FrancophonIA/ELRC3.0 huggingface dataset:
English: The veterinary medicinal product is exclusively indicated when use against ticks or fleas and one or more of the other target parasites is indicated at the same time.
Danish: Veterinærlægemidlet er udelukkende beregnet til brug, når anvendelse mod flåter eller lopper og en eller flere af de øvrige ovennævnte parasitter er indiceret samtidigt.
English: The sachets should only be opened immediateley prior to use.
Danish: Brevet må først åbnes umiddelbart før brug.
English: The cap will stay on the pipette; it is not possible to remove it.
Danish: Hætten bliver siddende på pipetten; det er ikke muligt at tage den helt af.
English: Step 1: Immediately before use, open the sachet and remove the pipette.
Danish: Trin 1: Umiddelbart før brug åbnes brevet og pipetten tages ud.
English: Care should be taken to avoid contact with the eyes of the animal.
Danish: Man bør omhyggeligt undgå, at produktet kommer i kontakt med dyrets øjne.
English: Do not allow the product to enter water courses as this may be dangerous for fish and other aquatic organisms.
Danish: Bravecto Plus må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet.
English: It is therefore recommended, in accordance with good veterinary practice, that animals of 6 months of age or older and living in areas where a vector exists, should be tested for existing adult heartworm infections before application of the veterinary medicinal product for the prevention of heartworm disease.
Danish: Det anbefales derfor, i overensstemmelse med god veterinærpraksis, at dyr på 6 måneder eller derover, som lever i områder, hvor organismen, som er bærer af det smitsomme stof, findes, testes for eksisterende infektion med voksne hjerteorm, før behandling med veterinærlægemidlet indledes til forebyggelse af hjerteorm.
English: Read package leaflet for full user safety information.
Danish: Læs indlægssedlen med alle oplysninger om sikker brug.
English: Do not use directly on skin lesions.
Danish: Må ikke anvendes direkte på beskadiget hud.
English: Hypersensitivity reactions to another veterinary medicinal product containing fluralaner and the same excipients as Bravecto Plus have been reported in a small number of people.
Danish: Der er rapporteret overfølsomhedsreaktioner over for et andet veterinærlægemiddel, som indeholder fluralaner og de samme hjælpestoffer som Bravecto Plus, hos et lille antal personer.
English: Each ml of solution contains 280 mg fluralaner and 14 mg moxidectin.
Danish: 1 ml opløsning indeholder 280 mg fluralaner og 14 mg moxidectin.
English: Moxidectin lacks substantial efficacy against fleas and ticks.
Danish: Moxidectin mangler væsentlig effekt over for lopper og flåter.
English: Skin rashes, tingling or numbness have been reported in a small number of individuals after skin contact.
Danish: Hududslæt, prikken eller følelsesløshed er rapporteret hos et lille antal personer efter hudkontakt.
English: The onset of effect (killing effect) for ticks (I. ricinus) and fleas (C. felis) is within 48 hours after treatment.
Danish: Effekten (dræbende) indtræder for flåter (I. ricinus) og lopper (C. felis) inden for 48 timer efter behandling.
English: Wear gloves when handling and administering this product.
Danish: Anvend beskyttelseshandsker, når produktet håndteres og administreres.
English: The product contributes towards the control of environmental flea populations in areas to which treated cats have access.
Danish: Produktet bidrager til kontrol af forekomsten af lopper i de områder, som behandlede katte har adgang til.
English: Binding of glutamate-gated chloride channels, which are specific to invertebrates and do not exist in mammals, is considered the main mechanism for the anthelmintic and insecticidal activity.
Danish: Binding af glutamat-regulerede chloridkanaler, som er specifikke for hvirveldyr og ikke findes i pattedyr, betragtes som den vigtigste virkningsmekanisme for den anthelmintiske og insekticide aktivitet.
English: Each pipette delivers:
Danish: 1 pipette indeholder:
English: Intervet UK Limited Walton Manor, Walton, Milton Keynes, Buckinghamshire, MK7 7AJ United Kingdom
Danish: Intervet UK Limited Walton Manor, Walton Milton Keynes Buckinghamshire, MK7 7AJ Det Forenede Kongerige
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 får bivirkninger i løbet af en behandling) - almindelige (flere end 1, men færre end 10 ud af 100 behandlede dyr) - ikke almindelige (flere end 1, men færre end 10 ud af 1.000 behandlede dyr) - sjældne (flere end 1, men færre end 10 ud af 10.000 behandlede dyr) - meget sjældne (færre end 1 ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: For cats more than 12.5 kg, use a combination of two pipettes that most closely matches the body weight.
Danish: Til katte, der vejer mere end 12,5 kg, anvendes to pipetter, hvis styrke tilsammen passer bedst til kropsvægten.
English: Avoid frequent swimming or shampooing the animal because the maintenance of effectiveness of the product in these cases has not been tested.
Danish: Dyret skal afholdes fra hyppig badning eller vask med shampoo, da det ikke er testet, hvorvidt produktets effekt i disse tilfælde forbliver uændret.
English: Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, endectocides, milbemycins.
Danish: Farmakoterapeutisk gruppe: Antiparasiticider, insecticider og repellanter, endectocider, milbemyciner.
English: Milton Keynes Buckinghamshire MK7 7AJ
Danish: Buckinghamshire MK7 7AJ
English: The product is highly flammable.
Danish: Produktet er letantændeligt.
English: In case of spillage onto, for example table or floor surfaces, remove excess product using paper tissue and clean the area with detergent.
Danish: I tilfælde af spild på overflader såsom bord eller gulv fjernes det spildte produkt med et stykke køkkenrulle, og området rengøres med rengøringsmiddel.
English: Treatment of male breeding animals is not recommended.
Danish: Behandling af hankatte til avl anbefales ikke.
English: Moxidectin is only active on larvae (L3 and L4) of Dirofilaria immitis and not on adult worms.
Danish: Moxidectin udviser kun aktivitet over for larver (L3 og L4) af Dirofilaria immitis og ikke over for voksne orm.
English: Bravecto Plus spot-on solution is available in three pipette sizes.
Danish: Bravecto Plus spot-on, opløsning, fås i tre pipettestørrelser.
English: The use of this veterinary medicinal product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
Danish: Anvendelse af dette veterinærlægemiddel bør baseres på en individuel vurdering i hvert enkelt tilfælde og på lokal epidemiologisk viden om de pågældende arters følsomhed for at begrænse muligheden for fremtidig resistensudvikling.
English: Ticks and fleas need to start feeding on the host to become exposed to fluralaner; therefore the risk of the transmission of parasite borne diseases cannot be excluded.
Danish: Flåter og lopper skal have startet indtag af føde hos værten, før de udsættes for fluralaner; derfor kan risikoen for sygdomme overført fra parasitter ikke udelukkes.
English: Butylhydroxytoluene 1.07 mg/ml Clear colourless to yellow solution.
Danish: Butylhydroxytoluen 1,07 mg/ml Klar, farveløs til gul opløsning.
English: Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Danish: Lopper og flåter skal sætte sig fast på værten og starte indtag af føde, før de udsættes for det aktive stof.
English: Unit dose pipette made of laminated aluminium/polypropylene foil closed with a high-density polyethylene (HDPE) cap and packed in a laminated aluminium foil sachet.
Danish: Enkeltdosispipette fremstillet af lamineret aluminium/polypropylen-folie lukket med en hætte fremstillet af højdensitetspolyethylen (HDPE) og pakket i et lamineret aluminiumsfoliebrev.
English: The following table defines the size of pipette to be used according to the body weight of the cat (corresponding to a dose of 40-94 mg fluralaner/kg body weight and 2-4.7 mg moxidectin/kg body weight):
Danish: Nedenstående tabel angiver, hvilken størrelse pipette der skal bruges afhængigt af kattens kropsvægt (svarende til en dosis på 40-94 mg fluralaner/kg kropsvægt og 2-4,7 mg moxidectin/kg kropsvægt):
English: The choice of the additional treatment (monosubstance or combination product) should be determined by the prescribing veterinarian.
Danish: Valg af yderligere behandling (enkeltstof eller kombinationspræparat) skal vurderes af den ordinerende dyrlæge.
English: Fluralaner has a high potency against ticks and fleas by exposure via feeding, i.e. it is systemically active on target parasites.
Danish: Fluralaner har en kraftig effekt over for flåter og lopper ved eksponering via fødeindtag, dvs. det er systemisk aktivt i selve parasitten.
English: In molecular on-target studies on insect GABA receptors of flea and fly, fluralaner is not affected by dieldrin resistance.
Danish: I molekylære on target-studier på insekters GABA-receptorer (loppe og flue) blev fluralaner ikke påvirket af resistens over for dieldrin.
English: Moxidectin, a semisynthetic derivative of nemadectin, belongs to the milbemycin group of macrocyclic lactones (avermectins being the other) and has parasiticidal activity against a range of internal and external parasites (including ear mites (Otodectes cynotis)).
Danish: Moxidectin, som er et semisyntetisk derivat af nemadectin, tilhører milbemycin-gruppen af makrocykliske laktoner (denne gruppe består yderligere af avermectiner) og har antiparasitær aktivitet over for et bredt spektrum af endo- og ektoparasitter (herunder øremider (Otodectes cynotis)).
English: For the prevention of heartworm disease in cats that are only temporarily in endemic areas, the product should be applied before the first expected exposure to mosquitoes.
Danish: Til forebyggelse af hjerteorm hos katte, der kun midlertidigt opholder sig i endemiske områder, bør produktet anvendes før, de første gang forventes at blive udsat for myg.
English: Oral uptake of the product at the maximum recommended dose of 93 mg fluralaner + 4.65 mg moxidectin/kg body weight induced some self-limiting salivation or single incidences of vomiting immediately after administration.
Danish: Oral optagelse af produktet ved den højeste anbefalede dosis på 93 mg fluralaner + 4,65 mg moxidectin/kg kropsvægt forårsagede nogen selvbegrænsende savlen eller enkelte tilfælde af opkastning umiddelbart efter administration.
English: This leads to an increased membrane permeability of nematode and arthropod nerve and/or muscle cells for chloride ions and results in hyperpolarization, paralysis and death of the parasites.
Danish: Dermed øges cellemembranens permeabilitet over for chloridioner i nerve- og/eller muskelceller hos nematoder og arthropoder og resulterer i hyperpolarisering, paralyse og parasittens død.
English: The pharmacokinetic profiles of fluralaner and moxidectin are not affected by co-administration.
Danish: De farmakokinetiske egenskaber for hhv. fluralaner og moxidectin påvirkes ikke ved samtidig administration.
English: For the treatment of infections with ear mites (Otodectes cynotis) or the gastrointestinal nematodes T. cati and A. tubaeforme, the need for, and the frequency of, re-treatment as well as the choice of the treatment (monosubstance or combination product) should be evaluated by the prescribing veterinarian.
Danish: Ved behandling af infektioner med øremider (Otodectes cynotis) eller gastrointestinale nematoder af arten T. cati og A. tubaeforme bør behovet for og hyppigheden af genbehandling samt valg af behandling (enkeltstof eller kombinationspræparat) vurderes af den ordinerende dyrlæge.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske
English: For the treatment of infestations with ear mites (Otodectes cynotis).
Danish: Til behandling af infestationer med øremider (Otodectes cynotis).
English: It is efficacious against ticks (Ixodes ricinus), fleas (Ctenocephalides felis) and ear mites (Otodectes cynotis) on the cat.
Danish: Det er effektivt mod flåter (Ixodes ricinus), lopper (Ctenocephalides felis) og øremider (Otodectes cynotis) på katte.
English: This veterinary medicinal product does not require any special temperature storage conditions.
Danish: Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel.
English: Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class under specific circumstances.
Danish: Der kan under særlige omstændigheder udvikles parasitresistens over for enhver gruppe af anthelmintika efter hyppig og gentagen brug af et anthelmintikum fra samme gruppe.
English: For the treatment of tick and flea infestations in cats providing immediate and persistent flea (Ctenocephalides felis) and tick (Ixodes ricinus) killing activity for 12 weeks.
Danish: Til behandling af flåt- og loppeangreb hos katte med øjeblikkelig og vedvarende dræbende effekt på lopper (Ctenocephalides felis) og flåter (Ixodes ricinus) i 12 uger.
English: For the treatment of infections with intestinal roundworm (4th stage larvae, immature adults and adults of Toxocara cati) and hookworm (4th stage larvae, immature adults and adults of Ancylostoma tubaeforme).
Danish: Til behandling af infektioner med intestinal rundorm (4.-stadie larver, umodne voksne og voksne Toxocara cati) og hageorm (4.-stadie larver, umodne voksne og voksne Ancylostoma tubaeforme).
English: In in vitro bio-assays, fluralaner is not affected by proven field resistances against amidines (tick), organophosphates (tick), cyclodienes (tick, flea), phenylpyrazoles (tick, flea), benzophenyl ureas (tick), and pyrethroids (tick).
Danish: I in vitro-bioassays påvirkes fluralaner ikke af påvist resistens over for amidiner (flåt), organophosphater (flåt), cyclodiener (flåt, loppe), phenylpyrazoler (flåt, loppe), benzophenyl-urinstof (flåt) og pyrethroider (flåt).
English: For spot-on use.
Danish: Til spot-on anvendelse.
English: Therefore, during treatment with Bravecto Plus, other products that can inhibit p-glycoprotein (e.g. cyclosporine, ketoconazole, spinosad, verapamil) should only be used concomitantly according to the benefit-risk assessment of the responsible veterinarian.
Danish: Under behandling med Bravecto Plus bør andre produkter, der kan hæmme P-glykoprotein (fx ciclosporin, ketoconazol, spinosad, verapamil) derfor kun anvendes samtidigt i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit/risk-forholdet.
English: In case of contact with the eyes, immediately rinse thoroughly with water.
Danish: I tilfælde af at produktet kommer i øjnene, skylles øjeblikkeligt med rigelige mængder vand.
English: Fluralaner is slowly eliminated from plasma (t1/2 = 15 days) and excreted in faeces and to a very low extent in urine.
Danish: Fluralaner elimineres langsomt fra plasma (t1/2 = 15 dage) og udskilles i fæces og i meget lav grad i urin.
English: Newly emerged fleas on a cat are killed before viable eggs are produced.
Danish: Nye loppeangreb på katten bekæmpes, før loppen kan nå at producere levedygtige æg.
English: For the concurrent treatment of infections with ear mites (Otodectes cynotis), a single dose of the product should be applied.
Danish: Til samtidig behandling af infektioner med øremider (Otodectes cynotis) bør der anvendes en enkelt dosis af produktet.
English: Intervet International B. V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Danish: Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: For cats with, or at risk from, mixed parasitic infestations by ticks or fleas and ear mites, gastrointestinal nematodes or heartworm.
Danish: Til katte med eller hvor der er risiko for blandede parasitære infestationer med flåter eller lopper og øremider, gastrointestinale nematoder samt hjerteorm.
English: The following other adverse reactions were uncommonly observed in clinical trials shortly after administration: dyspnoea after licking the application site, hypersalivation, emesis, haematemesis, diarrhoea, lethargy, pyrexia, tachypnoea, mydriasis.
Danish: Følgende ikke almindelige bivirkninger blev observeret i kliniske studier kort tid efter administration: dyspnø efter at have slikket på applikationsstedet, hypersalivation, emese, hæmatemesis, diarré, letargi, pyreksi, takypnø, mydriasis.
English: − very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Danish: − meget sjældne (færre end 1 ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: The need for and frequency of retreatment should be in accordance with the advice of the prescribing veterinarian and take into account the local epidemiological situation.
Danish: Behovet for og hyppigheden af genbehandling bør ske i overensstemmelse med den ordinerende dyrlæges vurdering og under hensyntagen til lokale risikofaktorer for udvikling af sygdom.
English: In order to avoid contact, disposable protective gloves obtained with this product at the point of sale must be worn when handling and administering the product.
Danish: For at undgå kontakt skal der anvendes engangsbeskyttelseshandsker, når produktet håndteres og administreres.
English: Special precautions for use in animals:
Danish: Særlige forholdsregler vedrørende brug til dyr:
English: Marketing authorisation holder: Intervet International B. V. Wim de Körverstraat 35
Danish: Indehaver af markedsføringstilladelsen: Intervet International B.V.
English: Fluralaner is readily systemically absorbed from the topical administration site, reaching maximum concentrations in plasma between 3 and 21 days after administration.
Danish: Fluralaner absorberes hurtigt systemisk fra det topikale administrationssted, idet maksimal plasmakoncentration nås inden for 3-21 dage efter administration.
English: If you notice any side effects, even those not already listed in this package leaflet or you think the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel, eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: For the concurrent treatment of infections with the gastrointestinal nematodes T. cati and A. tubaeforme, a single dose of the product should be applied.
Danish: Til samtidig behandling af infektioner med gastrointestinale nematoder af typen T. cati og A. tubaeforme bør der anvendes en enkelt dosis af produktet.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pipette
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Pipette
English: Moxidectin is readily systemically absorbed from the topical administration site, reaching maximum concentrations in plasma between 1 and 5 days after administration.
Danish: Moxidectin absorberes hurtigt systemisk fra det topikale administrationssted, idet maksimal plasmakoncentration nås inden for 1-5 dage efter administration.
English: Fluralaner is a potent inhibitor of parts of the arthropod nervous system by acting antagonistically on ligand-gated chloride channels (GABA-receptor and glutamate-receptor).
Danish: Fluralaner er en potent hæmmer af dele af leddyrs nervesystem, idet stoffet har en antagonistisk virkning på ligand-styrede chloridkanaler (GABA-receptor og glutamat-receptor).
English: Make sure that your animal's application site is no longer noticeable before resuming contact with the site of application.
Danish: applikationssted på dyret ikke længere er synligt, før applikationsstedet igen berøres.
English: BRAVECTO PLUS spot-on solution
Danish: BRAVECTO PLUS spot-on, opløsning
English: In case of accidental ingestion, seek medical advice and show the package leaflet or the label to the physician.
Danish: I tilfælde af indtagelse ved hændeligt uheld skal der søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: EU/2/18/224/001 (112.5 mg + 5.6 mg, 1 pipette) EU/2/18/224/002 (112.5 mg + 5.6 mg, 2 pipettes) EU/2/18/224/003 (250 mg + 12.5 mg, 1 pipette) EU/2/18/224/004 (250 mg + 12.5 mg, 2 pipettes) EU/2/18/224/005 (500 mg + 25 mg, 1 pipette) EU/2/18/224/006 (500 mg + 25 mg, 2 pipettes)
Danish: EU/2/18/224/001 (112,5 mg + 5,6 mg, 1 pipette) EU/2/18/224/002 (112,5 mg + 5,6 mg, 2 pipetter) EU/2/18/224/003 (250 mg + 12,5 mg, 1 pipette) EU/2/18/224/004 (250 mg + 12,5 mg, 2 pipetter) EU/2/18/224/005 (500 mg + 25 mg, 1 pipette) EU/2/18/224/006 (500 mg + 25 mg, 2 pipetter)
English: Keep the pipette in the sachet until use.
Danish: Opbevar pipetten i brevet indtil brug.
English: Moxidectin is slowly eliminated from plasma (t1/2 = 26 days) and excreted in faeces and to a very low extent in urine.
Danish: Moxidectin elimineres langsomt fra plasma (t1/2 = 26 dage) og udskilles i fæces og i meget lav grad i urin.
English: Mild and transient skin reactions at the application site (alopecia, flaking skin and pruritus) were commonly observed in clinical trials.
Danish: Milde og forbigående hudreaktioner på applikationsstedet (alopeci, afskallende hud og pruritus) er almindelige bivirkninger, som blev observeret i kliniske studier.
English: Rotate cap (cap cannot be removed).
Danish: Drej hætten (hætten kan ikke tages af).
English: The product should not be used by persons with a hypersensitivity to the active substance or to any of the excipients (see contraindications, section 5).
Danish: Produktet må ikke anvendes af personer med overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne (se kontraindikationer, pkt.
English: Apply to skin.
Danish: Påfør indholdet på huden.
English: Milbemycins and avermectins have a common mode of action that is based on the binding of ligandgated chloride channels (glutamate-R and GABA-R).
Danish: Milbemyciner og avermectiner har en fælles virkningsmekanisme, der er baseret på binding af ligandstyrede chloridkanaler (glutamat-receptor og GABA-receptor).
English: The pipette should be held by the base or by the upper rigid portion below the cap in an upright position (tip up) for opening it.
Danish: Hold om pipetten i bunden, der hvor den er sammensvejset, eller omkring den hårde del lige under hætten; pipetten skal være i oprejst stilling (spidsen skal vende opad), når den åbnes.
English: Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product.
Danish: Lad pipetten blive i den originale emballage indtil brug for at undgå, at børn får direkte adgang til produktet.
English: For spot-on use
Danish: Til spot-on anvendelse
English: Cats in areas endemic for heartworm, or cats which have travelled to endemic areas, may be infected with adult heartworms.
Danish: Katte, der lever i områder, som er endemiske for hjerteorm, eller katte, som er flyttet til endemiske områder, kan være inficeret med voksne hjerteorm.
English: The pipettes should be kept in the sachet to prevent solvent loss or moisture uptake.
Danish: Pipetten skal opbevares i brevet for at undgå fordampning af opløsningen eller optagelse af fugt.
English: FRANCE
Danish: Holland
English: The product should be applied on cats up to 6.25 kg body weight in one spot at the base of the skull and in two spots at the base of the skull on cats greater than 6.25 kg bodyweight.
Danish: For katte med en kropsvægt på op til 6,25 kg anvendes produktet ved at påføre indholdet på ét sted i nakken, der hvor man kan mærke, kraniet slutter, og for katte med en kropsvægt på mere end 6,25 kg på to steder i nakken, der hvor man kan mærke, kraniet slutter.