FrancophonIA/ELRC3.0 huggingface dataset:
English: Guillain-Barre Syndrome, Inflammation of the nerve of the eye that leads to impaired vision, Brain inflammation, Exacerbation of multiple sclerosis, Multiple sclerosis, Convulsions, Headache,
Maltese: • Disturbi fis-sistema nervuża bħal tingiż u tnemnim, Paralisi tal-wiċċ, Infjammazzjoni tan nervituri inkluż is-Sindrome ta' Guillain-Barre, Infjammazzjoni tan-nerv tal-għajn li jwassal għal vista mnaqqsa, Infjammazzjoni tal-moħħ, Taħrix ta' sklerożi multipla,
English: HBVAXPRO 5 micrograms is a suspension for injection in a syringe.
Maltese: HBVAXPRO 5 mikrogrammi huwa suspensjoni għall-injezzjoni f'siringa.
English: UAB Merck Sharp & Dohme Tel.: +370.5.2780.247 msd_lietuva@merck.com dpoc_belux@merck.com
Maltese: +370.5.2780.247 msd_lietuva@merck.com
English: HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe Hepatitis B vaccine (recombinant DNA)
Maltese: HBVAXPRO 5 mikrogrammi suspensjoni għall-injezzjoni Tilqima tal-epatite B (DNA rikombinanti)
English: In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck's recombinant hepatitis B vaccine in healthy adults.
Maltese: Barra minn hekk, il-persistenza ta' memorja immunoloġika permezz tat-tilqima għall-antiġen tal-wiċċ tal-virus tal-epatite B (HbsAg) intweriet permezz ta' rispons anamnestiku tal-antikorpi għal doża booster ta' formulazzjoni ta' qabel tat-tilqima tal-epatite B rikombinanti ta' Merck f'adulti b'saħħithom.
English: 0, 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration.
Maltese: 0, 1, 6 xhur: żewġ injezzjonijiet b'intervall ta' xahar; it-tielet injezzjoni tingħata 6 xhur wara l-ewwel waħda.
English: The deltoid muscle is the preferred site for injection in adults and adolescents.
Maltese: Il-muskolu deltojd huwa l-lok ippreferut għall-injezzjoni fl-adulti u l-adolexxenti.
English: EU/1/01/183/027 - pack of 10 EU/1/01/183/028 - pack of 1
Maltese: EU/1/01/183/028 - pakkett ta' 1
English: • Low platelet count, Lymph node disease
Maltese: • Livelli għoljin ta' enzimi fil-fwied
English: The recommended dose for each injection (0.5 ml) is 5 micrograms for individuals from birth through 15 years of age.
Maltese: Id-doża rakkomandata għal kull injezzjoni (0.5 ml) hija 5 mikrogrammi għal individwi mit-twelid sa letà ta' 15-il sena.
English: EU/1/01/183/029 - pack of 10 EU/1/01/183/032 - pack of 20
Maltese: EU/1/01/183/032 - pakkett ta' 20
English: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Maltese: Fi trabi li twieldu ħafna qabel iż-żmien (fit-28 ġimgħa ta' tqala jew qabel), jista' jkun hemm ħin itwal minn dak normali bejn nifs u ieħor għal bejn 2-3 ijiem wara t-tilqima.
English: Suspension for injection 1 single dose 1 ml vial
Maltese: U KONTENUT Suspensjoni għall-injezzjoni Doża waħda f'kunjett ta'1 ml
English: 1 ml of suspension in pre-filled syringe (glass) with 1 separate needle with a plunger stopper (gray chlorobutyl).
Maltese: 1 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ) mingħajr labra bi planġer tapp (lastku griż chlorobutyl).
English: METHOD OF ADMINISTRATION
Maltese: U MANIFATTUR RESPONSABBLI
English: Pack sizes of 1 and 10 vials without syringe/needle.
Maltese: Daqsijiet tal-pakkett ta' kunjett wieħed u 10 kunjetti mingħajr siringa/labra.
English: Latex rubber may cause severe allergic reactions.
Maltese: Il-latex jista' jikkawża reazzjonijiet allerġiċi qawwija.
English: HBVAXPRO 10 micrograms is a suspension for injection in a syringe.
Maltese: HBVAXPRO 10 mikrogrammi suspensjoni għall-injezzjoni
English: Predialysis and dialysis adult patients: 1 dose (1 ml) at each injection.
Maltese: Adulti qabel u waqt id-dijalisi: doża waħda (1 ml) f'kull injezzjoni.
English: HBVAXPRO 10 micrograms - single dose pre-filled syringe without needle - Pack of 1, 10
Maltese: HBVAXPRO 10 mikrogrammi - doża waħda f'siringa mimlija għal-lest b'labra waħda separata - Pakkett ta' 1, 10
English: • Asthma-like symptoms
Maltese: • Sintomi bħal tal-ażma
English: Dosage recommendation for neonates of mothers who are hepatitis B virus carriers
Maltese: Rakkomandazzjonijiet għal trabi tat-twelid ta' ommijiet li huma carriers tal-virus tal-epatite B
English: 1 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps.
Maltese: 1 ml ta'suspensjoni f'siringa mimlija għal-lest (ħġieġ) b'labra waħda seperata bi planġer tapp (lastku griż chlorobutyl).
English: 0.5 ml of suspension in pre-filled syringe (glass) without needle with a plunger stopper (gray chlorobutyl).
Maltese: 0.5 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ) mingħajr labra bi planġer tapp (chlorobutyl griż).
English: Merck Sharp & Dohme Ireland (Human Health) Limited
Maltese: Merck Sharp & Dohme Limited Tel: +44
English: Pack size of 1 vial.
Maltese: Daqs tal pakkett ta' 1.
English: UAB Merck Sharp & Dohme Tel.: +370.5.2780.247 msd_lietuva@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201 msd.slovenia@merck.com
English: HBVAXPRO 10 micrograms - single dose vial - Pack of 1, 10
Maltese: HBVAXPRO 10 mikrogrammi - doża waħda f'siringa mimlija għal-lest mingħajr labraPakkett ta' 1, 10
English: Two primary immunisation schedules can be recommended:
Maltese: Jistgħu jiġu rakkomandati żewġ skedi ta' tilqim primarju:
English: The concomitant administration of pneumococcal conjugate vaccine (PREVENAR) given with hepatitis B vaccine using the 0, 1 and 6 and 0, 1, 2 and 12 month schedules has not been sufficiently studied.
Maltese: Għadu ma ġiex studjat biżżejjed l-għoti flimkien tat-tilqima konjugata pnewmokokkali (PREVENAR) mogħtija mat-tilqima għall-epatite B permezz tal-iskedi ta' 0,1 u 6 u 0,1,2, u 12-il xahar.
English: Invented name Strength Pharmaceutical Form
Maltese: Prodott mediċinali li m'għadux awtorizzat
English: Medicinal product no longer authorised
Maltese: Utgått markedsføringstillatelse
English: EU Number
Maltese: Kontenut
English: 36400 O Porriño Pontevedra, Spain and
Maltese: 36400 O Porriño Pontevedra, Spanja
English: Singapore 637377
Maltese: Singapor 637377
English: 15 Seconds
Maltese: 15 Sekondi
English: N Failure N (%)
Maltese: N Falliment N (%)
English: Singapore 637022
Maltese: Singapor 637022
English: UNIQUE INDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: 10 Seconds
Maltese: 10 Sekondi
English: • tuberculosis
Maltese: • tuberkulosi
English: ATC code: L04AB04
Maltese: L04AB04
English: p = 0.031
Maltese: c p = 0.031
English: Clinical remission Clinical response (CR-100)
Maltese: Rispons kliniku (CR-100)
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Humira jiġi injettat taħt il-ġilda (użu għal taħt il-ġilda).
English: Placebo Humira 40 mg eow
Maltese: Plaċebo Humira 40 mg eow
English: ASDAS Inactive Disease hs-CRP
Maltese: ASDAS Marda Inattiva hs-CRP
English: Low dose Standard dose < 40 kg 10 mg eow 20 mg eow ≥ 40 kg 20 mg eow 40 mg eow
Maltese: Doża baxxa Doża standard < 40 kg 10 mg eow 20 mg eow ≥ 40 kg 20 mg eow 40 mg eow
English: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Maltese: - infezzjonijiet, inkluż tuberkulosi - kanċer - problemi fis-sistema nervuża - tilqim
English: 2D code
Maltese: Kodiċi 2D
English: The active substance is adalimumab.
Maltese: Is-sustanza attiva hi adalimumab.
English: h MRI Sacroiliac Joints d,i
Maltese: SPARCCh MRI Ġogi Sacroiliac d,i
English: Leukopenia (including neutropenia and agranulocytosis), anaemia
Maltese: Lewkopenja (li tinkludi newtropenja u agranulocytosis), anemija
English: 2-sided P value from log rank test. NE = not estimable.
Maltese: 2-naħat valur P minn test log rank.
English: Note: P = Placebo (Number at Risk (flared)); A = HUMIRA (Number at Risk (flared)).
Maltese: Nota: P = Plaċebo (Numru f'Riskju (flared)); A = HUMIRA (Numru f'Riskju (flared)).
English: • intestinal infections (including gastroenteritis)
Maltese: • infezzjonijiet intestinali (inkluża gastroenterite)
English: Leave Humira at room temperature for 15 to 30 minutes before injecting.
Maltese: Ħalli Humira f'temperatura ambjentali għal 15 sa 30 minuta qabel tinjetta.
English: Study UV II
Maltese: Studju UV II
English: P value*
Maltese: Valur P *
English: 95% confidence intervals for the differences in change scores between methotrexate and Humira.
Maltese: d methotrexate 95% intervall ta' konfidenza ghad-differenza bejn il-punteġġi ta' methotrexate u Humira.
English: Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods.
Maltese: Studju HS-II (PIONEER II) evalwa 326 pazjent bi perijodi ta' 2 trattamenti.
English: Store in a refrigerator (2C - 8C).
Maltese: Aħżen fi friġġ (2°C - 8°C).
English: System Organ Class
Maltese: Klassi tas-Sistema ta' lOrganu
English: • multiple sclerosis
Maltese: • sklerosi multipla
English: Hidradenitis Suppurativa Clinical Response (HiSCR)
Maltese: Hidradenitis Suppurativa Rispons Kliniku (HiSCR)
English: AbbVie (as logo)
Maltese: AbbVie (bħala logo)
English: Placebo/MTXHumira/MTX (95% Confidence Interval p-value
Maltese: Plaċebo/MTXHumira/MTX (95% Intervall ta' Konfidenza b)
English: STEP 8
Maltese: STADJU 8
English: Week 52 62.6% 54.4% 72.8% 0.013 < 0.001 0.043 Week 104 56.0% 49.3% 69.4% 0.002 < 0.001 0.140 ACR 50
Maltese: ACR 20 Ġimgħa52 62.6% 54.4% 72.8% 0.013 < 0.001 0.043 Ġimgħa 104 56.0% 49.3% 69.4% 0.002 < 0.001 0.140 ACR 50
English: Humira Δ Censored
Maltese: Humira Δ Ċensurat
English: Ankylosing Spondylitis Disease Activity Score Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Maltese: Flare Parzjali huwa definit bhala ASDAS ≥ 1.3 izda < 2.1 at 2 żjarat konsekuttivi.
English: Note: P = Placebo (Number at Risk); H = HUMIRA (Number at Risk).
Maltese: Nota: P = Plaċebo (Numru f'riskju); H = HUMIRA (Numru f'riskju).
English: • neuropathy (disorder of the nerves)
Maltese: • newropatija (disturb tan-nervituri)
English: METHOD AND ROUTE OF ADMINISTRATION
Maltese: Metodu u rotta ta' amministrazzjoni
English: Patients induced with 160/80 mg Humira 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 Humira kellhom titjib kliniku 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' informazzjoni osservata.
English: SPARCC MRI Spine d,j
Maltese: SPARCC Spina MRI
English: Humira 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: Humira wriet benefiċċju tat-trattament f'pazjenti b-psorjasi tad-dwiefer bi gradi differenti ta' involvement tal-ġilda (BSA≥10% (60% tal-pazjenti) u BSA‹10% u ≥5% (40% tal-pazjenti)).
English: Check the expiry (EXP) date.
Maltese: Iċċekkja d-data tal-iskadenza (EXP).
English: ≥ mNAPSI 75 (%) PGA-F clear/minimal and ≥2-grade improvement (%)
Maltese: PGA-F xejn/minimali u ≥2-grad ta' titjib (%)
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: Low Dose 20/10 mg eow
Maltese: Doża Baxxa 20/10 mg eow
English: STEP 9
Maltese: STADJU 9
English: MTX N=37
Maltese: MTXa N=37
English: • infections caused by viruses, fungi, parasites or bacteria
Maltese: • infezzjonijiet ikkawżati minn virus, fungus, parassiti jew batterji
English: In the pivotal trials, anti-adalimumab antibodies were identified in 5.5% (58/1053) of patients treated with adalimumab, compared to 0.5% (2/370) on placebo.
Maltese: Fil-provi pivitali, anti-korpi kontra adalimumab kienu identifikati fi 5.5% (58/1053) tal-pazjenti ikkurati b'adalimumab, imqabbla ma' 0.5% (2/370) fuq il-plaċebo.
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffetwaw sa persuna waħda minn kull 1,000)
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Table 12:
Maltese: Tabella 21:
English: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Maltese: Nisa li jistgħu joħorġu tqal
English: • Psoriasis,
Maltese: • Psorijasi
English: Table 18:
Maltese: Tabella 20:
English: For the pooled crossover RA studies VI and VII, a statistically significant difference for injection site pain immediately after dosing was observed between Humira 40 mg/0.8 ml and Humira 40 mg/0.4 ml (mean VAS of 3.7 cm versus 1.2 cm, scale of 0-10 cm, P < 0.001).
Maltese: Għal-studji crossover miġbura RA VI u VII, differenza statistikament sinifikanti għal uġigħ fis-sit ta' injezzjoni immedjatament wara d-dożaġġ ġiet osservata bejn Humira 40 mg / 0.8 ml u Humira 40 mg / 0.4 ml (medja VAS ta' 3.7 ċm versus 1.2 cm, l-iskala ta' 0 -10 ċm, P <0.001).
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Humira administration.
Maltese: Il-livelli fisserum ta' metalloproteinases fil-matriċi (MMP-1 u MMP-3) li jipproduċu tibdil fit-tessuti li hu responsabbli għall-qerda tal-qarquċa, naqsu ukoll wara li ngħata Humira.
English: STEP 5
Maltese: STADJU 5
English: P Value
Maltese: Valur P
English: Low Dose 20/10 mg eow N = 95
Maltese: Doża Baxxa 20/10 mg eow N = 95
English: STEP 1
Maltese: STADJU 1
English: • oedema (swelling)
Maltese: • edima (nefħa)
English: Study nr-axSpA I evaluated patients with active nr-axSpA.
Maltese: Studju nr-axSpA I evalwa pazjenti b'nr-axSpA attiv.
English: Double-Blind Response at Week 68
Maltese: ‘Double-Blind' Rispons fil-Ġimgħa 68
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
Maltese: Punteġġ Totali Sharp Punteġġ ta' lerożjoni Punteġġ JSNd 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) < 0.001 0.
English: The percent of Humira-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Maltese: Il-persentaġġ ta' pazjenti kkurati b'Humira li jilħqu risponsi għall-ACR 20, 50 u 70 kien konsistenti fi studji RA I, II u III.
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: Ilkonċentrazzjoni apparenti ta' adalimumab fil-plażma li tipproduċi nofs il-probabbiltà massima ta' rispons PedAc 50 (EC50) kienet ta' 3 μg / ml (95% CI: 1 6 μg / ml).
English: The safety and efficacy of multiple doses of Humira 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' Humira ġew stimati f' pazjenti adulti b'kolite ulċerattiva moderata sa severa (Punteġġ Mayo 6 sa 12; Sottopunteġġ 2 sa 3 bl-endoskopija) fi studji ikkontrollati bi plaċebo, randomizzati u double-blind.
English: D - 65205 Wiesbaden
Maltese: D - 65205
English: PASI 75 PGA: Clear/minimal a
Maltese: PGA: Xejn/minimali c a
English: Lifepharma (Z.A.M.)
Maltese: Lifepharma (Z.A.M.) Ltd Τηλ.:
English: Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine
Maltese: Limfoma tat-tip hepatosplenic T-cell Karċinoma taċ-ċelluli Merkel (karċinoma talġilda newroendokrinika)
English: The active ingredientin Humira, adalimumab, is ahumanmonoclonal antibody.
Maltese: L-ingredjent attiv f'Humira, adalimumab, huwa antikorp monoklonali uman.
English: HR a CI 95% for HR
Maltese: CI 95% għall-HR
English: Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Maltese: Fażi OL-LI 16 il-ġimgħa Ped ACR 30 rispons (n/N)
English: Table 14 Efficacy Response in Placebo-Controlled Study nr-axSpA I
Maltese: Tabella 14 Risponsi ta' l-Effikaċja fi Studju kontrollat bil-Plaċebo nr-axSpA I
English: and
Maltese: e
English: Total Sharp Score Erosion score JSN
Maltese: Punteġġ Totali Sharp Punteġġ ta' lerożjoni Punteġġ JSN
English: Humira 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: Humira huwa ndikat fi trattament ta' hidradenitis suppurativa (acne inversa) li hi minn attiva modera sa severa f'pazjenti adulti u adolexxenti minn 12-il sena b'rispons inadegwat għat-terapija konvenzjonali ta' HS sistemika (ara sezzjoni 5.1 u 5.2).
English: Table 12 Ped ACR 30 Responses in the JIA study
Maltese: Tabella 12 Rispons PedACR 30 fi studju JIA
English: Table 25 Maintenance regimen Patient Weight
Maltese: Tabella 25 Reġim ta' Manteniment
English: Excipients: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Maltese: Sustanzi mhux attivi: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide u ilma għall-injezzjonijiet.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
Maltese: Immunosuppressanti , Inibitturi ta' Tumur Nekrosi Fattur alfa (TNFα).
English: Number of patients at Baseline n (%)
Maltese: Numru ta' pazjenti f'linja bażi n (%)
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 tal-prodott f'636 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom  18 -il sena.
English: Placebo N=94
Maltese: Plaċebo N=94
English: In patients with non-radiographic axial spondyloarthritis, anti-adalimumab antibodies were identified in 8/152 subjects (5.3%) who were treated continuously with adalimumab.
Maltese: F'pazjenti b'spondyloarthrite axjali mhux radjografika, antikorpi anti-adalimumab ġew identifikati f'8/152 individwu (5.3%) li ġew ittrattati kontinwament b'adalimumab.
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% metamqabbel mal-plaċebo, kif inhu muri mill-proporzjon ta' periklu (HR = 0.25 [95% CI: 0.12, 0.49]).
English: STEP 3
Maltese: STADJU 3
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: 3%/61.3%/38.7% u 83.3%/73.
English: • moderate to severe hidradenitis suppurativa in adolescents aged 12to 17 years.
Maltese: • hidradenitis suppurativa moderata sa severa fl-adolexxenti minn 12 sa 17-il sena.
English: Placebo N=49
Maltese: Plaċebo N=49
English: • steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Maltese: • sterojdi jew medikazzjonijiet għall-uġigħ, li jinkludu mediċini anti-infjammatorji mhux sterojdi (NSAIDs).
English: STEP 7
Maltese: STADJU 7
English: • Humira can be used during breast-feeding.
Maltese: • Humira huwa likwidu ċara u mingħajr kulur.
English: 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
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
English: In CD Study III, 854 patients received open-label 80 mg at Week 0 and 40 mg at Week 2.
Maltese: Fi studju CD III, 854 pazjent irċevew 80 mg f'Ġimgħa 0 u 40 mg f'Ġimgħa 2, open label.
English: Corticosteroid taper was permitted after Week 8.
Maltese: It-tnaqqis tal-corticosteroid ftit ftit sakemm jitwaqqaf totalment, kien permess wara Ġimgħa 8.
English: Humira n=113
Maltese: Humira b n=113
English: 19.3% of patients had continued baseline oral antibiotic therapy during the study.
Maltese: 19.3% tal-pazjenti kellhom bil-linja bażi terapija kontinwa ta' antibijotiċi orali matul l-istudju.
English: • Ulcerative colitis
Maltese: • Kolite ulċerattiva
English: STEP 6
Maltese: STADJU 6
English: • haematoma;
Maltese: • ematoma;
English: p-value a p-value b p-value
Maltese: valur p a valur p b valur p c
English: • erythema multiforme (inflammatory skin rash)
Maltese: • erythema multiforme (raxx u infjammazzjoni fil-ġilda)
English: RA studies VI and VII each evaluated 60 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Maltese: Studji RA VI u VII evalwaw 60 pazjent li jbatu bi artrite rewmatika attiva minn moderata sa severa li kellhom ≥ 18 sena.
English: One hundred patients (n=100) from the Paediatric CD Study continued in an open-label long-term extension study.
Maltese: Mitt pazjent (n=100) mill-Istudju Pedjatriku CD komplew fi studju ta' estensjoni fit-tul u open-label.
English: Note: P# = Placebo (Number of Events/Number at Risk); A# = HUMIRA (Number of Events/Number at Risk).
Maltese: Nota: P# = Plaċebo (Numru ta' Avvenimenti/Numru fir-Riskju); A#
English: Date of first authorisation: 08 September 2003 Date of latest renewal: 08 September 2008
Maltese: Data ta' l-aħħar tiġdid ta' l-awtorizzazzjoni: 08 Settembru 2008
English: 40 mg/0.4 ml
Maltese: INDIVIDWALI 40 mg/0.4 ml
English: RA Study I a**
Maltese: Studju RA I a**
English: In patients with psoriatic arthritis, anti-adalimumab antibodies were identified in 38/376 subjects (10%) treated with adalimumab.
Maltese: F'pazjenti li jbatu minn artrite psorjatika, anti-korpi ta' kontra adalimumab ġew identifikati fi 38/376 suġġett (10%) ikkurati b'adalimumab.
English: In patients with Crohn's disease, anti-adalimumab antibodies were identified in 7/269 subjects (2.6%) and in 19/487 subjects (3.9%) with ulcerative colitis.
Maltese: F'pazjenti li jbatu mill-marda Crohn (Crohn's disease), anti-korpi ta' kontra adalimumab ġew identifikati f'7/269 suġġett (2.6%) u f'19/487 suġġett (3.9%) li għandhom kolite ulċerattiva.
English: • hepatitis
Maltese: • epatite
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of0.1-0.2 nM).
Maltese: Adalimumab jimmodula ukoll ir-risponsi bijoloġiċi li jiġu kkawżati jew regolati mit-TNF, inkluż tibdil fil-livelli tal-molekuli li jeħlu li huma risponsabbli għall-migrazzjoni tal-lewkoċite (ELAM-1, VCAM1, u ICAM-1 ma' xi IC50 ta'1-0.2 nM).
English: STEP 4
Maltese: STADJU 4
English: Table 15 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Maltese: Tabella 15 Ps Studju II (CHAMPION)