FrancophonIA/ELRC3.0 huggingface dataset:
English: Trocoxil chewable tablets for dogs were studied in one main study in dogs with osteoarthritis.
Danish: Trocoxil tyggetabletter til hunde blev undersøgt i én hovedundersøgelse af hunde med osteoarthritis.
English: The active substance in Trocoxil, mavacoxib, belongs to a class of medicines called non steroidal antiinflammatory drugs (NSAIDs).
Danish: Det aktive stof i Trocoxil, mavacoxib, hører til gruppen af lægemidler kaldet non-steroide antiinflammatoriske lægemidler (NSAID-præparater).
English: It must also not be used in dogs that are hypersensitive (allergic) to mavacoxib, any of the other ingredients in the tablet or sulphonamides.
Danish: Det må heller ikke bruges til hunde, der er overfølsomme (allergiske) over for mavacoxib, andre af indholdsstofferne i tabletterne eller sulfonamider.
English: Trocoxil is used for the treatment of pain and inflammation associated with degenerative joint disease (disease involving damage to the joints, such as osteoarthritis) in dogs at least one year of age.
Danish: Trocoxil anvendes til behandling af smerte og inflammation i forbindelse med degenerative ledsygdomme (sygdomme, der omfatter ledbeskadigelse såsom osteoarthritis) hos hunde, der mindst er ét år gamle.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af indtagelse ved uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: By blocking the production of prostaglandins, Trocoxil reduces the pain and inflammation caused by damage to the joints.
Danish: Ved at blokere for produktionen af prostaglandiner reducerer Trocoxil den smerte og inflammation, der er forårsaget af ledbeskadigelsen.
English: The results showed an improvement in lameness score in dogs with established osteoarthritis.
Danish: Resultaterne viste en bedring i score-værdien for halten hos hunde med konstateret osteoarthritis.
English: Trocoxil contains the active substance mavacoxib, which belongs to a class of medicines with anti inflammatory action.
Danish: Trocoxil indeholder det aktive stof mavacoxib, som tilhører gruppen af lægemidler med antiinflammatorisk effekt.
English: Why has Trocoxil been approved?
Danish: Hvorfor blev Trocoxil godkendt?
English: Trocoxil tablets for dogs improved pain relief and inflammation.
Danish: Trocoxil tabletter til hunde gav en bedre lindring af smerte og inflammation.
English: It must not be used in dogs with problems affecting the stomach or gut, including ulcers or bleeding, or in dogs that have signs of bleeding problems.
Danish: Det må ikke anvendes til hunde med problemer, der påvirker maven eller tarmen, herunder sår eller blødninger, eller til hunde med tegn på blødningsproblemer.
English: It must not be used in dogs with kidney or liver problems, or inadequate blood flow to the heart muscle, or in dogs that are pregnant, breeding or lactating.
Danish: Det må ikke bruges til hunde med nyreeller leverproblemer eller med utilstrækkelig blodtilstrømning til hjertemusklen eller til drægtige, avlende eller diegivende hunde.
English: What is Trocoxil?
Danish: Hvad er Trocoxil?
English: What is Trocoxil used for?
Danish: Hvad anvendes Trocoxil til?
English: How has Trocoxil been studied?
Danish: Hvordan blev Trocoxil undersøgt?
English: The dose and duration of treatment (maximum 6.5 months) will depend on the weight and type of animal and condition to be treated.
Danish: Dosis og behandlingens varighed (højst 6,5 mdr.)
English: What benefit has Trocoxil shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Trocoxil?
English: How does Trocoxil work?
Danish: Hvordan virker Trocoxil ?
English: What is the risk associated with Trocoxil?
Danish: Hvilke bivirkninger er der ved Trocoxil?
English: For details, please see the Package Leaflet.
Danish: De yderligere oplysninger fremgår af indlægssedlen.
English: MA (EU) number
Danish: MA (EU) nr.
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Indgivelsesvej
English: Content (concentration) Pack size
Danish: Indre emballage Indhold (Koncentration)
English: Immediate Packaging
Danish: Pakningsstørrel se
English: _ _ 1 25 mg rilpivirine (as hydrochloride) / 200 mg emtricitabine / 245 mg tenofovir disoproxil (as fumarate)
Danish: _ _ 1 25 mg rilpivirin (som hydrochlorid) / 200 mg emtricitabin / 245 mg tenofovirdisoproxil (som fumarat)
English: 3 x 30 tablets
Danish: 3 x 30 tabletter
English: Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage Paknings-størrelse
English: 20 January 2011
Danish: 20. januar 2011
English: Two of the studies lasted 12 weeks, and two lasted 52 weeks.
Danish: To af undersøgelserne varede 12 uger, og to af undersøgelserne varede 52 uger.
English: What is Ozespa?
Danish: Hvad er Ozespa?
English: The company informed the CHMP that its current clinical trials will continue.
Danish: Virksomheden har informeret CHMP om, at de igangværende kliniske undersøgelser vil fortsætte.
English: These cytokines are involved in causing the inflammation and other processes that cause psoriasis.
Danish: Disse cytokiner er med til at fremkalde inflammation og andre processer, der forårsager psoriasis.
English: By attaching to them, briakinumab was expected to block their activity, thereby reducing the activity of the immune system and the symptoms of the disease.
Danish: Ved at binde sig til dem forventedes briakinumab at blokere deres aktivitet og dermed mindske immunsystemets aktivitet og sygdommens symptomer.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Danish: Et monoklonalt antistof er et antistof (en type protein), der er opbygget, så det genkender og binder sig til en bestemt struktur (et antigen) i kroppen.
English: What was Ozespa expected to be used for?
Danish: Hvad forventedes Ozespa anvendt til?
English: The active substance in Ozespa, briakinumab, is a monoclonal antibody.
Danish: Det aktive stof i Ozespa, briakinumab, er et monoklonalt antistof.
English: Briakinumab was designed to attach to a part of two ‘cytokines' (messenger molecules) in the immune system called interleukin-12 and interleukin-23.
Danish: Briakinumab var opbygget således, at det skulle binde sig til en del af to "cytokiner" (signalstoffer) i immunsystemet, der kaldes interleukin-12 og interleukin-23.
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made the application?
Danish: Da CHMP evaluerede den oprindelige dokumentation, som virksomheden havde fremlagt, havde CHMP endnu ikke givet nogen anbefalinger.
English: How is Ozespa expected to work?
Danish: Hvordan forventes Ozespa at virke?
English: was the application when it was withdrawn?
Danish: Hvor langt var vurderingen af ansøgningen nået, da den blev trukket tilbage?
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Ozespa?
English: What were the reasons given by the company for withdrawing
Danish: Hvilke begrundelser gav virksomheden for tilbagetrækningen af ansøgningen?
English: The application was withdrawn before ‘day 120'.
Danish: Ansøgningsproceduren var endnu ikke ved dag 120, da virksomheden trak sin ansøgning tilbage.
English: Withdrawal of the marketing authorisation application for Ozespa (briakinumab) EMA/40202/2011
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Ozespa (briakinumab)
English: Ozespa was expected to be used to treat moderate to severe plaque psoriasis respond to or cannot use other systemic (whole-body) treatments for psorias methotrexate and PUVA (psoralen ultraviolet-A).
Danish: Ozespa forventedes anvendt til behandling af moderat til svær plaque-psoriasis hos voksne, som ikke har responderet på eller ikke kan anvende systemisk (helkrops-) behandling af psoriasis, herunder ciclosporin, methotrexat og PUVA (psoralen ultraviolet-A).
English: The letter from the company notifying the Agency of the withdrawal of the applicati under the ta
Danish: Brevet fra virksomheden, hvori EMA underrettes om tilbagetrækning af ansøgningen, kan ses under fanen "All documents".
English: 11, Abbott Laboratories Ltd officially notified the Committee for Medicinal Products thorisation for or the treatment of plaque psoriasis (a disease causing red, scaly patches on the skin).
Danish: Den 14. januar 2011 meddelte Abbott Laboratories Ltd officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Ozespa til behandling af plaque-psoriasis (en sygdom, der fremkalder røde, skællende pletter på huden).
English: What was the recommendation of the CHMP at that tim any recommendations.
Danish: Hvad anbefalede CHMP på daværende tidspunkt?
English: Ozespa is medicine that contains the ac for injection.
Danish: Ozespa er et lægemiddel, der indeholder det aktive stof briakinumab.
English: The effects of Ozespa were first tested in experimental models before being stud The company presented the results of four main studies in 2,479 adults with psor compared with placebo (a dummy treatment), etanercept and methotrexate (o treat p effectiveness was the change in the symptom scores, as measured using two sta
Danish: Virksomheden fremlagde resultaterne af fire hovedundersøgelser hos 2 479 voksne med psoriasis.
English: How far into the evaluation initial documentation provided by the company.
Danish: Det betyder, at CHMP stadig var i gang med at evaluere den oprindelige dokumentation, som virksomheden havde fremlagt.
English: The main measure of ndard scales for psoriasis.
Danish: Det primære effektmål var ændringen i symptomscorerne, målt ved hjælp af to standardskalaer for psoriasis.
English: Ozespa was ther medicines used to soriasis).
Danish: Ozespa blev sammenlignet med placebo (en virkningsløs behandling), etanercept og methotrexat (andre lægemidler til behandling af psoriasis).
English: The final concentrations of the vaccines will therefore also differ.
Danish: Den endelige koncentration af vaccinerne vil derfor også være forskellige.
English: * PU: Potency Units
Danish: * PU: Potensenheder
English: Date of first authorisation: 12/11/2019
Danish: Dato for første markedsføringstilladelse: 12/11/2019
English: Chickens and embryonated chicken eggs.
Danish: Kyllinger og embryonerede hønseæg.
English: Reconstitution of the vaccine:
Danish: Rekonstitution af vaccinen:
English: ATCvet code: QI01AD09
Danish: ATCvet-kode: QI01AD09
English: Solvent for GUMBOHATCH
Danish: Solvens til GUMBOHATCH.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på æsken og etiketten.
English: In practice, studies in commercial broiler chickens have shown an onset of immunity from between 24 days of age and 28 days of age.
Danish: I praksis viser studier i kommercielle slagtekyllinger at immuniteten indtræder i en alder af 24 til 28 dage.
English: This depletion does not cause immunosuppression in chickens.
Danish: Denne reduktion forårsager ikke immunsupprimering hos kyllinger.
English: Duration of immunity: up to 43 days of age.
Danish: Varighed af immunitet: op til 43 dages alderen.
English: The instructions for the calibration and use of the equipment should be strictly followed in order to deliver the appropriate dose.
Danish: Følg omhyggeligt instruktionerne for kalibrering og brug af udstyret, for at sikre at den rette dosis indgives.
English: This product should only be used after it has been demonstrated that very virulent IBDV strains are epidemiologically relevant in the area of vaccination.
Danish: Produktet bør kun anvendes, efter det er påvist at meget virulente IBDV stammer er epidemiologisk relevante i vaccinationsområdet.
English: The reconstituted vaccine is a slightly reddish homogeneous suspension which should be used within 2 hours after reconstitution.
Danish: Den rekonstituerede vaccine er en let rødlig, homogen suspension, der skal bruges inden for 2 timer efter rekonstitution.
English: For subcutaneous administration:
Danish: Til subkutan administration:
English: Calculate and prepare the required volume of the vaccine as per the table below:
Danish: Beregn og forbered den nødvendige mængde vaccine efter nedenstående tabel:
English: EU/2/19/245/001 (10 x 1,000 doses) EU/2/19/245/002 (10 x 2,000 doses) EU/2/19/245/003 (10 x 2,500 doses) EU/2/19/245/004 (10 x 4,000 doses) EU/2/19/245/005 (10 x 5,000 doses)
Danish: EU/2/19/245/001 (10 x 1.000 doser) EU/2/19/245/002 (10 x 2.000 doser) EU/2/19/245/003 (10 x 2.500 doser) EU/2/19/245/004 (10 x 4.000 doser) EU/2/19/245/005 (10 x 5.000 doser)
English: Do not use in birds in lay or breeding birds, or within 4 weeks before the start of the laying period.
Danish: Må ikke anvendes i æglægningsperioden eller til ynglefugle eller inden for 4 uger forud for æglægningsperiodens begyndelse.
English: Solvent: clear colourless solution.
Danish: Solvens: klar, farveløs opløsning.
English: Vaccinated birds may excrete the vaccine strain up to 3 weeks following vaccine take.
Danish: Vaccinerede kyllinger kan udskille vaccinestammen i op til 3 uger efter vaccination.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanser) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRLværdier ikke er påkrævet eller anses ikke for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: It is recommended to vaccinate all chickens on a site at the same time.
Danish: Det anbefales at alle kyllinger i besætningen vaccineres samtidigt.
English: Solvent volume to be used:
Danish: Solventvolumen, der skal bruges:
English: Marketing authorisation holder and manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Laboratorios Hipra, S.A.
English: Do not use in flocks without MDAs against IBDV.
Danish: Må ikke anvendes i flokke uden maternelle antistoffer (MDA) mod IBDV.
English: The efficacy of the vaccine has been demonstrated in broilers having an average MDA level from 4,500 to 5,100 ELISA units at hatching.
Danish: Vaccinens effektivitet er påvist hos slagtekyllinger med et gennemsnitligt MDA-niveau på 4500 til 5100 ELISA-enheder ved klækning.
English: Solvent: Do not store above 25 ºC.
Danish: Solvens: Må ikke opbevares over 25°C.
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with this veterinary medicinal product.
Danish: Må ikke blandes med andre lægemidler til dyr, undtagen med den medfølgende solvens til brug med dette veterinærlægemiddel.
English: An automated egg injection machine can be used.
Danish: Der kan anvendes en automatisk injektionsmaskine beregnet til æg.
English: Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible wild and domestic birds.
Danish: Der skal tages passende veterinære og landbrugsdriftsmæssige forholdsregler for at undgå at vaccinestammen spredes til modtagelige vilde og tamme fugle.
English: Wash and disinfect hands after handling vaccinated birds or their litter because the virus is excreted by vaccinated birds for up to 3 weeks.
Danish: Vask og desinficer hænder efter håndtering af vaccinerede fjerkræ eller deres affald, da virussen udskilles af fuglene i op til 3 uger.
English: During this time, contact between the vaccinated chickens and any immunosuppressed or unvaccinated birds should be avoided.
Danish: I denne periode skal kontakt mellem vaccinerede kyllinger og immunsupprimerede eller ikke vaccinerede fjerkræ undgås.
English: The onset of immunity depends on the initial maternally derived antibodies (MDA) level of the batch of chickens and even then will be different for individual chickens.
Danish: Indtræden af immunitet afhænger af niveauet af maternalt overførte antistoffer (maternally derived antibodies, MDA'Eer) hos kyllingerne, og selv da vil niveauet være forskelligt fra kylling til kylling.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Danish: Kontakt din dyrlæge eller apotekspersonalet vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: An automated syringe can be used.
Danish: Der kan anvendes en automatisk sprøjte.
English: Shelf life after reconstitution according to directions: 2 hours.
Danish: Opbevaringstid efter rekonstitution ifølge anvisning: 2 timer.
English: For in ovo administration:
Danish: Til administration in ovo:
English: Solvent: Polypropylene bags containing 200 ml, 400 ml, 800 ml or 1,000 ml.
Danish: Solvens: Polypropylen poser indeholdende 200 ml, 400 ml, 800 ml eller 1000 ml.
English: Laboratorios Hipra, S.A. Carretera C-63 km 48.300 Polígono Industrial El Rieral Amer, 17170 Girona Spain
Danish: Laboratorios Hipra, S.A. Carretera C-63 km 48.300 Polígono Industrial El Rieral Amer, 17170 Girona Spanien
English: The vaccine contains an intermediate-plus IBDV strain bound to specific IBDV immunoglobulins, forming an immune-complex which is administered through vaccination.
Danish: Vaccinen indeholder en intermediær-plus IBDV-stamme bundet til specifikke IBDVimmunoglobuliner, der tilsammen danner et immunkompleks der indgives gennem vaccination.
English: Onset of immunity: from 24 days of age.
Danish: Indtræden af immunitet: fra 24 dages alderen.
English: Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Potassium chloride Sodium chloride
Danish: Dinatriumphosphatdodecahydrat Kaliumdihydrogenphosphat Kaliumchlorid
English: Withdrawal period(s): Zero days.
Danish: Tilbageholdelsestid(er): Nul dage.
English: It is important to note that the volumes of solvent which must be used to reconstitute the vaccine are different depending on whether the vaccine will be administered in ovo to embryonated eggs, or by subcutaneous injection to 1-day-old chicks.
Danish: Det er vigtigt at bemærke, at mængderne af solvens, der skal bruges til at rekonstituere vaccinen, er forskellige alt efter om vaccinen skal indgives in ovo til embryonerede æg eller som subkutan injektion til daggamle kyllinger.
English: Each dose of reconstituted vaccine (0.05 ml for an in ovo dose or 0.2 ml for a subcutaneous dose) contains:
Danish: Hver dosis rekonstitueret vaccine (0,05 ml for en in ovo dosis eller 0,2 ml for en subkutan dosis) indeholder:
English: In ovo or subcutaneous use.
Danish: In ovo eller subkutan anvendelse.
English: Mix the contents of the vial by gentle agitation until the contents are completely resuspended, then withdraw the suspension obtained and inject it into the solvent bag.
Danish: Bland indholdet af hætteglasset ved forsigtig omrystning indtil indholdet er helt resuspenderet, og træk så den opnåede suspension ud og injicer den i posen med solvens.
English: Shelf life of the solvent as packaged for sale: 3 years.
Danish: Opbevaringstid for solvens i salgspakning: 3 år.
English: The safety of the veterinary medicinal product has not been established during lay.
Danish: Veterinærlægemidlets sikkerhed under æglægning er ikke fastlagt.
English: Shelf life of the lyophilisate as packaged for sale: 21 months.
Danish: Opbevaringstid for lyofilisat i salgspakning: 21 måneder.
English: Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccines, avian infectious bursal disease virus (Gumboro disease).
Danish: Farmakoterapeutisk gruppe: Immunologica til hønsefugle, tamfugle, levende virale vacciner, smitsom bursitis-virus (Gumboro disease).
English: In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af bivirkninger efter utilsigtet selvinjektion skal der straks søges lægehjælp og indlægssedlen eller etiketten bør vises til lægen.
English: To stimulate active immunity against very virulent bursal disease viruses (Gumboro disease) in broiler chickens.
Danish: Til at stimulere aktiv immunitet mod meget virulente infektiøs burssitis-vira (Gumboro-disease) hos slagtekyllinger.
English: Repeat step 2 to ensure that all the lyophilisate has been transferred into the solvent bag.
Danish: Gentag trin 2 for at sikre at al lyofilisaten er overført til posen med solvens.
English: The vaccine (0.2 ml dose) must be injected under the skin of the neck of the 1-day-old broiler chicks.
Danish: Vaccinen (0,2 ml dosis) skal injiceres under huden i halsen på daggamle slagtekyllinger.
English: EXP {month/year} Once reconstituted use within 2 hours.
Danish: {måned/år} Anvendes inden for 2 timer efter rekonstitution.
English: For active immunisation of 1-day-old broiler chicks and embryonated broiler chicken eggs to reduce clinical signs and lesions of the bursa of Fabricius caused by very virulent avian infectious bursal disease virus infection.
Danish: Til aktiv immunisering af daggamle slagtekyllinger og embryonerede æg til slagtekyllinger for at reducere kliniske tegn og læsioner i Bursa fabricii forårsaget af infektion med meget virulent, aviær infektiøs bursitis virusinfektion.
English: 1,000 doses 2,000 doses 2,500 doses 4,000 doses 5,000 doses
Danish: 1.000 doser 2.000 doser 2.500 doser 4.000 doser 5.000 doser
English: Withdraw 2 ml of the solvent and inject into the vial containing the lyophilisate.
Danish: Træk 2 ml af solvensen op og injicer det i hætteglasset med lyofilisat.
English: IBDV-specific antibody solution…………………………….. 2.7x106 VNU** of IgY per vial **VNU: Virus Neutralisation Units
Danish: IBDV-specifik antistofopløsning…………………….. 2,7x106 VNU'er** IgY pr. hætteglas **VNU: Virus-neutraliseringsenheder
English: In laboratory studies, lymphocyte depletion was very common after vaccine take, which was followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius.
Danish: I laborietoriestudier var reduktion af lymfocyttallet meget almindeligt efter indgivning af vaccine, og blev efterfulgt af lymfocytgendannelse og regenerering af Bursa fabricii.
English: Lyophilisate: brown reddish colour.
Danish: Lyofilisat: rødbrun farve.
English: In laboratory studies, lymphocyte depletion was very common, followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius.
Danish: I laborietoriestudier var reduktion af lymfocyttallet meget almindeligt, efterfulgt af lymfocytgendannelse og regenerering af Bursa fabricii.
English: Read the package leaflet supplied with the lyophilisate vial before use.
Danish: Læs indlægssedlen, der blev leveret med hætteglasset med lyofilisat, inden brug.
English: 17170 Amer (Girona) SPAIN
Danish: 17170 Amer (Girona) SPANIEN
English: Rinse the vial with another 2 ml of the solvent/lyophilisate suspension obtained in step 1, and inject it back into the solvent bag.
Danish: Skyl hætteglasset med 2 ml mere af solvens/lyofilisat-suspensionen fra trin 1, og injicer det i posen med solvens.
English: The vaccine (0.05 ml dose) must be injected into the amniotic sac of 18-day-old embryonated broiler chicken eggs.
Danish: Vaccinen (0,05 ml dosis) skal injiceres i fosterhinden på 18 dage gamle, embryonerede æg til slagtekyllinger.
English: Type I glass vials closed with Type I bromobutyl stoppers and sealed with aluminium caps containing 1,000 doses, 2,000 doses, 2,500 doses, 4,000 doses or 5,000 doses of the freeze-dried vaccine.
Danish: Hætteglassene indeholder 1.000 doser, 2.000 doser, 2.500 doser, 4.000 doser eller 5.000 doser af den frysetørrede vaccine.