FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaphylactic reaction
Croatian: Reakcija na transfuziju
English: Splenomegaly a
Croatian: Proljev a,e
English: See package leaflet for direction for use of the needle safe device.
Croatian: Vidjeti uputu o lijeku za upute o rukovanju sa štitnikom za iglu.
English: Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari acetatna kiselina, ledena natrijev hidroksid sorbitol (E 420) polisorbat 80 voda za injekciju
English: Nivestim 30 MU/0.5 ml solution for injection/infusion, Nivestim 48 MU/0.5 ml solution for injection/infusion
Croatian: Nivestim 30 MU/0,5 ml otopina za injekciju/infuziju, Nivestim 48 MU/0,5 ml otopina za injekciju/infuziju
English: Malignant cell growth
Croatian: Rast zloćudnih stanica
English: Cases of splenomegaly and splenic rupture have been reported following administration of filgrastim.
Croatian: Nakon primjene filgrastima zabilježeni su slučajevi splenomegalije i rupture slezene.
English: Acute respiratory distress syndrome a
Croatian: Sindrom akutnog respiratornog di stresa
English: Generally asymptomatic cases of splenomegaly and cases of splenic rupture have been reported in patients and normal donors following administration of filgrastim.
Croatian: Nakon primjene filgrastima u bolesnika i zdravih davatelja zabilježeni su većinom asimptomatski slučajevi splenomegalije i slučajevi rupture slezene.
English: Thrombocytopenia has been reported in patients receiving filgrastim.
Croatian: Trombocitopenija je prijavljena u bolesnika koji su primali filgrastim.
English: If your nurse or doctor recommends it, clean the area of skin with an antiseptic wipe.
Croatian: Očistite kožu na odabranom mjestu aseptičkom maramicom, ako su Vam to preporučili liječnik ili medicinska sestra.
English: Proteinuria
Croatian: Mučnina
English: Hepatobiliary disorders
Croatian: Hemoptiza Dispneja
English: Glomerulonephritis Urine abnormality
Croatian: Proteinurija Glomerulonefritis Odstupanja u rezultatima pretraga mokraće
English: Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Croatian: U bolesnika oboljelih od raka i zdravih darivatelja rijetko je zabilježena upala aorte (velike krvne žile koja prenosi krv iz srca u tijelo), čiji simptomi mogu uključivati vrućicu, bol u trbuhu, malaksalost, bol u leđima i povišene upalne markere.
English: • bone density decreased
Croatian: • smanjena gustoća kostiju
English: - osteoporosis (bone disease).
Croatian: Nivestim može uzrokovati krizu srpastih stanica. osteoporozu (bolest kostiju).
English: Sickle cell crises, in some cases fatal, have been reported with the use of filgrastim in patients with sickle cell trait or sickle cell disease.
Croatian: Pri primjeni filgrastima u bolesnika s nasljednim obilježjem srpastih stanica ili bolešću srpastih stanica zabilježene su krize srpastih stanica, u nekim slučajevima sa smrtnim ishodom.
English: • bumpy skin rash (rash maculo-papular)
Croatian: • neravan osip na koži (makulopapularni osip)
English: Tel: +420-283-004-111
Croatian: Česká republika Pfizer, spol. s r.o. Tel: +420-283-004-111
English: Long term daily administration is required to maintain an adequate neutrophil count.
Croatian: Za održavanje primjerenog broja neutrofila, nužna je dugotrajna primjena lijeka.
English: Transient cytogenetic abnormalities have been observed in normal donors following G-CSF use.
Croatian: U zdravih davatelja koji su primali G-CSF uočene su prolazne citogenetske abnormalnosti.
English: Pulmonary haemorrhage Interstitial lung disease a
Croatian: Intersticijska bolest pluća Infiltracija pluća
English: Muscle spasms
Croatian: Dizurija Hematurija
English: Alopecia a
Croatian: Alopecija
English: Mucosal inflammation a
Croatian: Anafilaktička reakc ija
English: There is no antidote available.
Croatian: Nema dostupnog antidota.
English: Wash hands after use.
Croatian: Operite ruke nakon primjene.
English: Do not use in dogs under 14 weeks of age.
Croatian: Ne primjenjivati psima mlađim od 14 tjedana.
English: These measures should help to protect the environment.
Croatian: Te mjere pomažu u zaštiti
English: Then start a new monthly dosing schedule from that day.
Croatian: Od tog dana započnite novi mjesečni raspored doziranja.
English: Each tablet contains:
Croatian: Svaka tableta sadrži:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/09/2013
Croatian: Datum prvog odobrenja: 19/09/2013.
English: ATCvet code: QP54AB51 (milbemycin combinations).
Croatian: ATCvet kod: QP54AB51 (kombinacije milbemicina).
English: Carton containing 1 blister pack.
Croatian: Karton sadrži 1 blister pakovanje.
English: The duration of efficacy may be reduced if the dose is administered on an empty stomach.
Croatian: Trajanje djelotvornosti može biti smanjeno ako se doza primjenjuje na prazan želudac.
English: All dogs within the household should be treated.
Croatian: Svi psi u kućanstvu moraju biti liječeni.
English: Seek veterinary advice regarding information on the optimal time to start treatment with this veterinary medicinal product.
Croatian: Potražite savjet veterinara u vezi informacija o optimalnom vremenu za početak liječenja ovim proizvodom.
English: Trough concentrations of spinosad doubled monthly up to month 5.
Croatian: Najniže koncentracije spinosada su se mjesečno udvostručile do 5. mjeseca.
English: Plasma protein binding is high (>96%).
Croatian: Vezanje proteina plazme je visoko (>96%).
English: Plasma protein binding is high (>98%).
Croatian: Vezanje proteina plazme je visoko (>98%).
English: The recommended dosage regimen must be followed but not exceeded.
Croatian: Režim preporučenog doziranja mora se poštovati i ne prekoračiti.
English: These effects are caused primarily by activation of nicotinic acetylcholine receptors (nAChRs).
Croatian: Ovi učinci prvenstveno su uzrokovani aktivacijom receptora nikotin acetilkolina (nAChRs).
English: Unlike spinosad, the consistent ratio of the individual factors is not maintained in pharmacokinetic studies.
Croatian: Za razliku od spinosada, dosljedan omjer individualnih faktora nije se održao u farmakokinetičkim ispitivanjima.
English: Body weight (kg) of dog
Croatian: Tjelesna težina psa u kg
English: At this time, the systemic exposure (AUC) in juveniles was comparable to adults.
Croatian: U tom trenutku sustavna izloženost (AUC) kod mladunaca bila je usporediva s odraslima.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please, inform your veterinary surgeon.
Croatian: Ako primijetite bilo koju ozbiljnu nuspojavu ili druge nuspojave koje nisu opisane u uputi o VMP, molimo obavijestite svog veterinara.
English: The increase in plasma concentrations was strongly correlated with an increase in terminal elimination half-lives.
Croatian: Porast koncentracije u plazmi je usko povezan s povećanjem konačnog poluvremena eliminacije.
English: This leads to hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of the parasite.
Croatian: To dovodi do hiperpolarizacije neuromuskularne membrane i flakcidne paralize i smrti parazita.
English: Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
Croatian: Prema tome, primjena ovog proizvoda mora se bazirati na procjeni od slučaja do slučaja kao i na lokalnoj epidemiološkoj informaciji o osjetljivosti na ciljne vrste kako bi se ograničila mogućnost buduće selekcije na otpornost.
English: Cmax was comparable between juveniles and adults starting at month 1, indicating no increased risk of acute toxicity.
Croatian: Cmax je bio usporediv između mladih pasa i odraslih počevši od 1. mjeseca, ne upućujući na povećan rizik akutne toksičnosti.
English: Parasite resistance to any particular class of anthelmintic may develop following the frequent, repeated use of an anthelmintic of that class.
Croatian: Otpornost parazita na bilo koju vrstu anthelmintika može se razviti nakon česte, ponovljene primjene anthelmintika te vrste.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu dostupne su na web stranici Europske agencije za lijekove (http://www.ema.europa.eu).
English: The recommended dosage regimen must be followed but not exceeded (see section 4.10) .
Croatian: Režim preporučenog doziranja mora se poštovati i ne smije se prekoračiti (vidi odjeljak 4.10).
English: Children must not come into contact with the veterinary medicinal product.
Croatian: Djeca ne smiju doći u kontakt s veterinarsko-medicinskim proizvodom.
English: The veterinary medicinal product must be administered 1 month before the expected appearance of mosquitoes.
Croatian: Ovaj veterinarsko-medicinski proizvod mora se primijeniti mjesec dana prije očekivane pojave komaraca.
English: Bioavailability was shown to be high.
Croatian: Pokazala se visoka bioraspoloživost.
English: If the dog does not accept the tablet(s) directly in its mouth then the tablet(s) may be mixed with food.
Croatian: Ako pas ne prihvaća tabletu(e) direktno u usta, ona(e) se mogu miješati s hranom.
English: Prior to treatment with Trifexis the advice in section 4.5 should be considered.
Croatian: Prije liječenja Trifexis-om, potrebno je uzeti u obzir savjet iz odjeljka 4.5.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA
English: The veterinary medicinal product should be administered with food or immediately after feeding.
Croatian: Veterinarsko-medicinski proizvod treba primijeniti s hranom ili neposredno nakon hranjenja.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Pročitati uputu o VMP prije primjene.
English: Pharmacotherapeutic group: Antiparasitic products, insecticides and repellents - endectocides.
Croatian: Farmakoterapijska grupa: Antiparazitski proizvodi, insekticidi i repelenti - endektocidi.
English: Vomiting is most likely caused by a local effect on the small intestine.
Croatian: Povraćanje je najvjerojatnije uzrokovano lokalnim učinkom na tanko crijevo.
English: The blister packs are formed from aluminium laminates, heat sealed with a PVC based coating (the product contact surface is PVC).
Croatian: Blister pakovanja se sastoje od aluminijevih laminata, zapečaćenih termozatvaranjem s PVC premazom (površina u kontaktu s proizvodom je PVC).
English: Trifexis tablets should be administered to the dog with its food, or immediately after feeding.
Croatian: Tablete Trifexis treba primijeniti psu s hranom ili neposredno nakon hranjenja.
English: The product can be administered as part of a seasonal prevention strategy when fleas and mosquitoes or snails/slugs are present.
Croatian: Proizvod se može primijeniti kao dio sezonske preventivne strategije kod pojave buha, komaraca ili puževa/golaća.
English: A commonly observed adverse reaction is vomiting, which occurs in the first 48 hours after dosing.
Croatian: Često primijećena nuspojava je povraćanje, koje se pojavljuje u prvih 48 sati nakon primjene.
English: The consistency of this figure in pharmacokinetic and other studies indicates comparability in the absorption, metabolism and elimination of the two major spinosyns.
Croatian: Postojanost ovih iznosa u farmakokinetičkim i drugim ispitivanjima pokazuje usporedivost apsorpcije, metabolizma i eliminacije dva glavna spinosina.
English: After administration of the tablet monitor the dog closely.
Croatian: Nakon primjene tableta, pomno nadzirite psa.
English: All adverse events were transient and did not require treatment.
Croatian: Sve su nuspojave bile prolazne i nisu zahtijevale liječenje.
English: The mean Tmax for spinosyns A and D was 4 hours and the mean elimination half-lives ranged between 131 and 135 hours.
Croatian: Srednji Tmax za spinosine A i D bio je 4 sata, a srednje poluvrijeme eliminacije bilo je u rasponu od 131 do 135 sati.
English: Spinosad starts killing fleas 30 minutes after administration; 100% of fleas are dead/moribund within 4 hours post-treatment.
Croatian: Spinosad počinje ubijati buhe 30 minuta nakon primjene: 100% buha je mrtvo/na umoru unutar 4 sata nakon liječenja.
English: Milbemycin oxime plasma concentrations and some pharmacokinetic parameters are increased in the presence of spinosad.
Croatian: Koncentracije milbemicin oksima u plazmi i neki farmakokinetički parametri povećani su u prisutnosti spinosada.
English: Prior to treatment with Trifexis the advice in section 12 should be considered.
Croatian: Prije liječenja Trifexi-om, potrebno je uzeti u obzir savjet iz odjeljka 12.
English: In case of a massive flea infestation, and at the beginning of the control measures, these areas should be treated with a suitable insecticide and then vacuumed regularly.
Croatian: U slučaju masovne infestacije buhama i na početku kontrolnih mjera, ova područja treba tretirati odgovarajućim insekticidom i redovno usisavati.
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,
English: Milbemycin oxime is a systemic macrocyclic lactone containing two major factors, A3 and A4 (ratio of A3:A4 is 20:80).
Croatian: Milbemicin oksim je sustavni makrociklički lakton koji sadrži dva glavna faktora, A3 i A4 (omjer A3:A4 je 20:80).
English: Faecal excretion accounted for the vast majority of metabolites in dogs.
Croatian: Fekalno izlučivanje odnosi se na veliku većinu metabolita kod pasa.
English: These dogs may be at a higher risk for adverse effects when treated with this product and should therefore be treated with special caution.
Croatian: Takvi psi mogu biti izloženi pojačanom riziku nuspojava kad se primjenjuje ovaj proizvod i stoga ih treba liječiti s posebnim oprezom.
English: At the discretion of the veterinarian, infected dogs must be treated with an adulticide to remove adult heartworms.
Croatian: Prema procjeni veterinara, zaraženi psi moraju se liječiti adulticidom kako bi se uklonili odrasli srčani crvi.
English: Milbemycin oxime is isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus.
Croatian: Milbemicin oksim izoliran je iz fermentacije Streptomyces hygroscopicus var. aureolacrimosus.
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 upotrijebiti kao dio strategije liječenja, za kontrolu alergijskog dermatitisa uzrokovanog ugrizom buhe (FAD).
English: The mean Tmax for milbemycin A3 and A4 5-oximes was typically 4 hours and the mean elimination half-lives were 33.9 and 77.2 hours.
Croatian: Srednji Tmax za milbemicin A3 i A4 5-oksime bio je uobičajena 4 sata, a srednje poluvrijeme eliminacije bilo je 33,9 i 77,2 sata.
English: Special precautions for each target species:
Croatian: Posebna upozorenja za svaku od ciljnih vrsta životinja:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Administer with food.
Croatian: NAČIN I PUT(EVI) PRIMJENE Primijeniti uz hranu.
English: The safety of this product in avermectin sensitive dogs/dogs with an MDR-1 mutation has not been sufficiently demonstrated.
Croatian: Neškodljivost ovog proizvoda kod pasa osjetljivih na avermektin i pasa s mutacijom MDR-1 nije dovoljno dokazana.
English: A single treatment is effective for the treatment of gastrointestinal nematodes.
Croatian: Jednokratno liječenje djelotvorno je protiv gastrointestinalnih nematoda.
English: If vomiting occurs within an hour of administration and the tablet is visible, re-dose with another full dose.
Croatian: Ako se povraćanje pojavi u roku od jednog sata od primjene, a tableta je vidljiva, ponovno dajte životinji istu punu dozu.
English: Decreased activity was seen at the same frequency in both control and dogs treated with 3 times the maximum recommended dose.
Croatian: Smanjena aktivnost je opažena u istoj učestalosti i u kontrolnih pasa i u pasa liječenih dozom 3 puta većom od maksimalno preporučene doze.
English: Strength and number of tablets to be administered:
Croatian: Jačina i broj tableta za primjenu:
English: The activity of milbemycin oxime is related to its action on invertebrate neurotransmission.
Croatian: Aktivnost milbemicin oksima povezana je s djelovanjem na neurotransmisiju beskralješnjaka.
English: The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 45 to 70 mg spinosad and 0.75 to 1.18 mg milbemycin oxime/kg bodyweight.
Croatian: Veterinarsko-medicinski proizvod treba primijeniti u skladu sa sljedećom tablicom kako bi se osigurala doza od 45-70 mg spinosada i 0,75 do 1,18 mg milbemicin oksima po kilogramu tjelesne težine.
English: In addition, in studies containing only spinosad, AUC and Cmax values were higher in fed than fasted dogs and therefore it is recommended to treat dogs with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Croatian: Dodatno, u ispitivanjima koja su sadržavala samo spinosad, PIK i Cmax vrijednosti su bile veće kod sitih nego kod gladnih pasa te se prema tome preporučuje liječenje pasa uz davanje hrane jer takav način povećava mogućnosti da buhe progutaju smrtonosnu dozu spinosada.
English: The following list shows the code and the number of dimples marked on each strength of tablet:
Croatian: Sljedeći popis navodi kodove i broj rupica zavisno o jačini tablete:
English: Trifexis can be used as part of the seasonal prevention of fleas (replacing treatment with a monovalent flea product) in dogs with diagnosed concurrent gastrointestinal nematode infections.
Croatian: Trifexis se može upotrijebiti kao dio sezonske prevencije od buha (umjesto liječenja monovalentnim proizvodom protiv buha) kod pasa kod kojih je dijagnosticirana istovremena gastrointestinalna infestacija nematodima.
English: Trifexis tablets should only be used when the veterinarian has confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see section 4).
Croatian: Tablete Trifexis smiju se dati samo nakon što je veterinar potvrdio dijagnozu mješovite infestacije u isto vrijeme (ili rizika od infestacija tamo gdje je prevencija potrebna) (vidi odjeljak 4).
English: Approximately 90% of spinosad is comprised of spinosyns A and D. Of that 90%, the ratio of spinosyn A to A+D is 0.85 when calculated as spinosyn A/spinosyn A+D.
Croatian: Od tih 90%, odnos spinosina A prema A+D je 0,85 kad se računa spinosin A/spinosin A+D.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 životinja pokazuju nuspojavu(e) za vrijeme trajanja tretmana) - česte (više od 1 ali manje od 10 životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 životinja) - vrlo rijetke (manje od 1 životinje na 10.000 životinja, uključujući izolirane slučajeve)
English: A slight increase in plasma liver enzymes and haemoglobin distribution width (HDW) was observed during the study but no clinically relevant signs was attributed to these changes.
Croatian: U ispitivanju su uočeni lagani porast jetrenih enzima u plazmi i širina distribucije hemoglobina (HDW), ali ovim promjenama nisu pripisani klinički značajni znaci.
English: Milbemycin A4 5-oxime tends to eliminate slower resulting in approximately 10-fold higher exposure than Milbemycin A3 5-oxime.
Croatian: Milbemicin A4 5-oksim ima tendenciju sporije eliminacije što rezultira otprilike desetorostruko višom izloženošću nego Milbemicin A3 5-oksim.
English: This combination product (Trifexis) must, however, not be given for more than 6 consecutive months in any one year.
Croatian: Međutim, ovaj kombinirani proizvod (Trifexis) ne smije se davati dulje od 6 mjeseci uzastopno unutar jedne godine.
English: Spinosad therefore has a different mode of action to other flea control or insect control products.
Croatian: Spinosad prema tome ima različit način djelovanja od ostalih proizvoda za kontrolu buha ili ostalih insekata.
English: At acute overdoses corresponding to 3 times the maximum recommended dose, vomiting occurred in half of the animals, sometimes repeatedly.
Croatian: Pri akutnom predoziranju dozom 3 puta većom od maksimalno preporučene doze, povraćanje se pojavilo kod polovice životinja, a ponekad se ponovilo i više puta.
English: Microcrystalline cellulose Hydroxypropyl cellulose Silica, colloidal anhydrous Croscarmellose sodium Magnesium stearate Artificial beef flavour
Croatian: Mikrokristalna celuloza Hidroksipropil celuloza Bezvodni koloidni silicijev dioksid Croskarmeloza natrij Magnezijev stearat Umjetni okus govedine
English: Milbemycin oxime is an antiparasitic endectocide belonging to the macrocyclic lactones.
Croatian: Milbemicin oksim je antiparazitski endektocid koji spada u grupu makrocikličkih laktona.
English: Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control, therefore, to minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season prior to starting monthly preventive treatments.
Croatian: Održavanje djelotvornosti makrocikličkih laktona kritično je za kontrolu parazita Dirofilaria immitis, što znači da se radi smanjenja rizika od selekcije na otpornost preporučuje, da se psi istovremeno provjere na cirkulirajuće antigene i mikrofilariju u krvi na početku svake sezone, prije početka preventivnih mjesečnih terapija.
English: The use of the product should be based on the confirmed diagnosis of mixed infection (or risk of infection, where prevention applies) at the same time (see also section 4.2).
Croatian: Primjena ovog proizvoda mora se bazirati na potvrđenoj dijagnozi istovremenih miješanih infestacija (ili rizika od infestacija u slučajevima prevencije) (vidi odjeljak 4.2).
English: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road Basingstoke
Croatian: Eli Lilly and Company Ltd Elanco Animal Health Priestley Road
English: Use with caution in dogs with pre-existing epilepsy.
Croatian: Primjenjujte s oprezom u pasa s epilepsijom.
English: It does not interact with known binding sites of other nicotinic or GABAergic insecticides such as neonicotinides (imidacloprid or nitenpyram), fiproles (fipronil), milbemycins, avermectins (e.g. selamectin) or cyclodienes but through a novel insecticidal mechanism.
Croatian: Nema međusobnog djelovanja s poznatim mjestima vezanja ostalih nikotinskih ili GABA-ergičnih insekticida kao što su neonikotinidi (imidakloprid ili nitenpiram), fiproli (fipronil), milbemicini, avermektini (npr. selamektin) ili ciklodieni, već kroz novi insekticidni mehanizam.
English: In a separate study with three consecutive monthly administrations, no increases in Cmax, AUC, or elimination half-lives were noted when comparing values from the third and first months.
Croatian: U zasebnom ispitivanju s tri uzastopne mjesečne primjene nije primijećeno povećanje Cmax, PIK ili poluvremena eliminacije prilikom usporedbe vrijednosti iz trećeg i prvog mjeseca.