natgillin/translations-raw huggingface dataset:
• Risikoen for infektioner, inklusive opportunistiske infektioner samt kontraindikation for anvendelse til immun-supprimerede patienter.
• The risk of infections, including opportunistic infections, and the contraindication for use in immuno-compromised patients.
Derfor kan den samlede forekomst af infektioner forøges (specielt rinit, bronkit og pneumoni).
Thus, the overall incidence of infections can increase (in particular of rhinitis, bronchitis and pneumonia).
Patienter med tuberkulose i anamnesen bør følges nøje på grund af risikoen for reaktivering af infektionen.
Patients with a history of tuberculosis should be carefully monitored because of the possibility of reactivation of the infection.
Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendix V.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Den ordinerende læge gøres opmærksom på risikoen for falsk negative resultater af tuberkulinhudtest, især hos patienter, der er alvorligt syge eller immunsupprimerede.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
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.
Dog sås en bred variabilitet i resultatet af seponeringen: hos nogle patienter forsvandt neuropatien, mens andre patienter havde vedvarende symptomer.
However there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
Læs denne indlægsseddel grundigt inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Effekten af Leflunomid Zentiva i behandlingen af reumatoid artrit er vist i 4 kontrollerede forsøg (1 i fase II og 3 i fase III).
The efficacy of Leflunomide Zentiva in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Da tilsvarende lægemiddelinteraktioner ikke kan udelukkes for leflunomid i de anbefalede doser, bør følgende forsøgsresultater og anbefalinger overvejes hos patienter i behandling med leflunomid:
As similar drug-drug interactions cannot be excluded for leflunomide at recommended doses, the following study results and recommendations should be considered in patients treated with leflunomide:
Dyreforsøg indikerer, at leflunomid og dets metabolitter passerer over i mælk.
Animal studies indicate that leflunomide or its metabolites pass into breast milk.
Læger og patienter skal gøres opmærksomme på, at at der findes en ad hoc-informationsservice, som rådgiver i forbindelse med laboratorieanalyser af plasma-leflunomid.
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.
• At der er risiko for teratogen effekt og at svangerskab derfor skal undgås, indtil plasmakoncentrationen af leflunomid er på et passende niveau.
• That there is a risk of teratogenicity and so pregnancy must be avoided until leflunomide plasma levels are at an appropriate level.
NSAID/ kortikosteroider
NSAIDS/Corticosteroids
Dette lægemiddel indeholder lactose (se indlægssedlen for yderligere information).
This medicinal product contains lactose (see leaflet for further information).
Der sås ingen forskelle mellem leflunomid og sulfasalazin (forsøg MN301).
No difference was observed between leflunomide and sulphasalazine (study MN301).
For at mindske den potentielle risiko bør mænd, som ønsker at blive fædre, overveje at stoppe behandlingen med leflunomid og tage colestyramin 8 g 3 gange daglig i 11 dage eller 50 g aktivt kul 4 gange daglig i 11 dage.
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.
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.
I tilfælde af tvivlsomme målinger anbefales det at fastsætte den samlede koncentration af albuminkorrigeret serumcalcium.
In case of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium concentration.
Leflunomid er indiceret ved behandling af voksne patienter med
Leflunomide is indicated for the treatment of adult patients with:
Det har immunmodulerende/immunsuppressive karakteristika, virker som et antiproliferativt stof og har antiinflammatoriske egenskaber.
It has immunomodulating/ immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties.
Andre påvirkninger af hjerte, lever, cornea og luftveje kan forklares med infektioner på grund af immunsuppression.
Other effects found on heart, liver, cornea and respiratory tract could be explained as infections due to immunosuppression.
Kvinder i den fertile alder skal anvende effektiv antikonception under og op til 2 år efter behandlingen (se ”pause” nedenfor) eller op til 11 dage efter behandling (se ”udvaskningsprocedure” nedenfor).
Women of childbearing potential have to use effective contraception during and up to 2 years after treatment (see “waiting period” below) or up to 11 days after treatment (see abbreviated “washout period” below).
Colestyramin eller aktivt kul
Cholestyramine or activated charcoal
Farmakoterapeutisk klassifikation: Selektive immunsuppressiva, ATC-kode: L04AA13.
Pharmacotherapeutic group: selective immunosuppressants, ATC code: L04AA13.
Kombinationer med anden behandling
Combinations with other treatments
Dette kan omfatte sygehistorie, mulig tidligere kontakt med tuberkulose, og/eller passende screening, såsom røntgenbillede af lunger, tuberkulintest og/eller interferon gamma-frigivelsesanalyse, hvis relevant.
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.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT
Graviditet skal udelukkes, inden behandling med leflunomid påbegyndes.
Pregnancy must be excluded before start of treatment with leflunomide.
Leflunomid er ikke antigent i dyremodeller.
Leflunomide was not antigenic in animal models.
Den indledende periode blev efterfulgt af en åben vedligeholdelsesperiode på tre måneder, gennem hvilken begge grupper fik 20 mg leflunomid daglig.
The initial period was followed by an open label maintenance period of three months, during which both groups received leflunomide 20 mg daily.
Hvad angår udvaskningsprocedure og andre anbefalede forholdsregler i tilfælde af ønsket eller utilsigtet graviditet se pkt.
For washout procedures and other recommended actions in case of desired or unintended pregnancy, see section 4.6.
Disse udvaskningsprocedurer kan gentages, hvis det er klinisk påkrævet.
These washout procedures may be repeated if clinically necessary.
I forsøg US301 sås ingen signifikante forskelle mellem leflunomid og methotrexat, hvad angår de primære effektparametre.
However, in study US301 no significant differences were observed between leflunomide and methotrexate in the primary efficacy parameters.
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.
lette allergiske reaktioner
mild allergic reactions
Filmovertrukket tablet.
Film-coated tablet.
Såfremt sådanne bivirkninger optræder eller hvis A771726 af eller anden årsag behøves clearet fra kroppen hurtigt, skal udvaskningsproceduren følges.
Therefore, when such toxicities occur or if for any other reason A771726 needs to be cleared rapidly from the body, the washout procedure has to be followed.
Hvis du glemmer at tage en dosis, skal du indtage den manglende tablet, så snart du kommer i tanke om det; dog ikke hvis tidspunktet for næste planlagte dosis er nært forestående.
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Selvom denne interaktion ikke forventes at påvirke effekten af p-piller negativt, bør typen af oral antikonception overvejes.
While this interaction is not expected to adversely impact the efficacy of oral contraceptives, consideration should be given to the type of oral contraceptive treatment.
Derfor bør lægemidler, der metaboliseres via CYP1A2 (såsom duloxetin, alosetron, theophyllin og tizanidin) anvendes med forsigtighed under behandling, da det kan føre til en reduktion af effekten af disse produkter.
Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.
I tilfælde af bivirkninger som svimmelhed kan patientens evne til at koncentrere sig og reagere på passende måde være nedsat.
In the case of side effects such as dizziness the patient's ability to concentrate and to react properly may be impaired.
I tilfælde af overdosering eller toksicitet anbefales det at give colestyramin eller aktivt kul for at fremme udskillelsen.
In the event of an overdose or toxicity, colestyramine or charcoal is recommended to accelerate elimination.
• aktiv arthritis psoriatica.
• active psoriatic arthritis.
Det kan også forårsage alvorlige allergiske reaktioner (herunder lægemiddelreaktion med eosinofili og systemiske symptomer [DRESS]) og øge risikoen for en alvorlig infektion.
It may also cause some serious allergic reactions (including Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), or increase the chance of a severe infection.
Dette gælder også medicin, som ikke er købt på recept.
This includes medicines obtained without a prescription.
I alle tilfælde skal en blodprøve bekræfte, at Leflunomid Zentiva er udskilt i tilstrækkelig grad fra kroppen og derefter skal du vente mindst 1 måned, før du bliver gravid.
In either case it should be confirmed by a blood test that Leflunomide Zentiva has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Både colestyramin og aktivt kul kan have indflydelse på absorptionen af østrogener og progesteroner, hvorfor sikker kontraception med orale kontraceptiva ikke kan garanteres under udvaskningsproceduren med colestyramin 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.
marginalt (reversibelt) fald i spermkoncentration, totalt spermtal og hurtig progressiv spermmotilitet
marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility
Andre symptomer der påvirker hele kroppen er appetitløshed, feber, mangel på energi og anæmi (mangel på røde blodlegemer).
Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anaemia (lack of red blood cells).
Den ubundne fraktion af A771726 er ca. 0,62%.
The unbound fraction of A771726 is about 0.62%.
Den terapeutiske effekt sætter sædvanligvis ind efter 4-6 uger og kan forbedres yderligere i op til 4-6 måneder.
The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
• Nødvendigheden af at rådgive patienterne om vigtige risici i forbindelse med behandling med leflunomid og om passende forholdsregler under behandlingen.
• The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Som følge af en potentiel risiko for additive hepatotoxiske virkninger anbefales det, at alkoholindtagelse undgås under behandling med leflunomid.
Due to a potential for additive hepatotoxic effects, it is recommended that alcohol consumption be avoided during treatment with leflunomide.
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.
Meget sjælden:
Very rare:
Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger, som forventes at ordinere/anvende Leflunomid Zentiva forsynes med en undervisningspakke for læger indeholdende følgende:
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Leflunomide Zentiva are provided with a physician educational pack containing the following:
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.
Leflunomid Zentiva tilhører en gruppe medicin der kaldes antireumatisk medicin.
Leflunomide Zentiva belongs to a group of medicines called anti-rheumatic medicines.
Tabletterne skal synkes hele med tilstrækkelig væske.
The tablets should be swallowed whole with sufficient amounts of liquid.
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Ikke almindelig: hypokaliæmi, hyperlipidæmi, hypofosfatæmi Sjælden:
Uncommon: hypokalaemia, hyperlipidemia, hypophosphataemia Rare:
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.
Visse vacciner bør ikke gives under behandling med Leflunomid Zentiva og i et vist stykke tid efter endt behandling.
Certain vaccinations should not be given while taking Leflunomide Zentiva, and for a certain amount of time after stopping treatment.
Imidlertid blev et fald på 25% i peak International Normalised Ratio (INR) observeret, når A771726 blev administreret samtidigt med warfarin sammenlignet med warfarin alene.
However, a 25% decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Symptomer fra lungerne, såsom hoste og dyspnø, kan være grund til at stoppe behandlingen og foretage yderligere undersøgelser efter behov.
Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.
Symptomer
Symptoms
Målingen kan vise fejlagtige lave calciumniveauer.
Falsely low levels of calcium can be detected.
Koncentrationen kan forventes at falde til under 0,02 mg/l ca. 2 år efter behandlingen med leflunomid er ophørt.
The concentration may be expected to decrease below 0.02 mg/L about 2 years after stopping the treatment with leflunomide.
Patienter med sjældne arveligt betingede problemer med galactoseintolerans, Lapp lactasemangel eller glucose/galactosemalabsorption bør ikke tage dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Leflunomid indgivet oralt og intraperitonealt er undersøgt i akutte toksicitetsforsøg på mus og rotter.
Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats.
Derfor skal der stilles spørgsmålstegn ved sandsynligheden for observerede reducerede ioniserede calciumniveauer hos patienter under behandling med leflunomid eller teriflunomid.
Therefore, the plausibility of observed decreased ionised calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide.
Elimination af A771726 er langsom og er kendetegnet ved en tilsyneladende clearance på ca. 31 ml/t.
Elimination of A771726 is slow and characterised by an apparent clearance of about 31 ml/hr.
Der er rapporteret tilfælde af øget prothrombintid, når leflunomid og warfarin blev administreret samtidigt.
There have been case reports of increased prothrombin time, when leflunomide and warfarin were co-administered.
Din læge vil tage regelmæssige blodprøver, før og under behandling med Leflunomid Zentiva, for at overvåge dine blodceller og din lever.
Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide Zentiva, to monitor your blood cells and liver.
Behandlingen bør initieres og overvåges af specialister med særligt kendskab til behandling af reumatoid artrit og arthritis psoriatica.
The treatment should be initiated and supervised by specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
CYP450 hæmmere og inducere
CYP450 inhibitors and inducers
Colestyramin 8 g administreres 3 gange daglig.
Colestyramine 8 g is administered 3 times daily.
Blodtryk skal kontrolleres før behandling med leflunomid påbegyndes og derefter regelmæssigt.
Blood pressure must be checked before the start of leflunomide treatment and periodically thereafter.
Hvis du har en formodning om, at du er gravid, enten mens du tager Leflunomid Zentiva eller inden for 2 år efter, du har stoppet behandlingen, skal du omgående kontakte lægen for at få foretaget en graviditetstest.
If you suspect that you are pregnant while taking Leflunomide Zentiva or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
I forsøg MN302 havde leflunomid signifikant mindre effekt end methotrexat.
In study MN302 leflunomide was significantly less effective than methotrexate.
Brug ikke dette lægemiddel efter den udløbsdato, som står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the packaging.
Mekanismen antages at skyldes afbrydelse af det enterohepatiske kredsløb og/eller gastrointestinal dialyse af A771726.
The mechanism is thought to be by interruption of enterohepatic recycling and/or gastrointestinal dialysis of A771726.
Såfremt der indtræder svære, ukontrollerbare infektioner, kan det blive nødvendigt at afbryde leflunomidbehandlingen, og foretage en udvaskningsprocedure som beskrevet nedenfor.
In the event that severe, uncontrolled infections occur, it may be necessary to interrupt leflunomide treatment and administer a washout procedure as described below.
Kontakt venligst indehaveren af markedsføringstilladelsen eller dennes lokale repræsentant (se pkt.
For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
Da leflunomid er i kroppen i lang tid, kan det at skifte til et andet DMARD (f.eks. methotrexat) uden at foretage udvaskningsproceduren (se nedenfor) eventuelt føre til additiv risiko selv lang tid efter præparatskiftet (dvs. kinetiske interaktioner, organtoksicitet).
As leflunomide has a long persistence in the body, a switching to another DMARD (e.g. methotrexate) without performing the washout procedure (see below) may raise the possibility of additive risks even for a long time after the switching (i.e. kinetic interaction, organ toxicity).
Ingen gradvis overordnet fordel blev observeret ved anvendelse af startdosisregime hos populationen i studiet.
No incremental overall benefit was observed in the studied population with the use of a loading dose regimen.
Synk tabletten hel med rigeligt vand.
Swallow the tablet whole and with plenty of water.
lettere blodtryksforhøjelse
mild increase in blood pressure
I et carcinogenicitetsforsøg på rotter udviste leflunomid ingen carcinogene egenskaber.
In a carcinogenicity study in rats, leflunomide did not show carcinogenic potential.
Leflunomid er ikke mutagent.
Leflunomide was not mutagenic.
Bindingen af A771726 er lineær i det terapeutiske koncentrationsinterval.
Binding of A771726 is linear in the therapeutic concentration range.
In vivo metaboliseres det hurtigt og næsten fuldstændigt til A771726, der er aktivt in vitro, og som antages at være ansvarlig for den terapeutiske effekt.
In vivo, it is rapidly and almost completely metabolised to A771726 which is active in vitro, and is presumed to be responsible for the therapeutic effect.
Kontakt lægen, apoteket eller sundhedspersonalet, før du tager Leflunomid Zentiva - hvis du nogensinde har haft betændelse i lungen (interstitiel lungesygdom).
Talk to your doctor, pharmacist or nurse before taking Leflunomide Zentiva - if you have ever suffered from inflammation of the lung (interstitial lung disease).
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 medicinal products is only increased by 10% to 50%.
Derfor anbefales kontrol af patienter med samtidig brug af lægemidler, der metaboliseres af CYP2C8 såsom repaglinid, paclitaxel, pioglitazon eller rosiglitazon, da de kan have en højere eksponering.
Therefore, monitoring patients with concomitant use of medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, is recommended as they may have higher exposure.
I tilfælde af ALAT-værdier mellem 2 og 3 gange det øvre normalområde, kan dosisreduktion fra 20 mg til 10 mg overvejes, og der bør foretages ugentlige kontroller.
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.
Leflunomid er effektivt i dyremodeller af artrit såvel som af andre autoimmune lidelser, allergi og transplantation, især hvis det gives i den sensibiliserende fase.
Leflunomide is effective in animal models of arthritis and of other autoimmune diseases and transplantation, mainly if administered during the sensitisation phase.
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.
Tag altid dette lægemiddel nøjagtigt efter lægens eller apotekspersonalets anvisning.
Always take this medicine exactly as your doctor or pharmacist has told you.
Leflunomid Zentiva bruges til at behandle voksne med aktiv rheumatoid artrit eller med aktiv arthritis psoriatica.
Leflunomide Zentiva is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Sikkerhedsdata fra de to behandlingsgrupper var i overensstemmelse med den kendte sikkerhedsprofil for leflunomid; imidlertid tenderede hyppigheden af gastrointestinale bivirkninger og forhøjede leverenzymer at være højere hos patienter, som fik startdosis på 100 mg leflunomid.
The safety data obtained from both treatment groups were consistent with the known safety profile of leflunomide, however, the incidence of gastrointestinal adverse events and of elevated liver enzymes tended to be higher in the patients receiving the loading dose of 100 mg leflunomide.