FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections observed in golimumab-treated patients included tuberculosis, bacterial infections including sepsis and pneumonia, invasive fungal infections and other opportunistic infections.
Maltese: Infezzjonijiet serji osservati f'pazjenti kkurati b'golimumab kienu jinkludu tuberkulożi, infezzjonijiet ikkawżati minn batterja inkluż sepsis u pnewmonja, infezzjonijiet ikkawżati minn fungi invażivi u infezzjonijiet opportunistiċi oħra.
English: Statistically significant improvements in spinal mobility as assessed by BASMI (Bath Ankylosing Spondylitis Metrology Index) and in physical function as assessed by the BASFI were demonstrated in Simponi 50 mg-treated patients as compared to placebo-treated patients (p < 0.0001).
Maltese: (Indiċi ta' Metroloġija Bath għal Ankylosing Spondylitis - Bath Ankylosing Spondylitis Metrology Index) u fil-funzjoni fiżika kif ivvalutat permezz tal-BASFI f'pazjenti ttrattati b'Simponi 50 mg meta mqabbla ma' pazjenti ttrattati bi plaċebo (p < 0.0001).
English: Dizziness may however occur following administration of Simponi (see section 4.8).
Maltese: It-twaqqif ta' golimumab għandu jiġi kkunsidrat jekk jiżviluppaw dawn id-disturbi (ara sezzjoni 4.8).
English: Adult rheumatoid arthritis
Maltese: Artrite rewmatojde fl-adulti
English: In this study, the incidence (95% CI) per 100 subject-years of follow-up in golimumab-treated subjects was 0.40 (0.01, 2.20) for lymphoma, 0.79 (0.10, 2.86) for non-melanoma skin cancers, and 1.99 (0.64, 4.63) for other malignancies.
Maltese: F'dan l-istudju, l-inċidenza (95% CI) għal kull 100 sena ta' individwu ta' follow-up fl-individwi ikkurati b'golimumab kienet 0.40 (0.01, 2.20) għal-limfoma, 0.79 (0.10, 2.86) għal tumuri tal-ġilda li mhumiex melanoma, u 1.99 (0.64, 4.63) għal tumuri malinni oħra.
English: • Injection site reactions (including redness, hardness, pain, bruising, itching, tingling and irritation)
Maltese: • Reazzjonijiet fis-sit tal-injezzjoni (inkluż ħmura, ebusija, uġigħ, tbenġil, ħakk, tingiż u irritazzjoni)
English: Autoimmune antibodies
Maltese: Antikorpi anti-immuni
English: The binding of human TNF by golimumab was shown to neutralise TNF-α-induced cell-surface expression of the adhesion molecules E-selectin, vascular cell adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1 by human endothelial cells.
Maltese: Intwera li t-twaħħil tat-TNF tal-bniedem b'golimumab jinnewtralizza l-espressjoni tal-molekuli ta' adeżjoni E-selektin, il-molekula ta' adeżjoni taċ-ċellula vaskulari (VCAM)-1 u l-molekula ta' adeżjoni interċellulari (ICAM)-1 fuq is-superfiċje taċ-ċelluli li timbeda mit-TNF-α miċ-ċelluli tal endotilju tal-bniedem.
English: • heart failure (rare).
Maltese: • insuffiċjenza tal-qalb (rari).
English: SPARCC score as measured by MRI showed statistically significant reductions in SI joint inflammation at week 16 in patients treated with Simponi 50 mg compared to placebo (Table 6).
Maltese: Il-punteġġ SPARCC kif tkejjel permezz tal-MRI wera tnaqqis statistikament sinifikanti fl-infjammazzjoni tal-ġog SI f'ġimgħa 16 f'pazjenti ttrattati b'Simponi 50 mg meta mqabbel mal-plaċebo (Tabella 6).
English: • Rheumatoid arthritis
Maltese: • Artrite rewmatojde
English: EXPIRY DATE
Maltese: Fl-istudji
English: Following induction doses of 200 mg and 100 mg golimumab at week 0 and 2, respectively, and maintenance doses of 50 mg or 100 mg golimumab subcutaneously every 4 weeks thereafter to patients with UC, serum golimumab concentrations reached steady state approximately 14 weeks after the start of therapy.
Maltese: Wara dożi ta' induzzjoni ta' 200 mg u 100 mg golimumab f'ġimgħat 0 u 2, rispettivament, u minn hemm 'il quddiem dożi ta' manteniment ta' 50 mg jew 100 mg golimumab taħt il-ġilda kull 4 ġimgħat lill-pazjenti b'UC, il-konċentrazzjonijiet ta' golimumab fis-serum laħqu stat fiss madwar 14-il ġimgħa wara l-bidu tat-terapija.
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Maltese: Il-kura għandha tinbeda u tingħata taħt is-superviżjoni ta' speċjalisti kwalifikati li jkollhom esperjenza fid-dijanjożi u l-kura ta' artrite rewmatojde, artrite poliartikulari idjopatika tat-tfal u ż-żgħażagħ, artrite psorijatika, ankylosing spondylitis, spondiloartrite tal-assi mhux radjugrafika jew kolite ulċerattiva.
English: This trend was not observed in the PsA population.
Maltese: Din it-tendenza ma dehrietx fil-popolazzjoni PsA.
English: Single doses up to 10 mg/kg intravenously have been administered in a clinical study without dose-limiting toxicity.
Maltese: Dożi mogħtija darba sa 10 mg/kg fil-vini ngħataw fi studju kliniku mingħajr ma kien hemm tossiċità li llimitat id-doża.
English: Population pharmacokinetic/pharmacodynamic modelling and simulation in children with pJIA confirmed the relationship between golimumab serum exposures and clinical efficacy and supports the dosing regimen of golimumab 30 mg/m2 every 4 weeks in children with pJIA.
Maltese: L-immudellar u s-simulazzjoni farmakokinetika/farmakodinamika tal-popolazzjoni fi tfal b'pJIA ikkonfermaw ir-relazzjoni bejn l-esponimenti għal golimumab fis-serum u l-effikaċja klinika u jsostnu l-iskeda ta' għoti tad-dożi ta' 30 mg/m2 golimumab kull 4 ġimgħat fi tfal b'pJIA.
English: In patients weighing less than 80 kg, a greater proportion of patients who received 50 mg maintenance therapy showed sustained clinical remission compared with those who received placebo.
Maltese: F'pazjenti li jiżnu inqas minn 80 kg, proporzjon akbar ta' pazjenti li rċivew terapija ta' manteniment ta' 50 mg urew remissjoni klinika sostnuta meta mqabbla ma' dawk li rċivew plaċebo.
English: It is important that the correct dose is administered as indicated in the posology (see section 4.2).
Maltese: Huwa importanti li tingħata d-doża korretta kif indikat fil-pożoloġija (ara sezzjoni 4.2).
English: Statistically significant improvements in signs and symptoms of severe active nr-Axial SpA were demonstrated in patients treated with Simponi 50 mg compared to placebo at week 16 (Table 6).
Maltese: Intwera titjib statistikament sinifikanti fis-sinjali u s-sintomi ta' nr-Axial SpA attiva severa f'pazjenti ttratti b'Simponi 50 mg meta mqabbel mal-plaċebo f'ġimgħa 16 (Tabella 6).
English: The induction study (PURSUIT-Induction) evaluated patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) who had an inadequate response to or failed to tolerate conventional therapies, or were corticosteroid dependent.
Maltese: L-istudju ta' induzzjoni (PURSUIT-Induzzjoni) evalwa pazjenti b'kolite ulċerattiva attiva b'mod moderat sa sever (punteġġ Mayo 6 sa 12; Sottopunteġġ tal-endoskopija ≥ 2) li kellhom rispons mhux adegwat għal jew li ma ttollerawx terapiji konvenzjonali, jew li kienu dipendenti fuq kortikosterojdi.
English: Simponi contains latex and sorbitol
Maltese: Intolleranza għas-sorbitol
English: Placebo-controlled efficacy data were collected and analysed through week 16.
Maltese: Dejta kkontrollata bi plaċebo dwar l-effikaċja nġabret u ġiet analizzata sa ġimgħa 16.
English: Instructions for Use Simponi 45 mg/0.45 mL solution for injection in pre-filled pen, VarioJect For paediatric use
Maltese: Instruzzjonijiet dwar l-Użu Simponi 45 mg/0.45 mL Soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest, VarioJect Għal użu pedjatriku
English: In the controlled periods of pivotal trials, 5.4% of golimumab-treated patients had injection site reactions compared with 2.0% in control patients.
Maltese: Fil-perjodi kkontrollati tal-provi pivitali, 5.4% tal-pazjenti ikkurati b'golimumab kellhom reazzjonijiet avversi fis-sit tal-injezzjoni mqabbel ma' 2.0% tal-pazjenti fuq kontroll.
English: In controlled and uncontrolled portions of the trials with a median follow-up of approximately 4 years, the incidence per 100 subject-years of infections was 81.1 events; 95% CI: 79.5, 82.8 for golimumab treated patients.
Maltese: Fil-partijiet ikkontrollati u mhux ikkontrollati tal-provi fejn il-pazjenti ġew segwiti għal medjan ta' madwar 4 snin, l-inċidenza ta' infezzjonijiet għal kull 100 sena ta' individwu kienet 81.1 każ; 95% CI: 79.5, 82.8 għal pazjenti kkurati b'golimumab.
English: In the controlled and uncontrolled period of pivotal trials with a median follow-up of up to 3 years, malignancies besides melanoma, non-melanoma skin cancer and lymphoma were diagnosed in 5 placebo-treated, 21 golimumab 50 mg-treated and 34 golimumab 100 mg-treated subjects with an incidence (95% CI) per 100 subject-years of follow-up of 0.48 (0.36, 0.62) for combined golimumab and 0.87 (0.28, 2.04) for placebo (see section 4.4).
Maltese: Fil-perjodu kkontrollat u mhux ikkontrollat ta' provi pivitali b'segwitu medjan sa 3 snin, tumuri malinni minbarra melanoma, kanċer tal-ġilda li mhux melanoma u limfoma kienu ddijanjostikati f'5 individwi kkurati bi plaċebo, 21 individwu kkurati b'50 mg ta' golimumab u 34 individwu kkurati b'100 mg ta' golimumab b'inċidenza (95%CI) għal kull 100 sena ta' segwitu ta' individwu ta' 0.48 (0.36, 0.62) għal gruppi ta' golimumab kombinati u 0.
English: A subcutaneous injection of 50 mg golimumab to healthy subjects produced a mean  standard deviation maximum serum concentration (Cmax) of 3.1  1.4 g/mL.
Maltese: Injezzjoni minn taħt il-ġilda ta' 50 mg golimumab lil individwi f'saħħithom ikkawżat medja ta' konċentrazzjoni massima fis-serum (Cmax) bi ± devjazzjoni standard ta' 3. 1  1.4 g/mL.
English: In controlled and uncontrolled portions of the studies with a median follow-up of approximately 4 years, the incidence per 100 subject-years of upper respiratory tract infections was 34.9 events; 95% CI: 33.8, 36.0 for golimumab treated patients.
Maltese: 4 snin, l-inċidenza ta' infezzjonijiet fil-parti ta' fuq tal-apparat tan-nifs għal kull 100 sena ta' individwu kienet 34.9 każijiet; 95% CI: 33.8, 36.0 għal pazjenti kkurati b'golimumab.
English: In general, no clinically meaningful differences in measures of efficacy were observed between the Simponi 50 mg and 100 mg dosing regimens with concomitant MTX, through week 104 in GO-FORWARD and GO-BEFORE and through week 24 in GO-AFTER.
Maltese: B'mod ġenerali, ma dehrux differenzi li jista' jkollhom sinifikat mill-lat kliniku fil-kejl tal-effikaċja bejn korsijiet b'Simponi 50 mg u 100 mg flimkien ma' MTX, sa ġimgħa 104 f'GO-FORWARD u GO-BEFORE u sa ġimgħa 24 f'GO-AFTER.
English: Let the pre-filled pen sit at room temperature for at least 30 minutes out of reach of children.
Maltese: Ħalli l-pinna toqgħod f'temperatura tal-kamra għal mill-inqas 30 minuta fejn ma tidhirx u ma tintlaħaqx mit-tfal.
English: EU/1/09/546/007 1 pre-filled syringe EU/1/09/546/008 3 pre-filled syringes
Maltese: EU/1/09/546/007 siringa 1 mimlija għal-lest EU/1/09/546/008 3 siringi mimlijin għal-lest
English: The potential risk with the combination of AZA or 6-MP and golimumab should be carefully considered.
Maltese: Ir-riskju potenzjali bil-kombinazzjoni ta' AZA jew 6-MP u golimumab għandu jiġi kkunsidrat b'attenzjoni.
English: Across the Phase III RA, PsA and AS studies through week 52, antibodies to golimumab were detected in 5% (105/2062) of golimumab treated patients and, where tested, nearly all antibodies were neutralising in vitro.
Maltese: III sa' ġimgħa 52, l-antikorpi għal golimumab, instabu f'5% (105/2062) tal-pazjenti ikkurati b'golimumab u, meta kienu ttestjati, kważi l-antikorpi kollha kienu newtralizzanti in vitro.
English: Improvement in C-reactive protein (CRP) levels were observed relative to placebo groups and treatment with Simponi resulted in significant reductions from baseline in serum levels of IL-6, ICAM-1, matrix-metalloproteinase (MMP)-3 and vascular endothelial growth factor (VEGF) compared to control treatment.
Maltese: Titjib fil-livelli tal-proteina reattiva-C (CRP) deher meta mqabbel mal-gruppi fuq plaċebo, u kura b'Simponi wasslet għal titjib sinifikanti mil-linja bażi tal-livelli fis-serum ta' IL-6, ICAM-1, matrixmetalloproteinase (MMP)-3 u fattur ta' tkabbir tal-endotilju vaskulari (VEGF) meta mqabbel malkura ta' kontroll.
English: An effect on serum golimumab concentrations was seen at titres of > 1:100 while an effect on efficacy was not seen until titres of > 1:1000, though the numbers of children with titres of > 1:1000 were low (N = 8).
Maltese: Effett fuq ilkonċentrazzjonijiet ta' golimumab fis-serum kien osservat b'titres ta' > 1:100 filwaqt li ma kienx osservat effett fuq l-effikaċja sa titres ta' > 1:1000, għalkemm in-numru ta' tfal b'titres ta' > 1:1000 kien żgħir (N = 8).
English: Paediatric population Simponi 100 mg is not recommended in children aged less than 18.
Maltese: Popolazzjoni pedjatrika Simponi 100 mg mhuwiex rakkomandat fi tfal li għandhom inqas minn 18-il sena.
English: Within the RA, PsA, AS, and nr-Axial SpA pivotal trials, one patient in an RA trial with pre-existing liver abnormalities and confounding medicinal products treated with golimumab developed non-infectious fatal hepatitis with jaundice.
Maltese: Fil-provi pivitali ta' RA, PsA, AS, u nr-Axial SpA pazjent wieħed fi prova ta' RA b'anormalitajiet talfwied li kienu jeżistu minn qabel u taħlita ta' prodotti mediċinali oħra li kien ikkurat b'golimumab żviluppa epatite b'suffejra mhux infettiva li kienet fatali.
English: Table 5 Key efficacy outcomes from GO-RAISE.
Maltese: Riżultati ewlenin minn GO-RAISE.
English: • Children weighing at least 40 kg:
Maltese: • Tfal li jiżnu mill-inqas 40 kg:
English: Tip
Maltese: Figura
English: • Thyroid disorders
Maltese: • Disturbi tat-tirojde
English: Uncommon: Thyroid disorder (such as hypothyroidism, hyperthyroidism and goitre)
Maltese: Disturbi tat-tirojde (bħal ipotajrojdiżmu, ipertajrojdiżmu u goitre)
English: Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis) Common: Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess
Maltese: Infezzjoni tal-passaġġ respiratorju fil-parti ta' fuq (nażofarinġite, farinġite, larinġite u rinite) Komuni: Infezzjonijiet ikkawżati minn batterja (bħal ċellulitis), infezzjoni fil-passaġġ respiratorju ta' isfel (bħal pnewmonja), infezzjonijiet virali (bħal influwenza u herpes), bronkite, sinużite, infezzjonijiet superfiċjali kkawżati minn fungi, axxess
English: Common: Pruritus, rash, alopecia, dermatitis Uncommon: Bullous skin reactions, psoriasis (new onset or worsening of pre-existing psoriasis, palmar/plantar and pustular), urticaria Rare: Lichenoid reactions, skin exfoliation, vasculitis (cutaneous) Musculoskeletal and connective tissue disorders
Maltese: Ħakk, raxx, alopeċja, dermatite Mhux komuni: Reazzjonijiet bl-infafet fil-ġilda, psorjasi (tfeġġ mill-ġdid jew psorjasi li tkun teżisti minn qabel taggrava, fil-pali tal-idejn jew tas-saqajn u pustulari), urtikarja Rari:
English: • 1 Cotton ball or gauze pad
Maltese: • Ballun tajjar jew biċċa garża 1
English: • You will also notice an air bubble, which is normal.
Maltese: • Tinnota wkoll bużżieqa tal-arja, li hi normali.
English: CARTON FOR 1 PRE-FILLED SYRINGE AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Maltese: KARTUNA TA' SIRINGA 1 MIMLIJA GĦAL-LEST BĦALA PAKKETT TAN-NOFS/ KOMPONENT TA' PAKKETT B'ĦAFNA (MINGĦAJR KAXXA ĊELESTI)
English: There were no patients age 45 and over in the non-radiographic axial spondyloarthritis (nr-Axial SpA) study.
Maltese: Ma kienu rrappurtati l-ebda każijiet fil-perjodi kkontrollati u mhux ikkontrollati talistudju nr-Axial SpA (sa sena).
English: Uncommon: Sepsis including septic shock, pyelonephritis Rare: Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis
Maltese: Tuberkulożi, infezzjonijiet opportunistiċi (bħal infezzjonijiet invażivi kkawżati minn fungi [istoplasmożi, kokkidjodomikożi, pnewmoċitożi], minn batterji, infezzjoni atipika tal-mikobatterji u tal-protozoa), attivazzjoni mill-ġdid tal-epatite B, artrite tal-batterji, bursite infettiva
English: Among patients remaining in the study and treated with Simponi, DAS28 and HAQ DI responses were similar from week 104 through week 256.
Maltese: Fost pazjenti li baqgħu fl-istudju u li kienu kkurati b'Simponi, risponsi DAS28 u HAQ DI kienu simili minn ġimgħa 104 sa ġimgħa 256.
English: The majority of children did not experience a flare between week 16 and week 48 (59% in the Simponi + MTX and 53% in the placebo + MTX groups, respectively; p = 0.41).
Maltese: Il-maġġoranza tat-tfal ma kellhomx marda li marret għall-agħar bejn ġimgħa 16 u ġimgħa 48 (59% fil-grupp ta' Simponi + MTX u 53% fil-grupp ta' plaċebo + MTX, rispettivament;
English: Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Simponi.
Maltese: Kważi l-pazjenti kollha kienu rċivew ukoll mediċini magħrufa bħala azathioprine jew 6-mercaptopurine.
English: At week 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) were seen in the Simponi-treated patients.
Maltese: F'ġimgħa 24 titjib fil-parametri tal-attività periferali karatteristika tal-artrite psorijatika (eż. Numru ta' ġogi minfuħin, numru ta' ġogi li jweġġhu/teneri, daktilite u enteżite) dehru fil-pazjenti ikkurati b'Simponi.
English: In the controlled and uncontrolled portions of the pivotal trials with a median follow-up of up to 3 years, there was a greater incidence of serious infections, including opportunistic infections and TB in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg.
Maltese: Fil-partijiet ikkontrollati u mhux ikkontrollati tal-provi pivitali b'segwitu medjan sa 3 snin, kien hemm inċidenza akbar ta' infezzjonijiet serji, inkluż infezzjonijiet opportunistiċi u TB f'pazjenti li kienu qed jirċievu 100 mg ta' golimumab meta mqabbla mal-pazjenti li kienu qed jirċievu 50 mg ta' golimumab.
English: The radiographic effects observed at week 52 were maintained through week 104.
Maltese: L-effetti radjugrafiċi li ġew osservati f'ġimgħa 52 inżammu sa ġimgħa 104.
English: o If you weigh more than 100 kg, the dose might be increased to 100 mg (the content of
Maltese: o Jekk tiżen aktar minn 100 kg, id-doża tista' tkun miżjuda għal 100 mg (il-kontenut ta'
English: • Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta wara “JIS”.
English: For patients weighing less than 40 kg, a 45 mg/0.45 mL pre-filled pen is available.
Maltese: Għal pazjenti li jiżnu inqas minn 40 kg, hija disponibbli pinna ta' 45 mg/0.45 mL mimlija għal-lest.
English: Nervous system disease
Maltese: Disturbi psikjatriċi
English: Select from the following areas for your injection:
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna:
English: In an exploratory clinical trial evaluating the use of golimumab in patients with severe persistent asthma, more malignancies were reported in patients treated with golimumab compared with control patients (see section 4.8).
Maltese: Fi prova klinika esploratorja biex jiġi evalwat l-użu ta' golimumab f'pazjenti b'ażma severa u persistenti, kien hemm aktar tumuri malinni rrappurtati f'pazjenti ikkurati b'golimumab meta mqabbla ma' pazjenti ikkurati b'kontroll (ara sezzjoni 4.8).
English: The efficacy of Simponi was demonstrated in three multi-centre, randomised, double-blind, placebo-controlled studies in over 1500 patients ≥ 18 years of age with moderately to severely active RA diagnosed according to American College of Rheumatology (ACR) criteria for at least 3 months prior to screening.
Maltese: L-effikaċja ta' Simponi ntweriet fi tliet studji kontrollati bi plaċebo, double-blind, randomised, multiċentriċi f'il fuq minn 1500 pazjent b'età ≥ 18-il sena b'RA moderata sa severa li kienet dijanjostikata skont il-kriterji tal-Kulleġġ Amerikan tar-Rewmatoloġija (ACR) għal mill-anqas 3 xhur qabel liscreening.
English: 1.1 Prior to Simponi treatment:
Maltese: 1.1. Qabel kura b'Simponi:
English: • Feeling numb or having a tingling feeling
Maltese: • Tħoss tnemnim jew ikollok sensazzjoni ta' tingiż
English: In GO-FORWARD, among 89 subjects randomised to Simponi 50 mg + MTX, 48 were still on this treatment at week 104.
Maltese: F'GO-FORWARD, fost 89 individwu randomised għal Simponi 50 mg + MTX, 48 kienu għadhom fuq din il-kura f'ġimgħa 104.
English: Dizziness may however occur after you take Simponi.
Maltese: Għandek tieqaf tredda' jekk ser tingħata Simponi.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age) in the post marketing setting.
Maltese: Tumuri malinni, xi wħud fatali, kienu rrappurtati fost tfal, adolexxenti u adulti żgħażagħ (sa 22 sena) ikkurati b'sustanzi li jinblukkaw it-TNF (terapija mibdija f'età ta' ≤ 18-il sena fi sfond ta' wara ttqegħid fis-suq.
English: Sorbitol intolerance This medicine contains 41 mg sorbitol (E420) in each pre-filled syringe.
Maltese: Intolleranza għas-sorbitol Din il-mediċina fiha 41 mg sorbitol (E420) f'kull pinna mimlija għal-lest.
English: EU/1/09/546/008 (3 packs, each containing 1 pre-filled syringe)
Maltese: EU/1/09/546/008 (3 pakketti, li kull wieħed fih siringa 1 mimlija għal-lest)
English: Common: Dyspepsia, gastrointestinal and abdominal pain, nausea, gastrointestinal inflammatory disorders (such as gastritis and colitis), stomatitis Uncommon: Constipation, gastro-oesophageal reflux disease
Maltese: Komuni: Dispepsja, uġigħ gastrointestinali u fl-addome, nawsja, disturbi gastrointestinali b'infjammazzjoni (bħal gastrite u kolite), stomatite Mhux komuni: Stitikezza, marda ta' rifluss gastroesofagali
English: Inject the medicine
Maltese: Infezzjonijiet u infestazzjonijiet
English: In the controlled periods of the pivotal UC trials, of golimumab induction, ALT elevations ≥ 5 x ULN occurred in similar proportions of golimumab-treated patients compared to placebo-treated patients (0.3% to 1.0%, respectively).
Maltese: Fil-perjodi kkontrollati tal-provi pivitali ta' UC, ta' induzzjoni b'golimumab, żidiet fl-ALT ta' ≥ 5 x ULN seħħew fi proporzjonijiet simili ta' pazjenti kkurati b'golimumab meta mqabbel ma' pazjenti kkurati bil-plaċebo (0.3% sa 1.0%, rispettivament).
English: • To ensure proper injection, allow the pre-filled syringe to sit at room temperature outside the box for 30 minutes, out of the reach of children.
Maltese: • Sabiex taċċerta injezzjoni kif suppost, ħalli s-siringa mimlija għal-lest toqgħod f'temperatura ambjentali barra mill-kaxxa għal 30 minuta fejn ma tintlaħaqx mit-tfal.
English: Population pharmacokinetic/pharmacodynamic modelling and simulation in children with pJIA confirmed the relationship between golimumab serum exposures and clinical efficacy and supports that the dosing regimen of golimumab 50 mg every 4 weeks in children with pJIA of at least 40 kg achieves similar exposures to those shown to be efficacious in adults.
Maltese: L-immudellar u s-simulazzjoni farmakokinetika/farmakodinamika tal-popolazzjoni fi tfal b'pJIA ikkonfermaw ir-relazzjoni bejn l-esponimenti għal golimumab fis-serum u l-effikaċja klinika u jsostnu li l-iskeda ta' għoti tad-dożi ta' 50 mg golimumab kull 4 ġimgħat fi tfal b'pJIA ta' mill-inqas 40 kg tikseb esponimenti jixxiebhu għal dawk li ntewerw li huma effikaċi fl-adulti.