FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: V študiji so proučevali učinek zdravila Orfadin na preživetje in izsledke primerjali s poročili, objavljenimi v medicinskih revijah, o preživetju bolnikov z dedno tirozinemijo tipa 1, ki so se zdravili samo s prilagojeno dieto.
English: Treatment with Orfadin should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
Slovenian: Zdravljenje z zdravilom Orfadin mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z dedno tirozinemijo tipa 1.
English: The full EPAR for Orfadin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Orfadin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Orfadin was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of the approval.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v izjemnih okoliščinah, saj so bile zaradi redkosti bolezni ob izdaji dovoljenja na voljo le omejene informacije.
English: Orfadin is a medicine that contains the active substance nitisinone.
Slovenian: Orfadin je zdravilo, ki vsebuje zdravilno učinkovino nitizinon.
English: The active substance in Orfadin, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Slovenian: Zdravilna učinkovina v zdravilu Orfadin, nitizinon, zavira encim, ki pretvarja tirozin v škodljive snovi.
English: Orfadin is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Slovenian: Zdravilo Orfadin se uporablja skupaj z dieto, ki omejuje vnos aminokislin tirozin in fenilalanin.
English: Why has Orfadin been approved?
Slovenian: Zakaj je bilo zdravilo Orfadin odobreno?
English: The diet also needs to be low in phenylalanine, as this is converted into tyrosine in the body.
Slovenian: Dieta mora vsebovati tudi čim manj fenilalanina, saj se ta v telesu pretvarja v tirozin.
English: Orfadin also provides a better outcome for patients than that reported in the literature in patients eating a modified diet alone.
Slovenian: Pri bolnikih, ki so jemali zdravilo Orfadin, so bili doseženi boljši rezultati kot pri osebah, ki so se zdravile zgolj s prilagojeno dieto, o katerih poroča literatura.
English: How has Orfadin been studied?
Slovenian: Kako je bilo zdravilo Orfadin raziskano?
English: What is Orfadin used for?
Slovenian: Za kaj se zdravilo Orfadin uporablja?
English: How does Orfadin work?
Slovenian: Kako zdravilo Orfadin deluje?
English: How is Orfadin used?
Slovenian: Kako se zdravilo Orfadin uporablja?
English: What is Orfadin?
Slovenian: Kaj je zdravilo Orfadin?
English: Neither of these clinical pathology changes appeared clinically significant.
Slovenian: Nobena od teh patoloških sprememb ni bila klinično pomembna.
English: Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALY
Slovenian: Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALIJA
English: Date of last renewal: 26/07/2018.
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet: 26/07/2018.
English: These tablets can be administered with or without food.
Slovenian: Te tablete se lahko daje s hrano ali brez nje.
English: Regarding susceptibility to infection and neoplastic conditions, see section 4.5.
Slovenian: Glede dovzetnosti za okužbe in neoplastična stanja, glejte poglavje 4.5.
English: The absolute bioavailability of oclacitinib maleate was 89%.
Slovenian: Absolutna biološka razpoložljivost oklacitinibijevega maleata je bila 89 %.
English: One major oxidative metabolite was identified in plasma and urine.
Slovenian: Glavni oksidativni presnovek so ugotovili v plazmi in urinu.
English: The tablets can be divided into equal halves.
Slovenian: Tablete se lahko delijo na enaki polovici.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo, alimislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
English: Do not use in dogs less than 12 months of age or less than 3 kg bodyweight.
Slovenian: Ne uporabite pri psih, mlajših od 12 mesecev ali pri psih, lažjih od 3 kg.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 (E1521)
Slovenian: Obloga tablete: laktoza monohidrat hipromeloza (E464) titanov dioksid (E171) makrogol 4000 (E1521)
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimizahtevami.
English: Adverse reactions observed in pruritus study up to day 7
Slovenian: Neželene reakcije, ki so jih opazili v študiji s pruritusom do dneva 7
English: 1BANNEX II
Slovenian: 1BPRILOGA II
English: The prandial state of the dog does not significantly affect the rate or extent of its absorption.
Slovenian: Jemanje s hrano ni bistveno vplivalo na stopnjo in obseg absorpcije.
English: Dogs receiving Apoquel tablets should therefore be monitored for the development of infections and neoplasia.
Slovenian: Zato je pse, ki prejemajo tablete Apoquel, potrebno spremljati glede pojava okužb in neoplazij.
English: Oclacitinib is a Janus kinase (JAK) inhibitor.
Slovenian: Oklacitinib je inhibitor Janusove kinaze (JAK).
English: polydipsia, lymphadenopathy, nausea, increased appetite and aggression have been observed commonly.
Slovenian: polidipsija, limfadenopatija, nauzea, povečan apetit in agresija so bili opaženi pogosto.
English: The dosing table below shows the number of tablets required.
Slovenian: Spodnja tabela o odmerjanju kaže število potrebnih tablet.
English: 20 tablets 50 tablets 100 tablets
Slovenian: 20 tablet 50 tablet 100 tablet
English: Oclacitinib modulates the immune system and may increase susceptibility to infection and exacerbate neoplastic conditions.
Slovenian: Oklacitinib modulira imunski sistem in lahko poveča dovzetnost za okužbe ter poslabša neoplastične bolezni.
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.
Slovenian: Vse jakosti tablet so pakirane ali v pretisne omote iz aluminija/PVC/aclar (vsak trak vsebuje 10 filmsko obloženih tablet), ki so pakirani v kartonske škatle ali pa v bele HDPE plastične steklenice z za otroke varno zaporko.
English: Lymphadenopathy of peripheral nodes was noted in all groups, increasing in frequency with increasing dose, and was frequently associated with interdigital furunculosis.
Slovenian: Limfadenopatijo perifernih bezgavk so ugotovili v vseh skupinah, pogostost je naraščala s povečanjem odmerka, pogosto je bila povezana z interdigitalno furunkulozo.
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.
Slovenian: Z zdravljenjem povezane klinično-patološke spremembe, so bile omejene na povečanje srednje vrednosti serumskega holesterola in zmanjšanje povprečnega števila levkocitov, vendar so vse srednje vrednosti ostale znotraj referenčnih vrednosti.
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.
Slovenian: Po peroralni uporabi pri psih se oklacitinibijev maleat hitro in dobro absorbira in doseže maksimalno plazemsko koncentracijo (tmax) v manj kot eni uri.
English: However, oclacitinib may also exert effects on other cytokines (for example, those involved in host defence or haematopoiesis) with the potential for unwanted effects.
Slovenian: Lahko pa oklacitinib delovanje razširi tudi na druge citokine (npr. tiste, ki so vključeni v obrambno reakcijo ali hematopoezo) pri čemer obstaja možnost neželenih učinkov.
English: Pack sizes of 20, 50 or 100 tablets.
Slovenian: Velikost pakiranja je 20, 50 ali 100 tablet.
English: Any remaining half tablets should be discarded after 3 days.
Slovenian: Morebitne polovice tablet je treba zavreči po 3 dneh.
English: The requirement for long-term maintenance therapy should be based on an individual benefit-risk assessment.
Slovenian: Odločitev za dolgotrajno zdravljenje mora temeljiti na individualni presoji koristi/tveganja.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the blister or bottle after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na pretisnem omotu ali steklenici po {EXP}.
English: The requirement for longterm maintenance therapy should be based on an individual benefit-risk assessment by the responsible veterinarian.
Slovenian: Odločitev za dolgotrajno zdravljenje mora temeljiti na individualni presoji koristi/tveganja odgovornega veterinarja.
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).
Slovenian: Polovice prelomljenih tablet vložite nazaj ali v odprt pretisni omot in shranite v originalno kartonsko škatlo ali pa v HDPE steklenico (za največ tri dni).
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.
Slovenian: So pa rezultati študije pokazali zmanjšan serološki odgovor na cepljenja proti CPI in RV pri zdravljenih mladičih v primerjavi z nezdravljenimi.
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.
Slovenian: Bele do sivkaste podolgovate filmsko obložene tablete z razdelilno zarezo na obeh straneh in črkovnimi oznakami "AQ" in "S", "M" oziroma "L" na obeh straneh.
English: It can inhibit the function of a variety of cytokines dependent on JAK enzyme activity.
Slovenian: Inhibira delovanje številnih citokinov, ki so odvisni od aktivnosti JAK encima.
English: Shelf life of the veterinary medicinal product as packaged for sale in bottles: 18 months.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo v steklenicah: 18 mesecev.
English: Apoquel tablets are supplied in either blister packs or bottles with 20, 50 or 100 tablets per pack.
Slovenian: Tablete Apoquel so na voljo ali v pretisnih omotih ali pa v steklenicah po 20, 50 ali 100 tablet.
English: The clinical relevance of these observed effects for animals vaccinated while being administered oclacitinib (in accordance with the recommended dosing regimen) is unclear.
Slovenian: Klinični pomen teh ugotovitev za cepljenje živali med prejemanjem oklacitiniba (v ustreznem odmerku) ni jasen.
English: Papilloma was considered treatment related, but not dose related.
Slovenian: Papilom naj bi bil povezan z zdravljenjem, vendar ne odvisen od odmerka.
English: Anaemia and lymphoma have been reported very rarely in spontaneous reports.
Slovenian: V spontanih poročilih so zelo redko poročali o anemiji in limfomu.
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.
Slovenian: Dodan plazmi se oklacitinib se slabo veže na beljakovine v plazmi psa - 66,3 % do 69,7 %, pri razponu nominalnih koncentracij 10 do 1000 ng/ml.
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.
Slovenian: Črke "S", "M" in "L" označujejo različne jakosti tablet: "S" je na 3,6-mg tabletah, "M" na 5,4-mg tabletah in "L" na 16-mg tabletah.
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.
Slovenian: Dermatitisne lezije so bile najverjetneje posledica interdigitalne furunkuloze na eni ali več nogah v času trajanja študije; število in pogostost je naraščala s povečanjem odmerka.
English: Therefore, the risk of metabolic drug-drug interactions due to oclacitinib inhibition is very low.
Slovenian: Tveganje za presnovne interakcije med zdravili zaradi oklacitiniba je zelo majhno.
English: Cellulose, microcrystalline Lactose monohydrate Magnesium stearate Sodium starch glycolate
Slovenian: Jedro tablete: celuloza, mikrokristalna laktoza monohidrat magnezijev stearat natrijev karboksimetilškrob
English: Treatment of clinical manifestations of atopic dermatitis in dogs.
Slovenian: Zdravljenje kliničnih oblik atopičnega dermatitisa pri psih.
English: Following intravenous and oral administration, the terminal t1/2s were similar at 3.5 and 4.1 hours respectively.
Slovenian: Končna razpolovna časa (t1/2) po intravenski in peroralni uporabi sta bila podobna, 3,5 ur po intravenski in 4,1 ure po peroralni uporabi.
English: Date of first authorisation: 12/09/2013.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 12/09/2013.
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.
Slovenian: Skupni telesni očistek oklacitiniba iz plazme je bil nizek - 316 ml/h/kg telesne mase (5,3 ml/min/kg telesne mase) in volumen porazdelitve v stanju dinamičnega ravnotežja je znašal 942 ml/kg telesne mase.
English: Dosage and treatment schedule:
Slovenian: Odmerjanje in načrt zdravljenja:
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.
Slovenian: Zmanjšanje števila leukocitov, ki so ga opazili pri psih, zdravljenih z oklacitinibom, ni bilo progresivno, zajelo je vse vrste belih krvnih celic (število neutrofilcev, eozinofilcev, monocitov).
English: There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically.
Slovenian: V primeru prevelikega odmerjanja je potrebno psa zdraviti simptomatsko.
English: Shelf life of the veterinary medicinal product as packaged for sale in blisters: 2 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo v pretisnih omotih: 2 leti.
English: The development of papillomas was noted in a number of dogs in a laboratory study.
Slovenian: Pri številnih psih, ki so prejeli zdravljenje v priporočenem odmerku, so v laboratorijski študiji opazili razvoj papilomov.
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.
Slovenian: Klinične ugotovitve, ki so verjetno povezane z oklacitinibom, vključujejo: alopecijo (lokalno), papilom, dermatitis, eritem, abrazije in kraste, »ciste« med prsti in edem stopal.
English: Each film-coated tablet contains 3.6 mg, 5.4 mg or 16 mg oclacitinib (as oclacitinib maleate).
Slovenian: Ena filmsko obložena tableta vsebuje 3,6 mg, 5,4 mg ali 16 mg oklacitiniba (kot oklacitinibijevega maleata).
English: Treatment of pruritus associated with allergic dermatitis in dogs.
Slovenian: Zdravljenje pruritusa v povezavi z alergijskim dermatitisom pri psih.
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.
Slovenian: Glede na možnost vpliva na nekatere klinično-patološke parametre (glejte poglavje 4.6) priporočamo, da pri psih, ki prejemajo dolgotrajno zdravljenje, izvajate redne preglede celotne krvne slike in serumske biokemije.
English: Lack or loss of appetite (Anorexia)
Slovenian: Pomanjkanje ali izguba apetita (anoreksija) Pojav novih kožnih ali podkožnih vozličev
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,
Slovenian: Po dnevu 16 so se pojavili sledeči neželeni učinki: - pioderma in nespecifični kožni vozliči so bili opaženi zelo pogosto, - otitis, bruhanje, driska, histiocitom, cistitis, okužbe kože s kvasovkami, pododermatitis, lipom,
English: Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Po dajanju zdravila pozorno opazujte psa, da se prepričate, da je pogoltnil (vsako) tableto.
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).
Slovenian: V primeru alergijskega in atopičnega dermatitisa pa priporočamo, da preučite in zdravite tudi dejavnike, ki zapletajo bolezen kot so bakterijske, glivične ali parazitarne okužbe/invazije (npr. bolhe in garje).
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.
Slovenian: Glede na možnost vpliva na nekatere klinično-patološke parametre (glejte poglavje 6) priporočamo, da pri psih, ki prejemajo dolgotrajno zdravljenje, izvajate redne preglede celotne krvne slike in serumske biokemije.
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.
Slovenian: Ne uporabite pri psih z dokazano imunosupresijo, npr. z hiperadrenokorticizmom ali z dokazano progresivno maligno neoplazijo.
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.
Slovenian: je bila v študiji varnosti pri živalih IC50 50-krat večja kot opazovana srednja Cmax (333 ng/ml ali 0,997 µM).
English: Film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA filmsko obložene tablete
English: Overall the major clearance route is metabolism, with minor contributions from renal and biliary elimination.
Slovenian: Glavna pot izločanja je presnova, v manjšem obsegu se izloči preko ledvic in z žolčem.
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.
Slovenian: Za vzdrževanje zdravljenja (po prvih 14 dnevih zdravljenja) dajemo enak odmerek (0,4 mg do 0,6 mg oklacitiniba/kg telesne mase) enkrat dnevno.
English: Please see dosing table below for the number of tablets required to achieve the recommended dose.
Slovenian: Spodnja tabela o odmerjanju kaže število potrebnih tablet za ustrezni odmerek.
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.
Slovenian: V preskušanjih na terenu niso opazili medsebojnega delovanja pri sočasni uporabi oklacitiniba in drugih zdravil za uporabo v veterinarski medicini, kot recimo zdravil proti endo- in ektoparazitom, protimikrobnih ter protivnetnih zdravil.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON for Blister
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA za pretisni omot
English: For oclacitinib, the target cytokines are those that are proinflammatory or have a role in allergic responses/pruritis.
Slovenian: Ciljni citokini oklacitiniba so provnetni oziroma tisti, ki so vključeni v alergični odgovor/pruritus.
English: Do not use in cases of hypersensitivity to oclacitinib or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na oclacitinib ali na katero koli pomožno snov.
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.
Slovenian: Pri predhodno necepljenih mladičih, starih 16 tednov, so preučili vpliv oklacitiniba na cepljenje z modificiranimi živimi cepivi, pasjim parvovirusom (CPV), virusom pasje kuge (CDV) in, virusom pasje parainfluence (CPI) ter inaktiviranim cepivom proti steklini (RV).
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)
Slovenian: EU/2/13/154/001 (1 x 20 tablet, 3,6 mg) EU/2/13/154/007 (1 x 50 tablet, 3,6 mg) EU/2/13/154/002 (1 x 100 tablet, 3,6 mg) EU/2/13/154/010 (20 tablet, 3.6 mg) EU/2/13/154/011 (50 tablet, 3.6 mg) EU/2/13/154/012 (100 tablet, 3.6 mg) EU/2/13/154/003 (1 x 20 tablet, 5,4 mg) EU/2/13/154/008 (1 x 50 tablet, 5,4 mg) EU/2/13/154/004 (1 x 100 tablet, 5,4 mg) EU/2/13/154/013 (20 tablet, 5.4 mg) EU/2/13/154/014 (50 tablet, 5.4 mg) EU/2/13/154/015 (100 tablet, 5.4 mg) EU/2/13/154/005 (1 x 20 tablet, 16 mg) EU/2/13/154/009 (1 x 50 tablet, 16 mg) EU/2/13/154/006 (1 x 100 tablet, 16 mg) EU/2/13/154/016 (20 tablet, 16 mg) EU/2/13/154/017 (50 tablet, 16 mg) EU/2/13/154/018 (100 tablet, 16 mg)
English: ATC vet code: QD11AH90.
Slovenian: Farmakoterapevtska skupina: Učinkovine za zdravljenje dermatitisa, razen kortikosteroidov Oznaka ATC vet: QD11AH90.
English: Tablet coating:
Slovenian: Ena filmsko obložena tableta vsebuje:
English: Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na oclacitinibali na katero koli pomožno snov.
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
Slovenian: Neželene reakcije, ki so jih opazili v študiji z atopičnim dermatitisom do dneva 16
English: The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Slovenian: Priporočen začetni odmerek je 0,4 mg do 0,6 mg oklacitiniba/kg telesne mase, peroralno, dvakrat dnevno do 14 dni.
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.
Slovenian: Priporočen začetni odmerek tablet Apoquel za psa je 0,4 mg do 0,6 mg oklacitiniba/kg telesne mase, ki ga dajemo peroralno dvakrat dnevno do 14 dni.