FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients taking Galvus in addition to insulin, with or without metformin, had a reduction in HbA1c levels of 0.77 percentage points, compared with 0.05 percentage points in patients taking placebo in addition to insulin.
Maltese: Il-pazjenti li kienu qed jieħdu Galvus flimkien malinsulina, bil-metformina jew mingħajrha, kellhom tnaqqis ta' 0.77 punti perċentwali fil-livelli ta' HbA1c, meta mqabbla ma' 0.05 punti perċentwali f'pazjenti li kienu qed jieħdu l-plaċebo flimkien mal-insulina.
English: In the study comparing Galvus with metformin, significantly better results were seen with metformin: a reduction in HbA1c of 1.5 percentage points after 52 weeks compared with a reduction of around 1 percentage point in patients treated with Galvus.
Maltese: Fl-istudju li qabbel lil Galvus mal-metformina, il-kura bil-metformina tat riżultati aħjar b'mod sinifikanti: tnaqqis fil-HbA1c b'1.5 punti perċentwali wara 52 ġimgħa meta mqabbla ma' tnaqqis ta' madwar punt perċentwal 1 f'pazjenti kkurati b'Galvus.
English: How has Galvus been studied?
Maltese: Kif ġie studjat Galvus?
English: Because vildagliptin has been associated with liver problems, patients should have tests to check their liver function before treatment with Galvus and at regular intervals during treatment.
Maltese: Billi l-vildagliptin kienet assoċjata ma' problemi fil-fwied, il-pazjenti għandhom jagħmlu testijiet talfwied qabel it-trattament b'Galvus u f'intervalli regolari matul it-trattament.
English: When used as an add-on to existing treatment for type 2 diabetes, Galvus was more effective than placebo in reducing HbA1c levels.
Maltese: Meta użat bħala terapija aġġuntiva mat-trattament eżistenti għad-dijabete tat-tip 2, irriżulta li Galvus kien aktar effikaċi minn plaċebo fit-tnaqqis tal-livelli tal-HbA1c.
English: For the full list of all side effects reported with Galvus, including side effects occurring when Galvus is taken with other antidiabetes medicines, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati bl-użu ta' Galvus, inklużi l-effetti tat-teħid ta' Galvus ma' mediċini antidijabetiċi oħrajn, ara l-fuljett ta' tagħrif.
English: A further study compared Galvus with placebo as an add-on treatment in 449 patients who were already taking a stable dose of long-acting insulin.
Maltese: Studju ieħor qabbel Galvus mal-plaċebo bħala trattament aġġuntiv f'449 pazjent li kienu diġà qed jirċievu doża stabbli tal-insulina li taħdem fit-tul.
English: Galvus has been studied in eleven main studies involving a total of over 5,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Maltese: Galvus ġie studjat ukoll f'disa' studji prinċipali li kienu jinvolvu total ta' aktar minn 5,000 pazjent li jbatu mid-dijabete tat-tip 2 u b'kontroll insuffiċjenti tal-livelli tal-glukożju fid-demm.
English: A further study compared Galvus with placebo as an add-on treatment in 318 patients who were already taking metformin and glimepiride.
Maltese: Studju ieħor qabbel Galvus mal-plaċebo bħala trattament aġġuntiv fi 318-il pazjent li kienu diġà qed jirċievu l-metformina u l-glimepiride.
English: By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi żżid il-livelli ta' ormoni inkretini fid-demm, ilvildagliptin tistimula l-frixa biex tipproduċi aktar insulina meta l-livelli tal-glukożju fid-demm ikunu għoljin.
English: Race/Ethnicity
Maltese: Razza/etniċità
English: (Primary endpoint)
Maltese: (Endpoint primarju)
English: • Reproductive toxicity:
Maltese: • Tossiċità riproduttiva:
English: Estimated CL/F (L/h)
Maltese: CL/F stmat (L/h)
English: Fertility and reproductive toxicity
Maltese: Fertilità u tossiċità riproduttiva
English: Herpes zoster
Maltese: Erpite zoster
English: Study A2304 (EXPAND) in SPMS
Maltese: Studju A2304 (EXPAND) f'SPMS
English: Siponimod Placebo
Maltese: Siponimod Plaċebo
English: Both are single nucleotide polymorphisms.
Maltese: It-tnejn huma polimorfiżmi nukleotidi singoli.
English: Mayzent contains the active substance siponimod.
Maltese: Mayzent fih is-sustanza attiva siponimod.
English: Siponimod is distributed to body tissues with a moderate mean volume of distribution of 124 litres.
Maltese: Siponimod jinfirex fit-tessuti tal-ġisem permezz ta' volum medju ta' distribuzzjoni moderata ta' 124 litru.
English: • Irregular heartbeat (atrioventricular block)
Maltese: • Taħbit tal-qalb irregolari (imblokk atrijoventrikulari)
English: Clinical endpoints
Maltese: Endpoints kliniċi
English: The absolute oral bioavailability of siponimod is approximately 84%.
Maltese: Il-bijodisponibbilità orali assoluta għal siponimod hi ta' madwar 84%.
English: • Convulsions, fits
Maltese: • Konvulżjonijiet, aċċessjonijiet
English: The test identifies two variant alleles for CYP2C9: CYP2C9*2 (rs1799853, c.430C>T) and CYP2C9*3 (rs1057910, c.1075A>C).
Maltese: It-test jidentifika żewġ varjazzjonijiet tal-alleli għal CYP2C9: CYP2C9*2 (rs1799853, c.430C>T) u CYP2C9*3 (rs1057910, c.1075A>C).
English: Table 2 Tabulated list of adverse reactions
Maltese: Tabella 2 Lista ta' reazzjonijiet avversi f'tabella
English: - Active malignancies.
Maltese: - Tumuri malinni attivi.
English: - Severe liver impairment (Child-Pugh class C).
Maltese: - Indeboliment tal-fwied gravi (Child-Pugh klassi Ċ).
English: MRI endpoints
Maltese: Endpoints tal-MRI
English: Atrioventricular conduction
Maltese: Trażmissjoni atrijoventrikulari
English: Patients who experienced bradycardia were generally asymptomatic.
Maltese: Pazjenti li kellhom bradikardija kienu normalment asintomatiċi.
English: • Pack containing 120 tablets
Maltese: • Pakkett li fih 120 pillola
English: Other medicines and Mayzent
Maltese: Mediċini oħra u Mayzent
English: Siponimod did not exert any phototoxic or dependence potential and was not genotoxic in vitro and in vivo.
Maltese: Siponimod ma weriex xi potenzjal fototossiku jew dipendenza u ma kienx ġenotossiku in vitro u in vivo.
English: • The other ingredients are: Tablet core: Lactose monohydrate (see “Mayzent contains lactose”), microcrystalline cellulose, crospovidone, glycerol dibehenate, colloidal anhydrous silica.
Maltese: Qalba tal-pillola: Lactose monohydrate (ara “Mayzent fih il-lattosju”), microcrystalline cellulose, crospovidone, glycerol dibehenate, colloidal anhydrous silica.
English: Bradycardia Atrioventricular block (first and second degree)
Maltese: Bradikardija Imblokk atrijuventrikulari (tal-ewwel u t-tieni grad)
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA42
Maltese: Immunosuppressanti, immunosuppressanti selettivi, Kodiċi ATC:
English: • Macular oedema:
Maltese: • Edima makulari:
English: Table 3 Clinical and MRI results of study A2304
Maltese: Tabella 3 Ir-riżultati kliniċi u tal-MRI fl-istudju A2304
English: Placebo (N=263)
Maltese: Plaċebo (N=263)
English: The effects of therapeutic (2 mg) and supratherapeutic (10 mg) doses of siponimod on cardiac repolarisation were investigated in a thorough QT study.
Maltese: (2 mg) u supraterapewtiċi (10 mg) ta' siponimod fuq ir-ripolarizzazzjoni kardijaka kienu investigati waqt studju ddettaljat tal-QT.
English: Compared to CYP2C9*1*1 subjects, individuals with the CYP2C9*2*2, *1*3, *2*3 and *3*3 genotypes have 20%, 35-38%, 45-48% and 74% smaller CL/F values, respectively.
Maltese: Imqabbel mas-suġġetti CYP2C9*1*1, individwi b'ġenotipi CYP2C9*2*2, *1*3, *2*3 u *3*3 għandhom il-valuri tasCL/F 20%, 35-38%, 45-48% u 74% iżgħar, rispettivament.
English: Bradyarrhythmia
Maltese: Bradirritmija
English: Risk of infections
Maltese: Riskju ta' infezzjonijiet
English: Proportion of patients with 4-point worsening in Symbol Digit Modality Test Risk reduction
Maltese: Proporzjon ta' pazjenti li marru għall-agħar b'4 punti fis-Symbol Digit Modality Test Tnaqqis fir-riskju
English: Potential to prolong the QT interval
Maltese: Potenzjal li jitwal l-intervall tal-QT
English: The median EDSS was 6.0 at baseline.
Maltese: L-EDSS medjan kien ta' 6.0 fil-linja bażi.
English: Siponimod exposure is therefore approximately 25%, 61%, 91% and 284% higher in CYP2C9*2*2, *1*3, *2*3 and *3*3 subjects, respectively, as compared to *1*1 subjects (see Table 4) (see sections 4.2 and 4.4).
Maltese: Għaldaqstant l-espożizzjoni ta' siponimod hi ta' madwar 25%, 61%, 91% u 284% ogħla fis-suġġetti CYP2C9*2*2, *1*3, *2*3 u *3*3, rispettivament, imqabbel mas-suġġetti *1*1 (ara Tabella 4) (ara sezzjonijiet 4.2 u 4.4).
English: The ARR (confirmed relapses) was reduced by 46% (ARR ratio 0.54; 95% CI: 0.39, 0.77) compared to placebo.
Maltese: L-ARR (rikaduti kkonfermati) tnaqqas b'46% (proporzjoni tal-ARR 0.54; 95% CI: 0.39, 0.77) imqabbel mal-plaċebo.
English: • Be familiar with the Mayzent Prescribing Information.
Maltese: • Kun midħla tal-Informazzjoni dwar il-Preskrizzjoni ta' Mayzent.
English: Mayzent is used to treat adults with secondary progressive multiple sclerosis (SPMS) with active disease.
Maltese: Mayzent jintuża biex jittratta adulti bi sklerożi multipla progressiva sekondarja (SPMS) bil-marda attiva.
English: CYP2C9 genotype
Maltese: Ġenotip CYP2C9
English: • Siponimod is contraindicated in patients with immunodeficiency syndrome.
Maltese: • Siponimod huwa kontraindikat f'pazjenti bis-sindrome tal-immunodefiċjenza.
English: • Bradyarrhythmia (including conduction defects) during treatment initiation:
Maltese: • Bradiarritimija (li tinkludi difetti ta' konduzzjoni) matul it-tnedija tat-trattament:
English: A very rare brain infection called progressive multifocal leukoencephalopathy (PML) can cause symptoms similar to SPMS.
Maltese: Infezzjoni rari ħafna fil-moħħ imsejħa lewkoenċefalopatija multifokali progressiva (PML) tista' tikkawża sintomi simili għall-SPMS.
English: Siponimod is a sphingosine-1-phosphate (S1P) receptor modulator.
Maltese: Siponimod huwa modulatur tar-riċettur tal-isfingosina-1-fosfat (S1P).
English: Antineoplastic, immune-modulating or immunosuppressive therapies
Maltese: Terapiji b'antineoplastiċi, immunomodulatorji jew b'immunosuppressivi
English: (95% CI: -1484, -843 mm 3) and 0.141% (95% CI: 0.020, 0.261%), respectively.
Maltese: 3) u 0.141% (95% CI: 0.020, 0.261%),
English: The co-administration of siponimod 2 mg daily in the presence of 600 mg daily doses of rifampin (strong CYP3A4 and moderate CYP2C9 inducer) decreased siponimod AUCtau,ss and Cmax,ss by 57% and 45%, respectively, in CY2C9*1*1 subjects.
Maltese: L-għoti flimkien ta' 2 mg siponimod kuljum fil-preżenza ta' dożi ta' 600 mg rifampin (induttur qawwi ta' CYP3A4 u moderat ta' CYP2C9) kuljum naqqas l-AUCtau,ss u s-Cmax,ss ta' siponimod b'57% u 45%, rispettivament, f'suġġetti CY2C9*1*1.
English: - During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6).
Maltese: - Matul it-tqala u f'nisa li jistgħu joħorġu tqal u mhux jużaw kontraċezzjoni effettiva (ara sezzjonijiet 4.4 u 4.6).
English: The immune system effects of siponimod may increase the risk of infections (see section 4.8).
Maltese: L-effetti ta' siponimod fuq is-sistema immuni jistgħu jżidu r-riskju ta' infezzjonijiet (ara sezzjoni 4.8).
English: Siponimod has not been studied in patients with arrhythmias requiring treatment with class Ia (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) antiarrhythmic medicinal products.
Maltese: Siponimod ma ġiex studjat f'pazjenti b'arritmija li jeħtieġu trattament bi prodotti mediċinali antiarritmiċi ta' klassi Ia (eż. quinidine, procainamide) jew ta' klassi III (eż. amiodarone, sotalol).
English: Bradyarrhythmic effects are more pronounced when siponimod is added to beta-blocker therapy.
Maltese: L-effetti bradirritmiċi jidhru aktar meta siponimod jiżdied ma' terapija b'imblukkatur beta.
English: The siponimod fraction found in plasma is 68% in humans.
Maltese: Ilfrazzjoni ta' siponimod misjuba fil-plażma hi ta' 68% fil-bnedmin.
English: Number of patients at risk
Maltese: Tnaqqis fir-riskju
English: Hazard ratio: 0.74, p=0.0058; (95% Cl: 0.60, 0.92); risk reduction: 26%
Maltese: Rata ta' periklu: 0.74, p=0.0058; (95% Cl: 0.60, 0.92); tnaqqis fir-riskju: 26%
English: In addition, the corresponding frequency category for each adverse drug reaction is based on 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).
Maltese: Barra minn hekk, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa tal-mediċina tissejjes fuq 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 <1/1,000); rari ħafna (<1/10,000).
English: Table 4 CYP2C9 genotype effect on siponimod CL/F and systemic exposure
Maltese: Tabella 4 L-effett tal-ġenotip CYP2C9 fuq is-CL/F ta' siponimod u l-espożizzjoni sistemika
English: • phototherapy with UV radiation or PUVA photochemotherapy.
Maltese: • fototerapija b'radjazzjoni UV jew fotokemjoterapija PUVA.
English: - Patients homozygous for CYP2C9*3 (CYP2C9*3*3) genotype (poor metaboliser).
Maltese: - Pazjenti omozigoti għall-ġenotip CYP2C9*3 (CYP2C9*3*3) (metabolizzatur dgħajjef).
English: Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity (see section 5.1).
Maltese: Mayzent huwa indikat bħala trattament għal pazjenti adulti bi sklerożi multipla progressiva sekondarja (SPMS) bil-marda attiva ppruvata permezz ta' rikaduti jew immaġinijiet bażilari li jixhdu attività infjammatorja (ara sezzjoni 5.1).
English: A significant reduction of siponimod exposure (by up to 76% and 51%, respectively) is expected under these conditions according to evaluation of the drug interaction potential using PBPK modelling.
Maltese: Hu mistenni tnaqqis qawwi fl-espożizzjoni ta' siponimod (sa 76% u 51%, rispettivament) taħt dawn ilkundizzjonijiet skont l-evalwazzjoni tal-interazzjoni tal-mediċina li jista' jkun hemm meta jintuża limmudellar PBPK.
English: In CYP2C9*2*2 patients, a 2.7-fold increase in the AUC of siponimod is expected in the presence of moderate CYP2C9/CYP3A4 inhibitors.
Maltese: F'pazjenti b'CYP2C9*2*2, hi mistennija żieda ta' 2.7 drabi fl-AUC ta' siponimod fil-preżenza ta' inibituri moderati ta' CYP2C9/CYP3A4.
English: Siponimod is metabolised primarily by cytochrome P450 2C9 (CYP2C9) (79.3%) and to a lesser extent by cytochrome P450 3A4 (CYP3A4) (18.5%).
Maltese: Siponimod hu mmetabolizzat primarjament biċ-ċitokromu P450 2C9 (CYP2C9) (79.3%) u b'ammont anqas biċ-ċitokromu P450 3A4 (CYP3A4) (18.5%).
English: Siponimod has not been studied in patients aged 65 years and above.
Maltese: Siponimod ma ġiex studjat f'pazjenti li għandhom 65 sena u aktar.
English: Siponimod binds selectively to two out of five G-protein-coupled receptors (GPCRs) for S1P, namely S1P1 and S1P5.
Maltese: Siponimod jeħel b'mod selettiv ma' tnejn mill-ħames riċetturi akkoppjati mal-proteina G (GPCRs) għal S1P, primarjament S1P1 u S1P5.
English: Change in cognitive processing speed on Symbol Digit Modality Test score was an exploratory endpoint.
Maltese: Il-bidla fil-ħeffa tal-ipproċessar konjittiv tal-punteġġ fis-Symbol Digit Modality Test kienet endpoint esploratorju.
English: Absolute lymphocyte counts <0.2 x 10
Maltese: Għadd assolut tal-limfoċiti ta' <0.2 x 10
English: Hazard ratio: 0.79, p=0.0134; (95% Cl: 0.65, 0.95); risk reduction: 21%
Maltese: Rata ta' periklu: 0.79, p=0.0134; (95% Cl: 0.65, 0.95); tnaqqis fir-riskju: 21%
English: Packs of 28 film-coated tablets in PA/alu/PVC/alu blisters.
Maltese: Pakketti ta' 28 pillola miksija b'rita f'folji PA/alu/PVC/alu.
English: Siponimod increased the placebo-corrected baseline-adjusted mean QTcF (ΔΔQTcF) by more than 5 ms, with a maximum mean effect of 7.8 ms (2 mg) and 7.2 ms (10 mg), respectively, at 3 h post-dose.
Maltese: Siponimod żied il-medja tal-QTcF korretta bil-plaċebo u aġġustata fil-linja bażi (ΔΔQTcF) b'aktar minn 5 ms, b'effett medju massimu ta' 7.8 ms (2 mg) u 7.2 ms (10 mg), rispettivament, fi 3 h wara d-doża.
English: Pulmonary function
Maltese: Funzjoni tal-pulmun
English: ALT levels returned to normal within approximately 1 month after discontinuation of siponimod (see section 4.4).
Maltese: Il-livelli tal-ALT reġgħu lura għan-normal fi żmien bejn wieħed u ieħor xahar wara ttwaqqif ta' siponimod (ara sezzjoni 4.4).
English: There is no specific antidote to siponimod available.
Maltese: M'hemmx antidotu speċifiku disponibbli għal siponimod.
English: • Siponimod is contraindicated in patients with history of progressive multifocal leukoencephalopathy or cryptococcal meningitis.
Maltese: • Siponimod huwa kontraindikat f'pazjenti bi storja ta' lewċoenċefalopatija multifokali progressiva jew meninġite kriptokokkali.
English: Siponimod was not studied in patients with significant QT prolongation (QTc >500 msec) or who were treated with QT-prolonging medicinal products.
Maltese: Siponimod ma ġiex studjat f'pazjenti b'titwil qawwi tal-QT (QTc >500 msek) jew li kienu ttrattati bi prodotti mediċinali li jtawlu l-QT.
English: • Mayzent is contraindicated in:
Maltese: • Mayzent huwa kontraindikat f':
English: The unbound siponimod pharmacokinetics AUC is 15% and 50% higher in subjects with moderate and severe hepatic impairment, respectively, in comparison with healthy subjects for the 0.25 mg single dose studied.
Maltese: Ilfarmakokinetiċi tal-AUC ta' siponimod mhux imwaħħal huma 15% u 50% ogħla fost suġġetti b'insuffiċjenza epatika moderata u gravi, rispettivament, imqabbel ma' suġġetti b'saħħithom għal doża waħda studjata ta' 0.25 mg.
English: Mayzent helps to protect the central nervous system (CNS) from attacks by the body's own immune system.
Maltese: Mayzent jgħinek tipproteġi s-sistema nervuża ċentrali (CNS) minn attakki mis-sistema immuni tal-ġisem tiegħek stess.
English: Primary efficacy endpoint:
Maltese: Endpoint primarju tal-effikaċja:
English: Packs of 120 film-coated tablets in PA/alu/PVC/alu blisters.
Maltese: Pakketti ta' 120 pillola miksija b'rita f'folji PA/alu/PVC/alu.
English: Siponimod treatment with single or multiple doses for 28 days is not associated with clinically relevant increases in airway resistance as measured by forced expiratory volume in 1 second (FEV1) and forced expiratory flow (FEF) during expiration of 25 to 75% of the forced vital capacity (FEF25-75%).
Maltese: It-trattament b'siponimod b'doża waħda jew multipla għal 28 jum mhuwiex assoċjat ma' żidiet relevanti klinikament fir-reżistenza tal-passaġġi respiratorji kif imkejjel fil-volum espiratorju sfurzat f'sekonda (FEV1) u fir-rata tal-fluss espiratorju sfurzat (FEF) matul l-espirazzjoni ta' 25 sa 75% tal-kapaċità vitali sfurzata (FEF25-75%).
English: Beta blockers
Maltese: Imblukkaturi beta
English: In the phase III clinical study, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) three times the upper limit of normal (ULN) was observed in 5.6% of patients treated with siponimod 2 mg compared to 1.5% of patients who received placebo (see section 4.8).
Maltese: III, kien hemm żieda ta' tliet darbiet tal-ogħla limitu tan-normal (ULN) flalanina aminotransferasi (ALT) jew fl-aspartat aminotransferasi (AST) f'5.6% tal-pazjenti ttrattati b'2 mg siponimod imqabbel ma' 1.5% tal-pazjenti mogħtija plaċebo (ara sezzjoni 4.8).
English: Additional exposure of 0.25 mg on day 5 does not compromise patient safety.
Maltese: Espożizzjoni addizzjonali ta' 0.25 mg fil-ħames jum ma jikkompromettix is-sigurtà tal-pazjent.
English: • lung function test results showing decreased function
Maltese: • riżultati tat-test tal-funzjoni tal-pulmun li juru funzjoni mnaqqsa
English: Difference in T2 lesion volume change
Maltese: Differenza fit-tibdil tal-volum tal-leżjoni T2
English: Siponimod is contraindicated in patients with severe liver impairment (Child-Pugh class C).
Maltese: Siponimod huwa kontraindikat f'pazjenti b'indeboliment gravi tal-fwied (Child-Pugh klassi Ċ).
English: Day 6
Maltese: Jum 6
English: Elderly patients (65 years of age and above)
Maltese: Pazjenti anzjani (65 sena u aktar)
English: The CYP2C9 genotype influences siponimod CL/F.
Maltese: Il-ġenotip CYP2C9 jinfluwenza s-CL/F ta' siponimod.
English: Siponimod concentration increases in an apparent dose proportional manner after multiple once-daily doses of siponimod 0.3 mg to 20 mg.
Maltese: Jidher li l-konċentrazzjoni ta' siponimod tiżdied proporzjonalment skont id-doża wara dożi multipli ta' 0.3 mg sa 20 mg siponimod darba kuljum.
English: An apparent systemic clearance (CL/F) of 3.11 l/h was estimated in MS patients.
Maltese: Kienet stmata tneħħija sistemika apparenti (CL/F) ta' 3.11 l/h f'pazjenti b'MS.
English: Intermediate metabolisers CYP2C9*2*2
Maltese: Metabolizzaturi intermedji CYP2C9*2*2
English: • Periodic safety update reports (PSURs) The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Interference with haematological testing
Maltese: Interferenza mal-ittestjar ematoloġiku
English: Siponimod causes a transient reduction in heart rate and atrioventricular conduction on treatment initiation (see sections 4.4 and 4.8), which is mechanistically related to the activation of G-protein-coupled inwardly rectifying potassium (GIRK) channels via S1P1 receptor stimulation leading to cellular hyperpolarisation and reduced excitability.
Maltese: Siponimod iwassal għal tnaqqis tranżitorju fir-rata tat-taħbit tal-qalb u fit-trażmissjoni atrijoventrikulari wara li jinbeda t-trattament (ara sezzjonijiet 4.4 u 4.8), li huwa relatat b'mod mekkanistiku mal-attivazzjoni talkanali tal-potassju rretifikanti 'l ġewwa akkopjati mal-proteina G (GIRK) permezz ta' stimulazzjoni tarriċettur S1P1 li twassal għal iperpolarizzazzjoni ċellulari u eċċitabbiltà mnaqqsa.
English: Extensive metabolisers CYP2C9*1*1
Maltese: Metabolizzaturi estensivi CYP2C9*1*1
English: Hazard ratio: 0.69 (95% Cl: 0.53, 0.91); risk reduction: 31%
Maltese: Rata ta' periklu: 0.69 (95% Cl: 0.53, 0.91); tnaqqis fir-riskju:
English: In the extension part of the phase III clinical study, a case of cryptococcal meningitis (CM) has been reported (see section 4.4).
Maltese: III, kien irrappurtat każ ta' menenġite kriptokokkali (CM) (ara sezzjoni 4.4).
English: Study A2304 was a randomised, double-blind, placebo-controlled, event and follow-up duration driven, phase III study in patients with SPMS who had documented evidence of progression in the prior 2 years in the absence or independent of relapses, no evidence of relapse in the 3 months prior to study enrolment and with a median Expanded Disability Status Scale (EDSS) score of 3.0 to 6.5 at study entry.
Maltese: III randomizzat, double-blind, ikkontrollat bil-plaċebo, dipendenti fuq kemm idum l-episodju u l-follow-up fost pazjenti b'SPMS li kellhom evidenza ddokumentata ta' progressjoni fis-sentejn ta' qabel fl-assenza ta' rikaduti jew indipendenti minn rikaduti, ma kellhom ebda evidenza ta' rikaduta fit-tliet xhur ta' qabel ma ssieħbu fl-istudju u li kellhom punteġġ medjan fl-Expanded Disability Status Scale (EDSS) ta' 3.0 sa 6.5 fil-mument ta' sħubija fl-istudju.
English: • Each tablet contains 0.25 mg siponimod (as siponimod fumaric acid).
Maltese: • Kull pillola fiha 0.25 mg siponimod (bħala aċidu fumariku siponimod).
English: • Cases of progressive multifocal leukoencephalopathy (PML) have been reported with another sphingosine 1-phosphate (S1P) receptor modulator.
Maltese: • Kienu rrappurtati każijiet ta' lewċoenċefalopatija multifokali progressiva (PML) flimkien ma' modulatur ieħor tar-riċettur tal-isfingosina-1-fosfat (S1P).