FrancophonIA/ELRC3.0 huggingface dataset:
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Norwegian Bokmål: TILVIRKER AV BIOLOGISK(E) VIRKESTOFF(ER) OG TILVIRKER ANSVARLIG FOR BATCH RELEASE
English: Marketing authorisation holder and manufacturer responsible for the batch release
Norwegian Bokmål: Innehaver av markedsføringstillatelse og tilvirker ansvarlig for batchfrigivelse:
English: Content
Norwegian Bokmål: Navn
English: 1 ml (120 mg/ml) 1 pre-filled pen + 2 alcohol pads
Norwegian Bokmål: 1 ml (120 mg/ml) 1 ferdigfylt penn + 2 alkoholservietter
English: em., H-1036 Budapest Hungary
Norwegian Bokmål: H-1036 Budapest Hungary
English: 92931 PARIS LA DEFENSE FRANCE
Norwegian Bokmål: 92931 Paris la Defence France
English: 28108 Alcobendas (Madrid) Spain
Norwegian Bokmål: 28108 Alcobendas Madrid
English: London SW5 9JL
Norwegian Bokmål: London SW5 9JL United Kingdom
English: Comprimidos
Norwegian Bokmål: Tablett
English: MAROUSSI GR-15125 ATHENS
Norwegian Bokmål: Athens GR-15125 Greece
English: Osa Mayor, 4 28023 Aravaca (Madrid) Spain
Norwegian Bokmål: Osa Mayor, 4 28023 Aravaca Madrid
English: Sandoz d.d Verovskova 57, 1000 Ljubljana
Norwegian Bokmål: Sandoz d.d Verovskova 57 1000 Ljubljana Slovenia
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for cyproterone acetate/ethinylestradiol containing medicinal products
Norwegian Bokmål: VEDLEGG I LISTE OVER NAVN, LEGEMIDDELFORMER, LEGEMIDDELSTYRKER, ADMINISTRASJONSMÅTE, INNEHAVERE AV MARKEDSFØRINGSTILLATELSEN I MEDLEMSLANDENE
English: United Kingdom Chatfiled Pharmaceuticals Limited, Kramer Mews,
Norwegian Bokmål: Chatfield Pharmaceuticals Limited Kramer Mews
English: FIDIA Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/A, 35031 Abano Terme (PD) Italy
Norwegian Bokmål: Via Ponte della Fabbrica 3/A 35031 Abano Terme (PD) Italy
English: 49 avenue Georges Pompidou 92593 LEVALLOIS PERRET CEDEX
Norwegian Bokmål: 49 avenue Georges Pompidou 92593 Levallois Perret Cedex France
English: Parc d'Activités des Peupliers - 25 rue des Peupliers 92000 NANTERRE FRANCE
Norwegian Bokmål: ZYDUS France Parc d'Activités des Peupliers 25 rue des Peupliers 92000 Nanterre France
English: Bayer S.p.A. Viale Certosa, 130 - 20156 Milano (MI) Italy
Norwegian Bokmål: Viale Certosa, 130 20156 Milano (MI) Italy
English: United Kingdom Teva UK Limited, Brampton Road, Hampden Park,
Norwegian Bokmål: Teva UK Limited Brampton Road Hampden Park Eastbourne
English: CYPROTERONE/ETHIN YLESTRADIOL BAYER 35 µg
Norwegian Bokmål: CYPROTERONE/ETHINYLESTRADIOL BAYER 35 µg
English: United Kingdom Bayer plc, Bayer House, strawberry Hill, Newbury, Berkshire RG14 1JA
Norwegian Bokmål: Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA, United Kingdom
English: SANOFI AVENTIS FRANCE 1-13 BOULEVARD ROMAIN ROLLAND
Norwegian Bokmål: Sanofi Aventis France 1-13 Boulevard Romain Rolland 75014 Paris
English: United Kingdom Stragen UK Limited, Castle Court, 41 London Road,
Norwegian Bokmål: Stragen UK Limited Castle Court 41
English: 3 DDD Pharma N.V. Diestersteenweg 349 3510 Hasselt Belgium
Norwegian Bokmål: Diestersteenweg 349 3510 Hasselt Belgium
English: 11-15 quai de Dion Bouton 92800 PUTEAUX FRANCE
Norwegian Bokmål: Ranbaxy Pharmacie Generiques 11-15 quai de Dion Bouton 92800 Puteaux
English: TEVA PHARMA, SLU Anabel Segura 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Norwegian Bokmål: Teva Pharma, SLU Anabel Segura 11 Edificio Albatros B 1ª planta
English: SANDOZ FARMACEUTICA, S.A.
Norwegian Bokmål: Sandoz Farmaceutica, S.A. Avda.
English: Rua Quinta Pinheiro, 5, Outurela - Carnaxide
Norwegian Bokmål: Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide Portugal
English: United Kingdom Farmalider SA, Calle Aragoneses 15, Alcobendas, Madrid E-28108
Norwegian Bokmål: Farmalider SA Calle Aragoneses 15 Alcobendas Madrid E-28108 Spain
English: Diane 2000 micrograms/35 micrograms filmcoated tablets
Norwegian Bokmål: Diane 2000 micrograms/35 micrograms film-coated tablets
English: Poland acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grunwald Germany
Norwegian Bokmål: Acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany
English: Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège
Norwegian Bokmål: Mithra Pharmaceuticals S.A. Rue Saint Georges 5
English: United Kingdom Fannin (UK) Limited, 42-46 Booth Drive, Park Farm
Norwegian Bokmål: Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough Kent NN8 6GT United Kingdom
English: Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul.
Norwegian Bokmål: Farmaceutyczne Polfa S.A.
English: Reigate, Surrey RH2 9RJ
Norwegian Bokmål: Reigate, Surrey RH2 PRJ United Kingdom
English: Marszałka J.Piłsudskiego 5 95-200 Pabianice Poland
Norwegian Bokmål: 95-200 Pabianice Poland
English: Generis Farmaceutica, S.A. Rua Joao de Deus, 19Amadora
Norwegian Bokmål: Generis Farmaceutica, S.A. Rua Joao de Deus, 19 2700-487 Amadora Portugal
English: U kabelovny 130 102 37 Praha Czech Republic
Norwegian Bokmål: U kabelovny 130 102 37 Praha 10
English: Bayer Pharma
Norwegian Bokmål: Bayer plc
English: Castle Court 41, London Road, Reigate, Surrey RH2 PRJ,
Norwegian Bokmål: London Road Reigate, Surrey RH2 PRJ United Kingdom
English: BAYER ΕΛΛΑΣ ΑΒΕΕ SOROU 18-20
Norwegian Bokmål: Bayer Hellas ABEE Sorou 18-20
English: PIERRE FABRE DERMATOLOGIE 45 place Abel Gance 92100 BOULOGNE FRANCE
Norwegian Bokmål: Luxembourg Pierre Fabre Dermatologie 45, place Abel Gance
English: United Kingdom Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL
Norwegian Bokmål: Generics (UK) Limited Station Close Potters Bar
English: Camberley, Surrey GU16 7SR UK
Norwegian Bokmål: Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
English: United Kingdom Strandhaven Limited, 600 High Road, Seven Kings,
Norwegian Bokmål: Strandhaven Limited 600 High Road Seven Kings, Ilford Essex IG3 8BS United Kingdom
English: 05-340 Kołbiel Poland
Norwegian Bokmål: Człekówka 75 05-340 Kołbiel
English: Almirall Hermal GmbH Scholzstr.
Norwegian Bokmål: Taurus Pharma GmbH Benzstr.
English: ACETATO DE CIPROTERONA/ETINIL ESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
Norwegian Bokmål: CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
English: Jennifer 35 2 mg/0,035 mg Filmtabletten
Norwegian Bokmål: Jennifer 35 2 mg/0,035 mg Filmtabletten 0,035 mg 2,00 mg
English: 21465 Reinbek Germany
Norwegian Bokmål: 61352 Bad Homburg Germany
English: Estonia ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Norwegian Bokmål: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
English: United Kingdom Cipla (EU) Limited, Millbrow House, Millbrow Road, Esher, Surrey KT10 9NW
Norwegian Bokmål: Cipla (EU) Limited Hillbrow House Hillbrow Road Esher
English: LADEEPHARMA PHARMACEUTICAL Limited Lajos u. 48-66, E ép.
Norwegian Bokmål: Lajos u. 48-66
English: BN22 9AG
Norwegian Bokmål: East Sussex BN22 9AG United Kingdom
English: Co-Cyprindiol Tablets 2mg/0.035mg
Norwegian Bokmål: Co-Cyprindiol Tablets 2mg/0.035mg 0,035 mg 2,00 mg
English: Strandhaven CoCyprindiol 2000/35 Tablets
Norwegian Bokmål: Strandhaven Co-Cyprindiol 2000/35 Tablets
English: Cyproteronacetaat/Eth inylestradiol Sandoz 2/0,035, omhulde tabletten
Norwegian Bokmål: Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten
English: Cyproteronacetaat/eth inylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
Norwegian Bokmål: Cyproteronacetaat/ethinylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
English: 0,035mg/2mg überzogene Tablette
Norwegian Bokmål: Diane-35 0,035mg/2mg überzogene Tablette
English: Alternova A/S, Lodshusvej 11, DK-4230 Skælskør Denmark
Norwegian Bokmål: DK-4230 Skælskør Denmark
English: Ratiopharm GmbH - Graf Arco Strasse 3 - 89079 UlmGermany
Norwegian Bokmål: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm
English: Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S
Norwegian Bokmål: Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg
Norwegian Bokmål: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg Comprimidos
English: Sandoz Co-Cyprindiol Tablets 2000/35
Norwegian Bokmål: Co-Cyprindiol Tablets 2000/35
English: Cyproteronacetaat/Eth inylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
Norwegian Bokmål: Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL DCI PHARMA 2 mg/0,035 mg
Norwegian Bokmål: CYPROTERONE/ETHINYLESTRADIOL DCI PHARMA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL RATIOPHARM 2 mg/0,035 mg
Norwegian Bokmål: CYPROTERONE/ETHINYLESTRADIOL RATIOPHARM 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL RANBAXY 2 mg/0,035 mg
Norwegian Bokmål: CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/0,035 mg
English: Cyproteronacetaat/eth inylestradiol Apotex 2/0,035 mg, omhulde tabletten
Norwegian Bokmål: Cyproteronacetaat/ethinylestradiol Apotex 2/0,035 mg, omhulde tabletten
English: RANBAXY PHARMACIE GENERIQUES
Norwegian Bokmål: Ladeepharma Pharmaceutical Limited
English: Orifarm Generics Energivej 15 - POB 69 DK-5260 Odense S Denmark
Norwegian Bokmål: DK-5260 Odense S. Denmark
English: Cyproteronacetaat/Eth inylestradiol CF 2/0,035 mg, omhulde tablet
Norwegian Bokmål: Cyproteronacetaat/Ethinylestradiol CF 2/0,035 mg, omhulde tablet
English: Cyproteronacetaat/eth inylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
Norwegian Bokmål: Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
English: Pliva Hungária Kereskedelmi és Szolgáltató Kft. Rákóczi út 70-72 Budapest 1074 Hungary
Norwegian Bokmål: Rákóczi út 70-72
English: Diane 0,035 mg/2 mg obložene tablete
Norwegian Bokmål: Diane 0,035 mg/2 mg obložene tablete 0,035 mg 2,00 mg
English: CYPROTERONE/ETHIN YLESTRADIOL ZENTIVA 2 mg/0,035 mg
Norwegian Bokmål: CYPROTERONE/ETHINYLESTRADIOL ZENTIVA 2 mg/0,035 mg
English: Cyproteronacetaat/Eth inylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
Norwegian Bokmål: Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
English: CYPROTERONE/ETHIN YLESTRADIOL TEVA 2 mg/0,035 mg
Norwegian Bokmål: CYPROTERONE/ETHINYLESTRADIOL TEVA 2 mg/0,035 mg
English: CYPROTERONE/ETHIN YLESTRADIOL ZYDUS 2 mg/0,035 mg
Norwegian Bokmål: CYPROTERONE/ETHINYLESTRADIOL ZYDUS 2 mg/0,035 mg
English: GINESERVICE 0,035 mg/2 mg comprimidos EFG
Norwegian Bokmål: ETINILESTRADIOL/CIPROTERONA GINESERVICE 0,035 mg/2 mg comprimidos EFG
English: CYPROTERONE/ETHIN YLESTRADIOL EG 2 mg/0,035 mg
Norwegian Bokmål: CYPROTERONE/ETHINYLESTRADIOL EG 2 mg/0,035 mg
English: Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S., Denmark
Norwegian Bokmål: Orifarm Generics A/S Postbox 69
English: Cyproteronacetaat/Eth inylestradiol 2 mg/0,035 mg, omhulde tabletten
Norwegian Bokmål: Cyproteronacetaat/Ethinylestradiol 2 mg/0,035 mg, omhulde tabletten
English: Praga 10, Dolni Mecholupy
Norwegian Bokmål: Dolní Měcholupy
English: This is especially important if you are taking:
Norwegian Bokmål: Dette er spesielt viktig dersom du tar:
English: C study indicated that at least about 82 to 95 % of the dose is absorbed.
Norwegian Bokmål: C-studien indikerte at minst omkring 82 - 95 % av dosen blir absorbert.
English: Tell your doctor immediately if you experience:
Norwegian Bokmål: Fortell legen umiddelbart dersom du opplever:
English: Date of latest renewal: 23 March 2015
Norwegian Bokmål: Dato for siste fornyelse: 23 mars 2015
English: • if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Norwegian Bokmål: • hvis du noen gang har hatt tuberkulose eller hvis du har vært i nærkontakt med noen som har eller har hatt tuberkulose.
English: • if you are pregnant, think you may be pregnant, or are breast-feeding.
Norwegian Bokmål: • hvis du er gravid, tror at du kan være gravid eller ammer.
English: 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).
Norwegian Bokmål: Svært vanlige (≥ 1/10); vanlige (≥ 1/100 til < 1/10); mindre vanlige (≥ 1/1000 til < 1/100); sjeldne (≥ 1/10 000 til < 1/1000); svært sjeldne (< 1/10 000), ikke kjent (kan ikke anslås utifra tilgjengelige data).
English: No dosage adjustment is required in patients above 65 years of age.
Norwegian Bokmål: Ingen dosejusteringer er nødvendig hos pasienter over 65 år.
English: The tablets are packed in bottles.
Norwegian Bokmål: Tablettene er pakket i bokser.
English: • if you are suffering from a serious infection,
Norwegian Bokmål: • hvis du lider av en alvorlig infeksjon,
English: • severe and potentially severe allergic reactions,
Norwegian Bokmål: • kraftige og potensielt alvorlige allergiske reaksjoner,
English: Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Norwegian Bokmål: Forskrivere må huske risikoen for falske negative tuberkulintest-resultater, særlig hos pasienter som er alvorlig syke eller immunkompromitterte.
English: Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Norwegian Bokmål: Farmakokinetiske data hos eldre (> 65 år) er begrenset, men er tilsvarende farmakokinetikken hos yngre voksne.
English: • if you have any problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets,
Norwegian Bokmål: • hvis du har noen problemer med beinmargen din, eller hvis du har lavt antall røde eller hvite blodceller eller redusert antall blodplater,
English: In a study with radiolabelled
Norwegian Bokmål: I en studie med radioaktivt merket
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the bottle after EXP.
Norwegian Bokmål: Bruk ikke dette legemidlet etter utløpsdatoen som er angitt på den ytre emballasjen og på boksen etter Utl.dato.
English: • zidovudine for HIV infection
Norwegian Bokmål: • zidovudin mot HIV infeksjon
English: • if you suffer from any problem which affects your immune system (e.g. AIDS),
Norwegian Bokmål: • hvis du har noen problemer som påvirker immunsystemet ditt (f.eks.
English: The efficacy of Leflunomide medac in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Norwegian Bokmål: Effekten av Leflunomide medac i behandlingen av revmatoid artritt er vist i 4 kontrollerte studier (1 i fase II og 3 i fase III).
English: 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.
Norwegian Bokmål: Dette kan inkludere medisinsk historie, mulig tidligere kontakt med tuberkulose, og/eller passende screening slik som røntgen, tuberkulintest og/eller interferon gamma release assay (IGRA-test).
English: If you are allergic to peanut or soya, do not use this medicine.
Norwegian Bokmål: Hvis du er allergisk overfor peanøtter eller soya skal du ikke bruke dette legemiddelet.
English: If you are affected, do not drive or use machines.
Norwegian Bokmål: Hvis du er føler deg svimmel skal du ikke kjøre bil eller bruke maskiner.
English: Tell your doctor immediately and stop taking Leflunomide medac:
Norwegian Bokmål: Fortell legen umiddelbart og slutt å ta Leflunomide medac:
English: • tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the feet or hands),
Norwegian Bokmål: • tendinitt (smerte forårsaket av betennelse i hinnen rundt senene, vanligvis i hender eller føtter),
English: There have been reports of chronic overdose in patients taking Leflunomide medac at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Norwegian Bokmål: Det har vært rapportert kronisk overdose hos pasienter som daglig har inntatt Leflunomide medac i doser på opp til fem ganger anbefalt daglig dose, og akutt overdose hos voksne og barn har vært rapportert.
English: Not known: marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility
Norwegian Bokmål: marginal (reversibel) reduksjon av spermiekonsentrasjon, totalt spermieantall og hurtig progressiv bevegelighet
English: • increased hair loss,
Norwegian Bokmål: • økt hårtap,
English: • warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine
Norwegian Bokmål: • warfarin og andre orale blodfortynnende legemidler, fordi kontroller er nødvendig for å redusere risikoen for bivirkninger av dette legemidlet
English: • rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
Norwegian Bokmål: • rosuvastatin, simvastatin, atorvastatin, pravastatin mot hyperkolesterolemi (høyt kolesterol)
English: • if you have severely low numbers of proteins in your blood (hypoproteinaemia),
Norwegian Bokmål: • hvis du har svært lavt antall proteiner i blodet (hypoproteinemi),
English: Leflunomide medac can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Norwegian Bokmål: Leflunomide medac kan av og til forårsake problemer med blod, lever, lunger eller nerver i armer eller ben.
English: If you are pregnant or become pregnant while taking Leflunomide medac, the risk of having a baby with serious birth defects is increased.
Norwegian Bokmål: Hvis du er gravid eller blir gravid mens du bruker Leflunomide medac, øker risikoen for å føde et barn med alvorlige fødselsskader.
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Leflunomide medac from your body.
Norwegian Bokmål: Dette kan reduseres til noen få uker ved å ta visse medisiner som fjerner Leflunomide medac raskere fra kroppen din.
English: Germany medac
Norwegian Bokmål: Tyskland medac
English: Your doctor will also check your blood pressure regularly as Leflunomide medac can cause an increase in blood pressure.
Norwegian Bokmål: Legen vil også regelmessig måle blodtrykket ditt fordi Leflunomide medac kan gi økt blodtrykk.
English: Uncommon: hypokalaemia, hyperlipidemia, hypophosphataemia Rare:
Norwegian Bokmål: Mindre vanlige: hypokalemi, hyperlipidemi, hypofosfatemi Sjeldne:
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Leflunomide medac
Norwegian Bokmål: Advarsler og forsiktighetsregler Rådfør deg med lege, apotek eller sykepleier før du bruker Leflunomide medac.
English: Leflunomide medac can make you feel dizzy which may impair your ability to concentrate and react.
Norwegian Bokmål: Leflunomide medac kan gjøre at du føler deg svimmel, noe som kan svekke konsentrasjons- og reaksjonsevnen.
English: At steady state plasma levels accumulate about 33- to 35-fold compared with single dose.
Norwegian Bokmål: Ved steady state akkumulerer plasmakonsentrasjonene 33 - 35 ganger sammenlignet med en enkeltdose.
English: • a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide medac which is absorbed by the body.
Norwegian Bokmål: • et legemiddel som heter kolestyramin (brukes til å redusere høyt kolesterol) eller aktivt kull da disse legemidlene kan redusere mengden Leflunomide medac som blir tatt opp av kroppen.
English: Leflunomide medac is not recommended for use in children and adolescents below 18 years of age.
Norwegian Bokmål: Barn og ungdom Leflunomide medac anbefales ikke til barn og unge under 18 år.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 July 2010
Norwegian Bokmål: DATO FOR FØRSTE MARKEDSFØRINGSTILLATELSE / SISTE FORNYELSE Dato for første markedsføringstillatelse: 27 juli 2010
English: • if you have moderate to severe kidney problems,
Norwegian Bokmål: • hvis du har moderate til alvorlige nyreproblemer,
English: • cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
Norwegian Bokmål: • cefaklor, benzylpenicillin (penicillin G), ciprofloksacin mot infeksjoner
English: You will normally take Leflunomide medac over long periods of time.
Norwegian Bokmål: Du vil vanligvis bruke Leflunomide medac over en lang periode.
English: C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Norwegian Bokmål: C-leflunomid hos tre friske frivillige, ble det ikke funnet uforandret leflunomid i plasma, urin eller feces.
English: • inflammation of the mouth or mouth ulcers,
Norwegian Bokmål: • betennelse i munnen eller munnsår,
English: What Leflunomide medac is and what it is used for
Norwegian Bokmål: Hva Leflunomide medac er og hva det brukes mot
English: If a patient is hypersensitive to peanut or soya, Leflunomide medac must not be used.
Norwegian Bokmål: Dersom en pasient er overfølsom overfor peanøtter eller soya skal Leflunomide medac ikke brukes.
English: For women receiving leflunomide treatment and who wish to become pregnant, one of the following procedures is recommended in order to ascertain that the foetus is not exposed to toxic concentrations of A771726 (target concentration below 0.02 mg/l):
Norwegian Bokmål: For kvinner som behandles med leflunomid, og som ønsker å bli gravide, anbefales én av følgende prosedyrer for å sikre at fosteret ikke blir eksponert for toksiske konsentrasjoner av A771726 (dvs. lavere enn 0,02 mg/l):
English: Leflunomide medac tablets should be swallowed whole with sufficient amounts of liquid.
Norwegian Bokmål: Leflunomide medac tabletter bør svelges hele med en tilstrekkelig mengde væske.
English: • Physician Leaflet The Physician Leaflet should contain the following key messages:
Norwegian Bokmål: • Brosjyre til leger Brosjyren til leger skal inneholde følgende hovedbudskap:
English: Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide medac, to monitor your blood cells and liver.
Norwegian Bokmål: Legen din vil regelmessig ta blodprøver av deg, både før og under behandling med Leflunomide medac, for å sjekke blodceller og lever.
English: LIST OF EXCIPIENTS This medicinal product contains lactose and soya lecithin (see leaflet for further information).
Norwegian Bokmål: LISTE OVER HJELPESTOFFER Dette legemidlet inneholder laktose og soyalecitin (se pakningsvedlegget for ytterligere informasjon).
English: Drinking alcohol while taking Leflunomide medac may increase the chance of liver damage.
Norwegian Bokmål: Inntak av alkohol mens du tar Leflunomide medac kan øke sjansen for leverskade.
English: Warfarin and other coumarin anticoagulants
Norwegian Bokmål: Warfarin og andre antikoagulantia av kumarintype
English: • mild allergic reactions,
Norwegian Bokmål: • milde allergiske reaksjoner,
English: However, a 25 % decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Norwegian Bokmål: En 25 % reduksjon i maksimumsnivå av internasjonalt normalisert ratio (INR) ble imidlertid sett når A771726 ble gitt sammen med warfarin sammenlignet med warfarin alene.
English: If you are already taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide medac.
Norwegian Bokmål: Dersom du allerede tar et ikke-steroid antiinflammatorisk legemiddel (NSAID) og/eller kortikosteroider, kan du fortsette å ta disse etter at du begynner med Leflunomide medac.
English: If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Leflunomide medac rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Norwegian Bokmål: Hvis testen bekrefter at du er gravid, kan legen din foreslå behandling med visse legemidler for å fjerne Leflunomide medac raskt og tilstrekkelig fra kroppen din og dermed redusere risikoen for skader på barnet.