natgillin/translations-raw huggingface dataset:
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow
Sage House, 319 Pinner Road North Harrow,
While you are taking Imatinib Accord, your doctor will regularly check whether the medicine is working.
Med jemanjem zdravila Imatinib Accord bo zdravnik redno spremljal, ali zdravilo deluje.
Study 0109 40.5-month data Accelerated phase (n=235)
Študija 0109 podatki pri 40,5 meseca pospešena faza (n=235)
However, some of these reactions may be serious or life-threatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Vendar so nekatere od teh reakcij lahko resne ali smrtno nevarne.Več bolnikov z blastno krizo je namreč umrlo z zapleteno klinično anamnezo plevralnega izliva, kongestivnega popuščanja srca in ledvične odpovedi.
A further 6DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
Nadaljnjih 6 bolnikov z DFSP, zdravljenih z imatinibom, so opisali v 5 publikacijah opisov primera, njihova starost se je gibala med 18 meseci in 49 leti.
Imatinib Accord will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Zdravilo Imatinib Accord vam lahko predpiše samo zdravnik, ki ima izkušnje z zdravili za zdravljenje krvnih rakov in solidnih tumorjev.
The rate ofresponse was also higher in the patients treated at 600 mg (33%) as compared to the patients treated at 400 mg (16%, p=0.0220).
Stopnja odziva je bila tudi večja pri bolnikih, zdravljenih s 600 mg (33 %), kot pri bolnikih, zdravljenih s 400 mg (16 %, p=0,0220).
In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 3).
V tej študiji je 65 % bolnikov doseglo pomemben citogenetični odziv, ki je bil popoln pri 53 % (potrjen pri 43 %) bolnikov (preglednica 3).
Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
Zaradi znanega povečanega tveganja za krvavitve v povezavi z uporabo imatiniba (na primer hemoragija) naj bolniki, pri katerih je potrebna antikoagulantna terapija, dobivajo nizkomolekularni ali standardni heparin namesto kumarinskih derivatov, kot je varfarin.
• Do not use this medicine after the expiry date which is stated on the carton and blister after
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake “EXP”.
Women of childbearing potential must be advised to use effective contraception during treatment.
Ženske v rodni dobi Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem uporabljajo učinkovito kontracepcijo.
In patients treated with metoprolol clinical monitoring should be considered.
Pri bolnikih, ki se zdravijo z metoprololom, je treba razmisliti o kliničnem nadzoru.
They may increase or decrease the effect of Imatinib Accord, either leading to increased side effects or making Imatinib Accord less effective.
Lahko povečajo ali zmanjšajo učinek zdravila Imatinib Accord in zato bodisi povečajo verjetnost za nastanek neželenih učinkov, bodisi zmanjšajo učinkovitost zdravila Imatinib Accord.
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Nosečnost, dojenje in plodnost - Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 μM).
Imatinib ni oviral biotransformacije 5-fluorouracila, je pa zaviral presnovo paklitaksela zaradi kompetitivne inhibicije CYP2C8 (Ki = 34,7 μM).
The percentage of some adverse reactions was higher in the 40 patients in whom the dose was increased to 800 mg daily compared to the population of patients before dose increase (n=551).
Odstotni delež nekaterih neželenih reakcij je bil večji pri tistih 40 bolnikih, pri katerih je bil odmerek zvečan na 800 mg na dan, kot pri populaciji bolnikov pred zvečanjem odmerka (n=551).
Pharmacokinetics in children and adolescents
Farmakokinetika pri otrocih in mladostnikih
Imatinib Accord inhibits the growth of these cells in a certain subtype of these diseases.
Zdravilo Imatinib Accord zavira rast teh celic pri določenih podskupinah teh bolezni.
If you are being treated for CML
- Če se zdravite zaradi KML
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).
Izkušenj pri otrocih s KML, mlajših od 2 let, in pri otrocih s Ph+ALL, mlajših od 1 leta, ni (glejte poglavje 5.1).
The doctor will tell you how many tablets of Imatinib Accord to give to your child.
Zdravnik vam bo povedal, koliko tablet zdravila Imatinib Accord dajte svojemu otroku.
8 to 10 g (single dose): Vomiting and gastrointestinal pain have been reported.
Odmerki od 8 do 10 g (enkratni odmerki): Opisovali so bruhanje in bolečine v prebavilih.
This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
To je bila skupina že prej močno zdravljenih bolnikov, saj jih je pred začetkom raziskave 46 % prejelo BMT, 73 % pa kemoterapijo z več zdravili.
The yearly rates of progression of any type for Imatinib also decreased over time.
Tudi letne stopnje kakršnegakoli napredovanja bolezni za zdravilo Imatinib Accord so se sčasoma zmanjševale.
If this applies to you, tell your doctor without taking Imatinib Accord.
Če to velja za vas, povejte zdravniku in ne jemljite zdravila Imatinib Accord.
The majority of patients who achieved a CCyR developed the CCyR between months 3 and 10 with a median time to response based on the Kaplan-Meier estimate of 5.6 months.
Večina bolnikov, ki je dosegla popolni citogenetični odziv, ga je dosegla med 3. in 10. mesecem s povprečnim časom do odziva 5,6 meseca glede na Kaplan-Meierjevo oceno.
Renal function should, therefore, be evaluated prior to the start of imatinib therapy and closely monitored during therapy, with particular attention to those patients exhibiting risk factors for renal dysfunction.
Zato je treba pred začetkom zdravljenja z imatinibom oceniti delovanje ledvic in ga med zdravljenjem natančno spremljati, še posebej pri tistih bolnikih, ki kažejo dejavnike tveganja za ledvično disfunkcijo.
Imatinib Accord is a medicine containing an active substance called imatinib.
Imatinib Accord je zdravilo, ki vsebuje zdravilno učinkovino z imenom imatinib.
Imatinib Accord inhibits the growth of these cells.
Zdravilo Imatinib Accord zavira rast teh celic.
Long-term treatment with imatinib may be associated with a clinically significant decline in renal function.
Dolgotrajno zdravljenje z imatinibom je lahko povezano s klinično pomembnim zmanjšanjem delovanja ledvic.
Imatinib and the N-demethyl metabolite together accounted for about 65% of the circulating radioactivity (AUC(0-48h)).
Imatinib in N-demetilirani presnovek sta skupaj prispevala okrog 65 % radioaktivnosti v krvi (AUC(048h)).
Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Ara-C: citozin arabinozid; CP: ciklofosfamid; DEX: deksametazon; MTX: metotreksat; 6-MP: 6merkaptopurin; VM26: tenipozid; VCR: vinkristin; IDA: idarubicin; i.v.
If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Imatinib Accord should not be resumed.
V primeru, da je koncentracija protiteles proti ADAMTS13 zvišana, aktivnost ADAMTS13 pa nizka, se zdravljenja z zdravilom Imatinib Accord ne sme nadaljevati.
The safety and efficacy of imatinib in children and adolescents with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Varnost in učinkovitost uporabe imatiniba pri otrocih in mladostnikih, ki imajo MDS/MPD, DFSP ali HES/CEL in so stari manj kot 18 let, nista bili dokazani v kliničnih preskušanjih.
Imatinib Accord can help you to fight this condition.
Zdravilo Imatinib Accord vam lahko pomaga pri premagovanju te bolezni.
Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP.
Konstitutivna aktivacija receptorja za rastni faktor iz trombocitov ali Abl protein-tirozin-kinaze kot posledica združitve različnih sodelujočih proteinov, ali konstitutivna tvorba PDGF sta vpleteni v patogenezo MDS/MPD, HES/CEL in DFSP.
Increased blood urea nitrogen (BUN) and creatinine were observed in several of these animals.
Pri mnogih od teh živali sta se zvišala dušik sečnine v krvi (BUN) in kreatinin.
In clinical trials, there was an increased incidence of these events in elderly and those with a prior history of cardiac disease.
V kliničnih preskušanjih so bili ti učinki pogostejši pri starejših in pri bolnikih z anamnezo bolezni srca.
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 1,5-kratnemu zvišanju alfa kislega proteina v plazmi, na katerega se imatinib močno veže.
- if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Imatinib Accord - če ste alergični na imatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
FIP1L1PDGFRα pozitivni so bili še štirje bolniki s HES, ki so jih opisovali v drugih 3 objavljenih poročilih.
Packs containing 10, 30, or 90 film-coated tablets.
Škatle, ki vsebujejo po 10, 30 ali 90 filmsko obloženih tablet.
For adult patients with relapsed or refractory Ph+ALL Imatinib monotherapy at 600 mg/day is safe, effective and can be given until disease progression occurs.
Za odrasle bolnike z relapsom ali neodzivno Ph+ ALL je zdravilo Imatinib kot monoterapija v odmerku 600 mg/dan varno in učinkovito ter ga lahko prejemajo dokler ne pride do napredovanja bolezni.
This clinical effect was associated with a higher reduction in bcr-abl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Ta klinični učinek je bil povezan z večjim zmanjšanjem količine transkriptov bcrabl pri bolnikih, zdravljenih z imatinibom, kot pri skupini, zdravljeni s kemoterapijo po 2 tednih zdravljenja (p=0,02).
What you need to know before you take Imatinib Accord
Kaj morate vedeti, preden boste vzeli zdravilo Imatinib Accord
In contrast, there were 165 (29.8%) events in the IFN+Ara-C arm, of which 130 occurred during first-line treatment with IFN+Ara-C.
Za razliko od tega je bilo v kraku z IFN+Ara-C 165 (29,8 %) dogodkov, od tega se jih je 130 zgodilo v času zdravljenja z IFN+Ara-C kot zdravilom prvega izbora.
The 23 patients enrolled in this registry received imatinib at a median daily dose of 264 mg (range: 100 to 400 mg) for a median duration of 7.2 years (range 0.1 to 12.7 years).
23 bolnikov, ki so bili vključeni v register, je prejemalo zdravilo imatiniba z mediano dnevnega odmerka 264 mg (v razponu od 100 do 400 mg) in z mediano trajanja zdravljenja 7,2 leti (v razponu od 0,1 do 12,7 leta).
• adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
• odraslih in pediatričnih bolnikov s Ph+ KML v kronični fazi po neuspelem zdravljenju z interferonom alfa, ali v pospešeni fazi ali blastni krizi;
The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1).
Izkušenj z imatinibom pri bolnikih MDS/MPD v povezavi s preureditvijo genov za PDGFR je malo (glejte poglavje 5.1).
In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children and adolescents from 340 to 260 mg/m2/day.
Pri odraslih je treba zmanjšati odmerek s 400 na 300 mg ali s 600 na 400 mg ali z 800 na 600 mg, pri otrocih in mladostnikih pa s 340 na 260 mg/m2/dan.
Packs containing 20, 60, 120 or 180 film-coated tablets.
Škatle, ki vsebujejo po 20, 60, 120 ali 180 filmsko obloženih tablet.
Do not stop taking Imatinib Accord unless your doctor tells you to.
Ne prenehajte jemati zdravila Imatinib Accord, razen če vam tako naroči zdravnik.
What Imatinib Accord is and what it is used for
Kaj je zdravilo Imatinib Accord in za kaj ga uporabljamo
The high rate of CHR is accompanied by the development of a completecytogenetic response (CCyR) of 65% which is comparable to the results observed in adults.
Ob veliki stopnji popolnega hematološkega odziva je prišlo tudi do popolnega citogenetičnega odziva (CCyR) v 65 %, kar je primerljivo z zabeleženimi rezultati pri odraslih.
The effect of Imatinib treatment on survival in chronic phase, newly diagnosed CML has been further examined in a retrospective analysis of the above reported Imatinib data with the primary data from another Phase III study using IFN+Ara-C (n=325) in an identical regimen.
Vpliv zdravljenja z zdravilom Imatinib Accord na preživetje v kronični fazi pri novo diagnosticirani KML so nadalje preiskovali z retrospektivno analizo zgoraj opisanih podatkov o zdravilu Imatinib Accord skupaj s prvotnimi podatki druge študije faze III, v kateri so uporabljali IFN+Ara-C s povsem enakim režimom zdravljenja (n=325).
Imatinib Accord may cause your body to retain water (severe fluid retention).
Zaradi zdravila Imatinib Accord lahko telo zadržuje vodo (lahko pride do močnega zastajanja tekočine).
of the dose was recovered within 7 days in faeces (68% of dose) and urine (13% of dose).
81 % odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Ugotovili so, da je plazemska AUC tega presnovka samo 16 % AUC imatiniba.
Chronic phase CML, MDS/MPD (starting dose 400 mg) HES/CEL (at dose 400 mg)
kronična faza KML, MDS/MPD (začetni odmerek 400 mg) HES/CEL (pri odmerku 400 mg)
Imatinib Accord may do the same to some other medicines.
Zdravilo Imatinib Accord lahko enako vpliva na druga zdravila.
The degree of cytogenetic response and molecular response had a clear effect on long-term outcomes in patients on Imatinib.
Stopnja citogenetičnega in molekularnega odziva ima nedvomen učinek na dolgoročni izid pri bolnikih, zdravljenih z zdravilom Imatinib Accord.
Study 0102 38-month data Myeloid blast crisis (n=260)
Študija 0102 podatki pri 38 mesecih mieloidna blastna kriza (n=260)
Study AJP01 Induction therapy
Študija AJP01 indukcijsko zdravljenje
Dosing for children and adolescents should be on the basis of body surface area (mg/m2).
Odmerjanje pri KML pri otrocih in mladostnikih Odmerjanje za otroke in mladostnike mora temeljiti na telesni površini (mg/m2).
At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised Imatinib and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Po 84 mesecih je ocenjeno celotno preživetje v skupini randomizirani na zdravilo Imatinib Accord 86,4 % (83, 90) v primerjavi z 83,3 % (80, 87) v skupini randomizirani na IFN+Ara-C (p=0,073, test log-rank).
Imatinib Accord is also a treatment for children and adolescents with CML.
Zdravilo Imatinib Accord je namenjeno tudi zdravljenju otrok in mladostnikov s KML.
In this retrospective analysis, the superiority of Imatinib over IFN+Ara-C in overall survival was demonstrated (p<0.001); within 42 months, 47 (8.5%) Imatinib patients and 63 (19.4%) IFN+Ara-C patients had died.
V tej retrospektivni analizi se je z vidika celotnega preživetja zdravilo Imatinib Accord izkazalo za boljše od IFN+Ara-C (p<0,001): v 42 mesecih je umrlo 47 (8,5 %) bolnikov z zdravilom Imatinib Accord in 63 (19,4 %) bolnikov z IFN+Ara-C.
When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4%) compared to fasting conditions.
Če so imanitib dajali z zelo mastnim obrokom, se je obseg njegove absorpcije minimalno zmanjšal (Cmax se je zmanjšala za 11 %, tmax pa se je podaljšala za 1,5 ure), AUC pa se je v primerjavi z razmerami na tešče malo zmanjšala (7,4 %).
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).
Pri seštevku koncentracij imatiniba in njegovega presnovka je pri največji zaužiti količini materinega mleka na dan mogoče pričakoviti nizko skupno izpostavljenost dojenčka zdravilu in presnovku (~10 % terapevtskega odmerka).
- Patients who are concerned about their fertility while taking Imatinib Accord are advised to consult with their doctor.
- Bolniki, ki jih skrbi glede njihove plodnosti v času zdravljenja z zdravilom Imatinib Accord, naj se posvetujejo s svojim zdravnikom.
The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon.
Predpisano število tablet je treba dati v primerno količino napitka (približno 50 ml za tableto po 100 mg in 200 ml za tableto po 400 mg) in premešati z žlico.
Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Imatinib je majhna molekula in je zaviralec protein-tirozin-kinaze, ki močno zavira aktivnost Bcr-Abl tirozin-kinaze, pa tudi nekaj receptorskih tirozin-kinaz: pri receptorju Kit, ki je receptor za dejavnik matičnih celic (stem cell factor, SCF), ki ga kodira protoonkogen c-Kit, pri receptorjih za diskoidinsko domeno (DDR1 in DDR2), pri receptorju za kolonije stimulirajoči faktor (CSF-1R) in pri receptorjih za rastni faktor iz trombocitov alfa in beta (platelet-derived growth factor PDGFR-alfa in PDGFRbeta).
Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]).
Imatinib je v odmerku 400 mg dvakrat dnevno zaviral presnovo metoprolola s CYP2D6, tako da sta se Cmax in AUC metoprolola povečala za približno 23 % (90 % IZ [1,16-1,30]).
Imatinib Accord is a treatment for adults and children and adolescents for:
Zdravilo Imatinib Accord je zdravilo za odrasle in otroke ter mladostnike:
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia, or return to chronic phase CML using the same criteria as for the study in accelerated phase.
Primarna učinkovitostna spremenljivka je bila stopnja hematološkega odziva, opisanega bodisi kot popolni hematološki odziv, kot odsotnost dokazov levkemije ali kot vrnitev v kronično fazo KML, pri čemer so uporabljali enaka merila kot pri študiji v pospešeni fazi.
In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intratumoural haemorrhages were reported (see section 4.8).
V študiji pri bolnikih z neresektabilnimi in/ali metastatskimi GIST so poročali tako o gastrointestinalnih kot o intratumorskih krvavitvah (glejte poglavje 4.8).
In paediatric CML patients the most frequent toxicities observed were grade3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
Pri pediatričnih bolnikih s KML so izmed toksičnih učinkov najpogosteje opažali citopenije 3. ali 4. stopnje, ki vključuje nevtropenijo, trombocitopenijo in anemijo.
3) [95% CI]
3) [95 %-ni interval zaupanja] delen
Haematological response Complete haematological response (CHR) No evidence of leukaemia
Hematološki odziv popolni hematološki odziv (CHR) nobenih znakov levkemije (NEL)
Considering the limited safety database, the adverse events thus far reported in children and adolescents are consistent with the known safety profile in adult patients with Ph+ ALL.
Baza podatkov do zdaj sporočenih neželenih dogodkov pri otrocih in mladostnikih je majhna, vendar se podatki v njej ujemajo z varnostnimi lastnostmi zdravila pri odraslih bolnikih s Ph+ ALL.
1800 to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
Odmerki od 1800 do 3200 mg (tudi do 3200 mg na dan 6 dni): oslabelost, mialgija, zvišana kreatinkinaza, zvišan bilirubin, bolečine v prebavilih.
Close monitoring of growth in children and adolescents under imatinib treatment is recommended (see section 4.8).
Pri otrocih in mladostnikih, ki prejemajo imatinib, je priporočeno natančno spremljanje njihove rasti (glejte poglavje 4.8).
Total bilirubin: = 1.5 ULN AST: > ULN (can be normal or < ULN if total bilirubin is > ULN)
AST: > IULN (lahko je normalna ali < IULN, če je celotni bilirubin > IULN)
• For Alu/Alu blisters This medicine does not require any special storage conditions.
• Za pretisne omote iz aluminija/aluminija • Za shranjevanje tega zdravila niso potrebna posebna navodila.
A total of 71 (12.8%) and 85 (15.4%) patients died in the Imatinib and IFN+Ara-C groups, respectively.
Skupno je umrlo 71 (12,8 %) bolnikov iz skupine z zdravilom Imatinib Accord in 85 (15,4 %) iz skupine z IFN+Ara-C.
Other medicines and Imatinib Accord
Druga zdravila in zdravilo Imatinib Accord
The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Spojina selektivno zavira proliferacijo in inducira apoptozo pri Bcr-Abl pozitivnih celičnih linijah, pa tudi pri svežih limfatičnih celicah bolnikov s KML, s prisotnim kromosomom Philadelphia, in z akutno limfoblastno levkemijo (ALL).
The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)-positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z imatinibom za vse skupine pediatrične populacije s kronično mieloično levkemijo s prisotnim kromosomom Philadelphia (s translokacijo bcr-abl) (za podatke o uporabi pri pediatrični populaciji glejte poglavje
The median duration of second-line treatment with Imatinib was 64 months.
Mediano trajanje zdravljenja z zdravilom Imatinib Accord kot zdravilom drugega izbora je bilo 64 mesecev.
There have been post-marketing reports of spontaneous abortions and infant congenital anomalies from women who have taken imatinib.
V obdobju trženja zdravila so poročali o spontanih splavih in prirojenih nepravilnostih pri dojenčkih mater, ki so med nosečnostjo prejemale zdravilo imatiniba.
At a dose of 60 mg/kg, female rats had significant post-implantation foetal loss and a reduced number of live foetuses.
Pri odmerku 60 mg/kg je prišlo pri samicah do znatne izgube plodov po vgnezditvi in do zmanjšanja števila živih plodov.
Table 4 Chemotherapy regimen used in combination with imatinib
Preglednica 4 Kemoterapevtske sheme, uporabljene v kombinaciji z imatinibom