FrancophonIA/ELRC3.0 huggingface dataset:
English: The CAPS interventional trials with canakinumab included a total of 80 paediatric patients with an age range from 2 to 17 years (approximately half of them treated on an mg/kg basis).
Maltese: Il-provi kliniċi intervenzjonali b'canakinumab fost pazjenti bil-CAPS kienu jinkludu total ta' 80 pazjent pedjatriku ta' età ta' bejn sentejn u 17-il sena (madwar nofshom ingħataw il-kura skont ilformula mg/kg).
English: The primary objective was the proportion of patients at day 15 who achieved a minimum 30% improvement in the paediatric American College of Rheumatology (ACR) response criterion adapted to include absence of fever.
Maltese: L-għan ewlieni kien ilproporzjon ta' pazjenti fil-15-il ġurnata li kisbu titjib ta' mill-inqas 30% skont il-kriterji ta' rispons tal-American College of Rheumatology (ACR) pedjatriku addattati sabiex jinkludu n-nuqqas ta' deni.
English: Reported experience with overdose is limited.
Maltese: L-esperjenza rrappurtata b'doża eċċessiva hi limitata.
English: If full treatment response after 7 days, maintenance dose: 600 mg or 8 mg/kg every 8 weeks
Maltese: Jekk wara 7t ijiem hemm rispons sħiħ għattrattament, id-doża ta' manutenzjoni: 600 mg jew 8 mg/kg kull 8 ġimgħat
English: Paediatric patients:
Maltese: Kategorija farmakoterapewtika:
English: Uric acid
Maltese: Jekk tuża
English: Resolution of the index disease flare was defined as having a Physician's Global Assessment (PGA) of Disease Activity score < 2 (“minimal or no disease”) and CRP within normal range (≤ 10 mg/l) or reduction ≥ 70% from baseline.
Maltese: Ir-riżoluzzjoni tal-indiċi ta' tħeġġiġ tal-marda kien iddefinit bħala li għandu skor ta' < 2 (“minimu jew ebda marda”) skont l-Istima Globali tat-Tabib (PGA) talAttività tal-Marda u s-CRP skont il-firxa normali (≤ 10 mg/l) jew tnaqqis ta' ≥ 70% mil-linja bażi.
English: Study G2301 was a randomised, double-blind, placebo-controlled withdrawal study of flare prevention by canakinumab.
Maltese: L-Istudju G2301 kien studju b'canakinumab b'perjodu ta' waqfien randomizzat, double-blind, ikkontrollat bil-plaċebo li jipprevjeni li jerġa' jkun hemm tħeġġiġ.
English: Canakinumab also demonstrated superior efficacy compared to placebo on the secondary endpoints of PGA < 2 and CRP ≤ 10 mg/l in all three cohorts.
Maltese: Canakinumab wera wkoll effikaċja superjuri mqabbel mal-plaċebo fejn jidħlu l-endpoints sekondarji ta' < 2 skont il-PGA u s-CRP ta' ≤ 10 mg/l fit-tliet koorti kollha.
English: Giving the injection
Maltese: Infezzjonijiet u infestazzjonijiet
English: One vial contains 150 mg of canakinumab*.
Maltese: Kunjett wieħed fih 150 mg canakinumab*.
English: A total of 185 patients aged 28 days and above were enrolled and a total of 181 patients aged 2 years and above were randomised in part II of the study.
Maltese: Total ta' 185 pazjent li kellhom minn 28 jum 'il fuq issieħbu u total ta' 181 pazjent li kellhom sentejn jew aktar kienu randomizzati f'parti II tal-istudju.
English: 2 In gouty arthritis
Maltese: 2 F'artrite bil-gotta
English: Study G2305
Maltese: L-istudju G2305
English: Secondary endpoints, all based on week 16 results (end of Part II), included the proportion of patients who achieved a PGA score of < 2, the proportion of patients with serological remission (defined as CRP ≤ 10 mg/l), and the proportion of patients with a normalised SAA level (defined as SAA ≤ 10 mg/l).
Maltese: Endpoints sekondarji, ilkoll imsejsa fuq riżultati tas-16-il ġimgħa (tmiem Parti II), inkludew il-proporzjon ta' pazjenti li kisbu skor ta' < 2 skont il-PGA, il-proporzjon ta' pazjenti b'remissjoni seroloġika (iddefinit bħala CRP ta' ≤ 10 mg/l), u l-proporzjon ta' pazjenti b'livell ta' SAA normalizzat (iddefinit bħala SAA ta' ≤ 10 mg/l).
English: Table 3 Tabulated summary of efficacy in Phase III trial, pivotal, randomised, placebocontrolled treatment period (Part II)
Maltese: Tabella 3 Sommarju ttabbulat tal-effikaċja tal-perjodu tat-trattament waqt prova pivotali, randomizzata, ikkontrollata bi plaċebo f'Fażi III (Parti
English: Ensure that the correct amount of solution is in the syringe.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: The expression of hepatic CYP450 enzymes may be suppressed by the cytokines that stimulate chronic inflammation, such as interleukin-1 beta (IL-1 beta).
Maltese: Iċ-ċitokini li jistimulaw infjammazzjoni kronika, bħall-interleukin-1 beta (IL-1 beta), jistgħu jrażżnu lespressjoni tal-enzimi CYP450 epatiċi.
English: Part I: A complete clinical and biomarker response to canakinumab (defined as composite of physician's global assessment on autoinflammatory and on skin disease ≤ minimal and CRP or SAA values < 10 mg/litre) was observed in 97% of patients and appeared within 7 days of initiation of treatment.
Maltese: Parti I: Kien osservat rispons kliniku u bijomarkatur komplut għal canakinumab (imfisser bħala r-riżultat tal-istima globali tat-tabib tal-mard awtoinfjammatorju u tal-mard tal-ġilda ≤ minimu u l-valuri tas-CRP jew tal-SAA < 10 mg/litru) f'97% tal-pazjenti u deher fi żmien sebat ijiem mit-tnedija tal-kura.
English: Significant improvements were seen in physician's clinical assessment of autoinflammatory disease activity: global assessment of autoinflammatory disease activity, assessment of skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, assessment of other related symptoms, and patient's assessment of symptoms.
Maltese: Deher titjieb sinifikanti fl-istima klinika tat-tabib tal-attività tal-marda awtoinfjammatorja: stima globali tal-attività tal-marda awtoinfjammatorja, stima ta' mard talġilda (raxx tal-ġilda minħabba urtikarja), ta' artralġja, ta' mijalġja, ta' uġigħ ta' ras/emigranja, ta' konġuntivite, ta' għeja/telqa tal-ġisem, stima ta' sintomi relatati oħrajn, u stima tas-sintomi min-naħa tal-pazjent.
English: Patients on urate lowering therapy (ULT)
Maltese: Pazjenti b'terapija li tbaxxi l-urat (ULT)
English: The apparent volume of distribution per kg (V/F per kg) was 0.14 l/kg.
Maltese: Jidher li l-volum ta' distribuzzjoni għal kull kg (V/F kull kg) kien ta' 0.14 l/kg.
English: Laboratory abnormalities in gouty arthritis patients Haematology
Maltese: PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX
English: Corticosteroid dose tapering:
Maltese: Tnaqqis bil-mod il-mod tad-doża bil-kortikosterojdi:
English: Pain in joints (arthralgia).
Maltese: Uġigħ fil-ġogi (artralġja).
English: • Severe forms of familial cold auto-inflammatory syndrome (FCAS) / familial cold urticaria (FCU) presenting with signs and symptoms beyond cold-induced urticarial skin rash.
Maltese: • Forom gravi tas-sindromu awtoinfjammatorju tal-kesħa fil-familja (FCAS) / tas-sindromu tal-urtikarja tal-kesħa fil-familja (FCAS) li jidhru permezz ta' sinjali u sintomi li jmorru lil hinn minn sempliċiment raxx tal-ġilda riżultat ta' urtikarja minħabba l-kesħa.
English: Still's disease (AOSD and SJIA)
Maltese: Il-marda ta' Still (AOSD u SJIA)
English: CAPS, TRAPS, HIDS/MKD, FMF and SJIA: Ilaris can be used in children aged 2 years and older.
Maltese: CAPS, TRAPS, HIDS/MKD, FMF u SJIA: Ilaris ma jistax jintuża fi tfal li ta' sentejn jew aktar.
English: canakinumab treatment improved all paediatric ACR response scores as compared to placebo at days 15 and 29 (Table 4).
Maltese: It-trattament b'canakinumab tejjeb ir-rispons tal-ACR pedjatriku mqabbel mal-plaċebo fil-15 u d-29 ġurnata (Tabella 4).
English: For the overall study population, pain intensity was statistically significantly lower for canakinumab 150 mg compared with triamcinolone acetonide at 72 hours.
Maltese: Għall-popolazzjoni sħiħa tal-istudju, l-intensità tal-uġigħ kienet statistikament u sinjifikament aktar baxxa meta mogħtija 150 mg canakinumab imqabbel ma' triamcinolone acetonide wara 72 siegħa.
English: After 24 weeks, 71% (27/38) of patients who received the reduced dose (2 mg/kg every 4 weeks) and 84% (31/37) of patients who received the prolonged dosing interval (4 mg/kg every 8 weeks) were able to maintain inactive disease status for 6 months.
Maltese: 24 ġimgħa, 71% (27/38) tal-pazjenti li ngħataw doża mnaqqsa (2 mg/kg kull 4 ġimgħat) u 84% (31/37) tal-pazjenti li ngħataw intervall imtawwal bejn doża u oħra (4 g/kg kull 8 ġimgħat) kienu kapaċi jżommu qagħda inattiva tal-marda għal 6 xhur.
English: • 150 mg for patients with body weight > 40 kg
Maltese: • 150 mg għal pazjenti li jiżnu aktar minn 40 kg
English: Two open-label, uncontrolled, long-term phase III studies were performed.
Maltese: III fit-tul, open-label u mhux ikkontrollati.
English: Treatment with canakinumab resulted in clinically relevant improvements in patients' physical function and quality of life.
Maltese: It-trattament b'canakinumab wassal għal titjib relevanti klinikament fil-funzjoni fiżika u l-kwalità talħajja tal-pazjenti.
English: 3 Based on estimated creatinine clearance, most were transient 4 Most represented transient trace to 1+ positive urinary protein by dipstick 5 See further information below
Maltese: 3 Skont stima tat-tneħħija tal-kreatinina, bosta kienu tranżitorji 4 Irrappreżentata l-aktar bi traċċa temporanja ta' 1+ pożittiv ta' proteina fl-awrina permezz tal-istikka 5
English: The distribution volume (Vss) of canakinumab varied according to body weight.
Maltese: Il-volum tad-distribuzzjoni (Vss) ta' canakinumab varja skont il-piż tal-ġisem.
English: Uncap the injection needle.
Maltese: Ilma għall-injezzjonijiet
English: Predicted canakinumab steady state exposures at a dose level of 4 mg/kg (maximum 300 mg) in patients over the age of 20 years were comparable to those in SJIA patients younger than 20 years of age.
Maltese: Esponimenti mbassra għal canakinumab fi stat fiss f'livell ta' doża ta' 4 mg/kg (massimu 300 mg) f'pazjenti b'età ta' aktar minn 20 sena kienu komparabbli ma' dawk f'pazjenti b'SJIA b'età inqas minn 20 sena.
English: Ilaris is available in packs containing one vial.
Maltese: Ilaris huwa disponibbli f'pakketti li fihom kunjett wieħed.
English: The efficacy of canakinumab for the treatment of acute gouty arthritis attacks was demonstrated in two multicentre, randomised, double-blind, active-controlled studies in patients with frequent gouty arthritis (≥ 3 attacks in the previous 12 months) unable to use NSAIDs or colchicine (due to contraindication, intolerance or lack of efficacy).
Maltese: L-effikaċja ta' canakinumab fil-kura ta' attakki gravi ta' artrite bil-gotta dehret f'żewġ studji multiċentriċi, randomizzati, double-blind, ikkontrollati bl-attiv f'pazjenti b'artrite frekwenti bil-gotta (≥ 3 attakki fl-aħħar 12-il xahar) li ma setgħux jużaw NSAIDs jew colchicine (minħabba kontraindikazzjoni, intolleranza jew nuqqas ta' effikaċja).
English: Data from the first 12 weeks of canakinumab treatment from studies G2305, G2301 and the extension study were pooled to assess maintenance of efficacy.
Maltese: G2305, G2301 u mill-istudju ta' estensjoni nġabru biex tkun evalwata l-manutenzjoni tal-effikaċja.
English: In early clinical trials, patients and healthy volunteers received doses as high as 10 mg/kg, administered intravenously or subcutaneously, without evidence of acute toxicity.
Maltese: Fi provi kliniċi bikrija, pazjenti u voluntiera b'saħħithom ingħataw dożi għoljin sa 10 mg/kg, mogħtija mill-vina jew minn taħt il-ġilda, mingħajr xhieda ta' tossiċità akuta.
English: A murine antimurine IL-1 beta antibody had no undesirable effects on fertility in male or female mice (see section 5.3).
Maltese: L-antikorp antimurin tal-ġrieden IL-I beta ma kellux effetti mhux mixtieqa fuq il-fertilità fost ġrieden irġiel jew nisa (ara sezzjoni 5.3).
English: TRAPS n=number of responders; N=number of evaluable patients * indicates statistical significance (one-sided) at the 0.025 level based on Fisher exact test **Indicates statistical significance (one-sided) at the 0.025 level based on the logistic regression model with treatment group and baseline PGA, CRP or SAA respectively, as explanatory variables for each cohort
Maltese: TRAPS n=l-għadd ta' dawk li rrispondew; N=l-għadd ta' pazjenti valutabbli * Jindika sinjifikat statistiku (fuq naħa waħda) fil-livell ta' 0.025 skont it-test eżatt ta' Fisher ** Jindika sinjifikat statistiku (fuq naħa waħda) fil-livell ta' 0.025 skont il-mudell ta' rigressjoni loġistika mal-grupp ta' trattament u l-linja bażi PGA, CRP jew SAA rispettivament, bħala varjabbli esplikattivi għal kull koort
English: In a subset of young adult SJIA patients aged 16 to 20 years (n=31), the safety profile of canakinumab was consistent with what was observed in SJIA patients less than 16 years of age.
Maltese: F'sottogrupp ta' pazjenti adulti żgħażagħ b'SJIA ta' età minn 16 sa 20 sena (n=31), il-profil ta' sigurtà ta' canakinumab kien konsistenti ma' dak li kien osservat f'pazjenti b'SJIA b'età inqas minn 16-il sena.
English: Avoid injecting into a vein.
Maltese: Evita li tittaqqab fil-vina.
English: Ilaris is indicated for the treatment of active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.
Maltese: Ilaris hu indikat għat-trattament tal-marda attiva ta' Still inkluż il-marda ta' Still li toħroġ fl-adulti (AOSD - Adult-Onset Still's Disease) u artrite idjopatika ġovanili sistematika (SJIA) f'pazjenti li għandhom sentejn jew aktar li ma rrispondewx kif jixraq għat-terapija mogħtija qabel b'mediċini mhux sterojdi anti-infjammatorji (NSAIDs) u b'kortikosterojdi sistemiċi.
English: Component of a multipack.
Maltese: Komponent ta' pakketti b'ħafna.
English: In TRAPS, HIDS/MKD and FMF, exposure parameters (trough concentrations) were comparable across age groups from 2 to < 20 years old following subcutaneous administration of canakinumab 2 mg/kg every 4 weeks.
Maltese: Fi TRAPS, HIDS/MKD u FMF, il-parametri ta' espożizzjoni (l-anqas konċentrazzjonijiet) kienu komparabbli fost il-gruppi kollha tal-etajiet minn sentejn sa < 20 sena wara l-għoti ta' 2 mg/kg canakinumab minn taħt il-ġilda kull 4 ġimgħat.
English: Transient and asymptomatic cases of elevations of serum transaminases or bilirubin have been reported in clinical trials (see section 4.8).
Maltese: Provi kliniċi rrappurtaw każijiet momentarji u asintomatiċi ta' żidiet tat-transaminasi jew tal-bilirubin (ara sezzjoni 4.8).
English: The terminal half-life ranged from 22.9 to 25.7 days, similar to the pharmacokinetic properties observed in adults.
Maltese: 7 ġranet, simili għall-proprjetajiet farmakokinetiċi osservati f'adulti.
English: The overall predicted mean (±SD) for Cmin,ss, Cmax,ss and AUC,ss4w were 14.7±8.8 μg/ml, 36.5 ± 14.9 μg/ml and 696.1 ± 326.5 μg*d/ml, respectively.
Maltese: 7±8.8 μg/ml, 36.5 ± 14.9 μg/ml and 696
English: Other activators of the innate immune system, such as endogenous agonists of toll-like receptors, may contribute to the transcriptional activation of the IL1 beta gene, initiating a gouty arthritis attack.
Maltese: Attivaturi oħrajn tas-sistema immuna innata, bħal agonisti endoġenji ta' riċetturi toll-like, jistgħu jikkontribwixxu għall-attivazzjoni tattraskrizzjoni tal-ġene IL-1 beta, li jwasslu għal attakk ta' artrite bil-gotta.
English: Ilaris 150 mg/ml solution for injection
Maltese: Ilaris 150 mg/ml soluzzjoni għall-injezzjoni
English: Based on the population pharmacokinetic modelling analysis, the expected exposures after a dose of 2 mg/kg were comparable across the CAPS paediatric age groups, but were approximately 40% lower in paediatric patients of very low body weight (e.g. 10 kg) than in adult patients (150 mg dose).
Maltese: Abbażi ta' analiżi ta' immudellar tal-farmakokinetika tal-popolazzjoni, l-esponimenti mistennija wara doża ta' 2 mg/kg kienu komparabbli matul il-gruppi ta' età ta' pazjenti pedjatriċi bil-CAPS, iżda kienu madwar 40% anqas f'pazjenti pedjatriċi b'piż tal-ġisem baxx ħafna (eż. 10 kg) milli f'pazjenti adulti (doża ta' 150 mg).
English: The mean change in patient pain score (0-100 mm visual analogue scale) at day 15 was -50.0 mm for canakinumab (N=43), as compared to +4.5 mm for placebo (N=25).
Maltese: Il-bidla medja fil-punteġġ tal-uġigħ tal-pazjent (0-100 mm skala analoga viżiva) fil-15-il jum kienet ta' -50.0 mm għal canakinumab (N=43), kif imqabbel ma' +4.5 mm għal plaċebo (N=25). Ilbidla medja fil-punteġġ tal-uġigħ fost il-pazjenti ttrattati b'canakinumab kienet konsistenti fid-29 jum.
English: Higher proportions of patients had normalised SAA (≤ 10 mg/l) at week 16 with canakinumab treatment compared to placebo in all three cohorts, with a statistically significant difference observed in TRAPS patients (see Table 3 with study results below).
Maltese: Proporzjonijiet ogħla għall-pazjenti kellhom SAA normalizzata (≤ 10 mg/l) fis-16-il ġimgħa bi trattament b'canakinumab imqabbel mal-plaċebo fit-tliet koorti kollha, b'differenza sinjifikanti statistikament osservata fost ilpazjenti bi TRAPS (ara Tabella 3 bir-riżultati tal-istudju hawn taħt).
English: Maintenance dose: 150 mg or 2 mg/kg every 8 weeks
Maltese: Doża ta' manutenzjoni: 150 mg jew 2 mg/kg kull 8 ġimgħat
English: These crystals cause excessive production of IL-1 beta, which in turn can lead to sudden, severe pain, redness, warmth and swelling in a joint (known as a gouty arthritis attack).
Maltese: Dawn il-kristalli jikkawżaw produzzjoni żejda ta' IL-1 beta, li fi ftit kliem jista' jwassal biex f'daqqa waħda jkun hemm uġigħ qawwi, ħmura, sħana u nefħa fil-ġog (magħrufa bħala attakk tal-artrite bil-gotta).
English: • 2 mg/kg for patients with body weight ≥ 7.5 kg and ≤ 40 kg
Maltese: 2 mg/kg għal pazjenti li jiżnu bejn 7.5 kg u anqas minn 40 kg
English: Mean exposure in a typical gouty arthritis patient (93 kg) after a single subcutaneous 150 mg dose (Cmax: 10.8 µg/ml and AUCinf: 495 µg*d/ml) was lower than in a typical 70 kg CAPS patient (15.9 µg/ml and 708 µg*d/ml).
Maltese: 8 µg/ml u AUCinf: 495 µg*d/ml) kienet anqas minn pazjent tipiku ta' 70 kg bil-CAPS (15.
English: The results of a 56-week, open label study in CAPS patients aged 4 years and younger demonstrated that all patients who received non-live, standard of care childhood vaccinations developed protective antibody levels.
Maltese: Ir-riżultati ta' studju open-label mifrux fuq 56 ġimgħa f'pazjenti bil-CAPS ta' 4 snin u inqas urew li lpazjenti kollha li ngħataw vaċċini tat-tfulija mhux ħajjin u ta' standard ta' kura żviluppaw livelli ta' antikorpi protettivi.
English: - Part III: Patients who completed 16 weeks of treatment and were classified as responders were re-randomised into a 24-week, double-blind withdrawal period during which they received canakinumab 150 mg (2 mg/kg for patients ≤ 40 kg) s.c. or placebo every 8 weeks.
Maltese: - Parti III: Pazjenti li temmew it-trattament ta' 16-il ġimgħa u kienu kklassifikati bħala individwi li rrispondew reġgħu ġew randomizzati għal perjodu ta' rtirar double-blind ta' 24 ġimgħa, li matulu ingħataw canakinumab 150 mg (2 mg/kg għal pazjenti ta' ≤ 40 kg) s.c. jew plaċebo kull 8 ġimgħat.
English: Malignancy events have been reported in patients treated with canakinumab.
Maltese: Kienu rrappurtati episodji ta' tumuri malinni f'pazjenti ttrattati b'canakinumab.
English: After repeated subcutaneous administration of 150 mg every 4 weeks, canakinumab minimal concentration at week 16 (Cmin) was estimated to be 15.4 ± 6.6 g/ml.
Maltese: Wara l-għoti minn taħt il-ġilda b'mod ripetut ta' 150 mg kull 4 ġimgħat, il-konċentrazzjoni minima ta' canakinumab fis-16-il ġimgħa (Cmin) kien stmat li kienet ta' 15.4 ± 6.6 g/ml.
English: Feeling dizzy, spinning sensation (dizziness or vertigo).
Maltese: Tħossok stordut, tħoss rasek iddur bik (sturdament jew vertigo).
English: Apparent clearance per kg body weight (CL/F per kg) was comparable between the SJIA and CAPS population (0.004 l/d per kg).
Maltese: Jidher li ttneħħija għal kull kg tal-piż (CL/F għal kull kg) tqabblet bejn il-popolazzjoni b'SJIA u dik b'CAPS (0.004 l/d għal kull kg).
English: By blocking the activity of IL-1 beta, Ilaris may improve these symptoms.
Maltese: Minħabba li jwaqqaf l-attività ta' IL-1 beta, Ilaris jista' jtejjeb dawn is-sintomi.
English: The expected accumulation ratio was 1.3-fold following 6 months of subcutaneous administration of 150 mg canakinumab every 8 weeks.
Maltese: Ilproporzjon mistennija kienet ta' 1.3 drabi aktar wara 6 xhur mill-għoti ta' 150 mg canakinumab minn taħt il-ġilda kull 8 ġimgħat.
English: These include shivering, chills, malaise, loss of appetite, body aches, typically in connection with a sudden onset of illness, sore throat or mouth ulcers, cough, phlegm, chest pain, difficulty breathing, ear pain, prolonged headache or localised redness, warmth or swelling of your skin or inflammation of connective tissue (cellulitis).
Maltese: Dawn jinkludu tregħid, dehxiet ta' kesħa, nuqqas ta' aptit, uġigħ fil-ġisem, normalment b'rabta ma' deni li jitla' f'daqqa, grieżem ħomor jew ulċeri fil-ħalq, sogħla, bili, uġigħ fis-sider, diffikultà biex tieħu n-nifs, uġigħ fil-widna, uġigħ ta' ras li jdum, ħmura f'post partikulari filġilda jew il-ġilda tinħass sħuna jew tintefaħ jew infjammazzjoni tat-tessuti konnettivi (ċellulite).
English: Disease activity was rated as absent or mild/moderate in more than 90% of patients at all post-baseline time points in the study, and median serological markers of inflammation (CRP and SAA) were normal (< 10 mg/litre) at all post-baseline time points.
Maltese: L-attività tal-marda kienet iggradata bħala assenti jew ħafifa/moderata f'aktar minn 90% tal-pazjenti f'waqtiet speċifiċi lil hinn mil-linja bażi fl-istudju, u lmarkaturi sereloġiċi medjani tal-infjammazzjoni (CRP u SAA) kienu normali (< 10 mg/litru) filwaqtiet speċifiċi kollha lil hinn mil-linja bażi.
English: Up-titration
Maltese: TAL-PRODOTT
English: One vial of powder contains 150 mg canakinumab.
Maltese: Kunjett wieħed fih 150 mg canakinumab.
English: Based on the population pharmacokinetic modelling analysis, the pharmacokinetics of canakinumab in young adult SJIA patients aged 16 to 20 years were similar to those in patients less than 16 years of age.
Maltese: Abbażi tal-analiżi tal-immudellar tal-farmakokinetika tal-popolazzjoni, il-farmakokinetika ta' canakinumab f'pazjenti adulti żgħażagħ b'SJIA ta' età minn 16 sa 20 sena kienet simili għal dik f'pazjenti iżgħar minn 16-il sena.
English: Overall, the efficacy, safety and tolerability profile of canakinumab in elderly patients ≥ 65 years of age was comparable to patients < 65 years of age.
Maltese: Kollox ma' kollox, il-profil ta' sigurtà u tollerabbiltà ta' canakinumab f'pazjenti anzjani ta' ≥ 65 sena kien jitqabbel ma' dak ta' pazjenti < 65 sena.
English: Maintenance dose: 300 mg or 4 mg/kg every 8 weeks
Maltese: 300 mg jew 4 mg/kg kull 8 ġimgħat
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: • 4 mg/kg for patients with body weight ≥ 7.5 kg
Maltese: • 4 mg/kg għal pazjenti li jiżnu 7.5 kg jew aktar.
English: In Part II of the study, patients treated with canakinumab who had persistent disease activity received an additional dose of 150 mg (or 2 mg/kg for patients ≤ 40 kg) within the first month.
Maltese: II tal-istudju, il-pazjenti ttrattati b'canakinumab li kellhom attività persistenti tal-marda ngħataw doża addizzjonali ta' 150 mg (jew 2 mg għal pazjenti ta' ≤ 40 kg) matul l-ewwel xahar.
English: Increases in uric acid level (0.7 mg/dl at 12 weeks and 0.5 mg/dl at 24 weeks) were observed after canakinumab treatment in comparative trials in gouty arthritis.
Maltese: Kienu osservati żidiet fil-livell tal-aċidu uriku (0.7 mg/dl fit-12-il ġimgħa u 0.5 mg/dl fl-24 ġimgħa) wara trattament b'canakinumab waqt provi komparattivi fost pazjenti b'artrite bil-gotta.