FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical studies of Tecfidera had limited exposure to patients aged 55 years and above, and did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients (see section 5.2).
Maltese: Studji kliniċi dwar Tecfidera kellhom esponiment limitat għal pazjenti ta' 55 sena jew aktar, u ma inkludewx numri suffiċjenti ta' pazjenti li kellhom 65 sena jew aktar biex jiġi stabbilit jekk dawn jirrispondux b'mod differenti minn individwi iżgħar (ara sezzjoni 5.2).
English: Oral administration of dimethyl fumarate to female rats at 25, 100, and 250 mg/kg/day prior to and during mating, and continuing to Day 7 of gestation, induced reduction in the number of estrous stages per 14 days and increased the number of animals with prolonged diestrus at the highest dose tested (11 times the recommended dose on an AUC basis).
Maltese: L-għoti orali ta' dimethyl fumarate lil firien nisa f'doża ta' 25, 100, u 250 mg/kg/jum qabel u waqt it-tgħammir, li kompla sa Jum 7 tat-tqala, ikkaġuna tnaqqis fin-numru ta' stadji estrous kull 14-il jum u żied in-numru ta' annimali b'diestrus imtawwal fl-ogħla doża ttestjata (11-il darba tad-doża rakkomandata bbażata fuq l-AUC).
English: The benefit/risk in patients with lymphocyte counts ≥0.5 x 109/L and <0.8 x 109/L for more than six months should be assessed.
Maltese: Il-benefiċċju/riskju f'pazjenti b'għadd ta' limfoċiti ta' ≥0.5 x 109/L u <0.8 x 109/L għal aktar minn sitt xhur għandu jiġi evalwat.
English: How Tecfidera works
Maltese: X'inhu Tecfidera
English: Taking into account the PRAC Assessment Report on the PSUR(s) for dimethyl fumarate (multiple sclerosis), the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal dimethyl fumarate (sklerożi multipla), il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: The terminal half-life of monomethyl fumarate is short (approximately 1 hour) and no circulating monomethyl fumarate is present at 24 hours in the majority of individuals.
Maltese: Il-half-life terminali ta' monomethyl fumarate hi qasira (madwar siegħa) u l-ebda monomethyl fumarate li jkun jiċċirkola ma nstab wara 24 siegħa fil-maġġoranza tal-individwi.
English: Tecfidera 120mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate.
Maltese: Tecfidera 120mg kapsuli ibsin gastroreżistenti Kull kapsula iebsa gastroreżistenti fiha 120 mg ta' dimethyl fumarate.
English: Capsule print (black ink)
Maltese: Stampar tal-kapsula (linka sewda)
English: Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7799
Maltese: Biogen Spain, S.L. Tel: +34 91 310 7110
English: The downstream metabolism of fumaric acid occurs through the tricarboxylic acid cycle, with exhalation of CO2 serving as a primary route of elimination.
Maltese: Il-metaboliżmu downstream ta' fumaric acid iseħħ permezz taċ-ċiklu ta' tricarboxylic acid,
English: Fertility
Maltese: Rimettar
English: Consumption of large quantities of strong alcoholic drinks (more than 30% alcohol by volume) should be avoided within an hour of taking Tecfidera, as alcohol may lead to increased frequency of gastrointestinal adverse reactions.
Maltese: Tecfidera, għax l-alkoħol jista' jwassal għal żieda fil-frekwenza ta' reazzjonijiet avversi gastrointestinali.
English: Oral administration of dimethyl fumarate at 25, 75, and 150 mg/kg/day to pregnant rabbits during organogenesis had no effect on embryo-fetal development and resulted in reduced maternal body weight at 7 times the recommended dose and increased abortion at 16 times the recommended dose, on an AUC basis.
Maltese: L-għoti orali ta' dimethyl fumarate f'dożi ta' 25, 75, u 150 mg/kg/jum lil fniek tqal matul lorganoġenesi ma kellu l-ebda effett fuq l-iżvilupp embrijufetali u rriżulta fi tnaqqis fil-piż tal-ġisem tal-omm f'doża li kienet 7 darbiet tad-doża rakkomandata u żied l-abort f'doża li kienet 16-il darba tad-doża rakkomandata bbażat fuq l-AUC.
English: The active substance is dimethyl fumarate.
Maltese: X'fih Tecfidera Is-sustanza attiva hi dimethyl fumarate.
English: 109/L and <0.8 x 109/L for at least six months; 2% of patients experienced lymphocyte counts <0.5 x 109/L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 x 109/L with continued therapy.
Maltese: Fi studji kliniċi (kemm ikkontrollati kif ukoll mhux ikkontrollati), 9% tal-pazjenti kellhom għadd ta' limfoċiti ≥0.5 x 109/L u <0.8 x 109/L għal mill inqas sitt xhur; 2% tal-pazjenti esperjenzaw għadd ta' limfoċiti <0.5 x 109/L għal mill-inqas sitt xhur, u f'dan il-grupp il-maġġoranza tal-għadd ta' limfoċiti baqa' <0.5 x 109/L b'terapija kontinwa.
English: Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate
Maltese: Kull kapsula iebsa gastroreżistenti fiha 120 mg ta' dimethyl fumarate
English: In the placebo-controlled studies most patients (>98%) had normal lymphocyte values prior to initiating treatment.
Maltese: Fl-istudji kkontrollati bi plaċebo, il-biċċa l-kbira tal-pazjenti (>98%) kellhom valuri normali ta'
English: Importantly, Fanconi syndrome can occur without elevated creatinine levels or low glomerular filtration rate.
Maltese: Fuq kollox, is-sindrome ta' Fanconi jista' jseħħ mingħajr livelli għolja ta' krejatinina jew rata baxxa ta' filtrazzjoni glomerulari.
English: Kidney changes were observed after repeated oral administration of dimethyl fumarate in mice, rats, dogs, and monkeys.
Maltese: Tibdil fil-kliewi ġie osservat wara għoti orali ripetut ta' dimethyl fumarate fil-ġrieden, fil-firien, filklieb, u fix-xadini.
English: If JCV testing is undertaken, it should be considered that the influence of lymphopenia on the accuracy of anti-JCV antibody test has not been studied in dimethyl fumarate treated patients.
Maltese: Jekk isir l-ittestjar għal JCV, għandu jiġi kkunsidrat li l influwenza tal-limfopenija fuq il-preċiżjoni tat-test tal-antikorpi anti-JCV ma ġietx studjata f'pazjenti kkurati b'dimethyl fumarate.
English: MS, such as fingolimod, natalizumab, teriflunomide, alemtuzumab, ocrelizumab or cladribine, or some commonly used cancer treatments (rituximab or mitoxantrone).
Maltese: MS hi kundizzjoni fit-tul li taffettwa lis-sistema nervuża ċentrali (CNS), li tinkludi l-moħħ u s-sinsla.
English: Efficacy (see table below) and safety were demonstrated in subjects with Expanded Disability Status Scale (EDSS) scores ranging from 0 to 5 inclusive, who had experienced at least 1 relapse during the year prior to randomisation, or, in the 6 weeks before randomisation had a brain Magnetic Resonance Imaging (MRI) demonstrating at least one gadolinium-enhancing (Gd+) lesion.
Maltese: L-effikaċja (ara t-tabella hawn taħt) u s-sigurtà ntwerew f'individwi b'punteġġi tal-Expanded Disability Status Scale (EDSS) li jvarjaw minn 0 sa 5 inklużivi, li kellhom mill-inqas 1 rikaduta matul is-sena qabel ma ntgħażlu b'mod każwali, jew fis-6 ġimgħat qabel ma ntgħażlu b'mod każwali kellhom Immaġni bir-Riżonanza Manjetika (MRI) li turi mill-inqas leżjoni waħda li ttejjeb gadolinium (Gd+).
English: - liver inflammation and increase in levels of liver enzymes (ALT or AST in combination with bilirubin)
Maltese: - proteini (albumina) fl-awrina - żieda fil-livelli ta' enzimi tal-fwied(ALT, AST) fid-demm
English: It should also be noted that a negative anti JCV antibody test (in the presence of normal lymphocyte counts) does not preclude the possibility of subsequent JCV infection.
Maltese: Għandu jiġi nnutat ukoll li test tal-antikorpi anti-JCV b'riżultat negattiv (fil-preżenza ta' għadd normali ta' limfoċiti) ma jipprekludix il-possibbiltà ta' infezzjoni sussegwenti b'JCV.
English: Two, 2-year, randomised, double-blind, placebo controlled studies [Study 1 (DEFINE) with 1234 subjects and Study 2 (CONFIRM) with 1417 subjects] of subjects with relapsing-remitting multiple sclerosis (RRMS) were performed.
Maltese: Effikaċja klinika u sigurtà Saru żewġ studji kkontrollati bi plaċebo li damu sentejn, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, [Studju 1 (DEFINE), b'1234 individwu u Studju 2 (CONFIRM) b'1417-il individwu] fuq individwi bi sklerożi multipla li tirkadi u tbatti (RRMS).
English: Elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN, were not observed in placebo-controlled studies.
Maltese: Żidiet fit-transaminases ta' ≥ 3 darbiet tal-ULN b'żidiet fl-istess ħin fil-bilirubina totali ta' > darbtejn tal-ULN, ma kinux osservati fl-istudji kkontrollati bi plaċebo.
English: Cases of herpes zoster have occurred with Tecfidera.
Maltese: Seħħew każijiet ta' herpes zoster b'Tecfidera.
English: Tecfidera is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5.1 for important information on the populations for which efficacy has been established).
Maltese: Tecfidera huwa indikat għall-kura ta' pazjenti adulti li għandhom sklerożi multipla li tirkadi u tbatti (ara sezzjoni 5.1 għal informazzjoni importanti dwar il-popolazzjonijiet li għalihom l-effikaċja ġiet determinata).
English: What Tecfidera is used for Tecfidera is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients.
Maltese: Għalxiex jintuża Tecfidera Tecfidera jintuża għal kura ta' sklerożi multipla (MS) li tirkadi u tbatti f'pazjenti adulti.
English: Tecfidera 240 mg gastro-resistant hard capsules dimethyl fumarate
Maltese: Tecfidera 240 mg kapsuli ibsin gastroreżistenti dimethyl fumarate
English: Preclinical studies indicate that dimethyl fumarate pharmacodynamic responses appear to be primarily mediated through activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway.
Maltese: Studji ta' qabel l-użu kliniku jindikaw li r-risponsi farmakodinamiċi ta' dimethyl fumarate jidhru li jiġu medjati primarjament permezz tal-attivazzjoni tal-passaġġ traskrizzjonali tal-fattur Nukleari (erythroid-derived 2)-like 2 (Nrf2).
English: MRI Endpointsb
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Orally administered dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its primary metabolite, monomethyl fumarate, which is also active.
Maltese: Dimethyl fumarate mogħti mill-ħalq jgħaddi minn idrolisi presistemika mgħaġġla minn esterases u jinbidel għall-metabolit primarju tiegħu, monomethyl fumarate, li hu attiv ukoll.
English: Tecfidera 120 mg gastro-resistant hard capsules dimethyl fumarate
Maltese: Tecfidera 120 mg kapsuli ibsin gastroreżistenti dimethyl fumarate
English: Clinical Endpointsa
Maltese: Punti Aħħarin Kliniċia
English: 14 gastro-resistant hard capsules
Maltese: 14-il kapsula iebsa gastroreżistenti
English: However, Tecfidera should be taken with food due to improved tolerability with respect to flushing or gastrointestinal adverse events (see section 4.2).
Maltese: Tecfidera għandu jittieħed mal-ikel minħabba tollerabilità mtejba fir-rigward ta' fwawar jew avvenimenti gastrointestinali avversi (ara sezzjoni 4.2).
English: Tecfidera 240 mg: Each capsule contains 240 mg of dimethyl fumarate.
Maltese: Kull kapsula fiha 240 mg ta' dimethyl fumarate.
English: In rare cases hypophosphataemic osteomalacia with nonlocalised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur.
Maltese: F'każijiet rari jistgħu jseħħu osteomalaċja ipofosfatemika b'uġigħ fl-għadam mhux lokalizzat, livelli għolja ta' alkaline phosphatase fis-serum u ksur ta' stress.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali wrew effett tossiku fuq is-sistema riproduttiva (ara 5.3).
English: There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or <0.5x109/L (see Section 4.8).
Maltese: limfoċiti ta' <0.8x109/L jew <0.
English: The incidence of serious flushing, which may be characterised by generalised erythema, rash and/or pruritus, was seen in less than 1% of patients treated with Tecfidera (see sections 4.2, 4.4 and 4.5).
Maltese: L-inċidenza ta' fwawar serji li jistgħu jkunu kkaratterizzati minn eritema ġeneralizzata, raxx u/jew ħakk tal-ġilda ġiet osservata f'inqas minn 1% tal-pazjenti kkurati b'Tecfidera (ara sezzjonijiet 4.2, 4,4 u 4.5). Gastrointestinali
English: When switching patients from another disease modifying therapy to Tecfidera, the half-life and mode of action of the other therapy should be considered in order to avoid an additive immune effect while at the same time, reducing the risk of reactivation of MS.
Maltese: Meta l-pazjenti jaqilbu minn terapiji oħrajn li jimmodifikaw il-marda, għal Tecfidera, ilhalf-life u l-mod ta' azzjoni tat-terapija l-oħra, għandhom jiġu kkunsidrati sabiex jiġi evitat effett immuni addittiv filwaqt li fl-istess ħin jiġi jitnaqqas ir-riskju tal-attivazzjoni mill-ġdid tal-marda ta' MS.
English: Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate
Maltese: Kull kapsula iebsa gastroreżistenti fiha 240 mg ta' dimethyl fumarate
English: Severe active gastrointestinal disease
Maltese: Mard gastrointestinali sever attiv
English: Fri.
Maltese: rispettivament.
English: The contribution of prior immunosuppressive therapy to the development of PML in dimethyl fumarate treated patients is unknown.
Maltese: Il-kontribuzzjoni ta' terapija immunosoppressiva fil-passat għall-iżvilupp ta' PML f'pazjenti kkurati b'dimethyl fumarate mhijiex magħrufa.
English: Therefore, all pharmacokinetic analyses related to dimethyl fumarate were performed with plasma monomethyl fumarate concentrations.
Maltese: Għalhekk, l-analiżijiet farmakokinetiċi kollha relatati ma' dimethyl fumarate twettqu b'konċentrazzjonijiet ta' monomethyl fumarate fil-plażma.
English: This resulted in a minimal accumulation of exposure yielding an increase in the median Cmax of 12% compared to the twice daily dosing (1.72 mg/l for twice daily compared to 1.93 mg/l for three times daily) with no safety implications.
Maltese: Dan irriżulta f'akkumulazzjoni minima ta' esponiment li tirriżulta f'żieda fil-medjan tas-Cmax ta' 12% meta mqabbla mad-dożaġġ ta' darbtejn kuljum (1.72 mg/l għal darbtejn kuljum meta mqabbel ma' 1.93 mg/l għal tliet darbiet kuljum)
English: Oral administration of dimethyl fumarate to male rats at 75, 250, and 375 mg/kg/day prior to and during mating had no effects on male fertility up to the highest dose tested (at least 2 times the recommended dose on an AUC basis).
Maltese: L-għoti orali ta' dimethyl fumarate lil firien irġiel f'doża ta' 75, 250, u 375 mg/kg/jum qabel u waqt it tgħammir ma kellu l-ebda effetti fuq il-fertilità tal-irġiel sal-ogħla doża ttestjata (mill-inqas darbtejn tad-doża rakkomandata bbażata fuq l-AUC).
English: Dimethyl fumarate was negative in the in vivo micronucleus assay in the rat.
Maltese: Dimethyl fumarate kien negattiv in vivo fl assaġġ tal-mikronukleu fil-firien.
English: In an ongoing long-term extension study, in which 1736 MS patients are treated with Tecfidera, approximately 5% experienced one or more events of herpes zoster, the majority of which were mild to moderate in severity.
Maltese: Fi studju ta' estensjoni fit-tul li għadu għaddej, li fih 1736 individwu b'MS qed jiġu ttrattati b'Tecfidera, madwar 5% tal-individwi esperjenzaw avveniment wieħed jew aktar ta' herpes zoster, il-maġġoranza tagħhom kienu ħfief sa moderati fis-severità.
English: Flushing is usually described as flushing or hot flush, but can include other events (e.g. warmth, redness, itching, and burning sensation).
Maltese: Il-fwawar normalment huma deskritti bħala fwawar jew fwawar jaħarqu, iżda jistgħu jinkludu avvenimenti oħrajn (eż. sħana, ħmura, ħakk, u sensazzjoni ta' ħruq).
English: Grade 2 and 3 lymphopenia prevailed in subjects with concurrent lymphocytopenia.
Maltese: Dawn l-avvenimenti jistgħu jseħħu fi kwalunkwe ħin matul il-kura.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Cases of Fanconi syndrome have been reported for a medicinal product containing dimethyl fumarate in combination with other fumaric acid esters.
Maltese: Każijiet tas-sindrome ta' Fanconi ġew irrappurtati għal prodott mediċinali li fih dimethyl fumarate flimkien ma' fumaric acid esters oħra.
English: The symptoms described in these cases were consistent with the known adverse reaction profile of Tecfidera.
Maltese: Is-sintomi deskritti f'dawn il-każijiet kienu konsistenti mal-profil ta' reazzjonijiet avversi magħrufa ta' Tecfidera.
English: What you need to know before you take Tecfidera Do not take Tecfidera:
Maltese: Każijiet ta' doża eċċessiva ġew irrappurtati b'Tecfidera.
English: In patients with flushing, the majority had flushing events that were mild or moderate in severity.
Maltese: F'pazjenti bi fwawar, il-maġġoranza kellhom avvenimenti ta' fwawar li kienu ħfief jew moderati fis severità.
English: In humans, dimethyl fumarate is extensively metabolised by esterases before it reaches the systemic circulation and further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Maltese: Fil-bnedmin, dimethyl fumarate jiġi metabolizzat b'mod estensiv permezz ta' esterases qabel jilħaq iċċirkolazzjoni sistemika u metaboliżmu addizzjonali jseħħ permezz taċ-ċiklu ta' tricarboxylic acid,
English: A rare but serious kidney disorder (Fanconi Syndrome) has been reported for a medicine containing dimethyl fumarate, in combination with other fumaric acid esters, used to treat psoriasis (a skin disease).
Maltese: Disturb tal-kliewi rari iżda serju (Sindrome ta' Fanconi) ġie rrappurtat għal mediċina li fiha dimethyl fumarate, flimkien ma' fumaric acid esters oħra, li tintuża biex tittratta l-psorjasi (marda tal-ġilda).
English: Compared to placebo, subjects treated with Tecfidera had a clinically meaningful and statistically significant reduction on: the primary endpoint in Study 1, proportion of subjects relapsed at 2 years; and the primary endpoint in Study 2, annualised relapse rate at 2 years.
Maltese: Meta mqabbla mal-plaċebo, individwi kkurati b'Tecfidera kellhom tnaqqis klinikament sinifikanti u statistikament sinifikanti fuq dawn iż-żewġ punt aħħarin: il-punt aħħari primarju fi Studju 1, ilproporzjon ta' individwi li rkadew wara sentejn; u l-punt aħħari primarju fi Studju 2, ir-rata ta' rikaduta annwalizzata wara sentejn.
English: Treatment initiation
Maltese: TAL-PRODOTT MEDIĊINALI
English: Oral administration of dimethyl fumarate at 25, 100, and 250 mg/kg/day to rats during pregnancy and lactation resulted in lower body weights in the F1 offspring, and delays in sexual maturation in F1 males at 11 times the recommended dose on an AUC basis.
Maltese: L-għoti orali ta' dimethyl fumarate f'dożi ta' 25, 100, u 250 mg/kg/jum lil firien matul it-tqala u t treddigħ irriżulta f'piż tal-ġisem iktar baxx fil-frieħ F1, u dewmien fil-maturazzjoni sesswali f'irġiel F1 f'doża li kienet 11-il darba tad-doża rakkomandata bbażata fuq l-AUC.
English: Dimethyl fumarate and mono-methylfumarate were negative in a battery of in vitro assays (Ames, chromosomal aberration in mammalian cells).
Maltese: Dimethyl fumarate u mono-methylfumarate kienu negattivi f'sensiela ta' assaġġi in vitro assaġġi
English: Swallow each capsule whole, with some water.
Maltese: Ibla' kull kapsula sħiħa, ma' ftit ilma.
English: In the majority of patients who experienced gastrointestinal events, it was mild or moderate in severity.
Maltese: Fil-maġġoranza tal-pazjenti li kellhom avvenimenti gastrointestinali, dawn kienu ħfief jew moderati fis-severità.
English: Laboratory abnormalities
Maltese: Anormalitajiet fir-riżultati tat-testijiet tal-laboratorju
English: Consumption of more than a small quantity (more than 50 ml) of strong alcoholic drinks (more than 30% alcohol by volume, e.g. spirits) should be avoided within an hour of taking Tecfidera, as alcohol can interact with this medicine.
Maltese: 30% alkoħol skont il-volum, eż. spirti) għandu jiġi evitat fi żmien siegħa minn meta jittieħed Tecfidera, għax l-alkoħol jista' jinteraġixxi ma' din il-mediċina.
English: Based on data from placebo-controlled studies, the majority of patients with elevations had hepatic transaminases that were <3 times the upper limit of normal (ULN).
Maltese: Fuq il-bażi ta' studji kkontrollati bi plaċebo, il-maġġoranza ta' pazjenti biż-żidiet kellhom transaminases tal-fwied li kienu <3 darbiet il-limitu ta' fuq tan-normal (ULN).
English: Since the renal pathway is a secondary route of elimination for dimethyl fumarate accounting for less than 16% of the dose administered, evaluation of pharmacokinetics in individuals with renal impairment was not conducted.
Maltese: Billi l-passaġġ mill-kliewi hi rotta sekondarja ta' eliminazzjoni għal dimethyl fumarate li tammonta għal inqas minn 16% tad-doża mogħtija, ma saritx evalwazzjoni tal-farmakokinetika f'individwi b'indeboliment tal-kliewi.
English: Patients treated with Tecfidera may develop severe prolonged lymphopenia (see section 4.8).
Maltese: Il-kura m'għandhiex terġa' tinbeda (ara sezzjoni 4.8).
English: Thu.
Maltese: T TL E
English: There are no known therapeutic interventions to enhance elimination of Tecfidera nor is there a known antidote.
Maltese: M'hemm l-ebda interventi terapewtiċi magħrufa biex itejbu l-eliminazzjoni ta' Tecfidera, u lanqas m'hemm antidot magħruf.
English: Substances called ketones, which are naturally produced in the body, very commonly show up in urine tests while taking Tecfidera.
Maltese: Sustanzi msejħa ketoni, li huma magħmula b'mod naturali fil-ġisem, jidhru b'mod komuni ħafna fit testijiet tal-awrina meta tkun tieħu Tecfidera.
English: MRI imaging may be considered as part of increased vigilance in patients considered at increased risk of PML.
Maltese: MRI jistgħu jiġu kkunsidrati bħala parti minn viġilanza miżjuda f'pazjenti kkunsidrati li huma f'riskju akbar ta' PML.
English: There was no case explicitly reporting Fanconi syndrome in the Multiple Sclerosis (MS) indication; however, it has been reported in literature that that female patients with psoriasis treated long-term with fumaric acid esters seem to be at particular risk.
Maltese: Ma kien hemm l-ebda każ ta' rapport espliċitu tas-sindrome ta' Fanconi fl-indikazzjoni tal-Isklerożi Multipla (MS, Multiple Sclerosis); madankollu, ġie rrappurtat fil-letteratura li pazjenti nisa li għandhom psorjasi ttrattata fit-tul b'esteri ta' aċidu fumariku jidhru li huma f'riskju partikolari.
English: Medis Adria d.o.o.
Maltese: leżjonijiet Gd wara sentejn
English: Common White blood cell count decreased Common 1 Adverse reactions derived only during post marketing experience
Maltese: Komuni 1 Reazzjonijiet avversi derivati biss matul l-esperjenza ta' wara t-tqegħid fis-suq
English: • Acute coronary syndrome (including myocardial infarction) within the last 30 days
Maltese: • Sindromu koronarju akut (inkluż infart mijokardijaku) fl-aħħar 30 jum
English: - Alert HCP about BRINAVESS special warnings and precautions in patients with, clinically meaningful valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis, previously documented LVEF ≤ 35%, advanced hepatic impairment.
Maltese: Wissi lill-HCP dwar twissijiet u prekawżjonijiet speċjali ta' BRINAVESS f'pazjenti bi stenożi valvulari klinikament importanti, kardjomijopatija ostruttiva ipertrofika, kardjomijopatija restrittiva, jew perikardite kostrittiva, LVEF iddokumentata preċedentament ≤ 35%, indeboliment avvanzat tal-fwied.
English: - Alert HCP on BRINAVESS contraindications:
Maltese: - Wissi lill-HCP dwar kontra-indikazzjonijiet ta' BRINAVESS: