FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information on generic medicines, see the question-and-answer document here.
Danish: Nærmere oplysninger om generiske lægemidler kan du finde i dokumentet med spørgsmål og svar her.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Mylan.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoledronsyre Mylan.
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Danish: Når infusionen gives til forebyggelse af knoglekomplikationer, kan den gentages hver tredje til fjerde uge, og patienterne bør desuden have tilskud af kalcium og vitamin D. Der tilrådes lavere dosis til patienter med knoglemetastaser (dvs. kræft, der har bredt sig til knoglerne), hvis de har lette til moderate nyreproblemer.
English: The usual dose of Zoledronic acid Mylan is one infusion of 4 mg over at least 15 minutes.
Danish: Den normale dosis af Zoledronsyre Mylan er én infusion af 4 mg, der gives i løbet af mindst 15 minutter.
English: The company provided data from the published literature on zoledronic acid.
Danish: Virksomheden fremlagde oplysninger fra den offentliggjorte litteratur om zoledronsyre.
English: By preventing the breakdown of bones, Zoledronic acid Mylan also helps to reduce the amount of calcium released into the blood.
Danish: Ved at forhindre nedbrydningen af knoglerne mindsker Zoledronsyre Mylan også mængden af kalcium, der frigives til blodet.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Danish: Hertil hører knoglebrud, spinal kompression (sammenpresning af rygmarven pga. knoglerne), knoglesygdomme, der kræver behandling med stråling eller operation, samt hyperkalcæmi (for højt kalciumindhold i blodet).
English: No additional studies in patients were needed as Zoledronic acid Mylan is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Danish: Der var ikke brug for flere undersøgelser hos patienter, da Zoledronsyre Mylan er et generisk lægemiddel, der gives ved infusion og indeholder samme aktive stof som referencelægemidlet Zometa.
English: Because Zoledronic acid Mylan 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: Da Zoledronsyre Mylan er et generisk lægemiddel og bioækvivalent med referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet.
English: Zoledronic acid Mylan must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Danish: Zoledronsyre Mylan må kun gives af en læge med erfaring i brug af denne type medicin ved indgift i en vene.
English: It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Danish: Det hæmmer virkningen af osteoklasterne, dvs. de celler i kroppen, der medvirker ved nedbrydning af knoglevæv.
English: Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Danish: CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Zometa.
English: Zoledronic acid Mylan can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Danish: Zoledronsyre Mylan kan anvendes til at forebygge knoglekomplikationer hos voksne med fremskreden kræft i knoglerne.
English: What are the benefits and risks of Zoledronic acid Mylan?
Danish: Hvilke fordele og risici er der forbundet med Zoledronsyre Mylan?
English: Patients with tumours can have high levels of calcium in their blood, released from the bones.
Danish: Hos patienter med svulster kan blodet have for højt indhold af kalcium, der frigives fra knoglerne.
English: Other information about Zoledronic acid Mylan
Danish: Andre oplysninger om Zoledronsyre Mylan
English: The active substance in Zoledronic acid Mylan, zoledronic acid, is a bisphosphonate.
Danish: Det aktive stof i Zoledronsyre Mylan, zoledronsyre, er et bifosfonat.
English: Zoledronic acid Mylan is a medicine that contains the active substance zoledronic acid.
Danish: Zoledronsyre Mylan er et lægemiddel, der indeholder det aktive stof zoledronsyre.
English: Zoledronic acid Mylan can also be used to treat the hypercalcaemia caused by tumours.
Danish: Zoledronsyre Mylan kan desuden anvendes til behandling af hyperkalcæmi forårsaget af svulster.
English: Zoledronic acid Mylan is a ‘generic medicine'.
Danish: Zoledronsyre Mylan er et “generisk lægemiddel”.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Mylan has been shown to have comparable quality and to be bioequivalent to Zometa.
Danish: CHMP konkluderede, at Zoledronsyre Mylan er påvist at være af samme kvalitet som Zometa og er bioækvivalent med dette i overensstemmelse med EU-kravene.
English: The Committee recommended that Zoledronic acid Mylan be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Zoledronsyre Mylan.
English: EPAR summary for the public zoledronic acid
Danish: EPAR - sammendrag for offentligheden zoledronsyre
English: It is not recommended for patients with severe kidney problems.
Danish: Til patienter med svære nyreproblemer frarådes det at anvende lægemidlet.
English: It is available as a 4mg/5ml concentrate for a solution for infusion.
Danish: Det leveres som et koncentrat til infusionsvæske, opløsning, 4 mg/5 ml.
English: Why has Zoledronic acid Mylan been approved?
Danish: Hvorfor blev Zoledronsyre Mylan godkendt?
English: What is Zoledronic acid Mylan?
Danish: Hvad er Zoledronsyre Mylan?
English: How has Zoledronic acid Mylan been studied?
Danish: Hvordan blev Zoledronsyre Mylan undersøgt?
English: How does Zoledronic acid Mylan work?
Danish: Hvordan virker Zoledronsyre Mylan?
English: What is Zoledronic acid Mylan used for?
Danish: Hvad anvendes Zoledronsyre Mylan til?
English: How is Zoledronic acid Mylan used?
Danish: Hvordan anvendes Zoledronsyre Mylan?
English: - An instruction how to take Pradaxa
Danish: Instruktion i, hvordan man tager Pradaxa
English: This educational pack is aimed at increasing awareness about the potential risk of bleeding during treatment with Pradaxa and providing guidance on how to manage that risk.
Danish: Dette uddannelsesmateriale skal øge opmærksomheden om den potentielle risiko for blødning ved behandling med Pradaxa og give vejledning i, hvorledes denne risiko håndteres.
English: - The educational pack must be available for distribution for both therapeutic indications prior to the launch of the new indication (prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors) in the Member State.
Danish: Uddannelsesmaterialet skal være klar til distribution for begge terapeutiske indikationer før lancering af den nye indikation (forebyggelse af apopleksi og systemisk emboli hos voksne patienter med nonvalvulær atrieflimren med en eller flere risikofaktorer) i medlemslandet.
English: The Patient alert card should contain the following key safety messages: o Signs or symptoms of bleeding and when to seek attention from a health care provider.
Danish: Patientoplysningskortet skal indeholde følgende hovedpunkter om sikkerhed: Tegn og symptomer på blødning, og hvornår man skal kontakte sundhedspersonale
English: o Importance of treatment compliance o The need to inform Health Care Professionals that they are taking Pradaxa if they need to have any surgery or invasive procedure.
Danish: Nødvendigheden af at oplyse sundhedspersonale om, at man tager Pradaxa, hvis man skal opereres eller have foretaget andre former for indgreb.
English: - The content and format of the educational material, together with a communication plan, is agreed with the MAH prior to distribution of the educational pack.
Danish: Indehaveren af markedsføringstilladelsen og den nationale ansvarlige myndighed skal blive enige om indhold og udformning af uddannelsesmaterialet og om en kommunikationsplan forud for udlevering af uddannelsesmaterialet.
English: The Prescriber Guide should contain the following key safety messages: - Details of populations potentially at higher risk of bleeding - Recommendation not to use Pradaxa in patients with prosthetic heart valves - Recommendation for kidney function measurement - Recommendations for dose reduction in at risk populations - Management of overdose situations - The use of coagulation tests and their interpretation - That all patients should be provided with a Patient alert card and be counselled about:
Danish: Anbefalinger til dosisnedsættelse i risikopopulationer Håndtering af overdosering Brug af koagulationstests og tolkning af samme At alle patienter skal have udleveret et patientoplysningskort og informeres om: Tegn og symptomer på blødning, og hvornår man skal kontakte sundhedspersonale Vigtigheden af compliance Nødvendigheden af altid at have patientoplysningskortet på sig Nødvendigheden af at oplyse sundhedspersonale om, at man tager Pradaxa, hvis man skal opereres eller have foretaget andre former for indgreb.
English: The Member States shall ensure that the following conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: - The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Danish: Medlemslandene skal sikre, at følgende betingelser eller begrænsninger i forhold til sikker og korrekt anvendelse af lægemidlet beskrevet herunder er implementeret:
English: The physician educational pack should contain: - The Summary of Product Characteristics - Prescriber Guide - Patient Alert Cards
Danish: Vigtigheden af compliance Nødvendigheden af altid at have patientoplysningskortet på sig
English: Member State EU/EEA
Danish: Medlemsstat EU/EAA
English: 15 OTHER INFORMATION
Danish: 15 ANDRE OPLYSNINGER
English: 4 INDICATIONS
Danish: 4 INDIKATIONER
English: Overall summary of the scientific evaluation of Seresto and its associated name Foresto (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Seresto og det relaterede navn Foresto (se bilag I)
English: Assessment of the data submitted
Danish: Vurdering af de fremlagte data
English: All risks relating to the target animal, the user and the environment are adequately addressed in the product literature.
Danish: Alle risici, der er relateret til måldyrearten, brugeren og miljøet, er tilstrækkeligt beskrevet i produktlitteraturen.
English: Add the following text in the relevant sections of the product information:
Danish: Følgende tekst skal tilføjes i de relevante afsnit af produktinformationen.
English: All three field studies were performed in animal shelter situations within a limited geographical area.
Danish: Alle tre feltundersøgelser blev gennemført på dyreinternater inden for et begrænset geografisk område.
English: The benefit-risk balance for the agreed indication is considered favourable.
Danish: Benefit/risk-forholdet for den godkendte indikation vurderes at være gunstigt.
English: Seresto contains the active substances imidacloprid 10% and flumethrin 4.5%.
Danish: Seresto indeholder de aktive stoffer imidacloprid 10% og flumethrin 4,5%.
English: The dogs were each infested with 80 female sand flies on 13 occasions (D7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215, and 222).
Danish: Hundene blev hver især påført 80 hunsandfluer på 13 forskellige tidspunkter (dag 7, 14, 21, 28, 56, 84, 112, 140, 166, 196, 208, 215 og 222).
English: In this laboratory study, 14 dogs were randomised to either treatment with Seresto collar (n=7) or untreated control (n=7).
Danish: I denne laboratorieundersøgelse blev 14 hunde randomiseret til enten behandling med Serestohalsbånd (n = 7) eller ingen behandling (n = 7).
English: The study duration was 300 days ± 10 days, and the treated animals wore the collar for the first 210 ± 10 days of this period.
Danish: Undersøgelsen varede 300 dage ± 10 dage, og de behandlede dyr havde halsbåndet på i de første 210 ± 10 dage.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Danish: Fortegnelse over lægemidlets navn, lægemiddelform, styrk for det veterinærmedicinske produkt, dyreart, indgivelsesvej, indehaver af markedsføringstilladelse i medlemsstaterne
English: The benefit-risk assessment is made on this basis.
Danish: Vurdering af fordele og risici er foretaget på denne baggrund.
English: Both Guideline 7AE17a and Guideline EMEA/CVMP/EWP/005/2000-Rev.2 state that field studies should be performed in at least two geographical regions and the animal population studied should be representative of the target population.
Danish: Både vejledning 7AE17a og vejledning EMEA/CVMP/EWP/005/2000-Rev.2 anfører, at feltundersøgelser bør gennemføres i mindst to geografiske regioner, og at den undersøgte dyrepopulation bør være repræsentativ for målpopulationen.
English: According to Guideline 7AE17a, the threshold of efficacy for Diptera should be 80-100% (preferably more than 90%).
Danish: Ifølge vejledning 7AE17a bør effekttærsklen for Diptera være 80-100% (helst over 90%).
English: Mommaertslaan 14 1831 Diegem (Machelen),
Danish: Mommaertslaan 14 1831 Diegem (Machelen), Belgium
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Danish: Gældende produktresume, etikettering og indlægsseddel er de endelige versioner, der er udarbejdet af koordineringsgruppen under proceduren med følgende ændringer:
English: The study ran between April/May and December 2013 (approximately eight months), and there was a post-treatment phase which ran until April/May 2014.
Danish: Undersøgelsen blev gennemført mellem april/maj og december 2013 (ca. otte måneder), og efterbehandlingsfasen løb frem til april/maj 2014.
English: However, as they were conducted in animal shelters in Southern Italy, the UK considered that it is not possible to extrapolate the findings from these studies relating to transmission of leishmaniosis to all areas of the EU where the disease is endemic.
Danish: Da disse undersøgelser blev gennemført på dyreinternater i Syditalien, vurderede Storbritannien imidlertid, at det ikke er muligt at ekstrapolere resultaterne fra disse undersøgelser, hvad angår overførsel af leishmaniose, til alle de områder i EU, hvor sygdommen er endemisk.
English: Treated dogs were continually treated with Seresto throughout the study period, with the collar being replaced as necessary due to growth of the animal or according to the label instructions for the product.
Danish: De behandlede hunde blev kontinuerligt behandlet med Seresto i hele undersøgelsesperioden, hvor halsbåndet blev udskiftet ved behov, efterhånden som hunden voksede, eller i henhold til produktetiketten.
English: Therefore, the new indication of prevention of transmission of L. infantum can only be accepted if the vector, i.e. P. perniciosus would also be part of the clinical indication'.
Danish: Derfor kan den nye indikation, "forebyggelse af overførsel af L. infantum", kun accepteres, hvis vektoren, dvs. P. perniciosus, også er omfattet af den kliniske indikation".
English: In the same studies, the incidence density rates in untreated dogs (60.7%, 46.2% and 67.0% respectively) demonstrated the high infection pressure present in the field situations used.
Danish: I de samme undersøgelser viste incidensraterne hos ubehandlede hunde (hhv. 60,7%, 46,2% og 67,0%) et højt infektionspres i de anvendte feltsituationer.
English: An animal was considered positive for leishmaniosis if positive to one or more tests used.
Danish: En hund blev anset for at være leishmaniose-positiv, hvis den blev testet positiv ved en eller flere af de anvendte prøver.
English: Netherlands Bayer B.V., Animal Health Division Energieweg 1
Danish: Bayer B.V., Animal Health Division Energieweg 1
English: Scientific conclusions and grounds for the granting of the variation of the marketing authorisations
Danish: Videnskabelige konklusioner og begrundelser for godkendelse af ændringen af markedsføringstilladelserne
English: A total of 122 dogs, of several breeds aged between 1.5 and 6 months, were enrolled (mostly as litters) on individual start dates between March and May 2011.
Danish: I alt 122 hunde af forskellige racer i alderen 1½-6 måneder blev inkluderet (mest som kuld) på individuelle startdatoer mellem marts og maj 2011.
English: Seresto and its associated name Foresto (thereinafter “Seresto”) is a medicated collar containing 10% imidacloprid and 4.5% flumethrin.
Danish: Seresto og det relaterede navn Foresto (i det følgende benævnt "Seresto") er et loppehalsbånd, der indeholder 10% imidacloprid og 4,5% flumethrin.
English: 12 SPECIAL WARNING(S)
Danish: 12 SÆRLIGE ADVARSLER
English: The efficacy threshold of 80-100% (preferably 90%) as recommended in the guideline Demonstration of Efficacy of Ectoparasiticides (7AE17a)1 was not met at sufficient time points.
Danish: Effekttærsklen på 80-100% (helst 90%), jf. anbefalingerne i vejledningen "Demonstration of Efficacy of Ectoparasiticides" (7AE17a)1 [påvisning af effekt ved ektoparasiticider], var ikke opfyldt på tilstrækkeligt mange tidspunkter.
English: The study ran between March 2011 and April 2012, with a post-treatment phase commencing April 2012 and completing October 2012.
Danish: Undersøgelsen blev gennemført mellem marts 2011 og april 2012 med en efterbehandlingsfase, der startede i april 2012 og blev afsluttet i oktober 2012.
English: Most dogs in normal household situations in countries endemic for leishmaniosis would be expected to be exposed to sand flies infected with leishmaniosis to a substantially lower extent, and therefore it was considered possible to extrapolate the results with confidence to the general target population.
Danish: De fleste hunde i normale husholdningssituationer i lande, der er endemiske for leishmaniose, forventedes at være eksponeret for sandfluer inficeret med leishmaniose i langt lavere omfang, og derfor vurderedes det muligt og trygt at ekstrapolere resultaterne til den generelle målpopulation.
English: 400 South Oak Way Green Park Reading
Danish: Storbritannien Bayer plc, 400 South Oak Way Green Park
English: Of the thirteen assessment time points, an anti-feeding efficacy above 80% was only achieved on three occasions.
Danish: Ud af de 13 vurderingstidspunkter blev der kun konstateret en repellerende effekt på over 80% i tre tilfælde.
English: As a result, bites by sand flies may occur, and the transmission of L. infantum cannot be completely excluded.
Danish: Som følge deraf kan bid fra sandfluer forekomme, og overførsel af L. infantum kan ikke helt udelukkes.
English: It should be noted that Guideline 7AE17a provides general guidance including a threshold for efficacy against Diptera, but was not established with the aim of providing guidance on studies to support claims relating to vector-borne diseases such as reduction of canine leishmaniosis.
Danish: Det skal bemærkes, at vejledning 7AE17a giver generelle retningslinjer, herunder om effekttærsklen i forhold til Diptera, men at den ikke er udarbejdet for at vejlede om undersøgelser til understøttelse af ansøgninger om godkendelse af en indikation mod vektorbårne sygdomme, f.eks. hundeleishmaniose.
English: Furthermore, there are specific difficulties inherent in the demonstration of such a claim: there is, at present, no validated laboratory model which can determine the efficacy of a veterinary medicinal product against leishmaniosis.
Danish: Derudover er det særligt vanskeligt at underbygge en sådan indikation, da der aktuelt ikke findes en godkendt laboratoriemodel, som kan bestemme et veterinærlægemiddels effekt mod leishmaniose.
English: During the course of the procedure, the indication was amended by the reference Member State (RMS) who stated that ‘the demonstration of efficacy of the product against the sand flies over the whole season is a prerequisite for the claimed indirect prevention of transmission of L. infantum.
Danish: Under proceduren blev indikationen ændret af referencemedlemsstaten, der anførte, at "påvisning af produktets effekt mod sandfluer i hele sæsonen er en forudsætning for den påberåbte indirekte forebyggelse af overførsel af L. infantum.
English: Due to the use of a very low sample size in two of the studies, only one study was considered to have produced reliable results and so the following comments are based on just this study.
Danish: Da kun den ene af de tre undersøgelser vurderes at have givet pålidelige resultater, fordi prøvestørrelsen i de to øvrige var meget lille, er nedenstående kommentarer baseret på denne ene undersøgelse alene.
English: Amendments in the relevant sections of the summary of product characteristics and package leaflet
Danish: Ændringer til relevante afsnit i produktresumeet og indlægssedlen
English: Relevant information relating to the supporting studies should be added to the SPC.
Danish: Der bør tilføjes relevante oplysninger om de understøttende undersøgelser i produktresuméet.
English: Data from 3 clinical field studies performed in endemic areas indicate a significant reduction in the risk of Leishmania infantum transmission by sand flies in treated dogs compared to non-treated dogs.
Danish: Data fra 3 kliniske feltstudier udført i endemiske områder indikerer en betydelig reduktion i risikoen for overførsel af Leishmania infantum fra sandfluer i behandlede hunde sammenlignet med ikke-behandlede hunde.
English: The collar should be applied just before the beginning of the period of activity of sand fly vectors corresponding to the Leishmania infantum transmission season and worn continuously throughout the risk period.
Danish: Halsbåndet bør påsættes umiddelbart inden perioden hvor sandflue-vektoren for overførsel af Leishmania infantum bliver aktiv og bæres i hele risikoperioden.
English: In summary, the UK considered that the efficacy of Seresto for the proposed indication has not been sufficiently demonstrated and that accepting the indication could pose a serious risk to animal and human health.
Danish: Storbritannien vurderede således, at effekten ved Seresto i den anførte indikation ikke er tilstrækkeligt påvist, og at det kan udgøre en alvorlig risiko for dyrs og menneskers sundhed, hvis indikationen godkendes.
English: Animals were tested for leishmaniosis with samples of blood and skin tissue being collected on study day 0, in July 2011, September 2011, November 2011, April 2012, and October 2012.
Danish: Dyrene blev testet for leishmaniose ved hjælp af blod- og hudprøver, der blev indsamlet dag 0, juli 2011, september 2011, november 2011, april 2012 og oktober 2012.
English: Laboratory studies did not demonstrate a sufficient anti-feeding (repellent) effect against sand flies (P. perniciosus) to support a direct indication against the sand fly.
Danish: Laboratorieundersøgelser viste ikke tilstrækkelig repellerende (anti-blodsugende) effekt mod sandfluer (P. perniciosus) til at kunne understøtte en direkte indikation mod sandfluer.