FrancophonIA/ELRC3.0 huggingface dataset:
English: Interference with determination of ionised calcium levels 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: Study MN301 randomised 358 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n = 133), sulphasalazine 2 g/day (n = 133), or placebo (n = 92).
Maltese: Dawn kienu mqassmin, mingħajr għazla, fi tlett gruppi: dawk li ngħataw 20 mg leflunomide kuljum (n = 133), dawk li ngħataw 2 g sulphasalazine kuljum (n = 133) jew il-plaċebo (n = 92).
English: diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis
Maltese: dijarrea, tqalligħ, rimettar, disturbi tal-mukuża fil-ħalq (e.g. stomatite bl-afte, ulċeri tal-ħalq), uġigħ addominali, kolite inkluż kolite mikroskopika bħal kolite limfoċitika, kolite kollaġenika
English: • abnormal skin sensations like tingling (paraesthesia),
Maltese: • sensazzjonijiet abnormali fil-ġilda bħat-tnemnim (parasteżija),
English: Very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients treated with leflunomide.
Maltese: Każjiet rari ħafna tas-sindrome ta' Stevens-Johnson jew in-nekrożi tossika u esfoljattiva tal-ġilda u Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS) kienu rrapportati f'pazjenti fuq leflunomide.
English: Do not take Leflunomide medac
Maltese: Tiħux Leflunomide medac
English: Uncommon: anaemia, mild thrombocytopenia (platelets < 100 G/l) Rare:
Maltese: anemija, tromboċitopenja ħafifa (plejtlets < 100 G/l)
English: Interaction studies with cimetidine (non-specific cytochrome P450 inhibitor) and rifampicin (non-specific cytochrome P450 inducer), indicate that in vivo CYP enzymes are involved in the metabolism of leflunomide only to a small extent.
Maltese: Studji fuq l-interazzjoni ta' cimetidine (inibitur mhux speċifiku ta' ċitokromju P450) u rifampicin (induttur mhux speċifiku ta ċitokromju P450) juru li l-involviment ta' l-enżimi CYP in vivo fil-metaboliżmu ta' leflunomide huwa zgħir ħafna.
English: Leflunomide medac 10 mg film-coated tablets Leflunomide medac 15 mg film-coated tablets Leflunomide medac 20 mg film-coated tablets leflunomide
Maltese: Leflunomide medac 10 mg pilloli miksija b'rita Leflunomide medac 15 mg pilloli miksija b'rita Leflunomide medac 20 mg pilloli miksija b'rita leflunomide
English: Tel: + 385 (0) 1 230 34 46 Leflunomid@medac.eu
Maltese: +385 (0) 1 230 34 46 Leflunomid @ medac .eu
English: An in vivo interaction study with leflunomide and cimetidine (non-specific weak cytochrome P450 (CYP) inhibitor) has demonstrated a lack of a significant impact on A771726 exposure.
Maltese: Studju in vivo dwar l-interazzjoni leflunomide u cimetidine (inibitur dgħajjef u mhux speċifiku taċ-ċitokromju P450 [CYP]) wera li ma kellux impatt sinifikanti fuq l-espożizzjoni ta' A771726.
English: Study MN302 randomised 999 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n = 501) or methotrexate at 7.5 mg/week increasing to 15 mg/week (n = 498).
Maltese: Fl-istudju MN302 999 pazjent bl-artrite rewmatika attiva tqassmu f'żewġ gruppi, wieħed fejn ingħataw 20 mg leflunomide kuljum (n = 501), u l-ieħor fejn ingħataw 7.5 mg methotrexate filġimgħa, b'żieda għall-15 mg fil-ġimgħa (n = 498).
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: Dożi ripetuti A771726.ma kellhom l-ebda effett fuq il-farmakokinetika ta' warfarin S, u dan jindika li A771726 mhuwiex inibitur jew stimulatur ta' CYP2C9.
English: • inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis),
Maltese: • infjammazzjoni tal-pajpijiet żgħar tad-demm (vaskulite, li tinkludi l-vaskulite nekrotika talġilda),
English: • warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine
Maltese: • warfarin u mediċini orali oħra użati biex iraqqu d-demm, għax ikun hemm bżonn ta' monitoraġġ sabiex jitnaqqas ir-riskju ta' effetti sekondarji minn din il-mediċina
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`lefunomide tibda b'doża ta` kkargar ta' 100 mg darba kuljum għal tlitt ijiem.
English: • problems in the nerves of the arms or legs (peripheral neuropathy).
Maltese: • problemi bin-nervaturi tad-dirgħajn u r-riġlejn (newropatija periferali),
English: Colestyramine given orally at a dose of 8 g three times a day for 24 hours to three healthy volunteers decreased plasma levels of A771726 by approximately 40 % in 24 hours and by 49 % to 65 % in 48 hours.
Maltese: Meta colestyramine ingħata mill-ħalq f'doża ta' 8 g tliet darbiet kuljum għal 24 siegħa lil tliet voluntieri b'saħħithom, il-livelli ta' A771726 fil-plażma tnaqqsu b'madwar 40 % f'24 siegħa, u b'49% sa 65 % f'48 siegħa.
English: • severe infections called sepsis which may be fatal,
Maltese: • infezzjonijiet qawwija msejħa s-sepsis, li tista' tkun fatali,
English: • zidovudine for HIV infection
Maltese: • zidovudine għall-infezzjoni bl-HIV
English: • For rheumatoid arthritis: 10 to 20 mg Leflunomide medac once daily, depending on the severity of the disease.
Maltese: • Għall-artrite rewmatika: 10 mg sa 20 mg ta' Leflunomide medac darba kuljum , skond is-severità tal-marda.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil- metaboliżmu u n-nutrizzjoni Komuni:
English: Alanine aminotransferase (ALT) (or serum glutamopyruvate transferase SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency:
Maltese: Alanine aminotransferase (ALT) (jew serum glutamopyruvate transferase SGPT) u test komplut taddemm, fejn jingħaddu ċ-ċelluli kollha, inklużi t-tipi diversi kollha taċ-ċelluli bojod u l-plejtlits, iridu jsiru simultanjament u bl-istess frekwenza:
English: <Leflunomide medac 10 mg:> 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Maltese: <Leflunomide medac 10 mg:> 30 pilloli miksija b'rita 60 pilloli miksija b'rita 100 pilloli miksija b'rita
English: • an increase of certain enzymes in the blood (creatine phosphokinase),
Maltese: • żieda ta' ċerta enżimi fid-demm (creatine phosphokinase).
English: • severe increase in blood pressure,
Maltese: • reazzjonijiet allerġiċi severi u potenzjalment serji,
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme Not known: cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Maltese: Mhux magħruf lupus eritematożu kutanju, psorijażi pustulari jew il-psorijażi tmur għall-agħar, Reazzjoni għall-Mediċina b'Eosinofilja u Sintomi Sistemiċi (DRESS)
English: EU/1/10/637/005 (20 mg, 15 tablets) EU/1/10/637/006 (20 mg, 30 tablets) EU/1/10/637/007 (20 mg, 60 tablets) EU/1/10/637/009 (20 mg, 100 tablets)
Maltese: EU/1/10/637/005 (20 mg, 15-il pilloli miksija b'rita) EU/1/10/637/006 (20 mg, 30 pilloli miksija b'rita) EU/1/10/637/007 (20 mg, 60 pilloli miksija b'rita) EU/1/10/637/009 (20 mg, 100 pilloli miksija b'rita)
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 tal-prodott metaboliku attiv ikunu 'l fuq minn 0.02 mg/l (ara sezzjoni 4.6).
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: • alosetron for the management of severe diarrhoea
Maltese: • alosetron għall-immaniġġar ta' dijarea severa
English: EU/1/10/637/010 (15 mg, 30 tablets) EU/1/10/637/011 (15 mg, 60 tablets) EU/1/10/637/012 (15 mg, 90 tablets) EU/1/10/637/013 (15 mg, 100 tablets)
Maltese: EU/1/10/637/010 (15 mg, 30 pilloli miksija b'rita) EU/1/10/637/011 (15 mg, 60 pilloli miksija b'rita) EU/1/10/637/012 (15 mg, 90 pilloli miksija b'rita) EU/1/10/637/013 (15 mg, 100 pilloli miksija b'rita)
English: • an increase of certain enzymes in the blood (lactate dehydrogenase).
Maltese: • żieda ta' ċerta enżimi fid-demm (lactate dehydrogenase).
English: Leflunomide medac is contraindicated in pregnancy (see section 4.3).
Maltese: Leflunomide medac m'għandux jingħata waqt it-tqala (ara sezzjoni 4.3).
English: • sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
Maltese: • sulfasalazine għall-mard infjammatorju tal-imsaren jew artrite rewmatojdeja
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing.
Maltese: L-ispeċjalisti u l-pazjenti għandhom jiġu mgħarrfa li hemm disponibbli servizz ta' konsulenza ad hoc li jagħti informazzjoni dwar l-ittestjar fil-laboratorju tal-livell ta' leflunomide fil-plażma.
English: No dosage adjustment is required in patients above 65 years of age.
Maltese: M'hemmx bżonn ta' tibdil fid-doża f'pazjenti ta'età 'l fuq minn 65 sena.
English: Other medicines and Leflunomide medac
Maltese: Mediċini oħra u Leflunomide medac
English: One tablet of Leflunomide medac 20 mg film-coated tablets contains 20 mg of leflunomide.
Maltese: Kull pillola ta' Leflunomide medac 20 mg pilloli miksija b'rita fiha 20 mg ta' leflunomide.
English: In a study in which leflunomide was given concomitantly with a triphasic oral contraceptive pill containing 30 μg ethinyloestradiol to healthy female volunteers, there was no reduction in contraceptive activity of the pill, and A771726 pharmacokinetics were within predicted ranges.
Maltese: Fi studju fejn leflunomide ngħata flimkien mal-pillola kontraċettiva orali tat-tip ta' tlett fażijiet, li kellha 30 μg ethinyloestradiol, lill-voluntiera nisa b'saħħithom, ma kienx hemm tnaqqis ta' l-effett kontraċettiv tal-pillola, u l-komportament farmakokinetiku ta' l-A771726 kien fil-limitu previst.
English: Leflunomide medac contains lactose
Maltese: Leflunomide medac fih il-lactose
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: However, a 25 % decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Maltese: Madankollu, ġie osservat tnaqqis ta' 25 % fil-proporzjon normalizzat internazzjonali (INR) massimu meta A771726. ingħata flimkien ma'
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 4.2).
Maltese: Ir-riżultati ta' l-analiżi farmakokinetika ta' dan il-grupp ta' 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: One tablet of Leflunomide medac 15 mg film-coated tablets contains 15 mg of leflunomide.
Maltese: Kull pillola ta' Leflunomide medac 15 mg pilloli miksija b'rita fiha 15 mg ta' leflunomide.
English: Absorption Excretion data from the
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: You will normally take Leflunomide medac over long periods of time.
Maltese: Normalment sejjer tieħu Leflunomide medac għal perijodi twal.
English: Not known: renal failure
Maltese: insuffiċjenza renali
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: Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Maltese: L-effett fuq BCRP (Proteina ta' Reżistenza għal Kanċer fis-Sider) u/jew substrati ta' polypeptide B1 u B3 li jittrasportaw l-anjoni organiċi (OATP1B1/B3) Kien hemm żieda fil-medja tas-Cmax u l-AUC (2.65 u 2.51 darbiet, rispettivament) ta' rosuvastatin, wara l-għoti ta' dożi ripetuti ta' A771726.
English: Leflunomide medac is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Maltese: Leflunomide medac huwa wżat biex jittratta pazjenti adulti b'artrite rewmatojde attiva jew b'artrite psorjatika attiva.
English: One tablet of Leflunomide medac 10 mg film-coated tablets contains 10 mg of leflunomide.
Maltese: Kull pillola ta' Leflunomide medac 10 mg pilloli miksija b'rita fiha 10 mg ta' leflunomide.
English: Uncommon: hypokalaemia, hyperlipidemia, hypophosphataemia Rare:
Maltese: żieda qawwija fil-pressjoni tad-demm Disturbi respiratorji, toraċiċi u medjastinali Rari:
English: If ALT (SGPT) elevations of more than 2-fold the upper limit of normal persist or if ALT elevations of more than 3-fold the upper limit of normal are present, leflunomide must be discontinued and wash-out procedures initiated.
Maltese: F'każ li l-livelli ta' l-ALT (SGPT) ikunu għoljin minn darbtejn sa 3 darbiet l-ogħola limitu tan-normal, trid titqies jekk għandiex titnaqqas id-doża għal 10 mg, u l-osservazzjoni għandha ssir kull ġimgħa.
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 16-il ġimgha trattament, id-differenzi fir-rati tar-rispons kienu statistikament sinifikanti favur methotrexate għall-JRA Definition of Improvement (DOI) > 30 % (p = 0.02).
English: Tél/Tel: +31 162 51 49 04 Leflunomide@medac.eu
Maltese: +31 162 51 49 04 Leflunomide@medac.eu
English: Leflunomide medac is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Maltese: Leflunomide medac huwa kontra-indikat f'pazjenti li għandhom livelli baxxi ħafna ta' proteini fid-demm jew indeboliment tal-fwied (ara sezzjoni 4.3).
English: EU/1/10/637/001 (10 mg, 30 tablets) EU/1/10/637/002 (10 mg, 60 tablets) EU/1/10/637/004 (10 mg, 100 tablets)
Maltese: EU/1/10/637/001 (10 mg, 30 pilloli miksija b'rita) EU/1/10/637/002 (10 mg, 60 pilloli miksija b'rita) EU/1/10/637/004 (10 mg, 100 pilloli miksija b'rita)
English: NSAIDS/Corticosteroids
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: • In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for
Maltese: • Fl-artrite psorjatika: it-terapija b'leflunomide tibda b'doża ta' kkargar ta' 100 mg darba kuljum għal tlitt ijiem.
English: There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of OAT3 in vivo.
Maltese: L-effett fuq substrati tat-trasportatur tal-anjoni organiċi 3 (OAT3) Kien hemm żieda fil-medja tas-Cmax u tal-AUC (1.43 u 1.54 darbiet rispettivament) ta' cefaclor, wara l-għoti ta' dożi ripetuti ta' A771726, u dan jissuġġerixxi li A771726 hu inibitur ta' OAT3 in vivo.
English: The use of leflunomide with antimalarials used in rheumatic diseases (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents including Tumour Necrosis Factor alpha-Inhibitors has not been adequately studied up to now in randomised trials (with the exception of methotrexate, see section 4.5).
Maltese: S'issa, l-użu ta` leflunomide flimkien mal-mediċini kontra l-malarja użati fir-rewmatiżmu, (e.g. chloroquine u hydroxychloroquine), deheb li jingħata sew fil-muskoli kif ukoll mill-ħalq, D-penicillamine, azathioprine u sustanzi oħra li jrażżnu l-istat immuni inklużi l-inibituri alfa tal-Fattur ta' Nekrosi Tumurali, għadu ma ġiex studjat biżżejjed f'studji magħmulin b'mod arbitrarju (bl-eċċezzjoni ta' methotrexate, ara sezzjoni 4.5).
English: Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS may also occur with an unknown frequency.
Maltese: Effetti sekondarji oħra bħal insuffiċjenza tal-kliewi, tnaqqis fil-livell ta' l-aċidu uriku fid-demm tiegħek, ipertensjoni pulmonari, infertilita' maskili (li hija riversibbli ġaladarba t-trattament b'din il-mediċina titwaqqaf), lupus kutanju (ikkaratterizzat minn raxx/eritema fuq dawk il-partijiet tal-ġilda esposti għax-xemx), psorijażi (tal-ewwel darba jew li tmur għall-agħar) u DRESS jistgħu jseħħu wkoll b'frekwenza mhux magħrufa.
English: Patients were 317 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: Τηλ: + 49 4103 8006-0 Leflunomide@medac.eu
Maltese: Tel: +49 4103 8006-0 Leflunomid @ medac .eu
English: 40 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container (white silica gel), containing either 30, 60, 90 or 100 film-coated tablets per container.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Flixkun tal-HDPE b'għonqu wiesa' ta' 40 ml, b'għatu bil-kamini, b'kontenitur integrat bid-dessikant (ġel abjad tas-silika), li fih jew 30, 60, 90 jew 100 pilloli miksija b'rita f'kull kontenitur.
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 għall-A771726, 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: Leflunomide medac 20 mg film-coated tablets leflunomide
Maltese: Leflunomide medac 20 mg pilloli miksija b'rita leflunomide
English: • Alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period of 11 days.
Maltese: • Inkella, 50 g ta' trab ta' charcoal mediċinali attivat li jittieħed 4 darbiet kuljum għall-perijodu ta' 11-il jum.
English: • Patients with severe immunodeficiency states, e.g. AIDS.
Maltese: • Pazjenti li għandhom stat ta' defiċjenza immunoloġika e.g. l-AIDS
English: If a patient taking Leflunomide medac develops a peripheral neuropathy, consider discontinuing Leflunomide medac therapy and performing the drug elimination procedure (see section 4.4).
Maltese: Jekk pazjent jiżviluppa newropatija periferika b' Leflunomide medac, ikkunsidra li twaqqaf il-kura b' Leflunomide medac u li ssir il-proċedura tal-eliminazzjoni tal-mediċina (ara sezzjoni 4.4).
English: • indomethacin, ketoprofen for pain or inflammation
Maltese: • indomethacin, ketoprofen għall-uġigħ jew għall-infjammazzjoni
English: Leflunomide medac 15 mg film-coated tablets leflunomide
Maltese: Leflunomide medac 15 mg pilloli miksija b'rita leflunomide
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Breast-feeding women must, therefore, not receive leflunomide.
Maltese: Ħafna mill-pazjenti rkupraw wara li twaqqaf Leflunomide medac.
English: Leflunomide medac 10 mg film-coated tablets leflunomide
Maltese: Leflunomide medac 10 mg pilloli miksija b'rita leflunomide
English: 40 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container (white silica gel), containing either 15, 30, 60 or 100 film-coated tablets per container.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Flixkun tal-HDPE b'għonqu wiesa' ta' 40 ml, b'għatu bil-kamini, b'kontenitur integrat bid-dessikant (ġel abjad tas-silika), li fih jew 15, 30, 60 jew 100 pillola miksija b'rita f'kull kontenitur.
English: • other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e.g. methotrexate) as these combinations are not advisable,
Maltese: • mediċini oħra għall-artrite rewmatika bħal mediċini kontra l-malarja (e.g. chloroquine u hydroxychloroquine), deheb li jingħata sew fil-muskoli kif ukoll mill-ħalq, D-penicillamine,
English: • cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension),
Maltese: • sogħla jew problemi bin-nifs billi dawn jistgħu jindikaw problemi tal-pulmun (mard interstizjali tal-pulmun jew ipertensjoni pulmonari).
English: NAME OF THE MEDICINAL PRODUCT Leflunomide medac 20 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Leflunomide medac 20 mg pilloli miksija b'rita
English: If both plasma concentrations are below 0.02 mg/l, and after a waiting period of at least 3 months, the risk of foetal toxicity is very low.
Maltese: Jekk il-livelli fil-plażma jkunu inqas minn 0.02 mg/l, u wara stennija ta' mhux anqas minn 3 xhur, ir-riskju ta' tossiċità għall-fetu huwa żgħir ħafna.
English: The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment with leflunomide.
Maltese: Illivell mistenni jonqos taħt dak ta' 0.02 mg/l wara madwar sentejn li titwaqqaf il-kura b'leflunomide.
English: Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by approximately 40 %, whereas the AUC was not significantly changed.
Maltese: Wara t-teħid konkomittanti ta' doża waħda ta' leflunomide, f'pazjenti li kienu qed jieħdu dożi multipli ta` rifampicin (stimulatur mhux speċifiku taċ-ċitokromju P450), il-livelli l-aktar għoljin ta' A771726 żdiedu b'madwar 40 %, fil-waqt li l-AUC ma nbidlitx b'mod sinifikanti.
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.