FrancophonIA/ELRC3.0 huggingface dataset:
English: ↔ Elbasvir AUC 0.81 (0.57, 1.17) Cmax 0.89 (0.61, 1.29) C24 0.80 (0.55, 1.16)
Croatian: AUC 0,81 (0,57; 1,17) Cmax 0,89 (0,61; 1,29) C24 0,80 (0,55; 1,16)
English: • feeling very tired (fatigue)
Croatian: • jaki umor (iscrpljenost)
English: Subjects with baseline NS3 polymorphisms, % (n/N)
Croatian: Ispitanici s polimorfizmima NS3 na početku ispitivanja, % (n/N)
English: (due in part to OATP1B and CYP3A inhibition)
Croatian: (dijelom zbog inhibicije OATP1B i CYP3A)
English: No clinically relevant change in exposure is represented by a horizontal arrow “↔”.
Croatian: Vodoravna strelica "↔" znači da nije došlo do klinički značajne promjene izloženosti.
English: Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Croatian: Ciklosporin (400 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: Haemodialysis does not remove elbasvir or grazoprevir.
Croatian: Elbasvir i grazoprevir ne mogu se ukloniti hemodijalizom.
English: Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Croatian: Mofetilmikofenolat (1000 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: ↔ Elbasvir AUC 1.07 (1.00, 1.14) Cmax 1.07 (0.98, 1.16) C24 1.05 (0.97, 1.14)
Croatian: AUC 1,07 (1,00; 1,14) Cmax 1,07 (0,98; 1,16) C24 1,05 (0,97; 1,14)
English: Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Croatian: Takrolimus (2 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: ↔ Elbasvir AUC 0.98 (0.93, 1.02) Cmax 0.97 (0.89, 1.05) C24 0.97 (0.92, 1.02)
Croatian: AUC 0,98 (0,93; 1,02) Cmax 0,97 (0,89; 1,05) C24 0,97 (0,92; 1,02)
English: Overall prevalence of GT1a-infected subjects with baseline NS5A polymorphisms in the pooled analyses was
Croatian: SVR prema prisutnosti polimorfizama NS5A povezanih s rezistencijom na početku ispitivanja Odsutni
English: Laboratory abnormalities
Croatian: Laboratorijske vrijednosti
English: ↔ Elbasvir AUC 0.98 (0.93, 1.04) Cmax 0.97 (0.89, 1.05) C24 0.98 (0.93, 1.03)
Croatian: AUC 0,98 (0,93; 1,04) Cmax 0,97 (0,89; 1,05) C24 0,98 (0,93; 1,03)
English: (600 mg once daily)/ grazoprevir (200 mg once daily)
Croatian: (600 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: (600 mg PO single dose)/ grazoprevir (200 mg once daily)
Croatian: (600 mg u jednokratnoj peroralnoj dozi)/grazoprevir (200 mg jedanput na dan)
English: Sodium laurilsulfate Vitamin E polyethylene glycol succinate Copovidone
Croatian: Jezgra tablete natrijev laurilsulfat vitamin E polietilenglikolsukcinat kopovidon hipromeloza mikrokristalična celuloza manitol laktoza hidrat umrežena karmelozanatrij natrijev klorid koloidni, bezvodni silicijev dioksid magnezijev stearat
English: Pravastatin (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Croatian: Pravastatin (40 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: Placebo-controlled study in subjects with CKD Stage 4 (eGFR 15-29 mL/min/1.73 m2) or Stage 5 (eGFR < 15 mL/min/1.73 m2), including subjects on hemodialysis, Subjects were randomised in a 1:1 ratio to one of the following treatment groups: EBR + GZR for 12 weeks (ITG) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (DTG).
Croatian: Placebom kontrolirano ispitivanje u ispitanika s kroničnom bolesti bubrega stadija 4 (eGFR: 15-29 ml/min/1,73 m ili stadija 5 (eGFR <15 ml/min/1,73 m uključujući ispitanike na hemodijalizi.
English: FRI
Croatian: Nuspojave
English: Grazoprevir is active in vitro against the following genotype 1a NS3 substitutions which confer resistance to other NS3/4A protease inhibitors: V36A/L/M, Q41R, F43L, T54A/S, V55A/I, Y56F, Q80K/R, V107I, S122A/G/R/T, I132V, R155K, A156S, D168N/S, I170T/V.
Croatian: Kod genotipa 1a, grazoprevir je aktivan in vitro protiv sljedećih supstitucija u proteinu NS3 koje uzrokuju rezistenciju na druge inhibitore proteaze NS3/4A: V36A/L/M, Q41R, F43L, T54A/S,
English: General disorders and administration site conditions: Very common fatigue
Croatian: Opći poremećaji i reakcije na mjestu primjene: vrlo često umor često astenija, iritabilnost
English: Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Croatian: ANTIVIROTICI ZA LIJEČENJE INFEKCIJE HCV-om Sofosbuvir (sofosbuvir 400 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: Based on pooled data from patients treated with ZEPATIER for 12 weeks without ribavirin ULN: Upper limit of normal according to testing laboratory.
Croatian: Na temelju objedinjenih podataka prikupljenih u bolesnika liječenih lijekom ZEPATIER bez ribavirina tijekom 12 tjedana.
English: ↔ S-Methadone AUC 1.23 (1.12, 1.35) Cmax 1.15 (1.07, 1.25)
Croatian: AUC 1,23 (1,12; 1,35)
English: Sunitinib
Croatian: • mučnina
English: Calcium acetate (2,668 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Croatian: Cmax 0,93 (0,84; 1,03) LIJEKOVI KOJI VEZUJU FOSFATE Kalcijev acetat (2668 mg u jednokratnoj dozi)/elbasvir (50 mg u jednokratnoj dozi)/grazoprevir (100 mg u jednokratnoj dozi)
English: STIMULANTS
Croatian: STIMULANSI Modafinil
English: Prednisone (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Croatian: Prednizon (40 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
English: Avoid contact with eyes.
Croatian: Izbjegavati dodir s očima.
English: • Take out one pipette from the box.
Croatian: 1 - Izvadite jednu pipetu iz kutije.
English: Do not use in dogs with generalised demodecosis.
Croatian: Ne primjenjivati kod pasa s generaliziranom demodikozom.
English: Pregnancy and lactation:
Croatian: Graviditeta i laktacije:
English: Not all pack sizes may be marketed.
Croatian: Ne moraju sve veličine pakovanja biti u prometu
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Croatian: Detaljne informacije o ovom VMP možete naći na web stranicama Europske agencije za lijekove http://www.ema.europa.eu
English: (Reference is made to the drawing in section 1)
Croatian: (Upute su dane na slici u odjeljku 1)
English: Date of first renewal: 11/11/2013.
Croatian: Datum prvog produljenja odobrenja: 11.11.2013.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements
Croatian: Bilo koji neupotrebljeni veterinarsko medicinski proizvod ili otpadni materijal dobiven primjenom tih veterinarsko medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
English: In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
Croatian: U svim navedenim slučajevima primjena ovog VMP nije prekinuta, a svi psi su se u potpunosti oporavili bez primjene bilo kakve specifične terapije.
English: Since many bacterial strains may be involved in otitis externa in dogs, the mechanisms of resistance can vary.
Croatian: Pošto mnogo različitih sojeva bakterija može biti uključeno u upalu vanjskog slušnog kanala kod pasa, mehanizmi otpornosti također mogu biti različiti.
English: Interaction with other medicinal products and other forms of interaction: Compatibility with ear cleaners has not been demonstrated.
Croatian: Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Kompatibilnost s preparatima za higijenu i čišćenje ušiju nije utvrđivana.
English: Hydrocortisone aceponate - Miconazole - Gentamicin
Croatian: Hidrokortizon aceponat - mikonazol - gentamicin
English: Hydrocortisone aceponate
Croatian: Hidrokortizon aceponat
English: • To open: hold up the pipette upright and break the top of the cannula.
Croatian: 3 - Da biste otvorili pipetu: držite pipetu vrhom okrenutu prema gore i slomite vrh kanile.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 5, 10, 50, 100 or 200 PIPETTES
Croatian: PODACI NA VANJSKOM PAKOVANJU KUTIJA S 5, 10, 50, 100 ILI 200 PIPETA
English: Liquid paraffin.
Croatian: Tekući parafin.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports.
Croatian: Učestalost nuspojava je određena sukladno sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e)) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja) - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Do not use concurrently with substances known to cause ototoxicity.
Croatian: Ne primjenjivati zajedno s tvarima za koje je poznato da uzrokuju ototoksičnost.
English: Incompatibilities: Do not mix with other veterinary medicinal products.
Croatian: Inkompatibilnosti: Ne miješati s bilo kojim drugim VMP.
English: Cardboard box containing 5, 10, 50, 100 or 200 pipettes.
Croatian: U kutiji može biti 5, 10, 50, 100 ili 200 pipeta.
English: Gentamicin resistant bacteria isolated from the field between 2008 and 2010 in canine otitis before treatment (determined according to CLSI guideline breakpoint ≥ 8 for all isolates except for Staphylococci ≥ 16 μg/ml) were low: 4.7%, 2.9% and 12.5% for Staphylococcus spp., Pseudomonas and Proteus spp.
Croatian: Bakterije otporne na gentamicin, izolirane na terenu između 2008. i 2010. kod upale uha pasa prije primjene terapije (određena na osnovu CLSI smjernica za prijelomne toke - ≥ 8 μg/mL za sve izolate osim za Stafilokoke gdje je to ≥ 16 μg/mL), su bile rijetke, odnosno, 4,7 % za Staphylococcus spp., 2,9 % za Pseudomonas i 12,5 % za Proteus spp. Svi izolati koji su sadržavali E. coli bili su u potpunosti osjetljivi na gentamicin.
English: The diesters are transformed inside the skin structures in C17 monoesters responsible for the potency of the therapeutic class.
Croatian: Diesteri se u koži transformiraju u C17 monoester koji je odgovoran za snagu djelovanja ove terapeutske skupine VMP.
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Croatian: Primjenjivati nakon cjelokupne procjene rizika/koristi od strane veterinara.
English: See section 4.5 of the SPC.
Croatian: Vidi dio 4.5 u Sažetku opisa svojstava.
English: Squeeze gently but firmly in the middle of the body of the pipette.
Croatian: Nježno, ali snažno pritisnite pipetu oko sredine.
English: Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity.
Croatian: Mikonazol nitrat je sintetički derivate imidazola s naglašenom antigljivičnom aktivnosti.
English: Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis.
Croatian: Gentamicin sulfat je aminoglikozidni bakterijski antibiotik koji inhibira sintezu proteina.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml (10 doses).
Croatian: SADRŽAJ: TEŽINA, VOLUMEN I BROJ DOZA 10 ml (10 doza).
English: In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces.
Croatian: Kod laboratorijskih životinja hidrokortizon aceponat se izlučuje iz organizma na isti način kao i hidrokortizon (drugo ime za endogene kortizole) - urinom i fecesom.
English: ROUTE(S) OF ADMINISTRATION (Reference is made to the drawing in section 1)
Croatian: PUT(EVI) PRIMJENE (Upute su dane na slici u odjeljku 1)
English: RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only.
Croatian: U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo Samo za primjenu na životinjama.
English: The diesters are lipophilic components ensuring an enhanced penetration into the skin associated with low systemic bioavailability.
Croatian: Diesteri su lipolitički dio koji osigurava pojačanu prodornost kroz kožu, a što je povezano s niskom sustavnom biodostupnosti.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Croatian: RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” Samo za primjenu na životinjama.
English: Shelf life after first opening the immediate packaging: 10 days.
Croatian: Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 10 dana.
English: Cross-resistance is mainly linked with efflux pumps which confer resistance to β-lactams, quinolones and tetracyclines depending on the specificity of the pump with its substrate.
Croatian: Križna otpornost uglavnom je vezana za efluks pumpe koje pokazuju otpornost prema β-laktamima, kinolinima i tetraciklinima ovisno o specifičnosti tih bjelančevina i njihovog supstrata.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere predostrožnosti za odlaganje neupotrijebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
English: In case of parasitic otitis, an appropriate acaricidal treatment should be implemented.
Croatian: U slučaju parazitarne upale uha treba primijeniti pravilnu antiparazitarnu terapiju.
English: Pipette composed of high density polyethylene (body and cannula) containing a steel ball.
Croatian: Jednodozni spremnikPipeta od polietilena visoke gustoće (tijelo i kanila) koja sadržava čeličnu kuglicu.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/085/001
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/085/001
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju nehotičnog gutanja ovog VMP odmah zatražiti savjet/pomoć liječnika i pokazati mu “Uputu” ili etiketu.
English: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Croatian: Višedozni spremnik Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci.
English: Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses.
Croatian: Za gentamicin je poznato da može biti ototoksičan ako se primjenjuje sustavno u velikim dozama.
English: Its spectrum of activity includes Gram-positive and Gram-negative bacteria, such as the following pathogenic organisms isolated from the ears of dogs: Staphylococcus intermedius, Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli, etc.
Croatian: Njegov spektar djelovanja uključuje G+ i G- bakterije, kao što su uzročnici izolirani kod upale vanjskog slušnog kanala u pasa - Staphylococcus intermedius, Pseudomonas aeruginosa, Proteus mirabilis, Escherichia coli, itd.
English: Papules were observed uncommonly (less than 1% of treated dogs).
Croatian: Pojava ograničenog crvenila (papula) primijećena je vrlo rijetko (manje od 1% pasa kod kojih je primijenjen ovaj VMP).
English: No standardised in-vitro susceptibility breakpoints have been defined for miconazole; however, using the method by Diagnostics Pasteur, no resistant strains were found.
Croatian: Za mikonazole nije utvrđena standardna granica osjetljivosti in vitro, no primjenom Pasteurove dijagnostičke metode nisu utvrđeni rezistentni sojevi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 1 MULTI-DOSE CONTAINER OF 10 DOSES
Croatian: PODACI NA VANJSKOM PAKOVANJU KUTIJA S 1 VIŠEDOZNIM SPREMNIKOM, S 10 DOZA
English: It is recommended that the external ear canal should be cleaned and dried before treatment and excess hair around the treatment area be cut.
Croatian: Prije primjene treba očistiti i osušiti vanjski slušni kanal, a okolne dlake treba odrezati.
English: Overdose (symptoms, emergency procedures, antidotes):
Croatian: 4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno
English: After application of the veterinary medicinal product into the ear canal, absorption of miconazole and gentamicin through the skin is negligible.
Croatian: Nakon primjene ovog VMP u vanjski slušni kanal, apsorpcija mikonazola i gentamicina kroz kožu je zanemariva.
English: Single-dose container: Shelf life of the veterinary medicinal product as packaged for sale: 18 months.
Croatian: Jednodozni spremnik Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci.
English: The veterinary medicinal product should be used at room temperature (i.e. do not instil cold product).
Croatian: Ovaj VMP treba biti sobne temperature prije primjene (npr. ne primjenjivati hladan VMP).
English: Do not use this veterinary medicinal product after the expiry date, which is stated on the label.
Croatian: Ne koristiti nakon isteka roka valjanosti koji je otisnut na etiketi.
English: However, serum cortisol response levels post ACTH stimulation remained in the normal range during the extended treatment period, indicating a preserved adrenal function.
Croatian: Ipak, nivo kortizola u serumu kao odgovor na stimulaciju ACTH ostao je normalan tijekom produljene primjene ovog VMP što ukazuje na očuvanu funkciju nadbubrežne žlijezde.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA OTPUŠTANJE PROIZVODNE SERIJE, AKO JE RAZLIČITO
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Croatian: Neškodljivost ovog VMP tijekom graviditeta i laktacije nije utvrđivana.
English: Gentamicin as sulphate
Croatian: Gentamicin (u obliku sulfata)
English: INDICATION(S) METHOD AND ROUTE(S) OF ADMINISTRATION For auricular use only.
Croatian: INDIKACIJA(E) NAČIN I PUT(EVI) PRIMJENE Samo za uho.
English: 1 dose x 100 1 dose x 200
Croatian: 1 doza x 5 pipeta 1 doza x 10 pipeta 1 doza x 50 pipeta 1 doza x 100 pipeta 1 doza x 200 pipeta
English: Single-dose container:
Croatian: Jednodozni spremnik:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE Veterinarsko-medicinski proizvod se izdaje na veterinarski recept
English: Compatibility with ear cleaners has not been demonstrated.
Croatian: Kompatibilnost s preparatima za higijenu i čišćenje ušiju nije utvrđivana.
English: In very rare cases, the use of the veterinary medicinal product has been associated with hearing impairment (partial hearing loss or deafness), usually temporary, and primarily in geriatric dogs.
Croatian: U vrlo malo slučajeva (< 0.01%) prilikom primjene ovog VMP primijećena je pojava oštećenja sluha (djelomičan gubitak sluha ili gluhoća), uglavnom privremeno i najčešće kod starih pasa.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY ANDUSE
Croatian: UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
English: Mechanisms of resistance to azoles consist of either failure in antifungal accumulation or modification of target enzyme.
Croatian: Rezistencija na azole nastaje zbog izostanka nakupljanja antigljivičnih tvari ili zbog modifikacije ciljanog enzima.
English: Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis.
Croatian: Mikonazol inhibira sintezu ergosterola koji je važan dio stanične opne kvasaca i gljivica, uključujući i Malassezia pachydermatis.
English: After application, the base of the ear may be massaged briefly and gently to allow the preparation to penetrate to the lower part of the ear canal.
Croatian: Nakon primjene potrebno je nakratko i nježno masirati bazu uha kako bi omogućili ovom VMP da uđe i u dublje dijelove vanjskog slušnog kanala.
English: Do not use in cases of hypersensitivity to the active substances or to any of the excipients, to corticosteroids, to other azole antifungal agents and to other aminoglycosides.
Croatian: Ne primjenjivati u slučajevima preosjetljivosti na bilo koju od djelatnih tvari, bilo koju pomoćnu tvari, na kortikosteroide, na ostale azolne antigljivične preparate i na ostale aminoglikozide.
English: The bacterial resistance phenotypes to gentamicin are mainly based on three mechanisms: enzymatic modification of aminoglycosides, failure of intracellular penetration of the active substance and alteration of the aminoglycoside target.
Croatian: Fenotip bakterijske otpornosti na gentamicin uglavnom se svodi na tri glavna oblika, a to su: enzimska modifikacija aminoglukozida, nemogućnost prodora djelatne tvari u stanicu i promjena ciljnog mjesta za aminoglikozide.
English: Mild to moderate redness of the ear was common (2.4% of treated dogs).
Croatian: Umjereno do srednje jako crvenilo uha je relativno često (2,4% pasa kod kojih je primijenjen ovaj VMP).
English: Hydrocortisone aceponate belongs to the diesters' class of glucocorticosteroids.
Croatian: Hidrokortizon aceponat spada u diesterske glukokortikoide.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs Hydrocortisone aceponate - Miconazole - Gentamicin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Easotic kapi za uho suspenzija za pse Hidrokortizon aceponat - mikonazol - gentamicin
English: One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1,505 IU gentamicin (as sulphate).
Croatian: 1 mL ovog VMP sadržava 1,11 mg hidrokortizon aceponata, 15,1 mg mikonazola (u obliku nirata) i 1505 IJ gentamicina (u obliku sulfata).
English: The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic):
Croatian: Ovaj VMP je fiksna kombinacija tri djelatne tvari (kortikosteroida, antigljivičnih preparata i antibiotika):
English: [Multi-dose container:] Shake the bottle thoroughly before first administration and prime the pump by pressing it.
Croatian: Višedozni spremnik : Dobro protresti bočicu prije prve primjene i pritiskanjem napuniti pumpu za aplikaciju.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: KARENCIJA(E) POSEBNA UPOZORENJA, UKOLIKO JE POTREBNO Pročitati uputu o VMP prije primjene.
English: To administer one dose (1 ml) of the product in the affected ear:
Croatian: Za primjenu jedne doze (1 mL) ovog VMP u inficirano uho:
English: Systemic absorption of hydrocortisone aceponate, gentamicin sulphate and miconazole nitrate being negligible, it is unlikely for teratogenic, foetotoxic or maternotoxic effects to occur at the recommended dosage in dogs.
Croatian: Sustavna apsorpcija hidrokortizon aceponata, gentamicin sulfata i mikonazol nitrata je zanemariva i malo je vjerojatno da bi ove djelatne tvari imale teratogeni, fetotoksični ili maternotoksični učinak, ukoliko se primjenjuju preporučene doze ovog VMP.
English: In case of accidental skin contact, it is recommended to wash thoroughly with water.
Croatian: U slučaju nehotičnog dodira ovog VMP s kožom preporuča se odmah isprati većom količinom vode.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20/11/2008.
Croatian: Datum prvog odobrenja: 20.11.2008
English: Multi-dose container:
Croatian: Višedozni spremnik: