FrancophonIA/ELRC3.0 huggingface dataset:
English: Treated dogs should not be allowed to enter surface water for 48 hours after treatment to avoid adverse effects on aquatic organisms.
Danish: Behandlede hunde bør ikke gives adgang til overfladevand i 48 timer efter behandling for at undgå bivirkninger hos vandorganismer.
English: Each spot-on applicator delivers:
Danish: Fra hver spot-on-applikator afgives:
English: Following topical application, dinotefuran and pyriproxyfen are partially absorbed through the dog's skin leading to systemic exposure.
Danish: Efter topikal applikation absorberes dinotefuran og pyriproxyfen delvist gennem hundens hud, hvilket fører til systemisk udbredelse.
English: Determine the correct size of spot-on applicator needed for your dog (the use in dogs younger than 7 weeks or weighing less than 1.5 kg is not recommended, see also section “Special warnings”.
Danish: Bestem hvilken applikatorstørrelse der er korrekt i forhold til din hund (brug hos hunde yngre end 7 uger eller som vejer under 1,5 kg anbefales ikke, se også afsnittet ”Særlige advarsler”).
English: N-octyl-2-pyrrolidone
Danish: N-octyl-2-pyrrolidon
English: Remove the spot-on applicator from the pack.
Danish: Tag spot-on-applikatoren ud af pakken.
English: In case of exposure of this type seek veterinary advice immediately.
Danish: I tilfælde af denne type eksponering skal der omgående tages kontakt til dyrlæge.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Spot-on applicator label
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Spot-on-applikator-etiket
English: The safety of the veterinary medicinal product has not been established in dogs younger than 7 weeks or weighing less than 1.5 kg.
Danish: Veterinærlægemidlets sikkerhed er ikke blevet påvist for hunde, der er yngre end 7 uger eller vejer mindre end 1,5 kg.
English: Step 3: The dog should be standing or in a comfortable position for easy application.
Danish: Trin 3: For at lette applikationen skal hunden stå i en behagelig position.
English: • If the veterinary medicinal product accidentally gets into the eyes, they should be thoroughly flushed with water.
Danish: • Hvis veterinærlægemidlet utilsigtet rammer øjnene, skylles grundigt med vand.
English: Red
Danish: Rød
English: 1 spot-on applicator 3 spot-on applicators 4 spot-on applicators 6 spot-on applicators 12 spot-on applicators 24 spot-on applicators 48 spot-on applicators
Danish: 1 spot-on-applikator 3 spot-on-applikatorer 4 spot-on-applikatorer 6 spot-on-applikatorer 12 spot-on-applikatorer 24 spot-on-applikatorer 48 spot-on-applikatorer
English: A synergistic effect was observed in vitro when dinotefuran was administered in conjunction with permethrin, leading to a faster onset of insecticidal activity in vivo.
Danish: En synergisk effekt kunne observeres in vitro, når dinotefuran blev administreret sammen med permethrin, hvilket medførte en hurtigere indtræden af den insekticidale effekt in vivo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes of 1, 3, 4, 6, 12, 24 and 48 spot-on applicators
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæsker med 1, 3, 4, 6, 12, 24 og 48 spot-on-applikatorer
English: Cardboard box of 1, 3, 4, 6, 12, 24 or 48 spot-on applicators of 0.8 ml, 1.6 ml, 3.6 ml, 4.7 ml or 8.0 ml.
Danish: Kartonæsker med 1, 3, 4, 6, 12, 24 eller 48 spot-on-applikatorer à 0,8 ml, 1,6 ml, 3,6 ml, 4,7 ml eller 8,0 ml.
English: The anticipated clinical benefit resulting from a combination of dinotefuran with permethrin was demonstrated in one laboratory study on dogs which showed a prolongation of the duration of efficacy against C. canis fleas to 4 weeks.
Danish: Den forventede kliniske fordel af at kombinere dinotefuran med permethrin blev demonstreret i en laboratorieundersøgelse hos hunde og viste en forlængelse af effektivitetsvarigheden mod C. canislopper til 4 uger.
English: Pyriproxyfen is a photostable insect growth regulator (IGR).
Danish: Pyriproxyfen er en fotostabil insektvækstregulator (eng. insect growth regulator, IGR).
English: Step 1: Hold the applicator upright, placing fingers below the larger disk as shown.
Danish: Trin 1: Hold applikatoren lodret og placér fingrene under den store skive som vist.
English: Due to their unique physiology and inability to metabolise permethrin (one of the active substances in this veterinary medicine), this veterinary medicine must not be used on cats.
Danish: Pga. kattens unikke fysiologi og manglende evne til at metabolisere permethrin (et af de aktive stoffer i dette veterinærlægemiddel) må dette veterinærlægemiddel ikke anvendes til kat.
English: The three active substances rapidly distribute over the body surface of the animal within the first day, with maximum concentrations obtained 3 days after the application.
Danish: De tre aktive stoffer distribueres inden for det første døgn hurtigt over dyrets kropsoverflade, og maksimumskoncentrationen nås tre dage efter applikation.
English: This veterinary medicine does not require any special storage conditions.
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: In case of massive flea infestation and at the beginning of the control measures, these areas should be treated with a suitable insecticide and then vacuumed regularly.
Danish: I tilfælde af en omfattende loppeinfestation bør disse områder - som led i de indledende bekæmpelsesforanstaltninger - behandles med et passende insekticid og støvsuges regelmæssigt.
English: Prevention of flea multiplication for 2 months.
Danish: Forebyggelse af opformering af lopper i 2 måneder.
English: N-methylpyrrolidone
Danish: N-methylpyrrolidon
English: Behavioural disorders such as hyperactivity, vocalisation or anxiety, systemic signs such as lethargy or anorexia, and neurological signs such as muscle tremor have been reported in rare cases.
Danish: Adfærdsforstyrrelser bl.a. hyperaktivitet, vokalisering og frygt; systemiske tegn som sløvhed eller anoreksi samt neurologiske symptomer som muskelsitren, er blevet rapporteret i sjældne tilfælde.
English: The treatment provides persistent repellent (anti-feeding) activity.
Danish: Ved behandling fås vedvarende repellerende (afvisende) aktivitet.
English: Treatment and prevention of infestations with ticks and fleas up to 1 month.
Danish: Behandling of forebyggelse af infestationer af flåter og lopper i op til 1 måned.
English: Weight of dog (kg)
Danish: Hunden vægt (kg)
English: Flea insecticide activity starts within 12 hours after application.
Danish: Insketicid virkning hos lopper begynder indenfor 12 timer efter påføring.
English: Blue
Danish: Blå
English: Dinotefuran has low affinity to mammalian acetylcholine receptor sites.
Danish: Dinotefuran har en lav affinitet for pattedyrs acetylkolinreceptor-bindingssteder.
English: Pyriproxyfen targets the immature stages of insects (eggs, larvae, pupae) by disruption of their reproduction and development.
Danish: Pyriproxyfen angriber insekternes immature stadier (æg, larver, pupper) ved at forstyrre deres reproduktion og udvikling.
English: Fleas can infest the dog's basket, bedding and regular resting areas such as carpets and soft furnishings.
Danish: Lopper kan infestere hundens kurv, underlag og sædvanlige opholdssteder som gulvtæpper og bløde møbler.
English: Pyrethroids act as neurotoxins on voltage-gated sodium channels by slowing their activation and inactivation properties.
Danish: Pyrethroider virker som neurotoksiner på de elektrisk ladede natriumkanaler ved at forsinke deres aktiverings- og inaktiveringsegenskaber.
English: Step 2: With the other hand, press downwards on the smaller disk until the 2 disks meet evenly.
Danish: Trin 2: Med den anden hånd presses den lille skive nedad, indtil de to skiver når helt sammen.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: • In case of accidental spillage onto skin, wash off immediately with soap and water.
Danish: • I tilfælde af utilsigtet spild på huden vaskes straks med vand og sæbe.
English: Care should be taken to avoid contact between the veterinary medicine and the eyes of the dog.
Danish: Sørg for at undgå kontakt mellem veterinærlægemidlet og hundens øjne.
English: Pharmacotherapeutic group: Ectoparasiticides, insecticides and repellents, permethrin combinations.
Danish: Farmakoterapeutisk gruppe: Ektoparasitære midler, insekticider og repellenter, permethrinkombinationer
English: To remove ticks, it is recommended to use an appropriate tick removal device.
Danish: Det anbefales at fjerne disse flåter ved hjælp af et passende flåtfjernelsesredskab.
English: Vectra 3D should not enter water courses as it is dangerous for fish and other aquatic organisms.
Danish: Vectra 3D må ikke komme i kontakt med vandløb, da det er farligt for fisk og andre vandorganismer.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Spot-on use for external application to the skin.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Spot-on anvendelse til påføring udenpå huden.
English: The following table shows the size of spot-on applicator to be used according to the weight of the dog:
Danish: Nedenstående skema viser størrelsen af spot-on-applikator, der skal bruges i forhold til hundens vægt:
English: In case of suspicion of dermatitis (itch and skin irritation), seek veterinary advice.
Danish: I tilfælde af mistanke om dermatitis (kløe og hudirritation), søges dyrlægehjælp.
English: Treatment and prevention of flea infestation (Ctenocephalides felis and Ctenocephalides canis).
Danish: Behandling og forebyggelse af loppeinfestation (Ctenocephalides felis og Ctenocephalides canis).
English: On the day of first treatment this veterinary medicinal product results in adequate flea adulticidal activity within 12 hours after application.
Danish: På behandlingens første dag har veterinærlægemidlet en tilstrækkelig dræbende effekt på voksne lopper 12 timer efter påføring.
English: Apply the veterinary medicine (as directed in step 4 below) slowly with the tip of the applicator on the skin.
Danish: Påfør veterinærlægemidlet (som vist i trin 4 nedenfor) langsomt og med applikatorspidsen mod huden.
English: Cats in the household should only be treated with a veterinary medicinal product authorised for use in cats.
Danish: Husstandens katte bør kun behandles med et veterinærlægemiddel, der er godkendt til brug hos katte.
English: To prevent cats from being accidentally exposed to the veterinary medicine, keep cats away from treated dogs until the application site is dry.
Danish: For at forhindre katte i utilsigtet at blive eksponeret for veterinærlægemidlet skal katte holdes borte fra behandlede hunde, indtil applikationsstedet er tørt.
English: To avoid adverse reactions:
Danish: For at forhindre bivirkninger:
English: However, in case of frequent shampooing, or bathing within 48 hours after treatment, the duration of activity may be reduced.
Danish: Dog kan aktivitetens varighed formindskes ved hyppig shampoobehandling eller badning inden for 48 timer efter behandling.
English: ROUTE(S) OF ADMINISTRATION Spot-on use
Danish: INDGIVELSESVEJ(E) Spot-on-anvendelse
English: This veterinary medicinal product can induce convulsions in cats that could be fatal, due to the unique physiology of this species which is unable to metabolise certain compounds, including permethrin.
Danish: Dette veterinærlægemiddel kan udløse fatale kramper hos katte pga. denne arts unikke fysiologi og manglende evne til at metabolisere visse stoffer heriblandt permithrin.
English: Do not contaminate ponds, waterways or ditches with the veterinary medicine or with used containers.
Danish: Undlad at forurene brønde, vandveje og grøfter med veterinærlægemidlet eller med brugte beholdere.
English: In case of accidental exposure, wash the cat with shampoo or soap, and seek veterinary advice immediately.
Danish: I tilfælde af utilsigtet eksponering skal katten vaskes med shampoo eller sæbe, og der skal omgående tages kontakt til dyrlæge.
English: Do not eat, drink or smoke while handling the veterinary medicine.
Danish: Spis, drik eller ryg ikke, når veterinærlægemidlet håndteres.
English: Once bound to these receptors, the agonist action of repeated excitatory impulses kills the insect.
Danish: Når bindingen til receptorerne har fundet sted, dræbes insekterne af den agonistiske påvirkning med gentagne eksitatoriske impulser.
English: If skin or eye irritation persists, or if the veterinary medicinal product is accidentally swallowed, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Hvis øjen- eller hudirritationen varer ved, eller hvis veterinærlægemidlet indtages utilsigtet, bør man straks rådføre sig med lægen og fremvise indlægssedlen eller etiketten.
English: The three active ingredients in the veterinary medicine spread over the body surface of the dog within the first day after application and remain for 1 month.
Danish: De tre aktive stoffer i veterinærlægemidlet spredes over hundens kropsoverflade inden for det første døgn efter behandling og vedbliver at være der i 1 måned.
English: This veterinary medicine should not enter water courses as it is dangerous for fish and other aquatic organisms.
Danish: Dette veterinærlægemiddel må ikke komme i kontakt med vandløb, da det er farligt for fisk og andre vandorganismer.
English: Each spot-on applicator contains dinotefuran 44 mg / pyriproxyfen 3.9 mg / permethrin 317 mg Each spot-on applicator contains dinotefuran 87 mg / pyriproxyfen 7.7 mg / permethrin 635 mg Each spot-on applicator contains dinotefuran 196 mg / pyriproxyfen 17.4 mg / permethrin 1429 mg Each spot-on applicator contains dinotefuran 256 mg / pyriproxyfen 22.7 mg / permethrin 1865 mg Each spot-on applicator contains dinotefuran 436 mg / pyriproxyfen 38.7 mg / permethrin 3175 mg
Danish: Hver spot-on-applikator indeholder 44 mg dinotefuran / 3,9 mg pyriproxyfen / 317 mg permethrin Hver spot-on-applikator indeholder 87 mg dinotefuran / 7,7 mg pyriproxyfen / 635 mg permethrin Hver spot-on-applikator indeholder 196 mg dinotefuran / 17,4 mg pyriproxyfen / 1429 mg permethrin Hver spot-on-applikator indeholder 256 mg dinotefuran / 22,7 mg pyriproxyfen / 1865 mg permethrin Hver spot-on-applikator indeholder 436 mg dinotefuran / 38,7 mg pyriproxyfen / 3175 mg permethrin
English: Studies with each active ingredient (dinotefuran, permethrin or pyriproxyfen) in rats and rabbits have not produced any evidence of toxicity on pregnant or lactating animals.
Danish: Studier med hvert aktivt stof (dinotefuran, permethrin eller pyriproxyfen) hos rotter og kaniner har ikke afsløret tegn på toksicitet hos drægtige eller diegivende dyr.
English: Following a single administration, the veterinary medicine will prevent infestation for one month.
Danish: Veterinærlægemidlet vil efter en enkelt administration forhindre infestation i en måned.
English: If applied to a cat, or ingested by a cat that actively grooms a recently treated dog, this veterinary medicinal product may have serious harmful effects.
Danish: Hvis veterinærlægemidlet påføres en kat eller hvis katten aktivt indtager det ved at slikke på en nyligt behandlet hund, kan dette veterinærlægemiddel medføre meget alvorlige bivirkninger.
English: Gastrointestinal signs such as vomiting or diarrhoea have also been reported very rarely.
Danish: Gastrointestinale symptomer som opkast og diarré er ligeledes meget sjældent rapporteret.
English: The attachment of a single tick after treatment cannot be excluded.
Danish: Efter behandling kan det ikke udelukkes, at en enkelt flåt hæfter sig fast.
English: Apart from erythema and cosmetic hair coat changes at the site of application, no adverse reactions were observed in healthy puppies aged 7 weeks, topically treated 7 times at 2 week intervals and with up to 5 times the highest recommended dose.
Danish: Bortset fra rødme og kosmetiske forandringer i pelsen på applikationsstedet sås ingen bivirkninger hos sunde hvalpe på 7 uger, der blev behandlet topikalt 7 gange med 2 ugers interval og med op til 5 gange den anbefalede dosis.
English: Laboratory studies, with each of the components, dinotefuran, pyriproxyfen or permethrin, in rats and rabbits have not produced any evidence of maternotoxic, teratogenic or foetotoxic effects.
Danish: Laboratorieundersøgelser med hver af komponenterne dinotefuran, pyriproxyfen og permethrin hos rotter og kaniner har ikke afsløret teratogene virkninger, føtal toksicitet eller maternel toksicitet.
English: Pyriproxyfen also blocks the development of juvenile stages (larvae and early (pharate) pupae) into adult emergence.
Danish: Pyriproxyfen blokerer også de juvenile stadiers (laver og puppers) udvikling til voksne individer.
English: If ticks are present when the veterinary medicinal product is applied, the ticks may not all be killed within the first 48 hours, but they may be killed within a week.
Danish: Hvis hunden er angrebet af flåter, når veterinærlægemidlet påføres, dræbes alle flåterne muligvis ikke inden for de første 48 timer - men sandsynligvis inden for en uge.
English: If the veterinary medicine is accidentally swallowed it can cause convulsions in cats that could be fatal.
Danish: Hvis veterinærlægemidlet utilsigtet indtages gennem mundenaf katte, kan det udløse fatale kramper hos katte.
English: Cats in the household should only be treated with a veterinary medicinal product authorised for use in that species.
Danish: Husstandens katte bør kun behandles med et veterinærlægemiddel, der er godkendt til brug hos denne dyreart.
English: Kills mosquitoes and stable flies for 1 month.
Danish: Dræber myg og stikfluer i 1 måned.
English: After accidental swallowing of the highest recommended dose, vomiting, salivation and diarrhoea may occur, however these should disappear without treatment.
Danish: Efter utilsigtet indtagelse af den højst anbefalede dosis kan der forekomme opkastning, savlen og diarré.
English: Pyriproxyfen stops the flea life cycle by both inducing premature oviposition and also suppressing yolk deposition in flea eggs, leading to the production of infertile eggs.
Danish: Pyriproxyfen standser loppens livscyklus dels ved at inducere førtidig æglægning dels ved at undertrykke æggeblommedannelse i loppeægget, hvilket medfører sterile æg.
English: The treatment also provides persistent insecticidal activity for one month against mosquitoes (Aedes aegypti) and stable flies (Stomoxys calcitrans).
Danish: Behandlingen giver også vedvarende insekticidal aktivitet i en måned mod myg (Aedes aegypti) og stikfluer (Stomoxys calcitrans).
English: Repels (prevents biting) flying insects such as sand flies, mosquitoes and stable flies for 1 month.
Danish: Afskrækker (forhindrer bid) flyvende insekter såsom sandfluer, myg og stikfluer i 1 måned.
English: PHARMACEUTICAL FORM Spot-on solution
Danish: LÆGEMIDDELFORM Spot-on-opløsning
English: In case of accidental exposure, if undesirable effects occur, wash the cat with shampoo or soap.
Danish: I tilfælde af utilsigtet eksponering skal katten vaskes med shampoo eller sæbe.
English: The treatment prevents flea infestation for one month.
Danish: Behandlingen forhindrer loppeinfestation i en måned.
English: Sand flies, mosquitoes and stable flies:
Danish: Sandfluer, myg og stikfluer:
English: Weight of dog (kg) Colour of applicator cap
Danish: Hunden vægt (kg) Applikatorhættens farve
English: Red The veterinary medicine is a pale yellow spot-on solution, packaged in single dose spot-on applicators.
Danish: Veterinærlægemidlet er en bleggullig spot-on-opløsning pakket i spot-on-applikatorer med enkeltdoser.
English: N-methylpyrrolidone, an excipient in the veterinary medicinal product, has shown to be teratogenic in laboratory animals.
Danish: Et af veterinærlægemidlets hjælpestoffer N-methylpyrrolidon er påvist at være teratogent hos laboratoridyr.
English: Applicator to be used for dogs 1.5-4 kg
Danish: Applikator der skal anvendes til hunde 1.5-4 kg
English: Its structure is derived from the neurotransmitter acetylcholine and acts on nicotinic acetylcholine receptors of the insect nerve synapse.
Danish: Dinotefuran er et insekticid, hvis struktur er udledt fra neurotransmitteren acetylkolin, og som påvirker de nikotinerge acetylkolinreceptorer på insekternes nervesynapser.
English: Permethrin is acaricide and insecticide.
Danish: Permethrin er et acaricid og insekticid, og har også repellerende (afvisende) egenskaber.
English: STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS Each ml contains 54 mg dinotefuran, 4.84 mg pyriproxyfen and 397 mg permethrin.
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hver ml indeholder 54 mg dinotefuran, 4,84 mg pyriproxyfen, og 397 mg permethrin.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION Spot-on use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG
English: Water immersion repeated weekly for one month and starting 48 hours after treatment, as well as shampooing 2 weeks after treatment do not affect the efficacy of this product.
Danish: Måling af produktets effektivitet efter en måned viste, at effektiviteten ikke påvirkedes af ugentligt nedsænkning i vand, når denne var påbegyndt 48 timer efter behandling, ej heller ved shampoobehandling påbegyndt 2 uger efter behandling.
English: It prevents biting from sand flies (Phlebotomus perniciosus), mosquitoes (Culex pipiens, Aedes aegypti) and from stable flies (Stomoxys calcitrans) for one month post-application.
Danish: Behandlingen forhindrer bid fra sandfluer (Phlebotomus perniciosus), myg (Culex pipiens, Aedes aegypti) og fra stikfluer (Stomoxys calcitrans) i en måned efter applikation.
English: Do not use in cases of hypersensitivity to any of the active substances or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for nogen af de aktive stoffer eller hjælpestoffer.
English: Permethrin repels and kills parasites by targeting their nervous system, leading to hyperexcitability (hot-foot effect for ticks), and resulting to knock-down, anti-attachment and anti-feeding actions against parasites.
Danish: Permethrin repellerer og dræber parasitter ved at angribe deres nervesystem, hvilket fører til hyperexcitabilitet (‘hot-foot effect' for flåter) og resulterer i 'knock-down' samt forhindring af evnen til at holde sig fast og indtage næring hos parasitterDinotefuran og permethrin forstærker hinandens virkning ved synergi, for at medføre en hurtigere virkningsindtræden in vivo.
English: The use of the veterinary medicinal product in pregnant and lactating bitches or in dogs intended for breeding should be based on a benefit/risk assessment by the responsible veterinarian.
Danish: Brugen af veterinærlægemidlet hos drægtige og lakterende tævehunde eller hos hunde der påtænkes anvendt til avl bør baseres på den ansvarlige dyrlæges vurdering af fordele og ulemper.
English: Transient cosmetic effects (wet appearance, spiking of hair coat and deposits) at the application site have been reported very rarely, however these effects are usually not noticeable after 48 hours.
Danish: Forbigående kosmetiske gener (vådt udseende, tjavset pels og aflejringer) på applikationsstedet er meget sjældent rapporteret, og disse gener er sædvanligvis ikke synlige efter to døgn.
English: Other precautions
Danish: Andre forsigtighedsregler:
English: Care should be taken to apply the veterinary medicinal product only onto intact (undamaged) dog's skin.
Danish: Vær omhyggelig med kun at påføre veterinærlægemidlet på hundens intakte (ubeskadigede) hud.
English: Transient erythema, pruritus or other signs of discomfort at the application site have been reported rarely and usually disappear spontaneously, within 24 hours following administration of the product.
Danish: Forbigående rødme, kløe og andre symptomer på ubehag på applikationsstedet er rapporteret i sjældne tilfælde og forsvinder sædvanligvis spontant inden for et døgn efter administration af produktet.