FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk for increases in dabigatran plasma concentrations cannot be excluded (inhibition of intestinal P-gp).
Maltese: Riskju ta' żidiet fil-konċentrazzjonijiet fil-plażma ta' dabigatran ma jistax jiġi eskluż (inibizzjoni ta' P-gp intestinali).
English: After single dose oral administration of [14C]-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Maltese: Wara l-għoti mill-ħalq ta' doża unika ta' [14C]--rilpivirine, bħala medja 85% u 6.1% tar-radjuattivittà tista' tiġi rkuprata fl-ippurgar u fl-awrina, rispettivament.
English: Clinical efficacy of Odefsey was established from studies conducted with emtricitabine + tenofovir alafenamide when given with elvitegravir + cobicistat as an E/C/F/TAF FDC tablet, from studies conducted with rilpivirine when given with FTC/TDF as individual components or as a FTC/RPV/TDF FDC tablet, and from studies conducted with Odefsey.
Maltese: FDC, minn studji mwettqa b'rilpivirine meta mogħtija ma' FTC/TDF bħala komponenti individwali jew bħala pillola FTC/RPV/TDF FDC, u minn studji mwettqa b'Odefsey.
English: Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Maltese: Prodotti mediċinali li jinduċu jew jinibixxu CYP3A jistgħu jaffettwaw it-tneħħija ta' rilpivirine (ara sezzjoni 5.2).
English: and CD4+ T-lymphocytes.
Maltese: - Żomm dan il-fuljett.
English: AUC: ↓ 80% Cmin: ↓ 89% Cmax: ↓ 69%
Maltese: AUC: ↓ 80% Cmin: ↓ 89% Cmax: ↓ 69% Induzzjoin ta' CYP3A
English: omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn, acid reflux disease) dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
Maltese: carbamazepine, oxcarbazepine, phenobarbital u phenytoin (użati biex jittrattaw l-epilessija u jipprevjenu aċċessjonijiet) rifabutin, rifampicin and rifapentine (użati biex jittrattaw ċertu infezzjonijiet batterjali bħat-tuberkulożi) omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole u esomeprazole (użati biex jipprevjenu u jittrattaw ulċeri tal-istonku, ħruq tal-istonku, marda tar-rifluss gastroesofagali) dexamethasone (mediċina kortikosterojdi użata biex tittratta l-infjammazzjoni u trażżan is-sistema immuni) meta tittieħed mill-ħalq jew tiġi injettata (ħlief bħala trattament b'doża unika) prodotti li fihom il-St.
English: AUC: ↔ Cmin: ↔ Cmax: ↑ 17%
Maltese: AUC: ↔ Cmax: ↑ 21%
English: The terminal elimination half-life of rilpivirine is approximately 45 hours.
Maltese: Il-half-life terminali tat-tneħħija ta' rilpivirine hija ta' madwar 45 siegħa.
English: Renal elimination of rilpivirine is negligible.
Maltese: L-eliminazzjoni mill-kliewi ta' rilpivirine hija negliġibbli.
English: Changes in serum creatinine for rilpivirine-containing regimens The pooled data from the Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients also demonstrate that serum creatinine increased and estimated glomerular filtration rate (eGFR) decreased over 96 weeks of treatment with rilpivirine.
Maltese: Tibdil fil-kreatinina fis-serum għal korsijiet li jinkludu rilpivirine Id-dejta miġbura flimkien mill-istudji ta' Fażi 3 TMC278-C209 u TMC278-C215 ta' pazjenti li ma kinux ingħataw trattament qabel, turi wkoll li l-kreatinina fis-serum żdiedet u r-rata ta' filtrazzjoni glomerulari (eGFR, glomerular filtration rate) stmata naqset fuq 96 ġimgħa tat-trattament b'rilpivirine.
English: In Study GS-US-366-1160, the mean change from baseline in CD4+ cell count at Week 96 was 12 cells/mm3 in patients who switched to Odefsey and 6 cells/mm3 in those who stayed on EFV/FTC/TDF.
Maltese: CD4+ f'Ġimgħa 96 kienet ta' 12-il ċellula/mm3 f'pazjenti li qalbu għal Odefsey u ta' 6 ċelluli/mm3 f'dawk li baqgħu fuq EFV/FTC/TDF.
English: • If you are allergic to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
Maltese: • Jekk inti allerġiku għal emtricitabine, rilpivirine, tenofovir alafenamide jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
Maltese: Famotidine (40 mg doża waħda meħuda 12-il siegħa qabel rilpivirine)/Rilpivirine1
English: In the Phase 3 studies (C209 and C215), lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
Maltese: III (C209 u C215), esponiment iktar baxx għal rilpivirine, simili għal dak li deher matul it-tqala, kien ġie assoċjat ma' żieda fir-riskju ta' insuffiċjenza viroloġika, għalhekk l-ammont virali għandu jiġi mmonitorjat mill-qrib (ara sezzjonijiet 4.6, 5.1 u 5.2).
English: The adverse reactions in Table 2 are listed by system organ class and highest frequency observed.
Maltese: Ir-reazzjonijiet avversi f'Tabella 2 huma elenkati skont is-sistema tal-klassifika tal-organi u l-ogħla frekwenza osservata.
English: Medicines that must never be taken with Odefsey: carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and prevent seizures) rifabutin, rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis)
Maltese: • Jekk qed tieħu kwalunkwe mill-mediċini li ġejjin: carbamazepine, oxcarbazepine, phenobarbital u phenytoin (użati biex jittrattaw l-epilessija u jipprevjenu aċċessjonijiet) rifabutin, rifampicin and rifapentine (użati biex jittrattaw ċertu infezzjonijiet batterjali bħat-tuberkulożi) omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole u esomeprazole (użati biex jipprevjenu u jittrattaw ulċeri tal-istonku, ħruq tal-istonku, marda tar-rifluss gastroesofagali)
English: Cmax: ↔* *based on historic controls
Maltese: ↔* *fuq il-bażi ta' kontrolli storiċi
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Maltese: Is-sigurtà ta' emtricitabine + tenofovir alafenamide ġiet evalwata sa 48 ġimgħa fi studju kliniku open-label (GS-US-292-0106) f'50 pazjent pedjatriku infettati bl-HIV-1, li qatt ma ngħataw trattament fil-passat, u li kellhom minn 12 sa < 18-il sena.
English: Some medicinal products should not be co-administered with Odefsey (see sections 4.3 and 4.5).
Maltese: Xi prodotti mediċinali m'għandhomx jingħataw flimkien ma' Odefsey (ara sezzjonijiet 4.3 u 4.5).
English: As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.9).
Maltese: Billi rilpivirine jeħel ħafna mal-proteini tal-plażma, mhux mistenni li se jitneħħa b'mod sinifikanti permezz ta' emodijaliżi jew dijaliżi peritoneali (ara sezzjoni 4.9).
English: Emtricitabine systemic exposure was unaffected when emtricitabine was administered with food.
Maltese: L-esponiment sistemiku ta' emtricitabine ma ġiex affettwat meta emtricitabine ingħata mal-ikel.
English: had emerging resistance-associated substitutions and/or phenotypic resistance to rilpivirine (7/288) than patients with baseline viral load > 100,000 copies/mL (30/262).
Maltese: Il-proporzjon ta' individwi b'rispons kien ogħla f'individwi b'ammont virali fil-linja bażi ≤ 100,000 kopja/mL (78.6%, 22/28) mqabbel ma' dawk b'ammont virali fil-linja bażi > 100,000 kopja/mL (50.0%, 4/8).
English: TFVc
Maltese: TFVċ
English: Odefsey should generally be avoided but may be used with caution in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Maltese: Odefsey ġeneralment għandu jiġi evitat iżda jista' jintuża b'kawtela f'adulti b'marda tal-kliewi flaħħar stadju (CrCl stmata ta' < 15-il mL/min) fuq emodijalisi kronika jekk il-benefiċċji potenzjali jkunu akbar mir-riskji potenzjali (ara sezzjoni 4.2).
English: The combination of Odefsey with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Maltese: L-għoti flimkien ta' Odefsey ma' dawn l-antibijotiċi makrolidi jista' jikkawża żieda fil-konċentrazzjonijiet fil-plażma ta' rilpivirine (inibizzjoni ta' CYP3A) u tenofovir alafenamide (inibizzjoni ta' P-gp).
English: HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Maltese: John's wort (Hypericum perforatum) (rimedju li ġej mill-ħxejjex li jintuża għad-depressjoni u l-ansjetà)
English: TAFc
Maltese: TAFċ
English: Co-administration is likely to cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp).
Maltese: L-għoti flimkien huwa probabbli li jikkawża tnaqqis sinifikanti fil-konċentrazzjonijiet fil-plażma ta' rilpivirine (induzzjoni ta' CYP3A) u tenofovir alafenamide (induzzjoni ta' P-gp).
English: Co-administration may cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp).
Maltese: Odefsey fil-konċentrazzjonijiet fil-plażma ta' rilpivirine (induzzjoni ta' CYP3A) u tenofovir alafenamide (induzzjoni ta' P-gp).
English: Significant dose dependent decreases in rilpivirine plasma concentrations are expected (induction of CYP3A).
Maltese: Tnaqqis sinifikanti li jiddependi fuq id-doża fil-konċentrazzjonijiet fil-plażma ta' rilpivirine huwa mistenni (induzzjoni ta' CYP3A).
English: Patients co-infected with HIV and hepatitis B or C virus
Maltese: Infezzjoni bil-virus tal-epatite B u/jew b'epatite Ċ ukoll
English: (may affect up to 1 in 100 people)
Maltese: (jistgħu jaffettwaw sa 1 minn kull 100 persuna)
English: It is important not to miss a dose of Odefsey.
Maltese: Huwa importanti li ma tinsiex tieħu ebda doża ta' Odefsey.
English: • increased fatty acids (triglycerides), bilirubin or lipase in the blood
Maltese: • żieda fl-aċidi xaħmija (trigliċeridi), il-bilirubina jew il-lipase fid-demm
English: Co-administration of ciclosporin is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Maltese: L-għoti flimkien ta' ciclosporin hu mistenni li jżid il-konċentrazzjonijiet fil-plażma ta' rilpivirine (inibizzjoni ta' CYP3A) u tenofovir alafenamide (inibizzjoni ta' P-gp).
English: In this study, the safety profile in adolescent patients was similar to that in adults (see section 5.1).
Maltese: F'dan l-istudju, il-profil tas-sigurtà f'pazjenti adolexxenti kien simili għal dak fl-adulti (ara sezzjoni 5.1).
English: Table 6: Pharmacokinetics of emtricitabine and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Maltese: Il-farmakokinetika ta' emtricitabine u tenofovir alafenamide f'adolexxenti u adulti li qatt ma ngħataw antiretrovirali fil-passat
English: There have been reports of mitochondrial dysfunction in HIV negative infants exposed in utero and/or postnatally to nucleoside analogues; these have predominantly concerned treatment with regimens containing zidovudine.
Maltese: Kien hemm rapporti ta' disfunzjoni tal-mitokondrija fi trabi li huma negattivi għal HIV li kienu esposti in utero u/jew wara t-twelid għall-analogi tan-nukleosidi; dawn kienu jikkonċernaw l-aktar trattament b'korsijiet li jinkludu zidovudine.
English: Co-administration is likely to cause significant decreases in the plasma concentrations of tenofovir alafenamide (induction of P-gp).
Maltese: L-għoti flimkien huwa probabbli li jikkawża tnaqqis sinifikanti fil-konċentrazzjonijiet fil-plażma ta' tenofovir alafenamide (induzzjoni ta' P-gp).
English: In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving emtricitabine with other medicinal products is low.
Maltese: Studji in vitro u studji kliniċi farmakokinetiċi dwar l-interazzjoni bejn mediċina u oħra wrew li l-potenzjal għal interazzjonijiet medjati minn CYP li jinvolvu emtricitabine ma' prodotti mediċinali oħrajn hu baxx.
English: More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Maltese: Kien hemm għadd ikbar ta' pazjenti li kellhom falliment viroloġiku fuq rilpivirine li żviluppaw reżistenza assoċjata ma' lamivudine/emtricitabine minn dawk b'falliment viroloġiku fuq efavirenz (ara sezzjoni 5.1).
English: • signs or symptoms of inflammation or infection
Maltese: • sinjali jew sintomi ta' infjammazzjoni jew infezzjoni
English: No dose adjustment of Odefsey is required in adults or in adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Maltese: L-ebda aġġustament fid-doża ta' Odefsey mhu meħtieġ f'adulti jew adolexxenti (li jkollhom 12-il sena u aktar u li jiżnu mill-inqas 35 kg) bi tneħħija tal-kreatinina (CrCl) stmata ta' ≥ 30 mL/min.
English: Immune Reactivation Syndrome
Maltese: Disturbi fis-sistema immuni
English: dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
Maltese: dexamethasone (mediċina kortikosterojdi użata biex tittratta l-infjammazzjoni u trażżan is-sistema immuni) meta tittieħed mill-ħalq jew tiġi injettata (ħlief bħala trattament b'doża unika) prodotti li fihom il-St.
English: The safety and efficacy of Odefsey in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Odefsey fit-tfal ta' età inqas minn 12-il sena, jew li jiżnu < 35 kg, għadhom ma ġewx determinati s'issa.
English: If you have hepatitis B infection, liver problems may become worse after you stop taking Odefsey.
Maltese: Jekk għandek infezzjoni tal-epatite B, il-problemi tal-fwied jistgħu jaggravaw wara li tieqaf tieħu Odefsey.
English: There is no specific antidote for overdose with Odefsey.
Maltese: Ma hemm l-ebda antidotu speċifiku għal doża eċċessiva b'Odefsey.
English: The mean steady-state plasma trough concentration at 24 hours post-dose was equal to or greater than the mean in vitro IC90 value for anti-HIV-1 activity.
Maltese: Il-medja tal-konċentrazzjoni minima fil-plażma fl-istat fiss 24 siegħa wara d-doża kienet daqs jew akbar mill-medja in vitro tal-valur IC90 għall-attività kontra l-HIV-1.
English: However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate impairment.
Maltese: Madankollu, ma jistax jiġi eskluż li l-esponiment farmakoloġikament attiv, mhux marbut ta' rilpivirine jiżdied b'mod sinifikanti f'indeboliment moderat.
English: Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by prior treatment regimend EFV/FTC/TDF FTC/TDF plus boosted atazanavir E/C/F/TDF
Maltese: trattament fil-passatd EFV/FTC/TDF FTC/TDF flimkien ma' atazanavir imsaħħaħ
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Maltese: F'xi pazjenti b'infezzjoni avvanzata tal-HIV (AIDS) u bi storja medika ta' infezzjonijiet opportunistiċi (infezzjonijiet li jseħħu f'nies b'sistema immuni dgħajfa), sinjali u sintomi ta' infjammazzjoni minn infezzjonijiet fil-passat jistgħu jseħħu dritt wara li jinbeda t-trattament kontra l-HIV.
English: Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Maltese: Minħabba li rilpivirine huma marbut ħafna mal-proteini, huwa improbabbli li d-dijaliżi tirriżulta fi tneħħija sinifikanti tas-sustanza attiva.
English: AUC: ↑ 49% Cmin: ↑ 76% Cmax: ↑ 30%
Maltese: AUC: ↑ 49% Cmin: ↑ 76% Cmax: ↑ 30% Inibizzjoni ta' CYP3A.
English: Findings in adolescents (12 to less than 18 years of age) in Study C213 were generally in line with these data (for details see section 5.1).
Maltese: Sejbiet f'adolexxenti (minn età ta' 12 sa inqas minn 18-il sena) fl-Istudju C213 kienu jikkonformaw b'mod ġenerali ma din id-dejta (għad-dettalji ara sezzjoni 5.1).
English: The K103N substitution alone did not result in reduced susceptibility to rilpivirine, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Maltese: Is-sostituzzjoni K103N waħedha ma rriżultatx fi tnaqqis tas-suxxettibbiltà għal rilpivirine, iżda l-kombinazzjoni ta' K103N u L100I irriżultat f'suxxettibbiltà mnaqqsa b'7 darbiet għal rilpivirine.
English: Fifty-two percent of HIV-1 isolates with emergent resistance in the rilpivirine arm developed concomitant NNRTI and NRTI mutations, most frequently E138K and M184V.
Maltese: Tnejn u ħamsin fil-mija tal-iżolati tal-HIV-1 b'reżistenza emerġenti fil-fergħa tal-istudju b'rilpivirine żvilluppaw mutazzjonijiet fl-istess ħin ta' NNRTI u NRTI, l-aktar frekwentament E138K u M184V.
English: No clinically relevant differences in tenofovir alafenamide pharmacokinetics were observed in patients with end stage renal disease on chronic haemodialysis as compared to those with normal renal function.
Maltese: Ma kinux osservati differenzi klinikament rilevanti fil-farmakokinetika ta' tenofovir alafenamide f'pazjenti b'marda tal-kliewi fl-aħħar stadju fuq emodijalisi kronika meta mqabbla ma' dawk b'funzjoni renali normali.
English: In another study, the Y188L substitution resulted in a reduced susceptibility to rilpivirine of 9-fold for clinical isolates and 6-fold for site-directed mutants.
Maltese: Fi studju ieħor, is-sostituzzjoni Y188L irriżultat f'suxxettibbiltà mnaqqsa għal rilpivirine b'9 darbiet għal iżolati kliniċi u b'6 darbiet għal mutanti direzzjonati lejn is-sit.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: Proprjetajiet farmakodinamiċi
English: Sylvant (siltuximab)
Maltese: Sylvant (siltussimab)
English: Sylvant received a marketing authorisation valid throughout the EU on 22 May 2014.
Maltese: Sylvant ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-22 ta' Mejju 2014.
English: Further information on Sylvant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Sylvant
Maltese: Informazzjoni oħra dwar Sylvant
English: Sylvant has been investigated in one main study involving 79 adults with multicentric Castleman's disease who did not have HIV or HHV-8 infection.
Maltese: Sylvant ġie investigat fi studju ewlieni wieħed li involva 79 adult milqut bil-marda multiċentrika ta' Castleman li la kienu infettati bl-HIV u lanqas bl-HHV-8.
English: Siltuximab has been designed to attach to a protein in the body called interleukin 6 (IL-6).
Maltese: Issiltussimab tfasslet biex teħel ma' proteina fil-ġisem imsejħa interleukin 6 (IL-6).
English: It is given by infusion (drip) into a vein.
Maltese: Huwa jingħata bħala infużjoni (dripp) ġo vina.
English: Sylvant is a medicine that is used to treat multicentric Castleman's disease in adults who are not infected with human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8).
Maltese: Sylvant huwa mediċina li tintuża biex tikkura l-marda multiċentrika ta' Castleman f'adulti li mhumiex infettati bil-virus tal-immunodefiċjenza umana (HIV) u bil-ħerpesvirus uman 8 (HHV-8).
English: What are the risks associated with Sylvant?
Maltese: X'inhuma r-riskji assoċjati ma' Sylvant?
English: The active substance in Sylvant, siltuximab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Sylvant hija s-siltussimab, li hija antikorp monoklonali.
English: Castleman's disease is rare, and Sylvant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 November 2007.
Maltese: Il-marda ta' Castleman hija rari, u fit-30 ta' Novembru 2007, Sylvant ġie denominat bħala "mediċina orfni" (mediċina li tintuża f'mard rari).
English: Sylvant was more effective than placebo in reducing tumour size and disease symptoms: 17 out of 53 patients who received Sylvant showed a partial response and one showed a complete response, compared with none of the 26 patients who received placebo.
Maltese: Sylvant kien iktar effettiv mill-plaċebo fit-tnaqqis tad-daqs tat-tumur u s-sintomi tal-marda: 17 minn 53 pazjent li rċevew Sylvant urew rispons parzjali u pazjent wieħed wera rispons sħiħ, meta mqabbel ma' ħadd mis-26 pazjent li rċevew il-plaċebo.
English: The effect of the medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients who responded to treatment for at least 18 weeks, as shown by a 50% reduction (‘partial response') or complete disappearance (‘complete response') of tumours and symptoms of the disease.
Maltese: L-effett tal-mediċina tqabbel ma' plaċebo (trattament finta) u l-kejl ewlieni tal-effikaċja kien il-proporzjon ta' pazjenti li rrispondew għal trattament għal mill-inqas 18-il ġimgħa, kif muri bi tnaqqis ta' 50% (‘rispons parzjali') għejbien totali (‘rispons sħiħ') ta' tumuri u sintomi tal-marda.
English: Sylvant contains the active substance siltuximab.
Maltese: Sylvant fih is-sustanza attiva siltussimab.
English: Symptoms can include tiredness, sweating at night, fever, peripheral neuropathy (pins and needles due to nerve damage) and swelling of liver and spleen.
Maltese: Is-sintomi jistgħu jinkludu għeja, għaraq bil-lejl, deni, newropatija periferika (effett ta' tingiż (pins and needles) minħabba ħsara fin-nervituri) u nefħa fil-fwied u l-milsa.
English: The most serious side effect is anaphylactic reaction (a severe allergic reaction).
Maltese: L-iktar effett sekondarju serju huwa reazzjoni anafilattika (reazzjoni allerġika severa).
English: Castleman's disease is a disorder of the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream) in which cells in lymph nodes start growing abnormally, causing benign tumours.
Maltese: Il-marda ta' Castleman hija disturb tas-sistema limfatika (netwerk ta' vażi li jġorru fluwidu mit-tessuti għal ġol-nodi limfatiċi u għal ġol-fluss tad-demm) fejn iċ-ċelluli tan-nodi limfatiċi jibdew jikbru b'mod anormali u jikkawżaw tumuri beninni.
English: As for all medicines, data on the use of Sylvant are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Sylvant hija ssorveljata kontinwament.
English: The most common side effects with Sylvant (which may affect more than 1 in 5 people) are infections (including upper respiratory tract infections such as those of the throat and nose), itching, rash, joint pain and diarrhoea.
Maltese: L-iktar effetti sekondarji komuni ma' Sylvant (li jistgħu jaffettwaw aktar minn pazjent wieħed (1) minn kull ħames (5) persuni) huma infezzjonijiet (inklużi infezzjonijiet fil-parti ta' fuq tal-passaġġ respiratorju bħalma huma dawk tal-griżmejn u l-imnieħer), ħakk, raxx, uġigħ fil-ġogi u dijarea.
English: Sylvant is given every three weeks, until the patient no longer benefits from treatment.
Maltese: Sylvant jingħata kull tliet ġimgħat, sakemm il-pazjent ma jibqax jibbenefika mit-trattament.