natgillin/translations-raw huggingface dataset:
Posology for CML in children and adolescents
Doziranje za KML u djece i adolescenata
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 and adolescents (based on AUC) at 340 mg/m2/day.
Bubrežni adenom/karcinom, papilom mokraćnog mjehura i uretre, adenokarcinomi tankog crijeva, adenomi paratireoidnih žlijezda, dobroćudni i zloćudni medularni tumori nadbubrežnih žlijezda i papilomi/karcinomi nežljezdanog dijela želuca zabilježeni su uz 60 mg/kg/dan, što odgovara otprilike 1,7, odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 1,2 puta dnevne izloženosti u djece i adolescenata (temeljeno na AUC) kod 340 mg/m2/dan.
In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/m2/day subcutaneously in combination with subcutaneous Ara-C 20 mg/m2/day for 10 days/month.
U IFN kraku, bolesnici su liječeni ciljanom dozom IFN-a od 5 MIU/m2/dan supkutano u kombinaciji sa supkutanim Ara-C u dozi od 20 mg/m2/dan u trajanju od 10 dana/mjesec.
6 doses)iii: days 2, 3, 16, and 17
6 doza)iii: Dani 2, 3, 16 i 17
Dose increases from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe nonleukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Povećanja doze od 400 mg do 600 mg ili 800 mg u bolesnika s kroničnom fazom bolesti, ili od 600 mg do maksimalno 800 mg (dano kao 400 mg dvaput na dan) u bolesnika s ubrzanom fazom ili blastičnom krizom može se razmotriti u odsustvu teške nuspojave na lijek i teške neutropenije ili trombocitopenije nepovezanih s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
- Do not breast-feed during the treatment with Imatinib Accord.
- Nemojte dojiti tijekom liječenja Imatinib Accordom.
Total bilirubin: = 1.5 ULN AST: > ULN (can be normal or < ULN if total bilirubin is > ULN)
AST: > GGN (može biti normalan ili < GGN ako je ukupni bilirubin > GGN)
Papilloma/carcinoma of the preputial/clitoral gland were noted from 30 mg/kg/day onwards, representing approximately 0.5 or 0.3 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 0.4 times the daily exposure in children and adolescents (based on AUC) at 340 mg/m2/day.
Papilom/karcinom žlijezde prepucija/klitorisa su zabilježeni pri dozama od 30 mg/kg/dan na više, što odgovara otprilike 0,5, odnosno 0,3 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 0,4 puta dnevne izloženosti u djece i adolescenata (temeljeno na AUC) kod 340 mg/m2/dan.
Imatinib Accord 100 mg film-coated tablets are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Imatinib Accord 100 mg filmom obložene tablete dostupne su u pakiranjima koja sadrže 20, 60, 120 ili 180 tableta, ali ona sva ne moraju biti dostupna u Vašoj zemlji.
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%.
Kada je imatinib samostalno korišten u bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om, rezultirao je s odgovorom u 53 od 411 procijenjenih bolesnika, sa stopom hematološkog odgovora od 30% (9% potpuni) i stopom većeg citogenetskog odgovora od 23%.
If you are being treated for DFSP
Ako se liječite zbog DFSP-a
• Use about 50 ml for each 100 mg tablet or 200 ml for each 400 mg tablet.
• Uzmite oko 50 ml za svaku tabletu od 100 mg ili 200 ml za svaku tabletu od 400 mg.
Depression, libido decreased, anxiety
Manje često Depresija, smanjeni libido, anksioznost Rijetko
Posology for Ph+ ALL in children and adolescents
Doziranje za Ph+ ALL u djece i adolescenata
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
• mučnina uz gubitak apetita, tamno obojenje mokraće, žutilo kože ili očiju (znakovi problema s jetrom).
Reactivation of hepatitis B in patients who are chronic carriers of this virus has occurred after these patients received BCR-ABL tyrosine kinase inhibitors.
U bolesnika koji su kronični nositelji virusa hepatitisa B pojavila se reaktivacija tog virusa nakon što su primili inhibitore BCR-ABL tirozin kinaze.
Major response n (%) [95% CI]
Citogenski odgovor Veliki odgovor n (%) [95% CI]
20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 30x1 film-coated tablets 60x1 film-coated tablets 90x1 film-coated tablets 120x1 film-coated tablets 180x1 film-coated tablets
20 filmom obloženih tableta 60 filmom obloženih tableta 120 filmom obloženih tableta 180 filmom obloženih tableta 30x1 filmom obložena tableta 60x1 filmom obložena tableta 90x1 filmom obložena tableta 120x1 filmom obložena tableta 180x1 filmom obložena tableta
• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• crvenilo i/ili oticanje dlanova ruku i tabana stopala koje može biti praćeno trncima i bolnim žarenjem.
A further 6DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
U 5 objavljenih prikaza slučajeva zabilježeno je dodatnih 6 bolesnika s DFSP-om liječenih imatinibom, s rasponom starosti od 18 mjeseci do 49 godina.
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
• osjećaj ošamućenosti, omaglica ili nesvjestica (znakovi sniženog krvnog tlaka).
Major response at 84 months (%)
Veliki odgovor nakon 24 mjeseci (%) Veliki odgovor nakon 84 mjeseci (%)
If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accord to 260 mg/m2.
Ako citopenija nije povezana s leukemijom, dozu Imatinib Accorda treba smanjiti na 260 mg/m2.
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.
Supstancija selektivno inhibira proliferaciju te inducira apoptozu u BcrAbl pozitivnim staničnim linijama, kao i u svježim leukemijskim stanicama osoba koje boluju od kronične mijeloične leukemije (KML) s pozitivnim Philadelphia kromosomom i od akutne limfoblastične leukemije (ALL).
Neoplasm benign, malignant and unspecified (including cysts and polyps) Rare
Nepoznato Reaktivacija hepatitisa B* Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Rijetko
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Flatulencija, distenzija abdomena, gastroezofagealni refluks, konstipacija, suha usta, gastritis
What Imatinib Accord is and what it is used for
Što je Imatinib Accordi za što se koristi
Dose adjustments for neutropenia and thrombocytopenia: HES/CEL (starting dose 100 mg)
Prilagođavanje doze zbog neutropenije i trombocitopenije: HES/KEL (početna doza 100 mg)
These effects were not seen at doses ≤ 30 mg/kg.
Ti učinci nisu uočeni pri dozama od ≤ 30 mg/kg.
• adult patients with relapsed or refractory Ph+ ALL as monotherapy.
• odraslih bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om u obliku monoterapije.
Confusional state Nervous system disorders Very common Headache2
Konfuzno stanje Poremećaji živčanog sustava Vrlo često
Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Imatinib povećava srednju vrijednost Cmaxi AUC simvastatina (CYP3A4 supstrat) za 2, odnosno 3,5-puta, što ukazuje na to da imatinib inhibira CYP3A4.
Daunorubicin 45 mg/ m2 i.v., days 6-7, 13-14
Daunorubicin 45 mg/m2 i.v., dani 6-7, 13-14
Do not take Imatinib Accord
Nemojte uzimati Imatinib Accord
4 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
4 Crvenilo uz osjećaj vrućine je bilo najčešće u GIST bolesnika, a krvarenje (hematomi, hemoragija) je bilo najčešće u bolesnika s GIST-om i s transformiranim KML-om (KMLubrzana faza i KML-blastična kriza).
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• iscjedak iz oka sa svrbežom, crvenilom ili oteklinom (konjunktivitis), suzne oči ili zamućen vid.
CHR rate n (%) [95% CI]
Hematološki odgovor CHR stopa n (%) [95% CI]
Posology for MDS/MPD
Doziranje za MDS/MPD
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).
Procijenjena stopa bolesnika bez progresije u ubrzanu fazu ili blastičnu krizu nakon 84 mjeseca bila je značajno viša u Imatinib kraku u usporedbi s IFN krakom (92,5% prema 85,1%, p<0,001).
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
Pedijatrijska ubrzana faza KML-a i blastična kriza (početna doza 340 mg/m2)
Blood amylase increased * These types of reactions have been reported mainly from post-marketing experience with Imatinib.
* Ove vrste reakcija zabilježene su uglavnom nakon stavljanja Imatiniba u promet.
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
• grčevi mišića s vrućicom, crveno-smeđe obojena mokraća, bol ili slabost mišića (znakovi mišićnih problema).
Accelerated phase is defined by the presence of any of the following: blasts ≥ 15% but < 30% in blood or bone marrow, blasts plus promyelocytes ≥ 30% in blood or bone marrow (providing < 30% blasts), peripheral blood basophils ≥ 20%, platelets < 100 x 109/l unrelated to therapy.
Ubrzana faza se definira prisutnošću bilo kojeg od sljedećih kriterija: blasti ≥ 15% ali < 30% u krvi ili koštanoj srži, blasti plus promijelociti ≥ 30% u krvi ili koštanoj srži (što daje <3 0% blasta), bazofili u perifernoj krvi ≥ 20%, trombociti <100 x 109/l nevezano uz terapiju.
PVC/PVdC/Alu or Alu/Alu blisters.
PVC/PVdC/Alu ili Alu/Alu blisteri.
If cytopenia is unrelated to leukaemia, reduce dose of Imatinib Accordto 400 mg. 3.
Ako citopenija nije povezana s leukemijom, dozu Imatinib Accorda treba smanjiti na 400 mg.
Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Zbog toga se preporučuje oprezno postupati kada se imatinib primjenjuje s CYP3A4 supstratima s uskom terapijskom širinom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel i kvinidin).
In newly diagnosed chronic phase CML grade 4neutropenia (ANC < 0.5x109/1) and thrombocytopenia (platelet count < 10x109/1) were observed in 3.6% and < 1% of patients, respectively.
U novodijagnosticiranoj kroničnoj fazi KML-a, neutropenija 4. stupnja (ABN < 0,5 x 109/l) i trombocitopenija (broj trombocita < 10 x 109/l) zapažene su u 3,6% odnosno <1% bolesnika.
Overall, in patients receiving first-line Imatinib, the average daily dose delivered was 406 ± 76 mg.
Ukupno gledajući, prosječna vrijednost dnevne doze dane bolesnicima koji su primali prvu liniju liječenja Imatinibom iznosila je 406 ± 76 mg.
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people)
Vrlo česte (mogu se javiti u više od 1 na 10 osoba) ili česte (mogu se javiti u do 1 na 10 osoba)
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
1 Upala pluća je najčešće zabilježena u bolesnika s transformiranim KML-om i u bolesnika s GIST-om.
Hepatitis B reactivation has been reported in association with BCR-ABL TKIs.
Reaktivacija hepatitisa B zabilježena je u vezi s inhibitorima BCR-ABL tirozin kinaze.
10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
10 Mišićno-koštana bol i srodni događaji su češće uočeni u bolesnika s KML-om, nego u bolesnika s GIST-om.
G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 μM, q6h = every 6 hours, Gy= Gray
= u mišić, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA= natrijev 2merkaptoetan sulfonat, iii= ili dok vrijednost MTX-a ne bude <0,1 µm, Gy= Gray
In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).When needed,discontinuation of Imatinib treatment may be considered.
Osim toga, gastrična antralna vaskularna ektazija (GAVE), rijetki uzrok gastrointestinalnog krvarenja, zabilježena je nakon stavljanja lijeka u promet u bolesnika s KML-om, ALL-om i drugim bolestima (vidjeti dio 4.8).
Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycinand telithromycin) could decrease metabolism and increase imatinib concentrations.
Tvari koje inhibiraju djelovanje CYP3A4 izoenzima citokroma P450 (npr. inhibitori proteaze kao što su indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotici uključujući ketokonazol, itrakonazol, posakonazol, vorikonazol; određeni makrolidi kao što su eritromicin, klaritromicin i telitromicin) mogle bi smanjiti metabolizam i povećati koncentracije imatiniba.
The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Najčešće zabilježene nuspojave ( 10%) koje su povezane s primjenom lijeka, bile su u obje situacije blaga mučnina, povraćanje, proljev, bol u trbuhu, umor, bol u mišićima, grčevi u mišićima i osip.
In the Imatinib arm, patients were treated with 400 mg daily.
U Imatinib kraku, bolesnici su liječeni dozom od 400 mg na dan.
VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
VCR 2 mg ukupna doza i.v., dani 1, 8, 15, 22; CP 750 mg/m2 i.v., dani 1, 8;
ANC = absolute neutrophil count aoccurring after at least 1 month of treatment Special populations Hepatic insufficiency
ABN = apsolutni broj neutrofila a javlja se nakon najmanje 1 mjeseca liječenja
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Poboljšanja su zabilježena u srčanom, živčanom, koži/potkožnom tkivu, dišnom/prsnom košu/sredoprsju, mišićno-koštanom/vezivnom tkivu/krvožilnom i probavnom organskom sustavu.
As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Budući da su srčaništetni događaji zabilježeni manje često uz imatinib, prije početka liječenja u HES/KEL populaciji potrebno je uzeti u obzir pažljivu procjenu omjera koristi i rizika od terapije imatinibom.
PVC/PVdC/Alu blisters
PVC/PVdC/Alu blisteri
This was not seen at doses ≤ 20 mg/kg.
To nije uočeno pri dozama od ≤ 20 mg/kg.
(NEL) Return to chronic phase
Vraćanje na kroničnu fazu (RTC)
Haematological response
Hematološki odgovor1
Major response at 12 months (%)
Molekularni odgovor** Veliki odgovor nakon 12 mjeseci (%)
Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
Trostruka i.t. terapija (prilagođena dobi): dani 1, 29 VCR (1,5 mg/m2, i.v.): dani 1, 29
There is no experience in children and adolescents with CML below 2 years of age.
Ne postoji iskustvo kod djece s KML-om mlađe od 2 godine i adolescenata s KLM-om.
Daunorubicin 30 mg/ m2 i.v., days 1-3, 15-16;
Daunorubicin 30 mg/m2 i.v., dani 1-3, 15-16;
If you are being treated for CML
Ako se liječite zbog KML-a
In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses ≥ 6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
U ispitivanju kod štakora koje je trajalo 13 tjedana zapažena je hiperplazija prijelaznog epitela u bubrežnoj papili te u mokraćnom mjehuru uz doze ≥ 6 mg/kg, bez promjena parametara za serum ili mokraću.
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.
< 18 godina bilo s kroničnom fazom KML-a (n=11), bilo s KML-om u blastičnoj krizi ili Ph+ akutnim leukemijama (n=15).
Hypromellose 6 cps (E464) Microcrystalline cellulose pH 102 Crospovidone
Hipromeloza 6 cps (E464) celuloza, mikrokristalična pH 102 krospovidon silicijev dioksid, koloidni, bezvodni magnezijev stearat
Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with imatinib.
Bolesnike treba obavijestiti o postojanju mogućnosti da tijekom liječenja imatinibom nastupe nuspojave poput omaglice, zamagljenog vida ili somnolencije.Stoga se preporučuje oprez pri upravljanju vozilima ili radu sa strojevima.
One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) koje je uključivalo 12 bolesnika s DFSP-om liječenih imatinibom 800 mg na dan.
Posology for HES/CEL
Doziranje za HES/KEL
What Imatinib Accord contains
Što Imatinib Accord sadrži
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Manje često Hipokalemija, povećan apetit, hipofosfatemija, smanjen apetit, dehidracija, giht, hiperuricemija, hiperkalcemija, hiperglikemija, hiponatremija
The starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Početna doza je 100 mg, a uzima se jedna tableta od 100 mg jednom dnevno.
Acute respiratory failure11*, interstitial lung disease* Gastrointestinal disorders
Nepoznato Akutno zatajenje disanja11*, intersticijska plućna bolest* Poremećaji probavnog sustava
Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions
Manje često Pustularni osip, kontuzije, pojačano znojenje, urtikarija, ekhimoza, povećana sklonost modricama, hipotrihoza, hipopigmentacija kože, eksfolijativni dermatitis, onihoklazija, folikulitis, petehije, psorijaza, purpura, hiperpigmentacija kože, bulozne erupcije
Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Aritmija, fibrilacija atrija, srčani zastoj, infarkt miokarda, angina pektoris, perikardijalna efuzija Nepoznato Perikarditis*, tamponada srca* Krvožilni poremećaji4
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
• mučnina, nedostatak zraka, nepravilni otkucaji srca, zamućenje mokraće, umor i/ili osjećaj nelagode u zglobovima udruženi s poremećenim nalazima laboratorijskih pretraga (npr. visoke razine kalija, mokraćne kiseline i kalcijate niske razine fosforau krvi).
The same publication reported long term follow-up data from 12 MDS/MPD patients with PDGFR
Ista publikacija je objavila i podatke dugotrajnog praćenja od 12 MDS/MPD bolesnika s preraspodjelom PDGFR gena (5 bolesnika iz studije B2225).
INFORMATION IN BRAILLE Imatinib Accord 100 mg
16. PODACI NA BRAILLEOVOM PISMU Imatinib Accord 100 mg
INFORMATION IN BRAILLE Imatinib Accord 400 mg
16. PODACI NA BRAILLEOVOM PISMU Imatinib Accord 400 mg
How long to take Imatinib Accord
Koliko dugo uzimati Imatinib Accord
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5).
Potreban je oprez kada seimatinib uzima sinhibitorima proteaze, azolnim antimikoticima, određenim makrolidima (vidjeti dio 4.5), CYP3A4 supstratima s uskom terapijskom širinom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel, kvinidin) ilivarfarinomi drugimderivatimakumarina (vidjeti dio 4.5).
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop Imatinib Accord until ANC ≥ 1 x 109/1 and platelets ≥ 20 x 109/1, then resume treatment at 300 mg.
Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu Imatinib Accorda sve dok ABN ne bude  1 x 109/l i trombociti  20 x 109/l, nakon toga nastaviti liječenje u dozi od 300 mg.
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.
Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) za ispitivanje imatinibom u raznim populacijama bolesnika koji pate od bolesti opasnih po život povezanih s Abl, Kit ili PDGFR protein tirozin kinazama.
Relapsed/refractory Ph+ ALL
Recidivirajući ili refraktorni Ph+ ALL
Active substances that may increase imatinib plasma concentrations
Djelatne tvari koje mogu povećati koncentracije imatiniba u plazmi:
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
MESNA (360 mg/m2/doza svaka 3 sata x 8 doza/dan, i.v.): dani 1-5 G-CSF (5 μg/kg, s.c.): dani 6-15 ili do porasta ANC >1500 nakon najniže izmjerene vrijednosti i.t. metotreksat (prilagođeno dobi): SAMO dan 1