FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
Danish: • Almindeligt: svimmelhed, kvalme/opkastning, træthed og blodprøver, der viser en forhøjet mængde af et enzym, der måler muskel- og hjertefunktionen (kreatinin-kinase-enzym).Der er hos patienter med forhøjet blodtryk og type 2-diabetes med nyresygdom også indberettet svimmelhed, når man rejser sig op fra liggende eller siddende stilling, lavt blodtryk når man rejser sig op fra liggende eller siddende stilling, led- og muskelsmerter og en nedsat mængde protein i de røde blodlegemer (hæmoglobin).
English: diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Danish: I samtlige af behandlingsgrupperne fik patienterne typisk mellem 2 og 4 antihypertensive lægemidler (f.eks. diuretikum, betablokkere, alfablokkere)for at opnå en foruddefineret blodtryksværdi på ≤ 135/85 mmHg eller en 10 mmHg reduktion i systolisk tryk, hvis baseline var > 160 mmHg.
English: Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Danish: Leverfunktionsnedsættelse: Dosisjustering er ikke nødvendig hos patienter med let/moderat leverfunktionsnedsættelse.
English: • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory
Danish: • til at beskytte nyrerne hos patienter med for højt blodtryk, type 2-diabetes og blodprøver, der viser nedsat nyrefunktion.
English: 5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Danish: (≥5,5 mEq/l) hos 29,4% af patienterne i irbesartan 300 mg-gruppen og
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however irbesartan has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Danish: På trods af dette er irbesartan uden risiko blevet administreret sammen med andre antihypertensive lægemidler som beta-blokkere, langtidsvirkende calcium-antagonister samt diuretika af thiazidtypen.
English: What Sabervel looks like and contents of the pack Sabervel 75 mg film-coated tablets are white, concave, round, film-coated tablets with 7 mm diameter.
Danish: Sabervel 75 mg filmovertrukne tabletter er hvide, konkave, runde, filmovertrukne tabletter med 7 mm diameter
English: Sabervel 300mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Danish: Sabervel 300 mg filmovertrukne tabletter leveres i blisterpakninger å 28, 56, 90 eller 98 filmovertrukne tabletter.
English: White, concave, round, film-coated tablet with 11 mm diameter.
Danish: Hvide, konkave, runde, filmovertrukne tabletter med 11 mm diameter
English: Musculoskeletal and connective tissue disorders: Common:
Danish: Leukocytoklastisk vaskulitis Knogler, led, muskler og bindevæv: Almindelig:
English: Sabervel 150mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Danish: Sabervel 150 mg filmovertrukne tabletter leveres i blisterpakninger å 28, 56, 90 eller 98 filmovertrukne tabletter.
English: Sabervel 75mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Danish: Sabervel 75 mg filmovertrukne tabletter leveres i blisterpakninger å 28, 56, 90 eller 98 filmovertrukne tabletter.
English: • Patients with high blood pressure and type 2 diabetes with kidney disease
Danish: Hypertensive patienter med type 2-diabetisk nyresygdom
English: White, concave, round, film-coated tablet with 7 mm diameter.
Danish: Hvide, konkave, runde, filmovertrukne tabletter med 7 mm diameter
English: Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Danish: Nedsat leverfunktion: Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med mild/moderat cirrhose.
English: What Sabervel looks like and contents of the pack Sabervel 300 mg film-coated tablets are white, concave, round, film-coated tablets with 11 mm diameter.
Danish: Sabervel 300 mg filmovertrukne tabletter er hvide, konkave, runde, filmovertrukne tabletter med 11 mm diameter
English: 40 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
Danish: 40 mg lactosemonohydrat per filmovertrukne tablet Alle hjælpestoffer er anført under pkt.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apoteket hvis der er noget, du er i tvivl om eller følger dig usikker på.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of irbesartan Excipient with known effect:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 75 mg irbesartan.
English: White, concave, round, film-coated tablet with 9 mm diameter.
Danish: Hvide, konkave, runde, filmovertrukne tabletter med 9 mm diameter
English: jaundice
Danish: Gulsot
English: NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Sabervel 75 mg filmovertrukne tabletter
English: What Sabervel looks like and contents of the pack Sabervel 150 mg film-coated tablets are white, concave, round, film-coated tablets with 9 mm diameter.
Danish: Sabervel 150 mg filmovertrukne tabletter er hvide, konkave, runde, filmovertrukne tabletter med 9 mm diameter
English: 80 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
Danish: 80 mg lactosemonohydrat per filmovertrukne tablet Alle hjælpestoffer er anført under pkt.
English: • Patients with high blood pressure The usual dose is 150 mg once a day.
Danish: Den sædvanlige dosis er 150 mg 1 gang dagligt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan Excipient with known effect:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 300 mg irbesartan.
English: 20 mg of lactose monohydrate per film-coated tablet For the full list of excipients, see section 6.1.
Danish: 20 mg lactosemonohydrat per filmovertrukne tablet Alle hjælpestoffer er anført under pkt.
English: Posology
Danish: Indgivelsesmåe
English: NAME OF THE MEDICINAL PRODUCT Sabervel 75 mg film-coated tablets irbesartan
Danish: LÆGEMIDLETS NAVN Sabervel 75 mg filmovertrukne tabletter irbesartan
English: Sabervel is for oral use.
Danish: Sabervel skal tages gennem munden.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan Excipient with known effect:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 150 mg irbesartan.
English: NAME OF THE MEDICINAL PRODUCT Sabervel 150 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Sabervel 150 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets irbesartan
Danish: LÆGEMIDLETS NAVN Sabervel 300 mg filmovertrukne tabletter irbesartan
English: NAME OF THE MEDICINAL PRODUCT Sabervel 300 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Sabervel 300 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Sabervel 150 mg film-coated tablets irbesartan
Danish: LÆGEMIDLETS NAVN Sabervel 150 mg filmovertrukne tabletter irbesartan
English: Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Danish: Nedsat nyrefunktion: Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med nedsat nyrefunktion eller i hæmodialyse.
English: tachycardia Vascular disorders: Common:
Danish: Vaskulære sygdomme: Almindelig:
English: If a child swallows some tablets, contact your doctor immediately.
Danish: Du skal straks kontakte lægen, hvis et barn får indtaget én eller flere tabletter.
English: Sabervel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Danish: Sabervel forebygger at angiotensin-II binder sig til disse receptorer.
English: PSURs
Danish: Hoste
English: Cardiac disorders: Uncommon:
Danish: Hjerte: Ikke almindelig:
English: Hrvatska Pharmathen S.A.
Danish: Slove nija Pharmathen S.A.
English: It contains the active substance filgrastim (30 or 48 million units).
Danish: Den indeholder det aktive stof filgrastim (30 eller 48 millioner enheder).
English: The full EPAR for Filgrastim Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Filgrastim Hexal findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The main measure in these studies was the neutrophil count over the first 10 days of treatment.
Danish: Den vigtigste målestok i disse undersøgelser var neutrofiltallet i løbet af de første 10 dage af behandlingen.
English: The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim Hexal on 06 February 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Filgrastim Hexal den 6. februar 2009.
English: This means that Filgrastim Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Danish: Det betyder, at Filgrastim Hexal svarer til et biologisk lægemiddel, der allerede er godkendt i Den Europæiske Union (EU), og som indeholder det samme aktive stof (også kaldet »referencelægemidlet«).
English: This is a summary of the European public assessment report (EPAR) for Filgrastim Hexal.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Filgrastim Hexal.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Filgrastim Hexal.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Filgrastim Hexal skal anvendes.
English: Four studies looked at the levels of neutrophils in the blood in a total of 146 healthy volunteers who received Filgrastim Hexal or Neupogen.
Danish: Der blev gennemført fire undersøgelser af antallet af neutrofiler i blodet hos i alt 146 raske frivillige, som fik Filgrastim Hexal eller Neupogen.
English: A risk management plan has been developed to ensure that Filgrastim Hexal is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Filgrastim Hexal anvendes så sikkert som muligt.
English: The replacement acts in the same way as naturally produced G CSF by encouraging the bone marrow to produce more white blood cells.
Danish: Det kunstigt fremstillede middel virker på samme måde som det naturligt fremstillede G CSF ved at tilskynde knoglemarven til at producere flere hvide blodlegemer.
English: For more information about treatment with Filgrastim Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Filgrastim Hexal, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Filgrastim Hexal, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF).
Danish: Det aktive stof i Filgrastim Hexal, filgrastim, svarer i høj grad til et humant protein kaldet granulocyt kolonistimulerende faktor (G CSF).
English: The studies looked at the effects of single and repeated administration of various doses of the medicines, either injected under the skin or infused into a vein.
Danish: I undersøgelserne så man nærmere på virkningen af enkelte og gentagne indgivelser af forskellige doser af lægemidlerne, enten som injektion under huden eller ved infusion i en vene.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim Hexal is being used for.
Danish: Andre bivirkninger kan optræde hos flere end 1 ud af 10 patienter, afhængig af den lidelse, som Filgrastim Hexal anvendes til behandling af.
English: Filgrastim Hexal can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Danish: Filgrastim Hexal kan også anvendes til personer, der skal donere blodstamceller til transplantation, for at hjælpe med at frigøre disse celler fra knoglemarven.
English: The most common side effect with Filgrastim Hexal (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Danish: Den hyppigste bivirkning ved Filgrastim Hexal (som optræder hos flere end 1 ud af 10 patienter) er smerter i muskler og knogler.
English: Filgrastim Hexal is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Danish: Filgrastim Hexal gives sædvanligvis på et specialiseret behandlingscenter, selv om de patienter, der får lægemidlet gennem injektion under huden, selv kan give injektionerne, når de først er blevet behørigt instrueret heri.
English: Filgrastim Hexal is used to stimulate the production of white blood cells in the following situations:
Danish: Filgrastim Hexal anvendes til at stimulere dannelsen af hvide blodlegemer i følgende tilfælde:
English: This was considered sufficient to demonstrate that the benefits of Filgrastim Hexal are comparable to those of the reference medicine.
Danish: Dette blev anset for at være tilstrækkeligt til at påvise, at fordelene ved Filgrastim Hexal svarer til fordelene ved referencelægemidlet.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Filgrastim Hexal, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Filgrastim Hexal, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Filgrastim Hexal is a ‘biosimilar' medicine.
Danish: Filgrastim Hexal er et »biosimilært« lægemiddel.
English: The CHMP decided that, in accordance with EU requirements, Filgrastim Hexal has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Danish: CHMP konkluderede, at Filgrastim Hexal i overensstemmelse med EU's krav har vist sig at have en kvalitet, sikkerhed og virkning, som er sammenlignelig med Neupogen.
English: What measures are being taken to ensure the safe and effective use of Filgrastim Hexal?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Filgrastim Hexal?
English: The reference medicine for Filgrastim Hexal is Neupogen.
Danish: Referencelægemidlet for Filgrastim Hexal er Neupogen.
English: Filgrastim Hexal and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies.
Danish: Filgrastim Hexal og Neupogen forøgede neutrofiltallet i samme grad hos raske, frivillige forsøgspersoner i løbet af undersøgelserne.
English: Filgrastim Hexal was studied to show that it is comparable to the reference medicine, Neupogen.
Danish: Filgrastim Hexal blev undersøgt for at påvise, at det er sammenligneligt med referencelægemidlet Neupogen.
English: The Committee recommended that Filgrastim Hexal be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Filgrastim Hexal.
English: Filgrastim Hexal is given by injection under the skin or infusion into a vein.
Danish: Filgrastim Hexal gives ved injektion under huden eller ved infusion i en vene.
English: Other information about Filgrastim Hexal
Danish: Andre oplysninger om Filgrastim Hexal
English: What is the risk associated with Filgrastim Hexal?
Danish: Hvilken risiko er der forbundet med Filgrastim Hexal?
English: Filgrastim Hexal is a solution for injection or infusion (drip into a vein) in a pre-filled syringe.
Danish: Filgrastim Hexal er en opløsning til injektion eller infusion (drop i en vene) i en fyldt injektionssprøjte.
English: Why has Filgrastim Hexal been approved?
Danish: Hvorfor blev Filgrastim Hexal godkendt?
English: What is Filgrastim Hexal?
Danish: Hvad er Filgrastim Hexal?
English: How has Filgrastim Hexal been studied?
Danish: Hvordan blev Filgrastim Hexal undersøgt?
English: What benefit has Filgrastim Hexal shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Filgrastim Hexal?
English: How is Filgrastim Hexal used?
Danish: Hvordan anvendes Filgrastim Hexal?
English: What is Filgrastim Hexal used for?
Danish: Hvad anvendes Filgrastim Hexal til?
English: How does Filgrastim Hexal work?
Danish: Hvordan virker Filgrastim Hexal?
English: EU/1/16/1130/001
Danish: EU/1/16/1130/001 ONIVYDE pegyleret liposomal
English: 4.3 mg/ml Concentrate for solution for infusion
Danish: 4.3 mg/ml
English: ONIVYDE pegylated liposomal
Danish: Koncentrat til infusionsvæske, opløsning
English: Its effect may improve further for up to six months.
Danish: Virkningen kan blive forbedret yderligere i op til seks måneder.
English: EMA/CHMP/149365/2011 EMEA/H/C/002356
Danish: EMA/149365/2011 EMEA/H/C/002356
English: usually starts to have an effect after four to six weeks.
Danish: Lægemidlet begynder som regel at virke efter fire til seks uger.
English: The recommended maintenance dose is 10 to 20 mg once a day.
Danish: Den anbefalede vedligeholdelsesdosis er 10-20 mg én gang dagligt.
English: The full EPAR for Leflunomide Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Leflunomide Teva findes på EMA's websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (white and round: 10 mg; dark beige and triangular: 20 mg).
Danish: Det fås som tabletter (hvide, runde tabletter: 10 mg; mørk beige, trekantformede tabletter: 20 mg).
English: Leflunomide Teva EMA/CHMP/149365/2011
Danish: Leflunomide Teva EMA/149286/2011
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Leflunomide Teva.
English: This is a summary of the European public assessment report (EPAR) for Leflunomide Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Leflunomide Teva.
English: This means that Leflunomide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Danish: Det betyder, at Leflunomide Teva er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Arava.
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide Teva, and regularly during treatment.
Danish: Lægen skal tage blodprøver for at kontrollere patientens lever, antal hvide blodlegemer og trombocyttal, inden Leflunomide Teva ordineres, og regelmæssigt under behandlingen.
English: Leflunomide Teva treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Danish: Behandlingen med Leflunomide Teva indledes med en startdosis på 100 mg én gang dagligt i tre dage efterfulgt af en vedligeholdelsesdosis.
English: With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis.
Danish: Med færre lymfocytter opstår der mindre betændelse, hvilket er med til at dæmpe symptomerne på artrit.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide Teva to TEVA Pharma B.V. on 10 March 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Leflunomide Teva til TEVA Pharma B.V.
English: Because Leflunomide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Eftersom Leflunomide Teva er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som referencelægemidlets.
English: What are the benefits and risks of Leflunomide Teva?
Danish: Hvilke fordele og risici er der ved Leflunomide Teva?
English: For more information about treatment with Leflunomide Teva, read the package leaflet (also part of the EPAR) or contact your
Danish: Hvis du ønsker yderligere oplysninger om behandling med Leflunomide Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Leflunomide Teva treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis.
Danish: Behandling med Leflunomide Teva bør indledes og overvåges af en specialist med erfaring i behandling af patienter med reumatoid artrit.
English: Leflunomide Teva is a ‘generic medicine'.
Danish: Leflunomide Teva er et "generisk lægemiddel".
English: Because Leflunomide Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Danish: Eftersom Leflunomide Teva er et generisk lægemiddel, har undersøgelserne hos patienter været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet, Arava.
English: Therefore, the CHMP's view was that, as for Arava, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene er større end de identificerede risici, ligesom det er tilfældet med Arava.
English: The CHMP concluded that, in accordance with EU requirements, Leflunomide Teva has been shown to have comparable quality and to be bioequivalent to Arava.
Danish: CHMP konkluderede, at det i overensstemmelse med EU-kravene er påvist, at Leflunomide Tevas kvalitet svarer til Aravas, og at Leflunomide Teva er bioækvivalent med Arava.
English: Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase', which is necessary for the lymphocytes to multiply.
Danish: Leflunomid sikrer dette ved at hæmme enzymet "dihydroorotatdehydrogenase", som er nødvendigt for, at lymfocytter kan dele sig.
English: It reduces inflammation by reducing the production of immune cells called ‘lymphocytes', which are responsible for inflammation.
Danish: Det reducerer betændelsen ved at mindske dannelsen af immunceller kaldet "lymfocytter", som forårsager betændelsen.
English: The active substance in Leflunomide Teva, leflunomide, is an immunosuppressant.
Danish: Det aktive stof i Leflunomide Teva, leflunomid, er et immunosupressivt stof.
English: Leflunomide Teva is a medicine that contains the active substance leflunomide.
Danish: Leflunomide Teva er et lægemiddel, der indeholder det aktive stof leflunomid.