FrancophonIA/ELRC3.0 huggingface dataset:
English: Each gastro-resistant tablet contains 136.8 mg lactose (as monohydrate).
Maltese: Kull pillola gastroreżistenti fiha 136.8 mg lactose (bħala monoidrat).
English: The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia).
Maltese: L-iktar sinjali importanti huma: proteinurja, glukożurja (b'livelli normali ta' zokkor fid-demm), iperaminoaċidurja u fosfaturja (possibbilment konkurrenti ma' ipofosfatemija).
English: - the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) and simethicone.
Maltese: - Is-sustanzi l-oħrajn huma: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) u simethicone.
English: Fumaderm = Active comparator, a combination product with the same content of dimethyl fumarate plus 3 monoethyl hydrogen fumarate salts; n=number of patients with available data; N=number of patients in population; PASI=Psoriasis Area Severity Index; PGA=Physician's Global Assessment; a Superiority of Skilarence vs.
Maltese: Fumaderm = Kumparatur attiv,prodott ikkombinat bl-istess kontenut tal-dimethyl fumarate flimkien ma' flimkien ma' 3 imluħ tal-monoethyl hydrogen fumarate; n=numru ta' pazjenti b'dejta disponibbli; N=numru ta' pazjenti fil-popolazzjoni; PASI=Indiċi tas-Severità tal-Erja tal-Psorijażi; PGA=Valutazzjoni Globali tat-Tabib; a Superjorità ta' Skilarence vs.
English: Skilarence 30 mg is available in packs containing 42, 70 and 210 gastro-resistant tablets.
Maltese: Skilarence 30 mg huwa disponibbli f'pakketti li fihom 42, 70 u 210 pillola gastroreżistenti.
English: Skilarence should be used cautiously in combination with other systemic antipsoriatic therapy (e.g. methotrexate, retinoids, psoralens, ciclosporin, immunosuppressants or cytostatics) (see section 4.4).
Maltese: Skilarence għandu jintuża bil-galbu flimkien ma' terapija antipsorijatika sistemika oħra (eż. methotrexate, retinojdi, psoralens, ciclosporin, immunosuppressanti jew ċitostatiċi) (ara sezzjoni 4.4).
English: Placebo with a difference of 22.2% for PASI 75 and 20.0% for PGA score clear or almost clear, superiority of Fumaderm vs Placebo with a difference of 25.0% for PASI 75 and 24.4% for PGA score clear or almost clear; b Non-inferiority of Skilarence vs. Fumaderm with a difference of -2.8% for PASI 75 and -4.4% for PGA score clear or almost clear.
Maltese: Plaċebo b'differenza ta' 22.2 % għal PASI 75 u 20.0 % għal Punteġġ tal-PGA kklirjat jew kważi kklirjat, superjorità ta' Fumaderm vs Plaċebo b'differenza ta' 25.0
English: - the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide.
Maltese: - Is-sustanzi l-oħrajn huma: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine
English: Skilarence may decrease leukocyte and lymphocyte counts (see section 4.8).
Maltese: Skilarence jista' jnaqqas l-għadd ta' lewkoċiti u linfoċiti (ara sezzjoni 4.8).
English: There was a trend in the efficacy endpoint PASI score mean % change from baseline, indicating the onset of a clinical response to Skilarence as early as week 3 (-11.8%) which became statistically significant compared to placebo by week 8 (-30.9%).
Maltese: Kien hemm tendenza fil-punteġġ tal-PASI tal-end-point tal-effikaċja u fil-bidla medja % mil-linja bażi, li tindika l-feġġa ta' rispons kliniku għal Skilarence sa minn kmieni minn ġimgħa 3 (-11.8 %) li saret statistikament sinifikanti meta mqabbel mal-plaċebo sa ġimgħa 8 (-30.9 %).
English: Each gastro-resistant tablet contains 34.2 mg lactose (as monohydrate).
Maltese: Kull pillola gastroreżistenti fiha 34.2 mg lactose (bħala monoidrat).
English: EU/1/17/1201/001 42 tablets EU/1/17/1201/013 70 tablets EU/1/17/1201/014 210 tablets
Maltese: EU/1/17/1201/001 42 pillola EU/1/17/1201/013 70 pillola EU/1/17/1201/014 210 pillola
English: Early diagnosis of Fanconi syndrome and discontinuation of Skilarence treatment are important to prevent the onset of renal impairment and osteomalacia, as the syndrome is usually reversible.
Maltese: Id-dijanjożi bikrija tas-sindrome ta' Fanconi u t-twaqqif ta' kura bi Skilarence huma importanti għallprevenzjoni tal-feġġa ta' indeboliment renali u tal-osteomalaċja, peress li normalment is-sindrome huwa reversibbli.
English: 9/L or other pathological results are identified.
Maltese: 9/L jew riżultati patoloġiċi oħrajn.
English: The safety and efficacy of Skilarence was assessed in one double-blind, 3-arm, placebo- and active comparator-controlled Phase III study (1102) in patients with moderate to severe plaque psoriasis (Study 1102).
Maltese: Is-sigurtà u l-effikaċja ta' Skilarence ġew ivvalutati fi studju wieħed ikkontrollat bil-plaċebo u l-attiv u komparatur bi 3 arms u double-blind tal-Fażi III (1102) f'pazjenti bi psorijażi tal-plakka moderata sa severa (Studju 1102).
English: The tablets are packed in PVC/PVDC-aluminium blisters.
Maltese: Il-pilloli huma ppakkjati f'folji talPVC/PVDC-aluminju.
English: Despite the high inter-subject variability, the exposure measured as AUC and Cmax was generally dose-proportional after single dose administration of 4 x 30 mg dimethyl fumarate tablets (total dose of 120 mg) and 2 x 120 mg dimethyl fumarate tablets (total dose of 240 mg).
Maltese: Minkejja l-varjabbiltà għolja bejn is-suġġetti, l-espożizzjoni mkejla bħala AUC u Cmax ġeneralment kienet proporzjonata għad-doża wara l-għoti ta' doża waħda ta' 4 x pilloli tat-30 mg fumarat dimetil (doża totali ta' 120 mg) u 2 x pilloli tal-120 mg dimethyl fumarate (doża totali ta' 240 mg).
English: Skilarence 30 mg gastro-resistant tablets Skilarence 120 mg gastro-resistant tablets
Maltese: Skilarence 30 mg pilloli gastroreżistenti Skilarence 120 mg pilloli gastroreżistenti
English: - Dimethyl fumarate or other fumarates.
Maltese: - Dimethyl fumarate jew fumarates oħrajn.
English: Skilarence 30 mg gastro-resistant tablets dimethyl fumarate
Maltese: Skilarence 30 mg pilloli gastroreżistenti Dimethyl fumarate
English: Of the 699 patients, most were Caucasian (99%) and male (65%), and the mean age was 44 years.
Maltese: Mis699 pazjent, ħafna kienu Kawkażi (99%) u rġiel (65%), u l-età medja kienet ta' 44 sena.
English: More than 90% of these diarrhoea events were of mild to moderate severity (see section 4.4).
Maltese: Aktar minn 90 % ta' dawn l-avvenimenti ta' dijarea kienu ta' severità ħafifa sa moderata (ara sezzjoni 4.4)
English: EU/1/17/1201/010 EU/1/17/1201/011 EU/1/17/1201/012 EU/1/17/1201/013 EU/1/17/1201/014
Maltese: EU/1/17/1201/011 EU/1/17/1201/012 EU/1/17/1201/013 EU/1/17/1201/014
English: Gastrointestinal disorders
Maltese: Mard gastrointestinali preeżistenti
English: 9/L were observed in 1/29 (3.5%) patient at 6 months and 0/28 (0%) at 12 months after stopping treatment.
Maltese: 9/L ġew osservati f'1/29 (3.5 %) pazjent wara 6 xhur u f'0/28 (0 %) wara 12-il xahar wara li twaqqfet ilkura.
English: The inflammatory cytokine production is reduced with induction of proapoptotic events, inhibition of keratinocyte proliferation, reduced expression of adhesion molecules, and diminished inflammatory infiltrate within psoriatic plaques.
Maltese: Il-produzzjoni ta' ċitokina infjammatorja titnaqqas b'induzzjoni ta' avvenimenti proapoptotiċi, inibizzjoni ta' proliferazzjoni tal-keratinoċita, tnaqqis tal-espressjoni ta' molekoli tal-adeżjoni, u tnaqqis tal-infiltrat infjammatorju fil-plakki bil-psorijażi.
English: Blue, film-coated, round, biconvex tablet with a diameter of approximately 11.6 mm.
Maltese: Pillola blu, miksija b'rita, tonda, imżaqqa miż-żewġ naħat b'dijametru ta' madwar 11.6 mm.
English: Gastro-resistant tablet.
Maltese: Pillola gastroreżistenti.
English: 3/279 (1.1%) of the patients started on Skilarence.
Maltese: 9/L, li jirrappreżentaw 3/279 (1.1 %) tal-pazjenti li bdew fuq Skilarence.
English: Skilarence 120 mg gastro-resistant tablets dimethyl fumarate
Maltese: Skilarence 120 mg pilloli gastroreżistenti Dimethyl fumarate
English: Diarrhoea was a common adverse reaction (36.9%) among patients taking Skilarence, leading to medicinal product withdrawal in about 10% of patients.
Maltese: Id-dijarea kienet reazzjoni avversa komuni (36.9 %) fost il-pazjenti li kienu qed jieħdu Skilarence, li f'madwar 10 % tal-pazjenti, wasslet għat-twaqqif tal-prodott mediċinali.
English: Skilarence with alcohol
Maltese: Skilarence ma' alkoħol
English: • The guide for healthcare professionals shall contain the following key elements: o Relevant information on PML (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for PML o Details on how to minimise the risk of PML through appropriate monitoring and management, including laboratory monitoring of lymphocyte and leukocyte prior to and during treatment, and criteria for treatment discontinuation o Key messages to convey in counselling of patients
Maltese: • Il-gwida għall-professjonisti tal-kura tas-saħħa għandu jkollha l-elementi ewlenin li ġejjin: o Informazzjoni rilevanti dwar PML (eż. gravità, severità, frekwenza, ħin għall-bidu, reversibilità tal-AE skont kif applikabbli) o Dettalji tal-popolazzjoni li għandha riskju ogħla ta' PML o Dettalji dwar kif jiġi mminimizzat ir-riskju ta' PML permezz ta' monitoraġġ u ġestjoni xierqa, inkluż monitoraġġ fil-laboratorji tal-linfoċiti u l-lewkoċiti qabel u matul il-kura, u kriterji għat-twaqqif tal-kura o Messaġġi ewlenin li għandhom jingħataw fl-għoti ta' pariri lill-pazjenti
English: Date of first authorisation: 23 june 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta' Ġunju 2017
English: Concurrent therapy with nephrotoxic substances (e.g. methotrexate, ciclosporin, aminoglycosides, diuretics, NSAIDs or lithium) may increase the potential for renal adverse reactions (e.g. proteinuria) in patients taking Skilarence.
Maltese: Terapija konkurrenti b'sustanzi nefrotossiċi (eż. methotrexate, ciclosporin, aminoglycosides, dijuretiċi, NSAIDs jew litju) tista' żżid il-potenzjal għal reazzjonijiet avversi renali (eż. proteinurja) fil-pazjenti li jkunu qed jieħdu Skilarence.
English: Further metabolism occurs through oxidation via the tricarboxylic acid cycle forming carbon dioxide and water.
Maltese: Iseħħ metaboliżmu ulterjuri permezz ta' ossidazzjoni miċ-ċiklu tal-aċidu trikarbossiliku, li jifforma diossidu tal-karbonju u ilma.
English: Skilarence is a medicine that contains the active substance dimethyl fumarate.
Maltese: Skilarence huwa mediċina li fiha s-sustanza attiva dimethyl fumarate.
English: Polska Almirall Sp.z o. o., Tel.: +48 22 330 02 57
Maltese: o., Tel.: +48 22 330 02 57
English: At week 16 of treatment, 13/175 (7.4%) of patients were noted to have lymphocyte levels <0.7x 10
Maltese: Wara ġimgħa 16 ta' kura, 13/175 (7.4 %) pazjent ġew innutati li kellhom livelli ta' linfoċiti <0.
English: What Skilarence 30 mg looks like and contents of the pack Skilarence 30 mg is a white, round tablet with a diameter of approximately 6.8 mm.
Maltese: Kif jidher Skilarence 30 mg u l-kontenut tal-pakkett Skilarence 30 mg huwa pillola bajda tonda b'dijametru ta' madwar 6.8 mm.
English: Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness.
Maltese: Ilprogressjoni tista' tinvolvi sintomi bħal polijurja, polidipsija u dgħufija prossimali fil-muskoli.
English: Non-inferiority of Skilarence vs. Fumaderm PASI 75, n (%) p-value
Maltese: Fumaderm PASI 75, n (%) valur-p b
English: What Skilarence 120 mg looks like and contents of the pack Skilarence 120 mg is a blue, round tablet with a diameter of approximately 11.6 mm.
Maltese: Kif jidher Skilarence 120 mg u l-kontenut tal-pakkett Skilarence 120 mg huwa pillola blu tonda b'dijametru ta' madwar 11.6 mm.
English: After oral administration of a single Skilarence 120 mg tablet in healthy subjects, monomethyl fumarate reached plasma peak concentrations of around 1325 ng/mL and 1311 ng/mL under fasted or fed conditions, respectively.
Maltese: Wara l-għoti mill-ħalq ta' Skilarence 120 mg pillola waħda f'suġġetti b'saħħithom, il-monomethyl fumarate laħaq konċentrazzjonijiet massimi tal-plażma ta' madwar 1325 ng/mL u 1311 ng/mL f'kundizzjonijiet ta' sawm jew wara l-ikel, rispettivament.
English: The NOAEL for maternal and embryo-foetal toxicity was 40 mg/kg/day, corresponding to 0.2-fold and 2.0-fold the human systemic exposure at the highest recommended dose (720 mg/day), as AUC and Cmax values, respectively.
Maltese: In-NOAEL għat-tossiċità materna u talembriju-fetu kien ta' 40 mg/kg/jum li jikkorrispondi 0.2 darbiet u 2.0 darbiet tal-espożizzjoni sistemika tal-bniedem fl-ogħla doża rakkomandata (720 mg/jum), bħala valuri ta' AUC u Cmax, rispettivament.
English: For monitoring recommendations and clinical management of adverse reactions, see section 4.4.
Maltese: Għal rakkomandazzjonijiet tal-monitoraġġ u ġestjoni klinika ta' reazzjonijiet avversi, ara sezzjoni 4.4.
English: The plasma protein binding of monomethyl fumarate is around 50%.
Maltese: Il-legar tal-proteina tal-plażma tal-monomethyl fumarate huwa ta' madwar 50%.
English: Pharmacotherapeutic group: Other immunosuppressants, ATC code: L04AX07
Maltese: Immunosuppressanti oħrajn, Kodiċi ATC:
English: Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Maltese: Skilarence hu indikat għall-kura ta' psorijażi severa tal-plakka fl-adulti bi bżonn ta' terapija sistemika bil-mediċina.
English: In vitro studies have shown that dimethyl fumarate at a therapeutic dose does not inhibit CYP3A4/5 and BCRP and is a weak P-glycoprotein inhibitor.
Maltese: Studji in vitro urew li dimethyl fumarate f'doża terapewtika ma jinibixxix CYP3A4/5 u BCRP u huwa inibitur dgħajjef ta' P-glycoprotein.
English: What Skilarence 120 mg contains - the active substance is dimethyl fumarate.
Maltese: X'fih Skilarence 120 mg - Is-sustanza attiva hi dimethyl fumarate.
English: Experience with related products containing dimethyl fumarate shows treatment benefit for at least up to 24 months.
Maltese: Esperjenza bi prodotti relatati li jkun fihom dimethyl fumarate turi benefiċċju tal-kura sa tal-inqas 24 xahar.
English: There is no evidence for Skilarence interaction with cytochrome P450 and the most common efflux and uptake transporters, thus no interactions are expected with medicinal products metabolised or transported by these systems (see section 5.2).
Maltese: M'hemm l-ebda evidenza għall-interazzjoni ta' Skilarence ma' ċitokromu P450 u għall-aktar trasportaturi komuni tal-efflus u tat-teħid, għalhekk mhi mistennija l-ebda interazzjoni bi prodotti mediċinali metabolizzati jew ittrasportati minn dawn is-sistemi (ara sezzjoni 5.2).
English: How to store Skilarence 6.
Maltese: Kif taħżen Skilarence 6.
English: The main activity of dimethyl fumarate and monomethyl fumarate is considered to be immunomodulatory, resulting in a shift in T helper cells (Th) from the Th1 and Th17 profile to a Th2 phenotype.
Maltese: L-attività ewlenija tal-dimethyl fumarate u l-monomethyl fumarate hija meqjusa immunomodulatorja, li tirriżulta f'bidla fiċ-ċelloli T helper (Th) mill-profil Th1 u Th17 għal fenotip Th2.
English: Tablet strength
Maltese: Tip ta' pillola
English: The no-observed adverse-effect-level (NOAEL) after 3 months of treatment was 30 mg/kg/day, which corresponds to 2.9-fold and 9.5-fold the human systemic exposure at the highest recommended dose (720 mg/day), as AUC and Cmax values, respectively.
Maltese: Il-livell bla effett ħażin osservat (NOAEL) wara 3 xhur ta' kura kien ta' 30 mg/kg/jum, li jikkorrispondi għal 2.9 darbiet u 9.5 darbiet tal-espożizzjoni sistemika tal-bniedem flogħla doża rakkomandata (720 mg/jum), bħala valuri ta' AUC u Cmax, rispettivament.
English: Skilarence tablets are used to treat moderate to severe plaque psoriasis in adults.
Maltese: Il-pilloli Skilarence jintużaw biex jikkuraw psorijażi moderata sa severa tal-plakka f'adulti.
English: There are no data available with Skilarence in paediatric patients.
Maltese: M'hemm l-ebda data disponibbli bi Skilarence f'pazjenti pedjatriċi.
English: During the Phase III placebo-controlled clinical trial, renal function was not seen to deteriorate during therapy across treatment groups.
Maltese: Matul il-prova klinika kkontrollata bil-plaċebo tal-Fażi III, il-funzjoni renali ma dehritx sejra għallagħar matul it-terapija fil-gruppi tal-kura.
English: Importantly, Fanconi syndrome can occur without elevated creatinine levels or low glomerular filtration rate.
Maltese: B'mod importanti, issindrome ta' Fanconi jista' jseħħ mingħajr żidiet fil-livelli tal-kreatinina jew rata tal-filtrazzjoni glomerulari baxxa.
English: The coating of the gastro-resistant tablets is designed to prevent gastric irritation.
Maltese: Il-kisja tal-pilloli gastroreżistenti hija mfassla biex tipprevjeni irritazzjoni gastrika.
English: EU/1/17/1201/001 EU/1/17/1201/002 EU/1/17/1201/003 EU/1/17/1201/004 EU/1/17/1201/005 EU/1/17/1201/006 EU/1/17/1201/007 EU/1/17/1201/008 EU/1/17/1201/009
Maltese: EU/1/17/1201/006 EU/1/17/1201/007 EU/1/17/1201/008 EU/1/17/1201/009 EU/1/17/1201/010
English: In the event of a clinically relevant change in renal function, particularly in the absence of alternative explanations, consideration should be given to dosage reduction or treatment discontinuation.
Maltese: F'każ ta' bidla klinikament relevanti fil-funzjoni renali, speċjalment fin-nuqqas ta' spjegazzjonijiet alternattivi, għandu jiġi kkunsidrat tnaqqis fid-dożaġġ jew waqfien tal-kura.
English: What Skilarence 30 mg contains - the active substance is dimethyl fumarate.
Maltese: X'fih Skilarence 30 mg - Is-sustanza attiva hi dimethyl fumarate.
English: One tablet contains 30 mg dimethyl fumarate.
Maltese: Kull pillola fiha 30 mg dimethyl fumarate.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: − Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: One tablet contains 120 mg dimethyl fumarate.
Maltese: Kull pillola fiha 120 mg dimethyl fumarate.
English: A transient increase in mean values of eosinophils was noted as early as week 3, reached a maximum at week 5 and 8, and had returned to baseline values at week 16.
Maltese: Ġiet osservata tendenza ta' żieda fil-valuri medji ta' esinofili sa kmieni minn ġimgħa 3 laħqet massimu f'ġimgħa 5 u 8, u reġgħu lura għal-valuri tal-linja bażi fil-ġimgħa 16.
English: The apparent terminal elimination half-life of monomethyl fumarate is about 2 hours.
Maltese: In-nofs ħajja apparenti tal-eliminazzjoni terminali tal-monomethyl fumarate hija ta' madwar sagħtejn.
English: Leukocytosis
Maltese: Lewkoċitożi
English: No dose adjustment is needed in patients with mild to moderate renal impairment (see section 5.2).
Maltese: Ma hemm bżonn ta' ebda aġġustament f'pazjenti b'indeboliment renali ħafif sa moderat (ara sezzjoni 5.2).
English: Eosinophilia
Maltese: Osinofilja
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-fojl wara “EXP”.
English: No dose adjustment is needed in patients with mild to moderate hepatic impairment (see section 5.2).
Maltese: Ma hemm bżonn ta' ebda aġġustament tad-doża f'pazjenti b'indeboliment epatiku ħafif sa moderat (ara sezzjoni 5.2).
English: Prior to launch of Skilarence in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Skilarence f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fisSuq (Marketing Authorisation Holder, MAH) għandu jaqbel fuq il-kontenut u l-format tal-programm edukattiv, li jinkludi midja ta' komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: However, because renal elimination plays a minor role in the total clearance from plasma, it is unlikely that renal impairment may affect the pharmacokinetic characteristics of Skilarence (see section 4.2).
Maltese: Madankollu, peress li leliminazzjoni renali għandha rwol minuri fl-ikklirjar totali mill-plażma, mhuwiex probabbli li lindeboliment renali jista' jaffettwa l-karatteristiċi farmakokinetiċi ta' Skilarence (ara sezzjoni 4.2).
English: Further studies have shown that dimethyl fumarate (and to a lesser extent monomethyl fumarate) reacts partially with reduced glutathione forming a glutathioneadduct.
Maltese: Studji ulterjuri wrew li dimethyl fumarate (u sa ċertu punt anqas monomethyl fumarate) jirreaġixxi parzjalment mal-glutatjon imnaqqas u jifforma addott tal-glutatjon.
English: White, film-coated, round, biconvex tablet with a diameter of approximately 6.8 mm. Skilarence 120 mg
Maltese: Pillola bajda, miksija b'rita, tonda, imżaqqa miż-żewġ naħat b'dijametru ta' madwar 6.8 mm.
English: Published clinical experience with dimethyl fumarate-containing products shows that individual episodes of flushing usually begin shortly after taking the tablets and resolve within a few hours.
Maltese: Esperjenza klinika ppubblikata bi prodotti li fihom dimethyl fumarate turi li episodji individwali ta' fwawar normalment jibdew ftit wara li jittieħdu l-pilloli u jkunu għaddew fi ftit sigħat.
English: Skilarence is for oral use.
Maltese: Skilarence huwa għal użu orali.
English: 704 patients were randomised to receive Skilarence, an active comparator (Fumaderm, a combination product with the same content of dimethyl fumarate plus 3 monoethyl fumarate salts) and placebo in a ratio of 2:2:1.
Maltese: Intgħażlu b'mod aleatorju 704 pazjent sabiex jingħataw Skilarence, komparatur attiv (Fumaderm, prodott ikkombinat bl-istess kontenut tal-dimethyl fumarate flimkien ma' 3 imluħ tal-monoethyl fumarate) u plaċebofi proporzjon ta' 2:2:1.
English: The following is a list of adverse reactions experienced by patients treated with Skilarence during the clinical study and with Fumaderm, a related medicinal product containing dimethyl fumarate along with other fumaric acid esters.
Maltese: Din li ġejja hija lista ta' reazzjonijiet avversi esperjenzati minn pazjenti kkurati bi Skilarence matul listudju kliniku u b'Fumaderm, prodott mediċinali relatat li jkun fih dimethyl fumarate flimkien ma' esteri tal-aċidu fumariku oħrajn.
English: In the event of a clinically relevant change in hepatic parameters, particularly in the absence of alternative explanations, consideration should be given to dose reduction or treatment discontinuation.
Maltese: F'każ ta' bidla klinikament relevanti fil-parametri epatiċi, speċjalment fin-nuqqas ta' spjegazzjonijiet alternattivi, għandu jiġi kkunsidrat tnaqqis fid-doża jew waqfien tal-kura.
English: At 12 months after stopping treatment 3/28 (10.7%) of patients had lymphocyte values below 1.0x10
Maltese: Wara 12-il xahar li twaqqfet il-kura 3/28 (10.7 %) tal-pazjenti kellhom valuri tal-linfoċiti taħt 1.0x10
English: It changes the activity of the immune system and reduces the production of substances involved in causing psoriasis.
Maltese: Din tibdel l-attività tas-sistema immuni u tnaqqas il-produzzjoni tas-sustanzi involuti li jikkawżaw il-psorijażi.