Den europeiske union - italiensk - EMA (European Medicines Agency)

zentiva k.s. - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosoppressori - leflunomide è indicato per il trattamento di pazienti adulti con:artrite reumatoide attiva, come una 'malattia farmaci antireumatici modificanti la' (dmard);artrite psoriasica attiva. recenti o in trattamento concomitante con epatotossici o haematotoxic dmards (e. metotrexato) può comportare un aumento del rischio di reazioni avverse gravi; pertanto, l'inizio del trattamento con leflunomide deve essere attentamente considerato per quanto riguarda questi aspetti benefici / rischi. inoltre, il passaggio da leflunomide ad un altro dmard, senza seguire la procedura di washout può anche aumentare il rischio di gravi reazioni avverse, anche per lungo tempo dopo la commutazione.

USA - engelsk - NLM (National Library of Medicine)

trigen laboratories, llc - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 10 mg - leflunomide tablets usp are indicated for the treatment of adults with active rheumatoid arthritis (ra).  leflunomide is contraindicated in: ·            pregnant women. leflunomide may cause fetal harm. if a woman becomes pregnant while taking this drug, stop leflunomide, apprise the patient of the potential hazard to the fetus, and begin a drug elimination procedure [see warnings and precautions (5.1 and 5.3) and use in specific populations (8.1)].   ·            patients with severe hepatic impairment [see warnings and precautions (5.2)]. ·            patients with known hypersensitivity to leflunomide or any of the other components of leflunomide. known reactions include anaphylaxis [see adverse reactions (6.1)]. ·             patients being treated with teriflunomide [see drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy. health care providers and patients are encouraged to report pr

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - leflunomide, quantity: 20 mg - tablet, film coated - excipient ingredients: magnesium stearate; crospovidone; maize starch; povidone; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000 - treatment of active rheumatoid arthritis.,treatment of active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. the combined use of leflunomide with other disease modifying antirheumatic drugs (dmards) has not been adequately studied (see precautions).

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - leflunomide, quantity: 10 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; povidone; crospovidone; magnesium stearate; lactose monohydrate; maize starch; titanium dioxide; hypromellose; macrogol 4000 - treatment of active rheumatoid arthritis.,treatment of active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. the combined use of leflunomide with other disease modifying antirheumatic drugs (dmards) has not been adequately studied (see precautions).

USA - engelsk - NLM (National Library of Medicine)

dispensing solutions, inc. - leflunomide (unii: g162gk9u4w) (leflunomide - unii:g162gk9u4w) - leflunomide 20 mg - leflunomide tablets are indicated in adults for the treatment of active rheumatoid arthritis (ra): - to reduce signs and symptoms - to inhibit structural damage as evidenced by x-ray erosions and joint space narrowing - to improve physical function (see clinical studies). aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with leflunomide tablets (see precautions - drug interactions – nsaids). the combined use of leflunomide tablets with antimalarials, intramuscular or oral gold, d penicillamine, azathioprine, or methotrexate has not been adequately studied. (see warnings - immunosuppression potential/bone marrow suppression). leflunomide tablets are contraindicated in patients with known hypersensitivity to leflunomide or any of the other components of leflunomide tablets. leflunomide tablets can cause fetal harm when administered to a pregnant woman. leflunomide, when administered orally to rats during organogenesis at a dose of 15 mg/kg, was ter

Den europeiske union - fransk - EMA (European Medicines Agency)

zentiva k.s. - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosuppresseurs - le léflunomide est indiqué pour le traitement de patients adultes atteints:la polyarthrite rhumatoïde active comme un "antirhumatismaux modificateurs de la maladie de drogue" (aral);actif de l'arthrite psoriasique. récente ou un traitement concomitant avec hépatotoxiques ou hématotoxiques aral (e. méthotrexate) peut entraîner un risque accru de réactions indésirables graves; par conséquent, l'initiation du traitement par le léflunomide doit être soigneusement examinée en ce qui concerne ces aspects avantages / risques. en outre, le passage du leflunomide à l'autre aral sans suite de la procédure de lavage peut également augmenter le risque de réactions indésirables graves, même longtemps après la commutation.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

zentiva k.s. - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosoppressanti - leflunomide huwa indikat għall-kura ta ' pazjenti adulti bil:artrite rewmatika attiva bħala 'mard tal-anti-rewmatiċi li jimmodifikaw il-mediċina' (dmard);artrite psorjatika attiva. riċenti jew fl-istess waqt it-trattament b'tossiku għall-fwied jew haematotoxic dmards (e. methotrexate) jista 'jirriżulta f'riskju akbar ta' reazzjonijiet avversi serji; għalhekk, il-bidu tat-trattament ta 'leflunomide għandu jiġi kkunsidrat bir-reqqa fir-rigward ta' dawn l-aspetti ta 'benefiċċju / riskju. barra minn hekk, il-qlib minn leflunomide għal dmard ieħor, mingħajr wara l-proċedura tat-tneħħija jistgħu wkoll iżidu r-riskju ta ' reazzjonijiet avversi serji anke għal żmien twil wara l-qlib tal -.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

apotex nz ltd - leflunomide 10mg - tablet - 10 mg - active: leflunomide 10mg excipient: colloidal silicon dioxide crospovidone lactose magnesium stearate - apo-leflunomide is indicated for the treatment of: · rheumatoid arthritis, to improve signs and symptoms to retard joint destruction and to improve functional ability and quality of life. leflunomide may be used in patients who have failed to respond to other treatments or as a first line of treatment in patients who have a contraindication to other treatments. · active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

apotex nz ltd - leflunomide 20mg - tablet - 20 mg - active: leflunomide 20mg excipient: colloidal silicon dioxide crospovidone lactose magnesium stearate - apo-leflunomide is indicated for the treatment of: · rheumatoid arthritis, to improve signs and symptoms to retard joint destruction and to improve functional ability and quality of life. leflunomide may be used in patients who have failed to respond to other treatments or as a first line of treatment in patients who have a contraindication to other treatments. · active psoriatic arthritis. leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.

Den europeiske union - nederlandsk - EMA (European Medicines Agency)

zentiva k.s. - leflunomide - arthritis, rheumatoid; arthritis, psoriatic - immunosuppressiva - leflunomide is geïndiceerd voor de behandeling van volwassen patiënten met actieve reumatoïde artritis als een 'disease-modifying antirheumatic drug' (dmard);actieve artritis psoriatica. recente of gelijktijdige behandeling met hepatotoxische of haematotoxic dmard ' s (e. methotrexaat) kan leiden tot een verhoogd risico op ernstige bijwerkingen; daarom moet de start van de behandeling met leflunomide zorgvuldig worden overwogen met betrekking tot deze voordelen / risiceaspecten. bovendien, het overschakelen van leflunomide naar een ander dmard, zonder de wash-out procedure kan ook het risico van ernstige bijwerkingen, zelfs voor een lange tijd na het overschakelen.