natgillin/translations-raw huggingface dataset:
Clinical studies in DFSP One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Provedeno je jedno otvoreno, multicentrično kliničko ispitivanje faze II (studija B2225) koje je uključivalo 12 bolesnika s DFSP-om liječenih imatinibom 800 mg na dan.
Skin and subcutaneous tissue disorders
Poremećaji kože i potkožnog tkiva Vrlo često
Thyroid stimulating hormone (TSH) levels should be closely monitored in such patients.
U takvih bolesnika trebaju se pažljivo pratiti razine tireotropina (TSH).
Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Ginekomastija, erektilna disfunkcija, menoragija, nepravilne mjesečnice, poremećaj seksualne funkcije, bol u bradavicama, povećanje dojki, edem skrotuma
Treatment schedule: On the basis of the existing data, imatinib has been shown to be effective and safe when administered at 600 mg/day in combination with chemotherapy in the induction phase, the consolidation and maintenance phases of chemotherapy (see section 5.1) for adult patients with newly diagnosed Ph+ ALL.
600 mg/ dan u kombinaciji s kemoterapijom u indukcijskoj fazi te u konsolidacijskoj fazi i fazi održavanja kemoterapije (vidjeti dio 5.1) u odraslih bolesnika s novodijagnosticiranim Ph+ ALL-om.
Liver dysfunction
Poremećaj funkcije jetre
Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day, in the morning and in the evening.
Doze od 400 mg ili 600 mg trebaju se primijeniti jednom na dan, dok se dnevna doza od 800 mg treba primijeniti kao 400 mg dvaput na dan,
8 Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
8 Zabilježeno je nekoliko smrtnih slučajeva zbog zatajenja jetre i nekroze jetre.
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
MESNA (360 mg/m2/doza svaka 3 sata x 8 doza/dan, i.v.): dani 1-5 G-CSF (5 μg/kg, s.c.): dani 6-15 ili do porasta ANC >1500 nakon najniže izmjerene vrijednosti i.t. metotreksat (prilagođeno dobi): SAMO dan 1 Trostruka i.t. terapija (prilagođena dobi): dan 8, 15
Paediatric patients: A total of 26 paediatric patients of age < 18 years with either chronic phase CML (n=11) or CML in blast crisis or Ph+ acute leukaemias (n=15) were enrolled in a dose-escalation phase I trial.
<18 godina bilo s kroničnom fazom KML-a (n=11), bilo s KML-om u blastičnoj krizi ili Ph+ akutnim leukemijama (n=15).
The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m2 daily.
Dob tih bolesnika bila je u rasponu od 3 mjeseca do 4 godine, a imatinib se primjenjivao u dozi od 50 mg na dan ili dozama u rasponu od 92,5 do 340 mg/m2 na dan.
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Herpes zoster, herpes simplex, nazofaringitis, upala pluća1, sinusitis, celulitis, infekcija gornjih dišnih puteva, gripa, infekcija mokraćnog sustava,
- If you are being treated for CML:
- Ako se liječite zbog KML-a:
- Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
- blijeda koža, umor i gubitak daha te tamno obojena mokraća (znakovi snižene razine crvenih krvnih stanica).
Excipients(s)
Pomoćna(e) tvar(i)
Triple IT therapy (age-adjusted): days 1 and 22
Trostruka i.t. terapija (prilagođena dobi): dani 1 i 22
- 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).
Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%; p=0.0001).
Novodijagnosticirani Ph+ ALL: u kontroliranom ispitivanju (ADE10) imatiniba u odnosu na kemoterapiju u 55 novodijagnosticiranih bolesnika u dobi od 55 godina i više, imatinib korišten samostalno izazvao je značajno višu stopu potpunog hematološkog odgovora nego kemoterapija (96,3% u odnosu na 50%; p=0,0001).
Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10
Spazam mišića i grčevi, mišićno-koštana bol uključujući mialgiju, artralgiju,
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5).
Potreban je oprez kada se imatinib uzima s inhibitorima proteaze, azolnim antimikoticima, određenim makrolidima (vidjeti dio 4.5), CYP3A4 supstratima s uskim terapijskim prozorom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib, docetaksel, kinidin) ili varfarinom i drugim derivatima kumarina (vidjeti dio 4.5).
Substances that are inducers of CYP3A4 activity e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidone or Hypericum perforatum, also known as St. John's Wort) may significantly reduce exposure to imatinib, potentially increasing the risk of therapeutic failure.
Tvari koje induciraju djelovanje CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital, fosfenitoin, primidon ili Hypericum perforatum, poznat također kao gospina trava) mogu značajno smanjiti izloženost imatinibu, čime se potencijalno povećava rizik od neuspjeha terapije.
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
ARA-C (3 g/m2/doza svakih 12 sati x 4, i.v.): dani 2 i 3 G-CSF (5 μg/kg, s.c.): dani 4-13 ili do porasta ANC >1500 nakon najniže izmjerene vrijednosti
Methotrexate (20 mg/m2/week, PO): days 8, 15, 22, 29, 36, 43, 50
Metotreksat (20 mg/m2/tjedan, p.o.): dani 8, 15, 22, 29, 36, 43, 50
- Severely decreased urine output, feeling thirsty (signs of kidney problems).
- jako smanjeno mokrenje, žeđ (znakovi bubrežnih problema).
5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML.
Pleuralni izljev je češće zabilježen u bolesnika s GIST-om i u bolesnika s transformiranim KML-om (KML-ubrzana faza i KML-blastična kriza), nego u bolesnika s kroničnim KML-om.
Ifosfamide (1.8 g/m2/day, IV): days 1-5
Ifosfamid (1,8 g/m2/dan, i.v.): dani 1-5
Thrombotic microangiopathy
Trombotična mikroangiopatija
Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50
Metotreksat (20 mg/m2/tjedan, p.o.): dani 1, 8, 15, 22, 29, 36, 43, 50
In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/L) and thrombocytopenia (platelet count < 10 x 109/L) were observed in 3.6% and < 1% of patients, respectively.
<0,5 x 109/l) i trombocitopenija (broj trombocita <10 x 109/l) zapažene su u 3,6% odnosno <1%
Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.
4.2 Doziranje i način primjene Terapiju treba započeti liječnik s iskustvom u liječenju bolesnika s hematološkim zloćudnim bolestima, odnosno malignim sarkomima.
11th Ion Mihalache Ave, The 1st district, RO-011171 Bucharest
RO-011171 Bucharest Rumunjska
Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel and quinidine).
Zbog toga se preporučuje oprezno postupati kada se imatinib primjenjuje s CYP3A4 supstratima s uskim terapijskim prozorom (npr. ciklosporin, pimozid, takrolimus, sirolimus, ergotamin, diergotamin, fentanil, alfentanil, terfenadin, bortezomib,
Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin instead of coumarin derivatives such as warfarin.
bolesnici kojima je potrebna antikoagulacija trebaju primati heparin niske molekularne težine ili standardni heparin, umjesto kumarinskih derivata kao što je varfarin.
Pack sizes: The tablets are supplied in aluminium blister packs of 10, 30, 60 or 90 film-coated tablets.
Veličine pakiranja: Tablete se isporučuju u aluminijskim blisterima od 10, 30, 60, ili 90 filmom obloženih tableta.
- The other ingredients are: Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous).
Drugi sastojci su: Sadržaj kapsule: mikrokristalična celuloza, kopovidon, krospovidon, natrijev stearilfumarat, silicijev dioksid (koloidni hidrofobni i koloidni bezvodni).
Active substances that may increase imatinib plasma concentrations:
Djelatne tvari koje mogu povećati koncentracije imatiniba u plazmi:
Your doctor will tell you exactly how many tablets of Imatinib Actavis to take.
Liječnik će Vam reći točno koliko tableta Imatinib Actavisa trebate uzeti.
You may feel dizzy or drowsy or get blurred vision while taking this medicine.
Tijekom uzimanja ovog lijeka možete osjetiti omaglicu, omamljenost ili imati zamagljen vid.
6-MP (75 mg/m2/day, PO): days 1-56
6-MP (75 mg/m2/dan, p.o.): dani 1-56
- Painful and/or blistering skin lesions.
- lezije (oštećenja) kože koje su bolne i/ili s mjehurićima.
15 mg intrathecal, days 1, 8, 15, 22; Ara-C 40 mg intrathecal, days 1, 8, 15, 22; methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
MTX 15 mg intratekalno, dani 1, 8, 15, 22; Ara-C 40 mg intratekalno, dani 1, 8, 15, 22; metilprednizolon 40 mg intratekalno, dani 1, 8, 15, 22
Return to chronic phase (RTC) Major cytogenetic response2
Vraćanje na kroničnu fazu (RTC)
VCR 1.3 g/m2 i.v., day 1; prednisolone 60 mg/m2 oral, days 1-5
VCR 1,3 g/m2 i.v., dan 1; prednizolon 60 mg/m2 peroralno, dani 1-5
Imatinib Actavis 50 mg hard capsules Al/PVC/Aclar blister.
Imatinib Actavis 50 mg tvrde kapsule Al/PVC/Aclar blister.
The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m2 daily.
Dob tih bolesnika bila je u rasponu od novorođenčadi do 14 godina, a imatinib se primjenjivao u dozi od 50 mg na dan ili u dozama u rasponu od 400 do 520 mg/m2 na dan.
The doctor will tell you how many tablets of Imatinib Actavis to give to your child.
Liječnik će Vam reći koliko tableta Imatinib Actavisa trebate dati djetetu.
- The other ingredients are cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous), polyvinyl alcohol partly hydrolysed, talc, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172), lecithin (soya) (E322), xanthan gum (E415).
Drugi sastojci su: mikrokristalična celuloza, kopovidon, krospovidon, natrijev stearilfumarat, silicijev dioksid (koloidni hidrofobni i koloidni bezvodni), poli(vinilni alkohol) djelomično hidroliziran, talk, žuti željezov oksid (E172), titanijev dioksid (E171), crveni željezov oksid (E172), sojin lecitin (E322), ksantanska guma (E415).
All 65 FIP1L1-PDGFRα fusion kinase positive patients achieved a CHR sustained for months (range from 1+ to 44+ months censored at the time of the reporting).
Svih 65 bolesnika s pozitivnom FIP1L1-PDGFRα fuzijskom kinazom postiglo je CHR održan mjesecima
Neutropenia, thrombocytopenia, anaemia
Neutropenija, trombocitopenija, anemija
The doctor will tell you how many capsules of Imatinib Actavis to give to your child.
Liječnik će Vam reći koliko kapsula Imatinib Actavisa trebate dati djetetu.
Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6
Mučnina, proljev, povraćanje, dispepsija, bol u trbuhu6
The European Medicines Agency has waived the obligation to submit the results of studies with imatinib in all subsets of the paediatric population in Philadelphia chromosome (bcr-abl translocation)positive chronic myeloid leukaemia (see section 4.2 for information on paediatric use).
Europska Agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka imatiniba u svim podskupinama pedijatrijske populacije s kroničnom mijeloičnom leukemijom s pozitivnim
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.
(oko 50 ml za tabletu od 100 mg i 200 ml za tabletu od 400 mg) i promiješati žlicom.
Imatinib Actavis 100 mg hard capsules Al/PVC/Aclar blister.
Imatinib Actavis 100 mg tvrde kapsule Al/PVC/Aclar blister.
The dose is 800 mg per day (2 tablets), to be taken as one tablet in the morning and a second tablet in the evening.
Doza je 800 mg na dan (2 tablete), koje se uzimaju kao jedna tableta ujutro i druga tableta navečer.
Your doctor will tell you exactly how many capsules of Imatinib Actavis to take.
Liječnik će Vam reći točno koliko kapsula Imatinib Actavisa trebate uzeti.
days 2, 3, 16, and 17
6 doza) iii: dani 2, 3, 16 i 17
Days 2, 3, 16, and 17
6 doza)iii: Dani 2, 3, 16 i 17
CPM (300 mg/m2, IV): days 29-33
CPM (300 mg/m2, i.v.): dani 29-33
Active substances that may decrease imatinib plasma concentrations:
Djelatne tvari koje mogu smanjiti koncentracije imatiniba u plazmi:
MESNA (150 mg/m2/day, IV): days 22-26
MESNA (150 mg/m2/dan, i.v.): dani 22-26
If any of these apply to you, tell your doctor before taking Imatinib Actavis.
Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije uzimanja Imatinib
The tablets are supplied in aluminium blister packs of 10, 20, 30, 60, 90, 120 or 180 film-coated tablets.
Veličine pakiranja: Tablete se isporučuju u aluminijskim blisterima od 10, 20, 30, 60, 90, 120 ili 180 filmom obloženih tableta
Nervous system disorders
Poremećaji živčanog sustava Vrlo često
Imatinib Actavis 100 mg film-coated tablets Each film-coated tablet contains 100 mg imatinib (as mesilate).
Imatinib Actavis 100 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 100 mg imatiniba (u obliku imatinibmesilata).
DEX (6 mg/m2/day, PO): days 1-7 and 15-21
DEX (6 mg/m2/dan, p.o.): dani 1-7 i 15-21
The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 daily or doses ranging from 200 to 400 mg daily.
Dob tih bolesnika bila je u rasponu od 2 do 16 godina, a imatinib se primjenjivao u dozi od 300 mg/m2 na dan ili u dozama u rasponu od 200 do 400 mg na dan.
Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/kg,
Imatinib je bio teratogen u štakora kada je primjenjivan tijekom organogeneze u dozama ≥100 mg/kg, koje su približno jednake maksimalnoj kliničkoj dozi od 800 mg/dan, temeljeno na veličini površine tijela.
VP-16 (100 mg/m2/day, IV): days 1-5
VP-16 (100 mg/m2/dan, i.v.): dani 1-5
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 (PDGFR
EU/1/13/825/003 24 capsules EU/1/13/825/004 48 capsules EU/1/13/825/019 60 capsules EU/1/13/825/005 96 capsules EU/1/13/825/006 120 capsules EU/1/13/825/007 180 capsules
EU/1/13/825/003 24 kapsule EU/1/13/825/004 48 kapsula EU/1/13/825/019 60 kapsula EU/1/13/825/005 96 kapsula EU/1/13/825/006 120 kapsula EU/1/13/825/007 180 kapsula
Imatinib Actavis 400 mg hard capsules Al/PVC-PVDC blister.
Imatinib Actavis 400 mg tvrde kapsule Al/PVC-PVDC blister.
Pack sizes: The capsules are supplied in aluminium blister packs of 10, 30, 60, or 90 capsules.
Veličine pakiranja: Kapsule se isporučuju u aluminijskim blisterima od 10, 30, 60 ili 90 kapsula.
Imatinib Actavis 100 mg film-coated tablets 2 years
Imatinib Actavis 100 mg filmom obložene tablete 2 godine
Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5).
U bolesnika u kojih je obavljena tireoidektomija i koji primaju nadomjesnu terapiju levotiroksinom zabilježeni su klinički slučajevi hipotireoze tijekom liječenja imatinibom (vidjeti dio 4.5).
DEX (6 mg/m2/day, PO): days 1-5; 29-33
DEX (6 mg/m2/dan, p.o.): dani 1-5; 29-33
Hepatic failure8, hepatic necrosis
Zatajenje jetre8, nekroza jetre
4 cycles
Dodatna četiri
- Pain or swelling in your abdomen, flatulence, heartburn or constipation.
- bol ili oticanje u trbuhu, vjetrovi, žgaravica ili zatvor. - svrbež.
How to take Imatinib Actavis
Kako uzimati Imatinib Actavis
GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Uzrok GI krvarenja mogle bi biti lokacije GI tumora (vidjeti dio
Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8; prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28; MTX
Daunorubicin 30 mg/m2 i.v., dani 1-3, 15-16; VCR 2 mg ukupna doza i.v., dani 1, 8, 15, 22; CP 750 mg/m2 i.v., dani 1, 8; prednizon 60 mg/m2 peroralno, dani 1-7, 15-21; IDA 9 mg/m2 peroralno, dani 1-28;
Imatinib Actavis is also a treatment for children with CML.
Actavis se kod djece također koristi za liječenje KML-a.
Laboratory test abnormalities
Abnormalne vrijednosti laboratorijskih testova Hematologija
Tumour haemorrhage/tumour necrosis*
Tumorsko krvarenje/tumorska nekroza*
Printing ink: shellac glaze-45%, black iron oxide (E172), propylene glycol, ammonium Hydroxide 28%.
Tinta za označavanje: šelak glazura-45%, crni željezov oksid (E172), propilenglikol, amonijev hidroksid 28%.
- Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
- Akutne limfoblastične leukemije s pozitivnim Philadelphia kromosomom (Ph-pozitivni ALL).
EU/1/13/825/015 10 tablets EU/1/13/825/016 30 tablets EU/1/13/825/017 60 tablets EU/1/13/825/018 90 tablets
EU/1/13/825/015 10 tableta EU/1/13/825/016 30 tableta EU/1/13/825/017 60 tableta EU/1/13/825/018 90 tableta
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Trombocitemija, limfopenija, depresija koštane srži, eozinofilija, limfadenopatija
Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)*
Ileus/intestinalna opstrukcija*, gastrointestinalna perforacija*, divertikulitis*,
The compound selectively inhibits proliferation and induces apoptosis in Bcr-Abl positive cell lines as well as fresh leukaemic cells from Philadelphia chromosome positive CML and acute lymphoblastic leukaemia (ALL) patients.
Abl pozitivnim staničnim linijama, kao i u svježim leukemijskim stanicama osoba koje boluju od kronične mijeloične leukemije (KML) s pozitivnim Philadelphia kromosomom i od akutne limfoblastične leukemije (ALL).
The dose is 800 mg per day (2 capsules), to be taken as one 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.
Posology for MDS/MPD The recommended dose of imatinib is 400 mg/day for adult patients with MDS/MPD.
Za odrasle bolesnike s MDS/MPD-om preporučena doza imatiniba iznosi 400 mg/dan.
Tablet coat
bol u kostima10
Imatinib Actavis 400 mg film-coated tablets 21 month
Imatinib Actavis 400 mg filmom obložene tablete 21 mjesec
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Flatulencija, abdominalna distenzija, gastroezofagealni refluks, konstipacija,
EU/1/13/825/008 10 tablets EU/1/13/825/009 20 tablets EU/1/13/825/010 30 tablets EU/1/13/825/011 60 tablets EU/1/13/825/012 90 tablets EU/1/13/825/013 120 tablets EU/1/13/825/014 180 tablets
EU/1/13/825/008 10 tableta EU/1/13/825/009 20 tableta EU/1/13/825/010 30 tableta EU/1/13/825/011 60 tableta EU/1/13/825/012 90 tableta EU/1/13/825/013 120 tableta EU/1/13/825/014 180 tableta
If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second in the evening.
Ako Vaša dnevna doza iznosi 800 mg (2 tablete), trebate uzimati jednu tabletu ujutro i drugu navečer.
EU/1/13/825/020 10 capsules EU/1/13/825/021 30 capsules EU/1/13/825/022 60 capsules EU/1/13/825/023 90 capsules
EU/1/13/825/020 10 kapsula EU/1/13/825/021 30 kapsula EU/1/13/825/022 60 kapsula EU/1/13/825/023 90 kapsula
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
If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.
Ako Vaša dnevna doza iznosi 800 mg (8 tableta), trebate uzimati 4 tablete ujutro i 4 tablete navečer.
Each film-coated tablet contains 0.75 mg lecithin (soya) (E322) For the full list of excipients, see section 6.1.
Svaka filmom obložena tableta sadrži 0,75 mg sojinog lecitina (E322)
Complete blood counts must be performed regularly during therapy with imatinib.
Laboratorijske pretrage Tijekom terapije imatinibom mora se redovito kontrolirati kompletna krvna slika.
Newly diagnosed Ph+ ALL: In a controlled study (ADE10) of imatinib versus chemotherapy induction in 55 newly diagnosed patients aged 55 years and over, imatinib used as single agent induced a significantly higher rate of complete haematological response than chemotherapy (96.3% vs. 50%;
Novodijagnosticirani Ph+ ALL: u kontroliranom ispitivanju (ADE10) imatiniba u odnosu na kemoterapiju u 55 novodijagnosticiranih bolesnika u dobi od 55 godina i više, imatinib korišten samostalno izazvao je značajno višu stopu potpunog hematološkog odgovora nego kemoterapija
Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Kada se imatinib primjenjuje s inhibitorima porodice CYP3A4, potrebno je oprezno postupati.
- Joint pain with swelling.
- bolovi u zglobovima s oticanjem.
The usual starting dose is 600 mg to be taken as one capsule of 400 mg plus 2 capsules of 100 mg once a day.
Uobičajena početna doza je 600 mg, koja se uzima kao jedna kapsula od 400 mg plus 2 kapsule od 100 mg jednom na dan.
Shellac Glaze-45% Black iron oxide (E172) Propylene glycol Ammonium Hydroxide 28%
Tinta za označavanje šelak glazura-45% željezov oksid, crni (E172) propilenglikol amonijev hidroksid 28%
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po filmom obloženoj tableti, tj. zanemarive količine natrija.
In GIST the study drug was discontinued for drug-related adverse reactions in 4% of patients.
U ispitivanju GIST-a, primjena ispitivanog lijeka je prekinuta u 4% bolesnika zbog nuspojava povezanih s njegovom primjenom.
(0.5 h), days 7, 8, 14, 15; CP 500 mg/m2 i.v.
8 mg/m i.v. (0,5 h), dani 7, 8, 14, 15; CP 500 mg/m i.v.(1 h) dan 1; Ara
VP-16 (100 mg/m2/day, IV): days 22-26
VP-16 (100 mg/m2/dan, i.v.): dani 22-26
(1 h) day 1; AraC 60 mg/m2 i.v., days 22-25, 29-32
C 60 mg/m2 i.v., dani 22-25, 29-32