FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that Bravecto Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove je odlučila da koristi od VMP-a Bravecto Plus nadmašuju s njim povezane rizike te se može izdati odobrenje za njegovu primjenu u EU-u.
English: The most common side effects with Bravecto Plus (which may affect up to 1 in 10 animals) are mild and short-lived reactions at the application site such as hair loss, flaking skin and scratching.
Croatian: Najčešće su nuspojave VMP-a Bravecto Plus (mogu se javiti u više od 1 na 10 životinja) blage i kratkotrajne reakcije na mjestu primjene kao što su gubitak dlake, ljuštenje kože i svrbež.
English: Fluralaner kills fleas before they can lay eggs and so helps to reduce contamination of the cats' environment.
Croatian: Fluralaner ubija buhe prije nego što one izlegnu jajašca te tako pomaže u smanjivanju kontaminacije okruženja mačke.
English: Fluralaner and moxidectin are already authorised on their own for the treatment of parasitic infestations.
Croatian: Fluralaner i moksidektin pojedinačno su već odobreni za liječenje infestacija parazitima.
English: Bravecto Plus is a veterinary medicine used in cats to treat mixed infestations with both ticks or fleas and ear mites and/or worms that live inside the body.
Croatian: Bravecto Plus je veterinarsko-medicinski proizvod koji se primjenjuje za liječenje mačaka od mješovite infestacije krpeljima ili buhama i ušnim šugarcima i/ili crvima koji žive u tijelu.
English: Why is Bravecto Plus authorised in the EU?
Croatian: Zašto je Bravecto Plus odobren u EU-u?
English: What are the risks associated with Bravecto Plus?
Croatian: Koji su rizici povezani s VMP-om Bravecto Plus?
English: An overview of Bravecto Plus and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Bravecto Plus i zašto je odobren u EU-u
English: The medicine can be used:
Croatian: Ovaj se VMP može primjenjivati za:
English: This means that it kills parasites present on the skin or in the fur or ears of animals, such as fleas, ticks and ear mites.
Croatian: To znači da ubija parazite koji se nalaze na koži ili u krznu životinja, poput buha, krpelja i ušnih šugaraca.
English: In case of spillage on table or floor surfaces, excess Bravecto Plus spot-on solution should be removed using paper tissue and the area cleaned with a detergent.
Croatian: U slučaju izlijevanja na površinu stola ili poda, višak otopine Bravecto Plus za nakapavanje potrebno je ukloniti papirnatom maramicom, a površinu očistiti deterdžentom.
English: In order to be exposed to the active substance fluralaner, fleas and ticks must commence feeding on the cat.
Croatian: Kako bi ih se izložilo djelatnoj tvari fluralaneru, buhe i krpelji moraju se početi hraniti krvlju mačke.
English: Bravecto Plus was as effective as selamectin, another medicine already licensed for the treatment of ear mites in cats.
Croatian: VMP Bravecto Plus bio je jednako djelotvoran kao selamektin, drugi lijek već odobren za liječenje ušnih šugaraca u mačaka.
English: In a field study of 167 cats infested with 5 or more ear mites, treatment with Bravecto Plus resulted in 94% of cats free from ear mites 14 days after treatment and 100% of cats free from ear mites 28 days after treatment.
Croatian: Tijekom terenskog ispitivanja na 167 mačaka infestiranih s pet ili više ušnih šugaraca, u mačaka liječenih VMP-om Bravecto Plus ušni šugarci u cijelosti su nestali 14 dana nakon liječenja u 94 % mačaka, a 28 dana nakon liječenja ušni su šugarci u cijelosti nestali u 100 % mačaka.
English: Bravecto Plus received a marketing authorisation valid throughout the EU on 8 May 2018.
Croatian: Za VMP Bravecto Plus izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 8. svibnja
English: Bravecto Plus is effective at preventing heartworm disease for 8 weeks.
Croatian: VMP Bravecto Plus djelotvorno sprječava bolest srčanog crva tijekom osam tjedana.
English: Two laboratory studies involving healthy cats which were artificially infected with heartworm larvae showed Bravecto Plus to be 100% effective in preventing heartworm disease during 8 weeks.
Croatian: U dvama laboratorijskim ispitivanjima na zdravim mačkama koje su umjetno zaražene ličinkama srčanog crva dokazano je da je VMP Bravecto Plus 100 % učinkovit u sprječavanju bolesti srčanog crva tijekom osam tjedana.
English: The content of one full Bravecto Plus pipette is applied to the cat's skin at the base of the skull.
Croatian: Sadržaj jedne pipete u potpunosti napunjene VMP-om Bravecto Plus primjenjuje se na koži baze lubanje mačke.
English: Bravecto Plus was as effective as another medicine containing emodepside and praziquantel.
Croatian: Bravecto Plus bio je jednako učinkovit kao i drugi VMP koji sadrži emodepsid i prazikvantel.
English: The pipette to use is selected on the basis of the cat's weight.
Croatian: Odabir pipete koja se primjenjuje ovisi o težini mačke.
English: Skin rashes, tingling or numbness have been reported in a small number of individuals after skin contact, either when handling the product or when handling the treated animal.
Croatian: Kod manjeg broja ljudi prijavljeni su kožni osip, trnci ili utrnulost nakon kontakta s kožom prilikom primjene proizvoda ili dodirivanja tretirane životinje.
English: For more information about using Bravecto Plus, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Bravecto Plus pogledajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: The active substances in Bravecto Plus, fluralaner and moxidectin, work via different routes to kill parasites.
Croatian: Djelatne tvari VMP-a Bravecto Plus, fluralaner i moksidektin, imaju različite načine djelovanja kojima ubijaju parazite.
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: Ako neka osoba slučajno proguta ovaj proizvod, potrebno je odmah potražiti liječnički savjet te liječniku pokazati uputu o VMP-u ili njegovu etiketu.
English: A field study involving cats naturally infested with ticks and/or fleas showed treatment with Bravecto Plus to reduce tick and flea counts by more than 95% and to be as effective as treatment using fipronil, another medicine already licensed for the treatment of ticks and fleas.
Croatian: U terenskom ispitivanju na mačkama koje su bile prirodno infestirane krpeljima i/ili buhama dokazano je da tretiranje VMP-om Bravecto Plus smanjuje broj krpelja i buha za više od 95 % te da je jednako djelotvorno kao i tretiranje fipronilom, drugim VMP-om odobrenim za tretiranje krpelja i buha.
English: Bravecto Plus is available as a spot-on solution in a pipette.
Croatian: VMP Bravecto Plus dostupan je u obliku otopine za nakapavanje u pipeti.
English: • to prevent heartworm disease Bravecto Plus must only be used when there is a need to treat ticks or fleas and one or more of the parasites listed above.
Croatian: VMP Bravecto Plus smije se primjenjivati samo ako životinju treba tretirati protiv krpelja ili buha i protiv jednog ili više prethodno navedenih parazita.
English: How is Bravecto Plus used?
Croatian: Kako se Bravecto Plus koristi?
English: Moxidectin kills parasites present in the body of animals such as roundworms, hookworms and heartworm as well as ear mites.
Croatian: Moksidektin ubija parazite prisutne u tijelu životinja kao što su oblići, ankilostomi, srčani crvi i ušni šugarci.
English: If skin reactions occur, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: Ako se pojave reakcije kože, potrebno je odmah potražiti liječnički savjet te liječniku pokazati uputu o VMP-u ili njegovu etiketu.
English: Bravecto Plus contains the active substances fluralaner and moxidectin.
Croatian: Bravecto Plus sadrži djelatne tvari fluralaner i moksidektin.
English: Another field study involving cats naturally infected with roundworms and/or hookworms showed treatment with Bravecto Plus to reduce faecal egg counts by 100%.
Croatian: U drugom terenskom ispitivanju na mačkama koje su bile prirodno infestirane glistama i/ili trakavicama dokazano je da tretiranje VMP-om Bravecto Plus smanjuje broj jajašaca u fecesu za 100 %.
English: • to treat flea infestations.
Croatian: • tretiranje infestacije buhama.
English: The medicine's actions against fleas and ticks last for 12 weeks after being applied.
Croatian: Nakon što se primijeni, VMP djeluje 12 tjedana protiv buha i krpelja.
English: How does Bravecto Plus work?
Croatian: Kako djeluje Bravecto Plus ?
English: • to treat tick infestations
Croatian: • tretiranje infestacije krpeljima
English: What benefits of Bravecto Plus have been shown in studies?
Croatian: Koje su koristi VMP-a Bravecto Plus utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions of Bravecto Plus, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni VMP-a Bravecto Plus potražite u uputi o VMP-u.
English: • to treat ear mite infestations
Croatian: • tretiranje infestacije ušnim šugarcem
English: Suitable gloves should be worn when handling or applying Bravecto Plus to cats.
Croatian: Prilikom rukovanja VMP-om Bravecto Plus ili njegove primjene u mačaka moraju se nositi zaštitne rukavice.
English: • to treat roundworms and hookworms in the gut
Croatian: • tretiranje crijevnih oblića i ankilostoma
English: Duration of immunity: at least 6 months.
Croatian: Trajanje imunosti: najmanje 6 mjeseci.
English: Do not touch!
Croatian: Ne dirati!
English: The vaccination area should be as large as possible (preferably larger than 5,000 km2).
Croatian: Područje cijepljenja mora biti što je veće moguće (po mogućnosti veće od 5 000 km2).
English: Pregnancy and lactation: Can be used during pregnancy.
Croatian: Graviditet i laktacija: Može se primijeniti tijekom graviditeta.
English: No field studies were conducted.
Croatian: Nisu provedena terenska istraživanja.
English: Interaction with other medicinal products and other forms of interaction: Not known.
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Nije poznato.
English: 17493 Greifswald - Insel Riems Germany
Croatian: 17493 Greifswald - Insel Riems Njemačka
English: The efficacy of the vaccine was demonstrated in laboratory studies.
Croatian: Djelotvornost cjepiva dokazana je u laboratorijskim ispitivanjima.
English: b) the disease to which product is intended to confer immunity is largely absent from the territory in question.
Croatian: b) je bolest, za koju je proizvod namijenjen da pruži imunost, u velikoj mjeri odsutna s odnosnog područja.
English: Store and transport frozen, below -15 °C.
Croatian: Čuvati i prevoziti zamrznuto, ispod -15 °C.
English: Distribution of baits manually or by air.
Croatian: Distribucija mamaca ručno ili zrakom.
English: Restricted to duly designated competent administrative authorities.
Croatian: Ograničeno na službeno imenovana nadležna administrativna tijela.
English: a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Croatian: a) će primjena proizvoda na životinjama interferirati s provedbom nacionalnih programa za otkrivanje, kontrolu ili iskorjenjivanje bolesti životinja ili će prouzročiti poteškoće u certificiranju odsutnosti zaraze u živih životinja ili hrani ili drugim proizvodima dobivenim od tretiranih životinja.
English: Do not refreeze.
Croatian: Ne zamrzavati ponovno.
English: In case of contact of the vaccine fluid, immediately remove it by thoroughly rinsing with water and soap.
Croatian: U slučaju kontakta s tekućinom cjepiva, odmah je uklonite temeljitim ispiranjem vodom i sapunom.
English: Stability after distribution in the environment was shown for 7 days at temperatures up to 25 °C.
Croatian: Dokazana je stabilnost nakon distribucije u okolišu tijekom 7 dana na temperaturama do 25 °C.
English: If you notice any side effects, even those not listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Croatian: Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj uputi o VMP ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
English: It is recommended to wear disposable rubber gloves when handling and distributing baits.
Croatian: Preporučuje se nositi jednokratne gumene rukavice pri rukovanju i distribuiranju mamaca.
English: The vaccination campaigns in rabies-free areas should be designed in such a way that the area covers a 50 km belt ahead of the rabies front.
Croatian: Kampanje cijepljenja u područjima slobodnim od bjesnoće treba osmisliti tako da područje pokriva pojas od 50 km ispred fronte bjesnoće.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years at/below -15 °C.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda zapakiranog za prodaju: 2 godine na/ispod -15°C.
English: Finally, the pseudogen located between the G - and L-gene has been deleted.
Croatian: Naposljetku, pseudogen smješten između gena G i L je deletiran.
English: Vaccination should not be attempted when temperatures are expected to reach 25 °C or more, and never during the summer season.
Croatian: Ne treba pokušavati s cijepljenjem kada se očekuje da će temperature doseći 25 °C ili više te nikada tijekom ljetne sezone.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/Aluminium blister
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA PVC/aluminijski blister
English: A differentiation of this vaccine virus from any other rabies virus strains is possible, including its parental strain, for example by PCR methods.
Croatian: Moguća je diferencijacija ovog virusnog cjepiva od bilo kojih drugih sojeva bjesnoće uključujući njegov ishodišni soj, primjerice PCR metodama.
English: Handle the baits with care.
Croatian: Pažljivo rukujte mamcima.
English: Proposed first aid measures immediately after direct human exposure to the vaccine fluid should follow the recommendations of the WHO as outlined in the “WHO Guide for Rabies Pre- and PostExposure Prophylaxis (PEP) in Humans”.
Croatian: Predložene mjere prve pomoći, odmah nakon izravnog izlaganja ljudi tekućini cjepiva trebaju slijediti preporuke Svjetske zdravstvene organizacije (SZO) kako je opisano u dokumentu “WHO Guide for Rabies Pre- and Post-Exposure Prophylaxis (PEP) in Humans” ("Smjernice SZO za preekspozicijsku i postekspozicijsku profilaksu protiv bjesnoće u ljudi").
English: The distribution rate depends on the topography, on the population density of the target species and on the epizootiological situation.
Croatian: Brzina distribucije ovisi o topografiji, o gustoći populacije ciljnih vrsta te o epizootiološkoj situaciji.
English: A higher distribution density is recommended in areas with a high population density of foxes/raccoon dogs.
Croatian: Veća gustoća distribucije preporučuje se u područjima s vrlo visokom gustoćom populacije lisica/kunopasa.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and cardboard after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na etiketi i kutiji poslije EXP.
English: As each of these modifications on the genome were shown to further attenuate the SAD B19 virus strain, their multiple effect helps to avoid the reversion to the parental strain.
Croatian: S obzirom da se pokazalo da svaka od ovih izmjena genoma dodatno oslabljuje soj virusa SAD B19, njihov višestruki učinak pomaže u izbjegavanju povratka na ishodišni soj.
English: The genome carries mutations in the G-protein (glycoprotein) located at 2 independent loci of the genome (at amino acid positions 194 and 333 in Gprotein), where all three nucleotides ‘codon' were exchanged resulting in amino acid changes at both positions.
Croatian: Genom nosi mutacije u G-proteinu (glikoproteinu) smještene na 2 neovisna lokusa u genomu (na položajima aminokiselina 194 i 333 u G-proteinu), gdje su sva tri nukleotidna „kodona“ zamijenjena što rezultira u promjenama aminokiselina na oba položaja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.7 ml) contains:
Croatian: 1 doza (1.7 ml) sadrži:
English: Overdose (symptoms, emergency procedures, antidotes): The administration of the vaccine at 10 times the recommended dose induced no undesirable effects.
Croatian: Predoziranje (simptomi, hitni postupci, antidoti): Primjena cjepiva u dozi 10 puta većoj od preporučene nije izazvala štetne učinke.
English: The administration of the vaccine at 10 times the recommended dose induced no undesirable effects.
Croatian: Primjena cjepiva u dozi 10 puta većoj od preporučene nije izazvala štetne učinke.
English: Not known.
Croatian: Nisu poznate.
English: The baits are distributed by land or by air within the framework of vaccination campaigns against rabies.
Croatian: Mamci se distribuiraju kopnenim ili zračnim putem unutar kampanja cijepljenja protiv bjesnoće.
English: Gelatin (porcine) Disodium phosphate dihydrate Potassium dihydrogen phosphate Neomycin sulfate
Croatian: Cjepivo: voda za injekciju saharoza želatina (svinjska) dinatrijev fosfat dihidrat kalijev dihidrogen fosfat neomicin sulfat
English: Since this vaccine has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process, e.g. by wearing appropriate protective clothes.
Croatian: S obzirom da je ovo cjepivo pripremljeno sa živim, atenuiranim mikroorganizmima, potrebno je poduzeti odgovarajuće mjere kako bi se spriječila kontaminacija rukovatelja i drugih osoba koji surađuju u procesu, primjerice nošenjem odgovarajuće zaštitne odjeće.
English: The suspension has a yellow colour in a frozen state and a reddish colour in the liquid state.
Croatian: Suspenzija je žute boje u zamrznutom stanju te crvenkaste boje u tekućem stanju.
English: Gastrointestinal signs (potentially due to the indigestible blister material) have been reported in dogs following accidental ingestion of the bait.
Croatian: Probavni znakovi (moguće zbog neprobavljivog materijala blistera) zabilježeni su u pasa nakon slučajnog gutanja mamca.
English: Baits should be distributed immediately after thawing.
Croatian: Mamce treba distribuirati neposredno nakon otapanja.
English: Aerial distribution of the baits by any suitable flight devices (such as airplane, helicopter, drones or similar) is recommended for open or sparsely populated areas, and manual distribution in areas with a high human population.
Croatian: Distribucija mamaca zrakom prikladnim letjelicama (kao što su zrakoplov, helikopter, dronovi ili slično) preporučuje se kod otvorenih ili rijetko naseljenih područja, a ručna distribucija u područjima s gustom ljudskom populacijom.
English: HAZARD WARNING Rabies vaccine.
Croatian: Rabies vaccine.
English: The import, possession, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory, see package insert for further information.
Croatian: Proizvodnja, uvoz, posjedovanje, prodaja, opskrba i/ili primjena ovog veterinarsko-medicinskog proizvoda je ili može biti zabranjena u određenim državama članicama na cijelom ili na dijelu njihovog teritorija, za daljnje informacije vidi uputu o VMP.
English: The vaccination should be preferably carried out biannually (e.g. in spring and autumn), for a number of consecutive years, for at least two years after the last confirmed case of rabies in the region, however vaccination should not be attempted when temperatures are expected to reach 25 °C or more, and never during the summer season.
Croatian: Cijepljenje po mogućnosti treba provesti dva puta godišnje (primjerice u proljeće i u jesen), tijekom nekoliko uzastopnih godina, tijekom najmanje dvije godine nakon posljednjeg potvrđenog slučaja bjesnoće u regiji, međutim ne treba pokušavati s cijepljenjem kada se očekuje da će temperature doseći 25 °C ili više te nikada tijekom ljetne sezone.
English: IDT Biologika (Riems) GmbH & Co. KG An der Wiek 7
Croatian: IDT Biologika (Riems) GmbH & Co.
English: In contrast to its parental strain SAD B19, the Rabitec vaccine's active ingredient proved to be apathogenic for immunocompetent mice, the most sensitive species for rabies virus infection.
Croatian: Za razliku od svog ishodišnog soja SAD B19, djelatna tvar cjepiva Rabitec dokazano je apatogena za imunokompetentne miševe, vrste koja je najosjetljivija na infekciju virusom bjesnoće.
English: Since this vaccine has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process.
Croatian: S obzirom da je ovo cjepivo pripremljeno sa živim, atenuiranim mikroorganizmima, potrebno je poduzeti odgovarajuće mjere kako bi se spriječila kontaminacija rukovatelja i drugih osoba koji surađuju u procesu cijepljenja.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni od tog veterinarsko-medicinskog proizvoda trebaju se odlagati u skladu s lokalnim propisima.
English: Plastic foil sleeves or bags in cardboard boxes of:
Croatian: Navlake od plastične folije ili vrećice u kartonskim kutijama s:
English: Immunized animals are protected against field rabies virus infection and do not transmit rabies.
Croatian: Imunizirane životinje su zaštićene od infekcije terenskim virusom bjesnoće i ne prenose bjesnoću.
English: In addition, the genome carries an exact duplicate of the modified immune-relevant Gprotein (glycoprotein) gene, which results in the significant higher expression of the G protein gene.
Croatian: Pored toga, genom nosi točni duplikat modificiranog za imunost relevantnog gena G-proteina (glikoproteina), što rezultira u znatno višoj ekspresiji gena za G-protein.
English: To protect regions which are free of rabies, baiting may be carried out to create a vaccination belt or in the form of spot vaccinations.
Croatian: Kako biste zaštitili regije u kojima nema bjesnoće, distribucija mamaca može se provesti kreiranjem pojasa cijepljenja ili u obliku točaka cijepljenja.
English: As an exception, the thawed vaccine may be stored for up to 7 days at 2 °C - 8 °C before use.
Croatian: Kao iznimka, otopljeno cjepivo može se pohraniti do 7 dana pri temperaturi od 2 °C - 8 °C prije primjene.
English: The intake of single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.
Croatian: Unos jednog mamca dovoljan je da se osigura aktivna imunizacija radi sprječavanja infekcije virusom bjesnoće.
English: Therefore the recommendations / request of the duly designated competent authority are followed concerning distribution rate, vaccination area, distribution/baiting method and other local/areal conditions as specified by the competent authority.
Croatian: Stoga treba slijediti preporuke/zahtjeve službeno imenovanog nadležnog tijela u vezi s brzinom distribucije, područjem cijepljenja, metodom distribucije/podjele mamaca i drugi lokalni/područni uvjeti kako to nadležno tijelo navodi.
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.
Croatian: Farmakoterapijska grupa: imunološki proizvodi za kanide, živa virusna cjepiva ATCvet kod:
English: The safety of the veterinary medicinal product has not been established during lactation.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme laktacije.