FrancophonIA/ELRC3.0 huggingface dataset:
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 almindelige (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 ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: The effect of shampooing or immersion in water of the animal has not been tested and should be avoided.
Danish: Virkningen af shamponering/badning i vand af dyret er ikke undersøgt og bør undgås.
English: Unlike other species, fipronil sulfone is not formed in cat.
Danish: Til forskel fra andre arter dannes fipronilsulfon ikke i katten.
English: Children should not be allowed to play with treated animals during this period.
Danish: Børn bør ikke gives lov til at lege med det behandlede dyr i den periode.
English: BROADLINE or empty container should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Danish: BROADLINE eller tom emballage må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Disintegrated and partially digested fragments may occasionally be seen in the faeces.
Danish: Opløste og delvist fordøjede fragmenter kan lejlighedsvis ses i fæces.
English: Applicator
Danish: Applikator
English: Praziquantel has a moderate tissue distribution, and about 64-84% of praziquantel is bound to plasma proteins.
Danish: Praziquantel har moderat vævsdistribution, og ca. 64-84 % praziquantel bindes til plasmaproteiner.
English: For treatment against Aelurostrongylus abstrusus, a second administration one month after the initial treatment may be recommended.
Danish: Ved behandling mod Aelurostrongylus abstrusus anbefales eventuelt en opfølgende administration en måned efter den første behandling.
English: Therefore, epidemiological information about current susceptibility of the target species should be taken into account in order to limit the possibility of a future selection for resistance.
Danish: Derfor bør der tages hensyn til epidemiologiske oplysninger om gældende følsomhed hos målarterne for at begrænse muligheden for fremtidig selektion for resistens.
English: Fipronil sulfone, as a photodegradation product of fipronil, is also found on the hair.
Danish: Fipronilsulfon, som et fotonedbrydningsprodukt af fipronil, er også fundet i pelsen.
English: The peak plasma concentrations of the absorbed fraction of fipronil and (S)-methoprene are reached within 8 to 9 hours.
Danish: Maksimal plasmakoncentration af den absorberede del af fipronil og (S)-methopren nås inden for 8-9 timer.
English: Treatment should not be extrapolated from one animal to the other without veterinary opinion.
Danish: Behandling bør ikke ekstrapoleres fra et dyr til et andet uden dyrlægens vurdering.
English: No data on the effect of bathing/shampooing on the efficacy of the veterinary medicinal product in cats is available.
Danish: Der foreligger ingen data for, hvordan badning/shamponering påvirker veterinærlægemidlets virkning hos kat.
English: Avoid contact with the cat's eyes.
Danish: Undgå at præparatet kommer i kontakt med kattens øjne.
English: The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.
Danish: Veterinærlægemidlet er udelukkende indiceret når der behandles samtidigt for alle tre grupper.
English: The veterinary medicinal product is not intended for use in dogs.
Danish: Veterinærlægemidlet er ikke beregnet til hunde.
English: Once absorbed, eprinomectin is highly bound to plasma proteins (> 99%), has low clearance from blood, and distributes well into tissues.
Danish: Når eprinomectin er absorberet bindes det især til plasmaproteiner (>99 %), har en lav blodclearance og distribueres godt i væv.
English: Echinococcosis represents a hazard for humans, and is a notifiable disease to the World Organisation for Animal Health (OIE).
Danish: Ekinokok-infektion er farlig for mennesker, og sygdommen er anmeldepligtig ifølge World Organisation for Animal Health (OIE).
English: Cat weight
Danish: Kattens vægt
English: Select the applicator size (or combination of applicators, for cats >7.5 kg) adapted to the cat's weight.
Danish: Vælg den applikatorstørrelse (eller kombination af applikatorer, til katte >7,5 kg) som passer til kattens vægt.
English: The ectoparasitic activity of fipronil and (S)-methoprene is mediated by direct contact with the ectoparasites rather than by systemic exposure.
Danish: Den ektoparasitære aktivitet af fipronil og (S)-methopren sker via direkte kontakt med ektoparasitterne snarere end via systemisk eksponering.
English: In case of massive flea infestation and at the beginning of the control measures, these areas should be treated with a suitable environmental product and then vacuumed regularly.
Danish: I tilfælde af massivt loppeangreb samt ved starten af behandlingen skal omgivelserne derfor behandles med et egnet bekæmpelsesmiddel og derefter støvsuges regelmæssigt.
English: 4 Chemin du Calquet, 31000 Toulouse FRANCE
Danish: 4 Chemin du Calquet 31000 Toulouse FRANKRIG
English: In these severe cases concomitant treatment may be necessary.
Danish: I disse tilfælde kan anden samtidig behandling blive nødvendig.
English: Some cats with patent Joyeuxiella spp.
Danish: Nogle katte med persisterende Joyeuxiella spp.
English: Symptomatic treatment can be required if the signs do not resolve spontaneously within 24 hours.
Danish: Symptomatisk behandling kan være nødvendig hvis disse symptomer ikke forsvinder spontant inden for 24 timer.
English: When applying the veterinary medicinal product, special attention should be paid in long hair breeds in order to ensure that it is applied directly to the skin and not on the hair, as this could lead to a lower bioavailability of the active substances and thus, to a reduced efficacy.
Danish: Når veterinærlægemidlet påføres, skal man ved behandling af langhårede racer være særlig opmærksom på, at det påføres direkte på huden og ikke i pelsen, da dette kan føre til en lavere biotilgængelighed af de aktive stoffer og dermed reduceret virkning.
English: (S)-methoprene, once absorbed, is very quickly metabolised and excreted.
Danish: (S)-methopren metaboliseres og udskilles meget hurtigt efter absorption.
English: Do not use in sick or convalescent animals.
Danish: Må ikke anvendes til syge eller afkræftede dyr.
English: The topical application, with additional potential oral exposure from grooming, also results in partial systemic exposure that decreases over time.
Danish: Den topikale applikation, hvor der kan forekomme oral eksponering via soignering, medfører ligeledes en delvis systemisk eksponering som aftager over tid.
English: For topical application onto the skin (spot-on).
Danish: Til udvortes brug på huden (spot-on).
English: Its metabolism is limited, and it is mainly excreted unchanged in the faeces.
Danish: Dets metabolitter er begrænsede og udskilles hovedsagelig uforandret i fæces.
English: The recommended minimum doses are 10 mg/kg bodyweight for fipronil, 12 mg/kg for (S)-methoprene, 0.5 mg/kg for eprinomectin and 10 mg/kg for praziquantel.
Danish: Den anbefalede minimumsdosis er 10 mg/kg kropsvægt for fipronil, 12 mg/kg for (S)-methopren, 0,5 mg/kg for eprinomectin og 10 mg/kg for praziquantel.
English: - Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
Danish: - Forebyggelse af hjerteorm (Dirofilaria immitis larver) i en måned.
English: Place the tip of the applicator on the skin and apply the entire content directly onto the skin in one spot.
Danish: Placer applikatorens spids på huden og anbring hele indholdet direkte på huden på ét og samme sted.
English: (S)-Methoprene is an insect growth regulator (IGR) of the class of compounds known as juvenile hormone analogues that inhibit the development of immature stages of insects.
Danish: (S)-methopren er en insektvækstregulator (IGR) der tilhører stofgruppen ”juvenile hormon-analoger”, som hæmmer udviklingen af immature insektstadier.
English: Correct application will minimise the occurrence of such events (see section DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION).
Danish: Korrekt påføring vil minimere forekomsten af sådanne tilfælde (se DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ).
English: Special warnings for each target species: Avoid animals licking each other following treatment.
Danish: Særlige advarsler for hver dyreart: Undgå at dyr slikker hinanden efter behandling.
English: Store the applicator in the blister package in order to protect from light.
Danish: Opbevar applikatoren i blisterpakningen for at beskytte mod lys.
English: People with a known hypersensitivity to fipronil, (S)-methoprene, eprinomectin or praziquantel or to any of the excipients should avoid contact with the veterinary medicinal product.
Danish: Mennesker med kendt overfølsomhed over for fipronil, (S)-methopren, eprinomectin eller praziquantel eller over for nogen af hjælpestofferne bør undgå kontakt med veterinærlægemidlet.
English: The on-animal ovicidal activity of (S)-methoprene results from either direct penetration of the eggshell of newly laid eggs or from absorption through the cuticle of the adult fleas.
Danish: Den ovicide effekt af (S)-methopren på dyret skyldes enten direkte penetration gennem skallen af det nylagte æg eller absorption gennem den voksne loppes cuticula.
English: After treatment, ticks will generally be killed within 48 hours after infestation without having a blood meal.
Danish: Efter behandling dræbes flåter sædvanligvis inden for 48 timer efter infestation uden at have fået et blodmåltid.
English: This results in severe damage to the parasite integument, contraction and paralysis, disruption of metabolism and finally leads to the death and expulsion of the parasite.
Danish: Dette fører til alvorlige skader i parasittens integument, kontraktion og paralyse, afbrudt metabolisme og endelig til parasittens død og udstødelse.
English: Cestodes - Treatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis,
Danish: Bændelorm - Behandling af infestationer med bændelorm (Dipylidium caninum, Taenia taeniaeformis,
English: Pharmacotherapeutic group: antiparasitic products, insecticides, avermectins, eprinomectin in combinations.
Danish: Farmakoterapeutisk gruppe: antiparasitære midler, insekticider, avermectiner, eprinomectinkombinationer.
English: Fipronil is an insecticide and acaricide belonging to the phenylpyrazole family.
Danish: Fipronil er et insekticid og acaricid hørende til phenylpyrazolfamilien.
English: Handling of treated animals should be limited until the application site is dry.
Danish: Begræns håndtering af behandlede dyr indtil påføringsstedet er tørt.
English: However there may be attachment of single ticks and transmission of infectious diseases cannot thus be completely excluded if conditions are unfavourable.
Danish: Tilhæftning af enkelte flåter kan imidlertid forekomme, og overførsel af infektiøse lidelser kan ikke helt udelukkes, hvis betingelserne er ugunstige.
English: To reduce re-infestation from emergence of new fleas, it is recommended that all cats in a household be treated.
Danish: For at reducere risikoen for re-infestation med nyligt klækkede lopper anbefales det, at alle katte i husholdningen behandles.
English: Elimination of ticks within
Danish: Lopper dræbes inden for
English: Echinococcus multilocularis, Joyeuxiella pasqualei (adult), Joyeuxiella fuhrmanni (adult)).
Danish: Echinococcus multilocularis, Joyeuxiella pasqualei (voksne), Joyeuxiella fuhrmanni (voksne)).
English: Parasite resistance to any particular class of antiparasitic drug may develop following frequent use of a compound of that class.
Danish: Resistens hos parasitter kan udvikles over for enhver klasse af antiparasitære lægemidler ved hyppig anvendelse af et stof fra samme klasse.
English: In vitro metabolism assays and in vivo studies have demonstrated that there are no pharmacodynamic or pharmacokinetic interactions between fipronil, (S)-methoprene, eprinomectin and praziquantel.
Danish: In vitro metabolismestudier og in vivo studier har vist, at der ikke er farmakodynamiske eller farmakokinetiske interaktioner mellem fipronil, (S)-methopren, eprinomectin og praziquantel.
English: - Prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month.
Danish: - Forebyggelse af loppesmitte til omgivelserne ved at hæmme udviklingen af umodne loppestadier (æg, larver og pupper) i mere end en måned.
English: Prevention of heartworm disease (Dirofilaria immitis larvae) should start within 1 month after the first expected exposure to mosquitoes.
Danish: Forebyggelse af hjerteorm (Dirofilaria immitis larver) bør påbegyndes indenfor 1 måned efter, at katten første gang kan forventes at blive udsat for myg.
English: Unit dose syringe-shaped applicators (clear siliconised cyclic olefin copolymer (COC)) containing 0.3 ml or 0.9 ml of product, closed with a polymer cap and placed in individual plastic blisters.
Danish: Sprøjteformet enkeltdosis-applikator (klar silikonebehandlet cyclic olefin copolymer (COC)) indeholdende 0,3 ml eller 0,9 ml, lukket med en polymerhætte og placeret i individuelle plastikblistere.
English: After a single topical application of the veterinary medicinal product, the actives were detected at various regions of the cat's body, including the caudal region, within the first days of application, indicating distribution/movement from the site of application (between the head and shoulder blades) across the body of the animal.
Danish: De første dage efter en enkelt topikal applikation af veterinærlægemidlet blev aktivstofferne fundet på forskellige områder af kattens krop, også i haleregionen, hvilket indikerer distribution/spredning fra applikationsstedet (området mellem hoved og skulderblade) til hele dyrets krop.
English: It has also been confirmed in healthy adult cats treated 3 times at two-week intervals with up to 5 times the recommended doses.
Danish: Sikkerheden er ligeledes demonstreret hos voksne raske katte, som blev behandlet 3 gange med to-ugers intervaller med op til 5 gange den anbefalede dosis.
English: Glycerol formal Disodium edetate (E385) Propyl gallate (E310) Thiodipropionic acid Dimethyl isosorbide Butylhydroxytoluene (E321)
Danish: Glycerol formal Dinatriumedetat (E385) Propylgallat (E310) Thiodipropionsyre Dimethylisosorbid Butylhydroxytoluen (E321)
English: Opened applicators should be disposed of immediately.
Danish: Anbrudte applikatorer skal destrueres umiddelbart efter brug.
English: In certain individual cats, Notoedres cati infestation may be severe or complicated by bacterial infections.
Danish: Hos enkelte katte kan Notoedres cati infestation være svær eller kompliceres af bakteriel infektion.
English: Fipronil is mainly excreted in the faeces as unchanged drug.
Danish: Fipronil udskilles hovedsagelig via fæces som uforandret lægemiddel.
English: Any unused veterinary medicinal product or waste material derived from it should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Ectoparasites - Treatment and prevention of infestations by fleas (Ctenocephalides felis).
Danish: Ektoparasitter - Behandling og forebyggelse af loppeangreb (Ctenocephalides felis).
English: Praziquantel is a synthetic isoquinoline-pyrazine derivative with activity against tapeworms.
Danish: Praziquantel er et syntetisk isoquinolon-pyrazin derivat med aktivitet over for bændelorm.
English: Avoid contact of the applicator content with the fingers.
Danish: Undgå at applikatorens indhold kommer på fingrene.
English: After treatment with BROADLINE, ticks will generally be killed within 48 hours after infestation without having a blood meal.
Danish: Efter behandling med BROADLINE dræbes flåter sædvanligvis inden for 48 timer efter infestation uden at have fået et blodmåltid.
English: If eye irritation persists or if side effects are noted, seek medical advice and show the package leaflet or the label to the physician.
Danish: I tilfælde af vedvarende øjenirritation eller hvis der ses bivirkninger, skal der søges lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: Avoid animals licking each other following treatment.
Danish: Undgå at dyr slikker hinanden efter behandling.
English: Eprinomectin and praziquantel act systemically, with plasma concentrations reaching a maximum within 48 hours and 6 hours after treatment, respectively, reaching mean maximum concentrations (Cmax) of 20.1 ng/ml for eprinomectin and 157 ng/ml for praziquantel.
Danish: Eprinomectin og praziquantel agerer systemisk, og når maksimal plasmakoncentration inden for henholdsvis 48 timer og 6 timer efter behandling, med gennemsnitlige maksimale koncentrationer (Cmax) på 20,1 ng/ml for eprinomectin og 157 ng/ml for praziquantel.
English: This compound mimics the action of juvenile hormone and causes impaired development and death of the developing stages of fleas.
Danish: Stoffet efterligner virkningen af juvenilt hormon, og det forårsager nedsat udvikling og død af loppens udviklingsstadier.
English: Use only according to the benefit-risk assessment by the prescribing veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-risk-forholdet.
English: The concentrations in the hair coat of fipronil, fipronil sulfone and (S)-methoprene decrease with time but remain detectable for at least 42 days after dosing.
Danish: Koncentrationen i pelsen af fipronil, fipronilsulfon og (S)-methopren aftager over tid men kan påvises i min. 42 dage efter behandling.
English: Transitory blindness or impaired vision have been observed in very rare cases based on post marketing safety experience.
Danish: I meget sjældne tilfælde er der set kortvarig blindhed eller nedsat syn baseret på sikkerhedserfaringer efter markedsføring.
English: The spectrum of efficacy of eprinomectin has been shown to cover gastrointestinal and extraintestinal nematodes.
Danish: Det er vist, at eprinomectins virkningsspekter dækker gastrointestinale og ekstraintestinale nematoder.
English: However, as a precaution, it is not recommended to bath animals within 2 days after treatment.
Danish: For en sikkerheds skyld anbefales det, at man ikke bader dyr inden for 2 dage efter påføring.
English: It is therefore recommended that all cats 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infestation before being treated with the product for heartworm prevention.
Danish: Det anbefales derfor, at alle katte som er 6 måneder gamle eller ældre, som lever i områder med endemisk hjerteorm, testes for eksisterende infestation med hjerteorm, før de behandles med præparatet til forebyggelse af hjerteorm.
English: Cats infected with adult heartworms tolerated up to 3 times the maximum exposure dose (i.e. up to 9 times the recommended dose), every 4 weeks for 3 treatments, without any adverse effects.
Danish: Katte der var inficeret med voksne hjerteorm tålte op til 3 gange den maksimale dosis (dvs. op til 9 gange den anbefalede dosis), givet 3 gange med 4 ugers interval uden at få bivirkninger.
English: 74.7 mg (S)-Methoprene 90.0 mg Eprinomectin 3.60 mg Praziquantel
Danish: 74,7 mg (S)-Methopren 90,0 mg Eprinomectin 3,60 mg Praziquantel
English: Transient salivation and/or vomiting could also be observed, both in kittens and adult cats, in isolated cases.
Danish: Desuden kunne der i enkeltstående tilfælde observeres forbigående savlen og/eller opkastning hos såvel killinger som voksne katte.
English: It is important to apply the veterinary medicinal product to a skin area where the cat cannot lick it off: on the neck, in between shoulders.
Danish: Det er vigtigt, at præparatet påføres på huden på et sted, hvor katten ikke kan slikke det af: i nakken eller mellem skulderbladene.
English: Laboratory studies with the individual ingredients in rats and rabbits have not produced teratogenic, foetotoxic or maternotoxic effects.
Danish: Laboratorieundersøgelser med de individuelle indholdsstoffer i rotter og kaniner har ikke afsløret teratogene virkninger, føtal toksicitet eller maternel toksicitet.
English: External use only.
Danish: Kun til udvortes brug.
English: Praziquantel is rapidly adsorbed via the surface of the parasites and affects membrane permeability in cestodes, influencing divalent cation fluxes, particularly calcium ion homeostasis, which is thought to contribute to the rapid muscle contraction and vacuolisation.
Danish: Praziquantel absorberes hurtigt via parasittens overflade og påvirker cestoders membranpermeabilitet, og dermed gennemstrømningen af divalente kationer, især calcium homeostase, der antages at bidrage til hurtig muskelsammentrækning og vakuolisering.
English: These signs usually resolve spontaneously within 24 hours.
Danish: Normalt forsvinder disse symptomer spontant inden for 24 timer.
English: The product should be applied to dry skin in an area where the cat cannot lick it off.
Danish: - Påfør præparatet på tør hud på et sted, hvor katten ikke kan slikke det af.
English: Cats in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms.
Danish: Katte fra områder med endemisk hjerteorm, eller som har rejst til endemiske områder, kan blive smittet med voksne hjerteorm.
English: Digestive tract and/or neurological disorders may result following an accidental oral ingestion of the veterinary medicinal product (see section 4.5).
Danish: Symptomer fra fordøjelseskanalen og/eller neurologiske symptomer kan ses efter utilsigtet oral indtagelse af veterinærlægemidlet (se punkt 4.5).
English: Some dog breeds may present increased susceptibility to macrocyclic lactones, potentially leading to signs of neurotoxicity.
Danish: Visse hunderacer kan have øget følsomhed over for makrocykliske laktoner, hvilket potentielt kan medføre tegn på neurotoksicitet.
English: - Treatment and prevention of infestations by ticks (Ixodes ricinus).
Danish: - Behandling og forebyggelse af flåtangreb (Ixodes ricinus).
English: Unused applicators must be stored in the intact blister package.
Danish: Ubrugte applikatorer skal opbevares i den ubrudte blisterpakning.
English: Oral uptake by dogs, specifically by Collies, Old English Sheepdogs and related breeds or crossbreeds should thus be avoided.
Danish: Det bør derfor undgås at hunde, specielt collier, old english sheepdogs og beslægtede racer eller krydsninger, indtager præparatet oralt.
English: Remove the applicator from the package and hold it upright.
Danish: Tag applikatoren ud af pakningen og hold den lodret.
English: One treatment prevents further infestations for at least one month.
Danish: En behandling forebygger nye angreb i mindst en måned.
English: One treatment prevents further infestations for up to 3 weeks.
Danish: En behandling forebygger nye angreb i op til 3 uger.
English: Use the applicator size adapted to the weight of the cat.
Danish: Anvend den applikatorstørrelse der passer til kattens vægt.