FrancophonIA/ELRC3.0 huggingface dataset:
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these medicinal products is only increased by 10% to 50%.
Maltese: A771726 jisposta lil ibuprofen, lil diclofenac u lil tolbutamide, iżda l-parti mhux marbuta ta' dawn il-prodotti mediċinali tiżdied biss b'10% sa 50%.
English: CYP450 inhibitors and inducers
Maltese: Inibituri u stimulaturi ta' CYP450
English: Leflunomide at a daily dose of at least 10 mg (10 to 25 mg in study YU203, 20 mg in studies MN301 and US301) was statistically significantly superior to placebo in reducing the signs and symptoms of rheumatoid arthritis in all 3 placebo-controlled trials.
Maltese: Leflunomide, f'doża ta' mhux inqas minn 10 mg kuljum (minn 10 sa 25 mg fl-istudju YU203, 20 mg fl-istudji MN301 u US301), kien superjuri għall-plaċebo, u statistikament sinifikanti, fit-tnaqqis tas sinjali u s-sintomi ta' l-artrite rewmatika fit-3 provi kollha ikkontrollati bil-plaċebo.
English: colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain
Maltese: kolite inkluż kolite mikroskopika bħal kolite limfoċitika, kolite kollaġenuża, dijarea, tqalligħ, rimettar, disturbi tal-mukuża fil-ħalq (e.g. stomatite bl-afte, ulċeri tal-ħalq), uġigħ addominali
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 MN301/303) in sulphasalazine patients, 64.8% (study MN302), and 43.9% (study US301) in methotrexate patients.
Maltese: Wara 12-il xahar ta' kura attiva, ir-rati ta' rispons skond l-ACR fil-pazjenti fuq leflunomide kienu 52.3% (studji MN301/303), 50.5% (studju MN302) u 49.4% (studju US301), ikkomparati ma' 53.8% (studji MN301/303) tal-pazjenti fuq sulphasalzine, 64.8% (studju MN302), u 43.9% (studju US301) tal-pazjenti fuq methotrexate.
English: However, in study US301 no significant differences were observed between leflunomide and methotrexate in the primary efficacy parameters.
Maltese: Madankollu, fl-istudju US301 ma kienx hemm differenzi sinifikanti bejn leflunomide u methotrexate fil-parametri t'effikaċja primarja.
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide or to any of the excipients listed in section 6.1.
Maltese: • Sensitività eċċessiva (speċjalment jekk kellhom preċedentement is-sindromu Stevens-Johnson, in-nekrożi tossika u esfoljattiva tal-ġilda, l-eritema multiforme) għas-sustanza attiva, għall prodott metaboliku attiv prinċipali jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy.
Maltese: Disturbi ta' l-interstitium tal-pulmun huwa potenzjalment fatali, li jista' jiġri b'mod akut waqt it-terapija.
English: At a dose level of 20 mg/day, average plasma concentration of A771726 at steady state is approximately 35 µg/ml.
Maltese: F'doża ta' 20 mg kuljum, il-livell medju fil-plażma ta' A771726 fi stat stabbli kien ta' madwar 35 µg/ml.
English: The recommended maintenance dose is leflunomide 20 mg once daily (see section 5.1).
Maltese: 20 mg ta' leflunomide darba kuljum (ara sezzjoni 5.1).
English: In a small prospective study in women (n=64) who became inadvertently pregnant while taking leflunomide for no more than three weeks after conception and followed by a drug elimination procedure, no significant differences (p=0.13) were observed in the overall rate of major structural defects (5.4%) compared to either of the comparison groups (4.2% in the disease matched group [n=108] and 4.2% in healthy pregnant women [n=78]).
Maltese: F'studju prospettiv żgħir fin-nisa (n=64) li nqabdu tqal b'mod mhux intenzjonat waqt li kienu qed jieħdu leflunomide għal mhux aktar minn tliet ġimgħat minn wara l-konċezzjoni u li ġie segwit minn proċedura ta' eliminazzjoni tal-mediċina, ma ġiet osservata ebda differenza sinifikanti (p=0.13) fir-rata totali ta' difetti strutturali maġġuri (5.4 %) meta mqabbla maż-żewġ gruppi ta' paragun (4.2 % filgrupp xebbieħi fil-mard [n=108] u 4.2% fin-nisa tqal b'saħħithom [n=78]).
English: Pharmacokinetic data in elderly (>65 years) are limited but consistent with pharmacokinetics in younger adults.
Maltese: It-tagħrif farmakokinetiku fl-anzjani (>65 sena) huwa limitat, iżda hija konsistenti mal-komportament farmakokinetiku f'pazjenti adulti ta' età iżgħar.
English: Uncommon: anaemia, mild thrombocytopenia (platelets <100 G/L) Rare:
Maltese: anemija, tromboċitopenja ħafifa (plejtlets <100 G/L)
English: Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Maltese: Talc (E553b) Hypromellose (E464) Titanium dioxide (E171)
English: The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks.
Maltese: Il-prodott metaboliku attiv ta' leflunomide, A771726, għandu half-life twila, ġeneralment 1 sa 4 ġimgħat.
English: A pharmacokinetic interaction with oral contraceptives was observed with A771726 (see below).
Maltese: Ġiet osservata interazzjoni farmakokinetika bejn kontraċettivi orali u A771726 (ara aktar 'l isfel).
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: There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of
Maltese: Kien hemm żieda fil-medja tas-Cmax u l-AUC0-24 (1.58 u 1.54 darbiet, rispettivament) ta' ethinylestradiol, u fis-Cmax u l-AUC0-24 (1.33 u 1.41 darbiet, rispettivament) ta' levonorgestrel, wara l għoti ta' dożi ripetuti ta' A771726.
English: Interstitial lung disease, as well as rare cases of pulmonary hypertension have been reported during treatment with leflunomide (see section 4.8).
Maltese: Disturbi ta' l-interstitium tal-pulmun, kif ukoll każijiet rari ta' ipertensjoni pulmonarja ġew irrapportati waqt it-trattament b'leflunomide (ara sezzjoni 4.8).
English: Excipients with known effect Each tablet contains 138.42 mg of lactose monohydrate
Maltese: Kull pillola fiha 138.42 mg ta' lactose monohydrate.
English: Zentiva Pharma GmbH Tel: +49 (0) 800 53 53 010 PV-Germany@zentiva.com
Maltese: Zentiva Pharma GmbH Tel: +49 (0) 800 53 53 010
English: The efficacy of Leflunomide Zentiva was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Maltese: L-effikaċja ta' Leflunomide Zentiva intwera fi studju wieħed 3L01, li kien ikkontrollat, randomised u double blind u li sar fuq 188 pazjent bl-artrite psorjatika, ittrattati b'20 mg/jum.
English: Interactions studies have only been performed in adults.
Maltese: Studji ta' interazzjoni twettqu biss f'adulti
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: 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: A pack of 3 tablets is available
Maltese: Pakketti ta' 3 pilloli huma disponibbli.
English: You will normally take Leflunomide Zentiva over long periods of time.
Maltese: Normalment sejjer tieħu Leflunomide Zentiva għal perijodi twal.
English: 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: In human plasma, A771726 is extensively bound to protein (albumin).
Maltese: Fil-plażma tal-bniedem, A771726 kien marbut sew mal-proteina (l-albumina).
English: Effect on organic anion transporter 3 (OAT3) substrates 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: INSTRUCTIONS ON USE 16.
Maltese: Wara 16
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: 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% filproporzjon normalizzat internazzjonali (INR) massimu meta A771726. ingħata flimkien ma' warfarin meta mqabbel ma' warfarin waħdu.
English: Clinical efficacy and safety
Maltese: Effikaċja klinika u sigurta'
English: Other medicines and Leflunomide Zentiva
Maltese: Mediċini oħra u Leflunomide Zentiva
English: • For psoriatic arthritis: 20 mg Leflunomide Zentiva once daily.
Maltese: • Għall-artrite psorjatika: 20 mg Leflunomide Zentiva darba kuljum .
English: Talc(E553b)
Maltese: Talc (E553b) Hypromellose (E464)
English: Administration of activated charcoal (powder made into a suspension) orally or via nasogastric tube (50 g every 6 hours for 24 hours) has been shown to reduce plasma concentrations of the active metabolite A771726 by 37% in 24 hours and by 48% in 48 hours.
Maltese: Intwera li t-teħid ta' charcoal attivat (trab f'suspensjoni) mill-ħalq jew permezz ta' tubu li jgħaddi mill-imnieħer u jidħol fl-istonku (50 g kull 6 sigħat għal 24 siegħa), jnaqqas il-livelli fil-plażma talprodott metaboliku attiv, A771726, b' 37% f'24 siegħa u b'48% f'48 siegħa.
English: The following pharmacokinetic and pharmacodynamic interaction studies were conducted with A771726 (principal active metabolite of leflunomide).
Maltese: L-istudji ta' interazzjoni farmakokinetika u farmakodinamika li ġejjin saru b' A771726 (il-prodott metaboliku attiv prinċipali ta' leflunomide).
English: Duration of a complete washout is usually 11 days.
Maltese: Il-proċedura tat-tneħħija sħiħa hija normalment ta' 11-il jum.
English: Film-coated tablet.
Maltese: Żomm fil-pakkett oriġinali.
English: Leflunomide Zentiva 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Leflunomide Zentiva 20 mg
English: Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats.
Maltese: Leflunomide, li ngħata oralment u fil-kavita tal-peritonew, kien studjat mill-aspett ta' tossiċità akuta fil-ġrieden u l-firien.
English: Adverse events consistent with the safety profile for leflunomide were: abdominal pain, nausea, diarrhoea, elevated liver enzymes, anaemia, leucopenia, pruritus and rash.
Maltese: L-effetti avversi konsistenti mal-profil ta' sigurtà ta' leflunomide kienu: uġigħ addominali, dardir, dijarrea, livelli għoljin ta' l-enżimi tal-fwied, anemija, lewkopenja, ħakk u raxx.
English: The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases (especially ALT), less often gamma-GT, alkaline phosphatise, bilirubin)).
Maltese: lewkopenja, parasteżija, uġigħ ta' ras, sturdament, dijarrea, tqalligħ, rimettar, disturbi tal-mukuża filħalq (e.g. stomatite bl-afte, ulċeri tal-ħalq), uġigħ addominali, twaqqigħ tax-xagħar aktar minn normal, ekżema, raxx (jinkludi raxx ikkaratteriżżat minn titbigħ u ponot), ħakk, ġilda xotta, tenosynovitis, żieda fi CPK, anoreksja, telf fil-piż (normalment mhux sinifikanti), astenja, reazzjonijiet allerġiċi ħfief u livelli għoljin tal-parametri tal-fwied (l-enżimi transaminases [speċjalment ALT], anqas spiss gamma-GT, alkaline phosphatase, bilirubin).
English: Excipients with known effect Each tablet contains 78 mg of lactose monohydrate.
Maltese: Kull pillola fiha 78 mg ta' lactose monohydrate.
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: Effect of other medicinal products on leflunomide:
Maltese: L-effett ta' prodotti mediċinali oħra fuq leflunomide:
English: Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy.
Maltese: Età ta' aktar minn 60 sena, mediċini newrotossiċi li jingħataw fl-istess waqt, u d-dijabete jistgħu jżidu r-riskju tannewropatija periferika.
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes <2 G/L), eosinophilia
Maltese: panċitopenja (probabilment minn mekkaniżmu anti-proliferattiv), lewkopenja
English: Leflunomide was not mutagenic.
Maltese: Leflunomide m'huwiex mutaġeniku.
English: Binding of A771726 is linear in the therapeutic concentration range.
Maltese: Ir-rabta ta' A771726 hija linejari fil-firxa tal-livelli terapewtiċi.
English: Store in the original package.
Maltese: Aħżen fil-pakkett oriġinali.
English: All patients received folate 1 mg bid.
Maltese: Il-pazjenti kollha ngħataw 1 mg folate bid.
English: Colitis
Maltese: Kolite
English: agranulocytosis
Maltese: tenosinovite
English: pulmonary hypertension Gastrointestinal disorders Common:
Maltese: Disturbi gastro-intestinali
English: Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
Maltese: Kolite, inkluż kolite mikroskopika ġiet irrapportata f'pazjenti kkurati b'leflunomide.
English: Packs of 30 and 100 tablets are available.
Maltese: Pakketti ta' 30 u 100 pilloli huma disponibbli.
English: Tel: +356 277 82 052 PV-Malta@zentiva.com
Maltese: +356 277 82 052 PV-Malta@zentiva.com
English: The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Maltese: Il-prodott metaboliku attiv, A771726, huwa estensivament marbut mal-proteina u jitneħħa permezz tal metaboliżmu tal-fwied u s-sekrezzjoni biljari.
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: One film-coated tablet contains 20 mg of leflunomide - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 and yellow ferric oxide (E172) in the film-coating.
Maltese: Kull pillola miksija b'rita fiha 20 mg ta' leflunomide - Is-sustanżi l-oħra huma: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), u lactose monohydrate fil-qalba tal-pillola, kif ukoll, talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 u ferric oxide isfar (E172) fir-rita tal-pillola.
English: To minimise any possible risk, men wishing to father a child should consider discontinuing use of leflunomide and taking colestyramine 8 g 3 times daily for 11 days or 50 g of activated powdered charcoal 4 times daily for 11 days.
Maltese: Biex jitnaqqas kull riskju possibbli, l-irġiel li jixtiequ jsiru missirijiet għandhom iqisu jekk għandhomx iwaqqfu l-użu ta' leflunomide, u jieħdu 8 g colestyramine 3 darbiet kuljum għal 11-il jum, jew 50 g ta' trab ta` charcoal mediċinali attivat 4 darbiet kuljum għal 11-il jum.
English: Results of animal fertility studies have shown no effect on male and female fertility, but adverse effects on male reproductive organs were observed in repeated dose toxicity studies (see section 5.3).
Maltese: iżda effetti avversi ġew osservati fuq l-organi riproduttivi maskili f'studji ta' tossiċità b'dożi ripetuti
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 tad demm, fejn jingħaddu ċ-ċelluli kollha, inklużi t-tipi diversi kollha taċ-ċelluli bojod u l-plejtlits, iridu jsiru simultanjament u bl-istess frekwenza:
English: If both plasma concentrations are below 0.02 mg/L no teratogenic risk is to be expected.
Maltese: Jekk il-livelli fil-plażma taż-żewġ kampjuni huma inqas minn 0.02 mg/L, mhux mistenni li jkun hemm riskju teratoġeniku.
English: Tél/Tel: +352 208 82330 PV-Luxembourg@zentiva.com
Maltese: +352 208 82330 PV-Luxembourg@zentiva.com
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: 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: 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: Leflunomide Zentiva with food, drink and alcohol
Maltese: Leflunomide Zentiva ma' ikel, xorb u alkoħol
English: Leflunomide Zentiva 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Leflunomide Zentiva 10 mg
English: The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n=102), leflunomide 5 mg (n=95), 10 mg (n=101) or 25 mg/day (n=104).
Maltese: II, YU203, 402 pazjenti li kellhom l-artrite rewmatikaattiva kienu mqassmin, mingħajr għażla, f'erba' gruppi: dawk bil-plaċebo (n = 102) u dawk b'5 mg (n = 95),
English: Zentiva Pharma UK Limited Tel: +44 (0) 845 372 7101
Maltese: United Kingdom Zentiva Pharma UK Limited Tel: +44
English: Leflunomide Zentiva 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Leflunomide Zentiva 100 mg
English: • For rheumatoid arthritis: 10 or 20 mg Leflunomide Zentiva once daily, depending on the severity of the disease.
Maltese: • Għall-artrite rewmatika: 10 mg jew 20 mg ta' Leflunomide Zentiva darba kuljum , skond is severità tal-marda.
English: • Patients with severe immunodeficiency states, e.g. AIDS.
Maltese: • Pazjenti li għandhom stat ta' defiċjenza immunoloġika e.g. l-AIDS.
English: Puh/Tel: +358 942 598 648 PV-Finland@zentiva.com
Maltese: +358 942 598 648 PV-Finland@zentiva.com
English: How to store Leflunomide Zentiva
Maltese: Tiħux Leflunomide Zentiva
English: Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=182), methotrexate 7.5 mg/week increasing to 15 mg/week (n=182), or placebo (n=118).
Maltese: dawk li ngħataw 20 mg leflunomide kuljum (n = 182), dawk li ingħataw 7.5 mg methotrexate filġimgħa b'żieda għall-15 mg fil-ġimgħa (n = 182) u dawk bil-plaċebo (n = 118).
English: LDH increased
Maltese: żieda f'LDH
English: - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), 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: - Is-sustanżi l-oħra huma: maize starch, povidone (E1201), crospovidone (E1202), 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: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Therefore, when co-administered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indomethacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended.
Maltese: ciprofloxacin, indometacin, ketoprofen, furosemide, cimetidine, methotrexate u zidovudine, il-kawtela hi rrakkomandata.
English: • before initiation of leflunomide,
Maltese: • qabel ma jinbeda leflunomide,
English: The pharmacokinetics of A771726 in CAPD subjects appeared to be similar to healthy volunteers.
Maltese: A771726 fil- pazjenti ta' CAPD deher simili għal dik f'voluntiera b'saħħithom.
English: No dose 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: The principal urinary metabolites were glucuronide products derived from leflunomide (mainly in 0 to 24 hour samples) and an oxanilic acid derivative of A771726.
Maltese: Il-prodotti metaboliċi prinċipali li dehru fl-awrina kienu sustanzi glukoronidi derivati minn leflunomide (prinċiplament f'kampjuni meħudin f'0 sa 24 siegħa) u xi derivattiv ta' A771726 tat-tip oxalinic acid.