FrancophonIA/ELRC3.0 huggingface dataset:
English: In another published study involving 229 patients, measurement of creatinine clearance (an indication of how well the kidneys are working) did not show kidney damage 14 months after patients were treated with arginine and lysine at the same time as lutetium (177Lu) oxodotreotide.
Maltese: Fi studju ieħor ippubblikat li kien jinvolvi 229 pazjent, il-kejl ta' tneħħija tal-kreatinina (indikazzjoni ta' kemm il-kliewi qed jaħdmu tajjeb) ma weriex ħsara fil-kliewi 14-il xahar wara li l-pazjenti kienu kkurati b'arġinina u liżina fl-istess ħin bħal-lutezju (177Lu) ossodotreotide.
English: How is LysaKare used?
Maltese: Kif jaħdem LysaKare?
English: LysaKare is a medicine used to protect the kidneys from radiation damage during cancer treatment with a radioactive medicine called lutetium (177Lu) oxodotreotide.
Maltese: LysaKare hija mediċina li tintuża biex tipproteġi l-kliewi minn ħsara kkawżata mir-radjazzjoni waqt ilkura tal-kanċer b'mediċina radjuattiva msejħa lutezju (177Lu) ossodotreotide.
English: Side effects reported with LysaKare are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi LysaKare huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: LysaKare is also associated with hyperkalaemia (high blood potassium levels), but the frequency of this side effect is not known.
Maltese: LysaKis huwa assoċjat ukoll mal-iperkalimja (livelli għoljin ta' potassju fid-demm), iżda l-frekwenza ta' dan l-effett sekondarju mhijiex magħrufa.
English: Radiation from lutetium (177Lu) oxodotreotide can cause damage when the medicine passes through tubules in the kidney.
Maltese: Ir-radjazzjoni mil-lutezju (177Lu) ossodotreotide tista' tikkawża ħsara meta l-mediċina tgħaddi mittubuli fil-kilwa.
English: The use of arginine and lysine during treatment with lutetium (177Lu) oxodotreotide has been shown to reduce kidney damage and allow patients to be given an effective dose of radioactive treatment for their cancer.
Maltese: Intwera li l-użu tal-arġinina u l-liżina waqt il-kura bil-lutezju (177Lu) ossodotreotide inaqqas il-ħsara filkliewi u jippermetti lill-pazjenti li jingħataw doża effettiva ta' kura radjuattiva għall-kanċer tagħhom.
English: For the full list of side effects and restrictions with LysaKare, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'LysaKare, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of LysaKare?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' LysaKare?
English: It may harm them,
Maltese: Rabdomijoliżi,
English: MRI Sacroiliac Joints d,i
Maltese: MRI Ġogi Sacroiliac d,i
English: CI 95% for HR
Maltese: CI 95% għallHR
English: Placebo/MTXadalimumab /MTX (95% confidence interval b)
Maltese: Plaċebo/MTXAdalimumab/MT X (95% Intervall ta' Konfidenza b)
English: ACR 20 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 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
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: Total Sharp Score c
Maltese: Punteġġ Totali Sharp c
English: Date of first authorisation: 22 March 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Marzu 2017
English: confidence interval)
Maltese: Konfidenza)
English: Clinical remission Clinical response (CR-100)
Maltese: Titjib kliniku Rispons kliniku (CR-100)
English: Table 13 Ps study IV efficacy results at 16, 26 and 52 weeks
Maltese: Tabella 13 Riżultati tal-Effikaċja ta' Studju Ps IV wara 16, 26 u 52 ġimgħa
English: PGA: Clear/minimal c a
Maltese: PGA: Xejn/minimali a
English: HS study II
Maltese: HS Studju II
English: a a a p < 0.001, Adalimumab versus placebo
Maltese: a a a p < 0.001, Adalimumab kontra plaċebo
English: Spondyloarthritis Research Consortium of Canada i n = 84 placebo and adalimumab j n = 82 placebo and n = 85 adalimumab ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo
Maltese: Konsorzju tal-Kanada għar-riċerka ta' Spondyloarthritis i n= 84 plaċebo u adalimumab j n= 82 plaċebo u n=85 adalimumab ***, **, * Statistikament sinifikanti meta p < 0.001, < 0.01, u < 0.05, rispettivament, għal paraguni kollha bejn adalimumab u l-plaċebo.
English: Pleural effusion
Maltese: Effużjoni plerali
English: Usually, SOLYMBIC is used with methotrexate.
Maltese: Ġeneralment, SOLYMBIC jintuża ma' methotrexate.
English: PGA: Clear/minimal a, b a p < 0.001 adalimumab versus placebo b p < 0.001 adalimumab versus methotrexate c p < 0.01 adalimumab versus placebo d p < 0.05 adalimumab versus methotrexate
Maltese: PGA: Xejn/minimali a, b a p < 0.001 adalimumab kontra l-plaċebo b p < 0.001 adalimumab kontra methotrexate c p < 0.01 adalimumab kontra l-plaċebo d p < 0.05 adalimumab kontra methotrexate
English: Do not use SOLYMBIC:
Maltese: Tużax SOLYMBIC:
English: Table 9 Efficacy response in placebo-controlled axial SpA study
Maltese: Tabella 9 Risponsi tal-Effikaċja fi Studju Axial SpA kontrollat bil-Plaċebo
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 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: MTX = methotrexate b P = 0.027, adalimumab 0.8 mg/kg versus MTX
Maltese: 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: Systemic lupus erythematosus Lupus-like syndrome
Maltese: Lupus erythematosus sistemiku Sindrome bħal ta' lupus
English: Table 12 Ps study II (CHAMPION) efficacy results at 16 weeks
Maltese: Tabella 12 Studju Ps II (CHAMPION)
English: The response for the two monotherapy arms was similar (p = 0.447).
Maltese: Irrispons għaż-żewġ sezzjonijiet ta' kura mhux ikkombinata kien simili (p=0.447).
English: Side effects may occur at least up to 4 months after the last SOLYMBIC injection.
Maltese: L-effetti sekondarji jistgħu jseħħu mill-inqas sa 4 xhur wara l-aħħar injezzjoni ta' SOLYMBIC.
English: SOLYMBIC is a biosimilar medicinal product.
Maltese: SOLYMBIC huwa prodott mediċinali bijoloġiku simili.
English: Table 5 ACR responses in RA study V (percent of patients)
Maltese: Risponsi għall-ACR fi Studju RA V (persentaġġ ta' pazjenti)
English: Table 11 Ps study I (REVEAL) - efficacy results at 16 weeks
Maltese: Tabella 11 Studju Ps I (REVEAL)Riżultati tal-Effikaċja f' 16 -il Ġimgħa
English: RA study III
Maltese: Studju RA III
English: EU/1/16/1163/006 1 pack EU/1/16/1163/007 2 pack EU/1/16/1163/008 4 pack EU/1/16/1163/009 6 pack
Maltese: EU/1/16/1163/006 pakkett wieħed EU/1/16/1163/007 2 pakketti EU/1/16/1163/008 4 pakketti EU/1/16/1163/009 6 pakketti
English: EU/1/16/1163/002 1 pack EU/1/16/1163/003 2 pack EU/1/16/1163/004 4 pack EU/1/16/1163/005 6 pack
Maltese: EU/1/16/1163/002 pakkett wieħed EU/1/16/1163/003 2 pakketti EU/1/16/1163/004 4 pakketti EU/1/16/1163/005 6 pakketti
English: SOLYMBIC is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
Maltese: SOLYMBIC huwa indikat fi trattament ta' hidradenitis suppurativa (acne inversa) li hi minn attiva modera sa severa f'pazjenti adulti b'rispons inadegwat għat-terapija konvenzjonali ta' HS sistemika.
English: Uncommon Pulmonary embolism Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis,
Maltese: Emboliżmu fil-pulmun Mard tal-interstizju tal-pulmun, Mard kroniku ta' imblukkar fil-pulmun, Pulmonite,
English: *P < 0.05, ***P < 0.001, adalimumab versus placebo a
Maltese: * P < 0.05, ***P < 0.001, adalimumab kontra plaċebo.
English: Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Maltese: Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide u ilma għall-injezzjoni.
English: SOLYMBIC contains sodium
Maltese: SOLYMBIC fih sodium
English: ***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24
Maltese: ***, ** Statistikament sinifikanti f'p < 0.001, < 0.01 għall-paraguni kollha bejn adalimumab u l-plaċebo f'Ġimgħa 2, 12 u 24
English: Rare side effects (may affect up to 1 in 1,000 people):
Maltese: Effetti sekondarji rari (jistgħu jaffetwaw sa persuna waħda minn kull 1,000):
English: Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Maltese: Stimi f'Ankylosing Spondylitis b Indiċi tal-Attività tal-Mard Bath Ankylosing Spondylitis
English: Stevens-Johnson syndrome1),
Maltese: Erythema multiforme Sindrome ta' Stevens-Johnson Anġjoedima
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 3 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: Il-lista li jmiss ta' reazzjonijiet avversi hija bbażata fuq esperjenza li ġejja minn studji kliniċi u minn esperjenza ta' wara t-tqegħid fis-suq, u hija mniżżla skont il-klassi tas-sistema tal-organu u l-frekwenza f'Tabella 3 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: SOLYMBIC contains the active substance adalimumab, a selective immuno suppressive agent.
Maltese: SOLYMBIC fih is-sustanza attiva adalimumab li huwa aġent silettiv immuno suppressiv.
English: SOLYMBIC 40 mg injection adalimumab
Maltese: SOLYMBIC 40 mg injezzjoni adalimumab
English: SOLYMBIC is used to treat hidradenitis suppurativa in adults.
Maltese: SOLYMBIC jintuża biex jittratta hidradenitis suppurativa fl-adulti.
English: SOLYMBIC 20 mg injection adalimumab
Maltese: SOLYMBIC 20 mg injezzjoni adalimumab
English: Hepatitis,
Maltese: Pankreatite,
English: N = 248 N=248
Maltese: N=248
English: Table 22 Response, remission and mucosal healing in study UC-II (percent of patients)
Maltese: Tabella 22 Rispons, Titjib kliniku u Fejqan tal-Mukoża fi Studju UC-II (Persentaġġ ta' Pazjenti)
English: 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: Punteġġ a. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'methotrexate waħdu u adalimumab u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney. b. il-valur-p jiġi mit-tqabbil bejn pari ta' trattament b'adalimumab waħdu u adalimumab u methotrexate mgħotija flimkien bl-użu tat-test U Mann-Whitney.
English: ≥30% Reduction in Skin Pain b
Maltese: ≥ 30% Tnaqqis fl-uġigħ fil-ġilda b
English: SOLYMBIC 40 mg pen
Maltese: SOLYMBIC 40 mg pinna
English: Each pack contains 1, 2, 4, or 6 single use SureClick pre-filled pens.
Maltese: Kull pakkett fih 1, 2, 4 jew 6 pinen mimlija għal-lest SureClick għall-użu ta' darba.
English: Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab versus placebo pairwise comparison of proportions ** p < 0.001 for adalimumab versus placebo pairwise comparison of proportions a
Maltese: Rispons kliniku huwa tnaqqis mill-linja bażi fil-punteġġ Mayo ta' ≥ 3 punti u ≥ 30% flimkien ma' tnaqqis filfsada rektali b'sottopunteġġ [RBS] ta' ≥ 1 jew RBS assolut ta' 0 jew 1; * p < 0.05 għal adalimumab vs. placebo bil-proporzjonijiet imqabblin flimkien ** p < 0.001 għal adalimumab vs. placebo bil-proporzjonijiet imqabblin flimkien a min dawk li rċevew kortikosterojdi f'linja bażi
English: Table 7 Radiographic mean changes at week 52 in RA study V
Maltese: Tabella 7 Tibdil medju radjografiku f'Ġimgħa 52 fi studju RA V
English: SOLYMBIC is used to treat ulcerative colitis in adults.
Maltese: SOLYMBIC huwa intenzjonat għat-trattament ta' kolite ulċerattiva fl-adulti.
English: Not known Worsening of symptoms of dermatomyositis
Maltese: Aggravar tas-sintomi tad-dermotomijosite
English: Not known Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
Maltese: Limfoma tat-tip hepatosplenic T-cell Karċinoma taċ-ċelluli Merkel (karċinoma tal-ġilda newroendokrinika)
English: 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
Maltese: Punteġġ tal-Attivita tal-Mard Ankylosing Spondylitis d Bidla medja mil-linja bażi e n=91 plaċebo u n=87 adalimumab f
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leucopenia) have been reported with adalimumab.
Maltese: Effetti avversi tas-sistema ematoloġika, li jinkludu ċitopenja li hi medikament sinifikanti (eż thrombocytopaenia, lewkopenja) ma ġewx irrappurtati b'adalimumab.
English: Table 2 SOLYMBIC dose in milligrams (mg) by weight for patients with paediatric psoriasis
Maltese: Doża ta' SOLYMBIC bħala milligrammi (mg) skont il-piż għall-pazjenti b'psorjasi pedjatrika
English: Plunger rod
Maltese: Studju RA
English: Adalimumab 40 mg eow
Maltese: Plaċebo Adalimumab 40 mg eow
English: SOLYMBIC 20 mg syringe
Maltese: SOLYMBIC 20 mg siringa
English: Other medicines and SOLYMBIC
Maltese: Mediċini oħra u SOLYMBIC
English: SOLYMBIC is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Maltese: SOLYMBIC jintuża għat-trattament ta' artrite relatata mal-entesite fi tfal u adolexxenti ta' età minn 6 snin sa 17-il sena.
English: Table 15 Efficacy results at 12 weeks, HS studies I and II
Maltese: Riżultati ta' effikaċja fi 12-il Ġimgħat, HS Studji I u II
English: Bruising (including purpura), Dermatitis (including eczema), Onychoclasis,
Maltese: Tbenġil (li jinkludi l-purpura), Dermatite (li tinkludi l-ekżema), Onikoklasi,
English: Thirty-three (18%) of patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
Maltese: Tlieta u tletin (18%) pazjent kienu kkurati fl-istess ħin b'mediċini anti-rewmatiċi li jimmodifikaw ilmarda, u 146 (79%) pazjent b'NSAIDs fil-linja bażi.
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leucocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 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: Amgen NV
Maltese: Amgen n.v.
English: RA study II
Maltese: Studju RA II
English: SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis (patients weighing either 23 to 28 kg or 47 kg and greater), Crohn's disease in adults and children, ulcerative colitis and non-infectious uveitis affecting the back of the eye.
Maltese: SOLYMBIC huwa intenzjonat għat-trattament tal-artrite rewmatika, artrite relatata mal-entesite fi tfal ta' 6 snin sa 17-il sena, infjammazzjoni tal-vertebri li jirriżulta fil-vertebri jitwaħħlu flimkien (ankylosing spondylitis), axial spondyloarthritis mingħajr evidenza radjografika ta' ankylosing spondylitis, artrite psorjatika, psorjasi, hidradenitis suppurativa, psorjasi pedjatrika (pazjenti li jiżnu minn 23 sa 28 kg jew 47 kg u aktar), marda ta' Crohn fl-adulti u t-tfal, kolite ulċerattiva u uveite mhux infettiva li taffettwa n-naħa ta' wara tal-għajn.
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 dwar it-tħassib tas-sigurtà ta' infezzjonijiet serji, sepsi, tuberkulosi u infezzjonijiet opportunistiċi; insuffiċjenza konġestiva tal-qalb; disturbi ta' demjelinazzjoni; tumuri malinni, li għandhom jiġu indirizzati permezz ta' miżuri addizzjonali għallminimizzazzjoni tar-riskji (eż. serjetà, severità, frekwenza, żmien biex beda, riversibbiltà tal-AE kif applikabbli)
English: Table 10 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Maltese: Tabella 10 Rispons għall-ACR fi Studji tal-Artrite Psorjatika kontrollati bil-Plaċebo (Persentaġġ ta' Pazjenti)
English: SOLYMBIC in combination with methotrexate, is indicated for:
Maltese: SOLYMBIC, flimkien ma' methotrexate, huwa indikat għal:
English: 2-sided P value from log rank test. c NE = not estimable.
Maltese: b 2-naħat valur P minn test log rank.
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 days a
Maltese: Rispons kliniku (CR-100) Pazjenti li kellhom titjib mingħajr sterojdi għal > = 90 ġurnata a
English: d score a methotrexate b
Maltese: d a methotrexate.
English: * Maximum single dose is 40 mg (0.8 mL)
Maltese: * Doża massima waħda hija ta' 40 mg (0.8 mL)
English: PGA-F clear/minimal and ≥ 2-grade improvement a a
Maltese: PGA-F xejn/minimali u titjib ta' ≥ 2 gradi (%)
English: Reactivation of hepatitis B1), Autoimmune hepatitis Not known Liver failure
Maltese: Riattivazzjoni tal-epatite B1) Epatite awtoimmuni
English: Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
Maltese: Adalimumab huwa anti-korp monoklonali rikombinanti uman espress fiċ-ċelluli tal-Ovarju talĦamster Ċiniż.
English: HS study I
Maltese: HS Studju I
English: a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b
Maltese: Studju RA I fir-24 ġimgħa, Studju RA II fis-26 ġimgħa, u Studju RA III fl-24 u t-52 ġimgħa b
English: Room spinning sensation and vision disturbances may occur after taking SOLYMBIC.
Maltese: Jista jkun hemm sensazzjoni li l-kamra qed iddur bik u disturbi fil-vista wara li tingħata SOLYMBIC.
English: What SOLYMBIC contains - The active substance is adalimumab.
Maltese: X'fih SOLYMBIC - Is-sustanza attiva hi adalimumab.
English: Demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)
Maltese: Disturbi li jeffetwaw il-myelin (bħal newrite flgħajnejn, sindrome ta' Guillain-Barré)
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open-label extension studies 1) including spontaneous reporting data
Maltese: * hemm iżjed informazzjoni pprovduta f'partijiet oħra f'sezzjonijiet 4.3, 4.4 u 4.8 ** li jinkludu l-istudji ta' estensjoni open-label
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3month trial of systemic antibiotic therapy.
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew evalwati fi studji li kienu imqassma b'mod każwali, doubleblind, ikkontrollati bi plaċebo u studju ta' estensjoni open-label f'pazjenti adulti bi hidradenitis suppurativa (HS) moderata sa severa li kienu intoleranti, kellhom kontraindikazzjoni jew rispons inadegwat għal mill-inqas ta' 3 xhur provi ta' terapija antibijotika sistemika.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with SOLYMBIC cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż ir-riskju li tiżviluppa hepatosplenic T-cell lymphoma f'pazjenti ttratati b' SOLYMBIC (ara sezzjoni 4.8).
English: SOLYMBIC is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Maltese: SOLYMBIC huwa indikat għat-trattament ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li ma kellhomx rispons adegwat meta ngħataw trattament konvenzjonali li jinkludi kortikosterojdi u 6-mercaptopurine (6-MP) jew azathioprine (AZA), jew f'pazjenti li għandhom intolleranza jew kontraindikazzjonijiet mediċi għal dawn it-terapiji.
English: Congestive heart failure
Maltese: Infart mijokardiku
English: This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża ta' 0.8 mL, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Paediatric Crohn's disease patients < 40 kg:
Maltese: Il-marda ta' Crohn f'pazjenti pedjatriċi < 40 kg:
English: Children or adolescents weighing 40 kg or more:
Maltese: Tfal jew adolexxenti li jiżnu inqas minn 40 kg:
English: SOLYMBIC is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: SOLYMBIC huwa kontro-indikat f'pazjenti li jbatu minn insuffiċjenza talqalb minn moderata sa severa (ara sezzjoni 4.3).
English: SOLYMBIC is used to treat moderate to severe plaque psoriasis in adults.
Maltese: SOLYMBIC jintuża biex jittrata psorijasi tal-plakka moderata sa severa fl-adulti.
English: Impaired renal and/or hepatic function
Maltese: Funzjoni renali u/jew epatika indebolita
English: NE
Maltese: NA
English: CD study I: infliximab naïve patients
Maltese: Studju CD I: Pazjenti li qatt ma ħadu infliximab
English: Paediatric Crohn's disease patients ≥ 40 kg:
Maltese: Il-marda ta' Crohn f'pazjenti pedjatriċi ≥ 40 kg:
English: 40 mg adalimumab administered every other week c MTX = methotrexate ** p < 0.01, adalimumab versus placebo
Maltese: MTX = methotrexate ** p < 0.01, adalimumab kontra l-plaċebo
English: SOLYMBIC is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Maltese: SOLYMBIC huwa indikat għat-trattament ta' psorjasi tal-plakka severa u kronika fit-tfal u adolexxenti minn 4 snin il-fuq u li kellhom rispons mhux adegwat jew huma kandidati mhux xierqa għat-terapija topika u fototerapiji.
English: The double-blind period is followed by an openlabel (OL) period during which patients received 24 mg/m
Maltese: Il-perjodu double-blind huwa segwit mill-perjodu open-label (OL) fejn ilpazjenti rċevew 24 mg/m