FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tablet core: lactose monohydrate, povidone, crospovidone type A, pregelatinized starch (maize), talc, anhydrous colloidal silica, lactose anhydrous and magnesium stearate.
Maltese: • Il-qalba tal-pillola: lactose monohydrate, povidone, crospovidone tip A, pregelatinized starch
English: - Dizziness.
Maltese: - Remettar.
English: Repso with food, drink and alcohol
Maltese: Repso ma' ikel, xorb u alkoħol
English: OUTER CARTON/BOTTLE PACK
Maltese: KARTUNA TA' BARRA/PAKKETT TAL-FOLJI
English: The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 pediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) who ranged in age from 3 to 17 years.
Maltese: Il-komportament farmakokinetiku ta' A771726 wara t-teħid orali ta' leflunomide kien studjat f'73 pazjent pedjatriku li kellhom bejn 3 snin sa 17-il sena fl-età u li kellhom Artrite Rewmatojde Giovanili, li effettwat diversi ġogi.
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 ma' cimetidine (impeditur mhux speċifiku ta' cytochrome P450) u rifampicin (induttur mhux speċifiku ta' cytochrome P450i), in vivo juru li l-involviment ta' enzimi CYP mhumiex involuti b'mod estensiv fil-metaboliżmu ta' leflunomide.
English: - Mild allergic reactions.
Maltese: - Reazzjoni allerġika severa.
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: Dożi ripetuti ta' A771726 naqqsu l-medja tas-Cmax u l-AUC ta' kaffeina (substrat ta' CYP1A2) bi 18% u 55%, rispettivament, u dan jissuġġerixxi li A771726 jista' jkun induttur dgħajjef ta' CYP1A2 in vivo.
English: Leflunomide is metabolised to one primary (A771726) and many minor metabolites including TFMA (4-trifluoromethylaniline).
Maltese: Leflunomide huwa metabolizzat għal sustanza waħda ewlenija (A771726) u ħafna oħrajn minuri inkluż TFMA (4-trifluoromethylaniline).
English: - Cimetidine, medicine for the treatment of heartburn and peptic ulcers
Maltese: - Cimetidine, mediċina għall-kura ta' qrusa fl-istonku u ulċeri peptiċi
English: Repso is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Maltese: Repso jintuża fuq pazjenti adulti b'artrite rewmatojde attiva jew artrite psorijatika attiva.
English: Leflunomide 20 mg/day was significantly superior to placebo in reducing the symptoms of arthritis in patients with psoriatic arthritis: the PsARC (Psoriatic Arthritis treatment Response Criteria) responders were 59 % in the leflunomide group and 29.7 % in the placebo group by 6 months (p < 0.0001).
Maltese: Dawk li rrispondew għall PsARC (il-kriterja ta' rispons għalltrattament ta' Artrite Psorijatika) kienu 59 % fil-grupp li kienu qed jieħdu leflunomide u 29.7 % filgrupp tal-plaċebo sa 6 xhur (p < 0.0001).
English: - Problems in the nerves of the arms or legs (peripheral neuropathy).
Maltese: - Problemi fin-nervituri tad-dirgħin jew tar-riġlejn (newropatija periferika).
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: Common: Rare:
Maltese: Rari ħafna:
English: Repso is contraindicated in pregnancy (see section 4.3).
Maltese: Repso huwa kontraindikat fit-tqala (ara sezzjoni 4.3).
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: Fl-istudju US301, 482 individwu bl-artrite rewmatojdi attiva għal leflunomide 20 mg kuljum (n = 182), methotrexate 7.5 mg fil-ġimgħa, b'żieda għall-15 mg fil-ġimgħa (n = 182) jew plaċebo (n=118).
English: Interstitial lung disease, as well as rare cases of pulmonary hypertension have been reported during treatment with leflunomide (see section 4.8).
Maltese: Mard tal-interstizju tal-pulmun, kif ukoll każijiet rari ta' ipertensjoni pulmonari ġew irrapportati waqt il-kura b'leflunomide (ara sezzjoni 4.8).
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 fi studju ta' farmakoloġija klinika (ara hawn taħt).
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 drabi, rispettivament) ta' rosuvastatin, wara l-għoti ta' dożi ripetuti ta' A771726.
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 rewmatika attiva kienu mqassmin, b'mod mhux każwali, f'erba' gruppi: dawk bil-plaċebo (n = 102) u dawk b'5 mg (n = 95), 10 mg (n = 101) jew 25 mg (n = 104) leflunomide kuljum.
English: The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
Maltese: L-effett terapewtiku ġeneralment jibda wara 4 sa 6 ġimgħat u jista' jaqleb għall-aħjar wara 4 sa 6 xhur.
English: Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats.
Maltese: Leflunomide, li ngħata oralment u fil-kavità tal-peritonew, kien studjat mill-aspett ta' tossiċità akuta fil-ġrieden u l-firien.
English: A pharmacokinetic interaction with oral contraceptives was observed with A771726 (see below).
Maltese: Ġiet osservata interazzjoni farmakokinetika bejn kontraċettivi orali u A771726 (ara hawn taħt).
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' S-warfarin, u dan jindika li A771726 mhuwiex inibitur jew induttur ta' CYP2C9.
English: anorexia, weight loss (usually insignificant), asthenia
Maltese: anoreksja, telf fil-piż (ġeneralment mhux sinifikanti), astenja
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: Therefore, when co-administered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indomethacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended.
Maltese: Għalhekk, meta jingħata flimkien ma' substrati ta' OAT3, bħal cefaclor, benzylpenicillin, ciprofloxacin, indometacin, ketoprofen, furosemide, cimetidine, methotrexate u zidovudine, hija rrakkomandata l-kawtela.
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 b'mod każwali u double-blind fi prova waħda li saret f'diversi ċentri, ikkontrollata b'mod attiv f'94 pazjent (47 kull driegħ) b'kors poliartikulari ta' artrite rewmatojdi ġovanili.
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 iqisu jekk għandhomx iwaqqfu l-użu ta' leflunomide u jieħdu 8 g 3 darbiet kuljum ta' colestyramine għal 11-il jum jew 50 g ta' trab ta' charcoal attivat 4 darbiet kuljum għal 11-il jum.
English: The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Maltese: Il-metabolit attiv A771726, huwa estensivament marbut mal-proteina u jitneħħa permezz tal-metaboliżmu tal-fwied u s-sekrezzjoni biljari.
English: paraesthesia, headache, dizziness, peripheral neuropathy
Maltese: paraestesija, uġigħ ta' ras, sturdament, newropatija periferika
English: Repso may make you dizzy.
Maltese: Repso jista' jisturdik.
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: Fi studju prospettiv żgħir fin-nisa (n=64)li saru involontarjament tqal waqt li kienu qegħdin jieħdu leflunomide għal mhux aktar minn tliet ġimgħat wara l-konċepiment u segwew il-proċedura tattneħħija tad-droga, l-ebda differenzi (p=0.13) ma kienu osservati fir-rata ġenerali tad-difetti strutturali kbar (5.4%) meta mqabbel ma' wieħed jew l-ieħor mil-gruppi komparati (4.2% tal-grupp mqabbel tal-marda[n=108] u 4.2% f'nisa tqal b'saħħithom [n=78]).
English: • In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.
Maltese: • Fl-artrite psorijatika: it-terapija b'leflunomide tibda b'doża ta' kkargar ta' 100 mg darba kuljum għal tlitt ijiem.
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 rewmatojdi 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: 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 ta' leflunomide u cimetidine (inibitur dgħajjef u mhux speċifiku taċ-ċitokromju P450 (CYP)) wera li ma kellux impatt sinifikanti fuq l-espożizzjoni ta' A771726.
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 rewmatojde, il-parametri farmakokinetiċi ta' A771726 kienu linejari, f'firxa ta' dożaġġ ta' bejn 5 sa 25 mg.
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 tac-charcoal attivat jingħata 4 darbiet kuljum għal perjodu ta' 11-il jum.
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: dijarea, dardir, remettar, disturbi mukosali marbuta mal-ħalq (eż., stomatite aftusa, ulċerazzjoni tal-ħalq), uġigħ ta' żaqq; kolite inkluż kolite mikroskopika bħal kolite limfoċitika, kolite kollaġenika
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: 30 film-coated tablets 100 film-coated tablets
Maltese: 30 pillola 100 pillola
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 wrew li ibuprofen u diclofenac ma spustawx lil A771726, fil-waqt li l-parti mhux marbuta ta' A771726 żdiedet minn darbtejn sa 3 darbiet fil-preżenza ta' tolbutamide.
English: pulmonary hypertension
Maltese: Mhux magħruf: ipertensjoni pulmonari
English: Tel: +44 1977 628500
Maltese: United Kingdom Teva UK Limited Tel: +44 1977 628500
English: INFORMATION IN BRAILLE Repso 20 mg film-coated tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Repso 10 mg pilloli miksija b'rita
English: Animal pharmacology
Maltese: PROPRJETAJIET FARMAKOLOGIĊI
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: L-aktar effetti avversi frekwenti rapportati b'leflunomide kienu: żieda ħafifa fil-pressjoni tad-demm, lewkopenija, paraestesija, uġigħ ta' ras, sturdament, dijarea, dardir, remettar, disturbi tal-ħalq marbuta mal-mukosa (eż. stomatite aftusa, ulċerazzjoni fil-ħalq), uġigħ ta' żaqq, żieda fit-telf tax-xagħar, ekżema, raxx (li jinkludi raxx makulo-papulari), ħakk, ġilda xotta, tenosinovite, żieda fis-CPK, anoreksja, telf fil-piż (ġeneralment mhux sinifikanti), astenja, reazzjonijiet allerġiċi ħfief u parametri tal-fwied ogħla (transaminases (speċjalment ALT), inqas ta' spiss gamma-GT, alkaline phosphatise, bilirubin).
English: Common: Uncommon:
Maltese: Mhux komuni Rari ħafna:
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-metabolit attiv prinċipali ta' leflunomide).
English: For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution.
Maltese: Għal substrati oħrajn ta' BCRP (eż., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) u l-familja ta' OATP, speċjalment l-inibituri ta' HMG-Co reductase (eż., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) l-għoti fl-istess ħin għandu wkoll isir b'kawtela.
English: - Nettle rash (urticaria).
Maltese: - Raxx - Ħakk.
English: 28 film-coated tablets 30 film-coated tablets 100 film-coated tablets
Maltese: 28 pillola miksija b'rita 30 pillola miksija b'rita 100 pillola miksija b'rita
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 ta' trattament, id-differenzi fir-rati tar-rispons kienu statistikament sinifikanti favur methotrexate għall-JRA Definition of Improvement (DOI) >30% (p = 0.02).
English: - Cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension).
Maltese: - Sogħla jew problemi fit-teħid tan-nifs peress li dawn jistgħu jindikaw problemi tal-pulmun (mard interstizjali tal-pulmun jew ipertensjoni pulmonari).
English: All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days.
Maltese: III inbdew fuq doża inizjali ta' 100 mg għal 3 ijiem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/674/001-010
Maltese: EU/1/11/674/001-010
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: Kien hemm żieda fil-medja tas-Cmax u tal-AUC (1.43 u 1.54 drabi rispettivament) ta' cefaclor, wara lgħoti ta' dożi ripetuti ta' A771726, u dan jissuġġerixxi li A771726 hu inibitur ta' OAT3 in vivo.
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: Intwera li fil-bniedem it-teħid ta' suspenzjoni orali tat-trab ta' charcoal mediċinali attivat jew ta' colestyramine iwassal għal żieda mgħaġġla u sinifikanti fir-rata t'eliminazzjoni ta' A771726 u tnaqqis fil-livelli fil-plażma (ara sezzjoni 4.9).
English: Effect of other medicinal products on leflunomide
Maltese: L-effett ta' prodotti mediċinali oħra fuq leflunomide
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 drabi rispettivament) ta' repaglinide, wara lgħoti ta' dożi ripetuti ta' A771726 u dan jissuġġerixxi li A771726 huwa inibitur ta' CYP2C8 in vivo.
English: The results of a population pharmacokinetic analysis of these trials have demonstrated that pediatric 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 tal-popolazzjoni farmakokinetika ta' dan il-grupp ta' individwi f'dawn il-provi wrew li l-pazjenti pedjatriċi li kellhom piż ta' ≤ 40 kg kellhom espożizzjoni sistemika mnaqqsa (mkejla permezz ta' Css) ta' A771726 meta mqabbla ma' pazjenti adulti bl-artrite rewmatojde (ara sezzjoni 4.2).
English: Repso belongs to a group of medicines called anti-rheumatic medicines.
Maltese: Repso jappartjeni għall-grupp ta' mediċini msejħa antirewmatiċi.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Some people will notice further improvement after 4 to 6 months of treatment.
Maltese: Xi persuni ser iħossuhom aħjar wara 4 sa 6 xhur ta' kura.
English: Pharmacokinetic data in elderly people (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Maltese: It-tagħrif farmakokinetiku fuq persuni anzjani (>65 sena) huwa limitat, iżda huwa konsistenti malkomportament farmakokinetiku f'pazjenti ta' età iżgħar.
English: EU/1/11/674/002 100 film-coated tablets
Maltese: EU/1/11/674/002 100 pilloli miksija b'rita
English: - The other ingredients are (see section 2 “Repso contains lactose”)
Maltese: Is-sustanzi l-oħra huma (ara sezzjoni 2 “Repso fih lactose”)
English: How to take Repso
Maltese: X'fih Repso
English: EU/1/11/674/008 28 film-coated tablets EU/1/11/674/009 30 film-coated tablets EU/1/11/674/010 100 film-coated tablets
Maltese: EU/1/11/674/008 28 pilloli miksija b'rita EU/1/11/674/009 30 pilloli miksija b'rita EU/1/11/674/010 100 pilloli miksija b'rita
English: The initial period was followed by an open label maintenance period of three months, during which both groups received leflunomide 20 mg daily.
Maltese: Dan l-ewwel perijodu ġie segwit minn perijodu ta' manteniment open-label ta' tliet xhur li matulhom iż-żewġ gruppi rċevew 20 mg ta' leflunomide kuljum.
English: There have been case reports of increased prothrombin time, when leflunomide and warfarin were co-administered.
Maltese: Kien hemm rapporti ta' każijiet ta' żieda fil-ħin ta' protrombin, meta leflunomide u warfarin ingħataw flimkien.
English: HDPE tablet containers: 2 years
Maltese: Kontenituri tal-HDPE:
English: Each film-coated tablet contains 20 mg of leflunomide.
Maltese: Kull pillola miksija b'rita fiha 20 mg ta' leflunomide.
English: - If you are woman of child-bearing age and not using effective contraception.
Maltese: - Jekk inti mara f'età li jista' jkollok it-tfal u m'intix qed tuża kontraċezzjoni effettiva.
English: Repso 20 mg film-coated tablets leflunomide
Maltese: Repso 20 mg pilloli miksija b'rita leflunomide
English: Dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Maltese: Pilloli miksija b'rita, ta' lewn beige skur, b'forma ta' trijangolu, li fuqhom hemm intaljat “20” fuq naħa waħda u “L” fuq in-naħa l-oħra.
English: • Each film-coated tablet contains 20 mg of leflunomide.
Maltese: • Kull pillola miksija b'rita fiha 20 mg ta' leflunomide.
English: - Inflammation of the lung (interstitial lung disease), which may be fatal.
Maltese: - Infjammazzjoni tal-pulmun (mard interstizzjali tal-pulmun), li jista' jkun fatali.
English: For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly.
Maltese: F'każ li l-livelli tal-ALT (SGPT) ikunu għoljin bid-doppju u tliet darbiet l-limitu normali ta' fuq, għandu jiġi kkonsidrat li d-doża titnaqqas minn 20 mg sa 10 mg u monitoraġġ isir kull ġimgħa.
English: A771726 was still detectable in urine and faeces 36 days after a single administration.
Maltese: A771726 kien għadu jiġi osservat fl-awrina u fl-ippurgar 36 jum wara t-teħid ta' doża waħda.
English: The efficacy of leflunomide 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 kienet murija fi studju wieħed 3L01 li sar b'mod każwali, double blind u b'kontrolli fuq 188 pazjent b'artrite psorijatika ttrattati b'20 mg/jum.
English: Leflunomide was administered as a single oral 100 mg dose to 3 haemodialysis patients and 3 patients on continuous peritoneal dialysis (CAPD).
Maltese: Leflunomide ngħata bħal doża waħda orali ta' 100 mg lil 3 pazjenti fuq id-dijaliżi tad-demm u lil 3 pazjenti oħra fuq id-dijaliżi kontinwa mill-peritonew (CAPD).
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 littestjar fil-laboratorju tal-livell ta' leflunomide fil-plażma.
English: - An increase in the number of blood cells called eosinophiles (eosinophilia).
Maltese: - Żieda fl-għadd ta' tip ta' ċelluli tad-demm, imsejħa eosinofiliċi (eosinofilja).
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-tuberkulożi u/jew skrinjar xieraq bħal x-ray tal-pulmun, test tat-tuberkulin u/jew analiżi permezz ta' interferon-gamma release, skont il-bżonn.
English: Repso 20 mg film-coated tablets
Maltese: Repso 20 mg pilloli miksija b'rita
English: EU/1/11/674/003 28 film-coated tablets EU/1/11/674/004 30film-coated tablets EU/1/11/674/005 100 film-coated tablets
Maltese: EU/1/11/674/003 28 pillola miksija b'rita EU/1/11/674/004 30 pillola miksija b'rita EU/1/11/674/005 100 pillola miksija b'rita