FrancophonIA/ELRC3.0 huggingface dataset:
English: - a marked decrease of some white blood cells (agranulocytosis), - severe and potentially severe allergic reactions, - inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis), - inflammation of the pancreas (pancreatitis), - severe liver injury such as liver failure or necrosis which may be fatal, - severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Maltese: - reazzjonijiet allerġiċi severi u potenzjalment serji, - infjammazzjoni tal-pajpijiet żgħar tad-demm (vaskulite, li tinkludi l-vaskulite nekrotika tal ġilda), - infjammazzjoni tal-frixa (pankreatite), - leżjoni serja fil-fwied bħal insuffiċjenzja tal-fwied jew nekrosi li tista' tkun fatali, - reazzjonijiet severi, x'imdaqqiet fatali (is-sindrome ta' Stevens-Johnson, in-nekrosi tossika u esfoljattiva tal-ġilda, eritema multiforme).
English: The only plasma-radiolabelled metabolite detected was A771726.
Maltese: L-uniku prodott metaboliku radjuattiv li deher fil-plażma kien A771726.
English: Breast-feeding
Maltese: fil-fażi
English: There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of CYP2C8 in vivo.
Maltese: Kien hemm żieda fil-medja tas-Cmax u tal-AUC (1.7 u 2.4 darbiet rispettivament) ta' repaglinide, wara l-għoti ta' dożi ripetuti ta' A771726 u dan jissuġġerixxi li A771726 hu inibitur ta' CYP2C8 in vivo.
English: A pharmacodynamics interaction with warfarin was observed with A771726 in a clinical pharmacology study (see below).
Maltese: Kienet osservata interazzjoni farmakodinamika bejn warfarin u A771726 f'studju ta'
English: EU/1/09/604/005 30 tablets EU/1/09/604/006 50 tablets EU/1/09/604/007 100 tablets
Maltese: EU/1/09/604/005 30 pillola EU/1/09/604/006 50 pillola EU/1/09/604/007 100 pillola
English: How to store Leflunomide Zentiva Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: • The risk of infections, including opportunistic infections, and the contraindication for use in immuno-compromised patients.
Maltese: • Ir-riskju ta' infezzjonijiet, li jinkludu infezzjonijiet opportunistiċi u li huwa kontra-indikat għall-użu f'pazjenti li għandhom defiċjenza immunitarja.
English: Leflunomide Zentiva belongs to a group of medicines called anti-rheumatic medicines.
Maltese: Leflunomide Zentiva jappartjeni għall-grupp ta' s mediċini msejħa antirewmatiċi.
English: In rats and dogs, Heinz bodies and/or Howell-Jolly bodies were found.
Maltese: Fil-firien u l-klieb, instabu l-korpi ta' Heinz u/jew il-korpi ta' Howell-Jolly.
English: In multiple dose studies in patients with rheumatoid arthritis, the pharmacokinetic parameters of A771726 were linear over the dose range of 5 to 25 mg.
Maltese: Fi studji b'dożi multipli, f'pazjenti li kellhom l-artrite rewmatika, il-parametri farmakokinetiċi ta' A771726 kienu linejari,
English: Pack size: 3 film-coated tablets.
Maltese: Daqst tal-pakkett: 3 pilloli miksija b'rita.
English: Leflunomide is rapidly converted to the active metabolite, A771726, by first-pass metabolism (ring opening) in gut wall and liver.
Maltese: Leflunomide jiġi mibdul malajr fil-prodott metaboliku attiv, A771726, permezz tal-first pass metabolism (ftuħ taċ-ċirku) fit-tessut tal-musrana u l-fwied.
English: Similar studies showed that ibuprofen and diclofenac did not displace A771726, whereas the unbound fraction of A771726 is increased 2- to 3-fold in the presence of tolbutamide.
Maltese: Studji simili li saru b'ibuprofen u diclofenac, urew li dawn ma spustjawx lil A771726, fil-waqt li l-parti mhux marbuta ta' A771726 żdiedet minn darbtejn sa 3 darbiet fil-preżenza ta' tolbutamide.
English: In a small (n=30) study with co-administration of leflunomide (10 to 20 mg per day) with methotrexate (10 to 25 mg per week) a 2- to 3-fold elevation in liver enzymes was seen on 5 of 30 patients.
Maltese: Fi studju żgħir (n = 30) fejn leflunomide (10 sa 20 mg kuljum) ingħata ma' methotrexate (10 sa 25 mg fil-ġimgħa), il-livelli ta' l-enżimi tal-fwied żdiedu minn darbtejn sa 3 darbiet aktar f'5 minn 30 pazjent.
English: Excretion data from the 14C study indicated that at least about 82 to 95% of the dose is absorbed.
Maltese: Tagħrif dwar it-tneħħija, fl-istudju tal-14C uriet li mhux inqas minn 82 sa 95% tad-doża kienet assorbita.
English: If a patient taking Leflunomide Zentiva develops a peripheral neuropathy, consider discontinuing Leflunomide Zentiva therapy and performing the drug elimination procedure (see section 4.4).
Maltese: ikkunsidra li twaqqaf il-kura b' Leflunomide Zentiva , u li ssir il-proċedura tal-eliminazzjoni tal mediċina (ara sezzjoni 4.4).
English: 3 film-coated tablets
Maltese: II u 3 fil-fażi
English: Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo.
Maltese: Effett fuq il-kaffeina(substrat ta' CYP1A2) Dożi ripetuti ta' A771726 naqqsu l-medja tas-Cmax u l-AUC ta' kaffeina (substrat ta' CYP1A2) bi 18%
English: Alternatively, 50 g of activated powdered charcoal is administered 4 times daily.
Maltese: Minnflok, jista' jingħata 50 g ta' charcoal mediċinali attivat 4 darbiet kuljum.
English: The measurement of ionised calcium levels might show falsely decreased values under treatment with leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised calcium analyser used (e.g. blood gas analyser).
Maltese: Interferenza b'determinazzjoni ta' livelli ta' kalċju jonizzat Il-kejl tal-livelli ta' kalċju jonizzat jista' juri tnaqqis falz fil-valuri taħt il-kura b'leflunomid u/jew teriflunomid (il-metabolit attiv ta' leflunomid) skont it-tip ta' analizzatur ta' kalċju jonizzat użat (pereżempju analizzatur bil-gass tad-demm).
English: In female mice an increased incidence, dose-dependent, of bronchiolo-alveolar adenomas and carcinomas of the lung was noted.
Maltese: adenomi u kanċer tal-pulmun tat-tip bronkjolo-alvejolari, li kienu iddeterminati mid-doża użata.
English: Animal pharmacology
Maltese: PROPRJETAJIET FARMAKOLOGIĊI 5
English: Film-coating:
Maltese: Mhux komuni:
English: Patients were 3-17 years of age with active polyarticular course JRA regardless of onset type and naive to methotrexate or leflunomide.
Maltese: Il-pazjenti kienu minn 3 snin sa 17-il sena fl-età b'JRA attiva u li involviet diversi ġogi, irrespettivament ta' kif bdiet, u fejn il-pazjenti qatt ma' kienu ngħataw methotrexate jew leflunomide.
English: In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: <20 kg, 20-40 kg, and >40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥30% (p=0.02).
Maltese: Wara 16il ġimgha trattament, id-differenzi fir-rati tar-rispons kienu statistikament sinifikanti favur methotrexate għall-JRA Definition of Improvement (DOI) >30% (p = 0.02).
English: The efficacy of Leflunomide Zentiva in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Maltese: Artrite rewmatika L-effikaċja ta' Leflunomide Zentiva fil-kura ta' l-artrite rewmatika ntweriet f' 4 provi ikkontrollati (1
English: It has been shown in man that administration of an oral suspension of activated powdered charcoal or colestyramine leads to a rapid and significant increase in A771726 elimination rate and decline in plasma concentrations (see section 4.9).
Maltese: colestyramine iwassal għal żieda mgħaġġla u sinifikanti fir-rata t'eliminazzjoni ta' A771726 u tnaqqis fil-livelli fil-plażma (ara sezzjoni 4.9).
English: • In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.
Maltese: • Fl-artrite psorjatika: it-terapija b'leflunomide tibda b'doża ta' kkargar ta' 100 mg darba kuljum għal tlitt ijiem.
English: Zentiva k.s.
Maltese: FIS-SUQ Zentiva k.s.
English: Pack sizes: 30 and 100 film-coated tablets.
Maltese: Daqsijiet tal-pakketti: 30 u 100 pilloli miksija b'rita.
English: The duration may be modified depending on clinical or laboratory variables.
Maltese: It-tul ta' żmien jista' jkun modifikat skond ir-reperti kliniċi u dawk tal-laboratorju.
English: Leflunomide was studied in a single multicenter, randomized, double-blind, active-controlled trial in 94 patients (47 per arm) with polyarticular course juvenile rheumatoid arthritis.
Maltese: Leflunomide kien studjat f'diversi ċentri fi prova waħda, tat-tip randomised, double blind u active controlled, f'94 pazjent (47 f'kull grupp) li kellhom l-artrite rewmatika taż-żgħażagħ u li nvolviet diversi ġogi tul il-kors tagħha.
English: There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726.
Maltese: Kien hemm żieda fil-medja tas-Cmax u l-AUC (2.65 u 2.51 darbiet, rispettivament) ta' rosuvastatin,
English: Leflunomide Zentiva is contraindicated in pregnancy(see section 4.3).
Maltese: Leflunomide Zentiva m'għandux jingħata waqt it-tqala (ara sezzjoni 4.3).
English: Effect of leflunomide on other medicinal products:
Maltese: L-effett ta' leflunomide fuq prodotti mediċinali oħra:
English: • That there is a risk of teratogenicity and so pregnancy must be avoided until leflunomide plasma levels are at an appropriate level.
Maltese: • Li hemm ir-riskju ta' teratoġeniċità u għalhekk għandha tiġi evitata t-tqala sakemm il-livelli fil-plażma ta' leflunomide jkunu fl-livell xieraq.
English: Leflunomide Zentiva 100 mg film-coated tablets leflunomide
Maltese: Kull pillola fiha 100 mg ta' leflunomide
English: Bottle:
Maltese: Flixkun:
English: - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), talc (E553b), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), and macrogol 8000 in the film-coating.
Maltese: (E1202), talc (E553b), silica colloidal anhydrous, magnesium stearate (E470b), u lactose monohydrate fil-qalba tal-pillola, kif ukoll, talc (E553b), hypromellose (E464), titanium dioxide (E171), u macrogol 8000 fir-rita tal-pillola.
English: Pregnancy and breast-feeding
Maltese: Disturbi fis-sistema reproduttiva u fis-sider
English: The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 paediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) who ranged in age from 3 to 17 years.
Maltese: Il-komportament farnakokinetiku ta' A771726 wara t-teħid orali ta' leflunomide kien studjat f'73
English: Leflunomide Zentiva 20 mg film-coated tablets leflunomide
Maltese: Leflunomide Zentiva 20 mg pilloli miksija b'rita leflunomide
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (tista' taffettwa sa 1 minn kull 10 persuni)
English: EU/1/09/604/008 30 tablets EU/1/09/604/009 100 tablets
Maltese: EU/1/09/604/008 30 pillola EU/1/09/604/009 100 pillola
English: Repeated doses of A771726 had no effect on the pharmacokinetics of S-warfarin, indicating that A771726 is not an inhibitor or an inducer of CYP2C9.
Maltese: A771726. mhuwiex inibitur jew stimulatur ta' CYP2C9.
English: Uncommon: taste disturbances
Maltese: Mhux magħruf: ipojuriċimja Disturbi psikjatriċi
English: Study MN303 was an optional 6-month blinded continuation of MN301 without the placebo arm, resulting in a 12-month comparison of leflunomide and sulphasalazine.
Maltese: L-istudju MN303, li kien blinded ma kienx obbligatorju u kien twil 6 xhur; u sar bħala kontinwazzjoni tal-MN301, mingħar ma kien ikkontrollat bil-plaċebo.
English: A randomised, double-blind, parallel-group non-inferiority study compared the relative efficacy of two different daily maintenance doses of leflunomide, 10 mg and 20 mg. From the results it can be concluded that efficacy results of the 20 mg maintenance dose were more favourable, on the other hand, the safety results favoured the 10 mg daily maintenance dose.
Maltese: Studju randomised u double blind fejn il-pazjenti nqassmu f'żewġ gruppi paralleli, u li kellhom mard ta' l-istess grad ta' severità, qabbel l-effikaċja relattiva ta' dożi regolari u mantnuti ta' wara, b'10 mg u 20 mg ta' leflunomide.
English: Co-administration of teriflunomide with leflunomide is not recommended, as leflunomide is the parent compound of teriflunomide.
Maltese: Mhux irrakkomandat it-teħid flimkien ta' teriflunomide u leflunomide, peress li leflunomide huwa l kompost oriġinali ta' teriflunomide.
English: • Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/L (see section 4.6).
Maltese: • Nisa tqal b'tarbija, jew dawk in-nisa li għadhom fl-età li jkollhom it-tfal u mhux qegħdin jużaw kontraċettivi effettivi waqt il-kura b'leflunomide, u wara, sakemm il-livelli fil-plażma talprodott metaboliku attiv ikunu 'l fuq minn 0.02 mg/L (ara sezzjoni 4.6).
English: • In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days.
Maltese: • Fl-artrite rewmatika: normalment, it-terapija b'leflunomide tibda b'doża ta' kkargar ta' Il-kura b`lefunomide tibda b'doża kbira inizjali, ta` 100 mg darba kuljum għal tlitt ijiem.
English: Batch
Maltese: ZBN
English: Blood and lymphatic system disorders Common:
Maltese: Disturbi tad demm u tas-sistema limfatika Komuni:
English: Each tablet contains 20 mg of leflunomide.
Maltese: Kull pillola fiha 20 mg ta' leflunomide.
English: In such cases re-exposure to leflunomide is contraindicated (see section 4.3).
Maltese: l-użu mill-ġdid ta' leflunomide huwa kontra-indikat (ara sezzjoni 4.3).
English: EU/1/09/604/001 30 tablets EU/1/09/604/002 100 tablets
Maltese: EU/1/09/604/001 30 pillola EU/1/09/604/002 100 pillola
English: Each film-coated tablet contains 20 mg leflunomide.
Maltese: Għall-artrite psorjatika: 20 mg Leflunomide Zentiva darba kuljum.
English: A771726.
Maltese: wara l-għoti ta' dożi ripetuti ta' A771726.
English: Leflunomide Zentiva 10 mg film-coated tablets leflunomide
Maltese: Leflunomide Zentiva 10 mg pilloli miksija b'rita leflunomide
English: The safety data obtained from both treatment groups were consistent with the known safety profile of leflunomide, however, the incidence of gastrointestinal adverse events and of elevated liver enzymes tended to be higher in the patients receiving the loading dose of 100 mg leflunomide.
Maltese: It-tagħrif dwar is-sigurtà li nkiseb miż-żewġ gruppi ta' kura kien konsistenti mal-profil ta' sigurtà magħruf ta' leflunomide, madankollu, l-inċidenza ta' avvenimenti avversi gastro-intestinali u ta' żieda fl-enzimi tal-fwied kellhom tendenza li jkunu ogħla fil-pazjenti li kienu qed jirċievu d-doża ta' kkargar ta' 100 mg ta' leflunomide.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Ir-Repubblika Ċeka NUMRU(I)
English: The results of a population pharmacokinetic analysis of these trials have demonstrated that paediatric patients with body weights ≤40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section
Maltese: suġġetti, f'dawn il-provi, urew li l-pazjenti pedjatriċi li kellhom piż ta' ≤40 kg, kellhom espożizzjoni sistemika mnaqqsa (mkejjla permezz ta' Css) ta' A771726, meta mqabblin ma' pazjenti adulti bl-artrite rewmatika (ara sezzjoni 4.2).
English: This is especially important if you are taking: - other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable, - warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine - teriflunomide for multiple sclerosis - repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes - daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer - duloxetine for depression, urinary incontinence or in kidney disease in diabetics - alosetron for the management of severe diarrhoea - theophylline for asthma - tizanidine, a muscle relaxant - oral contraceptives (containing ethinylestradiol and levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections - indomethacin, ketoprofen for pain or inflammation - furosemide for heart disease (diuretic, water pill)
Maltese: - teriflunomide għas-sklerożi multipla - repaglinide, pioglitazone, nateglinide, jew rosiglitazone għad-dijabete - daunorubicin, doxorubicin, paclitaxel, jew topotecan għal kanċer - duloxetine għad-depressjoni, inkontinenza awrinarja jew għall-mard tal-kliewi fid-dijabetiċi - alosetron għall-immaniġġar ta' dijarea severa - theophylline għall-ażma
English: Leflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range and exerted adverse effects on male reproductive organs in repeated dose toxicity studies.
Maltese: Eżerċita wkoll effetti fuq l-organi riproduttivi maskili b'dożi repetuti, fi studji fuq it tossiċità.
English: Leflunomide Zentiva contains lactose
Maltese: Leflunomide Zentiva fih il-lactose
English: EU/1/09/604/003 30 tablets EU/1/09/604/004 100 tablets
Maltese: EU/1/09/604/003 30 pillola EU/1/09/604/004 100 pillola
English: Treatment duration was 6 months.
Maltese: It-tul ta' żmien tattrattament kien ta' 6 xhur.
English: It has immunomodulating/ immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties.
Maltese: Għandu karatteristiċi immunosuppressivi u li jikkontrollaw r-reazzjonijiet immunoloġiċi, jaġixxi bħala sustanza anti-proliferattiva, u juri karatteristiċi anti-infjammatorji.
English: One film-coated tablet contains 10 mg of leflunomide.
Maltese: Kull pillola miksija b'rita fiha 10 mg leflunomide.
English: Symptoms of rheumatoid arthritis include inflammation of joints, swelling, difficulty moving and pain.
Maltese: Is-sintomi tal-artrite rewmatika jinkludu infjammazzjoni tal-ġogi, nefħa, diffikultà fil-movimenti u uġigħ.
English: • Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Maltese: • Pazjenti li għandhom livelli baxxi ħafna tal-proteini fid-demm, e.g. is-sindromu nefrotiku.
English: Folate supplementation was optional and only used in 10% of patients.
Maltese: It-teħid addizzjonali ta' folate ma kienx obbligatorju u ntuża biss minn 10% tal-pazjenti.
English: Zentiva, a.s.
Maltese: Slovenská republika Zentiva, a.s.
English: Leflunomide Zentiva is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Maltese: Leflunomide Zentiva huwa wżat biex jittratta pazjenti adulti b'artrite rewmatojde attiva jew b'artrite psorjatika attiva.
English: The metabolic biotransformation of leflunomide to A771726 and subsequent metabolism of A771726 is not controlled by a single enzyme and has been shown to occur in microsomal and cytosolic cellular fractions.
Maltese: Il-bijotrasformazzjoni metabolika ta' leflunomide għallA771726, u l-metaboliżmu sussegwenti ta' A771726, mhumiex ikkontrollat b'enżima waħda, u ntwera li dan jiġri fil-mikrożomi u l-likwidu taċ-ċitoplażma fil-frazzjonijiet ċellulari.
English: paraesthesia, headache, dizziness, peripheral neuropathy Cardiac disorders
Maltese: parasteżija, uġigħ ta' ras, sturdament, newropatija periferali
English: severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility
Maltese: anoreksja, telf fil-piż (normalment mhux sinifikanti), astenja Rappurtar ta' reazzjonijiet avversi suspettati
English: Each tablet contains 10 mg leflunomide.
Maltese: Kull pillola fiha 10 mg ta' leflunomide.
English: The concentration may be expected to decrease below 0.02 mg/L about 2 years after stopping the treatment with leflunomide.
Maltese: xahar u nofs mit-test li juri livell ta' inqas minn 0.02 mg/L, huwa meħtieġ qabel il-fertilizzazzjoni.
English: In study MN302 leflunomide was significantly less effective than methotrexate.
Maltese: Fl-istudju MN302 leflunomide kien anqas effettiv minn methotrexate b'mod sinifikanti.
English: Human pharmacology
Maltese: GĦAMLA FARMAĊEWTIKA
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 26.3% (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3% (studies MN301/303), 50.5% (study MN302) and 49.4% (study US301), compared to 53.8% (studies
Maltese: III, ir-rati ta' rispons skond l-ACR għal 20 mg leflunomide kuljum kontra l-plaċebo, kienu ta' 54.6% kontra 28.6% (studju MN301), u 49.
English: Method of administration
Maltese: MANIFATTUR RESPONSABBLI
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: trattamenti b'sustanzi konkomittanti, sezzjoni 4.4).
English: There have been case reports of increased prothrombin time, when leflunomide and warfarin were co-administered.
Maltese: Warfarin u antikoagulanti coumarin oħra Kien hemm rapporti ta' każijiet ta' żieda fil-ħin ta' prothrombin, meta leflunomide u warfarin jittieħdu flimkien.
English: Leflunomide Zentiva 20 mg film-coated tablets
Maltese: Leflunomide Zentiva 20 mg pilloli miksija b'rita.
English: 100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30, 50 or 100 film-coated tablets.
Maltese: Flixkun tal-HDPE b'għonqu wiesa' ta' 100 ml, b'tapp tal-kamin, b'dessikant integrat filkontenitur li fih jew 30, jew 50 jew 100 pilloli miksija b'rita.
English: Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.
Maltese: It-teħid orali u repetut ta' leflunomide fil-ġrieden għal perijodu sa 3 xhur, filfirien u l-klieb għal perijodu sa 6 xhur, u fix-xadini għal-perijodu ta' xahar, svela li l-organi maġġuri milquta mit-tossiċità kienu l-mudullun, id-demm, il-passaġġ gastro-intestinali, il-ġilda, il-milsa, it-timu u l-glandoli limfatiċi.
English: In vivo, it is rapidly and almost completely metabolised to A771726 which is active in vitro, and is presumed to be responsible for the therapeutic effect.
Maltese: In vivo, huwa metaboliżżat malajr u kważi kompletament għal A771726, li huwa attiv in vitro u li huwa preżunt li jikkawża l-effett terapewtiku.
English: Leflunomide Zentiva is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Maltese: Leflunomide Zentiva huwa kontra-indikat f'pazjenti li għandhom livelli baxxi ħafna ta' proteini fid-demm jew indeboliment tal-fwied (ara sezzjoni 4.3).
English: PHARMACEUTICAL FORM
Maltese: TAL-PRODOTT MEDIĊINALI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BOTTLE PACK
Maltese: PAKKETT TA' BARRA/FLIXKUN
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Zentiva, k.s.
English: This can include medical history, possible previous contact with tuberculosis, and/or appropriate screening such as lung x-ray, tuberculin test and/or interferon-gamma release assay, as applicable.
Maltese: Dan jista' jinkludi l-passat mediku, il-possibbiltà ta' kuntatt preċedenti mat-tuberkulosi u/jew skreening xieraq bħal x-ray tal-pulmun, test ta' reazzjoni għat-tuberkulin u/jew analiżi permezz ta' interferon-gamma release, skont il-bżonn.
English: tenosynovitis Uncommon: tendon rupture
Maltese: - tizanidine, rilassant tal-muskoli
English: Effect on caffeine (CYP1A2 substrate)
Maltese: Effetti sekondarji rari (tista' taffettwa sa 1 minn kull 1000 persuna)