FrancophonIA/ELRC3.0 huggingface dataset:
English: - 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 almindelig (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 af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: Administer with or after food.
Danish: Indgives sammen med eller efter foderet.
English: The terminal half-life is approximately 4 weeks (harmonic mean).
Danish: Den terminale halveringstid er ca. 4 uger (harmonisk gennemsnit).
English: STATEMENT OF THE MRLs Not applicable.
Danish: C. ANGIVELSE AF MRL-VÆRDIER Ikke relevant.
English: Body weight of cat (kg)
Danish: Kattens kropsvægt (kg)
English: 10 DATE OF REVISION OF THE TEXT DD/MM/YYYY
Danish: DATO FOR ÆNDRING AF TEKSTEN DD/MM/ÅÅÅÅ
English: Body weight of dog (kg)
Danish: Hundens kropsvægt (kg)
English: For optimal control of tick and flea 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 optimal kontrol af loppe- og flåtangreb skal veterinærlægemidlet gives med månedlige intervaller igennem hele loppe- og/eller flåtsæsonen baseret på lokale epidemiologiske forhold.
English: Lotilaner is approximately 10 times more bioavailable when administered with food.
Danish: Biotilgængeligheden af lotilaner er cirka 10 gange større ved indgift med foder.
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 på værten og begynde at indtage blod for at blive eksponeret for det aktive stof.
English: Lotilaner is metabolized to a small extent into more hydrophilic compounds which are observed in faeces and urine.
Danish: Lotilaner metaboliseres i mindre grad til mere hydrofile forbindelser, som observeres i afføring og urin.
English: Credelio chewable tablets lotilaner (mg)
Danish: Credelio tyggetabletter lotilaner (lotilanerum) (mg)
English: Lotilaner is a potent inhibitor of gamma-aminobutyric acid (GABA)-gated chloride channels, resulting in rapid death of ticks and fleas.
Danish: Lotilaner er en potent hæmmer af gamma-aminobutansyre (GABA)-styrede chloridkanaler, hvilket resulterer i en hurtig død for flåter og lopper.
English: The veterinary medicinal product kills existing and newly emerged fleas on cats before they can lay eggs.
Danish: Veterinærlægemidlet dræber eksisterende og nye lopper på katten, før de kan lægge æg.
English: Parasites need to start feeding on the host to become exposed to lotilaner; therefore the risk of the transmission of parasite borne diseases cannot be completely excluded.
Danish: Parasitterne skal sætte sig på værten og begynde at indtage blod for at blive eksponeret for lotilaner; derfor kan risikoen for overførsel af parasitbårne sygdomme ikke fuldstændig udelukkes.
English: Acceptable levels of efficacy may not be achieved if the veterinary medicinal product is not administered with food or within 30 minutes after feeding.
Danish: Acceptable effektniveauer opnås muligvis ikke, hvis veterinærlægemidlet ikke gives med foder eller inden for 30 minutter efter fodring.
English: The veterinary medicinal product kills existing and newly emerged fleas on dogs before they can lay eggs.
Danish: Veterinærlægemidlet dræber eksisterende og nye lopper på hunden, før de kan lægge æg.
English: This long terminal half-life provides effective blood concentrations for the entire duration of the interdosing interval.
Danish: Denne lange terminale halveringstid giver effektive blodkoncentrationer i hele intervallet mellem doseringerne.
English: Mild and transient gastrointestinal effects such as vomiting and diarrhoea have been reported to occur very rarely based on post-marketing safety experience.
Danish: Baseret på sikkerhedserfaring efter markedsføring, er milde og forbigående gastrointestinale bivirkninger såsom opkastning og diarré rapporteret at forekomme meget sjældent.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each chewable tablet contains: Credelio chewable tablets lotilaner (mg)
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Hver tyggetablet indeholder: Credelio tyggetabletter lotilaner (mg)
English: Manufacturer responsible for batch release: Elanco France S.A.S., 26 rue de la Chapelle, 68330 Huningue, France
Danish: Fremstiller ansvarlig for batchfrigivelse: Elanco France S.A.S., 26 rue de la Chapelle, 68330 Huningue, Frankrig
English: This terminal half-life provides effective blood concentrations for the entire duration of the inter-dosing interval.
Danish: Denne terminale halveringstid giver effektive blodkoncentrationer i hele intervallet mellem doseringerne.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/206/016-21
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/2/17/206/016-21
English: The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Danish: Produktet kan indgå i en behandlingsstrategi til kontrol af loppeallergi-dermatitis (Flea Allergy Dermatitis - FAD).
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
Danish: I tilfælde af utilsigtet indgift skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Danish: Veterinærlægemidlet kan indgå i en behandlingsstrategi til kontrol af loppeallergi-dermatitis (Flea Allergy Dermatitis - FAD).
English: Credelio 900 mg chewable tablets for dogs: 2 years
Danish: Credelio 900 mg tyggetabletter til hunde 900: 2 år
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton box and blister after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på blisterpakningen og kartonen efter EXP. Udløbsdatoen refererer til den sidste dag i den pågældende måned.
English: Use an appropriate combination of available strengths to achieve the recommended dose of 2043 mg/kg.
Danish: Brug en passende kombination af de tilgængelige styrker for at opnå den anbefalede dosis på 20-43 mg/kg.
English: Credelio 56 mg, 112 mg, 225 mg, 450 mg chewable tablets for dogs: 3 years
Danish: Credelio 56 mg, 112 mg, 225 mg, 450 mg tyggetabletter til hunde: 3 år
English: Laboratory studies in rats have not produced any evidence of teratogenic effects.
Danish: Laboratorieundersøgelser af rotter har ikke afsløret teratogene virkninger.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters (cats)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister (katte)
English: For cats of more than 8 kg body weight use an appropriate combination of available strengths to achieve the recommended dose of 6- 24 mg/kg.
Danish: For katte med en kropsvægt på mere end 8 kg, skal der bruges en passende kombination af de tilgængelige styrker for at opnå den anbefalede dosis på 6-24 mg/kg.
English: White to beige round chewable tablets with brownish spots.
Danish: Hvide til beige runde tyggetabletter med brunlige pletter.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/206/001-015
Danish: 8 MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/2/17/206/001-015
English: Administer the chewable tablet(s) monthly with or after food.
Danish: Indgiv tyggetabletten/-tabletterne én gang om måneden sammen med eller efter foderet.
English: Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached within 2 hours.
Danish: Lotilaner absorberes hurtigt efter peroral administration, og maksimal blodkoncentration opnås inden for 2 timer.
English: The tablets are packaged in aluminium/ aluminium blisters packaged into an outer cardboard box.
Danish: Tabletterne er pakket i en aluminium/aluminium blisterfolie i en ydre karton.
English: ADVICE ON CORRECT ADMINISTRATION Credelio is a palatable chewable flavoured tablet.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Credelio er en velsmagende tyggetablet tilsat smagsstof.
English: EU/2/17/206/016 (12 mg lotilaner; 1 chewable tablet) EU/2/17/206/017 (12 mg lotilaner; 3 chewable tablet) EU/2/17/206/018 (12 mg lotilaner; 6 chewable tablet) EU/2/17/206/019 (48 mg lotilaner; 1 chewable tablet) EU/2/17/206/020 (48 mg lotilaner; 3 chewable tablet) EU/2/17/206/021 (48 mg lotilaner; 6 chewable tablet)
Danish: EU/2/17/206/016 (12 mg lotilaner; 1 tyggetablet) EU/2/17/206/017 (12 mg lotilaner; 3 tyggetabletter) EU/2/17/206/018 (12 mg lotilaner; 6 tyggetabletter) EU/2/17/206/019 (48 mg lotilaner; 1 tyggetablet) EU/2/17/206/020 (48 mg lotilaner; 3 tyggetabletter) EU/2/17/206/021 (48 mg lotilaner; 6 tyggetabletter)
English: Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached at 4 hours.
Danish: Lotilaner absorberes hurtigt efter peroral administration, og maksimal blodkoncentration opnås efter 4 timer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (cats)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske (katte)
English: EU/2/17/206/001 (56 mg lotilaner; 1 chewable tablet) EU/2/17/206/002 (56 mg lotilaner; 3 chewable tablets) EU/2/17/206/003 (56 mg lotilaner; 6 chewable tablets) EU/2/17/206/004 (112 mg lotilaner; 1 chewable tablet) EU/2/17/206/005 (112 mg lotilaner; 3 chewable tablets) EU/2/17/206/006 (112 mg lotilaner; 6 chewable tablets) EU/2/17/206/007 (225 mg lotilaner; 1 chewable tablet) EU/2/17/206/008 (225 mg lotilaner; 3 chewable tablets) EU/2/17/206/009 (225 mg lotilaner; 6 chewable tablets) EU/2/17/206/010 (450 mg lotilaner; 1 chewable tablet) EU/2/17/206/011 (450 mg lotilaner; 3 chewable tablets) EU/2/17/206/012 (450 mg lotilaner; 6 chewable tablets) EU/2/17/206/013 (900 mg lotilaner; 1 chewable tablet)
Danish: EU/2/17/206/001 (56 mg lotilaner; 1 tyggetablet) EU/2/17/206/002 (56 mg lotilaner; 3 tyggetabletter) EU/2/17/206/003 (56 mg lotilaner; 6 tyggetabletter) EU/2/17/206/004 (112 mg lotilaner; 1 tyggetablet) EU/2/17/206/005 (112 mg lotilaner; 3 tyggetabletter) EU/2/17/206/006 (112 mg lotilaner; 6 tyggetabletter) EU/2/17/206/007 (225 mg lotilaner; 1 tyggetablet) EU/2/17/206/008 (225 mg lotilaner; 3 tyggetabletter) EU/2/17/206/009 (225 mg lotilaner; 6 tyggetabletter) EU/2/17/206/010 (450 mg lotilaner; 1 tyggetablet) EU/2/17/206/011 (450 mg lotilaner; 3 tyggetabletter) EU/2/17/206/012 (450 mg lotilaner; 6 tyggetabletter) EU/2/17/206/013 (900 mg lotilaner; 1 tyggetablet) EU/2/17/206/014 (900 mg lotilaner; 3 tyggetabletter)
English: Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue FRANCE
Danish: 26 Rue de la Chapelle 68330 Huningue FRANKRIG
English: Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the dog has access.
Danish: Derfor bryder produktet loppernes livscyklus og forhindrer således spredning af lopperne til de områder, hvor hunden færdes.
English: Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the cat has access.
Danish: Derfor bryder produktet loppernes livscyklus og forhindrer således spredning af lopperne til de områder, hvor katten færdes.
English: EU/2/17/206/014 (900 mg lotilaner; 3 chewable tablets) EU/2/17/206/015 (900 mg lotilaner; 6 chewable tablets)
Danish: EU/2/17/206/015 (900 mg lotilaner; 6 tyggetabletter)
English: Credelio is a palatable chewable flavoured tablet.
Danish: Credelio er en velsmagende tyggetablet tilsat smagsstof.
English: Safety and efficacy data has been studied in cats aged 8 weeks and older with a body weight of 0.5 kg or more.
Danish: Sikkerheds- og effektdata er blevet undersøgt hos katte på 8 uger eller ældre med en kropsvægt på mindst 0,5 kg.
English: Each tablet strength is available in pack sizes of 1, 3 or 6 tablets.
Danish: Hver tabletstyrke fås i pakningsstørrelser med 1, 3 eller 6 tabletter.
English: Laboratory studies in rats have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females.
Danish: Laboratorieundersøgelser af rotter har ikke afsløret teratogene virkninger eller nogen skadelig effekt på reproduktionsevnen hos han- og hundyr.
English: Administer the veterinary medicinal product with food or within 30 minutes after feeding.
Danish: Giv veterinærlægemidlet sammen med foder eller inden for 30 minutter efter fodring.
English: The major route of elimination is biliary excretion and renal excretion is the minor route of elimination (less than 10% of the dose).
Danish: Lægemidlet udskilles primært via galdevejene og sekundært via nyrerne (mindre end 10 % af dosis).
English: Each strength of Credelio chewable tablets for cats is available in pack sizes of 1, 3 or 6 tablets.
Danish: Hver enkelt styrke af Credelio tyggetabletter til katte fås i pakningsstørrelser med 1, 3 eller 6 tabletter.
English: For the treatment of flea and tick infestations on cats.
Danish: Til behandling af loppe- og flåtangreb hos katte.
English: Laboratory studies in rats have not produced any evidence of any adverse effect on the reproductive capacity of males and females.
Danish: Laboratorieundersøgelser af rotter har ikke afsløret nogen skadelig effekt på reproduktionsevnen hos han- og hundyr.
English: for dogs (1.3-2.5 kg) for dogs (>2.5-5.5 kg) for dogs (>5.5-11 kg) for dogs (>11-22 kg) for dogs (>22-45 kg)
Danish: til hunde (1,3-2,5 kg) til hunde (>2,5-5,5 kg) til hunde (>5,5-11 kg) til hunde (>11-22 kg) til hunde (>22-45 kg)
English: for cats (0.5-2.0 kg) for cats (>2-8.0 kg)
Danish: til katte (0,5-2,0 kg) til katte (> 2-8,0 kg)
English: The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 20 to 43 mg lotilaner/kg bodyweight.
Danish: Veterinærlægemidlet skal administreres i henhold til nedenstående tabel for at sikre en dosering på 20-43 mg lotilaner/kg kropsvægt.
English: ADVICE ON CORRECT ADMINISTRATION Administer the veterinary medicinal product with food or within 30 minutes after feeding.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Indgiv veterinærlægemidlet med foder eller inden for 30 minutter efter fodring.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Administer with food or within 30 minutes after feeding.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Indgives med foder eller inden for 30 minutter efter fodring.
English: PHARMACEUTICAL FORM Chewable tablet.
Danish: 3 LÆGEMIDDELFORM Tyggetablet.
English: for cats (0.5-2.0 kg) for cats (>2.0-8.0 kg)
Danish: til katte (0,5-2,0 kg) til katte (>2,0-8,0 kg)
English: In in vitro studies, the activity of lotilaner against some arthropod species was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin).
Danish: I in vitro studier blev lotilaner-aktiviteten mod visse arter af leddyr ikke påvirket af resistens over for organochloriner (cyclodiener, f.eks. dieldrin), phenylpyrazoler (f.eks. fipronil), neonicotinoider (f.eks. imidacloprid), formamidiner (f.eks. amitraz) og pyrethroider (f.eks. cypermethrin).
English: Each strength of Credelio chewable tablets is available in pack sizes of 1, 3 or 6 tablets.
Danish: Hver enkelt styrke af Credelio-tyggetabletter fås i pakningsstørrelser med 1, 3 eller 6 tabletter.
English: Treatment of flea and tick infestations in dogs.
Danish: Behandling af loppe- og flåtangreb hos hunde.
English: The activity of lotilaner was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin).
Danish: Lotilaner-aktiviteten blev ikke påvirket af resistens over for organokloriner (cyclodiener, f.eks. dieldrin), phenylpyrazoler (f.eks. fipronil), neonicotinoider (f.eks. imidacloprid), formamidiner (f.eks. amitraz) og pyrethroider (f.eks. cypermethrin).
English: All safety and efficacy data have been acquired from dogs and puppies 8 weeks of age and older and 1.3 kg of body weight and greater.
Danish: Alle sikkerheds- og effektdata er indsamlet fra hunde og hvalpe, der er mindst 8 uger gamle og har en kropsvægt på mindst 1,3 kg.
English: Lotilaner, a pure enantiomer from the isoxazoline class, is active against fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Ixodes ricinus).
Danish: Lotilaner, en ren enantiomer af isoxazolin-familien, virker både mod lopper (Ctenocephalides felis og Ctenocephalides canis) og flåter (Ixodes ricinus).
English: The flavoured veterinary medicinal product should be administered in accordance with the following table to ensure a single dose of 6 to 24 mg lotilaner/kg bodyweight.
Danish: Det smagssatte veterinærlægemiddel skal administreres i henhold til nedenstående tabel for at sikre en enkeltdosis på 6-24 mg lotilaner/kg kropsvægt.
English: No adverse reactions were observed following oral administration to puppies aged 8-9 weeks and weighing 1.3-3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Danish: Der blev ikke observeret nogen bivirkninger efter peroral administration til hvalpe, der var 8-9 uger gamle og vejede 1,3-3,6 kg og blev behandlet med overdoser på op til 5 gange den maksimale anbefalede dosis (43 mg, 129 mg og 215 mg lotilaner/kg kropsvægt) ved otte lejligheder med månedlige intervaller.
English: Use only accordingly to the benefit-risk assessment of the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-risk forholdet.
English: Fleas on the animal prior to administration are killed within 6 hours.
Danish: Lopper, der forefindes på dyret før administrationen, dræbes i løbet af 6 timer.
English: This veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).
Danish: Veterinærlægemidlet virker øjeblikkeligt dræbende og har en langtidsvirkning på 1 måned mod lopper (Ctenocephalides felis og C. canis) og flåter (Ixodes ricinus).
English: Use only according to the benefit-risk assessment of the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit-risk-forholdet.
English: 1 tablet 3 tablets 6 tablets
Danish: PAKNINGSSTØRRELSE 1 tablet
English: All safety and efficacy data have been acquired from cats and kittens 8 weeks of age and older and 0.5 kg of body weight and greater.
Danish: Alle sikkerheds- og effektdata er indsamlet fra katte og killinger, der er mindst 8 uger gamle og har en kropsvægt på mindst 0,5 kg.
English: Existing I. ricinus ticks on the animal prior to administration are killed within 8 hours.
Danish: Flåter (I.ricinus), der forefindes på dyret før administrationen, dræbes i løbet af 8 timer.
English: No adverse reactions were observed following oral administration to kittens aged 8 weeks and weighing 0.5 kg treated with overdoses of more than 5 times the maximum recommended dose rate (130 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Danish: Der blev ikke observeret nogen bivirkninger efter peroral administration til killinger, der var 8 uger gamle og vejede 0,5 kg og blev behandlet med overdoser på mere end 5 gange den maksimale anbefalede dosis (130 mg lotilaner/kg kropsvægt) ved otte lejligheder med månedlige intervaller.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forsigtighedsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Vask hænder efter håndtering af produktet.
English: Excipients:
Danish: Overdosis:
English: The safety of the veterinary medicinal product in cats has not been established during pregnancy and lactation.
Danish: Veterinærlægemidlets sikkerhed er ikke blevet fastlagt hos katte under drægtighed og laktation.
English: Lotilaner, a pure enantiomer from the isoxazoline class is active against fleas (Ctenocephalides felis and Ctenocephalides canis) as well as the tick species Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus.
Danish: Lotilaner, en ren enantiomer af isoxazolin-familien, virker både mod lopper (Ctenocephalides felis og Ctenocephalides canis) og flåtarter Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus og Rhipicephalus sanguineus.
English: This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).
Danish: Veterinærlægemidlet virker øjeblikkeligt dræbende og har en langtidsvirkning på 1 måned på lopper (Ctenocephalides felis og C. canis) og flåter (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus og Dermacentor reticulatus).
English: Cellulose, powdered Lactose monohydrate Silicified microcrystalline cellulose Meat dry flavour
Danish: Gærpulver (smagsstof) Silicificeret mikrokrystallinsk cellulose Cellulose
English: Fleas on the animal prior to administration are killed within 8 hours.
Danish: Lopper, der forefindes på dyret før administrationen, dræbes i løbet af 8 timer.
English: 10 DATE OF REVISION OF THE TEXT <{DD/MM/YYYY}>
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN {DD måned ÅÅÅÅ}
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Credelio 12 mg (0.5-2.0 kg)
Danish: Credelio 12 mg (0,5-2,0 kg)
English: Existing ticks on the animal prior to administration are killed within 18 hours.
Danish: Flåter, der forefindes på dyret før administrationen, dræbes i løbet af 18 timer.
English: The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has not been established.
Danish: Veterinærlægemidlets sikkerhed er ikke blevet fastlagt hos avlshunde, drægtige eller diegivende hunde.
English: Use of this veterinary medicinal product in puppies younger than 8 weeks of age or less than 1.3 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
Danish: Brugen af dette veterinærlægemiddel til behandling af hvalpe, der er under 8 uger gamle eller har en kropsvægt på mindre end 1,3 kg, bør baseres på en benefit-riskvurdering foretaget af den ansvarlige dyrlæge.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Credelio 12 mg chewable tablets for cats (0.5-2.0 kg) Credelio 48 mg chewable tablets for cats (>2.0-8.0 kg)
Danish: VETERINÆRLÆGEMIDLETS NAVN Credelio 12 mg, tyggetabletter, til katte (0,5-2,0 kg) Credelio 48 mg, tyggetabletter, til katte (>2,0-8.0 kg)
English: Overdose (symptoms, emergency procedures, antidotes): No adverse reactions were observed following oral administration to puppies aged 8-9 weeks and weighing 1.3-3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt Der blev ikke observeret nogen bivirkninger efter peroral administration til killinger, der var 8 uger gamle og vejede 0,5 kg, som blev behandlet med mere end 5 gange den maksimale anbefalede dosis (130 mg lotilaner/kg kropsvægt) ved otte lejligheder med månedlige intervaller.