FrancophonIA/ELRC3.0 huggingface dataset:
English: Ilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate (see section 5.1).
Maltese: Ilaris hu indikat għat-trattament sintomatiku ta' pazjenti adulti b'attakki frekwenti ta' artrite bil-gotta (mill-inqas 3 attakki fl-aħħar 12-il xahar) li għalihom mediċini mhux sterojdi antiinfjammatorji (NSAIDs) u colchicine huma kontraindikati, mhumiex ittollerati, jew ma jipprovdux rispons xieraq, u li għalihom korsijiet ripetuti ta' kortikosterojdi mhumiex xierqa (ara sezzjoni 5.1).
English: Efficacy results in a subgroup of patients unable to use both NSAIDs and colchicine and who were on ULT, failed ULT or had a contraindication to ULT (N=101) were consistent with the overall study population with a statistically significant difference compared to triamcinolone acetonide in pain intensity at 72 hours (-10.2 mm, p=0.0208) and in reduction of risk of subsequent attacks (Hazard ratio 0.39, p=0.0047 at 24 weeks).
Maltese: Ir-riżultati ta' effikaċja f'sottogrupp ta' pazjenti mhux kapaċi li jużaw kemm NSAIDs u colchicine u li kienu fuq ULT, fallew kura b'ULT jew kellhom kontraindikazzjoni għal ULT (N=101) kienu konsistenti mal-istudju tal-popolazzjoni sħiħa b'differenza sinifikanti b'mod statistiku meta mqabbla ma' triamcinolone acetonide fl-intensita` tal-uġigħ wara 72 siegħa (-10.2 mm, p=0.0208) u fit-tnaqqis tar-riskju ta' attakki sussegwenti (Proporzjon ta' periklu 0.39, p=0.0047 fl-24 ġimgħa).
English: Table 4 Paediatric ACR response and disease status at days 15 and 29
Maltese: Tabella 4 Rispons tal-ACR pedjatriku u l-istatut tal-marda fil-15 u d-29 ġurnata
English: p=0.2798 Risk reduction of subsequent gouty arthritis attacks as measured by time to first new flare (24 weeks)
Maltese: p=0.2798 Tnaqqis fir-riskju ta' attakki sussegwenti ta' artrite bil-gotta mkejla permezz taż-żmien salewwel attakk ġdid (24 ġimgħa)
English: Not included in the pack one vial (or ampoule) of sterile water for injections (“water”) (at room temperature) one 1.0 ml syringe one 18 G x 2 inch (50 mm) needle for reconstituting the powder (“transfer needle”) one 27 G x 0.5 inch (13 mm) needle for injecting (“injection needle”) alcohol swabs clean, dry cotton swabs an adhesive plaster a proper disposal container for used needles, syringe and vials (sharps container)
Maltese: X'ma fihx dan il-pakkett kunjett wieħed (jew ampulla) b'ilma sterili għall-injezzjonijiet (“ilma”) (f'temperatura talkamra) siringa waħda ta' 1.0 ml labra ta' 18 G x 2 pulzieri (50 mm) għar-rikostituzzjoni tat-trab (“labra għat-trasferiment”) labra ta' 27 G x 0.5 pulzieri (13-il mm) għall-injezzjoni (“labra għall-injezzjoni”) gareż bl-alkoħol gareż nodfa u xotti stikka kontenitur xieraq fejn tarmi labar, siringi u kunjetti użati (kontenitur għall-affarijiet bix-xifer jew bil-ponta)
English: The mean number of gouty arthritis attacks in the previous 12 months was 6.5.
Maltese: In-numru medju ta' attakki ta' artrite bil-gotta fit-12-il xahar ta' qabel kien ta' 6.5.
English: Ilaris contains the active substance canakinumab, a monoclonal antibody that belongs to a group of medicines called interleukin inhibitors.
Maltese: Ilaris fih is-sustanza attiva canakinumab, antikorp monoklonali li jappartjeni għal grupp ta' mediċini msejħa inibituri ta' interleukin.
English: In approximately 12% of CAPS patients tested with a PPD (purified protein derivative) skin test in clinical trials, follow-up testing yielded a positive test result while treated with canakinumab without clinical evidence of a latent or active tuberculosis infection.
Maltese: Minn testijiet li komplew isiru f'pazjenti bil-CAPS li sarilhom it-test tad-PPD (derivattiv tal-proteina ppurifikata) tal-ġilda waqt provi kliniċi ħareġ li, f'madwar 12% tagħhom kien hemm riżultat pożittiv tat-test huma u jingħataw il-kura b'canakinumab mingħajr ma kien hemm evidenza klinika ta' infezzjoni ta' tuberkulosi rieqda jew attiva.
English: SJIA in young adults and AOSD
Maltese: SJIA f'adulti żgħażagħ u AOSD
English: OTHER
Maltese: II)
English: In the long-term, open-label studies with dose escalation, events of infections (gastroenteritis, respiratory tract infection, upper respiratory tract infection), vomiting and dizziness were more frequently reported in the 600 mg or 8 mg/kg dose group than in other dose groups.
Maltese: Fi studji open-label fit-tul b'dawk iż-żidiet, l-episodji ta' infezzjonijiet (gastroenterite, infezzjoni talapparat respiratorju, infezzjoni tal-parti ta' fuq tal-apparat respiratorju), rimettar u sturdament kienu rrappurtati b'aktar frekwenza fil-grupp mogħti dożi ta' 600 mg jew 8 mg/kg milli fi gruppi mogħtija dożi oħrajn.
English: Adult-onset Still's disease and systemic juvenile idiopathic arthritis are severe autoinflammatory diseases, driven by innate immunity by means of pro-inflammatory cytokines, a key one being IL-1beta.
Maltese: Il-marda ta' Still li toħroġ fl-adulti u l-artrite idjopatika ġovanili sistematika huma mard awtoinfjammatorja gravi, riżultat ta' immunità innata minħabba ċitokini proinfjammatorji, fosthom ewlieni IL-1-beta.
English: In patients with periodic fever syndromes (CAPS, TRAPS, HIDS/MKD and FMF), the body produces too much IL-1 beta.
Maltese: F'pazjenti b'sindromi perjodiċi ta' deni (CAPS, TRAPS, HIDS/MKD u FMF), il-ġisem jipproduċi wisq IL-1 beta.
English: In clinical studies, CAPS, TRAPS, HIDS/MKD and FMF patients who have uncontrolled overproduction of IL-1 beta show a rapid and sustained response to therapy with canakinumab, i.e. laboratory parameters such as high C-reactive protein (CRP) and serum amyloid A (SAA), high neutrophil and platelet counts, and leukocytosis rapidly returned to normal.
Maltese: Waqt studji kliniċi, pazjenti bil-CAPS, TRAPS, HIDS/MKD u FMF li jipproduċu b'mod eċċessiv u bla kontroll l-IL-1 beta, urew li jirrispondu malajr u b'mod sostenibbli għal terapija b'canakinumab, jiġifieri l-parametri tal-laboratorju bħal ma huma l- livelli għoljin tal-proteina reattiva għal C (CRP) u tal-amilojd fis-serum A (SAA), l-għadd għoli ta' newtrofils u plejtlits, u l-lewkoċitosi malajr marru lura għan-normal.
English: In the overall SJIA programme, high ALT and/or AST > 3 x upper limit of normal (ULN) were reported in 19 patients (9.5%).
Maltese: Fil-programm sħiħ SJIA, kienu rrappurtati ALT u/jew AST għolja ta' > 3 x l-ogħla limitu tan-normal (ULN) f'19-il pazjent (9.5%).
English: Decreases in absolute neutrophil counts (ANC) to less than 1 x 10
Maltese: Kien irrappurtat tnaqqis fl-ammonti assoluti ta' newtrofili (ANC) ta' anqas minn 1 x 10
English: Active, severe infections (see section 4.4).
Maltese: Infezzjonijiet attivi, qawwija (ara sezzjoni 4.4).
English: At day 15, the median change from baseline in the number of joints with active arthritis and limited range of motion were -67% and -73% for canakinumab (N=43), respectively, compared to a median change of 0% and 0% for placebo (N=41).
Maltese: Fil-15-il jum, il-bidla medja mil-linja bażi fl-għadd ta' ġogi b'artrite attiva u l-firxa limitata ta' moviment kienu ta' -67% u ta' -73% għal canakinumab (N=43), rispettivament, imqabbla mal-bidla medja ta' 0% u ta' 0% għall-plaċebo (N=41).
English: Set the syringe aside.
Maltese: Infezzjonijiet ta' kull xorta.
English: Treatment with Ilaris may result in dizziness/vertigo or asthenia (see section 4.8).
Maltese: It-trattament b'Ilaris jista' jwassal għal sturdament/vertigo jew astenja (ara sezzjoni 4.8).
English: The risk for the development of malignancies with anti-interleukin (IL)-1 therapy is unknown.
Maltese: Mhuwiex magħruf irriskju li jiżviluppaw tumuri malinni riżultat ta' terapija b'anti-interleukin (IL)-1.
English: Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during canakinumab treatment.
Maltese: Każijiet iżolati ta'infezzjonijiet mhux tas-soltu jew opportunistiċi (inkluż asperġillożi, infezzjonijiet mikobatteriċi atipiċi, herpes zoster) kienu rrappurtati waqt it-trattament b'canakinumab.
English: • 2 mg/kg for patients with body weight ≥ 15 kg and ≤ 40 kg
Maltese: • 2 mg/kg għal pazjenti li jiżnu bejn 15 kg u 40 kg
English: Heartburn (gastro-oesophageal reflux disease).
Maltese: Ħruq fl-istonku (il-marda tar-rifluss gastroesofagali).
English: Also contains: sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80.
Maltese: Fih ukoll: sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80.
English: UNIT PACK CARTON
Maltese: KARTUNA INTERMEDJA TAL-PAKKETTI
English: A total of 324 SJIA patients aged 2 to < 20 years have received Ilaris in interventional clinical trials, including 293 patients aged 2 to < 16 years old, 21 patients aged 16 to < 18 years old and 10 patients aged 18 to < 20 years old.
Maltese: Total ta' 324 pazjent b'SJIA li għandhom minn sentejn sa < 20 sena ngħataw Ilaris waqt provi intervenzjonali klinikament, li jinkludu 293 pazjent li għandhom minn sentejn sa < 16-il sena, 21 pazjent li għandhom minn 16 sa < 18-il sena u 10 pazjenti li għandhom minn 18 sa < 20 sena. Leffikaċja u s-sigurtà ta' canakinumab f'pazjenti adulti żgħażagħ b'SJIA li għandhom minn 16 sa 20 sena kienu konsistenti mal-effikaċja u s-sigurtà osservati għal pazjenti b'età inqas minn 16-il sena.
English: CI p-value, 1-sided p < 0.0001*
Maltese: Proporzjon ta' periklu għal triamcinolone acetonide CI valur-p, 1-sided p < 0.0001*
English: Decreased white blood cell counts (WBC) ≤ 0.8 x lower limit of normal (LLN) were reported in 6.7% of patients treated with canakinumab compared to 1.4% treated with triamcinolone acetonide.
Maltese: Kien irrappurtat tnaqqis fl-ammont ta' ċelloli bojod tad-demm (WBC) ta' ≤ 0.8x il-limitu l-aktar baxx tan-normal (LLN) f'6.7% tal-pazjenti ttrattati b'canakinumab imqabbel mal-1.4% kkurati b'triamcinolone acetonide.
English: In active-controlled gouty arthritis trials, there was a mean increase in triglycerides of 33.5 mg/dl in canakinumab-treated patients compared with a modest decrease of -3.1 mg/dl with triamcinolone acetonide.
Maltese: Waqt provi kkontrollati bl-attiv fost pazjenti b'artrite bil-gotta, kien hemm żieda medja fit-trigliċeridi ta' 33.5 mg/dl fil-pazjenti kkurati b'canakinumab imqabbel mat-tnaqqis ċkejken ta' -3.1 mg/dl bi triamcinolone acetonide.
English: This is clinically relevant for CYP450 substrates with a narrow therapeutic index where the dose is individually adjusted.
Maltese: Dan huwa klinikament rilevanti għas-substrati ta' CYP450 b'indiċi terapewtiċi stretti fejn id-doża tiġi aġġustata b'mod individwali.
English: Packs containing 1 vial or multipacks containing 4 (4x1) vials.
Maltese: Pakketti li fihom kunjett wieħed jew pakketti b'ħafna li fihom 4 (4x1) kunjetti.
English: Warning and precautions
Maltese: Għeja/astenja
English: TRAPS, HIDS/MKD and FMF patients with body weight > 40 kg
Maltese: Pazjenti bi TRAPS, HIDS/MKD u FMF b'piż ta' > 40 kg
English: Using aseptic technique, reconstitute each vial of canakinumab at room temperature (typically 15°C to 25°C) by slowly injecting 1 ml water for injections with a 1 ml syringe and an 18 G x 2 inch (50 mm) needle.
Maltese: Filwaqt li tuża teknika asettika, irrikostitwixxi kull kunjett ta' canakinumab f'temperatura tal-kamra (tipikament 15°C sa 25°C) billi b'siringa ta' 1 ml u b'labra ta' 18 G x 2 pulzieri (50 mm) tinjetta bilmod 1 ml ilma għal injezzjonijiet.
English: Safety results showed an increased incidence of adverse events for canakinumab compared to triamcinolone acetonide, with 66% vs 53% of patients reporting any adverse event and 20% vs 10% of patients reporting an infection adverse event over 24 weeks.
Maltese: Riżultat dwar sigurtà urew żieda fl-inċidenza ta' episodji avversi għal canakinumab meta mqabbel ma' triamcinolone acetonide, b'66% vs 53% tal-pazjenti jirrappurtaw xi episodju avvers u 20% vs 10% tal-pazjenti jirrappurtaw episodju avvers ta' infezzjoni fuq perjodu ta' 24 ġimgħa.
English: Long term data from observational study
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: • Cryopyrin-associated periodic syndromes (CAPS),
Maltese: • Sindromi perjodiċi assoċjati mal-Cryopyrin (CAPS),
English: A gouty arthritis attack is caused by urate (monosodium urate monohydrate) crystals in the joint and surrounding tissue, which trigger resident macrophages to produce IL-1 beta via the “NALP3 inflammasome” complex.
Maltese: Attakk ta' artrite bil-gotta jiġi kkawżat permezz tal-kristalli tal-urat (urat monosodiku monoidrat) filġog u fit-tessut tal-madwar, li jattivaw il-makrofagi residenti biex jipproduċu IL-1 beta permezz tal-kumpless “NALP3 inflammasome”.
English: Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).
Maltese: Ilaris hu indikat għat-trattament tas-sindromu tal-iperimmunoglobulina D (HIDS)/defiċjenza ta' mevalonate kinasi (MKD).
English: - Tumour necrosis factor receptor associated periodic syndrome (TRAPS) - Hyperimmunoglobulin D syndrome (HIDS) also known as mevalonate kinase deficiency (MKD) - Familial Mediterranean fever (FMF): Ilaris is used to treat FMF.
Maltese: - Is-sindromu perjodiku assoċjat mar-riċettur tal-fattur tan-nekrożi tat-tumur (TRAPS) - Is-sindromu tal-iperimmunoglobulina D (HIDS) magħrufa wkoll bħala defiċjenza ta' mevalonate kinasi (MKD) - Id-deni Mediterranju familjari (FMF): Ilaris jintuża biex jittratta FMF.
English: The pivotal study consisted of a 48-week three-part multicentre study, i.e. an 8-week open-label period (Part I), a 24-week randomised, double-blind, placebo-controlled withdrawal period (Part II), followed by a 16-week open-label period (Part III).
Maltese: L-istudju pivitali kien jikkonsisti fi studju multiċentriku mifrux fuq tliet partijiet u mqassam fuq 48 ġimgħa, jiġifieri perjodu open-label ta' 8 ġimgħat (Parti I), perjodu ta' waqfien randomised, double-blind u kkontrollat bil-plaċebo ta' 24 ġimgħa (Parti II), u wara perjodu open-label ta' 16il ġimgħa (Parti
English: CAPS in children 2-< 4 years of age or children  4 years of age  7.5 kg and < 15 kg
Maltese: CAPS fi ffal bejn sentejn u < 4 snin jew tfal  4 snin  7.5 kg u < 15 kg
English: The co-primary endpoints were: (i) gouty arthritis pain intensity (visual analogue scale, VAS) at 72 hours post-dose, and (ii) time to first new gouty arthritis attack.
Maltese: L-endpoinds koprimarji kienu: (i) artrite bil-gotta b'uġigħ qawwi (skala analoga viżwali, VAS) 72 siegħa wara l-għoti tad-doża, u (ii) il-ħin sal-ewwwel attakk ġdid ta' artrite bil-gotta.
English: Although ≥ Grade 2 reductions in neutrophil count occurred in 6.5% of patients (common) and Grade 1 reductions occurred in 9.5% of patients, the reductions are generally transient and neutropenia-associated infection has not been identified as an adverse reaction.
Maltese: Minkejja tnaqqis ta' ≥ Grad 2 fl-għadd ta' newtrofili li seħħ f'6.5% tal-pazjenti (komuni) u ta' tnaqqis fi Grad 1 li seħħ f'9.5% tal-pazjenti, it-tnaqqis hu ġeneralment temporanju u l-infezzjoni assoċjata man-newtropenija ma ġietx identifikata bħala reazzjoni mhux mixtieqa.
English: Mild and transient Grade 1 reduction in platelets occurred in 15.9% of patients without any associated bleeding adverse events.
Maltese: Tnaqqis ħafif u tranżitorju fi Grad 1 fil-plejtlis seħħ fi 15.9% tal-pazjenti mingħajr ebda episodju mhux mixtieq ta' fsada assoċjata ma'dan.
English: The efficacy and safety of canakinumab have been demonstrated in a total of 211 adult and paediatric patients with varying degrees of disease severity and different CAPS phenotypes (including FCAS/FCU, MWS, and NOMID/CINCA).
Maltese: L-effikaċja u s-sigurtà ta' canakinumab dehru f'total ta' 211-il pazjent adulti u pedjatriċi b'firxa sħiħa fejn tidħol il-gravità tal-marda u b'fenotipi differenti tal-CAPS (fosthom b'FCAS/FCU, b'MWS, u b'NOMID/CINCA).
English: Ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) including:
Maltese: Ilaris huwa indikat għall-kura tas-sindromi perjodiċi assoċjati mal-cryopyrin (CAPS)fosthom:
English: • Respiratory infections such as chest infection, flu, sore throat, runny nose, blocked nose, sneezing, feeling of pressure or pain in the cheeks or forehead with or without fever (pneumonia, bronchitis, influenza, sinusitis, rhinitis, pharyngitis, tonsilitis, nasopharyngitis, upper respiratory tract infection).
Maltese: • Infezzjonijiet respiratorji bħalma huma infezzjoni fis-sider, influwenza, griżmejn misluħin, imnieħer iqattar, imnieħer misdud, għatis, tħoss pressjoni jew uġigħ f'ħaddejk jew fuq xbinek bid-deni jew le (pnewmonja, bronkite, influwenza, sinusite, rinite, farinġite, tonsillite, nażofarinġite, infezzjoni fil-parti ta' fuq tal-apparat respiratorju).
English: Isolated cases of ANC counts < 0.5 x 10
Maltese: Kienu osservati wkoll każijiet iżolati ta' ammonti ANC ta' < 0.5 x 10
English: Do not shake.
Maltese: Titrazzjoni 'l fuq
English: Laboratory abnormalities in TRAPS, HIDS/MKD and FMF patients Neutrophils
Maltese: Anormalitajiet tal-laboratorju f'pazjenti bi TRAPS, HIDS/MKD u FMF Newtrofili
English: • Neonatal-onset multisystem inflammatory disease (NOMID), also called chronic infantile neurological, cutaneous, articular syndrome (CINCA),
Maltese: • Is-sindromu ta' Muckle-Wells (MWS),Il-marda ta' infjammazzjoni multisistemika li tibda mit-twelid (NOMID), magħrufa wkoll bħala s-sindromu kroniku infantili newroloġiku, tal-ġilda u artikulari (CINCA),
English: Fifty-seven (62%) of the 92 patients who attempted to taper were able to successfully taper their corticosteroid dose and 42 (46%) discontinued corticosteroids.
Maltese: Sebgħa u ħamsin (62%) mit-92 pazjent li ppruvaw inaqqsu bil-mod ilmod il-kortikosterojdi kienu kapaċi li jnaqqsu b'suċċess id-doża tal-kortikosterojdi u 42 (46%) waqqfu għal kollox il-kortikosterojdi.
English: Uncap the transfer needle again.
Maltese: Aqla' l-labra għat-trasferiment mis-siringa.
English: Fewer patients aged 2 to < 4 years achieved complete response (57.1%) than older paediatric and adult patients.
Maltese: Kien hemm ftit anqas pazjenti li kellhom bejn sentejn u < 4 snin kellhom rispons sħiħ (57.1%) minn pazjenti pedjatriċi akbar u adulti.
English: Study G2305 was a randomised, double-blind, placebo-controlled, 4-week study assessing the shortterm efficacy of canakinumab in 84 patients randomised to receive a single dose of 4 mg/kg (up to 300 mg) canakinumab or placebo.
Maltese: L-istudju G2305 kien studju ta' 4 ġimgħat, randomizzat, double-blind, ikkontrollat bi plaċebo u li jevalwa l-effikaċja fi żmien qasir ta' canakinumab f'84 pazjent magħżula b'mod randomizzat biex jirċievu doża singola ta' 4mg/kg (sa 300 mg) canakinumab jew plaċebo.
English: The study included 243 CAPS patients (including 85 patients less than 18 years of age).
Maltese: L-istudju kien jinkludi 243 pazjent bil-CAPS (inkluż 85 pazjent li kellhom anqas minn 18-il sena).
English: Treatment with canakinumab resulted in a rapid and sustained improvement of both the articular and the systemic features of SJIA with significant reduction of the number of inflamed joints, prompt resolution of fever and reduction of acute phase reactants in the majority of patients (see Clinical efficacy and safety).
Maltese: Trattament b'canakinumab wassal għal titjib rapidu u sostenibbli kemm talfatturi artikulari u sistemiċi ta' SJIA fi tnaqqis qawwi fl-għadd ta' ġogi infjammati, fejqan minnufih tad-deni u tnaqqis ta' reatturi waqt il-fażi akuta fil-biċċa l-kbira tal-pazjenti (ara Effikaċja klinika u sigurtà).
English: Of the patients in clinical remission who continued with further dose reduction (1 mg/kg every 4 weeks) or dose interval prolongation (4 mg/kg every 12 weeks), 93% (26/28) and 91% (30/33) of patients, respectively, were able to maintain inactive disease status for 6 months.
Maltese: Mill-pazjenti f'remissjoni klinika li baqgħu għaddejjin b'aktar tnaqqis fid-doża (1 mg/kg kull 4 ġimgħat) jew b'intervall itwal bejn doża u oħra (4 mg/kg kull 12-il ġimgħa), 93% (26/28) u 91% (30/33) tal-pazjenti, rispettivament, kienu kapaċi jżommu qagħda inattiva tal-marda għal 6 xhur.
English: Tumour necrosis factor receptor associated periodic syndrome (TRAPS) Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).
Maltese: Ilaris hu indikat għat-trattament tas-sindromu perjodiku assoċjat mar-riċettur tal-fattur tan-nekrożi tattumur (TNF) (TRAPS).
English: Tuberculosis screening
Maltese: Ittestjar għat-tuberkulożi
English: The recommended dose of Ilaris for patients with Still's disease (AOSD or SJIA) with body weight of 7.5 kg and above is 4 mg/kg (up to a maximum of 300 mg).
Maltese: Id-doża rrakkomandata ta' Ilaris għal pazjenti bil-marda ta' Still (AOSD jew SJIA) b'piż ta' 7.5 kg u aktar hi ta' 4 mg/kg (sa massimu ta' 300 mg).
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda f'kull 100):
English: Seventy five patients aged 2 to 22 years who maintained inactive disease status for at least 6 consecutive months (clinical remission) with canakinumab monotherapy, including patients who were able to maintain inactive disease status with discontinuation of concomitant corticosteroid and/or methotrexate use for at least 4 weeks, were randomised to receive canakinumab 2 mg/kg every 4 weeks (N=38) or canakinumab 4 mg/kg every 8 weeks (N=37).
Maltese: Ħamsa u sebgħin pazjent li kellhom bejn sentejn u 22 sena li żammew qagħda inattiva talmarda għal mill-inqas 6 xhur wara xulxin (remissjoni klinika) b'monoterapija b'canakinumab, li kienu jinkludu pazjenti li kienu kapaċi jżommu qagħda inattiva tal-marda wara li waqqfu l-użu flimkien ta' kortikosterojdi u/jew methotrexate għal mill-inqas 4 ġimgħat, kienu randomizzati sabiex jingħataw canakinumab 2 mg/kg kull 4 ġimgħat (N=38) jew canakinumab 4 mg/kg kull 8 ġimgħat (N=37).
English: Vulvovaginal candidiasis Nervous system disorders Common
Maltese: Disturbi fis-sistema nervuża Komuni
English: It is unknown whether the use of interleukin-1 (IL-1) inhibitors such as canakinumab increases the risk of reactivation of tuberculosis.
Maltese: Mhuwiex magħruf jekk l-użu ta' inibituri ta' interleukin-1 (IL-1) bħal canakinumab iżidx ir-riskju ta' riattivazzjoni tat-tuberkulosi.
English: Canakinumab also reduced the risk of subsequent attacks (see Table 5).
Maltese: Canakinumab naqqas ukoll ir-riskju ta' attakki sussegwenti (ara Tabella 5).
English: Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:
Maltese: Ilaris hu indikat għat-trattament tas-sindromi perjodiċi ta' deni awtoinfjammatorju li ġejjin f'adulti, adolexxenti u tfal li għandhom sentejn jew aktar:
English: Treatment of CAPS, TRAPS, HIDS/MKD, FMF and Still's disease (AOSD and SJIA) Canakinumab should not be initiated or continued in patients during an active infection requiring medical intervention.
Maltese: Trattament ta' CAPS, TRAPS, HIDS/MKD, FMF u l-marda ta' Still (AOSD u SJIA) Canakinumab m'għandux jinbeda jew jitkompla f'pazjenti matul infezzjoni attiva li titlob intervent mediku.
English: Patients taking canakinumab in Part II had a 64% reduced risk of a flare event as compared to the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75; p=0.0032).
Maltese: Pazjenti li jieħdu canakinumab f'Parti II kellhom 64% tnaqqis fir-riskju li l-kundizzjoni terġa' titħeġġeġ imqabbel mal-grupp mogħti l-plaċebo (proporzjon ta' periklu ta' 0.36; 95% CI: 0.17 sa 0.75; p=0.0032). Tlieta u sittin mill-100 pazjent li daħlu f'Parti II, kemm jekk mogħtija plaċebo jew canakinumab, ma kellhomx tħeġġiġ wara l-perjodu ta' osservazzjoni (sa massimu ta' 80 ġimgħa).