natgillin/translations-raw huggingface dataset:
When female rats were dosed 14 days prior to mating and through to gestational day 6, there was no effect on mating or on number of pregnant females.
14 dana prije parenja pa sve do 6. gestacijskog dana, nije bilo učinka na parenje ili na broj skotnih ženki.
- Blood clots in small blood vessels (thrombotic microangiopathy).
- krvni ugrušci u malim krvnim žilama (trombotična mikroangiopatija).
- Take Imatinib Actavis with a meal.
- Imatinib Actavis uzimajte uz obrok.
Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44%) and 3 (33%) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77%.
Od 9 bolesnika s kroničnom fazom KML-a i raspoloživim citogenetskim podacima, 4 (44%) i 3 (33%) je postiglo potpuni, odnosno djelomični citogenetski odgovor, za stopu MCyR-a od 77%.
In addition, children and adolescents have been treated in two phase I studies (in patients with CML or Ph+ acute leukaemia) and one phase II study.
Osim toga, djeca su liječeni u dva ispitivanja faze I (bolesnici s KML ili Ph+ akutnom leukemijom) i jednom ispitivanju faze II.
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia (i.e. clearance of blasts from the marrow and the blood, but without a full peripheral blood recovery as for complete responses), or return to chronic phase CML.
Primarna varijabla djelotvornosti bila je stopa hematološkog odgovora, koja je zabilježena bilo kao potpuni hematološki odgovor, bez dokaza leukemije (tj. klirens blasta iz koštane srži i krvi, ali bez potpunog oporavka periferne krvi kao kod potpunih odgovora), ili kao vraćanje na kroničnu fazu
- adult patients with Ph+ CML in blast crisis.
- odraslih bolesnika s Ph+ KML-om u blastičnoj krizi.
Other medicines and Imatinib Actavis
Drugi lijekovi i Imatinib Actavis
One blister contains 10 capsules.
Jedan blister sadrži 10 kapsula.
Depression, libido decreased, anxiety
Depresija, smanjeni libido, anksioznost
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 nije ometao biotransformaciju 5-fluorouracila, ali je inhibirao metabolizam paklitaksela, što je bila posljedica kompetitivne inhibicije CYP2C8 (Ki - 34,7 µM).
Treatment duration: In the only clinical trial performed up to now, treatment with imatinib was continued until disease progression (see section 5.1).
Trajanje liječenja: u jedinom kliničkom ispitivanju provedenom do sada, liječenje imatinibom je nastavljeno do progresije bolesti (vidjeti dio 5.1).
Imatinib and its metabolites are not excreted via the kidney to a significant extent.
Imatinib i njegovi metaboliti ne izlučuju se u značajnoj mjeri preko bubrega.
An unexpected rapid weight gain should be carefully investigated and if necessary appropriate supportive care and therapeutic measures should be undertaken.
Neočekivani, nagli porast tjelesne težine treba pažljivo ispitati te, ukoliko je potrebno, poduzeti odgovarajuće suportivne i terapijske mjere.
- paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
- pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi nakon neuspjeha terapije interferonom alfa, ili u ubrzanoj fazi ili u blastičnoj krizi.
At the same dose, the number of stillborn pups as well as those dying between postpartum days 0 and 4 was increased.
Pri istoj dozi povećao se broj mrtvorođenih mladunaca, kao i onih koji su uginuli postpartalno između dana 0 i 4. U F1
The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
Povećanje je otprilike 1,5 do 2 puta veće, a odgovara 1,5 puta većem povećanju α-kiselog glikoproteina u plazmi, za koji se imatinib snažno veže.
As expected on the basis of the study design, no difference was observed in remission duration, disease-free survival or overall survival, although patients with complete molecular response and remaining in minimal residual disease had a better outcome in terms of both remission duration (p=0.01) and disease-free survival (p=0.02).
Kao što se očekivalo na temelju dizajna studije, nije uočena razlika u trajanju remisije, preživljenju bez bolesti ili ukupnom preživljenju, premda su bolesnici s potpunim molekularnim odgovorom i s minimalnom rezidualnom bolešću imali bolji ishod u smislu dužine remisije (p=0,01) i preživljenja bez bolesti
- if you are allergic to imatinib, soya, peanut or any of the other ingredients of this medicine (listed in section 6).
- ako ste alergični na imatinib, soju, kikiriki ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Cerebral oedema*
Cerebralni edem*
Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Farmakoterapijska skupina: antineoplastici, inhibitor protein-kinaze, ATK oznaka: L01XE01 Mehanizam djelovanja
Fungal infection
Gljivična infekcija
Treatment duration: In clinical trials, treatment with imatinib was continued until disease progression.
Trajanje liječenja: u kliničkim ispitivanjima se liječenje imatinibom nastavljalo sve do progresije bolesti.
The comparison of AUC(0-24) on day 8 and day 1 at the 340 mg/m2/day dose level revealed a 1.7-fold drug accumulation after repeated once-daily dosing.
Usporedba AUC(0-24) na dan 8 i dan 1 na nivou doze od 340 mg/m2/dan otkrila je 1,7 puta veću akumulaciju lijeka nakon ponovljenog doziranja jednom na dan.
Table 3 Chemotherapy regimen used in combination with imatinib Study ADE10
Tablica 3 Režim kemoterapije korišten u kombinaciji s imatinibom Studija ADE10
The effect of bodyweight on the clearance of imatinib is such that for a patient weighing 50 kg the mean clearance is expected to be 8.5 L/h, while for a patient weighing 100 kg the clearance will rise to 11.8 L/h.
Učinak tjelesne težine na klirens imatiniba takav je da se za bolesnika koji teži 50 kg očekuje da će srednji klirens biti 8,5 l/h, dok će se za bolesnika od 100 kg klirens povećati na 11,8 l/h.
20 out of the 50 (40%) patients in cohort 5 received haematopoietic stem cell transplant.
Od 50 bolesnika u kohorti 5, 20 (40%) ih je primilo transplantirane hematopoetske matične stanice.
- Patients who are concerned about their fertility while taking Imatinib Actavis are advised to consult with their doctor.
- Bolesnicima koji su zabrinuti za svoju plodnost tijekom uzimanja Imatinib Actavisa preporučuje se da se posavjetuju sa svojim liječnikom.
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 400 mg dvaput na dan imao je inhibitorni učinak na metabolizam metoprolola posredovan CYP2D6, pri čemu su se Cmax i AUC metoprolola povećali za otprilike 23% (90%CI [1,16 - 1,30]).
What Imatinib Actavis is and what it is used for
Što je Imatinib Actavis i za što se koristi
Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Osim toga, djelomični citogenetski odgovor (PCyR) uočen je u 16%, a veliki citogenetski odgovor (MCyR) u 81%.
If you have accidentally taken too many tablets, talk to your doctor straight away.
Ako ste zabunom uzeli previše tableta, odmah se obratite liječniku.
There is no experience in children with CML below 2 years of age.
Ne postoji iskustvo kod djece s KML-om mlađe od 2 godine.
Paediatric use: There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1).
Posebne populacije Primjena u pedijatriji: Ne postoji iskustvo kod djece s KML-om mlađe od 2 godine i s Ph+ALL mlađe od 1 godine (vidjeti dio 5.1).
One blister contains either 8 or 10 capsules.
Jedan blister sadrži 8 ili 10 kapsula.
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 from 340 to 260 mg/m2/day.
Dozu u odraslih treba sniziti s 400 na 300 mg ili sa 600 na 400 mg ili s 800 na 600 mg, a u djece s 340 na 260 mg/m2/dan.
- Hot flushes, chills or night sweats.
- navale vrućine, zimica ili noćno znojenje.
Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Limfoidna blastična kriza: u ispitivanjima faze I uključen je ograničeni broj bolesnika (n=10).
Patients were treated with imatinib 340 mg/m2/day, with no interruptions in the absence of dose limiting toxicity.
Bolesnici su liječeni s 340 mg/m2/dan imatiniba, bez prekida u odsutnosti toksičnosti vezane uz dozu.
Total bilirubin: = 1.5 ULN AST: >ULN (can be normal or <ULN if total bilirubin is >ULN)
Ukupni bilirubin: = 1,5 GGN AST: >GGN (može biti normalan ili <GGN ako je ukupni bilirubin >GGN)
Imatinib should not be used during pregnancy unless clearly necessary.
Imatinib se ne smije primjenjivati u trudnoći osim ako njegova primjena nije izrazito neophodna.
Unchanged imatinib accounted for 25% of the dose (5% urine, 20% faeces), the remainder being metabolites.
Na nepromijenjeni imatinib otpadalo je 25% doze (5% mokraća, 20% stolica), dok su ostalo bili metaboliti.
This is because Imatinib Actavis could cause hepatitis B to become active again, which can be fatal in some cases.
To je potrebno jer Imatinib Actavis može uzrokovati ponovnu aktivaciju hepatitisa B što u nekim slučajevima može rezultirati smrtnim ishodom.
When salvage therapy with imatinib was administered in patients who did not respond or who responded poorly to chemotherapy, it resulted in 9 patients (81.8%) out of 11 achieving a complete haematological response.
Kada je terapija imatinibom primijenjena bolesnicima koji nisu odgovarali ili su slabo odgovarali na kemoterapiju, 9 od 11 bolesnika (81,8%) postiglo je potpuni hematološki odgovor.
Safety data from this study seem to be in line with the safety profile of imatinib in Ph+ ALL patients.
Podaci o sigurnosti primjene iz ovog ispitivanja u skladu su sa sigurnosnim profilom imatiniba u bolesnika s Ph+ ALL.
The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Odrasli bolesnici navedeni u objavljenoj literaturi su liječeni ili s 400 mg (4 slučaja) ili s 800 mg (1 slučaj) imatiniba na dan.
In the study in patients with unresectable and/or metastatic GIST, grade 3 and 4 anaemia was reported in 5.4% and 0.7% of patients, respectively, and may have been related to gastrointestinal or intratumoural bleeding in at least some of these patients.
U ispitivanju s bolesnicima s inoperabilnim i/ili metastazirajućim GIST-om, anemije 3. i 4. stupnja zabilježene su u 5,4% odnosno 0,7% bolesnika i mogle su biti povezane s gastrointestinalnim ili intratumorskim krvarenjem barem u nekih od tih bolesnika.
What Imatinib Actavis looks like and contents of the pack
Kako Imatinib Actavis izgleda i sadržaj pakiranja
Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk.
Ispitivanja u dvije dojilje su otkrila da se i imatinib i njegov djelatni metabolit mogu distribuirati u mlijeko.
Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.
Bolesnike sa srčanom bolešću, faktorom rizika za zatajenje srca ili ranijim zatajenjem bubrega treba pažljivo pratiti, a svakog bolesnika sa znakovima ili simptomima koji ukazuju na zatajenje srca ili bubrega treba pregledati i liječiti.
Imatinib Actavis inhibits the growth of these cells in a certain subtype of these diseases.
Imatinib Actavis inhibira rast ovih stanica u određenoj podvrsti ovih bolesti.
- If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation.
- Ako ste trudni ili možete ostati trudni, a pokušavate otvoriti kapsule, morate pažljivo rukovati sa sadržajem te izbjegavati kontakt s kožom i očima ili inhaliranje.
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).
Dvadeset i tri bolesnika uključena u ovaj registar primala su imatinib s medijanom dnevne doze od 264 mg (raspon: 100 do 400 mg) i medijanom vremena trajanja od 7,2 godine (raspon od 0,1 do 12,7 godina).
What you need to know before you take Imatinib Actavis
Što morate znati prije nego počnete uzimati Imatinib Actavis
Complete haematological response (CHR)
Hematološki odgovor1 Potpuni hematološki odgovor (CHR)
The pharmacokinetics of imatinib have been evaluated over a dosage range of 25 to 1,000 mg.
Farmakokinetika imatiniba ispitivana je u rasponu doza od 25 do 1000 mg.
When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Kada se imatinib kombinirao s visokim dozom kemoterapije u Ph+ ALL bolesnika, uočena je prolazna jetrena toksičnost u obliku povišenja transaminaze i hiperbilirubinemije.
There was high between-patient variability in plasma imatinib AUC levels after an oral dose.
Između bolesnika postojala je velika varijabilnost u AUC razinama imatiniba u plazmi nakon jedne oralne doze.
In addition, mortality was observed in juvenile animals (around weaning phase) at approximately 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
K tome, mortalitet je uočen u juvenilnih životinja (oko faze odbijanja) pri izloženosti koja je iznosila otprilike 2 puta prosječne izloženosti u djece pri najvišoj preporučenoj dozi od 340 mg/m2.
The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Ukupna dnevna doza u djece ne smije prijeći 800 mg kod KML-a i 600 mg kod Ph+ALL-a.
Based on pooled population pharmacokinetic analysis in paediatric patients with haematological disorders (CML, Ph+ALL, or other haematological disorders treated with imatinib), clearance of imatinib increases with increasing body surface area (BSA).
Na temelju farmakokinetičke analize zbirne populacije pedijatrijskih bolesnika s hematološkim poremećajima (CML, Ph+ALL ili drugi hematološki poremećaji koji se liječe imatinibom), klirens imatiniba povećava se s rastom tjelesne površine (BSA).
24 hard capsules 48 hard capsules 60 hard capsules 96 hard capsules 120 hard capsules 180 hard capsules
24 tvrde kapsule 48 tvrdih kapsula 60 tvrdih kapsula 96 tvrdih kapsula 120 tvrdih kapsula 180 tvrdih kapsula
Dosing in children at 260 and 340 mg/m2/day achieved the same exposure, respectively, as doses of 400 mg and 600 mg in adult patients.
Doziranje u djece od 260 odnosno 340 mg/m2/dan postiglo je istu izloženost, kao i doze od 400 mg i 600 mg u odraslih bolesnika.
- Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
- teška glavobolja, slabost ili paraliza udova ili lica, otežan govor, iznenadni gubitak svijesti (znakovi problema živčanog sustava kao što su krvarenje ili oticanje u lubanji/mozgu).
BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Actavis (see section 4.8).
Inhibitori BCR-ABL tirozin kinaze (TKI-jevi) povezani su s trombotičnom mikroangiopatijom (TMA), uključujući izvješća o pojedinačnom slučaju za Imatinib Actavis (vidjeti dio 4.8).
The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Utvrđeno je da AUC za taj metabolit u plazmi iznosi samo 16% AUC-a imatiniba.
In the F1 offspring, at the same dose level, mean body weights were reduced from birth until terminal sacrifice and the number of litters achieving criterion for preputial separation was slightly decreased.
potomstva, pri istoj dozi, smanjile su se srednje tjelesne težine od poroda sve do konačnog žrtvovanja, a broj okota koji su postigli kriterij za prepucijsku separaciju bio je malo smanjen.
- Chronic myeloid leukaemia (CML).
- Kronične mijeloične leukemije (KML).
95 (37%) had received prior chemotherapy for treatment of either accelerated phase or blast crisis (“pretreated patients”) whereas 165 (63%) had not (“untreated patients”).
Njih je 95 (37%) prethodno primilo kemoterapiju zbog liječenja bilo ubrzane faze, bilo blastične krize („prethodno liječeni bolesnici“), a 165 (63%) ispitanika nije („neliječeni bolesnici“).
In vitro, imatinib inhibits paracetamol O-glucuronidation with Ki value of 58.5 micromol/L.
In vitro, imatinib inhibira paracetamol O-glukuronidaciju s Ki vrijednosti od 58,5 mikromol/l.
The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Povećanje srednje AUC vrijednosti uz povećanje doze bilo je linearno i proporcionalno prema dozi u rasponu od 25 do 1000 mg imatiniba nakon peroralne primjene.
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.: intravenski
The free drug clearance of imatinib is probably similar between patients with renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
Klirens slobodnog lijeka za imatinib je vjerojatno sličan između bolesnika s oštećenjem bubrega i onih s normalnom funkcijom bubrega, budući da izlučivanje bubregom predstavlja samo manji metabolički put eliminacije za imatinib (vidjeti dijelove 4.2 i 4.4).
Imatinib was administered intermittently in cohorts 1-5, with increasing duration and earlier start of imatinib from cohort to cohort; cohort 1 receiving the lowest intensitiy and cohort 5 receiving the highest intensity of imatinib (longest duration in days with continuous daily imatinib dosing during the first chemotherapy treatment courses).
Imatinib je povremeno primjenjivan u kohortama 1-5, uz progresivno produljenje i raniji početak primjene imatiniba od jedne do druge kohorte, pri čemu je kohorta 1 primala najmanji intenzitet, a kohorta 5 najveći intenzitet imatiniba (najdulje trajanje u danima kontinuiranog uzimanja dnevne doze imatiniba tijekom prvih ciklusa kemoterapije).
In clinical trials in CML, drug discontinuation for drug-related adverse reactions was observed in 2.4% of newly diagnosed patients, 4% of patients in late chronic phase after failure of interferon therapy, 4% of patients in accelerated phase after failure of interferon therapy and 5% of blast crisis patients after failure of interferon therapy.
U kliničkim ispitivanjima KML-a je ukidanje lijeka zbog nuspojava povezanih s njegovom primjenom zapaženo u 2,4% novodijagnosticiranih bolesnika, 4% bolesnika u kasnoj kroničnoj fazi nakon neuspjeha terapije interferonom, 4% bolesnika u ubrzanoj fazi nakon neuspjeha terapije interferonom i
In the event of overdose the patient should be observed and appropriate symptomatic treatment given.
U slučaju predoziranja bolesnika treba promatrati i poduzeti odgovarajuće simptomatsko liječenje.
1800 to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
1800 do 3200 mg (najviše 3200 mg na dan tijekom 6 dana): slabost, mialgija, povišenje vrijednosti kreatinin fosfokinaze, povišenje vrijednosti bilirubina, bol u trbuhu.
If elevations in bilirubin > 3 x institutional upper limit of normal (IULN) or in liver transaminases > 5 x IULN occur, imatinib should be withheld until bilirubin levels have returned to < 1.5 x IULN and transaminase levels to < 2.5 x IULN.
Ako je povećanje bilirubina >3 x institucionalne gornje granice normale (IGGN), ili jetrenih transaminaza >5 x IGGN vrijednosti, primjenu imatiniba treba ukinuti sve dok se razine bilirubina ne vrate na vrijednost <1,5 x IGGN vrijednosti, a razine transaminaze na vrijednost <2,5 x IGGN
At clinically relevant concentrations of imatinib, binding to plasma proteins was approximately 95% on the basis of in vitro experiments, mostly to albumin and alpha-acid-glycoprotein, with little binding to lipoprotein.
Kod klinički značajnih koncentracija imatiniba vezanje na proteine plazme bilo je oko 95% na temelju in vitro pokusa, uglavnom na albumin i α-kiseli glikoprotein, uz slabo vezanje na lipoproteine.
Do not take Imatinib Actavis:
Nemojte uzimati Imatinib Actavis:
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 bolesnike s recidivirajućim ili refraktornim Ph+ ALL-om, monoterapija imatinibom u dozi od 600 mg/dan je sigurna, učinkovita te se može davati do pojave progresije bolesti.
In eleven patients PDGFR gene rearrangements was detected, 9 of them achieved a CHR and 1 PHR.
U jedanaest bolesnika otkrivene su preraspodjele PDGFR gena, od kojih je 9 postiglo CHR, a 1 PHR.
An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
HES bolesnika su otkrivena kao FIP1L1-PDGFRα-pozitivni u druga 3 objavljenja slučaja.
The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m2 once daily (not exceeding 400 mg once daily) or 340 mg/m2 once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Analizom je potvrđeno da je izloženost imatinibu u pedijatrijskih bolesnika koji su primali 260 mg/m2 jedanput na dan (najviše 400 mg jedanput na dan) ili 340 mg/m2 jedanput na dan (najviše 600 mg jedanput na dan) bila slična onoj u odraslih bolesnika koji su primali imatinib 400 mg ili 600 mg jedanput na dan.
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Povišen kreatinin u krvi, povišena kreatin-fosfokinaza u krvi, povišena laktatdehidrogenaza u krvi, povišena alkalna fosfataza u krvi
- adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
- odraslih bolesnika s uznapredovalim hipereozinofilnim sindromom (HES) i/ili kroničnom eozinofilnom leukemijom (KEL) s FIP1L1-PDGFRα preraspodjelom.
This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
To je bila populacija bolesnika koja je ranije intenzivno liječena, budući da ih je 46% ranije primilo transplantaciju koštane srži (BMT), a 73% kemoterapiju s više lijekova.
CHR: In study 0102 [ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, no blood blasts, BM blasts < 5% and no extramedullary disease]
CHR: U studiji 0102 [ABN ≥1,5 x 109/l, trombociti ≥100 x 109/l, nema blasta u krvi, blasti u KS <5% i bez ekstramedularne bolesti]
Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients).
Imatinib u kombinaciji s indukcijskom kemoterapijom (vidjeti Tablicu 3) rezultira postizanjem stope potpunog hematološkog odgovora od 93% (147 od 158 procijenjenih bolesnika) i stope velikog citogenetskog odgovora od 90% (19 od 21 procijenjenog bolesnika).
In patients treated with metoprolol clinical monitoring should be considered.
U bolesnika liječenih metoprololom potrebno je razmisliti o kliničkom nadzoru.
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): - Rapid weight gain.
Vrlo česte (mogu se javiti u više od 1 na 10 osoba) ili česte (mogu se javiti u do 1 na 10 osoba): - brzo dobivanje na težini.