FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 µg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 µg/mL with concomitant methotrexate.
Maltese: Wara l-ammistrazzjoni ta' 24 mg/m2 (sa massimu ta' 40 mg) taħt il-ġilda ġimgħa iva u ġimgħa le lillpazjenti b'artrite relatata mal-entesite li kellhom minn 6 sa 17-il sena, il-konċentrazzjonijiet minimi u massimi medji fi stat fiss (valuri mkejla f'Ġimgħa 24) ta' adalimumab fis-serum kienu 8.8 ± 6.6 μg/mL għal adalimumab mingħajr użu ta' methotrexate fl-istess waqt u 11.8 ± 4.3 μg/mL flimkien ma' methotrexate
English: Pack sizes of one, two, four or multipack of six (3x2) pre-filled syringes.
Maltese: Daqsijiet tal-pakkett ta' wieħed, tnejn, erbgħa jew pakkett multiplu ta' sitt (3x2) siringi mimlija għal-lest.
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Maltese: Hidradenitis suppurativa fl-adolexxenti (minn 12-il sena, li jiżnu mill-anqas 30 kg)
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
Maltese: Fi studju UC-II, min dawk il-pazjenti ttrattati b'adalimumab u li kellhom titjib kliniku f' Ġimgħa 8, 21/41 (51%) kellhom ukoll titjib kliniku f' Ġimgħa 52.
English: AMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Maltese: AMGEVITA huwa indikat għat-trattament ta' psorjasi tat-tip li tikkawża qoxra mhux normali fuq ilġilda, li hi minn moderata sa severa, f'pazjenti adulti li li huma kandidati għal terapija sistemika.
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Maltese: L-iskop primarju fi Studju RA V kien ilpersentaġġ ta' pazjenti li laħqu rispons ACR 50 f'Ġimgħa 52.
English: - The expiration date printed on the label has passed.
Maltese: - Id-data ta' meta tiskadi stampata fuq it-tikketta tkun għaddiet.
English: The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic exposure.
Maltese: L-esponimenti mbassra jindikaw li fin-nuqqas ta' methotrexate, doża kbira tista' twassal għal żieda inizjali fl-esponiment sistemiku.
English: 1) including spontaneous reporting data
Maltese: 1) li jinkludu informazzjoni minn rapporti spontanji
English: Efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms
Maltese: Risponsi tal-effikaċja fi studju AS kontrollat bil-plaċebo - Studju I tnaqqis fissinjali u s-sintomi
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with adalimumab alone.
Maltese: Fi studji tal-marda ta' Crohn fl-adulti, kien hemm inċidenzi aktar għoljin ta' avvenimenti avversi malinni u serji relatati mall-infezjoni meta adalimumab kien ikkombinat ma' azathioprine/6-mercaptopurine meta mqabbla ma' adalimumab waħdu.
English: Re-introduction of AMGEVITA after discontinuation for 70 days or longer should result in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Maltese: Jekk terġa' tingħata AMGEVITA wara li tkun twaqqfet għal 70 gurnata jew aktar għandha twassal għall-istess rispons kliniku u profil ta' sigurta' li jixbaħ lil dak ta' qabel ma twaqqfet id-doża.
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5 ± 5.6 μg/mL for the standard dose group and 3.5 ± 2.2 μg/mL for the low dose group.
Maltese: Għall-pazjenti i li baqgħu jieħdu l-kura każwali tagħhom, il-medja (±SD) tal-aktar konċentrazzjonijiet baxxi ta' adalimumab fis-serum f'Ġimgħa 52 kienet 9.5±5.6 µg/mL għal grupp li qed jingħata Doża Standard u 3.5±2.2 µg/mL għal grupp li qed jingħata Doża Baxxa.
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Maltese: Fi studju li sar fuq 226 suġġetti adulti li jbatu minn artrite rewmatika u li kienu kkurati b'adalimumab jew bil-plaċebo, ġew osservati risponsi simili ta'anti-korpi għat-tilqima b'vaċċin stàndard 23-valent ta' newmokokku u t-tilqima tal-virus trivalenti tal-influwenza.
English: Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Maltese: Proporzjon ta' Pazjentia li kisbu HiSCRb fil-Ġimgħat 24 u 36 Wara Trattament Assenjat mill-ġdid minn adalimumab Kull Ġimgħa f'Ġimgħa 12
English: ● The needle cover of the AMGEVITA pre-filled pen is made from dry natural rubber, which contains latex.
Maltese: ● L-għatu tal-labra ta' AMGEVITA pinna mimlija għal-lest huwa magħmul minn lastku naturali niexef, li fih latex.
English: Children and adolescents from 2 years of age weighing 30 kg or more
Maltese: Tfal u adolexxenti minn 4 snin sa 17-il sena li jiżnu 30 kg jew aktar
English: Seventy-nine (20.1%) patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Maltese: 1%) pazjent ġew ikkurati flimkien ma' mediċini anti-rewmatiċi li li jaffetwaw ilproċess tal-marda, u 37 (9.4%) pazjent flimkien ma' glukokortikojdi.
English: The combination of AMGEVITA and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Maltese: Loftalmologi huma avżati biex jikkonsultaw ma' speċjalist xieraq qabel ma jinbeda t-trattament b'AMGEVITA (ara sezzjoni 4.4).
English: AMGEVITA is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Maltese: Axial spondyloarthritis mingħajr evidenza radjografika ta' AS AMGEVITA huwa indikat għat-trattament ta' adulti li jbatu minn axial spondyloarthritis mingħajr evidenza radjografika ta' AS imma b'sinjali oġġettivi għoljin ta' infjammazzjoni minn CRP u/jew MRI, li ma kellhomx rispons adegwat jew ma jittolerawx il-mediċini kontra l-infjammazzjoni li mhumiex sterojdi.
English: For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Maltese: F'pazjenti li jkollhom test pożittiv għal infezzjoni ta' epatite B, huwa rakkomandat li jkun hemm konsultazzjoni ma tabib espert fit-trattament tal-epatite B.
English: Nocturia
Maltese: Newropatija
English: Patients were randomised to receive either 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Maltese: Il-pazjenti kienu magħżula b'mod każwali biex jirċievu 24 mg/m2 tal-erja tal-wiċċ tal-ġisem (BSA - body surface area) ta' adalimumab sa massimu ta' 40 mg, jew plaċebo ġimgħa iva u ġimgħa le għal 12-il ġimgħa.
English: Not known (frequency cannot be estimated from available data)
Maltese: Mhux magħruf (frekwenza ma tistax tiġi stabbilita min informazzjoni li hemm)
English: • trouble breathing, swallowing;
Maltese: • telf ta' smigħ, żanżin;
English: There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Maltese: M'hemm l-ebda użu rilevanti ta' adalimumab fil-popolazzjoni pedjatrika għall-indikazzjonijiet ta' ankylosing spondylitis u artrite psorjatika.
English: Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Maltese: F'dawn il-pazjenti, id-dijanjosi u l-amministrazzjoni ta' terapija ewlenija antifungali, għandhom isiru wara konsultazzjoni ma tabib espert fil-kura ta' pazjenti b'infezzjonijiet fungali invażivi.
English: UAB "JOHNSON & JOHNSON" filiāle Latvijā
Maltese: JOHNSON" filiāle Latvijā
English: DK - 3400 Hillerød Denmark
Maltese: DK - 3400 Hillerød Id-Danimarka
English: The other ingredients are microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal anhydrous, magnesium stearate, triethyl citrate, methacrylic acid - methyl methacrylate copolymer (1:1), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, simeticone, sodium laurilsulfate , polysorbate 80, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide and black iron oxide (E172).
Maltese: Is-sustanzi mhux attivi l-oħra huma microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal anhydrous, magnesium stearate, triethyl citrate, methacrylic acid - methyl methacrylate copolymer (1:1), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, simeticone, sodium laurilsulfate, polysorbate 80, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), shellac, potassium hydroxide u black iron oxide (E172).
English: Magnetic Resonance imaging (MRI)
Maltese: Immaġni ta' riżonanza manjetika (MRI)
English: The Tmax of monomethyl fumarate is 2 to 2.5 hours.
Maltese: It-Tmax ta' monomethyl fumarate hu minn sagħtejn sa 2.5 sigħat.
English: Sun as a symbol Moon as a symbol
Maltese: Ix-xemx bħala simbolu Il-qamar bħala simbolu
English: Progressive multifocal leukoencephalopathy (PML) 1
Maltese: Lewkoenċefalopatija multifokali progressiva (PML) 1
English: - Very common (≥1/10) - Common (≥1/100 to <1/10) - Uncommon (≥1/1, 000 to <1/100) - Rare (≥1/10, 000 to <1/1,000)
Maltese: - Komuni ħafna (≥1/10) - Komuni (≥1/100 sa <1/10) - Mhux komuni (≥1/1,000 sa <1/100)
English: Dimethyl fumarate was administered orally at doses of 25, 75, 200 and 400 mg/kg/day in mice, and at doses of 25, 50, 100, and 150 mg/kg/day in rats.
Maltese: Dimethyl fumarate ingħata mill-ħalq f'dożi ta' 25, 75, 200 u 400 mg/kg/jum fil-ġrieden, u f'dożi ta' 25, 50, 100, u 150 mg/kg/jum fil-firien.
English: Progressive Multifocal Leukoencephalopathy (PML)
Maltese: Lewkoenċefalopatija Multifokali Progressiva (PML)
English: Hazard ratio (95% CI) Proportion with 24 week confirmed disability progression Hazard ratio (95% CI)
Maltese: Proporzjon ta' periklu (hazard ratio) (95% CI)
English: 240 mg capsules: 56 or 168 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Maltese: Kapsuli ta' 240 mg: 56 jew 168 kapsula f'pakketti bil-folji tal-PVC/PE/PVDC-PVC aluminju.
English: Herpes zoster infections
Maltese: Infezzjonijiet ta' herpes zoster
English: Tecfidera with alcohol
Maltese: Tecfidera ma' alkoħol
English: Date of first authorisation: 30 January 2014 Date of latest renewal: 20 September 2018
Maltese: Data tal-aħħar tiġdid: 20 Settembru 2018
English: The safety and efficacy of Tecfidera in children and adolescents aged 10 to 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Tecfidera fi tfal u adolexxenti minn età ta' 10 sa 18-il sena għadhom ma ġewx determinati s'issa.
English: 120 mg capsules: 14 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Maltese: Kapsuli ta' 120 mg: 14-il kapsula f'pakketti bil-folji tal-PVC/PE/PVDC-PVC aluminju.
English: The incidence of serious gastrointestinal events, including gastroenteritis and gastritis, was seen in 1% of patients treated with Tecfidera (see section 4.2).
Maltese: L-inċidenza ta' avvenimenti gastrointestinali serji, li jinkludu gastroenterite u gastrite, ġiet osservata f'1% tal-pazjenti kkurati b'Tecfidera (ara sezzjoni 4.2).
English: Small numerical differences in the response to tetanus toxoid and pneumococcal serotype 3 polysaccharide were noted in favour of non-pegylated interferon.
Maltese: Differenzi numeriċi żgħar fir-rispons għat-toxoid tat-tetnu u polysaccharide ta' serotip 3 pnewmokokkali ġew osservati favur non-pegylated interferon.
English: Tecfidera is a medicine that contains the active substance dimethyl fumarate.
Maltese: Tecfidera hi mediċina li fiha s-sustanza attiva dimethyl fumarate.
English: Relapsing-remitting MS is characterised by repeated attacks (relapses) of nervous system symptoms.
Maltese: MS li tirkadi u tbatti hi kkaratterizzata minn attakki ripetuti (rikaduti) tas-sintomi tas-sistema nervuża.
English: However, when reported, most patients experienced grade 2 (< 0.8 × 109/L to 0.5 × 109/L) or grade 3 (<0.5 × 109/L to 0.2 × 109/L) lymphopenia (see section 4.4).
Maltese: 8 × 109/L sa 0.5 × 109/L) jew grad 3 (<0.5 × 109/L sa 0.2 × 109/L) (ara sezzjoni 4.4).
English: If therapy is continued in the presence of moderate to severe prolonged lymphopenia, the risk of an opportunistic infection, including PML, cannot be ruled out (see section 4.4 subsection PML).
Maltese: limfopenija fit-tul moderata sa severa, ir-riskju ta' infezzjoni opportunistika, li tinkludi PML, ma jistax jiġi eskluż (ara sezzjoni 4.4 sottosezzjoni PML).
English: България ТП ЕВОФАРМА
Maltese: ТП ЕВОФАРМА Teл:
English: Capsule contents (enteric-coated microtablets)
Maltese: Kontenut tal-kapsula (mikropilloli b'kisja enterika)
English: Other circulating metabolites included fumaric acid, citric acid and monomethyl fumarate.
Maltese: Metaboliti oħrajn li jkunu jiċċirkolaw kienu jinkludu fumaric acid, citric acid u monomethyl fumarate.
English: Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, ATC code: L04AX07
Maltese: Mediċini antineoplastiċi u immunomodulatorji, Kodiċi ATC:
English: Assessment of serum aminotransferases (e.g. alanine aminotransferase (ALT), aspartate aminotransferase (AST)) and total bilirubin levels are recommended prior to treatment initiation and during treatment as clinically indicated.
Maltese: L-evalwazzjoni ta' aminotransferases tas-serum (eż. alanine aminotransferase (ALT), aspartate aminotransferase (AST)) u l-livelli totali tal-bilirubina huma rakkomandati qabel il-bidu tal-kura u matul il-kura, kif indikat klinikament.
English: In a clinical study involving a total of 71 patients with relapsing remitting multiple sclerosis, patients on Tecfidera 240 mg twice daily for at least 6 months (n=38) or non-pegylated interferon for at least 3 months (n=33), mounted a comparable immune response (defined as ≥2-fold increase from pre- to post-vaccination titer) to tetanus toxoid (recall antigen) and a conjugated meningococcal C polysaccharide vaccine (neoantigen), while the immune response to different serotypes of an unconjugated 23-valent pneumococcal polysaccharide vaccine (T-cell independent antigen) varied in both treatment groups.
Maltese: Fi studju kliniku li kien jinvolvi total ta' 71 pazjent bi sklerożi multipla li tbatti u tirkadi, pazjenti fuq Tecfidera 240 mg darbtejn kuljum għal mill-inqas 6 xhur (n=38) jew non pegylated interferon għal mill-inqas 3 xhur (n=33), ħolqu rispons immuni komparabbli (definit bħala żieda ta' ≥2 darbiet aktar mit-titru ta' qabel it-tilqima sat-titru wara t-tilqima) għat-toxoid tat-tetnu (recall antigen) u tilqima konjugata polysaccharide C meningokokkali (neoantigen), filwaqt li r rispons immuni għal serotipi differenti ta' tilqima polysaccharide pnewmokokkali 23-valent mhux konjugata (antiġen indipendenti taċ-ċelluli T) varja fiż-żewġ gruppi ta' kura.
English: In clinical trials, 3 patients out of a total of 2,560 patients treated with dimethyl fumarate experienced serious flushing symptoms that were probable hypersensitivity or anaphylactoid reactions.
Maltese: Fil-provi kliniċi, 3 pazjenti minn total ta' 2,560 pazjent kkurati b'dimethyl fumarate kellhom sintomi ta' fwawar serji li probabbli kienu sensittività eċċessiva jew reazzjonijiet anafilattojdi.
English: 1171 LP Badhoevedorp The Netherlands
Maltese: Biogen Netherlands B.V. Prins Mauritslaan 13 1171 LP Badhoevedorp L-Olanda
English: Commonly used medicinal products in patients with multiple sclerosis, intramuscular interferon beta-1a and glatiramer acetate, were clinically tested for potential interactions with dimethyl fumarate and did not alter the pharmacokinetic profile of dimethyl fumarate.
Maltese: Prodotti mediċinali komunement użati f'pazjenti bi sklerożi multipla, interferon beta-1a u glatiramer acetate mogħtija ġol-muskoli, kienu klinikament ittestjati għal interazzjonijiet potenzjali ma' dimethyl fumarate u ma bidlux il-profil farmakokinetiku ta' dimethyl fumarate.
English: 56 gastro-resistant hard capsules 168 gastro-resistant hard capsules
Maltese: 56 kapsula ibsin gastroreżistenti 168 kapsula ibsin gastroreżistenti
English: In vitro CYP induction studies did not demonstrate an interaction between Tecfidera and oral contraceptives.
Maltese: Studji dwar induzzjoni ta' CYP in vitro ma wrewx interazzjoni bejn Tecfidera u kontraċettivi orali.
English: The pharmacokinetics of Tecfidera in these adolescent patients was consistent with that previously observed in adult patients (Cmax: 2.00±1.29 mg/l; AUC0-12hr: 3.62±1.16 h.mg/l, which corresponds to an overall daily AUC of 7.24 h.mg/l).
Maltese: Ilfarmakokinetika ta' Tecfidera f'dawn il-pazjenti adolexxenti kienu konsistenti ma' dak li ġie osservat fil-passat f'pazjenti adulti (Cmax: 2.00±1.29 mg/L; AUC0-12hr: 3.62±1.16 h.mg/L, li jikkorrispondi għal
English: The incidence of gastrointestinal events (e.g. diarrhoea [14% versus 10%], nausea [12% versus 9%], upper abdominal pain [10% versus 6%], abdominal pain [9% versus 4%], vomiting [8% versus 5%] and dyspepsia [5% versus 3%]) was increased in patients treated with Tecfidera compared to placebo, respectively.
Maltese: uġigħ addominali fin-naħa ta' fuq [10% kontra 6%], uġigħ addominali [9% kontra 4%], rimettar [8% kontra 5%] u dispepsja [5% kontra 3%]) żdiedet f'pazjenti kkurati b'Tecfidera meta mqabbla mal-plaċebo, rispettivament.
English: In placebo-controlled and uncontrolled clinical studies, a total of 2,468 patients have received Tecfidera and been followed for periods up to 4 years with an overall exposure equivalent to 3,588 person-years.
Maltese: Fi studji kliniċi kkontrollati bi plaċebo u mhux ikkontrollati, total ta' 2,468 pazjent irċivew Tecfidera u kienu segwiti għal perjodi sa 4 snin b'esponiment totali ekwivalenti għal 3,588 sena ta' persuni.
English: In phase III placebo-controlled studies, the incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with Tecfidera or placebo, respectively.
Maltese: III ikkontrollati bi plaċebo, l-inċidenza ta' infezzjonijiet (60% kontra 58%) u infezzjonijiet serji (2% kontra 2%) kienet simili f'pazjenti kkurati b'Tecfidera jew plaċebo,
English: The annualised relapse rate for glatiramer acetate and placebo was 0.286 and 0.401 respectively in Study 2, corresponding to a reduction of 29% (p=0.013), which is consistent with approved prescribing information.
Maltese: Ir-rata ta' rikaduta annwalizzata għal glatiramer acetate u plaċebo kienet ta' 0.286 u 0.401 rispettivament fi Studju 2, li tikkorrispondi għal tnaqqis ta' 29% (p=0.013), li hu konsistenti mal informazzjoni approvata ta' kif jiġi preskritt.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjonijiet 4.8, 5.1 u 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: PML is an opportunistic infection caused by John-Cunningham virus (JCV), which may be fatal or result in severe disability.
Maltese: John-Cunningham virus (JCV), li tista' tkun fatali jew tirriżulta f'diżabilità severa.
English: Dyspnoea1
Maltese: Dispnea1
English: Potential drug interaction risks were not identified from in vitro CYP-inhibition and induction studies, a p-glycoprotein study, or studies of the protein binding of dimethyl fumarate and monomethyl fumarate (a primary metabolite of dimethyl fumarate).
Maltese: Riskji potenzjali ta' interazzjonijiet tal-mediċina ma ġewx identifikati minn studji in vitro dwar inibizzjoni ta' CYP u studji ta' induzzjoni, studju dwar p-glikoproteina, jew studji dwar it-twaħħil mal-proteini ta' dimethyl fumarate u monomethyl fumarate (metabolit primarju ta' dimethyl fumarate).
English: Serious effects
Maltese: Effetti serji
English: The majority of cases were non-serious, however, serious cases, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster oticus, herpes zoster infection neurological, herpes zoster meningoencephalitis and herpes zoster meningomyelitis have been reported.
Maltese: Il-maġġoranza tal-każijiet ma kinux serji, iżda, ġew irrappurtati każijiet serji, li jinkludu herpes zoster mifruxa, herpes zoster oftalmika, herpes zoster oticus, infezzjoni newroloġika b'herpes zoster, herpes zoster meninġoenċefalite, u herpes zoster meninġomijelite.
English: Subjects received Tecfidera 120 mg twice a day for 7 days followed by 240 mg twice a day for 24 weeks.
Maltese: L-individwi rċivew Tecfidera 120 mg darbtejn kuljum għal 7 ijiem segwiti minn 240 mg darbtejn kuljum għal 24 ġimgħa.
English: Symptoms may include dyspnoea, hypoxia, hypotension, angioedema, rash or urticaria.
Maltese: Is-sintomi jistgħu jinkludu dispnea, ipossija (hypoxia), pressjoni għolja, anġjoedema, raxx jew urtikarja.
English: Elevations of alanine aminotransferase and aspartate aminotransferase ≥3 times ULN, respectively, were seen in 5% and 2% of patients treated with placebo and 6% and 2% of patients treated with Tecfidera.
Maltese: Żidiet ta' alanine aminotransferase u aspartate aminotransferase li kienu ≥3 darbiet il-ULN, rispettivament, ġew osservati f'5% u 2% tal-pazjenti kkurati bi plaċebo u f'6% u 2% tal-pazjenti kkurati b'Tecfidera.
English: Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions.
Maltese: Tnaqqis temporanju fid-doża għal 120 mg darbtejn kuljum jista' jnaqqas l-okkorrenza ta' fwawar u reazzjonijiet avversi gastrointestinali.
English: Gastro-resistant hard capsule
Maltese: Qoxra tal-kapsula
English: Gastrointestinal disorder
Maltese: Disturbi gastro-intestinali
English: In some cases, serious complications have occurred.
Maltese: F'xi każijiet, seħħew komplikazzjonijiet serji.
English: After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice a day (see section 4.4).
Maltese: Wara 7 ijiem, id-doża tiżdied għad-doża ta' manteniment rakkomandata ta' 240 mg darbtejn kuljum (ara sezzjoni 4.2).
English: The pharmacokinetics in patients aged 65 and over has not been studied.
Maltese: Il-farmakokinetika f'pazjenti li kellhom 65 sena u iktar ma ġietx studjata.
English: The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class.
Maltese: Ir-reazzjonijiet avversi huma ppreżentati bħala termini ppreferuti MedDRA taħt is-Sistema talKlassifika tal-Organi
English: Limited data is available on ALC in patients with herpes zoster infection in the post-marketing setting.
Maltese: Hemm data limitata disponibbli dwar ALC f'pazjenti b'infezzjoni ta' herpes zoster fl-ambitu ta' wara t-tqegħid fissuq.
English: Tecfidera 240 mg gastro-resistant hard capsules are green and printed with ‘BG-12 240 mg' and are available in packs containing 56 or 168 capsules.
Maltese: Tecfidera 240 mg kapsuli ibsin gastroreżistenti huma ħodor u stampati b'‘BG-12 240 mg' u huma disponibbli f'pakketti li fihom 56 jew 168 kapsula.
English: Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg' containing microtablets.
Maltese: Kapsula ibsin gastroreżistenti ħodor, daqs 0, stampati b'‘BG-12 240 mg' li fihom mikropilloli.
English: PML has occurred in the setting of moderate to severe prolonged lymphopenia (see section 4.4).
Maltese: PML seħħet fl-isfond ta' limfopenija moderata sa severa u fit-tul (ara sezzjoni 4.4).