FrancophonIA/ELRC3.0 huggingface dataset:
English: A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below.
Maltese: Livell sostnut ta' l-emoglobina ta' aktar minn 12 g/dl (7.5 mmol/l) għandu jiġi evitat; gwida għall-aġġustament xieraq tad-doża għal meta jiġu osservati valuri ta' l-emoglobina li jaqbżu 12 g/dl (7.5 mmol/l) hija deskritta isfel.
English: If the rate of rise in haemoglobin is greater than 2 g/dl (1.25 mmol/l) in one month or if the haemoglobin level is increasing and approaching 12 g/dl (7.45 mmol/l), the dose is to be reduced by approximately 25 %.
Maltese: Jekk ir-rata ta' żieda ta' emoglobina hija ikbar minn 2 g/dl (1.25 mmol/l) f'xahar wieħed, jew jekk il-livell ta' l-emoglobina qed jiżdied u jqarreb 12 g/dl (7.45 mmol/l), id-doża għandha titnaqqas b'madwar 25%.
English: Patients in an autologous blood predonation programme Patients in an autologous blood predonation programme have been reported to show a slightly higher frequency of thromboembolic events.
Maltese: Pazjenti fi programm ta' donazzjoni minn qabel ta' demm awtologu Pazjenti fi programm ta' donazzjoni minn qabel ta' demm awtologu kienu rrappurtati li juru frekwenza ta' avvenimenti trombo-embolitiċi kemmxejn akbar.
English: To avoid the risk of cross-infection always follow aseptic techniques and use disposable sterile syringes and needles for each administration.
Maltese: Pazjenti mhux fuq emodijalisi, normalment jingħataw injezzjonijiet taħt il-ġilda.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoRecormon 6000 IU injection epoetin beta
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa mimlija għal-lest waħda fiha 6000
English: Patients should be monitored closely to ensure that the lowest approved effective dose of NeoRecormon is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below to 12g/dl (7.45mmol/l).
Maltese: Il-pazjenti għandhom jiġu sorveljati mill-viċin sabiex jiġi assigurat li tiġi wżata l-inqas doża effettiva approvata ta' NeoRecormon biex jiġi pprovdut kontoll adegwat tas-sintomi ta' l-anemija waqt li lkonċentrazzjoni tal-emoglobina tinżamm taħt jew f'livell ta' 12g/dl (7.45mmol/l).
English: · The other ingredients are: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine and water for injections.
Maltese: • Is-sustanzi l-oħra huma: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phospate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, LThreonine, L-Glutamic acid, u L-Phenylalanine u ilma għall-injezzjonijiet.
English: Allow to stand for 5 minutes.
Maltese: Ħallih joqgħod għal 5 minuti.
English: Centre de Biotechnologie 8, rue de l'Industrie 68330 Huningue France
Maltese: Centre de Biotechnologie 8, rue de l'Industrie 68330
English: Dizziness/vertigo
Maltese: Sturdament/vertigo
English: C-reactive protein ≤ 10 mg/l
Maltese: Proteina reattiva-C ≤ 10 mg/l
English: * Denotes significant p-value ≤ 0.025
Maltese: * tindika valur-p sinifikanti ≤ 0.025
English: • Muckle-Wells syndrome (MWS),
Maltese: Is-sindromu ta' Muckle-Wells (MWS),
English: Placebo N=16 n(%)
Maltese: Plaċebo N=16 n(%)
English: Placebo n/N (%)
Maltese: Plaċebo n/N (%)
English: Familial Mediterranean fever (FMF)
Maltese: Deni Mediterranju familjari (FMF)
English: The active substance is canakinumab.
Maltese: Is-sustanza attiva hi canakinumab.
English: Table 1 Tabulated list of adverse reactions
Maltese: Tabella 1 Lista ta' reazzjonijiet avversi f'tabella
English: • Familial Mediterranean fever (FMF).
Maltese: • Deni Mediterranju familjari (FMF).
English: Canakinumab binds to serum IL-1 beta.
Maltese: Canakinumab jeħel mas-serum IL-1 beta.
English: The AUCss4w in each age group was 692, 615, 707 and 742 µg*d/ml for 2-3, 4-5, 6-11, and 12-19 years old, respectively.
Maltese: L-AUCss f'kull grupp ta' età kien ta' 692, 615, 707 u 742 µg*d/ml għal 2-3, 4-5, 6-11, u 12-19-il sena, rispettivament.
English: Date of first authorisation: 23 October 2009 Date of latest renewal: 19 June 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 23 Ottubru 2009 Data tal-aħħar tiġdid: 19 Ġunju 2014
English: The apparent volume of distribution (V/F) was 4.96 l at body weight of 55 kg.
Maltese: Il-volum apparenti ta' distribuzzjoni (V/F) kien ta' 4.96 l b'piż ta' 55 kg.
English: Serum amyloid A ≤ 10 mg/l
Maltese: Amilojd fis-Serum A ≤ 10 mg/l
English: Neutropenia (absolute neutrophil count [ANC] < 1.5 x 10
Maltese: Newtropenija (għadd assolut tan-newtrofils [ANC] < 1.5 x 10
English: The estimated steady state AUCtau was 636.7 ± 260.2 μg*d/ml.
Maltese: L-istat wieqaf stmat talAUCtau kien ta' 636.7 ± 260.2 μg*d/ml.
English: Steady state was reached after 110 days.
Maltese: L-istat wieqaf intlaħaq wara 110 ijiem.
English: MedDRA System Organ Class
Maltese: Sistema talklassifika talorgani fiddatabase MedDRA
English: Canakinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype.
Maltese: Canakinumab huwa antikorp antiuman interleukin-1 beta (IL-1 beta) monoklonali uman tal-isotip IgG1/κ.
English: Physician Global Assessment < 2
Maltese: Stima Globali tat-Tabib < 2
English: Mild (< LLN and > 75 x 10
Maltese: Kien osservat tnaqqis ħafif (< LLN u > 75 x 10
English: At week 12, the adapted paediatric ACR30, 50, 70, 90 and 100 responses were: 70%, 69%, 61%, 49% and 30%, respectively and 28% of patients had inactive disease (N=178).
Maltese: Fit-12-il ġimgħa, l-ACR30, 50, 70, 90 u 100 pedjatriku addattat kienu ta' 70%, 69%, 61%, 49% u 30%, rispettivament u 28% tal-pazjenti kellhom marda mhux attiva (N=178).
English: Inflammatory markers* C-reactive protein, mg/l Serum amyloid A, mg/l * mean (median) change from beginning of Part II
Maltese: Markaturi infjammatorji* Proteina reattiva għal C, mg/l Amilojd fis-serum A, mg/l * il-bidla medja (il-medjan) sa mill-bidu ta' Parti II
English: 9/l) and leukopenia have been observed with medicinal products that inhibit IL-1, including canakinumab.
Maltese: 9/l) u lewkopenija kienu osservati bi prodotti mediċinali li jinibixxu IL-1, inkluż canakinumab.
English: Satisfactory clinical response after 7 days?
Maltese: Rispons kliniku sodisfaċenti wara 7t ijiem?
English: 9/l were also observed (see section 4.4).
Maltese: 9/l (ara sezzjoni 4.4).
English: 1 In SJIA
Maltese: 1 F'SJIA
English: Predicted steady-state exposure values (Cmin,ss, Cmax,ss, AUC,ss,8w) after 150 mg subcutaneous administration (or 2 mg/kg, respectively) every 8 weeks were slightly higher in the weight category 40-70 kg (6.6 µg/ml, 24.3 µg/ml, 767 µg*d/ml) compared to the weight categories < 40 kg (4.0 µg/ml, 19.9 µg/ml, 566 µg*d/ml) and > 70 kg (4.6 µg/ml, 17.8 µg/ml, 545 µg*d/ml).
Maltese: Il-valuri (Cmin,ss, Cmax,ss, AUC,ss,8w) mbassra tal-espożizzjoni fi stat wieqaf wara l-għoti ta' 150 mg minn taħt il-ġilda (jew 2 mg/kg, rispettivament) kull 8 ġimgħat kienu ħarira ogħla filkategorija tal-piż 40-70 kg (6.6 µg/ml, 24.3 µg/ml, 767 µg*d/ml) mqabbel mal-kategoriji tal-piż ta' < 40 kg (4.0 µg/ml, 19.9 µg/ml, 566 µg*d/ml) u ta' > 70 kg (4.6 µg/ml, 17.8 µg/ml, 545 µg*d/ml).
English: Candida - vaginal yeast infection (vulvovaginal candidiasis).
Maltese: Kandida - infezzjoni fil-ħimira vaġinali (kandidjażi vulvovaġinali).
English: Phase III trial, pivotal placebo-controlled withdrawal period (Part II) Canakinumab N=15 n(%)
Maltese: III tal-prova, perjodu pivitali ta' waqfien ikkontrollat bil-plaċebo (Parti II) Canakinumab N=15 n(%)
English: • Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD),
Maltese: • Is-sindromu tal-iperimmunoglobulina D (HIDS)/defiċjenza ta' mevalonate kinasi (MKD),
English: Frequency categories are defined using the following convention: 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); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma ddefiniti bl-użu tal-konvenzjoni li ġejja: 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); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Study G2306
Maltese: Studju G2306
English: Treatment difference for all ACR scores was significant (p ≤ 0.0001)
Maltese: Id-differenza fit-trattament fil-punteġġi kollha tal-ACR kien qawwi (p ≤ 0.0001)
English: CAPS in adults and children  4 years of age  15 kg
Maltese: CAPS f'adulti u tfal  4 snin  15 kg
English: Over 85% of patients had comorbidity, including hypertension (60%), diabetes (15%), ischaemic heart disease (12%), and stage ≥ 3 chronic kidney disease (25%).
Maltese: Aktar minn 85% tal-pazjenti kellhom mard ieħor, inkluż pressjoni għolja (60%), dijabete (15%), mard iskemiku tal-qalb (12%), u mard kroniku tal-kliewi ta' stadju ≥ 3 (25%).
English: Statistically significant improvements in the Child Health Questionnaire-PF50 scores were reported for canakinumab vs placebo in study G2305 (physical p=0.0012; psychosocial well-being p=0.0017).
Maltese: Kien irrappurtat titjib qawwi statistikament fil-punteġġi taċ-Child Health Questionnaire-PF50 għal canakinumab kontra l-plaċebo fl-istudju G2305 (p fiżika=0.0012; benesseri psikosoċjali=0.0017).
English: Study G2301
Maltese: Studju G2301
English: Triglycerides
Maltese: Trigliċeridi
English: The efficacy of canakinumab for the treatment of active SJIA was assessed in two pivotal studies (G2305 and G2301).
Maltese: L-effikaċja ta' canakinumab għat-trattament ta' SJIA attiva kienet evalwata f'żewġ studji pivitali (G2305 u G2301).
English: Neutropenia and leukopenia
Maltese: Newtropenija u lewkopenija
English: Secondary endpoints (disease and inflammatory markers)
Maltese: Endpoints sekondarji (markaturi tal-mard u l-infjammazzjoni)
English: The median improvement from baseline to end of Part I of study G2301 was 0.88 (79%).
Maltese: It-titjib medju mil-linja bażi sa tmiem Parti I talistudju G2301 kien ta' 0.88 (79%).
English: The Marketing Authorisation Holder has completed four Paediatric Investigation Plans for Ilaris (for CAPS, SJIA, FMF - HIDS/MKD and TRAPS respectively).
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq mela l-Pjanijiet ta' Investigazzjoni Pedjatrika għal Ilaris (għal CAPS, SJIA, FMF - HIDS/MKD u TRAPS rispettivament).
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC08
Maltese: Immunosoppressanti, inibituri tal-interleukin, Kodiċi ATC:
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: There is no significant difference in safety profile observed in patients ≥ 65 years of age.
Maltese: Mhemmx differenza qawwija fil-profil ta' sigurtà osservata f'pazjenti li għandhom ≥ 65 sena.
English: 150 mg or 2 mg/kg
Maltese: 150 mg jew 2 mg/kg
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2°C- 8°C).
English: Adverse reactions are listed according to MedDRA system organ class.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-klassi tas-sistemi tal-organi MedDRA.
English: Mixing Ilaris
Maltese: X'inhu Ilaris
English: 9/l were reported in 2% of patients in the comparative trials.
Maltese: 9/l fi 2% tal-pazjenti waqt il-provi komparattivi.
English: Laboratory abnormalities in SJIA patients
Maltese: Anormalitajiet fil-laboratorju f'pazjenti b'SJIA
English: All indications: CAPS, TRAPS, HIDS/MKD, FMF, SJIA, gouty arthritis
Maltese: L-indikazzjonijiet kollha: CAPS, TRAPS, HIDS/MKD, FMF, SJIA, artrite tal-gotta
English: Very common Respiratory tract infections (including pneumonia, bronchitis, influenza, viral infection, sinusitis, rhinitis, pharyngitis, tonsillitis, nasopharyngitis, upper respiratory tract infection)
Maltese: Komuni ħafna Infezzjonijiet fil-passaġġ respiratorju (inkluż pnewmonja, bronkite, influwenza, infezzjoni virali, sinużite, rinite, farinġite, tonsillite, nasofarinġite, infezzjoni filparti ta' fuq tal-apparat respiratorju)
English: There were no antibodies against Ilaris observed in TRAPS, HIDS/MKD and FMF patients treated with doses of 150 mg and 300 mg over 16 weeks of treatment.
Maltese: Ma kienx hemm antikorpi kontra Ilaris f'pazjenti bi TRAPS, HIDS/MKD u FMF ittrattati b'dożi ta' 150 mg u 300 mg tul 16-il ġimgħa ta' trattament.
English: Medicines called tumour necrosis factor (TNF) inhibitors, such as etanercept, adalimumab or infliximab.
Maltese: Mediċini magħrufa bħala inibituri tal-fattur tan-nekrosi tat-tumur (TNF), bħalma huma etanercept, adalimumab jew infliximab.
English: The incidence of patients with triglyceride elevations > 5 x upper limit of normal (ULN) was 2.4% with canakinumab and 0.7% with triamcinolone acetonide.
Maltese: L-inċidenza ta' pazjenti b'żidiet tat-trigliċeridi > 5x l-ogħla limitu tannormal (ULN) kien ta' 2.4% b'canakinumab u ta' 0.7% bi triamcinolone acetonide.
English: Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF).
Maltese: Ilaris hu indikat għat-trattament tad-Deni Mediterranju Familjari (FMF).
English: When stratified by weight, a lower (30-40%) median of exposure for Cmin,ss (11.4 vs 19 µg/ml) and AUCss (594 vs 880 µg*d/ml) for the lower bodyweight category (≤ 40 kg) vs the higher bodyweight category (> 40 kg) was observed.
Maltese: Meta stratifikati skont il-piż, kien osservat medjan ta' espożizzjoni aktar baxx (30-40%) għal Cmin,ss (11.4 vs 19 µg/ml) u AUCss (594 vs 880 µg*d/ml) għall-kategorija tal-aktar piż baxx tal-ġisem (≤ 40 kg) vs il-kategorija tal-aktar piż għoli (> 40 kg).
English: CAPS, TRAPS, HIDS/MKD and FMF
Maltese: CAPS, TRAPS, HIDS/MKD u FMF
English: It was estimated to be 6.2 litres in a CAPS patient of body weight 70 kg.
Maltese: Kien stmat li kien ta' 6.2 litri f'pazjent tipiku bil-CAPS li jiżen 70 kg.
English: In the overall SJIA programme, transient decreased white blood cell (WBC) counts ≤ 0.8 x LLN were reported in 33 patients (16.5%).
Maltese: Fil-programm sħiħ SJIA, kien irrappurtat tnaqqis temporanju fl-għadd taċ-ċelluli l-bojod fid-demm (WBC) ta' ≤ 0.8 x LLN fi 33 pazjent (16.5%).
English: Abnormal levels of triglycerides in your blood (lipid metabolism disorder).
Maltese: Livelli mhux normali tat-trigliċeridi fid-demm tiegħek (disturbi tal-metaboliżmu tal-lipidi).
English: Antibodies against Ilaris were observed in approximately 1.5%, 3% and 2% of the patients treated with Ilaris for CAPS, SJIA and gouty arthritis, respectively.
Maltese: Kien hemm antikorpi kontra Ilaris f'madwar 1.5%, 3% u 2% tal-pazjenti ttrattati b'Ilaris għall-CAPS, SJIA u artrite bil-gotta, rispettivament.
English: Overall study population; N=454
Maltese: Il-popolazzjoni sħiħa talistudju; N=454
English: Approximately one-third of the patients enrolled (76 [33.8%] in the canakinumab group and 84 [36.7%] in the triamcinolone acetonide group) had documented inability (intolerance, contraindication or lack of response) to use both NSAIDs and colchicine.
Maltese: Madwar terz tal-pazjenti rreġistrati (76 [33.8%] fil-grupp ta' canakinumab u 84 [36.7%] fil-grupp ta' triamcinolone acetonide) ma setgħux b'mod iddokumentat jużaw(intolleranza, kontraindikazzjoni jew nuqqas ta' rispons) kemm NSAIDs kif ukoll colchicine.
English: Hypersensitivity reactions have been reported in patients treated with canakinumab (see sections 4.3 and 4.4).
Maltese: Kienu rrappurtati reazzjonijiet ta' ipersensittività fost pazjenti ttrattati b'canakinumab (ara sezzjonijiet 4.3 u 4.4).
English: All patients who received non-live, standard of care childhood vaccinations (N=7) developed protective antibody levels.
Maltese: Il-pazjenti kollha li ngħataw vaċċini tat-tfulija mhux ħajjin u ta' standard ta' kura (N=7) żviluppaw livelli ta' antikorpi protettivi.
English: * human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology
Maltese: * antikorp monoklonali uman prodott f'ċelloli tal-majeloma Sp2/0 fil-ġrieden b'teknoloġija tat-tfassil tad-DNA
English: Apparent clearance (CL/F) in the TRAPS, HIDS/MKD and FMF population at body weight of 55 kg (0.14 l/d) was comparable to CAPS population at body weight of 70 kg (0.17 l/d).
Maltese: It-tneħħija apparenti (CL/F) fil-popolazzjoni bi TRAPS, HIDS/MKD u FMF b'piż ta' 55 kg (0.14 l/d) kien komparabbli mal-popolazzjoni bil-CAPS b'piż ta' 70 kg (0.17 l/d).
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-Rskju (RMP)
English: In study G2305, the Childhood Health Assessment Questionnaire Least Squares means improvement was 0.69 for canakinumab vs placebo representing 3.6 times the minimal clinically important difference of 0.19 (p=0.0002).
Maltese: Fl-istudju G2305, it-titjib medju taċ-Childhood Health Assessment Questionnaire Least Squares kien ta' 0.69 għal canakinumab kontra l-plaċebo li jirrappreżenta 3.6 drabi id-differenza minima importanti klinikament ta' 0.
English: Of the total 128 patients who entered Part I taking corticosteroids, 92 attempted corticosteroid tapering.
Maltese: Mit-total ta' 128 pazjent li daħlu f'Parti I u li qed jieħdu l-kortikosterojdi, 92 ippruvaw inaqqsu bilmod il-mod il-kortikosterojdi.
English: Opportunistic infections have been reported in patients treated with canakinumab (see section 4.4).
Maltese: Infezzjonijiet opportunistiċi kienu rrappurtati f'pazjenti ttrattati b'canakinumab (ara sezzjoni 4.4).
English: 9/l) and transient decreases in platelet counts were observed at a higher incidence (12.7%) with canakinumab in the active-controlled clinical studies versus the comparator (7.7%) in gouty arthritis patients.
Maltese: 9/l) u tranżitorju fl-ammonti tal-plejtlits b'aktar inċidenza (12.7%) b'canakinumab waqt studji kliniċi kkontrollati bl-attiv kontra l-komparatur (7.7%) f'pazjenti b'artrite bil-gotta.
English: A new flare was defined as a PGA score ≥ 2 (“mild, moderate, or severe disease”) and CRP ≥ 30 mg/l.
Maltese: Tħeġġiġ ġdid kien iddefinit bħala skor ta' ≥ 2 skont il-PGA (“marda ħafifa, moderata, jew gravi”) u CRP ta' ≥ 30 mg/l.
English: Other medicines and Ilaris
Maltese: Mediċini oħra u Ilaris
English: An additional pharmacokinetics analysis showed that the pharmacokinetics of canakinumab in 6 paediatric CAPS patients under the age of 2 years were similar to the pharmacokinetics in paediatric patients 2-4 years of age.
Maltese: Analiżi tal-farmakokinetika addizzjonali wriet li l-farmakokinetika ta' canakinumab f'6 pazjenti pedjatriċi bil-CAPS taħt is-sentejn kienet simili għall-farmakokinetika f'pazjenti ta' età minn 2-4 snin.
English: TRAPS, HIDS/MKD and FMF patients with body weight  7.5 kg and ≤ 40 kg
Maltese: Pazjenti bi TRAPS, HIDS/MKD u FMF b'piż ta'  7.5 kg u ≤ 40 kg
English: The efficacy observed in the studies G2305 and G2301 was maintained in the ongoing, open-label long-term extension study (data available through median of 49 weeks of follow-up).
Maltese: L-effikaċja osservata fl-istudji G2305 u G2301 nżammu fl-istudju kontinwu ta' estenzjoni, open-label u fit-tul (dejta disponibbli permezz tal-medja mid-49 ġimgħa sussegwenti).
English: Mean and median increases in alanine transaminase (ALT) of 3.0 U/l and 2.0 U/l, respectively, and in aspartate transaminase (AST) of 2.7 U/l and 2.0 U/l, respectively, from baseline to end of study were seen in the canakinumab-treated groups versus the triamcinolone acetonide-treated group(s), however the incidence of clinically significant changes (≥ 3 x the upper limit of normal) was greater for patients treated with triamcinolone acetonide (2.5% for both AST and ALT) compared with canakinumabtreated patients (1.6% for ALT and 0.8% for AST).
Maltese: U/l, rispettivament, mil-linja bażi sa tmiem l-istudju fil-gruppi kkurati b'canakinumab kontra l-grupp(i) ikkurat(i) bi triamcinolone acetonide, madanakollu l-inċidenza ta' tibdiliet sinjifikanti klinikament (≥ 3x l-ogħla limitu tan-normal) kienet akbar fost pazjenti kkurati bi triamcinolone acetonide (2.5% kemm għal AST u ALT) imqabbel ma' pazjenti ttrattati b'canakinumab (1.6% għal ALT u 0.8% għal AST).
English: There were 102 TRAPS, HIDS/MKD and FMF patients (2-17 years of age) who received canakinumab in a 16-week study.
Maltese: Kien hemm 102 pazjenti bi TRAPS, HIDS/MKD u FMF (bejn sentejn u 17-il sena) li ngħataw canakinumab waqt l-istudju ta' 16-il ġimgħa.
English: The mean terminal half-life was 26 days.
Maltese: Il-half-life terminali medja kienet ta' 26 jum.
English: Accordingly, Tmax was shorter (3.6 days) in younger SJIA patients (2-3 years) compared to older SJIA patients (12-19 years; Tmax 6 days).
Maltese: Għaldaqstant, it-Tmax kien iqsar (3.6 ġranet) fost l-iżgħar pazjenti b'SJIA (2-3 snin) imqabbel mal-pazjenti l-kbar b'SJIA (12-19-il sena; Tmax 6 ġranet).
English: A total of 243 CAPS patients (85 paediatric patients aged ≥ 2 to ≤ 17 years and 158 adult patients aged ≥ 18 years) were treated with canakinumab in routine clinical practice in a long-term registry study (mean of 3.8 years of canakinumab exposure).
Maltese: Total ta' 243 pazjent bil-CAPS (85 pazjent pedjatriċi li kellhom ≥ 2 sa ≤ 17-il sena u 158 pazjent adulti li kellhom ≥ 18-il sena) kienu ttrattati b'canakinumab waqt prattika klinika ta' rutina tul studju tar-reġistru fuq perjodu twil ta' żmien (medja ta' 3.8 snin ta' espożizzjoni għal canakinumab).
English: In Part I (open label) 177 patients were enrolled and received 4 mg/kg (up to 300 mg) canakinumab administered every 4 weeks for up to 32 weeks.
Maltese: F'Parti I (open label)177 pazjent issieħbu u ngħataw 4 mg/kg (sa 300 mg) canakinumab mogħtija kull 4 ġimgħat sa 32 ġimgħa.
English: Canakinumab had no effect on male fertility parameters in marmosets (C. jacchus).
Maltese: Canakinumab ma kellu l-ebda effett fuq il-parametri tal-fertilità fl-irġiel fost il-marmosets (C. jacchus).
English: A total of 225 patients were treated with subcutaneous canakinumab 150 mg and 229 patients were treated with intramuscular triamcinolone acetonide (TA) 40 mg at study entry, and when experiencing a new attack thereafter.
Maltese: Total ta' 225 pazjent kienu kkurati b'150 mg canakinumab minn taħt il-ġilda u 229 pazjent kienu kkurati b' 40 mg triamcinolone acetonide (TA) intramuskolari fil-bidu tal-istudju, u wara kull meta esperjenzaw attakk ġdid.
English: Abnormal kidney function test results (creatinine renal clearance decreased, proteinuria).
Maltese: Riżultati mhux normali tat-test tal-funzjoni tal-kliewi (tnaqqis fit-tneħħija tal-kreatinina millkliewi, proteinurija).
English: Unable to use both NSAIDs and colchicine; on ULT N=62 Treatment of gouty arthritis attacks as measured by pain intensity (VAS) at 72 h Least Squares mean estimated difference to triamcinolone acetonide CI p-value, 1-sided p < 0.0001*
Maltese: Li ma setgħux jużaw kemm NSAIDs kif ukoll colchicine; fuq kura b'ULT N=62 Kura ta' attakki ta' artrite bil-gotta mkejla permezz tal-intensità tal-uġigħ (VAS) fit-72 siegħa Stima tad-differenza medja b'Least Squares għal triamcinolone acetonide CI valur-p, 1-sided p < 0.0001*
English: There were 80 paediatric CAPS patients (2-17 years of age) who received canakinumab in the interventional studies.
Maltese: Kien hemm 80 pazjent pedjatriku bil-CAPS (ta' bejn sentejn u 17-il sena) li ngħataw canakinumab flistudji intervenzjonali.
English: - Still's disease including adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) - Gouty arthritis
Maltese: - Il-marda ta' Still inkluż il-marda ta' Still li toħroġ fl-adulti (AOSD - Adult-Onset Still's Disease) u artrite idjopatika ġovanili sistematika (SJIA) - Artrite tal-gotta
English: Ilaris 150 mg/ml injection canakinumab SC
Maltese: Ilaris 150 mg/ml injezzjoni canakinumab