FrancophonIA/ELRC3.0 huggingface dataset:
English: At the discretion of the veterinarian, infected dogs must be treated with an adulticide to remove adult heartworms.
Danish: Inficerede hunde skal efter dyrlægens skøn behandles med et insektdræbende middel for at fjerne de voksne hjerteorme.
English: Milbemycin oxime plasma concentrations and some pharmacokinetic parameters are increased in the presence of spinosad.
Danish: Plasmakoncentrationer af milbemycinoxim og visse farmakokinetiske parametre er højere ved tilstedeværelsen af spinosad.
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 indgift ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: These dogs may be at a higher risk for adverse effects when treated with this product and should therefore be treated with special caution.
Danish: Disse hunde vil muligvis have en højere risiko for skadelige virkninger ved behandling med dette produkt og skal derfor behandles ekstra forsigtigt.
English: At three times the maximum recommended dose adverse events of potentially neurological origin e.g. decreased activity (8%), hypersalivation (17%) or stumbling (8%) were observed.
Danish: Ved tre gange den maksimale anbefalede dosis blev der observeret bivirkninger, som muligvis er af neurologisk oprindelse, f.eks. reduceret aktivitet (8%), øget spytflåd (17%) eller snublen (8%).
English: The increase in plasma concentrations was strongly correlated with an increase in terminal elimination half-lives.
Danish: Stigningen i plasmakoncentrationer havde en stærk korrelation med en stigning i terminale elimineringshalveringstider.
English: The safety of this product in avermectin sensitive dogs/dogs with an MDR-1 mutation has not been sufficiently demonstrated.
Danish: Sikkerheden af produktet hos hunde med en MDR-1 mutation, der er følsomme over for avermectin, er ikke blevet tilstrækkeligt påvist.
English: Mottled tan to brown, round, biconvex tablets with a debossed code on one side and dimples on the other side.
Danish: Spættet gyldenbrune til brune, runde, bikonvekse tabletter med en præget kode på den ende side og små fordybninger på den anden side.
English: Special precautions for use in animals: Use with caution in dogs with pre-existing epilepsy.
Danish: Særlige forsigtighedsregler vedrørende brugen: Vær forsigtig ved anvendelse til hunde med præeksisterende epilepsi.
English: The mean Tmax for milbemycin A3 and A4 5-oximes was typically 4 hours and the mean elimination half-lives were 33.9 and 77.2 hours.
Danish: Den gennemsnitlige Tmax for milbemycin A3 og A4 5-oximer var typisk 4 timer, og de gennemsnitlige elimineringshalveringstider var 33,9 og 77,2 timer.
English: Cmax was comparable between juveniles and adults starting at month 1, indicating no increased risk of acute toxicity.
Danish: Cmax var sammenlignelig mellem unge hunde og voksne hunde fra 1. måned, hvilket indikerer , at der ikke er øget risiko for akut toksicitet.
English: At acute overdoses corresponding to 3 times the maximum recommended dose, vomiting occurred in half of the animals, sometimes repeatedly.
Danish: Ved akutte overdoser, svarende til 3 gange den maksimale anbefalede dosis, forekom opkastning hos halvdelen af dyrene, undertiden flere gange.
English: These dogs may be at a higher risk for adverse effects when treated with it and should therefore be treated with special caution.
Danish: Disse hunde vil muligvis have en højere risiko for skadelige virkninger ved behandling dermed og skal derfor behandles ekstra forsigtigt.
English: The following list shows the code and the number of dimples marked on each strength of tablet: Trifexis 270 mg/4.5 mg tablets:
Danish: Følgende liste angiver koden og antallet af fordybninger indpræget på hver tabletstyrke: Trifexis 270 mg/4,5 mg tabletter:
English: If a dose is missed, administer the veterinary medicinal product with the next offering of food.
Danish: Hvis en dosis springes over, skal veterinærlægemidlet indgives med det næste måltid.
English: AUC values increased approximately linearly while Cmax increased slightly less than linearly with increasing dose-rates over the intended therapeutic dose range.
Danish: AUC-værdierne steg nogenlunde lineært, mens Cmax steg lidt mindre end lineært med tiltagende dosishastigheder over det tilsigtede doseringsinterval for behandling.
English: Faecal excretion accounted for the vast majority of metabolites in dogs.
Danish: Udskillelse gennem afføringen udgjorde langt størstedelen af metabolitter hos hunde.
English: Milbemycin A4 5-oxime tends to eliminate slower resulting in approximately 10-fold higher exposure than Milbemycin A3 5-oxime.
Danish: Milbemycin A4 5-oxim har tendens til langsommere eliminering, hvilket resulterer i en eksponering på cirka 10 gange højere end milbemycin A3 5-oxim.
English: Trifexis can be used as part of the seasonal prevention of fleas (replacing treatment with a monovalent flea product) in dogs with diagnosed concurrent gastrointestinal nematode infections.
Danish: Trifexis kan anvendes i et program til sæsonmæssig forebyggelse af lopper (til erstatning af behandling med et enkeltstofpræparat) hos hunde, som samtidig er blevet diagnosticeret med gastrointestinal nematodeinfektion.
English: Neurotoxicity characterised by transient mild depression, ataxia, trembling, mydriasis, and excessive salivation has been observed in dogs given higher dose multiples of milbemycin oxime alone (5 to 10 mg/kg).
Danish: Neurotoksicitet, karakteriseret ved forbigående mild depression, ataksi, rysten, mydriasis og overdreven spytafsondring, er blevet observeret hos hunde, som har fået flere høje doser af milbemycinoxim alene (5 til 10 mg/kg).
English: The activity of milbemycin oxime is related to its action on invertebrate neurotransmission.
Danish: Effekten af milbemycinoxim er relateret til dets virkning på neurotransmissionen hos invertebrater.
English: At acute overdoses corresponding to 1.5 times the maximum recommended dose, vomiting occurred in 17% of the dogs, and hypersalivation occurred in 8% of the dogs.
Danish: Ved akutte overdoser, svarende til 1,5 gang den maksimale anbefalede dosis, forekom opkastning hos 17% af hundene, og øget spytflåd forekom hos 8% af hundene.
English: Trifexis tablets should be administered to the dog with its food, or immediately after feeding.
Danish: Indgivelsesvej: Trifexis tabletter skal indgives til hunden med foder eller umiddelbart efter fodring.
English: Special precautions for each target species:
Danish: Særlige advarsler for hver dyreart:
English: Milbemycin oxime is an antiparasitic endectocide belonging to the macrocyclic lactones.
Danish: Milbemycinoxim er et antiparasitært endectocid, som hører til gruppen af makrocykliske laktoner.
English: Spinosad comprises spinosyn A and spinosyn D. The insecticidal activity of spinosad is characterised by nervous excitation leading to muscle contractions and tremors, prostration, paralysis and rapid death of the flea.
Danish: Spinosad omfatter spinosyn A og spinosyn D. Spinosads insektdræbende aktivitet er karakteriseret ved nerveexcitation, som fører til muskelsammentrækninger og rysten, svækkelse, lammelse og hurtig død for loppen.
English: The mean Tmax for spinosyns A and D was 4 hours and the mean elimination half-lives ranged between 131 and 135 hours.
Danish: Middelværdien for Tmax for spinosyner A og D var 4 timer og middelværdierne for elimineringshalveringstiden var mellem 131 og 135 timer.
English: It does not interact with known binding sites of other nicotinic or GABAergic insecticides such as neonicotinides (imidacloprid or nitenpyram), fiproles (fipronil), milbemycins, avermectins (e.g. selamectin) or cyclodienes but through a novel insecticidal mechanism.
Danish: Det reagerer ikke med kendte bindingssteder i andre nikotin- eller GABAergiske insekticider, såsom neonicotinoider (imidacloprid eller nitenpyram), fiproler (fipronil), milbemyciner, avermectiner (f.eks. selamectin) eller cyclodiener, men virker gennem en ny insektbekæmpelsesmekanisme.
English: The recommended dosage regimen must be followed but not exceeded (see section 4.10) .
Danish: Det anbefalede doseringsregimen bør følges, men ikke overstiges (se pkt.
English: In studies performed with spinosad only, the primary biliary, faecal and urinary metabolites in both rat and dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and to a lesser extent in the urine.
Danish: I studier udelukkende med spinosad blev de primære biliære, fækale og urinmetabolitter hos både rotter og hunde identificeret som demetylerede spinosyner, glutathion konjugater af forbindelsen, samt N-demetylerede spinosyner A og D. Udskillelse sker hovedsagligt gennem galde og afføring og i mindre udstrækning i urinen.
English: The primary faecal and urinary metabolites in dog were identified as glucuronide conjugates of milbemycin A3 or A4 5-oximes, dealkylated milbemycin A3 or A4 5-oximes, and hydroxylated milbemycin A4 5-oxime.
Danish: De primære fækale og urinmetabolitter hos hunde blev identificeret som glucuronid-konjugat af A3 eller A4 5-oximer, dealkylerede milbemycin A3 eller A4 5-oximer, og hydroxyleret milbemycin A4 5oxim.
English: In the case of adverse clinical signs, treat symptomatically.
Danish: I tilfælde af kliniske bivirkninger skal der gives symptomatisk behandling.
English: Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne.
English: Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABA and glycine receptors).
Danish: I lighed med avermectiner og andre milbemyciner øger milbemycinoxim nematode- og insektmembranens permeabilitet over for chloridioner via glutamatstyrede chloridionkanaler (relateret til vertebrat GABA og glycinreceptorer).
English: Hypersalivation, muscle tremors, ataxia and seizures were uncommon.
Danish: Øget spytflåd, muskeltrækninger, ataksi og krampeanfald var ualmindelige.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Administer with food.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Skal gives med et måltid.
English: Prior to first use of this product, dogs in heartworm endemic areas or who have visited heartworm endemic areas must be tested for existing heartworm infection.
Danish: Inden første anvendelse af produktet skal hunde i områder, hvor hjerteorm er endemisk, eller som har besøgt områder, hvor hjerteorm er endemisk, testes for eksisterende infektion med hjerteorm.
English: Fleas may be observed for a period of time after administration of the product due to the emergence of adult fleas from pupae already present in the environment.
Danish: Der kan vedblive med at være lopper i et stykke tid efter indgift af produktet pga. udklækning af voksne lopper fra loppelarver, som allerede er i omgivelserne.
English: Treatment and prevention of flea infestation when concurrent prevention of heartworm disease, angiostrongylosis and/or concurrent treatment of nematode infections is indicated.
Danish: Behandling og forebyggelse af loppeinfestationer, når samtidig forebyggelse af hjerteorm, angiostrongylose og/eller samtidig behandling af nematodeinfektioner er indiceret.
English: Spinosad is excreted in the colostrum and milk of lactating bitches.
Danish: Spinosad udskilles i kolostrum og mælk hos diegivende tæver.
English: Milbemycin A3 and A4 5-oximes are rapidly absorbed and extensively distributed in dogs after oral administration.
Danish: Milbemycin A3 og A4 5-oximer absorberes hurtigt og fordeles vidt hos hunde efter oral indgift.
English: Decreased activity was seen at the same frequency in both control and dogs treated with 3 times the maximum recommended dose.
Danish: Reduceret aktivitet forekom med samme hyppighed hos både hunde i kontrolgruppen og hunde, behandlet med 3 gange den maksimale anbefalede dosis.
English: The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see also section 4.2).
Danish: Brugen af produktet skal ske ud fra en bekræftet diagnose af en samtidig blandet infektion (eller risiko for infektion, hvor behandlingen er forebyggende) (Se desuden pkt.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Eli Lilly and Company Ltd
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Eli Lilly and Company Ltd
English: It is recommended to observe the treated dog up to 24 hours post-administration of the product for possible adverse reactions (see section 4.6).
Danish: Det anbefales at holde den behandlede hund under observation for eventuelle bivirkninger i op til 24 timer efter indgift af produktet (se afsnit 4.6).
English: Regular monthly treatments with the insecticidal active substance in this product (spinosad) break the fleas' life cycle and may be used to control the flea population in contaminated households.
Danish: Regelmæssig månedlig behandling med det insektdræbende aktive stof i dette produkt (spinosad), afbryder loppernes livscyklus og kan anvendes til at kontrollere loppebestanden i kontaminerede husstande.
English: Prior to first administration, dogs in heartworm endemic areas or who have visited heartworm endemic areas must be tested for existing heartworm infection.
Danish: Inden første indgift skal hunde i områder, hvor hjerteorm er endemisk, eller som har besøgt områder, hvor hjerteorm er endemisk, testes for eksisterende infektion med hjerteorm.
English: Manufacturer responsible for batch release: Eli Lilly and Company Ltd Speke Operations
Danish: Fremstiller ansvarlig for batchfrigivelse: Eli Lilly and Company Ltd Speke Operations
English: Adverse reactions seen during the course of this study included vomiting, diarrhoea, skin lesions, salivation, tremors, decreased activity, coughing and vocalization.
Danish: Bivirkninger set under forsøget inkluderede opkastning, diaré, hudlæsioner, spytafsondring, rysten, nedsat aktivitet, hoste og vokalisering.
English: spinosad / milbemycin oxime
Danish: spinosad/milbemycinoxim
English: At doses in excess of the recommended dose, vomiting becomes a very common event.
Danish: Ved højere doser end den anbefalede dosis bliver opkastninger en meget almindelig bivirkning.
English: Fleas from pets often infest the animal's basket, bedding and regular resting areas such as carpets and soft furnishings.
Danish: Lopper fra kæledyr infesterer ofte dyrets kurv, leje og sædvanlige hvilesteder, såsom tæpper og bløde møbler.
English: Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control, therefore, to minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season prior to starting monthly preventive treatments.
Danish: Med henblik på at minimere selektionen af resistens, anbefales det derfor, at hunde kontrolleres både for cirkulerende antigener og microfilariae i blodet ved start af hver sæson inden start af månedlige forebyggende behandlinger.
English: Regular monthly treatments with the insecticidal active substance, spinosad, break the fleas' life cycle and may be used to control the flea population in contaminated households.
Danish: Regelmæssig månedlig behandling med det insektdræbende aktive stof, spinosad, afbryder loppernes livscyklus og kan anvendes til at kontrollere loppebestanden i kontaminerede husstande.
English: It is recommended to observe the treated dog up to 24 hours post-administration of the product for possible adverse reactions (see section 6).
Danish: Det anbefales at holde den behandlede hund under observation for eventuelle bivirkninger i op til 24 timer efter indgift af produktet (se afsnit 6).
English: Safe use in overdose situations up to 3.6 times the recommended dose has been demonstrated following 6 monthly administrations.
Danish: Sikker brug i situationer med overdosis op til 3,6 gange den anbefalede dosis er blevet påvist efter månedlig indgift i 6 måneder.
English: Trifexis tablets should only be used when the veterinarian has confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see section 4).
Danish: Brugen af Trifexis tabletter skal kun ske ud fra en bekræftet diagnose af en samtidig blandet infektion (eller risiko for infektion, hvor behandlingen er forebyggende) (se afsnit 4).
English: Strength and number of tablets to be administered:
Danish: Antal tabletter og tabletstyrke:
English: Marketing authorisation holder: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road
Danish: Indehaver af markedsføringstilladelsen: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road
English: The safe use of the maximum recommended dose (70 mg/kg spinosad and 1.18 mg/kg milbemycin oxime) given as capsules has been demonstrated for 12 months.
Danish: Sikker brug af den maksimale anbefalede dosis (70 mg/kg spinosad og 1,18 mg/kg milbemycinoxim) givet som kapsler er blevet påvist i 12 måneder.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER
English: In rats dosed with milbemycin A4 5-oxime, the main metabolites identified in urine and faeces were mono-, di-, and trihydroxy milbemycin A4 5-oximes.
Danish: Hos rotter doseret med milbemycin A4 5-oxim, var hovedmetabolitterne identificeret i urinen og afføringen mono-, di-, og trihydroxy-milbemycin A4 5-oximer.
English: After oral administration of 45 mg spinosad and 0.75 mg milbemycin oxime/kg bodyweight to fed dogs, spinosyns A and D are rapidly absorbed and extensively distributed.
Danish: Efter oral indgift af 45 mg spinosad og 0,75 mg milbemycinoxim/kg legemsvægt til fodrede hunde absorberes spinosyner A og D hurtigt og distribueres vidt.
English: Microcrystalline cellulose Hydroxypropyl cellulose Silica, colloidal anhydrous Croscarmellose sodium Magnesium stearate Artificial beef flavour
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose Silica, kolloid vandfrit
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 3 år 6.4 Særlige opbevaringsforhold
English: Dogs living in non-heartworm endemic areas:
Danish: Hunde, der bor i områder, hvor hjerteorm ikke er endemisk:
English: 4347 and no dimples
Danish: 4347 og ingen fordybninger
English: For the prevention of heartworm disease and the concurrent treatment and prevention of flea infestations, the veterinary medicinal product must be given at regular monthly intervals during the time of the year when mosquitoes and fleas are present.
Danish: Til forebyggelse af hjerteorm og den samtidige behandling og forebyggelse af loppeinfestationer, skal veterinærlægemidlet indgives regelmæssigt med en måneds mellemrum i den del af året, hvor der er myg og lopper.
English: Dogs living in heartworm endemic areas:
Danish: Hunde, der bor i områder, hvor hjerteorm er endemisk:
English: No studies have been performed in sick or convalescent dogs, therefore the product should only be used based on a benefit-risk assessment of the responsible veterinarian.
Danish: Ingen forsøg er blevet foretaget med syge hunde eller hunde, som er i bedring, så produktet må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit/risk-forholdet.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: For the prevention of lungworm disease by reducing the level of infection with immature adult (L5) Angiostrongylus vasorum larvae and the concurrent treatment and prevention of flea infestation, the veterinary medicinal product must be given at regular monthly intervals during the time of the year when snails/slugs and fleas are present.
Danish: Til forebyggelse af lungeorm ved at reducere infektionsniveauet med umodne voksne (L5) Angiostrongylus vasorum-larver og samtidig behandling og forebyggelse af loppeinfestation skal veterinærlægemidlet gives med regelmæssige månedlige intervaller på den årstid, hvor snegle og lopper er til stede.
English: Accidental ingestion may cause adverse reactions.
Danish: Indtagelse ved hændeligt uheld kan forårsage bivirkninger.
English: Vomiting was seen in both treated and control dogs with similar frequencies.
Danish: Opkastning blev set med de samme hyppigheder hos behandlede hunde og hunde i kontrolgruppen.
English: The tablets are a mottled tan to brown colour, and are round and chewable.
Danish: Tabletterne er spættet gyldenbrune til brune, runde tyggetabletter.
English: Method of administration:
Danish: Indgivelsesvej:
English: Monthly repeated oral administration of spinosad and milbemycin oxime over six months revealed evidence of spinosad and milbemycin oxime accumulation in juvenile dogs.
Danish: Gentagen oral indgift af spinosad og milbemycinoxim en gang om måneden over 6 måneder viste tegn på akkumulation af spinosad og milbemycinoxim hos unge hunde.
English: This product should therefore only be used during pregnancy and lactation according to the benefit-risk assessment of the responsible veterinarian.
Danish: Produktet må kun anvendes under drægtighed og laktation i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit/risk-forholdet.
English: PACKAGE SIZE 1 chewable tablet 3 chewable tablets 6 chewable tablets
Danish: 3 tyggetabletter 6 tyggetabletter
English: As the safety of the veterinary medicinal product in male dogs used for breeding has not been determined, it should only be used according to the benefit-risk assessment of the responsible veterinarian.
Danish: Da lægemidlets sikkerhed hos hanhunde anvendt til avl ikke er fastlagt, må det kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit/risk-forholdet.
English: In dogs, hydroxymilbemycin A4 5-oxime was detected only in plasma, but not in urine or faeces, suggesting predominant excretion of conjugated metabolites in the dog.
Danish: Hos hunde blev hydroxymilbemycin A4 5-oxim kun detekteret i plasma, men ikke i urinen eller afføringen.
English: Laboratory studies on the effect of spinosad and milbemycin oxime in rats and rabbits have neither produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor any effect on the reproductive capacity in males and females.
Danish: Laboratorieundersøgelser af effekten af spinosad og milbemycinoxim hos rotter og kaniner har hverken afsløret teratogene virkninger, føtal toksicitet eller maternel toksicitet.
English: Post-marketing reports following the concomitant use of spinosad with ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Danish: Rapporter efter markedsføringen efter samtidig brug af spinosad og ivermectin angiver, at der er forekommet rysten/trækninger, spytafsondring/savlen, krampeanfald, ataksi, mydriasis, blindhed og desorientering hos hunde.
English: Speke Operations Fleming Road Liverpool
Danish: Eli Lilly and Company Ltd Speke Operations Fleming Road Liverpool
English: PHARMACEUTICAL FORM Chewable tablets
Danish: LÆGEMIDDELFORM Tyggetabletter
English: 6.5 Nature and composition of immediate packaging Blister packs (of 1, 3 or 6 chewable tablets) in a carton.
Danish: Blisterpakker (med 1, 3 eller 6 tyggetabletter) i en kartonpakke.
English: Trifexis 1620 mg/27 mg tablets:
Danish: Trifexis 1620 mg/27 mg tabletter: