natgillin/translations-raw huggingface dataset:
↔ Elbasvir AUC 1.09 (0.98, 1.21) Cmax 1.11 (0.99, 1.26) C24 0.96 (0.86, 1.08) 
AUC 1,09 (0,98; 1,21) Cmax 1,11 (0,99; 1,26) C24 0,96 (0,86; 1,08)
Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose) 
ANTIASTMATICI Montelukast (10 mg u jednokratnoj dozi)/grazoprevir (200 mg u jednokratnoj dozi)
Rifampicin (600 mg IV single dose)/ elbasvir (50 mg single dose) 
LIJEKOVI Rifampicin (600 mg u jednokratnoj i.v. dozi)/elbasvir (50 mg u jednokratnoj dozi)
(combination of OATP1B and CYP3A inhibition) 
(kombinacija inhibicije OATP1B i CYP3A)
↔ Elbasvir AUC 1.05 (0.92, 1.18) Cmax 1.11 (0.98, 1.26) C24 1.03 (0.91, 1.17) 
AUC 1,05 (0,92; 1,18) Cmax 1,11 (0,98; 1,26) C24 1,03 (0,91; 1,17)
(300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily) 
(300 mg jedanput na dan)/elbasvir (50 mg jedanput na dan)/grazoprevir (100 mg jedanput na dan)
Subjects without baseline NS5A polymorphisms, % (n/N) 
Ispitanici bez polimorfizama NS5A na početku ispitivanja, % (n/N)
Subjects without baseline NS3 polymorphisms, % (n/N) 
Ispitanici bez polimorfizama NS3 na početku ispitivanja, % (n/N)
(OATP1B inhibition and CYP3A induction) 
(inhibicija OATP1B i indukcija CYP3A)
↔ Elbasvir AUC 1.13 (0.94, 1.37) Cmax 1.07 (0.88, 1.29) C24 1.22 (1.02, 1.45) 
AUC 1,13 (0,94; 1,37) Cmax 1,07 (0,88; 1,29) C24 1,22 (1,02; 1,45)
↔ Elbasvir AUC 0.93 (0.82, 1.05) Cmax 0.88 (0.77, 1.00) C24 0.92 (0.18, 1.05) 
AUC 0,93 (0,82; 1,05) Cmax 0,88 (0,77; 1,00) C24 0,92 (0,18; 1,05)
↔ Elbasvir AUC 1.05 (0.93, 1.18) Cmax 1.02 (0.92, 1.14) C24 1.03 (0.92, 1.17) 
AUC 1,05 (0,93; 1,18) Cmax 1,02 (0,92; 1,14) C24 1,03 (0,92; 1,17)
(10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily) 
(10 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER. 
Pri istodobnoj primjeni s lijekom ZEPATIER, doza atorvastatina ne smije biti viša od dnevne doze od 20 mg.
Subjects were not excluded or discontinued from the trial based on a positive urine drug screen. 
Pozitivan nalaz pretrage mokraće na drogu nije bio razlog za neuključivanje ispitanika u ispitivanje ili isključivanje iz njega.
↔ Elbasvir AUC 0.97 (0.90, 1.06) Cmax 0.99 (0.88, 1.10) C24 0.92 (0.83, 1.02) 
AUC 0,97 (0,90; 1,06) Cmax 0,99 (0,88; 1,10) C24 0,92 (0,83; 1,02)
Subjects with baseline NS5A polymorphisms, % (n/N) 
Ispitanici s polimorfizmima NS5A na početku ispitivanja, % (n/N)
(600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily) 
(600 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 1.17 (0.98, 1.39) Cmax 1.29 (1.06, 1.58) C24 1.21 (1.03, 1.43) 
AUC 1,17 (0,98; 1,39) Cmax 1,29 (1,06; 1,58) C24 1,21 (1,03; 1,43)
(300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily) 
(300 mg jedanput na dan)/ritonavir (100 mg jedanput na dan)/grazoprevir (200mg jedanput na dan)
↔ Elbasvir AUC 1.07 (1.00, 1.15) Cmax 1.07 (0.99, 1.16) C24 1.04 (0.98, 1.11) 
AUC 1,07 (1,00; 1,15) Cmax 1,07 (0,99; 1,16) C24 1,04 (0,98; 1,11)
↔ Elbasvir AUC 0.92 (0.75, 1.14) Cmax 0.86 (0.71, 1.04) C24 0.87 (0.70, 1.09) 
AUC 0,92 (0,75; 1,14) Cmax 0,86 (0,71; 1,04) C24 0,87 (0,70; 1,09)
(300 mg once daily)/ grazoprevir (200 mg once daily) 
(300 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
(400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily) 
(400 mg dvaput na dan)/ritonavir (100 mg dvaput na dan)/grazoprevir (200 mg jedanput na dan)
(400 mg twice daily)/ grazoprevir (200 mg once daily) 
(400 mg dvaput na dan)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 0.81 (0.57, 1.17) Cmax 0.89 (0.61, 1.29) C24 0.80 (0.55, 1.16) 
AUC 0,81 (0,57; 1,17) Cmax 0,89 (0,61; 1,29) C24 0,80 (0,55; 1,16)
• feeling very tired (fatigue) 
• jaki umor (iscrpljenost)
Subjects with baseline NS3 polymorphisms, % (n/N) 
Ispitanici s polimorfizmima NS3 na početku ispitivanja, % (n/N)
(due in part to OATP1B and CYP3A inhibition) 
(dijelom zbog inhibicije OATP1B i CYP3A)
No clinically relevant change in exposure is represented by a horizontal arrow “↔”. 
Vodoravna strelica "↔" znači da nije došlo do klinički značajne promjene izloženosti.
Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily) 
Ciklosporin (400 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
Haemodialysis does not remove elbasvir or grazoprevir. 
Elbasvir i grazoprevir ne mogu se ukloniti hemodijalizom.
Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily) 
Mofetilmikofenolat (1000 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 1.07 (1.00, 1.14) Cmax 1.07 (0.98, 1.16) C24 1.05 (0.97, 1.14) 
AUC 1,07 (1,00; 1,14) Cmax 1,07 (0,98; 1,16) C24 1,05 (0,97; 1,14)
Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily) 
Takrolimus (2 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
↔ Elbasvir AUC 0.98 (0.93, 1.02) Cmax 0.97 (0.89, 1.05) C24 0.97 (0.92, 1.02) 
AUC 0,98 (0,93; 1,02) Cmax 0,97 (0,89; 1,05) C24 0,97 (0,92; 1,02)
Overall prevalence of GT1a-infected subjects with baseline NS5A polymorphisms in the pooled analyses was 
SVR prema prisutnosti polimorfizama NS5A povezanih s rezistencijom na početku ispitivanja Odsutni
Laboratory abnormalities 
Laboratorijske vrijednosti
↔ Elbasvir AUC 0.98 (0.93, 1.04) Cmax 0.97 (0.89, 1.05) C24 0.98 (0.93, 1.03) 
AUC 0,98 (0,93; 1,04) Cmax 0,97 (0,89; 1,05) C24 0,98 (0,93; 1,03)
(600 mg once daily)/ grazoprevir (200 mg once daily) 
(600 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
(600 mg PO single dose)/ grazoprevir (200 mg once daily) 
(600 mg u jednokratnoj peroralnoj dozi)/grazoprevir (200 mg jedanput na dan)
Sodium laurilsulfate Vitamin E polyethylene glycol succinate Copovidone 
Jezgra tablete natrijev laurilsulfat vitamin E polietilenglikolsukcinat kopovidon hipromeloza mikrokristalična celuloza manitol laktoza hidrat umrežena karmelozanatrij natrijev klorid koloidni, bezvodni silicijev dioksid magnezijev stearat
Pravastatin (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily) 
Pravastatin (40 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
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). 
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.
FRI 
Nuspojave
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. 
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,
General disorders and administration site conditions: Very common fatigue 
Opći poremećaji i reakcije na mjestu primjene: vrlo često umor često astenija, iritabilnost
Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily 
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)
Based on pooled data from patients treated with ZEPATIER for 12 weeks without ribavirin ULN: Upper limit of normal according to testing laboratory. 
Na temelju objedinjenih podataka prikupljenih u bolesnika liječenih lijekom ZEPATIER bez ribavirina tijekom 12 tjedana.
Sunitinib 
• mučnina
Calcium acetate (2,668 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose) 
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)
STIMULANTS 
STIMULANSI Modafinil
Prednisone (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily 
Prednizon (40 mg u jednokratnoj dozi)/elbasvir (50 mg jedanput na dan)/grazoprevir (200 mg jedanput na dan)
Avoid contact with eyes. 
Izbjegavati dodir s očima.
• Take out one pipette from the box. 
1 - Izvadite jednu pipetu iz kutije.
Do not use in dogs with generalised demodecosis. 
Ne primjenjivati kod pasa s generaliziranom demodikozom.
Pregnancy and lactation: 
Graviditeta i laktacije:
Not all pack sizes may be marketed. 
Ne moraju sve veličine pakovanja biti u prometu
Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/). 
Detaljne informacije o ovom VMP možete naći na web stranicama Europske agencije za lijekove http://www.ema.europa.eu
(Reference is made to the drawing in section 1) 
(Upute su dane na slici u odjeljku 1)
Date of first renewal: 11/11/2013. 
Datum prvog produljenja odobrenja: 11.11.2013.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements 
Bilo koji neupotrebljeni veterinarsko medicinski proizvod ili otpadni materijal dobiven primjenom tih veterinarsko medicinskih proizvoda mora se odlagati u skladu s lokalnim propisima.
In all cases, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy. 
U svim navedenim slučajevima primjena ovog VMP nije prekinuta, a svi psi su se u potpunosti oporavili bez primjene bilo kakve specifične terapije.
Since many bacterial strains may be involved in otitis externa in dogs, the mechanisms of resistance can vary. 
Pošto mnogo različitih sojeva bakterija može biti uključeno u upalu vanjskog slušnog kanala kod pasa, mehanizmi otpornosti također mogu biti različiti.
Interaction with other medicinal products and other forms of interaction: Compatibility with ear cleaners has not been demonstrated. 
Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija: Kompatibilnost s preparatima za higijenu i čišćenje ušiju nije utvrđivana.
Hydrocortisone aceponate - Miconazole - Gentamicin 
Hidrokortizon aceponat - mikonazol - gentamicin
Hydrocortisone aceponate 
Hidrokortizon aceponat
• To open: hold up the pipette upright and break the top of the cannula. 
3 - Da biste otvorili pipetu: držite pipetu vrhom okrenutu prema gore i slomite vrh kanile.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 5, 10, 50, 100 or 200 PIPETTES 
PODACI NA VANJSKOM PAKOVANJU KUTIJA S 5, 10, 50, 100 ILI 200 PIPETA
Liquid paraffin. 
Tekući parafin.
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. 
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).
Do not use concurrently with substances known to cause ototoxicity. 
Ne primjenjivati zajedno s tvarima za koje je poznato da uzrokuju ototoksičnost.
Incompatibilities: Do not mix with other veterinary medicinal products. 
Inkompatibilnosti: Ne miješati s bilo kojim drugim VMP.
Cardboard box containing 5, 10, 50, 100 or 200 pipettes. 
U kutiji može biti 5, 10, 50, 100 ili 200 pipeta.
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. 
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.
The diesters are transformed inside the skin structures in C17 monoesters responsible for the potency of the therapeutic class. 
Diesteri se u koži transformiraju u C17 monoester koji je odgovoran za snagu djelovanja ove terapeutske skupine VMP.
Use only accordingly to the benefit-risk assessment by the responsible veterinarian. 
Primjenjivati nakon cjelokupne procjene rizika/koristi od strane veterinara.
See section 4.5 of the SPC. 
Vidi dio 4.5 u Sažetku opisa svojstava.
Squeeze gently but firmly in the middle of the body of the pipette. 
Nježno, ali snažno pritisnite pipetu oko sredine.
Miconazole nitrate is a synthetic imidazole derivative with a pronounced antifungal activity. 
Mikonazol nitrat je sintetički derivate imidazola s naglašenom antigljivičnom aktivnosti.
Gentamicin sulphate is an aminoglycoside bactericidal antibiotic which acts by inhibiting protein synthesis. 
Gentamicin sulfat je aminoglikozidni bakterijski antibiotik koji inhibira sintezu proteina.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml (10 doses). 
SADRŽAJ: TEŽINA, VOLUMEN I BROJ DOZA 10 ml (10 doza).
In laboratory animals, hydrocortisone aceponate is eliminated the same way as hydrocortisone (other name for endogenous cortisol) through urine and faeces. 
Kod laboratorijskih životinja hidrokortizon aceponat se izlučuje iz organizma na isti način kao i hidrokortizon (drugo ime za endogene kortizole) - urinom i fecesom.
ROUTE(S) OF ADMINISTRATION (Reference is made to the drawing in section 1) 
PUT(EVI) PRIMJENE (Upute su dane na slici u odjeljku 1)
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only. 
U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo Samo za primjenu na životinjama.
The diesters are lipophilic components ensuring an enhanced penetration into the skin associated with low systemic bioavailability. 
Diesteri su lipolitički dio koji osigurava pojačanu prodornost kroz kožu, a što je povezano s niskom sustavnom biodostupnosti.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 
RIJEČI “ SAMO ZA PRIMJENU NA ŽIVOTINJAMA ” Samo za primjenu na životinjama.
Shelf life after first opening the immediate packaging: 10 days. 
Rok valjanosti poslije prvog otvaranja unutarnjeg pakovanja: 10 dana.
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. 
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.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products 
6.6 Posebne mjere predostrožnosti za odlaganje neupotrijebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda
In case of parasitic otitis, an appropriate acaricidal treatment should be implemented. 
U slučaju parazitarne upale uha treba primijeniti pravilnu antiparazitarnu terapiju.
Pipette composed of high density polyethylene (body and cannula) containing a steel ball. 
Jednodozni spremnikPipeta od polietilena visoke gustoće (tijelo i kanila) koja sadržava čeličnu kuglicu.
MARKETING AUTHORISATION NUMBER(S) EU/2/08/085/001 
16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/085/001
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. 
U slučaju nehotičnog gutanja ovog VMP odmah zatražiti savjet/pomoć liječnika i pokazati mu “Uputu” ili etiketu.
Shelf life of the veterinary medicinal product as packaged for sale: 18 months. 
Višedozni spremnik Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci.
Gentamicin is known to be associated with ototoxicity when administered by the systemic route at higher doses. 
Za gentamicin je poznato da može biti ototoksičan ako se primjenjuje sustavno u velikim dozama.
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. 
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.
Papules were observed uncommonly (less than 1% of treated dogs). 
Pojava ograničenog crvenila (papula) primijećena je vrlo rijetko (manje od 1% pasa kod kojih je primijenjen ovaj VMP).
No standardised in-vitro susceptibility breakpoints have been defined for miconazole; however, using the method by Diagnostics Pasteur, no resistant strains were found. 
Za mikonazole nije utvrđena standardna granica osjetljivosti in vitro, no primjenom Pasteurove dijagnostičke metode nisu utvrđeni rezistentni sojevi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX OF 1 MULTI-DOSE CONTAINER OF 10 DOSES 
PODACI NA VANJSKOM PAKOVANJU KUTIJA S 1 VIŠEDOZNIM SPREMNIKOM, S 10 DOZA
It is recommended that the external ear canal should be cleaned and dried before treatment and excess hair around the treatment area be cut. 
Prije primjene treba očistiti i osušiti vanjski slušni kanal, a okolne dlake treba odrezati.
Overdose (symptoms, emergency procedures, antidotes): 
4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno
After application of the veterinary medicinal product into the ear canal, absorption of miconazole and gentamicin through the skin is negligible. 
Nakon primjene ovog VMP u vanjski slušni kanal, apsorpcija mikonazola i gentamicina kroz kožu je zanemariva.
Single-dose container: Shelf life of the veterinary medicinal product as packaged for sale: 18 months. 
Jednodozni spremnik Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju: 18 mjeseci.
The veterinary medicinal product should be used at room temperature (i.e. do not instil cold product). 
Ovaj VMP treba biti sobne temperature prije primjene (npr. ne primjenjivati hladan VMP).
Do not use this veterinary medicinal product after the expiry date, which is stated on the label. 
Ne koristiti nakon isteka roka valjanosti koji je otisnut na etiketi.
However, serum cortisol response levels post ACTH stimulation remained in the normal range during the extended treatment period, indicating a preserved adrenal function. 
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.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA OTPUŠTANJE PROIZVODNE SERIJE, AKO JE RAZLIČITO
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. 
Neškodljivost ovog VMP tijekom graviditeta i laktacije nije utvrđivana.
Gentamicin as sulphate 
Gentamicin (u obliku sulfata)
INDICATION(S) METHOD AND ROUTE(S) OF ADMINISTRATION For auricular use only. 
INDIKACIJA(E) NAČIN I PUT(EVI) PRIMJENE Samo za uho.
1 dose x 100 1 dose x 200 
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
Single-dose container: 
Jednodozni spremnik:
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. 
UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE Veterinarsko-medicinski proizvod se izdaje na veterinarski recept
Compatibility with ear cleaners has not been demonstrated. 
Kompatibilnost s preparatima za higijenu i čišćenje ušiju nije utvrđivana.
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. 
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.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY ANDUSE 
UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE
Mechanisms of resistance to azoles consist of either failure in antifungal accumulation or modification of target enzyme. 
Rezistencija na azole nastaje zbog izostanka nakupljanja antigljivičnih tvari ili zbog modifikacije ciljanog enzima.
Miconazole selectively inhibits the synthesis of ergosterol, which is an essential component of the membrane of yeasts and fungi including Malassezia pachydermatis. 
Mikonazol inhibira sintezu ergosterola koji je važan dio stanične opne kvasaca i gljivica, uključujući i Malassezia pachydermatis.
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. 
Nakon primjene potrebno je nakratko i nježno masirati bazu uha kako bi omogućili ovom VMP da uđe i u dublje dijelove vanjskog slušnog kanala.
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. 
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.
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. 
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.
Mild to moderate redness of the ear was common (2.4% of treated dogs). 
Umjereno do srednje jako crvenilo uha je relativno često (2,4% pasa kod kojih je primijenjen ovaj VMP).
Hydrocortisone aceponate belongs to the diesters' class of glucocorticosteroids. 
Hidrokortizon aceponat spada u diesterske glukokortikoide.
NAME OF THE VETERINARY MEDICINAL PRODUCT Easotic ear drops, suspension for dogs Hydrocortisone aceponate - Miconazole - Gentamicin 
NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Easotic kapi za uho suspenzija za pse Hidrokortizon aceponat - mikonazol - gentamicin
One ml contains 1.11 mg hydrocortisone aceponate, 15.1 mg miconazole (as nitrate) and 1,505 IU gentamicin (as sulphate). 
1 mL ovog VMP sadržava 1,11 mg hidrokortizon aceponata, 15,1 mg mikonazola (u obliku nirata) i 1505 IJ gentamicina (u obliku sulfata).
The veterinary medicinal product is a fixed combination of three active substances (corticosteroid, antifungal and antibiotic): 
Ovaj VMP je fiksna kombinacija tri djelatne tvari (kortikosteroida, antigljivičnih preparata i antibiotika):