FrancophonIA/ELRC3.0 huggingface dataset:
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. stomatie 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,
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Maltese: nekroliżi tossika tal-ġilda, is-sindrome ta' Stevens-Johnson, eritema multiforme
English: Interstitial lung disease has been reported during treatment with leflunomide (see section 4.8).
Maltese: Mard tal-interstizzju tal-pulmun ġie rapportat waqt it-trattament b'leflunomide (ara sezzjoni 4.8).
English: Leflunomide was not mutagenic.
Maltese: Leflunomide ma kienx mutaġeniku.
English: A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity.
Maltese: A771726, li huwa il-prodott metaboliku attiv ta' leflunomide, jinibixxi l-enżima dihydroorotate dehydrogenase (DHODH) fil-bniedem, u juri attività antiproliferattiva
English: urticaria
Maltese: Tilqim
English: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
Maltese: livelli ogħla fil-parametri tal-fwied (transaminases [speċjalment ALT], inqas komuni gammaGT, alkaline phosphatase, bilirubin)
English: • Hypersensitivity to the active substance (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva (speċjalment sindromu preċedenti ta' StevensJohnson, nekrosi tossika epidermali, eritema multiforme) jew għal kwalunkwe wieħed milleċċipjenti elenkati fis-sezzjoni 6.1.
English: - Severe allergic reaction.
Maltese: - Reazzjoni allerġika severa.
English: • Patients with severe immunodeficiency states, e.g. AIDS.
Maltese: • Pazjenti bi stat ta' defiċjenza immunoloġika, eż.
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' jitjieb aħjar wara 4 sa 6 xhur.
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 tal-artrite rewmatojdi fit-3 provi kollha kkontrollati bil-plaċebo.
English: - Hepatitis (inflammation of the liver).
Maltese: - Epatite (infjammazzjoni tal-fwied).
English: The unbound fraction of A771726 is about 0.62 %.
Maltese: Il-parti ta' A771726 mhix marbuta hija ta' madwar 0.62%.
English: Leflunomide is indicated for the treatment of adult patients with active rheumatoid arthritis as a "disease modifying antirheumatic drug" (DMARD).
Maltese: Leflunomide hu indikat għall-kura ta' pazjenti adulti b'artrite rewmatojdi bħala "mediċina antirewmatika li timmodifika l-marda" (DMARD).
English: Rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving leflunomide among other immunosuppressants.
Maltese: Każijiet rari ta' Progressive Multifocal Leukoencephalopathy (PML) kienu rrapportati f'pazjenti li jirċievu l-kura b'leflunomide fost immunosoppressivi oħra.
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'modestensiv fil-metaboliżmu ta' leflunomide.
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs 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-mediċini tiżdied biss b'10% sa 50%.
English: - If you suffer from moderate to severe kidney problems.
Maltese: - Jekk tbati minn problemi moderati għal severi tal-kliewi.
English: anaemia, mild thrombocytopenia (platelets < 100 G/l)
Maltese: Mhux komuni anemija, tromboċitopenija ħafifa (plejtlits < 100 G/l)
English: Pack sizes of 28, 30 and 100 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 28, 30 u 100 pillola miksija b'rita.
English: - Abdominal pain.
Maltese: - Uġigħ addominali.
English: Excretion data from the 14C study indicated that at least about 82 to 95 % of the dose is absorbed.
Maltese: Tagħrif dwar l-eliminazzjoni mill-istudju ta' 14C indika li tal-anqas 82 sa 95 % tad-doża tiġi assorbita.
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: il-parametri farmakokinetiċi ta' A771726 kienu linejari, f'firxa ta' dożaġġ ta' bejn 5 sa 25 mg.
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: L-istudju MN301 kien magħmul minn 358 individwu magħżula b'mod każwali u b'artrite rewmatojdi għal leflunomide 20 mg/jum (n=133), sulphasalazine 2 g/jum (n=133), jew plaċebo (n=92).
English: • Patients with serious infections (see section 4.4).
Maltese: • Pazjenti b'infezzjonijiet serji (ara sezzjoni 4.4).
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/l), eosinophilia
Maltese: panċitopenija (probabilment minħabba mekkaniżmu antiproliferattiv), lewkopenija
English: The principal faecal component was A771726.
Maltese: Il-komponent ewlieni fl-ippurgar kien A771726.
English: - Cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light)
Maltese: - lupus kutanju (ikkaratterizzat minn raxx/eritema fuq dawk il-partijiet tal-ġilda esposti għax xemx)
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 ewlenin li dehru fl-awrina kienu prodotti glukoronidi derivati minn leflunomide (prinċiplament f'kampjuni meħudin f'0 sa 24 siegħa) u xi derivat ta' A771726 minn oxalinic acid.
English: Adverse events consistent with the safety profile for leflunomide were: abdominal pain, nausea, diarrhoea, elevated liver enzymes, anaemia, leucopenia, pruritus and rash.
Maltese: Reazzjonijiet avversi konsistenti mal-profil tas-sigurtà għal leflunomide kienu: uġigħ ta' żaqq, dardir, dijarea, livelli ogħla ta' enzimi tal-fwied, anemija, lewkopenija, ħakk u raxx.
English: - Abnormal decrease in the levels of blood uric acid.
Maltese: - Tnaqqis mhux normali fil-livelli ta' uric acid fid-demm.
English: Study MN303 was an optional 6-month blinded continuation of MN301 without the placebo arm, resulting in a 12-month comparison of leflunomide and sulphasalazine.
Maltese: L-istudju MN303 kien kontinwazzjoni fakultattiva fl-għama ta' 6-xhur ta' MN301 mingħajr id-driegħ ta' plaċebo, li rriżulta fi tqabbil ta' 12-il xahar ta' leflunomide ma' sulphasalazine.
English: - A decrease in the levels of phosphate in the blood.
Maltese: - Tnaqqis fil-livelli ta' fosfat fid-demm.
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 minn ġimgħa sa 4 ġimgħat.
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: It contains the
Maltese: It-tul ta'
English: EXP
Maltese: PSURs
English: Leflunomide Teva tablets
Maltese: Mediċini oħra u Leflunoamide Teva
English: In rats and dogs, Heinz bodies and/or Howell-Jolly bodies were found.
Maltese: Fil-firien u l-klieb, instabu korpi ta' Heinz u/jew korpi ta' Howell-Jolly.
English: In vitro plasma protein binding interaction studies with warfarin at clinically relevant concentrations, however, showed no interaction.
Maltese: Madanakollu studji ta' interazzjoni fuq proteini marbuta fil-plażma li saru in vitro mal-warfarina f'konċentrazzjonijiet klinikament rilevanti, ma wrew ebda interazzjoni.
English: The only plasma-radiolabelled metabolite detected was A771726.
Maltese: L-uniku metabolit radjutikkettat fil-plażma kien A771726.
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
English: Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in
Maltese: It-tagħrif farmakokinetiku fl-anzjani (>65 sena) huwa limitat, iżda huma konsistenti mal komportament farmakokinetiku f'pazjenti ta' età iżgħar.
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 tal-prodott metaboliku attiv, A771726, b'37% f'24 siegħa u b'48% f'48 siegħa.
English: - problems in the nerves of the arms or legs (peripheral neuropathy).
Maltese: - Problemi fin-nervituri tad-dirgħin jew tar-riġlejn (newropatija periferika).
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 segwit minn proċedura tat tneħħija 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: Human pharmacology
Maltese: PROPRJETAJIET FARMAKOLOGIĊI
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: 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: 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 dawn ma spustawx lil A771726, fil-waqt li l-parti mhux marbuta ta' A771726 żdiedet minn darbtejn sa 3 darbiet fil-preżenza ta' tolbutamide.
English: Combinations with other treatments
Maltese: .2 Inkompatibbiltajiet
English: Marketing Authorisation Holder: Teva Pharma B.V.
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Teva Pharma B.V.
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 kull ġimgħa) żieda minn darbtejn sa 3 darbiet fl-enzimi tal-fwied ġie osservat fuq 5 pazjenti minn 30.
English: Caution is advised when leflunomide is given together with drugs, other than NSAIDs, metabolised by CYP2C9 such as phenytoin, warfarin, phenprocoumon and tolbutamide.
Maltese: Huwa rrakomandat li tittieħed il-kawtela meta leflunomide jingħata flimkien ma' mediċina oħra, ħlief l-NSAIDs, li huma metaboliżżati minn CYP2C9 bħal phenytoin, warfarin, phenprocoumon u tolbutamide.
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 tal-effett kontraċettiv tal-pillola, u l-komportament farmakokinetiku tal-A771726 kien fil-limitu previst.
English: - Diarrhoea.
Maltese: - Dijarea.
English: Especially if you are taking any of the following: - Any other medicine used to treat rheumatoid arthritis, e.g. methotrexate and azathioprine (immunosuppressants), chloroquine and hydroxychloroquine (antimalarials), gold (by mouth or injection), and D-penicillamine.
Maltese: - Mediċina oħra għall-artrite rewmatojde, eż. methotrexate u azathioprine (mediċini li jrażżnu s-sistema immunitarja), chloroquine u hydroxychloroquine (mediċini ta' kontra l-malarja),
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), 10
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 tan-newropatija periferika.
English: There is no
Maltese: Ελλάδα
English: Very rare cases of Stevens Johnson syndrome or toxic epidermal necrolysis 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 kienu rapportati f'pazjenti fuq leflunomide.
English: Treatment duration was 6 months.
Maltese: It-tul tat-trattament kien ta' 6 xhur.
English: The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Maltese: A771726, huwa estensivament marbut mal-proteina u jitneħħa permezz tal- metaboliżmu tal-fwied u s-sekrezzjoni biljari.
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'
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
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: However, in study US301 no significant differences were observed between leflunomide and methotrexate in the primary efficacy parameters.
Maltese: Madanakollu, fl-istudju US301 ma dehrux differenzi sinifikanti bejn leflunomide u methotrexate fil-parametri ta' effikaċja ewlenin.
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 teħid konkomitanti ta' doża waħda ta' leflunomide f'pazjenti li kienu qed jieħdu dożi multipli ta' rifampicin (induttur mhux speċifiku ta' cytochrome P450) A771726 l-ogħla livelli żdiedu b'madwar 40 %, filwaqt li l-AUC ma kienx mibdul.
English: Package leaflet: Information for the user
Maltese: Mhux magħruf: ipourikemija
English: A randomised, double-blind, parallel-group non-inferiority study compared the relative efficacy of two different daily maintenance doses of leflunomide, 10 mg and 20 mg. From the results it can be concluded that efficacy results of the 20 mg maintenance dose were more favourable, on the other hand, the safety results favoured the 10 mg daily maintenance dose.
Maltese: Studju każwali, double-blind, u bi grupp parallel mhux ta' inferjorità qabbel l-effikaċja relattiva ta' żewġ dożi differenti ta' kuljum ta' manteniment ta' leflunomide, 10 mg u 20 mg.
English: - Other medicines that are broken down by an enzyme called CYP2C9 e.g. phenytoin (an epilepsy treatment), warfarin and phenprocoumon (blood thinners), and tolbutamide (a type 2 diabetes treatment).
Maltese: - Mediċini oħra li jinkisru b'enzima li tissejjah CYP2C9 eż. phenytoin (għal kura tal-epilessija),
English: Leflunomide is rapidly converted to the active metabolite, A771726, by first-pass metabolism (ring opening) in gut wall and liver.
Maltese: Leflunomide jiġi mibdul malajr fil-prodott metaboliku attiv, A771726, permezz tal-first-pass metabolism (ftuħ taċ-ċirku) fit-tessuti tal-musrana u l-fwied.
English: Leflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range and exerted adverse effects on male reproductive organs in repeated dose toxicity studies.
Maltese: Leflunomide kien tossiku għall-embriju u teratoġeniku fil-firien u l-fniek f'dożi fil-firxa terapewtika għall-bniedem u eżerċita wkoll effetti avversi fuq l-organi riproduttivi maskili b'dożi repetuti, fi studji fuq it-tossiċità.
English: What Leflunomide Teva looks like and contents of the pack Leflunomide Teva 20 mg film-coated tablets are dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Maltese: Kif jidher Leflunomide Teva u l-kontenut tal-pakkett Il-pilloli miksija b'rita ta' Leflunomide Teva 20 mg huma ta' lewn beġ skur, f'għamla triangolari u miksija b'rita,u fuqhom hemm intaljat ”20” fuq naħa waħda u “L”fuq in-naħa l-oħra.
English: Leflunomide Teva is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Maltese: Leflunomide Teva huwa kontraindikat f'pazjenti li għandhom livelli baxxi ħafna ta' proteini fid-demm jew indeboliment tal-fwied (ara sezzjoni 4.3).
English: • Patients with significantly impaired bone marrow function or significant anaemia, leucopenia,
Maltese: • Pazjenti li għandhom indeboliment sinifikanti fil-funzjoni tal-mudullun, jew anemija sinifikanti,
English: - An increase of certain enzymes in the blood (creatine phosphokinase).
Maltese: - Żieda f'ċertu enzimi fid-demm (creatine phosphokinase).
English: Suomi/Finland ratiopharm Oy Puh/Tel: +358 20 180 5900
Maltese: Ísland ratiopharm Oy Sími: +358 20 180 5900
English: Alternatively, 50 g of activated powdered charcoal is administered 4 times daily.
Maltese: Inkella, 50 g ta' trab tac-charcoal attivat jingħata 4 darbiet kuljum.
English: Name and address of the manufacturers responsible for batch release TEVA Pharmaceutical Works Private Limited Company
Maltese: Teva Pharmaceutical Works Private Limited Company Pallagi út 13
English: EXPIRY DATE
Maltese: Newropatija periferika
English: Leflunomide Teva 20 mg film-coated tablets leflunomide
Maltese: Leflunomide Teva 20 mg pilloli miksija b'rita leflunomide
English: 54.5 % for 25 mg/day.
Maltese: madwar 35 μg/ml.
English: - Vomiting.
Maltese: - Sturdament.
English: Tel: +(44) 1977 628500
Maltese: United Kingdom Teva UK Limited Tel: +(44) 1977 628 500
English: The pharmacokinetics of A771726 in CAPD subjects appeared to be similar to healthy volunteers.
Maltese: A771726 f'individwi ta' CAPD deher simili għal dak f'voluntiera b'saħħithom.
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: Blood and lymphatic system disorders Common:
Maltese: Disturbi tad-Demm u tas-Sistema Limfatika Komuni:
English: Binding of A771726 is linear in the therapeutic concentration range.
Maltese: Ir-rabta ta' A771726 hija linejari fil-firxa tal-livelli terapewtiċi
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: Leflunomide Teva with food, drink and alcohol
Maltese: Leflunomide Teva ma' ikel, xorb u alkoħol
English: No clinical data are available on the efficacy and safety of vaccinations under leflunomide treatment.
Maltese: Tilqim M'hemmx data klinika fuq l-effikaċja u s-sigurtà tat-tilqim waqt il-kura b'leflunomide.
English: Leflunomide Teva stored in blisters are available in pack sizes of 28, 30 and 100 film-coated tablets.
Maltese: Il-pilloli ta' Leflunomide Teva miżmuma fil-folji jiġu f'daqsijiet ta' 28 u 30 u 100 pillola miksija b'rita.