natgillin/translations-raw huggingface dataset:
• If Palladia is accidentally ingested (swallowed or eaten) by you or a family member, seek medical advice immediately.
• V primeru nenamernega zaužitja (pogoltnjena ali pojedena) zdravila Palladia se vi ali vaš družinski član takoj posvetujte z zdravnikom.
METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
NAČIN IN POT(I) UPORABE Za peroralno uporabo.
{Alu-PVC/Blisters}
{Alu-PVC/Pretisni omot}
Palladia-treated dogs had a significantly greater objective response rate (37.2 %) compared to dogs treated with placebo (7.9 %).
Pri psih zdravljenih z zdravilom Palladia je bil objektivni odgovor statistično značilno boljši (37,2%) v primerjavi s psi zdravljenih s placebo (7,9%).
The number of tablets given to your dog may be adjusted by your veterinarian to manage side effects.
Število tablet, ki jih bo prejel vaš pes bo prilagodil lečeči veterinar za obvladovanje neželenih učinkov.
If a broken tablet is rejected by the dog after chewing, it should be disposed of.
Če pes zlomljeno tableto po žvečenju zavrne, jo je potrebno odstraniti.
4.4 Special warnings for each target species
4.4 Posebna opozorila za vsako ciljno živalsko vrsto>
The absolute bioavailability of toceranib when dosed orally at 3.25 mg/kg was determined to be 86%.
Absolutna biorazpoložljivost toceraniba je po oralnem dajanju 3,25 mg/kg določena 86%.
In case of tumour progression, treatment is unlikely to be successful and should be reviewed.
V primeru napredovanja tumorja, je malo verjetno, da bo zdravljenje uspešno zato naj se ponovno oceni.
*A 0.5 mg/kg dose decrease is a decrease from 3.25 mg/kg to 2.75 mg/kg or from 2.75 mg/kg to 2.25 mg/kg.
* 0.5 mg/kg znižanje odmerka je znižanje s 3.25 mg/kg na 2.75 mg/kg ali z 2.75 mg/kg na 2.25 mg/kg.
Palladia are round tablets and have a coloured film coat to minimise risk of exposure and to help identify the correct tablet strength.
Palladia so okrogle tablete prevlečene z obarvanim filmom, ki zniža tveganje za izpostavitev in pomaga pri identifikaciji pravilne jakosti tablete:
Your veterinarian will advise you if this is the case for your dog.
Lečeči veterinar bo presodil, če je to zdravilo za vašega psa.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
50 mg (red)
50 mg (rdeča)
No information relating to potential crossresistance with other cytostatics products is available.
Podatki o morebitni navzkrižni rezistenci z drugimi citostatičnimi produkti niso na voljo.
The dose given should be based on veterinary assessments conducted weekly for the first six weeks and, thereafter, every six weeks.
Dani odmerek naj temelji na veterinarjevi tedenski oceni prvih šest tednov in nato vsakih šest tednov.
PACKAGE SIZE 20 tablets.
VELIKOST PAKIRANJA 20 tablet
Median TTP for Palladia treated dogs was 9 to 10 weeks and for placebo treated dogs it was 3 weeks.
Srednji čas napredovanja za pse zdravljene z zdravilom Palladia je bil 9 do 10 tednov in za placebo zdravljene pse 3 tedne.
If a dose is missed, the next schedule dose should be given as prescribed.
Če je bil odmerek izpuščen, se da naslednji odmerek, kot je predpisano.
To appropriately use the dose adjustment table it is advised that a complete blood cell count, serum chemistry panel and urinalysis be conducted prior to initiation of treatment and approximately one month after treatment is initiated; thereafter at approximately six week intervals or as determined by the veterinarian.
Za pravilno uporabo tabele za prilagajanje odmerkov se svetuje spremljanje celotne krvne slike, serumskih biokemičnih parametrov in urinograma, pred začetkom zdravljenja in približno en mesec po začetku zdravljenja; nato vsakih šest mesecev ali kot določi veterinar.
As toceranib is likely eliminated to a large extent by metabolism in the liver, the combination with other drugs capable of inducing or inhibiting liver enzymes should be used with caution.
Ker se verjetno v veliki večini toceranib izloči z jetrnim metabolizmom, je potrebno kombinacije z drugimi substancami, ki so zmožne inducirati ali inhibirati jetrne encime, uporabiti previdno.
Do not use in dogs with evidence of stomach bleeding.
Ne uporabite pri psih s krvavitvami želodca.
No gender differences in pharmacokinetics were observed in-vivo.
In-vivo ni bilo opaznih razlik farmakokinetike med spoloma.
If systemic mastocytosis is present, standard pre-emptive care (e.g., H-1 and H-2 blockers) should be implemented prior to initiation of Palladia to avoid or minimize clinically significant mast cell degranulation and subsequent potentially severe systemic side effects.
V primeru prisotnosti sistemske mastocitoze, naj se uvede standardno preventivno zdravljenje sistemskih učinkov (npr. H-1 in H-2 blokatorji) pred začetkom zdravljenja z zdravilom Palladia, v izogib ali zmanjšanje klinično signifikantne degranulacije mastocitov in posledično možnih resnih sistemskih stranskih učinkov.
Palladia has been associated with diarrhoea or gastrointestinal bleeding which may be severe and requires prompt treatment.
Palladia lahko izzove diarejo ali gastrointestinalne krvavitve, ki so lahko resne in zahtevajo takojšnje zdravljenje.
Severe:
Resni:
Linear pharmacokinetics were seen irrespective of the route of administration at doses up to 5 mg/kg given twice daily.
Linearna farmakokinetika je bila opažena ne glede na odmerjanje pri odmerkih do 5 mg/kg danih dvakrat dnevno.
Your veterinarian may need to take blood and urine samples from your dog to perform these checks.
Lečeči veterinar bo vašemu psu po potrebi vzel vzorce krvi in urina, da opravi potrebne preglede.
Overdosing signs were observed in a toxicity study conducted in healthy adult Beagle dogs treated with 2 mg/kg, 4 mg/kg or 6 mg toceranib/kg once every other day for 13 consecutive weeks without dose interruption.
Znaki prevelikega odmerjanja so bili opazovani v študiji toksičnosti opravljeni na zdravih odraslih psih pasme Beagle zdravljenih z 2 mg/kg, 4 mg/kg ali 6 mg toceraniba/kg enkrat vsak drugi dan 13 zaporednih tednov brez prekinitve odmerka.
• There were two deaths that were possibly treatment related.
• Dve smrti sta bili verjetno povezani z zdravljenjem.
Dogs carrying wild-type c-kit and dogs carrying mutated c-kit responded significantly better to treatment as compared to placebo.
Psi, nosilci divjega tipa c-kit in psi, nosilci mutirane c-kit so se na zdravljenje odzvali signifikantno bolje kot placebo.
Other compounds in the anti-angiogenic class of anti-neoplastic agents are known to increase embryolethality and foetal abnormalities.
Za druge sestavine v tem proti-angiogenem razredu proti neoplastičnih agensov je znano, da povečajo smrtnost embrijev in nenormalnosti pri fetusih.
Ingestion of Palladia may be harmful for children.
Zaužitje zdravila Palladia je lahko škodljivo za otroke.
Use non-steroidal anti-inflammatory drugs with caution in conjunction with Palladia due to an increased risk of gastrointestinal ulceration or perforation.
Nesteroidna protivnetna zdravila je potrebno uporabiti previdno v kombinaciji z zdravilom Palladia zaradi povečanega tveganja gastrointestinalne ulceracije ali perforacije.
Diarrhoea <4 watery stools/day for < 2 days or soft stools
Diareja <4 tekoči iztrebki/dan za < 2 dni ali mehki iztrebki
For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment.
Za vsak mastocitom, ki se lahko zdravi s kirurškim posegom, naj bo operacija prva izbira zdravljenja.
In an in-vitro study, metabolism of toceranib was primarily to the N-oxide derivative in dogs and cats.
V in-vitro študiji je bil toceranib primarno metaboliziran zaradi derivata N-oksida pri psih in mačkah.
There are no in vivo data on the hepatic metabolism in dogs.
Ni podatkov o in-vivo jetrnem metabolizmu pri psih.
The following handling procedures will help to minimise exposure to the active ingredient in Palladia for you and other members of your household:
Sledeči postopek rokovanja z zdravilom Palladia bo pomagal zmanjšati tveganje za izpostavitev zdravilni učinkovini za vas in druge družinske člane v gospodinjstvu:
Dose interruptions and dose reductions may be needed depending upon the severity of clinical signs.
Prekinitev odmerjanja ali zmanjšanje odmerkov bo potrebno glede na resnost kliničnih znakov.
• Absolute neutrophil count >1500/microlitre
• Absolutno število neutrofilcev >1500/mikroliter
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.
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.
Special precautions for each target species: For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment.
Posebni previdnostni ukrepi za vsako živalsko vrsto: Pri vsakemu mastocitomu, ki ga je možno operativno zdraviti, naj bo operacija prva izbira zdravljenja.
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.
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.
Dogs in the 6 mg/kg every other day group exhibited the most adverse effects which included decreased food consumption and weight loss.
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.
Palladia may impair male and female fertility and embryo/foetal development.
Palladija lahko škoduje moški in ženski plodnosti in razvoju embrija/fetusa.
In one dog, pathology findings revealed vascular thrombosis with disseminated intravascular coagulopathy (DIC) and pancreatitis.
Pri enem psu so patološki izvidi pokazali vaskularno trombozo z diseminirano intravaskularno koagulopatijo (DIC) in pankreatitis.
Cardboard carton containing four aluminium-PVC child resistant blister packs, each blister containing 5 film-coated tablets.
Kartonasta škatla vsebuje štirialuminijasta-PVC za otroke varna pretisna omota, vsak pretisni omot vsebuje 5 filmsko obloženih tablet.
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.
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.
The main target organs of toxicity include the gastrointestinal tract, bone marrow, gonads and musculoskeletal system.
Glavni tarčni organi toksičnosti vključujejo gastrointestinalni trakt, kostni mozeg, žleze in mišično skeletni sistem.
This will reduce the risk for children or other household members to accidentally come into contact with Palladia.
S tem boste zmanjšali tveganja, da pridejo v stik z zdravilom Palladia otroci ali drugi člani v gospodinjstvu.
Treatment should continue in the case of stable disease, or partial or complete response, provided that the product is sufficiently well tolerated.
Zdravljenje naj se nadaljuje v primeru stabilnosti bolezni, delnega ali popolnega odgovora pod pogojem, da zdravljena žival produkt dobro prenaša.
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.
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.
• Three dogs had seizure-like activity; however, relation to treatment could not be established.
• Trije psi so kazali aktivnost podobno seizmičnim krčem toda povezava z zdravljenjem ni bila dokazana.
Sporadic dose related lameness, stiffness, weakness and pain in limbs resolved without treatment.
Sporadično šepanje, otrdelost, slabost in bolečina v okončinah je izzvenelo brez zdravljenja.
The other dog died following gastric perforation.
Drugi pes je umrl po perforaciji želodca.
Toceranib is a small molecule, multi-kinase inhibitor, that has both direct anti-tumour and antiangiogenic activity.
Toceranib je mala molekula, inhibitor multi-kinaze, z direktnim protitumorskim in antiangiogenim delovanjem.
Gastrointestinal Bleeding Fresh blood in stool or black tarry stool for >2 days or frank haemorrhage or blood clots in stool
Gastrointestinalne krvavitve Sveža kri v iztrebku ali črn katranast iztrebek > kot 2 dni ali čista krvavitev ali krvni strdki v iztrebku
No interaction studies have been performed with toceranib.
Ni študij o medsebojnem delovanju toceraniba.
Palladia can cause vascular dysfunction which can lead to oedema and thromboembolism, including pulmonary thromboembolism.
Palladia lahko povzroči žilno disfunkcijo, ki vodi v edem in tromboembolijo, vključno s pljučno tromboembolijo.
Toceranib induces cell cycle arrest and subsequent apoptosis in tumour cell lines expressing activating mutations in the split kinase RTK, c-Kit.
Toceranib inducira zastoj celičnega ciklusa in posledično apoptozo v linijah tumorskih celic z izraženo aktivirano mutacijo split kinazi RTK, c-Kit.
Following oral administration of toceranib phosphate, approximately 92% of the administered drug is excreted in faeces with another 7% excreted in urine.
Po oralnem dajanju se okoli 92% toceranibovega fosfata izloči z iztrebki, ostalih 7% se izloči z urinom.
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.
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.
In case of adverse events following overdose, treatment should be discontinued until resolution and then resumed at the recommended therapeutic dose level.
V primeru neželenih učinkov zaradi prekomernega odmerjanja naj se zdravljenje prekine do izboljšanja in nato nadaljuje s priporočeno višino terapevtskega odmerka.
• Two dogs developed epistaxis that was not associated with thrombocytopenia.
• Dva psa sta razvila epistakso, ki ni bila povezana s trombocitopenijo.
Palladia 10 mg: blue Palladia 15 mg: orange Palladia 50 mg: red
Palladia 10 mg: modra Palladia 15 mg: oranžna Palladia 50 mg: rdeča
C. STATEMENT OF THE MRLs Not applicable.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL) Ni smiselno.
Anaemia and neutropaenia and eosinopaenia were doserelated.
Pojav anemije in neutropenije ter eozinopenije je bil odvisen od odmerka.
Treatment should be reviewed weekly for the first six weeks and every six weeks thereafter or at intervals deemed appropriate by the veterinarian.
Zdravljenje je potrebno preverjati tedensko prvih šest tednov, nato vsakih šest tednov ali v intervalih po presoji veterinarja.
Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Po odmerjanju psa pazljivo opazujte, da zagotovite zaužitje vsake tablete.
The following adverse events were uncommon (more than 1 but less than 10 animals in 1,000 treated):
Sledeči neželeni učinki so bili redki (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) :
* 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.
* 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.
>4 watery stools/day or ≥2 days
>4 vodeni iztrebki/dan ali ≥ 2 dni
Toceranib exerts an antiproliferative effect on endothelial cells in-vitro.
Toceranib kaže anti proliferativen učinek na endotelne celice v in vitro.
PHARMACEUTICAL FORM Film-coated tablets.
FARMACEVTSKA OBLIKA Filmsko obložene tablete.
Film-coated tablets.
Filmsko obložene tablete.
• Platelet count >75,000/microlitre
• Število trombocitov > 75,000/mikroliter
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.
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.
Neutropenia (neutrophil count) >1000/ul
Nevtropenija (število neutrofilcev) >1000/µl
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.
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.
• Severe circulatory shock
• resen cirkulatorni šok
• Bilirubin <1.25 X upper normal limit
• Bilirubin <1.25 X nad zgornjo mejo
In the case of accidental ingestion, seek medical advice immediately and show Package Leaflet or label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
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).
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).
• Severe lameness/musculoskeletal disorder.
• Močno šepanje/mišično skeletne motnje
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.
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.
In rare cases, serious and sometimes fatal gastrointestinal complications including gastrointestinal perforation occurred in dogs treated with Palladia (See section 4.6).
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).
Pregnant women should not routinely administer Palladia, should avoid contact with faeces, urine and vomit from treated dogs and broken or moistened Palladia tablets.
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.
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.
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.
Treatment of non-resectable Patnaik grade II (intermediate grade) or III (high grade), recurrent, cutaneous mast cell tumours.
Zdravljenje neoperabilnega Patnaika stopnje II (srednja stopnja) ali stopnje III (visoka stopnja) ponavljajočega se kožnega mastocitoma pri psih.
Treatment should be permanently discontinued if severe adverse events recur or persist, despite appropriate supportive care and dose reduction.
Zdravljenje je potrebno začasno ali trajno prekiniti, če se resni neželeni učinki ponovijo ali perzistirajo, kljub pravilni podporni terapiji in zmanjšanju odmerka.
Maintain dose level
Ohraniti enak odmerek
• Severe circulatory shock.
• Resen cirkulatorni šok
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.
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.
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.
Če sumite na gastrointestinalne ulkuse, zaradi zdravila Palladia ali degranulacije mastocitoma, prekinite zdravljenje z zdravilom Palladia in zdravite kot je primerno.
Cardboard carton containing four Aluminium-PVC child resistant blister packs.
Kartonasta škatla vsebuje štirialuminijasta-PVC za otroke varna pretisna omota.
The tablets must be administered as a whole and should not be broken or ground.
Tablete morajo biti dane cele in se ne smejo lomiti ali drobiti.
Palladia film-coated tablets are available in 10 mg, 15 mg and 50 mg strength.
Palladia filmsko obložene tablete so na voljo v 10 mg, 15 mg in 50 mg jakostih.
Do not use in pregnant or lactating bitches or in dogs intended for breeding (see section 4.3).
Ne uporabite pri brejih ali psicah v laktaciji ali pri psih namenjenih za razplod (glej poglavje 4.3).
It is important to show the doctor a copy of this package leaflet.
Pomembno je, da zdravniku pokažete to navodilo za uporabo.
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.
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.
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.
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.
Tablet coating: Palladia 10 mg tablets: Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Indigo Carmin Lake (E132)
Prevleka tablet: Palladia 10 mg tablete: Makrogol, titanijev dioksid (E171), laktoza monohidrat, triacetin, hipomeloza, Indigo Carmin Lake (E132)
Another dog developed epistaxis with concurrent disseminated intravascular coagulopathy.
Drugi pes je razvil epistakso z istočasno diseminirano intravaskularno koagulopatijo.