FrancophonIA/ELRC3.0 huggingface dataset:
English: In all four studies, the combination of rosiglitazone and glimepiride was shown to be more effective than either of its components used on its own in lowering the levels of HbA1c.
Maltese: Fl-erba' studji kollha, il-kombinazzjoni ta' rosiglitazone u glimepiride wriet ruħha aktar effikaċi minn kull wieħed mill-komponenti użat waħdu fit-tnaqqis tal-livelli ta' l-HbA1C.
English: For the full list of restrictions, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara lFuljett ta' Tagħrif.
English: Avaglim is used in patients who cannot satisfactorily control their blood glucose (sugar) when using an adequate dose of a sulphonylurea (a type of antidiabetes medicine) on its own, and for whom metformin (another antidiabetes medicine) is
Maltese: Avaglim jintuża f'pazjenti li jirnexxilhomx jikkontrollaw b'mod suffiċjenti l-glukożju (zokkor) fid-demm b'doża adegwata ta' sulfonilurea (sulphonylurea - tip ta' mediċina kontra d-dijabete) waħedha u li għalihom il-metformina (metformin - tip ieħor ta' mediċina kontra d-dijabete) mhijiex adatta.
English: The studies measured the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: Dawn l-istudji kejlu l-livell ta' sustanza magħrufa bħala emoglobina glikosilata (HbA1cglycosylated haemoglobin) fid-demm, li jagħti indikazzjoni ta' l-effikaċja tal-kontroll tal-glukożju fiddemm.
English: • rosiglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces;
Maltese: • rosiglitazone jagħmel iċ-ċelluli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi;
English: The full EPAR for Avaglim can be found here.
Maltese: Informazzjoni oħra dwar Avaglim:
English: Avaglim contains two active substances, which have different modes of action:
Maltese: Avaglim fih żewġ sustanzi attivi, kull waħda minnhom għandha azzjoni differenti:
English: The CHMP concluded that Avaglim's benefits are greater than its risks and recommended that it be
Maltese: Is-CHMP ikkonkluda li l-benefiċċji ta' Avaglim huwa akbar mir-riskji tiegħu u rrakkomanda li jingħata lawtorizzazzjoni għat-tqegħid fis-suq.
English: The dose can be increased to the 8-mg/4-mg tablets after eight weeks if needed, but this should be done with caution, due to the risk of fluid retention.
Maltese: Id-doża tista' tiżdied sa 8-mg/4-mg wara tmien ġimgħat, jekk dan ikun meħtieġ, iżda dan għandu jsir b'kawtela minħabba r-riskju ta' żamma ta' fluwidi.
English: What benefit has Avaglim shown during the studies?
Maltese: Kif ġie studjat Avaglim?
English: Doctors must be careful when switching patients who are at risk of developing hypoglycaemia (low blood sugar levels) to Avaglim, such as elderly patients, patients with low weight or those who have been taking certain
Maltese: It-tobba għandhom joqogħdu attenti meta jippreskrivu Avaglim lill-pazjenti b'riskju ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm), per eżempju pazjenti anzjani, pazjenti b'piż baxx jew pazjenti li ħadu ċerti mediċini oħra.
English: It can be used in combination with a sulphonylurea when metformin is not suitable.
Maltese: Jista' jintuża f'kombinazzjoni ma' sulphonylurea meta metformin ma jkunx xieraq.
English: What is the risk associated with Avaglim?
Maltese: X'inhu r-riskju assoċjat ma' Avaglim?
English: Because they have been used in the EU for a number of years, studies of rosiglitazone and glimepiride used on their own were used as the basis for Avaglim.
Maltese: Minħabba li ilhom jintużaw fl-UE għal numru ta' snin, l-istudji ta' rosiglitazone u glimepiride użati waħidhom intużaw bħala l-bażi għal Avaglim.
English: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Maltese: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey L­Iżvizzera
English: ASDAS inactive disease hs-CRPd,f,g
Maltese: ASDAS marda inattiva hs-CRPd,f,g
English: • Made of a heavy-duty plastic;
Maltese: • Magħmul minn plastik heavy­duty;
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 2 April 2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 2 t'April 2019
English: 2-sided p value from log rank test.
Maltese: b 2­naħat valur P minn test log rank.
English: For the full list of excipients, see section 6.1.
Maltese: Għal­lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Table 25 Maintenance regimen
Maltese: Tabella 25 Reġim ta' manteniment
English: Label area (Idacio, dose, expiration date)
Maltese: Parti tat-tikketta (Idacio, doża, data ta' skadenza)
English: Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Maltese: Ir­rispons kliniku (CR­100) kien mantenut f'102 u 233 pazjent, rispettivament.
English: Table 19 Maintenance regimen
Maltese: Tabella 19 Reġim ta' manteniment
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C ­ 8°C).
English: CI 95% for HRa p Value b
Maltese: HRa CI 95% għall-HRa
English: 79 (73.1) a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Maltese: 79 (73.1) a, b a p<0.001 adalimumab vs. plaċebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. plaċebo d p<0.05 adalimumab vs. methotrexate
English: ASASa,b 20 ASASa,b 40
Maltese: ASASa,b 20
English: ACR 20 Week 52 62.6% 54.4% 72.8% Week 104 56.0% 49.3% 69.4% ACR 50 Week 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Week 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 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: Ġimgħa 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Ġimgħa 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Ġimgħa 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Ġimgħa 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 a. il­valur­p jiġi mit­tqabbil bejn pari ta' trattament b'methotrexate waħdu u adalimumab u methotrexate mgħotija flimkien bl­użu tat­test U Mann-Whitney. b. il­valur­p jiġi mit­tqabbil bejn pari ta' trattament b'adalimumab waħdu u adalimumab u methotrexate mgħotija flimkien bl­użu tat­test U Mann-Whitney.
English: Moderate to severe heart failure (NYHA class III/IV) (see section 4.4).
Maltese: Insuffiċjenza tal­qalb minn moderata sa severa (NYHA klassi III/IV) (ara sezzjoni 4.4).
English: - The active substance is adalimumab.
Maltese: Is-sustanza attiva hi adalimumab.
English: At week 12 and week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Maltese: F'ġimgħa 12 u ġimgħa 24, ir­rispons PedACR30 kien ta' 93.5% u 90.0% rispettivament meta intużat is­sitema ta' informazzjoni osservata.
English: 61352 Bad Homburg v.d.Höhe Germany
Maltese: 61352 Bad Homburg v.d.Höhe Il­Ġermanja
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Maltese: Din it­tip ta' T­cell lymphoma rari hi aggressiva ħafna u ġeneralment tkun fatali.
English: Hidradenitis suppurativa clinical response (HiSCR)a
Maltese: Hidradenitis suppurativa rispons kliniku (HiSCR)a
English: Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Maltese: Limfoma**, neoplażmi fl­organi solidi (li jinkludu kanċer tas­sider, neoplażma fil­pulmun u neoplażma fit-tirojde), melanoma**
English: 36.8% (14/38) 64.9% (24/37)b 43.3% (13/30) 71.4% (20/28)c
Maltese: 36.8% (14/38) 64.9% (24/37)b
English: Idacio is a biosimilar medicinal product.
Maltese: Idacio huwa prodott mediċinali bijoloġiku simili.
English: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1), lichenoid skin reaction1)
Maltese: Erythema multiforme1), sindromu ta' Stevens-Johnson1), angioedema1), vaskulite tal­ ġilda reazzjoni tal­lichenoid fil­ġilda1)
English: Pack sizes of:
Maltese: Daqs tal-pakketti ta':
English: cAnkylosing Spondylitis Disease Activity Score dPartial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Maltese: c Punteġġ tal­Attività ta' Ankylosing Spondylitis Disease d Flare parzjali huwa definit bhala ASDAS ≥ 1.3 izda < 2.1 at 2 żjarat konsekuttivi.
English: Usually, Idacio is used with methotrexate.
Maltese: Ġeneralment, Idacio jintuża ma' methotrexate.
English: Steroid-free remission for ≥ 90 days a
Maltese: Titjib tal­kundizzjoni migħajr sterojdi għal ≥ 90 days a
English: urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia1),
Maltese: urtikarja, tbejnġil (li tinkludi l­purpura), dermatite (li tinkludi l­ekżema), onikoklasi, iperidrożisi, alopeċja1),
English: In CD study III, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis.
Maltese: III, f'ġimgħa 4, 58% (499/854) tal­pazjenti kellhom rispons kliniku u ġew assessjati fl­ analiżi primarja.
English: **p < 0.01, adalimumab versus placebo
Maltese: **p < 0.01, adalimumab kontra l-plaċebo
English: • Push the injection button (Figure P).
Maltese: • Agħfas il­buttuna tal­injezzjoni (Stampa P).
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18% vs. 9% respectively, p=0.031) and study UC-II (17% vs. 9% respectively, p=0.019).
Maltese: Pazjenti li ngħataw 160/80 mg adalimumab kellhom titjib kliniku f'perċentwali akbar li kienu statistikament sinjifikanti meta mqabbla ma plaċebo f'ġimgħa 8 fi studju UC­I (18% vs. 9% rispettivament, p=0.031) u fi studju UC-II (17% vs. 9% rispettivament, p=0.019).
English: • psoriasis,
Maltese: • psorijasi
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Maltese: Il­qlib għall­aħjar fl­istat kliniku (definit bhala CDAI < 150) ġie evalwat f'żewġ studji, studju CD I (CLASSIC I) u studju CD II (GAIN).
English: • angioedema (localized swelling of the skin);
Maltese: • anġjoedima (nefħa lokalizzata tal­ġilda);
English: Placebo/MTXAdalimumab/MTX (95% confidence intervalb)
Maltese: Plaċebo/MTX­ Adalimumab/MTX (95% Intervall ta' Konfidenzab)
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Maltese: Melanoma u karċinoma taċ­ċelluli Merkel kienu wkoll irrapurtati f'pazjenti kkurati bl­antagonisti ta' TNF inkluż adalimumab (ara sezzjoni 4.8).
English: SPARCCh MRI sacroiliac jointsd,i SPARCC MRI spined,j a Assessment of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Maltese: SPARCCh MRI ġogi sakroiljaċi d,i SPARCC spinaMRI d,j a Valutazzjonijiet tas­Soċjetà Internazzjonali dwar l­Ispondiloartrite b Indiċi tal­Attività tal­Mard Bath Ankylosing Spondylitis c Punteġġ tal­Attivita tal­Marda Ankylosing Spondylitis d Bidla medja mil­linja bażi e n=91 plaċebo u n=87 adalimumab f Proteina Ċ­reattiva b'sensittività għolja (mg/L) g n=73 plaċebo u n=70 adalimumab h Konsorzju tal­Kanada għar­riċerka tal­Ispondiloartrite i n= 84 plaċebo u adalimumab j n= 82 plaċebo u n=85 adalimumab
English: Hepatitis, reactivation of hepatitis B1), autoimmune hepatitis1)
Maltese: Epatite riattivazzjoni tal-epatite B1) epatite awtoimmuni1)
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: Il­lista li jmiss ta' reazzjonijiet avversi hija bbażata fuq esperjenza li ġejja minn studji kliniċi u minn esperjenza ta' wara t­tqegħid fis­suq, u hija mniżżla skont il­klassi tas­sistema ta' l­organu 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 mill­informazzjoni eżistenti).
English: Following 3 years of adalimumab therapy, 75% (301/402) continued to be in clinical remission per partial Mayo score.
Maltese: Wara 3 snin ta' terapija b'adalimumab, 75% (301/402) baqgħu fi stat ta' titjib kliniku skont il­punteġġ Mayo parzjali.
English: PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX c P=0.083, adalimumab 0.8 mg/kg versus MTX
Maltese: PGA: Xejn/minimalic a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg kontra MTX c P=0.083, adalimumab 0.8 mg/kg kontra MTX
English: Adalimumab significantly decreased the risk of treatment failure by 75% relative to placebo, as shown by the hazard ratio (HR = 0.25 [95% CI: 0.12, 0.49]).
Maltese: Adalimumab naqqas b'mod sinifikanti r-riskju ta' falliment tat-trattament b'75% meta mqabbel mal­plaċebo, kif inhu muri mill­proporzjon ta' periklu (HR = 0.25 [95% CI: 0.12, 0.49]).
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
Maltese: • epatite awtoimmuni (infjammazzjoni tal­fwied ikkawżata mis­sistema immunitarja tal­istess ġisem);
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Maltese: • lifoma hepatosplenic T-cell (kanċer tad­demm rari li ħafna drabi huwa fatali);
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Maltese: Il­persentaġġ ta' pazjenti kkurati b'adalimumab li jilħqu risponsi għall­ACR 20, 50 u 70 kien konsistenti fi studji RA I, II u III.
English: Maintenance of clinical remission was evaluated in CD study III (CHARM).
Maltese: Il­fatt jekk ġiex mantenut it­titjib kliniku ġie evalwat fi studju CD III (CHARM).
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Maltese: Il­ konċentrazzjoni apparenti ta' adalimumab fil­plażma li tipproduċi nofs il­probabbiltà massima ta' rispons PedAc 50 (EC50) kienet ta' 3 μg/ml (95% CI: 1­6 μg/ml).
English: Mean exposure in all adalimumab population was 762 days.
Maltese: L­esponiment medju fil­ popolazzjoni kollha ta' adalimumab kien ta' 762 ġurnata.
English: Impaired lung function may increase the risk for developing infections.
Maltese: Indeboliment fil­funzjoni tal­pulmun jista' iżid ir­riskju li tiżviluppa infezzjoni.
English: INFORMATION IN BRAILLE Idacio 40 mg/0.8 mL
Maltese: Idacio 40 mg/0.8 mL
English: Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Maltese: Emboliżmu fil­pulmun1), mard ta' l-interstizju tal-pulmun, mard kroniku ta' imblukkar fil-pulmun, pulmonite, effużjoni plerali1)
English: Erosion score JSNd score amethotrexate b95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
Maltese: Punteġġ tal-erożjoni Punteġġ JSNd amethotrexate b95% intervalli ta' konfidenza ghad­differenza bejn il­punteġġi ta' methotrexate u adalimumab.
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Maltese: Is­sigurtà u l­effikaċja ta' dożi multipli ta' adalimumab ġew stimati f'pazjenti adulti b'kolite ulċerattiva moderata sa severa (Punteġġ Mayo 6 sa 12; Sottopunteġġ 2 sa 3 bl­endoskopija) fi studji ikkontrollati bi plaċebo, randomizzati u double-blind.
English: • erythema multiforme (inflammatory skin rash);
Maltese: • erythema multiforme (raxx u infjammazzjoni fil­ġilda);
English: Hepatosplenic T-cell lymphoma1), Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Maltese: Limfoma tat-tip hepatosplenic T-cell 1) Karċinoma taċ­ċelluli Merkel (karċinoma tal­ ġilda newroendokrinika)
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg /kg/day or 10 mg/day maximum).
Maltese: Il­pazjenti nżammu fuq dożi stabbli ta' NSAIDs u jew prednisolone ( 0.2 mg /kg/ġurnata jew massimu ta' 10 mg/ġurnata).
English: Table 28 Response, remission and mucosal healing in study UC-II (percent of patients)
Maltese: Tabella 28 Rispons, titjib kliniku u fejqan tal-mukoża fi studju UC-II (persentaġġ ta' pazjenti)
English: 6.4 Inject
Maltese: 6.3 Agħti l­injezzjoni
English: Contents of the pack and other information 7.
Maltese: Kontenut tal­pakkett u informazzjoni oħra 7.
English: Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Maltese: Anewriżma ta' l­aorta, sadd fl-arterji, tromboflebite
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Maltese: PASI 75 u PGA ċari jew minimi żdiedu b'konċentrazzjonijiet għoljin ta' adalimumab, it­tnejn b'EC50 apparenti simili ta' madwar 4.5 μg/mL (95% CI 0.4­47.6 u 1.9­10.5, rispettivament).
English: Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Maltese: F'dawn is­suġġetti, ried ikun hemm falliment tat­terapija konvenzjonali (inkluż kortikosterojde u/jew immunomodulatur) għal CD.
English: Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods.
Maltese: Studju HS­II (PIONEER II) evalwa 326 pazjenti b'żewġ perjodi ta' trattament.
English: Idacio is used to treat ulcerative colitis in adults.
Maltese: Idacio jintuża bħala trattament ta' kolite ulċerattiva fl­adulti.
English: Week 2 Week 12 Week 24 ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Maltese: Ġimgħa 2 Ġimgħa 12 Ġimgħa 24 ***,** Statistikament sinifikanti f'p < 0.001, <0.01 għall­paraguni kollha bejn adalimumab u l­plaċebo f'ġimgħat 2, 12 u 24 a Stima f'Ankylosing Spondylitis b Indiċi tal­Attività tal­Mard Bath Ankylosing Spondylitis
English: Each pack contains 1 vial (0.8 mL sterile solution), 1 sterile injection syringe, 1 sterile needle, 1 vial adaptor and 2 alcohol pads.
Maltese: Kull pakkett fih kunjett wieħed (0.8 mL soluzzjoni sterili), siringa sterili 1, labra sterili 1, adapter tal­kunjett wieħed u 2 kuxxinetti bl­alkoħol.
English: In study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.
Maltese: Fi studju UV I kienu osservati differenzi statistikament sinifikanti favur adalimumab kontra plaċebo għal kull komponent tal­falliment tat­trattament.
English: Table 14 Efficacy response in placebo-controlled study nr-axSpA I Double-blind response at week 12
Maltese: Tabella 14 Risponsi tal-effikaċja fi studju nr-axSpA I bil-plaċebo bħala kontroll Rispons double-blind f'ġimgħa 12
English: 19.3% of patients had continued baseline oral antibiotic therapy during the study.
Maltese: 19.3% tal­pazjenti kellhom bil­linja bażi terapija kontinwa ta' antibijotiċi orali matul l­istudju.
English: Percent change in total fingernail NAPSI (%)
Maltese: Bidla perċentwal tat­ total tad-dwiefer NAPSI (%)
English: Table 8 ACR responses in RA study V (percent of patients)
Maltese: Tabella 8 Risponsi għall-ACR fi studju RA V (persentaġġ ta' pazjenti)
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir­rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is­sigurtà għal dan il­prodott mediċinali huma mniżżla fil­lista tad­dati ta' referenza tal­Unjoni (lista EURD) prevista skont l­ Artikolu 107c(7) tad­Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il­portal elettroniku Ewropew tal­mediċini.>
English: Idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Maltese: Idacio huwa ndikat fi trattament ta' hidradenitis suppurativa (acne inversa) li hi minn attiva modera sa severa f'pazjenti adulti u adolexxenti minn 12­il sena b'rispons inadegwat għat­terapija konvenzjonali ta' HS sistemika (ara sezzjoni 5.1 u 5.2).
English: Low dose 20/10 mg eow p value1
Maltese: Doża baxxa 20/10 mg eow valur p1
English: ASAS partial remission BASDAIb 50
Maltese: ASAS titjin parzjali kliniku BASDAIb 50
English: The active ingredient in Idacio, adalimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Idacio, adalimumab, hija antikorp monoklonali.
English: ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo.
Maltese: ***, **, * Statistikament sinifikanti meta p < 0.001, < 0.01, u < 0.05, rispettivament, għal paraguni kollha bejn adalimumab u l­plaċebo.
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Maltese: Il­Kartuniet ta' Tfakkir għall­Pazjent (adulti u pedjatriċi) fihom l­elementi ewlenin li ġejjin ­ infezzjonijiet, inkluż tuberkulosi ­ kanċer ­ problemi fis­sistema nervuża - tilqim
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Maltese: • infezzjonijiet fis­sistema respiratorja (li jinkludu riħ, flissjoni, infezzjoni fis­sinus, pnewmonja);
English: NA 4.5% 23.2% a RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Maltese: NA NA 4.5% 23.2% a Studju RA I fl­24 ġimgħa, Studju RA II fis­26 ġimgħa, u Studju RA III fl­24 u t­52 ġimgħa b 40 mg adalimumab mgħoti ġimgħa iva u ġimgħa le c MTX = methotrexate
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Maltese: Il­kwalità tal­ħajja relatata mas­saħħa u l­funzjoni fisika kienu evalwati bl­użu tal­kwestjonarji HAQ­ S u SF­36.
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) 1),
Maltese: Aggravar jew bidu ta' psoriażi (li jinkludu psoriażi tat tip palmoplantar pustular)1),
English: Week 26 Week 52 1 p value for Standard Dose versus Low Dose comparison.
Maltese: Ġimgħa 26 Ġimgħa 52, 1 valur p li huwa paragun tad­Doża Standard kontra Doża Baxxa.
English: Improved physical function continued during the open label extension up to week 136.
Maltese: It­titjib fil­funzjoni fiżika tkompla matul l­estensjoni open-label sa ġimgħa 136.
English: Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Maltese: Trattament b' adalimumab 40 mg kull ġimgħa naqqas b'mod sinifikanti r­riskju ta' aggravar ta' axxessi u fistuli li jnixxu.
English: * P < 0.05, ***P < 0.001, adalimumab versus placebo a Among all randomised patients.
Maltese: * P < 0.05, ***P < 0.001, adalimumab kontra plaċebo a