FrancophonIA/ELRC3.0 huggingface dataset:
English: Study 2 contained a rater-blinded (i.e. study physician/ investigator assessing the response to study treatment was blinded) reference comparator of glatiramer acetate.
Maltese: Studju 2 kien jinkludi komparatur ta' referenza raterblinded (i.e. it-tabib tal-istudju/investigatur li evalwaw ir-rispons għall-kura tal-istudju kien blinded) ta' glatiramer acetate.
English: Following 240 mg twice a day administered with food, the median peak (Cmax) was 1.72 mg/l and overall area under the curve (AUC) exposure was 8.02 h.mg/l in subjects with multiple sclerosis.
Maltese: Wara l-għoti ta' 240 mg darbtejn kuljum mal ikel, il-medjan massimu (Cmax) kien ta' 1.72 mg/l u l-esponiment totali taż-żona ta' taħt il-kurva (“area under the curve”, AUC) kien ta' 8.02 h.mg/l f'individwi bi sklerożi multipla.
English: In a small 24-week open-label uncontrolled study in paediatric patients with RRMS aged 13 to 17 years (120 mg twice a day for 7 days followed by 240 mg twice a day for the remainder of treatment; safety population, n=22), followed by a 96 week extension study (240mg twice per day ; safety population n=20), the safety profile appeared similar to that observed in adult patients.
Maltese: f'pazjenti pedjatriċi b'RRMS li kellhom minn 13 sa 17-il sena (120 mg darbtejn kuljum għal 7 ijiem, segwiti minn 240 mg darbtejn kuljum għall-bqija tal-kura; popolazzjoni tas-sigurtà, n=22), segwit minn studju ta' estensjoni ta' 96 ġimgħa (240 mg darbtejn kuljum; popolazzjoni tas-sigurtà n=20) il profil tas-sigurtà deher simili għal dak osservat f'pazjenti adulti.
English: Overall, Cmax and AUC increased approximately doseproportionally in the dose range studied (120 mg to 360 mg).
Maltese: AUC żdiedu bejn wieħed u ieħor b'mod proporzjonali mad-doża fil-medda tad-doża studjata (120 mg sa 360 mg).
English: A single 240 mg 14C-dimethyl fumarate dose study identified glucose as the predominant metabolite in human plasma.
Maltese: Studju dwar doża waħda ta' 240 mg ta' 14C-dimethyl fumarate identifika lil glucose bħala l-metabolit predominanti fil-plażma tal bniedem.
English: Interstitial fibrosis and cortical atrophy were observed at 6 times the recommended dose based on AUC.
Maltese: Fibrożi interstizjali u atrofija kortikali ġew osservati f'livell li kien 6 darbiet taddoża rakkomandata bbażat fuq l-AUC.
English: Regular dose 240 mg twice a day.
Maltese: Doża regolari 240 mg darbtejn kuljum.
English: Progression might involve symptoms such as polyuria, polydipsia and proximal muscle weakness.
Maltese: Il-progressjoni tista' tinvolvi sintomi bħal poliurija, polidipsija u dgħufija prossimali fil-muskoli.
English: The most important signs are: proteinuria, glucosuria (with normal blood sugar levels), hyperaminoaciduria and phosphaturia (possibly concurrent with hypophosphatemia).
Maltese: L-iktar sinjali importanti huma: proteinurija, glukosurja (b'livelli normali ta' zokkor fid-demm), iperaminoakidurja u fosfaturija
English: In clinical studies with psoriasis patients, dimethyl fumarate affected lymphocyte phenotypes through a down-regulation of pro-inflammatory cytokine profiles (TH1, TH17), and biased towards anti-inflammatory production (TH2).
Maltese: Fi studji kliniċi f'pazjenti bi psorjasi, dimethyl fumarate affettwata l-fenotipi tal-limfoċiti permezz ta' regolazzjoni 'l isfel ta' profili ta' cytokine proinfjammatorji (TH1, TH17), u għandu tendenza lejn il-produzzjoni kontra l-infjammazzjoni (TH2).
English: Four per cent (4%) of patients treated with Tecfidera discontinued due to gastrointestinal events.
Maltese: Erba' fil-mija (4%) tal-pazjenti kkurati b'Tecfidera waqqfu l-kura minħabba avvenimenti gastrointestinali.
English: Lymphocyte counts <0.5x109/l were observed in <1% of patients treated with placebo and 6% of patients treated with Tecfidera.
Maltese: Għadd ta' limfoċiti ta' <0.5x109/l ġie osservat f'<1% tal-pazjenti kkurati bi plaċebo uf'6% tal-pazjenti kkurati b'Tecfidera.
English: Over the full treatment period (120-week), ARR was 0.2 representing an 84.5% relative reduction in relapses (n=20; 95% CI [66.8, 92.8], p<0.0001), when compared to the year prior to treatment initiation.
Maltese: 5% fir-rikaduti (n=20; 95% CI [66.8, 92.8], p<0.0001), meta mqabbel mas-sena ta' qabel il-bidu tal-kura.
English: Concurrent therapy with nephrotoxic medicinal products (such as aminoglycosides, diuretics, nonsteroidal anti-inflammatory drugs or lithium) may increase the potential of renal adverse reactions (e.g. proteinuria see section 4.8) in patients taking Tecfidera (see section 4.4 Blood/laboratory tests).
Maltese: Terapija fl-istess ħin bi prodotti mediċinali nefrotossiċi (bħal aminoglycosides, dijuretiċi, mediċini antinfjammatorji nonsterojdali jew lithium) jista' jżid il-potenzjal ta' reazzjonijiet avversi tal-kliewi (eż. proteinurija ara sezzjoni 4.8) f'pazjenti li jkunu qed jieħdu Tecfidera (ara sezzjoni 4.4
English: Data from preclinical studies do not suggest that dimethyl fumarate would be associated with an increased risk of reduced fertility (see section 5.3).
Maltese: Data minn studji ta' qabel l-użu kliniku ma tissuġġerixxix li dimethyl fumarate se jkun assoċjat ma' żieda fir-riskju ta' fertilità mnaqqsa (ara sezzjoni 5.3).
English: In an in vivo study, co-administration of Tecfidera with a combined oral contraceptive (norgestimate and ethinyl estradiol) did not elicit any relevant change in oral contraceptive exposure.
Maltese: Fi studju in vivo, l-għoti flimkien ta' Tecfidera ma' kontraċettiv orali kombinat (norgestimate u ethinyl estradiol) ma kkawża l-ebda bidla rilevanti fl-esponiment tal-kontraċettiv orali.
English: Tecfidera 120 mg: Each capsule contains 120 mg of dimethyl fumarate.
Maltese: Tecfidera 120 mg: Kull kapsula fiha 120 mg ta' dimethyl fumarate.
English: Drug-induced liver injury, including liver enzyme increase (≥ 3 upper limit of normal (ULN)) and elevation of total bilirubin levels (≥ 2 ULN) can result from treatment with dimethyl fumarate.
Maltese: Ħsara fil-fwied ikkawżata mill-mediċina, li tinkludi żieda fl-enzimi tal-fwied (≥ 3 tal-limitu normali tan-naħa ta' fuq (upper limit of normal, ULN)) u żieda fil-livelli totali tal-bilirubina (≥ 2 ULN) tista' tirriżulta mill-kura b'dimethyl fumarate.
English: The pharmacokinetic profile of 240 mg dimethyl fumarate twice a day was evaluated in a small, openlabel, uncontrolled study in patients with RRMS aged 13 to 17 years (n=21).
Maltese: Il-profil farmakokinetiku ta' 240 mg ta' dimethyl fumarate darbtejn kuljum ġie evalwat fi studju żgħir mhux ikkontrollat, open-label, f'pazjenti b'RRMS li kellhom minn 13 sa 17-il sena (n=21).
English: In clinical trials, 34% of Tecfidera treated patients experienced flushing.
Maltese: Fil-provi kliniċi, 34% tal-pazjenti kkurati b'Tecfidera kellhom il-fwawar.
English: Further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Maltese: mingħajr ebda involviment tas-sistema ta' ċitokrom P450 (CYP).
English: Assessment of renal function (e.g. creatinine, blood urea nitrogen and urinalysis) is recommended prior to treatment initiation, after 3 and 6 months of treatment, every 6 to 12 months thereafter and as clinically indicated.
Maltese: Evalwazzjoni tal-funzjoni tal-kliewi (eż. kreatinina, urea nitrogen fid-demm u analiżi tal-awrina) hi rakkomandata qabel il-bidu tal-kura, wara 3 u 6 xhur ta' kura, kull 6 sa 12-il xahar wara dak ilperjodu, u kif indikat klinikament.
English: Tecfidera 240mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate For the full list of excipients, see section 6.1.
Maltese: Kull kapsula iebsa gastroreżistenti fiha 240 mg ta' dimethyl fumarate Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: then this may represent a severe allergic reaction (anaphylaxis)
Maltese: Reazzjonijiet allerġiċi (sensittività eċċessiva)
English: No untoward clinical consequences were observed in clinical trials.
Maltese: L-ebda konsegwenzi kliniċi negattivi ma ġew osservati fil-provi kliniċi.
English: The frequencies described in the table below are based on 769 patients treated with Tecfidera 240 mg twice a day and 771 patients treated with placebo
Maltese: Il-frekwenzi deskritti fit-tabella hawn taħt huma bbażati fuq 769 pazjent ikkurati b'Tecfidera 240 mg darbtejn kuljum u 771 pazjent ikkurati bi plaċebo
English: The most common adverse reactions (incidence ≥10%) for patients treated with dimethyl fumarate were flushing and gastrointestinal events (i.e. diarrhoea, nausea, abdominal pain, abdominal pain upper).
Maltese: L-iktar reazzjonijiet avversi komuni (inċidenza ta' ≥10%) għal pazjenti kkurati b'dimethyl fumarate kienu fwawar u avvenimenti gastrointestinali (i.e. dijarea, dardir, uġigħ addominali, uġigħ addominali fin-naħa ta' fuq).
English: Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg' containing microtablets.
Maltese: Kapsuli ibsin gastroreżistenti ħodor u bojod, daqs 0, stampati b'‘BG-12 120 mg' li fihom mikropilloli.
English: Dimethyl fumarate has been shown to up regulate Nrf2-dependent antioxidant genes in patients (e.g. NAD(P)H dehydrogenase, quinone 1; [NQO1]).
Maltese: Intwera li dimethyl fumarate jirregola 'l fuq ġeni antiossidanti dipendenti fuq Nrf2 fil-pazjenti (eż. NAD(P)H dehydrogenase,
English: Placebo Tecfidera 240 mg twice a day
Maltese: Plaċebo Tecfidera 240 mg darbtejn kuljum
English: The experience in uncontrolled clinical trials is consistent with the experience in the placebo-controlled clinical trials.
Maltese: L-esperjenza fi provi kliniċi mhux ikkontrollati hi konsistenti mal-esperjenza fil-provi kliniċi kkontrollati bi plaċebo.
English: In the placebo-controlled studies, the incidence of flushing (34% versus 4%) and hot flush (7% versus 2%) was increased in patients treated with Tecfidera compared to placebo, respectively.
Maltese: Fi studji kkontrollati bi plaċebo, l-inċidenza ta' fwawar (34% kontra 4%) u fwawar jaħarqu (7% kontra 2%) żdiedet f'pazjenti kkurati b'Tecfidera meta mqabbla ma' plaċebo, rispettivament.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Tel: +385 (0) 1 230 34 46
Maltese: Medis Adria d.o.o. Tel: +385 (0) 1 230 34 46
English: Pharmacokinetic data were obtained in subjects with multiple sclerosis and healthy volunteers.
Maltese: Datafarmakokinetika nkisbet f'individwi bi sklerożi multipla u f'voluntiera b'saħħithom.
English: Changes in renal laboratory tests have been seen in clinical trials in subjects treated with dimethyl fumarate (see section 4.8).
Maltese: Tibdil fir-riżultati fit-testijiet tal-laboratorju tal-kliewi ġew osservati fi provi kliniċi f'individwi kkurati b'dimethyl fumarate (ara sezzjoni 4.8).
English: Dimethyl fumarate exposure increases in an approximately dose proportional manner with single and multiple doses in the 120 mg to 360 mg dose range studied.
Maltese: L-esponiment għal dimethyl fumarate jiżdied b'mod bejn wieħed u ieħor proporzjonali mad-doża b'dożi waħidhom u dożi multipli fil-medda ta' doża ta' 120 mg sa 360 mg li ġiet studjata.
English: There were no effects on fertility in the F1 offspring.
Maltese: Ma kien hemm l-ebda effetti fuq il-fertilità fil-frieħ F1.
English: Dimethyl fumarate and monomethyl fumarate, the primary metabolite of dimethyl fumarate, significantly reduced immune cell activation and subsequent release of proinflammatory cytokines in response to inflammatory stimuli in preclinical models.
Maltese: Dimethyl fumarate u monomethyl fumarate, il-metabolit primarju ta' dimethyl fumarate, naqqas b'mod sinifikanti l-attivazzjoni taċ-ċelluli immuni u l-ħruġ sussegwenti ta' cytokines proinfjammatorji b'risposta għal stimuli infjammatorji f'mudelli ta' qabel l użu kliniku.
English: Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules
Maltese: Tecfidera 120 mg kapsuli ibsin gastroreżistenti Tecfidera 240 mg kapsuli ibsin gastroreżistenti
English: In the MRI cohort 45% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 2.4).
Maltese: Fil-koorti tal-MRI, 45% tal-pazjenti li daħlu fl-istudju kellhom leżjonijiet Gd+ fil-linja bażi (medja tan-numru ta' leżjonijiet Gd+ ta' 2.4).
English: The frequency of severe allergic reactions cannot be estimated from the available data (not known).
Maltese: Il-frekwenza ta' reazzjonijiet allerġiċi severi ma tistax tiġi stmata mill-informazzjoni disponibbli (mhux magħrufa).
English: As dimethyl fumarate and monomethyl fumarate are metabolised by esterases, without the involvement of the CYP450 system, evaluation of phamacokinetics in individuals with hepatic impairment was not conducted.
Maltese: Billi dimethyl fumarate u monomethyl fumarate huma metabolizzati minn esterases, mingħajr linvolviment tas-sistema CYP450, ma saritx evalwazzjoni tal-farmakokinetika f'individwi b'indeboliment tal-fwied.
English: The apparent volume of distribution following oral administration of 240 mg dimethyl fumarate varies between 60 L and 90 L. Human plasma protein binding of monomethyl fumarate generally ranges between 27% and 40%.
Maltese: Il-volum apparenti tad-distribuzzjoni wara l-għoti orali ta' 240 mg ta' dimethyl fumarate jvarja bejn 60 L u 90 L.
English: In the MRI cohort 36% of patients entering the study had Gd+ lesions at baseline (mean number of Gd+ lesions 1.4).
Maltese: Fil-koorti tal-MRI, 36% tal-pazjenti li daħlu fl-istudju kellhom leżjonijiet Gd+ fil-linja bażi (medja tan-numru ta' leżjonijiet Gd+ 1.4).
English: Blood/laboratory tests
Maltese: Testijiet tal-laboratorju/demm
English: For those patients who may experience flushing or gastrointestinal adverse reactions, taking Tecfidera with food may improve tolerability (see sections 4.4, 4.5 and 4.8).
Maltese: Għal dawk il-pazjenti li jista' jkollhom reazzjonijiet avversi ta' fwawar jew gastrointestinali, li jieħdu Tecfidera mal-ikel jista' jtejjeb it tollerabilità (ara sezzjonijiet 4.4, 4.5 u 4.8).
English: PML can only occur in the presence of a JCV infection.
Maltese: PML tista' sseħħ biss fil-preżenza ta' infezzjoni b'JCV.
English: In mice, the incidence of renal tubular carcinoma was increased at 75 mg/kg/day, at equivalent exposure (AUC) to the recommended human dose.
Maltese: Fil-ġrieden, l-inċidenza ta' karċinoma tubulari talkliewi żdiedet f'doża ta' 75 mg/kg/jum, f'esponiment ekwivalenti (AUC) għad-doża rakkomandata filbniedem.
English: Exhalation of CO2 is the primary route of dimethyl fumarate elimination accounting for 60% of the dose.
Maltese: It-tneħħija mill-imnifsejn ta' CO2 hi r-rotta primarja tal-eliminazzjoni ta' dimethyl fumarate li tammonta għal 60% tad-doża.
English: Early diagnosis of Fanconi syndrome and discontinuation of dimethyl fumarate treatment are important to prevent the onset of renal impairment and osteomalacia, as the syndrome is usually reversible.
Maltese: Dijanjosi bikrija tas-sindrome ta' Fanconi u t-twaqqif tattrattament b'dimethyl fumarate huma importanti sabiex jiġi evitat il-bidu ta' indeboliment tal-kliewi u l-osteomalaċja, minħabba li s-sindrome normalment ikun riversibbli.
English: No. subjects Mean (median) number of new or newly enlarging T2 lesions over 2 years Lesion mean ratio (95% CI) Mean (median) number of Gd lesions at 2 years Odds ratio (95% CI) Mean (median) number of new T1 hypointense lesions over 2 years Lesion mean ratio (95% CI) aAll analyses of clinical endpoints were intent-to-treat; bMRI analysis used MRI cohort *P-value < 0.05; **P-value < 0.01; ***P-value < 0.0001; #not statistically significant
Maltese: aL-analiż kollha tal-punti kliniċi aħħarin kienu tat-tip intenzjoni-biex-tikkura; bL-analiżi bl-MRI użat koorti MRI *valur P < 0.05; **valur P < 0.01; ***valur P < 0.0001; #mhux statistikament sinifikanti
English: Tecfidera treatment should be started gradually to reduce the occurrence of flushing and gastrointestinal adverse reactions (see section 4.2).
Maltese: It-trattament b'Tecfidera għandu jinbeda b'mod gradwali biex inaqqas l-okkorrenza ta' fwawar u reazzjonijiet avversi gastrointestinali (ara sezzjoni 4.2).
English: Levels of 1,25-dihydroxyvitamin D decreased in Tecfidera treated patients relative to placebo (median percentage decrease from baseline at 2 years of 25% versus 15%, respectively) and levels of parathyroid hormone (PTH) increased in Tecfidera treated patients relative to placebo (median percentage increase from baseline at 2 years of 29% versus 15%, respectively).
Maltese: Il-livelli ta' 1,25-dihydroxyvitamin D naqsu fil-pazjenti kkurati b'Tecfidera meta mqabbla mal plaċebo (medjan ta' tnaqqis perċentwali mil-linja bażi wara sentejn ta' 25% kontra 15%,
English: Tecfidera 120 mg gastro-resistant hard capsules are green and white and printed with ‘BG-12 120 mg' and are available in packs containing 14 capsules.
Maltese: Tecfidera 120 mg kapsuli ibsin gastroreżistenti huma ħodor u bojod u stampati b'‘BG-12 120 mg' u huma disponibbli f'pakketti li fihom 14-il kapsula.
English: MT Ltd. Tel: +356 21337008
Maltese: Tel: +356 21337008
English: Administration of dimethyl fumarate at oral doses of 25, 100, and 250 mg/kg/day to pregnant rats during the period of organogenesis resulted in maternal adverse effects at 4 times the recommended dose on an AUC basis, and low fetal weight and delayed ossification (metatarsals and hindlimb phalanges) at 11 times the recommended dose on an AUC basis.
Maltese: 25, 100, u 250 mg/kg/jum lil firien tqal matul il-perjodu ta' organoġenesi rriżulta f'effetti avversi materni f'doża li kienet 4 darbiet tad-doża rakkomandata bbażata fuq l-AUC, u piż baxx fetali u ossifikazzjoni li ttardjat (metatarsali u falanġi tar-riġlejn ta' wara) f'doża li kienet 11-il darba tad-doża rakkomandata bbażata fuq l-AUC.
English: The most commonly reported adverse reactions leading to discontinuation (incidence >1%) in patients treated with Tecfidera were flushing (3%) and gastrointestinal events (4%).
Maltese: f'pazjenti kkurati b'Tecfidera kienu fwawar (3%) u avvenimenti gastrointestinali (4%).
English: These data were derived from 2 pivotal Phase 3 placebo-controlled, double-blind clinical trials with a total of 1,529 patients treated with Tecfidera and for up to 24 months with an overall exposure of 2,371 person-years (see section 5.1).
Maltese: 1,529 pazjenti kkurati b'Tecfidera u għal sa 24 xahar b'esponiment totali ta' 2371 sena ta' persuni (ara sezzjoni 5.1).
English: Aspartate aminotransferase increased Common Alanine aminotransferase increased Common Drug-induced liver injury1
Maltese: Żieda f'alanine aminotransferase Komuni Ħsara fil-fwied ikkawżata millmediċina1
English: Gender and age did not have a clinically significant impact on the pharmacokinetics of dimethyl fumarate.
Maltese: Is-sess u l-età ma kellhomx impatt klinikament sinifikanti fuq il-farmakokinetika ta' dimethyl fumarate.
English: Effects on the immune system In preclinical and clinical studies, dimethyl fumarate demonstrated anti-inflammatory and immunomodulatory properties.
Maltese: Fi studji kliniċi ta' qabel l-użu kliniku u fi studji kliniċi, dimethyl fumarate wera propjetajiet kontra l infjammazzjoni u immunomodulatorji.
English: Tecfidera can generally be started immediately after discontinuation of interferon or glatiramer acetate.
Maltese: Tecfidera ġeneralment jista' jinbeda immedjatament wara t-twaqqif ta' interferon jew glatiramer acetate.
English: Mean and median lymphocyte counts remained within normal limits.
Maltese: kellhom għadd ta' limfoċiti ogħla mil-limitu t'isfel tan-normal.
English: In the placebo-controlled studies, measurement of urinary ketones (1+ or greater) was higher in patients treated with Tecfidera (45%) compared to placebo (10%).
Maltese: Fl-istudji kkontrollati bi plaċebo, il-kejl ta' ketoni fl-awrina (1+ jew iktar) kien ogħla f'pazjenti kkurati b'Tecfidera (45%) meta mqabbel mal-plaċebo (10%).
English: Herpes zoster infections have been reported with Tecfidera use.
Maltese: Ġew irrappurtati infezzjonijiet ta' herpes zoster bl-użu ta' Tecfidera.
English: Nonclinical studies in rodent, rabbits, and monkeys were conducted with a dimethyl fumarate suspension (dimethyl fumarate in 0.8% hydroxypropyl methylcellulose) administered by oral gavage.
Maltese: Saru studji mhux kliniċi f'annimali gerriema, fil-fniek, u fix-xadini b'suspensjoni ta' dimethyl fumarate (dimethyl fumarate f'0.8% ta' hydroxypropyl methylcellulose) mogħti permezz ta' gavage orali.
English: - medicines that affect the kidneys including some antibiotics (used to treat infections), “water tablets” (diuretics), certain types of painkillers (such as ibuprofen and other similar antiinflammatories and medicines purchased without a doctor's prescription) and medicines that contain lithium - Taking Tecfidera with certain types of vaccines (live vaccines) may cause you to get an infection and should, therefore, be avoided.
Maltese: infezzjonijiet), “pilloli tal-pipi” (dijuretiċi), ċerti tipi ta' pilloli kontra l-uġigħ (bħal ibuprofen u mediċini simili oħrajn kontra l-infjammazzjonijiet u mediċini li jinxtraw mingħajr riċetta tattabib) u mediċini li fihom il-lithium - Li tieħu Tecfidera ma' ċerti tipi ta' tilqim (tilqim ħaj) jista' jikkawża li tiżviluppalek infezzjoni u, għalhekk, għandu jiġi evitat.
English: Dimethyl fumarate demonstrated therapeutic activity in multiple models of inflammatory and neuroinflammatory injury.
Maltese: Dimethyl fumarate wera attività terapewtika f'mudelli multipli ta' ħsara infjammatorja u newroinfjammatorja.
English: PML cases have occurred with dimethyl fumarate and other medicinal products containing fumarates in the setting of moderate to severe prolonged lymphopenia.
Maltese: Każijiet ta' PML seħħew b'dimethyl fumarate u prodotti mediċinali oħrajn li fihom fumarates flisfond ta' limfopenija moderata sa severa u fit-tul.
English: A short course of treatment with 75 mg non-enteric coated acetylsalicylic acid may be beneficial in patients affected by intolerable flushing (see section 4.5).
Maltese: Kors qasir ta' kura b'75 mg acetylsalicylic acid mhux b'kisja enterika jista' jkun ta' benefiċċju f'pazjenti affettwati minn fwawar intollerabbli (ara sezzjoni 4.5).
English: Since early diagnosis of Fanconi syndrome and discontinuation of the potentially causative drug, e.g. dimethyl fumarate, are important steps to prevent the onset of renal impairment and osteomalacia, the PRAC recommends the inclusion of a warning in SmPC section 4.4 to make physicians aware of the potential risk of Fanconi syndrome including the description of corresponding symptoms.
Maltese: Minħabba li dijanjosi bikrija tas-sindrome ta' Fanconi u t-twaqqif tal-mediċina potenzjalment kawżattiva, eż. dimethyl fumarate, huma passi importanti biex jiġi evitat il-bidu ta' indeboliment talkliewi u osteomalaċja, il-PRAC jirrakkomanda l-inklużjoni ta' twissija fis-sezzjoni 4.4 tal-SmPC biex it-tobba jkunu konxji tar-riskju potenzjali tas-sindrome ta' Fanconi inkluża d-deskrizzjoni tas-sintomi korrispondenti.
English: - Very rare (<1/10,000) - Not known (frequency cannot be estimated from the available data)
Maltese: - Rari ħafna (<1/10,000) - Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli tal-frekwenza)
English: Anaphylaxis1
Maltese: Anafilassi 1
English: Potential risks associated with acetylsalicylic acid therapy should be considered prior to co-administration with Tecfidera in patients with Relapsing Remitting MS. Long term (> 4 weeks) continuous use of acetylsalicylic acid has not been studied (see sections 4.4 and 4.8).
Maltese: użu fit-tul (> 4 ġimgħat) kontinwu ta' acetylsalicylic acid ma ġiex studjat (ara sezzjonijiet 4.4 u 4.8).
English: If treatment is continued despite a persistent lymphocyte count < 0.5x109/L, enhanced vigilance is recommended (see also subsection on PML).
Maltese: Jekk il-kura titkompla minkejja għadd persistenti ta' limfoċiti ta' < 0.5x109/L, hi rakkomandata viġilanza mtejba (ara wkoll is-sottosezzjoni fuq PML).
English: Tecfidera 240mg gastro-resistant hard capsules
Maltese: Tecfidera 240mg kapsuli ibsin gastroreżistenti