natgillin/translations-raw huggingface dataset:
MARKETING AUTHORISATION NUMBER(S) EU/2/17/211/001-004 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/06/2017 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET Z ZDRAVILOM EU/2/17/211/001-004
The volume of distribution at steady-state (Vss) was 2.3 l/kg and systemic clearance was 0.51 l/h/kg. 
Volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je bil 2,3 l/kg, sistemski očistek pa 0,51 l/h/kg.
TARGET SPECIES Dogs and cats. 
CILJNE ŽIVALSKE VRSTE Psi in mačke
Following a single intravenous dose at 1 mg/kg the initial plasma concentration was 363 ng/ml. 
Po enkratnem intravenskem odmerku 1 mg/kg je bila začetna plazemska koncentracija 363 ng/ml.
Following a single intravenous dose at 1 mg/kg the initial plasma concentration was 1040 ng/ml. 
Po enkratnem intravenskem odmerku 1 mg/kg je bila začetna plazemska koncentracija 1040 ng/ml.
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to dogs was characterised by a maximum concentration (Cmax) in plasma of approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (Tmax). 
Za farmakokinetični profil maropitanta, danega psom v enkratnem subkutanem odmerku 1 mg/kg telesne mase, je značilna najvišja koncentracija (Cmax) v plazmi okoli 92 ng/ml; ta je dosežena v 0,75 ure po dajanju (Tmax).
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 8.84 hours. 
Vrhu koncentracije sledi upadanje sistemske izpostavljenosti z razpolovnim časom izločanja (t1/2) 8,84 ure.
The veterinary medicinal product should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels. 
Ne uporabljajte zdravila hkrati z antagonisti Ca kanalov, saj ima maropitant afiniteto do Ca kanalov.
Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 16.8 hours. 
Vrhu koncentracije sledi upadanje sistemske izpostavljenosti z razpolovnim časom izločanja (t1/2) 16,8 ure.
The volume of distribution at steady-state (Vss) was 9.3 l/kg and systemic clearance was 1.5 l/h/kg. 
Volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je bil 9,3 l/kg, sistemski očistek pa 1,5 l/h/kg.
Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 146%. 
Pri ponavljajočem se subkutanem dajanju 5 zaporednih dni, dnevni odmerek 1 mg/kg telesne mase, je akumulacija 146 %.
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1 mg/kg body weight to cats was characterised by a maximum concentration (Cmax) in plasma of approximately 165 ng/ml; this was achieved on average 0.32 hours (19 min) post-dosing (Tmax). 
Za farmakokinetični profil maropitanta, danega mačkam v enkratnem subkutanem odmerku 1 mg/kg telesne mase, je značilna najvišja koncentracija (Cmax) v plazmi okoli 165 ng/ml; ta je v povprečju dosežena v 0,32 ure (19 min) po dajanju (Tmax).
Prevomax solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg of maropitant/kg body weight (1 ml/10 kg body weight). 
Prevomax raztopino za injiciranje dajemo enkrat dnevno subkutano ali intravensko, v odmerku 1 mg maropitanta/kg telesne mase (1 ml/10 kg telesne mase).
Plasma protein binding of maropitant in cats was estimated to be 99.1%. 
Ocenjujemo, da je vezava maropitanta na plazemske proteine pri mačkah 99,1 %.
D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
D. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM Posebne zahteve glede farmakovigilance:
Maropitant is metabolised in the liver and therefore should be used with caution in dogs and cats with liver disease. 
Maropitant se metabolizira v jetrih, zato je potrebna previdna uporaba pri psih z jetrnimi obolenji.
For the major metabolite 10.4% of the maropitant dose was recovered in urine and 9.3% in faeces. 
V urinu najdemo 10,4 % oziroma v blatu 9,3 % njegovega glavnega presnovka.
A variety of in vitro assays have demonstrated that maropitant binds selectively at the NK1 receptor with dose-dependent functional antagonism of substance P activity. 
V več in vitro poskusih je bilo dokazano, da se maropitant selektivno veže na NK1 receptor.
Intravenous administration of the veterinary medicinal product should be given as a single bolus without mixing the product with any other fluids. 
Zdravilo za uporabo v veterinarski medicini je treba dajati intravensko kot posamezen bolus brez mešanja zdravila z drugimi tekočinami.
Apart from transient reactions at the injection site following subcutaneous administration, maropitant was well tolerated in dogs and young cats injected daily with up to 5 mg/kg (5 times the recommended dose) for 15 consecutive days (3-times the recommended duration of administration). 
Razen prehodnih reakcij na mestu injiciranja so psi in mlade mačke dobro prenašali dnevno injiciranje odmerka maropitanta do 5 mg/kg (5× večji odmerek od priporočenega) 15 zaporednih dni (3× daljše obdobje od priporočenega).
Maropitant displays linear kinetics when administered subcutaneously within the 0.25-3 mg/kg dose range. 
Maropitant kaže linearno kinetiko po subkutanem dajanju v odmerku 0,25-3 mg/kg.
Intravenous administration of Prevomax should be given as a single bolus without mixing the product with any other fluids. 
Zdravilo Prevomax je treba dajati intravensko kot poseben bolus brez mešanja zdravila z drugimi tekočinami.
• For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness. 
• Za preprečevanje bruhanja in zmanjšanje navzeje, razen tiste, ki je posledica slabosti zaradi vožnje
The veterinary medicinal product solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg of maropitant / kg bodyweight (1 ml/10 kg bodyweight) for up to 5 consecutive days. 
Zdravilo za uporabo v veterinarski medicini v obliki raztopine za injiciranje dajemo enkrat dnevno subkutano ali intravensko, v odmerku 1 mg maropitanta/kg telesne mase (1 ml/10 kg telesne mase) do 5 zaporednih dni.
Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 250%. 
Pri ponavljajočem se subkutanem dajanju 5 zaporednih dni, dnevni odmerek 1 mg/kg telesne mase, je akumulacija 250 %.
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: 
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml vsebuje: Zdravilna učinkovina: maropitant
Maropitant displays linear kinetics when administered subcutaneously within the 0.5-2 mg/kg dose range. 
Maropitant kaže linearno kinetiko po subkutanem dajanju v odmerku 0,5-2 mg/kg.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 
PODATKI NA ZUNANJI OVOJNINI Zunanja škatla
METHOD AND ROUTE(S) OF ADMINISTRATION SC, IV 
NAČIN IN POT(I) UPORABE ZDRAVILA s.c., i.v.
4.1 Target species 
Ciljne živalske vrste
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products 
Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
• For the prevention of vomiting except that induced by motion sickness. 
• Za preprečevanje bruhanja, razen bruhanja, ki je posledica slabosti zaradi vožnje
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 ml contains: 
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN 1 ml vsebuje: Zdravilna učinkovina: maropitant
As maropitant is accumulated in the body during a 14 day treatment period due to metabolic saturation, careful monitoring of liver function and any adverse events should be implemented during long term treatment. 
Med dolgotrajnim zdravljenjem je treba skrbno spremljati delovanje jeter in druge neželene učinke, ker se maropitant zaradi saturacije presnove med 14-dnevnim zdravljenjem kopiči v telesu.
NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Prevomax 10 mg/ml raztopina za injiciranje za pse in mačke
4.2 Indications for use, specifying the target species 
Indikacije za uporabo pri ciljnih živalskih vrstah Psi
5.2 Pharmacokinetic particulars 
Farmakokinetični podatki
PACKAGE LEAFLET: Prevomax 10 mg/ml solution for injection for dogs and cats 
NAVODILO ZA UPORABO: Prevomax 10 mg/ml raztopina za injiciranje za pse in mačke
NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats maropitant 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Prevomax 10 mg/ml raztopina za injiciranje za pse in mačke maropitant
The responsible veterinarian should make a benefit-risk assessment before using the veterinary medicinal product in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, or in pregnant or lactating bitches and cats. 
Pri psih, mlajših od 8 tednov, mačkah, mlajših od 16 tednov ter pri psicah in mačkah v obdobju brejosti in laktacije uporabite le v skladu z oceno koristi odgovornega veterinarja.
EXPIRY DATE EXP {month/year} Once broached use within 56 days. 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
Prevomax must not be mixed with other veterinary medicinal products in the same syringe as its compatibility with other products has not been tested. 
Zaradi pomanjkanja študij kompatibilnosti zdravila Prevomax ne smemo v isti brizgi mešati z drugimi zdravili za uporabo v veterinarski medicini.
ROUTE(S) OF ADMINISTRATION SC, IV 
POT(I) UPORABE ZDRAVILA s.c., i.v.
(3 weeks) 
(3 tedne)
If this happens, do not drive or use any tools or machines until you are feeling well again. 
Če pride do tega, ne vozite in ne upravljajte nobenih naprav ali strojev, dokler se ne počutite spet
Follow all your doctor's instructions carefully, even if they differ from the general information contained in 
Skrbno se ravnajte po vseh navodilih vašega zdravnika, tudi če se razlikujejo od splošnih informacij v
Results are provided in Table 5. 
Rezultati so prikazani v preglednici 5.
* Full follow-up period; NE - Not estimable 
* celotno obdobje spremljanja; NO - ni mogoče oceniti
ULN = upper limit of normal for the institution 
IULN = zgornja meja normalnih vrednosti, specifična za ustanovo
The median overall survival has not been reached. 
Mediano celotno preživetje ni bilo doseženo.
The Kaplan-Meier estimate for survival after 36-month follow-up is 68%. 
KaplanMeierjeva ocena za preživetje po 36-mesečnem spremljanju je 68 %.
could cause hepatitis B to become active again, which can be fatal in some cases. 
namreč lahko povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
There were no differences in response rates between the two dose groups. 
Med obema skupinama z različnima odmerkoma ni bilo razlik v odzivnosti.
Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria. 
Tumorji so morali biti merljivi vsaj na eni bolezenski lokaciji, karakterizacija odzivnosti pa je temeljila na merilih Southwestern Oncology Group (SWOG).
% of patients (CI95%) 
% bolnikov (IZ 95 %)
Optimal treatment duration is not yet established. 
Ustrezno trajanje zdravljenja še ni ugotovljeno.
- if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6). 
če ste alergični na imatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
36 months 48 months 60 months Survival 36 months 48 months 60 months 
12 mesecev 24 mesecev 36 mesecev 48 mesecev 60 mesecev preživetje 36 mesecev 48 mesecev 60 mesecev
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o
Dosing for children should be on the basis of body surface area (mg/m2). 
Odmerjanje za otroke mora temeljiti na telesni površini (mg/m2).
(Of note, out of the 411 patients, 353 were treated in an expanded access program without primary response data collected.) 
411 bolnikov jih je bilo 353 zdravljenih v programu razširjenega dostopa brez zbranih podatkov o primarnem odzivu.)
2031GA Haarlem Netherlands 
2031 GA Haarlem Nizozemska
Decreased values of albumin caused a reduced clearance (CL/f); and higher levels of WBC led to a reduction of CL/f. 
Zmanjšane vrednosti albumina so povzročile zmanjšan očistek (CL/f); večje koncentracije WBC so povzročile zmanjšanje CL/f.
Table 5 Best tumour response in trial STIB2222 (GIST) 
Najboljši tumorski odziv v preskušanju STIB2222 (GIST)
A major response combines both complete and partial responses: complete (0% Ph+ metaphases), 
Pomemben odziv združuje tako popolne kot delne odzive: popoln (0 % Ph+ metafaz),
Ki values in human liver microsomes were 27, 7.5 and 7.9 µmol/l, respectively. 
Vrednosti Ki v mikrosomih človeških jeter so bile 27, 7,5 oziroma 7,9 μmol/l.
If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight 
Če zdravila ne morete jemati tako, kot vam je predpisal zdravnik, ali se vam zdi, da zdravila ne potrebujete več, takoj
Women of childbearing potential must be advised to use effective contraception during treatment. 
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem uporabljajo učinkovito kontracepcijo.
The decreases in white blood cell (WBC) and neutrophil counts occurred mainly during the first six weeks of therapy, with values remaining relatively stable thereafter. 
(WBC - white blood cell) in nevtrofilcev je prišlo predvsem v prvih šestih tednih zdravljenja, zatem pa so vrednosti ostale relativno stabilne.
All doses (n=147) 400 mg (n=73) 600 mg (n=74) n (%) 
Vsi odmerki (n = 147) 400 mg (n = 73) 600 mg (n = 74) n (%)
These patients ranged in age from 18 to 83 years old and had a pathologic diagnosis of Kit-positive malignant GIST that was unresectable and/or metastatic. 
Ti bolniki so bili stari od 18 do 83 let in so imeli patološko diagnozo Kit-pozitivnega malignega GIST, ki je bil neresektabilen in/ali metastatičen.
A significant number of patients who had stable disease at the time of the interim analysis achieved a partial response with longer treatment (median follow-up 31 months). 
Pomembno število bolnikov, ki so imeli v času vmesne analize stabilno bolezen, je doseglo pri daljšem zdravljenju delni odziv (mediano obdobje spremljanja je bilo 31 mesecev).
AST: >ULN (can be normal or < ULN if total bilirubin is > ULN) 
AST: > IULN (lahko je normalna ali < IULN, če je celotni bilirubin >
However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by 
Vendar so bili ti edemi redko težki in jih lahko zdravimo z diuretiki, drugimi podpornimi ukrepi ali z
The median time of follow-up was 54 months (from date of randomisation to data cut-off), with a total of 83 months between the first patient randomised and the cut-off date. 
Srednja vrednost trajanja spremljanja bolnikov je bila 54 mesecev (od datuma randomizacije do predvidenega zaključka zbiranja podatkov), pri čemer je med randomizacijo prvega bolnika in datumom zaključka zbiranja podatkov minilo 83 mesecev.
It arises from uncontrolled cell growth of the supporting tissues of these organs. 
Nastane z nekontrolirano rastjo celic vezivnih tkiv teh organov.
In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of 
V vseh kliničnih študijah je bilo 38-40 % bolnikov, starih ≥ 60 let, 10-12 % bolnikov pa je bilo starih ≥ 70 let.
Patients who have a low or very low risk of recurrence should not receive adjuvant treatment. 
Bolniki z majhnim ali zelo majhnim tveganjem za ponovitev bolezni ne smejo prejemati adjuvantnega zdravljenja;
Frequency categories are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). 
Kategorije pogostnosti so opredeljene z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
(Confirmed3) [95% CI] Partial 
(potrjen3) [95 %-ni interval zaupanja]
The long-term effects of prolonged treatment with imatinib on growth in children are unknown. 
Dolgoročni učinki na rast pri dolgotrajni uporabi imatiniba pri otrocih niso znani.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver 
• ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba
Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent 
V razvrstitvah pogostnosti so neželeni učinki navedeni po pogostnosti, najpogostejši najprej.
The effect of stopping treatment after achieving a response has not been investigated. 
Učinek prekinitve zdravljenja po doseženem odzivu ni raziskan.
GIST is a cancer of the stomach and bowels. 
GIST je rak želodca in črevesa.
The majority of paediatric patients treated for GIST lacked data confirming c-kit or PDGFR mutations which may have led to mixed clinical outcomes. 
Pri večini pediatričnih bolnikov, ki so jih zdravili zaradi GIST, ni bilo na voljo podatkov za potrditev mutacije c-kit ali PDGFR, ki bi lahko povzročile mešane klinične izide.
However, these associations are not sufficiently pronounced to warrant dose adjustment. 
Vendar te povezave niso dovolj izrazite, da bi bila potrebna prilagoditev odmerka.
Mitotic index data were available for 556 of the 713 intention-to-treat (ITT) population. 
Podatki o mitotskem indeksu so bili dostopni za 556 od 713 bolnikov, ki so jih nameravali zdraviti v študiji
The safety and efficacy of imatinib in children with MDS/MPD, DFSP, GIST and HES/CEL aged less than 18 years of age have not been established in clinical trials. 
Varnost in učinkovitost imatiniba pri otrocih, ki imajo MDS/MPD, DFSP in HES/CEL in so stari manj kot 18 let, nista bili dokazani v kliničnih preskušanjih.
At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months). 
V času analize je bilo mediano trajanje zdravljenja 7 mesecev (7 dni do 13 mesecev).
The results of subgroup analyses according to the United States National Institutes of Health (NIH) and the Armed Forces Institute of Pathology (AFIP) risk classifications are shown in Table 6. 
Ameriškega državnega inštituta za zdravje (United States National Institutes of Health - NIH) in Inštituta za patologijo ameriških kopenskih sil (AFIP - Armed Forces Institute of Pathology), so prikazani v preglednici 6.
Some children and adolescents taking Imatinib Teva B.V. may have slower than normal growth. 
Pri nekaterih otrocih in mladostnikih, ki jemljejo zdravilo Imatinib Teva B.V., je lahko rast počasnejša od normalne.
If it is used during pregnancy, the patient must be informed of the potential risk to the foetus. 
Če se uporablja med nosečnostjo, je treba bolnico poučiti o možnih nevarnostih za
The safety database for children with Ph+ALL is very limited though no new safety 
Čeprav je baza podatkov za otroke s Ph+ ALL zelo majhna, zaenkrat niso odkrili nobenih novih
Older people: Imatinib pharmacokinetics have not been specifically studied in older people. 
Farmakokinetike imatiniba pri starejših niso posebej proučili.
Hands should be washed immediately after handling open capsules. 
Takoj po rokovanju z odprtimi kapsulami si je treba umiti
* These types of reactions have been reported mainly from post-marketing experience with imatinib. 
* O teh vrstah neželenih učinkov so poročali večinoma v okviru izkušenj v obdobju trženja imatiniba.
Detailed information on this medicine is available on the European Medicines Agency web 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
The risk of recurrence in patients after surgery of their primary GIST was retrospectively assessed based on the following prognostic factors: tumour size, mitotic index, tumour location. 
Tveganje za ponovitev bolezni pri bolnikih po operaciji primarnega GIST so ocenjevali retrospektivno glede na naslednje prognostične dejavnike: velikost tumorja, mitotski indeks in mesto tumorja.
The primary endpoint of the study was recurrence-free survival (RFS), defined as the time from date of randomisation to the date of recurrence or death from any cause. 
Primarni cilj opazovanja te študije je bilo preživetje brez ponovitve bolezni (RFS), ki je bilo opredeljeno kot čas od dneva randomizacije do dneva ponovitve bolezni ali smrti iz kateregakoli
The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet 
Mehanizem in pomen teh ugotovitev iz študij karcinogenosti pri podganah za ljudi doslej še nista
Unchanged imatinib accounted for 25% of the dose (5% urine, 20% faeces), the remainder being metabolites. 
Nespremenjeni imatinib je predstavljal 25 % odmerka (5 % v urinu, 20 % v blatu), preostanek pa so
• The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. 
• adjuvantno zdravljenje odraslih bolnikov s precejšnjim tveganjem za relaps po resekciji GIST, pozitivnega na Kit (CD117).
If you take more Imatinib Teva B.V. than you should If you have accidentally taken too many tablets, talk to your doctor straight away. 
Če ste vzeli večji odmerek zdravila Imatinib Teva B.V., kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte z zdravnikom.
Treatment with imatinib may be interrupted or the dose may be reduced, as recommended in section 
Zdravljenje z imatinibom lahko prekinemo ali odmerek zmanjšamo, kot je priporočeno v poglavju 4.2.
- Swallow the tablets whole with a large glass of water. 
Tablete pogoltnite cele z velikim kozarcem vode.
No conclusions can be drawn for other less common mutation subgroups due to the low number of observed events. 
Za druge podskupine z manj pogostimi mutacijami zaključkov ni mogoče podati, ker je bilo število opazovanih dogodkov premajhno.
- The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow 
- Obloga tablete vsebuje polivinilalkohol delno hidroliziran, makrogol, rumeni železov oksid
8 to 10 g (single dose): Vomiting and gastrointestinal pain have been reported. 
Odmerki od 8 g do 10 g (enkratni odmerki): opisovali so bruhanje in bolečine v prebavilih.
The content of the capsule is white to light yellow granulated powder. 
Vsebina kapsule je bel do svetlo rumen granuliran prašek.
• Adult patients with Ph+ CML in blast crisis. 
• odraslih bolnikov s Ph+ KML v blastni krizi;
This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. 
Zdravilo deluje tako, da zavira rast nenormalnih celic pri spodaj navedenih boleznih, med katerimi so tudi nekatere
The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly. 
Gre za približno 1,5 do 2-kratno zvišanje, ki ustreza 1,5kratnemu zvišanju alfa kislega proteina v plazmi, na katerega se imatinib močno veže.
Patients were included who had a histological diagnosis of primary GIST expressing Kit protein by immunochemistry and a tumour size ≥ 3 cm in maximum dimension, with complete gross resection of primary GIST within 14-70 days prior to registration. 
Vključili so bolnike, ki so imeli histološko diagnozo primarnega GIST z imunokemično določenim izražanjem proteina Kit in velikost tumorja ≥ 3 cm v največjem premeru ter makroskopsko popolnoma odstranjen primarni GIST v 14-70 dneh pred vključitvijo v študijo.