FrancophonIA/ELRC3.0 huggingface dataset:
English: People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Danish: Folk med følsom hud eller kendt allergi over for denne type veterinærlægemiddel, bør håndtere dette med forsigtighed.
English: The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian.
Danish: Behovet for og hyppigheden af gentagen behandling skal være i overensstemmelse med den ordinerende dyrlæges råd og vejledning.
English: Interactions with other medicinal products and other forms of interactions:
Danish: Interaktion med andre lægemidler og andre former for interaktion:
English: Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 30 måneder.
English: The administration to animals with adult heartworm infection did not pose safety concerns.
Danish: Behandling af dyr med voksne hjerteorm infektion ikke udgør sikkerhedsproblemer.
English: BATCH NUMBER Lot {number}
Danish: BATCHNUMMER Lot {nummer}
English: Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).
Danish: Bør ikke anvendes til katte, der lider af en samtidig sygdom, eller som er invalideret eller undervægtig (i forhold til størrelse og alder).
English: This veterinary medicinal product is not effective against adult D. immitis.
Danish: Dette veterinærlægemiddel er ikke virksomt mod voksne D. immitis.
English: Use of this veterinary medicinal product is indicated in cats aged at least 8 weeks old and weighing at least 1.25 kg bodyweight.
Danish: Brug af dette veterinærlægemiddel er indikeret til katte på 8 uger og derover med en kropsvægt på mindst 1,25 kg.
English: Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.
Danish: Hold behandlede dyr fra åben ild og andre antændelseskilder i mindst 30 minutter, eller indtil pelsen er tør.
English: Avoid direct contact with treated animals until the application area is dry.
Danish: Undgå direkte kontakt med behandlede dyr, til applikationsområdet er tørt.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Danish: FREMSTILLERENS BATCHNUMMER Lot {nummer}
English: These effects do not affect the safety or efficacy of the veterinary medicinal product.
Danish: Disse virkninger har dog ingen betydning for sikkerheden eller virkningen af veterinærlægemidlet.
English: Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product.
Danish: Opbevar produktet i den originale emballage, til det skal bruges, for at forhindre børn i at få adgang til det.
English: EXPIRY DATE EXP {month/year}
Danish: UDLØBSDATO EXP {måned/år}
English: Identification of selamectin metabolites in faeces indicated that metabolic clearance also contributes to the elimination.
Danish: Fund af selamectinmetabolitter i fæces tyder på, at metabolisk clearance også bidrager til eliminationen.
English: Bodyweight of cat (kg)
Danish: Kattens kropsvægt (kg)
English: Keep away from heat, sparks, open flame or other sources of ignition.
Danish: Hold det fra varme, gnister, åben ild eller andre antændelseskilder.
English: During clinical field testing, no interactions between this veterinary medicinal product and routinely used veterinary medicinal products were observed.
Danish: I kliniske feltstudier blev der ikke påvist interaktioner mellem dette veterinærlægemiddel og rutinemæssigt anvendte veterinærlægemidler.
English: Whilst not routinely indicated, the potential benefits of performing periodic testing for heartworm infection in individual cases should be considered by the responsible veterinarian.
Danish: Mens ikke rutinemæssigt indiceret, bør de potentielle fordele ved at udføre periodisk prøvning af hjerteorm infektion i enkelte tilfælde blive overvejet af den ansvarlige dyrlæge.
English: - Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
Danish: - Forebyggelse af hjerteorm forårsaget af Dirofilaria immitis ved månedlig administration.
English: Following topical administration of the Felisecto Plus both selamectin and sarolaner are well absorbed with bioavailability mean values of 40.5% and 57.9%, respectively and distribute systemically.
Danish: Efter topisk administration af Felisecto Plus er både selamectin og sarolaner absorberet godt med middelværdier for biotilgængelighed på henholdsvis 40,5 % og 57,9 % med systemisk distribution.
English: Do not remove the pipette from the blister until ready to use.
Danish: Fjern ikke pipetten ud af blisterpakningen, før den er klar til brug.
English: Disposal: read package leaflet.
Danish: Bortskaffelse: læs indlægssedlen.
English: If accidental eye exposure occurs, flush the eyes immediately with water and seek medical attention.
Danish: I tilfælde af utilsigtet øjenkontakt skylles øjnene straks med vand, og der søges lægehjælp.
English: Ticks must attach to the host and commence feeding in order to be exposed to sarolaner.
Danish: Flåter skal sætte sig på værten og begynde at æde for at blive udsat for sarolaner.
English: Pregnancy and lactation:
Danish: Drægtighed og laktation:
English: Seek further veterinary examination 30 days after treatment to determine whether a second administration is necessary.
Danish: En yderligere dyrlægeundersøgelse anbefales 30 dage efter behandlingen for at vurdere om en yderligere behandling er nødvendig.
English: Felisecto Plus should not enter water courses as this may be dangerous to aquatic organisms.
Danish: Felisecto Plus må ikke udledes i vandløb, da dette kan være farligt for fisk og andre organismer i vandet.
English: Avoid contact between the product and your fingers.
Danish: Undgå at få produktet på fingrene.
English: Avoid eye contact including hand-to-eye-contact.
Danish: Undgå kontakt med øjnene, herunder kontakt med hånd og øjne.
English: SPECIAL STORAGE CONDITIONS Store below 30 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 30 °C.
English: Mild to moderate alopecia at the application site, erythema and drooling have been uncommonly observed.
Danish: Svagt til moderat alopeci på applikationsstedet, erytem og savlen har været observeret i ualmindelige tilfælde.
English: The veterinary medicinal product is exclusively indicated when use against ticks and one or more of the other target parasites is indicated at the same time.
Danish: Veterinærlægemidlet er udelukkende indikeret til samtidig brug mod tæger og en eller flere af øvrige ovennævnte parasitter.
English: Apply the tip of the pipette directly to the skin, without massaging.
Danish: Sæt spidsen af pipetten direkte på huden, uden at massere.
English: The periodic safety update report (PSUR) submissions shall be synchronised and submitted at the same frequency as for the originator product.
Danish: Den periodiske, opdaterede sikkerhedsindberetninger (PSUR) cyklus skal synkroniseres og indsendes eftersamme tidsplan som for referencelægemiddelet.
English: - Treatment of ear mites (Otodectes cynotis).
Danish: - Behandling af øremider (Otodectes cynotis).
English: Do not apply when the animal's hair coat is wet.
Danish: Må ikke appliceres, når dyrets pels er våd.
English: The product is available in packs of three pipettes (all pipette sizes).
Danish: Produktet fås i pakninger med 3 pipetter (alle størrelser pipetter).
English: Prevention of heartworm disease
Danish: Forebyggelse mod hjerteorm
English: In cats, selamectin and sarolaner are low clearance compounds with long half-life values, 12.5 days and 41.5 days respectively, following topical administration.
Danish: For katte er selamectin og sarolaner stoffer med en lav clearance og langvarige halveringstider på henholdsvis 12,5 og 41,5 dage efter udvortes administration.
English: Therefore, it effectively breaks the flea life cycle by killing adults (on the animal), preventing the hatching of eggs (on the animal and in its environment) and by killing larvae (environment only).
Danish: Loppens livscyklus brydes derfor effektivt ved at dræbe voksne lopper (på dyret), forhindre udklækning af æg (på dyret og i dets omgivelser) og dræbe larver (kun i omgivelserne).
English: Sarolaner is an acaricide and insecticide belonging to the isoxazoline family.
Danish: Sarolaner er et acaricid og insekticid tilhørende isoxazolinfamilien.
English: The product is harmful after ingestion.
Danish: Produktet er skadeligt efter indtagelse.
English: Following administration of the product, the adult fleas on the animal are killed within 24 hours, no viable eggs are produced, and larvae (found only in the environment) are also killed.
Danish: Ved behandling med produktet dræbes de voksne lopper på dyret i løbet af 24 timer, produktionen af levedygtige æg ophører, og larver (kun fundet i omgivelserne) dræbes.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.emea.europa.eu/).
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu/).
English: Felisecto Plus should be administered as a single spot-on (topical) application in accordance with the following table (corresponding to a minimum of 6 mg/kg selamectin and 1 mg/kg sarolaner).
Danish: Felisecto Plus skal administreres som en enkelt spot-on (topisk) applikation i henhold til nedenstående oversigt (svarende til minimum 6 mg/kg selamectin and 1 mg/kg sarolaner).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Spot-on use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Spot-on anvendelse.
English: Spot-on solution.
Danish: Spot-on anvendelse.
English: Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, macrocyclic lactones, combinations.
Danish: Farmakoterapeutisk gruppe: Antiparasitmidler, insekticider og afskrækningsmidler, makrocykliske laktoner, kombinationer.
English: It is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more, living in countries where a vector exists should be tested for existing adult heartworm infection before beginning preventive use with the veterinary medicinal product.
Danish: Det anbefales, i overensstemmelse med god veterinær praksis, at alle dyr på 6 måneder og derover, og som lever i lande, hvor vektoren findes, bliver testet for infektion med voksne hjerteorm, før forebyggelse med veterinærlægemidlet indledes.
English: Apply topically to the skin at the base of the neck in front of the shoulder blades.
Danish: Påføres lokalt på huden i nakken foran skulderbladene.
English: This veterinary medicinal product is to be applied to the skin surface only.
Danish: Dette veterinærlægemiddel må kun applikeres på huden.
English: Use of the veterinary medicinal product may result in mild and transient pruritus at the application site.
Danish: Brugen af veterinærlægemidlet kan medføre forbigående svag pruritus på applikationsstedet.
English: 6.2 Major incompatibilities
Danish: 6.2 Væsentlige uforligeligheder Ikke relevant.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/238/001-003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/2/19/238/001-003
English: - The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Danish: - Produktet kan indgå i en behandlingsstrategi til kontrol af loppeallergi-dermatitis (Flea Allergy Dermatitis - FAD).
English: In cats the primary route of selamectin elimination is in faeces and the majority is parent compound.
Danish: Hos katte er den primære rute for eliminering af selamectin i fæces, og det meste af det er moderstof.
English: Cats.
Danish: Katte.
English: Translucent polypropylene unit dose pipettes individually packed in aluminium and aluminium/PVC blisters.
Danish: Gennemsigtige polypropylen pipetter med en dosis, pakket individuelt i aluminium og aluminium/PVC blisterpakninger.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this 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: NAME OF THE VETERINARY MEDICINAL PRODUCT Felisecto Plus ≤2.5 kg
Danish: VETERINÆRLÆGEMIDLETS NAVN Felisecto Plus ≤2,5 kg
English: Wash hands after use and wash off any product in contact with the skin immediately with soap and water.
Danish: Vask hænder efter brug, og afvask straks produktet med vand og sæbe, hvis det har været i berøring med huden.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PIPETTE
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER PIPETTE
English: Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Sarolaner exhibits higher functional potency to block insect/acarine receptors compared to mammalian receptors.
Danish: Sarolaner udviser større funktionel styrke til blokering af receptorerne hos insekter/acariner sammenlignet med receptorerne hos pattedyr.
English: Sarolaner does not interact with known insecticidal binding sites of nicotinic or other GABAergic insecticides such as neonicotinoids, fiproles, milbemycins, avermectins, and cyclodienes.
Danish: Sarolaner reagerer ikke med kendte insektbindingssteder i nikotin- eller GABAergiske insekticider, såsom neonicotinoider, fiproler, milbemyciner, avermectiner og cyclodiener.
English: The final dose must be given within one month after the last exposure to mosquitoes.
Danish: Den sidste dosis skal gives inden for 1 måned efter, dyret sidst blev udsat for myg.
English: This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods leading to their paralysis and/or death.
Danish: Dette hæmmer den elektriske aktivitet i nematodernes nerveceller og i arthropodernes muskelceller, hvilket fører til, at parasitterne paralyseres og/eller dør.
English: Selamectin paralyzes and/or kills a wide range of invertebrate parasites through interference with their chloride channel conductance causing disruption of normal neurotransmission.
Danish: Selamectin paralyserer og/eller dræber en lang række hvirvelløse parasitter ved at interferere med indstrømningen af kloridioner i nervecellerne, hvorved den normale neurotransmission forstyrres.
English: The primary route of elimination for sarolaner is biliary elimination of parent sarolaner, with contributions by metabolic clearance.
Danish: Den primære måde til eliminering af sarolaner er biliær eliminering af modersarolaner, hjulpet af metabolisk clearance.
English: Total volume of unit dose (ml)
Danish: Mængde i alt pr. enhedsdose (ml)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each unit dose (pipette) delivers: Active substances: Felisecto Plus spot-on solution
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosisenhed (pipette) indeholder: Aktive stoffer: Felisecto Plus spot-on opløsning
English: However, selamectin is considered safe for use in breeding, pregnant and lactating cats.
Danish: Selamectin anses dog for sikker til brug til katte, der er beregnet til avl, samt drægtige og diegivende katte.
English: - Treatment of tick infestations.
Danish: - Behandling af tægeinfestationer.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Danish: Kontakt din dyrlæge vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for.
English: Fleas and ticks
Danish: Lopper og flåter
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: 5.2 Pharmacokinetic particulars
Danish: 5.2 Farmakokinetiske egenskaber
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each unit dose (pipette) delivers: Active substances: Felisecto Plus spot-on solution
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hver dosisenhed (pipette) indeholder: Aktive stoffer: Felisecto Plus spot-on opløsning
English: - Treatment of biting lice infestations (Felicola subrostratus).
Danish: - Behandling af infestationer med bidende lus (Felicola subrostratus).
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forholdsregler, der skal træffes af personer, der administrerer lægemidlet til dyr:
English: Selamectin is a semi-synthetic compound of the avermectin class.
Danish: Selamectin er et halvsyntetisk avermectin.
English: While the safety of sarolaner has not been evaluated in breeding, pregnant or lactating cats, laboratory studies with sarolaner in rats and rabbits have not produced any evidence of teratogenic effects.
Danish: Sikkerheden af sarolaner ikke er vurderet for katte, der er beregnet til avl, samt drægtige og diegivende katte, men laboratoriestudier med sarolaner til rotter og kaniner har ikke givet beviser for virkninger på fostre.
English: For ear mite treatment, do not apply directly to the ear canal.
Danish: Ved behandling mod øremider må veterinærlægemidlet ikke appliceres direkte i ørekanalen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON
English: For fleas, the onset of efficacy is within 24 hours for 5 weeks after product application.
Danish: Virkningen indtræffer for lopper inden for 24 timer i 5 uger efter applikation af produktet.
English: Disruption of these receptors by sarolaner prevents the uptake of chloride ions by GABA and glutamate gated ion channels, thus resulting in increased nerve stimulation and death of the target parasite.
Danish: Når disse receptorer ødelægges af sarolaner, hindres optagelsen af kloridioner af GABA og de glutamatstyrede ionkanaler, hvilket resulterer i øget nervestimulation og døden for den parasit, der er målet for behandlingen.
English: Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines.
Danish: Sarolaner blokerer for GABA og de glutamatstyrede kloridkanaler i centralnervesystemet hos insekter og acariner.
English: For optimal control of tick and fleas infestations, the veterinary medicinal product should be administered at monthly intervals and continued throughout the flea and/or tick season based on local epidemiological situations.
Danish: For at opnå optimal kontrol over flåt- og loppeangrebet skal veterinærlægemidlet administreres månedligt, og behandlingen bør fortsætte gennem hele loppe- og/eller flåtsæsonen ud fra lokale epidemiologiske forhold.
English: The product is available in packs of three pipettes (all pipette sizes) placed in cardboard boxes.
Danish: Produktet fås i kartonpakninger med 3 pipetter (alle størrelser pipetter).
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Use only according to the benefit-risk assessment by the prescribing veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ordinerende dyrlæges vurdering af benefit-risk-forholdet.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinier.
English: If a dose is missed and a monthly interval between dosing is exceeded, then immediate administration of the product and resumption of monthly dosing will minimise the opportunity for the development of adult heartworms.
Danish: I tilfælde af en dosis er glemt , og intervallet på 1 måned mellem behandlingerne overskrides, behandles straks med præparatet, og de månedlige behandlinger genoptages for derved at minimere risikoen for udvikling af voksne hjerteorm.
English: Selamectin may adversely affect aquatic organisms.
Danish: Selamectin kan være farligt for organismer i vandet.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Spot-on use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Felisecto Plus 30 mg/5 mg (orange cap)
Danish: Felisecto Plus 30 mg/5 mg (orange hætte)
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: (ml)
Danish: FAD).
English: The product may be administered year-round or at least within one month of the animal's first exposure to mosquitoes and monthly thereafter until the end of the mosquito season.
Danish: Dettepræparat kan anvendes hele året eller højst 1 måned efter, at dyret har været udsat for myg først gang, og herefter til myggesæsonen er slut.
English: Method and route of administration
Danish: Anvendelsesmåde og indgivelsesvej
English: Strength and number of pipettes to be administered Felisecto Plus 15 mg/2.5 mg (yellow cap)
Danish: Styrke og antal administrerede pipetter Felisecto Plus 15 mg/2,5 mg (gul hætte)
English: For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm.
Danish: Til katte, der er angrebet af, eller som risikerer blandet infestation med flåter og lopper, lus, mider, gastroentistinale nematoder eller hjerteorm.
English: When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the product must be given within a month of the last dose of the former veterinary medicinal product.
Danish: Hvis behandling med et veterinærlægemiddel erstatter en behandling med et andet præparat til forebyggelse af hjerteorm, skal første dosis af præparatet gives senest 1 måned efter den sidste behandling med det tidligere veterinærlægemiddel.
English: Medicines should not be disposed of via wastewater.
Danish: Lægemidler må ikke bortskaffes sammen med spildevand eller husholdningsaffald.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/19/238/001 (3 x 0.25 ml) EU/2/19/238/002 (3 x 0.5 ml) EU/2/19/238/003 (3 x 1 ml)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/2/19/238/001 (3 x 0.25 ml)
English: - For the treatment and prevention of flea infestations (Ctenocephalides spp.).
Danish: - Til behandling og forebyggelse af loppeinfestationer (Ctenocephalides spp.).
English: Through its ovicidal and larvicidal action, the veterinary medicinal product may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Danish: På grund af dets ovicidale og larvicidale virkning kan veterinærlægemidlet være med til at behandle eksisterende loppeinfestationer i dyrets omgivelser.
English: 0.2 mg/ml butylated hydroxytoluene.
Danish: Butyleret hydroxytoluen 0,2 mg/ml Spot-on opløsning.
English: The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors).
Danish: Sarolaner virker hovedsageligt på insekter og acariner ved at foretage en funktionel blokade af den ligandstyrede kloridkanal (GABAreceptorer og glutamatreceptorer).