FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms reported included sudden onset of severe headache, nausea, vomiting, altered mental status, visual disturbances and seizure.
Maltese: Sintomi rrappurtati kienu jinkludu bidu f'daqqa ta' uġigħ ta' ras qawwi, dardir, rimettar, stat mentali alterat, disturbi fil-vista u aċċessjonijiet.
English: Study D2302 (TRANSFORMS) was a 1-year randomised, double-blind, double-dummy, active (interferon beta-1a)-controlled Phase III study of 1,280 patients (n=429 on 0.5 mg, 420 on 1.25 mg, 431 on interferon beta-1a, 30 µg by intramuscular injection once weekly).
Maltese: L-istudju D2302 (TRANSFORMS) kien studju randomizzat ta' sena f'Fażi III, double-blind, doubledummy, ikkontrollat b'mod attiv (interferon beta-1a) fost 1,280 pazjent (n=429 b'0.5 mg, 420 b'1.25 mg, 431 b'interferon beta-1a, 30 μg permezz ta' injezzjoni intramuskulari kull ġimgħa).
English: Hypertension was reported in 6.5% of patients on fingolimod 0.5 mg and in 3.3% of patients on placebo.
Maltese: Kienet irrappurtata pressjoni għolja f'6.5% tal-pazjenti mogħtija 0.5 mg fingolimod u fi 3.3% tal-pazjenti mogħtija plaċebo.
English: In total, 920 patients entered (n=331 continued on 0.5 mg, 289 continued on 1.25 mg, 155 switched from placebo to 0.5 mg and 145 switched from placebo to 1.25 mg).
Maltese: B'kollox, 920 pazjent daħlu (n=331 komplew fuq 0.5 mg, 289 komplew fuq 1.25 mg, 155 għaddew minn plaċebo għal 0.5 mg u 145 għaddew minn plaċebo għal 1.25 mg).
English: Further analyses of clinical trial data demonstrate consistent treatment effects in highly active subgroups of relapsing remitting multiple sclerosis patients.
Maltese: Aktar analiżi tad-dejta minn provi kliniċi turi effetti ta' kura konsistenti f'sottogruppi ta'pazjenti bi sklerożi multipla attiva ħafna li tirkadi u tbatti.
English: Vascular disorders
Maltese: Episodji vaskulari
English: Study D2301 (FREEDOMS) was a 2-year randomised, double-blind, placebo-controlled Phase III study of 1,272 patients (n=425 on 0.5 mg, 429 on 1.25 mg, 418 on placebo).
Maltese: L-Istudju D2301 (FREEDOMS) kien studju randomizzat ta' sentejn f'Fażi III, double-blind, ikkontrollat bi plaċebo u li sar fost 1,272 pazjent (n=425 b'0.5 mg, 429 b'1.25 mg, 418 bi plaċebo).
English: In the controlled paediatric trial D2311 (see section 5.1), the safety profile in paediatric patients (10 to below 18 years of age) receiving fingolimod 0.25 mg or 0.5 mg daily was overall similar to that seen in adult patients.
Maltese: Waqt il-prova D2311 ikkontrollata fost pazjenti pedjatriċi (ara s-sezzjoni 5.1), il-profil ta' sigurtà f'pazjenti pedjatriċi (minn 10 snin sa taħt it-18-il sena) mogħtija 0.25 mg jew 0.5 mg fingolimod kuljum kien kollox ma' kollox jixbah lil dak li deher f'pazjenti adulti.
English: Consequently, fingolimod is contraindicated during pregnancy (see section 4.3).
Maltese: Konsegwentament, fingolimod huwa kontraindikat għal waqt it-tqala (ara sezzjoni 4.3).
English: Study D2311 (PARADIGMS) was a double-blind, double-dummy, active-controlled study with flexible duration up to 24 months, with 215 patients 10 to <18 years old (n=107 on fingolimod, 108 on interferon beta-1a 30 µg by intramuscular injection once weekly).
Maltese: L-istudju D2311 (PARADIGMS) kien studju double-blind, double-dummy, ikkontrollat bl-attiv bi żmien flessibbli sa 24 xahar, b'215-il pazjent minn 10 snin sa <18-il sena (n=107 fuq fingolimod, 108 fuq interferon beta-1a 30 µg permezz ta' injezzjoni fil-muskoli darba fil-ġimgħa).
English: PVC/PVDC/aluminium perforated unit dose blister packs containing 7x 1 hard capsules.
Maltese: PVC/PVDC/pakketti b'folji pperforati tal-aluminju li fihom 7x 1 kapsuli iebsin.
English: Due to the long half-life of natalizumab, elimination usually takes up to 2-3 months following discontinuation.
Maltese: Minħabba l-half-life twila ta' natalizumab, l-eliminazzjoni normalment tieħu sa xahrejn-3 xhur wara li jitwaqqaf.
English: Fingolimod is eliminated by oxidative biotransformation catalysed mainly via CYP4F2 and possibly other isoenzymes and subsequent fatty acid-like degradation to inactive metabolites.
Maltese: Fingolimod jitneħħa bilbijotrasformazzjoni ossidattiva katalizzata l-aktar permezz ta' CYP4F2 u possibilment isoenzimi oħra u d-degradazzjoni sussegwenti ta' dawk li jixbhu lix-xaħmijiet aċidużi f'metaboliti inattivi.
English: Fingolimod-phosphate concentration at steady state is approximately 25% lower in paediatric patients (10 years of age and above) following daily administration of 0.25 mg or 0.5 mg fingolimod compared to the concentration in adult patients treated with fingolimod 0.5 mg once daily.
Maltese: Il-konċentrazzjoni ta' fingolimod-fosfat fi stat wieqaf hi ta' madwar 25% anqas f'pazjenti pedjatriċi (minn 10 snin 'il fuq) wara l-għoti ta' 0.25 mg jew 0.5 mg fingolimod kuljum imqabbel malkonċentrazzjoni f'pazjenti adulti ttrattati b'fingolimod 0.5 mg darba kuljum.
English: Second-degree atrioventricular block was detected in less than 0.2% adult patients on Gilenya 0.5 mg.
Maltese: Deher imblokk atrijoventrikulari tat-tieni grad f'anqas minn 0.2% tal-pazjenti adulti mogħtija 0.5 mg Gilenya.
English: Increased hepatic enzymes, in particular alanine aminotransaminase (ALT) but also gamma glutamyltransferase (GGT) and aspartate transaminase (AST) have been reported in multiple sclerosis patients treated with Gilenya.
Maltese: Żieda fl-enzimi tal-fwied, b'mod partikolari alanine aminotransaminase (ALT) iżda ukoll gamma glutamyltransferase (GGT) u aspartate transaminase (AST) kienet irrappurtata f'pazjenti bi sklerożi multipla kkurati b'Gilenya.
English: Tumefactive lesions
Maltese: Feriti tumefattivi
English: For DLCO the reductions at month 24 were 3.3% for fingolimod 0.5 mg and 2.7% for placebo.
Maltese: Fil-każ tad-DLCO t-tnaqqis fl-24 xahar kien ta' 3.3% b'0.5 mg fingolimod u ta' 2.7% bi plaċebo.
English: The most common foetal visceral malformations included persistent truncus arteriosus and ventricular septum defect.
Maltese: L-aktar malformazzjonijiet vixxerali komuni fil-fetu kienu jinkludu truncus arteriosus persistenti u difett fis-septum ventrikulari.
English: Table 1 Study D2301 (FREEDOMS): main results
Maltese: Tabella 1 Studju D2301 (FREEDOMS): riżultati ewlenin
English: Subjects on fingolimod treatment have a normal bronchodilator response to inhaled beta-agonists.
Maltese: Pazjenti kkurati b'fingolimod għandhom reazzjoni normali talbronkodilataturi meta jiġbdu man-nifs il-beta-agonisti.
English: Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation***
Maltese: Reazzjonijiet minħabba sensittività eċċessiva, inkluż raxx, ħakk u anġjoedima wara li jinbeda t-trattament***
English: In multiple sclerosis clinical studies macular oedema occurred in 0.5% of patients treated with the recommended dose of 0.5 mg and 1.1% of patients treated with the higher dose of 1.25 mg.
Maltese: Fi studji kliniċi dwar sklerożi multipla l-edima makulari dehret f'0.5% tal-pazjenti kkurati bid-doża rrakkomandata ta' 0.5 mg u f'1.1% tal-pazjenti kkurati b'doża ogħla ta' 1.25 mg.
English: Gilenya 0.5 mg capsules are available in packs containing 7, 28 or 98 capsules or in multipacks containing 84 capsules (3 packs of 28 capsules).
Maltese: Il-kapsuli Gilenya ta' 0.5 mg huma disponibbli f'pakketti li fihom 7, 28 jew 98 kapsula jew f'pakketti b'ħafna li fihom 84 kapsula (3 pakketti ta' 28 kapsula).
English: After 12 months (month 36), 856 patients (93%) were still enrolled.
Maltese: Wara 12-il xahar (xahar 36), 856 pazjent (93%) kienu għadhom fl-istudju.
English: Median values for baseline characteristics were: age 41 years, disease duration 8.9 years, EDSS score 2.5.
Maltese: Il-numri medji għall-karatteristiċi fillinja bażi kienu: età 41sena, tul ta' żmien tal-marda 8.9 snin, riżultat EDSS 2.5.
English: Expanded Disability Status Score (EDSS) was between 0 and 5.5.
Maltese: L-Iskala Mwessgħa tal-Istat ta' Diżabbiltà (EDSS) kienet bejn 0 u 5.5.
English: At month 24, the reduction from baseline values in percentage of predicted FEV1 was 2.7% for fingolimod 0.5 mg and 1.2% for placebo, a difference that resolved after treatment discontinuation.
Maltese: Fl-24 xahar, it-tnaqqis mill-valuri tal-linja bażi fil-perċentwali ta' FEV1 mbassra kien ta' 2.7% b'0.5 mg fingolimod u ta' 1.2% bi plaċebo, differenza li ssolviet wara li twaqqfet ilkura.
English: In the post-marketing setting, cases of infections with opportunistic pathogens, such as viral (e.g. varicella zoster virus [VZV], John Cunningham virus [JCV] causing Progressive Multifocal Leukoencephalopathy, herpes simplex virus [HSV]), fungal (e.g. cryptococci including cryptococcal meningitis) or bacterial (e.g. atypical mycobacterium), have been reported, some of which have been fatal (see section 4.4).
Maltese: Wara li l-prodott tqiegħed fis-suq, kienu rrappurtati każijiet ta' infezzjonijiet b'patoġeni opportunistiċi, fosthom virali (eż. il-mikrobu tal-variċella zoster, il-mikrobu ta' John Cunningham [JCV] li jwassal għal Lewkoenċefalopatija Multifokali Progressiva, il-mikrobu tal-herpes simplex [HSV]), fungali (eż. kriptokokki inkluż meninġite kriptokokkali) jew batteriċi (eż. myocbacterium atipiku), li wħud minnhom wasslu għall-mewt (ara sezzjoni 4.4).
English: Co-administration of fingolimod with ketoconazole resulted in a 1.7-fold increase in fingolimod and fingolimod phosphate exposure (AUC) by inhibition of CYP4F2.
Maltese: L-għoti flimkien ta' fingolimod ma' ketokonazol wassal għal żieda ta' 1.7 drabi flespożizzjoni (AUC) għal fingolimod u fingolimod fosfat bl-inibizzjoni ta' CYP4F2.
English: Musculoskeletal and connective tissue disorders Very common:
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi Komuni ħafna:
English: Very rare (may affect up to 1 in 10,000 people): - Electrocardiogram anomaly (T-wave inversion) - Tumour related to infection with human herpes virus 8 (Kaposi's sarcoma)
Maltese: - Anomalija elettrokardjogramma (inverżjoni tal-mewġa T) - Tumur relatat ma' infezzjoni bil-virus 8 tal-epatite uman (sarkoma ta' Kaposi)
English: PML is an opportunistic infection caused by John Cunningham virus (JCV), which may be fatal or result in severe disability.
Maltese: Il-PML hi infezzjoni opportunistika kkawżata mill-mikrobu virali John Cunningham (JCV), li jista' jkun fatali jew iwassal għal diżabbiltà gravi.
English: Posterior reversible encephalopathy syndrome
Maltese: Sindrome ta' enċefalopatija posterjuri riversibbli (PRES - Posterior reversible encephalopathy syndrome)
English: In clinical trials, elevations 3-fold the upper limit of normal (ULN) or greater in ALT occurred in 8.0% of adult patients treated with fingolimod 0.5 mg compared to 1.9% of placebo patients.
Maltese: Fi provi kliniċi, ALT żdied bi 3 darbiet jew aktar l-ogħla limitu tan-normal (ULN) fi 8.0% tal-pazjenti adulti kkurati b'0.5 mg fingolimod mqabbel ma' 1.9% tal-pazjenti kkurati bi plaċebo.
English: Table 2 Study D2309 (FREEDOMS 2): main results
Maltese: Tabella 2 Studju D2309 (FREEDOMS): riżultati ewlenin
English: Switch from other treatments to Gilenya
Maltese: Mediċini oħra u Gilenya
English: - Patients with severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or class III anti-arrhythmic medicinal products (see section 4.4).
Maltese: - Pazjenti b'arritmija tal-qalb gravi li jeħtieġu trattament għal kontra l-arritmija bi prodotti mediċinali għal kontra l-arritimija ta' klassi Ia jew klassi III (ara sezzjoni 4.4).
English: Magnesium stearate
Maltese: Sterat tal-manjeżju
English: Lymphopenia Leucopenia
Maltese: Limfopenija Lewkopenija
English: Merkel cell carcinoma*** Blood and lymphatic system disorders Common:
Maltese: Karċinoma taċ-ċellula ta' Merkel*** Disturbi tad-demm u tas-sistema limfatika Komuni:
English: The apparent absolute oral bioavailability is 93% (95% confidence interval: 79-111%).
Maltese: Ilbijodisponibbiltà orali assoluta jidher hi ta' 93% (95% tal-intervall ta' kunfidenza:
English: In patients with severe hepatic impairment (Child-Pugh class C), fingolimodphosphate Cmax was decreased by 22% and AUC was not substantially changed.
Maltese: F'pazjenti b'indeboliment gravi tal-fwied (klassi C ta' Child-Pugh), is-Cmax ta' fingolimod fosfat niżel bi 22% u l-AUC ma nbidilx b'mod sostanzjali.
English: Ammonia solution, concentrated (E527) Potassium hydroxide Black iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Dimethicone
Maltese: Ossidu tal-ħadid iswed (E172) Ossidu tal-ħadid isfar (E172) Dijossidu tat-titanju (E171) Dimetikonu
English: Iron oxide black (E172) Propylene glycol (E1520) Ammonia solution, concentrated(E527)
Maltese: Ossidu tal-ħadid iswed (E172) Glikol tal-propilen(E1520) Soluzzjoni tal-ammonja, ikkonċentrata (E527)
English: - In the controlled paediatric trial D2311, cases of seizures, anxiety, depressed mood and depression have been reported with a higher incidence in patients treated with fingolimod compared to patients treated with interferon beta-1a.
Maltese: - Waqt il-prova D2311 ikkontrollata fost pazjenti pedjatriċi, kienu rrappurtati każijiet ta' aċċessjonijiet, ansjetà, burdata dipressa u dipressjoni b'inċidenza ogħla fost pazjenti ttrattati b'fingolimod imqabbel ma' pazjenti ttrattati b'interferon beta-1a.
English: 7 hard capsules 28 hard capsules
Maltese: 7 kapsuli iebsa 28 kapsula iebsa
English: In the paediatric study, cases of seizures were reported in 5.6% of fingolimod-treated patients and 0.9% of interferon beta-1a-treated patients.
Maltese: Waqt l-istudju pedjatriku, kienu rrappurtati każijiet ta' aċċessjonijiet f'5.6% tal-pazjenti ttrattati b'fingolimod u f'0.9% tal-pazjenti ttrattati b'interferon beta-1a.
English: Pharmacokinetic data were obtained in healthy adult volunteers, in renal transplant adult patients and in multiple sclerosis adult patients.
Maltese: Tagħrif farmakokinetiku nkiseb minn voluntiera adulti b'saħħithom, minn pazjenti adulti bi trapjant tal-kliewi u minn pazjenti adulti bi sklerożi multipla.
English: PVC/PVDC/aluminium blister packs containing 7, 28 or 98 hard capsules or multipacks containing 84 (3 packs of 28) hard capsules.
Maltese: PVC/PVDC/pakketti b'folji tal-aluminju b'7, 28 jew 98 kapsula iebsa jew pakketti b'ħafna li fihom 84 (3 pakketti bi 28) kapsula iebsa.
English: - The other ingredients are: Capsule fill: mannitol, hydroxypropylcellulose, hydroxypropylbetadex, magnesium stearate.
Maltese: Il-mili tal-kapsula: mannitol, idroksipropilċellulosa, idroksipropilbetadeks, sterat tal-manjeżju.
English: Fingolimod is transformed in humans by reversible stereoselective phosphorylation to the pharmacologically active (S)-enantiomer of fingolimod phosphate.
Maltese: Fingolimod jinbidel fil-bnedmin permezz ta' fosforilazzjoni stereoselettiva riversibbli tal-(S)enantiomer attiv farmakoloġikament ta' fingolimod fosfat.
English: If PML is suspected, treatment with GILENYA should be suspended until PML has been excluded.
Maltese: Jekk hemm suspett ta' PML, it-trattament b'GILENYA għandu jitwaqqaf sakemm ma tkunx eskluża PML.
English: In total, 1,030 patients entered, however, 3 of these patients did not receive treatment (n=356 continued on 0.5 mg, 330 continued on 1.25 mg, 167 switched from interferon beta-1a to 0.5 mg and 174 from interferon beta-1a to 1.25 mg).
Maltese: B'kollox, 1,030 pazjent daħlu, madanakollu, tlieta minn dawn il-pazjenti ma ngħatawx trattament (n=356 komplew fuq 0.5 mg, 330 komplew fuq 1.25 mg, 167 għaddew minn interferon beta-1a għal 0.5 mg u 174 minn interferon beta1a għal 1.25 mg).
English: Proportion with 3-month Confirmed Disability Progression†
Maltese: Proporzjon bi 3 xhur ta' Progressjoni
English: The main enzyme involved in the metabolism of fingolimod is partially identified and may be either CYP4F2 or CYP3A4.
Maltese: L-enzim prinċipali involut fil-metaboliżmu ta' fingolimod huwa identifikat parzjalment u jista' jkun jew CYP4F2 jew CYP3A4.
English: Due to the risk of serious rhythm disturbances or significant bradycardia, Gilenya should not be used in patients with sino-atrial heart block, a history of symptomatic bradycardia, recurrent syncope or cardiac arrest, or in patients with significant QT prolongation (QTc>470 msec [adult female], QTc >460 msec [paediatric female] or >450 msec [adult and paediatric male]), uncontrolled hypertension or severe sleep apnoea (see also section 4.3).
Maltese: Minħabba r-riskju ta' disturbi ritmiċi serji jew bradikardija sinifikanti, Gilenya m'għandux jintuża f'pazjenti b'imblokk sinoatrijali tal-qalb storja ta' bradikardija sintomatika, sinkope rikorrenti jew arrest kardijaku, jew f'pazjenti bi prolungament qawwi tal-QT (QTc>470 msek [nisa adulti], QTc ta' >460 msek [nisa pedjatriċi] jew >450 msek [irġiel adulti u pedjatriċi]), pressjoni għolja mhux ikkontrollata jew b'apnea tal-irqad gravi, ftit jittolleraw bradikardija qawwija (ara wkoll sezzjoni 4.3).
English: Fingolimod is metabolised by sphingosine kinase to the active metabolite fingolimod phosphate.
Maltese: Fingolimod jiġi mmetabolizzat permezz tal-kinasi tal-isfingosina fil-metabolit attiv tal-fingolimod fosfat.
English: Gilenya has not been studied in multiple sclerosis patients with diabetes mellitus, a disease which is associated with an increased risk for macular oedema (see section 4.4).
Maltese: Gilenya għadu ma ġiex studjat f'pazjenti bi sklerożi multipla li għandhom dijabete mellitus, marda li hi marbuta ma' żieda fir-riskju ta' edima makulari (ara sezzjoni 4.4).
English: Gilenya 0.25 mg capsules are available in packs containing 7 or 28 capsules.
Maltese: Il-kapsuli Gilenya ta' 0.25 mg huwa disponibbli f'pakketti li fihom 7 jew 28 kapsula.
English: Median values for baseline characteristics were: age 36 years, disease duration 5.9 years, and EDSS score 2.0.
Maltese: Ilvaluri medji tal-karatteristiċi fil-linja bażi kienu: età 36 sena, id-dewmien tal-marda 5.9 snin u lpunteġġ tal-EDSS 2.0.
English: Comparable results were shown in a replicate 2-year randomised, double-blind, placebo-controlled Phase III study on fingolimod in 1,083 patients (n=358 on 0.5 mg, 370 on 1.25 mg, 355 on placebo) with RRMS (D2309; FREEDOMS 2).
Maltese: Ir-riżultati mqabbla dehru fi studju mtenni dwar fingolimod f'Fażi III randomizzat, double-blind, ikkontrollat bi plaċebo u li dam għaddej sentejn fost 1,083 pazjent (n=358 fuq 0.5 mg, 370 fuq 1.25 mg, 355 fuq plaċebo) b'RRMMS (D2309; FREEDOMS 2).
English: Caution should be exercised with substances that may inhibit CYP3A4 (protease inhibitors, azole antifungals, some macrolides such as clarithromycin or telithromycin).
Maltese: Wieħed għandu joqgħod attent minn sustanzi li jistgħu jinibixxu CYP3A4 (inibituri proteasi, antifungali azole, xi makrolidi bħalma huma clarithromycin jew telithromycin).
English: Experience with Gilenya in elderly patients (over 65 years) is limited.
Maltese: L-esperjenza b'Gilenya f'pazjenti anzjani 'l fuq minn 65 sena hija limitata.
English: Treatment with Gilenya should not be initiated in patients receiving beta blockers, or other substances which may decrease heart rate, such as class Ia and III antiarrhythmics, calcium channel blockers (such as verapamil or diltiazem), ivabradine, digoxin, anticholinesteratic agents or pilocarpine because of the potential additive effects on heart rate (see sections 4.4 and 4.8).
Maltese: It-trattament b'Gilenya m'għandux jibda f'pazjenti li qed jirċievu mblukkaturi beta, jew sustanzi oħrajn li jistgħu jnaqqsu r-rata tat-taħbit tal-qalb, bħalma huma antiarritmiċi ta' klassi Ia u III, imblokkaturi tal-kanali tal-kalċju (bħalma huma verapamil jew diltiazem), ivabradine, digoxin, aġenti antikolinesteratiċi jew pilocarpine minħabba l-potenzjal ta' effetti addittivi fuq ir-rata tat-taħbit tal-qalb (ara sezzjonijiet 4.4 u 4.8).
English: The majority of cases occurred within the first 3-4 months of therapy.
Maltese: Għaldaqstant huwa rrakkomandat li ssir evalwazzjoni oftalmoloġika 3-4 xhur wara li tinbeda l-kura.
English: This could be serious (see “If you stop taking Gilenya” in section 3, and also section 4, “Possible side effects”).
Maltese: Dan jista' jkun serju (ara “Jekk tieqaf tieħu Gilenya” f'sezzjoni 3, u wkoll sezzjoni 4, “Effetti sekondarji possibbli”).
English: • Liver function should be monitored at months 1, 3, 6, 9 and 12 during GILENYA therapy and periodically thereafter; the approved dosing of 0.5 mg daily (or 0.25 mg once daily in pediatric patients 10 years of age and above with a body weight of ≤40 kg) should be administered.
Maltese: • Għandu jkun hemm monitoraġġ tal-funzjoni tal-fwied fix-xhur 1, 3, 6, 9 u 12 matul it-terapija b'GILENYA u wara minn żmien għal żmien; għandha tingħata d-doża approvata ta' 0.5 mg kuljum (jew 0.25 mg darba kuljum lil pazjenti pedjatriċi minn 10 snin 'il fuq b'piż ta' ≤40 kg).
English: Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment since marketing authorisation (see section 4.8).
Maltese: Kienet irrappurtata lewkoenċefaloptija multifokali progressiva (PML) waqt it-trattament b'fingolimod minn mindu nħarġet l-awtorizzazzjoni għat-tqegħid fis-suq (ara sezzjoni 4.8).
English: Least Square Mean # One patient randomised to receive interferon beta-1a by intramuscular injection was unable to swallow the double-dummy medication and discontinued from study.
Maltese: Pazjent wieħed randomizzat sabiex jirċievi injezzjoni ta' interferon beta-1a fil-muskoli ma kienx kapaċi jibla' l-medikazzjoni double-dummy u waqaf mill-istudju.
English: Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:
Maltese: Gilenya huwa indikat bħala terapija waħda li timmodifika l-marda fi sklerożi multipla attiva ħafna b'rikaduti u tnaqqis fil-qawwa għall-gruppi li ġejjin ta' pazjenti adulti u pazjenti pedjatriċi minn 10 snin 'il fuq:
English: Printing ink: shellac (E904), iron oxide black (E172), propylene glycol (E1520), ammonia solution, concentrated (E527).
Maltese: Il-linka għall-istampar: xellak (E904), ossidu tal-ħadid iswed (E172), glikol talpropilen(E1520), soluzzjoni tal-ammonja, ikkonċentrata (E527).
English: Gilenya has not been studied in patients with arrhythmias requiring treatment with class Ia (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol) antiarrhythmic medicinal products.
Maltese: Ia (eż. quinidine, disopyramide) jew tal-klassi III (eż. amiodarone, sotalol).
English: Other strong CYP3A4 enzyme inducers, for example rifampicin, phenobarbital, phenytoin, efavirenz and St. John's Wort, may reduce the AUC of fingolimod and its metabolite at least to this extent.
Maltese: Indutturi oħrajn qawwija tal-enzim CYP3A4, ngħidu aħna rifampicin, phenobarbital, phenytoin, efavirenz u St.
English: Rare cases of peripheral arterial occlusive disease occurred in patients treated with fingolimod at higher doses (1.25 mg).
Maltese: Każijiet rari ta' mard okklussiv arterjali periferali seħħew f'pazjenti kkurati b'dożi ogħla ta' fingolimod (1.25 mg).
English: If this risk is suspected, discontinuation of treatment should be considered by the physician on a case-bycase basis (see also section 4.4 “Infections” and “Cutaneous neoplasms” and section 4.8 “Lymphomas”).
Maltese: Jekk hemm suspett ta' riskju, it-tabib għandu jqis li jwaqqaf għal kollox it-trattament skont il-każ partikulari (ara wkoll sezzjoni 4.4 “Infezzjonijiet” u “Neoplażmi tal-ġilda” u sezzjoni 4.8 “Limfomi”).
English: Formation of pharmacologically inactive non-polar ceramide analogues of fingolimod was also observed.
Maltese: Kienet osservata wkoll formazzjoni ta' ċeramidi analogi mhux polari inattivi farmakoloġikament.
English: In paediatric patients (10 years of age and above), fingolimod-phosphate concentrations increase in an apparent dose proportional manner between 0.25 mg and 0.5 mg.
Maltese: F'pazjenti pedjatriċi (minn 10 snin 'il fuq), il-konċentrazzjonijiet ta' fingolimod-fosfat jiżiedu b'manjiera apparenti proporzjonalment għad-doża bejn 0.25 mg u 0.5 mg.
English: Fingolimod phosphate Cmax was slightly decreased by 34% but AUC was unchanged.
Maltese: Fingolimod fosfat Cmax naqas kemm kemm b'34% imma l-AUC ma nbidilx.