natgillin/translations-raw huggingface dataset:
The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Adenome/karcinome ledvic, papilome sečnega mehurja in sečnice, adenokarcinome tankega črevesa, adenome obščitničnih žlez, benigne in maligne medularne tumorje nadlevičnih žlez in papilome/karcinome ne-žleznega dela želodca so opazili pri odmerku 60 mg/kg/dan, kar predstavlja približno 1,7 do 1-kratnik dnevne izpostavljenosti človeka (na podlagi AUC) pri odmerku 400 mg/dan oziroma 800 mg/dan in 1,2-kratnik dnevne izpostavljenosti otrok (na podlagi AUC) pri 340
In this study, dose escalations were allowed from 400 mg daily to 600 mg daily, then from 600 mg daily to 800 mg daily.
V tej študiji so bila dovoljena zvečanja odmerka s 400 mg na dan na 600 mg na dan, nato s 600 mg na dan na 800 mg na dan.
The no observed effect level (NOEL) for both the maternal animals and the F1 generation was 15 mg/kg/day (one quarter of the maximum human dose of 800 mg).
tako na samice-matere kot na generacijo F1 je bil 15 mg/kg/dan (ena četrtina največjega odmerka za človeka, ki je 800 mg).
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.
One open-label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
V enem odprtem multicentričnem kliničnem preskušanju faze II (študija B2225) so preskušali imatinib pri različnih populacijah bolnikov z življensko ogrožujočimi boleznimi v povezavi z Abl, Kit ali PDGFR protein tirozin kinazami.
• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• kombinacija hudo razširjenega hudega izpuščaja, slabosti s siljenjem na bruhanje, povišane telesne temperature, visoke vrednosti nekaterih vrst belih krvnih celic ali rumene obarvanosti kože ali oči (znaka zlatenice) z zasoplostjo, bolečino/neugodjem v prsnem košu, izrazito zmanjšanim izločanjem urina in žejo itd. (znaki alergijske reakcije na zdravljenje).
Active substances that may increase imatinib plasma concentrations
Učinkovine, ki lahko zvišajo plazemske koncentracije imatiniba:
• Adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
• odraslih in pediatričnih bolnikov z na novo diagnosticirano akutno limfoblastno levkemijo, s prisotnim kromosomom Philadelphia (Ph+ ALL) skupaj s kemoterapijo;
30 film-coated tablets 30x1 film-coated tablets 90 film-coated tablets 90x1 film-coated tablets
30 filmsko obloženih tablet 30x1 filmsko obloženih tablet 90 filmsko obloženih tablet 90x1 filmsko obloženih tablet
The doctor will tell you how many tablets of Imatinib Teva to give to your child.
Zdravnik vam bo povedal, koliko tablet zdravila Imatinib Teva dajte svojemu otroku.
The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Celotni dnevni odmerek pri otrocih ne sme preseči 800 mg pri zdravljenju KML in 600 mg pri zdravljenju Ph pozitivne ALL.
The length of the film-coated tablet is approximately 20 mm and the width is approximately 10 mm.
Dolžina filmsko obložene tablete je približno 20 mm in širina približno 10 mm.
Patients had received a median of 14 months of prior IFN therapy at doses ≥ 25 x 106 IU/week and were all in late chronic phase, with a median time from diagnosis of 32 months.
14 mesecev, bolniki pa so bili vsi v pozni kronični fazi s povprečnim časom 32 mesecev od postavitve diagnoze.
At the time of the original analysis, three of the four patients with detected PDGFR gene rearrangements developed haematological response (2 CHR and 1 PHR).
času prvotne analize so trije od štirih bolnikov z dokazano preureditvijo gena za PDGFR dosegli hematološki odziv (2 sta dosegla popolni in 1 delni hematološki odziv).
5 patients responded, 3 completely and 2 partially.
bolnikih, pri enem do popolnega in pri 8 do delnega.
Imatinib Teva is also a treatment for children and adolescents with CML.
Zdravilo Imatinib Teva je namenjeno tudi zdravljenju otrok s KML.
Relapsed/refractory Ph+ ALL
Relaps/neodzivna Ph+ ALL
Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19-60) and 47 months (range 16-59), respectively.
Hematološki odzivi so ostali enaki mediano 49 mesecev (od 19 do 60), citogenetični odzivi pa 47 mesecev (od 16
(24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20
(24 ur), 1., 15. dan; 6-MP 25 mg/m2 peroralno, 1.-20. dan
- If you are being treated for HES/CEL:
Če se zdravite zaradi HES/CEL:
The capsules are approximately 19 mm long and 7 mm wide.
Kapsule so približno 19 mm dolge in 7 mm široke.
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem The Netherlands
Teva B.V., Swensweg 5, 2031 GA Haarlem, Nizozemska
(3 h, q 12 h),
(3 ure, na 12 ur),
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
herpes zoster, herpes simpleks, nazofaringitis, pljučnica1, sinuzitis, flegmona, okužba zgornjih dihal, gripa, okužba sečil, gastroenteritis, sepsa redki:
If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice:
Če ne morete pogoltniti tablet, jih lahko raztopite v kozarcu navadne vode ali jabolčnega soka:
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Pilogo I : Povzetek glavnih značilnosti zdravila, poglavje 4.2).
The estimated rate of patients free of progression to accelerated phase or blast crisis at 84 months was significantly higher in the imatinib arm compared to the IFN arm (92.5% versus 85.1%, p<0.001).
Ocenjeni odstotek bolnikov, ki niso napredovali v pospešeno fazo ali blastno krizo pri 84 mesecih, je bil bistveno večji na kraku z imatinibom v primerjavi s krakom z IFN (92,5 % proti 85,1 %, p < 0,001).
(1 h) day 1;
(1 ura) 1. dan;
(2 h, q 12 h), days 2-3 (total of 8
(2 uri, na 12 ur), 2.-3. dan (skupno 8 kur)
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
O pljučnici so najpogosteje poročali pri bolnikih s transformacijo KML in pri bolnikih z
In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, non-randomized phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
V odprto, nerandomizirano, multicentrično preizkušanje faze III z oznako I2301 in z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do 22 let) s Ph+ ALL in jih zdravili z imatinibom (340 mg/m2/dan) v kombinaciji z intenzivno kemoterapijo po indukcijskem zdravljenju.
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
• znaki okužbe, na primer povišana telesna temperatura, huda mrzlica, vnetje žrela ali razjede po ustih.
Posology for CML in paediatric patients Dosing for children should be on the basis of body surface area (mg/m2).
Odmerjanje pri KML pri otrocih Odmerjanje za otroke mora temeljiti na telesni površini (mg/m2).
3 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
3 Dogodke v zvezi s srcem, vključno s kongestivno odpovedjo srca, so na podlagi enote bolnikleto pogosteje opažali pri bolnikih s transformacijo KML kot pri bolnikih s kroničnim potekom KML.
• Adult patients with relapsed or refractory Ph+ ALL as monotherapy.
• odraslih bolnikov z relapsom ali neodzivno Ph+ ALL v monoterapiji;
(q 12 h), days 2-3, for 4 cycles
(na 12 ur), 2.-3. dan, v 4 ciklusih
When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30% (9% complete) and a major cytogenetic response rate of 23%.
Zdravljenje z imatinibom kot edinim zdravilom pri bolnikih z relapsom/neodzivno Ph+ ALL je povzročilo pri 53 od 411 za oceno odziva primernih bolnikov stopnjo hematološkega odziva 30 % (v 9 % popolni hematološki odziv) in stopnjo pomembnega citogenetičnega odziva 23 %.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
• oslabelost mišic in mišični spazmi z nepravilnim ritmom bitja srca (znaki spremenjenih vrednosti kalija v krvi), • modrice,
9/l) and thrombocytopenias frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 10 (platelet count < 50 x 109/l) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Nevtropenija 3. ali 4. stopnje (ANC < 1,0 x 109/l) in trombocitopenija (koncentracija trombocitov < 50 x 109/l) sta bili štirikrat do šestkrat pogostejši v blastni krizi in pospešeni fazi (nevtropenija 59-64 % in trombocitopenija 44-63 %) kot pri na novo diagnosticiranih bolnikih v kronični fazi KML (nevtropenija 16,7 % in trombocitopenija 8,9 %).
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) ali redki (pojavijo se lahko pri največ 1 od
Imatinib Teva is indicated for
Zdravilo Imatinib Teva je indicirano za:
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Razen za na novo diagnosticirano KML v kronični fazi ni kontroliranih kliničnih preskušanj, ki bi dokazovala klinično koristnost, na primer izboljšanje bolezenskih simptomov ali povečano preživetje.
Manufacturer
Izdelovalci:
Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
400-miligramski odmerek imatiniba, je povzročilo zmanjšanje Cmax oziroma AUC(0-∞) za vsaj 54 % oziroma 74 % zadevnih vrednosti brez zdravljenja z rifampicinom.
The patients were distributed in three main categories: haematological failure (29%), cytogenetic failure (35%), or intolerance to interferon (36%).
532 odraslih bolnikov so zdravili z začetnim odmerkom 400 mg. Bolniki so bili razdeljeni v tri glavne kategorije: hematološki neuspeh (29 %), citogenetični neuspeh (35 %) ali neprenašanje interferona (36 %).
- Do not breast-feed during the treatment with Imatinib Teva.
Med zdravljenjem z zdravilom Imatinib Teva ne dojite.
Similar findings were found based on a 18months landmark analysis.
Izsledki so bili podobni, če so odziv in število transkriptov ocenjevali pri 18 mesecih.
Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common
lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, izpuščaj zaradi zdravila z eozinofilijo in sistemskimi simptomi (DRESSdrug rash with eosinophilia and systemic symptoms)* , psevdoporfirija*
Talk to your doctor before taking Imatinib Teva: - if you have or have ever had a liver, kidney or heart problem.
Pred začetkom jemanja zdravila Imatinib Teva se posvetujte z zdravnikom: - če imate ali ste kdaj imeli težave z jetri, ledvicami ali srcem; - če jemljete zdravilo levotiroksin, ker so vam odstranili ščitnico.
Stop imatinib until ANC ≥
Prekinite zdravljenje z imatinibom dokler ni ANC ≥
Imatinib Teva is indicated for the treatment of
Zdravilo Imatinib Teva je indicirano za zdravljenje:
Overall, in patients receiving first-line imatinib, the average daily dose delivered was 406 ±76 mg.
Povprečni odmerek v skupini vseh bolnikov, ki so prejemali imatinib kot zdravilo prvega izbora, je bil 406 ± 76 mg na dan.
a
V
In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Novo odkrita Ph+ ALL V kontrolirani študiji (ADE10) imatiniba v primerjavi z indukcijo s kemoterapijo pri 55 bolnikih z novo odkrito boleznijo, ki so bili stari 55 let ali več, je imatinib kot edino zdravilo povzročil značilno večji delež bolnikov s popolnim hematološkim odzivom kot kemoterapija (96,3 % v primerjavi s 50 %; p=0,0001).
Muscular weakness, arthritis, rhabdomyolysis/myopathy
oslabelost mišic, artritis, rabdomioliza/miopatija pogostnost neznana:
This is because Imatinib Teva could cause hepatitis B to become active again, which can be fatal in some cases.
- če ste kdaj bili ali ste sedaj okuženi z virusom hepatitisa B. Zdravilo Imatinib Teva namreč lahko povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
Paediatric chronic phase CML (at dose 340 mg/m2)
kronična faza KML pri pediatričnih bolnikih (ob odmerku 340 mg/m2)
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Izkušenj pri otrocih s KML, mlajših od 2 let, ni. Izkušnje so pri otrocih s Ph pozitivno ALL omejene, pri otrocih z MDS/MPD, DFSP in HES/CEL pa zelo omejene.
20x1 film-coated tablets 60 film-coated tablets 60x1 film-coated tablets 120 film-coated tablets 120x1 film-coated tablets 180x1 film-coated tablets
20x1 filmsko obloženih tablet 60 filmsko obloženih tablet 60x1 filmsko obloženih tablet 120 filmsko obloženih tablet 120x1 filmsko obloženih tablet 180x1 filmsko obloženih tablet
Patients with renal dysfunction or on dialysis should be given the minimum recommended dose of 400 mg daily as starting dose.
Bolniki s poslabšanim delovanjem ledvic ali bolniki na dializi naj za začetni odmerek prejmejo najmanjši priporočeni odmerek 400 mg na dan.
MTX 12 mg intrathecal, day 1
MTX 12 mg intratekalno, 1. dan
Chronic phase, newly diagnosed This phase III study in adult patients compared treatment with either single-agent imatinib or a combination of interferon-alpha (IFN) plus cytarabine (Ara-C).
V tej študiji tretje faze z odraslimi bolniki so primerjali zdravljenje z imatinibom kot edinim zdravilom na eni strani in s kombinacijo interferona alfa (IFN) s citarabinom (Ara-C) na drugi strani.
Hyper-CVAD regimen: CP 300 mg/m2 i.v.
Indukcijsko-konsolidacijsko zdravljenje hiper-CVAD shema: CP 300 mg/m2 i.v.
A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
V preskušanje stopnjevanja odmerka prve faze so vključili skupaj 26 pediatričnih bolnikov, starih < 18 let, bodisi s kronično fazo KML (n=11) bodisi s KML v blastni krizi ali Ph+ akutnimi levkemijami (n=15).
FIP1L1-PDGFRα fusion kinase was identified.
Pri 61 od teh 117 bolnikov so odkrili FIP1L1-PDGFRα fuzijsko kinazo.
6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
Odmerek 6400 mg (enkraten odmerek): v literaturi je opisan en primer pri enem bolniku, pri katerem je prišlo do navzee, bruhanja, bolečin v trebuhu, zvišane telesne temperature, otekanja v obraz, zmanjšane koncentracije nevtrofilcev in zvišanja aminotransferaz.
Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, by which time plasma concentrations had reached steady state.
Farmakokinetiko imatiniba so ovrednotili v območju odmerjanja od 25 mg do 1000 mg. Plazemski farmakokinetični profili so bili analizirani 1. dne, nato pa bodisi 7. bodisi 28. dne, ko so plazemske koncentracije že dosegle stanje dinamičnega ravnovesja.
The capsules are approximately 23 mm long and 9 mm wide.
Kapsule so približno 23 mm dolge in 9 mm široke.
In non-clinical studies, the fertility of male and female rats was not affected (see section 5.3).
Predklinične študje niso pokazale vpliva na plodnost pri podganjih samcih in samicah (glejte poglavje
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Razen za novo diagnosticirano KML v kronični fazi ni kontroliranih preskušanj, ki bi pokazala klinično koristnost ali izboljšanje preživetja pri teh boleznih.
Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Poleg tega so zabeležili tudi delen citogenetični odziv (PCyR - partial cytogenetic response) pri 16 %
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
zvišana vrednost kreatinina v krvi, zvišana vrednost kreatin-kinaze v krvi, zvišana vrednost laktat-dehidrogenaze v krvi, zvišana vrednost alkalne fosfataze v krvi redki:
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
pospešena faza KML in blastna kriza pri pediatričnih bolnikih (začetni odmerek 340 mg/m2)
Blood amylase increased
zvišana vrednost amilaze v krvi
Posology for MDS/MPD The recommended dose of Imatinib Teva is 400 mg/day for adult patients with MDS/MPD.
Odmerjanje pri MDS/MPD Priporočeni odmerek zdravila Imatinib Teva pri odraslih bolnikih z MDS/MPD je 400 mg/dan.
Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
aritmija, atrijska fibrilacija, zastoj srca, miokardni infarkt, angina pektoris, perikardialni izliv pogostnost neznana:
Table 3 Response in adult CML study
Preglednica 3 Odziv pri odraslih bolnikih s KML v kliničnih študijah
Prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28;
prednizon 60 mg/m2 peroralno, 1.-7., 15.-21. dan; IDA 9 mg/m2 peroralno, 1.-28. dan;
Anaphylactic shock* Blood and lymphatic system disorders Very common
Bolezni krvi in limfatičnega sistema zelo pogosti:
Headache2
glavobol2
9/l and platelets ≥ 20 x 109/l, then resume treatment at 200 mg/m2.
9/l in koncentracija trombocitov ≥ 20 x 109/l, nato spet začnite zdravljenje z odmerkom 200 mg/m2.
For doses of 400 mg and above (see dose recommendation below) a 400 mg film-coated tablet is available.
Za odmerke 400 mg in več (glejte spodaj navedeno priporočeno odmerjanje) so na voljo 400 mg filmsko obložene tablete.
A total of 1.106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
Randomiziranih je bilo skupno 1.106 bolnikov, 553 na vsak krak.
MTX 15 mg intrathecal, day 1; Methylprednisolone 40 mg intrathecal, day 1
MTX 15 mg intratekalno, 1.dan; metilprednizolon 40 mg intratekalno, 1. dan
9/l and platelets ≥ 75 x 109/l.
9/l in koncentracija trombocitov ≥ 75 x 109/l.
ANC < 1.0 x 109/l and/or platelets < 50 x 109/l
ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/l
h), days 2-3 (total of 8 courses)
2.-3. dan (skupno 8 kur)
days 3-5;
3.-5. dan;
The results observed in a population of 211 newly diagnosed Ph+ ALL patients in four uncontrolled clinical studies (AAU02, ADE04, AJP01 and AUS01) are consistent with the results described above.
Pri populaciji 211 bolnikov z novo odkrito Ph+ ALL iz štirih nekontroliranih kliničnih študij (AAU02,
- The other ingredients are mannitol, crospovidone, magnesium stearate and silica colloidal anhydrous.
- Druge sestavine zdravila manitol, krospovidon, magnezijev stearat, brezvodni koloidni silicijev dioksid.
- If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.
Če kapsul ne morete pogoltniti, jih lahko odprete in vsebino zmešate v kozarec navadne vode ali jabolčnega soka.
Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
hipertenzija, hematom, subduralni hematom, hladni distalni deli udov, hipotenzija, Raynaudov fenomen pogostnost neznana:
(1 h) days 4-5; Ara-C 2x 2 g/m2 i.v.
(1 ura) 4.-5. dan; Ara-C 2x 2 g/m2 i.v.
This time-to-event endpoint is strongly affected by the high crossover rate from IFN+Ara-C to imatinib.
Na ta opazovani dogodek, ki se veže na čas do dogodka, je močno vplival velik delež bolnikov, ki so z zdravljenja z IFN+Ara-C prešli na imatinib.
Periorbital oedema, dermatitis/eczema/rash
periorbitalni edemi, dermatitis/ekcem/izpuščaj pogosti:
The tablets are approximately 20 mm long and 10 mm wide.
Tablete so dolge približno 20 mm in široke 10 mm.
CHR: Study 0110 [WBC < 10 x 109/l, platelets < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l (0102 and 0109 only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
CHR študija 0110 [WBC < 10 x 109/l, trombociti < 450 x 109/l, mielociti+metamielociti < 5 % v krvi, brez blastov in promielocitov v krvi, bazofilci < 20 %, brez prizadetosti zunaj kostnega mozga] in v študijah 0102 in 0109 [ANC ≥ 1,5 x 109/l, trombociti ≥ 100 x 109/l, brez blastov v krvi, BM blasti < 5 % in brez bolezni zunaj kostnega mozga] NEL enaki kriteriji kot za CHR, a ANC ≥ 1 x 109/l in trombociti ≥ 20 x 109/l (samo 0102 in
Clinical studies in DFSP
Odmerjanje pri DFSP
• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
• izpuščaj, rdeča koža z mehurčki na ustnicah, očeh, koži ali v ustih, luščenje kože, povišana telesna temperatura, rdeče ali vijolične lise nad nivojem kože, srbenje, pekoč občutek, gnojni izpuščaj
Calcium hydrogen phosphate Crospovidone
Jedro tablete kalcijev hidrogenfosfat krospovidon magnezijev stearat
The printing ink is composed of shellac, iron oxide black (E172) and propylene glycol.
Tiskarska barva pa vsebuje šelak, črni železov oksid (E172) in propilenglikol.
The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m2 daily.
Ti bolniki so bili stari od 3 mesece do 4 leta, imatinib pa so prejemali v odmerku 50 mg na dan ali v odmerkih od 92,5 do 340 mg/m2 na dan.
Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
palpitacije, tahikardija, kongestivno popuščanje srca3, pljučni edem redki: