FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 μg/mL (79% CV).
Maltese: Wara l-amministrazzjoni ta' 0.8 mg/kg (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lil pazjenti pedjatriċi bi psorjasi tal-plakka kronika, il-medja ± SD ta' koncetrazzjoni minimali medja fissa ta' adalimumab kienet ta' madwar 7.4 ± 5.8 μg/mL (79% CV).
English: Of the 417 subjects included in the uncontrolled long-term extension of Studies UV I and UV II, 46 subjects were regarded ineligible (e.g. developed complications secondary to diabetic retinopathy, due to cataract surgery or vitrectomy) and were excluded from the primary analysis of efficacy.
Maltese: Mill-417 individwu inklużi fl-estensjoni mhux ikkontrollata fit-tul tal-Istudji UV I u UV II, 46 individwu kienu meqjusa ineliġibbli (eż. żviluppaw kumplikazzjonijiet sekondarji għal retinopatija dijabetika, minħabba kirurġija tal-katarretti jew vitrektomija) u kienu esklużi mill-analiżi primarja taleffikaċja.
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: Fil-Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti bi Psorjasi tal-plakka bi durazzjoni ta' perjodu kkontrollat tvarja minn 12 sa 24 ġimgħa, ALT ≥ 3 x ULN seħħew f'1.8% tal-pazjenti ttrattati b'adalimumab u 1.8% tal-pazjenti ttrattati kkontrollati.
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 UC-I, 390 pazjent li ma kienux ħadu antagonisti tat-TNF kienu randomizzati biex jew jirċievu l-plaċebo 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: These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Maltese: Dawn jinkludu rapporti rari ta' panċitopenja, anemija aplastika, avvenimenti li jeffetwaw il-myelin b'mod ċentrali jew periferali u rapporti ta' lupus, kundizzjonijiet relatati ma lupus u s-sindromu ta' Stevens-Johnson.
English: ACR responses in placebo-controlled trials (percent of patients)
Maltese: Risponsi ACR fi Provi kontrollati bil-plaċebo (persentaġġ ta' pazjenti)
English: Aortic aneurysm, Vascular arterial occlusion, Thrombophlebitis
Maltese: Anewriżma tal-aorta, Sadd fl-arterji,
English: Neurological infections (including viral meningitis), Opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection),
Maltese: Infezzjonijiet opportunistiċi u tuberkulosi (li jinkludu coccidioidomycosis, histoplasmosis u infezzjoni tal-mycobacterium avium complex), Infezzjonijiet tal-batterji, Infezzjonijiet fl-għajnejn, divertikulite1)
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with AMGEVITA and is positive for antibodies against double-stranded DNA, further treatment with AMGEVITA should not be given (see section 4.8).
Maltese: Jekk pazjent jiżviluppa sintomi li jindikaw sindromu li jixbaħ lis-sindromu tal-lupus wara li tkun ingħatat kura b'AMGEVITA, u jkun pożittiv għall-anti-korpi kontra DNA li hi double stranded, m'għandhiex tingħata aktar kura b'AMGEVITA (ara sezzjoni 4.8).
English: In controlled phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
Maltese: Fil-Fażi 3 ta' provi kontrollati ta' adalimumab f'pazjenti b'artrite idjopatika poliartikulari taż-żagħżagħ li kellhom minn 4 sa 17-il sena u pazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, kien hemm żidiet f'ALT ta' ≥ 3 x ULN f'6.1% tal-pazjenti trattati b'adalimumab u 1.3% tal-pazjenti trattati bil-kontroll.
English: EU/1/16/1164/007 - 2 pack
Maltese: EU/1/16/1164/007 - 2 pakketti
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated patients and 0.6% of control-treated patients.
Maltese: Fi provi kkontrollati ta' adalimumab (dożi inizjali ta' 160 mg f'Ġimgħa 0 u 80 mg f'Ġimgħa 2, segwiti minn 40 mg kull ġimgħa li jibdew f'Ġimgħa 4), f'pazjenti bi suppurativa hidradenitis bil-perjodu ta' kontroll b'durazzjoni li tvarja minn 12 sa 16-il ġimgħa, elevazzjonijiet ta' ALT ≥ 3 x ULN seħħew f'0.3% tal-pazjenti ttrattati b'adalimumab u 0.6% tal-pazjenti ttrattati kkontrollati.
English: Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
Maltese: Mill-pazjenti li kellhom rispons f' Ġimgħa 8, 47% kienu fi stat tar-rispons, 29% kienu fi stat ta' titjib, 41% kellhom fejqan tal-mukuża, u 20% kienu fl-istat ta' titjib mingħajr sterojdi għal ≥ 90 jum f' Ġimgħa 52.
English: The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above.
Maltese: Il-mira ta' adalimumab hija proteina msejħa fattur tan-nekrosi tat-tumur (TNFα - tumour necrosis factor), li hija involuta fis-sistema immuni (difiża) u hija preżenti f'livelli ogħla fil-mard infjammatorju elenkat hawn fuq.
English: By Week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (table 15).
Maltese: Sa Ġimgħa 68, pazjenti li kienu qegħdin jirċievu trattament kontinwu ta' adalimumab urew titjib akbar statistikament sinifikanti fis-sinjali u s-sintomi ta' nr-axSpA attiva meta mqabbel ma' pazjenti allokati għall-irtirar tat-trattament matul il-perjodu double-blind tal-istudju (tabella 15).
English: GI haemorrhage, Dyspepsia,
Maltese: Emorraġija gastrointestinali, Dispepsja,
English: Lupus-like syndrome1)
Maltese: Sindrome bħal ta' lupus1)
English: AMGEVITA is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: AMGEVITA huwa kontro-indikat f'pazjenti li jbatu minn insuffiċjenza talqalb minn moderata sa severa (ara sezzjoni 4.3).
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab.
Maltese: Wara li l-prodott tqiegħed fis-suq, kienu identifikati każijiet rari ta' hepatosplenic T-cell lymphoma f'pazjenti trattati b'adalimumab.
English: Week 26 Clinical remission Clinical response Week 52 Clinical remission Clinical response * p value for standard dose versus low dose comparison
Maltese: Qlib għall-aħjar fl-istat kliniku Rispons kliniku Ġimgħa 52 Qlib għall-aħjar fl-istat kliniku Rispons kliniku * valur p li huwa paragun tad-Doża Standard kontra Doża Baxxa.
English: Placebo Adalimumab 40 mg weekly
Maltese: Adalimumab 40 mg
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Maltese: *** p < 0.001 għall-paraguni kollha bejn adalimumab u l-plaċebo * p < 0.05 f għall-paraguni kollha bejn adalimumab u l-plaċebo N/A ma japplikax
English: The frequency of serious infections among adalimumab-treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Maltese: Il-frekwenza ta' infezzjonijiet serji (3.7%) f'pazjenti li għandhom aktar minn 65 sena u kkurati b' adalimumab, kienet akar għolja mill-frekwenza ta' infezzjonijiet f'pazjenti taħt il-65 sena (1.5%).
English: Finger flange
Maltese: Labra użata
English: Blood lactate dehydrogenase increased
Maltese: Uveite mhux infettiva fl-adulti u tfal
English: Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II
Maltese: Rispons tal-Effikaċja fil-Perjodu Kkontrollat bil-Plaċebo għal Studju nr-axSpA II
English: EU/1/16/1164/003 - 2 pack
Maltese: EU/1/16/1164/003 - 2 pakketti
English: Figure 3: Kaplan-Meier curves summarising time to treatment failure in the paediatric uveitis study
Maltese: Figura 3: Kurvi ta' Kaplan-Meier li Jiġbru fil-Qosor iż-Żmien għall-Falliment fl-Istudju
English: Adults with Crohn's disease
Maltese: Adulti bil-marda ta' Crohn
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new onset lupus-like syndrome.
Maltese: Żewġ pazjenti minn 3,441 li kienu kkurati b'adalimumab fl-istudji kollha tal-artrite rewmatika u artrite psorjatika żviluppaw sinjali kliniċi li jindikaw bidu ta' sindromu li jixbaħ lis-sindromu tal-lupus.
English: AMGEVITA 40 mg solution for injection in pre-filled syringe 0.8 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Maltese: AMGEVITA 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 0.8 mL ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ tip I) b'tapp tal-bastun li jimbotta l-mediċina (bromobutyl rubber) u labra tal-azzar li ma jissaddadx b'għatu ta' protezzjoni tal-labra (thermoplastic elastomer).
English: AMGEVITA can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Maltese: AMGEVITA jista' ukoll jintuża għat-trattament tal-artrite rewmatika attiva u progressiva severa, mingħajr ma tkun ingħatat trattament b'methotrexate qabel.
English: An AMGEVITA 20 mg pre-filled syringe is however available for the 20 mg dose.
Maltese: Siringa mimlija għal-lest ta' AMGEVITA 20 mg hija madankollu disponibbli għad-doża ta' 20 mg.
English: Week 4 Clinical remission Clinical response (CR-100) All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001 ** p < 0.01
Maltese: Il-valuri-p kollha huma paraguni magħmula għal kull par ta' proporzjonijiet għal adalimumab kontra l-plaċebo * p < 0.001 ** p < 0.01
English: Adalimumabb n = 113
Maltese: Adalimum abb n=113
English: In the pivotal controlled trials in adults and children, 12.9% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
Maltese: Fil-provi pivitali kontrollati li saru fl-adulti u fit-tfal, 12.9% tal-pazjenti kkurati b'adalimumab żviluppaw reazzjonijiet fil-post tal-injezzjoni (eritema u/jew ħakk, emorraġija, uġigħ jew nefħa), ipparagunati ma' 7.2% tal-pazjenti li kienu qegħdin jirċievu l-plaċebo jew sustanza attiva użata bħala kontroll.
English: AMGEVITA is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Maltese: AMGEVITA huwa indikat għat-trattament tal-marda ta' Crohn attiva minn moderata sa severa fit-tfal (minn 6 snin il-fuq) li ma kellhomx rispons kif mistenni għal trattament konvenzjonali inkluż terapija ta' nutrizzjoni primarja u kortikosterojde u/jew immunomodulatur, jew ma jittollerawx jew għandhom kontraindikazzjonijiet għal dawn it-terapiji.
English: Intestinal infections (including gastroenteritis viral), Skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), Ear infections,
Maltese: Infezzjonijiet sistemiċi (li jinkludu sepsis, candidiasis u influwenza), Infezzjonijiet intestinali (li jinkludu gastroenterite virali),
English: AMGEVITA 20 mg solution for injection in pre-filled syringe 0.4 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Maltese: AMGEVITA 20 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest 0.4 mL ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ tip I) b'tapp tal-bastun li jimbotta l-mediċina (bromobutyl rubber) u labra tal-azzar li ma jissaddadx b'għatu ta' protezzjoni tal-labra (thermoplastic elastomer).
English: AMGEVITA 40 mg solution for injection in pre-filled syringe Each single dose pre-filled syringe contains 40 mg of adalimumab in 0.8 mL (50 mg/mL) solution.
Maltese: AMGEVITA 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Kull pinna mimlija għal-lest b'doża waħda fiha 40 mg ta' adalimumab f'0.8 mL (50 mg/mL) ta' soluzzjoni.
English: Patients were then retreated with adalimumab 0.8 mg/kg every other week for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9% (15 of 19 subjects) and PGA clear or minimal of 52.6% (10 of 19 subjects).
Maltese: Pazjenti kienu mgħotija mill-ġdid it-trattament ta' adalimumab 0.8 mg/kg ġimgħa iva u ġimgħa le għal 16-il ġimgħa oħra u r-rati ta' rispons li kienu osservati matul it-trattament kienu simili għall-perjodu precedent ta' double-blind: PASI 75 rispons ta' 78.9% (15 minn 19-il suġġett) u PGA xejn jew minimali ta' 52.6% (10 minn 19-il suġġett).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION AMGEVITA 40 mg injection adalimumab
Maltese: U MNEJN GĦANDU JINGĦATA AMGEVITA 40 mg injezzjoni adalimumab
English: The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2 - < 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati fi studju tat-tip multiċentru u “open-label” fi 32 tfal (2 - < 4 snin jew li għandhom min 4 snin il-fuq u li jiżnu < 15 kg) li għandhom artrite poliartikulari
English: • If you receive AMGEVITA during your pregnancy, your baby may have a higher risk for getting an infection.
Maltese: • Jekk inti tirċievi AMGEVITA waqt it-tqala tiegħek, it-tarbija tiegħek jista' jkollha riskju akbar ta' infezzjoni.
English: Results from the overall UC-II study population are shown in table 28.
Maltese: Riżultati ġenerali li ħarġu mill-popolazzjoni tal-istudju UC-II huma preżentati f'tabella 28.
English: EU/1/16/1164/008 - 4 pack
Maltese: EU/1/16/1164/008 - 4 pakketti
English: Pancreatitis, Dysphagia, Face oedema
Maltese: Meta l-injezzjoni tkun lesta, ittieqa ssir safra
English: • lichenoid skin reaction (itchy reddish-purple skin rash).
Maltese: • reazzjoni tal-lichenoid tal-ġilda (raxx tal-ġilda ħamrani fil-vjola bil-ħakk).
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), Benign neoplasm
Maltese: Kanċer tal-ġilda li mhux melanoma (li jinkludi karċinoma tal-ġilda tat-tip basal cell u karċinoma tal-ġilda biċ-ċelluli tat-tip squamous), Neoplażma beninna
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 l-effett tat-tossiċità waqt l-iżvilupp embrijo-fetali/l-iżvilupp fiż-żmien immedjatament qabel jew wara t-twelid, fuq xadini ċinomologi li b' 0, 30 u 100 mg/kg (9-17 -il xadina/grupp) u dan ma wera l-ebda evidenza ta' dannu kkaġunat b'adalimumab fuq il-feti.
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab kienu evalwati fi studju b'aktar minn ċentru wieħed, randomised, double-blind f'46 pazjenti pedjatriċi (6 sa 17-il sena) b'artrite moderata relatata malentesite.
English: • low blood potassium.
Maltese: • potassium fid-demm baxx.
English: Maintenance regimen
Maltese: Reġim ta' manteniment
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to  2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Maltese: [BASDAI] kienet ta' 7.0) li kellhom rispons inadegwat għal  2 NSAIDs, jew intolleranza għal jew kontraindikazzjoni għal NSAIDs kienu irreġistrati fil-perjodu open-label ta' Studju nr-axSpA II li matulu rċivew adalimumab 40 mg eow għal 28 ġimgħa.
English: 2 SureClick pre-filled pens.
Maltese: 2 pinen mimlija għal-lest SureClick.
English: AMGEVITA is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Maltese: Ankylosing spondylitis u axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis, huma mard infjammatorju tal-ispina.
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Maltese: Fi Studju nr-axSpA I, adalimumab 40 mg ġimgħa iva u ġimgħa le kien stimat fi 185 pazjent fi studju double-blind, ikkontrollat bil-plaċebo li ħa 12-il ġimgħa u li sar b'ordni addoċċ f'pazjenti b'nr-axSpA attiva (punteġġ medju mil-linja bażi tal-attività tal-marda [Indiċi tal-Attività tal-Mard Bath Ankylosing Spondylitis (BASDAI)] kien 6.4 għal pazjenti kkurati b'adalimumab u 6.5 għal dawk li qed jieħdu lplaċebo) li ma kellhomx rispons adegwat jew ma kienux tolleranti għal ≥ 1 NSAIDs, jew NSAIDs huma kontraindikati.
English: Idiopathic thrombocytopenic purpura
Maltese: Żieda fil-bilirubina
English: A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and 88.8% [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Maltese: Total ta' 76.5% (218/285) tal-pazjenti li daħlu fil-perjodu li fih reġgħa nbeda t-trattament, kellhom PGA mingħajr rispons jew b'rispons minimu wara 16-il ġimgħa minn meta reġgħa nbeda t-trattament, irrispettivament minn jekk dawn il-pazjenti reġgħux esperjenzaw tfaċċar mill-ġdid ta' sintomi ta' Psorjasi matul il-perjodu li fih twaqqaf it-trattament (69.1% [123/178] u 88.8% [95/107] għal dawk il-pazjenti li esperjenzaw tfaċċar mill-ġdid ta' sintomi tal-Psorjasi u dawk li m'esperjenzawx tfaċċar mill-ġdid ta' sintomi tal-Psorjasi rispettivament, matul il-perjodu li fih twaqqaf it-trattament).
English: • impaired healing.
Maltese: • Uveite mhux infettiva.
English: In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg every other week thereafter, and 246 patients received placebo.
Maltese: Fi studju UC-II, 248 pazjent irċevew 160 mg ta' adalimumab f'Ġimgħa 0, 80 mg f'Ġimgħa 2 u 40 mg eow min hemm il-quddiem, filwaqt li 246 pazjent irċevew plaċebo.
English: EU/1/16/1164/004 - 4 pack
Maltese: EU/1/16/1164/004 - 4 pakketti
English: In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through week 520 (120 months) of open-label treatment.
Maltese: Fi Studju RA III, ħafna mis-suġġetti kellhom titjib fil-funzjoni fiżika u t-titjib ġie mantenut waqt li tkompliet il-kura matul Ġimgħa 520 (120 xahar) tal-kura open-label.
English: Chest pain, Oedema, Pyrexia1)
Maltese: Uġigħ fis-sider, Edima,
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Maltese: Titjib fil-kwalità tal-ħajja rrelatata mas-saħħa u funzjoni fiżika nżamm matul l-estensjoni open-label sa Ġimgħa 156.
English: The safety and efficacy of adalimumab were assessed in over 1,500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew stimati f''il fuq minn 1,500 pazjent li jbatu mill-marda ta' Crohn attiva b'mod minn moderat sa sever (Indiċi tal-Attività tal-Marda ta' Crohn (CDAI) ≥ 220 u ≤ 450) fi studji double-blind, kontrollati bil-plaċebo, li saru b'ordni addoċċ.
English: if you have a severe infection, including active tuberculosis (see “Warnings and precautions”).
Maltese: - Jekk għandhek infezzjoni severa, inkluż tuberkulosi attiva (ara “Twissijiet u prekawzjonijiet”).
English: In study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Maltese: Fi Studju UV II, kienu osservati differenzi statistikament sinifikanti għal akutezza viżiva biss, iżda l-komponenti l-oħra kienu numerikament favur adalimumab.
English: ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Maltese: ≥ 40 kg • 80 mg f'ġimgħa 0 u 40 mg f'ġimgħa
English: Very common Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
Maltese: Infezzjonijiet fis-sistema respiratorja (li jinkludu Infezzjoni fin-naħa ta' isfel u fin-naħa ta' fuq tassistema respiratorja, pnewmonja, sinożite, fariniġite, rinofarinġite u pnewmonja virali talherpes)
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Maltese: Minn dawn il-kanċer tal-ġilda, kien hemm l-okkorrenza ta' karċinoma biċ-ċelluli tat-tip squamous b'rati (95% intervall ta' konfidenza) ta' 2.7 (1.4, 5.4) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 0.6 (0.1, 4.5) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: Very common Rash (including exfoliative rash) Common
Maltese: Komuni ħafna raxx (li jinkludi raxx bil-qxur)
English: At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 21).
Maltese: F'Ġimgħa 12, proporzjon ogħla b'mod sinifikanti ta' pazjenti fi Studju HS-II esperjenzaw tnaqqis klinikament rilevanti fl-uġigħ fil-ġilda relatati ma' HS (ara tabella 21).
English: Children, adolescents and adults with polyarticular juvenile idiopathic arthritis Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg The recommended dose of AMGEVITA is 20 mg every other week.
Maltese: Tfal, adolexxenti u adulti b'artrite idjopatika poliartikulari taż-żagħżagħ Tfal u adolexxenti minn sentejn 'il fuq li jiżnu minn 10 kg sa inqas minn 30 kg Id-doża rakkomandata ta' AMGEVITA hija 20 mg ġimgħa iva u ġimgħa le.
English: AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe adalimumab
Maltese: AMGEVITA 20 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest AMGEVITA 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest adalimumab