natgillin/translations-raw huggingface dataset:
Imatinib Teva 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters.
Teva 100 mg tvrde kapsule dostupne su u veličinama pakiranja od 60 ili 120 tvrdih kapsula u blisterima.
Special precautions for disposal
POSEBNE MJERE ČUVANJA
Clinical studies in Ph+ ALL
Klinička ispitivanja kod Ph+ ALL-a Novodijagnosticirana Ph+ ALL
Common (may affect up to 1 in 10 people):
Česte (mogu se javiti kod manje od 1 na 10 ljudi):
The starting dose is 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day.
Početna doza je 600 mg koja se uzima kao 1 kapsula od 400 mg plus 2 kapsule od 100 mg jednom na dan.
In study I2301, a total of 93 paediatric, adolescent and young adult patients (from 1 to 22 years old) with Ph+ ALL were enrolled in an open-label, multicentre, sequential cohort, non-randomized phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
s Ph+ ALL bilo je uključeno u otvoreno, multicentrično, sekvencijsko kohortno, nerandomizirano ispitivanje faze III u kojem su primali imatinib (340 mg/m2/dan) u kombinaciji s intenzivnom kemoterapijom nakon indukcijskog liječenja.
Active substances that may have their plasma concentration altered by imatinib 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 srednu vrijednost Cmax i AUC simvastatina (supstrat CYP3A4) za 2, odnosno 3,5 puta, što ukazuje na to da imatinib inhibira CYP3A4.
Haemolytic anaemia, thrombotic microangiopathy Metabolism and nutrition disorders Common
Hemolitička anemija, trombotična mikroangiopatija
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,
For doses of 400 mg and above (see dose recommendation below) a 400 mg film-coated tablet is available.
Za doze od 400 mg i više (vidjeti niže navedenu preporuku doziranja) postoji filmom obložena tableta od 400 mg.
Therefore, caution should be exercised in patients with cardiac dysfunction.
Zbog toga se u bolesnika s poremećenom srčanom funkcijom mora postupati s oprezom.
Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
stem cell factor) kodiran c-Kit protoonkogenom, receptore za diskoidinsku domenu (DDR1 i DDR2, engl. discoidin domain receptors), receptor za faktor stimulacije kolonija (CSF-1R, engl. colony stimulating factor receptor) te alfa i beta receptore za faktor rasta koji potječe od trombocita (PDGFRalfa i PDGFR-beta).
Imatinib Teva 400 mg film-coated tablets Pack sizes of 30 or 90 film-coated tablets in blisters.
Teva 400 mg filmom obložene tablete Veličine pakiranja od 30 ili 90 filmom obloženih tableta u blisterima.
In the imatinib arm, patients were treated with 400 mg daily.
U kraku koji je primao imatinib, bolesnici su liječeni dozom od 400 mg na dan.
Avascular necrosis/hip necrosis*, growth retardation in children* Renal and urinary disorders
Avaskularna nekroza/nekroza kuka*, zastoj u rastu kod djece*
It should be noted that GIST patients may have hepatic metastases which could lead to hepatic impairment.
GIST-om mogu imati metastaze u jetri koje mogu dovesti do oštećenja jetre.
Pack sizes of 60 or 120, hard capsules in blisters.
Veličine pakiranja od 60 ili 120 tvrdih kapsula u blisterima.
The effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival.
Klinička ispitivanja kod kronične mijeloične leukemije Učinkovitost imatiniba temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez znakova progresije bolesti.
Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP.
U patogenezu MDS/MPB-a, HES/KEL-a i DFSP-a uključena je ili konstitutivna aktivacija receptora za PDGF ili Abl proteintirozin kinaza koja nastaje kao posljedica fuzije pri čemu se javljaju različiti partnerski proteini ili konstitutivno stvaranje PDGF-a.
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
Pedijatrijska ubrzana faza KML-a i blastična kriza (početna doza
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• Bol ili oticanje u trbuhu, vjetrovi, žgaravica ili zatvor.
• Painful and/or blistering skin lesions.
• Lezije (oštećenja) kože koje su bolne i/ili s mjehurićima.
For doses other than 400 mg and 800 mg (see dose recommendation below) a 100 mg hard capsule is available.
Za doze različite od doza od 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) postoji tvrda kapsula od 100 mg.
Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
U 4 publikacije zabilježeno je pet (5) bolesnika s MDS/MPD-om povezanim s preuredbom gena za PDGFR.
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
• Mučnina s proljevom i povraćanjem, bol u trbuhu ili vrućica (znakovi crijevnih problema).
At the time of analysis, the treatment duration was a median of 47 months (24 days - 60 months).
47 mjeseci (raspon 24 dana - 60 mjeseci).
Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5).
U tireoidektomiranih bolesnika koji primaju nadomjesnu terapiju levotiroksinom zabilježeni su klinički slučajevi hipotireoze tijekom liječenja imatinibom (vidjeti dio 4.5).
600 mg to be taken as 6 capsules once a day.
600 mg se uzima kao 6 kapsula jednom na dan.
ANC < 1.0 x 109/l and/or platelets < 50 x 109/l
ABN <1,0 x 109/l i/ili trombociti <50 x 109/l
600 mg to be taken as 6 tablets once a day.
600 mg se uzima kao 6 tableta jednom na dan.
Your doctor will tell you exactly how many tablets of Imatinib Teva to take.
Liječnik će Vam reći točno koliko tableta Imatiniba Teva trebate uzeti.
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• Jako smanjeno mokrenje, žeđ (znakovi bubrežnih problema).
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the
Međutim, pojava citopenija također je jasno ovisila o fazi bolesti, kod čega je učestalost neutropenija 3. i 4.
Non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Neprozirne narančaste kapsule s crnom oznakom 7629 na tijelu kapsule i crnom oznakom TEVA na kapici kapsule.
For doses other than 400 mg and 800 mg (see dose recommendation below) a 100 mg film-coated tablet is available.
Za doze različite od doza od 400 mg i 800 mg (vidjeti niže navedenu preporuku doziranja) postoji filmom obložena tableta od 100 mg.
CHR: Study 0110 [WBC < 10 x 109/l, platelets < 450 x 109/l, myelocyte+metamyelocyte < 5% in blood, no blasts and promyelocytes in blood, basophils < 20%, no extramedullary involvement] and in studies 0102 and 0109 [ANC ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, no blood blasts, BM blasts < 5% and no extramedullary disease] NEL Same criteria as for CHR but ANC ≥ 1 x 109/l and platelets ≥ 20 x 109/l (0102 and 0109 only) RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB, no extramedullary disease other than spleen and liver (only for 0102 and 0109).
CHR: Studija 0110 [L <10 x 109/l, trombociti <450 x 109/l, mijelociti+metamijelociti <5% u krvi, u krvi nema blasta i promijelocita, bazofili <20%, nema ekstramedularne zahvaćenosti], a u studijama 0102 i 0109 [ABN ≥1,5 x 109/l, trombociti ≥100 x 109/l, nema blasta u krvi, blasti u
a ANC < 0.5 x 109/l and/or platelets < 10 x 109/l
aABN <0,5 x 109/l i/ili trombociti <10 x 109/l
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 kraku koji je primao imatinib u usporedbi s krakom koji je primao IFN (92,5% prema
The starting dose is 600 mg to be taken as 1 tablet of 400 mg plus 2 tablets of 100 mg or as 1 ½ tablets of 400 mg once a day.
Početna doza je 600 mg, koja se uzima kao 1 tableta od 400 mg i 2 tablete od 100 mg ili kao 1 ½ tableta od 400 mg jednom na dan.
9/l and platelets ≥ 75 x 109/l.
≥75 x 109/l.
Non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Neprozirne narančaste kapsule s crnom oznakom 7630 na tijelu kapsule i crnom oznakom TEVA na kapici kapsule.
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3, 4, 5;
DEX 10 mg/m2 peroralno, dani 1-5; CP 200 mg/m2 i.v., dani 3, 4, 5;
Complete blood counts must be performed regularly during therapy with imatinib.
Tijekom terapije imatinibom potrebno je redovito kontrolirati kompletnu krvnu sliku.
Imatinib Teva 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters.
Teva 400 mg tvrde kapsule dostupne su u veličinama pakiranja od 30 ili 90 tvrdih kapsula u blisterima
• Bruising.
• Svrbež.
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 potraje 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.
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• Grčevi u mišićima ili bol u zglobovima, mišićima ili kostima, tijekom liječenja Imatinibom
Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
U 3 publikacije zabilježeno je pet (5) bolesnika s DFSP-om i preuredbom gena za PDGFR.
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Teška bol u trbuhu, krv u sadržaju povraćanja, stolici ili mokraći, crne stolice (znakovi probavnih problema).
Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm Germany
3, 89079 Ulm
The dose is 800 mg per day (2 capsules), to be taken as 1 capsule in the morning and a second capsule in the evening.
Doza je 800 mg na dan (2 kapsule), koja se uzima kao jedna kapsula ujutro i druga kapsula navečer.
The capsule shell is composed of gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
Ovojnica kapsule se sastoji od želatine, titanijevog dioksida (E171), žutog željezovog oksida (E172)i crvenog željezovog oksida (E172).
Pack sizes of 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Veličine pakiranja od 30x1 ili 90x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
Your doctor will tell you exactly how many capsules of Imatinib Teva to take.
Liječnik će Vam reći točno koliko kapsula Imatiniba Teva trebate uzeti.
Imatinib was not considered genotoxic when tested in an in vitro bacterial cell assay (Ames test), an in vitro mammalian cell assay (mouse lymphoma) and an in vivo rat micronucleus test.
(Ames test), u in vitro pokusu na uzorku stanica sisavaca (mišji limfom) te u in vivo testu na mikronukleusu štakora.
The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.
Doza je 800 mg na dan (8 tableta), koja se uzima kao 4 tablete ujutro i 4 tablete navečer.
CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
CPM (250 mg/m2/doza svakih 12 sati x 4 doze, i.v.): dani 3 i 4 PEG-ASP (2500 IU/m2, i.m.): dan 4
The primary efficacy variable was the rate of haematological response, reported as either complete haematological response, no evidence of leukaemia, or return to chronic phase CML using the same criteria as for the study in accelerated phase.
Primarna varijabla djelotvornosti bila je stopa hematološkog odgovora, koja je zabilježena ili kao kompletni hematološki odgovor, stanje bez znakova leukemije ili kao vraćanje u kroničnu fazu KML
• Joint pain with swelling.
• Bolovi u zglobovima s oticanjem.
In patients with impaired renal function, imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an imatinib-binding protein, in these patients.
vjerojatno zbog povišene razine alfa-kiselog glikoproteina (AGP) u plazmi, proteina koji veže imatinib, u tih bolesnika.
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3 publications.
U 3 publikacije zabilježena su tri (3) bolesnika s HES-om i KEL-om povezanim s preuredbom gena za PDGFR.
The dose is 800 mg per day (2 tablets), to be taken as 1 tablet in the morning and a second tablet in the evening.
Doza je 800 mg na dan (2 tablete), koja se uzima kao 1 tableta ujutro i druga tableta navečer.
If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second tablet in the evening.
Ako Vaša dnevna doza iznosi 800 mg (2 tablete), trebate uzimati jednu tabletu ujutro i drugu tabletu navečer.
Haematological response1
Hematološki odgovor
Pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Veličine pakiranja od 20x1, 60x1, 120x1 ili 180x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
Liver dysfunction
Insuficijencija jetre
The dose is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.
Doza je 800 mg na dan (8 kapsula), koja se uzima kao 4 kapsule ujutro i 4 kapsule navečer.
Posology for DFSP The recommended dose of Imatinib Teva is 800 mg/day for adult patients with DFSP.
Doziranje za DFSP Za odrasle bolesnike s DFSP-om preporučena doza Imatiniba Teva iznosi 800 mg/dan.
Study 0109 40.5-month data Accelerated phase (n=235)
Ubrzana faza (n=235)
In this study 65% of the patients achieved a major cytogenetic response that was complete in 53% (confirmed 43%) of patients (Table 3).
53% (potvrđeno 43%) bolesnika (Tablica 3).
Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Ginekomastija, erektilna disfunkcija, menoragija, nepravilne menstruacije,
Imatinib Teva 100 mg hard capsules
Imatinib Teva 100 mg tvrde kapsule
Cytogenetic response Major response n (%) [95% CI]
Veliki odgovor n (%) [95% CI]
Pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Veličine pakiranja od 20x1, 60x1, 120x1 ili 180x1 tvrdih kapsula u perforiranim blisterima s jediničnim dozama.
Three large, international, open-label, non-controlled phase II studies were conducted in patients with Philadelphia chromosome positive (Ph+) CML in advanced, blast or accelerated phase disease, other Ph+ leukaemias or with CML in the chronic phase but failing prior interferon-alpha (IFN) therapy.
Tri velika, internacionalna, otvorena, nekontrolirana klinička ispitivanja faze II provedena su u bolesnika s Ph+KML-om u uznapredovaloj,blastičnoj ili ubrzanoj fazi bolesti, drugim Ph+
Concomitant use of imatinib and medicinal products that induce CYP3A4 (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
karbamazepin, rifampicin, fenobarbital ili Hypericum perforatum, poznat također kao gospina trava) može značajno smanjiti izloženost imatinibu, što potencijalno povećava rizik od neuspjeha terapije.
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
U bolesnika koji su tireidektomirani i uzimaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena, uz istodobnu primjenu imatiniba (vidjeti dio 4.4) te se stoga preporučuje oprez.
- The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow (E172), talc, titanium dioxide (E171) and iron oxide red (E172).
Ovojnica tablete poli(vinilni alkohol), djelomično hidroliziran makrogol željezov oksid, žuti (E172) talk titanijev dioksid (E171) željezov oksid, crveni (E172)
Clinical studies in chronic myeloid leukaemia
- Kronične mijeloične leukemije (KML).
Hypertension, haematoma, subdural haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Hipertenzija, hematom, subduralni hematom, periferna hladnoća, hipotenzija,
Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Stoga je pri primjeni imatiniba s lijekovima koji inhibiraju CYP3A4 potreban oprez.
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%.
rezultirala je s odgovorom u 53 od 411 evaluirana bolesnika, sa stopom hematološkog odgovora od 30% (9% kompletni) i stopom većeg citogenetskog odgovora od 23%.
The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon.
50 ml za tabletu od 100 mg te 200 ml za tabletu od 400 mg) te promiješati žlicom.
9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
9 Nakon stavljanja lijeka u promet primijećena je mišićno-koštana bol koja se javlja tijekom liječenja imatinibom ili nakon prekida liječenja.
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
Posology for HES/CEL The recommended dose of Imatinib Teva is 100 mg/day for adult patients with HES/CEL.
Doziranje za HES/KEL Za odrasle bolesnike s HES/KEL-om preporučena doza Imatiniba Teva iznosi 100 mg/dan.
Crospovidone Magnesium stearate Silica colloidal, anhydrous
Sadržaj kapsule manitol krospovidon magnezijev stearat silicijev dioksid, koloidni, bezvodni
400 mg to be taken as 4 capsules once a day,
400 mg se uzima kao 4 kapsule jednom na dan.
Liver dysfunction classification:
Klasifikacija poremećaja funkcije jetre: Poremećaj funkcije jetre Testovi funkcije jetre
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
omaglica ili nesvjestica zbog sniženog krvnog tlaka (znakovi problema s jajnicima ili maternicom).
Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
Pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Veličine pakiranja od 30x1 ili 90x1 tvrdih kapsula u perforiranim blisterima blisterima s jediničnim dozama.
Study AUS01 Induction-consolidation therapy
Studija AUS01
The starting dose is 400 mg, to be taken as 4 capsules once a day.
Početna doza je 400 mg, koja se uzima kao 4 kapsule jednom na dan.
The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day.
Početna doza je 100 mg, koja se uzima kao jedna kapsula od 100 mg jednom na dan.
EU/1/12/808/033 30 hard capsules EU/1/12/808/034 30 x 1 hard capsules EU/1/12/808/035 90 hard capsules EU/1/12/808/036 90 x 1 hard capsules EU/1/12/808/037 30 hard capsules EU/1/12/808/038 30 x 1 hard capsules EU/1/12/808/039 90 hard capsules EU/1/12/808/040 90 x 1 hard capsules
EU/1/12/808/033 30 tvrdih kapsula EU/1/12/808/034 30 x 1 tvrda kapsula EU/1/12/808/035 90 tvrdih kapsula EU/1/12/808/036 90 x 1 tvrda kapsula EU/1/12/808/037 30 tvrdih kapsula EU/1/12/808/038 30 x 1 tvrda kapsula EU/1/12/808/039 90 tvrdih kapsula EU/1/12/808/040 90 x 1 tvrda kapsula
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
• Osjećaj da Vam se vrti u glavi, omaglica ili nesvjestica (znakovi sniženog krvnog tlaka).
Imatinib Teva is also a treatment for children and adolescents with CML.
Teva se kod djece i adolescenata također koristi za liječenje KML-a.
• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
• Odraslih bolesnika s mijelodisplastičnim/mijeloproliferativnim bolestima (MDS/MPB)
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1
DEX 10 mg/m2 peroralno, dani 1-5; CP 200 mg/m2 i.v., dani 3-5; MTX 15 mg intratekalno, dan 1
• Difficulty hearing.
• Oslabljen sluh.
A total of 1.106 patients were randomised, 553 to each arm. Baseline characteristics were well balanced between the two arms.
Ukupan broj od 1106 bolesnika je randomiziran po 553 ispitanika u svaki krak.
(0.5 h), days 7, 8, 14, 15; CP 500 mg/m2 i.v.
IDA 8 mg/m i.v. (0,5 h), dani 7, 8, 14, 15; CP 500 mg/m i.v.(1 h) dan 1;
Imatinib Teva 100 mg hard capsules are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Teva 100 mg tvrde kapsule dostupne su u veličinama pakiranja od 20x1, 60x1, 120x1 ili 180x1 tvrdih kapsula u perforiranim blisterima s jediničnim dozama.
The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once a day.
Početna doza je 100 mg, koja se uzima kao 1 tableta od 100 mg jednom na dan.
EU/1/12/808/021 20 x 1 hard capsules EU/1/12/808/022 60 hard capsules EU/1/12/808/023 60 x 1 hard capsules EU/1/12/808/024 120 hard capsules EU/1/12/808/025 120 x 1 hard capsules EU/1/12/808/026 180 x 1 hard capsules EU/1/12/808/027 20 x 1 hard capsules EU/1/12/808/028 60 hard capsules EU/1/12/808/029 60 x 1 hard capsules EU/1/12/808/030 120 hard capsules EU/1/12/808/031 120 x 1 hard capsules EU/1/12/808/032 180 x 1 hard capsules
EU/1/12/808/021 20 x 1 tvrda kapsula EU/1/12/808/022 60 tvrdih kapsula EU/1/12/808/023 60 x 1 tvrda kapsula EU/1/12/808/024 120 tvrdih kapsula EU/1/12/808/025 120 x 1 tvrda kapsula EU/1/12/808/026 180 x 1 tvrda kapsula EU/1/12/808/027 20 x 1 tvrda kapsula EU/1/12/808/028 60 tvrdih kapsula EU/1/12/808/029 60 x 1 tvrda kapsula EU/1/12/808/030 120 tvrdih kapsula EU/1/12/808/031 120 x 1 tvrda kapsula EU/1/12/808/032 180 x 1 tvrda kapsula
ul.
om.
Imatinib Teva 400 mg hard capsules imatinib
Teva 400 mg tvrde kapsule imatinib