FrancophonIA/ELRC3.0 huggingface dataset:
English: Interaction with other medicinal products and other forms of interaction: Compatibility with ear cleaners has not been demonstrated.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Der er ikke fastlagt kompatibilitet med ørerens.
English: The diesters are transformed inside the skin structures in C17 monoesters responsible for the potency of the therapeutic class.
Danish: Diesterne omdannes i hudens struktur til C17 monoester, der er ansvarlige for potensen af den terapeutiske klasse.
English: The product as presented allows treating a dog suffering from bilateral otitis.
Danish: Som præsenteret gør produktet det muligt at behandle hunde, der lider af bilateral øregangsbetændelse.
English: In dogs treated at the therapeutic dose for ten consecutive days, serum cortisol levels decreased from five days onward and returned to normal values within ten days after the end of treatment.
Danish: Hos hunde, der blev behandlet med den terapeutiske dosis i ti sammenhængende dage, faldt niveauet af serum-cortisol fra dag fem og derefter og vendte tilbage til normale værdier indenfor ti dage efter endt behandling.
English: The airless pump allows the product to be administered whatever the position of the bottle is.
Danish: Den luftløse pumpe gør det muligt at dosere præparatet uanset flaskens position.
English: In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
Danish: I alle tilfælde fortsatte behandlingen med veterinærlægemidlet og alle hunde blev raske uden særlig behandling.
English: Whatever the size
Danish: Uanset hundens størrelse
English: Mild to moderate redness of the ear was common (2.4% of treated dogs).
Danish: Let til moderat rødme i øret er hyppig (2,4 % af de behandlede hunde).
English: Whatever the position
Danish: Uanset flaskens position
English: • Shake the pipette thoroughly before use.
Danish: • Ryst pipetten grundigt før brug.
English: See section 4.5 of the SPC.
Danish: Se afsnit 4.5 i produktresuméet.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: [Single-dose container:]
Danish: [Enkeltdosisbeholder:]
English: The diesters are lipophilic components ensuring an enhanced penetration into the skin associated with low systemic bioavailability.
Danish: Diestererne er fedtopløselige komponenter, der sikrer en forbedret penetration gennem huden sammen med lavere systemisk biotilgængelighed.
English: Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Danish: Gentamicin er kendt for at være forbundet med ototoxicitet når det anvendes systemisk i højere doser.
English: All Escherichia coli isolates were fully susceptible to gentamicin.
Danish: Alle isolerede Escherichia coli var fuldt modtagelige for gentamicin.
English: Liquid paraffin.
Danish: Flydende paraffin.
English: Papules were observed uncommonly (less than 1% of treated dogs).
Danish: Papeldannelse er sjælden (mindre end 1 % af de behandlede hunde).
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental skin contact, it is recommended to wash thoroughly with water.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Ved utilsigtet kontakt med huden anbefales det at skylle grundigt efter med vand.
English: Incompatibilities: Do not mix with other veterinary medicinal products.
Danish: Uforligeligheder: Må ikke blandes med andre lægemidler til dyr.
English: In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Danish: I tilfælde af parasitær otitis externa, bør en passende acaricidbehandling indledes.
English: See also “Special precautions for use in animals”.
Danish: Se også ”Særlige forholdsregler til brug hos dyr”.
English: Co-resistance has been described, i.e. gentamicin resistance genes are found to be physically linked to other antimicrobial resistance genes that are transferred between pathogens due to transferable genetic elements such as plasmids, integrons and transposons.
Danish: Co-resistens er blevet beskrevet, dvs. det er fastslået, at gentamicinresistente gener er fysisk forbundet med andre antimikrobielle resistente gener, som overføres mellem patogener på grund af genetiske elementer, der kan overføres, såsom plasmider, integroner og transposoner.
English: However, serum cortisol response levels post ACTH stimulation remained in the normal range during the extended treatment period, indicating a preserved adrenal function.
Danish: Alligevel forblev serum-cortisol-svarniveauet efter ACTH-stimulation på det normale niveau under den udvidede behandlingsperiode, hvilket indikerer fortsat adrenal funktion.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports.
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Date of first renewal: 11/11/2013.
Danish: Dato for første fornyelse af markedsføringstilladelse: 11/11/2013
English: The veterinary medicinal product should be used at room temperature (i.e. do not instil cold product).
Danish: Veterinærlægemidlet bør anvendes ved stuetemperatur (dvs. tilfør ikke koldt præparat).
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Ikke relevant
English: No standardised in-vitro susceptibility breakpoints have been defined for miconazole; however, using the method by Diagnostics Pasteur, no resistant strains were found.
Danish: For miconazol er der ikke defineret en standardiseret in-vitro følsomhed breakpoint, men ved undersøgelser efter Diagnostics Pasteurs metode, blev der ikke fundet resistente stammer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 5, 10, 50, 100 or 200 PIPETTES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 5, 10, 50, 100 eller 200 PIPETTER
English: Use of the veterinary medicinal product should be based on identification of infecting organisms and susceptibility testing and take into account official and local antimicrobial policies.
Danish: Brug af veterinærlægemidlet bør baseres på identifikation af de inficerende organismer og resistensbestemmelse samt tage højde for officielle lokale antimikrobielle politikker.
English: Multi-dose container composed of two extruded parts, one external white polypropylene rigid tube and one internal (ethylene-methacrylic acid)-zinc copolymer (Surlyn) flexible pouch containing a steel ball, closed with a 1 ml dosing airless pump equipped with a flexible atraumatic cannula and covered by a plastic cap.
Danish: Multidosisbeholder bestående af to ekstruderede dele, en rigid, hvid, ekstern polypropylentube og en intern fleksibel pose af (ethylen-methacrylsyre)-zink copolymer (Surlyn), der indeholder en stålbold lukket med en 1 ml luftfri doseringspumpe udstyret med en fleksibel atraumatisk kanyle og overdækket med en plasticprop.
English: Do not use concurrently with substances known to cause ototoxicity.
Danish: Bør ikke anvendes samtidig med stoffer, kendt for at forårsage ototoxicitet.
English: 20146 Milano Tel: 39 02 40 92 47 1
Danish: I-20146 Milano Tel: 39 02 40 92 47 1
English: Cross-resistance is mainly linked with efflux pumps which confer resistance to β-lactams, quinolones and tetracyclines depending on the specificity of the pump with its substrate.
Danish: Krydsresistens er hovedsagligt forbundet med effluxpumper, der giver resistens til β-lactamer, quinoloner og tetracycliner afhængigt af pumpens specificitet med ens substrat.
English: Before the veterinary medicinal product is applied, the external auditory canal must be examined thoroughly to ensure that the ear drum is not perforated in order to avoid the risk of transmission of the infection to the middle ear and to prevent damage to the cochlear and vestibular apparatus.
Danish: Før veterinærlægemidlet anvendes, bør den ydre øregang undersøges for at sikre, at trommehinden ikke er perforeret, for at undgå risiko for overførsel af infektion til mellemøret og for at forebygge skade på det cochleære og vestibulære apparat.
English: In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
Danish: I laboratoriet eliminerer dyr hydrocortisonaceponat på samme måde som hydrocortison (andet navn for endogen cortisol) gennem urin og afføring.
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria, such as the following pathogenic organisms isolated from the ears of dogs: Staphylococcus intermedius, Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli, etc.
Danish: Dets aktivitetsspektrum inkluderer grampositive og gramnegative bakterier, såsom følgende patogene organismer isoleret fra hundenes ører: Staphylococcus intermedius, Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli, osv.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Danish: Sikkerheden af veterinærlægemidlet under drægtighed og laktation er ikke fastlagt.
English: 23843 Bad Oldesloe Tel: 49 (4531) 805 111
Danish: D-23843 Bad Oldesloe Tel: 49 (4531) 805 111
English: Gentamicin resistant bacteria isolated from the field between 2008 and 2010 in canine otitis before treatment (determined according to CLSI guideline breakpoint ≥ 8 for all isolates except for Staphylococci ≥ 16 μg/ml) were low: 4.7%, 2.9% and 12.5% for Staphylococcus spp., Pseudomonas and Proteus spp.
Danish: Der var en lav forekomst af gentamicinresistente bakterier, isolerede i otitis hos hunde før behandling mellem 2008 og 2010 (fastsat ifølge CLSI guideline, breakpoint ≥ 8 for alle isoleringer undtagen for stafylokokker ≥ 16 μg/ml): 4,6%, 2,9% og 12,5% for henholdsvis Staphylococcus spp., Pseudomonas and Proteus spp.
English: Compatibility with ear cleaners has not been demonstrated.
Danish: Der er ikke fastlagt kompatibilitet med ørerens.
English: Hydrocortisone aceponate belongs to the diesters' class of glucocorticosteroids.
Danish: Hydrocortisonaceponat hører til diester-gruppen af glucocorticosteroider.
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 utilsigtet indtagelse søges omgående lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Box containing 1 multi-dose container (the content of 10 ml is equivalent to 10 doses).
Danish: Æske med 1 multidosisbeholder (indholdet på 10 ml svarer til 10 doser).
English: At 3 and 5 times the recommended dose, no local or general adverse reactions were observed with the exception of some dogs showing erythema and papulae in the ear canal.
Danish: Ved 3 og 5 gange den anbefalede dosis, blev der ikke observeret lokale eller generelle modreaktioner bortset fra få hunde, der fik rødmen og papeldannelse i øregangen.
English: After application of the veterinary medicinal product into the ear canal, absorption of miconazole and gentamicin through the skin is negligible.
Danish: Efter tilførsel af veterinærlægemidlet i øregangen, er absorption af miconazol og gentamicin gennem huden ubetydelig.
English: In very rare cases, the use of the veterinary medicinal product has been associated with hearing impairment (partial hearing loss or deafness), usually temporary, and primarily in geriatric dogs.
Danish: I meget sjældne tilfælde, er brugen af veterinærlægemidlet sat i forbindelse med høretab (nedsat hørelse eller døvhed), som normalt har været midlertidig, og primært hos geriatriske hunde.
English: This dose is adequately delivered by one pump activation.
Danish: Denne dosis svarer til et tryk på pumpen.
English: Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved.
Danish: Betændelse i øregangen forårsaget af bakterier og svampe er ofte af sekundær natur og en passende diagnose bør anvendes for at fastlægge de primære faktorer.
English: In very rare cases, Type-I Hypersensitivity reactions (facial swelling, allergic pruritus) have been observed.
Danish: I meget sjældne tilfælde, er der observeret type-I hypersensitivitetsreaktioner (hævelse i hovedet, allergisk pruritus).
English: C/Angel Guimera 179-18108950 - Esplugues de Llobregat (Barcelona) Tel: 34 (93) 470 79 40
Danish: C/Angel Guimera 179-181E-08950 - Esplugues de Llobregat (Barcelona) Tel: 34 (93) 470 79 40
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/085/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/08/085/001
English: In case of accidental contact, rinse with abundant quantities of water.
Danish: Ved utilsigtet kontakt med øjnene skylles øjnene med rigelige mængder vand.
English: It is recommended that the external ear canal should be cleaned and dried before treatment and excess hair around the treatment area be cut.
Danish: Det anbefales at rense og tørre den ydre øregang før behandling og overskydende hårvækst omkring behandlingsområdet bør afklippes.
English: EXPIRY DATE EXP {month/year} Once opened use within 10 days.
Danish: EXP Efter åbning anvendes indenfor 10 dage.
English: 23 rd Klm National Road Athens-Lamia 14565 Agios Stefanos (Athens) Tel: 30 210 6219520
Danish: 23 rd Klm National Road Athens-Lamia GR-14565 Agios Stefanos (Athens) Tel: 30 210 6219520
English: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted.
Danish: Hvis overfølsomhed overfor nogen af indholdsstofferne iagttages, bør behandlingen ophøre og passende terapi iværksættes.
English: 06516 Carros FRANCE
Danish: 06516 Carros FRANKRIG
English: The recommended dosage is 1 ml of the veterinary medicinal product per infected ear once a day for five consecutive days.
Danish: Den anbefalede dosis er 1 ml af veterinærlægemidlet per inficeret øre én gang dagligt i fem på hinanden følgende dage.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 1 MULTI-DOSE CONTAINER OF 10 DOSES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED 1 MULTIDOSISBEHOLDER MED 10 DOSER
English: 3771 ND-Barneveld Tel.: 31 (0) 342 427 100
Danish: NL-3771 ND-Barneveld Tel.: 31 (0) 342 427 100
English: In case of accidental skin contact, it is recommended to wash thoroughly with water.
Danish: Ved utilsigtet kontakt med huden anbefales det at skylle grundigt efter med vand.
English: [Multi-dose container:] Shake the bottle thoroughly before first administration and prime the pump by pressing it.
Danish: [Multidosisbeholder:] Før første dosering rystes flasken grundigt og pumpen fyldes ved at trykke på den.
English: United Kingdom VIRBAC LTD Suffolk IP30 9 UP Tel: 44 (0) 1359 243243
Danish: United Kingdom VIRBAC LTD UK-Suffolk IP30 9 UP Tel: 44 (0) 1359 243243
English: The recommended dosage is 1 ml of the veterinary medicinal product per ear once a day for five consecutive days.
Danish: Den anbefalede dosis er 1 ml af veterinærlægemidlet per øre en gang dagligt i fem dage.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):
Danish: Veterinærlægemidlet er en fast kombination af tre aktive substanser (corticosteroid, svampehæmmende og antibiotisk):
English: Shake the bottle thoroughly before first administration and prime the pump by pressing it. Introduce the atraumatic canula in the ear canal.
Danish: Før første dosering rystes flasken grundigt og pumpen fyldes ved at trykke på den. Indfør den atraumatiske kanyle i øregangen.
English: PACKAGE SIZE 10 ml (10 doses).
Danish: 10 ml (10 doser).
English: To administer one dose (1 ml) of the product in the affected ear:
Danish: For at tilføre 1 dosis (1 ml) af præparatet i det påvirkede øre:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs Hydrocortisone aceponate - Miconazole - Gentamicin
Danish: VETERINÆRLÆGEMIDLETS NAVN Easotic øredråber suspension til hunde hydrocortisonaceponat - miconazol - gentamicin
English: Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis.
Danish: Gentamicinsulfat er et bakteriedræbende antibiotika af typen aminoglycosid, som virker ved at hindre protein syntesen.
English: The bacterial resistance phenotypes to gentamicin are mainly based on three mechanisms: enzymatic modification of aminoglycosides, failure of intracellular penetration of the active substance and alteration of the aminoglycoside target.
Danish: Fænotypers bakterielle resistens overfor gentamicin er hovedsagligt baseret på tre mekanismer: enzymatisk modifikation af aminoglucosider, hæmning af de aktive substanser og ændring af aminoglycoside-målet.
English: Hydrocortisone aceponate belongs to the diester class of the glucocorticosteroids with a potent intrinsic glucocorticoid activity which means a relief of both inflammation and pruritus leading to an improvement of clinical signs observed in otitis externa.
Danish: Hydrocortisonaceponat hører til diester-klassen af glucocorticosteroider og har en potentiel indre glucocorticoidaktivitet, hvilket betyder lindring af både inflammation og kløe, der fører til forbedret kliniske tegn observeret i forbindelse med øregangsbetændelse.
English: Single-dose container: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Danish: Enkeltdosisbeholder: Opbevaringstid for veterinærlægemidlet i salgspakning: 18 måneder.
English: Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis.
Danish: Miconazol hæmmer selektivt syntesen af ergosterol, hvilket er et essentielt komponent af membranen i gær og svampe inklusiv Malassezia pachydermatis.
English: To be supplied only on veterinary prescription.
Danish: Må kun anvendes af dyrlæger.
English: The veterinary medicinal product is a fixed combination of three active substances: antibiotic, antifungal and corticosteroid.
Danish: Dette veterinærlægemiddel er en fast kombination af tre aktive substanser: antibiotika, svampehæmmende og corticosteroid.
English: 1 dose x 100 1 dose x 200
Danish: 1 dosis x 100 1 dosis x 200
English: 76505 Saue/Harjumaa Tel: + 372 6 709 006
Danish: ET - 76505 Saue/Harjumaa, ESTONIA Tel: + 372 6 709 006
English: Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria and fungi resistant to gentamicin and miconazole respectively and may decrease the effectiveness of treatment with aminoglycosides and azole antifungal agents, due to the potential for cross-resistance.
Danish: Brug af veterinærlægemidler, der afviger fra instruktionerne i produktresuméet kan føre til øget prævalens af henholdsvis gentamicin- og miconazol-resistente bakterier og svampe og kan mindske effektiviteten af behandlingen med aminoglycosider og antifungale azoler på grund af muligheden for krydsresistens.
English: Shelf life after first opening the multi-dose container: 10 days.
Danish: Opbevaringstid efter første åbning af multidosisbeholder: 10 dage.
English: Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca Tel: +357 24813333
Danish: Panchris Feeds (Veterinary) Ltd Industrial Area Aradippou, 7100, Larnaca, Cyprus (P.O.Box 40261, 6302 Larnaca, Cyprus) Tel: +357 24813333
English: Shelf life after first opening the immediate packaging: 10 days.
Danish: Opbevaringstid efter første åbning af den indre emballage: 10 dage.
English: Pharmacotherapeutic group: Otologicals, corticosteroids and antiinfectives in combination.
Danish: Farmakoterapeutisk gruppe: Otologica - hydrocortison og anti-infectiva.
English: INDICATION(S) METHOD AND ROUTE(S) OF ADMINISTRATION For auricular use only.
Danish: INDIKATION(ER) ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Kun til brug i ørerne.
English: Administer one dose (1 ml) of the product in each affected ear.
Danish: Tilfør en dosis (1 ml) af præparatet i hvert påvirket øre.
English: EXPIRY DATE EXP {month/year}
Danish: 10. UDLØBSDATO EXP
English: Do not use in case of hypersensitivity to the active substances or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer, et eller flere af hjælpestofferne, over for corticosteroider, over for andre antimykologiske azole-stoffer og over for aminoglycosider.
English: Mechanisms of resistance to azoles consist of either failure in antifungal accumulation or modification of target enzyme.
Danish: Resistensmekanismerne overfor azoler består enten af udeblivelse af ophobning af svampehæmmere eller modifikation af målenzymet.
English: Multi-dose container:
Danish: Multidosisbeholder:
English: After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.
Danish: Efter tilførsel masseres øret kort og blidt for at få præparatet til at trænge ind i de nedre dele af øregangen.
English: Treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to gentamicin and fungi susceptible to miconazole in particular Malassezia pachydermatis.
Danish: Behandling af akut betændelse i øregangen (otitis externa) og akut forværring af tilbagevendende betændelse i øregangen forårsaget af gentamicin-følsomme bakterier og miconazol-følsomme svampe, særligt Malassezia pachydermatis.
English: Systemic absorption of hydrocortisone aceponate, gentamicin sulphate and miconazole nitrate being negligible, it is unlikely for teratogenic, foetotoxic or maternotoxic effects to occur at the recommended dosage in dogs.
Danish: Systemisk optagelse af hydrocortisonaceponat, gentamicinsulfat og miconazolnitrat er minimal, og der er dermed ikke risiko for teratogene virkninger, føtal toksicitet eller maternel toksicitet ved anvendelse af de anbefalede doser til hunde.
English: Gentamicin as sulphate
Danish: Gentamicinsulfat
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: VIRBAC
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY ANDUSE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity.
Danish: Miconazolnitrat er et syntetisk imidazolderivat med en udpræget svampehæmmende virkning.
English: PHARMACEUTICAL FORM Ear drops, suspension.
Danish: LÆGEMIDDELFORM Øredråber, suspension.