FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 4.1 Therapeutic indications <Product name> should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI).
Slovenian: Kontrastno sredstvo <ime kontrastnega sredstva> se sme uporabljati le, ko so diagnostični podatki ključni in jih ni možno pridobiti z magnetnoresonančnim slikanjem (MRS) brez uporabe kontrastnega sredstva.
English: London, 23 February 2006 Doc.Ref.
Slovenian: London, 23. februar 2006 Dok.ref.
English: The company's letter of withdrawal is published on the EMEA website and can be found here.
Slovenian: Dopis podjetja o umiku je objavljen na spletni strani EMEA in je na voljo tukaj.
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF AN APPLICATION FOR AN EXTENSION OF THE MARKETING AUTHORISATION for OPATANOL
Slovenian: VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA RAZŠIRITEV DOVOLJENJA ZA PROMET za zdravilo OPATANOL
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.eu.int http://www.emea.eu.int EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Slovenian: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.eu.int http://www.emea.eu.int
English: International Non-proprietary Name (INN): Olopatadine hydrochloride
Slovenian: Mednarodno nelastniško ime (INN): olopatadin hidroklorid
English: The effects of the medicine were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
English: How far into the evaluation was the application when it was withdrawn?
Slovenian: Kako daleč je bil postopek ocenjevanja vloge, ko je bila vloga umaknjena?
English: The CHMP takes up to 210 days to evaluate an application for an extension of a marketing authorisation.
Slovenian: CHMP običajno potrebuje do 210 dni za ocenjevanje nove vloge za razširitev dovoljenja za promet.
English: This means that it blocks the action of histamine, a natural substance in the body that is released when the body is exposed to an allergen.
Slovenian: To pomeni, da prepreči delovanje histamina, naravne snovi v telesu, ki se sprošča ob izpostavitvi alergenu.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Opatanol?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe z zdravilom Opatanol?
English: The application was at ‘Day 120' when the Company withdrew.
Slovenian: Podjetje je umaknilo vlogo na „120.
English: Based on the currently available data, the CHMP has no concern regarding the use of Opatanol eye drops.
Slovenian: Na osnovi trenutno dostopnih podatkov CHMP nima zadržkov glede uporabe zdravila Opatanol kapljice za oko.
English: The studies in hay fever lasted two weeks and looked at how the symptoms were improved.
Slovenian: V raziskavah senenega nahoda, ki so trajale dva tedna, so preverjali izboljšanje simptomov.
English: Following CHMP opinion, it usually takes around 2 months for the European Commission to update a licence.
Slovenian: Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih posodobi dovoljenje.
English: The CHMP had formulated a list of questions to be answered by the Company, and the Company had not yet responded to them.
Slovenian: CHMP je pripravil seznam vprašanj, na katere naj bi podjetje odgovorilo.
English: On 14 February 2006, Alcon Laboratories (U.K.) Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for an extension of the marketing authorisation for Opatanol, to add a new pharmaceutical form, a nasal spray intended for a new use in the treatment of the signs and symptoms of seasonal and perennial rhinitis.
Slovenian: Podjetje Alcon Laboratories (Združeno kraljestvo) Limited je 14. februarja 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za razširitev dovoljenja za promet za zdravilo Opatanol, kjer bi dodali novo farmacevtsko obliko - pršilo za nos za zdravljenje znakov in simptomov sezonskega in celoletnega rinitisa.
English: Opatanol nasal spray was to be used to treat the signs and symptoms of allergic conditions of the nose, rhinitis (sneezing, itchy nose, runny nose and congestion), due to some materials (allergens) from pollens, house dust or animals.
Slovenian: Zdravilo Opatanol pršilo za nos naj bi se uporabljalo za zdravljenje znakov in simptomov alergijske bolezni - rinitisa (kihanje, srbeč nos, voden izcedek iz nosu in zamašen nos), ki ga povzročijo nekatere snovi (alergeni) iz cvetnega prahu, hišnega prahu ali živali.
English: Once the Company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions (at day 180) to be answered by the Company in writing or during a hearing.
Slovenian: Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja zaprosi podjetje še za odgovore na dodatna vprašanja (180. dan).
English: What is happening with regard to Opatanol eye drops used for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis?
Slovenian: Kaj se dogaja v zvezi z zdravilom Opatanol kapljice za oko za zdravljenje očesnih znakov in simptomov sezonskega alergijskega konjunktivitisa?
English: Opatanol has been authorised in the European Union since 17 May 2002 as eye drops for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
Slovenian: Zdravilo Opatanol je bilo v Evropski uniji odobreno od 17. maja 2002 v obliki kapljic za oko za zdravljenje očesnih znakov in simptomov sezonskega alergijskega konjunktivitisa.
English: The study in perennial rhinitis lasted one year.
Slovenian: Raziskava celoletnega rinitisa je trajala eno leto.
English: Olopatadine, the active substance in Opatanol, is an antihistaminic.
Slovenian: Zdravilna učinkovina zdravila Opatanol je olopatadin, ki je antihistaminik.
English: What documentation was presented by the Company to support the application to the CHMP?
Slovenian: Kakšno dokumentacijo je podjetje predstavilo CHMP za podlago vlogi?
English: Opatanol nasal spray is a solution containing 6 mg/ml of the active substance, olopatadine (as the hydrochloride).
Slovenian: Opatanol pršilo za nos je raztopina, ki vsebuje 6 mg zdravilne učinkovine olopatadina (v obliki hidroklorida) na ml.
English: In addition, the CHMP wanted to see the results of further tests carried out by the company to clarify the potential for harm of impurities contained in Opatanol nasal spray before making its recommendation.
Slovenian: Poleg tega je CHMP pred izdajo priporočila želel, da podjetje predstavi rezultate dodatnih preizkusov za razjasnitev potencialne škodljivosti nečistoč, ki jih vsebuje zdravilo Opatanol pršilo za nos.
English: The Company submitted the results of clinical studies where Opatanol nasal spray used twice a day was compared to a placebo (a dummy treatment) in the treatment of allergic seasonal rhinitis (hay fever) and in perennial rhinitis.
Slovenian: Podjetje je predložilo rezultate kliničnih raziskav, kjer so dvakrat dnevno uporabo zdravila Opatanol pršila za nos primerjali s placebom (navideznim zdravilom) za zdravljenje alergijskega sezonskega rinitisa (seneni nahod) in celoletnega rinitisa.
English: The CHMP had concerns and was of the provisional opinion that Opatanol nasal spray could not be approved, for the treatment of the signs and symptoms of seasonal and perennial rhinitis.
Slovenian: CHMP je imel zadržke in bil začasnega mnenja, da zdravila Opatanol pršila za nos ni mogoče odobriti za zdravljenje znakov in simptomov sezonskega in celoletnega rinitisa.
English: The CHMP wanted to see the effect of Opatanol nasal spray compared to other medicines for the treatment of hay fever and perennial rhinitis.
Slovenian: CHMP je želel videti, kakšni so učinki zdravila Opatanol pršila za nos v primerjavi z drugimi zdravili za zdravljenje senenega nahoda in celoletnega rinitisa.
English: There are no ongoing clinical trials or compassionate use programmes with Opatanol nasal spray in the EU.
Slovenian: Z zdravilom Opatanol pršilo za nos v EU ne poteka nobeno klinično preizkušanje / program sočutne uporabe.
English: By blocking the action of histamine, Opatanol nasal spray was expected to help to control the signs and symptoms of allergic rhinitis.
Slovenian: Zdravilo Opatanol pršilo za nos naj bi s preprečevanjem delovanja histamina pripomoglo k nadzorovanju znakov in simptomov alergijskega rinitisa.
English: What was Opatanol nasal spray expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Opatanol pršilo za nos uporabljalo?
English: How is Opatanol nasal spray expected to work?
Slovenian: Kako naj bi zdravilo Opatanol pršilo za nos delovalo?
English: Dogs should be carefully monitored.
Slovenian: Pse je potrebno skrbno nadzorovati.
English: See sections 4.4, 4.5 and 4.9 for Dose Adjustment Guidelines.
Slovenian: Glejte poglavje 4.4, 4.5 in 4.9 za navodila za prilagajanje odmerka.
English: Duration of treatment depends on the response to treatment.
Slovenian: Trajanje zdravljenja je odvisno od odgovora na zdravljenje.
English: • Hematocrit >25%
Slovenian: • Hematokrit > 25%
English: Toceranib is highly protein bound at between 91% and 93%.
Slovenian: Toceranib se v visoki meri med 91% in 93% veže na proteine.
English: • Children should not come in contact with Palladia.
Slovenian: • Otroci ne smejo priti v stik s Palladia-o.
English: Tablets can be administered with or without food.
Slovenian: Tablete se lahko dajejo s hrano ali brez.
English: The dose should not be <2.2 mg/kg.
Slovenian: Odmerek ne sme biti < 2.2 mg/kg.
English: Tablets are available in three different strengths.
Slovenian: Tablete so dosegljive v treh različnih jakostih.
English: Periodic monitoring of laboratory variables should be completed in the context of the clinical signs and condition of the animal and results of laboratory variables at prior visits.
Slovenian: Periodično spremljanje laboratorijskih spremenljivk naj se zaključi v smislu kliničnih znakov in stanja živali ter rezultatov laboratorijskih spremenljivk pri predhodnih obiskih.
English: Dog Bodyweight (kg)
Slovenian: Telesna teža psa (kg)
English: ≤1000/ul or neutropenic fever or infection
Slovenian: ≤1000/ µl ali nevtropenična vročina ali infekcija
English: Anaemia (hematocrit)
Slovenian: Anemija (hematokrit)
English: In order to achieve correct dosing, tablets of different strengths (“colours”) might need to be combined as described in the table.
Slovenian: Za dosego pravilnega odmerjanja bo potrebno kombinirati različne jakosti (»barve«), kot je opisano v tabeli.
English: Each tablet is marked with the strength (10, 15 or 50) on one side, the reverse side is blank.
Slovenian: Vsaka tableta je označena na eni strani z jakostjo (10, 15 ali 50), druga stran je prazna.
English: Hypoalbuminemia (albumin) Albumin <1.5 g/dl
Slovenian: Hipoalbuminemija (albumin) Albumin <1.5 g/dl
English: Number of Tablets
Slovenian: Število tablet
English: Evaluations should include assessment of clinical signs reported by the pet owner.
Slovenian: Vrednotenje naj vključuje oceno kliničnih znakov, ki jih poroča lastnik živali.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/09/2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 23/09/2009
English: There are some medicines that you should not give to your dog during treatment because together, they might cause serious adverse effects.
Slovenian: Obstajajo nekatera zdravila, ki jih vaš pes med zdravljenjem ne sme dobiti, ker lahko povzročijo resne neželene učinke.
English: It is not known to what extent toceranib could affect the elimination of other drugs.
Slovenian: Ni podatkov o tem do kakšne mere toceranib lahko vpliva na eliminacijo drugih substanc.
English: Special information for the veterinarian
Slovenian: Posebne informacije za veterinarje
English: Dose adjustment/reduction:
Slovenian: Prilagajanje odmerka/znižanje:
English: If the Palladia tablet is “hidden” in food, make sure that your dog has eaten the entire dose.
Slovenian: o Če ste Palladia tableto skrili v hrano, se prepričajte, da je pes zaužil celoten odmerek.
English: Therefore, the dosage given should be as described by your veterinarian, even if this is different from the dosing table.
Slovenian: Odmerek mora biti enak kot ga predpiše vaš veterinar, tudi če se razlikuje od tabele za odmerjanje.
English: Date of last renewal: 31/07/2014
Slovenian: Datum podaljšanja dovoljenja za promet: 31/07/2014
English: • Creatinine <2.5 mg/dl
Slovenian: • Kreatinin <2.5 mg/dl
English: Each blister contains 5 tablets.
Slovenian: Vsak pretisni omot vsebuje 5 tablet.
English: Dose Adjustment Based on Clinical Signs / Pathology Clinical signs / pathology
Slovenian: Prilagajanje odmerkov na osnovi kliničnih znakov / patologije klinični znaki / patologija
English: Tell your veterinarian about all medicines, including overthe-counter products, that you intend to administer to your dog.
Slovenian: Vašemu veterinarju povejte o vseh zdravilih, vključno z zdravili brez recepta, ki jih nameravate dati vašemu psu.
English: Tablet Core:
Slovenian: Jedro tablet:
English: Some dogs may also show a loss of colour around their nose, some dogs may show a change in coat colour which appears to lighten and some dogs may lose hair.
Slovenian: Pri nekaterih psih izgine barva okoli nosu, nekateri psi spremenijo barvo dlake, ki postane svetlejša in nekateri psi izgubijo dlako.
English: Anorexia <50% food intake ≥2 days
Slovenian: Anoreksija <50% zaužite hrane ≥2 dni
English: Before performing surgery, discontinue treatment for at least 3 days in order to assure vasculature homeostasis.
Slovenian: Pred kirurškim posegom se zdravljenje prekine vsaj za 3 dni, da se zagotovi krvna homeostaza.
English: Do not use in dogs with gastrointestinal bleeding.
Slovenian: Ne uporabite pri psih z gastrointestinalnimi krvavitvami.
English: After 6 weeks of treatment, a complete response was noted for 8.1 % and partial response was noted for 29.1 % of dogs treated with Palladia.
Slovenian: V šestih tednih zdravljenja je bil popoln odgovor dosežen pri 8,1% in delni odgovor pri 29,1% psov zdravljenih z zdravilom Palladia.
English: Dose Adjustment*
Slovenian: Prilagajanje odmerka*
English: Do not increase or double the dose.
Slovenian: odmerka ne povečujte ali podvajajte.
English: 10 mg (blue)
Slovenian: 10 mg (modra)
English: • Anyone in your household who administers Palladia to your dog should always wash their hands after handling the tablets.
Slovenian: • Kdorkoli daje zdravilo Palladia vašemu psu, si naj po rokovanju s tabletami vedno umije roke.
English: If more than the prescribed amount of tablets were given, contact your veterinarian.
Slovenian: Če ste dali več tablet, kot je predpisano, se posvetujte s svojim veterinarjem.
English: The safety of Palladia was evaluated in mast cell tumour-bearing dogs with the following:
Slovenian: Varnost zdravila Palladia je bila ocenjena pri psih z mastocitomom s sledečim:
English: Do not use in dogs less than 2 years of age or less than 3 kg body weight.
Slovenian: Ne uporabite pri psih mlajših od 2 let ali lažjih od 3 kg telesne teže.
English: 15 mg (orange)
Slovenian: 15 mg (oranžna)
English: • If Palladia is accidentally ingested (swallowed or eaten) by you or a family member, seek medical advice immediately.
Slovenian: • V primeru nenamernega zaužitja (pogoltnjena ali pojedena) zdravila Palladia se vi ali vaš družinski član takoj posvetujte z zdravnikom.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Slovenian: NAČIN IN POT(I) UPORABE Za peroralno uporabo.
English: {Alu-PVC/Blisters}
Slovenian: {Alu-PVC/Pretisni omot}
English: Palladia-treated dogs had a significantly greater objective response rate (37.2 %) compared to dogs treated with placebo (7.9 %).
Slovenian: Pri psih zdravljenih z zdravilom Palladia je bil objektivni odgovor statistično značilno boljši (37,2%) v primerjavi s psi zdravljenih s placebo (7,9%).
English: The number of tablets given to your dog may be adjusted by your veterinarian to manage side effects.
Slovenian: Število tablet, ki jih bo prejel vaš pes bo prilagodil lečeči veterinar za obvladovanje neželenih učinkov.
English: If a broken tablet is rejected by the dog after chewing, it should be disposed of.
Slovenian: Če pes zlomljeno tableto po žvečenju zavrne, jo je potrebno odstraniti.
English: 4.4 Special warnings for each target species
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto>
English: The absolute bioavailability of toceranib when dosed orally at 3.25 mg/kg was determined to be 86%.
Slovenian: Absolutna biorazpoložljivost toceraniba je po oralnem dajanju 3,25 mg/kg določena 86%.
English: In case of tumour progression, treatment is unlikely to be successful and should be reviewed.
Slovenian: V primeru napredovanja tumorja, je malo verjetno, da bo zdravljenje uspešno zato naj se ponovno oceni.
English: *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.
Slovenian: * 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.
English: Palladia are round tablets and have a coloured film coat to minimise risk of exposure and to help identify the correct tablet strength.
Slovenian: Palladia so okrogle tablete prevlečene z obarvanim filmom, ki zniža tveganje za izpostavitev in pomaga pri identifikaciji pravilne jakosti tablete:
English: Your veterinarian will advise you if this is the case for your dog.
Slovenian: Lečeči veterinar bo presodil, če je to zdravilo za vašega psa.
English: 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/).
Slovenian: 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/.
English: 50 mg (red)
Slovenian: 50 mg (rdeča)
English: No information relating to potential crossresistance with other cytostatics products is available.
Slovenian: Podatki o morebitni navzkrižni rezistenci z drugimi citostatičnimi produkti niso na voljo.
English: The dose given should be based on veterinary assessments conducted weekly for the first six weeks and, thereafter, every six weeks.
Slovenian: Dani odmerek naj temelji na veterinarjevi tedenski oceni prvih šest tednov in nato vsakih šest tednov.
English: PACKAGE SIZE 20 tablets.
Slovenian: VELIKOST PAKIRANJA 20 tablet
English: Median TTP for Palladia treated dogs was 9 to 10 weeks and for placebo treated dogs it was 3 weeks.
Slovenian: Srednji čas napredovanja za pse zdravljene z zdravilom Palladia je bil 9 do 10 tednov in za placebo zdravljene pse 3 tedne.
English: If a dose is missed, the next schedule dose should be given as prescribed.
Slovenian: Če je bil odmerek izpuščen, se da naslednji odmerek, kot je predpisano.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Do not use in dogs with evidence of stomach bleeding.
Slovenian: Ne uporabite pri psih s krvavitvami želodca.
English: No gender differences in pharmacokinetics were observed in-vivo.
Slovenian: In-vivo ni bilo opaznih razlik farmakokinetike med spoloma.
English: 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.
Slovenian: 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.
English: Palladia has been associated with diarrhoea or gastrointestinal bleeding which may be severe and requires prompt treatment.
Slovenian: Palladia lahko izzove diarejo ali gastrointestinalne krvavitve, ki so lahko resne in zahtevajo takojšnje zdravljenje.
English: Severe:
Slovenian: Resni:
English: Linear pharmacokinetics were seen irrespective of the route of administration at doses up to 5 mg/kg given twice daily.
Slovenian: Linearna farmakokinetika je bila opažena ne glede na odmerjanje pri odmerkih do 5 mg/kg danih dvakrat dnevno.
English: Your veterinarian may need to take blood and urine samples from your dog to perform these checks.
Slovenian: Lečeči veterinar bo vašemu psu po potrebi vzel vzorce krvi in urina, da opravi potrebne preglede.
English: 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.
Slovenian: 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.
English: • There were two deaths that were possibly treatment related.
Slovenian: • Dve smrti sta bili verjetno povezani z zdravljenjem.
English: Dogs carrying wild-type c-kit and dogs carrying mutated c-kit responded significantly better to treatment as compared to placebo.
Slovenian: Psi, nosilci divjega tipa c-kit in psi, nosilci mutirane c-kit so se na zdravljenje odzvali signifikantno bolje kot placebo.
English: Other compounds in the anti-angiogenic class of anti-neoplastic agents are known to increase embryolethality and foetal abnormalities.
Slovenian: Za druge sestavine v tem proti-angiogenem razredu proti neoplastičnih agensov je znano, da povečajo smrtnost embrijev in nenormalnosti pri fetusih.
English: Ingestion of Palladia may be harmful for children.
Slovenian: Zaužitje zdravila Palladia je lahko škodljivo za otroke.
English: Use non-steroidal anti-inflammatory drugs with caution in conjunction with Palladia due to an increased risk of gastrointestinal ulceration or perforation.
Slovenian: Nesteroidna protivnetna zdravila je potrebno uporabiti previdno v kombinaciji z zdravilom Palladia zaradi povečanega tveganja gastrointestinalne ulceracije ali perforacije.
English: Diarrhoea <4 watery stools/day for < 2 days or soft stools
Slovenian: Diareja <4 tekoči iztrebki/dan za < 2 dni ali mehki iztrebki
English: For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment.
Slovenian: Za vsak mastocitom, ki se lahko zdravi s kirurškim posegom, naj bo operacija prva izbira zdravljenja.
English: In an in-vitro study, metabolism of toceranib was primarily to the N-oxide derivative in dogs and cats.
Slovenian: V in-vitro študiji je bil toceranib primarno metaboliziran zaradi derivata N-oksida pri psih in mačkah.