FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Za mačke teže od 8 kg upotrijebite odgovarajuću kombinaciju raspoloživih jačina tableta kako biste postigli preporučenu dozu od 6 do 24 mg/kg.
English: Shelf life of the veterinary medicinal product as packaged for sale:
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju:
English: Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the dog has access.
Croatian: Dakle, proizvod prekida životni ciklus buha i sprječava kontaminaciju buhama, područja u koja pas ima pristup.
English: The veterinary medicinal product kills existing and newly emerged fleas on dogs before they can lay eggs.
Croatian: Veterinarsko-medicinski proizvod ubija buhe koje se već nalaze na psima i nove buhe prije nego stignu položiti jajašca.
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.
Croatian: Laboratorijski pokusi na štakorima nisu izazvali nikakav teratogeni učinak niti bilo kakav negativan učinak na reproduktivnu sposobnost ženki i mužjaka.
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).
Croatian: - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)
English: Lotilaner is metabolized to a small extent into more hydrophilic compounds which are observed in faeces and urine.
Croatian: Lotilaner se u maloj mjeri metabolizira u hidrofilne spojeve koji se primjećuju stolici i urinu.
English: Laboratory studies in rats have not produced any evidence of teratogenic effects.
Croatian: Laboratorijski pokusi na štakorima nisu izazvali nikakav teratogeni učinak.
English: Pharmacotherapeutic group: ectoparasiticides for systemic use, isoxazolines.
Croatian: Farmakoterapijska grupa: ektoparazitici, za sustavnu primjenu, izoksazolini.
English: Manufacturer responsible for batch release: Elanco France S.A.S., 26 rue de la Chapelle, 68330 Huningue, France
Croatian: Elanco France S.A.S., 26 rue de la Chapelle, 68330 Huningue, Francuska
English: Use only according to the benefit/risk assessment by the responsible veterinarian.
Croatian: Upotrijebiti samo u skladu s procjenom koristi/rizika od strane odgovornog veterinara.
English: Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached at 4 hours.
Croatian: Nakon primjene kroz usta, lotilaner se odmah apsorbira, a vršna koncentracija u krvi postiže se u roku od 4 sata.
English: Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached within 2 hours.
Croatian: Nakon primjene kroz usta, lotilaner se odmah apsorbira, a vršna koncentracija u krvi postiže se u roku od 2 sata.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/206/001-015
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/17/206/001-015
English: The tablets are packaged in aluminium/aluminium blisters packaged into an outer cardboard box.
Croatian: 6.5 Osobine i sastav unutarnjeg pakovanja Tablete se nalaze u aluminijskim/aluminijskim blisterima, pakiranim u kartonskoj kutiji.
English: The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Croatian: Proizvod se može primjenjivati kao dio strategije liječenja u kontroli alergijskog dermatitisa uzrokovanog buhama (FAD).
English: Sodium laurilsulfate Vanillin (flavour)
Croatian: Natrijev laurilsulfat
English: Use an appropriate combination of available strengths to achieve the recommended dose of 2043 mg/kg.
Croatian: Upotrijebite odgovarajuću kombinaciju raspoloživih jačina tableta kako biste postigli preporučenu dozu od 20 do 43 mg/kg.
English: EU/2/17/206/014 (900 mg lotilaner; 3 chewable tablets) EU/2/17/206/015 (900 mg lotilaner; 6 chewable tablets)
Croatian: EU/2/17/206/013 (lotilaner 900 mg; 1 tableta za žvakanje) EU/2/17/206/014 (lotilaner 900 mg; 3 tablete za žvakanje) EU/2/17/206/015 (lotilaner 900 mg; 6 tableta za žvakanje)
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)
Croatian: EU/2/17/206/001 (lotilaner 56 mg; 1 tableta za žvakanje) EU/2/17/206/002 (lotilaner 56 mg; 3 tablete za žvakanje) EU/2/17/206/003 (lotilaner 56 mg; 6 tableta za žvakanje) EU/2/17/206/004 (lotilaner 112 mg; 1 tableta za žvakanje) EU/2/17/206/005 (lotilaner 112 mg; 3 tablete za žvakanje) EU/2/17/206/006 (lotilaner 112 mg; 6 tableta za žvakanje) EU/2/17/206/007 (lotilaner 225 mg; 1 tableta za žvakanje) EU/2/17/206/008 (lotilaner 225 mg; 3 tablete za žvakanje) EU/2/17/206/009 (lotilaner 225 mg; 6 tableta za žvakanje) EU/2/17/206/010 (lotilaner 450 mg; 1 tableta za žvakanje) EU/2/17/206/011 (lotilaner 450 mg; 3 tablete za žvakanje) EU/2/17/206/012 (lotilaner 450 mg; 6 tableta za žvakanje)
English: Existing I. ricinus ticks on the animal prior to administration are killed within 8 hours.
Croatian: Postojeći I. ricinus krpelji koji se već nalaze na životinji prije primjene ugibaju u roku od 8 sati.
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.
Croatian: Lotilaner, čisti enantiomer iz skupine izoksazolina aktivno djeluje protiv buha (Ctenocephalides felis i Ctenocephalides canis) i krpelja vrsta Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus, Rhipicephalus sanguineus.
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.
Croatian: Svi podaci o neškodljivosti i djelotvornosti liječenja prikupljeni su od pasa i štenaca od 8 tjedana i starijih, teških 1,3 kg ili više.
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.
Croatian: Aromatiziran veterinarsko-medicinski proizvod treba davati u skladu sa sljedećom tablicom, kako bi se osiguralo jednokratno doziranje 6 do 24 mg lotilanera po kilogramu tjelesne težine.
English: Laboratory studies in rats have not produced any evidence of any adverse effect on the reproductive capacity of males and females.
Croatian: Laboratorijski pokusi na štakorima nisu izazvali nikakve nuspojave na reproduktivnu sposobnost ženki i mužjaka.
English: Each tablet strength is available in pack sizes of 1, 3 or 6 tablets.
Croatian: Pojedina jačina tablete dostupna je u pakiranjima od 1, 3 ili 6 tableta.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use.
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)
English: Administer the chewable tablet(s) monthly with or after food.
Croatian: Tabletu(e) za žvakanje dajte životinji jednom mjesečno uz obrok ili nakon njega.
English: During clinical testing, no interactions between Credelio chewable tablets and routinely used veterinary medicinal products were observed.
Croatian: Tijekom kliničkih ispitivanja nisu primijećene interakcije između tableta za žvakanje
English: The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Croatian: Veterinarsko-medicinski proizvod može se primjenjivati kao dio strategije liječenja u kontroli alergijskog dermatitisa uzrokovanog buhama (FAD).
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
Croatian: U slučaju da se nehotice proguta, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: PHARMACEUTICAL FORM Chewable tablet.
Croatian: OBLIK Tableta za žvakanje.
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)
Croatian: EU/2/17/206/016 (lotilaner 12 mg; 1 tableta za žvakanje) EU/2/17/206/017 (lotilaner 12 mg; 3 tablete za žvakanje) EU/2/17/206/018 (lotilaner 12 mg; 6 tableta za žvakanje) EU/2/17/206/019 (lotilaner 48 mg; 1 tableta za žvakanje) EU/2/17/206/020 (lotilaner 48 mg; 3 tablete za žvakanje) EU/2/17/206/021 (lotilaner 48 mg; 6 tableta za žvakanje)
English: Administer the veterinary medicinal product with food or within 30 minutes after feeding.
Croatian: Veterinarsko-medicinski proizvod dajte životinji uz obrok ili unutar 30 minuta nakon hranjenja.
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.
Croatian: Veterinarsko-medicinski proizvod treba davati u skladu sa sljedećom tablicom, kako bi se osiguralo doziranje 20 do 43 mg lotilanera po kilogramu tjelesne težine.
English: for cats (0.5-2.0 kg) for cats (>2.0-8.0 kg)
Croatian: za mačke (0,5-2,0 kg) za mačke (> 2,0-8,0 kg)
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.
Croatian: Svi podaci o neškodljivosti i djelotvornosti liječenja prikupljeni su od mačaka i mačića od 8 tjedana i starijih, teških 0,5 kg ili više.
English: PHARMACEUTICAL FORM Chewable tablet
Croatian: OBLIK Tableta za žvakanje
English: for cats (0.5-2.0 kg) for cats (>2-8.0 kg)
Croatian: za mačke (0,5 - 2,0 kg) za mačke (> 2,0 - 8,0 kg)
English: For the treatment of flea and tick infestations on cats.
Croatian: Za liječenje infestacije buhama i krpeljima na mačkama.
English: The safety of the veterinary medicinal product in cats has not been established during pregnancy and lactation.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda kod mačaka nije utvrđena tijekom graviditeta i laktacije.
English: Each strength of Credelio chewable tablets for cats is available in pack sizes of 1, 3 or 6 tablets.
Croatian: Credelio tableta za žvakanje za mačke dostupne su u pakiranjima od 1, 3 ili 6 tableta.
English: Fleas on the animal prior to administration are killed within 6 hours.
Croatian: Buhe koje se već nalaze na životinji prije liječenja ubijaju se u roku od 6 sati.
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).
Croatian: Veterinarsko-medicinski proizvod trenutačno i postojano ubija buhe (Ctenocephalides felis i C. canis)
English: White to beige round chewable tablets with brownish spots.
Croatian: Okrugle tablete za žvakanje, bijele do bež boje, sa smećkastim mrljama.
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).
Croatian: Na djelovanje lotilanera nije utjecala otpornost na organoklorne spojeve (ciklodiene, npr. dieldrin), fenilpirazole (npr. fipronil), neonikotinoide (npr. imidakloprid), formamidine (npr. amitraz) i piretroide (npr. cipermetrin).
English: Mild and transient gastrointestinal effects such as vomiting and diarrhoea have been reported to occur very rarely based on post-marketing safety experience.
Croatian: NUSPOJAVE Nakon puštanja lijeka u promet, vrlo rijetko su prijavljene blage i prolazne posljedice po gastrointestinalni trakt poput povraćanja i proljeva.
English: STATEMENT OF ACTIVE SUBSTANCES 12 mg lotilaner
Croatian: SASTAV DJELATNIH TVARI lotilaner 12 mg lotilaner 48 mg
English: Each strength of Credelio chewable tablets is available in pack sizes of 1, 3 or 6 tablets.
Croatian: Credelio tableta za žvakanje dostupne su u pakiranjima od 1, 3 ili 6 tableta.
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).
Croatian: In vitro ispitivanja djelovanja lotilanera protiv nekih artropodnih vrsta nije utjecala otpornost na organoklorne spojeve (ciklodiene, npr. dieldrin), fenilpirazole (npr. fipronil), neonikotinoide (npr. imidakloprid), formamidine (npr. amitraz) i piretroide (npr. cipermetrin).
English: Silicified microcrystalline cellulose Cellulose, powdered Lactose monohydrate Povidone K30
Croatian: Celuloza, prah Laktoza hidrat Povidon K30
English: Treatment of flea and tick infestations in dogs.
Croatian: Liječenje infestacije buhama i krpeljima kod pasa.
English: Fleas on the animal prior to administration are killed within 8 hours.
Croatian: Buhe koje se već nalaze na životinji prije liječenja ubijaju se u roku od 8 sati.
English: For the treatment of flea and tick infestations in dogs.
Croatian: Za liječenje infestacije buhama i krpeljima kod pasa.
English: Credelio is a palatable chewable flavoured tablet.
Croatian: Tablete Credelio ukusne su aromatizirane tablete za žvakanje.
English: Lotilaner, a pure enantiomer from the isoxazoline class, is active against fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Ixodes ricinus).
Croatian: Lotilaner, čisti enantiomer iz skupine izoksazolina aktivno djeluje protiv buha (Ctenocephalides felis i
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each chewable tablet contains: Credelio chewable tablets lotilaner (mg)
Croatian: Svaka tableta za žvakanje sadrži: Credelio tablete za žvakanje lotilaner (mg)
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.
Croatian: Nikakve negativne reakcije nisu primijećene prilikom primjene kroz usta, na štencima starim 8 - 9 tjedana, težine 1,3 - 3,6 kg, koji su predozirani dozama koje su bile do 5 puta veće od maksimalno preporučene doze (43 mg, 129 mg i 215 mg lotilanera po kilogramu tjelesne težine) u osam navrata, u razmacima od mjesec dana.
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)
Croatian: za pse (1,3-2,5 kg) za pse (> 2,5-5,5 kg) za pse (> 5,5-11 kg) za pse (> 11-22 kg) za pse (> 22-45 kg)
English: For oral use.
Croatian: SAVIJETI ZA ISPRAVNU PRIMJENU
English: The safety of the veterinary medicinal product in breeding dogs has not been established.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda kod pasa namijenjenih za uzgoj nije utvrđena.
English: PACKAGE LEAFLET: Credelio 12 mg chewable tablets for cats (0.5-2.0 kg) Credelio 48 mg chewable tablets for cats (>2.0-8.0 kg)
Croatian: Credelio 12 mg tablete za žvakanje za mačke (0,5-2,0 kg) Credelio 48 mg tablete za žvakanje za mačke (> 2,0-8,0 kg)
English: 10 DATE OF REVISION OF THE TEXT DD/MM/YYYY
Croatian: DD/MM/GGGG
English: The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has not been established.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda kod pasa namijenjenih za uzgoj, u vrijeme graviditeta i laktacije nije utvrđena.
English: Silica, colloidal anhydrous Magnesium stearate
Croatian: Natrijev laurilsulfat Silicijev dioksid, koloidni, bezvodni Magnezijev stearat
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.
Croatian: Ako se veterinarsko-medicinski proizvod ne primijeni uz obrok ili unutar 30 minuta nakon hranjenja,
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.
Croatian: Nikakve negativne reakcije nisu primijećene prilikom primjene kroz usta, na mačićima starim 8 tjedana, težine 0,5 kg, koji su predozirani dozama koje su bile više od 5 puta veće od maksimalno preporučene doze (130 mg lotilanera po kilogramu tjelesne težine) u osam navrata, u razmacima od mjesec dana.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Elanco
English: For ticks, the onset of efficacy is within 48 hours of attachment for one month after product administration.
Croatian: Početak djelotvornosti kod krpelja je unutar 48 sati od pričvršćivanja na životinju, djeluje mjesec dana od primjene proizvoda.
English: The safety of the veterinary medicinal product in pregnant and lactating dogs has not been established.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda kod pasa u vrijeme graviditeta i laktacije nije utvrđena.
English: For fleas, the onset of efficacy is within 12 hours of attachment for one month after product administration.
Croatian: Početak djelotvornosti na buhe je unutar 12 sati od pričvršćivanja na životinju, djeluje mjesec dana od primjene proizvoda.
English: Credelio 56 mg chewable tablets for dogs (1.3-2.5 kg) Credelio 112 mg chewable tablets for dogs (>2.5-5.5 kg) Credelio 225 mg chewable tablets for dogs (>5.5-11 kg) Credelio 450 mg chewable tablets for dogs (>11-22 kg) Credelio 900 mg chewable tablets for dogs (>22-45 kg)
Croatian: Credelio 56 mg tablete za žvakanje za pse (1,3-2,5 kg) Credelio 112 mg tablete za žvakanje za pse (> 2,5-5,5 kg) Credelio 225 mg tablete za žvakanje za pse (> 5,5-11 kg) Credelio 450 mg tablete za žvakanje za pse (> 11-22 kg) Credelio 900 mg tablete za žvakanje za pse (> 22-45 kg)
English: Use of this veterinary medicinal product in kittens younger than 8 weeks of age or less than 0.5 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
Croatian: Primjenu ovog veterinarsko-medicinskog proizvoda za liječenje mačića mlađih od 8 tjedana ili lakših od 0,5 kg treba temeljiti na procjeni koristi/rizika od strane odgovornog veterinara.
English: PACKAGE LEAFLET: Credelio 56 mg chewable tablets for dogs (1.3-2.5 kg) Credelio 112 mg chewable tablets for dogs (>2.5-5.5 kg) Credelio 225 mg chewable tablets for dogs (>5.5-11 kg) Credelio 450 mg chewable tablets for dogs (>11-22 kg) Credelio 900 mg chewable tablets for dogs (>22-45 kg)
Croatian: UPUTA O VMP: Credelio 56 mg tablete za žvakanje za pse (1,3-2,5 kg) Credelio 112 mg tablete za žvakanje za pse (> 2,5-5,5 kg) Credelio 225 mg tablete za žvakanje za pse (> 5,5-11 kg) Credelio 450 mg tablete za žvakanje za pse (> 11-22 kg) Credelio 900 mg tablete za žvakanje za pse (> 22-45 kg)
English: Cellulose, powdered Lactose monohydrate Silicified microcrystalline cellulose Meat dry flavour
Croatian: Celuloza, prah Laktoza monohidrat
English: Therefore, use of this veterinary medicinal product in kittens younger than 8 weeks of age or less than 0.5 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
Croatian: Stoga primjenu veterinarsko-medicinskog proizvoda za liječenje mačića mlađih od 8 tjedana ili lakših od 0,5 kg treba temeljiti na procjeni koristi/rizika od strane odgovornog veterinara.
English: For fleas, the onset of efficacy is within 4 hours of attachment for one month after product administration.
Croatian: Početak djelotvornosti na buhe je unutar 4 sata od pričvršćivanja na životinju, djeluje mjesec dana od primjene proizvoda.
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.
Croatian: Primjenu veterinarsko-medicinskog proizvoda za liječenje štenaca mlađih od 8 tjedana ili lakših od 1,3 kg treba temeljiti na procjeni koristi/rizika od strane odgovornog veterinara.
English: The administration of this 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.
Croatian: Primjenu proizvoda za liječenje štenaca mlađih od 8 tjedana ili lakših od 1,3 kg treba temeljiti na procjeni koristi/rizika od strane odgovornog veterinara.
English: For ticks, the onset of efficacy is within 24 hours of attachment for one month after product administration.
Croatian: Početak djelotvornosti kod krpelja je unutar 24 sata od pričvršćivanja na životinju, djeluje mjesec dana od primjene proizvoda.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Administer with food or within 30 minutes after feeding.
Croatian: Primijeniti uz obrok ili unutar 30 minuta nakon hranjenja.
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).
Croatian: i krpelje (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus i Dermacentor reticulatus), a djeluje mjesec dana.
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Kartonska kutija (psi)
English: The safety of the veterinary medicinal product in breeding queens has not been established.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda kod mačaka namijenjenih za uzgoj nije utvrđena.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (cats)
Croatian: Kartonska kutija (mačke)
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.
Croatian: Podaci o neškodljivosti i djelotvornosti liječenja ispitivani su na mačkama od 8 tjedana i starijim,
English: No adverse reactions were observed following oral administration to kittens aged 8 weeks, weighing 0.5 kg, which were treated with more than 5 times the maximum recommended dose (130 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Croatian: Nikakve nuspojave nisu primijećene prilikom primjene kroz usta, na mačićima starim 8 tjedana, težine 0,5 kg, koji su liječeni dozama koje su bile više od 5 puta veće od maksimalno preporučene doze (130
English: MA (EU) number
Croatian: Broj (EU) odobrenja (Zaštićeno ime)
English: Overall summary of the scientific evaluation of Kogenate Bayer and Helixate NexGen (see Annex A)
Croatian: Cjelokupan sažetak znanstvene ocjene lijekova Kogenate Bayer i Helixate NexGen (vidi Dodatak A)
English: No update of the RMP was considered necessary by the PRAC.
Croatian: PRAC nije smatrao da je potrebno ažuriranje RMPa.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen (see annexes A).
Croatian: • je PRAC razmotrio postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 za lijekove Kogenate Bayer i Helixate NexGen (vidi Dodatke A),