FrancophonIA/ELRC3.0 huggingface dataset:
English: However the argumentation provided by the marketing authorisation holder to date raises some concerns that by mixing the products some of the efficacy claims for the monovalent products would not be achieved.
Danish: Den argumentation, som indehaveren af markedsføringstilladelsen har fremført hidtil, giver anledning til visse betænkeligheder med hensyn til, hvorvidt nogle af virkningsangivelserne for de monovalente lægemidler opnås, når lægemidlerne blandes.
English: Rua Agualva dos Açores, n.º
Danish: Intervet PortugalSaúde Animal, Lda Rua Agualva dos Açores, n.º 16,
English: The marketing authorisation holder has presented data on safety studies (single dose, overdose, repeated dose) starting at 4 weeks of age with Porcilis PRRS mixed with Porcilis M Hyo, considering that 4 weeks is the youngest age recommended for the administration of the mixed product.
Danish: Indehaveren af markedsføringstilladelsen har fremlagt data om sikkerhedsundersøgelser (enkeltdosis, overdosis, gentagen dosis) fra 4 ugers alderen med Porcilis PRRS, som er blandet med Porcilis M Hyo, i betragtning af at 4 uger er den yngste alder, der anbefales til indgivelsen af det blandede lægemiddel.
English: The efficacy studies using appropriate challenges for Porcilis M Hyo and Porcilis PRRS have shown that there is no affect of simultaneous administration on the efficacy parameters of reduced viraemia and a reduction in lung lesions.
Danish: Sikkerhedsundersøgelserne, hvor der anvendes passende belastninger for Porcilis M Hyo og Porcilis PRRS, har vist, at samtidig indgivelse ikke har nogen indvirkning på virkningsparametrene for reduceret viræmi og reduktion af lungelæsioner.
English: As regards justifying why no potency test of the Porcilis M Hyo component has been carried out on the mixed vaccines both immediately after mixing and after the proposed in-use shelf life, the marketing authorisation holder has justified not performing a potency test for the Porcilis M Hyo component on the mixed vaccines that by provision of safety and efficacy studies using the mixed product the marketing authorisation holder has shown that there are no interactions within the mixture affecting the potency of the mixed product.
Danish: Hvad angår begrundelserne for, at der ikke blev foretaget nogen styrketest af Porcilis M Hyokomponenten i de blandede vacciner både umiddelbart efter blandingen og efter den foreslåede holdbarhed ved brug, begrundede indehaveren af markedsføringstilladelsen den manglende udførelse af en styrketest for Porcilis M Hyo-komponenten i de blandede vacciner med, at fremlæggelsen af virknings- og sikkerhedsundersøgelser for det blandede lægemiddel havde vist, at der ikke er nogen interaktioner i blandingen, som har indflydelse på det blandede lægemiddels styrke.
English: 2.2 Justification regarding the approach followed to demonstrate the safety of the individual vaccination schemes when the two products are administered together.
Danish: 2.2 Begrundelse for den anvendte tilgang med henblik på at påvise sikkerheden af de individuelle vaccinationsplaner, når de to lægemidler indgives sammen Den foreslåede vaccinationsplan for det blandede lægemiddel er som følger:
English: The marketing authorisation holder was requested to justify why the proposed vaccination scheme (Porcilis M Hyo at 1 week of age and Porcilis M Hyo mixed with Porcilis PRRS at 4 weeks of age) was not followed to show the safety of the mixed administration.
Danish: Indehaveren af markedsføringstilladelsen blev bedt om at begrunde, hvorfor den foreslåede vaccinationsplan (Porcilis M Hyo i 1 uges alderen og Porcilis M Hyo blandet med Porcilis PRRS i 4 ugers alderen) ikke blev fulgt for at påvise den indgivne blandings sikkerhed.
English: Postfach 1130
Danish: Deutschland GmbH Postfach 1130
English: - First vaccination: Porcilis M Hyo at 1 week of age.
Danish: - Første vaccination: Porcilis M Hyo i 1 uges alderen.
English: The marketing authorisation holder considered that, based on the “Guideline on requirements for concurrent administration of immunological veterinary medicinal products*, the efficacy data of the individual products, including duration of immunity, can be applied for the concurrent use of them if absence of immunological interference is demonstrated.
Danish: På baggrund af retningslinjerne for samtidig indgivelse af immunologiske veterinærlægemidler ("Guideline on requirements for concurrent administration of immunological veterinary medicinal products*") var indehaveren af markedsføringstilladelsen af den opfattelse, at virkningsdataene for de individuelle lægemidler, herunder immunitetsvarighed, kan anvendes for samtidig brug af lægemidlerne, hvis det påvises, at der ikke er immunologisk interferens.
English: Concerning Porcilis M Hyo the marketing authorisation holder has submitted data of adjuvant content (dl--tocopherol acetate), pH and sterility of the mixture after reconstitution of 2 batches of Porcilis PRRS in 2 batches of Porcilis M Hyo after storage for 3 hours at room temperature.
Danish: Hvad angår Porcilis M Hyo, har indehaveren af markedsføringstilladelsen fremsendt data om blandingens adjuvansindhold (dl--tocopherolacetat), pH og sterilitet efter rekonstituering af 2 batcher af Porcilis PRRS i 2 batcher af Porcilis M Hyo efter opbevaring i 3 timer ved stuetemperatur.
English: Animal species
Danish: Lægemiddelform Dyre-arter Indikationer
English: PORCILIS Mhyo
Danish: Porcilis M Hyo
English: - Second vaccination: Porcilis M Hyo mixed with Porcilis PRRS from 4 weeks of age.
Danish: - Anden vaccination: Porcilis M Hyo blandet med Porcilis PRRS fra 4 ugers alderen.
English: The product literature of Porcilis PRRS should also be consulted before administration of the mixed product.
Danish: Produktresumé/indlægsseddel for Porcilis PRRS bør læses inden administration af den blandede vaccine.
English: According to the advised vaccination schedule, Porcilis M Hyo and Porcilis PRRS are used simultaneously for the first time at the second administration of Porcilis M Hyo.
Danish: Ifølge den tilrådede vaccinationsplan skal Porcilis M Hyo og Porcilis PRRS først anvendes samtidig ved anden indgivelse af Porcilis M Hyo.
English: Product name
Danish: Lægemidlets navn Styrke
English: The marketing authorisation holder has demonstrated that there is no immunological interference when the vaccines were mixed resulting in maintenance of the same level of efficacy by investigating one efficacy parameter, reduction in viraemia (reduction of 70-75% after simultaneous use and reduction of 72-75% after use of Porcilis PRRS alone).
Danish: * CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf vaccinerne blandes, eftersom undersøgelsen af et virkningsparameter, nemlig reduktionen af viræmi, viste, at der opnås samme virkningsniveau (en reduktion på 70-75 % efter samtidig brug og en reduktion på 72-75 % efter brug af Porcilis PRRS alene).
English: Belgium Intervet International bv Wim de
Danish: Grækenland Intervet International bv Wim de
English: Data on laboratory efficacy studies and on one field study were provided showing that the reduction of lung lesion score of pigs vaccinated with the mixed product is similar to the reduction of lung lesion score of pigs vaccinated with Porcilis M Hyo alone.
Danish: 2.3 Potentiel indvirkning på virkningsparameteret immunitetsvarighed som følge af en interferens, der skyldes blandingen af de to lægemidler Der blev fremlagt data fra laboratorievirkningsundersøgelser og fra en feltundersøgelse, og de viste, at reduktionen af lungelæsionsscore hos svin, der er vaccineret med det blandede lægemiddel, svarer til reduktionen af lungelæsionsscore hos svin, der er vaccineret med Porcilis M Hyo alene.
English: Indications
Danish: BIVIRKNINGER
English: The Ph.Eur.
Danish: International B.V.
English: 3 years
Danish: Zero days
English: CARBAJOSA DE LA SAGRADA
Danish: CARBAJOSA DE LA SAGRADA 37188 SALAMANCA Spain
English: Marketing Authorisation Holder
Danish: Medlemstat/EU Indehaver af Markedsføringstilladelsen
English: Germany Intervet Deutschland GmbH
Danish: Unterschleißheim Germany
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: (Reference is made to the pictogram of a dog in section 1).
Danish: (Med reference til pictogrammet af en hund i sektion 1).
English: Date of first authorisation: 10/12/2019.
Danish: Dato for første markedsføringstilladelse: 10/12/2019.
English: EU/2/19/246/001 (2 tubes) EU/2/19/246/002 (10 tubes) EU/2/19/246/003 (20 tubes)
Danish: EU/2/19/246/001 (2 tuber) EU/2/19/246/002 (10 tuber) EU/2/19/246/003 (20 tuber)
English: Studies to determine the effect on fertility in dogs have not been conducted.
Danish: Studier til bestemmelse af effekten på fertiliteten hos hunde er ikke udført.
English: Single treatment.
Danish: Enkeltdosisbehandling.
English: The veterinary medicinal product has serious eye irritation potential.
Danish: Veterinærlægemidlet har et alvorligt potentiale for øjenirritation.
English: ATCvet code: QS02CA91
Danish: ATCvet-kode: QS02CA91
English: The maximum clinical response may not be seen until 28 days after administration.
Danish: Det maksimale kliniske respons ses muligvis ikke før 28 dage efter administrering.
English: Additional corticosteroid treatments should be avoided.
Danish: Yderligere behandling med kortikosteroider skal undgås.
English: Do not use in dogs with generalised demodicosis.
Danish: Bør ikke anvendes til hunde med generaliseret demodicose.
English: Accidental eye exposure may occur when the dog shakes its head during or just after administration.
Danish: Uhensigtsmæssig eksponering af øjnene, kan forekomme når hunden ryster hovedet under eller lige efter administration.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the outer carton and container label after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på den ydre emballage og etiketten efter EXP.
English: In cases of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Danish: I tilfælde af parasitær otitis bør en passende acaricidal behandling igangsættes.
English: 2 tubes 10 tubes 20 tubes
Danish: 2 tuber 10 tuber 20 tuber
English: May be harmful after ingestion.
Danish: Kan være skadelig efter indtagelse.
English: Whenever possible, the use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing.
Danish: Når det er muligt bør anvendelse af veterinærlægemidlet altid være baseret på identifikation af de inficerende organismer, samt en følsomhedstest.
English: Bacterial and fungal otitis is often secondary to other conditions.
Danish: Bakterie- og svampebetinget otitis opstår ofte sekundært til andre tilstande.
English: The extent of transcutaneous absorption of topical medications is determined by many factors including the integrity of the epidermal barrier.
Danish: Omfanget af transkutan absorption af topikale lægemidler bestemmes af mange faktorer, herunder tilstanden af den epidermale barriere.
English: In clinical trials, only saline was used for ear cleaning before treatment initiation with the veterinary medicinal product.
Danish: I kliniske forsøg blev der udelukkende anvendt saltvand til ørerensning inden behandling med veterinærlægemidlet blev påbegyndt.
English: Systemic absorption of the three active substances was determined after single co-administration into one ear canal of healthy beagle dogs.
Danish: Den systemiske absorption af de tre aktive stoffer blev fastlagt efter en enkelt co-administrering ind i en øregang på raske hunde af racen beagle.
English: Like other corticosteroids, it has antiinflammatory and anti-pruritic properties.
Danish: Som andre kortikosteroider har det antiinflammatoriske og anti-puritiske egenskaber.
English: Inflammation can increase the transcutaneous absorption of veterinary medicinal products across the skin adjacent to the external opening of the ear canal.
Danish: Inflammation kan øge den transkutane absorption af veterinærlægemidler over den tilstødende hud omkring den udvendige åbning af ørekanalen.
English: The safety of the veterinary medicinal product has not been established in dogs less than 3 months of age.
Danish: Veterinærlægemidlets sikkerhed er ikke fastlagt hos hunde, der er under 3 måneder gamle.
English: Auricular administration of up to five times the recommended dose at biweekly intervals for a total of three treatments was generally well tolerated.
Danish: Anvendelse i øret med op til 5 gange den anbefalede dosis i hver anden uge med ialt 3 behandlinger blev generelt tolereret godt.
English: Propylene carbonate Propylene glycol Ethanol (96 per cent) Macrogol 8000
Danish: Propylencarbonat Propylenglycol Ethanol 96% Macrogol 8000
English: Re-evaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment.
Danish: Undersøg hunden igen hvis der observeres tab af hørelse eller tegn på vestibulær dysfunktion under behandlingen.
English: Terbinafine hydrochloride is an allylamine with a pronounced fungicidal activity.
Danish: Terbinafinhydrochlorid er et allylamin med udtalt fungicid aktivitet.
English: Pharmacotherapeutic group: Otologicals/Corticosteroids and anti-infectives in combination.
Danish: Farmakoterapeutisk gruppe: Otologica - cortikosteroider og antiinfectiva i kombination.
English: Shake well before use for 5 seconds.
Danish: Ryst grundigt i 5 sekunder før brug.
English: Mometasone furoate is a corticosteroid with high potency.
Danish: Mometasonfuroat er et høj potent kortikosteroid.
English: Clear, colourless to yellow, slightly viscous liquid.
Danish: Klar, farveløs til gul, svagt viskøs væske.
English: To avoid this risk for the owners, it is recommended that this veterinary product is administered only by veterinarians or under their close supervision.
Danish: For at undgå unødig risiko for ejerne, er det anbefalet at dette veterinærlægemiddel kun administreres af dyrlæger eller under en dyrlæges nøje overvågning.
English: The recommended dosage is 1 single-dose container (i.e. 1 ml of solution) per infected ear.
Danish: Den anbefalede dosis er 1 enkeltdosisbeholder (dvs. 1 ml opløsning) per inficeret øre.
English: However, no safety issues were identified in field studies in dogs weighing less than 4kg.
Danish: Dog sås der ingen sikkerhedsproblemer i feltstudier af hunde med en vægt på under 4 kg.
English: Restrain the dog's head to prevent shaking, for 2 minutes.
Danish: Undgå at hunden ryster hovedet i 2 minutter.
English: Pack sizes: 2, 10 or 20 tubes.
Danish: Pakningsstørrelser: 2, 10 eller 20 tuber.
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria including Staphylococcus pseudintermedius (MIC90 of 2 μg/ml).
Danish: Dets aktivitetsspektrum omfatter Gram-positive og Gram-negative bakterier inklusive Staphylococcus pseudintermedius (MIC90 på 2 μg/ml).
English: After 3 weekly administrations of up to 5x the recommended posology, the test product induced slight erythema in one or both ears that returned to normal within 48 hours.
Danish: Efter 3 ugentlige behandlinger med op til 5 gange den anbefalede dosis, inducerede testproduktet et let erytem i et eller begge ører, som blev normale igen efter 48 timer.
English: Avoid ingestion of the product including hand-to-mouth exposure.
Danish: Undgå indtagelse af produktet inklusive hånd-til-mund kontakt.
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic).
Danish: Lægemidlet er en kombination af tre aktive stoffer (kortikosteroid, antimykotikum og antibiotikum).
English: Gently massage the base of the ear for 30 seconds to allow distribution of the solution.
Danish: Massér blidt basis af øret i 30 sekunder for at opløsningen fordeler sig jævnt.
English: Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis, through binding to and acting on the 50S ribosomal subunit of bacteria.
Danish: Florfenicol er et bakteriostatisk antibiotikum, hvis effekt er at hæmme proteinsyntesen ved at binde sig til og virke på bakteriens 50S ribosomale subunit.
English: Do not use in case of hypersensitivity to the active substances, to other corticosteroids or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed overfor de aktive stoffer, overfor andre kortikosteroider eller overfor et eller flere af hjælpestofferne.
English: Administration by a veterinarian surgeon or under their close supervision.
Danish: Administreres af en dyrlæge eller under en dyrlæges nøje overvågning.
English: In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes.
Danish: I tilfælde af utilsigtet kontakt med øjnene, skylles øjnene grundigt med vand i 10-15 minutter.
English: Use with caution in dogs with a suspected or confirmed endocrine disorder (e.g., diabetes mellitus, hypo- or hyperthyroidism, etc.).
Danish: Anvendes med forsigtighed til hunde med formodet eller bekræftet endokrin lidelse (f.eks. diabetes mellitus, hypo- eller hyperthyroidisme osv.).
English: Cfr modifies the RNA in the drug binding site (causing reduced affinity to chloramphenicol, florfenicol and clindamycin) and the cfr gene can be present in plasmids or other transmissible elements.
Danish: Cfr modificerer RNA'et i stoffets bindingssted (resulterer i reduceret affinitet overfor chloramphenicol, florfenicol og clindamycin), og cfr genet kan være tilstede i plasmider eller andre transmissible elementer.
English: Other potentially treatment-related effects included mild changes to aspartate aminotransferase (AST), total protein, cholesterol, inorganic phosphorus, creatinine and calcium.
Danish: Andre potentielt behandlings relaterede virkninger inkluderer lette ændringer til aspartat aminotransferase (AST), total protein, kolesterol, uorganisk fosfor, kreatin og calcium.
English: Ears must be cleaned before administration of the product.
Danish: Ørerne skal renses inden administration af produktet.
English: Although no potential for skin irritation was indicated by experimental studies, contact of the product with the skin should be avoided.
Danish: Selv om der ikke ses hudirritation i eksperimentelle studier, bør kontakt med huden undgås.
English: FexA codes for a membrane associated efflux system (affecting both florfenicol and chloramphenicol efflux) and is found in chromosomes as well as in plasmids.
Danish: FexA koder for et membran associeret efflux system (påvirker både florfenicol og cloramphenicol efflux) og er fundet i kromosomer, samt plasmider.
English: Terbinafine hydrochloride has a different mode of action to azole antifungals, therefore there is no cross-resistance with azole antifungals.
Danish: Terbinafinhydrochlorid har en anden virkningsmekanisme end azolantimykotika, og der er derfor ingen krydsresistens med azolantimykotika.
English: It selectively inhibits the early synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis (MIC90 of 1 μg/ml).
Danish: Det hæmmer selektivt den tidlige syntese af ergosterol, som er en vigtig del af membranen i gærsvampe og svampe, inklusiv Malassezia pachydermatis (MIC90 på 1 μg/ml).
English: Appropriate measures (e.g. wearing safety glasses during administration, massaging the ear canal well after administration to ensure even distribution of product, restraining the dog after administration) are needed to avoid exposure to the eyes.
Danish: Der skal foretages nødvendige foranstaltninger (fx brug af sikkerhedsbriller under administration, massage af ørekanalen for at sikre en jævn fordeling af produktet, fastholdelse af hunden efter administration) for at undgå eksponering af øjnene.
English: Carton containing 2, 10 or 20 blisters.
Danish: Æske med 2, 10 eller 20 blistere.
English: Compatibility with ear cleaners, other than saline solution, has not been demonstrated.
Danish: Der er ikke påvist forligelighed med andre ørerensningsmidler end saltvandsopløsninger.
English: Florfenicol resistance genes detected in staphylococci include cfr and fexA.
Danish: Florfenicol resistente gener detekteret i stafylokokker inkluderer cfr og fexA.
English: Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324, 24106 Kiel
Danish: Fremstiller ansvarlig for batchfrigivelse: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324, 24106 Kiel
English: Decreased cortisol levels were observed after product instillation in tolerance studies (before and after ACTH stimulation), indicating that mometasone furoate is absorbed and enters the systemic circulation.
Danish: I tolerance studier (før og efter ACTH stimulering) blev der observeret reducerede niveauer af kortisol efter inddrypning af produkt, hvilket indikerer, at mometasonfuroat bliver absorberet og indgår i den systemiske cirkulation.
English: It is recommended not to repeat ear cleaning until 28 days after administration of the product.
Danish: Ørerne bør ikke renses igen før 28 dage efter administration af produktet.
English: Ear drops, solution.
Danish: Øredråber, opløsning.
English: In case of exposure to the eye, rinse with plenty of water.
Danish: I tilfælde af produktet kommer i øjet skylles med rigeligt vand.
English: Do not use during pregnancy and lactation.
Danish: Må ikke anvendes under drægtighed eller laktation.
English: Mean peak plasma concentrations (Cmax) were low with 1.73 ng/ml florfenicol, 0.35 ng/ml mometasone furoate and 7.83 ng/ml terbinafine HCl reached at the tmax of 24 h, 0.5 h and 20 h after treatment, respectively.
Danish: De gennemsnitlige maksimale serumkoncentrationer (Cmax) var lave med 1,73 ng/ml florfenicol, 0,35 ng/ml mometasonfuroat og 7,83 ng/ml terbinafin HCl opnået ved tmax på hhv. 24 t, 0.5 t og 20 t efter behandling.
English: Single-use sealed laminated tube containing 1 ml solution, with polypropylene cap and separate LDPE applicator nozzle packed in a transparent plastic blister.
Danish: Forseglet og lamineret enkeltdosistube, indeholdende 1 ml opløsning, med polypropylen hætte og separat LDPE påføringsspids pakket i blister af transparant plastik.
English: Do not use if the ear drum is perforated.
Danish: Bør ikke anvendes, hvis trommehinden er perforeret.
English: Clean and dry the external ear canal before administering the product.
Danish: Rens og tør den ydre øregang før administrering af produktet.
English: Insert the applicator nozzle into the affected external ear canal and squeeze the entire contents into the ear.
Danish: Indfør påføringsspidsen i den påvirkede ydre øregang og tryk hele indholdet ind i øret.
English: In animals with a history of recurrent otitis externa, the underlying causes of the condition such as allergy or anatomical conformation of the ear must be addressed in order to avoid ineffective treatment with a veterinary medicinal product.
Danish: Hos dyr med en historik af recidiverende otitis externa skal den underliggende årsag f.eks. allergi eller ørets anatomi tages i betragtning for at undgå ineffektiv behandling med et veterinærlægemiddel.
English: Ataxia, internal ear disorder, nystagmus, emesis, application site erythema, hyperactivity, anorexia and application site inflammation were reported very rarely in spontaneous (pharmacovigilance) reports.
Danish: Ataksi, forstyrrelser i det indre øre, nystagmus, opkastning, erythem på applikationsstedet, hyperaktivitet, anorexi og inflammation på applikationsstedet blev rapporteret men er sjældne i spontane bivirkningsrapporter.
English: If hypersensitivity to any of the components occurs, the ear should be thoroughly washed.
Danish: Hvis der opstår overfølsomhed overfor et eller flere af indholdsstofferne bør øret vaskes grundigt.