Deafness, tinnitus
Maltese: • Jekk inti tirċievi
English: Fresenius Kabi Deutschland GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Fresinius Kabi Deutschland GmbH
English: Exposure-response relationship in paediatric population On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Maltese: Relazzjoni bejn espożizzjoni u rispons fil­popolazzjoni pedjatrika Fuq il­bażi tad­dejta tal­prova klinika f'pazjenti b'JIA (pJIA u ERA), ġiet stabbilita relazzjoni bejn l­ espożizzjoni u r­rispons bejn il­konċentrazzjonijiet fil­plażma u r­rispons PedACR 50.
English: Idacio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Maltese: Idacio huwa ndikat għall­trattament ta' intermedja, posterjuri u panuveite mhux infettiva f'pazjenti adulti li ma kellhomx rispons adegwat għal kortikosterojdi, f'pazjenti fl­użu meqjus tal­ kortikosterojdi, jew li fihom it-trattament b'kortikosterojdi mhux xieraq.
English: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Maltese: Tnaqqis ta' leżjonijiet infjammatorji u prevenzjoni ta' aggravar ta' axxessi u tal­fistuli li jnixxu ġew evalwati bl­użu ta' Hidradenitis Suppurativa Rispons Kliniku (HiSCR; mill­inqas tnaqqis ta' 50% fl­ axxess total u l­għadd tal­noduli infjammatorji bl­ebda żieda fl­għadd tal­axxess u l­ebda żieda fil­
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 Crohn (Crohn's disease), id­doża kbira ta' 80 mg adalimumab f'ġimgħa 0 segwita b'40 mg adalimumab f'ġimgħa 2 tilħaq konċentrazzjonijiet minimali tas­serum f'adalimumab ta' bejn wieħed u ieħor 5.5 g/ml matul il­perijodu tal­bidu.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Maltese: • disturbi fl­immunità li jistgħu jeffetwaw il­pulmun, ġilda u in­nodi tal­limfa (komunement kondizzjoni msejħa sarcoidosis);
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 16).
Maltese: Valutazzjoni tal­psorjasi tad­dwiefer tinkludi l­Indiċi Modifikata tas­Severità tal­Psorjasi tad­Dwiefer (mNAPSI), l­Evalwazzjoni Globali tat­Tobba tal­Psorjasi tad­dwiefer (PGA­F) u l­Indiċi tas­Severità tal­Psorjasi tad­Dwiefer (NAPSI) (ara Tabella 16).
English: Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability.
Maltese: Meta jingħata mil­ħalq, il­proteini tal­immunoglobulina G jgħaddu minn proteoliżi intestinali u għandhom bijodisponibilità baxxa.
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level.
Maltese: Informazzjoni limitata mil­litteratura ppubblikata tindika li adalimumab joħroġ mal­ħalib tas­sider tal­ bniedem f'konċentrazzjonijiet baxxi ħafna bil­preżenza ta' adalimumab fil­ħalib tal­bniedem f'konċentrazzjonijiet ta' 0.1% sa 1% tal­livell tas­serum maternali.
English: • Hold the syringe like a pencil.
Maltese: • Armi l­għatu tal­labra.
English: Idacio 40 mg/0.8 mL solution for injection (injection) for paediatric use is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Maltese: Idacio 40 mg/0.8 mL soluzzjoni għall­injezzjoni (injezzjoni) għall­użu pedjatriku jiġi bħala soluzzjoni sterili ta' 0.8 mL ċara u mingħajr kulur ta' 40 mg adalimumab.
English: Efficacy results The primary endpoint of the study was clinical remission at week 26, defined as PCDAI score ≤ 10.
Maltese: Riżultati tal-EffikaċjaIl­punt tat­tmiem primarju kien il­qlib għall­aħjar fl­istat kliniku f'ġimgħa 26, definit bħala riżultat tal­PCDAI  10.
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Maltese: Wara l­kura b' adalimumab, ġie osservat tnaqqis rapidu fil­livelli ta' sustanzi li jirreaġixxu fil­fażi akuta ta' l­infjammazzjoni (proteina C­reactive (CRP) u r­rata ta' tagħqid ta' l­eritroċit (ESR)) u cytokines fis­serum (IL­6), meta pparagunat ma' linja bażi f'pazjenti li jbatu minn artrite rewmatika.
English: Syringe plunger
Maltese: Planġer tas­siringa
English: - if your child has a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
Maltese: - jekk għandek infezzjoni severa, li tinkludi t­tuberkulosi, sepsis (avvelenament tad­demm) jew infezzjonijiet opportunistiċi oħrajn (infezzjonijiet mhux tas­soltu assoċjati ma' sistema immuni dgħajfa).
English: Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine.
Maltese: Skala tal­Klassifikazzjoni Numerika 0 - 10; 0 = l­ebda uġigħ tal­ġilda, 10 = uġigħ ħafna tal­ġilda daqs kemm tista' timmaġina.
English: Psoriasis study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Maltese: Studju Psorajisi I (REVEAL) evalwa 1,212­il pazjent fi żmien tliet perjodi tat­trattament.
English: ACR responses were maintained in the open-label extension study for up to 136 weeks.
Maltese: Fl­istudju ta' estensjoni open-label, ir­risponsi għall­ACR ġew mantenuti sa 136 ġimgħa.
English: • signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
Maltese: • sinjali u sintomi ta' infezzjoni bħal deni, tħossok marid, feriti, problemi tas­snien, ħruq waqt li qed tgħaddi l­awrina, tħossok dgħajjef jew għajjien jew tisgħol;
English: patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment.
Maltese: B'kollox fost il­pazjenti li waqqfu l­istudju, 18% waqfu minħabba avvenimenti avversi, u 8% minħabba rispons insuffiċjenti għal trattament b'adalimumab.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Maltese: • Jekk int iġġorr il­virus tal­epatite B (HBV), jekk għandek HBV attiv jew jekk taħseb li għandek riskju li jaqbdek l­HBV, għarraf lit­tabib tiegħek.
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: Livelli minimali medji fissi tal­konċentrazzjoni f'ġimgħa 12 sa ġimgħa 36 kienu bejn wieħed u ieħor 8 sa 10 μg/mL matul trattament b'adalimumab 40 mg kull ġimgħa.
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 segwit b'80 mg f'ġimgħa 2 kisbu konċentrazzjonijiet baxxi t'adalimumab fis­serum ta' madwar 7­8 μg/ mL f'ġimgħa 2 u ġimgħa 4.
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Maltese: Infezzjonijiet fatali u infezzjonijiet li jistgħu jpoġġu l­ħajja fil­periklu, (li jinkludu sepsis, infezzjonijiet opportunistiċi u TB), riattivazzjoni tal­HBV u tumuri malinni oħra (li jinkludu lewkimja, limfoma u HSTCL) gew irrapurtati ukoll bl­użu ta' adalimumab.
English: Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Maltese: L­artrite psorjatika hija marda infjammatorja tal­ġogi assoċjata mal­psorijasi.
English: In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Maltese: Fil­każ ta' suġġetti kkurati b'adalimumab li ma wrew l­ebda progress radjografiku mil­linja bażi sa ġimgħa 48 (n=102), 84% baqgħu ma urew l­ebda progress radjografiku matul 144 ġimgħa ta' kura.
English: Tuberculosis can develop during therapy even if your child has had preventative treatment for tuberculosis.
Maltese: It­tuberkulosi tista' tiżviluppa matul il­kura anke jekk inti rċivejt trattament ta' prevenzjoni għat­tuberkulosi.
English: Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment.
Maltese: Id­dejta disponibbli jissuġġerixxi li r­rispons kliniku huwa normalment milħuq fi żmien 2­8 ġimgħat ta' trattament.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 19).
Maltese: Valutazzjoni tal­psorjasi tad­dwiefer tinkludi l­Indiċi Modifikata tas­Severità tal­Psorjasi tad­Dwiefer (mNAPSI), l­Evalwazzjoni Globali tat­Tobba tal­Psorjasi tad­dwiefer (PGA­F) u l­Indiċi tas­Severità tal­Psorjasi tad­Dwiefer (NAPSI) (ara Tabella 19).
English: The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Maltese: Il­kombinazzjoni ta' adalimumab kif ukoll ta' antagonisti TNF oħrajn u anakinra jew abatacept mhix rakkomandata abbażi ta' riskju ogħla ta' infezzjonijiet, li jinkludu infezzjonijiet serji u interazzjonijiet farmakoloġiċi potenzjali.
English: • Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
Maltese: • sindromu Stevens­Johnson (reazzjoni li tista' tkun ta' theddida għall­ħajja b'sintomi bħal tal­
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 24).
Maltese: Riżultati minn żewġ studji wrew tnaqqis statistikament sinifikanti tar­riskju tal­falliment tat­trattament f'pazjenti ttrattati b'adalimumab kontra pazjenti li ngħataw plaċebo (Ara t­Tabella 24).
English: - 2 pre-filled syringes, with 2 alcohol pads 6 pre-filled syringes, with 6 alcohol pads Idacio 40 mg solution for injection in pre-filled pen
Maltese: - 2 pinen mimlijin lesti, b'2 kuxxinetti tal­alkoħolsiringi mimlijin għal­lest, b'6 kuxxinetti tal­
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: Fl­istudji tal­Psorijasi I u II, l­iskop primarju kien il­proporzjon ta' pazjenti li rnexxielhom jilħqu rispons tal­PASI ta' 75 mil­linja bażi f'ġimgħa 16 (ara Tabelli 17 u 18).
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.
Maltese: L­ebda tumuri malinni ma ġew osservati f'60 pazjent pedjatriku b'espożizzjoni ta' 58.4 snin ta' pazjenti waqt prova ta' adalimumab f'pazjenti pedjatriċi b'uveite.
English: The patients improved following discontinuation of therapy.
Maltese: Il­pazjenti marru għall­aħjar meta twaqqfet it­terapija.
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/mL (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/mL (71.2% CV) with concomitant methotrexate.
Maltese: adalimumab fis­serum kien 6.0 ± 6.1 µg/mL (101% CV) meta adalimumab ma kienx użat flimkien ma' methotrexate u 7.9 ± 5.6 µg/mL(71.2% CV) flimkien ma methotrexate.
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: Is­sigurtà u l­effikaċja ta'' adalimumab ġew ivvalutati f'żewġ studji randomised, double-blind ikkontrollati bil­plaċebo f'pazjenti b'spondyloarthrite axjali mhux radjografika (nr­axSpA).
English: pruritus
Maltese: Fażi
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus 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 l­effett tat­tossiċità waqt l­iżvilupp embrijo­fetali/l­iżvilupp fiż­żmien immedjatament qabel jew wara t­twelid, fuq xadini ċinomolgi li b' 0, 30 u 100mk/kg (9­17 -il xadina/grupp) u dan ma wera l­ebda evidenza ta' dannu kkaġunat b'adalimumab fuq il­feti.
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
Maltese: Disturbi fil­koagulazzjoni tad­demm u fil­ħruġ tad­demm (li jinkludu żieda parzjali fil­ħin ta' thromboplastin attivat), test pożittiv ta' autoantibody (li jinkludi DNA antibody bi strand doppja), żieda fil­blood lactate dehydrogenase
English: • chest pain;
Maltese: • uġigħ fis­sider;
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD
Maltese: L­OR aġġustata (li tammonta għal differenzi fil­linja bażi) kienet 1.10 (95% CI 0.
English: Placebo/ MTXa Adalimumab/MTX
Maltese: Plaċebo/MTX­ Adalimumab/MTX (95% Konfidenzab)
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Maltese: L­effikaċja ta' adalimumab kienet evalwata fi studju każwali, double-blind, ikkontrollat ta' 114-il pazjent pedjatriku minn 4 snin il-fuq bi psorjasi tal-plakka severa kronika (kif definit minn involviment ta' PGA ≥ 4 jew> 20% BSA jew> 10% involviment ta' BSA b'leżjonijiet ħoxnin ħafna jew PASI ≥ 20 jew ≥ 10 bi klinikament rilevanti involviment tal­wiċċ, ġenitali, jew idejn/saqajn) li ma kienux ikkontrollati b'mod adegwat b'terapija topika u ħeljoterapija jew fototerapija.
English: In CD study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Maltese: Fi studju CD II, 325 pazjent li ma kinux baqgħu juru rispons għall­kura jew li ma kinux jittolleraw infliximab kienu mqassma bl­addoċċ biex jirċievu jew 160 mg adalimumab f'ġimgħa 0 u 80 mg f'ġimgħa 2 jew plaċebo f'ġimgħat 0 u 2.
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Maltese: Id­dejta disponibbli tissuġġerixxi li r­rispons kliniku huwa normalment milħuq fi żmien 12­il ġimgħa ta' trattament.
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration
Maltese: Hypokalaemia, żieda fl­aċtu uriku, is-sodju fid-demm ikun arormali, ipokalċimija, ipergliċemija, ipofosfatemija, deidratazzjoni
English: Erosion 3.7 (2.7-4.7) 1.7 (1.0-2.4) JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Maltese: Ir­rispons għaż­żewġ sezzjonijiet ta' kura mhux ikkombinata kien simili (p=0.447). Minn 342 suġġetti li oriġinarjament kienu magħżula b'mod każwali għal monoterapija bi adalimumab jew terapija kkombinata b' adalimumab /methotrexate li daħlu fl­istudju ta' estensjoni open-label, 171 suġġetti temmew 10 snin ta' trattament b'adalimumab.
English: Table 22 Induction of clinical remission and response (percent of patients) CD study I: infliximab naive patients
Maltese: Tabella 22 Qlib għall-aħjar fl-Istat Kliniku u Rispons (Persentaġġ ta' Pazjenti) Studju I ta' CD: Pazjenti li qatt ma ħadu infliximab
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Idacio.
Maltese: Mediċini glukokortikojdi, saliċilati u mediċini anti­infjammatorji mhux sterojdi, jew mediċini analġeżiċi jistgħu jitkomplew waqt il­kura b'Idacio.
English: Table 29 Time to treatment failure in studies UV I and UV II
Maltese: Tabella 29 Żmien għall-falliment tat-trattament fi studji
English: In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively.
Maltese: Fl­istudju RA estiż bit­tikketta tingħaraf V, il­bidla medja mil­linja bażi f'Sena 10 fil­Punteġġ Totali Sharp modifikati kienet ta' 10.8, 9.2 u 3.9 f'pazjenti magħżula b'mod każwali oriġinarjament għal monoterapija b'methotrexate, monoterapija b' adalimumab u terapija kkombinata b'adalimumab/methotrexate, rispettivament.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 mL pre-filled pen contains 40 mg adalimumab
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kunjett wieħed ta' 0.8 mL fih 40 mg adalimumab.
English: Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Maltese: Ir­rapporti inkludew każijiet ta' tuberkulosi li nstabet fil­pulmun u tuberkulosi li instabet barra mill­pulmun (jiġifieri l­infezzjoni kienet mifruxa).
English: • With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (Figure P).
Maltese: • B'moviment qasir, u ta' malajr, imbotta l-labra kollha 'l isfel ġol­ġilda f'angolu ta' bejn 45° u 90° (Stampa P).
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 14 and 15).
Maltese: Fl-istudji Psorajisi I u II, punt ta' tmiem primarju kien il-proporzjon ta' pazjenti li kisbu rispons ta' PASI 75 mill­linja bażi f'Ġimgħa 16 (ara t­Tabelli 14 u15).
English: Detailed instructions on how to inject Idacio are provided in section 7 ‘Instructions for use'.
Maltese: Idacio huma pprovduti f'sezzjoni 7, ‘Istruzzjonijiet dwar lużu'.
English: Table 15 Ps study II (CHAMPION) efficacy results at 16 weeks Placebo N=53 n (%)
Maltese: Tabella 15 Ps Studju II (CHAMPION)
English: Idacio is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Maltese: Idacio huwa indikat għall­kura tal­marda ta' Crohn fit-tfal ta' bejn 6 u 17 il-sena.