FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment initiation recommendation in patients with certain pre-existing cardiac conditions As a precautionary measure, patients with the following cardiac conditions should be observed for a period of 6 hours after the first dose of siponimod for signs and symptoms of bradycardia (see also section 4.3): - sinus bradycardia (heart rate <55 bpm), - history of first- or second-degree [Mobitz type I] AV block, - history of myocardial infarction, or - history of heart failure (patients with NYHA class I and II).
Maltese: Rakkomandazzjoni biex jitnieda t-trattament f'pazjenti li diġà għandhom ċerti kundizzjonijiet kardijaċi Bħala miżura ta' prekawzjoni, il-pazjenti li għandhom il-kundizzjonijiet kardijaċi li ġejjin għandhom ikunu osservati għal sitt sigħat wara l-ewwel doża ta' siponimod għal sinjali u sintomi ta' bradikardija (ara wkoll sezzjoni 4.3): - bradikardija tas-sinus (rata tat-taħbit tal-qalb ta' <55 bpm), - storja ta' imblokk AV tal-ewwel jew it-tieni grad [tip Mobitz I], - storja ta' infart mijokardijaku, jew - storja ta' insuffiċjenza tal-qalb (pazjenti b'NYHA klassi I u II).
English: The receptor affected by siponimod (sphinosine-1-phosphate receptor) is known to be involved in vascular formation during embryogenesis.
Maltese: Ir-riċettur affettwat minn siponimod (riċettur tal-isfingosina-1-fosfat) huwa magħruf li għandu sehem filformazzjoni vaskulari waqt l-embrijoġenesi.
English: Macular oedema with or without visual symptoms was more frequently reported on siponimod (1.8%) than on placebo (0.2%) in the phase III clinical study (see section 4.8).
Maltese: Edima makulari b'sintomi viżivi jew mingħajrhom kienu rrappurtati b'aktar frekwenza b'siponimod (1.8%) milli bil-plaċebo (0.2%) waqt l-istudju kliniku f'fażi III (ara sezzjoni 4.8).
English: Stopping siponimod therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Siponimod did not affect male and female fertility in rats up to the highest dose tested, representing an approximate 19-fold safety margin based on human systemic exposure (AUC) at a daily dose of 2 mg.
Maltese: Siponimod ma affettwax il-fertilità tal-firien irġiel u nisa meta ttestjat sal-ogħla doża, li tirrappreżenta madwar 19-il darba aktar mill-marġni ta' sigurtà skont l-espożizzjoni sistemika umana (AUC) b'doża ta' 2 mg kuljum.
English: For 2 mg siponimod given once daily over 10 days, a mean Cmax of 30.4 ng/ml and mean AUCtau of 558 h*ng/ml were observed on day 10.
Maltese: F'każ ta' 2 mg siponimod mogħtija darba kuljum għal għaxart ijiem, is-Cmax medju ta' 30.4 ng/ml u l-AUCtau medja ta' 558 h*ng/ml dehru fl-għaxar jum.
English: Siponimod may be combined with most types of CYP2C9 and CYP3A4 inducers.
Maltese: Siponimod jista' jingħata ma' bosta tipi ta' indutturi ta' CYP2C9 u CYP3A4.
English: CYP2C9 is polymorphic and the genotype influences the fractional contributions of the two oxidative metabolism pathways to overall elimination.
Maltese: CYP2C9 hu polimorfiku u l-ġenotip jinfluwenza l-kontribuzzjonijiet frazzjonali taż-żewġ mogħdijiet talmetaboliżmu ossidattiv sal-eliminazzjoni sħiħa.
English: Oedema peripheral Asthenia
Maltese: Edima periferali
English: This reduces the recirculation of T cells into the central nervous system (CNS) to limit central inflammation.
Maltese: Dan inaqqas iċ-ċirkulazzjoni mill-ġdid taċ-ċelluli T fis-sistema nervuża ċentrali (CNS) biex tkun limitata l-infjammazzjoni ċentrali.
English: Siponimod has not been studied in combination with antineoplastic, immune-modulating or immunosuppressive therapies.
Maltese: Siponimod ma ġiex studjat meta mogħti flimkien ma' terapiji b'antineoplastiċi, immunomodulatorji jew b'immunosuppressivi.
English: Mayzent 0.25 mg film-coated tablets Mayzent 2 mg film-coated tablets siponimod
Maltese: Informazzjoni għall-pazjent Mayzent 0.25 mg pilloli miksija b'rita Mayzent 2 mg pilloli miksija b'rita siponimod
English: CYP2C9 is a polymorphic enzyme and the drug-drug interaction (DDI) effect in the presence of CYP3A or CYP2C9 perpetrator drugs is predicted to be dependent on the CYP2C9 genotype.
Maltese: CYP2C9 hu enzim polimorfiku u hu mbassar li l-effett tattaħlit bejn mediċina u oħra (DDI) fil-preżenza tal-mediċini perpetraturi CYP3A jew CYP2C9 jistrieħ fuq ilġenotip CYP2C9.
English: Siponimod is contraindicated in patients with active malignancies.
Maltese: Siponimod huwa kontraindikat f'pazjenti b'malinni attivi.
English: Mayzent 0.25 mg film-coated tablets Mayzent 2 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Mayzent 0.25 mg pilloli miksija b'rita Mayzent 2 mg pilloli miksija b'rita
English: Melanocytic naevus
Maltese: Frekwenza fost il-Kawkażjatiċi
English: While in rats a higher number of foetuses with external, skeletal and visceral malformations (e.g. cleft palate and misshapen clavicles, cardiomegaly and oedema) were noted, in rabbit foetuses skeletal and visceral variations were predominantly observed.
Maltese: Filwaqt li fil-firien kien innutat numru ogħla ta' feti b'malformazzjonijiet esterni, skeletriċi u vixxerali (eż. saqaf talħalq mixquq u deformazzjonijiet klavikoli, kardjomegalija u edima), fil-fniek kienu osservati b'mod predominanti varjazzjonijiet skeletriċi u vixxerali fil-feti.
English: • Novartis has put in place a PRegnancy outcomes Intensive Monitoring (PRIM) programme, which is a registry based on enhanced follow-up mechanisms to collect information about pregnancy in patients exposed to siponimod immediately before or during pregnancy and on infant outcomes 12 months post-delivery.
Maltese: • Novartis fasslet il-programm PRegnancy outcomes Intensive Monitoring (PRIM), li huwa reġistru msejjes fuq mekkaniżimi msaħħa ta' follow-up sabiex tinġabar informazzjoni dwar ittqala f'pazjenti esposti għal siponimod eżatt qabel it-tqala jew waqtha u fi trabi sa 12-il xahar wara l-ħlas.
English: A core pharmacodynamic effect of siponimod is a dose-dependent reduction of the peripheral lymphocyte count to 20-30% of baseline values.
Maltese: Effett farmakodinamiku ewlieni ta' siponimod huwa t-tnaqqis fl-għadd tal-limfoċiti periferali għal 20-30% mill-valuri fil-linja bażi bis-saħħa tad-doża.
English: In study A2304, basal cell carcinoma was the most common neoplasm and was reported with a similiar incidence in the siponimod 2 mg (1.01%, 12 patients) and placebo (1.23%, 7 patients) groups.
Maltese: Fl-istudju A2304, il-karċinoma taċ-ċellula bażali kienet l-aktar neoplażma komuni u kienet irrappurtata blistess inċidenza fil-gruppi mogħtija 2 mg siponimod (1.01%, 12-il pazjent) u plaċebo (1.23%, seba' pazjenti).
English: Siponimod belongs to a group of medicines called sphingosine-1-phosphate (S1P) receptor modulators.
Maltese: Siponimod jagħmel parti minn grupp ta' mediċini msejħa modulaturi tar-riċettur tal-isfingosina-1-fosfat (S1P).
English: Excipient with known effect Each tablet contains 57.3 mg lactose (as monohydrate) and 0.092 mg soya lecithin.
Maltese: Kull pillola fiha 57.3 mg lattosju (bħala monoidrat) u 0.
English: Mayzent 0.25 mg film-coated tablets siponimod
Maltese: Mayzent 0.25 mg pilloli miksija b'rita siponimod
English: Co-administration with siponimod did not reveal clinically relevant effects on the pharmacokinetics and pharmacodynamics of the combined ethinylestradiol and levonorgestrel oral contraceptive.
Maltese: L-għoti flimkien ma' siponimod ma kixef l-ebda effett relevanti klinikament fuq il-farmakokinetiċi u lfarmakodinamiċi tal-kontraċettiv orali magħmul minn ethinylestradiol u levonorgestrel flimkien.
English: The apparent elimination half-life of siponimod is approximately 30 hours.
Maltese: Il-half-life apparenti taleliminazzjoni ta' siponimod hi ta' madwar 30 siegħa.
English: Titration dose
Maltese: Doża ta' titrazzjoni
English: • medicines that slow down the heartbeat, such as diltiazem or verapamil (which belong to a group of medicines called calcium channel blockers), digoxin or ivabradine.
Maltese: • mediċini li jbaxxu t-taħbit tal-qalb, bħalma huma diltiazem jew verapamil (li jagħmlu parti minn grupp ta' mediċini msejħa mblukkaturi tal-kanal tal-kalċju), digoxin jew ivabradine.
English: Key secondary endpoints were time to 3-month confirmed worsening of at least 20% from baseline in the timed 25-foot walk test (T25W) and change from baseline in T2 lesion volume.
Maltese: Proporzjon ta' pazjenti b'żieda kkonfermata ta' 20% fit-test ta' 25 pass imkejjel bil-ħin għal tliet xhur
English: Your doctor will decide to stop treatment (see “If you stop taking Mayzent” in section 3).
Maltese: It-tabib tiegħek se jiddeċiedi li jitwaqqaf it-trattament (ara “Jekk tieqaf tieħu Mayzent” f'sezzjoni 3).
English: In patients with a CYP2C9*2*3 or *1*3 genotype, the recommended maintenance dose is 1 mg taken once daily (four tablets of 0.25 mg) (see sections 4.4 and 5.2).
Maltese: Fil-każ ta' pazjenti b'ġenotip CYP2C9*2*3 jew *1*3, id-doża ta' manutenzjoni rrakkomandata hi ta' 1 mg meħuda darba kuljum (erba' pilloli ta' 0.25 mg) (ara sezzjonijiet 4.4 u 5.2).
English: Based on clinical pharmacology studies, no dose adjustment is needed in patients with renal impairment (see section 5.2).
Maltese: Skont studji kliniċi farmakoloġiċi, mhuwiex meħtieġ aġġustament tad-doża f'pazjenti b'indeboliment talkliewi (ara sezzjoni 5.2).
English: The most common adverse drug reactions are headache (15%) and hypertension (12.6%).
Maltese: L-aktar reazzjonijiet avversi komuni tal-mediċina huma l-uġigħ ta' ras (15%) u l-pressjoni għolja (12.6%).
English: According to evaluation of the drug interaction potential using physiologically based pharmacokinetic (PBPK) modelling, a maximum of a 2-fold increase in the AUC of siponimod is predicted across genotypes with any type of CYP3A4 and CYP2C9 inhibitors except for patients with a CYP2C9*2*2 genotype.
Maltese: Skont l-evalwazzjoni tal-potenzjal ta' interazzjoni tal-mediċina bl-użu ta' mmudellar farmakokinetiku bbażat fuq il-fiżjoloġija (PBPK), qed titbassar żieda massima doppja fl-AUC ta' siponimod fost il-ġenotipi bi kwalunkwe tip ta' inibitur ta' CYP3A4 u CYP2C9 ħlief għal pazjenti bil-ġenotip CYP2C9*2*2.
English: • Mayzent is not recommended in:
Maltese: • Mayzent mhuwiex irrakkomandat f':
English: In the subgroup of patients (n=827) without signs and symptoms of disease activity (defined as patients without relapse in the 2 years prior to the study and without presence of Gd-enhancing T1 lesions at baseline), effects on 3-month and 6-month CDP were small (risk reductions were 7% and 13%, respectively).
Maltese: Fis-sottogrupp ta' pazjenti (n=827) mingħajr sinjali u sintomi tal-marda attiva (iddefiniti bħala pazjenti mingħajr rikaduta fis-sentejn ta' qabel l-istudju u mingħajr leżjonijiet T1 li jidhru aħjar b'Gd fil-linja bażi), leffetti ta' CDP għal 3 xhur u 6 xhur kienu żgħar (it-tnaqqis fir-riskju kien ta' 7% u 13%, rispettivament).
English: • Initiate treatment with a titration pack that lasts for 5 days.
Maltese: • Ibda t-trattament b'pakkett ta' titrazzjoni li jdum ħamest ijiem.
English: Patient/Caregiver Guide:
Maltese: Gwida għall-Pazjent/Kuratur:
English: Treatment with siponimod resulted in an increase of systolic and diastolic blood pressure starting early after treatment initiation, reaching maximum effect after approximately 6 months of treatment (systolic 3 mmHg, diastolic 1.2 mmHg) and staying stable thereafter.
Maltese: It-trattament b'siponimod wassal għal żieda fil-pressjoni sistolika u dijastolika tad-demm li dehret bikri wara t-tnedija tat-trattament, u li laħqet l-effett massimu wara madwar sitt xhur ta' trattament (sistolika 3 mmHg, dijastolika 1.2 mmHG) u baqgħet stabbli minn dak iż-żmien 'l hemm.
English: Macular oedema was more frequently reported in patients receiving siponimod (1.8%) than in those given placebo (0.2%).
Maltese: L-edima makulari kienet irrappurtata b'aktar frekwenza fost pazjenti mogħtija siponimod (1.8%) milli f'dawk mogħtija plaċebo (0.2%).
English: A case of cryptococcal meningitis (CM) has been reported for siponimod.
Maltese: Kien irrappurtat każ ta' meninġite kriptokokkali (CM) waqt siponimod.
English: • Siponimod is contraindicated during pregnancy and in women of childbearing potential not using effective contraception.
Maltese: • Siponimod huwa kontraindikat għal waqt it-tqala u għal nisa li jistgħu joħorġu tqal u li mhumiex qed jużaw kontraċezzjoni effettiva.
English: Anti-arrhythmic medicinal products, QT-prolonging medicinal products, medicinal products that may decrease heart rate
Maltese: Prodotti mediċinali antiarritmiċi, prodotti mediċinali li jtawlu l-QT, prodotti mediċinali li jistgħu jnaqqsu rrata tat-taħbit tal-qalb
English: Hypertension was more frequently reported in patients on siponimod (12.6%) than in those given placebo (9.0%) in the phase III clinical study in patients with SPMS.
Maltese: Il-pressjoni għolja kienet rrappurtata b'aktar frekwenza fil-pazjenti mogħtija siponimod (12.6%) milli f'dawk mogħtija plaċebo (9.0%) waqt l-istudju kliniku f'fażi
English: Start treatment with 0.25 mg on day 1, up-titrated to the maintenance dose of 2 mg or 1 mg on day 6 based on the CYP2C9 metaboliser status.
Maltese: Ibda t-trattament b'0.25 mg flewwel jum, b'titrazzjoni 'l fuq sa ma tintlaħaq id-doża ta' manutenzjoni ta' 2 mg jew 1 mg fissitt jum skont il-qagħda tal-metabolizzatur ta' CYP2C9.
English: Annualised relapse rate (ARR) Rate reduction
Maltese: Rata ta' rikaduta fis-sena (ARR) Tnaqqis fir-rata
English: • Do not prescribe siponimod in patients homozygous for CYP2C9*3*3.
Maltese: • Tagħtix siponimod għall-omozigoti tal-pazjenti għal CYP2C9*3*3.
English: 120 film-coated tablets
Maltese: 120 pillola miksija b'rita
English: Bradycardia was reported in 6.2% of patients treated with siponimod compared to 3.1% on placebo and AV block in 1.7% of patients treated with siponimod compared to 0.7% on placebo (see section 4.4).
Maltese: Il-bradikardija kienet irrappurtata f'6.2% tal-pazjenti ttrattati b'siponimod imqabbel ma' 3.1% mogħtija l-plaċebo u l-imblokk AV f'1.7% talpazjenti ttrattati b'siponimod imqabbel ma' 0.7% mogħtija l-plaċebo (ara sezzjoni 4.4).
English: Mayzent 2 mg film-coated tablets
Maltese: Mayzent 2 mg pilloli miksija b'rita
English: • Should a pregnancy occur during treatment or within 10 days following discontinuation of treatment with siponimod, it should be immediately reported to the doctor or to Novartis by calling [insert local number] or visiting [insert URL], irrespective of adverse outcomes observed.
Maltese: • Jekk ikun hemm tqala waqt it-trattament jew fi żmien 10 ijiem mit-twaqqif tat-trattament b'siponimod, jekk jogħġbok irrapporta li Novartis billi ċċempel fuq [daħħal in-numru tattelefown lokali] jew iżżur is-sit elettroniku [daħħal il-URL], irrispettivament mir-riżultati avversi osservati.
English: Average cumulative number of Gd-enhancing T1 weighted lesions (95% CI) Rate reduction
Maltese: Għadd kumulattiv medju ta' leżjonijiet T1 miżuna li jidhru aħjar b'Gd (95% CI) Tnaqqis fir-rata
English: If resting heart rate is ≤50 bpm, then beta-blocker treatment should be interrupted until the baseline heart rate is >50 bpm.
Maltese: ≤50 bpm, mela t-trattament b'imblukkatur beta għandu jitwaqqaf sakemm il-linja bażi tar-rata tat-taħbit talqalb ma tkunx ta' >50 bpm.
English: Excipient with known effect Each tablet contains 59.1 mg lactose (as monohydrate) and 0.092 mg soya lecithin.
Maltese: Kull pillola fiha 59.1 mg lattosju (bħala monoidrat) u 0.
English: Titration pack
Maltese: Pakkett ta' titrazzjoni
English: From Cox modelling for time to progression
Maltese: Mill-immudellar Cox saż-żmien ta' progressjoni Minn mudell ta' episodji rikorrenti
English: Multiple doses of siponimod were associated with mild to moderate changes in FEV1 and FEF25-75% which were not dose- and daytime-dependent and were not associated with any clinical signs of increased airway resistance.
Maltese: Dożi multipli ta' siponimod kienu assoċjati ma' tibdiliet ħfief sa moderati fl-FEV1 u FEF25-75% li ma kenux dipendenti fuq id-doża u l-ħin tal-ġurnata u ma kenux assoċjati ma' xi sinjali kliniċi ta' żieda firreżistenza tal-passaġġi respiratorji.
English: o QTc prolongation >500 msec o Severe untreated sleep apnoea o History of symptomatic bradycardia o History of recurrent syncope o Uncontrolled hypertension o Concomitant treatment with class Ia (e.g. quinidine, procainamide) or class III anti-arrhythmic medications, calcium channel blockers (such as verapamil, diltiazem) and other medications (e.g. ivabradine or digoxin)
Maltese: Trattament flimkien ma' terapiji b'antineoplastiċi, immunomodulatorji jew b'immunosuppressivi Terapiji b'antineoplastiċi, immunomodulatorji jew b'immunosuppressivi (li jinkludu kortikosterojdi) għandhom jingħataw flimkien b'kawtela minħabba r-riskju ta' effetti addittivi fuq is-sistema immuni waqt ittali terapija (ara sezzjoni 4.5).
English: In patients with CYP2C9*2*3 or *1*3 genotype, the recommended maintenance dose is 1 mg taken once daily (4 x 0.25 mg) (see above and sections 4.4 and 5.2).
Maltese: Fil-każ ta' pazjenti b'ġenotip CYP2C9*2*3 jew *1*3, id-doża ta' manutenzjoni rrakkomandata hi ta' 1 mg meħuda darba kuljum (4 x 0.25 mg) (ara hawn fuq u s-sezzjonijiet 4.4 u 5.2).
English: Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported for another sphingosine 1-phosphate (S1P) receptor modulator.
Maltese: Kienu rrappurtati każijiet rari ta' sindrome ta' enċefalopatija posterjuri riversibbli (PRES) għal modulatur ieħor tar-riċettur tal-isfingosina-1-fosfat (S1P).
English: % of CYP2C9*1*1 CL/F
Maltese: % ta' CL/F f'CYP2C9*1*1
English: Siponimod must not be used in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Maltese: Siponimod m'għandux jintuża ma' pazjenti b'indeboliment tal-fwied gravi (Child-Pugh klassi Ċ) (ara sezzjoni 4.3).
English: This is due to the reversible sequestration of lymphocytes in lymphoid tissues (see section 5.1).
Maltese: Dan iseħħ minħabba s-sekwestrazzjoni riversibbli tal-limfoċiti f'tessuti limfatiċi (ara sezzjoni 5.1).
English: Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of another S1P receptor modulator.
Maltese: Tħarrix gravi tal-marda, inkluż rikaduta tal-marda, rari ġie rrappurtat wara li twaqqaf modulatur ieħor tarriċettur S1P.
English: In both species, prenatal mortality was increased.
Maltese: Fiż-żewġ speċijiet, żdiedet il-mortalità prenatali.
English: Change from baseline in T2 lesion volume (mm
Maltese: Bidla mil-linja bażi fil-volum tal-leżjoni T2 (mm
English: In healthy subjects, the single maximum tolerated dose was determined to be 25 mg based upon the occurrence of symptomatic bradycardia after single doses of 75 mg. A few subjects received unintended doses of up to 200 mg daily for 3 to 4 days and experienced asymptomatic mild to moderate transient elevations of liver function tests.
Maltese: F'suġġetti b'saħħithom, ġie deċiż li d-doża massima singola ttollerata tkun 25 mg u dan skont il-frekwenza ta' bradikardija sintomatika wara dożi singoli ta' 75 mg.
English: On day 6, you will switch to your regular treatment dose.
Maltese: Fis-sitt jum, se tgħaddi għad-doża regolari tiegħek ta' trattament.
English: Pregnant women should be advised of potential serious risks to the foetus, and ultrasonography examinations should be performed.
Maltese: Nisa tqal għandhom ikunu mgħarrfa dwar ir-riskji serji li jista' jkun hemm għall-fetu, u għandhom jitwettqu eżamijiet ultrasonografiċi.
English: Time to onset of 3-month and 6-month CDP was significantly delayed in siponimod-treated patients with active disease, by 31% compared to placebo (hazard ratio [HR] 0.69; 95% CI: 0.53, 0.91) and by 37% compared to placebo (HR 0.63; 95% CI: 0.47, 0.86), respectively.
Maltese: u b'37% imqabbel mal-plaċebo (HR 0.63; 95% CI: 0.47, 0.86), rispettivament.
English: Titration pack 12 film-coated tablets 120 film-coated tablets
Maltese: Pillola miksija b'rita Pakkett ta' titrazzjoni 12-il pillola miksija b'rita 120 pillola miksija b'rita
English: The tablets contain soya lecithin.
Maltese: Il-pilloli fihom il-leċitina tas-soja.
English: Your doctor may instruct you to take only 1 mg once daily (four 0.25 mg tablets) if the blood test performed before the start of treatment showed that your body breaks down Mayzent slowly (see “Tests before and during treatment”).
Maltese: It-tabib tiegħek jaf jgħidlek sabiex tieħu 1 mg darba kuljum (erba' pilloli tal-0.25 mg) jekk it-test tad-demm li sar qabel ma nbeda t-trattament wera li ġismek ikisser Mayzent bilmod (ara “Testijiet qabel it-trattament u waqtu”).
English: • If a woman becomes pregnant while on treatment with siponimod, treatment must be discontinued.
Maltese: • Jekk mara toħroġ tqila waqt li għaddejja bit-trattament b'siponimod, it-trattament għandu jitwaqqaf.
English: 9/l in a patient already receiving siponimod 1 mg should lead to interruption of siponimod therapy until the level reaches 0.6 x 10 9/l when re-initiation of siponimod can be considered.
Maltese: 9/l f'pazjent li diġà jingħata 1 mg siponimod għandu jwassal sabiex titwaqqaf itterapija b'siponimod sakemm il-livell ma jilħaqx 0.6 x 10
English: Tests before and during treatment
Maltese: Testijiet qabel it-trattament u waqtu
English: However, an increase in the rate of herpes zoster infections was reported on siponimod (2.5%) compared to placebo (0.7%).
Maltese: Madanakollu, kienet irrappurtata żieda fir-rata ta' infezzjonijiet minn erpite zoster fost dawk mogħtija siponimod (2.5%) mqabbel ma' dawk mogħtija plaċebo (0.7%).
English: Patients were randomised 2:1 to receive either once-daily siponimod 2 mg or placebo.
Maltese: Il-pazjenti ntgħażlu b'mod randomizzat 2:1 biex jirċievu jew 2 mg siponimod darba kuljum jew plaċebo.
English: The results did not suggest an arrhythmogenic potential related to QT prolongation with siponimod.
Maltese: Ir-riżultati ma jissuġġerixxux potenzjal arritmoġeniku relatat mat-titwil tal-QT b'siponimod.
English: Carcinogenicity
Maltese: Kanċeroġenità
English: The main target organs of toxicity in rodents included the lung, liver, thyroid, kidney and uterus/vagina.
Maltese: L-organi ewlenin milquta minn tossiċità fir-rodenti kienu jinkludu l-pulmun, il-fwied, it-tirojde, il-kliewi u l-utru/il-vaġina.
English: • Adjust the maintenance dose to 1 mg in patients with CYP2C9*2*3 or *1*3 genotypes.
Maltese: • Aġġusta d-doża ta' manutenzjoni għal 1 mg f'pazjenti b'ġenotipi ta' CYP2C9*2*3 jew *1*3.
English: Potential of other medicinal products to affect siponimod pharmacokinetics
Maltese: Il-potenzjal li prodotti mediċinali oħrajn jaffettwaw il-farmakokinetiċi ta' siponimod
English: Siponimod absorption is extensive (≥70%, based on the amount of radioactivity excreted in urine and the amount of metabolites in faeces extrapolated to infinity).
Maltese: L-assorbiment ta' siponimod hu estensiv (≥70%, skont l-ammont ta' radjuattività li tgħaddi mal-awrina u l-ammont ta' metaboliti fl-ippurgar estrapolati għall-infinit).
English: In rare cases, the test result may indicate that you should not take Mayzent.
Maltese: F'każijiet rari, ir-riżultat tat-test jista' jindika li m'għandekx tieħu Mayzent.
English: In patients with a CYP2C9*3*3 genotype, siponimod should not be used (see sections 4.3, 4.4 and
Maltese: F'każ ta' pazjenti b'ġenotip CYP2C9*3*3, siponimod m'għandux jintuża (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: • if you have symptoms such as sudden onset of severe headache, confusion, seizures and vision changes.
Maltese: • jekk għandek sintomi bħal uġigħ ta' ras qawwi f'daqqa, konfużjoni, aċċessjonijiet u tibdiliet fil-vista.
English: • Rash with small fluid-filled blisters, appearing on reddened skin (symptoms of a viral infection called herpes zoster that can be severe)
Maltese: • Raxx bi nfafet żgħar mimlijin bi fluwidu, li jidher fuq ġilda ħamra (sintomi ta' infezzjoni virali msejħa erpite zoster li taf tkun gravi)
English: This genotyping can be done using a Sanger sequencing method or PCR-based assay methods.
Maltese: Din il-ġenotipazzjoni tista' ssir billi jintuża l-metodu sekwenzjali Sanger jew il-metodi ta' provi msejsa fuq il-PCR.