FrancophonIA/ELRC3.0 huggingface dataset:
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 lleflunomide għal mhux aktar minn tliet ġimgħat wara l-konċepiment u segwit minn 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 talmarda [n=108] u 4.2% f'nisa tqal b'saħħithom [n=78]).
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 talmetaboliżmu tal-fwied u s-sekrezzjoni biljari.
English: Sanofi-Aventis Deutschland GmbH
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Sanofi-Aventis Deutschland GmbH
English: The pharmacokinetics of A771726 in CAPD subjects appeared to be similar to healthy volunteers.
Maltese: Il-komportament farmakokinetiku ta' A771726 fil- pazjenti ta' CAPD deher simili għal dik f'voluntiera b'saħħithom.
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: Sustanżi oħra jinkludu: maize starch, povidone (E1201), crospovidone (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: Arava belongs to a group of medicines called anti-rheumatic medicines.
Maltese: Arava jappartjeni għall-grupp ta' mediċini msejħa antirewmatiċi.
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: 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: 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: Ir-riżultati ta' studji dwar il-fertilità fl-annimali ma wrew ebda effett fuq il-fertilità kemm maskili u kemm femminili iżda ġew osservati effetti avversi fuq l-organi riproduttivi maskili f'studji ta' tossiċità b'dożaġġ ripetut (ara sezzjoni 5.3).
English: Arava 20 mg film-coated tablets leflunomide
Maltese: Arava 20 mg pilloli miksija b'rita leflunomide
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 activecontrolled, f'94 pazjent (47 f'kull grupp) li kellhom l-artrite rewmatika taż-żgħażagħ u li nvolviet diversi ġogi tul il-kors tagħha.
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: Ir-reazzjonijiet avversi l-aktar irrapportati bi leflunomide huma: żieda ħafifa fil-pressjoni tad-demm, 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: The recommended maintenance dose is leflunomide 10 mg to 20 mg once daily depending on the severity (activity) of the disease.
Maltese: Id-doża irrakkomandata ta` manteniment hija ta' 10 mg sa 20 mg ta' leflunomide, skont is-severità (l-attività) tal-marda.
English: Arava is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Maltese: Arava huwa wżat biex jittratta pazjenti adulti b'artrite rewmatojde attiva jew b'artrite psorjatika attiva.
English: paraesthesia, headache, dizziness, peripheral neuropathy Cardiac disorders
Maltese: parasteżija, uġigħ ta' ras, sturdament, newropatija periferika
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes <2 G/L), eosinophilia
Maltese: lewkopenja (lewkoċiti >2 G/L) Mhux komuni: anemija, tromboċitopenja ħafifa (plejtlets <100 G/L) Rari: panċitopenja (probabilment minn mekkaniżmu anti-proliferattiv), lewkopenja (lewkoċiti <2 G/L), esinofilja,
English: Arava 100 mg film-coated tablets leflunomide
Maltese: Arava 100 mg pilloli miksija b'rita leflunomide
English: Leflunomide is indicated for the treatment of adult patients with:
Maltese: L-effett ta' leflunomide fuq prodotti mediċinali oħra:
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) - zidovudine for HIV infection
Maltese: monitoraġġ sabiex jitnaqqas ir-riskju ta' effetti sekondarji minn din il-mediċina - 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 - tizanidine, rilassant tal-muskoli - kontraċettivi orali (li fihom ethinylestradiol u levonorgestrel) - cefaclor, benzylpenicillin (penicillin G), ciprofloxacin għall-infezzjonijiet
English: Symptoms of rheumatoid arthritis include inflammation of joints, swelling, difficulty moving and pain.
Maltese: Is-sintomi ta' l-artrite rewmatika jinkludu infjammazzjoni tal-ġogi, nefħa, diffikultà fil-movimenti u uġigħ.
English: Arava is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Maltese: Arava huwa kontra-indikat f'pazjenti li għandhom livelli baxxi ħafna ta' proteini fid-demm jew indeboliment talfwied (ara sezzjoni 4.3).
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' prothrombin, meta leflunomide u warfarin jittieħdu flimkien.
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) - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
Maltese: Dan huwa importanti speċjalment jekk qiegħed tieħu: 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, azathioprine u mediċini oħra li jrażżnu l-istat immuni (e.ż. methotrexate), peress li t-teħid ta' dawn il-prodotti flimkien mhuwiex irrakkomandati. 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 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 tizanidine, rilassant tal-muskoli kontraċettivi orali (li fihom ethinylestradiol u levonorgestrel) cefaclor, benzylpenicillin (penicillin G), ciprofloxacin għall-infezzjonijiet indomethacin, ketoprofen għall-uġigħ jew għall-infjammazzjoni furosemide għall-mard tal-qalb (dijuretiku, pillola tal-ilma) zidovudine għall-infezzjoni bl-HIV rosuvastatin, simvastatin, atorvastatin, pravastatin għall-iperkolesterolimja (kolesterol għoli) sulfasalazine għall-mard infjammatorju tal-imsaren jew artrite rewmatojdeja mediċina li tissejjaħ colestyramine (użata biex tnaqqas livell għoli ta' kolesterol) jew charcoal attivat għax dawn il-mediċini jistgħu jnaqqsu l-ammont ta' Leflunomide Winthrop li jiġi assorbit mill-ġisem.
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 g 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: However, also following either of the washout procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/L and fertilisation is required.
Maltese: Madankollu, anke wara li tintuża waħda minn dawn il-proċeduri ta' tneħħija, il-verifika b'żewġ testijiet separati, magħmulin b'intervall ta' mhux inqas minn 14-il jum, u perijodu ta' stennija ta' xahar u nofs mit-test li juri livell ta' inqas minn 0.02 mg/L, huwa meħtieġ qabel il-fertilizzazzjoni.
English: Cases of peripheral neuropathy have been reported in patients receiving Arava.
Maltese: Ġew irrappurtati każijiet ta' newropatija periferika f'pazjenti li rċevew ARAVA.
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: Arava 10 mg film-coated tablets leflunomide
Maltese: Arava 10 mg pilloli miksija b'rita leflunomide
English: • Patients with severe immunodeficiency states, e.g. AIDS.
Maltese: • Pazjenti li għandhom stat ta' defiċjenza immunoloġika e.g. l-AIDS,
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: A771726 plasma levels can be expected to be above 0.02 mg/L for a prolonged period.
Maltese: Il-livelli fil-plażma ta' A771726 huma mistennija li jkunu 'l fuq minn 0.02 mg/L għal żmien twil.
English: hypouricemia Psychiatric disorders Uncommon: anxiety Nervous system disorders Common:
Maltese: Disturbi fis-sistema nervuża Komuni:
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: 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: The duration may be modified depending on clinical or laboratory variables.
Maltese: It-tul ta' żmien jista' jkun modifikat skont ir-reperti kliniċi u dawk tal-laboratorju.
English: In female mice an increased incidence, dose-dependent, of bronchiolo-alveolar adenomas and carcinomas of the lung was noted.
Maltese: Fil-ġrieden ta' sess femminil, kien hemm żieda fl-inċidenza ta' adenomi u kanċer tal-pulmun tat-tip bronkjolo-alvejolari, li kienu iddeterminati mid-doża użata.
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, 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: tenosynovitis Uncommon: tendon rupture
Maltese: Mhux komuni: disturbi tat-tegħim
English: • For rheumatoid arthritis: 10 or 20 mg Arava once daily, depending on the severity of the disease.
Maltese: • Għall-artrite rewmatika: 10 mg jew 20 mg ta' Arava darba kuljum , skont is-severità tal-marda.
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: 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 fil kontenitur li fih jew 30, jew 50 jew 100 pilloli miksija b'rita.
English: Excipients with known effect Each tablet contains 72 mg of lactose monohydrate.
Maltese: Kull pillola fiha 72 mg ta' lactose monohydrate
English: Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Maltese: It-teħid flimkien ta' mediċini tal-klassitad-DMARD li huma tossiċi għall-fwied u għad-demm (e.g. methotrexate) mhux irrakkomandat.
English: EU/1/99/118/009 3 tablets
Maltese: EU/1/99/118/006 100 pillola
English: severe infections, including sepsis which may be fatal Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4).
Maltese: Bħal sustanzi oħra li għandhom potenzjal immunosoppressiv, leflunomide jista' jżid is-suxxettibbiltà għall-infezzjonijiet, inklużi dawk opportunistiċi (ara wkoll sezzjoni 4.4).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BLISTER PACK
Maltese: Id-data ta' meta tiskadi tirreferi għal l-aħħar ġurnata ta'dak ix-xahar Żomm fil-pakkett oriġinali
English: Film-coating:
Maltese: Disturbi fil-qalb Komuni:
English: EU/1/99/118/001 30 tablets EU/1/99/118/002 100 tablets
Maltese: EU/1/99/118/002 100 pillola
English: Uncommon: anaemia, mild thrombocytopenia (platelets <100 G/L) Rare:
Maltese: Kull pillola miksija b'rita fiha 100 mg ta' leflunomide Is-sustanżi l-oħra huma:
English: Uncommon: taste disturbances
Maltese: Mhux magħruf: ipojuriċimja
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: Each film-coated tablet contains 20 mg leflunomide.
Maltese: Kull pillola miksija b'rita fiha 20 mg ta' leflunomide.
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 skont l-ACR għal 20 mg leflunomide kuljum kontra l-plaċebo, kienu ta' 54.6% kontra 28.6% (studju MN301), u 49.
English: Sanofi-Aventis
Maltese: Sanofi AB
English: Arava contains lactose
Maltese: Arava fih il-lactose
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: EU/1/99/118/003 30 tablets EU/1/99/118/004 100 tablets
Maltese: EU/1/99/118/004 100 pillola
English: The efficacy of Arava in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Maltese: L-effikaċja ta' Arava fil-kura ta' l-artrite rewmatika ntweriet f' 4 provi ikkontrollati (1 fil-fażi
English: severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis
Maltese: reazzjonijiet severi anafilattiċi jew reazzjonijiet anafilattojdi, vaskulite, li tinkludi lvaskulite nekrotika tal-ġilda
English: Arava 20 mg film-coated tablets
Maltese: Arava 20 mg pilloli miksija b'rita.
English: Hepatobiliary disorders Common:
Maltese: Disturbi tal-qalb Komuni:
English: Each film-coated tablet contains 100 mg leflunomide.
Maltese: Kull pillola miksija b'rita fiha 100 mg ta' leflunomide.
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: Effetti sekondarji rari ħafna (tista' taffettwa sa 1 minn kull 10,000 persuna) tnaqqis immarkat fl-għadd ta' xi tipi ta' ċelluli bojod tad-demm (agranuloċitosi), reazzjonijiet allerġiċi severi u potenzjalment serji, infjammazzjoni tal-pajpijiet żgħar tad-demm (vaskulite, li tinkludi l-vaskulite nekrotika talġilda), problemi bin-nervaturi tad-dirgħajn u r-riġlejn (newropatija periferali), 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: • 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: • Breast-feeding women (see section 4.6).
Maltese: (ara wkoll sezzjoni 4.6).
English: LDH increased
Maltese: U L-UŻU
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 ta' l-ALT (SGPT) ikunu għoljin minn darbtejn sa 3 darbiet l-ogħola limitu tan-normal, trid titqies jekk għandiex titnaqqas id-doża minn 20 mg għal 10 mg, u l-osservazzjoni għandha ssir kull ġimgħa.
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, Dpenicillamine, 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: If a patient taking Arava develops a peripheral neuropathy, consider discontinuing Arava therapy and performing the drug elimination procedure (see section 4.4).
Maltese: Jekk pazjent jiżviluppa newropatija periferika b'ARAVA, ikkunsidra li twaqqaf il-kura b'ARAVA u li ssir il-proċedura tal-eliminazzjoni tal-mediċina (ara sezzjoni 4.4).