FrancophonIA/ELRC3.0 huggingface dataset:
English: Consistent with half-life after the first dose, serum concentrations reached steady-state levels by the sixth infusion (intervals every 3 weeks) with mean (± SD) peak and trough concentrations of 332 ± 139 and 84 ± 66 mcg/mL, respectively.
Maltese: B'konsistena mal-half-life wara l-ewwel doża, konċentrazzjonijiet fisserum laħqu livelli ta' stat fiss mas-sitt infużjoni (intervalli kull 3 ġimgħat) b'medja (± SD) tal-ogħla konċentrazzjonijiet u ta' dawk l-aktar baxxi ta' 332 ± 139 u 84 ± 66 mkg/mL, rispettivament.
English: The repeat-dose toxicology studies conducted in young cynomolgus monkeys at doses of 9.2 and 46 mg/kg/week (up to 22-fold greater exposure than in patients receiving 11 mg/kg every 3 weeks) with siltuximab showed no signs indicative of toxicity.
Maltese: L-istudji ta' tossiċità minn dożi ripetuti li saru f'xadini cynomolgus żgħar b'dożi ta' 9.2 u 46 mg/kg/ġimgħa (esponiment sa 22 darba akbar minn dak f'pazjenti li qed jirċievu 11-il mg/kg kull 3 ġimgħat) ta' siltuximab ma wrew l-ebda sinjali li jindikaw tossiċità.
English: Following the first administration of siltuximab (doses ranging from 0.9 to 15 mg/kg), the area under the concentration-time curve (AUC) and maximal serum concentration (Cmax) increased in a dose-proportional manner and clearance (CL) was independent of dose.
Maltese: Wara l-ewwel għoti ta' siltuximab (dożi fuq medda minn 0.9 sa 15-il mg/kg), iż-żona taħt il-kurva talkonċentrazzjoni kontra l-ħin (AUC - area under the curve) u l-ogħla l-konċentrazzjoni fis-serum (Cmax - maximal serum concentration) żdiedu b'manjiera fi proporzjon mad-doża u t-tneħħija (CLclearance) kienet indipendenti mid-doża.
English: • abnormal kidney function test
Maltese: • riżultat mhux normali ta' test tal-funzjoni tal-kliewi
English: Median age was 47 years (range 20-74) in the siltuximab arm and 48 years (range 27-78) in the placebo arm. More male patients were enrolled in the placebo arm (85% in placebo vs. 56% in the siltuximab group).
Maltese: Letà medjana kienet ta' 47 sena (fuq medda minn 20-74) fil-fergħa ta' siltuximab u 48 sena (fuq medda minn 27-78) fil-fergħa tal-plaċebo.
English: As with all therapeutic proteins, there is potential for the generation of anti-medicine antibodies (immunogenicity).
Maltese: Bħal ma jiġri bil-proteini terapewtċi l-oħra kollha, hemm potenzjal għall-produzzjoni ta' antikorpi kontra l-mediċina (immunoġeniċità).
English: Siltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6.
Maltese: Siltuximab huwa antikorp monoklonali kimeriku mill-bniedem u l-ġurdien li jifforma kumplessi b'affinità kbira, stabbli ma' forom bijoattivi li jdubu ta' IL-6 uman.
English: In the
Maltese: U LUŻU
English: During an embryo-fetal development study where siltuximab was administered intravenously to pregnant cynomolgus monkeys (gestation day 20 - 118) at doses of 9.2 and 46 mg/kg/week, no maternal or fetal toxicity was observed.
Maltese: Waqt studju ta' żvilupp tal-embriju u tal-fetu fejn siltuximab ingħata fil-vini lill-xadini cynomolgus tqal (jum tat-tqala 20 - 118) b'dożi ta' 9.2 u 46 mg/kg/ġimgħa, ma kienet osservata l-ebda tossiċità flomm jew fil-fetu.
English: Within the system organ class, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to
Maltese: Fil-klassi tas-sistemi u tal-organi, ir-reazzjonijiet avversi huma elenkati taħt it-titli ta' frekwenza bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10) mhux komuni (≥1/1000 u <1/100); rari (≥1/10000 u <1/1000); rari ħafna (<1/10000).
English: Haemoglobin response was defined as a change from baseline of ≥ 15 g/L (0.9 mmol/L) at Week 13.
Maltese: Rispons tal-emoglobina ġie ddefinit bħala bidla mill-linja bażi ta' ≥ 15 g/L (0.9 mmol/L) filĠimgħa 13.
English: Two cases of reactivated hepatitis B have been reported when SYLVANT was administered concomitantly with high dose dexamethasone, and bortezomib, melphalan and prednisone in multiple myeloma patients.
Maltese: Ġew irrappurtati żewġ każijiet ta' epatite B rijattivata meta SYLVANT ingħata flimkien ma' doża għolja ta' dexamethasone, u bortezomib, melphalan u prednisone f'pazjenti b'mijeloma multipla.
English: Data from all patients treated with siltuximab monotherapy (n = 370) form the overall basis of the safety evaluation.
Maltese: Dejta mill-pazjenti kollha ttrattati b'monoterapija ta' siltuximab (n = 370) tifforma l-bażi totali talevalwazzjoni tas-sigurtà.
English: Elevations in triglycerides and cholesterol (lipid parameters) were observed in patients treated with SYLVANT (see section 4.8).
Maltese: Żidiet fil-livelli tat-trigliċeridi u tal-kolesterol (parametri ta' xaħmijiet fid-demm) ġew osservati f'pazjenti kkurati b'SYLVANT (ara t-taqsima 4.8).
English: Histopathological examination of lymphoid tissues from GD140 fetuses showed no morphological abnormalities in the development of the immune system.
Maltese: Eżami istopatoloġiku tat-tessuti tal-limfojd minn feti GD140 ma wrew lebda anormalitajiet morfoloġiċi fl-iżvilupp tas-sistema immuni.
English: • rash, itchy skin rash (eczema)
Maltese: • raxx, raxx bil-ħakk fil-ġilda (ekżema)
English: The powder should dissolve in less than 60 minutes.
Maltese: It-trab għandu jinħall f'inqas minn 60 minuta.
English: Overproduction of IL-6, in chronic inflammatory diseases and malignancies has been linked to anaemia and cachexia and has been hypothesised to play a central role in driving plasma cell proliferation and systemic manifestations in patients with CD.
Maltese: Produzzjoni żejda ta' IL-6, f'mard infjammatorju kroniku u tumuri malinni kienet marbuta ma' anemija u kakessija u saret ipotesi li għandu rwol ċentrali fejn iġiegħel il-proliferazzjoni taċ-ċelluli tal-plażma u l-manifestazzjonijiet sistemiċi f'pazjenti b'CD.
English: Following the repeat dose administration at the recommended dose, siltuximab clearance was found to be time-invariant, and systemic accumulation was moderate (accumulation index of 1.7).
Maltese: Wara għoti ta' dożi ripetuti bid-doża rrakkomandata, it-tneħħija ta' siltuximab instabet li ma tinbidilx mal-ħin, u l-akkumulazzjoni sistemika kienet moderata (indiċi ta' akkumulazzjoni ta' 1.7).
English: The safety and efficacy of siltuximab in children aged 17 years and younger have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' siltuximab fit-tfal tal-età ta' 17-il sena u anqas ma ġewx stabbiliti.
English: Vascular disorders very common
Maltese: Disturbi vaskulari komuni ħafna
English: Oropharyngeal pain
Maltese: Tumuri malinni
English: Dilute the total volume of the reconstituted solution dose to 250 mL with sterile Dextrose 5%, by withdrawing a volume equal to the volume of reconstituted SYLVANT from the Dextrose 5%, 250 mL bag.
Maltese: Iddilwi l-volum totali tad-doża tas-soluzzjoni ta' siltuximab irrikostitwita sa 250 mL b'Dextrose 5% sterili, billi mill-borża ta' 250 mL tas-soluzzjoni ta' Dextrose 5%, tiġbed volum li huwa daqs il-volum ta' SYLVANT irrikostitwit.
English: SYLVANT 100 mg powder for concentrate for solution for infusion EU/1/14/928/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ SYLVANT 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni EU/1/14/928/001
English: SYLVANT 100 mg powder for concentrate SYLVANT 400 mg powder forconcentrate siltuximab
Maltese: SYLVANT 100 mg trab għall-konċentrat SYLVANT 400 mg trab għall-konċentrat siltuximab
English: Upon initation or discontinuation of siltuximab in patients being treated with concomitant medicinal products that are CYP450 substrates and have a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or concentration of medicinal product (e.g., cyclosporine or theophylline) is recommended.
Maltese: Malli siltuximab jinbeda jew jitwaqqaf f'pazjenti li qed jiġu kkurati bi prodotti mediċinali konkomittanti li huma sustrati ta' CYP450 u għandhom indiċi terapewtiċi stretti, huwa rrakkomandat il-monitoraġġ tal-effett (eż., warfarin) jew tal-konċentrazzjoni tal-prodott mediċinali (eż., cyclosporine jew theophylline).
English: Cross-study population PK analyses were performed using data from 378 patients with a variety of conditions who received single-agent siltuximab at doses ranging from 0.9 to 15 mg/kg.
Maltese: Analiżi cross-study PK ta' popolazzjoni saru bl-użu ta' dejta minn 378 pazjent b'varjetà ta' kundizzjonijiet li rċivew sustanza waħda ta' siltuximab f'dożi fuq medda minn 0.9 sa 15-il mg/kg.
English: • The recommended dose is 11 milligrams per kilogram of body weight, given once every
Maltese: • Id-doża rrakkomandata hija ta' 11-il milligramma għal kull kilogramma ta' piż tal-ġisem,
English: Table 2 reflects the frequencies of identified adverse reactions in the 87 MCD patients (Study 1, Study 2 and Study 3) treated at the recommended dosage of 11 mg/kg every 3 weeks (details provided in section 5.1).
Maltese: Tabella 2 tirrifletti l-frekwenzi tar-reazzjonijiet avversi identifikati f'87 pazjent b'MCD (Studju 1, Studju 2 u Studju 3) trattati bid-dożaġġ irrakkomandat ta' 11-il mg/kg kull 3 ġimgħat (dettalji pprovduti f'sezzjoni 5.1).
English: • drop in the number of platelets (thrombocytopenia)
Maltese: • tnaqqis fin-numru ta' ċelluli bojod tad-demm (newtropenija)
English: As this medicine will be given to you by your doctor or nurse, it is unlikely that you will be given too much.
Maltese: Minħabba li din il-mediċina se tingħatalek mit-tabib jew mill-infermier tiegħek, mhux probabbli li inti tingħata wisq.
English: A total of 79 patients with symptomatic MCD were randomised and treated.
Maltese: Total ta' 79 pazjent b'MCD bis-sintomi ntgħazlu b'mod każwali u ġew ikkurati.
English: Gastointestinal disorders very common
Maltese: Disturbi gastrointestinali komuni ħafna
English: MCD-related signs and symptoms were prospectively collected.
Maltese: Sinjali u sintomi marbuta ma' MCD inġabru b'mod prospettiv.
English: A Phase 2, multinational, randomised (2:1) double-blind, placebo-controlled study was conducted to assess the efficacy and safety of siltuximab (11 mg/kg every 3 weeks) compared with placebo in combination with best supportive care in patients with MCD.
Maltese: Studju ta' Fażi 2, multinazzjonali, double-blind, ikkontrollat bi plaċebo, fejn il-pazjenti ntagħzlu b'mod każwali (2:1) sar biex jistma l-effikaċja u s-sigurtà ta' siltuximab (11-il mg/kg kull 3 ġimgħat)
English: Chemical and physical in-use stability has been demonstrated for up to 8 hours at room temperature (see section 6.6).
Maltese: L-istabbilità fiżika u kimika waqt l-użu ntweriet li hija sa 8 sigħat f'temperatura tal-kamra (ara sezzjoni 6.6).
English: Following treatment with SYLVANT in clinical trials, transient or intermittent mild-to-moderate elevation of hepatic transaminase levels or other liver function tests such as bilirubin have been reported.
Maltese: Wara trattament b'SYLVANT fi provi kliniċi, kienu rrappurtati żidiet minn ħfief sa moderati temporanji jew intermittenti fil-livelli tat-transaminase tal-fwied jew testijiet oħra tal-funzjoni talfwied bħal bilirubin.
English: The effect of siltuximab on CYP450 enzyme activity can persist for several weeks after stopping therapy.
Maltese: L-effett ta' siltuximab fuq l-attività tal-enzima CYP450 jista' jippersisti għal diversi ġimgħat wara l-waqfien tat-terapija.
English: Gastrointestinal (GI) perforation has been reported in siltuximab clinical trials although not in MCD trials.
Maltese: Perforazzjoni gastrointestinali (GI - gastrointestinal) ġiet irrappurtata fi provi kliniċi b'siltuximab għalkemm mhux fil-provi MCD.
English: The following factors had no clinical effect on the clearance of siltuximab: gender, age, and ethnicity.
Maltese: Il-fatturi li ġejjin ma kellhom l-ebda effett kliniku fuq it-tneħħija ta' siltuximab: sess, età, u etniċità.
English: Pharmacodynamic effects In vitro, siltuximab dose-dependently inhibited the growth of an IL-6-dependent murine plasmacytoma cell line in response to human IL-6.
Maltese: In vitro, siltuximab b'mod dipendenti mid-doża inibixxa tkabbir dipendenti fuq IL-6 ta' linja ta' ċelluli murini ta' plasmaċitoma b'rispons għal IL-6 uman.
English: The incidence rate of detectable anti-siltuximab antibodies was 0.9% (4/432) overall and 2.1% (4/189) in patients with at least once sample tested with the high medicinal product tolerant ECLIA assay.
Maltese: (4/432) globalment u 2.1% (4/189) f'pazjenti b'mill-inqas kampjun wieħed li ġie ttestjat bl-assaġġ ECLIA li huwa tolleranti ħafna għall-prodott mediċinali.
English: Women of childbearing potential must use effective contraception during and up to 3 months after treatment (see section 4.5).
Maltese: Nisa f'età li jista' jkollhom it-tfal għandhom jużaw kontraċezzjoni effettiva waqt u sa 3 xhur wara ttrattament (ara sezzjoni 4.5).
English: For patients with baseline calculated creatinine clearance of 12 mL/min or greater, there was no meaningful effect on siltuximab PK. Four patients with severe renal impairment (creatinine clearance 12 to 30 mL/min) were included in the data set.
Maltese: Erba' pazjenti b'indeboliment qawwi tal-kliewi (tneħħija tal-kreatinina minn 12 sa 30 mL/min) kienu inklużi fis-sett ta' dejta.
English: No dose adjustment is required (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża (ara ttaqsima 5.2).
English: Complete symptom response was defined as a 100% reduction from the baseline overall in the MCD-related overall symptom score sustained for at least 18 weeks prior to treatment failure.
Maltese: Rispons sħiħ għas-sintomi kien iddefinit bħala tnaqqis ta' 100% mill-linja bażi totali fil-punteġġ ta' sintomi totali marbuta ma' MCD li jservi għal mill-inqas 18-il ġimgħa qabel ma l-kura ma tibqax taħdem aktar.
English: Pregnancy
Maltese: Bijomarkaturi
English: • stomach pain or discomfort, constipation, diarrhoea, heartburn, ulcers (sores) in the mouth,
Maltese: • uġigħ jew skumdità fl-istonku, stitikezza, dijarea, ħruq ta' stonku, ulċeri (selħiet) fil-ħalq,
English: * Best Supportive Care a Adjusted for corticosteroid use at randomisation b At the time of primary analysis data for 19 of 20 tumour and symptomatic responders were censored due to on-going response c N/A = “Not applicable”, there were no responders in the placebo arm, therefore, duration is not applicable d Complete symptomatic response is defined as a 100% reduction in the baseline MCD overall symptom score sustained for at least 18 weeks prior to treatment failure e Data from 11 of 13 complete symptomatic responders were censored due to on-going response
Maltese: N/A = “Ma japplikax (Not applicable)”, ma kien hemm l-ebda persuna li wriet rispons fil-fergħa tal-plaċebo, għalhekk, it-tul ta' żmien ma japplikax d Rispons sħiħ għas-sintomi huwa ddefinit bħala tnaqqis ta' 100% fil-punteġġ globali tas-sintomi fil-linja bażi ta' MCD li nżamm għal mill-anqas 18-il ġimgħa qabel falliet il-kura e Dejta ta' 11 minn 13-il persuna li kellhom rispons għas-sintomi b'mod sħiħ ġiet iċċensurata minħabba rispons li baqa' għaddej
English: negative.
Maltese: Co.
English: SYLVANT 400 mg powder for concentrate for solution for infusion 30 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of siltuximab.
Maltese: SYLVANT 400 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni kunjett ta' 30 mL tal-ħġieġ tat-Tip 1 b'tapp elastomeriku u siġill tal-aluminju b'buttuna fil-wiċċ li tinqala' b'daqqa ta' saba' li fih 400 mg ta' siltuximab.
English: Hypertriglyceridaemia, hyperuricaemia common
Maltese: Ipertrigliċeridemija, iperuriċemija komuni
English: Administer the diluted solution over a period of 1 hour using administration sets lined with PVC, or polyurethane (PU), or PE, containing a 0.2-micron inline polyethersulfone (PES) filter.
Maltese: Agħti s-soluzzjoni ddilwita fuq perjodu ta' siegħa billi tuża settijiet tal-għoti infurrati bil-PVC, jew bilpolyurethane (PU), jew bil-PE, li fil-pajp ikun fihom filtru tal-polyethersulfone (PES) ta' 0.2mikron.
English: A slight reduction in T-cell dependent antibody response and a reduction in the size of the splenic germinal centers following Keyhole limpet hemocyanin (KLH) immunisation was observed which were considered to be pharmacological responses of IL-6 inhibition and not of toxicological significance.
Maltese: Kien osservat tnaqqis żgħir ħafna fir-rispons tal-antikorp dipendenti miċ-ċellula T u tnaqqis fid-daqs taċ-ċentri ġerminali tal-milsa wara tilqim b'hemocyanin mill-imħar Keyhole (KLH - Keyhole limpet immunization) li kienu meqjusa bħala risponsi farmakoloġiċi għal inibizzjoni ta' IL-6 u mhux ta' sinifikat tossiku.
English: EXP
Maltese: Cork
English: In cultures of human hepatoma cells, IL-6-stimulated production of the acute-phase protein serum amyloid A was dose-dependently inhibited by siltuximab.
Maltese: F'kolturi ta' ċelluli umani tal-epatoma, ilproduzzjoni tal-fażi akuta tal-proteina amyloid A fis-serum stimulata minn IL-6 kienet inibita minn siltuximab b'mod dipendenti mid-doża.
English: Rash, pruritus, eczema
Maltese: nawsja, rimettar
English: No formal studies have been conducted to investigate the PK of siltuximab in patients with renal or hepatic impairment (see section 4.4).
Maltese: Ma saru l-ebda studji formali biex tiġi investigata l-PK ta' siltuximab f'pazjenti b'indeboliment talkliewi jew tal-fwied (ara t-taqsima 4.4).
English: Each vial contains 100 mg of siltuximab.
Maltese: Kull kunjett fih 100 mg ta' siltuximab.
English: Table 2 lists adverse reactions observed in MCD patients treated with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks.
Maltese: Tabella 2 telenka reazzjonijiet avversi osservati f'pazjenti b'MCD kkurati b'siltuximab bid-dożaġġ irrakkomandatat ta' 11-il mg/kg kull 3 ġimgħat.
English: Similarly, in cultures of human Burkitt's B-lymphoma cells, the production of immunoglobulin M protein in response to IL-6 was dose-dependently inhibited by siltuximab.
Maltese: B'mod jixxiebah, f'kolturi ta' ċellui B umani tal-limfoma ta' Burkitt, il-produzzjoni tal-proteina immunoglobulina M b'rispons għal IL-6 kienet inibita minn siltuximab b'mod li jiddependi mid-doża.
English: • feeling dizzy
Maltese: * L-Aħjar
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar rikostituzzjoni u dilwizzjoni tal-prodott mediċinali qabel jingħata, ara ttaqsima 6.6.
English: First tabulated update:
Maltese: Data tal-aħħar tiġdid:
English: Each vial contains 400 mg of siltuximab.
Maltese: Kull kunjett fih 400 mg ta' siltuximab.
English: Median duration of siltuximab treatment was 5.52 years (range: 0.8 to 10.8 years); more than 50% of patients received siltuximab treatment for ≥5 years.
Maltese: Il-medjan tat-tul tat-trattament b'siltuximab kien 5.52 snin (firxa: 0.8 sa 10.
English: • drop in the number of white blood cells (neutropenia)
Maltese: • tnaqqis fin-numru ta' plejtlits (tromboċitopenija)
English: Measurement of IL-6 concentrations in serum or plasma during treatment should not be used as a pharmacodynamic marker, as siltuximab-neutralised antibody-IL-6 complexes interfere with current immunological-based IL-6 quantification methods.
Maltese: Kejl tal-konċnetrazzjonijiet ta' IL-6 fis-serum jew fil-plażma waqt il-kura m'għandux jintuża bħala markatur farmakodinamiku, minħabba li l-kumplessi ta' antikorpi-IL-6 innewtralizzati minn siltuximab jinterferixxu mal-metodi b'bażi immunoloġika ta' kwantifikazzjoni ta' IL-6 li qed jintużaw bħalissa.
English: Each 400 mg vial should be reconstituted with 20 mL of single-use water for injections to yield a 20 mg/mL solution.
Maltese: Kull kunjett ta' 400 mg għandu jiġi rrikostitwit b'20 mL ta' ilma għall-injezzjonijiet li jintuża darba biss biex jagħti soluzzjoni ta' 20 mg/mL.
English: * Best Supportive Care a 95% confidence interval for the for the difference in proportions b N/A = “Not applicable”, there were no responders therefore 95% CI is not applicable c 95% confidence interval for the hazard ratio d Complete symptomatic response is defined as a 100% reduction in the baseline MCD overall symptom score sustained for at least 18 weeks prior to treatment failure
Maltese: N/A = “Ma japplikax (Not applicable)”, ma kien hemm ħadd li rrisponda għalhekk l-intervall ta' kunfidenza ta' 95% ma japplikax c
English: Dizziness, headache
Maltese: • uġigħ ta' ras
English: How to store SYLVANT
Maltese: X'fih SYLVANT
English: Arthralgia, pain in extremity
Maltese: Artralġja, uġigħ fid-dirgħajn u fir-riġlejn
English: Available non-clinical data do not suggest an effect on fertility under siltuximab treatment (see section 5.3).
Maltese: Dejta li mhijiex klinka disponibbli ma tissuġġerixxix effett fuq il-fertilità taħt kura b'siltuximab (ara t-taqsima 5.3).
English: • theophylline, used to treat asthma
Maltese: • theophylline, jintuża biex jikkura l-ażma
English: Durable tumour & symptomatic response (independent review)
Maltese: Skop primarju finali ta' effikaċja Rispons li jservi għat-tumur u għas-sintomi (analiżi indipendenti)
English: Each 100 mg vial should be reconstituted with 5.2 mL of single-use water for injections to yield a 20 mg/mL solution.
Maltese: Kull kunjett ta' 100 mg għandu jiġi rrikostitwit b'5.2 ml ta' ilma għall-injezzjonijiet li jintuża darba biss biex jagħti soluzzjoni ta' 20 mg/mL.
English: From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
Maltese: Mill-aspett mikrobijoloġiku, sakemm il-metodu ta' ftuħ/rikostituzzjoni /dilwizzjoni ma jipprekludix irriskju ta' kontaminazzjoni bil-mikrobi, il-prodott għandu jintuża immedjatament.
English: • SYLVANT will be given as an “intravenous infusion” (a drip into a vein, usually in your arm).
Maltese: • SYLVANT se jingħata bħala “infużjoni fil-vini” (dripp ġo vina, ġeneralment fid-driegħ tiegħek).
English: • SYLVANT is available in packs containing 1 vial.
Maltese: • SYLVANT huwa disponibbli f'pakketti li fihom kunjett wieħed.
English: Gently mix.
Maltese: TAGĦRIF
English: IL-6 to both soluble and membrane-bound IL-6 receptors (IL-6R), thus inhibiting the formation of the hexameric signaling complex with gp130 on the cell surface.
Maltese: Siltuximab ma jħallix IL-6 uman jintrabat kemm ma' riċetturi ta' IL-6 li jdubu kif ukoll ma' dawk marbuta mal-membrana, b'hekk jinibixxi l-formazzjoni tal-kumpless eksameriku li jagħti s-sinjali, b'gp130 fuq il-wiċċ taċ-ċellula.
English: The mechanism of action of siltuximab is neutralisation of IL-6 bioactivity, which can be measured indirectly by suppression of CRP.
Maltese: L-effetti ta' siltuximab fuq il-fertilità ma ġewx evalwati fil-bniedem.
English: N/Ac
Maltese: • ħakk
English: • The other ingredients (excipients) are histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.
Maltese: • L-ingredjenti l-oħra (eċċipjenti) huma histidine, histidine hydrochloride monohydrate,
English: SYLVANT 100 mg powder for concentrate for solution for infusion 8 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of siltuximab.
Maltese: SYLVANT 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Kull kunjett li jintuża darba biss fih 100 mg trab ta' siltuximab għall-konċentrat għal soluzzjoni għallinfużjoni.
English: • high fat levels in your blood (hypertriglyceridaemia)
Maltese: • livelli għoljin ta' xaħam fid-demm (ipertrigliċeridemija)
English: The European Medicines Agency has waived the obligation to submit the results of studies with siltuximab in all subsets of the paediatric population in CD (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini neħħiet l-obbligu li jiġu sottomessi r-riżultati tal-istudji b'siltuximab fis-subsettijiet kollha tal-popolazzjoni pedjatrika b'CD (ara t-taqsima 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Pack size of 1 vial.
Maltese: Daqs tal-pakkett ta' kunjett wieħed.