natgillin/translations-raw huggingface dataset:
Mild to moderate:
Blage do umjerene:
Use non-steroidal anti-inflammatory drugs with caution in conjunction with Palladia due to an increased risk of gastrointestinal ulceration or perforation.
Oprezno upotrebljavajte nesteroidne protuupalne lijekove u kombinaciji s Palladijom zbog povećane opasnosti od gastrointestinalne ulceracije ili perforacije.
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.
U režimu od 3,25 mg toceraniba na kilogram tjelesne težine koji se primjenjuje peroralno tabletama svakog drugog dana tijekom 2 tjedna (7 doza), prijavljeni su sljedeći farmakokinetički parametri toceraniba u plazmi zdravih pasa pasmine beagle: poluživot eliminacije (t1/2) 17,2 ± 3,9 sati, vrijeme do maksimalne koncentracije plazme (Tmax) približno 6,2 ± 2,6 sati, maksimalna koncentracija plazme (Cmax) približno 108 ± 41 ng/ml, minimalna koncentracija plazme (Cmin) 18,7 ± 8,3 ng/ml i područje pod vremenskom krivuljom koncentracije plazme (AUC0-48) 2640 ± 940 ng·h/ml.
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.
Budući da se toceranib vjerojatno u velikoj mjeri eliminira metabolizmom u jetrima, ostale lijekove koji mogu inducirati ili inhibirati jetrene enzime treba kombinirati oprezno.
Before performing surgery, discontinue treatment for at least 3 days in order to assure vasculature homeostasis.
Prekinite terapiju barem tri dana prije operacije kako bi se osigurala vaskularna homeostaza.
Linear pharmacokinetics were seen irrespective of the route of administration at doses up to 5 mg/kg given twice daily.
Linearna farmakokinetika uočena je bez obzira na način unošenja, u dozama do 5 mg/kg davanim dvaput dnevno.
Anorexia <50% food intake ≥2 days
Anoreksija < 50 % unosa hrane ≥ 2 dana
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard Carton/tablets
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonska kutija/tablete
The dose given should be based on veterinary assessments conducted weekly for the first six weeks and, thereafter, every six weeks.
Doza bi se trebala temeljiti na procjeni veterinara, procijenjenu dozu trebalo bi davati jednom tjedno prvih šest tjedana, a nakon toga svakih šest tjedana.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
I POGLEDA DJECE” Držati izvan pogleda i dosega djece.
Anaemia and neutropaenia and eosinopaenia were doserelated.
Anemija, neutropenija i eozinopenija bile su povezane s doziranjem.
The main target organs of toxicity include the gastrointestinal tract, bone marrow, gonads and musculoskeletal system.
Glavni organi pogođeni toksičnošću uključuju gastrointestinalni trakt, koštanu srž, gonade i mišićnokoštani sustav.
Toceranib exerts an antiproliferative effect on endothelial cells in-vitro.
Toceranib ima antiproliferacijski učinak na endotelne stanice in-vitro.
• Absolute neutrophil count >1500/microlitre
• Apsolutni broj neutrofila > 1500/mikrolitra
Gastrointestinal Bleeding Fresh blood in stool or black tarry stool for >2 days or frank haemorrhage or blood clots in stool
Svježa krv u stolici ili crna katranasta stolica > 2 dana ili očito krvarenje ili krvni ugrušci u stolici
There was also a significant advantage of Palladia over placebo in the secondary efficacy endpoint, time to tumour progression.
Zabilježena je i značajna prednost Palladije pred placebom u napredovanju tumora u vremenu sekundarne krajnje točke učinkovitosti.
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.
U slučaju sustavne mastocitoze, prije primjene Palladije, potrebno je primijeniti standardnu preventivnu njegu (npr. blokatore H-1 i H-2) kako bi se izbjegla ili maksimalno umanjila klinički značajna degranulacija mastocita i kasnije, potencijalno teške sustavne nuspojave.
>4 watery stools/day or ≥2 days
> 4 vodene stolice dnevno ili ≥ 2 dana
Median TTP for Palladia treated dogs was 9 to 10 weeks and for placebo treated dogs it was 3 weeks.
Srednje vrijeme progresije bolesti kod pasa liječenih Palladijom bilo je od 9 do 10 tjedana, a kod pasa liječenih placebom 3 tjedna.
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.
Istovremena anaemija, azotemija, hipoalbuminemija i hiperfosfatemija Prekinuti terapiju na 1 do 2 tjedna dok se vrijednosti ne poprave i albumin > 2,5 g/dl, zatim smanjivati dozu po 0,5 mg/kg.
In an in-vitro study, metabolism of toceranib was primarily to the N-oxide derivative in dogs and cats.
U in-vitro studiji toceranib se primarno metabolizirao u derivate dušikovih oksida kod pasa i mačaka.
The number of tablets given to your dog may be adjusted by your veterinarian to manage side effects.
Broj tableta koji se daje psu veterinar može prilagoditi kako bi se izbjegle nuspojave.
Palladia can cause vascular dysfunction which can lead to oedema and thromboembolism, including pulmonary thromboembolism.
Palladia može uzrokovati vaskularnu disfunkciju koja može dovesti do edema i tromboembolije, uključujući plućnu tromboemboliju.
Dogs in the 6 mg/kg every other day group exhibited the most adverse effects which included decreased food consumption and weight loss.
Kod pasa iz skupine koja je dobivala 6 mg/kg svaki drugi dan uočeno je najviše nuspojava koje su uključivale smanjenu konzumaciju hrane i gubitak tjelesne težine.
Treatment should be reviewed weekly for the first six weeks and every six weeks thereafter or at intervals deemed appropriate by the veterinarian.
Tijekom prvih šest tjedana terapiju bi trebalo korigirati svaki tjedan, a nakon toga svakih šest tjedana ili u intervalima koje odredi veterinar.
5.2 Pharmacokinetic particulars
5.2 Farmakokinetičke podaci
The absolute bioavailability of toceranib when dosed orally at 3.25 mg/kg was determined to be 86%.
Utvrđeno je da je apsolutna biodostupnost toceraniba pri peroralnom doziranju od 3,25 mg/kg 86 %.
50 mg (red)
50 mg (crvena)
Dogs carrying wild-type c-kit and dogs carrying mutated c-kit responded significantly better to treatment as compared to placebo.
Psi s c-kit-om divljeg tipa i psi s mutiranim c-kit-om reagirali su zamjetno bolje na terapiju nego na placebo.
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 su (6 mg/kg) eutanazirana otprilike u 3. tjednu zbog kliničkog toksiciteta povezanog s terapijom koji je pokrenuo smanjen unos hrane i melenu, a kulminirao je anoreksijom, gubitkom tjelesne težine i hematokezijom.
Pregnant women should not routinely administer Palladia, should avoid contact with faeces, urine and vomit from treated dogs and broken or moistened Palladia tablets.
Trudnice ne bi smjele redovito davati Palladiju, trebale bi izbjegavati kontakt s fekalijama, urinom i povraćanim sadržajem liječenih pasa i slomljenim ili vlažnim tabletama Palladia.
Sporadic dose related lameness, stiffness, weakness and pain in limbs resolved without treatment.
Sporadično šepanje, ukočenost, slabost i bol u udovima povezani s doziranjem nestali su bez liječenja.
Cardboard carton containing four aluminium-PVC child resistant blister packs, each blister containing 5 film-coated tablets.
Kartonska kutija sadrži četiri aluminijska PVC blistera sa zaštitom za djecu, svaki blister sadrži 5 filmom obloženih tableta.
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 pravilnu upotrebu tabele za prilagodbu doze preporučuje se napraviti kompletnu krvnu sliku, kemijsku analizu seruma i analizu prije početka terapije i otprilike mjesec dana nakon početka terapije, nakon toga u intervalima od šest tjedana ili u intervalima koje odredi veterinar.
Palladia has been associated with diarrhoea or gastrointestinal bleeding which may be severe and requires prompt treatment.
Palladia je povezana s proljevom ili gastrointestinalnim krvarenjem koji mogu biti teški i zahtijevaju terapiju bez odgode.
The safety of Palladia was evaluated in mast cell tumour-bearing dogs with the following:
Sigurnost Palladije procijenjena je kod pasa s tumorom mastocita sa sljedećim nalazima:
Canine mast cell tumour growth is frequently driven by an activating mutation in c-Kit.
Rast psećeg tumora mastocita često je potaknut aktivacijskom mutacijom u c-Kit-u.
If a broken tablet is rejected by the dog after chewing, it should be disposed of.
Ako pas nakon žvakanja izbaci prelomljenu tabletu, treba je baciti.
Oral use.
Peroralna upotreba.
Do not use in case of hypersensitivity to the active substance or to any of the other ingredients of Palladia.
Ne davati u slučaju preosjetljivosti na djelatnu tvar ili bilo koji od ostalih sastojaka Palladije.
Wash hands thoroughly with soap and water following handling of the product, and disposing of vomit, urine, or faeces of treated dogs.
Temeljito operite ruke sapunom i vodom nakon rukovanja proizvodom i čišćenja povraćanog sadržaja, urina ili fekalija liječenog psa.
Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Pažljivo nadgledajte psa nakon davanja lijeka kako biste se uvjerili da je progutao svaku tabletu.
• Severe lameness/musculoskeletal disorder.
• Teško šepanje/mišićno-koštani poremećaj.
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 djelovanje tirozin kinaze, nekoliko članova obitelji razgradnog receptora tirozin kinaze (RTK), od kojih su neki uključeni u rast tumora, patološku angiogenezu i metastatsku progresiju raka.
10 mg (blue)
10 mg (plava)
15 mg (orange)
15 mg (narančasta)
• Bilirubin <1.25 X upper normal limit
• Bilirubin < 1,25 puta gornja normalna granica
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.
Djelotvornost i neškodljivost peroralnih tableta Palladia u terapiji tumora mastocita procijenjena je u nasumičnoj, dvostruko slijepoj placebo-kontroliranoj kliničkoj studiji, koja je provođena u više središta i uključivala je 151 psa s rekurentnim, kutanim tumorom mastocita drugog ili trećeg stupnja prema Patnaiku, sa zahvaćenim lokalnim limfnim čvorovima ili bez njihove zahvaćenosti.
• There were two further deaths; however, relation to treatment could not be established.
• Zabilježena su još dva smrtna slučaja, međutim, nije se mogla utvrditi veza s terapijom.
For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment.
Ako je tumor mastocita operabilan, operacija bi trebala biti prva opcija liječenja.
Evaluations should include assessment of clinical signs reported by the pet owner.
Procjene bi trebale uključivati zapažanja vlasnika ljubimca o kliničkim simptomima.
• Platelet count >75,000/microlitre
• Broj trombocita > 75 000/mikrolitra
Each tablet also contains lactose monohydrate, cellulose microcrystalline, magnesium stearate, silica colloidal anhydrous and Crospovidone.
Svaka tableta također sadrži laktozu monohidrat, mikrokristalnu celulozu, magnezij stearat, koloidni bezvodni silicij-dioksid i krospovidon.
In the case of accidental ingestion, seek medical advice immediately and show Package Leaflet or label to the physician.
U slučaju da se nehotice proguta, odmah potražite pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
In case of adverse events following overdose, treatment should be discontinued until resolution and then resumed at the recommended therapeutic dose level.
U slučaju nuspojava uzrokovanih predoziranjem, terapiju treba prekinuti do nestanka simptoma pa nastaviti u preporučenoj dozi.
MANUFACTURER'S BATCH NUMBER Lot
BROJ PROIZVODNE SERIJE Serija Lot
No information relating to potential crossresistance with other cytostatics products is available.
Nema dostupnih informacija o mogućoj međusobnoj otpornosti s ostalim citostatičnim proizvodima.
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 staničnog ciklusa i daljnju apoptozu u staničnim linijama tumora koje izražavaju aktivirajuće mutacije u RTK-u razgrađene kinaze, c-Kit-u.
Palladia may impair male and female fertility and embryo/foetal development.
Palladia može uzrokovati poremećaje plodnosti u mužjaka i ženki te embrio/fetalni razvoj.
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).
Radi obuzdavanja nuspojava doza se može smanjiti na 2,75 mg na kilogram tjelesne težine ili dalje na 2,25 mg na kilogram tjelesne težine svaki drugi dan, a terapija se može i prekinuti na dva tjedna (vidi tabelu Prilagodba doze u odjeljku 4.5).
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.
Ako se sumnja na gastrointestinalnu ulceraciju, bez obzira na to je li ili nije uzrokovana Palladijom ili degranulacijom tumora mastocita, zaustavite primjenu Palladije i primijenite odgovarajuću terapiju.
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 je inhibirao djelovanje tirozin kinaze Flk-1/KDR (receptor vaskularno endotelnog čimbenika rasta, VEGFR2), receptor trombocitnog čimbenika rasta (PDGFR) i receptora čimbenika matičnih stanica (c-Kit) u biokemijskim analizama i na staničnim pokusima.
PHARMACEUTICAL FORM Film-coated tablets.
OBLIK Filmom obložena tableta.
* 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.
* Broj tableta potreban za pse lakše od 5,0 kg ili teže od 63 kg treba izračunati na temelju režima doziranja od 3,25 mg na kilogram tjelesne težine.
In rare cases, serious and sometimes fatal gastrointestinal complications including gastrointestinal perforation occurred in dogs treated with Palladia (See section 4.6).
U rijetkim slučajevima, kod pasa liječenih Palladijom došlo je do ozbiljnih i ponekad fatalnih gastrointestinalnih komplikacija, uključujući gastrointestinalnu perforaciju (vidi odjeljak 4.6).
Toceranib is a small molecule, multi-kinase inhibitor, that has both direct anti-tumour and antiangiogenic activity.
Toceranib je inhibitor malih molekula multi-kinaze koji djeluje izravno protutumorski i antiangiogeno.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
6.6 Posebne mjere opreza prilikom odlaganje neupotrjebljenog veterinarsko-medicinskog proizvoda ili otpadnih materijala dobivenih primjenom tih proizvoda Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
Film-coated tablets.
Filmom obložena tableta.
Do not use in pregnant or lactating bitches or in dogs intended for breeding (see section 4.3).
Ne davati kujama koje su skotne ili koje doje ili rasplodnim psima (vidi odjeljak 4.3).
Cardboard carton containing four Aluminium-PVC child resistant blister packs.
Kartonska kutija sadrži četiri aluminijska PVC blistera sa zaštitom za djecu.
• There were two deaths that were possibly treatment related.
• Zabilježena su dva smrtna slučaja koja su možda povezane s terapijom.
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 u jetri, a budući da nema studija o utjecaju na bubrežna ili jetrena oštećenja, trebalo bi ga primjenjivati s oprezom kod pasa s bolestima jetara.
Other compounds in the anti-angiogenic class of anti-neoplastic agents are known to increase embryolethality and foetal abnormalities.
Poznato je da ostali antiangiogeni spojevi antineoplastičnih sredstava povećavaju postotak smrtnosti embrija i abnormalnosti fetusa.
No information relating to the potential of cross-resistance with other cytostatics products is available.
Nema dostupnih informacija o mogućoj unakrižnoj otpornosti s ostalim citostatičnim proizvodima.
The other dog died following gastric perforation.
Drugi je pas uginuo zbog perforacije želuca.
Common (more than 1 but less than 10 animals in 100 animals treated)
Česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja)
The tablets must be administered as a whole and should not be broken or ground.
Tablete se moraju davati u cijelosti i ne smiju se lomiti ili mljeti.
Do not use in pregnant or lactating bitches or in dogs intended for breeding (see section 5).
Ne davati kujama koje su skotne ili koje doje ili rasplodnim psima (vidi odjeljak 5).
In one dog, pathology findings revealed vascular thrombosis with disseminated intravascular coagulopathy (DIC) and pancreatitis.
Kod jednog je psa patološki nalaz otkrio vaskularnu trombozu s diseminiranom intravaskularrnom koagulopatijom (DIC) i pankreatitis.
Palladia 10 mg: blue Palladia 15 mg: orange Palladia 50 mg: red
Palladia 15 mg: narančasta Palladia 50 mg: crvena
Palladia film-coated tablets are available in 10 mg, 15 mg and 50 mg strength.
Filmom obložene tablete Palladia dostupne su u jačinama od 10 mg, 15 mg i 50 mg.
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.
Simptomi predoziranja primijećeni su u studiji toksičnosti na zdravim odraslim psima pasmine beagle koji su dobivali 2 mg/kg, 4 mg/kg ili 6 mg toceraniba na kilogram po jedanput svakog drugog dana, 13 tjedana uzastopce, bez prekidanja doze.
Hepatic Toxicity (ALT, AST) >1X - 3X upper normal limit
Jetrena toksičnost (ALT, AST) > jednostruka - trostruka gornja normalna granica
Diarrhoea <4 watery stools/day for < 2 days or soft stools
Proljev < 4 vodene stolice dnevno u periodu < 2 dana ili mekane stolice
Tablet coating: Palladia 10 mg tablets: Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Indigo Carmin Lake (E132)
Obloga tablete: Tablete Palladia od 10 mg: Makrogol, titan-dioksid (E171), laktoza monohidrat, triacetin, hipromeloza, boja “Indigo Carmin Lake” (E132)
• ALT or AST <3 X upper normal limit
• ALT ili AST < trostruka gornja normalna granica
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 je dobro podnošen u dozi od 2 mg/kg, a nuspojave su primijećene u nekih pasa koji su dobivali 4 mg/kg pa se (NOAEL) najviša doza koja ne uzrokuje oštećenje nije mogla ustanoviti.
• Two dogs developed epistaxis that was not associated with thrombocytopenia.
• U dva psa se razvio epistaksis koji nije povezan s trombocitopenijom.
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.
Također česte, ali s lakšim učinkom, bile su lokalizirana ili opća bol, mučnina, nadimanje, tahipneja, polidipsija, vrućica, infekcija urinarnog trakta, sniženi bilirubin i sniženi kreatinin.
In rare cases, serious and sometimes fatal gastrointestinal complications including gastrointestinal perforation have occurred in dogs treated with Palladia.
U rijetkim slučajevima, kod pasa liječenih Palladijom došlo je do ozbiljnih i ponekad fatalnih gastrointestinalnih komplikacija, uključujući gastrointestinalnu perforaciju.
Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Sunset Yellow Lake (E110), Iron oxide red (E172)
Makrogol, titan-dioksid (E171), laktoza monohidrat, triacetin, hipromeloza, boja „Sunset Yellow Lake” (E110), crvena željeznog oksida (E172)
Uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Manje česte (više od 1 ali manje od 10 životinja na 1000 tretiranih životinja)
In cases of accidental ingestion of Palladia, you may experience stomach discomfort, including vomiting or diarrhoea.
U slučaju nehotičnog uzimanja Palladije možete osjetiti želučane smetnje, koje uključuju povraćanje i proljev.
EU/2/09/100/003 (50 mg tablets)
EU/2/09/100/003 (tablete od 50 mg)
Lactose monohydrate Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Crospovidone
Laktoza monohidrat Mikrokristalna celuloza Magnezij stearat
• Three dogs had seizure-like activity; however, relation to treatment could not be established.
• U tri psa se pojavila aktivnost slična epileptičkom napadaju, međutim, nije se mogla utvrditi veza s terapijom.
Avoid skin contact with the tablets, faeces, urine, and vomit of treated dogs.
Izbjegavajte kontakt kože s tabletama, fekalijama, urinom i povraćanim sadržajem liječenog psa.
Discontinue treatment until >26%, then decrease dose by 0.5 mg/kg
Prekinuti terapiju do > 26%, zatim smanjivati terapiju po 0,5 mg/kg
DOSING TABLE: PALLADIA TABLETS:- 3.25 mg/kg BODYWEIGHT
TABELA ZA DOZIRANJE PALLADIA TABLETE: 3,25 mg/kg TJELESNE TEŽINE
The initial recommended dose is 3.25 mg/kg bodyweight, administered every second day (see Dosing table for details).
Početna preporučena doza je 3,25 mg na kilogram tjelesne težine, svaki drugi dan (pojedinosti su navedene u Tabeli za doziranje).
Macrogol, Titanium dioxide (E171), Lactose monohydrate, Triacetin, Hypromellose, Talc, Iron oxide red (E172)
Makrogol, titan-dioksid (E171), laktoza monohidrat, triacetin, hipromeloza, talk, crvena željeznog oksida (E172)
MARKETING AUTHORISATION NUMBER(S) EU/2/09/100/001
16. BROJEVI ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/100/001
• Blood urea nitrogen <1.5 X upper normal limit
• Urea nitrat u krvi < 1,5 puta gornja normalna granica
EU/2/09/100/002 (15 mg tablets)
EU/2/09/100/002 (tablete od 15 mg)
Each film-coated tablet contains toceranib phosphate equivalent to 10 mg, 15 mg or 50 mg of toceranib as active substance.
Svaka filmom obložena tableta sadrži toceranib fosfat ekvivalentan količini od 10 mg, 15 mg ili 50 mg toceraniba kao djelatne tvari.
Each film-coated tablet contains toceranib phosphate equivalent to 10 mg, 15 mg or 50 mg of toceranib.
Svaka filmom obložena tableta sadrži toceranib fosfat ekvivalentan količini od 10 mg, 15 mg ili 50 mg toceraniba.
Maintain dose level and institute supportive care
Zadržati razinu doze i uvesti potpornu skrb
It is important to show the doctor a copy of this package leaflet.
Važno je liječniku pokazati uputu o VMP.