natgillin/translations-raw huggingface dataset:
Både kolestyramin og aktivt kul kan have indflydelse på absorptionen af østrogener og progesteroner, hvorfor sikker kontraception med perorale kontraceptiva ikke kan garanteres under ” wash- out ” proceduren med kolestyramin og aktivt kul.
Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal.
De hyppigst indrapporterede bivirkninger som almindelige bivirkninger (≥1/ 100, < 1/ 10) ved behandling med leflunomid er: mild blodtryksstigning, leukopeni, paræstesi, hovedpine, svimmelhed, diarré, kvalme, opkastning, påvirkniger i mundslimhinderne, (f. eks. aftøs stomatitis, mundsår), abdominalsmerter, øget hårtab, eksem, udslæt (inklusive maculopapulært udslæt), pruritus, tør hud, seneskedehindebetændelse, øget CPK, anoreksi, vægttab (sædvanligvis ubetydeligt), asteni, milde allergiske reaktioner og stigning i leverparametre (transaminaser særligt ALAT), mindre hyppigt gamma- GT, basisk fosfatase og bilirubin)
The most frequently adverse effects reported commonly (≥ 1/ 100 to < 1/ 10) 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))
Meget almindelig (≥1/ 10); almindelig (≥1/ 100, < 1/ 10); ikke almindelig (≥1/ 1000, < 1/ 100); sjælden (≥1 / 10. 000, < 1/ 1000); meget sjælden (< 1 / 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
leukopeni (leukocyter > 2 G/ l)
leucopenia (leucocytes > 2 G/ l)
anæmi, let thrombocytopeni (thrombocyter < 100 G/ l)
anaemia, mild thrombocytopenia (platelets < 100 G/ l)
pancytopeni (formentlig via en antiproliferativ mekanisme) leukopeni (leukocyter < 2 G/ l), eosinofili
Rare: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/ l), eosinophilia
agranulocytose,
agranulocytosis
Nylig, samtidig eller umiddelbart efterfølgende anvendelse af potentielt myelotoksiske stoffer kan
8
8 være forbundet med øget risiko for hæmatologiske virkninger.
Recent, concomitant or consecutive use of potentially myelotoxic agents may be associated with a higher risk of haematological effects.
paræstesi, hovedpine, svimmelhed,
paraesthesia, headache, dizziness
perifer neuropati
peripheral neuropathy
interstitial lungesygdom (inklusive interstitial pneumonitis) som kan være fatal.
Rare: interstitial lung disease (including interstitial pneumonitis), which may be fatal
diarré, kvalme, opkastning, påvirkning af mundslimhinden (f. eks. aftøs stomatit, mundsår), abdominalsmerter
diarrhoea, nausea, vomiting, oral mucosal disorders (e. g., aphthous stomatitis, mouth ulceration), abdominal pain
smagsforstyrrelser
taste disturbances
pancreatitis
pancreatitis
nyresvigt
renal failure
øget hårtab, eksem, udslæt (inklusive maculopapulært udslet), kløe, tør hud
increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin
urticaria
urticaria
toksisk epidermal nekrolyse, Stevens- Johnson syndrom, erythema multiforme
toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
seneskedehindebetændelse
tenosynovitis
seneruptur
tendon rupture
hypokaliæmi, hyperlipidæmi, hypophosphatæmi
hypokalaemia, hyperlipidemia, hypophosphataemia
hypouricæmi
hypouricemia
alvorlige infektioner inklusive sepsis, som kan være fatal.
Rare: severe infections, including sepsis which may be fatal
Som andre lægemidler med immunosuppresiv effekt, kan leflunomid forøge modtageligheden for infektioner, inklusive opportunistiske infektioner (se også afsnit 4. 4).
9 Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4).
Derfor kan den samlede forekomst af infektioner forøges (specielt rhinit, bronchit og pneumoni).
Thus, the overall incidence of infections can increase (in particular of rhinitis, bronchitis and pneumonia).
9 Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Risikoen for ondartethed, særligt lymfoproliferative lidelser, øges ved samtidig behandling med visse immunosuppressive stoffer.
The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
svære anafylaktiske/ anafylaktoide reaktioner, vasculitis inklusive kutan nekrotisk vasculitis.
severe anaphylactic/ anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis
forhøjede leverprøver (transaminaser (specielt ALAT), mindre hyppigt gammaglutamyltransferase, basisk fosfatase, bilirubin).
elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
hepatitis, gulsot, kolestase.
hepatitis, jaundice/ cholestasis
svær leverskade som f. eks. leversvigt og akut hepatisk nekrose, som kan være livstruende
severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
angst
anxiety
40% i løbet af 24 timer og 49- 65% i løbet af 48 timer.
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.
Indgift af aktivt kul (suspension ud fra pulver) peroralt eller via sonde (50 g hver 6. time i 24 timer) har vist sig at reducere plasmakoncentrationen af den aktive metabolit, A771726, med 37% i løbet af 24 timer og med 48% i løbet af 48 timer.
10 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.
Disse “ wash- out ” - procedurer kan gentages, hvis det er klinisk påkrævet.
These washout procedures may be repeated if clinically necessary.
10 Forsøg med både hæmodialyse og CAPD (Chronic ambulatory peritoneal dialysis) tyder på at A771726, den primære metabolit af leflunomid ikke kan dialyseres.
Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable.
Selektive immunosuppressive stoffer, ATC- kode:
Pharmacotherapeutic group: selective immunosuppressive agents, ATC code:
L04AA13.
L04AA13.
I fase II forsøget, forsøg YU203, blev 402 forsøgspersoner med aktiv reumatoid artrit randomiseret til placebo (n = 102), leflunomid 5 mg (n = 95), 10 mg (n = 101) eller 25 mg daglig (n = 104).
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).
Alle leflunomid- patienter i fase III forsøgene fik en initialdosis på 100 mg i 3 dage.
All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days.
I forsøg MN301 blev 358 forsøgspersoner med reumatoid artrit randomiseret til leflunomid 20 mg daglig (n = 133), sulfasalazin 2 g daglig (n = 133) eller placebo (n = 92).
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).
Forsøg MN303 var en valgfri 6- måneders blindet fortsættelse af MN301 uden placeboarmen, hvilket gav en 12 måneders sammenligning af leflunomid og sulfasalazin.
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.
I forsøg MN302 blev 999 forsøgspersoner med aktiv reumatoid artrit randomiseret til leflunomid 20 mg daglig (n = 501) eller methotrexate 7, 5 mg ugentlig stigende til 15 mg ugentlig (n = 498).
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).
I forsøg US301 blev 482 forsøgspersoner med aktiv reumatoid artrit randomiseret til leflunomid 20 mg daglig (n = 182), methotrexate 7, 5 mg ugentlig stigende til 15 mg ugentlig (n = 182), eller placebo (n = 118).
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).
Leflunomid var ved døgndoser på mindst 10 mg (10- 25 mg i forsøg YU203, 20 mg i forsøg MN301 og US301) statistisk signifikant bedre end placebo til at reducere tegn og symptomer på reumatoid artrit i alle 3 placebokontrollerede forsøg.
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.
ACR (American College of Rheumatology) responsraten i forsøg YU203 var 27, 7% for placebo, 31, 9% for 5 mg, 50, 5% for 10 mg og 54, 4% for 25 mg daglig.
The ACR (American College of Rheumatology) response rates in study YU203 were 27.7% for placebo, 31.9% for 5 mg, 50.5% for 10 mg and 54.5% 11 for 25 mg/ day.
I fase III forsøgene var ACR responsraterne for leflunomid 20 mg daglig vs. placebo 54, 6% vs.
In the phase III trials, the ACR response rates for leflunomide 20 mg/ day vs. placebo were 54.6% vs.
28, 6% (forsøg MN301) og 49, 4% vs.
28.6% (study MN301), and 49.4% vs.
Efter 12 måneder med aktiv behandling var ACR responsraterne hos leflunomidpatienterne 52, 3% (forsøg MN301/ 303), 50, 5% (forsøg MN302)
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.
Effekten af leflunomidbehandlingen sås efter 1 måned, og den stabiliserede sig efter 3- 6 måneder og forsatte gennem hele behandlingsforløbet.
The leflunomide treatment effect was evident by 1 month, stabilised by 3 to 6 months and continued throughout the course of treatment.
Et randomiseret dobbelt- blind, parallelgruppe non- inferior forsøg sammenlignede den relative effekt af to forskellige daglige vedligeholdelsesdoser på leflunomid, 10 mg og 20 mg.
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.
På den anden side favoriserede sikkerhedsresultaterne den 10 mg daglige vedligeholdelsesdosis.
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.
Leflunomid blev undersøgt i et single, multicenter, randomiseret dobbelt- blind, aktiv- kontrol forsøg i 94 patienter (47 i hver arm) med polyartikulært forløb af børnegigt.
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.
Patienterne var 3- 17 år gamle med et aktivt polyartikulært forløb af børnegigt (JRA) uanset starttype og ikke forud testet overfor methotrexate eller leflunomide.
Patients were 3– 17 years of age with active polyarticular course JRA regardless of onset type and naive to methotrexate or leflunomide.
I dette studiet var start - og vedligeholdelsesdosis af leflunomid baseret på 3 vægtkategorier: < 20 kg, 20- 40 kg og > 40kg.
In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories :< 20kg, 20-40 kg, and > 40kg.
Efter 16 ugers behandling var forskellen i responsraterne statistisk signifikant til methotrexates fordel til børnegigt ” definition of improvement (DOI) ” ≥30% (p=0, 02%).
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).
Dette respons blev vedligeholdt gennem 48 uger (se afsnit 4. 2).
In responders, this response was maintained during 48 weeks.
Mønsteret af bivirkninger ved leflunomid og methotrexate synes at være ens.
(see section 4.2).
Dog har doseringen til lette individer resulteret i en relativ lav eksponering over for leflunomid (se afsnit 5. 2).
The pattern of adverse events of leflunomide and methotrexate seems to be similar, but the dose used in lighter subjects resulted in a relatively low exposure (see section 5.2).
Effekten af Arava blev vist i et kontrolleret randomiseret dobbeltblindt forsøg 3L01 med 188 patienter med arthritis psoriatica, behandlet med 20mg/ dag.
The efficacy of Arava was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20mg/ day.
PsARC respons (Psoriatic Arthritis treatment Response Criteria) var 59% i leflunomidgruppen og 29, 7% i placebogruppen ved 6 måneder (p < 0, 0001).
Leflunomide 20mg/ 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).
Leflunomid omdannes hurtigt til den aktive metabolit, A771726, via ” first pass ” - metabolisme (ringåbning) i tarmvæggen og leveren.
Leflunomide is rapidly converted to the active metabolite, A771726, by first-pass metabolism (ring opening) in gut wall and liver.
I et forsøg med radioaktivt mærket 14C- leflunomid hos tre raske forsøgspersoner genfandt man ikke uomdannet leflunomid i plasma, urin og fæces.
In a study with radiolabelled 14C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
I andre forsøg er plasmakoncentrationer af uomdannet leflunomid sjældent blevet genfundet, og da i plasmakoncentrationer i ng/ ml.
In other studies, unchanged leflunomide levels in plasma have rarely been detected, however, at ng/ ml plasma levels.
Denne metabolit er ansvarlig for praktisk talt hele Aravas in vivo- effekt.
This metabolite is responsible for essentially all the in-vivo activity of Arava.
82- 95% af en dosis absorberes.
Excretion data from the 14C study indicated that at least about 82 to 95% of the dose is absorbed.
Maksimale plasmakoncentrationer kan indtræde mellem 1- 24 timer efter indgift af enkeltdosis.
The time to peak plasma concentrations of A771726 is very variable; peak plasma levels can occur between 1 hour and 24 hours after single administration.
På grund af den lange halveringstid af A771726 (ca.
Due to the very long half-life
2 uger), blev der i kliniske forsøg givet en initialdosis på 100 mg i 3 dage for at opnå hurtig steady- state koncentrationer af A771726.
12 of A771726 (approximately 2 weeks), a loading dose of 100 mg for 3 days was used in clinical studies to facilitate the rapid attainment of steady-state levels of A771726.
Uden en initialdosis regner man med, at steady- state plasmakoncentrationer først vil kunne opnås efter næsten 2 måneders behandling.
Without a loading dose, it is estimated that attainment of steady-state plasma concentrations would require nearly two months of dosing.
I forsøg med gentagen dosering til patienter med reumatoid artrit er de farmakokinetiske parametre for A771726 lineære i doseringsintervallet 5- 25 mg.
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.
Ved dosisniveauet på
In these studies, the clinical effect was closely related to the plasma concentration of A771726 and to the daily dose of leflunomide.
35 μg/ ml.
At a dose level of 20 mg/ day, average plasma concentration of A771726 at steady state is approximately 35 µg/ ml.
Ved steady- state akkumuleres plasmakoncentrationerne 33- 35 gange sammenlignet med enkeltdosis.
At steady state plasma levels accumulate about 33- to 35-fold compared with single dose.
0, 62%.
The unbound fraction of A771726 is about 0.62%.
In vitro plasmaproteinbindings- interaktionsforsøg med warfarin i klinisk relevante koncentrationer viser dog ingen interaktion.
In vitro plasma protein binding interaction studies with warfarin at clinically relevant concentrations, however, showed no interaction.
Tilsvarende forsøg viser, at ibuprofen og diclofenac ikke forskyder A771726, hvorimod den ubundne fraktion af A771726 stiger 2- 3 gange ved tilstedeværelse af tolbutamid.
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.
A771725 forskyder ibuprofen, diclofenac og tolbutamid, men den ubundne fraktion af disse lægemidler øges kun med 10- 50%.
A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs is only increased by 10% to 50%.
11 liter).
Consistent with extensive protein binding A771726 has a low apparent volume of distribution (approximately 11 litres).
Der sker ingen præference- optagelse i erytrocytterne.
There is no preferential uptake in erythrocytes.
Leflunomid metaboliseres til 1 primær (A771726) og mange mindre væsentlige metabolitter herunder TFMA (4- trifluoromethylanilin).
Leflunomide is metabolised to one primary (A771726) and many minor metabolites including TFMA (4-trifluoromethylaniline).
Interaktionsforsøg med cimetidin (non - specifik cytochrom P450 hæmmer) og rifampicin (non- specifik cytochrom P450 inducer) tyder på, at CYP enzymer in vivo kun er ansvarlig for en lille del af metaboliseringen af leflunomid.
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.
31 ml/ t.
Elimination of A771726 is slow and characterised by an apparent clearance of about 31 ml/ hr.
2 uger.
The elimination half-life in patients is approximately 2 weeks.
De væsentligste metabolitter i urinen var glukoronidprodukter afledt af leflunomid (især opsamlet i tiden 0- 24 timer) og et oxanilderivat af A771726.
The principal urinary metabolites were glucuronide products derived from leflunomide (mainly in 0 to 24 hour samples) and an oxanilic acid derivative of A771726.
Indgift af en peroral suspension af aktivt kul eller kolestyramin til mennesker fører til en hurtig og markant øgning i eliminationen af A771726 og fald i plasmakoncentrationen (se afsnit “ 4. 9 ”).
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).
Dette skyldes formentlig en gastrointestinal dialysemekanisme og/ eller en afbrydelse af det enterohepatiske kredsløb.
This is thought to be achieved by a gastrointestinal dialysis mechanism and/ or by interrupting enterohepatic recycling.
Farmakokinetik ved nyreinsufficiens
Pharmacokinetics in renal failure
Farmakokinetik ved leverinsufficiens
13 Pharmacokinetics in liver failure
Farmakokinetik i pædiatri
Pharmacokinetics in paediatrics
Farmakokinetikken af A771726 efter oral administration af leflunomid er blevet undersøgt i 73
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.
Resultaterne af en befolkningsfarmakokinetik analyse af disse forsøg har vist at pædiatriske patienter med en legemesvægt ≤40 kg har en reduceret systemisk eksponering (målt ved Css) af A771726 i forhold til voksne patienter med rheumatoid artrit (se afsnit 4. 2).
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).
Farmakokinetik i ældre
Pharmacokinetics in elderly
Gentagen peroral indgift af leflunomid til mus i op til 3 måneder, og til rotter og hunde i op til 6 måneder og aber i op til 1 måned viste, at de overvejende målorganer for toksicitet var rygmarv, blod, mave- tarmkanalen, hud, milt, thymus og lymfekirtler.
Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.
De primære virkninger er anæmi, leukopeni, fald i trombocyttal og panmyelopati, hvilket afspejler stoffets primære virkningsmekanisme (hæmning af DNA- syntesen).
The main effects were anaemia, leucopenia, decreased platelet counts and panmyelopathy and reflect the basic mode of action of the compound (inhibition of DNA synthesis).
Hos rotter og hunde er set Heinz- legemer og/ eller Howell- Jones legemer.
In rats and dogs, Heinz bodies and/ or Howell-Jolly bodies were found.
Den mindre metabolit TFMA (4- trifluoromethylamilin) har dog in vitro forårsaget klastogenicitet og punktmutationer, hvorimod der er utilstrækkelig information tilgængelig hvad angår dets potentielle mulighed for også at udøve denne effekt in vivo.
However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.
Hos hunmus sås en dosisafhængig øget forekomst af bronkiole- alveolære adenomer og lungecarcinomer.
In female mice an increased incidence, dose-dependent, of bronchiolo-alveolar adenomas and carcinomas of the lung was noted.
Majsstivelse povidon (E 1201) crospovidon, (E 1202) kolloid vandfri silica magnesiumstearat (E 470b) lactosemonohydrat
Maize starch povidone (E1201) crospovidone (E1202) 14 silica colloidal anhydrous magnesium stearate (E470b) lactose monohydrate
Talkum (E 553b) hypromellose (E 464) titandioxid (E 171) macrogol 8000
Talc (E553b) hypromellose (E464) titanium dioxide (E171) macrogol 8000
Blister:
Blister:
Hold flasken tæt tillukket.
Keep the container tightly closed.
Aluminium/ aluminium blister.
Aluminium / Aluminium blister.
30 og 100 filmovertrukne tabletter.
30 and 100 film-coated tablets.
HDPE- bredhalset flaske, 100 ml med skruelåg og integreret fugtbeholder.
HDPE-wide-necked bottle, 100 ml with screw cap with integrated desiccant container.
30 og 100 filmovertrukne tabletter.
30 and 100 film coated tablets.
Sanofi- Aventis Deutschland GmbH, D- 65926 Frankfurt am Main, Tyskland
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
2. september 1999 Dato for seneste genregistrering:
02 September 1999 Date of latest renewal:
2. september 2004
02 September 2004
Hver filmovertrukken tablet indeholder 20 mg leflunomid og 72 mg laktose.
Each film-coated tablet contains 20 mg of leflunomide and 72 mg of lactose.
Leflunomid er indiceret ved behandling af voksne patienter med • aktiv reumatoid artrit som et sygdomsmodificerende antireumatisk middel ("Disease- Modifying Antirheumatic Drug", DMARD). • Aktiv arthritis psoriatica.
Leflunomide is indicated for the treatment of adult patients with: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD), • active psoriatic arthritis.