FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people): - Ringworm, a fungal infection of the skin (tinea versicolor) - Dizziness - Severe headache often accompanied by nausea, vomiting and sensitivity to light (migraine) - Low level of white blood cells (lymphocytes, leucocytes) - Weakness - Itchy, red, burning rash (eczema) - Itching - Blood fat (triglycerides) level increased - Hair loss - Breathlessness - Depression - Blurred vision (see also the section on macular oedema under “Some side effects could be or could become serious”) - Hypertension (Gilenya may cause a mild increase in blood pressure) - Muscle pain - Joint pain
Maltese: (emigranja) - Livell baxx ta' ċelluli bojod tad-demm (limfoċiti, lewkoċiti) - Dgħufija - Raxx aħmar u jaħraq li jġiegħlek tħokk (ekżema) - Ħakk - Żieda fil-livell ta' xaħam (trigliċeridi) fid-demm - Telf ta' xagħar - Qtugħ ta' nifs - Dipressjoni - Vista mċajpra (ara wkoll it-taqsima dwar l-edima makulari taħt “Uħud mill-effetti sekondarji jistgħu jkunu jew isiru gravi”) - Pressjoni għolja (Gilenya jista' jikkawża żieda ħafifa fil-pressjoni tad-demm) - Uġigħ fil-muskoli - Uġigħ fil-ġogi
English: stroke/transient ischaemic attack (TIA), decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure; o Severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or class III
Maltese: o Li fl-aħħar 6 xhur kellhom infart mijokardijaku (MI), angina pectoris instabbli, puplesija/attakk iskemiku tranżitorju (TIA), insuffiċjenza tal-qalb dekompensata (li teħtieġ trattament fl-isptar), jew insuffiċjenza tal-qalb fi klassi III/IV skont in-New York Heart Association (NYHA).
English: After 12 months (month 24), 882 patients (86%) were still enrolled.
Maltese: Wara 12-il xahar (xahar 24), 882 pazjent (86%) kienu għadhom fl-istudju.
English: In multiple sclerosis clinical studies first-degree atrioventricular block (prolonged PR interval on ECG) was detected after treatment initiation in adult and paediatric patients.
Maltese: Fi studji kliniċi dwar sklerożi multipla deher imblokk atrijoventrikulari tal-ewwel grad (intervall PR imtawwal fuq l-ECG) u dan wara li nbdiet il-kura f'pazjenti adulti u pedjatriċi.
English: The efficacy of Gilenya has been demonstrated in two studies which evaluated once-daily doses of fingolimod 0.5 mg and 1.25 mg in adult patients with relapsing-remitting multiple sclerosis (RRMS).
Maltese: L-effikaċja ta' Gilenya dehret f'żewġ studji li evalwaw l-għoti ta' doża darba kuljum ta' 0.5 mg u 1.25 mg fingolimod lil pazjenti adulti bi sklerożi multipla b'rikaduti jew rikorrenti (RRMS).
English: Pharmacokinetic interactions of other substances on fingolimod
Maltese: Interazzjonijiet farmakokinetiċi ta' sustanzi oħrajn fuq fingolimod
English: 0.5 mg daily, due to the potential for bradyarrhythmia; o Monitor the patient for sign and symptoms of depression and anxiety; o Emphasize treatment compliance and misuse to patients, especially about treatment interruption and the importance of repeating cardiovascular monitoring; o Emphasize GILENYA immunosuppressive effects; o Consider a complete vaccination schedule before starting GILENYA; o Provide guidance on seizure monitoring.
Maltese: 0.25 mg għal 0.5 mg kuljum, minħabba li jista' jkun hemm bradiarritmija; o Jiċċekkjaw il-pazjent għal sinjali u sintomi ta' dipressjoni u ansjetà; o Jisħqu l-importanza li l-pazjenti jimxu mal-medikazzjoni u ma jużawhiex ħażin, b'mod speċjali fejn jidħol it-twaqqif tat-trattament u l-ħtieġa li jerġa' jsir monitoraġġ kardjovaskulari; o Jisħqu l-effetti immunosuppressivi ta' GILENYA;
English: There have been reports of slow atrioventricular conduction, with isolated reports of transient, spontaneously resolving complete AV block (see sections 4.4 and 4.8).
Maltese: Kien hemm rapporti ta' konduzzjoni atrijoventrikulari bil-mod, b'rapporti iżolati ta' imblokk komplut tal-AV tranżitorju, li jgħaddi waħdu (ara sezzjonijiet 4.4 u 4.8).
English: The mechanism of action of bradycardia and vasoconstriction were also studied in vitro in guinea pigs and isolated rabbit aorta and coronary artery.
Maltese: Il-mekkaniżmu tal-azzjoni tal-bradikardija u l-vażokostrizzjoni kienu wkoll studjati in vitro fl-aorta u l-arterja koronorja ta' fniek tal-indi u fniek iżolati.
English: It is recommended that patients without a health care professional confirmed history of chickenpox or documentation of a full course of vaccination with varicella vaccine undergo antibody testing to varicella zoster virus (VZV) before initiating Gilenya therapy.
Maltese: Huwa rrakkomandat li pazjenti mingħajr passat ta' ġidri r-riħ ikkonfermat minn professjonist fil-kura tas-saħħa jew dokumentazzjoni ta' kors sħiħ ta' tilqim b'vaċċin għall-ġidri r-riħ għandhom jagħmlu testijiet għall-antikorpi għall-virus tal-variċella zoster (VZV - varicella zoster virus) qabel ma tinbeda terapija b'Gilenya.
English: Macular oedema with or without visual symptoms has been reported in 0.5% of patients treated with fingolimod 0.5 mg, occurring predominantly in the first 3-4 months of therapy (see section 4.8).
Maltese: Edima makulari b'sintomi viżivi jew mingħajrhom kienet irrappurtata f'0.5% tal-pazjenti kkurati b'0.5 mg fingolimod, u li dehret l-aktar matul l-ewwel 3-4 xhur tat-terapija (ara sezzjoni 4.8).
English: Each 0.25 mg capsule contains 0.25 mg fingolimod (as hydrochloride).
Maltese: Kull kapsula iebsa ta' 0.25 mg fiha 0.25 mg fingolimod (bħala hydrochloride).
English: Gilenya 0.5 mg hard capsules
Maltese: Gilenya 0.5 mg kapsuli iebsa
English: Titanium dioxide (E171) Yellow iron oxide (E172)
Maltese: Dijossidu tat-titanju (E171) Ossidu tal-ħadid isfar (E172)
English: For PML, section 4.4 of the SmPC and section 2 of the PL should be updated in order to highlight the importance of MRI finding.
Maltese: Rigward il-PML, sezzjoni 4.4 tal-SmPC u sezzjoni 2 tal-PL għandhom ikunu aġġornati sabiex jisħqu limportanza tas-sejbiet tal-MRI.
English: Blood levels of fingolimod and fingolimod phosphate decline in parallel in the terminal phase, leading to similar half-lives for both.
Maltese: Il-livelli ta' fingolimod u fingolimod fosfat fid-demm jonqsu b'mod paralleli fil-fażi terminali, li jwassal għal half-lives simili għat-tnjen li huma.
English: In the twoyear placebo-controlled study, hypertension was reported as an adverse event in 6.5% of patients on fingolimod 0.5 mg and in 3.3% of patients on placebo.
Maltese: Fl-istudju kkontrollat bi plaċebo u li dam sentejn, kienet irrappurtata pressjoni għolja bħala episodju mhux mixtieq f'6.5% tal-pazjenti mogħtija 0.5 mg fingolimod u fi 3.3% tal-pazjenti mogħtija plaċebo.
English: Patient / Parent / Caregiver guide
Maltese: Gwida għall-Pazjent / Ġenitur / Kuratur
English: A CBC is recommended prior to initiating Gilenya to ensure that immune effects of the previous therapy (i.e. cytopenia) have resolved.
Maltese: Huwa rrakkomandat li jsir CBC qabel ma jinbeda Gilenya biex ikun assigurat li l-effetti immuni mit-terapija ta' qabel (i.e. ċitopenija) jkunu ġew solvuti.
English: Capsule of 16 mm with ivory opaque cap and body, with black radial imprint “FTY 0.25mg” on cap and black radial band on body.
Maltese: Kapsula ta' 16 mm b'għatu u qafas lewn l-avorju opak, b'“FTY 0.25 mg” miktuba b'linka sewda radjali fuq l-għatu u strixxa sewda radjali pprintjati fuq il-qafas.
English: Gilenya 0.25 mg hard capsules
Maltese: Gilenya 0.25 mg kapsuli iebsa
English: • Children and adolescents with body weight above 40 kg: one 0.5 mg capsule per day.
Maltese: • Tfal u adolexxenti li jiżnu aktar minn 40 kg: kapsula waħda ta' 0.5 mg kuljum.
English: One capsule contains 0.25 mg fingolimod (as hydrochloride).
Maltese: Kull kapsula fiha 0.25 mg fingolimod (bħala hydrochloride).
English: Caution is also indicated when stopping fingolimod therapy due to the risk of a rebound (see “Return of disease activity (rebound) after fingolimod discontinuation” above).
Maltese: Wieħed għandu joqgħod attent ukoll meta titwaqqaf it-terapija b'fingolimod minħabba r-riskju ta' rikaduta (ara “Treġġigħ lura tal-attività tal-marda (rikaduta) wara li jitwaqqaf fingolimod” hawn fuq).
English: Fingolimod should not be used in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Maltese: Fingolimod m'għandux jintuża f'pazjenti b'indeboliment gravi tal-fwied (klassi C ta' Child-Pugh) (ara sezzjoni 4.3).
English: Pooled results of Studies D2301 and D2302 showed a consistent and statistically significant reduction in annualised relapse rate compared to comparator in subgroups defined by gender, age, prior multiple sclerosis therapy, disease activity or disability levels at baseline.
Maltese: Ir-riżultati miġbura flimkien tal-Istudji D2301 u D2302 urew tnaqqis konsistenti u statistikament sinifikanti fir-rata ta' rikaduta annwalizzata meta mqabbel mal-komparatur fis-sottogruppi ddefiniti skont is-sess, l-età, it-terapija ta' qabel għall-isklerożi multipla, l-attività tal-marda jew il-livelli taddiżabbiltà fil-linja bażi.
English: Gilenya 0.25 mg hard capsules Gilenya 0.5 mg hard capsules fingolimod
Maltese: Informazzjoni għall-utent Gilenya 0.25 mg kapsuli iebsa Gilenya 0.5 mg kapsuli iebsa Fingolimod
English: Additionally, if after 6 hours the heart rate is <45 bpm in adults, <55 bpm in paediatric patients aged 12 years and above, or <60 bpm in paediatric patients aged 10 years to below 12 years, or if the ECG at 6 hours after the first dose shows second degree or higher AV block, or if it shows a QTc interval ≥500 msec, monitoring should be extended at least for overnight and until the findings have resolved.
Maltese: Barra minn hekk, jekk wara 6 sigħat, ir-rata tat-taħbit tal-qalb fl-adulti hi <45 bpm, <55 bpm f'pazjenti pedjatriċi minn 12-il sena 'l fuq, jew <60 bpm f'pazjenti pedjatriċi minn 10 snin sa taħt it-12-il sena, jew l-ECG juri li kien hemm episodju ġdid ta' mblokk AV tat-tieni livell jew ogħla jew intervall talQTc ≥500 msek, għandu jkun hemm estensjoni tal-monitoraġġ (għall-inqas monitoraġġ għal matul illejl), u sakemm dawn iċ-ċirkostanzi ma jissolvewx.
English: Before initiating treatment with fingolimod, a baseline MRI should be available (usually within 3 months) as a reference.
Maltese: MRI fil-linja bażi (normalment fi żmien 3 xhur) bħala referenza.
English: Mild isolated bilirubin increases have been noted in paediatric patients on fingolimod.
Maltese: Kienu rrappurtati wkoll dipressjoni u ansjetà fost pazjenti pedjatriċi ttrattati b'fingolimod.
English: Not known (frequency cannot be estimated from the available data): - Peripheral swelling
Maltese: Mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-dejta disponibbli): - Nefħa periferali
English: • Vaccines.
Maltese: • Tilqim.
English: One capsule contains 0.5 mg fingolimod (as hydrochloride).
Maltese: Kull kapsula fiha 0.5 mg fingolimod (bħala hydrochloride).
English: Severe exacerbation of disease after Gilenya discontinuation***
Maltese: Tħarrix gravi tal-marda wara li jitwaqqaf Gilenya***
English: If liver transaminases rise above 5 times the ULN, more frequent monitoring should be instituted, including serum bilirubin and alkaline phosphatase (ALP) measurement.
Maltese: Jekk it-transaminases tal-fwied jogħlew aktar minn 5 darbiet il-ULN, għandu jinbeda monitoraġġ aktar frekwenti, li jinkludi kejl tal-bilirubin u l-alkaline phosphatase (ALP) fisserum.
English: You may need to be monitored more closely.
Maltese: Se jitwettaq monitoraġġ speċjalizzat qabel ma twelled.
English: There have been cases of lymphoma in clinical studies and the post-marketing setting (see section 4.8).
Maltese: Kien hemm każijiet ta' limfoma waqt studji kliniċi u wara li l-prodott tqiegħed fis-suq (ara sezzjoni 4.8).
English: What Gilenya contains - The active substance is fingolimod.
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Gilenya - Is-sustanza attiva hi fingolimod.
English: Fingolimod and its metabolites crossed the placental barrier in pregnant rabbits.
Maltese: Fingolimod u l-metaboliti tiegħu għaddew mill-barriera plaċentali ta' fniek tqal.
English: Within 4-6 hours after the first dose of fingolimod 0.5 mg, the lymphocyte count decreases to approximately 75% of baseline in peripheral blood.
Maltese: Fi żmien 4-6 sigħat wara li tingħata l-ewwel doża ta' 0.5 mg fingolimod, l-ammont ta' limfoċiti jonqos għal madwar 75% tal-linja bażi tad-demm periferali.
English: Gilenya must not be used in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Maltese: Gilenya m'għandux jintuża f'pazjenti b'indeboliment qawwi tal-fwied (klassi C ta' Child-Pugh) (ara sezzjoni 4.3).
English: Gilenya should be used with caution in patients with severe respiratory disease, pulmonary fibrosis and chronic obstructive pulmonary disease (see also section 4.8).
Maltese: Gilenya għandu jintuża b'għaqal f'pazjenti b'mard respiratorju gravi, b'fibrożi pulmonarja u b'mard pulmonari ostruttiv kroniku (ara wkoll sezzjoni 4.8).
English: • GILENYA reduces peripheral blood lymphocyte counts.
Maltese: • Il-pazjenti jridu jużaw kontraċezzjoni effettiva waqt li qed jieħdu GILENYA.
English: Medicinal products that may prolong QTc interval are best avoided in patients with relevant risk factors, for example, hypokalaemia or congenital QT prolongation.
Maltese: Ikun l-aħjar kieku l-prodotti mediċinali li jistgħu jtawwlu l-QTc jiġu evitati minn pazjenti li għandhom fatturi ta' riskju relevanti, pereżempju ipokalemija jew prolungament tal-QT konġenitali.
English: Each 0.5 mg capsule contains 0.5 mg fingolimod (as hydrochloride).
Maltese: Kull kapsula iebsa ta' 0.5 mg fiha 0.5 mg fingolimod (bħala hydrochloride).
English: Regarding the signal ‘autoimmune haemolytic anaemia (AIHA)', the PRAC concluded that the cumulative review provided by the MAH as well as the plausible theoretical mechanism support a causal relationship between therapy with fingolimod and occurrence of AIHA:
Maltese: Rigward is-sinjal ‘anemija emolitika awtoimmuni (AIHA)', il-PRAC ikkonkluda li r-reviżjoni kumulattiva pprovduta mill-MAH kif ukoll il-mekkaniżmu teoretiku plawżibbli jwieżnu r-relazzjoni każwali bejn it-terapija b'fingolimod u l-okkorrenza tal-AIHA:
English: You must use effective contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).
Maltese: Għandek tuża kontraċezzjoni effettiva waqt it-trattament u sa xahrejn wara li jitwaqqaf ittrattament (ara s-sezzjoni “Tqala u treddigħ”).
English: Concomitant administration with St John's wort is not recommended (see section 4.5).
Maltese: John's wort mhuwiex irrakkomandat (ara sezzjoni 4.5).
English: Caution should also be exercised when switching patients from long-acting therapies with immune effects such as natalizumab, teriflunomide or mitoxantrone (see section 4.4).
Maltese: Għandu jkun hemm attenzjoni meta pazjenti jinqalbu minn terapiji b'effetti immuni li jaħdmu fit-tul bħal natalizumab, teriflunomide jew mitoxantrone (ara sezzjoni 4.4).
English: Chronic fingolimod dosing leads to a mild decrease in the neutrophil count to approximately 80% of baseline.
Maltese: Doża kronika b'fingolimod twassal għal żieda ħafifa fl-ammont ta' newtrofili għal madwar 80% tal-linja bażi.
English: Myalgia Arthralgia General disorders and administration site conditions Common:
Maltese: Burdata dipressa Disturbi fis-sistema nervuża Komuni ħafna:
English: The pharmacokinetics of fingolimod and fingolimod phosphate do not differ in males and females, in patients of different ethnic origin, or in patients with mild to severe renal impairment.
Maltese: Il-farmakokinetiċi ta' fingolimod u fingolimod fosfat huma l-istess fl-irġiel u n-nisa, f'pazjenti ta' oriġini etnika differenti, jew f'pazjenti b'indeboliment tal-kliewi minn ħafif għal gravi.
English: The pharmacokinetics of fingolimod-phosphate were not evaluated in patients with mild or moderate hepatic impairment.
Maltese: Il-farmakokinetiċi ta' fingolimod fosfat ma ġewx evalwati f'pazjenti b'indeboliment ħafif jew moderat tal-kliewi.
English: Patients with history of uveitis and patients with diabetes mellitus are at increased risk of macular oedema (see section 4.8).
Maltese: Pazjenti bi storja ta' uveitis u pazjenti b'dijabete mellitus jinsabu f'riskju akbar ta' edima makulari (ara sezzjoni 4.8).
English: Posterior reversible encephalopathy syndrome (PRES) A condition called posterior reversible encephalopathy syndrome (PRES) has been rarely reported in MS patients treated with Gilenya.
Maltese: Kondizzjoni msejħa sindrome ta' enċefalopatija posterjuri riversibbli (PRES) kienet irrappurtata b'mod rari f'pazjenti b'MS ikkurati b'Gilenya.
English: What Gilenya is The active substance of Gilenya is fingolimod.
Maltese: X'inhu Gilenya Is-sustanza attiva ta' Gilenya hi fingolimod.
English: Median values for baseline characteristics were: age 16 years, median disease duration 1.5 years and EDSS score 1.5.
Maltese: Il-valuri medjani għall-karatteristiċi fil-linja bażi kienu: età 16-il sena, dewmien medjan tal-marda 1.5 snin u punteġġ EDSS 1.5.
English: Symptoms vary from patient to patient but typically involve walking difficulties, numbness, vision problems or disturbed balance.
Maltese: Is-sintomi jvarjaw minn pazjent għal ieħor imma normalment jinvolvu diffikultajiet fil-mixi, tnemnim, problemi fil-vista jew diffikultà biex iżżomm ilbilanċ.
English: o Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and HPVrelated cancer, has been reported in the post-marketing setting.
Maltese: o Kienu rrappurtati virus tal-papilloma uman (HPV), fosthom papilloma, displasija, felul u kanċer relatat mal-HPV, wara li l-prodott tqiegħed fis-suq.
English: The combination of fingolimod with potent CYP450 inducers should be used with caution.
Maltese: L-għoti flimkien ta' fingolimod ma' indutturi potenti ta' CYP450 għandha tintuża b'kawtela.
English: Capsule of 16 mm with bright yellow opaque cap and white opaque body; imprint with black ink, “FTY0.5 mg” on cap and two radial bands imprinted on the body with yellow ink.
Maltese: Kapsula ta' 16 mm b'għatu isfar opak jgħajjat u b'qafas opak; b'kitba b'linka sewda, “FTY0.5 mg” fuq l-għatu u żewġ strixxi radjali pprintjati fuq il-qafas b'linka safra.
English: Irregular heartbeat usually returns to normal in less than one day.
Maltese: Normalment taħbit irregolari tal-qalb jerġa' lura għan-normal f'anqas minn ġurnata.
English: • GILENYA is not recommended in patients concomitantly taking medicines known to decrease the heart rate.
Maltese: • GILENYA mhuwiex irrakkomandat f'pazjenti li jieħdu mediċini li jnaqqsu r-rata tat-taħbit talqalb.
English: There were no significant differences between the 0.5 mg and the 1.25 mg doses as regards either endpoint.
Maltese: Ma kienx hemm differenzi sinifikanti bejn id-doża ta' 0.5 mg u dik ta' 1.25 mg fejn jidħol kull endpoint.
English: Autoimmune haemolytic anaemia*** Peripheral oedema***
Maltese: Anemija emolitika awtoimmuni*** Edima periferali*** Disturbi fis-sistema immune Mhux magħruf:
English: Gilenya is for oral use.
Maltese: Gilenya jista' jaffettwa l-funzjoni tal-fwied tiegħek.
English: Experience with Gilenya is limited in patients receiving concurrent therapy with beta blockers, heartrate-lowering calcium channel blockers (such as verapamil or diltiazem), or other substances which may decrease heart rate (e.g. ivabradine, digoxin, anticholinesteratic agents or pilocarpine).
Maltese: L-esperjenza b'Gilenya hi limitata f'pazjenti li fl-istess ħin jirċievu terapija b'imblukkaturi beta, b'imblukkaturi tal-kanal tal-kalċju li jbaxxu r-rata tat-taħbit tal-qalb (bħalma huma verapamil jew diltiazem), jew sustanzi oħrajn li jistgħu jnaqqsu t-taħbit tar-rata tal-qalb (eż. ivabradine, digoxin, aġenti antikolinesteratiċi jew pilocarpine).
English: • Stopping GILENYA therapy may result in return of disease activity.
Maltese: • Li meta twaqqaf it-terapija b'GILENYA jista' jwassal sabiex l-attività tal-marda terġa' lura.
English: In renal transplant clinical studies in which patients with diabetes mellitus were included, therapy with fingolimod 2.5 mg and 5 mg resulted in a 2-fold increase in the incidence of macular oedema.
Maltese: Fi studji kliniċi dwar trapjanti tal-kliewi li matulhom kienu inklużi pazjenti b'dijabete mellitus, it-terapija bi 2.5 mg u b'5 mg fingolimod wasslet sabiex tirdoppja linċidenza tal-edima makulari.
English: The patient was excluded from the full analysis and safety set.
Maltese: Il-pazjent kien eskluż mis-sett ta' analiżi sħiħa u sigurtà.
English: Capsule shell Gelatin
Maltese: Il-qafas tal-kapsula Ġelatina
English: The following major malformations were most frequently reported: - Congenital heart disease such as atrial and ventricular septal defects, tetralogy of Fallot - Renal abnormalities - Musculoskeletal abnormalities
Maltese: Il-marformazzjonijiet maġġuri li ġejjien kienu rrappurtati bl-aktar mod frekwenti: - Mard tal-qalb konġenitali bħalma huma difetti atrijali u settali ventrikulari, tetraloġija ta' Fallot - Anormalitajiet renali - Anormalitajiet muskoluskeletriċi
English: Increased hepatic enzymes have been reported in adult and paediatric multiple sclerosis patients treated with Gilenya.
Maltese: F'pazjenti adulti u pedjatriċi bi sklerożi multipla kkurati b'Gilenya kienet irrappurtata żieda fl-enzimi tal-fwied.
English: • GILENYA is contraindicated in patients with: o Known immunodeficiency syndrome; o Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies); o Severe active infections, active chronic infections (hepatitis, tuberculosis); o Known active malignancies; o Severe liver impairment (Child-Pugh class C); o In the previous 6 months, myocardial infarction (MI), unstable angina pectoris,
Maltese: • GILENYA għandu effett immunosuppressiv li jippredisponi pazjenti għal riskju ta' infezzjoni, li jinkludi infezzjonijiet opportunistiċi li jistgħu jkunu fatali, u riskju miżjud li tiżviluppa limfomi (li jinkludu mikożi fungoidi) u tumuri malinni oħrajn, b'mod partikulari dawk tal-ġilda.
English: It was concluded that bradycardia could be mediated primarily by activation of inward-rectifying potassium channel or G-protein activated inwardly rectifying K
Maltese: Kien konkluż li lbradikardija tista' sseħħ primarjament bl-attivazzjoni tal-kanal tal-potassju rettifikanti 'l ġewwa jew ta' kanal tal-K
English: It should also be noted that a negative anti-JCV antibody test does not preclude the possibility of subsequent JCV infection.
Maltese: Wieħed għandu wkoll jisħaq li test negattiv tal-antikorp għal kontra l-JCV ma jxekkilx il-possibbiltà ta' infezzjoni sussegwenti mill-JCV.
English: Fingolimod was teratogenic in the rat when given at doses of 0.1 mg/kg or higher.
Maltese: Fingolimod kien teratoġeniku fil-firien meta mogħtija dożi ta' 0.1 mg/kg jew aktar.
English: Very common (may affect more than 1 in 10 people): - Infection from flu virus with symptoms such as tiredness, chills, sore throat, aching in the joints or muscles, fever - Feeling of pressure or pain in the cheeks and forehead (sinusitis) - Headache - Diarrhoea - Back pain - Blood testing showing higher levels of liver enzymes - Cough
Maltese: - Infezzjoni mill-virus tal-influwenza b'sintomi bħalma huma għeja, tkexkix ta' bard, grieżem ħomor, uġigħ fil-ġogi jew fil-muskoli, deni - Sensazzjoni ta' pressjoni jew uġigħ fil-ħaddejn u fil-moħħ (sinożite) - Uġigħ ta' ras - Dijarrea - Uġigħ fid-dahar - Test tad-demm juri livelli għolja tal-enzimi tal-fwied - Sogħla
English: Basal cell carcinoma
Maltese: GĦAMLA FARMAĊEWTIKA Kapsula iebsa
English: Gilenya can pass into breast milk and there is a risk of serious side effects for the baby.
Maltese: Gilenya jista' jwassal biex tintefaħ il-makula, kundizzjoni magħrufa bħala edima makulari.
English: Vision blurred
Maltese: Konklużjonijiet xjentifiċi
English: In clinical trials, fingolimod was discontinued if the elevation exceeded 5 times the ULN.
Maltese: Fi provi kliniċi, fingolimod ma baqax jingħata jekk iż-żieda kienet ta' aktar minn 5 darbiet il-ULN.