FrancophonIA/ELRC3.0 huggingface dataset:
English: The systemic bioavailability of the veterinary medicinal product is approximately 40%.
Croatian: Sustavna bioraspoloživost veterinarskomedicinskog proizvoda je otprilike 40%.
English: Such data should be submitted to the Agency together with the periodic safety update reports.
Croatian: Takvi podaci moraju se podnijeti Agenciji zajedno s periodičkim izvješćem o neškodljivosti.
English: Repeat until the entire calculated volume has been applied to the dog.
Croatian: Ponovite dok se cijela količina ne primijeni na psa.
English: Your veterinarian should not administer Recuvyra:
Croatian: Vaš veterinar ne smije dati Recuvyru:
English: • Except as a single dose at the recommended dose rate.
Croatian: • Osim u jednokratnoj dozi u predviđenoj količini.
English: Pharmacotherapeutic group: Analgesic, opioid, phenylpiperidene derivative.
Croatian: Farmakoterapijska grupa: Analgetik, opioid, derivat fenilpiperidina.
English: Following application to dogs, do not touch the site for 5 minutes.
Croatian: Nakon primjene kod pasa, nemojte dirati mjesto primjene 5 minuta.
English: If there is a risk of contact with the application site, suitable protective gloves must be worn.
Croatian: Ako postoji rizik od kontakta s mjestom primjene, potrebno je nositi prikladne zaštitne rukavice.
English: The veterinary medicinal product is strictly limited for use in dogs.
Croatian: Veterinarsko-medicinski proizvod striktno je ograničen na upotrebu za pse.
English: • To anywhere except between your dogs shoulder blades.
Croatian: • Na bilo kojem drugom mjestu osim između lopatica.
English: It is important that you do not allow any other dogs or pets you may have to lick or come into contact with the area between your dog's shoulder blades where your veterinarian has applied Recuvyra for at least 3 days (72 hours) following treatment, as this might cause adverse reactions in these animals.
Croatian: Važno je da ne dozvolite ostalim psima ili kućnim ljubimcima da ližu ili dođu u kontakt sa regijom lopatice vašeg psa gdje je vaš veterinar primijenio Recuvyru najmanje 3 dana (72 sata) nakon liječenja, jer to može uzrokovati nuspojave kod tih životinja.
English: Site preparation: It is not necessary to clip the hair over the application site.
Croatian: Priprema mjesta primjene: Nije potrebno ošišati dlaku oko mjesta primjene.
English: Appropriate eye lubrication should therefore be applied prior to and following surgery and continued until the dog resumes normal blinking function.
Croatian: Odgovarajuća lubrikacija oka mora se stoga primijeniti prije i nakon operacije i nastaviti sve dok pas ne povrati normalnu funkciju treptanja očima.
English: The unbroached vial does not require any special storage conditions.
Croatian: Neotvorena bočica ne zahtijeva posebne uvjete čuvanja.
English: Mild reductions in body temperature and heart and respiratory rates for up to 3 days following use are common.
Croatian: Blago smanjenje tjelesne temperature i ritma disanja do 3 dana nakon upotrebe su uobičajeni.
English: Rarely (i.e. in 0,01 to 0,1% of treated dogs) • Dysphoria and urinary retention.
Croatian: Rijetko (to jest, u 0,01 do 0,1% liječenih pasa) • Disforija i zadržavanje mokraće.
English: • Vomiting and diarrhoea.
Croatian: • Povraćanje i dijareja.
English: Only up to 0.5 ml can be applied to one area of skin.
Croatian: Najviše 0,5 ml smije se primijeniti na jedno područje kože.
English: If necessary, your veterinarian may administer treatment to your dog (for example a reversal agent called naloxone which has a very rapid effect within 1 - 2 minutes).
Croatian: Ako je potrebno, vaš veterinar može primijeniti liječenje vašeg psa (npr. tvar za oporavak pod nazivom nalokson koja ima vrlo brzo djelovanje u roku od 1-2 minute).
English: D. STATEMENT OF THE MRLs Not applicable.
Croatian: IZVJEŠĆE O MRL Nije primjenjivo.
English: SPECIAL WARNING(S), IF NECESSARY Accidental administration is dangerous - see Summary of Product Characteristics before use
Croatian: POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Slučajna primjena je opasna - vidi Sažetak opisa svojstava prije upotrebe.
English: Tell your veterinarian if your dog is sick or was recently ill, if it has ever had breathing, heart or blood pressure problems or epilepsy, if it has ever had bowel or kidney problems or problems with its eyes, and what medicines your dog has taken, especially within the last month.
Croatian: Recite svom veterinaru ako je vaš pas bolestan ili je bio nedavno bolestan, ako je ikada imao dišnih, srčanih problema ili problema s tlakom ili epilepsijom, ako je ikada imao problema s bubrezima, crijevima ili očima i koje lijekove je uzimao naročito u posljednjih mjesec dana.
English: For the attention of dog owner
Croatian: Za vlasnike pasa
English: It may be necessary to evacuate air from the syringe back into the vial.
Croatian: Možda će biti potrebno izvući zrak iz štrcaljke natrag u bočicu.
English: Vomiting and diarrhoea are also common adverse reactions.
Croatian: Povraćanje i dijareja također su uobičajene nuspojave.
English: Restrain the dog for approximately 2 minutes and avoid contact with the application site for 5 minutes to allow complete drying of the solution.
Croatian: Obuzdajte psa oko 2 minute i izbjegavajte kontakt s mjestom primjene 5 minuta kako bi osigurali potpuno sušenje otopine.
English: The veterinary medicinal product should not be used in animals with systemic illness.
Croatian: Veterinarsko-medicinski proizvod ne smije se upotrebljavati na životinjama sa sustavnim bolestima.
English: Each pack is supplied with one vial adaptor, 15 syringes and 15 applicator tips, as well as 15 package leaflets for animal owners, and 1 SPC (for the veterinarian).
Croatian: Svaki paket sadrži 1 adapter za bočicu, 15 štrcaljki i 15 vrhova aplikatora kao i 15 uputa o VMP za vlasnike životinja i 1 Sažetak opisa svojstava (za veterinara).
English: Recuvyra is supplied to your veterinarian in an amber glass bottle containing 10 ml of product.
Croatian: Recuvyra se isporučuje vašem veterinaru u staklenoj boci boje jantara i sadrži 10 ml proizvoda.
English: The ranges (90% interval) of pharmacokinetic parameters in dogs are given below:
Croatian: Raspon (90% intervala) farmakokinetičkih parametara kod pasa dan je u nastavku:
English: However, in dogs with thick hair coats, it is advisable to clip the hair prior to application to assure direct contact of the veterinary medicinal product with the skin.
Croatian: Međutim, kod pasa s gustom dlakom, preporučuje se ošišati dlaku prije primjene kako bi se osigurao direktan kontakt veterinarsko-medicinskog proizvoda s kožom.
English: Your dog will only be allowed to go home once it has recovered from its surgery, and is drinking and eating normally.
Croatian: Vaš pas će biti otpušten iz klinike nakon što se oporavio od operacije i pije i jede normalno.
English: Recuvyra also contains octyl salicylate and isopropyl alcohol.
Croatian: Recuvyra također sadrži oktil salicilat i izopropilni alkohol.
English: Do not allow other animals contact with the application site for at least 72 hours after application.
Croatian: Ne dozvolite drugim životinjama kontakt s mjestom primjene najmanje 72 sata nakon primjene.
English: Do not administer to areas other than the dorsal scapular region.
Croatian: Ne primjenjivati na druga mjesta osim na dorsalno-skapularnoj regiji.
English: • Lowering of heart and breathing rates.
Croatian: • Smanjenje ritma srca i disanja.
English: The pharmacokinetic profile of the veterinary medicinal product is primarily characterised by the long period of systemic absorption.
Croatian: Farmakokinetički profil veterinarsko-medicinskog proizvoda primarno se karakterizira dugim razdobljem sustavne apsorpcije.
English: Therefore, α2-adrenergic agonists should be used with caution in animals dosed with the veterinary medicinal product due to potentially additive or synergistic effects.
Croatian: Prema tome, α2-adrenergički agonisti moraju se primijeniti s oprezom kod životinja kod kojih je primijenjen veterinarsko-medicinski proizvod radi mogućih dodatnih ili sinergičkih učinaka.
English: Recuvyra should only be used for dogs.
Croatian: Recuvyra se smije primijeniti samo na psima.
English: Fentanyl plasma protein binding is estimated at approximately 60% in dogs.
Croatian: Vezanje fentanila na proteine u plazmi procijenjeno je na otprilike 60% kod pasa.
English: Do not store or use near a naked flame.
Croatian: Nemojte čuvati ili upotrebljavati pored otvorenog plamena.
English: The safety of the veterinary medicinal product in animals less than 6 months of age has not been established.
Croatian: Sigurnost veterinarsko-medicinskog proizvoda kod životinja mlađih od 6 mjeseci starosti nije utvrđena.
English: To help you remember when your dog was given Recuvyra by your veterinarian and how long you should not let children touch your dog in the place where the product was applied, your veterinarian will make a note in the spaces provided below.
Croatian: Kako bi vam pomogli sjetiti se kad je vaš pas primio Recuvyru i koliko dugo ne smijete dopustiti djeci da diraju psa na mjestu gdje je proizvod primijenjen, vaš će veterinar napraviti zabilješku u za to niže namijenjeni prostor.
English: Unless your dog has thick hair it will not usually be necessary to clip/ shave your dog's hair between the shoulder blades for correct application.
Croatian: Osim ako vaš pas nema gustu dlaku, obično ga neće biti potrebno ošišati/obrijati između lopatica za ispravnu primjenu.
English: Dispose of waste material in accordance with local requirements
Croatian: Odlaganje otpadnih materijala u skladu s lokalnim propisima.
English: As Recuvyra contains fentanyl (the active substance), it will only ever be kept in a veterinarian's surgery under secure conditions.
Croatian: Budući da Recuvyra sadrži fentanil (djelatna tvar), čuvat će se samo kod veterinara u sigurnim uvjetima.
English: At the moment of drying, approximately 2 to 5 minutes after application, fentanyl and octyl salicylate are absorbed into the stratum corneum.
Croatian: U trenutku sušenja, otprilike 2 do 5 minuta nakon primjene, fentanil i oktil salicilat apsorbiraju se u rožnati sloj kože (stratum corneum).
English: 50 mg/ml For a full list of excipients, see section 6.1.
Croatian: 50 mg/ml Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Centre the adaptor directly over the top of the vial.
Croatian: Centrirajte adapter direktno na vrh bočice.
English: Mild side effects such as sedation, may occur after a single accidental oral administration of more than 20 µg/kg of fentanyl (0.4 µl/kg Recuvyra).
Croatian: Blage nuspojave kao što su sedacija mogu se dogoditi nakon slučajne jednokratne peroralne primjene više od 20 µg/kg fentanila (0,4 µl/kg Recuvyra).
English: Therefore, dogs should be continuously monitored for rectal temperature, pulse rate, respiratory rate and heart rhythm during surgical anaesthesia.
Croatian: Stoga je pse potrebno konstantno nadzirati rektalnim mjerenjem temperature, rada srca i ritma disanja i srca za vrijeme kirurške anestezije.
English: However, for small children (15 kg) such contact might still result in serious exposure to fentanyl.
Croatian: Međutim, kod male djece (do 15 kg) takav kontakt još uvijek može rezultirati ozbiljnim izlaganjem fentanilu.
English: You should tell your veterinarian if you know any of these applies about your dog before treatment is given.
Croatian: Morate informirati vašeg veterinara ako vam je poznata bilo koja od tih okolnosti prije započinjanja liječenja.
English: • To your dog if it has already had a dose of Recuvyra within the last 7 days.
Croatian: • Ako je vaš pas već primio dozu Recuvyre u posljednjih 7 dana.
English: Do not allow the dog or other animals to lick the site of application as oral bioavailability following licking is high in the first five minutes after application.
Croatian: Ne dozvolite psima ili drugim životinjama da ližu mjesto primjene jer je oralna bioraspoloživost uslijed lizanja visoka u prvih pet minuta nakon primjene.
English: If your dog is more than mildly sedated, or has decreased appetite or water intake, you should contact your veterinary surgeon for advice.
Croatian: Ako je vaš pas više nego umjereno sediran ili ima smanjeni tek ili uzima manje vode, morate kontaktirati vašeg veterinara radi savjeta.
English: Fentanyl very commonly causes dose-dependent sedation in dogs which is associated with potential decreased food and water intake, decreased stool production and transient weight loss.
Croatian: Fentanil vrlo često uzrokuje sedaciju pasa, ovisno o dozi, što je povezano s potencijalnim smanjenjem uzimanja hrane i vode, smanjenom proizvodnjom stolice i prolaznim gubitkom težine.
English: Fentanyl partitions from the stratum corneum through the deeper skin layers and into the systemic circulation over a period of days.
Croatian: Čestice fentanila iz stratum corneuma raspodjeljuju se kroz dublje slojeve kože u sustavnu cirkulaciju tokom više dana.
English: Fentanyl exerts its analgesic action by binding to and activating µ (mu) opioid receptors that are predominantly found in the pain regulating areas of the brain and spinal cord.
Croatian: Fentanil djeluje analgetički na način da se veže za i aktivira µ (mu) opioidne receptore koji sepredominantno nalaze u zonama koje reguliraju bol u mozgu i kralježničkoj moždini.
English: France (France) Lilly France S.A.S.
Croatian: Lilly France S.A.S.
English: Shelf life after first broaching the vial: 30 days.
Croatian: Rok valjanosti poslije prvog otvaranja bočice: 30 dana.
English: It is imperative that the veterinary medicinal product is not applied to any other site on the body than the dorsal scapular area, as absorption has been shown to vary between different locations of skin.
Croatian: Izuzetno je važno da se veterinarsko-medicinski proizvod ne primijeni na bilo koje drugo mjesto nego na dorzalno-skapularnu zonu, jer je dokazano da apsorpcija varira ovisno o različitim zonama kože.
English: Also, the veterinary medicinal product might cause skin irritation.
Croatian: Isto tako, veterinarsko-medicinski proizvod može uzrokovati iritaciju kože.
English: Attaching adaptor (see Figure 1):
Croatian: Postavljanje adaptera (vidi Prikaz 1):
English: • A 3 ml polypropylene syringe with a silicone O-ring fitted to the plunger.
Croatian: • Polipropilenska štrcaljka od 3 ml sa silikonskim O-prstenom ugrađenim na čep.
English: The most common symptoms associated with fentanyl overdose in people include respiratory depression, sedation and myosis.
Croatian: Najčešći simptomi povezani s predoziranjem fentanila kod ljudi uključuju respiratornu depresiju, sedaciju i miozu.
English: If a small child touches the application site within 72 hours of application, the child's skin that touched the dog (for example, fingers) should not contact the child's mouth, and the skin should be washed with soap and water.
Croatian: Ako malo dijete dotakne mjesto primjene unutar 72 sata od primjene, dio kože kojim je dijete dotaklo psa (npr. prsti), ne smije doći u kontakt s djetetovim ustima, a kožu je potrebno oprati sapunom i vodom.
English: The vial must be placed upright on a firm, stable surface during placement and application of the adaptor.
Croatian: Bočica mora biti postavljena u uspravnom položaju na čvrstoj, stabilnoj podlozi za vrijeme postavljanja i primjene aplikatora.
English: In case of accidental exposure of protective clothing to the veterinary medicinal product, immediately remove any contaminated clothing.
Croatian: U slučaju slučajnog izlaganja zaštitne odjeće veterinarsko-medicinskom proizvodu, odmah skinite kontaminiranu odjeću.
English: The veterinary medicinal product has a narrow margin of safety and it is important to measure the dose accurately to avoid over-dosing.
Croatian: Veterinarsko-medicinski proizvod ima uski pojas sigurnosti i važno je točno izmjeriti dozu kako bi se izbjeglo predoziranje.
English: B-1000 Brussels Tel.: +32 2 548 8484 Belgium
Croatian: B-1000 Brussels Tel.: +32 2 548 8484 Belgija
English: Fentanyl
Croatian: Fentanil
English: To address the safety concerns remaining in relation to the novel type of product, and the uncertainty about possible interactions of concomitantly used products during the operation and in the postoperative period, the marketing authorisation holder should arrange for collation and assessment of detailed data on the clinical safety of the product in a representative sample of dogs.
Croatian: Za odgovore na pitanja neškodljivostinove vrste proizvoda i neškodljivosti u vezi mogućih interakcija s usporedno primijenjenim proizvodima za vrijeme operacije i u postoperativnom razdoblju, nositelj odobrenja za stavljanje u promet mora omogućiti uspoređivanje i procjenu detaljnih podataka o kliničkoj neškodljivosti proizvoda na reprezentativnom uzorku pasa.
English: Very commonly (i.e. in more than 10% of treated dogs)
Croatian: Vrlo često (tj. kod više od 10% liječenih pasa)
English: Accumulation of fentanyl following repeated administration could result in severe adverse reactions, including death.
Croatian: Akumulacija fentanila nakon ponovljenih primjena može rezultirati teškim nuspojavama, uključujući i smrt.
English: • A polycarbonate Robertsite vial adaptor (allowing needleless luer connection to the vial).
Croatian: • Robertsite adapter za bočicu od polikarbonata (omogućuje priključenje na bočicu bez igle pomoću luer priključka).
English: As a class, opioids, including this veterinary medicinal product, may cause low body temperature, slow respiratory rate, low blood pressure or slow heart rate.
Croatian: Opioidna skupina lijekova, uključujući ovaj veterinarsko-medicinski proizvod, mogu uzrokovati sniženje tjelesne temperature, usporavanje ritma disanja, nizak krvni tlak i usporavanje rada srca.
English: Application of Recuvyra will not cause your dog any pain and your veterinarian will use a dosing table and a specially designed applicator to carefully apply the product onto the skin surface without using any needles.
Croatian: Primjena Recuvyre neće vašem psu uzrokovati bol i vaš veterinar će upotrijebiti tablicu za doziranje i posebno dizajnirani aplikator za pažljivu primjenu proizvoda na površinu kože bez upotrebe igle.
English: The veterinary medicinal product should be administered with caution.
Croatian: Veterinarsko-medicinski proizvod potrebno je primjenjivati s oprezom.
English: Once Recuvyra has been administered, your veterinarian will carefully monitor your dog to ensure it responds safely to the product.
Croatian: Nakon što je Recuvyra primijenjena, vaš veterinar će pažljivo nadzirati vašeg psa kako bi se uvjerio da sigurno odgovara na proizvod.
English: Place applicator tip at an approximate 45º angle directly onto the skin in the dorsal scapular region.
Croatian: Položite vrh aplikatora pod kutom od otprilike 45º direktno na kožu na dorzalno-skapularnoj regiji.
English: SMALL CHILDREN SHOULD NOT TOUCH THE DOG FOR 72 HOURS (3 days) AFTER RECUVYRA IS APPLIED TO THE DOG.
Croatian: MALA DJECA NE SMIJU DIRATI PSE 72 SATA (3 dana) NAKON ŠTO JE RECUVYRA
English: 1 vial (10 ml) 1 vial adaptor 15 syringes 15 applicator tips
Croatian: 1 bočica (10 ml) 1 adapter za bočicu 15 štrcaljki 15 vrhova aplikatora
English: The use of the veterinary medicinal product is intended as a single application administered 2 to 4 hours prior to surgery to provide analgesia for at least 4 days.
Croatian: Upotreba veterinarsko-medicinskog proizvoda namijenjena je kao jednokratna aplikacija primijenjena 2 do 4 sata prije operacije kako bi se osigurala analgezija u trajanju od najmanje 4 dana.
English: The effects of transdermal fentanyl could last longer than the effects of the opioid reversal agent.
Croatian: Utjecaj transdermalnog fentanila mogao bi trajati dulje od utjecaja tvari za oporavak od opioida.
English: In case of accidental spillage onto skin, immediately flush the area with water, then wash the area with copious amounts of soap and water and seek prompt medical advice, showing the physician this warning, the package leaflet or the label.
Croatian: U slučaju slučajnog izlijevanja na kožu, odmah isperite vodom zahvaćene zone, nakon toga operite obilnom količinom sapuna i vode i odmah potražite pomoć liječnika i pokažite liječniku ovo upozorenje, uputu o VMP ili etiketu.
English: Before using the product it is recommended to consider the availability of an opiate antagonist, e.g. naloxone, in case reversal is required (see sections 4.6 and 4.10).
Croatian: Prije upotrebe proizvoda, preporučuje se razmisliti o dostupnosti opioidnih antagonista, npr. nalokson u slučaju da je potreban oporavak od opijata (vidi dijelove 4.6 i 4.10).
English: • Has broken, damaged or diseased skin at the treatment site.
Croatian: • Ima ispucanu, oštećenu ili bolesnu kožu na mjestu primjene.
English: Eli Lilly Romania SRL
Croatian: Eli Lilly Romania SRL Str.
English: If a child orally contacts the application site within 72 hours of application, medical attention should be sought immediately.
Croatian: Ako dijete dođe u oralni kontakt s mjestom primjene u roku od 72 sata od primjene, potrebno je odmah potražiti pomoć liječnika.
English: The veterinary medicinal product should not come into direct contact with the oral cavity or mucous membranes of dogs.
Croatian: Veterinarsko-medicinski proizvod ne smije doći u direktan kontakt s usnom šupljinom ili mukoznim membranama psa.
English: The above side effects can occur up to 3 days (72 hours) after Recuvyra was given to your dog.
Croatian: Gore navedene nuspojave mogu se pojaviti do 3 dana (72 sata) nakon primjene Recuvyra vašem psu.
English: At a high dose, fentanyl is known to cause a potentially fatal respiratory depression.
Croatian: Pri visokim dozama, poznato je da fentanil može uzrokovati fatalnu respiratornu depresiju.
English: In rare cases, dysphoria and urinary retention have also been observed.
Croatian: U rijetkim slučajevima, disforija i zadržavanje mokraće također su opaženi.
English: Isopropyl alcohol
Croatian: Izopropilni alkohol
English: To accurately withdraw the correct amount, align the top of the O-ring on the syringe plunger with the appropriate tick mark on the syringe barrel.
Croatian: Kako biste precizno izvukli točnu količinu, poravnajte vrh O-prstena na klipu štrcaljke s odgovarajućom oznakom na spremniku štrcaljke.
English: Do not give more than the recommended dose of the veterinary medicinal product.
Croatian: Nemojte davati više od preporučene doze veterinarsko-medicinskog proizvoda.
English: Following application to the skin, fentanyl is rapidly absorbed into the skin.
Croatian: Nakon primjene na kožu, fentanil se brzo apsorbira u kožu.
English: The application site should be clean and free of any surface matter.
Croatian: Mjesto primjene mora biti čisto i bez prisutnosti površinskih tvari.
English: Blot up any noticeable solution using an absorbent material such as paper tissues.
Croatian: Upijte primijećenu otopinu pomoću upijajućeg materijala kao što su papirnate maramice.
English: 6.2 Incompatibilities None known.
Croatian: 6.2 Inkompatibilnosti
English: Fentanyl is highly lipid soluble and distributes rapidly into a variety of tissues readily crossing the blood-brain barrier in the dog.
Croatian: Fentanil je visoko topiv u lipidima i distribuira se brzo u veliki broj tkiva i odmah prolazi moždano krvnu barijeru psa.
English: If needed, your veterinarian might administer more than one dose of naloxone to your dog.
Croatian: Ako je potrebno vaš će veterinar primijeniti više od jedne doze naloksona vašem psu.
English: Dogs must not be discharged to owners until post-operative sedation is mild or absent and dogs are drinking water and eating voluntarily at an appropriate level for the condition that required surgery.
Croatian: Psi se ne smiju predati vlasnicima dok postoperativna sedacija ne bude blaga ili ne nestane i psi počnu piti vodu i jesti hranu svojom voljom na odgovarajućoj razini za stanje koje je zahtijevalo operaciju.
English: If needed, re-administer naloxone.
Croatian: Ako je potrebno, ponovo primijenite nalokson.
English: Apply up to 0.5 ml onto the skin without moving the applicator tip.
Croatian: Primijenite do 0,5 ml na kožu bez pomicanja vrha aplikatora.