natgillin/translations-raw huggingface dataset:
Orfadin also provides a better outcome for patients than that reported in the literature in patients eating a modified diet alone. 
Orfadin također rezultira boljim ishodima za bolesnika u odnosu na one prijavljene u literaturi u slučaju bolesnika koji su jeli samo prilagođenu prehranu.
However, as tyrosine remains in the body during Orfadin treatment, patients need to eat a special diet low in tyrosine. 
No, budući da tirozin ostaje u tijelu tijekom terapije Orfadinom, bolesnici trebaju primjenjivati posebnu prehranu koja je siromašna tirozinom.
This is a summary of the European public assessment report (EPAR) for Orfadin. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Orfadin.
What is the risk associated with Orfadin? 
Koji su rizici povezani s lijekom Orfadin?
The study looked at the effect of Orfadin on survival, and compared this with reports published in medical journals describing survival in patients with HT-1 who were only receiving a modified diet. 
Ovo je ispitivanje istražilo djelovanje lijeka Orfadin na preživljenje i usporedilo je to s izvještajima objavljenima u medicinskim časopisima koji opisuju preživljenje u bolesnika s HT-1 koji su primali samo prilagođenu prehranu.
The full EPAR for Orfadin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Orfadin nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Many of these side effects can be the result of high tyrosine levels caused by patients not eating the right foods. 
Mnoge od navedenih nuspojava mogu rezultirati visokim koncentracijama tirozina što može biti rezultat nepravilne prehrane bolesnika.
The diet also needs to be low in phenylalanine, as this is converted into tyrosine in the body. 
Prehrana također treba biti siromašna fenilalaninom, budući da se isti pretvara u tirozin u tijelu.
Treatment with Orfadin should be started and monitored by doctors who have experience in the treatment of patients with HT-1. 
Liječenje lijekom Orfadin mora započeti i nadzirati liječnik iskusan u liječenju bolesnika s HT-1.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Orfadin, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju tog plana u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Orfadin nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
For more information about treatment with Orfadin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o terapiji lijekom Mekinist pročitajte u uputama o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
Therefore, the CHMP decided that Orfadin's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je odlučio da koristi od lijeka Orfadin nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Orfadin is a medicine that contains the active substance nitisinone. 
Orfadin je lijek koji sadrži djelatnu tvar nitizinon.
Why has Orfadin been approved? 
Zašto je lijek Orfadin odobren?
Orfadin is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine. 
Orfadin se koristi zajedno s prehranom koja ograničava unos amino kiselina naziva tirozin i fenilalanin.
What benefit has Orfadin shown during the studies? 
Koje su koristi lijeka Orfadin dokazane u ispitivanjima?
The active substance in Orfadin, nitisinone, blocks an enzyme that converts tyrosine into harmful substances. 
Djelatna tvar lijeka Orfadin, nitizinon, inhibira enzim koji pretvara tirozin u štetne tvari.
What is Orfadin? 
Što je Orfadin?
Tyrosine is broken down in the body by a number of enzymes. 
Niz enzima razgrađuju tirozin u tijelu.
For the full list of all side effects and restrictions with Orfadin, see the package leaflet. 
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Orfadin potražite u uputi o lijeku.
What is Orfadin used for? 
Za što se Orfadin koristi?
How does Orfadin work? 
Kako djeluje Orfadin?
How is Orfadin used? 
Kako se Orfadin koristi?
How has Orfadin been studied? 
Kako je Orfadin ispitivan?
Date of first authorisation: 12/09/2013. 
Datum prvog odobrenja: 12/09/2013.
ATC vet code: QD11AH90. 
ATCvet kod: QD11AH90.
Date of last renewal: 26/07/2018. 
Datum posljednjeg produljenja: 26/07/2018.
These tablets can be administered with or without food. 
Ove tablete se mogu primijeniti sa ili bez hrane.
Wash hands after administration. 
Operite ruke nakon primjene.
The tablets can be divided into equal halves. 
Tablete se mogu razdijeliti u jednake polovine.
Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALY 
Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALIJA
Neither of these clinical pathology changes appeared clinically significant. 
Niti jedna od ovih kliničkih patoloških promjena nema klinički značaj.
Anaemia and lymphoma have been reported very rarely in spontaneous reports. 
Anemija i limfom zabilježeni su vrlo rijetko u spontanim izvješćima.
Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 (E1521) 
Laktoza monohidrat Hipromeloza (E464) Titanijev dioksid (E171) Makrogol 400 (E1521)
The absolute bioavailability of oclacitinib maleate was 89%. 
Apsolutna bioraspoloživost oklacitinib maleata je bila 89%.
One major oxidative metabolite was identified in plasma and urine. 
Jedan od glavnih oksidativnih metabolita je identificiran u plazmi i u mokraći.
Dogs receiving Apoquel tablets should therefore be monitored for the development of infections and neoplasia. 
Pse koji primaju Apoquel tablete treba promatrati zbog razvoja infekcija i neoplazija.
Do not use in dogs less than 12 months of age or less than 3 kg bodyweight. 
Ne primjenjivati kod pasa mlađih od 12 mjeseci ili lakših od 3 kg.
It can inhibit the function of a variety of cytokines dependent on JAK enzyme activity. 
Može inhibirati funkciju raznih citokina ovisno o aktivnosti JAK enzima.
Oclacitinib is a Janus kinase (JAK) inhibitor. 
Oklacitinib je inhibitor Janus kinaze (JAK).
Regarding susceptibility to infection and neoplastic conditions, see section 4.5. 
Informacije vezane uz podložnost prema infekcijama i neoplastičnim stanjima vidi u odjeljku 4.5.
Therefore, the risk of metabolic drug-drug interactions due to oclacitinib inhibition is very low. 
Zbog toga je rizik metaboličke interakcije lijeka sa lijekom radi inhibicije oklacitiniba vrlo nizak.
For oclacitinib, the target cytokines are those that are proinflammatory or have a role in allergic responses/pruritis. 
Za oclacitinib, ciljni citokini su oni koji su proinflamatorni ili imaju ulogu u alergijskoj reakciji/pruritusu.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation, or in breeding male dogs, therefore its use is not recommended during pregnancy, lactation or in dogs intended for breeding. 
Neškodljivost veterinarsko-medicinskog proizvoda nije utvrđena za vrijeme graviditeta i laktacije, ili kod muških rasplodnih pasa, stoga nije preporučena primjena za vrijeme graviditeta i laktacije, ili kod muških rasplodnih pasa.
There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically. 
Ne postoji specifični antidot u slučajevima predoziranja, pse treba liječiti simptomatski.
However, oclacitinib may also exert effects on other cytokines (for example, those involved in host defence or haematopoiesis) with the potential for unwanted effects. 
Međutim, oklacitinib može proširiti učinke na druge citokine (npr. onih vezanih za obranu domaćina ili hematopoezu) uz potencijalnu mogućnost neželjenih učinaka.
Do not use this veterinary medicinal product after the expiry date which is stated on the blister or bottle after EXP. 
Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na blisteru ili bočici poslije EXP.
Following oral administration in dogs, oclacitinib maleate is rapidly and well absorbed, with a time to peak plasma concentration (tmax) of less than 1 hour. 
Nakon peroralne primjene u pasa, oklacitinib maleat se vrlo brzo i dobro resorbira, s vremenom postizanja najviše koncentracije u plazmi (tmax) manje od jednog sata.
Cellulose, microcrystalline Lactose monohydrate Magnesium stearate Sodium starch glycolate 
Mikrokristalinična celuloza Laktoza monohidrat Magnezijev stearat Natrijev škrobni glikolat
White to off-white, oblong shaped film-coated tablets with a score-line on both sides and marked with the letters "AQ" and "S", "M" or "L" on both sides. 
Bijela do prljavo bijela, duguljasta filmom obložena tableta sa razdjelnom linijom na obje strane te označena slovima „AQ“ i „S“, „M“ ili „L“ na obje strane.
1BANNEX II 
1BDODATAK II
Treatment-related clinical pathology changes were restricted to an increase in mean serum cholesterol and a decrease in mean leukocyte count, however, all mean values remained within the laboratory reference range. 
Kliničke patološke promjene vezane uz liječenje ograničene su na povećanje srednjih vrijednosti kolesterola u serumu i smanjenje broja leukocita, iako su sve srednje vrijednosti bile unutar laboratorijskog referentnog raspona.
Oclacitinib exhibits low protein binding with 66.3% to 69.7% bound in fortified canine plasma at nominal concentrations ranging from 10 to 1,000 ng/ml. 
Oklacitinib pokazuje slabo vezanje za proteine, 66,3% do 69,7% vezanja u pojačanoj plazmi pasa kod nominalne koncentracije u rasponu od 10 do 1000 ng/ml.
Please see dosing table below for the number of tablets required to achieve the recommended dose. 
Molimo pročitajte priloženu tablicu doziranja koja pokazuje potreban broj tableta kako bi se postigla preporučena doza.
The requirement for longterm maintenance therapy should be based on an individual benefit-risk assessment by the responsible veterinarian. 
Uvjeti za dugotrajno potporno liječenje bi trebali biti temeljeni na individualnoj procjeni odnosa koristi/rizika od strane odgovornog veterinara.
Pack sizes of 20, 50 or 100 tablets. 
Kutija sadrži 20, 50 ili 100 tableta.
The dosing table below shows the number of tablets required. 
Tablica doziranja pokazuje potreban broj tableta.
Adverse reactions observed in pruritus study up to day 7 
Nuspojave uočene u studiji pruritusa/svrbeža do 7. dana
Shelf life of the veterinary medicinal product as packaged for sale in bottles: 18 months. 
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju u bočicama: 18 mjeseci.
The requirement for long-term maintenance therapy should be based on an individual benefit-risk assessment. 
Uvjeti za dugotrajno potporno liječenje bi trebali biti temeljeni na individualnoj procjeni odnosa koristi/rizika.
Apoquel tablets are supplied in either blister packs or bottles with 20, 50 or 100 tablets per pack. 
Apoquel tablete su dostupne u blisteru ili u bočici sa 20, 50 ili 100 tableta u pakiranju.
Shelf life of the veterinary medicinal product as packaged for sale in blisters: 2 years. 
Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju u blisterima: 2 godine.
The development of papillomas was noted in a number of dogs in a laboratory study. 
Razvoj papiloma uočen je kod brojnih pasa u laboratorijskim ispitivanjima.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA
Following intravenous and oral administration, the terminal t1/2s were similar at 3.5 and 4.1 hours respectively. 
Nakon intravenske i peroralne aplikacije, završna poluvremena eliminacije (t1/2) su bila vrlo slična, 3,5
The letters "S", "M" and "L" refer to the different strengths of tablets: "S" is on the 3.6 mg tablets, "M" on the 5.4 mg tablets, and "L" on the 16 mg tablets. 
Slova „S“, „M“ i „L“ označavaju različite jačine tablete: „S“ na tabletama od 3,6 mg, „M“ na tabletama od 5,4 mg i „L“ na tabletama od 16 mg.
The common adverse reactions seen up to day 16 of the field trials are listed in the following table: Adverse reactions observed in atopic dermatitis study up to day 16 
NUSPOJAVE Najčešće nuspojave uočene do 16. dana terenskog ispitivanja navedene su u sljedećoj tablici: Nuspojave uočene u studiji atopijskog dermatitisa do 16. dana
Dogs 
Psi.
However, the findings of this study indicated a reduction in serological response to vaccination with CPI and RV in puppies being treated with oclacitinib compared to untreated controls. 
Međutim, nalaz studije je pokazao smanjeni serološki odgovor nakon cijepljenja sa CPI i RV kod štenaca tretiranih oclacitinibom u usporedbi sa kontrolnom grupom.
The decrease in mean leukocyte count observed in oclacitinib-treated dogs was not progressive, and affected all white blood cell counts (neutrophil, eosinophil and monocyte counts) except lymphocyte counts. 
Smanjenje broja leukocita uočeno kod pasa tretiranih oclacitinibom nije bilo progresivno i utjecalo je na broj svih bijelih krvnih tjelešaca (broj neutrofila, eozinofila i monocita), osim broja limfocita.
Oclacitinib modulates the immune system and may increase susceptibility to infection and exacerbate neoplastic conditions. 
Oklacitinib utječe na imunološki sustav i može povećati osjetljivost prema infekcijama i pogoršati neoplastična stanja.
Inhibition of canine cytochrome P450s is minimal with IC50s 50-fold greater than the observed mean Cmax (333 ng/ml or 0.997 µM) following 0.6 mg/kg bw oral administration in the target animal safety study. 
Inhibicija psećeg citokroma P450 je minimalna kod IC50 50 puta veće nego kod praćene srednje Cmax (333 ng/ml ili 0,997 µM) nakon peroralnog davanja doze od 0,6 mg/kg tjelesne težine tijekom studije neškodljivosti kod ciljnih vrsta životinja.
Pharmacotherapeutic group: Agents for dermatitis, excluding corticosteroids. 
Farmakoterapijska grupa: Ostali dermatološki pripravci, agensi za dermatitise osim kortikosteroida.
Treatment of clinical manifestations of atopic dermatitis in dogs. 
Liječenje kliničkih znakova atopijskog dermatitisa kod pasa.
Oclacitinib tablets were administered to healthy, one year old Beagle dogs twice daily for 6 weeks, followed by once per day for 20 weeks, at 0.6 mg/kg bw, 1.8 mg/kg bw and 3.0 mg/kg bw for a total of 26 weeks. 
Oklacitinib tablete su primjenjivane zdravom psu pasmine bigl, starom godinu dana, dva puta dnevno kroz 6 tjedana, nakon toga jednom dnevno kroz 20 tjedana, u dozi od 0,6 mg/kg tjelesne težine, 1,8 mg/kg tjelesne težine i 3,0 mg/kg tjelesne težine ukupno 26 tjedana.
Treatment of pruritus associated with allergic dermatitis in dogs. 
Liječenje svrbeža povezanog s alergijskim dermatitisom kod pasa.
Any remaining half tablets should be discarded after 3 days. 
Svaku prepolovljenu tabletu treba baciti nakon 3 dana.
Any remaining half tablet should be placed back in the opened blister and stored in the original cardboard carton, or in the HDPE bottle (for a maximum of 3 days). 
Svaku preostalu polovicu tablete treba vratiti u već otvoreni blister i čuvati u originalnoj kartonskoj kutiji ili HDPE bočici (za maksimalno 3 dana).
Total body oclacitinib clearance from plasma was low - 316 ml/h/kg bodyweight (5.3 ml/min/kg bodyweight), and the apparent volume of distribution at steady-state was 942 ml/kg bodyweight. 
Potpuno izlučivanje oklacitiniba iz plazme je sporo - 316 ml/h/kg tjelesne težine (5,3 ml/minuta/kg tjelesne težine), i vidljivi volumen distribucije u stanju mirovanja je bio 942 ml/kg tjelesne težine.
Furthermore, in cases of allergic dermatitis and atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange). 
Nadalje, kod slučajeva alergijskog i atopijskog dermatitisa, preporučeno je ispitati i tretirati otežavajuće čimbenike, kao što su bakterijske, gljivične ili parazitarne infekcije/infestacije (npr. buhe i šugarci).
Dogs should be carefully observed following administration to ensure that each tablet is swallowed. 
Pažljivo nadgledajte psa nakon primjene kako biste se uvjerili da je progutao sve tablete.
An adequate immune response (serology) to CDV and CPV vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg bodyweight (bw) twice daily for 84 days. 
Zadovoljavajući imunološki odgovor (serološki) na CDV i CPV je postignut kada je oklacitinib primijenjen u dozi od 1,8 mg/kg tjelesne težine dva puta dnevno kroz 84 dana.
Overall the major clearance route is metabolism, with minor contributions from renal and biliary elimination. 
Ukupno gledajući glavni put izlučivanja je metabolizam, uz manji značaj izlučivanja putem bubrega i žuči.
The tablets are breakable along the score line. 
Tablete se mogu prelomiti po razdjelnoj liniji.
Papilloma was considered treatment related, but not dose related. 
Smatra se da su papilomi vezani uz liječenje, ali ne i uz dozu.
The clinical relevance of these observed effects for animals vaccinated while being administered oclacitinib (in accordance with the recommended dosing regimen) is unclear. 
Klinički značaj navedenih učinaka kod životinja koje su cijepljene dok su bile tretirane oclacitinibom (sukladno sa propisanim količinama koje se primjenjuju) je nejasan.
Given the potential for effects on certain clinicopathological parameters (see section 4.6), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment. 
Zbog potencijalnih učinaka na neke kliničko patološke parametre (vidi odjeljak 4.6), preporučeno je praćenje cjelokupne krvne slike i biokemije seruma kod pasa koji su podvrgnuti dugotrajnom liječenju.
Oclacitinib is metabolised in the dog to multiple metabolites. 
Oklacitinib se kod pasa metabolizira u više metabolita.
16 mg oclacitinib (as oclacitinib maleate) For the full list of excipients, see section 6.1. 
16 mg oklacitiniba (u obliku oklacitinib maleata) Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
Lymphadenopathy of peripheral nodes was noted in all groups, increasing in frequency with increasing dose, and was frequently associated with interdigital furunculosis. 
Limfadenopatija perifernih čvorova je uočena u svim grupama, učestalost se povećava sa povećanjem doze, i često je povezana s interdigitalnim furunkulozama.
Given the potential for effects on certain clinicopathological parameters (see section 6), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment. 
Zbog potencijalnih učinaka na neke kliničko patološke parametre (vidi odjeljak 6), preporučeno je praćenje cjelokupne krvne slike i biokemije seruma kod pasa koji su podvrgnuti dugotrajnom liječenju.
For maintenance therapy (after the initial 14 days of treatment), the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day. 
Kao potporna terapija (nakon prvih 14 dana terapije), ista doza (0,4 do 0,6 mg oklacitiniba/kg tjelesne težine) se primjenjuje jednom dnevno.
All tablets strengths are packaged in either aluminium/PVC/Aclar blisters (each strip containing 10 film-coated tablets) packed into an outer cardboard box, or white HDPE plastic bottle with child resistant closure. 
Sve jačine tableta su pakirane u aluminijske/PVC/Aclar blistere (svaka traka sadrži 10 filmom obloženih tableta).
Film-coated tablets 
OBLIK Filmom obložena tableta
Do not use in dogs with evidence of immune suppression, such as hyperadrenocorticism, or with evidence of progressive malignant neoplasia as the active substance has not been evaluated in these cases. 
Ne primjenjivati kod pasa s potvrđenom imunosupresijom, kao što je hiperadrenokorticizam ili kod pasa sa potvrđenom progresivnom malignom neoplazijom stoga što djelatna tvar nije procijenjena u takvim slučajevima.
polydipsia, lymphadenopathy, nausea, increased appetite and aggression have been observed commonly. 
pododermatitis, lipom, polidipsija, limfadenopatija, mučnina, pojačani apetit i agresija.
The impact of oclacitinib administration on vaccination with modified live vaccines, canine parvovirus (CPV), canine distemper virus (CDV) and canine parainfluenza (CPI) and inactivated rabies vaccine (RV), on 16 week old vaccine naïve puppies has been studied. 
Učinak primjene oklacitiniba na cijepljenje s modificiranim živim cjepivima, parvovirusom pasa (CPV), virusom štenećaka (CDV) i parainfluencom pasa (CPI) i s inaktiviranim cjepivom bjesnoće (RV), kod 16 tjedana starih štenaca (nikad prije liječenih) je praćen u studiji.
Each film-coated tablet contains 3.6 mg, 5.4 mg or 16 mg oclacitinib (as oclacitinib maleate). 
Svaka filmom obložena tableta sadrži 3,6 mg, 5,4 mg ili 16 mg oklacitiniba u obliku oklacitinib maleata.
Any remaining half tablet should be stored in the bottle and discarded if not used within 3 days. 
Svaku preostalu polovicu tablete treba vratiti u bocu i baciti ako se ne iskoristi unutar 3 dana.
Clinical observations that were considered likely to be related to oclacitinib treatment included: alopecia (local), papilloma, dermatitis, erythema, abrasions and scabbing/crusts, interdigital "cysts", and oedema of the feet. 
Klinička opažanja za koja se smatra da su povezana sa terapijom oclacitinibom uključuju: alopecije (lokalne), papilome, dermatitis, eriteme, abrazije i kraste, interdigitalne „ciste“ i edeme ekstremiteta.
EU/2/13/154/001 (1 x 20 tablets, 3.6 mg) EU/2/13/154/007 (1 x 50 tablets, 3.6 mg) EU/2/13/154/002 (1 x 100 tablets, 3.6 mg) EU/2/13/154/010 (20 tablets, 3.6 mg) EU/2/13/154/011 (50 tablets, 3.6 mg) EU/2/13/154/012 (100 tablets, 3.6 mg) EU/2/13/154/003 (1 x 20 tablets, 5.4 mg) EU/2/13/154/008 (1 x 50 tablets, 5.4 mg) EU/2/13/154/004 (1 x 100 tablets, 5.4 mg) EU/2/13/154/013 (20 tablets, 5.4 mg) EU/2/13/154/014 (50 tablets, 5.4 mg) EU/2/13/154/015 (100 tablets, 5.4 mg) EU/2/13/154/005 (1 x 20 tablets, 16 mg) EU/2/13/154/009 (1 x 50 tablets, 16 mg) EU/2/13/154/006 (1 x 100 tablets, 16 mg) EU/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg) 
EU/2/13/154/001 (1 x 20 tableta, 3,6 mg) EU/2/13/154/007 (1 x 50 tableta, 3,6 mg) EU/2/13/154/002 (1 x 100 tableta, 3,6 mg) EU/2/13/154/010 (20 tableta, 3,6 mg) EU/2/13/154/011 (50 tableta, 3,6 mg) EU/2/13/154/012 (100 tableta, 3,6 mg) EU/2/13/154/003 (1 x 20 tableta, 5,4 mg) EU/2/13/154/008 (1 x 50 tableta, 5,4 mg) EU/2/13/154/004 (1 x 100 tableta, 5,4 mg) EU/2/13/154/013 (20 tableta, 5,4 mg) EU/2/13/154/014 (50 tableta, 5,4 mg) EU/2/13/154/015 (100 tableta, 5,4 mg) EU/2/13/154/005 (1 x 20 tableta, 16 mg) EU/2/13/154/009 (1 x 50 tableta, 16 mg) EU/2/13/154/006 (1 x 100 tableta, 16 mg) EU/2/13/154/016 (20 tableta, 16 mg) EU/2/13/154/017 (50 tableta, 16 mg) EU/2/13/154/018 (100 tableta, 16 mg)
No accumulation was observed in the blood of dogs treated for 6 months with oclacitinib. 
Nije uočeno nakupljanje u krvi pasa nakon šestomjesečnog davanja oklacitiniba.
The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days. 
Preporučena početna doza je 0,4 do 0,6 mg oklacitiniba/kg tjelesne težine, primijenjena peroralno, dva puta dnevno kroz najviše 14 dana.
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). 
- rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja).
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. 
U slučaju da se nehotice proguta, odmah potražiti pomoć liječnika i pokazati mu uputu o VMP ili etiketu.
Apoquel 16 mg tablets for dogs. 
Apoquel 16 mg tablete za pse.