FrancophonIA/ELRC3.0 huggingface dataset:
English: The preventive effect against re-infestations is a result of the activity against adult fleas and the reduction in their production of eggs.
Danish: Den forebyggende virkning mod nye infestationer er et resultat af aktiviteten mod voksne lopper og reduktionen i deres produktion af æg.
English: In the majority of cases, vomiting was transient, mild and did not require symptomatic treatment.
Danish: I størstedelen af tilfælde var opkastningen forbigående, mild og krævede ikke symptomatisk behandling.
English: Use with caution in dogs and cats with pre-existing epilepsy.
Danish: Vær forsigtig ved anvendelse til hunde og katte med præeksisterende epilepsi.
English: Keep the blister in the outer carton to protect from light.
Danish: Opbevar blisteren i den ydre karton for at beskytte mod lys.
English: INDICATION(S) For the treatment and prevention of flea infestations.
Danish: INDIKATION(ER) Til behandling og forebyggelse af loppeinfestationer.
English: Treatment and prevention of flea infestations (Ctenocephalides felis).
Danish: Behandling og forebyggelse af loppeinfestationer (Ctenocephalides felis).
English: Approximately 90% of spinosad is comprised of spinosyns A and D. Of that 90%, the ratio of spinosyn A to A+D is 0.85 when calculated as spinosyn A/spinosyn A+D.
Danish: Cirka 90 % af spinosad består af spinosyner A og D. Af de 90 %, er forholdet af spinosyn A til A+D 0,85 når beregnet som spinosyn A/spinosyn A+D.
English: The duration of efficacy may be reduced if the dose is administered on an empty stomach.
Danish: Effektens varighed kan reduceres, hvis dosen gives på tom mave.
English: In case of adverse clinical signs, the animal should be treated symptomatically.
Danish: I tilfælde af tegn på kliniske bivirkninger, bør dyret behandles symptomatisk.
English: Spinosad could therefore interact with other PgP-substrates (for example, digoxin, doxorubicin) and possibly enhance adverse reactions from such molecules or compromise efficacy.
Danish: Spinosad kan derfor gensidigt påvirke andre PgP-substrater (for eksempel digoxin, doxorubicin) og muligvis forstærke bivirkninger fra sådanne molekyler eller kompromittere effekten.
English: In very rare cases, blindness, impaired vision and other eye disorders were observed.
Danish: I meget sjældne tilfælde blev blindhed, svækket syn og andre synsforstyrrelser observeret.
English: This activity persists for up to 4 weeks after a single administration of the product.
Danish: Denne aktivitet vedvarer i op til 4 uger efter en enkelt indgift af produktet.
English: Fleas may persist for a period of time after administration of the product due to the emergence of adult fleas from pupae already 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: The veterinary medicinal product may safely be given at monthly intervals at the recommended dose.
Danish: Veterinærlægemidlet kan indgives sikkert med en måneds mellemrum ved den anbefalede dosis.
English: Do not use in dogs or cats under 14 weeks of age.
Danish: Må ikke anvendes til hunde eller katte under 14 uger.
English: Furthermore, a reduction of food intake was observed in females, however a significant reduction in their bodyweight was not observed.
Danish: Desuden blev der set reduceret fødeindtag hos hunkatte, men ingen signifikant reduktion i deres legemsvægt blev observeret.
English: Phospholipidosis (vacuolation of lymphoid tissue) also occurred; although this was not related to clinical signs in dogs treated up to 6 months.
Danish: Fosfolipidose (vakuolisering af lymfevæv) forekom også, selvom dette ikke var relateret til kliniske tegn hos hunde, der blev behandlet i op til 6 måneder.
English: Microcrystalline cellulose Artificial beef flavour Hydroxypropylcellulose Colloidal silicon, anhydrous Croscarmellose sodium Magnesium stearate
Danish: Mikrokrystallinsk cellulose Kunstig oksekødsmag Hydroxypropylcellulose Kolloid silica, vandfri Croscarmellosenatrium Magnesiumstearat
English: Comfortis tablets are chewable and palatable for dogs.
Danish: Comfortis tabletter kan tygges og er velsmagende for hunde.
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: AUC and Cmax values were higher in fed than fasted cats.
Danish: AUC og Cmax-værdier var højere hos katte, der var blevet fodret, end hos fastende katte.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/115/016 (90 mg, 3 tablets)
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/10/115/016 (90 mg, 3 tabletter)
English: Accurate dosing is not possible in small dogs weighing less than 1.3 kg and in cats weighing less than 1.2 kg.
Danish: Nøjagtig dosering er ikke muligt hos små hunde, som vejer under 1,3 kg, og hos katte, som vejer under 1,2 kg.
English: Accurate dosing is not possible in dogs weighing less than 1.3 kg and in cats weighing less than 1.2 kg.
Danish: Nøjagtig dosering er ikke muligt hos hunde, som vejer under 1,3 kg, og hos katte, som vejer under 1,2 kg.
English: The mean Tmax for spinosyns A and D ranged from 2-4 hours and the mean elimination half-life ranged from 127.5 to 162.6 hours and 101.3 to 131.9 hours respectively.
Danish: Middelværdien for Tmax for spinosyner A og D var mellem 2-4 timer og middelværdien for elimineringshalveringstiden var mellem hhv. 127,5 og 162,6 timer og 101,3 og 131,9 timer.
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 lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: In cats, the full 4 week gap between treatments should be maintained, even if fleas reappear (due to an occasional slightly reduced persistent efficacy) before the end of the 4 weeks.
Danish: Hos katte skal hele behandlingsintervallet på 4 uger overholdes, selvom der ses lopper igen (pga. en lejlighedsvis reduceret vedvarende effekt) inden afslutningen af de 4 uger.
English: PACKAGE SIZE 3 tablets
Danish: PAKNINGSSTØRRELSE 3 tabletter
English: AUC and Cmax values were higher in fed than fasted dogs and increased approximately linearly with increasing dose-rates over the intended therapeutic dose range.
Danish: AUC og Cmax -værdier var højere hos hunde, der var blevet fodret, end hos hunde, som fastede, og de steg nogenlunde lineært med tiltagende dosishastigheder over det tilsigtede doseringsinterval for behandling.
English: The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.
Danish: Den forebyggende virkning mod nye infestationer er et resultat af adulticid aktivitet og reduktionen i ægproduktion og vedvarer i op til 4 uger efter en enkelt indgift af produktet.
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, prostration, lammelse og hurtig død for loppen.
English: Phospholipidosis (vacuolation of the cells of the liver, adrenal gland and lung) also occurred.
Danish: Fosfolipidose (vakuolisering af cellerne i leveren, binyren og lungerne) forekom også.
English: The use of the product in smaller dogs and smaller cats is therefore not recommended.
Danish: Anvendelsen af produktet til mindre hunde og mindre katte frarådes derfor.
English: The product starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment in dogs, and in cats within 24 hours.
Danish: 100 % af lopperne er døde/døende inden for 4 timer efter behandling hos hunde og inden for 24 timer hos katte.
English: The incidence of vomiting observed after the first and second treatments was higher (8%) in dogs dosed at the upper end of the dose band.
Danish: Incidensen af opkastning set efter den første og anden behandling var højere (8%) hos hunde, som fik en dosis i den øvre ende af doseringsområdet.
English: Other commonly observed adverse reactions in cats were diarrhoea and anorexia.
Danish: Andre almindeligt sete bivirkninger hos katte var diarré og anoreksi.
English: Mild elevations of an enzyme called ALT (alanine aminotransferase) occurred in all dogs treated with Comfortis, although values returned to their baseline by day 24.
Danish: Lette forhøjelser af et enzym kaldet ALAT (alanin-aminotransferase) forekom hos alle hunde behandlet med Comfortis, selvom værdierne vendte tilbage til baseline-værdierne inden dag 24.
English: Administer with food.
Danish: Skal gives med et måltid.
English: If vomiting occurs within an hour of administration and the tablet is visible, re-dose the animal with another full dose to ensure maximum effectiveness of the product.
Danish: Hvis der forekommer opkastning inden for en time efter indgivelse og tabletten kan ses, skal dyret gives en ny fuld dosis for at garantere maksimal effekt af produktet.
English: 6.5 Nature and composition of immediate packaging Clear PCTFE/PE/PVC blister sealed with aluminium foil containing 3 or 6 chewable tablets in cardboard box.
Danish: Kartonæske med klar PCTFE/PE/PVC blisterkort forseglet med aluminiumsfolie, som indeholder 3 eller 6 tyggetabletter.
English: In cats, the full 4 week gap between treatments should be maintained, even if fleas reappear before the end of the 4 weeks.
Danish: Hos katte skal hele behandlingsintervallet på 4 uger overholdes, selvom der ses lopper igen inden afslutningen af de 4 uger.
English: Do not use in case of known hypersensitivity to the active substance or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne.
English: In dogs, spinosyns A and D are rapidly absorbed and extensively distributed after oral administration.
Danish: Hos hunde absorberes spinosyner A og D hurtigt og distribueres vidt efter oral indgivelse.
English: Cardboard box containing blister, each containing 3 or 6 chewable tablets.
Danish: Kartonæske indeholdende blisterkort med 3 eller 6 tyggetabletter.
English: Therefore, it is recommended to treat cats with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Danish: Det anbefales derfor at behandle katte samtidigt med fodring, da dette maksimerer loppernes mulighed for at indtage dødelige mængder af spinosad.
English: Therefore, it is recommended to treat dogs with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Danish: Det anbefales derfor at behandle hunde samtidigt med fodring, da dette maksimerer loppernes mulighed for at indtage dødelige mængder af spinosad.
English: At doses of approximately 2.5 times the recommended dose, spinosad caused vomiting in the vast majority of dogs.
Danish: Ved doser på cirka 2,5 gange den anbefalede dosis forårsagede spinosad opkastning hos langt størstedelen af hundene.
English: In cats, spinosyns A and D are equally rapidly absorbed and extensively distributed after oral administration.
Danish: Hos katte absorberes spinosyner A og D ligeledes hurtigt og distribueres i vid udstrækning efter oral indgivelse.
English: The incidence of vomiting on the day of, or the day after, dosing has been observed to increase as a function of dose.
Danish: Forekomsten af opkastninger på dagen for eller dagen efter dosering er blevet observeret at stige som en funktion af dosis.
English: Post marketing reports, following the concomitant use of Comfortis with ‘off label' high dose ivermectin indicate that dogs have experienced trembling/twitching, salivation/drooling, seizures, ataxia, mydriasis, blindness and disorientation.
Danish: Rapporter efter markedsføring viser, at hunde, efter samtidig behandling med Comfortis og ”off label” høje doser af ivermectin, har oplevet rysten/trækninger, spytafsondring/savlen, krampeanfald, ataksi, mydriasis, blindhed og desorientering.
English: PHARMACEUTICAL FORM Chewable tablets.
Danish: LÆGEMIDDELFORM Tyggetabletter.
English: Comfortis 1620 mg chewable tablets for dogs spinosad
Danish: Comfortis 1620 mg tyggetabletter til hunde spinosad
English: Faecal excretion accounted for the vast majority of metabolites in cats.
Danish: Udskillelse gennem fæces udgjorde langt størstedelen af metabolitterne hos katte.
English: Comfortis 1040 mg chewable tablets for dogs
Danish: Comfortis 1040 mg tyggetabletter til hunde
English: In adult cats, the AUC increased over 3 consecutive months of dosing with 75 mg spinosad/kg bodyweight, after which steady state was achieved; however, no clinical impact occurred as a result of this.
Danish: Hos voksne katte steg AUC i 3 efterfølgende måneder med dosering med 75 mg spinosad/kg legemsvægt, hvorefter steady state blev opnået.
English: Lethargy, loss of condition and salivation were uncommon.
Danish: Letargi, nedsat almentilstand og savlen var ikke almindelig.
English: In dogs, the incidence of vomiting on the day of, or the day after, dosing has been observed to increase as a function of dose.
Danish: Hos hunde er forekomsten af opkastning på dagen for eller dagen efter dosering blevet observeret at stige som funktion af dosis.
English: However there was no evidence in the clinical observations and clinical chemistry parameters that indicated any loss in organ function.
Danish: Der sås imidlertid ingen tegn på organsvigt i klinisk undersøgelse eller i kliniske kemiparametre.
English: Date of latest renewal:
Danish: Dato for seneste fornyelse af markedsføringstilladelsen:
English: The tablets are speckled tan to brown, round, flat and chewable.
Danish: Tabletterne er spættet gyldenbrune til brune, runde, flade tyggetabletter.
English: The residual insecticidal properties of the product persist for up to 4 weeks after a single administration.
Danish: Produktets resterende insektdræbende egenskaber vedvarer i op til 4 uger efter en enkelt indgivelse.
English: Faecal excretion accounted for the vast majority of metabolites in dogs.
Danish: Udskillelse gennem fæces udgjorde langt størstedelen af metabolitterne hos hunde.
English: In cats, after a single acute overdose of 1.6 times the maximum label dose, spinosad caused vomiting in approximately half of the cats, and depression, pacing/panting and severe diarrhoea on rare occasions.
Danish: Hos katte, efter en enkelt akut overdosis på 1,6 gange den maksimale godkendte dosis, forårsagede spinosad opkastning hos cirka halvdelen af kattene, og i sjældne tilfælde depression, rastløshed/gispen og voldsom diarré.
English: As the safety of this for suckling puppies and kittens has not been established, the product should only be used during pregnancy and lactation according to the benefit/risk assessment by the responsible veterinarian.
Danish: Da sikkerheden deraf for diende hvalpe og killinger ikke er tilstrækkeligt klarlagt, skal produktet kun anvendes til drægtige og diegivende tæver og hunkatte efter den ansvarlige dyrlæges afvejning af fordele og ulemper.
English: Cat bodyweight (kg)
Danish: Legemsvægt hos katte (kg)
English: In lactating bitches, spinosad is excreted in the colostrum/milk.
Danish: I diegivende tæver udskilles spinosad i kolostrum/mælken.
English: If a dose is missed, administer the veterinary medicinal product with the next offering of food and resume a monthly dosing schedule.
Danish: Hvis en dosis springes over, skal veterinærlægemidlet indgives med det næste måltid, og den månedlige doseringsplan fortsættes.
English: In dogs lethargy, anorexia and diarrhoea were uncommon and muscle tremor, ataxia and seizures were rare.
Danish: Hos hunde var letargi, anoreksi og diarré ikke almindelige bivirkninger og muskeltremor, ataksi og krampeanfald var sjældene bivirkninger.
English: The primary faecal and urinary metabolites in both the rat and the cat were identified as the glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the faeces, and also to a lesser extent in the urine.
Danish: De primære metabolitter i fæces og urin hos både rotterne og kattene blev identificeret som udgangsstoffets glutathionkonjugater, samt N-demetylerede spinosyner A og D. Udskillelse sker hovedsagligt gennem fæces og i mindre udstrækning i urinen.
English: After a single acute overdose corresponding to 1.6 times the maximum label dose, spinosad caused vomiting in approximately half of the cats, and depression, pacing/panting and severe diarrhoea on rare occasions.
Danish: Efter en akut overdosis svarende til 1,6 gange den maksimale angivne dosis forårsagede spinosad opkastning hos cirka halvdelen af kattene og ved sjældne lejligheder depression, rastløshed/gispen og kraftig diarré.
English: If a dose is missed, administer the product with the next offering of food and resume a monthly dosing schedule.
Danish: Hvis en dosis springes over, skal produktet indgives sammen med det næste måltid, og den månedlige doseringsplan fortsættes.
English: The safety of spinosad in pregnant cats (queens) has not been evaluated.
Danish: Spinosads sikkerhed hos drægtige katte (hunkatte) er ikke blevet undersøgt.
English: At doses in excess of the recommended dose vomiting becomes a very common event.
Danish: Ved doseringer ud over den anbefalede dosis bliver opkastning en meget almindelig bivirkning.
English: Seizures were rare adverse reactions.
Danish: Krampeanfald var sjældne bivirkninger.
English: Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Danish: Laboratorieundersøgelser af rotter og kaniner har ikke afsløret teratogene virkninger, føtal toksicitet eller maternel toksicitet.
English: Dog bodyweight (kg)
Danish: Legemsvægt hos hunde (kg)
English: The safety of this product in male dogs and cats used for breeding has not been determined.
Danish: Dette produkts sikkerhed hos hanhunde og hankatte anvendt til avl er ikke fastlagt.
English: The safety of the product in male dogs and male cats used for breeding has not been determined.
Danish: Produktets sikkerhed hos hanhunde og hankatte anvendt til avl er ikke fastlagt.
English: Laboratory studies in rats and rabbits have not produced any evidence of any effect on the reproductive capacity in males and females.
Danish: Laboratoriestudier af rotter og kaniner har ikke vist tegn på nogen virkning på forplantningsevnen hos handyr og hundyr.
English: The primary biliary, faecal and urinary metabolites in both the rat and the dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and Ndemethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and also to a lesser extent in the urine.
Danish: De primære metabolitter i galde, fæces og urin hos både rotterne og hundene blev identificeret som demetylerede spinosyner, udgangsstoffets glutathionkonjugater, samt N-demetylerede spinosyner A og D. Udskillelse sker hovedsagligt gennem galde og fæces og i mindre udstrækning i urinen.
English: Dogs Dogs and cats
Danish: Hunde og katte
English: On the day of, or the day following administration of spinosad at a dose of 50-75 mg/kg bodyweight, the observed incidence of vomiting in the global field trial was between 6% and 11% in the first three months of treatment.
Danish: På dagen for eller dagen efter administration af spinosad ved en dosering på 50-75 mg/kg legemsvægt var den observerede incidens af opkastning i det globale feltstudie mellem 6% og 11% i de første tre måneder af behandlingen.
English: This vomiting is most likely caused by a local effect on the small intestines.
Danish: Denne opkastning skyldes sandsynligvis en lokal virkning på tyndtarmen.
English: The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 45-70 mg/kg bodyweight for dogs:
Danish: Veterinærlægemidlet skal indgives i overensstemmelse med den følgende tabel for at garantere en dosis på 45-70 mg/kg legemsvægt til hunde:
English: On the day of, or the day following administration of spinosad at a dose of 45-70 mg/kg bodyweight, the observed incidence of vomiting in the field trial was 5.6%, 4.2% and 3.6% after the first, second and third monthly treatments respectively.
Danish: På indgivelsesdagen eller dagen efter indgivelse af spinosad ved en dosis på 45-70 mg/kg legemsvægt var incidensen af opkastning set i feltstudiet 5,6%, 4,2% og 3,6% efter hhv. den første, anden og tredje månedlige behandling.
English: In pregnant dogs (bitches), the safety of spinosad has not been sufficiently established.
Danish: Spinosads sikkerhed er ikke tilstrækkeligt fastlagt hos drægtige hunde (tæver).
English: At doses of 75 to 100 mg/kg bodyweight per day for 5 days, given at monthly intervals for a period of six months, the most commonly observed clinical sign was vomiting.
Danish: Ved doser på 75 til 100 mg/kg legemsvægt per dag i 5 dage givet ved månedlige intervaller i en periode på seks måneder, var opkastning det mest almindeligt observerede kliniske tegn.
English: The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 50-75 mg/kg bodyweight for cats:
Danish: Veterinærlægemidlet skal indgives i overensstemmelse med den følgende tabel for at garantere en dosis på 50-75 mg/kg legemsvægt til katte:
English: Tan to brown, or speckled with embedded darker particles, round, flat, bevelled edge tablets plain on one side and debossed with a number and a line above on the other side:
Danish: Gyldenbrune til brune eller spættede med indlejrede mørkere partikler, runde, flade tabletter med skrå kant, som er glatte på den ene side og præget med et nummer og en linje oven over på den anden side:
English: In dogs, at doses up to 100 mg/kg bodyweight per day for 10 days, the only clinical symptom of overdose was vomiting, which occurred usually within 2.5 hours of dosing.
Danish: Hos hunde, ved doseringer op til 100 mg/kg legemsvægt per dag i 10 dage, var opkastning det eneste kliniske symptom på overdosering, der sædvanligvis forekom inden for 2,5 timer efter dosering.
English: At doses up to 100 mg/kg bodyweight per day for 10 days, the only clinical symptom of overdose was vomiting, which occurred usually within 2.5 hours of dosing.
Danish: Ved doseringer på op til 100 mg/kg legemsvægt per dag i 10 dage var opkastning det eneste kliniske symptom på overdosering, der sædvanligvis forekom inden for 2,5 timer efter dosering.
English: In dogs, a commonly observed adverse reaction is vomiting, which most commonly occurs in the first 48 hours after dosing.
Danish: Hos hunde er opkastning en almindelig bivirkning, der sædvanligvis forekommer i de første 48 timer efter dosering.
English: Number of tablets and strength (mg spinosad) 1 x 90 mg tablet 1 x 140 mg tablet 1 x 180 mg tablet 1 x 270 mg tablet 1 x 425 mg tablet 1 x 665 mg tablet 1 x 1040 mg tablet 1 x 1620 mg tablet 1 x 1620 mg tablet + 1 x 665 mg tablet 2 x 1620 mg tablets
Danish: Antal tabletter og tabletstyrke (mg spinosad) 1 x 90 mg tablet 1 x 140 mg tablet 1 x 180 mg tablet 1 x 270 mg tablet 1 x 425 mg tablet 1 x 665 mg tablet 1 x 1040 mg tablet 1 x 1620 mg tablet 1 x 1620 mg tablet + 1 x 665 mg tablet 2 x 1620 mg tabletter
English: Vomiting is most likely caused by a local effect on the small intestines.
Danish: Opkastninger skyldes sandsynligvis en lokal virkning på tyndtarmen.