natgillin/translations-raw huggingface dataset:
Haemolytic anaemia, thrombotic microangiopathy
Hemolitička anemija, trombotična mikroangiopatija
Very common (may affect more than 1 in 10 people): - Headache or feeling tired.
Vrlo česte (mogu se javiti u više od 1 na 10 osoba): - glavobolja ili umor.
This clinical effect was associated with a higher reduction in bcrabl transcripts in the imatinib-treated patients than in the chemotherapy arm after 2 weeks of therapy (p=0.02).
Ovaj klinički učinak povezan je s većim smanjenjem u bcr-abl transkripciji u bolesnika liječenih imatinibom, nego u kraku koji je primao kemoterapiju, nakon 2 tjedna terapije
The suspension should be administered immediately after complete disintegration of the tablet(s).
Lijek se mora iskoristiti odmah nakon potpunog otapanja tablete.
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 GIST
If cytopenia persists for 2 weeks, reduce further to 200 mg/m2.
Ako citopenija ustraje 2 tjedna, dozu dodatno smanjiti na 200 mg/m2.
The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Sigurnost i djelotvornost imatiniba u djece s MDS/MPD-om, DFSP-om i HES/KEL-om mlađe od 18
DAUN (45 mg/m2/day bolus, IV): days 1 and 2
DAUN (45 mg/m2/dan bolus, i.v.): dani 1 i 2
The age of these patients ranged from 25 to 72 years.
Starost tih bolesnika kretala se od 25 do 72 godine.
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
Svrbež, edem lica, suhoća kože, eritem, alopecija, noćno znojenje, reakcija preosjetljivosti na svjetlo
The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
AUC imatiniba u plazmi smanjio se za 73% u usporedbi s bolesnicima koji nisu primali antiepileptičke lijekove koji induciraju enzime.
Acute respiratory failure11*, interstitial lung disease*
Akutno zatajenje disanja11*, intersticijska plućna bolest* Poremećaji probavnog sustava Vrlo često
Paediatric chronic phase CML (at dose 340 mg/m2)
Pedijatrijska kronična faza KML-a (doza od 340 mg/m2)
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2.).
A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Opsežno međunarodno otvoreno i nekontrolirano ispitivanje faze II provedeno je u bolesnika s KMLom s pozitivnim Philadelphia (Ph+) kromosomom u fazi blastične krize.
30 hard capsules 90 hard capsules
30 tvrdih kapsula 90 tvrdih kapsula
For doses other than 400 mg and 800 mg (see dosage recommendation above) a 100 mg divisible tablet is available.
Za doze, osim 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) dostupna je tableta od 100 mg koja se može prepoloviti
If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 400 mg.
Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 400 mg.
- If you are being treated for HES/CEL:
- Ako se liječite zbog HES/KEL-a:
F1 fertility was not affected, while an increased number of resorptions and a decreased number of viable foetuses was noted at 45 mg/kg/day.
F1 fertilnost, dok je pri 45 mg/kg/dan zapažen povećani broj resorpcija i smanjeni broj fetusa sposobnih za život.
The dose can be reduced if not tolerated (see sections 4.2 and 5.2).
Doza se može smanjiti ako se ne podnosi (vidjeti dijelove 4.2 i 5.2).
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis,
Herpes zoster, herpes simplex, nazofaringitis, upala pluća1, sinusitis, celulitis,
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.
Resume treatment with imatinib at 600 mg.
Ponovno uvesti liječenje imatinibom u dozi od 600 mg.
Within each frequency grouping, undesirable effects are presented in order of frequency, the most frequent first.
Unutar svake grupe učestalosti nuspojave su prikazane prema redosljedu učestalosti, najučestalije su prve.
If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m2.
Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 260 mg/m2.
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 (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 (temeljeno na AUC) kod
When and how to take Imatinib Actavis
Kada i kako uzimati Imatinib Actavis
Induction therapy (de novo Ph+ ALL)
Indikcijska terapija (de novo Ph+ ALL)
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.
Dose increases from 600 mg to a maximum of 800 mg (given as 400 mg twice daily) in patients with 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.
Povećanje doze od 600 mg do maksimalno 800 mg (dano kao 400 mg dvaput na dan) u bolesnika s blastičnom krizom može se razmotriti u odsustvu teške nuspojave 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.
The age of these patients ranged from 20 to 72 years.
Starost tih bolesnika se kretala od 20 do 72 godine.
11 Ion Mihalache Blvd Bucharest
S.C. Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd Bucharest
Imatinib Actavis will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Što morate znati prije nego počnete uzimati Imatinib Actavis Imatinib Actavis Vam može propisati jedino liječnik koji ima iskustva s lijekovima za liječenje raka krvi ili čvrstih tumora.
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
Pustularni osip, kontuzije, pojačano znojenje, urtikarija, ekhimoza, povećana sklonost modricama, hipotrihoza, hipopigmentacija kože, eksfolijativni dermatitis, onihoklazija, folikulitis, petehije, psorijaza, purpura, hiperpigmentacija kože, bulozne erupcije
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane Često
10 hard capsules 30 hard capsules 60 hard capsules 90 hard capusles
10 tvrdih kapsula 30 tvrdih kapsula 60 tvrdih kapsula 90 tvrdih kapsula
6-MP (75 mg/m2/day, PO): days 11-56 (Withhold 6-MP during the 6-10 days of cranial irradiation beginning on day 1 of Cycle 5.
6-MP (75 mg/m2/dan, p.o.): dani 11-56 (Uskratiti 6-MP tijekom 6-10 dana kranijalne iradijacije dana 1, ciklusa 5. Započeti 6-MP 1-og dana nakon završetka kranijalne iradijacije.)
Similar results were observed in patients with malignant gliomas treated with imatinib while taking enzyme-inducing anti-epileptic medicinal products (EIAEDs) such as carbamazepine, oxcarbazepine and phenytoin.
Slični rezultati su uočeni u bolesnika s malignim gliomima koji su liječeni imatinibom dok su uzimali antiepileptičke lijekove koji induciraju enzime, poput karbamazepina,
There was more myelosuppression seen in CML patients than in GIST, which is probably due to the underlying disease.
U KML bolesnika uočen je veći postotak mijelosupresije, nego u bolesnika s GIST-om, što je vjerojatno uzrokovano osnovnom bolešću.
Patients were treated at doses of imatinib of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5).
Bolesnici su liječeni dozama imatiniba od 260 mg/m2/dan (n=5), 340 mg/m2/dan (n=9),
Events that have been reported at different dose ranges are as follows:
Zabilježeni su sljedeći događaji s različitim rasponima doza: Populacija odraslih osoba
- Bruising.
- modrice.
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
U bolesnika u kojih je obavljena tireoidektomija i koji primaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena, kada se imatinib istodobno primjenjuje (vidjeti dio 4.4).
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, clarithromycin and 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.
monthly for 13 months; prednisolone 200 mg oral, 5 days per month for 13 months
VCR 2 mg i.v. mjesečno tijekom 13 mjeseci; prednizolon 200 mg peroralno, 5 dana na mjesec tijekom 13 mjeseci
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
Ciljni organi neoplastičkih promjena bili su bubrezi, mokraćni mjehur, uretra, žlijezda prepucija i klitorisa, tanko crijevo, paratireoidne žlijezde, nadbubrežne žlijezde i ne-žljezdani želudac.
If cytopenia persists for 2 weeks, reduce further to 300 mg.
Ako citopenija ustraje 2 tjedna, dozu ponovno smanjiti na 300 mg.
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
U tom kliničkom ispitivanju, 14 bolesnika s HES/KEL-om je liječeno imatinibom od 100 mg do 1000 mg na dan.
- If you are being treated for DFSP:
Ako se liječite zbog DFSP-a:
There is very limited experience in children with MDS/MPD, DFSP, and HES/CEL.
Postoji vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om i
Maximal plasma concentrations of imatinib in patients are 2-4 μmol/L, consequently an inhibition of CYP2D6 and/or CYP3A4/5-mediated metabolism of co-administered drugs is possible.
Maksimalne koncentracije imatiniba u plazmi bolesnika iznose 2-4 μmol/l pa je prema tome moguζa inhibicija metabolizma istodobno primijenjenih lijekova, koji se odvija posredstvom CYP2D6 i/ili CYP3A4/5.
HES/CEL (at dose 400 mg)
HES/KEL (doza od 400 mg)
Imatinib treatment induces a rapid response in newly diagnosed paediatric CML patients with a CHR of 78% after 8 weeks of therapy.
Liječenje imatinibom izazvalo je brzi odgovor u novodijagnosticiranih pedijatrijskih KML bolesnika sa CHR-om od 78%
- The active substance is imatinib (as mesilate).
- Djelatna tvar je imatinib (u obliku imatinibmesilata).
Consolidation therapy
Konsolidacijska terapija
- Rash.
- osip.
A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Dodatnih 162 bolesnika s HES/KEL-om, zabilježenih u 35 objavljenih prikaza slučajeva i serija slučajeva, primalo je imatinib u dozama od 75
- adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
- odraslih i pedijatrijskih bolesnika s novodijagnosticiranom akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL) uz kemoterapiju.
Dose increases from 340 mg/m2 daily to 570 mg/m2 daily (not to exceed the total dose of 800 mg) may be considered in children in the absence of severe adverse drug reaction and severe non-leukaemiarelated 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.
U djece se mogu razmotriti povećanja doze od 340 mg/m2 na dan do 570 mg/m2 na dan (ne smije se prekoračiti ukupna doza od 800 mg) u odsustvu teške nuspojave 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.
Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
GGN = institucionalna gornja granica normale AST = aspartat-aminotransferaza
Hyperkalaemia, hypomagnesaemia
Hiperkalijemija, hipomagnezijemija
- Dry mouth, dry skin or dry eye. - Decreased or increased skin sensitivity.
- suha usta, suhoća kože ili suho oko. - smanjena ili povećana osjetljivost kože. - navale vrućine, zimica ili noćno znojenje.
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/L) and thrombocytopenias (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).
4 (ABN <1,0 x 109/l) i trombocitopenija (broj trombocita <50 x 109/l) bila između 4 i 6 puta veća u blastičnoj krizi i ubrzanoj fazi (5964% i 4463% za neutropeniju odnosno trombocitopeniju) u usporedbi s novodijagnosticiranim bolesnicima u kroničnoj fazi KML-a (16,7% neutropenija i 8,9% trombocitopenija).
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.
Weight decreased
Smanjena tjelesna težina
EU/1/13/825/001 30 capsules EU/1/13/825/002 90 capsules
EU/1/13/825/001 30 kapsula EU/1/13/825/002 90 kapsula
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
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.
U kliničkim ispitivanjima koja su uključivala preko 20% bolesnika u dobi od 65 godina i više nisu zapažene značajne farmakokinetičke razlike vezane uz dob kod odraslih bolesnika.
- 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.
MDS/MPD (starting dose 400 mg)
MDS/MPD (početna doza
- 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).
- osip, crvenilo kože s mjehurićima na usnama, očima, koži ili u ustima, ljuštenje kože, vrućica, izdignuti crveni ili ljubičasti plikovi na koži, svrbež, osjećaj žarenja, pojava gnojnih mjehurića
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 imatiniba u raznim populacijama bolesnika koji pate od bolesti opasnih po život povezanih s Abl, Kit ili PDGFR protein tirozin kinazama.
- If any of these affect you severely, tell your doctor.
- Ako se bilo što od navedenog kod Vas javi u teškom obliku, obavijestite svog liječnika.
Imatinib may increase plasma concentration of other CYP3A4 metabolised drugs (e.g. triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, i.e. statins, etc.).
CYP3A4 (npr. triazolo-benzodiazepini, dihidropiridinski blokatori kalcijevih kanala, određeni inhibitori HMG-CoA reduktaze odnosno statini, itd.).
Relapsed/refractory Ph+ ALL: 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%.
Recidivirajući ili refraktorni Ph+ ALL: 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%.
In GIST patients (study B2222), 6.8% of grade 3 or 4
U bolesnika s GIST-om (studija B2222), zapaženo je 6,8% ALT
Pack sizes: The capsules are supplied in aluminium blister packs of 24, 48, 60, 96, 120 or 180 capsules.
Veličine pakiranja: Kapsule se isporučuju u aluminijskim blisterima od 24, 48, 60, 96, 120 ili 180 kapsula.
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
= 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
How long to take Imatinib Actavis
Koliko dugo uzimati Imatinib Actavis
Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP)
Akutna febrilna neutrofilna dermatoza (Sweetov sindrom), promjena boje nokta, angioedem, vezikularni osip, multiformni eritem, leukocitoklastični vaskulitis, Stevens-Johnsonov sindrom, akutna generalizirana egzantematozna pustuloza (AGEP)
Pack sizes: The capsules are supplied in aluminium blister packs of 30 or 90 capsules.
Veličine pakiranja: Kapsule se isporučuju u aluminijskim blisterima od 30 ili 90 kapsula.
Study 0102 38-month data Myeloid blast crisis (n=260) % of patients (CI95%)
(n=260) % bolesnika (CI95%)
Imatinib Actavis inhibits the growth of these cells.
Imatinib Actavis inhibira rast ovih stanica.
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 (KML
Posology for CML in paediatric patients Dosing for children should be on the basis of body surface area (mg/m2).
U djece se doziranje treba temeljiti na veličini površine tijela (mg/m2).
The median time to progression in the overall population of 411 patients with relapsed/refractory Ph+ ALL ranged from 2.6 to 3.1 months, and median overall survival in the 401 evaluable patients ranged from 4.9 to 9 months.
Medijan vremena do progresije u ukupnoj populaciji od 411 bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om kretao se od 2,6 do 3,1
12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
18 Gy u 10 frakcija za bolesnike koji imaju CNS3 u trenutku dijagnoze VCR (1,5 mg/m2/dan, i.v.): dani 1, 29
In the study in patients with unresectable and/or metastatic GIST, 7 (5%) patients experienced CTC grade 3/4 GI bleeds (3 patients), intra-tumoural bleeds (3 patients) or both (1 patient).
bolesnika nastupilo je GI krvarenje CTC stupnja 3/4 (3 bolesnika), intratumorsko krvarenje (3 bolesnika) ili oboje (1 bolesnik).
- Muscle cramps or joint, muscle or bone pain, during imatinib treatment or after you have stopped taking imatinib.
- grčevi u mišićima ili bol u zglobovima, mišićima ili kostima, tijekom liječenja imatinibom ili nakon prekida uzimanja imatiniba..
Imatinib Actavis is indicated for - the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.
- liječenje odraslih bolesnika s inoperabilnim dermatofibrosarkomom protuberans (DFSP) i odraslih bolesnika s rekurentnim i/ili metastazirajućim DFSP-om koji nisu podobni za kirurški zahvat.
If any of these affect you severely, tell your doctor.
Ako se bilo što od navedenog kod Vas javi u teškom obliku, obavijestite svog liječnika.
Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Palpitacije, tahikardija, kongestivno zatajenje srca3, plućni edem
- Difficulty in sleeping (insomnia).
- omaglica ili slabost. - otežano spavanje (nesanica).
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L, then resume treatment at 200 mg/m2.
Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu imatiniba sve dok ABN ne bude ≥1 x 109/l i trombociti ≥20 x 109/l, nakon toga nastaviti liječenje u dozi od 200 mg/m2.
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L, then resume treatment at 300 mg.
Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu imatiniba sve dok ABN ne bude ≥1 x 109/l i trombociti ≥20 x 109/l, nakon toga nastaviti liječenje u dozi od 300 mg.
Methotrexate (20 mg/m2/week, PO): days 8, 15, 22 VP-16 (100 mg/m2, IV): days 29-33
Metotreksat (20 mg/m2/tjedan, p.o.): dani 8, 15, 22 VP-16 (100 mg/m2, i.v.): dani 29-33