FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors, ATC code: L04AC03
Maltese: Immunosoppressant, inibituri ta' interleukin, Kodiċi ATC:
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 definiti skond il-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
English: Normally, your body produces a protein that blocks the harmful effects of interleukin-1.
Maltese: Normalment, ġismek jipproduċi proteina li timblokka l-effetti ħżiena ta' interleukin-1.
English: Mean (SD) estimates of clearance (CL/F) and volume of distribution (Vd/F) by population analysis of data from two PK studies in 35 RA patients were 105(27) ml/min and 18.5(11) l, respectively.
Maltese: Stimi medji (SD) tat-tneħħija (CL/F) u l-volum tad-distribuzzjoni (Vd/F) skont analiżi ta' popolazzjoni ta' dejta minn żewġ studji farmakokinetiċi f'35 pazjent b'RA kienu ta' 105(27) mL/min u ta' 18.5(11) L, rispettivament.
English: - Thrombocytopenia (low level of blood platelets).
Maltese: - Tromboċitopenja (livell baxx ta' plejtlits fid-demm).
English: Anakinra inhibits responses elicited by IL-1 in vitro, including the induction of nitric oxide and prostaglandin E2 and/or collagenase production by synovial cells, fibroblasts, and chondrocytes.
Maltese: Anakinra jinibixxi r-rispons ikkawżat minn IL-1 in vitro, inkluż l-induzzjoni ta' nitric oxide u prostaglandin E2 u/jew il produzzjoni ta' collagenase miċ-ċelluli sinovjali, fibroblasts u kondroċiti.
English: The influence of demographic covariates on the pharmacokinetics of anakinra was studied using population pharmacokinetic analysis encompassing 341 patients receiving daily subcutaneous injection of anakinra at doses of 30, 75, and 150 mg for up to 24 weeks.
Maltese: L-influwenza ta' kovarjanti demografiċi fuq il-farmakokinetika ta' anakinra ġiet studjata permezz ta' analiżi farmakokinetika ta' popolazzjoni ta' 341 pazjent li kienu qed jirċievu injezzjoni taħt il-ġilda kuljum ta' anakinra f'dożi ta' 30, 75, u 150 mg sa 24 ġimgħa.
English: Other anti-rheumatic therapies have been associated with hepatitis B reactivation.
Maltese: Terapiji anti-rewmatiċi oħra kienu assoċjati ma' riattivazzjoni tal-epatite B.
English: In clinical trials, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory medicinal products, glucocorticoids, and DMARDs) have not been observed.
Maltese: Fi studji kliniċi, ma ġewx osservati interazzjonijiet bejn Kineret u prodotti mediċinali oħra (inkluż prodotti mediċinali kontra l-infjammazzjoni li mhumiex sterojdi, glukokortikojdi, u DMARDs).
English: Adverse events data in patients with Still's disease is based on a partially open-label and partially blinded, placebo-controlled study of 15 SJIA patients, treated for up to 1.5 years.
Maltese: Data ta' avvenimenti avversi f'pazjenti bil-marda ta' Still hija bbażata fuq studju kkontrollat bilplaċebo parzjalment open-label u parzjalment blinded, ta' 15-il pazjent b'SJIA, ittrattati sa 1.5 snin.
English: * Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in Escherichia coli cells by recombinant DNA technology.
Maltese: *Antagonist tar-riċettur ta' interleukin-1 uman (r-metHuIL-1ra) magħmul b'teknoloġija tad-DNA rikombinanti f'ċelluli ta' Escherichia coli.
English: Non-infectious hepatitis
Maltese: Epatite mhux infettiva
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-klassi tal-organi tas-sistema MedDRA u l-kategorija ta' frekwenza.
English: Eleven serious events in 4 (9.3%) patients were considered related to Kineret.
Maltese: Ħdax-il avvenimenti serju f'4 (9.3%) pazjenti kienu meqjusa relatati ma' Kineret.
English: Accordingly, the decrease in clearance is most likely explained by a decrease in renal function in this population.
Maltese: Għaldaqstant, it-tnaqqis fit-tneħħija huwa probabbilment spjegatb'indeboliment fil-funzjoni renali f'din il-popolazzjoni.
English: Treatment with Kineret resulted in normalization of body temperature in 18 of 20 patients.
Maltese: It-trattament b'Kineret wassal għal normalizzazzjoni tat-temperatura tal-ġisem fi 18 minn 20 pazjent.
English: 0.67 ml of solution for injection in a graduated pre-filled syringe (Type I glass) with a plunger stopper (bromobutyl rubber) and 29 gauge needle.
Maltese: 0.67 mL ta' soluzzjoni għall-injezzjoni ġo siringa (Ħġieġ ta' Tip I) mimlija għal-lest b'tapp planġer (lastku bromobutyl) u labra ta' gejġ 29.
English: Distribution into the cerebrospinal fluid has been demonstrated.
Maltese: Distribuzzjoni fil-fluwidu ċerebrospinali intweriet.
English: The plasma concentration decreased with no discernible distribution phase and the terminal half-life ranged from 4 to 6 hours.
Maltese: Il-konċentrazzjoni tal-plasma naqset mingħajr ebda fażi ta' distribuzzjoni li tintgħaraf u l-half-life terminali kienet minn 4 sa 6 sigħat.
English: Neutropenia (ANC < 1.5 x 109/l) was reported in 2.4% patients receiving Kineret compared with 0.4% of placebo patients.
Maltese: Newtropenija (ANC < 1.5 x 109/L) kienet irrapportata f'2.4% tal-pazjenti li rċevew Kineret meta mqabbel ma' 0.4% tal-pazjenti li ngħataw plaċebo.
English: This would be clinically relevant for CYP450 substrates with a narrow therapeutic index (e.g. warfarin and phenytoin).
Maltese: Dan ikun klinikament rilevanti għal substrati ta' CYP450 li għandhom indiċi terapewtiku dejjaq (eż. warfarin u phenytoin).
English: Placebo treatment (n=213) resulted in a decrease of approximately 2.2% in total cholesterol levels at week 2 and 2.3% at week 24.
Maltese: 2.2% fil-livelli totali tal-kolesterol fil-ġimgħa 2 u 2.3% fil-ġimgħa 24.
English: At 1 year follow-up, 18 of 20 patients showed at least an adapted ACRpedi 70 response, and 17 of 20 patients reached an adapted ACRpedi 90 response as well as inactive disease.
Maltese: Wara segwitu ta' sena, 18 minn 20 pazjent urew mill-inqas rispons ACRpedi 70 adattat, u 17 minn 20 pazjent laħqu rispons ACRpedi 90 adattat kif ukoll marda inattiva.
English: Combined anakinra and methotrexate treatment demonstrates a statistically and clinically significant reduction in the severity of the signs and symptoms of RA in patients who have had an inadequate response to methotrexate alone (38% vs. 22% responders as measured by ACR20 criteria).
Maltese: Kura b'anakinra u methotrexate flimkien turi tnaqqis statistikament u klinikament sinifikanti fil qawwa tas-sinjali u s-sintomi ta' RA f'pazjenti li kellhom rispons mhux adegwat għal methotrexate waħdu (38% vs. 22% tal-pazjenti li rrispondew, imkejla skont il-kriterju ACR20).
English: This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża ta' 100 mg, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The absolute bioavailability of anakinra after a 70 mg subcutaneous bolus injection in healthy subjects (n = 11) is 95%.
Maltese: Il-bijodisponibilità assoluta ta' anakinra wara injezzjoni bolus ta' 70 mg taħt il-ġilda f'pazjenti b'saħħithom (n = 11) hi ta' 95%.
English: MedDRA Organ System Frequency
Maltese: Sistema tal-Organi
English: A rapid and sustained decrease in the levels of the inflammatory biomarkers; serum amyloid A (SAA), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), and a normalization of inflammatory hematological changes are seen.
Maltese: Jidher tnaqqis mgħaġġel u sostnut fil-livelli tal-bijomarkaturi infjammatorji; amilojde serum A (SAA), il-proteina reattiva-C (CRP) u r-rata ta' sedimentazzjoni tal-eritroċiti (ESR), u normalizzazzjoni ta' bidliet ematoloġiċi infjammatorji.
English: RA: The efficacy of Kineret in children with RA (JIA) aged 0 to 18 years has not been established.
Maltese: RA: L-effikaċja ta' Kineret fit-tfal b'RA (JIA) minn età ta' 0 sa 18-il sena għadha ma ġietx determinata s'issa.
English: Kineret should be used with caution in patients with moderate renal impairment (CLcr 30 to 59 ml/min).
Maltese: Kineret għandu jintuża b'attenzjoni f'pazjenti b'indeboliment moderat tal-kliewi (CLcr 30 sa 59 mL/min).
English: Equipment:
Maltese: CAPS:
English: The majority of CAPS patients in Study 03-AR-0298 developed anakinra anti-drug antibodies.
Maltese: Il-maġġoranza tal-pazjenti b'CAPS fl-Istudju 03-AR-0298 żviluppaw antikorpi kontra l-mediċina anakinra.
English: Kineret was studied in a single randomized, blinded multi-center trial in 86 patients with polyarticular course JIA (ages 2-17 years) receiving a dose of 1 mg/kg subcutaneously daily, up to a maximum dose of 100 mg.
Maltese: Kineret ġie studjat fi prova randomizzata, blinded u multiċentrika f'86 pazjent b'kors poliartikulari ta' JIA (etajiet minn 2-17-il sena) li kienu qed jirċievu doża ta' 1 mg/kg taħt il-ġilda kuljum, sa doża massima ta' 100 mg.
English: No data are available in children under the age of 8 months.
Maltese: M'hemm l-ebda data disponibbli fi tfal ta' età inqas minn 8 xhur.
English: Untreated CAPS patients are characterized by increased CRP, SAA and IL-6 relative to normal serum levels.
Maltese: Pazjenti b'CAPS mhux ittrattat huma kkaraterizzati minn żieda fl-CRP, SAA u IL-6 mqabbla ma' livelli normali fis-serum.
English: In a placebo-controlled clinical trial (n = 126), no difference was detected in anti-tetanus antibody response between the Kineret and placebo treatment groups when a tetanus/diphtheria toxoid vaccine was administered concurrently with Kineret.
Maltese: Fi studju kliniku kkontrollat bil-plaċebo (n = 126), ma ġiet innotata l-ebda differenza fir-rispons talantikorpi kontra t-tetnu bejn il-grupp ikkurat b'Kineret u l-grupp li ngħata l-plaċebo meta ngħatat tilqima tat-toxoid tat-tetnu u difterite fl-istess ħin ma' Kineret.
English: Interactions between Kineret and other medicinal products have not been investigated in formal studies.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni L-interazzjonijiet bejn Kineret u prodotti mediċinali oħra ma ġewx investigati fi studji formali.
English: Kineret has been associated with an increased incidence of serious infections (1.8%) vs. placebo (0.7%) in RA patients.
Maltese: Kineret kien assoċjat ma' inċidenza akbar ta' infezzjonijiet serji (1.8%) kontra plaċebo (0.7%) f'pazjenti b'RA.
English: The mean plasma clearance of Kineret in subjects with mild (creatinine clearance 50-80 ml / min) and moderate (creatinine clearance 30-49 ml/min) renal insufficiency was reduced by 16% and 50%, respectively.
Maltese: It- tneħħija medja ta' Kineret mill-plażma f'individwi b'insuffiċjenza renali ħafifa (tneħħija tal krejatinina ta' 50-80 mL/min) u moderata (tneħħija tal-krejatinina ta' 30-49 mL/min) tnaqqset b'16% u 50%, rispettivament.
English: For subcutaneous use.
Maltese: Din tissejjaħ injezzjoni subkutaneja.
English: Still's disease: Data in elderly patients are limited.
Maltese: Il-marda ta' Still: Id-data f'pazjenti anzjani hija limitata.
English: During post-marketing use events of interstitial lung disease, pulmonary alveolar proteinosis and pulmonary hypertension have been reported mainly in paediatric patients with Still's disease treated with IL-6 and IL-1 inhibitors, including Kineret.
Maltese: proteinożi alveolari pulmonari u pressjoni pulmonari għolja, il-biċċa l-kbira f'pazjenti pedjatriċi bil marda ta' Still ittrattati b'inibituri ta' IL-6 u IL-1, inkluż Kineret.
English: No data are available on LDL or HDL cholesterol.
Maltese: L-ebda dejta mhija disponibbli dwar l-kolesterol LDL jew HDL.
English: The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation.
Maltese: Il-formazzjoni ta' enzimi CYP450 hija mrażżna minn żieda fil-livelli ta' ċitokini (eż., IL-1) matul infjammazzjoni kronika.
English: During the 5-year study 14 patients (32.6%) reported 24 serious events.
Maltese: Matul l-istudju fuq 5 snin, 14-il pazjent (32.6%) irrapportaw 24 każ serju.
English: Kineret has been studied in 36 CAPS patients, 15 SJIA patients and 71 patients with other forms of JIA, aged 8 months to <18 years, for up to 5 years.
Maltese: Kineret ġie studjat f'36 pazjent b'CAPS, 15-il pazjent b'SJIA u 71 pazjent b'forom oħra ta' JIA, minn età ta' 8 xhur sa <18-il sena, sa 5 snin.
English: The recommended dose is either 20 to 90 mg or 100 mg.
Maltese: Id-doża rakkomandata hija jew ta' 20 sa 90 mg jew ta' 100 mg.
English: Hypersensitivity to the active substance or to to any of the excipients listed in section 6.1 or to E. coli derived proteins.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1 jew għall-proteini ġejjin minn E. coli.
English: In clinical studies in RA patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
Maltese: Fi studji kliniċi f'pazjenti RA, tromboċitopenja ġiet irrapportata f'1.9% tal-pazjenti kkurati meta mqabbel ma' 0.3% fil-grupp ta' plaċebo.
English: Pharmacokinetic parameters were not substantially different from healthy volunteers, other than a decrease in clearance of approximately 30% in comparison with data from a study with healthy volunteers.
Maltese: Il-parametri farmakokinetiċi ma kinux sostanzjalment differenti minn voluntiera b'saħħithom, minbarra tnaqqis fit-tneħħija ta' madwar 30% meta mqabbla ma' dejta minn studju b'voluntiera b'saħħithom.
English: Each graduated pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml).
Maltese: Kull siringa gradwata mimlija għal-lest fiha 100 mg ta' anakinra* kull 0.67 mL (150 mg/mL).
English: Paediatric population (< 18 years)
Maltese: Popolazzjoni pedjatrika (˂ 18-il sena)
English: No dose adjustment is required for patients with moderate hepatic impairment (Child-Pugh Class B).
Maltese: Ma huwa meħtieġ l-ebda tibdil fid-doża għal pazjenti b'indeboliment epatiku moderat (Child-Pugh Klassi B).
English: Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).
Maltese: Kineret jista' jingħata bħala monoterapija jew flimkien ma' mediċini antiinfjammatorji oħra u mediċini antirewmatiċi li jimmodifikaw il-marda (DMARDs - disease-modifying antirheumatic drugs).
English: Analysis of treatment-emergent AEs classified by presence of CIAS1 mutation showed that there were no major differences between the CIAS1 and non-CIAS1 groups in overall AE reporting rates, 7.4 and 9.2, respectively.
Maltese: wriet li ma kien hemm l-ebda differenza maġġuri bejn il-gruppi ta' CIAS1 u mhux ta' CIAS1 fir-rati globali ta' rapportar ta' avvenimenti avversi, 7.4 u 9.2, rispettivament.
English: Patients with trisomy 21 seem to be overrepresented.
Maltese: (trisomija 21).
English: The subject incidence of serious adverse reactions in RA studies at the recommended dose of Kineret (100 mg/day) was comparable with placebo (7.1% compared with 6.5% in the placebo group).
Maltese: RA fil-pazjenti bid-doża rakkomandata ta' Kineret (100 mg/kuljum) kienet komparabbli ma' dawk bil plaċebo (7.1% imqabbel ma' 6.5% tal-grupp tal-plaċebo).
English: Hyperlink reference not valid.http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Administration of Kineret results in a decrease in the acute phase reactants and a decrease in IL-6 expression level has been observed.
Maltese: Kineret jwassal għal tnaqqis fis-sustanzi reattivi tal-fażi akuta u ġie osservat tnaqqis fil-livell tal espressjoni ta' IL-6.
English: Kineret treatment must not be initiated in patients with neutropenia (ANC <1.5 x 109/l) (see section 4.4).
Maltese: Kura b'Kineret m'għandhiex tinbeda f'pazjenti b'newtropenija (ANC <1.5 x 109/L) (ara sezzjoni 4.4). 4.4
English: Cutaneous, Articular Syndrome (CINCA) - Muckle-Wells Syndrome (MWS) - Familial Cold Autoinflammatory Syndrome (FCAS)
Maltese: - Is-Sindromu ta' Muckle-Wells (MWS) - Is-Sindromu Awtoinfjammatorju tal-Kesħa Familjali (FCAS)
English: The main objectives of the programme are to provide information on the method of administration, raise awareness on the potential risk of macrophage activation syndrome (MAS) and on the potential risk of serious infections.
Maltese: L-għanijiet ewlenin tal-programm huma li jipprovdi informazzjoni dwar il-metodu ta' għoti, iqajjem kuxjenza dwar ir-riskju potenzjali ta' sindrome ta' attivazzjoni ta' makrofaġi (MAS - macrophage activation syndrome) u dwar ir-riskju potenzjali ta' infezzjonijiet serji.
English: • a pre-filled syringe of Kineret
Maltese: • Id-doża preskritta ta' Kineret
English: Human and animal data demonstrated that the kidney is the major organ responsible for elimination of anakinra.
Maltese: Dejta mill-bnedmin u mill-annimali wriet li l kliewi huma l-organi prinċipali responsabbli għall-eliminazzjoni ta' anakinra.
English: Kineret contains the active substance anakinra.
Maltese: X'inhu Kineret u gћalxiex jintuża Kineret fih is-sustanza attiva anakinra.
English: Make sure you know what Kineret dose your doctor has prescribed; 20 to 90 mg, 100 mg or higher.
Maltese: Kun ċert li taf liema doża ta' Kineret it-tabib tiegħek ordnalek; 20 sa 90 mg, 100 mg jew ogħla.
English: In a clinical study including 43 adult and paediatric patients (36 patients aged 8 months to < 18 years) with severe CAPS (NOMID/CINCA and MWS), a clinical response to anakinra was seen within 10 days after initiation of treatment in all patients and was sustained for up to 5 years with the continued administration of Kineret.
Maltese: Fi studju kliniku li fih ħadu sehem 43 adult u pazjenti pedjatriċi (36 pazjent minn 8 xhur sa < 18-il sena) b'CAPS severi (NOMID/CINCA u MWS), rispons kliniku għal anakinra deher fi żmien
English: Store in a refrigerator (2 °C - 8 °C).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2 °C - 8 °C).
English: In 15 SJIA patients followed for up to 1.5 years, one event of transient neutropenia was reported.
Maltese: Fi 15-il pazjent b'SJIA segwiti sa 1.5 snin, kien irrappurtat avveniment wieħed ta' newtropenija temporanja.
English: The thrombocytopenias have been mild, i.e. platelet counts have been > 75 x109/l.
Maltese: It-tromboċitopenji kienu ħfief, jiġifieri l-għadd ta' plejtlits kienu ta' > 75 x109/L.
English: The active substance of Kineret is anakinra, this works in the same way as your natural interleukin-1 blocking protein.
Maltese: Is-sustanza attiva ta' Kineret hija anakinra, din taħdem bl-istess mod bħall-proteina naturali tiegħek li timblokka interleukin-1.
English: Significant improvements are seen in the pain, tender joint count, physical function (HAQ score), acute phase reactants and in the patient's and physician's global assessment.
Maltese: Kien osservat titjib sinifikanti fl-uġigħ, fl-għadd ta' ġogi sensittivi, fil-kapaċità fiżika (punteġġ HAQ), fir-reactants tal-fażi akuta u fl-evalwazzjoni globali mill-pazjent u mit-tabib.
English: A formal toxicologic and toxicokinetic interaction study in rats revealed no evidence that Kineret alters the toxicologic or pharmacokinetic profile of methotrexate.
Maltese: Kineret jbiddel il-profil tossikoloġiku jew farmakokinetiku ta' methotrexate.
English: During post-marketing use of Kineret, thrombocytopenia has been reported, including occasional case reports indicating severe thrombocytopenia (i.e. platelet counts <10 x109/l).
Maltese: Matul l-użu ta' wara t-tqegħid fis-suq ta' Kineret, ġiet irrapportata tromboċitopenja, inkluż rapporti ta' każijiet okkażjonali li jindikaw tromboċitopenja severa (jiġifieri għadd ta' plejtlits ta' < 10 x109/L).
English: Injection site reaction Uncommon (≥ 1/1,000 to < 1/100) Rash
Maltese: Mhux komuni (≥ 1/1,000 sa
English: The role of IL-1 in the pathogenesis of Still's disease has been demonstrated by ex vivo and gene expression studies.
Maltese: Ir-rwol ta' IL-1 fil-patoġenesi tal-marda ta' Still intwera permezz ta' studji ex vivo u tal-espressjoni tal-ġeni.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 7 PRE-FILLED SYRINGES AS AN INTERMEDIATE PACK (WITHOUT BLUE BOX)
Maltese: KARTUNA TA' 7 SIRINGI MIMLIJA GĦAL-LEST BĦALA PAKKETT INTERMEDJU (MINGĦAJR KAXXA BLU)
English: The usual maintenance dose in severe CAPS is 3-4 mg/kg/day, which can be adjusted to a maximum of 8 mg/kg/day.
Maltese: Id-doża ta' manteniment tas-soltu f'CAPS severi hija ta' 3-4 mg/kg/kuljum, li tista' tiġi aġġustata għal massimu ta' 8 mg/kg/kuljum.
English: These data support that no dose adjustment is required for patients with hepatic dysfunction of Child-Pugh Class B. See section 4.2.
Maltese: Din id-dejta tappoġġa li l-ebda aġġustament fid-doża ma huwa meħtieġ għal pazjenti b'disfunzjoni epatika ta' Child-Pugh Klassi B. Ara sezzjoni 4.2.
English: - Increased total blood cholesterol levels.
Maltese: - Żieda fil-livelli totali ta' kolesterol fid-demm.
English: Concurrent Kineret and TNF-α antagonist treatment In a clinical trial with RA patients receiving background methotrexate, patients treated with Kineret and etanercept were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept alone and higher than observed in previous trials where Kineret was used alone.
Maltese: Fi studju kliniku f'pazjenti b'RA li kienu diġà qed jieħdu methotrexate, ġie osservat li pazjenti li irċevew Kineret u etanercept kellhom rata ogħla ta' infezzjonijiet serji (7%) u newtropenija minn dawk il-pazjenti li ngħataw etanercept waħdu, u rata ogħla milli ġie osservat fi studji oħra ta' qabel fejn intuża
English: A study including 12 patients with hepatic dysfunction (Child-Pugh Class B) given a single 1mg/kg intravenous dose has been performed.
Maltese: Sar studju li fih ħadu sehem 12-il pazjent b'disfunzjoni epatika (Child-Pugh Klassi B) li ngħataw doża unika ġol-vina ta' 1mg/kg.
English: Spontaneous mutations in the CIAS1/NLRP3 gene have been identified in a majority of patients with CAPS.
Maltese: Mutazzjonijiet spontanji fil-ġene CIAS1/NLRP3 ġew identifikati f'maġġoranza ta' pazjenti b'CAPS.
English: Clinical efficacy and safety in CAPS
Maltese: Effikaċja klinika u sigurtà f'CAPS
English: In children with inadequate response the dose can be escalated up to 4 mg/kg/day.
Maltese: Fi tfal b'rispons inadegwat, id-doża tista' tiżdied sa 4 mg/kg/jum.
English: Check the expiry date on the pre-filled syringe label (EXP).
Maltese: Iċċekkja d-data ta' skadenza fuq it-tikketta tas-siringa mimlija għal-lest (EXP:).
English: In 15 SJIA patients followed for up to 1.5 years, the most common and consistently reported treatment-related adverse reactions associated with Kineret treatment were ISRs.
Maltese: Fi 15-il pazjent b'SJIA segwiti sa 1.5 snin, l-aktar reazzjonijiet avversi marbuta mat-trattament komuni u rrappurtati b'mod konsistenti assoċjati ma' trattament b'Kineret kienu ISRs.
English: Interleukin-1 (IL-1) is a pivotal pro-inflammatory cytokine mediating many cellular responses including those important in synovial inflammation.
Maltese: Interleukin-1 (IL-1) hu ċitokina pro-infjammatorja ta' importanza kbira u hi medjatur f'bosta risponsi ċellulari, fosthom dawk importanti f'infjammazzjoni sinovjali.
English: Kineret was commonly associated with neutropenia (ANC < 1.5 x 109/l) in placebo-controlled studies in RA and cases of neutropenia have been observed in patients with CAPS and Still's disease.
Maltese: Kineret kien komunement assoċjat ma' newtropenja (ANC < 1.5 x 109/L) fi studji kkontrollati bi plaċebo f'RA u każijiet ta' newtropenija ġew osservati f'pazjenti b'CAPS u l-marda ta' Still.
English: In patients who become neutropenic (ANC < 1.5 x 109/l) the ANC should be monitored closely and Kineret treatment should be discontinued.
Maltese: F'pazjenti li taqbadhom newtropenija (ANC < 1.5 x 109/L), l-ANC għandu jiġi mmonitorjat mill-qrib u l-kura b'Kineret għandha titwaqqaf.
English: Neutropenia Thrombocytopenia
Maltese: Żieda fl-enzimi epatiċi