FrancophonIA/ELRC3.0 huggingface dataset:
English: In repeat-dose toxicity studies in mice, rats and monkeys, siponimod markedly affected the lymphoid system (lymphopenia, lymphoid atrophy and reduced antibody response), which is consistent with its primary pharmacological activity at S1P1 receptors (see section 5.1).
Maltese: Waqt studji dwar tossiċità minn dożi ripetuti fil-ġrieden, il-firien u fix-xadini, siponimod affettwa b'mod ċar is-sistema limfatika (limfopenija, atrofija limfatika u tnaqqis fir-rispons tal-antikorpi), li hu konsistenti malattività farmakoloġika primarja tiegħu skont ir-riċetturi ta' S1P1 (ara sezzjoni 5.1).
English: PBPK modelling indicates a differential CYP2C9 genotype-dependent inhibition and induction of CYP3A4 pathways.
Maltese: L-immudellar PBPK jindika inibizzjoni differenzjali dipendenti fuq il-ġenotip CYP2C9 u induzzjoni tal-mogħdijiet CYP3A4.
English: The relative rate reduction of cumulative number of Gd-enhancing T1 weighted lesions over 24 months was 85% (rate ratio 0.155; 95% CI: 0.104, 0.231) compared to placebo.
Maltese: Ir-rata relattiva ta' tnaqqis tal-għadd kumulattiv ta' leżjonijiet T1 miżuna li jidhru aħjar b'Gd tul 24 xahar kienet ta' 85% (il-proporzjon tar-rata 0.155; 95% CI: 0.104, 0.231) imqabbel mal-plaċebo.
English: Figure 2 Patients with 3- and 6-month CDP based on EDSS-Kaplan-Meier curvesSubgroup with active SPMS (full analysis set, study A2304)
Maltese: 2 Pazjenti b'CDP għal tliet u sitt xhur skont il-kurvaturi EDSS-Kaplan-Meier - Sottogrupp b'SPMS attiva (sett ta' analiżi sħiħa, studju A2304)
English: The study involved randomisation of 1,651 patients to either siponimod 2 mg (N=1,105) or placebo (N=546); 82% of patients treated with siponimod and 78% of placebo-treated patients completed the study.
Maltese: L-istudju kien jinvolvi għażla randomizzata ta' 1,651 pazjent mogħtija jew 2 mg siponimod (N=1,105) jew plaċebo (N=546); 82% tal-pazjenti ttrattati b'siponimod u 78% tal-pazjenti ttrattati bil-plaċebo temmew listudju.
English: • medicines for an irregular heartbeat, such as amiodarone, procainamide, quinidine or sotalol.
Maltese: • mediċini minħabba taħbit irregolari tal-qalb, bħalma huma amiodarone, procainamide, quinidine jew sotalol.
English: • swollen hands, ankles, legs or feet (peripheral oedema)
Maltese: • nefħa fl-idejn, għekiesi, saqajn jew riġlejn (edima periferali)
English: Placebo (N=546)
Maltese: Plaċebo (N=546)
English: Median age was 47 years, median disease duration was 15 years and median EDSS score at baseline was 6.0.
Maltese: L-età medjana kienet ta' 47 sena, id-dewmien medjan talmarda kien ta' 15-il sena u l-punteġġ medjan tal-EDSS fil-linja bażi kien ta' 6.0.
English: - Patients who in the previous 6 months had a myocardial infarction (MI), unstable angina pectoris, stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure (see section 4.4).
Maltese: - Pazjenti li fl-aħħar sitt xhur kellhom infart mijokardijaku (MI), anġina pettorali instabbli, puplesija/attakk iskemiku tranżitorju (TIA), insuffiċjenza tal-qalb dekompensata (li teħtieġ trattament l-isptar), jew insuffiċjenza tal-qalb fi klassi III/IV skont in-New York Heart Association (NYHA) (ara sezzjoni 4.4).
English: The pharmacological activity of the main metabolites M3 and M17 is not expected to contribute to the clinical effect and the safety of siponimod in humans.
Maltese: L-attività farmakoloġika tal-metaboliti ewlenin M3 u M17 mhux mistennija li jkollha sehem fl-effett kliniku u fis-sigurtà ta' siponimod fil-bnedmin.
English: • Titration pack as wallet containing 12 tablets, and
Maltese: • Pakkett ta' titrazzjoni bħala pokit li fih 12-il pillola, u
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lattosju jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Hazard ratio: 0.63 (95% Cl: 0.47, 0.86); risk reduction: 37%
Maltese: Rata ta' periklu: 0.63 (95% Cl: 0.47, 0.86); tnaqqis fir-riskju:
English: • Each tablet contains 2 mg siponimod (as siponimod fumaric acid).
Maltese: • Kull pillola fiha 2 mg siponimod (bħala aċidu fumariku siponimod).
English: Time to onset of 3-month and 6-month CDP was significantly delayed for siponimod, with reduction in risk of 3-month CDP by 21% compared to placebo (hazard ratio [HR] 0.79, p=0.0134) and reduction in risk of 6-month CDP by 26% compared to placebo (HR 0.74, p=0.0058).
Maltese: Iż-żmien sakemm kien hemm CDP għal tliet xhur u sitt xhur ittardja b'ħafna b'siponimod, bi tnaqqis firriskju ta' CDP għal tliet xhur ta' 21% imqabbel mal-plaċebo (rata ta' periklu [HR] 0.79, p=0.0134) u tnaqqis fir-riskju ta' CDP għal sitt xhur ta' 26% imqabbel mal-plaċebo (HR 0.74, p=0.0058).
English: • Perform genotyping for CYP2C9 before treatment initiation to determine the siponimod maintenance dose.
Maltese: • Wettaq ġenotipazzjoni għal CYP2C9 qabel it-tnedija tat-trattament sabiex tiddetermina d-doża ta' manutenzjoni ta' siponimod.
English: Do not use this medicine after the expiry date which is stated on the carton/blister foil after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna/il-folja wara “EXP”.
English: In the phase III clinical study in patients with SPMS the overall rate of infections was comparable between the patients on siponimod and those on placebo (49.0% versus 49.1%, respectively).
Maltese: III fost pazjenti b'SPMS ir-rata totali ta' infezzjonijiet kienet komparabbli bejn il-pazjenti mogħtija siponimod u dawk mogħtija plaċebo (49.0% kontra 49.
English: Each film-coated tablet contains siponimod fumaric acid equivalent to 0.25 mg siponimod.
Maltese: Kull pillola miksija b'rita fiha aċidu fumariku siponimod ekwivalenti għal 0.25 mg siponimod.
English: The recommended maintenance dose is 1 mg daily in patients with a CYP2C9*2*3 genotype (1.4-1.7% of the population) and in patients with a *1*3 genotype (9-12% of the population) to avoid increased exposure to siponimod (see sections 4.2 and 5.2).
Maltese: Id-doża ta' manutenzjoni rrakkomandata hi ta' 1 mg kuljum f'pazjenti bil-ġenotip CYP2C9*2*3 (2.4-1.7% tal-popolazzjoni) u f'pazjenti bil-ġenotip *1*3 (9-12% tal-popolazzjoni) biex tkun evitata żieda fl-espożizzjoni għal siponimod (ara sezzjonijiet 4.2 u 5.2).
English: Macular oedema
Maltese: Edima makulari
English: CYP2C9 and CYP3A4 inducers
Maltese: Inibituri CYP2C9 u CYP3A4
English: Mayzent contains lactose and soya lecithin
Maltese: Mayzent fih il-lattosju u l-leċitina tas-soja
English: % exposure increase versus CYP2C9*1*1
Maltese: % ta' żieda flespożizzjoni kontra CYP2C9*1*1
English: Patients homozygous for CYP2C9*3 (CYP2C9*3*3 genotype: approximately 0.3 to 0.4% of the population) should not be treated with siponimod.
Maltese: Pazjenti omozigoti għallġenotip CYP2C9*3 (CYP2C9*3*3: madwar 0.3 sa 0.4% tal-popolazzjoni) m'għandhomx jingħataw trattament b'siponimod.
English: Mayzent 0.25 mg film-coated tablets are available in the following pack sizes:
Maltese: Il-pilloli miskija b'rita Mayzent 0.25 mg huma disponibbli fid-daqsijiet tal-pakketti li ġejjin:
English: Total and unbound AUCs were only slightly increased (by 23 to 33%) compared to healthy subjects.
Maltese: L-AUCs totali u mhux imwaħħla żdiedu biss bi ftit (bi 23 sa 33%) imqabbel mas-suġġetti b'saħħithom.
English: Each tablet contains 0.25 mg siponimod (as fumaric acid).
Maltese: Kull pillola fiha 0.25 mg siponimod (bħala aċidu fumariku).
English: Two population pharmacokinetic analyses indicated that CYP2C9*1*1 and *1*2 subjects behave as extensive metabolisers, *2*2 and *1*3 subjects as intermediate metabolisers and *2*3 and *3*3 subjects as poor metabolisers.
Maltese: Żewġ analiżijiet farmakokinetiċi tal-popolazzjoni indikaw li s-suġġetti CYP2C9*1*1 u *1*2 iġibu ruħhom bħala metabolizzaturi estensivi, is-suġġetti *2*2 u *1*3 bħala metabolizzaturi intermedji u s-suġġetti *2*3 u *3*3 bħala metabolizzaturi dgħajfa.
English: Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), talc, soya lecithin, xanthan gum.
Maltese: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), talc, soya lecithin, xanthan gum.
English: The co-administration of fluconazole (moderate CYP2C9/strong CYP3A4 inhibitor) 200 mg daily at steady state and a single dose of siponimod 4 mg in healthy volunteers with a CYP2C9*1*1 genotype led to a 2-fold increase in the area under the curve (AUC) of siponimod.
Maltese: L-għoti flimkien ta' 200 mg flunconazole (inibitur moderat ta' CYP2C9/qawwija ta' CYP3A4) kuljum f'qagħda stabbli ma' doża waħda ta' 4 mg siponimod f'voluntiera b'saħħithom b'ġenotip CYP2C9*1*1 wassal għal żieda doppja fiż-żona taħt il-kurva (AUC) ta' siponimod.
English: Mayzent 2 mg film-coated tablets are available in packs containing 28 tablets.
Maltese: Il-pilloli miskija b'rita Mayzent 2 mg huma disponibbli f'pakketti li fihom 28 pillola.
English: Blood pressure should be regularly monitored during treatment with siponimod.
Maltese: Il-pressjoni tad-demm għandha tiġi mmonitorata regolarment waqt it-trattament b'siponimod.
English: Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc, soya lecithin, xanthan gum.
Maltese: Polyvinyl alcohol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc, soya lecithin, xanthan gum.
English: These may be symptoms of a condition called posterior reversible encephalopathy syndrome (PRES).
Maltese: Dawn jistgħu jkunu sintomi ta' kundizzjoni msejħa sindrome enċefalopatika riversibbli posterjuri (PRES).
English: • Patients who, in the previous 6 months, had a myocardial infarction, unstable angina pectoris, stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring in-patient treatment), or New York Heart Association (NYHA) class III/IV heart failure.
Maltese: • Pazjenti li, fl-aħħar sitt xhur, kellhom infart mijokardijaku, anġina pettorali instabbli, puplesija/attakk iskemiku tranżitorju (TIA), insuffiċjenza kardijaka ddekompensata (li teħtieġ trattament l-isptar), jew insuffiċjenza kardijaka klassi III/IV skont il-New York Heart Association (NYHA).
English: Each tablet contains 2 mg siponimod (as fumaric acid).
Maltese: Kull pillola fiha 2 mg siponimod (bħala aċidu fumariku).
English: Minor reductions in forced expiratory volume in 1 second (FEV1) and in the diffusing capacity of the lung for carbon monoxide (DLCO) values were observed with siponimod treatment.
Maltese: Kien osservat tnaqqis żgħir fil-volum espiratorju sfurzat f'sekonda (FEV1) u fil-kapaċità tal-pulmun ta' tixrid tal-valuri tal-monossidu tal-karbonju (DLCO) waqt it-trattament b'siponimod.
English: The single-dose pharmacokinetic parameters were not different between Japanese and Caucasian healthy subjects, indicating absence of ethnic sensitivity on the pharmacokinetics of siponimod.
Maltese: Il-parametri tal-farmakokinetika ta' doża waħda ma kenux differenti bejn suġġetti b'saħħithom Ġappuniżi u Kawkażjatiċi, li jindika nuqqas ta' sensittività etnika fuq il-farmakokinetiċi ta' siponimod.
English: A slight trend of reduced FEV1 was detected at non-therapeutic single doses (>10 mg).
Maltese: Dehret tendenza żgħira ta' FEV1 imnaqqas meta mogħtija dożi singoli mhux terapewtiċi (>10 mg).
English: Figure 1 Patients with 3- and 6-month CDP based on EDSS-Kaplan-Meier curves (full analysis set, study A2304)
Maltese: Figura 1 Pazjenti b'CDP għal tliet u sitt xhur skont il-kurvaturi EDSS-Kaplan-Meier (sett ta' analiżi sħiħa, studju A2304)
English: Animal studies have demonstrated siponimod-induced embryotoxicity and foetotoxicity in rats and rabbits and teratogenicity in rats, including embryo-foetal deaths and skeletal or visceral malformations at exposure levels comparable to the human exposure at the daily dose of 2 mg (see section 5.3).
Maltese: Studji fl-annimali wrew tossiċità lill-embrijun u lill-fetu ta' firien u fniek u teratoġeniċità fil-firien minħabba siponimod, inkluż imwiet ta' embrijuni u feti u malformazzjonijiet skeletriċi jew vixxerali f'livelli ta' espożizzjoni komparabbli mal-espożizzjoni fil-bniedem b'doża ta' 2 mg kuljum (ara sezzjoni 5.3).
English: Siponimod treatment should be suspended until CM has been excluded.
Maltese: It-trattament b'siponimod għandu jitwaqqaf sakemm ma tkunx eskluża CM.
English: In clinical studies, second-degree AV blocks, usually Mobitz type I (Wenckebach), have been observed in less than 1.7% of patients at the time of treatment initiation.
Maltese: Fi studji kliniċi, dehru mblokki AV tattieni grad, normalment tat-tip Mobitz I (Wenckebach), f'anqas minn 1.7% tal-pazjenti fil-perjodu tat-tnedija tat-trattament.
English: - Patients with a history of second-degree Mobitz type II atrioventricular (AV) block, third-degree AV block, sino-atrial heart block or sick-sinus syndrome, if they do not wear a pacemaker (see section 4.4).
Maltese: - Pazjenti bi storja ta' imblokk atrijoventrikulari (AV) tat-tip Mobitz II tat-tieni grad, imblokk AV tattielet grad, imblokk sinoatrijali tal-qalb jew is-sindrome tas-sinus marid, jekk ma jġorrux pacemaker (ara sezzjoni 4.4).
English: The addition of propranolol on top of siponimod pharmacokinetic/pharmacodynamic steady state had less pronounced negative chronotropic effects (less than additive) in comparison to addition of siponimod on top of propranolol pharmacokinetic/pharmacodynamic steady state (additive HR effect).
Maltese: Iż-żieda ta' propranolol fuq il-qagħda stabbli farmakokinetika/farmakodinamika ta' siponimod kellha anqas effetti kronotropiċi negattivi qawwijin (anqas milli miżjudin) imqabbla maż-żieda ta' siponimod fuq il-qagħda stabbli farmakokinetika/farmakodinamika ta' propranolol (effett HR miżjud).
English: If PML is suspected, siponimod treatment should be suspended until PML has been excluded.
Maltese: Jekk hemm suspett ta' PML, it-trattament b'siponimod għandu jitwaqqaf sakemm ma tkunx eskluża PML.
English: Seizures were reported in 1.7% of patients treated with siponimod compared to 0.4% on placebo in the phase III clinical study in patients with SPMS.
Maltese: L-aċċessjonijiet kienu rrappurtati f'1.7% tal-pazjenti ttrattati b'siponimod imqabbel ma' 0.4% mogħtija lplaċebo waqt l-istudju kliniku f'fażi
English: • Infections, including varicella zoster reactivation, reactivation of the other viral infections, PML and other rare opportunistic infections:
Maltese: • Infezzjonijiet, li jinkludu l-attivazzjoni mill-ġdid tal-variċella zoster, attivazzjoni mill-ġdid talinfezzjonijiet virali l-oħrajn, PML u infezzjonijiet opportunistiċi rari oħrajn:
English: The exposure levels (AUC) at the respective NOAELs for embryofoetal (rats and rabbits) and pre/postnatal (rats) development were below the human systemic exposure (AUC) at a daily dose of 2 mg and consequently no safety margin exists.
Maltese: Il-livelli ta' espożizzjoni (AUC) fl-NOAELs rispettivi għall-iżvilupp embrijofetali (firien u fniek) u pre/postnatali (firien) kienu taħt l-espożizzjoni sistemika (AUC) fil-bniedem b'doża ta' 2 mg kuljum u bħala konsegwenza m'hemm l-ebda marġini ta' sigurtà.
English: With decreased CYP2C9 metabolic activity in the respective genotypes, a larger effect of the CYP3A4 perpetrators on siponimod exposure is anticipated (see section 4.5).
Maltese: Bi tnaqqis fl-attività metabolika ta' CYP2C9 fil-ġenotipi rispettivi, hu mbassar li jkun hemm effett akbar tal-perpetraturi CYP3A4 fuq lespożizzjoni ta' siponimod (ara sezzjoni 4.5).
English: Liver function tests
Maltese: Tnaqqis fit-test tal-funzjoni tal-pulmun
English: - if you have ever had progressive multifocal leukoencephalopathy or cryptococcal meningitis.
Maltese: - Storja ta' lewkoenċefalopatija multifokali progressiva jew meninġite kriptokokkali.
English: Prior treatment with immunosuppressive or immune-modulating therapies
Maltese: Trattament minn qabel b'terapiji b'immunosuppressivi jew immunomodulatorji
English: Titration packs of 12 film-coated tablets in PA/alu/PVC/alu blister in wallet.
Maltese: Pakketti ta' titrazzjoni ta' 12-il pillola miksija b'rita f'folja PA/alu/PVC/alu f'pokit.
English: Treatment starts with 0.25 mg once daily on days 1 and 2, followed by once-daily doses of 0.5 mg on day 3, 0.75 mg on day 4, and 1.25 mg on day 5, to reach the patient's prescribed maintenance dose of siponimod starting on day 6 (see Table 1).
Maltese: It-trattament jibda b'0.25 mg darba kuljum fl-ewwel u t-tieni ġurnata, segwiti b'dożi waħda kuljum ta' 0.5 mg fit-tielet ġurnata, 0.75 mg fir-raba' ġurnata, u 1.25 mg fil-ħames ġurnata, biex tintlaħaq id-doża ta' manutenzjoni ta' siponimod preskritta għall-pazjent fis-sitt ġurnata (ara Tabella 1).
English: • While on treatment, women must not become pregnant.
Maltese: • Waqt li għaddej it-trattament, in-nisa ma jistgħux joħorġu tqal.
English: The safety and efficacy of siponimod in children and adolescents aged 0 to 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' siponimod fit-tfal u l-adolexxenti minn età 0 sa 18-il sena għadhom ma ġewx determinati s'issa.
English: • Fever, sore throat and/or mouth ulcers due to infection (lymphopenia)
Maltese: • Deni, grieżem ħomor u/jew ulċeri fil-ħalq minħabba infezzjoni (limfopenija)
English: Nausea Diarrhoea Musculoskeletal and connective tissue disorders Common
Maltese: Dardir Dijarrea Disturbi muskoluskeletriċi u tat-tessuti konnettivi Komuni
English: With continued daily dosing, the lymphocyte count continues to decrease, reaching a nadir median (90% CI) lymphocyte count of approximately 0.560 (0.271-1.08) cells/nL in a typical CYP2C9*1*1 or *1*2 non-Japanese SPMS patient, corresponding to 20-30% of baseline.
Maltese: Billi titkompla tingħata d-doża kuljum, l-għadd tal-limfoċiti jkompli jinżel, u jilħaq l-għadd medjan ta' limfoċiti min-nadir (90% CI) ta' madwar 0.560 (0,271-1.08) ċelluli/nL f'pazjent b'SPMS mhux Ġappuniż b'CYP2C9*1*1 jew *1*2 tipiku, li jikkorrispondi għal 20-30% tal-linja bażi.
English: The upper bound of the one-sided 95% CI for the ΔΔQTcF at all time points remained below 10 ms. Categorical analysis revealed no treatment-emergent QTc values above 480 ms, no QTc increases from baseline of more than 60 ms and no corrected or uncorrected QT/QTc value exceeded 500 ms.
Maltese: Analiżi kategorika ma wriet l-ebda valur tal-QTc emerġenti mittrattament 'il fuq minn 480 ms, l-ebda żidiet fil-QTc mil-linja bażi ta' aktar minn 60 ms u l-ebda valur talQT/QTc korrett jew mhux korrett li jaqbeż il-500 ms.
English: • Patients with a history of second-degree Mobitz type II atrioventricular (AV) block, third-degree AV block, sino-atrial heart block or sick sinus syndrome, if they do not wear a pacemaker.
Maltese: • Pazjenti bi storja ta' imblokk atrijoventrikulari (AV) tat-tip Mobitz II tat-tieni grad, imblokk AV tat-tielet grad, imblokk sinoatrijali tal-qalb jew is-sindrome tas-sinus marid, jekk ma jġorrux pacemaker.
English: The atrioventricular conduction delays manifested in most of the cases as first-degree atrioventricular (AV) blocks (prolonged PR interval on electrocardiogram).
Maltese: Id-dewmien fit-trażmissjoni atrijoventrikulari deher f'bosta mill-każijiet ta' mblokki atrijoventrikulari (AV) tal-ewwel grad (intervall PR imtawwal fuq l-elettrokardjogramma).
English: Time to 6-month CDP versus placebo
Maltese: Żmien sa CDP għal sitt xhur kontra plaċebo
English: Table 1 Dose titration regimen to reach maintenance dosage
Maltese: Tabella 1 Titrazzjoni tar-reġim tad-doża sabiex tintlaħaq id-doża ta' manutenzjoni
English: • Perform liver function tests prior to initiating siponimod treatment.
Maltese: • Wettaq testijiet tal-funzjoni tal-fwied qabel ma jinbeda t-trattament b'siponimod.
English: MAINTENANCE
Maltese: MANUTENZJONI
English: Siponimod can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.
Maltese: Normalment siponimod jista' jinbeda minnufih wara li jitwaqqfu l-interferon beta jew il-glatiramer aċetat.
English: Mean siponimod half-life and Cmax (total and unbound) were comparable between subjects with severe renal impairment and healthy subjects.
Maltese: Il-half-life medja u s-Cmax ta' siponimod (totali u mhux imwaħħal) kienu komparabbli bejn issuġġetti b'insuffiċjenza renali gravi u suġġetti b'saħħithom.
English: Protein binding of siponimod is >99.9% in healthy subjects and in patients with hepatic or renal impairment.
Maltese: It-twaħħil ta' siponimod mal-proteini hu ta' >99.9% f'suġġetti b'saħħithom u f'pazjenti b'insuffiċjenza epatika jew renali.
English: In vitro investigations indicated that siponimod and its major systemic metabolites M3 and M17 do not show any clinically relevant drug-drug interaction potential at the therapeutic dose of 2 mg once daily for all investigated CYP enzymes and transporters, and do not necessitate clinical investigation.
Maltese: Investigazzjonijiet in vitro wrew li siponimod u l-metaboliti sistemiċi ewlenin tiegħu M3 u M17 ma jurux xi interazzjoni potenzjali relevanti klinikament bejn mediċina u oħra b'dożi terapewtiċi ta' 2 mg darba kuljum għall-enzimi u t-trasportaturi kollha ta' CYP mistħarrġa, u ma jeħtiġux investigazzjoni klinika.
English: Mayzent 2 mg film-coated tablets siponimod
Maltese: Mayzent 2 mg pilloli miksija b'rita siponimod
English: • Exercise caution when administering concomitant treatment with anti-neoplastic, immune-modulating or immunosuppressive therapies (including corticosteroids) due to the risk of additive immune system effects.
Maltese: • Oqgħod attent meta tagħti trattament flimkien ma' terapiji antineoplastiċi, immunomodulanti jew immunosuppressivi (li jinkludu kortikosterojdi) minħabba r-riskju ta' effetti miżjuda fuq issistema immuni.
English: During treatment initiation siponimod should not be concomitantly used in patients receiving class Ia (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) anti-arrhythmic medicinal products, QT-prolonging medicinal products with known arrhythmogenic properties, heart-rate-lowering calcium channel blockers (such as verapamil or diltiazem) or other substances that may decrease heart rate (e.g. ivabradine or digoxin) because of the potential additive effects on heart rate (see section 4.4).
Maltese: Waqt it-tnedija tat-trattament siponimod m'għandux jingħata lil pazjenti li diġà qed jirċievu prodotti mediċinali antiarritmiċi ta' klassi Ia (eż. quinidine, procainamide) jew klassi III (eż. amiodarone, sotalol), prodotti mediċinali li jtawlu l-QT u għandhom proprjetajiet arritmoġeniċi magħrufin, imblukkaturi tal-kanal tal-kalċju li jbaxxu r-rata tat-taħbit tal-qalb (bħalma huma verapamil jew diltiazem) jew sustanzi oħrajn li jistgħu jnaqqsu r-rata tat-taħbit tal-qalb (eż. ivabradine jew digoxin) minħabba l-effetti miżjuda li jista' jkun hemm fuq ir-rata tat-taħbit tal-qalb (ara sezzjoni 4.4).
English: If PML is suspected, treatment should be suspended until PML has been excluded.
Maltese: Jekk hemm suspett ta' PML, għandu jitwaqqaf it-trattament sakemm il-PML ikunu esklużi.
English: • if you have high blood pressure that cannot be controlled by medicines.
Maltese: • jekk għandek pressjoni għolja tad-demm li ma tistax tikkontrollaha bil-mediċini.
English: On chronic treatment, this reduction did not translate into clinically significant adverse events and was not associated with an increase in reports of cough or dyspnoea (see section 5.1).
Maltese: Waqt trattament kroniku, dan it-tnaqqis ma ssarrafx f'episodji avversi qawwija klinikament u ma kienx assoċjat ma' żieda fl-għadd ta' rapporti ta' sogħla jew deni (ara sezzjoni 5.1).
English: • Due to the potential teratogenic risk of siponimod women of childbearing potential should:
Maltese: • Minħabba r-riskju teratoġeniku li jista' jkun hemm minħabba siponimod nisa li jistgħu joħorġu tqal għandhom: