FrancophonIA/ELRC3.0 huggingface dataset:
English: België/Belgique/Belgien INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Icelandic: België/Belgique/Belgien INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: 102 µg
Icelandic: 102 μg.
English: Shake the vial gently and administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Icelandic: Hristið hettuglasið gætilega og gefið einn skammt (1 ml) af bóluefninu með inndælingu undir húð í samræmi við eftirfarandi bólusetningaráætlun:
English: After the second injection, and subsequent administrations, this reaction is markedly reduced.,
Icelandic: Þegar lyfið er gefið með inndælingu öðru sinni og þaðan í frá eru þessi einkenni mun vægari.
English: C/Josefa Valcárcel n°38 28027 Madrid, Spain
Icelandic: MSD Animal Health, S.L. C/Josefa Valcárcel n°38 28027
English: PSUR submissions for Nobivac LeuFel shall be synchronised and submitted at the same frequency as for LEUCOGEN.
Icelandic: LeuFel skulu samstillt og lögð fyrir sömu tíðni og fyrir LEUCOGEN.
English: Република България INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O.
Icelandic: Република България INTERVET INTERNATIONAL BV Wim de Körverstraat 35, P.O. Box 50
English: Nobivac LeuFel suspension for injection for cats
Icelandic: Nobivac LeuFel stungulyf, dreifa handa köttum.
English: Primary vaccination: - first injection in kittens from eight weeks of age - second injection 3 or 4 weeks later.
Icelandic: Önnur inndæling 3 til 4 vikum síðar.
English: Opalescent liquid.
Icelandic: Ópallýsandi vökvi.
English: Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Icelandic: Gefið einn skammt (1 ml) af bóluefninu með inndælingu undir húð í samræmi við eftirfarandi bólusetningaráætlun:
English: 10 µg
Icelandic: 10 μg.
English: Active substance: Minimum quantity of purified p45 FeLV-envelope antigen
Icelandic: Lágmarksmagn af hreinsuðum p45 FeLV-hjúps mótefnavaka :
English: PACKAGE LEAFLET Nobivac LeuFel suspension for injection for cats
Icelandic: Áætlanir um skil á samantektum um öryggi lyfsins fyrir Nobivac
English: Vial label
Icelandic: PAKKNINGASTÆRÐ
English: Marketing authorisation holder and manufacturer responsible for the batch release
Icelandic: Markaðsleyfishafi og framleiðandi sem ber ábyrgð á lokasamþykkt:
English: Medicinal product no longer authorised
Icelandic: Lyfið er ekki lengur m eð m arkaðsleyfi
English: Content
Icelandic: Heiti
English: Name Strength
Icelandic: Innihald (þéttni)
English: Route of Administration
Icelandic: Styrkur Lyfjaform Íkomuleið Umbúðir
English: 1 ml (120 mg/ml) 1 pre-filled pen + 2 alcohol pads
Icelandic: 1 ml (120 mg/ml)
English: em., H-1036 Budapest Hungary
Icelandic: H-1036 Budapest Hungary
English: 28108 Alcobendas (Madrid) Spain
Icelandic: 28108 Alcobendas Madrid
English: MAROUSSI GR-15125 ATHENS
Icelandic: Athens GR-15125 Greece
English: Sandoz d.d Verovskova 57, 1000 Ljubljana
Icelandic: Sandoz d.d Verovskova 57 1000 Ljubljana Slovenia
English: LABORATOIRES MAJORELLE 80-82 rue Gallieni 92100 BOULOGNE BILLANCOURT FRANCE
Icelandic: Laboratoires Majorelle 80-82 rue Gallieni 92100 Boulogne Billancourt
English: Bayer S.p.A. Viale Certosa, 130 - 20156 Milano (MI) Italy
Icelandic: Viale Certosa, 130 20156 Milano (MI) Italy
English: Parc d'Activités des Peupliers - 25 rue des Peupliers 92000 NANTERRE FRANCE
Icelandic: 25 rue des Peupliers 92000 Nanterre France
English: United Kingdom Teva UK Limited, Brampton Road, Hampden Park,
Icelandic: Teva UK Limited Brampton Road Hampden Park Eastbourne
English: United Kingdom Bayer plc, Bayer House, strawberry Hill, Newbury, Berkshire RG14 1JA
Icelandic: Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA, United Kingdom
English: United Kingdom Stragen UK Limited, Castle Court, 41 London Road,
Icelandic: Stragen UK Limited Castle Court 41
English: Baix Llobregat 3 y 5 08970 Sant Joan Despi (Barcelona)
Icelandic: 08970 Sant Joan Despi Barcelona
English: 3 DDD Pharma N.V. Diestersteenweg 349 3510 Hasselt Belgium
Icelandic: Diestersteenweg 349 3510 Hasselt Belgium
English: 220, avenue de la Recherche 59120 Loos
Icelandic: Bayer Santé 220, avenue de la Recherche 59120 Loos France
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
Icelandic: LISTI YFIR HEITI, LYFJAFORM, STYRKLEIKA LYFJANNA, ÍKOMULEIÐ, MARKAÐSLEYFISHAFA Í AÐILDARLÖNDUNUM
English: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier 92366 MEUDON LA FORET FRANCE
Icelandic: EFFIK bâtiment ''le Newton'' 9-11 rue Jeanne Braconnier
English: Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Icelandic: Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse
English: 49 avenue Georges Pompidou 92593 LEVALLOIS PERRET CEDEX
Icelandic: 92593 Levallois Perret Cedex
English: TEVA PHARMA, SLU Anabel Segura 11, Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Icelandic: Teva Pharma, SLU Anabel Segura 11 Edificio Albatros B 1ª planta
English: United Kingdom Farmalider SA, Calle Aragoneses 15, Alcobendas, Madrid E-28108
Icelandic: Farmalider SA Calle Aragoneses 15 Alcobendas Madrid E-28108 Spain
English: Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373 Leverkusen Germany
Icelandic: Bayer Vital GmbH Kaiser-Wilhelm-Allee 51373
English: The Netherlands ratiopharm Nederland B.V. Swensweg 5
Icelandic: Holland ratiopharm Nederland B.V.
English: SANOFI AVENTIS FRANCE 1-13 BOULEVARD ROMAIN ROLLAND
Icelandic: Sanofi Aventis France 1-13
English: EG LABO - LABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517 BOULOGNE BILLANCOURT CEDEX FRANCE
Icelandic: EG LABOLABORATOIRES EUROGENERICS 12 rue Danjou le Quintet bâtiment A 92517
English: Rua Quinta Pinheiro, 5, Outurela - Carnaxide
Icelandic: BerlifarmaEspecialidades Farmaceuticas, Lda. Rua Quinta Pinheiro, 5, Outurela
English: Diane 2000 micrograms/35 micrograms filmcoated tablets
Icelandic: Diane 2000 micrograms/35 micrograms film-coated tablets
English: Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
Icelandic: 6A 1560 Hoeilaart Belgium
English: Castle Court 41, London Road, Reigate, Surrey RH2 PRJ,
Icelandic: London Road Reigate, Surrey RH2 PRJ United Kingdom
English: LADEEPHARMA PHARMACEUTICAL Limited Lajos u. 48-66, E ép.
Icelandic: Ladeepharma Pharmaceutical Limited Lajos u.
English: United Kingdom Fannin (UK) Limited, 42-46 Booth Drive, Park Farm
Icelandic: Fannin (UK) Limited 42-46 Booth Drive Park Farm South Wellingborough Kent NN8 6GT United Kingdom
English: 05-340 Kołbiel Poland
Icelandic: Człekówka 75 05-340 Kołbiel
English: Mithra Pharmaceuticals S.A. Rue Saint Georges 5 4000 Liège
Icelandic: Rue Saint Georges 5 4000 Liège
English: Estonia ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Icelandic: Ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
English: Praga 10, Dolni Mecholupy
Icelandic: Baix Llobregat 3 y
English: Pabianickie Zakłady Farmaceutyczne Polfa S.A. ul.
Icelandic: Farmaceutyczne Polfa S.A.
English: 92931 PARIS LA DEFENSE FRANCE
Icelandic: Paris la Defence France
English: Bayer Pharma
Icelandic: Bayer plc
English: Camberley, Surrey GU16 7SR UK
Icelandic: Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom
English: U kabelovny 130 102 37 Praha Czech Republic
Icelandic: U kabelovny 130 102 37 Praha 10
English: Poland acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grunwald Germany
Icelandic: Acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031
English: Stragen UK Ltd.
Icelandic: Medico Uno Worldwide Ltd.
English: 11-15 quai de Dion Bouton 92800 PUTEAUX FRANCE
Icelandic: 92800 Puteaux France
English: United Kingdom Generics (UK) Limited, Station Close, Potters Bar, Hertfordshire EN6 1TL
Icelandic: Generics (UK) Limited Station Close Potters Bar
English: United Kingdom Strandhaven Limited, 600 High Road, Seven Kings,
Icelandic: Strandhaven Limited 600 High Road Seven Kings, Ilford Essex IG3 8BS United Kingdom
English: Osa Mayor, 4 28023 Aravaca (Madrid) Spain
Icelandic: Avda. Osa Mayor, 4 28023
English: LABORATORIOS EFFIK, S.A. San Rafael, 3
Icelandic: Laboratorios EFFIK, S.A.
English: BN22 9AG
Icelandic: East Sussex BN22 9AG United Kingdom
English: ACETATO DE CIPROTERONA/ETINIL ESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
Icelandic: CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/0,035 mg comprimidos recubiertos EFG
English: Jennifer 35 2 mg/0,035 mg Filmtabletten
Icelandic: Jennifer 35 2 mg/0,035 mg Filmtabletten 0,035 mg 2,00 mg
English: 21465 Reinbek Germany
Icelandic: 61352 Bad Homburg Germany
English: United Kingdom Cipla (EU) Limited, Millbrow House, Millbrow Road, Esher, Surrey KT10 9NW
Icelandic: Cipla (EU) Limited Hillbrow House Hillbrow Road Esher
English: London SW5 9JL
Icelandic: Pharmaceuticals Limited Kramer Mews London SW5 9JL United Kingdom
English: CYPROTERONE/ETHIN YLESTRADIOL RANBAXY 2 mg/0,035 mg
Icelandic: CYPROTERONE/ETHINYLESTRADIOL RANBAXY 2 mg/0,035 mg
English: ETINILESTRADIOL/CIP ROTERONA
Icelandic: CYPROTERONE/ETHINYLESTRADIOL
English: Strandhaven CoCyprindiol 2000/35 Tablets
Icelandic: Strandhaven Co-Cyprindiol 2000/35 Tablets
English: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg
Icelandic: Acetato Ciproterona/ Etinilestradiol 2 mg/ 0,035 mg Comprimidos
English: Cyproteronacetaat/Eth inylestradiol Sandoz 2/0,035, omhulde tabletten
Icelandic: Cyproteronacetaat/Ethinylestradiol Sandoz 2/0,035, omhulde tabletten
English: FIDIA Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/A, 35031 Abano Terme (PD) Italy
Icelandic: Via Ponte della Fabbrica 3/A
English: Cyproteronacetaat/eth inylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
Icelandic: Cyproteronacetaat/ethinylestradiol Actavis 2/0,035 mg, filmomhulde tabletten 2 mg/0,035 mg
English: 0,035mg/2mg überzogene Tablette
Icelandic: Diane-35 0,035mg/2mg überzogene Tablette
English: Alternova A/S, Lodshusvej 11, DK-4230 Skælskør Denmark
Icelandic: DK-4230 Skælskør Denmark
English: Sandoz Co-Cyprindiol Tablets 2000/35
Icelandic: Co-Cyprindiol Tablets 2000/35
English: Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 København S
Icelandic: Edvard Thomsens Vej 14 DK-2300 København S Denmark
English: Cyproteronacetaat/Eth inylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
Icelandic: Cyproteronacetaat/Ethinylestradiol 2/0,035 PCH, omhulde tabletten 2 mg/0,035 mg
English: Orifarm Generics Energivej 15 - POB 69 DK-5260 Odense S Denmark
Icelandic: DK-5260 Odense S. Denmark
English: Pliva Hungária Kereskedelmi és Szolgáltató Kft. Rákóczi út 70-72 Budapest 1074 Hungary
Icelandic: Rákóczi út 70-72
English: Cyproteronacetaat/eth inylestradiol Apotex 2/0,035 mg, omhulde tabletten
Icelandic: Cyproteronacetaat/ethinylestradiol Apotex 2/0,035 mg, omhulde tabletten
English: Cyproteronacetaat/Eth inylestradiol CF 2/0,035 mg, omhulde tablet
Icelandic: Cyproteronacetaat/Ethinylestradiol CF 2/0,035 mg, omhulde tablet
English: Cyproteronacetaat/eth inylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
Icelandic: Cyproteronacetaat/ethinylestradiol ratiopharm 2 mg/0,035 mg, omhulde tabletten
English: ZYDUS France
Icelandic: Leverkusen Germany
English: Cyproteronacetaat/Eth inylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
Icelandic: Cyproteronacetaat/Ethinylestradiol Mylan 2 mg/0,035 mg, omhulde tabletten
English: Clevia 2 mg/0,035 mg Filmtabletten
Icelandic: Ergalea 2,00/0,035 mg Filmtabletten
English: TEVASANTE
Icelandic: Tafla
English: DE-89079 Ulm Germany
Icelandic: 10 40789 Monheim Germany
English: GINESERVICE 0,035 mg/2 mg comprimidos EFG
Icelandic: ETINILESTRADIOL/CIPROTERONA GINESERVICE 0,035 mg/2 mg comprimidos EFG
English: RANBAXY PHARMACIE GENERIQUES
Icelandic: Ranbaxy Pharmacie Generiques 11-15 quai de Dion Bouton
English: Orifarm Generics A/S, Postbox 69, Energivej 15, DK-5260 Odense S., Denmark
Icelandic: Orifarm Generics A/S Postbox 69
English: Bayer Santé
Icelandic: Pabianickie Zakłady
English: Cyproteronacetaat/Eth inylestradiol 2 mg/0,035 mg, omhulde tabletten
Icelandic: Cyproteronacetaat/Ethinylestradiol 2 mg/0,035 mg, omhulde tabletten
English: Bayer Schering Pharma AG, Müllerstrasse 170-178 DE-13342 Berlin Germany
Icelandic: Ungverjaland Bayer Pharma AG Muellerstrasse 178 D-13353 Berlin Germany
English: Bayer Schering Pharma AG Müllerstr.
Icelandic: Lúxemborg Mithra Pharmaceuticals S.A.
English: RATIOPHARM GMBH Keilaranta 10
Icelandic: Taurus Pharma GmbH Benzstr. 11
English: Reigate, Surrey RH2 9RJ
Icelandic: Surrey KT10 9NW United Kingdom
English: Generis Farmaceutica, S.A. Rua Joao de Deus, 19Amadora
Icelandic: Rua Joao de Deus, 19 2700-487 Amadora Portugal
English: Tell your doctor immediately if you experience:
Icelandic: Láttu lækninn vita strax ef þú færð:
English: Folate supplementation was optional and only used in 10 % of patients.
Icelandic: Fólatuppbót var valfrjáls og einungis notuð af 10 % sjúklinganna.
English: Date of latest renewal: 23 March 2015
Icelandic: 23 mars 2015.
English: Leflunomide medac is not recommended for use in children and adolescents below 18 years of age.
Icelandic: Leflunomide medac á ekki að nota handa börnum og unglingum undir 18 ára aldri.
English: • theophylline for asthma
Icelandic: • theóphyllín við astma
English: The tablets are packed in bottles.
Icelandic: Töflunum er pakkað í glös.
English: Tell your doctor immediately and stop taking Leflunomide medac:
Icelandic: Láttu lækninn vita strax og hættu að nota Leflunomide medac:
English: Leflunomide medac with food, drink and alcohol Leflunomide medac may be taken with or without food.
Icelandic: Leflunomide medac með mat, drykk eða áfengi Leflunomide medac má nota með eða án matar.
English: If you are affected, do not drive or use machines.
Icelandic: Ef þú verður var/vör við þessi áhrif skaltu ekki aka bíl eða stjórna vélum.
English: Excipients with known effect:
Icelandic: Hjálparefn með þekkta verkun:
English: If you are allergic to peanut or soya, do not use this medicine.
Icelandic: Ef þú ert með ofnæmi fyrir jarðhnetum eða soja skaltu ekki taka þetta lyf.
English: 3 days.
Icelandic: 14 daga.
English: • severe and potentially severe allergic reactions,
Icelandic: heiftarlegt og hugsanlega alvarlegt ofnæmi
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).
Icelandic: Mjög algengar (≥ 1/10); algengar (≥ 1/100 til < 1/10), sjaldgæfar (≥ 1/1.000 til < 1/100); mjög sjaldgæfar (≥ 1/10.000 til < 1/1.000); koma örsjaldan fyrir (< 1/10.000), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
English: LIST OF EXCIPIENTS This medicinal product contains lactose and soya lecithin (see leaflet for further information).
Icelandic: HJÁLPAREFNI Þetta lyf inniheldur mjólkursykur og soja lesitín (sjá frekari upplýsingar í fylgiseðli).
English: Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in younger adults.
Icelandic: Gögn um lyfjahvörf hjá öldruðum (> 65 ár) eru takmörkuð en í samræmi við lyfjahvörf hjá yngri einstaklingum.
English: Leflunomide medac is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Icelandic: Ekki er mælt með notkun Leflunomide medac hjá sjúklingum yngri en 18 ára þar sem verkun og öryggi við barnaliðagigt (juvenile rheumatoid arthritis) hefur ekki verið staðfest (sjá kafla 5.1 og 5.2).
English: • if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Icelandic: ef þú hefur fengið berkla eða hefur verið í náinni snertingu við einhvern sem er með eða hefur fengið berkla.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Leflunomide medac
Icelandic: Leitið ráða hjá lækninum, lyfjafræðingi eða hjúkrunarfræðingnum áður en Leflunomide medac er notað
English: • alosetron for the management of severe diarrhoea
Icelandic: alosetron til að hafa stjórn á alvarlegum niðurgangi
English: If you suspect that you are pregnant while taking Leflunomide medac or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Icelandic: Ef þig grunar að þú sért barnshafandi á meðan þú ert að nota Leflunomide medac eða innan tveggja ára eftir að meðferð var hætt, átt þú strax að hafa samband við lækni og gera þungunarpróf.
English: C study indicated that at least about 82 to 95 % of the dose is absorbed.
Icelandic: Gögn um útskilnað úr 14C-rannsókn benda til þess að minnsta kosti 82 til 95 % af gefnum skammti frásogist.
English: • oral contraceptives (containing ethinylestradiol and levonorgestrel)
Icelandic: • getnaðarvarnartöflur (sem innihalda ethinýlestradíól og levonorgestrel)
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the bottle after EXP.
Icelandic: Ekki skal nota lyfið eftir fyrningardagsetningu sem tilgreind er á ytri öskju og glasinu á eftir Fyrnist.
English: If a patient is hypersensitive to peanut or soya, Leflunomide medac must not be used.
Icelandic: Ef sjúklingur er með ofnæmi fyrir jarðhnetum eða soja má ekki nota Leflunomide medac.
English: Your doctor will also check your blood pressure regularly as Leflunomide medac can cause an increase in blood pressure.
Icelandic: Læknirinn mun einnig fylgjast með blóðþrýstingi hjá þér, þar sem Leflunomide medac getur valdið blóðþrýstingshækkun.
English: This may be reduced to a few weeks by taking certain medicines which speed up removal of Leflunomide medac from your body.
Icelandic: Hægt er að stytta þennan tíma í nokkrar vikur með því að nota ákveðin lyf sem hraða því að Leflunomide medac hverfi úr líkamanum.
English: Leflunomide medac can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Icelandic: Leflunomide medac getur í einstaka tilfellum haft áhrif á blóðhag, lifur, lungu eða taugar í handleggjum eða fótleggjum.
English: Leflunomide medac is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Icelandic: Leflunomide medac er notað til meðferðar á fullorðnum sjúklingum með virka iktsýki (rheumatoid arthritis) eða með virka sóraliðbólgu (psoriatic arthritis).
English: Treatment withdrawal may be considered taking into account patient's disease and past history.
Icelandic: Íhuga skal að hætta meðferð út frá sjúkdómi og fyrri sögu sjúklingsins.
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures.
Icelandic: Upplýsingarnar í fylgiseðli fyrir lækna ættu að veita upplýsingar um skammtaminnkun, það að hætta meðferð og útskolunaraðferðir.
English: • cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
Icelandic: • cefaklor, benzýlpenicillín (penicillín G), cíprófloxacín við sýkingum
English: 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.
Icelandic: Gera þarf læknum og sjúklingum viðvart um að til er sérstök ráðgjafarþjónusta sem veitir upplýsingar um rannsóknarmælingar á leflúnómíði í blóðvökva.
English: • daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
Icelandic: • daunorúbicín, doxorúbicín, paklitaxel eða tópotekan við krabbameini
English: • That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
Icelandic: Að það er hætta á alvarlegum lifrarskaða og því er mikilvægt að mæla reglulega ALT (SGPT) gildi til að fylgjast með lifrarstarfsemi.
English: • if you are due to have a specific blood test (calcium level).
Icelandic: ef þú átt að fara í blóðprufu (kalsíumgildi mæld).
English: Leflunomide medac is contraindicated in pregnancy (see section 4.3).
Icelandic: Leflunomide medac er frábending á meðgöngu (sjá kafla 4.3).
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
Icelandic: warfarín og önnur lyf til inntöku sem notuð eru til blóðþynningar, því eftirlit er nauðsynlegt til að draga úr hættu á aukaverkunum af lyfinu
English: In a small prospective study in women (n = 64) who became inadvertently pregnant while taking leflunomide for no more than three weeks after conception and followed by a drug elimination procedure, no significant differences (p = 0.13) were observed in the overall rate of major structural defects (5.4 %) compared to either of the comparison groups (4.2 % in the disease matched group [n = 108] and 4.2 % in healthy pregnant women [n = 78]).
Icelandic: Í lítilli framsýnni rannsókn hjá konum (n = 64) sem urðu óvart barnshafandi á meðan þær tóku lefúnómíð, í að hámarki þrjár vikur eftir getnað, og eftirfarandi útskolunarferil fyrir lyfið, kom ekki fram marktækur munur (p = 0,13) á heildartíðni meiriháttar formgerðargalla (5,4 %) í samanburði við hvorn samanburðarhópinn sem var (4,2 % í sjúkdómsparaða hópnum [n = 108] og 4,2 % hjá heilbrigðum barnshafandi konum [n = 78]).
English: • The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Icelandic: Þörf á að ráðleggja sjúklingum varðandi mikilvæga áhættuþætti tengda meðferð með leflúnómíði og viðeigandi varúðarráðstafanir við notkun lyfsins.
English: What Leflunomide medac is and what it is used for
Icelandic: Upplýsingar um Leflunomide medac og við hverju það er notað
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.
Icelandic: Læknirinn mun taka blóðsýni til rannsóknar með reglulegu millibili, áður og meðan á meðferð með Leflunomide medac stendur, til að fylgjast með blóðhag og lifrarstarfsemi.
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs is only increased by 10 % to 50 %.
Icelandic: A771726 færði íbúprófen, díklófenak og tólbútamíð úr stað en óbundni hluti þessara lyfja jókst einungis um 10 % til 50 %.
English: Warfarin and other coumarin anticoagulants
Icelandic: Warfarín og önnur kúmarín segavarnarlyf
English: • loss of appetite, weight loss (usually insignificant),
Icelandic: • lystarleysi, þyngdartap (yfirleitt óverulegt)
English: If you are pregnant or become pregnant while taking Leflunomide medac, the risk of having a baby with serious birth defects is increased.
Icelandic: Ef þú ert barnshafandi eða verður barnshafandi meðan á meðferð með Leflunomide medac stendur er aukin hætta á að barnið fæðist með alvarlegar vanskapanir.
English: It is not recommended to drink alcohol during treatment with Leflunomide medac.
Icelandic: Ekki er ráðlegt að neyta áfengis á meðan á Leflunomide medac meðferð stendur.
English: 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 % for 25 mg/day.
Icelandic: ACR (American College of Rheumatology) svörunarhlutfall í YU203 rannsókninni var 27,7 % fyrir lyfleysu, 31,9 % fyrir 5 mg, 50,5 % fyrir 10 mg og 54,5 % fyrir 25 mg á sólarhring.
English: You will normally take Leflunomide medac over long periods of time.
Icelandic: Þú munt væntanlega nota Leflunomide medac í langan tíma.
English: C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Icelandic: 14C-leflúnómíði á þremur heilbrigðum sjálfboðaliðum, greindist ekkert leflúnómíð á óbreyttu formi í plasma, þvagi eða saur.
English: • tizanidine, a muscle relaxant
Icelandic: • tízanidín, vöðvaslakandi
English: Blood pressure Blood pressure must be checked before the start of leflunomide treatment and periodically thereafter.
Icelandic: Mæla á blóðþrýsting áður en leflúnómíðmeðferð hefst og síðan reglulega.