FrancophonIA/ELRC3.0 huggingface dataset:
English: Calves: For the treatment and prevention of bovine respiratory disease, associated with Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis, M. dispar and other organisms susceptible to tilmicosin.
Danish: Kalve: Til behandling og forebyggelse af bovin lufvejsinfektion associeret med Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis, M. dispar og andre organismer, som er påvirkelige af tilmicosin.
English: Chickens (except hens producing eggs for human consumption) Turkeys
Danish: Høns (undtagen æglæggende høner, hvis æg er bestemt til menneskeføde) Kalkuner
English: Pigs: For the treatment and prevention of respiratory disease in pig herds, associated with Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae and other organisms susceptible to tilmicosin.
Danish: Svin: Til behandling og forebyggelse af luftvejssygdomme i svinebesætninger associeret med Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae og andre organismer, som er påvirkelige af tilmicosin.
English: 4.2 Indications for use, specifying the target species Pigs: For the treatment and prevention of respiratory disease in pig herds, associated with Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae and other organisms susceptible to tilmicosin.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Svin: Til behandling og forebyggelse af luftvejsinfektioner i svinebesætninger associeret med Mycoplasma hyopneumoniae, Pasteurella multocida, Actinobacillus pleuropneumoniae og andre organismer, som er påvirkelige af tilmicosin.
English: Oral solution Tilmicosin 250 mg/ml
Danish: Oral opløsning Tilmicosin 250 mg/ml
English: Chickens Pigs
Danish: Høns Svin
English: The CVMP accepts that a claim for efficacy at a dose of 15-20 mg/kg bodyweight for 3 days for the treatment and prevention of respiratory disease in chicken flocks, associated with Mycoplasma gallisepticum and M. synoviae has been demonstrated.
Danish: CVMP accepterer, at en påstand om virkning ved en dosis på 15-20 mg/kg legemsvægt i 3 dage til behandling og forebyggelse af luftvejssygdomme i kyllingebestande i tilknytning til Mycoplasma gallisepticum og M. synoviae er blevet bevist.
English: the CVMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III Pulmotil AC and associated names.
Danish: - Opbevaringstiden for veterinærlægemidlet i salgspakning er 2 år anbefaler CVMP ændring af markedsføringstilladelserne for Pulmotil AC. Produktresumé og etikettering fremgår af bilag III.
English: Pulmotil AC Oral Solution Tilmicosin 250mg/ml
Danish: Pulmotil AC Oral opløsning Tilmicosin 250 mg/ml
English: Chickens (broilers) Pigs
Danish: Høns (slagtekyllinger) Svin
English: WITHDRAWAL PERIOD
Danish: Opbevaringstid
English: Chickens: For the treatment and prevention of respiratory disease in chicken flocks, associated with Mycoplasma gallisepticum and M. synoviae.
Danish: Høns: Til behandling og forebyggelse af luftvejssygdomme i hønseflokke associeret med Mycoplasma gallisepticum og M. synoviae.
English: Chicken Turkeys Pigs
Danish: Høns Kalkuner Svin
English: 6.1 List of excipients Disodium edetate
Danish: 6.1 Fortegnelse over hjælpestoffer
English: Pigs Broilers Calves
Danish: Høns Svin Kalve
English: Pigs: To be included in the drinking water to provide a daily dose of 15-20 mg/kg bodyweight for 5 days, which may be achieved by the inclusion of 200 mg tilmicosin per litre (80 ml Pulmotil AC per 100 litres).
Danish: Dette svarer til at iblande 200 mg tilmicosin pr. liter drikkevand (80 ml Pulmotil AC pr. 100 liter).
English: The Netherlands Eli Lilly Nederland B.V. Elanco Animal Health Grootslag 1-5
Danish: Nederlandene Eli Lilly Nederland B.V.
English: Turkeys: For the treatment and prevention of respiratory disease in turkey flocks, associated with Mycoplasma gallisepticum and M. synoviae.
Danish: Kalkuner: Til behandling og forebyggelse af luftvejssygdomme i kalkunflokke associeret med Mycoplasma gallisepticum og M. synoviae.
English: Chickens - 12 days Turkeys - 19 days Calves - 42 days Not for use in lactating animals.
Danish: Kyllinger - 12 dage Kalkuner - 19 dage Kalve - 42 dage
English: Active substance:
Danish: Ud fra følgende betragtninger:
English: Route of administration
Danish: Indgivelsesvej
English: Calves Chickens Turkeys
Danish: Kalve Høns Kalkuner
English: Chickens Turkeys
Danish: Høns Kalkuner
English: Contains disodium edetate; do not inject
Danish: Lægemidlet må ikke injiceres.
English: This may take up to 2 years.
Danish: Dette kan tage op til 2 år.
English: The mechanism of this effect is unclear.
Danish: Mekanismen bag denne virkning er uklar.
English: Interactions studies have only been performed in adults.
Danish: Interaktionsstudier er kun udført hos voksne.
English: 3 years.
Danish: 3 år.
English: Use of alternative contraceptive methods is recommended.
Danish: Anvendelse af alternative kontraceptionsmetoder anbefales.
English: Procreation (recommendations for men)
Danish: Formering (anbefalinger for mænd)
English: INSTRUCTIONS ON USE 16.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN 16.
English: • every two weeks during the first six months of treatment, and
Danish: • hver anden uge i de første 6 måneders behandling, og
English: Fertility was not reduced.
Danish: Fertiliteten blev ikke nedsat.
English: Duration of a complete washout is usually 11 days.
Danish: Varigheden af en total udvaskning er sædvanligvis 11 dage.
English: Your doctor may perform tests to see if you have tuberculosis.
Danish: Din læge kan udføre tests for at se, om du har tuberkulose.
English: However, animal studies to evaluate this specific risk have not been conducted.
Danish: Dyreforsøg, som skal vurdere denne særlige risiko, er endnu ikke gennemført.
English: Folate supplementation was optional and only used in 10% of patients.
Danish: Supplement med folininsyre var valgfri, og anvendtes kun til 10% af patienterne.
English: There is no indication that these effects are of clinical relevance.
Danish: Der er intet, der tyder på, at disse virkninger er klinisk relevante.
English: These processes may be affected by hepatic dysfunction.
Danish: Disse processer kan muligvis påvirkes af hepatisk dysfunktion.
English: The duration may be modified depending on clinical or laboratory variables.
Danish: Varigheden kan modificeres afhængig af kliniske og laboratoriemæssige variable.
English: - if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Danish: - hvis du nogensinde har haft tuberkulose eller, hvis du har været i kontakt med en, som har eller har haft tuberkulose.
English: It is considered essential that monitoring recommendations are strictly adhered to.
Danish: Det er væsentligt, at de anbefalede monitoreringsretningslinjer følges nøje.
English: Before starting treatment, all patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
Danish: Før behandlingen påbegyndes, skal alle patienter undersøges for aktiv og inaktiv ("latent") tuberkulose i henhold til lokale anbefalinger.
English: If you are affected, do not drive, or use machines.
Danish: Hvis du bliver påvirket må du ikke køre eller betjene maskiner.
English: No special requirements for disposal.
Danish: Ingen særlige forholdsregler ved bortskaffelse.
English: For more information on these, please read section 4 (Possible side effects).
Danish: For at få mere information om dette, skal du læse punkt 4 (Bivirkninger).
English: If possible, take your tablets or the box with you to show the doctor.
Danish: Hvis det er muligt skal du tage tabletterne eller æsken med dig, og vise til lægen.
English: Most of the cases occurred within the first 6 months of treatment.
Danish: Størstedelen af de rapporterede tilfælde opstod indenfor de første 6 måneders behandling.
English: A complete washout is essential in such cases.
Danish: En fuldstændig udvaskning ("wash-out") er af afgørende betydning i sådanne tilfælde.
English: U kabelovny 130 102 37 Prague 10 Czech Republic
Danish: U kabelovny 130 102 37 Prague 10 Tjekkiet
English: In responders, this response was maintained during 48 weeks (see section 4.2).
Danish: Dette respons blev vedligeholdt gennem 48 uger (se pkt.
English: Summary of the safety profile
Danish: Sammenfatning af sikkerhedsprofilen
English: Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.
Danish: Patienterne bør overvåges nøje for tegn og symptomer på overdreven eksponering af lægemidlerne, og reduktion af dosis af disse lægemidler bør overvejes.
English: Excretion data from the 14C study indicated that at least about 82 to 95% of the dose is absorbed.
Danish: Udskillelsesdata fra 14C-forsøget tyder på, at mindst ca. 82-95 % af en dosis absorberes.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Date of first authorisation: 08 January 2010 Date of latest renewal: 08 January 2015
Danish: Dato for første markedsføringstilladelse: 8. januar 2010 Dato for seneste fornyelse: 8. januar 2015
English: These data do not allow an effective and safe dose recommendation.
Danish: Disse data giver derfor ikke en effektiv og sikker dosisanbefaling.
English: There is no preferential uptake in erythrocytes.
Danish: Der sker ingen præference-optagelse i erytrocytterne.
English: Switching to other treatments
Danish: Skift til andre behandlinger
English: If used together, the dose of rosuvastatin should not exceed 10 mg once daily.
Danish: Hvis de bruges sammen, bør dosis af rosuvastatin ikke overstige 10 mg én gang dagligt.
English: A more than 3-fold increase was seen in another 5 patients.
Danish: En forhøjelse på mere end 3 gange sås hos andre 5 patienter.
English: It may take about 4 weeks or longer until you start to feel an improvement in your condition.
Danish: Det kan vare 4 uger eller længere, før du begynder at føle bedring i din sygdom.
English: Classification of expected frequencies:
Danish: Klassifikation af forventede bivirkningsfrekvenser:
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ} Andre informationskilder
English: Warfarin and other coumarine anticoagulants
Danish: Warfarin og andre coumarin antikoagulantia
English: However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity.
Danish: Men der var ingen synlig effekt af denne stigning i plasma rosuvastatin på HMG-CoA reduktase aktivitet.
English: Uncommon: taste disturbances
Danish: Ikke almindelig: smagsforstyrrelser
English: If you have to be vaccinated, ask your doctor for advice.
Danish: Hvis du skal vaccineres, skal du spørge din læge til råds.
English: No dose adjustment is required in patients above 65 years of age.
Danish: Dosisjustering er ikke nødvendig til patienter over 65 år.
English: • every 8 weeks thereafter (see section 4.4).
Danish: • herefter hver 8. uge (se pkt.
English: Co-treatment with other hepatotoxic medicinal products was frequently present.
Danish: Samtidig behandling med andre hepatotoksiske præparater var hyppigt forekommende.
English: Not known:
Danish: Ikke kendt:
English: The effect of leflunomide on improvement of function and on reduction of skin lesions was modest.
Danish: Effekten af leflunomid på forbedring af funktion og på reduktion af sår på huden var beskeden.
English: Postmarketing studies
Danish: Postmarketing-studier
English: Leflunomide Zentiva with food, drink and alcohol
Danish: Brug af Leflunomid Zentiva sammen med mad, drikke og alkohol
English: The risk associated with combination therapy, in particular in long-term treatment, is unknown.
Danish: Risikoen ved kombinationsbehandling især som langtidsbehandling er ikke kendt.
English: Oral contraceptives
Danish: Oral antikonception
English: The elimination half-life in patients is approximately 2 weeks.
Danish: Eliminationshalveringstiden hos patienter er ca. 2 uger.
English: Leflunomide Zentiva tablets are for oral use.
Danish: Leflunomid Zentiva tabletter er til oral anvendelse.
English: Leflunomide Zentiva can make you feel dizzy which may impair your ability to concentrate and react.
Danish: Leflunomid Zentiva kan gøre dig svimmel, hvilket kan hæmme din evne til at koncentrere dig og reagere.
English: Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy.
Danish: Alder over 60 år, samtidig behandling med neurotoksisk medicin samt diabetes kan øge riskikoen for perifer neuropati.
English: Pharmacokinetic data in elderly (>65 years) are limited but consistent with pharmacokinetics in younger adults.
Danish: Farmakokinetiske data på ældre (> 65 år) er begrænsede, men svarer til farmakokinetikken hos yngre voksne.
English: Infections may be more severe in nature and may, therefore, require early and vigorous treatment.
Danish: Infektioner kan få et mere alvorligt forløb og kan derfor kræve tidlig og intensiv behandling.
English: There have been reports of chronic overdose in patients taking Leflunomide Zentiva at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Danish: Der har været rapporter om kronisk overdosering hos patienter, som har taget Leflunomid Zentiva i daglige doser op til 5 gange den anbefalede daglige dosis og rapporter om akut overdosering hos voksne og børn.
English: Leflunomide Zentiva may be taken with or without food.
Danish: Du kan tage Leflunomid Zentiva med eller uden mad.
English: Vaccination with live attenuated vaccines is, however, not recommended.
Danish: Vaccination med levende svækkede vacciner kan derfor ikke anbefales.
English: • Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.
Danish: • Patienter med moderat til svær nyreinsufficiens, da der ikke findes tilstrækkelig klinisk erfaring hos denne patientgruppe,
English: Leflunomide Zentiva is not recommended for use in children and adolescents below 18 years of age.
Danish: Børn og teenagere Leflunomid Zentiva anbefales ikke til børn og unge under 18 år.
English: If you take more Leflunomide Zentiva than you should, contact your doctor or get other medical advice.
Danish: Hvis du tager mere Leflunomid Zentiva end du skal, skal du kontakte din læge eller få anden medicinsk rådgivning.
English: In such cases patients should refrain from driving cars and using machines.
Danish: I sådanne tilfælde bør patienten ikke føre motorkøretøj eller betjene maskiner.
English: The procedure may be repeated as clinically necessary.
Danish: Proceduren kan gentages hvis klinisk nødvendigt.
English: Peripheral neuropathy
Danish: Perifer neuropati
English: Toxicity in animals was found at doses equivalent to human therapeutic doses.
Danish: Toksicitet på dyr er set ved doser svarende til de terapeutiske doser til mennesker.
English: Vaccinations
Danish: Vaccinationer
English: Store in the original package.
Danish: Opbevares i den originale pakning.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Your doctor will also check your blood pressure regularly as Leflunomide Zentiva can cause an increase in blood pressure.
Danish: Din læge vil også kontrollere dit blodtryk jævnligt, da Leflunomid Zentiva kan medføre en stigning i blodtrykket.
English: Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Danish: Effekt på BCRP (Breast Cancer Resistance Protein) og/eller organisk anion-transporterende polypeptid B1 og B3 (OATP1B1/B3) substrater
English: LDH increased
Danish: forhøjet LDH
English: • The risk of infections, including opportunistic infections, and the contraindication for use in immuno-compromised patients.
Danish: • Risikoen for infektioner, inklusive opportunistiske infektioner samt kontraindikation for anvendelse til immun-supprimerede patienter.
English: Thus, the overall incidence of infections can increase (in particular of rhinitis, bronchitis and pneumonia).
Danish: Derfor kan den samlede forekomst af infektioner forøges (specielt rinit, bronkit og pneumoni).
English: Patients with a history of tuberculosis should be carefully monitored because of the possibility of reactivation of the infection.
Danish: Patienter med tuberkulose i anamnesen bør følges nøje på grund af risikoen for reaktivering af infektionen.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendix V.
English: Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Danish: Den ordinerende læge gøres opmærksom på risikoen for falsk negative resultater af tuberkulinhudtest, især hos patienter, der er alvorligt syge eller immunsupprimerede.
English: In rats and dogs, Heinz bodies and/or Howell-Jolly bodies were found.
Danish: Hos rotter og hunde er set Heinz-legemer og/eller Howell-Jones legemer.
English: However there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
Danish: Dog sås en bred variabilitet i resultatet af seponeringen: hos nogle patienter forsvandt neuropatien, mens andre patienter havde vedvarende symptomer.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: 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).
Danish: Effekten af Leflunomid Zentiva i behandlingen af reumatoid artrit er vist i 4 kontrollerede forsøg (1 i fase II og 3 i fase III).
English: 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:
Danish: Da tilsvarende lægemiddelinteraktioner ikke kan udelukkes for leflunomid i de anbefalede doser, bør følgende forsøgsresultater og anbefalinger overvejes hos patienter i behandling med leflunomid:
English: Animal studies indicate that leflunomide or its metabolites pass into breast milk.
Danish: Dyreforsøg indikerer, at leflunomid og dets metabolitter passerer over i mælk.
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.
Danish: Læger og patienter skal gøres opmærksomme på, at at der findes en ad hoc-informationsservice, som rådgiver i forbindelse med laboratorieanalyser af plasma-leflunomid.
English: • That there is a risk of teratogenicity and so pregnancy must be avoided until leflunomide plasma levels are at an appropriate level.
Danish: • At der er risiko for teratogen effekt og at svangerskab derfor skal undgås, indtil plasmakoncentrationen af leflunomid er på et passende niveau.
English: NSAIDS/Corticosteroids
Danish: NSAID/ kortikosteroider
English: This medicinal product contains lactose (see leaflet for further information).
Danish: Dette lægemiddel indeholder lactose (se indlægssedlen for yderligere information).
English: No difference was observed between leflunomide and sulphasalazine (study MN301).
Danish: Der sås ingen forskelle mellem leflunomid og sulfasalazin (forsøg MN301).
English: 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.
Danish: 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.
English: In vitro plasma protein binding interaction studies with warfarin at clinically relevant concentrations, however, showed no interaction.
Danish: In vitro plasmaproteinbindings-interaktionsforsøg med warfarin i klinisk relevante koncentrationer viser dog ingen interaktion.
English: In case of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium concentration.
Danish: I tilfælde af tvivlsomme målinger anbefales det at fastsætte den samlede koncentration af albuminkorrigeret serumcalcium.
English: Leflunomide is indicated for the treatment of adult patients with:
Danish: Leflunomid er indiceret ved behandling af voksne patienter med
English: It has immunomodulating/ immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties.
Danish: Det har immunmodulerende/immunsuppressive karakteristika, virker som et antiproliferativt stof og har antiinflammatoriske egenskaber.
English: Other effects found on heart, liver, cornea and respiratory tract could be explained as infections due to immunosuppression.
Danish: Andre påvirkninger af hjerte, lever, cornea og luftveje kan forklares med infektioner på grund af immunsuppression.
English: 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).
Danish: 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).
English: Cholestyramine or activated charcoal
Danish: Colestyramin eller aktivt kul
English: Pharmacotherapeutic group: selective immunosuppressants, ATC code: L04AA13.
Danish: Farmakoterapeutisk klassifikation: Selektive immunsuppressiva, ATC-kode: L04AA13.
English: Combinations with other treatments
Danish: Kombinationer med anden behandling
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.
Danish: 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.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP LÆGEMIDLETS NAVN
English: • Additional risk minimisation measures
Danish: Yderligere risikominimeringsforanstaltninger
English: Pregnancy must be excluded before start of treatment with leflunomide.
Danish: Graviditet skal udelukkes, inden behandling med leflunomid påbegyndes.
English: Leflunomide was not antigenic in animal models.
Danish: Leflunomid er ikke antigent i dyremodeller.
English: The initial period was followed by an open label maintenance period of three months, during which both groups received leflunomide 20 mg daily.
Danish: Den indledende periode blev efterfulgt af en åben vedligeholdelsesperiode på tre måneder, gennem hvilken begge grupper fik 20 mg leflunomid daglig.
English: For washout procedures and other recommended actions in case of desired or unintended pregnancy, see section 4.6.
Danish: Hvad angår udvaskningsprocedure og andre anbefalede forholdsregler i tilfælde af ønsket eller utilsigtet graviditet se pkt.
English: These washout procedures may be repeated if clinically necessary.
Danish: Disse udvaskningsprocedurer kan gentages, hvis det er klinisk påkrævet.