FrancophonIA/ELRC3.0 huggingface dataset:
English: Genvoya can also be used in children aged over 6 years who cannot tolerate other HIV-1 treatments because of side effects.
Croatian: Lijek Genvoya mogu uzimati i djeca starija od 6 godina koja ne podnose druge terapije protiv HIV-a zbog njihovih nuspojava.
English: Three of the active substances, elvitegravir, cobicistat and emtricitabine have already been shown to be effective.
Croatian: Tri djelatne tvari, elvitegravir, kobicistat i emtricitabin, već su se pokazale učinkovitima.
English: The fourth, tenofovir alafenamide, is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects.
Croatian: Četvrta djelatna tvar, tenofoviralafenamid, učinkovita je pri manjoj dozi od uobičajenog lijeka tenofovirdizoproksil i nudi mogućnost blažih nuspojava.
English: For practical information about using Genvoya, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Genvoya bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: In another study, Genvoya was given to adolescents aged 12 to 18 years with HIV-1 infection who had not been treated previously.
Croatian: U drugom je ispitivanju lijek Genvoya davan adolescentima u dobi između 12 i 18 godina s infekcijom virusom HIV-1 koji prethodno nisu liječeni.
English: How is Genvoya used?
Croatian: Kako se Genvoya koristi?
English: For the full list of all side effects reported with Genvoya, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Genvoya potražite u uputi o lijeku.
English: What benefits of Genvoya have been shown in studies?
Croatian: Koje su koristi lijeka Genvoya utvrđene u ispitivanjima?
English: How does Genvoya work?
Croatian: Kako djeluje Genvoya?
English: Tenofovir alafenamide had a milder effect on the kidney than tenofovir disoproxil.
Croatian: Tenofoviralafenamid imao je blaži učinak na bubrege od tenofovirdizoproksila.
English: In studies, the effectiveness of Genvoya was high and comparable to that of a medicine containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Croatian: Djelotvornost lijeka Genvoya u ispitivanjima se pokazala visokom i usporedivom s djelotvornošću lijeka koji sadrži elvitegravir, kobicistat, emtricitabin i tenofovirdizoproksil.
English: In both studies, Genvoya was compared with another antiviral medicine which contained the active ingredients elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Croatian: Lijek Genvoya u oba je ispitivanja uspoređen s drugim antivirusnim lijekom koji sadržava djelatne sastojke elvitegravir, kobicistat, emtricitabin i tenofovirdizoproksil.
English: Genvoya contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Croatian: Genvoya sadrži djelatne tvari elvitegravir, kobicistat, emtricitabin i tenofoviralafenamid.
English: The viral load was reduced to less than 50 copies/ml after 24 weeks in 90% (45 of 50) of patients.
Croatian: Nakon 24 tjedna u 90 % (45 od 50) bolesnika virusno opterećenje smanjeno je na manje od 50 kopija/ml.
English: It is recommended to treat animals in the evening.
Croatian: Preporučuje se životinje tretirati uvečer.
English: Avoid contact between the product and your fingers.
Croatian: Izbjegavajte kontakt između proizvoda i svojih prstiju.
English: ATC vet code: QP54AA55.
Croatian: ATCvet kod: QP54AA55.
English: Squeeze the pipette firmly 3-4 times to empty the contents in one spot.
Croatian: Čvrsto stisnite pipetu 3-4 puta da biste ispraznili sadržaj na jedno mjesto.
English: 5 weeks.
Croatian: tjedana.
English: The product is highly flammable.
Croatian: Ovaj proizvod je vrlo zapaljiv.
English: Do not administer orally or parenterally.
Croatian: Ne smije se primjenjivati oralno ni parenteralno.
English: Seek further veterinary examination 30 days after treatment to determine whether a second administration is necessary.
Croatian: Zatražite dodatni veterinarski pregled 30 dana nakon tretiranja da bi se odredilo je li potrebna druga primjena.
English: Appropriate combination of pipettes
Croatian: Prikladna kombinacija pipeta
English: Do not apply when the animal's hair coat is wet.
Croatian: Ne smije se aplicirati kada je dlaka životinje mokra.
English: Used pipettes should be disposed of immediately.
Croatian: Upotrijebljene pipete treba odmah baciti.
English: Medicines should not be disposed of via wastewater.
Croatian: Lijekovi se ne smiju odlagati putem otpadnih voda.
English: The pipette caps are colour-coded as follows:
Croatian: Poklopci pipeta kodirani su po bojama na sljedeći način:
English: Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product.
Croatian: Čuvajte proizvod u originalnom pakiranju do upotrebe kako biste spriječili djecu u izravnom pristupu proizvodu.
English: EXPIRY DATE EXP {month/year}
Croatian: EXP {mjesec/godina}
English: These effects do not affect the safety or efficacy of the veterinary medicinal product.
Croatian: Ovi učinci ne utječu na sigurnost i djelotvornost veterinarsko-medicinskog proizvoda.
English: Children are not allowed to play with treated cats for 4 hours after treatment.
Croatian: Djeca se ne smiju igrati s tretiranim mačkama tijekom 4 sata nakon tretiranja.
English: Avoid direct contact with treated animals until the application area is dry.
Croatian: Izbjegavajte izravni dodir s tretiranim životinjama dok se tretirano područje ne osuši.
English: This veterinary medicinal product is to be applied to the skin surface only.
Croatian: Ovaj veterinarsko-medicinski proizvod treba aplicirati samo na površinu kože.
English: During clinical field testing, no interactions between this veterinary medicinal product and routinely used veterinary medicinal products were observed.
Croatian: Za vrijeme kliničkog terenskog ispitivanja nisu zabilježene interakcije između ovog veterinarskomedicinskog proizvoda i rutinski korištenih veterinarsko-medicinskih proizvoda.
English: This veterinary medicinal product is not effective against adult D. immitis.
Croatian: Veterinarsko-medicinski proizvod nije učinkovit protiv odraslih D. immitis.
English: Felisecto Plus should not enter water courses as this may be dangerous to aquatic organisms.
Croatian: Felisceto Plus ne smije se odlagati u vodene tokove jer to može biti opasno za vodene organizme.
English: Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.
Croatian: Tretirane životinje držite podalje od vatre i drugih zapaljivih izvora tijekom najmanje 30 minuta ili dok im se dlaka ne osuši.
English: Interactions with other medicinal products and other forms of interactions:
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:
English: Pregnancy and lactation:
Croatian: Graviditet i laktacija:
English: The periodic safety update report (PSUR) submissions shall be synchronised and submitted at the same frequency as for the originator product.
Croatian: Periodička izvješća o neškodljivosti (PSUR) moraju biti sinhronizirana i dostavljena prema istoj učestalosti kao i za izvorni proizvod.
English: Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).
Croatian: Ne smije se upotrebljavati na mačkama koje imaju druge istodobne bolesti ili su oslabljene i premale tjelesne težine (za veličinu i dob).
English: On the day of treatment, treated animals should not be permitted to sleep in the same bed as their owner, especially children.
Croatian: Na dan tretiranja, tretiranim životinjama ne smije se dozvoliti da spavaju na krevetu s vlasnikom, a osobito ne s djecom.
English: The pipette should be removed from the protective package immediately prior to administration.
Croatian: Pipetu treba izvaditi iz zaštitnog pakiranja neposredno prije primjene.
English: The product may cause eye irritation.
Croatian: Proizvod može uzrokovati nadraženost očiju.
English: Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 30 mjeseci.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.emea.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove (http://www.emea.europa.eu/).
English: Total volume of unit dose (ml)
Croatian: Ukupni volumen jedinične doze (ml)
English: The final dose must be given within one month after the last exposure to mosquitoes.
Croatian: Završna doza mora se dati unutar jednog mjeseca od zadnjeg izlaganja komarcima.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara kako odlagati lijekove koji vam više nisu potrebni.
English: Clear, colourless to yellow solution.
Croatian: Bistra, bezbojna do žuta otopina.
English: It is important to apply the dose as indicated to prevent the animal from licking and ingesting the product.
Croatian: Važno je aplicirati dozu na način koji je indiciran kako bi životinju spriječili u lizanju i gutanju proizvoda.
English: For ear mite treatment, do not apply directly to the ear canal.
Croatian: Kod tretiranja ušne šuge, ne smije se aplicirati izravno u ušni kanal.
English: - The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Croatian: - Proizvod se može upotrebljavati kao dio strategije liječenja alergijskog dermatitisa uzrokovanog buhama (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.
Croatian: Proizvod se može primjenjivati tijekom cijele godine ili barem unutar jednog mjeseca od prve izloženosti životinje komarcima te jednom mjesečno nakon toga do kraja sezone komaraca.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26/04/2019
Croatian: Datum prvog odobrenja: 26/04/2019
English: The product is available in packs of three pipettes (all pipette sizes).
Croatian: Proizvod je dostupan u pakiranjima od tri pipete (sve veličine pipeta).
English: Identification of selamectin metabolites in faeces indicated that metabolic clearance also contributes to the elimination.
Croatian: Identifikacija metabolita selamektina u fecesu upućivala je na to da metabolički klirens također doprinosi eliminaciji.
English: Keep away from heat, sparks, open flame or other sources of ignition.
Croatian: Čuvati podalje od izvora topline, iskri, otvorenog plamena ili drugih izvora zapaljenja.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in animals intended for breeding.
Croatian: Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije ili kod životinja namijenjenih za rasplod.
English: Cats.
Croatian: Mačke.
English: The product is available in packs of three pipettes (all pipette sizes) placed in cardboard boxes.
Croatian: Proizvod je dostupan u pakiranjima od tri pipete (sve veličine pipeta) umetnutih u kartonske kutije.
English: Sarolaner is an acaricide and insecticide belonging to the isoxazoline family.
Croatian: Sarolaner je akaricid i insekticid koji pripada obitelji izoksazolina.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Croatian: 13. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, AKO JE PRIMJENJIVO
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.
Croatian: Iako sigurnost sarolanera nije evaluirana kod rasplodnih, gravidnih ili mačaka tijekom laktacije, laboratorijska ispitivanja sa sarolanerom na štakorima i kunićima nisu dala nikakve dokaze teratogenih učinaka.
English: Containers and residual contents should be disposed of along with collected domestic refuse to avoid contamination of any water courses.
Croatian: Spremnike i ostatke sadržaja treba odložiti zajedno s prikupljenim kućnim otpadom da bi se izbjegla kontaminacija vodenih tokova.
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.
Croatian: Ovaj veterinarsko-medicinski proizvod indiciran je isključivo kada je istovremeno indicirana upotreba protiv krpelja te jednog ili više drugih ciljnih parazita.
English: Part the hair at the base of the cat's neck in front of the shoulder blades to expose a small area of skin.
Croatian: Razdvojite dlaku na bazi vrata mačke ispred lopatica da biste izložili malo područje kože.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA BLISTER
English: Do not use this veterinary medicinal product after the expiry date which is stated on the blister after EXP.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na blisteru poslije EXP.
English: Store below 30 °C.
Croatian: Čuvati pri temperaturi ispod 30 °C.
English: Apply the tip of the pipette directly to the skin, without massaging.
Croatian: Aplicirajte vrh pipete izravno na kožu, bez masiranja.
English: The product kills adult fleas before they lay eggs for 5 weeks.
Croatian: Proizvod ubija odrasle buhe prije nego što polože jaja u periodu od 5 tjedana.
English: If accidental eye exposure occurs, flush the eyes immediately with water and seek medical attention.
Croatian: U slučaju nehotične izloženosti očiju proizvodu, odmah oči isperite vodom i potražite pomoć liječnika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KARTONSKA KUTIJA
English: The need for and frequency of re-treatment should be in accordance with the advice of the prescribing veterinarian.
Croatian: Potreba i učestalost ponovnog tretiranja trebaju biti u skladu sa savjetima veterinara koji propisuje proizvod.
English: For the full list of excipients, see section 6.1.
Croatian: Potpuni popis pomoćnih tvari vidjeti u odjeljku 6.1.
English: Ticks must attach to the host and commence feeding in order to be exposed to sarolaner.
Croatian: Krpelji se moraju početi hraniti na domaćinu da bi postali izloženi sarolaneru.
English: - Treatment of biting lice infestations (Felicola subrostratus).
Croatian: - Tretiranje infestacija paušima (Felicola subrostratus).
English: Translucent polypropylene unit dose pipettes individually packed in aluminium and aluminium/PVC blisters.
Croatian: Svjetlopropusne polipropilenske pipete s jediničnom dozom, pakirane pojedinačno u aluminijske i aluminijske/PVC blistere.
English: A single dose of the product should be administered.
Croatian: Treba primijeniti jednokratnu dozu proizvoda.
English: Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Croatian: Ne smije se upotrebljavati u slučaju preosjetljivosti na djelatne tvari ili na bilo koju od pomoćnih tvari.
English: Use of the veterinary medicinal product may result in mild and transient pruritus at the application site.
Croatian: Upotreba ovog veterinarsko-medicinskog proizvoda može rezultirati blagim i prolaznim svrbežom na mjestu aplikacije.
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).
Croatian: Stoga učinkovito prekida životni ciklus buhe tako što ubija odrasle buhe (na životinji), sprječavajući izlijeganje iz jajašaca (na životinji i u njezinu okolišu) te tako što ubija larve (samo u okolišu).
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.
Croatian: Ako se doza propusti, a mjesečni interval između doziranja prekorači, tada će primjena proizvoda bez odgode te ponovni nastavak mjesečnog doziranja minimizirati mogućnost za razvoj odraslih srčanih crva.
English: selamectin (mg)
Croatian: selamektin (mg)
English: Wash hands after use and wash off any product in contact with the skin immediately with soap and water.
Croatian: Operite ruke nakon upotrebe te odmah sapunom i vodom isperite proizvod koji je došao u dodir s kožom.
English: Transient cosmetic effects may occur at the application site such as temporary clumping or spiking of the hair, greasiness or dry white deposits, which normally resolve within 24 hours after product application.
Croatian: Mogući su prolazni kozmetički učinci na mjestu aplikacije, poput privremenog stvaranja grudica ili šiljaka na dlaci, masnoće ili suhih bijelih naslaga, ali obično nestaju u roku od 24 sata poslije apliciranja proizvoda.
English: 6.5 Nature and composition of immediate packaging
Croatian: 6.5 Osobina i sastav unutarnjeg pakiranja
English: Selamectin is a semi-synthetic compound of the avermectin class.
Croatian: Selamektin je polusintetički spoj iz klase avermektina.
English: Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents, macrocyclic lactones, combinations.
Croatian: Farmakoterapijska grupa: antiparazitici, insekticidi i repelenti, makrociklički laktoni, kombinacije.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 0.25 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA
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.
Croatian: U skladu s dobrom veterinarskom praksom, preporučuje se sve životinje stare 6 mjeseci ili više, koje žive u zemljama gdje postoji vektor, testirati na prisutnost infestacije odraslim srčanim crvima, prije nego se započne tretiranje ovim veterinarsko-medicinskim proizvodom.
English: The administration to animals with adult heartworm infection did not pose safety concerns.
Croatian: Primjena na životinjama infestiranim odraslim srčanim crvima nije predstavila sigurnosni rizik.
English: For fleas, the onset of efficacy is within 24 hours for 5 weeks after product application.
Croatian: Djelotvornost protiv buha počinje unutar 24 sata i traje pet tjedana nakon aplikacije proizvoda.
English: Selamectin paralyzes and/or kills a wide range of invertebrate parasites through interference with their chloride channel conductance causing disruption of normal neurotransmission.
Croatian: Selamektin paralizira i/ili ubija širok raspon beskralježnjačkih parazita tako što interferira s provodnošću njihovih kloridnih kanala te time uzrokuje prekid normalne neurotransmisije.
English: Prevention of heartworm disease
Croatian: Prevencija bolesti srčanog crva
English: This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods leading to their paralysis and/or death.
Croatian: Tako dolazi do inhibicije električne aktivnosti živčanih stanica nematoda i mišićnih stanica artropoda, što dovodi do njihove paralize i/ili smrti.
English: Ticks need to start feeding on the host to become exposed to sarolaner; therefore, the transmission of infectious tick-borne diseases cannot be excluded.
Croatian: Krpelji se moraju početi hraniti na domaćinu da bi postali izloženi sarolaneru, stoga se ne može isključiti prijenos zaraznih bolesti koje prenose krpelji.
English: For ticks (I. ricinus), the onset of efficacy is within 24 hours of attachment for one month after product application.
Croatian: Djelotvornost protiv krpelja (I. ricinus) počinje unutar 24 sata od njihova hvatanja na domaćina i traje jedan mjesec nakon aplikacije proizvoda.
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).
Croatian: Felisceto Plus treba primjenjivati kao jednu aplikaciju nakapavanjem (topikalno), u skladu sa sljedećom tablicom (što odgovara minimumu od 6 mg/kg selamektina i 1 mg/kg sarolanera).
English: - Treatment of ear mites (Otodectes cynotis).
Croatian: - Tretiranje ušnih šugaraca (Otodectes cynotis).
English: Bodyweight of cat (kg)
Croatian: Tjelesna masa mačke (kg)
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.
Croatian: Nakon primjene proizvoda odrasle buhe na životinji ugibaju u roku od 24 sata, ne proizvode vitalna jajašca, a larve (nalaze se samo u okolišu) također ugibaju.
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.
Croatian: Nakon topikalne primjene proizvoda Felisceto Plus, i selamektin i sarolaner dobro se apsorbiraju, sa srednjim vrijednostima bioraspoloživosti od 40,5 %, odnosno 57,9 % te se sistemski distribuiraju.
English: Sarolaner exhibits higher functional potency to block insect/acarine receptors compared to mammalian receptors.
Croatian: Sarolaner iskazuje veću funkcionalnu potentnost za blokadu receptora insekata/akarina u usporedbi s receptorima sisavaca.
English: Treatment schedule
Croatian: Raspored liječenja
English: No clinically significant adverse reactions were observed in kittens from 8 weeks of age treated with up to 5 times the maximum recommended dose of the product for up to 8 consecutive treatments at 28 day intervals, apart from a single cat administered 5 times the maximum dose that displayed transient hypersensitivity to touch, piloerection, mydriasis and mild tremor which resolved without treatment.
Croatian: Nisu zabilježene klinički značajne nuspojave kod mačića u dobi od 8 tjedana tretiranih količinom do 5 puta većom od maksimalne preporučene doze proizvoda u 8 uzastopnih tretiranja, u intervalima od 28 dana, osim jedne mačke kojoj je primijenjena količina 5 puta veća od maksimalne doze, a koja je manifestirala prolaznu preosjetljivost na dodir, nakostriješenost, midrijazu i blagi tremor, koji su se povukli bez liječenja.
English: In cats the primary route of selamectin elimination is in faeces and the majority is parent compound.
Croatian: Kod mačaka je primarni put eliminacije selamektina kroz feces, a većina je osnovni spoj.
English: Fleas and ticks
Croatian: Buhe i krpelji
English: SPECIAL STORAGE CONDITIONS Store below 30 °C.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati pri temperaturi do 30 °C.
English: People with sensitive skin or known allergy to veterinary medicinal products of this type should handle the veterinary medicinal product with caution.
Croatian: Osobe s osjetljivom kožom ili utvrđenom alergijom na veterinarsko-medicinske proizvode ove vrste, trebaju oprezno rukovati ovim veterinarsko-medicinskim proizvodom.
English: >2.5-5 kg >5-10 kg selamectin/sarolaner
Croatian: >2,5-5 kg >5-10 kg selamektin/sarolaner
English: Selamectin may adversely affect aquatic organisms.
Croatian: Selamektin može izazvati nuspojave kod vodenih organizama.
English: However, selamectin is considered safe for use in breeding, pregnant and lactating cats.
Croatian: Međutim, selamektin se smatra sigurnim za primjenu kod rasplodnih i gravidnih mačaka te mačaka tijekom laktacije.
English: - Treatment of tick infestations.
Croatian: - Tretiranje infestacija krpeljima.
English: Ectoparasites:
Croatian: Ektoparaziti: