natgillin/translations-raw huggingface dataset:
When the response rate is calculated from patients with at least one valid assessment, the response rate for CHR, CCyR and MR was 20/22 (90.9%), 9/9 (100%) and 11/17
Kad se stopa odgovora računa u bolesnika s barem jednom valjanom procjenom, stopa odgovora za CHR, CCyR i MR bila je 20/22 (90,9%), 9/9 (100%) odnosno 11/17 (64,7%).
Limited data exist on the effect of dose increases from 400 mg to 600 mg or 800 mg in patients progressing at the lower dose (see section 5.1).
Postoje ograničeni podaci o učinku povećanja doze s 400 mg na 600 mg ili 800 mg u bolesnika u kojih do progresije dolazi uz nižu dozu (vidjeti dio 5.1).
Myeloid blast crisis: 260 patients with myeloid blast crisis were enrolled.
Mijeloična blastična kriza: ispitivanje je uključeno 260 bolesnika s mijeloičnom blastičnom krizom.
Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Tri bolesnika postigla su kompletni hematološki odgovor (CHR), a jedan bolesnik parcijalni hematološki odgovor (PHR).
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).
Primjena u pedijatriji: Ne postoji iskustvo kod djece s KML-om mlađe od 2 godine i djece mlađe od 1 godine s Ph+ ALL-om (vidjeti dio 5.1).
Patients should be tested for HBV infection before initiating treatment with Imatinib Teva B.V.
Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja Imatinibom Teva B.V.
While you are taking Imatinib Teva B.V. your doctor will regularly check whether the medicine is working.
Dok uzimate Imatinib Teva B.V., liječnik će redovito pratiti da li lijek djeluje.
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 recidivirajućom ili refraktornom Ph+ ALL kretao se od 2,6 do 3,1 mjesec, a medijan ukupnog preživljenja kod 401 evaluiranog bolesnika kretao se od 4,9 do
Imatinib Teva B.V. can reduce the number of white blood cells, so you might get infections more easily.
B.V. može smanjiti broj bijelih krvnih stanica, pa možete lakše dobiti infekciju.
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 s 600 na 400 mg, ili s 800 mg na 600 mg, a u djece s 340 na 260 mg/m2/dan.
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 ukidanje lijeka zbog nuspojava povezanih s njegovom primjenom zapaženo je 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 5% bolesnika u blastičnoj krizi nakon neuspjeha terapije interferonom.
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. dana gestacije, nije bilo učinka na parenje ili na broj skotnih ženki.
An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
Dodatna četiri bolesnika s HES-om bila su pozitivna za FIP1L1-PDGFRα u ostala 3 objavljena slučaja.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of
• Mišićna slabost i grčevi mišića s abnormalnim srčanim ritmom (znakovi promjena količine
C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza
4, Poligono Industrial Malpica, 50016 Zaragoza
Total bilirubin: >1.5-3.0 ULN AST: any
Ukupni bilirubin: >1,5-3,0 GGN AST: bilo koja vrijednost
• The adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST.
• Adjuvantno liječenje odraslih bolesnika s visokim rizikom od recidiva bolesti nakon resekcije Kit (CD117)-pozitivnog GIST-a.
Your doctor will discuss with you the possible risks of taking Imatinib Teva B.V. during pregnancy.
Liječnik će Vam objasniti moguće rizike od uzimanja Imatiniba Teva B.V. tijekom trudnoće.
Lymphoid blast crisis: a limited number of patients were enrolled in phase I studies (n=10).
Limfatična blastična kriza: u ispitivanjima faze I uključen je ograničeni broj bolesnika (n=10).
• Adult patients with Ph+ CML in blast crisis.
• Odraslih bolesnika s Ph+ KML-om u blastičnoj krizi.
Overall hazard ratio (95% CI)*
Ukupni omjer rizika (95% CI) *
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 intra-tumoural bleeding in at least some of these patients.
U ispitivanju s bolesnicima s inoperabilnim i/ili metastazirajućim GIST-om, anemija 3. i 4. stupnja zabilježena je u 5,4% odnosno 0,7% bolesnika i mogla je biti povezana s gastrointestinalnim ili intratumorskim krvarenjem barem u nekih od tih bolesnika.
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor for advice before taking this medicine.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
The decreases in white blood cell (WBC) and neutrophil counts occurred mainly during the first six weeks of therapy, with values remaining relatively stable thereafter.
Do smanjenja broja leukocita (Lkc) i broja neutrofila uglavnom je došlo tijekom prvih šest tjedana terapije, a vrijednosti su nakon toga ostale relativno
Teva Pharmaceuticals Polska Sp. z o.o.
Teva Operations Poland Sp. z o.o. ul.
No specific dose recommendation is necessary in older people.
Za starije osobe nije potrebna posebna preporuka doziranja.
In adult patients, Imatinib Teva B.V. is intended for use in the most advanced phase of the disease (blast crisis).
U odraslih bolesnika, Imatinib Teva B.V. je namijenjen za liječenje najuznapredovanijih faza bolesti (blastična kriza).
Frequency categories are defined using the following convention: very common (≥1/10), common
Kategorije učestalosti se definiraju kao: vrlo često (≥1/10), često
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).
U vrijeme početne analize, kod tri od četiri bolesnika s utvrđenom preuredbom gena za PDGFR razvio se hematološki odgovor (2 CHR i 1 PHR).
At one year the overall RFS was significantly better for imatinib (97.7%) vs. placebo (82.3%), (p<0.0001).
Nakon jedne godine ukupno preživljenje bez recidiva bolesti bilo je značajno bolje za imatinib (97,7%) u odnosu na placebo (82,3%), (p<0,0001).
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 uz dozu od 340 mg/m2/dan otkrila je 1,7 puta veću akumulaciju lijeka nakon ponovljenog
Median time to response was 13 weeks (95% C.I.
Medijan vremena do odgovora bio je 13 tjedana (95% CI 12-23).
Carriers of HBV who require treatment with Imatinib Teva B.V. should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Nositelje virusa HBV kojima je potrebno liječenje Imatinibom Teva B.V. potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
Therefore, caution should be recommended when driving a car
Stoga se preporučuje oprez pri upravljanju vozilima ili radu sa strojevima.
Imatinib Teva B.V. may do the same to some other medicines.
Imatinib Teva B.V. može to isto napraviti nekim drugim lijekovima.
There are no controlled trials in paediatric patients with c-Kit positive GIST.
Nema kontroliranih ispitivanja u pedijatrijskih bolesnika s c-Kit pozitivnim GIST-om.
When needed, discontinuation of Imatinib Teva B.V. treatment may be considered.
Ukoliko je potrebno, može se razmotriti prekid liječenja Imatinibom Teva B.V.
You should wash your hands immediately after opening the capsules.
Operite ruke odmah nakon
In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of imatinib was escalated to 800 mg in patients progressing at the lower daily doses of 400 mg or 600 mg.
U dvije kliničke studije (studija B2222 i intergrupna studija S0033) dnevna doza imatiniba je povećana do 800 mg u bolesnika kod kojih je došlo do progresije pri nižim dnevnim dozama od 400
- 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.
• 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).
Thereafter, treatment can be resumed as appropriate depending on the initial severity
Nakon toga se liječenje može nastaviti ovisno o početnoj
- The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow
- Ovojnica tablete sastoji se od polivinilnog alkohola djelomično hidroliziranog, makrogola,
Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
divertikulitis*, gastrična antralna vaskularna ektazija (GAVE)*
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase
Povišen kreatinin u krvi, povišena kreatin-fosfokinaza u krvi, povišena laktatdehidrogenaza u krvi, povišena alkalna fosfataza u krvi
The total daily dose in children must not exceed 800 mg with CML and 600 mg with Ph+ALL.
Ukupna dnevna doza u djece i adolescenata ne smije prijeći 800 mg kod KML-a i 600 mg kod Ph+ALL-a.
In this patient population, the presence of hepatic metastases could potentially lead to hepatic insufficiency and reduced metabolism.
U toj bi populaciji bolesnika prisutnost metastaza u jetri mogla potencijalno dovesti do jetrene insuficijencije i
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 kompletnog hematološkog odgovora od 93% (147 od 158 evaluiranih bolesnika) i stope velikog citogenetskog odgovora od 90% (19 od 21 evaluiranog bolesnika).
Study 0102 38-month data Myeloid blast crisis (n=260)
Studija 0102 38-mjesečni podaci Mijeloična blastična kriza
They may increase or decrease the effect of Imatinib Teva B.V., either leading to increased side effects or making Imatinib Teva B.V. less effective.
Oni mogu povećati ili smanjiti učinak Imatiniba Teva B.V. bilo povećanjem nuspojava ili smanjenjem učinka Imatiniba Teva B.V.
• Chest pain, irregular heart rhythm (signs of heart problems).
• Bol u prsnom košu, nepravilan srčani ritam (znakovi srčanih problema).
1800 to 3200 mg (as high as 3200 mg daily for 6 days): Weakness, myalgia, increased creatine phosphokinase, increased bilirubin, gastrointestinal pain.
1800 mg do 3200 mg (najviše 3200 mg na dan tijekom 6 dana): slabost, mialgija, povišenje vrijednosti kreatinin fosfokinaze, povišenje vrijednosti bilirubina, bol u trbuhu.
What you need to know before you take Imatinib Teva B.V.
Što morate znati prije nego počnete uzimati Imatinib Teva B.V.
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 pedijatrijskih bolesnika s novodijagnosticiranim KML-om sa CHR-om od 78% nakon 8 tjedana terapije.
Keep taking Imatinib Teva B.V. every day for as long as your doctor tells you.
Imatinib Teva B.V. nastavite uzimati svaki dan onoliko dugo koliko Vam je liječnik rekao.
• The treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
• Liječenje odraslih bolesnika s Kit (CD 117) pozitivnim inoperabilnim i/ili metastazirajućim malignim gastrointestinalnim stromalnim tumorima (GIST).
The primary endpoint of the study was recurrence-free survival (RFS), defined as the time from date of randomisation to the date of recurrence or death from any cause.
Primarni ishod ispitivanja bio je preživljenje bez recidiva bolesti, definirano kao vrijeme od datuma randomizacije do datuma recidiva ili smrti zbog bilo kojeg uzroka.
After resection of primary GIST, patients were randomised to one of the two arms: imatinib at 400 mg/day or matching placebo for one year.
Nakon resekcije primarnog GIST-a, bolesnici su randomizirani u jedan od dva kraka: imatinib 400 mg/dan ili odgovarajući placebo tijekom jedne godine.
In patients with GIST steady-state exposure was 1.5-fold higher than that observed for CML patients for the same dosage (400 mg daily).
U bolesnika s GIST-om izloženost u stanju dinamičke ravnoteže bila je 1,5 puta veća od one koja je zapažena u bolesnika s KML-om uz isto doziranje (400 mg na dan).
Imatinib Teva B.V. inhibits the growth of these cells in a certain subtype of these diseases.
Imatinib Teva B.V. inhibira rast ovih stanica u određenoj podvrsti ovih bolesti.
Seventeen (17) patients with GIST (with or without Kit and PDGFR mutations) were reported in 7 publications.
U 7 publikacija zabilježeno je sedamnaest (17) bolesnika s GIST-om (sa ili bez Kit ili PDFGR mutacija).
Events that have been reported at different dose ranges are as follows:
Zabilježeni su sljedeći događaji u različitim
The content of the capsule is white to light yellow granulated powder.
Sadržaj kapsule je granulirani prašak bijele
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
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 obraditi i liječiti.
The effect of stopping treatment after the achievement of a complete cytogenetic response has not been
Učinak prekida liječenja nakon postizanja potpunog citogenetskog odgovora nije ispitivan.
- if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati Imatinib Teva B.V.: - ako ste alergični na imatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Other medicines and Imatinib Teva B.V.
Drugi lijekovi i Imatinib Teva B.V.
NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l 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.
NEL Isti kriteriji kao za CHR, ali je ABN ≥1 x 109/l, a trombociti ≥20 x 109/l RTC <15% blasta u KS i PK, <30% blasta+promijelocita u KS i PK, <20% bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri
The ages of these patients ranged from 18 to 91 years.
Dob tih bolesnika se kretala od 18 do 91 godine.
Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
Insuficijencija jetre: Imatinib se većinom metabolizira preko jetre.
Patients were included who had a histological diagnosis of primary GIST expressing Kit protein by immunochemistry and a tumour size ≥ 3 cm in maximum dimension, with complete gross resection of primary GIST within 14-70 days prior to registration.
Uključeni bolesnici imali su histološku dijagnozu primarnog GIST-a s imunokemijski dokazanom ekspresijom Kit proteina i veličinom tumora ≥3 cm u najvećem promjeru, uz potpunu makroskopsku resekciju primarnog GIST-a unutar 14-70 dana prije uključivanja u ispitivanje.
If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
Ako je bilo što od navedenog abnormalno, na početku terapije je potrebno razmisliti o profilaktičkoj primjeni sistemskih steroida (1-2 mg/kg) tijekom jednog do dva tjedna istodobno uz imatinib te redovitim kardiološkim
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides
Potreban je oprez kada se imatinib uzima s inhibitorima proteaze, azolnim antimikoticima,
One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhoea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count
Kod jednog trogodišnjeg dječaka izloženog jednokratnoj dozi od 400 mg došlo je do povraćanja, proljeva i anoreksije, dok je kod drugog trogodišnjeg dječaka izloženog jednokratnoj dozi od 980 mg došlo do smanjenog broja leukocita i proljeva.
Imatinib administration to patients without the genetic translocation generally results in no
Primjena imatiniba bez genetske translokacije obično ne rezultira poboljšanjem.
In the adjuvant setting, imatinib was investigated in a multicentre, double-blind, long-term, placebocontrolled phase III study (Z9001) involving 773 patients.
U sklopu adjuvantnog liječenja, imatinib je ispitivan u multicentričnom, dvostrukoslijepom, dugotrajnom placebo kontroliranom ispitivanju faze III (Z9001) koje je uključivalo 773 bolesnika.
Imatinib Teva B.V. may do the same to some other
Imatinib Teva B.V. može to isto napraviti nekim drugim
The plasma protein binding of the N-demethylated metabolite is similar to that of the parent
Vezanje N-demetiliranog metabolita za bjelančevine plazme je slično onom
- Gastrointestinal stromal tumours (GIST).
- Gastrointestinalnih stromalnih tumora (GIST).
Imatinib Teva B.V. is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Imatinib Teva B.V. se kod odraslih osoba također koristi za liječenje: - Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD).
What Imatinib Teva B.V. looks like and contents of the pack
Kako Imatinib Teva B.V. izgleda i sadržaj pakiranja
A second multicentre, open label phase III study (SSG XVIII/AIO) compared 400 mg/day imatinib 12 months treatment vs. 36 months treatment in patients after surgical resection of GIST and one of the following: tumour diameter > 5 cm and mitotic count > 5/50 high power fields (HPF); or tumour diameter > 10 cm and any mitotic count or tumour of any size with mitotic count > 10/50 HPF or tumours ruptured into the peritoneal cavity.
Drugo otvoreno multicentrično ispitivanje faze III (SSG XVIII/AIO) uspoređivalo je 12 mjeseci liječenja imatinibom 400 mg/dan u odnosu na 36 mjeseci liječenja u bolesnika nakon kirurške resekcije GIST-a i jednog od sljedećeg: promjer tumora >5 cm i broj mitoza >5/50 u vidnom polju mikroskopa pri velikom povećanju (HPF, engl. high power fields); ili promjer tumora >10 cm i bilo koji broj mitoza ili tumor bilo koje veličine s brojem mitoza >10/50 HPF ili ruptura tumora u peritonealnu šupljinu.
Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6% vs.
Stalna svakodnevna izloženost imatinibu u ranoj fazi liječenja u kombinaciji s kemoterapijom dovela je u bolesnika iz kohorte 5 (n=50) do poboljšanja stope 4-godišnjeg preživljavanja bez događaja (EFS) u usporedbi s bolesnicima iz kontrolne kohorte (n=120), koji su primali standardnu kemoterapiju bez imatiniba (69,6% u odnosu na 31,6%).
In a planned subgroup analysis by mutation type, the HR for RFS for 36 months of treatment for patients with mutations of exon 11 was 0.35 [95% CI: 0.22, 0.56].
U planiranoj analizi podskupine prema vrsti mutacije je omjer rizika za preživljenje bez recidiva bolesti kod 36-mjesečnog liječenja bolesnika s mutacijama na 11. eksonu bio 0,35 [95% CI: 0,22, 0,56].
Anaphylactic shock* Blood and lymphatic system disorders
Poremećaji imunološkog sustava Poremećaji krvi i limfnog sustava
• Paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in
• Pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi nakon neuspjeha terapije interferonom-alfa, ili u ubrzanoj fazi ili u blastičnoj krizi.
3 Complete cytogenetic response confirmed by a second bone marrow cytogenetic evaluation performed at least one month after the initial bone marrow study
3 Potpuni citogenetski odgovor potvrđen drugom citogenetskom procjenom koštane srži koja je provedena najmanje jedan mjesec nakon početnog ispitivanja koštane srži.
They are usually
Manje često
Imatinib Teva B.V. may cause your body to retain water (severe fluid retention).
Imatinib Teva B.V. može izazvati zadržavanje vode u tijelu (teška retencija
In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥30 mg/kg/day.
U 2-godišnjoj studiji kancerogenosti u štakora primjena imatiniba od 15, 30 i 60 mg/kg/dan rezultirala je statistički značajnim smanjenjem dužine života mužjaka uz 60 mg/kg/dan i ženki uz
12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at
Kranijalna iradijacija (Samo blok br. 5) 12 Gy u 8 frakcija za sve bolesnike koji imaju CNS1 i CNS2 u trenutku
Imatinib Teva B.V. is a medicine containing an active substance called imatinib.
Imatinib Teva B.V. je lijek koji sadrži djelatnu tvar zvanu imatinib.
In this study 147 patients were enrolled and randomised to receive either 400 mg or 600 mg orally once daily for up to 36 months.
U to je ispitivanje uključeno i randomizirano 147 bolesnika kako bi na dan primali bilo 400 mg bilo 600 mg peroralno tijekom razdoblja do 36 mjeseci.
(1 h) day 1;
i.v.(1 h) dan 1;
At the time of analysis, the treatment duration was a median of 47
U vrijeme analize, medijan trajanja liječenja bio je
(≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
(≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.
Postoji ograničeno iskustvo kod djece s Ph pozitivnim ALL-om te vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om, GIST-omi HES/KEL-om.
What Imatinib Teva B.V. is and what it is used for
Što je Imatinib Teva B.V. i za što se koristi
The effect of prior gastrointestinal surgery on drug absorption has not been investigated.
Učinak prethodnog gastrointestinalnog kirurškog zahvata na apsorpciju lijeka nije
All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to
Svih 65 bolesnika s pozitivnom FIP1L1-PDGFRα fuzijskom kinazom postiglo je CHR koji se održao mjesecima (raspon od 1+ do 44+ mjeseci, izostavljeno u trenutku izvještavanja).