FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been cases of lymphoma of different varieties, in both clinical studies and the postmarketing setting, including a fatal case of Epstein-Barr virus (EBV) positive B-cell lymphoma.
Maltese: Kien hemm każijiet ta' limfoma ta' varjetajiet differenti, kemm fi studji kliniċi u wara li l-prodott tqiegħed fis-suq, inkluż każ fatali ta' limfoma taċ-ċellula B pożittiva għall-vajrus Epstein-Barr (EBV).
English: Your doctor will decide to stop treatment (see “If you stop taking Gilenya” in section 3, and also section 4, “Possible side effects”).
Maltese: It-tabib tiegħek se jiddeċiedi sabiex twaqqaf it-trattament (ara “Jekk tieqaf tieħu Gilenya” f'sezzjoni 3, u wkoll sezzjoni 4, “Effetti sekondarji possibbli”).
English: Fingolimod is unlikely to interact with substances mainly cleared by the CYP450 enzymes or by substrates of the main transporter proteins.
Maltese: Mhuwiex normali li fingolimod jirreaġixxi ma' sustanzi li jitneħħew normalment bl-enżimi CYP450 jew bis-sottostrati tal-proteini trasportaturi ewlenin.
English: Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and HPV-related cancer, has been reported in patients treated with Gilenya.
Maltese: Kienu rrappurtati infezzjoni mill-virus tal-papilloma uman (HPV), displassija, felul u kanċers relatati f'pazjenti ttrattati b'Gilenya.
English: In a small number of patients (N=10 on 1.25 mg, N=2 on 0.5 mg) who experienced ALT elevations ≥5x ULN and who continued on Gilenya therapy, the ALT levels returned to normal within approximately 5 months (see also section 4.4, Liver function).
Maltese: F'numru żgħir ta' pazjenti (N=10 fuq 1.25 mg, N=2 fuq 0.5 mg) li kellhom żidiet fl-ALT ta' ≥5x ULN u li ssuktaw bit-terapija ta' Gilenya, il-livelli ta' ALT reġgħu lura għan-normal f'madwar 5 xhur (ara wkoll sezzjoni 4.4, Il-funzjoni tal-fwied).
English: Basal cell carcinoma (BCC) and other cutaneous neoplasms, including malignant melanoma, squamous cell carcinoma, Kaposi's sarcoma and Merkel cell carcinoma, have been reported in patients receiving Gilenya (see section 4.8).
Maltese: Kienu rrappurtati karċinoma taċ-ċellula bażali (BCC) u neoplażmi oħrajn fil-ġilda, inkluż melanoma malinna, karċinoma taċ-ċellula skwamuża, is-sarkoma ta' Kaposi u l-karċinoma taċ-ċellula Merkel, f'pazjenti mogħtija Gilenya (ara sezzjoni 4.8).
English: Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported at the 0.5 mg dose in clinical trials and in the post-marketing setting (see section 4.8).
Maltese: Kienu rrappurtati każijiet rari ta' sindrome ta' enċefalopatija posterjuri riversibbli (PRES - posterior reversible encephalopathy syndrome) bid-doża ta' 0.5 mg fi provi kliniċi u fl-ambjent ta' wara tqegħid fis-suq (ara sezzjoni 4.8).
English: Women of child-bearing potential, including adolescent females, should: o Be informed before treatment initiation and regularly thereafter by their physician about GILENYA's serious risks to the foetus, and about the contraindication in pregnant women and in women of childbearing potential not using effective contraception, facilitated by the pregnancy-specific patient reminder card; o Have a negative pregnancy test before starting GILENYA; o Be using effective contraception during and for at least two months following discontinuation of GILENYA treatment; o Report immediately to the prescribing physician any (intended or unintended) pregnancy during and up to two months following discontinuation of GILENYA treatment;
Maltese: Nisa li jistgħu joħorġu tqal, inkluż nisa adolexxenti, għandhom: o Ikunu mgħarrfa qabel it-tnedija tat-trattament u wara b'mod regolari mit-tabib tagħhom dwar ir-riskji serji ta' GILENYA għall-fetu, u dwar il-fatt li huwa kontraindikat għal nisa tqal u għal nisa li jistgħu joħorġu tqal li mhumiex qed jużaw kontraċezzjoni effettiva, blgħajnuna tal-kartuna li tfakkar lill-pazjenti speċifikament dwar it-tqala; o Ikollhom test tat-tqala negattiv, qabel ma jinbeda GILENYA;
English: Class Ia and class III antiarrhythmic medicinal products have been associated with cases of torsades de pointes in patients with bradycardia (see section 4.3).
Maltese: III kienu assoċjati ma' każijiet ta' torsades de pointes f'pazjenti bi bradikardija (ara sezzjoni 4.3).
English: Do not use this medicine after the expiry date which is stated on the carton and blister foil after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara “JIS/EXP”.
English: Median values for baseline characteristics were: age 37 years, disease duration 6.7 years, and EDSS score 2.0.
Maltese: Ilvaluri medji tal-karatteristiċi fil-linja bażi kienu: età 37 sena, id-dewmien tal-marda 6.7 snin u lpunteġġ tal-EDSS 2.0.
English: This has generally been observed within 12 weeks after stopping fingolimod, but has also been reported up to 24 weeks after fingolimod discontinuation.
Maltese: Dan deher ġeneralment fi żmien 12-il ġimgħa wara li twaqqaf fingolimod, imma kien ukoll irrappurtat sa 24 ġimgħa wara li twaqqaf fingolimod.
English: Anti-neoplastic, immunomodulatory or immunosuppressive therapies
Maltese: Terapiji b'antineoplastiċi, immunomodulatorji jew b'immunosuppressivi
English: Gilenya 0.25 mg hard capsules Gilenya 0.5 mg hard capsules
Maltese: Gilenya 0.25 mg kapsuli iebsa Gilenya 0.5 mg kapsuli iebsa
English: Tabulated list of adverse reactions
Maltese: Lista tal-effetti mhux mixtieqa forma ta' tabella
English: In a thorough QT interval study of doses of 1.25 or 2.5 mg fingolimod at steady-state, when a negative chronotropic effect of fingolimod was still present, fingolimod treatment resulted in a prolongation of QTcI, with the upper limit of the 90% CI ≤13.0 ms.
Maltese: Fi studju profond dwar l-intervall tal-QT b'dożi ta' 1.25 jew 2.5 mg fingolimod fi stat stabbli, meta kien għad hemm effett kronotropiku negattiv b'fingolimod, il-kura b'fingolimod wasslet għal titwil tal-QtcI, bl-ogħla limitu tad-90% tas-CI ≤13.0 ms.
English: • Fingolimod is an immunosuppressant and immunosuppression conditions are risk factors for dysimmunity.
Maltese: • Fingolimod huwa immunosuppressanti u l-kundizzjonijiet immunosuppressivi huma fatturi riskjużi għal disimmunità.
English: Based on human experience, post-marketing data suggest that use of fingolimod is associated with a 2-fold increased risk of major congenital malformations when administered during pregnancy compared with the rate observed in the general population (2-3%; EUROCAT).
Maltese: Mill-esperjenza umana, data miksuba wara t-tqegħid tal-prodott fis-suq tissuġġerixxi li l-użu ta' fingolimod jintrabat ma' żieda doppja fir-riskju ta' malformazzjonijiet konġenitali maġġuri meta jingħata waqt it-tqala mqabbel mar-rata osservata fil-popolazzjoni ġenerali (2-3%; EUROCAT).
English: Co-administration of fingolimod with oral contraceptives (ethinylestradiol and levonorgestrel) did not elicit any change in oral contraceptive exposure.
Maltese: L-għoti flimkien ta' fingolimod ma' kontraċettivi mill-ħalq (ethinylestradiol u levonorgestrel) ma qanqlu l-ebda bidla fl-espożizzjoni għall-kontraċettivi orali.
English: In a study in 13 male multiple sclerosis patients who received Gilenya 0.5 mg/day, the mean amount of fingolimod (and fingolimod phosphate) in seminal ejaculate, at steady-state, was approximately 10,000 times lower than the oral dose administered (0.5 mg).
Maltese: Fi studju fi 13-il pazjent maskili bi sklerożi multipla li rċevew Gilenya 0.5 mg/jum, l-ammont medju ta' fingolimod (u fingolimod phosphate) fil-fluwidu seminali, fi stat stabbli, kien madwar 10,000 darba anqas mid-doża orali mogħtija (0.5 mg).
English: The section 4.8 of the SmPC regarding lymphomas specifies that cases of lymphoma include also a fatal case of Epstein-Barr virus (EBV) positive B-cell lymphoma.
Maltese: Is-sezzjoni 4.8 tal-SmPC dwar il-limfomi jispeċifika li każijiet ta' limfoma jinkludu wkoll każ fatali ta' limfoma taċ-ċellula B pożittiva għall-virus EpsteinBarr (EBV).
English: Minor dose-dependent reductions in values for forced expiratory volume (FEV1) and diffusion capacity for carbon monoxide (DLCO) were observed with Gilenya treatment starting at month 1 and remaining stable thereafter.
Maltese: Kien osservat tnaqqis żgħir dipendenti fuq id-doża fil-valuri tal-volum espiratorju sfurzat (FEV1) u filkapaċità ta' tixrid tal-carbon monoxide (DLCO) bil-kura b'Gilenya li beda f'xahar 1 u li mbagħad baqa' stabbli.
English: In multiple sclerosis clinical studies the overall rate of infections (65.1%) at the 0.5 mg dose was similar to placebo.
Maltese: Waqt studji kliniċi relatati mal-isklerożi multipla r-rata totali ta' infezzjonijiet (65.1%) b'doża ta' 0.5 mg kienet l-istess bħal dik tal-plaċebo.
English: Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Maltese: Il-qafas tal-kapsula: ġelatina, dijossidu tat-titanju (E171), ossidu tal-ħadid isfar (E172).
English: The major target organs were the lymphoid system (lymphopenia and lymphoid atrophy), lungs (increased weight, smooth muscle hypertrophy at the bronchio-alveolar junction), and heart (negative chronotropic effect, increase in blood pressure, perivascular changes and myocardial degeneration) in several species; blood vessels (vasculopathy) in rats only at doses of 0.15 mg/kg and higher in a 2-year study, representing an approximate 4-fold margin based on the human systemic exposure (AUC) at a daily dose of 0.5 mg.
Maltese: L-organi ewlenin milquta kienu s-sistema limfatika (limfopenija u atrofija limfatika), ilpulmuni (żieda fil-piż, ipertrofija tal-muskoli lixxi tal-konnessjoni bronkoalveolari), u l-qalb (effett kronotropiku negattiv, żieda fil-pressjoni tad-demm, tibdiliet perivaskulari u diġenerazzjoni mijokardijaka) f'bosta speċi; il-vini tad-demm (vaskulopatija) fil-firien biss b'dożi ta' 0.15 mg/kg u aktar waqt studju ta' sentejn, li jirrappreżenta madwar 4 darbiet il-marġini msejsa fuq l-espożizzjoni sistemika (AUC) fil-bniedem b'doża ta' 0.5 mg kuljum.
English: In the multiple sclerosis studies, clinically relevant effects on prolongation of the QTc-interval have not been observed but patients at risk for QT prolongation were not included in clinical studies.
Maltese: Fl-istudji tal-isklerożi multipla, effetti klinikament relevanti dwar it-titwil tal-intervall-QTc ma ġewx osservati iżda pazjenti f'riskju ta' titwil tal-QT ma kinux imdaħħla fl-istudji kliniċi.
English: * p<0.01,** p<0.001, compared to interferon beta-1a All analyses of clinical endpoints were intent-to-treat.
Maltese: 01,** p<0.001, imqabbel ma' interferon beta-1a L-analiżi tal-endpoints kliniċi kollha kienet maħsuba sabiex tingħata l-kura.
English: Fingolimod phosphate binds at low nanomolar concentrations to sphingosine 1-phosphate (S1P) receptor 1 located on lymphocytes, and readily crosses the blood-brain barrier to bind to S1P receptor 1 located on neural cells in the central nervous system (CNS).
Maltese: Il-fingolimod fosfat jeħel f'konċentrazzjonijiet nanomolari baxxi mar-riċettur 1 tal-isfingosina 1-fosfat (S1P) misjub fuq illimfoċiti, u malajr jaqsam il-barriera tad-demm-moħħ biex jeħel mar-riċettur 1 ta' S1P misjub fuq iċċelloli newrali fis-sistema nervuża ċentrali (CNS - central nervous system).
English: Prior treatment with immunosuppressive or immunomodulatory therapies
Maltese: Kura minn qabel b'terapiji immunosuppressivi jew immunomodulatorji
English: o A negative pregnancy test result must be confirmed prior to starting treatment.
Maltese: o Irid ikun ikkonfermat test negattiv tat-tqala qabel ma jitnieda t-trattament.
English: - There are very limited data available in children between 10-12 years old, less than 40 kg or at Tanner stage <2 (see sections 4.8 and 5.1).
Maltese: Teżisti data mill-aktar limitata fit-tfal ta' bejn 10 snin u 12-il sena (ara sezzjonijiet 4.4, 4.8 u 5.1).
English: Some cases of disseminated herpes infection, including fatal cases, have been reported even at the 0.5 mg dose.
Maltese: Kienu rrappurtati xi każijiet ta' tixrid tal-infezzjoni tal-herpes, inkluż każijiet fatali, anke b'doża ta' 0.5 mg.
English: Single doses up to 80 times the recommended dose (0.5 mg) were well tolerated in healthy adult volunteers.
Maltese: Dożi singoli sa 80 darba aktar mid-doża rrakkomandata (0.5 mg) kienu ttollerati tajjeb f'voluntiera adulti b'saħħithom.
English: • Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol.
Maltese: • Mediċini minħabba taħbit irregolari tal-qalb, bħalma huma quinidine, disopyramide, amiodarone jew sotalol.
English: • A liver function test should be performed prior to treatment initiation; liver function monitoring should be performed at months 1, 3, 6, 9 and 12 during GILENYA therapy, and periodically thereafter;
Maltese: o Għandu jsir test tal-funzjoni tal-fwied qabel it-tnedija tat-trattament; għandu jitwettaq monitoraġġ tal-funzjoni tal-fwied fix-xhur 1, 3, 6, 9 u 12 matul it-terapija b'GILENYA u wara minn żmien għal żmien;
English: However, single fingolimod doses ≥5 mg (10-fold the recommended dose) are associated with a dose-dependent increase in airway resistance.
Maltese: Madanakollu, dożi singoli ta' fingolimod ≥5 mg (10 darbiet aktar mid-doża rrakkomandata) huma assoċjati ma' żieda fir-reżistenza tal-passaġġ respiratorju dipendenti mid-doża.
English: A core pharmacodynamic effect of Gilenya is a dose-dependent reduction of the peripheral lymphocyte count to 20-30% of baseline values.
Maltese: Effett farmakodinamiku ewlieni ta' Gilenya huwa t-tnaqqis fl-ammont ta' limfoċiti periferali għal 20-30% mill-valuri fil-linja bażi minħabba d-doża.
English: At 40 mg, 5 of 6 subjects reported mild chest tightness or discomfort which was clinically consistent with small airway reactivity.
Maltese: Meta mogħtija 40 mg, 5 mis-6 pazjenti rrappurtaw xi ftit tagħfis jew skumdità f'sidirhom li kien klinikament konsistenti ma' reazzjoni ħafifa fil-passaġġ respiratorju.
English: In multiple sclerosis clinical studies the maximal decline in heart rate was seen within 6 hours after treatment initiation, with declines in mean heart rate of 12-13 beats per minute for Gilenya 0.5 mg. Heart rate below 40 beats per minute in adults, and below 50 beats per minute in paediatric patients, was rarely observed in patients on Gilenya 0.5 mg.
Maltese: Rari dehret rata tattaħbit tal-qalb taħt l-40 taħbita fil-minuta fl-adulti, u taħt il-50 taħbita fil-minuta f'pazjenti pedjatriċi, f'pazjenti li ngħataw 0.5 mg Gilenya.
English: Annualised rate of the number of new or newly enlarging T2 lesions n=106
Maltese: Ir-rata annwalizzata tan-numru ta'leżjonijiet T2 ġodda jew li kibru dan l-aħħar n=106
English: Animal studies have shown that this redistribution reduces the infiltration of pathogenic lymphocytes, including pro-inflammatory Th17 cells, into the CNS, where they would be involved in nerve inflammation and nervous tissue damage.
Maltese: Studji fuq l-annimali wrew li din ir-ridistribuzzjoni tnaqqas l-infiltrazzjoni ta' limfoċiti patoġeniċi, inkluż ċelluli Th17 pro-infjammatorji, fis-CNS, fejn inkella jikkawżaw infjammazzjoni fin-nerv u jagħmlu ħsara lit-tessuti nervużi.
English: The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided (see sections 4.4 and 4.8).
Maltese: L-użu ta' tilqimiet ħajjin attenwati jista' joħloq riskju ta' infezzjonijiet u għaldaqstant għandu jkun evitat (ara sezzjonijiet 4.4 u 4.8).
English: Elevations 5-fold the ULN occurred in 1.8% of patients on fingolimod and 0.9% of patients on placebo.
Maltese: Seħħew żidiet ta' 5 darbiet il-ULN f'1.8% tal-pazjenti mogħtija fingolimod u f'0.9% f'pazjenti mogħtija plaċebo.
English: The apparent elimination half-life of fingolimod is unchanged in subjects with mild hepatic impairment, but is prolonged by about 50% in patients with moderate or severe hepatic impairment.
Maltese: Il-half-life apparenti tal-eliminazzjoni ta' fingolimod ma tinbidilx f'pazjenti b'indeboliment ħafif tal-fwied, imma tittawwal b'madwar 50% f'pazjenti b'indeboliment moderat jew gravi tal-fwied.
English: Conduct of a prospective cohort study assessing the incidence of cardiovascular adverse events in patients starting GILENYA treatment for relapsing remitting multiple sclerosis based on a CHMP approved protocol.
Maltese: Isir studju ta' cohort prospettiv li jevalwa l-inċidenza ta' episodji avversi kardjovaskulari f'pazjenti li qed jibdew trattament b'GILENYA għal sklerożi multipla rikorrenti msejjes fuq protokoll approvat tal-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP).
English: - Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV
Maltese: Prodotti mediċinali antiarritmiċi tal-klassi Ia u l-klassi
English: • GILENYA is contraindicated during pregnancy and in women of childbearing potential not using effective contraception.
Maltese: • GILENYA hu kontraindikat waqt it-tqala u għal nisa li jistgħu joħorġu tqal li mhumiex jużaw kontraċezzjoni effettiva.
English: Your doctor may switch you directly from beta interferon, glatiramer acetate or dimethyl fumarate to Gilenya if there are no signs of abnormalities caused by your previous treatment.
Maltese: It-tabib tiegħek jista' jaqilbek direttament minn interferon beta, glatiramer acetate jew dimethyl fumarate għal Gilenya jekk ma jkun hemm l-ebda sinjali ta' anormalitajiet ikkawżati mill-kura ta' qabel tiegħek.
English: • Skin cancers have been reported in multiple sclerosis patients treated with GILENYA.
Maltese: • Ġew irrappurtati kanċers tal-ġilda f'pazjenti bi sklerożi multipla ttrattati b'GILENYA.
English: Pruritus
Maltese: Tilqim
English: • Children and adolescents with body weight equal to or below 40 kg: one 0.25 mg capsule per day.
Maltese: • Tfal u adolexxenti li jiżnu daqs 40 kg jew anqas: kapsula waħda ta' 0.25 mg kuljum.
English: - Mild isolated bilirubin increases have been noted in paediatric patients on Gilenya.
Maltese: - Kienu nnutati żidiet ħfief u iżolati fil-bilirubina fost pazjenti pedjatriċi b'Gilenya.
English: 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 6 xhur kellhom infart mijokardijaku (MI), angina pectoris, 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) (ara sezzjoni 4.4).
English: The ARR for patients who switched from interferon beta-1a to fingolimod 0.5 mg was 0.33 (0.48 in the core study).
Maltese: L-APR għal pazjenti li għaddew minn inteferon beta-1a għal 0.5 mg fingolimod kienet ta' 0.33 (0.48 fl-istudju ewlieni).
English: QT interval
Maltese: Twissijiet u prekawzjonijiet
English: Before initiation of treatment, women of childbearing potential must be informed of this risk to the foetus, must have a negative pregnancy test and must use effective contraception during treatment and for 2 months after treatment discontinuation (see sections 4.3 and 4.6 and the information contained in the Physician Information Pack).
Maltese: Qabel it-tnedija tat-trattament, nisa li jistgħu joħorġu tqal għandhom ikunu mgħarrfa dwar ir-riskju għall-fetu, għandu jkollhom test negattiv tattqala u għandhom jużaw kontraċezzjoni effettiva matul it-trattament u sa xahrejn wara li jitwaqqaf ittrattament (ara sezzjonijiet 4.3 u 4.6 u t-tagħrif misjub fil-Pakkett ta' Informazzjoni għat-Tobba).
English: Macular oedema incidence is increased in multiple sclerosis patients with a history of uveitis (17% with a history of uveitis vs. 0.6% without a history of uveitis).
Maltese: L-inċidenza ta' edima makulari tiżdied f'pazjenti bi sklerożi multipla bi storja ta' uveitis (17% bi storja ta' uveitis kontra 0.6% mingħajr storja ta' uveitis).
English: Human papilloma virus (HPV) infection, including papilloma, dysplasia, warts and HPV-related cancer, has been reported under treatment with fingolimod in the post-marketing setting.
Maltese: Kienu rrappurtati infezzjoni bil-virus tal-papilloma uman (HPV), fosthom papilloma, displasija, felul u kanċer relatat mal-HPV, meta ngħata trattament b'fingolimod wara li l-prodott tqiegħed fis-suq.
English: • GILENYA is not recommended in patients with: o Sino-atrial heart block; o QTc prolongation >470 msec (adult females), QTc >460 msec (pediatric females) or
Maltese: • GILENYA mhuwiex irrakkomandat f'pazjenti b': o Imblokk tal-qalb sinoatrijali o Prolungament tal-QTc >470 msek (nisa adulti), QTc >460 msek (nisa pedjatriċi) jew ta' >450 msek (irġiel adulti u pedjatriċi); o Storja ta' arrest kardijaku o Apnea qawwija tal-irqad o Storja ta' bradikardija sintomatika o Storja ta' sinkope rinkorrenti o Pressjoni għolja mhux ikkontrollata
English: A type of cancer of the lymphatic system (lymphoma) has been reported in MS patients treated with Gilenya.
Maltese: Kien irrappurtat tip ta' kanċer tas-sistema limfatika (limfoma) f'pazjenti b'MS ittrattati b'Gilenya.
English: Fingolimod and fingolimod phosphate are highly protein bound (>99%).
Maltese: Fingolimod fosfat jgħaddi anqas fiċ-ċelloli tad-demm b'<17%. Fingolimod u fingolimod fosfat jintrabtu b'qawwa mal-proteini (>99%).
English: GILENYA 0.25 mg hard capsules fingolimod
Maltese: GILENYA 0.25 mg kapsuli iebsa fingolimod
English: If you have severe liver problems, you should not take Gilenya.
Maltese: Jekk għandek problemi gravi tal-fwied, m'għandekx tieħu Gilenya.
English: Gilenya may affect your liver function.
Maltese: Gilenya għandu effett ħafif fuq il-funzjoni tal-pulmun.
English: The efficacy and safety of once-daily doses of fingolimod 0.25 mg or 0.5 mg (dose selected based on body weight and exposure measurements) have been established in paediatric patients aged 10 to <18 years with relapsing-remitting multiple sclerosis.
Maltese: L-effikaċja u s-sigurtà ta' dożi ta' fingolimod 0.25 mg jew 0.5 mg darba kuljum (doża magħżula skont il-piż tal-persuna u l-miżuri ta' espożizzjoni) ġew stabbiliti f'pazjenti pedjatriċi minn 10 snin sa <18il sena bi sklerożi multipla li tirkadi u tbatti.
English: Lung problems
Maltese: Problemi fil-pulmun
English: Fingolimod is contraindicated in women of childbearing potential not using effective contraception (see section 4.3).
Maltese: Fingolimod huwa kontraindikat għal nisa li jistgħu joħorġu tqal u mhux qed jużaw kontraċezzjoni effettiva (ara sezzjoni 4.3).
English: INTERMEDIATE CARTON OF MULTIPACK - WALLET (WITHOUT BLUE BOX)
Maltese: BIL-POKITS (BIL-KAXXA BLU)
English: Co-administration of carbamazepine 600 mg twice daily at steady-state and a single dose of fingolimod 2 mg reduced the AUC of fingolimod and its metabolite by approximately 40%.
Maltese: L-għoti flimkien ta' carbamazepine 600 mg darbtejn kuljum fi stat wieqaf u ta' doża waħda ta' fingolimod 2 mg naqqas l-AUC ta' fingolimod u tal-metabolit tiegħu b'madwar 40%.
English: 28 hard capsules.
Maltese: 28 kapsuli iebsa.
English: GILENYA 0.5 mg hard capsules fingolimod
Maltese: GILENYA 0.5 mg kapsuli iebsa fingolimod
English: In clinical studies, rare events involving the nervous system occurred in patients treated with fingolimod at higher doses (1.25 or 5.0 mg) including ischaemic and haemorrhagic strokes and neurological atypical disorders, such as acute disseminated encephalomyelitis (ADEM)-like events.
Maltese: Waqt studji kliniċi, seħħew episodji rari li jinvolvu s-sistema nervuża f'pazjenti kkurati b'dożi ogħla ta' fingolimod (1.25 jew 5.0 mg) fosthom puplesiji iskemiċi u emorroġiċi u disturbi newroloġiċi atipiċi, bħal każijiet jixbhu l-enċefalomijelite akuta mifruxa (ADEM).
English: • Where at the 6-hour time point: a. Heart rate <45 bpm, <55 bpm in paediatric patients aged 12 years old and above, or <60 bpm in pediatric patients 10 to below 12 years of age; b. New onset second degree or higher AV block; c. QTc interval 500 msec.
Maltese: Ir-rata tat-taħbit tal-qalb <45 bpm, <55 bpm f'pazjenti pedjatriċi minn 12il sena 'l fuq, jew <60 bpm f'pazjenti pedjatriċi minn 10 snin sa taħt it-12il sena; b. Imblokk ġdid tal-AV tat-tieni livell jew ogħla; ċ.
English: CARTON OF UNIT PACK CONTAINING SINGLE-UNIT-DOSE BLISTERS
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM