FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Prevomax 10 mg/ml raztopina za injiciranje za pse in mačke
English: 4.2 Indications for use, specifying the target species
Slovenian: Indikacije za uporabo pri ciljnih živalskih vrstah Psi
English: 5.2 Pharmacokinetic particulars
Slovenian: Farmakokinetični podatki
English: PACKAGE LEAFLET: Prevomax 10 mg/ml solution for injection for dogs and cats
Slovenian: NAVODILO ZA UPORABO: Prevomax 10 mg/ml raztopina za injiciranje za pse in mačke
English: Le Vet Beheer B.V. Wilgenweg 7
Slovenian: Le Vet Beheer B.V.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats maropitant
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Prevomax 10 mg/ml raztopina za injiciranje za pse in mačke maropitant
English: 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.
Slovenian: 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.
English: EXPIRY DATE EXP {month/year} Once broached use within 56 days.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP {mesec/leto}
English: Prevomax must not be mixed with other veterinary medicinal products in the same syringe as its compatibility with other products has not been tested.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila Prevomax ne smemo v isti brizgi mešati z drugimi zdravili za uporabo v veterinarski medicini.
English: ROUTE(S) OF ADMINISTRATION SC, IV
Slovenian: POT(I) UPORABE ZDRAVILA s.c., i.v.
English: (3 weeks)
Slovenian: (3 tedne)
English: If this happens, do not drive or use any tools or machines until you are feeling well again.
Slovenian: Če pride do tega, ne vozite in ne upravljajte nobenih naprav ali strojev, dokler se ne počutite spet
English: Follow all your doctor's instructions carefully, even if they differ from the general information contained in
Slovenian: Skrbno se ravnajte po vseh navodilih vašega zdravnika, tudi če se razlikujejo od splošnih informacij v
English: Results are provided in Table 5.
Slovenian: Rezultati so prikazani v preglednici 5.
English: * Full follow-up period; NE - Not estimable
Slovenian: * celotno obdobje spremljanja; NO - ni mogoče oceniti
English: ULN = upper limit of normal for the institution
Slovenian: IULN = zgornja meja normalnih vrednosti, specifična za ustanovo
English: The median overall survival has not been reached.
Slovenian: Mediano celotno preživetje ni bilo doseženo.
English: The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
Slovenian: KaplanMeierjeva ocena za preživetje po 36-mesečnem spremljanju je 68 %.
English: could cause hepatitis B to become active again, which can be fatal in some cases.
Slovenian: namreč lahko povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
English: There were no differences in response rates between the two dose groups.
Slovenian: Med obema skupinama z različnima odmerkoma ni bilo razlik v odzivnosti.
English: Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria.
Slovenian: Tumorji so morali biti merljivi vsaj na eni bolezenski lokaciji, karakterizacija odzivnosti pa je temeljila na merilih Southwestern Oncology Group (SWOG).
English: % of patients (CI95%)
Slovenian: % bolnikov (IZ 95 %)
English: Optimal treatment duration is not yet established.
Slovenian: Ustrezno trajanje zdravljenja še ni ugotovljeno.
English: - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: če ste alergični na imatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: 36 months 48 months 60 months Survival 36 months 48 months 60 months
Slovenian: 12 mesecev 24 mesecev 36 mesecev 48 mesecev 60 mesecev preživetje 36 mesecev 48 mesecev 60 mesecev
English: 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
Slovenian: 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
English: Dosing for children should be on the basis of body surface area (mg/m2).
Slovenian: Odmerjanje za otroke mora temeljiti na telesni površini (mg/m2).
English: (Of note, out of the 411 patients, 353 were treated in an expanded access program without primary response data collected.)
Slovenian: 411 bolnikov jih je bilo 353 zdravljenih v programu razširjenega dostopa brez zbranih podatkov o primarnem odzivu.)
English: 2031GA Haarlem Netherlands
Slovenian: 2031 GA Haarlem Nizozemska
English: Decreased values of albumin caused a reduced clearance (CL/f); and higher levels of WBC led to a reduction of CL/f.
Slovenian: Zmanjšane vrednosti albumina so povzročile zmanjšan očistek (CL/f); večje koncentracije WBC so povzročile zmanjšanje CL/f.
English: Table 5 Best tumour response in trial STIB2222 (GIST)
Slovenian: Najboljši tumorski odziv v preskušanju STIB2222 (GIST)
English: A major response combines both complete and partial responses: complete (0% Ph+ metaphases),
Slovenian: Pomemben odziv združuje tako popolne kot delne odzive: popoln (0 % Ph+ metafaz),
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 µmol/l, respectively.
Slovenian: Vrednosti Ki v mikrosomih človeških jeter so bile 27, 7,5 oziroma 7,9 μmol/l.
English: 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
Slovenian: Če zdravila ne morete jemati tako, kot vam je predpisal zdravnik, ali se vam zdi, da zdravila ne potrebujete več, takoj
English: Women of childbearing potential must be advised to use effective contraception during treatment.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem uporabljajo učinkovito kontracepcijo.
English: 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.
Slovenian: (WBC - white blood cell) in nevtrofilcev je prišlo predvsem v prvih šestih tednih zdravljenja, zatem pa so vrednosti ostale relativno stabilne.
English: All doses (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
Slovenian: Vsi odmerki (n = 147) 400 mg (n = 73) 600 mg (n = 74) n (%)
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: AST: >ULN (can be normal or < ULN if total bilirubin is > ULN)
Slovenian: AST: > IULN (lahko je normalna ali < IULN, če je celotni bilirubin >
English: However, these oedemas were rarely severe and may be managed with diuretics, other supportive measures, or by
Slovenian: Vendar so bili ti edemi redko težki in jih lahko zdravimo z diuretiki, drugimi podpornimi ukrepi ali z
English: 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.
Slovenian: 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.
English: It arises from uncontrolled cell growth of the supporting tissues of these organs.
Slovenian: Nastane z nekontrolirano rastjo celic vezivnih tkiv teh organov.
English: In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of
Slovenian: V vseh kliničnih študijah je bilo 38-40 % bolnikov, starih ≥ 60 let, 10-12 % bolnikov pa je bilo starih ≥ 70 let.
English: Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
Slovenian: Bolniki z majhnim ali zelo majhnim tveganjem za ponovitev bolezni ne smejo prejemati adjuvantnega zdravljenja;
English: 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).
Slovenian: 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).
English: (Confirmed3) [95% CI] Partial
Slovenian: (potrjen3) [95 %-ni interval zaupanja]
English: The long-term effects of prolonged treatment with imatinib on growth in children are unknown.
Slovenian: Dolgoročni učinki na rast pri dolgotrajni uporabi imatiniba pri otrocih niso znani.
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver
Slovenian: • ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba
English: Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po pogostnosti, najpogostejši najprej.
English: The effect of stopping treatment after achieving a response has not been investigated.
Slovenian: Učinek prekinitve zdravljenja po doseženem odzivu ni raziskan.
English: GIST is a cancer of the stomach and bowels.
Slovenian: GIST je rak želodca in črevesa.
English: The majority of paediatric patients treated for GIST lacked data confirming c-kit or PDGFR mutations which may have led to mixed clinical outcomes.
Slovenian: 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.
English: However, these associations are not sufficiently pronounced to warrant dose adjustment.
Slovenian: Vendar te povezave niso dovolj izrazite, da bi bila potrebna prilagoditev odmerka.
English: Mitotic index data were available for 556 of the 713 intention-to-treat (ITT) population.
Slovenian: Podatki o mitotskem indeksu so bili dostopni za 556 od 713 bolnikov, ki so jih nameravali zdraviti v študiji
English: 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.
Slovenian: 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.
English: At the time of analysis, the treatment duration was a median of 7 months (7 days to 13 months).
Slovenian: V času analize je bilo mediano trajanje zdravljenja 7 mesecev (7 dni do 13 mesecev).
English: 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.
Slovenian: 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.
English: Some children and adolescents taking Imatinib Teva B.V. may have slower than normal growth.
Slovenian: Pri nekaterih otrocih in mladostnikih, ki jemljejo zdravilo Imatinib Teva B.V., je lahko rast počasnejša od normalne.
English: If it is used during pregnancy, the patient must be informed of the potential risk to the foetus.
Slovenian: Če se uporablja med nosečnostjo, je treba bolnico poučiti o možnih nevarnostih za
English: The safety database for children with Ph+ALL is very limited though no new safety
Slovenian: Čeprav je baza podatkov za otroke s Ph+ ALL zelo majhna, zaenkrat niso odkrili nobenih novih
English: Older people: Imatinib pharmacokinetics have not been specifically studied in older people.
Slovenian: Farmakokinetike imatiniba pri starejših niso posebej proučili.
English: Hands should be washed immediately after handling open capsules.
Slovenian: Takoj po rokovanju z odprtimi kapsulami si je treba umiti
English: * These types of reactions have been reported mainly from post-marketing experience with imatinib.
Slovenian: * O teh vrstah neželenih učinkov so poročali večinoma v okviru izkušenj v obdobju trženja imatiniba.
English: Detailed information on this medicine is available on the European Medicines Agency web
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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
English: The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet
Slovenian: Mehanizem in pomen teh ugotovitev iz študij karcinogenosti pri podganah za ljudi doslej še nista
English: Unchanged imatinib accounted for 25% of the dose (5% urine, 20% faeces), the remainder being metabolites.
Slovenian: Nespremenjeni imatinib je predstavljal 25 % odmerka (5 % v urinu, 20 % v blatu), preostanek pa so
English: • The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
Slovenian: • adjuvantno zdravljenje odraslih bolnikov s precejšnjim tveganjem za relaps po resekciji GIST, pozitivnega na Kit (CD117).
English: 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.
Slovenian: Če ste vzeli večji odmerek zdravila Imatinib Teva B.V., kot bi smeli Če ste pomotoma vzeli preveč tablet, se nemudoma posvetujte z zdravnikom.
English: Treatment with imatinib may be interrupted or the dose may be reduced, as recommended in section
Slovenian: Zdravljenje z imatinibom lahko prekinemo ali odmerek zmanjšamo, kot je priporočeno v poglavju 4.2.
English: - Swallow the tablets whole with a large glass of water.
Slovenian: Tablete pogoltnite cele z velikim kozarcem vode.
English: No conclusions can be drawn for other less common mutation subgroups due to the low number of observed events.
Slovenian: Za druge podskupine z manj pogostimi mutacijami zaključkov ni mogoče podati, ker je bilo število opazovanih dogodkov premajhno.
English: - The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow
Slovenian: - Obloga tablete vsebuje polivinilalkohol delno hidroliziran, makrogol, rumeni železov oksid
English: 8 to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Slovenian: Odmerki od 8 g do 10 g (enkratni odmerki): opisovali so bruhanje in bolečine v prebavilih.
English: The content of the capsule is white to light yellow granulated powder.
Slovenian: Vsebina kapsule je bel do svetlo rumen granuliran prašek.
English: • Adult patients with Ph+ CML in blast crisis.
Slovenian: • odraslih bolnikov s Ph+ KML v blastni krizi;
English: This medicine works by inhibiting the growth of abnormal cells in the diseases listed below.
Slovenian: Zdravilo deluje tako, da zavira rast nenormalnih celic pri spodaj navedenih boleznih, med katerimi so tudi nekatere
English: The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Slovenian: Učinkovina imatinib predstavlja okoljsko tveganje za organizme v sedimentih.
English: In clinical trials, there was an increased incidence of these events in older people and those with a prior history of cardiac disease.
Slovenian: V kliničnih preskušanjih so bili ti učinki pogostejši pri starejših in pri bolnikih z anamnezo bolezni srca.
English: Length of treatment in the clinical trial supporting this indication was 36 months (see section 5.1).
Slovenian: V kliničnem preskušanju za navedeno indikacijo je zdravljenje trajalo 36 mesecev (glejte poglavje 5.1).
English: The ages of these patients ranged from 18 to 91 years.
Slovenian: Starost bolnikov je segala od 18 do 91 let.
English: In the adjuvant setting, imatinib was investigated in a multicentre, double-blind, long-term, placebocontrolled phase III study (Z9001) involving 773 patients.
Slovenian: V okviru adjuvantnega zdravljenja so imatinib raziskovali v multicentrični, dvojno slepi, dolgoročni, s placebom kontrolirani študiji faze III (Z9001), ki je vključevala 773 bolnikov.
English: Your doctor has prescribed Imatinib Teva B.V. because you suffer from a serious condition.
Slovenian: Zdravnik vam je predpisal zdravilo Imatinib Teva B.V., ker imate resno bolezen.
English: Pharmacotherapeutic group: Protein kinase inhibitors, ATC code: L01XE01
Slovenian: Farmakoterapevtska skupina: zaviralec proteinskih kinaz, oznaka ATC: L01XE01
English: The diameter of the film-coated tablet is
Slovenian: Premer filmsko obložene tablete je
English: Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Slovenian: Blastno krizo opredeljuje ≥ 30 % blastov v krvi ali kostnem mozgu ali ekstramedularna bolezen, ki ni
English: In this patient population, the presence of hepatic metastases could potentially lead to hepatic insufficiency and reduced metabolism.
Slovenian: V tej skupini bolnikov bi lahko prisotnost metastaz v jetrih povzročila insuficienco jeter in zmanjšano presnovo.
English: 3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study
Slovenian: 3Popoln citogenetični odziv, potrjen z drugo citogenetično oceno kostnega mozga, opravljeno vsaj en mesec po prvi študiji kostnega mozga.
English: 36-month treatment arm % (CI)
Slovenian: skupina z 36-mesečnim zdravljenjem % (IZ)
English: When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17
Slovenian: Če se delež odziva izračuna pri bolnikih z vsaj eno veljavno oceno je delež odziva 20/22 (90,9 %) za CHR, 9/9 (100 %) za CCyR in
English: EU/1/17/1243/001 20x1 film-coated tablets EU/1/17/1243/002 60 film-coated tablets EU/1/17/1243/003 60x1 film-coated tablets EU/1/17/1243/004 120 film-coated tablets EU/1/17/1243/005 120x1 film-coated tablets EU/1/17/1243/006 180x1 film-coated tablets EU/1/17/1243/007 20x1 film-coated tablets EU/1/17/1243/008 60 film-coated tablets EU/1/17/1243/009 60x1 film-coated tablets EU/1/17/1243/010 120 film-coated tablets EU/1/17/1243/011 120x1 film-coated tablets EU/1/17/1243/012 180x1 film-coated tablets imatinib teva b.v. 100 mg film-coated tablets
Slovenian: EU/1/17/1243/001 20x1 filmska obložena tableta EU/1/17/1243/002 60 filmsko obloženih tablet EU/1/17/1243/003 60x1 filmsko obložena tableta EU/1/17/1243/004 120 filmsko obloženih tablet EU/1/17/1243/005 120x1 filmsko obložena tableta EU/1/17/1243/006 180x1 filmsko obložena tableta EU/1/17/1243/007 20x1 filmska obložena tableta EU/1/17/1243/008 60 filmsko obloženih tablet EU/1/17/1243/009 60x1 filmsko obložena tableta EU/1/17/1243/010 120 filmsko obloženih tablet EU/1/17/1243/011 120x1 filmsko obložena tableta EU/1/17/1243/012 180x1 filmsko obložena tableta
English: You should wash your hands immediately after opening the capsules.
Slovenian: Takoj po odpiranju kapsul si
English: Resume treatment with imatinib at 600 mg. 3.
Slovenian: Spet začnite zdravljenje z imatinibom z odmerkom 600 mg.
English: Clinical studies in adjuvant GIST
Slovenian: Klinične študije z adjuvantnim zdravljenjem GIST
English: No conclusions can be drawn for other less common mutation subgroups due to the low number of observed
Slovenian: Za druge podskupine z manj pogostimi mutacijami zaključkov ni mogoče podati, ker je bilo število opazovanih
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at
Slovenian: 12 Gy v 8 frakcijah za vse bolnike, ki imajo ob postavitvi diagnoze CNS1
English: No benefit was observed in the low and very low risk groups.
Slovenian: V skupinah bolnikov z majhnim oziroma z zelo majhnim tveganjem niso opažali nobene koristi zdravljenja.
English: Imatinib administration to patients without the genetic translocation generally results in no
Slovenian: Uporaba imatiniba pri bolnikih brez genetske translokacije večinoma ni povzročila izboljšanja.
English: However, since the effects of low-dose exposure of the infant to imatinib are unknown, women taking imatinib should not breast-feed.
Slovenian: Vendar učinki izpostavljenosti dojenčka majhnim odmerkom imatiniba niso znani, zato ženske, ki jemljejo imatinib,
English: The high rate of CHR is accompanied by the development of a complete cytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Slovenian: complete cytogenetic response) v 65 %, kar je primerljivo z zabeleženimi rezultati pri odraslih.
English: In patients with GIST steady-state exposure was 1.5-fold higher than that observed for CML patients for the same dosage (400 mg daily).
Slovenian: Pri bolnikih z GIST je bila izpostavljenost v stanju dinamičnega ravnovesja 1,5-krat večja od tiste, ki je bila opazovana pri bolnikih s KML pri enakem odmerjanju (400 mg na dan).
English: After resection of primary GIST, patients were randomised to one of the two arms: imatinib at 400 mg/day or matching placebo for one year.
Slovenian: Po resekciji primarnega GIST so bolnike randomizirali v enega od dveh krakov: z imatinibom v odmerku 400 mg/dan ali s skladnim placebom za eno leto.
English: If this applies to you, tell your doctor without taking Imatinib Teva B.V.
Slovenian: Če to velja za vas, povejte zdravniku in ne jemljite zdravila Imatinib Teva B.V.