FrancophonIA/ELRC3.0 huggingface dataset:
English: When monitoring a patients underlying hemostatic activity, please refer to section 4.4 for laboratory tests unaffected by emicizumab.
Maltese: Meta timmonitorja attività emostatika sottostanti ta' pazjenti, jekk jogħġbok irreferi għas-sezzjoni 4.4 għal testijiet tal-laboratorju mhux affettwati minn emicizumab.
English: There are limited data available on the use of Hemlibra in patients with moderate renal or hepatic impairment.
Maltese: Hemm data limitata disponibbli dwar l-użu ta' Hemlibra f'pazjenti b'indeboliment moderat tal-kliewi jew tal-fwied.
English: ● Guide for Laboratory Professionals
Maltese: ● Il-Gwida għall-Professjonisti tal-Laboratorju
English: 6 vials
Maltese: 6 kunjetti kunjett (ħġieġ)
English: Strength Pharmaceutical form
Maltese: Numru ta' l-EU tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 240 ml (10 mg/ml) 1 bottle + 1 syringe + 1 adapter
Maltese: 240 ml (10 mg/ml) flixkun wieħed + siringa waħda + adapter wieħed
English: MA (EU) number
Maltese: Numru tal-EU (MA)
English: Strength Pharmaceutical form Route of administration
Maltese: Isem Qawwa Għamla farmaċewtika
English: ≥ mNAPSI 75
Maltese: ≥ PASI 75
English: ASAS 20 ASAS 5/6
Maltese: ASAS 5/6
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 November 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 10 Novembru 2017
English: КГ
Maltese: KG
English: N Failure N (%)
Maltese: TAL-FALLIMENT TATTRATTAMENT (%)
English: p = 0.027, adalimumab 0.8 mg/kg versus MTX p = 0.083, adalimumab 0.8 mg/kg versus MTX
Maltese: P = 0.027, adalimumab 0.8 mg/kg kontra MTX p = 0.083, adalimumab 0.8 mg/kg kontra MTX
English: a, b c, d a, b
Maltese: c,d,e
English: Placebo/MTXAdalimumab/MTX (95 % Confidence Interval p-value
Maltese: Plaċebo/MTXAdalimumab/MTX (Intervall ta' Konfidenza ta' 95%
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: Induzzjoni ta' remissjoni klinika (definita bħala CDAI < 150) ġiet evalwata f'żewġ studji, studju CD I (CLASSIC I) u studju CD II (GAIN).
English: Wait 30 minutes for medication to warm.
Maltese: Stenna 30 minuta sakemm il-mediċina tisħon.
English: Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Maltese: Studju Ps IV Riżultati tal-Effikaċja wara 16, 26 u 52 ġimgħa Punt Finali
English: * p < 0.05, *** p < 0.001, adalimumab versus placebo
Maltese: * p < 0.05, *** p < 0,001, adalimumab kontra plaċebo
English: The proportions of subjects with PedACR50/70/90 at week 12 and week 24 were 90.3 %/61.3 %/38.7 % and 83.3 %/73.3 %/36.7 %, respectively.
Maltese: Il-proporzjonijiet ta' pazjenti b'PedACR50/70/90 f'ġimgħa 12 u ġimgħa 24 kienu ta' 90.3 %/61.3 %/38.7 % u 83.3 %/73.3 %/36.7 %, rispettivament.
English: Time to Treatment Failure in Studies UV I and UV II
Maltese: Żmien għall-Falliment tat-Trattament fi Studji UV I and UV II
English: HS Study II
Maltese: Studju HS II
English: Moderate to severe heart failure (NYHA class III/IV) (see section 4.4).
Maltese: Insuffiċjenza tal-qalb minn moderata sa severa (NYHA klassi III/IV) (ara sezzjoni 4.4). 4.4
English: Placebo/ MTX n = 200
Maltese: Plaċebo/ MTX n = 200
English: Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods.
Maltese: Studju HS-II (PIONEER II) evalwa 326 pazjenti b'żewġ perjodi ta' trattament.
English: Placebo N = 166
Maltese: Plaċebo N = 166
English: The corresponding proportions of patients with no radiographic progression were 31.3 %, 23.7 % and 36.7 %,
Maltese: Il-proporzjonijiet li jikkorrispondu ta' pazjenti bl-ebda progressjoni radjografika kienu 31.3 %, 23.7 % u 36.7 %, rispettivament.
English: The active ingredient in Cyltezo, adalimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Cyltezo, adalimumab, hija anti-korp monoklonali.
English: Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk).
Maltese: Nota: P# = Plaċebo (Numru ta' Avvenimenti/Numru f'Riskju); A# = Adalimumab (Numru ta' Avvenimenti/Numru f'Riskju).
English: Leukocytosis, thrombocytopenia
Maltese: Lewkoċitosi, tromboċitopenija
English: Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
Maltese: Hepatosplenic T-cell lymphoma karċinoma taċ-ċelluli Merkel (karċinoma talġilda newroendokrinika)
English: Clinical remission is Mayo score ≤ 2 with no subscore > 1;
Maltese: Remissjoni klinika hija punteġġ Mayo ta' ≤ 2 bl-ebda sottopunteġġ ta' > 1;
English: Note: P = Placebo (Number at Risk (flared)); A = adalimumab (Number at Risk (flared)).
Maltese: Nota: P = Plaċebo (Numru f'Riskju (flared)); A = adalimumab (Numru f'Riskju (flared)).
English: Leukopenia (including neutropenia and agranulocytosis), anaemia
Maltese: Lewkopenija (li tinkludi newtropenija u agranuloċitosi), anemija
English: NE = not estimable.
Maltese: NE = ma jistax ikun stmat.
English: Ped ACR 30 Responses in the JIA study
Maltese: Ped tal-ACR 30 fi studju JIA
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
Maltese: Immunosoppressanti, Inibitturi tal-Fattur tan-Nekrosi tat-Tumur alfa (TNF-α - Tumour Necrosis Factor alpha).
English: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);
Maltese: • hepatosplenic T-cell lymphoma (kanċer tad-demm rari li ħafna drabi huwa fatali);
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 indotti b'160/80 mg adalimumab kisbu remissjoni klinika f'perċentwali akbar li kienu statistikament sinjifikanti meta mqabbla ma plaċebo f'ġimgħa 8 fi studju UC-I (18 % vs. 9 % rispettivament, p = 0.031) u fi studju UC-II (17 % vs. 9 % rispettivament, p = 0.019).
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, ir-rispons PedACR30 kien ta' 93.5 % u 90.0 %, rispettivament meta intużat is-sitema ta' data osservata.
English: Usually, Cyltezo is used with methotrexate.
Maltese: Ġeneralment, Cyltezo jintuża ma' methotrexate.
English: • erythema multiforme (inflammatory skin rash);
Maltese: • erythema multiforme (raxx b'infjammazzjoni fil-ġilda);
English: The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Maltese: Il-każijiet l-oħra kienu varjetà ta' tumuri malinni differenti u inkludew tumuri malinni rari li normalment jiġu assocjati ma' immunosoppressjoni.
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60 % of patients) and BSA < 10 % and ≥ 5 % (40 % of patients)).
Maltese: Adalimumab wera benefiċċju tat-trattament f'pazjenti bi psorjasi tad-dwiefer bi gradi differenti ta' involvement tal-ġilda (BSA ≥ 10% (60% tal-pazjenti) u BSA < 10% u ≥ 5 % (40 % tal-pazjenti)).
English: Patients received adalimumab 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1-0.4 mg/kg weekly (up to 25 mg).
Maltese: Pazjenti rċevew adalimumab 0.8 mg/kg eow (sa 40 mg), 0.4 mg/kg eow (sa 20 mg), jew methotrexate 0.1 - 0.4 mg/kg kull ġimgħa (sa 25 mg).
English: The other ingredients are sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 80
Maltese: Sodium acetate trihydrate Acetic acid, glacial Trehalose dihydrate Polysorbate 80
English: NA
Maltese: Ara
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Maltese: Tuberkulosi attiva jew infezzjonijiet severi oħra bħal sepsis, u infezzjonijiet opportunistiċi (ara sezzjoni 4.4).
English: Table 10:
Maltese: Tabella 10:
English: Excipients: sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 80 and water for injections.
Maltese: Eċċipjenti: sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 80 u ilma għall-injezzjonijiet.
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 taċ-ċelluli Merkel kienu rrappurtati wkoll f'pazjenti ttrattati b'antagonisti ta' TNF inkluż adalimumab (ara sezzjoni 4.8).
English: Table 29:
Maltese: Tabella 29:
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 mal-plaċebo, kif inhu muri mill-proporzjon ta' periklu (HR = 0.25 [95 % CI: 0.12, 0.49]).
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) tal-pazjenti kellhom rispons kliniku u ġew assessjati flanaliżi primarja.
English: 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab.
Maltese: methotrexate intervalli ta' kunfidenza ta' 95% għad-differenza fil-punteġġi ta' bidla bejn methotrexate u adalimumab.
English: Placebo N = 108
Maltese: Plaċebo N = 108
English: Among those, 154 patients (90.6 %) had ACR 20 responses; 127 patients (74.7 %) had ACR 50 responses; and 102 patients (60.0 %) had ACR 70 responses.
Maltese: Fost dawn, 154 pazjent (90.6 %) kellhom risponsi tal-ACR 20; 127 pazjent (74.7 %) kellhom risponsi tal-ACR 50; u 102 pazjenti (60.0%) kellhom risponsi tal-ACR 70.
English: • That Cyltezo treatment may increase the potential risks of serious infections, sepsis, tuberculosis and opportunistic infections; congestive heart failure; demyelinating disorders; malignancies.
Maltese: • Li t-trattament b'Cyltezo jista' jżid ir-riskji potenzjali ta' infezzjonijiet serji, sepsis, tuberkulosi u infezzjonijiet opportunistiċi; insuffiċjenza konġestiva tal-qalb; disturbi ta' telf tal-majelin; tumuri malinni.
English: Table 24:
Maltese: Tabella 24:
English: Keep this
Maltese: Tista'
English: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Maltese: Figura 1: Sommarju tal-Kurvi Kaplan-Meier tal-Ħin tal-Flare fi Studju nr-axSpA II
English: If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Maltese: Jekk ikun hemm suspett ta' tuberkulosi rieqda, għandu jiġi kkonsultat tabib li jkun espert fit-trattament tat-tuberkulosi.
English: Cyltezo is a biosimilar medicinal product.
Maltese: Cyltezo huwa prodott mediċinali bijoloġiku simili.
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Maltese: Il-persentaġġ ta' pazjenti ttrattati b'adalimumab li jilħqu risponsi tal-ACR 20, 50 u 70 kien konsistenti fi studji RA I, II u III.
English: Lipids increased
Maltese: Rispons Ped tal
English: PsA Study II
Maltese: pJIA II
English: Table 14:
Maltese: Tabella 14:
English: Placebo N = 94
Maltese: Plaċebo N = 94
English: Note: P = Placebo (Number at Risk); H = ADALIMUMAB (Number at Risk).
Maltese: P = Plaċebo (Numru f'Riskju); H = ADALIMUMAB (Numru f'riskju).
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, it-tnejn b'EC50 apparenti simili ta' madwar 4.5 μg/mL (95% CI 0.4-47.6 u 1.9-10.5, rispettivament).
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' remissjoni klinika skont il-punteġġ Mayo parzjali
English: Hepatitis reactivation of hepatitis B autoimmune hepatitis
Maltese: Riattivazzjoni ta' Epatite B
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95 % confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab-treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for controltreated patients).
Maltese: Matul il-fażijiet ikkontrollati ta' provi pivitali ta' adalimumab fl-adulti li damu sejrin mill-inqas 12-il ġimgħa fuq pazjenti li jbatu minn artrite rewmatika attiva minn moderata sa severa, ankylosing spondylitis, axial spondyloarthritis mingħajr evidenza radjografika ta' AS, artrite psorjatika, psorjasi, hidradenitis suppurativa, mill-marda ta' Crohn, mill-kolite ulċerattiva u uveite, tumuri malinni minbarra limfoma u kanċer tal-ġilda li mhux melanoma, kienu osservati b'rata (intervall ta' konfidenza ta' 95 %) ta' 6.8 (4.4, 10.5) kull 1,000 sena ta' pazjent fost 5,291 pazjent ittrattat b'adalimumab, kontra rata ta' 6.3 (3.4, 11.8) kull 1,000 sena ta' pazjent fost 3,444 pazjent ittrattati bilkontroll (it-tul medjan tat-trattament kien ta' 4.0 xhur għal adalimumab u 3.8 xhur għall-pazjenti ttrattati bil-kontroll).
English: RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Maltese: Studju RA IV evalwa primarjament is-sigurtà f'636 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18-il sena.
English: Psoriasis Study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Maltese: L-Istudju tal-Psorjasi I (REVEAL) evalwa 1,212-il pazjent fi tliet perjodi ta' trattament.
English: The response for the two monotherapy arms was similar (p = 0.447).
Maltese: Ir-rispons għaż-żewġ gruppi ta' trattament mhux ikkombinat kien simili (p = 0.447).
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: Is-sigurtà u l-effikaċja ta' dożi multipli ta' adalimumab ġew stmati f'pazjenti adulti b'kolite ulċerattiva moderata sa severa (Punteġġ Mayo 6 sa 12 b'sottopunteġġ ta' 2 sa 3 bl-endoskopija) fi studji ikkontrollati bi plaċebo, randomised u double-blind.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo-controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Maltese: Tendenzi simili (mhux kollha statistikament sinifikanti) ġew osservati fl-istudju iżgħar AS II randomised, double-blind u kkontrollat bil-plaċebo ta' 82 pazjent adult li jbatu b'ankylosing spondylitis.
English: Placebo N = 49
Maltese: Plaċebo N = 49
English: Study nr-axSpA I evaluated patients with active nr-axSpA.
Maltese: Studju nraxSpA I evalwa pazjenti b'nr-axSpA attiv.
English: Cyltezo 40 mg solution for injection in pre-filled pen EU/1/17/1240/006
Maltese: Cyltezo 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/17/1240/001
English: Table 19:
Maltese: Tabella 19:
English: Adalimumab n = 113
Maltese: Adalimu mab n = 113
English: Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Maltese: Falliment tat-trattament kien definit permezz ta' riżultat b'ħafna komponenti bbażat fuq infjammazzjoni tal-chorioretina u/jew leżjonijiet vaskulari tar-retina infjammatorji, grad taċ-ċelluli tal-kompartiment anterjuri (AC - anterior chamber), grad taċ-ċpar fil-vitriju (VH - vitreous haze) u laqwa akutezza kkoreġuta tal-vista (BCVA - best corrected visual acuity).
English: Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Maltese: F'dawn l-individwi, ried ikun hemm falliment tat-terapija konvenzjonali (inkluż kortikosterojd u/jew immunomodulatur) għal CD.
English: Table 21:
Maltese: Tabella 21:
English: * p value for Standard Dose versus Low Dose comparison.
Maltese: * valur p għall-paragun tad-Doża Standard kontra Doża Baxxa.
English: p-value p-value p-value
Maltese: valur p a valur p b valur p
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration.
Maltese: Il-livelli fis-serum ta' metalloproteinases filmatriċi (MMP-1 u MMP-3) li jipproduċu tibdil fit-tessuti li hu responsabbli għall-qerda tal-qarquċa, naqsu wkoll wara li ngħata adalimumab.
English: Polyarticular juvenile idiopathic arthritis (pJIA)
Maltese: Artrite idjopatika poliartikulari taż-żagħżagħ (Pjia - Polyarticular juvenile idiopathic arthritis)
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Maltese: Għalkemm mhux statistikament sinifikanti, il-maġġoranza tal-pazjenti wrew titjib kliniku fil-punti finali sekondarji bħal numru ta' siti ta' entestie, għadd ta' ġogi sensittivi (TJC - tender joint count), għadd ta' ġogi minfuħa (SJC - swollen joint count), rispons Pedjatriku tal-ACR 50, u rispons Pedjatriku ACR 70.
English: Cyltezo contains sodium
Maltese: Cyltezo fih is-sodium
English: Efficacy Results at 12 Weeks, HS Studies I and II HS Study I
Maltese: HS I u II Studju HS I
English: At week 52, 42.9 % of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4 % of patients receiving adalimumab monotherapy.
Maltese: F'ġimgħa 52, 42.9% tal-pazjenti li rċevew it-terapija kombinata ta' adalimumab/methotrexate laħqu remissjoni klinika (DAS28 (CRP) < 2.6) meta pparagunati ma' 20.6 % tal-pazjenti li rċevew trattament b'methotrexate waħdu u 23.4% li rċevew adalimumab waħdu.
English: • Inspect Cyltezo pen, medication and expiration date.
Maltese: • Eżamina l-pinna ta' Cyltezo, il-mediċina u d-data ta' meta tiskadi.
English: If you have
Maltese: Jista'
English: Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Maltese: Titjib statistikament u klinikament sinifikanti mill-Linja Bażi kien ukoll osservat fiż-żewġ gruppi tattrattament għall-parametri tal-kwalità tal-ħajja (inkluż IMPACT III).
English: • Relevant information on the safety concerns of serious infections, sepsis, tuberculosis and opportunistic infections; congestive heart failure; demyelinating disorders; malignancies to be addressed by the additional risk minimisation measures (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable).
Maltese: • Informazzjoni rilevanti fuq tħassib dwar is-sigurtà ta' infezzjonijiet serji, sepsis, tuberkulosi u infezzjonijiet opportunistiċi; insuffiċjenza konġestiva tal-qalb; disturbi ta' telf tal-majelin; tumuri malinni li jridu jiġu indirizzati permezz ta' miżuri addizzjonali għall-minimizzazzjoni tar-riskju (eż. serjetà, severità, frekwenza, żmien sa meta bdew, riversibilità tal-AE (adverse event - avveniment avvers) kif applikabbli).
English: Boehringer Ingelheim Pharma GmbH & Co. KG
Maltese: Boehringer Ingelheim Pharma GmbH & Co.
English: Among those, 64 patients (79.0 %) had ACR 20 responses; 56 patients (69.1 %) had ACR 50 responses; and 43 patients (53.1 %) had ACR 70 responses.
Maltese: Fost dawn, 64 pazjent (79.0 %) kellhom risponsi tal-ACR 20; 56 pazjent (69.1 %) kellhom rispons tal-ACR 50; u 43 pazjent (53.1 %) kellhom rispons tal-ACR 70.
English: p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy
Maltese: il-valur p jiġi mit-tqabbil bejn pari ta' terapija b'methotrexate waħdu u adalimumab u methotrexate mogħtija flimkien bl-użu tat-test U Mann-Whitney. il-valur p jiġi mit-tqabbil bejn pari ta' terapija b'adalimumab waħdu u adalimumab u methotrexate mogħtija flimkien bl-użu tat-test U Mann-Whitney. il-valur p jiġi mit-tqabbil bejn pari ta' terapija b'adalimumab waħdu u methotrexate waħdu bl-użu tat-test U MannWhitney.
English: Boehringer Ingelheim RCV GmbH & Co KG
Maltese: Boehringer Ingelheim RCV GmbH & Co
English: Placebo Adalimumab 40 mg Weekly
Maltese: Plaċebo Adalimumab 40 mg Kull Ġimgħa
English: They 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: Huma mniżżla skont il-klassi tas-sistemi u tal-organi u lfrekwenza 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 (ma tistax tittieħed stima middata disponibbli).
English: • including cancer of the lymph system (lymphoma) and
Maltese: • inkluż tas-sistema limfatika (limfoma) u
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: • acid reflux disease;
Maltese: • infezzjonijiet fis-sistema riproduttiva;
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively).
Maltese: HS-I u HS-II, meta mqabbla ma' dawk fil-grupp adalimumab kellhom aggravar ta' axxessi (23.0 % vs 11.4 %, rispettivament) u fistuli li jnixxu (30.0 % vs 13.9 %, rispettivament).
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8 % and 61.2 % respectively) compared to methotrexate monotherapy (37.4 % and 33.5 % respectively, p < 0.001) and adalimumab monotherapy (50.7 %, p < 0.002 and 44.5 %, p < 0.001
Maltese: Wara 52 ġimgħa u 104 ġimgħat ta' trattament, il-persentaġġ ta' pazjenti li ma avvanzatilhomx ilmarda (bidla mil-linja bażi fil-Puteġġ Totali Sharp modifikat ta' ≤ 0.5) kien sinifikament ogħla bitterapija kombinata ta' adalimumab/methotrexate (63.8% u 61.2% rispettivament) meta pparagunat ma' trattament b' methotrexate waħdu (37.4% u 33.5% rispettivament, p < 0.001) u trattament b'adalimumab waħdu (50.7%, p < 0.002 u 44.5%, p < 0.001 rispettivament).