FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Estonian: Kassidele subkutaanselt manustatud maropitandi ühekordse annuse 1 mg/kg farmakokineetilist profiili iseloomustab maksimaalne plasmakontsentratsioon (Cmax) ligikaudu 165 ng/ml, mis saabus 0,32 tunni (19 min) jooksul pärast ravimi manustamist (Tmax).
English: To prevent vomiting, Prevomax solution for injection should be administered more than 1 hour in advance.
Estonian: Oksendamise ennetamiseks tuleb Prevomaxi süstelahust manustada rohkem kui 1 tund enne soovitud toime algust.
English: Increases of approximately 10% in the QT interval of the ECG were observed in a study on healthy Beagle dogs administered 8 mg/kg orally; however, such an increase is unlikely to be of clinical significance.
Estonian: Tervetel hagijatel (beagle), kellele manustati suu kaudu 8 mg/kg maropitanti, täheldati EKG-uuringul QT-intervalli pikenemist ligikaudu 10%, kuid tõenäoliselt ei ole see suurenemine kliiniliselt oluline.
English: The volume of distribution at steady-state (Vss) was 9.3 l/kg and systemic clearance was 1.5 l/h/kg.
Estonian: Tasakaaluseisundis oli jaotusruumala (Vss) 9,3 l/kg ja süsteemne kliirens 1,5 l/h/kg.
English: 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).
Estonian: Koertele subkutaanselt manustatud maropitandi ühekordse annuse 1 mg/kg farmakokineetilist profiili iseloomustab maksimaalne plasmakontsentratsioon (Cmax) ligikaudu 92 ng/ml, mis tekkis 0,75 tunni jooksul pärast ravimi manustamist (Tmax).
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated)
Estonian: Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast) - sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast) - aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast) - harv (rohkem kui 1-l, kuid vähem kui 10-l loomal 10000-st ravitud loomast) - väga harv (vähem kui 1-l loomal 10 000-st ravitud loomast, kaasaarvatud üksikjuhud)
English: Intravenous administration of Prevomax should be given as a single bolus without mixing the product with any other fluids.
Estonian: Prevomaxi intravenoosne manustamine peab toimuma üksiku boolussüstina, segamata ravimit ühegi teise vedelikuga.
English: Signs of nausea in dogs including excessive salivation and lethargy might remain after treatment.
Estonian: Ravi järel võivad koertel püsida iivelduse nähud, sealhulgas süljevoolus ja letargia.
English: Maropitant is metabolised in the liver and therefore should be used with caution in patients with hepatic disease.
Estonian: Maropitant metaboliseerub maksas ja seega tuleb ravimit maksahaigusega loomadel kasutada ettevaatlikult.
English: Intravenous administration of the veterinary medicinal product should be given as a single bolus without mixing the product with any other fluids.
Estonian: Veterinaarravimi intravenoosne manustamine peab toimuma ühe boolussüstina, segamata ravimit muude vedelikega.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Välispakend
English: TARGET SPECIES Dogs and cats.
Estonian: LOOMALIIGID Koerad ja kassid.
English: Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.
Estonian: Oksendamine võib olla seotud raskete, üldseisundit oluliselt halvendavate seisunditega, sealhulgas seedetrakti obstruktsiooniga.
English: Renal clearance is a minor route of elimination, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine as either maropitant or its major metabolite.
Estonian: Neerukliirensi osa eliminatsioonist on väike - uriiniga eritub maropitandi või selle peamise metaboliidina vähem kui 1% 1 mg/kg subkutaanselt manustatud annusest.
English: EXP Once broached use within 56 days.
Estonian: Pärast esmast avamist kasutada 56 päeva jooksul.
English: 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).
Estonian: Prevomaxi süstelahust tuleb süstida subkutaanselt (naha alla) või intraventoosselt (veeni) üks kord ööpäevas annuses 1 mg maropitanti kehamassi kilogrammi kohta (1 ml 10 kg kehamassi kohta).
English: • For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness.
Estonian: • Oksendamise ennetamiseks ja iivelduse vähendamiseks, välja arvatud kinetoosist tingitud probleemide korral.
English: Česká republika Sevaron ltd Palackeho trida 163 a 61200 Brno Tel. +420 541 426 370
Estonian: Palackeho trida 163 a 61200 Brno Tel. +420 541 426 370
English: The use of Prevomax solution for injection against vomiting due to motion sickness is not recommended.
Estonian: Prevomaxi süstelahust ei soovitata kasutada kinetoosist (liikumisest) tingitud oksendamise vastu.
English: Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 146%.
Estonian: Annuse 1 mg/kg korduval subkutaansel manustamisel 5 järjestikusel akumuleerus ravim 146%.
English: Plasma protein binding of maropitant in cats was estimated to be 99.1%.
Estonian: Kassidel seondub maropitant 99,1% ulatuses plasmavalkudega.
English: • For the treatment and prevention of nausea induced by chemotherapy.
Estonian: • Keemiaravist tingitud iivelduse raviks ja ennetamiseks.
English: Renal and faecal clearances are minor routes of elimination for maropitant, with less than 1% of a 1 mg/kg subcutaneous dose appearing in the urine or faeces as maropitant.
Estonian: Neeru- ja roojakliirensi osa eliminatsioonist on väike - uriini või roojaga eritub maropitandi või selle peamise metaboliidina vähem kui 1% 1 mg/kg subkutaanselt manustatud annusest.
English: Following repeated subcutaneous administration of once-daily doses of 1 mg/kg bodyweight for five consecutive days, accumulation was 250%.
Estonian: Annuse 1 mg/kg korduval subkutaansel manustamisel 5 järjestikusel akumuleerus ravim 250%.
English: CYP2D15 and CYP3A12 were identified as the canine isoforms involved in the hepatic biotransformation of maropitant.
Estonian: Koertel osalevad maropitandi biotransformatsioonil maksas CYP2D15 ja CYP3A12 isovormid.
English: Pain at injection site may occur when injected subcutaneously.
Estonian: Subkutaansel süstimisel võib esineda süstekoha valu.
English: CYP1A and CYP3A-related enzymes were identified as the feline isoforms involved in the hepatic biotransformation of maropitant.
Estonian: Kassidel osalevad maropitandi biotransformatsioonil maksas CYP1A- ja CYP3A-sarnased ensüümid.
English: C. STATEMENT OF THE MRLs Not applicable.
Estonian: RAVIMJÄÄKIDE PIIRNORMID Ei rakendata.
English: Maropitant displays linear kinetics when administered subcutaneously within the 0.25-3 mg/kg dose range.
Estonian: Maropitandi kineetika subkutaansel manustamisel annusevahemikus 0,25...3 mg/kg on lineaarne.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats
Estonian: VETERINAARRAVIMI NIMETUS Prevomax 10 mg/ml süstelahus koertele ja kassidele
English: Maropitant displays linear kinetics when administered subcutaneously within the 0.5-2 mg/kg dose range.
Estonian: Maropitandi kineetika subkutaansel manustamisel annusevahemikus 0,5...2 mg/kg on lineaarne.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Prevomax 10 mg/ml solution for injection for dogs and cats Maropitant
Estonian: VETERINAARRAVIMI NIMETUS Prevomax 10 mg/ml süstelahus koertele ja kassidele maropitant
English: • For the prevention of vomiting except that induced by motion sickness.
Estonian: • Oksendamise, välja arvatud kinetoosist tingitud oksendamise ennetamiseks.
English: Le Vet Beheer B.V. Wilgenweg 7
Estonian: Le Vet Beheer B.V.
English: Read the package leaflet before use.
Estonian: ERIHOIATUS(ED), KUI VAJALIK Enne ravimi kasutamist lugege pakendi infolehte.
English: PACKAGE LEAFLET: Prevomax 10 mg/ml solution for injection for dogs and cats
Estonian: PAKENDI INFOLEHT Prevomax 10 mg/ml süstelahus koertele ja kassidele
English: ROUTE(S) OF ADMINISTRATION SC, IV
Estonian: Česká republika Sevaron ltd
English: METHOD AND ROUTE(S) OF ADMINISTRATION SC, IV
Estonian: MANUSTAMISVIIS(ID) Subkutaanne, intravenoosne
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 ml contains:
Estonian: TOIMEAINETE JA ABIAINETE SISALDUS 1 ml sisaldab: Toimeaine: Maropitant
English: monthly for 13 months;
Estonian: igakuiselt 13 kuu jooksul;
English: Results are provided in Table 5.
Estonian: Tulemused on toodud tabelis 5.
English: No benefit was observed in the low and very low risk groups.
Estonian: Kasu ei täheldatud ei madalas ega ka väga madalas riskigrupis.
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
Estonian: Kui te ei suuda ravimit võtta nii, nagu arst määras, või kui te tunnete, et seda enam ei vaja, võtke otsekohe ühendust oma arstiga.
English: Tumours were required to be measurable in at least one site of disease, and response characterisation based on Southwestern Oncology Group (SWOG) criteria.
Estonian: Kasvajad pidid olema mõõdetavad vähemalt haiguse ühe paikme osas ning vastuse iseloomustus põhines Southwestern Oncology Group'i (SWOG) kriteeriumitel.
English: There were no differences in response rates between the two dose groups.
Estonian: Kahe annustamisrühma vahel puudusid erinevused.
English: Mitotic index data were available for 556 of the 713 intention-to-treat (ITT) population.
Estonian: Mitootilise indeksi andmed olid saadud 556 patsiendi kohta 713-st ITT (intention-to-treat) populatsioonis.
English: Studies on patients receiving imatinib and its effect on fertility and gametogenesis have not been performed.
Estonian: Uuringuid patsientidel, kes on saanud imatiniibi ning selle mõju kohta fertiilsusele ja gametogeneesile ei ole läbi viidud.
English: Longer duration of the treatment (> 36 months) may delay the onset of further recurrences; however the impact of this finding on the overall survival remains unknown.
Estonian: Pikem ravi kestus (> 36 kuud) võib hilisemate retsidiivide puhkemist edasi lükata; siiski ei ole selle leiu mõju üldisele elulemusele selge.
English: a occurring at least after 1 month of treatment
Estonian: a pärast vähemalt ühekuulist ravi
English: The median overall survival has not been reached.
Estonian: Üldise elulemuse mediaantaset ei ole saavutatud.
English: Table 5 Best tumour response in trial STIB2222 (GIST)
Estonian: Tabel 5 Parim kasvaja ravivastus uuringus STIB2222 (GIST)
English: If this happens, do not drive or use any tools or machines until you are feeling well again.
Estonian: Kui see juhtub teiega, ärge juhtige autot ega töötage mingite masinate või mehhanismidega kuni te tunnete end
English: Optimal treatment duration is not yet established.
Estonian: Optimaalne ravi kestus ei ole teada.
English: This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications.
Estonian: Siia kuuluvad kõrvaltoime teatised ja ka tõsised kõrvaltoimed hetkel käimasolevatest uuringutest, laiendatud juurdepääsu programmidest, kliinilise farmakoloogia uuringutest ja kinnitamata näidustuste uuringutest.
English: The doctor will monitor the growth at regular visits.
Estonian: Arst jälgib pikkuskasvu korralistel visiitidel.
English: All doses (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
Estonian: Kõik annused (n=147) 400 mg (n=73) 600 mg (n=74) n (%)
English: In this study, 31% of patients achieved a haematological response (36% in previously untreated patients and 22% in previously treated patients).
Estonian: Selles uuringus saavutasid 31% patsientidest hematoloogilise vastuse (36% eelnevalt ravimata patsientidest ja 22% eelnevalt ravitud patsientidest).
English: Slowing of growth in children and adolescents.
Estonian: - kasvu aeglustumine lastel ja noorukitel.
English: No overall survival benefit has been observed.
Estonian: Üleüldist kasu elulemusele ei ole täheldatud.
English: could cause hepatitis B to become active again, which can be fatal in some cases.
Estonian: võib põhjustada B-hepatiidi taasaktiveerumist, mis võib mõnel juhul põhjustada surma.
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).
Estonian: Oluline hulk patsiente, kellel vaheanalüüsi tegemise ajal oli haigus stabiilne, saavutasid osalise ravivastuse pikema ravi jooksul (jälgimise mdiaanaeg 31 kuud).
English: • Eye pain or deterioration in vision, bleeding in the eyes.
Estonian: - Valu silmades või nägemise halvenemine, veritsus silmades.
English: Follow all your doctor's instructions carefully, even if they differ from the general information contained in
Estonian: Järgige hoolikalt kõiki arsti juhiseid ka juhul, kui need erinevad käesolevas infolehes toodud
English: The median duration of the neutropenic and thrombocytopenic episodes usually ranged from 2 to 3 weeks, and from 3 to 4 weeks, respectively.
Estonian: Neutropeenia ja trombotsütopeenia episoodide mediaankestus oli tavaliselt vastavalt kaks kuni kolm nädalat ja kolm kuni neli nädalat.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja blistril pärast „Kõlblik kuni:“ või „EXP“.
English: (1 h), days 26, 46;
Estonian: (1 h), päevadel 26, 46;
English: In clinical trials, there was an increased incidence of these events in older people and those with a prior history of cardiac disease.
Estonian: Kliinilistes uuringutes täheldati taoliste juhtude suuremat esinemissagedust eakatel ja neil, kellel oli anamneesis varasem südamehaigus.
English: The prescribed dose should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal irritations.
Estonian: Määratud annus tuleb manustada suu kaudu koos söögi ja suure klaasitäie veega vähendamaks gastrointestinaalsete ärritusnähtude tekkeriski.
English: Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Estonian: Lümfoidne blastne kriis: I faasi uuringutes osales piiratud arv patsiente (n=10).
English: There is no experience with the treatment of children below 2 years of age.
Estonian: Puudub kogemus alla 2-aastaste laste raviks.
English: Five (5) patients responded, 3 completely and 2 partially.
Estonian: Viiel (5) patsiendil saavutati ravivastus, neist kolmel täielik ja kahel osaline.
English: It arises from uncontrolled cell growth of the supporting tissues of these organs.
Estonian: See tekib nende elundite toetavate kudede rakkude kontrollimatu kasvu tagajärjel.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Estonian: Täpne teave selle ravimi kohta on Euroopa Ravimiameti kodulehel: http://www.ema.europa.eu.
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.
Estonian: Uuringu esmane tulemusnäitaja oli retsidiivivaba elulemus (RVE), mida defineeriti kui aega randomiseerimise kuupäevast kuni retsidiivi või mis tahes põhjusel surma tekkimise kuupäevani.
English: Study 0102 38-month data Myeloid blast crisis (n=260) % of patients (CI95%)
Estonian: Uuring 0102 38 kuu andmed Müeloidne blastne kriis (n=260) Patsientide % (CI95%)
English: * These types of reactions have been reported mainly from post-marketing experience with imatinib.
Estonian: * Nendest kõrvaltoimetest on teatatud peamiselt imatiniibi turuletulekujärgselt.
English: 18 Gy in 10 fractions for patients that are CNS3 at diagnosis
Estonian: 18 Gy 10 fraktsioonina patsientidel, kellel oli diagnoosimisel CNS3
English: Table 6 Summary of Z9001 trial RFS analyses by NIH and AFIP risk classifications
Estonian: Tabel 6 Uuringu Z9001 retsidiivivaba elulemuse (RVE) analüüside kokkuvõte NIH ja AFIP riski klassifikatsiooni järgi
English: The Kaplan-Meier estimate for survival after 36-month follow-up is 68%.
Estonian: Pärast 36-kuulist jälgimist on Kaplan-Meieri hinnangufunktsioon 68%.
English: Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Estonian: Müeloidne blastne kriis: osales 260 patsienti müeloidse blastse kriisiga.
English: - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Estonian: 'd: • kui olete imatiniibi või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes
English: • Stir with a spoon until the tablets have completely dissolved.
Estonian: - Segage lusikaga kuni tabletid lahustuvad täielikult.
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver
Estonian: • B-hepatiidi infektsiooni taastekkimine (reaktiveerumine), kui teil on varem olnud B-hepatiit
English: An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken.
Estonian: Ootamatut kiiret kehakaalu tõusu tuleb hoolikalt uurida ja vajadusel määrata toetav ravi.
English: The median duration of therapy in study B2225 was 6.2 months, with a maximum duration of 24.3 months.
Estonian: Uuringus B2225 oli mediaanne ravi kestus 6,2 kuud, maksimaalne ravi kestus oli 24,3 kuud.
English: Long-term treatment with imatinib may be associated with a clinically significant decline in renal function.
Estonian: Pikaajalisel imatiniibravil võib olla seos neerufunktsiooni kliiniliselt olulise langusega.
English: The suspension should be administered immediately after complete disintegration of the tablet(s).
Estonian: Tekkinud suspensioon tuleb manustada koheselt pärast tablettide täielikku lagunemist.
English: However, these associations are not sufficiently pronounced to warrant dose adjustment.
Estonian: Siiski ei olnud need seosed piisavalt väljendunud, et õigustada annuse korrigeerimist.
English: However if it is nearly time for the next dose, - Then continue with your normal schedule.
Estonian: Kui juba on peaaegu järgmise annuse võtmise aeg, jätke ununenud annus vahele.
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.
Estonian: Esmase GIST operatsiooni järgse retsidiivi riski hinnati retrospektiivselt järgmiste prognostiliste tegurite alusel: kasvaja suurus, mitootiline indeks, kasvaja lokalisatsioon.
English: Table 1 Tabulated summary of adverse reactions
Estonian: Tabel 1 Kõrvaltoimete kokkuvõte tabelina
English: days 3-5;
Estonian: päevadel 3…5;
English: As reported in a recent publication 21 of these 65 patients also achieved complete molecular remission with a median follow-up of 28 months (range 13-67 months).
Estonian: Hiljutistes publikatsioonides on teateid, et nendest 65-st patsiendist 21 saavutasid ka täieliku molekulaarse remissiooni mediaaniga 28 kuud (vahemik 13…67 kuud).
English: No significant age-related pharmacokinetic differences have been observed in adult patients in clinical trials which included over 20% of patients age 65 and older.
Estonian: Täiskasvanud patsientidel ei ole täheldatud farmakokineetikas east sõltuvaid olulisi erinevusi kliinilistes uuringutes, milles rohkem kui 20% patsientidest olid 65-aastased ja vanemad.
English: Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Estonian: Vere uurea (BUN) ja kreatiniini tõusu täheldati mitmel loomal.
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.
Estonian: Tabelis 6 on toodud alagrupi analüüside tulemused vastavalt NIH (United States National Institutes of Health, Ühendriikide Riiklik Tervishoiu Instituut) ja AFIP (Armed Forces Institute of Pathology, Kaitsejõudude Patoloogia Instituut) riski klassifikatsioonile.
English: Dosing for children should be on the basis of body surface area (mg/m2).
Estonian: Lastel tuleb annustamise aluseks võtta keha pindala (mg/m2).
English: SPECIAL STORAGE CONDITIONS Store below 30°C
Estonian: SÄILITAMISE ERITINGIMUSED Hoida temperatuuril kuni 30ºC.
English: 11 Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
Estonian: 11 Surmaga lõppenud juhtudest on teatatud kaugelearenenud haiguse, raskete infektsioonide, raske neutropeenia ja teiste tõsiste kaasuvate seisunditega patsientidel.
English: * Full follow-up period; NE - Not estimable
Estonian: * täielik järelkontrolli periood; N.E.
English: Blast crisis is defined as blasts ≥ 30% in blood or bone marrow or extramedullary disease other than hepatosplenomegaly.
Estonian: Blastne kriis diagnoositakse juhul, kui blaste on veres või luuüdis ≥30% või esineb ekstramedullaarne haiguskolle, välja arvatud hepatosplenomegaalia.
English: The long-term effects of prolonged treatment with imatinib on growth in children are unknown.
Estonian: Pikaajalise imatiniibravi kaugtulemused laste kasvule on teadmata.
English: Considering the combined concentration of imatinib and the metabolite and the maximum daily milk intake by infants, the total exposure would be expected to be low (~10% of a therapeutic dose).
Estonian: Võttes arvesse imatiniibi ja metaboliidi kombineeritud kontsentratsiooni ning maksimaalset lapse poolt joodava piima kogust ööpäevas, on koguekspositsioon madal (ligikaudu 10% terapeutilisest annusest).
English: In this patient population, the presence of hepatic metastases could potentially lead to hepatic insufficiency and reduced metabolism.
Estonian: Selles patsientide rühmas võib maksametastaaside esinemine põhjustada maksapuudulikkust ja metabolismi vähenemist.
English: then resume treatment at 200 mg/m2.
Estonian: seejärel taasalustada ravi annusega 200 mg/m2.
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.
Estonian: Patsiendid olid vanuses 18...83 aastat ja neil oli patoloogiliselt diagnoositud Kit-positiivne pahaloomuline mitteopereeritav ja/või metastaseerunud GIST.
English: Therefore, caution should be recommended when driving a car
Estonian: Seetõttu soovitatakse autojuhtimisel või masinate käsitsemisel olla
English: Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1).
Estonian: Kasutamine lastel: Kasutamise kogemus alla 2-aastastel lastel KML korral ja alla 1 aasta vanustel lastel Ph+ ALL korral puudub (vt lõik 5.1).
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Estonian: Ara-C: tsütosiinarabinosiid; CP: tsüklofosfamiid; DEX: deksametasoon; MTX: metotreksaat; 6-MP: 6-merkaptopuriin; VM26: teniposiid; VCR: vinkristiin; IDA: idarubitsiin; i.v.