FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no in vivo data on the hepatic metabolism in dogs.
Slovenian: Ni podatkov o in-vivo jetrnem metabolizmu pri psih.
English: The following handling procedures will help to minimise exposure to the active ingredient in Palladia for you and other members of your household:
Slovenian: Sledeči postopek rokovanja z zdravilom Palladia bo pomagal zmanjšati tveganje za izpostavitev zdravilni učinkovini za vas in druge družinske člane v gospodinjstvu:
English: Dose interruptions and dose reductions may be needed depending upon the severity of clinical signs.
Slovenian: Prekinitev odmerjanja ali zmanjšanje odmerkov bo potrebno glede na resnost kliničnih znakov.
English: • Absolute neutrophil count >1500/microlitre
Slovenian: • Absolutno število neutrofilcev >1500/mikroliter
English: The field study comprised a 6-week double-blind placebo controlled phase followed by an un-blinded phase where all dogs received Palladia for a mean duration of 144 days.
Slovenian: Študija je v praksi vključevala 6 tednov dvojno zakrito placebo kontrolirano fazo, ki ji je sledila nezakrita faza, kjer so psi prejemali zdravilo Palladia v trajanju povprečno 144 dni.
English: Special precautions for each target species: For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment.
Slovenian: Posebni previdnostni ukrepi za vsako živalsko vrsto: Pri vsakemu mastocitomu, ki ga je možno operativno zdraviti, naj bo operacija prva izbira zdravljenja.
English: The efficacy and safety of Palladia oral tablets for the treatment of mast cell tumours was evaluated in a randomised, placebo-controlled, double-masked, multicenter clinical field study involving 151 dogs with Patnaik grade II or III, recurrent, cutaneous mast cell tumours with/without local lymph node involvement.
Slovenian: Učinkovitost in varnost oralnih tablet Palladia namenjenih za zdravljenje mastocitomov, sta bili ocenjeni v naključni, placebo kontrolirani, dvojno zakriti, multicentrični klinični študiji v praksi, ki je vključevala 151 psov s ponovljenimi kožnimi mastocitomi II ali III stopnje malignosti po Patnaiku, z/brez zasevkov v lokalnih limfnih vozlih.
English: Dogs in the 6 mg/kg every other day group exhibited the most adverse effects which included decreased food consumption and weight loss.
Slovenian: Psi v skupini s po 6 mg/kg vsak drugi dan so kazali največ neželenih učinkov, ki so vključevali znižano ješčnost in izgubo telesne teže.
English: Palladia may impair male and female fertility and embryo/foetal development.
Slovenian: Palladija lahko škoduje moški in ženski plodnosti in razvoju embrija/fetusa.
English: In one dog, pathology findings revealed vascular thrombosis with disseminated intravascular coagulopathy (DIC) and pancreatitis.
Slovenian: Pri enem psu so patološki izvidi pokazali vaskularno trombozo z diseminirano intravaskularno koagulopatijo (DIC) in pankreatitis.
English: Cardboard carton containing four aluminium-PVC child resistant blister packs, each blister containing 5 film-coated tablets.
Slovenian: Kartonasta škatla vsebuje štirialuminijasta-PVC za otroke varna pretisna omota, vsak pretisni omot vsebuje 5 filmsko obloženih tablet.
English: Concurrent anaemia, azotemia, hypoalbuminemia and hyperphosphatemia Discontinue treatment for 1 to 2 weeks until values have improved and albumin >2.5 g/dl, then decrease dose by 0.5 mg/kg.
Slovenian: Istočasna anemija, azotemija, hipoalbuminemija in hiperfosfatemija Prekinitev zdravljenja za 1 do 2 tedna dokler se vrednosti ne izboljšajo in je albumin >2.5 g/dl, nato zniznižanje odmerka za 0.5 mg/kg.
English: The main target organs of toxicity include the gastrointestinal tract, bone marrow, gonads and musculoskeletal system.
Slovenian: Glavni tarčni organi toksičnosti vključujejo gastrointestinalni trakt, kostni mozeg, žleze in mišično skeletni sistem.
English: This will reduce the risk for children or other household members to accidentally come into contact with Palladia.
Slovenian: S tem boste zmanjšali tveganja, da pridejo v stik z zdravilom Palladia otroci ali drugi člani v gospodinjstvu.
English: Treatment should continue in the case of stable disease, or partial or complete response, provided that the product is sufficiently well tolerated.
Slovenian: Zdravljenje naj se nadaljuje v primeru stabilnosti bolezni, delnega ali popolnega odgovora pod pogojem, da zdravljena žival produkt dobro prenaša.
English: As angiogenesis is a critical component of embryonic and foetal development, inhibition of angiogenesis following administration of Palladia should be expected to result in adverse effects on the pregnancy in the bitch.
Slovenian: Ker je angiogeneza ključni element pri razvoju embrija in fetusa, se lahko pričakuje, da se bo inhibicija angiogeneze, ki sledi dajanju Palladie, odrazila v neželenih učinkih na brejost pri psici.
English: • Three dogs had seizure-like activity; however, relation to treatment could not be established.
Slovenian: • Trije psi so kazali aktivnost podobno seizmičnim krčem toda povezava z zdravljenjem ni bila dokazana.
English: Sporadic dose related lameness, stiffness, weakness and pain in limbs resolved without treatment.
Slovenian: Sporadično šepanje, otrdelost, slabost in bolečina v okončinah je izzvenelo brez zdravljenja.
English: The other dog died following gastric perforation.
Slovenian: Drugi pes je umrl po perforaciji želodca.
English: Toceranib is a small molecule, multi-kinase inhibitor, that has both direct anti-tumour and antiangiogenic activity.
Slovenian: Toceranib je mala molekula, inhibitor multi-kinaze, z direktnim protitumorskim in antiangiogenim delovanjem.
English: Gastrointestinal Bleeding Fresh blood in stool or black tarry stool for >2 days or frank haemorrhage or blood clots in stool
Slovenian: Gastrointestinalne krvavitve Sveža kri v iztrebku ali črn katranast iztrebek > kot 2 dni ali čista krvavitev ali krvni strdki v iztrebku
English: No interaction studies have been performed with toceranib.
Slovenian: Ni študij o medsebojnem delovanju toceraniba.
English: Palladia can cause vascular dysfunction which can lead to oedema and thromboembolism, including pulmonary thromboembolism.
Slovenian: Palladia lahko povzroči žilno disfunkcijo, ki vodi v edem in tromboembolijo, vključno s pljučno tromboembolijo.
English: Toceranib induces cell cycle arrest and subsequent apoptosis in tumour cell lines expressing activating mutations in the split kinase RTK, c-Kit.
Slovenian: Toceranib inducira zastoj celičnega ciklusa in posledično apoptozo v linijah tumorskih celic z izraženo aktivirano mutacijo split kinazi RTK, c-Kit.
English: Following oral administration of toceranib phosphate, approximately 92% of the administered drug is excreted in faeces with another 7% excreted in urine.
Slovenian: Po oralnem dajanju se okoli 92% toceranibovega fosfata izloči z iztrebki, ostalih 7% se izloči z urinom.
English: Treatment should be permanently discontinued if severe adverse events recur or persist despite appropriate supportive care and dose reduction as described in the following table.
Slovenian: Zdravljenje je potrebno trajno prekiniti, če se resni neželeni učinki ponovno pojavijo ali vztrajajo ne glede na pravilno podporno terapijo in znižanju odmerka kot je opisano v sledeči tabeli.
English: In case of adverse events following overdose, treatment should be discontinued until resolution and then resumed at the recommended therapeutic dose level.
Slovenian: V primeru neželenih učinkov zaradi prekomernega odmerjanja naj se zdravljenje prekine do izboljšanja in nato nadaljuje s priporočeno višino terapevtskega odmerka.
English: • Two dogs developed epistaxis that was not associated with thrombocytopenia.
Slovenian: • Dva psa sta razvila epistakso, ki ni bila povezana s trombocitopenijo.
English: Palladia 10 mg: blue Palladia 15 mg: orange Palladia 50 mg: red
Slovenian: Palladia 10 mg: modra Palladia 15 mg: oranžna Palladia 50 mg: rdeča
English: C. STATEMENT OF THE MRLs Not applicable.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL) Ni smiselno.
English: Anaemia and neutropaenia and eosinopaenia were doserelated.
Slovenian: Pojav anemije in neutropenije ter eozinopenije je bil odvisen od odmerka.
English: Treatment should be reviewed weekly for the first six weeks and every six weeks thereafter or at intervals deemed appropriate by the veterinarian.
Slovenian: Zdravljenje je potrebno preverjati tedensko prvih šest tednov, nato vsakih šest tednov ali v intervalih po presoji veterinarja.
English: Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Slovenian: Po odmerjanju psa pazljivo opazujte, da zagotovite zaužitje vsake tablete.
English: The following adverse events were uncommon (more than 1 but less than 10 animals in 1,000 treated):
Slovenian: Sledeči neželeni učinki so bili redki (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) :
English: * The number of tablets required for dogs below 5.0 kg or above 63 kg bodyweight, should be calculated based on the 3.25 mg/kg dosage regime.
Slovenian: * število zahtevanih tablet za psa pod 5.0 kg ali nad 63 kg telesne teže, se izračuna na osnovi 3.25 mg/kg sistema odmerjanja.
English: >4 watery stools/day or ≥2 days
Slovenian: >4 vodeni iztrebki/dan ali ≥ 2 dni
English: Toceranib exerts an antiproliferative effect on endothelial cells in-vitro.
Slovenian: Toceranib kaže anti proliferativen učinek na endotelne celice v in vitro.
English: PHARMACEUTICAL FORM Film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA Filmsko obložene tablete.
English: Film-coated tablets.
Slovenian: Filmsko obložene tablete.
English: • Platelet count >75,000/microlitre
Slovenian: • Število trombocitov > 75,000/mikroliter
English: Toceranib selectively inhibits the tyrosine kinase activity of several members of the split kinase receptor tyrosine kinase (RTK) family some of which are implicated in tumour growth, pathologic angiogenesis, and metastatic progression of cancer.
Slovenian: Toceranib selektivno inhibira tirozin kinazno aktivnost številnih split kinaza receptorev družine tirozin kinaze (RTK), med katerimi so nekateri vpleteni v rast tumorja, patološko angiogenezo in pojava metastaz.
English: Neutropenia (neutrophil count) >1000/ul
Slovenian: Nevtropenija (število neutrofilcev) >1000/µl
English: Results from the clinical field study involving 151 treated and placebo-treated dogs showed that the clinical signs of the disease (mast cell tumour) and treatment related adverse reactions are very similar in nature.
Slovenian: Rezultati kliničnih študij v praksi, ki so vključevale 151 zdravljenih in placebo zdravljenih psov, so pokazali, da so si klinični znaki bolezni (mastocitoma) in neželeni učinki povezani z zdravljenjem po naravi zelo podobni.
English: • Severe circulatory shock
Slovenian: • resen cirkulatorni šok
English: • Bilirubin <1.25 X upper normal limit
Slovenian: • Bilirubin <1.25 X nad zgornjo mejo
English: In the case of accidental ingestion, seek medical advice immediately and show Package Leaflet or label to the physician.
Slovenian: V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
English: To manage adverse reactions, the dose may be reduced to 2.75 mg/kg bodyweight or further to 2.25 mg/kg bodyweight administered every second day or treatment can be discontinued for up to two weeks (see Dose Adjustment table in section 4.5).
Slovenian: Za obvladovanje neželenih učinkov se lahko odmerek zniža na 2.75 mg/kg telesne teže ali nadalje do 2.25 mg/kg telesne teže vsak drugi dan ali se zdravljenje lahko prekine do dveh tednov (glejte tabelo s pogoji prilagajanja odmerka v poglavju 4.5).
English: • Severe lameness/musculoskeletal disorder.
Slovenian: • Močno šepanje/mišično skeletne motnje
English: Toceranib is metabolised in the liver and in the absence of any studies on the effects of renal or hepatic impairment, should be used with caution in dogs suffering from hepatic disease.
Slovenian: Toceranib se metabolizira v jetrih in ker ni nobenih študij učinkovanja pri poslabšanem delovanju ledvic ali jeter, se pri psih z obolenji jeter uporablja previdno.
English: In rare cases, serious and sometimes fatal gastrointestinal complications including gastrointestinal perforation occurred in dogs treated with Palladia (See section 4.6).
Slovenian: V redkih primerih so se pri psih zdravljenih z zdravilom Palladia pojavili resni ali včasih smrtni gastrointestinalni zapleti, ki so vključevali gastointestinalno perforacijo (glej poglavje 4.6).
English: Pregnant women should not routinely administer Palladia, should avoid contact with faeces, urine and vomit from treated dogs and broken or moistened Palladia tablets.
Slovenian: Zdravila Palladia naj nosečnice ne dajejo rutinsko, naj se izogibajo stiku z iztrebki, urinom in izbruhani vsebini zdravljenih psov ter zlomljenim ali navlaženim tabletam Palladia.
English: Two dogs (6 mg/kg) were euthanised at approximately 3 weeks for treatment-related clinical toxicities initiated by decreased feed intake and melena culminating in anorexia, weight loss and hematochezia.
Slovenian: Dva psa (6 mg/kg) sta bila evtanazirana v približno treh tednih zaradi klinične toksičnosti povezane z zdravljenjem, ki so se kazali kot zmanjšanje ješčnosti do anoreksije in melene, hematohemeze z izgubo telesne teže.
English: Treatment of non-resectable Patnaik grade II (intermediate grade) or III (high grade), recurrent, cutaneous mast cell tumours.
Slovenian: Zdravljenje neoperabilnega Patnaika stopnje II (srednja stopnja) ali stopnje III (visoka stopnja) ponavljajočega se kožnega mastocitoma pri psih.
English: Treatment should be permanently discontinued if severe adverse events recur or persist, despite appropriate supportive care and dose reduction.
Slovenian: Zdravljenje je potrebno začasno ali trajno prekiniti, če se resni neželeni učinki ponovijo ali perzistirajo, kljub pravilni podporni terapiji in zmanjšanju odmerka.
English: Maintain dose level
Slovenian: Ohraniti enak odmerek
English: • Severe circulatory shock.
Slovenian: • Resen cirkulatorni šok
English: Toceranib was well tolerated at 2 mg/kg dose level whereas adverse reactions were noted in some dogs treated with 4 mg/kg and thus a NOAEL could not be established.
Slovenian: Toceranib so dobro prenašali pri 2 mg/kg, medtem ko so bili opaženi neželeni učinki pri nekaterih psih pri 4 mg/kg in zato največje toksične koncentracije ni bilo mogoče določiti.
English: If gastrointestinal ulceration is suspected, whether or not due to Palladia or to mast cell tumour degranulation, stop the administration of Palladia and treat appropriately.
Slovenian: Če sumite na gastrointestinalne ulkuse, zaradi zdravila Palladia ali degranulacije mastocitoma, prekinite zdravljenje z zdravilom Palladia in zdravite kot je primerno.
English: Cardboard carton containing four Aluminium-PVC child resistant blister packs.
Slovenian: Kartonasta škatla vsebuje štirialuminijasta-PVC za otroke varna pretisna omota.
English: The tablets must be administered as a whole and should not be broken or ground.
Slovenian: Tablete morajo biti dane cele in se ne smejo lomiti ali drobiti.
English: Palladia film-coated tablets are available in 10 mg, 15 mg and 50 mg strength.
Slovenian: Palladia filmsko obložene tablete so na voljo v 10 mg, 15 mg in 50 mg jakostih.
English: Do not use in pregnant or lactating bitches or in dogs intended for breeding (see section 4.3).
Slovenian: Ne uporabite pri brejih ali psicah v laktaciji ali pri psih namenjenih za razplod (glej poglavje 4.3).
English: It is important to show the doctor a copy of this package leaflet.
Slovenian: Pomembno je, da zdravniku pokažete to navodilo za uporabo.
English: Toceranib inhibited the activity of Flk1/KDR tyrosine kinase (vascular endothelial growth factor receptor, VEGFR2), platelet-derived growth factor receptor (PDGFR) and stem cell factor receptor (c-Kit) in both biochemical and cellular assays.
Slovenian: Toceranib inhibira aktivnost Flk-1/KDR tirozin kinaze (receptor rastnega faktorja žilnega endotela, VEGFR2), receptor rasnega faktorja trombocitov (PDGFR) in receptor faktorja matičnih celičnih analizah.
English: With a regimen of 3.25 mg toceranib/kg bodyweight administered by tablet orally every other day for 2 weeks (7 doses), the following pharmacokinetic parameters of toceranib in plasma in healthy Beagle dogs were reported: elimination half-life (t1/2) 17.2 ± 3.9 hours, time to maximum plasma concentration (Tmax) approximately 6.2 ± 2.6 hours, maximum plasma concentration (Cmax) approximately 108 ± 41 ng/ml, minimum plasma concentration (Cmin) 18.7 ± 8.3 ng/ml and the area under the plasma concentration time-curve (AUC0-48) 2640 ± 940 ng·h/ml.
Slovenian: Polovični čas eliminacije: (t1/2) 17.2 ± 3.9 ur, čas do dosega maksimalne koncentracije v palzmi (Tmax) je približno 6,2 ± 2,6 ur, najvišja koncentracija v plazmi (Cmax) je približno 108 ± 41 ng/ml, najnižja koncentracija v plazmi (Cmin) 18.7 ± 8.3 ng/ml in površina pod časovno krivuljo kovncentracije v plazmi (AUC0-48) 1640 ± 940 ng h/ml.
English: Tablet coating: Palladia 10 mg tablets: Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Indigo Carmin Lake (E132)
Slovenian: Prevleka tablet: Palladia 10 mg tablete: Makrogol, titanijev dioksid (E171), laktoza monohidrat, triacetin, hipomeloza, Indigo Carmin Lake (E132)
English: Another dog developed epistaxis with concurrent disseminated intravascular coagulopathy.
Slovenian: Drugi pes je razvil epistakso z istočasno diseminirano intravaskularno koagulopatijo.
English: Do not use in pregnant or lactating bitches or in dogs intended for breeding (see section 5).
Slovenian: Ne uporabite pri brejih ali psicah v laktaciji ali pri psih namenjenih za razplod (glej poglavje 5).
English: Each tablet also contains lactose monohydrate, cellulose microcrystalline, magnesium stearate, silica colloidal anhydrous and Crospovidone.
Slovenian: Vsaka tableta vsebuje tudi laktozo monohidrat, celulozo, mikrokristalinično, magnezijev stearat, silicijev dioksid, koloidni in krospovidon.
English: Palladia 10 mg: Round shaped, blue coloured tablets Palladia 15 mg: Round shaped, orange coloured tablets Palladia 50 mg: Round shaped, red coloured tablets
Slovenian: Palladia 10 mg: okrogle oblike, tablete modre barve Palladia 15 mg: okrogle oblike, tablete oranžne barve Palladia 50 mg: okrogle oblike, tablete rdeče barve
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/100/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/100/001
English: The tablets must be administered as a whole and should not be divided, broken or ground.
Slovenian: Tablete morajo biti dane cele in se ne smejo razpoloviti, lomiti ali drobiti.
English: Dose reductions and/or dose interruptions may be needed to manage adverse events.
Slovenian: Po potrebi se bo odmerek znižal in/ali prekinil zaradi obvladovanja neželenih učinkov.
English: Also seen commonly but with less severe effects, were localised or general pain, nausea, flatulence, tachypnea, polydipsia, fever, urinary tract infection, increased bilirubin, increased creatinine.
Slovenian: Pogosto opazni toda z manj resnim učinkom so bili lokalna ali generalizirana bolečina, slabost, flatulenca, tahipneja, polidipsija, vročina, infekcije urinarnega trakta, povečan bilirubin, povišan kreatinin.
English: In rare cases, serious and sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred in dogs treated with Palladia.
Slovenian: V redkih primerih so se pri psih zdravljenih z zdravilom Palladia pojavili resni ali včasih smrtni gastrointestinalni zapleti, ki so vključevali gastointestinalno perforacijo.
English: Wash hands thoroughly with soap and water following handling of the product, and disposing of vomit, urine, or faeces of treated dogs.
Slovenian: Po ravnanju z zdravilom si temeljito operite roke z milom in vodo ter po odstranjevanju izbruhane vsebine, urina ali iztrebkov zdravljenih psov.
English: • ALT or AST <3 X upper normal limit
Slovenian: • ALT ali AST <3 X nad zgornjo referenčno mejo
English: There was also a significant advantage of Palladia over placebo in the secondary efficacy endpoint, time to tumour progression.
Slovenian: Statistično značilno boljša je bil tudi sekundarna učinkovitost zdravila Palladia pred placebo, čas brez ponovitve bolezni.
English: Discontinue treatment until clinical signs and clinical pathology have normalised.
Slovenian: Zdravljenje se prekine do izboljšanja kliničnih znakov oziroma dokler znaki klinične patologije popolnoma ne izzvenijo.
English: Lactose monohydrate Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Crospovidone
Slovenian: Laktoza monohidrat Celuloza, mikrokristalinična Magnezijev stearat Silicijev dioksid, koloidni Krospovidon
English: Do not use in pregnant or lactating bitches or in dogs intended for breeding.
Slovenian: Ne uporabite v primeru brejosti ali laktacije pri psici ali pri psih namenjenih za vzrejo.
English: Discontinue treatment until >26%, then decrease dose by 0.5 mg/kg
Slovenian: Prekiniti zdravljenje dokler >26 %, nato znižati odmerek za 0.5 mg/kg
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after “EXP”.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini po EXP. Za shranjevanje ni posebnih navodil.
English: DOSING TABLE: PALLADIA TABLETS:- 3.25 mg/kg BODYWEIGHT
Slovenian: TABELA ZA ODMERJANJE: TABLETE PALLADIA: 3.25 mg/kg TELESNE TEŽE
English: Manufacturer responsible for the batch release:
Slovenian: Izdelovalec, odgovoren za sproščanje serij:
English: In cases of accidental ingestion of Palladia, you may experience stomach discomfort, including vomiting or diarrhoea.
Slovenian: V primeru nenamernega zaužitja zdravila Palladia se lahko pojavijo želodčne motnje vključno z bruhanjem ali diarejo.
English: Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Sunset Yellow Lake (E110), Iron oxide red (E172)
Slovenian: Makrogol, titanijev dioksid (E171), laktoza monohidrat, triacetin, hipomeloza, Sunset Yellow lake (E110), Iron oxide rdeča (E172)
English: Canine mast cell tumour growth is frequently driven by an activating mutation in c-Kit.
Slovenian: Mastocitomi pri psih pogosto napredujejo v rasti prav pod vplivom mutirane c-Kit.
English: Maintain dose level and institute supportive care
Slovenian: Ohraniti enak odmerek in začeti podporno terapijo
English: • If you are pregnant, you should not routinely administer Palladia; however, if you choose to give these tablets to your dog, you should be particularly careful and follow the handling procedures described below.
Slovenian: Če se odločite dajati tablete vašemu psu, bodite posebno pozorni in sledite spodaj opisanim postopkom rokovanja.
English: Disposal: read package leaflet
Slovenian: Odstranjevanje: preberite navodilo za uorabo.
English: The initial recommended dose is 3.25 mg/kg bodyweight, administered every second day (see Dosing table for details).
Slovenian: Začeten priporočen odmerek je 3.25 mg toceraniba/kg telesne teže, odmerjen vsak drugi dan (za podrobnosti glej tabelo za odmerjanje).
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/100/001 (10 mg tablets)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/100/001 (10 mg tablets)
English: • Localised or general pain, nausea, tachypnea, polydipsia, flatulence, pyrexia, nasal depigmentation; changes in coat colour, alopecia, urinary tract infection; increased bilirubin, increased creatinine.
Slovenian: • lokalna ali generalizirana bolečina, slabost, tahipneja, polidipsija, flatulenca, pireksija, depigmentacija nosu; spremembe v barvi dlake, alopecija, infekcije urinarnega trakta; povečan bilirubin, povečan kreatinin.
English: The initial dose is approximately 3.25 mg/kg bodyweight, given every second day (see dosing table for details).
Slovenian: Začetni odmerek je 3.25 mg toceraniba/kg telesne teže, odmerjen vsak drugi dan (za podrobnosti glej tabelo za odmerjanje).
English: DOSING TABLE: PALLADIA TABLETS AT 3.25 MG/KG BODYWEIGHT
Slovenian: TABELA ZA ODMERJANJE: TABLETE PALLADIA V ODMERKU 3.25 MG/KG TELESNE TEŽE