FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: Cellulose, microcrystalline Lactose monohydrate Magnesium stearate Sodium starch glycolate
Croatian: Mikrokristalinična celuloza Laktoza monohidrat Magnezijev stearat Natrijev škrobni glikolat
English: 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.
Croatian: 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.
English: 1BANNEX II
Croatian: 1BDODATAK II
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Please see dosing table below for the number of tablets required to achieve the recommended dose.
Croatian: Molimo pročitajte priloženu tablicu doziranja koja pokazuje potreban broj tableta kako bi se postigla preporučena doza.
English: The requirement for longterm maintenance therapy should be based on an individual benefit-risk assessment by the responsible veterinarian.
Croatian: Uvjeti za dugotrajno potporno liječenje bi trebali biti temeljeni na individualnoj procjeni odnosa koristi/rizika od strane odgovornog veterinara.
English: Pack sizes of 20, 50 or 100 tablets.
Croatian: Kutija sadrži 20, 50 ili 100 tableta.
English: The dosing table below shows the number of tablets required.
Croatian: Tablica doziranja pokazuje potreban broj tableta.
English: Adverse reactions observed in pruritus study up to day 7
Croatian: Nuspojave uočene u studiji pruritusa/svrbeža do 7. dana
English: Shelf life of the veterinary medicinal product as packaged for sale in bottles: 18 months.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju u bočicama: 18 mjeseci.
English: The requirement for long-term maintenance therapy should be based on an individual benefit-risk assessment.
Croatian: Uvjeti za dugotrajno potporno liječenje bi trebali biti temeljeni na individualnoj procjeni odnosa koristi/rizika.
English: Apoquel tablets are supplied in either blister packs or bottles with 20, 50 or 100 tablets per pack.
Croatian: Apoquel tablete su dostupne u blisteru ili u bočici sa 20, 50 ili 100 tableta u pakiranju.
English: Shelf life of the veterinary medicinal product as packaged for sale in blisters: 2 years.
Croatian: Rok valjanosti veterinarsko-medicinskog proizvoda kad je zapakiran za prodaju u blisterima: 2 godine.
English: The development of papillomas was noted in a number of dogs in a laboratory study.
Croatian: Razvoj papiloma uočen je kod brojnih pasa u laboratorijskim ispitivanjima.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA BLISTERIMA ILI TRAKAMA
English: Following intravenous and oral administration, the terminal t1/2s were similar at 3.5 and 4.1 hours respectively.
Croatian: Nakon intravenske i peroralne aplikacije, završna poluvremena eliminacije (t1/2) su bila vrlo slična, 3,5
English: 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.
Croatian: 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.
English: 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
Croatian: NUSPOJAVE Najčešće nuspojave uočene do 16. dana terenskog ispitivanja navedene su u sljedećoj tablici: Nuspojave uočene u studiji atopijskog dermatitisa do 16. dana
English: Dogs
Croatian: Psi.
English: 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.
Croatian: Međutim, nalaz studije je pokazao smanjeni serološki odgovor nakon cijepljenja sa CPI i RV kod štenaca tretiranih oclacitinibom u usporedbi sa kontrolnom grupom.
English: 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.
Croatian: 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.
English: Oclacitinib modulates the immune system and may increase susceptibility to infection and exacerbate neoplastic conditions.
Croatian: Oklacitinib utječe na imunološki sustav i može povećati osjetljivost prema infekcijama i pogoršati neoplastična stanja.
English: 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.
Croatian: 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.
English: Pharmacotherapeutic group: Agents for dermatitis, excluding corticosteroids.
Croatian: Farmakoterapijska grupa: Ostali dermatološki pripravci, agensi za dermatitise osim kortikosteroida.
English: Treatment of clinical manifestations of atopic dermatitis in dogs.
Croatian: Liječenje kliničkih znakova atopijskog dermatitisa kod pasa.
English: 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.
Croatian: 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.
English: Treatment of pruritus associated with allergic dermatitis in dogs.
Croatian: Liječenje svrbeža povezanog s alergijskim dermatitisom kod pasa.
English: Any remaining half tablets should be discarded after 3 days.
Croatian: Svaku prepolovljenu tabletu treba baciti nakon 3 dana.
English: 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).
Croatian: Svaku preostalu polovicu tablete treba vratiti u već otvoreni blister i čuvati u originalnoj kartonskoj kutiji ili HDPE bočici (za maksimalno 3 dana).
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Croatian: Pažljivo nadgledajte psa nakon primjene kako biste se uvjerili da je progutao sve tablete.
English: 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.
Croatian: 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.
English: Overall the major clearance route is metabolism, with minor contributions from renal and biliary elimination.
Croatian: Ukupno gledajući glavni put izlučivanja je metabolizam, uz manji značaj izlučivanja putem bubrega i žuči.
English: The tablets are breakable along the score line.
Croatian: Tablete se mogu prelomiti po razdjelnoj liniji.
English: Papilloma was considered treatment related, but not dose related.
Croatian: Smatra se da su papilomi vezani uz liječenje, ali ne i uz dozu.
English: The clinical relevance of these observed effects for animals vaccinated while being administered oclacitinib (in accordance with the recommended dosing regimen) is unclear.
Croatian: Klinički značaj navedenih učinaka kod životinja koje su cijepljene dok su bile tretirane oclacitinibom (sukladno sa propisanim količinama koje se primjenjuju) je nejasan.
English: 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.
Croatian: 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.
English: Oclacitinib is metabolised in the dog to multiple metabolites.
Croatian: Oklacitinib se kod pasa metabolizira u više metabolita.
English: 16 mg oclacitinib (as oclacitinib maleate) For the full list of excipients, see section 6.1.
Croatian: 16 mg oklacitiniba (u obliku oklacitinib maleata) Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: Lymphadenopathy of peripheral nodes was noted in all groups, increasing in frequency with increasing dose, and was frequently associated with interdigital furunculosis.
Croatian: Limfadenopatija perifernih čvorova je uočena u svim grupama, učestalost se povećava sa povećanjem doze, i često je povezana s interdigitalnim furunkulozama.
English: 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.
Croatian: 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.
English: 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.
Croatian: Kao potporna terapija (nakon prvih 14 dana terapije), ista doza (0,4 do 0,6 mg oklacitiniba/kg tjelesne težine) se primjenjuje jednom dnevno.
English: 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.
Croatian: Sve jačine tableta su pakirane u aluminijske/PVC/Aclar blistere (svaka traka sadrži 10 filmom obloženih tableta).
English: Film-coated tablets
Croatian: OBLIK Filmom obložena tableta
English: 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.
Croatian: 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.
English: polydipsia, lymphadenopathy, nausea, increased appetite and aggression have been observed commonly.
Croatian: pododermatitis, lipom, polidipsija, limfadenopatija, mučnina, pojačani apetit i agresija.
English: 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.
Croatian: 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.
English: Each film-coated tablet contains 3.6 mg, 5.4 mg or 16 mg oclacitinib (as oclacitinib maleate).
Croatian: Svaka filmom obložena tableta sadrži 3,6 mg, 5,4 mg ili 16 mg oklacitiniba u obliku oklacitinib maleata.
English: Any remaining half tablet should be stored in the bottle and discarded if not used within 3 days.
Croatian: Svaku preostalu polovicu tablete treba vratiti u bocu i baciti ako se ne iskoristi unutar 3 dana.
English: 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.
Croatian: 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.
English: 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)
Croatian: 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)
English: No accumulation was observed in the blood of dogs treated for 6 months with oclacitinib.
Croatian: Nije uočeno nakupljanje u krvi pasa nakon šestomjesečnog davanja oklacitiniba.
English: The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Croatian: Preporučena početna doza je 0,4 do 0,6 mg oklacitiniba/kg tjelesne težine, primijenjena peroralno, dva puta dnevno kroz najviše 14 dana.
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: - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja).
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
Croatian: U slučaju da se nehotice proguta, odmah potražiti pomoć liječnika i pokazati mu uputu o VMP ili etiketu.
English: Apoquel 16 mg tablets for dogs.
Croatian: Apoquel 16 mg tablete za pse.
English: Dosage and treatment schedule:
Croatian: Doziranje i raspored primjene:
English: After day 16, the following adverse reactions have been observed: - pyoderma and non-specified dermal lumps have been observed very commonly; - otitis, vomiting, diarrhoea, histiocytoma, cystitis, yeast skin infections, pododermatitis, lipoma,
Croatian: Nakon 16. dana, uočene su sljedeće nuspojave: - vrlo često su primijećene pioderma i nespecifične kožne kvržice, - često su primijećeni otitis, histiocitom, cistitis, kožne infekcije uzrokovane kvascima,
English: Lack or loss of appetite (Anorexia)
Croatian: Povraćanje Pomanjkanje ili gubitak apetita (Anoreksija) Novonastale kutane ili subkutane kvržice Slabost (Letargija) Pojačana žeđ (Polidipsija)
English: The recommended initial dose of Apoquel tablets to be given to the dog is to achieve 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Croatian: Preporučena početna doza Apoquel tableta koje se daju psu da bi se postigla 0,4 do 0,6 mg oklacitiniba/kg tjelesne težine, primijenjena peroralno, je dva puta dnevno kroz najviše 14 dana.
English: 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/2/13/154/013 (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/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg)
Croatian: 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/2/13/154/013 (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/2/13/154/016 (20 tableta, 16 mg) EU/2/13/154/017 (50 tableta, 16 mg) EU/2/13/154/018 (100 tableta, 16 mg)
English: Apoquel (n=152)
Croatian: (n=152)
English: 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/2/13/154/003 (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/2/13/154/005 (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)
Croatian: 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/2/13/154/003 (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/2/13/154/005 (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)
English: No drug interactions were observed in field studies where oclacitinib was administered concomitantly with veterinary medicinal products such as endo- and ectoparasiticides, antimicrobials and antiinflammatories.
Croatian: U terenskim ispitivanjima nisu uočene interakcije kada je oklacitinib primjenjivan usporedno sa drugim VMP, kao što su endo- ili ektoparazitici, antibiotici i protuupalni veterinarsko-medicinski proizvodi.
English: ANNEX I 0BSUMMARY OF PRODUCT CHARACTERISTICS
Croatian: 0BSAŽETAK OPISA SVOJSTAVA
English: For maintenance therapy, the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day.
Croatian: Kao potporna terapija, ista doza (0,4 do 0,6 mg oklacitiniba/kg tjelesne težine) se primjenjuje jednom dnevno.
English: oclacitinib
Croatian: oklacitinib
English: Apoquel (n=216)
Croatian: (n=216)
English: Any remaining half tablet should be stored in the blister and discarded if not used within 3 days.
Croatian: Svaku preostalu polovicu tablete treba vratiti u blister i baciti ako se ne iskoristi unutar 3 dana.
English: Apoquel 3.6 mg tablets for dogs.
Croatian: Apoquel 3,6 mg tablete za pse.
English: The prandial state of the dog does not significantly affect the rate or extent of its absorption.
Croatian: Uzimanje na tašte ili nakon obroka nema značajan učinak na brzinu i stupanj resorpcije.
English: Apoquel 5.4 mg tablets for dogs.
Croatian: Apoquel 5,4 mg tablete za pse.
English: Strength and number of tablets to be administered: Apoquel 3.6 mg tablets Apoquel 5.4 mg tablets Apoquel 16 mg tablets
Croatian: Jačina i broj tableta koje se primjenjuju: Apoquel 3.6 mg tablete Apoquel 5.4 mg tablete Apoquel 16 mg tablete
English: When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying causes (e.g., flea allergic dermatitis, contact dermatitis, food hypersensitivity).
Croatian: Kada se oclacitinibom liječi svrbež povezan sa alergijskim dermatitisom treba ispitati i tretirati osnovni uzrok svrbeža (npr. alergijski dermatitis uzrokovan buhama, kontaktni dermatitis, preosjetljivost na hranu).
English: Dermatitis lesions were mostly secondary to the development of interdigital furunculosis on one or more feet during the study, with the number and frequency of observations increasing with increasing dose.
Croatian: Za vrijeme provođenja studije uočeno je da su lezije uzrokovane dermatitisom uglavnom sekundarne pri stvaranju interdigitalnih furunkuloza na jednom ili više ekstremiteta, s time da se broj i učestalost lezija povećava sa povećavanjem doze.
English: 20 tablets 50 tablets 100 tablets
Croatian: 100 tableta
English: New cutaneous or subcutaneous lumps Lethargy
Croatian: Povraćanje Anoreksija Novonastale kutane ili supkutane kvržice Letargija
English: 16 mg oclacitinib per tablet (as oclacitinib maleate).
Croatian: 16 mg oklacitiniba po tableti (u obliku oklacitinib maleata).
English: 3.6 mg oclacitinib (as oclacitinib maleate)
Croatian: 3,6 mg oklacitiniba (u obliku oklacitinib maleata)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON for Blister
Croatian: KARTONSKA KUTIJA za blister
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE LABEL for Bottle
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU
English: 5.4 mg oclacitinib (as oclacitinib maleate)
Croatian: 5,4 mg oklacitiniba (u obliku oklacitinib maleata)
English: 5.4 mg oclacitinib per tablet (as oclacitinib maleate).
Croatian: 5,4 mg oklacitiniba po tableti (u obliku oklacitinib maleata).
English: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs oclacitinib
Croatian: Apoquel 3,6 mg filmom obložena tableta za pse Apoquel 5,4 mg filmom obložena tableta za pse Apoquel 16 mg filmom obložena tableta za pse oklacitinib
English: PACKAGE LEAFLET: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs
Croatian: UPUTA O VMP: Apoquel 3,6 mg filmom obložena tableta za pse Apoquel 5,4 mg filmom obložena tableta za pse Apoquel 16 mg filmom obložena tableta za pse
English: Diarrhoea
Croatian: FARMACEUTSKI
English: Vomiting
Croatian: Proljev
English: Name and address of the manufacturers responsible for batch release
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE U PROMET Naziv i adresa proizvođača odgovornogih za puštanje serije u promet Pfizer Italia S.R.L.
English: Blister (PVC/PVDC) 63 (3 x 21) tablets
Croatian: 20 mg filmom obložena tableta kroz usta blister (PVC/PVDC) 63 (3 x 21) tablete