natgillin/translations-raw huggingface dataset:
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/MPD-a, HES/KEL-a i DFSP-a uključena je ili konstitutivna aktivacija receptora za PDGF ili Abl protein-tirozin kinaza koja nastaje kao posljedica fuzije pri čemu se javljaju različiti partnerski proteini ili konstitutivno stvaranje PDGF-a.
The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m 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/m na dan ili u dozama u rasponu od 200 do 400 mg na dan.
Marketing Authorisation Holder medac
Nositelj odobrenja za stavljanje lijeka u promet medac
Therapeutic indication
Indukcijska terapija
The dose is 800 mg per day, to be taken as 1 capsule of 400 mg in the morning and 1 capsule of
Doza je 800 mg na dan, a uzima se kao 1 kapsula od 400 mg ujutro i 1 kapsula od 400 mg navečer.
Intensification block 1 (9 weeks)
Intenzifikacijska terapija 1 (9 tjedana)
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
Trombocitemija, limfopenija, depresija koštane srži, eozinofilija,
Positive genotoxic effects were obtained for imatinib in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity (chromosome aberration) in the presence of metabolic activation at a concentration of 125 μg/ml.Two intermediates of the manufacturing process, which are also present in the final product, are positive for mutagenesis in the Ames assay.
Pozitivni su genotoksični učinci dobiveni za imatinib u in vitro testu na stanicama sisavca (jajnik kineskog hrčka) na klastogenost (aberacija kromosoma) u prisutnosti metaboličke aktivacije pri koncentracijama od 125 μg/ml.
How to store Imatinib medac
Kako čuvati Imatinib medac
Triple IT therapy (age-adjusted): day 1
Trostruka i.t. terapija (prilagođena dobi): dan 1
DEX 10 mg/m oral, days 1-5;
DEX 10 mg/m² peroralno, dani 1-5;
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
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 4.5 and 4.8).
U slučajevima kada se imatinib kombinira s režimima kemoterapije za koje je poznato da su povezani s poremećajem funkcije jetre, potrebno je pažljivo praćenje jetrene funkcije (vidjeti dijelove 4.5 i 4.8).
Isolated cases of imatinib overdose have been reported spontaneously and in the literature.
Zabilježeni su spontani i literaturni izolirani slučajevi predoziranja imatinibom.
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or
• iscjedak iz oka sa svrbežom, crvenilom ili oteklinom (konjunktivitis), suzne oči ili zamućen vid
Imatinib medac 100 mg hard capsules EU/1/13/876/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Imatinib medac 100 mg tvrde kapsule EU/1/13/876/001
Imatinib medac is also a treatment for children and adolescents with CML.
Imatinib medac koristi se također za liječenje KML-a u djece i adolescenata.
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/m daily.
Dob tih bolesnika bila je u rasponu od novorođenačke do 14 godina, a imatinib se primjenjivao u dozi od 50 mg na dan ili u dozama u rasponu od 400 do 520 mg/m na dan.
Posology for MDS/MPD in adult patients 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.
Severe
Teški
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• jako smanjeno mokrenje, žeđ (znakovi bubrežnih problema)
Active substances that may decrease imatinib plasma concentrations 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.
Djelatne tvari koje mogu smanjiti koncentracije imatiniba u plazmi 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.
CPM (300 mg/m2, IV): days 29-33
CPM (300 mg/m², i.v.): dani 29-33
• Chronic renal failure.
• kronično zatajenje bubrega.
7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
7, podrigivanje, melena, ezofagitis, ascites, želučani ulkus, hematemeza, heilitis, disfagija,
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• bol ili oticanje u trbuhu, vjetrovi, žgaravica ili zatvor
Skin and subcutaneous tissue disorders Very common: Periorbital oedema, dermatitis/eczema/rash
Periorbitalni edem, dermatitis/ekcem/osip
Complete blood counts must be performed regularly during therapy with imatinib.
Tijekom terapije imatinibom mora se redovito kontrolirati kompletna krvna slika.
The mechanism and relevance of these findings in the rat carcinogenicity study for humans are not yet clarified.
Iz ovih nalaza studije kancerogenosti u štakora još nije razjašnjen mehanizam, kao ni važnost za ljude.
• Weight gain.
• povećanje tjelesne težine.
Musculoskeletal and connective tissue disorders Very common: Muscle spasm and cramps, musculoskeletal pain including myalgia
Spazam mišića i grčevi, mišićno-koštana bol uključujući mialgiju
9/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m
9/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 260 mg/m².
Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Metotreksat (5 g/m² kroz 24 sata, i.v.): dan 1 Leucovorin (75 mg/m² u 36. satu, i.v.; 15 mg/m² i.v. ili p.o. svakih
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 preraspodjelom gena za PDGFR.
DEX (6 mg/m 2/day, PO): days 1-5; 29-33
DEX (6 mg/m/²dan, p.o.): dani 1-5; 29-33
VP-16 (100 mg/m2/day, IV): days 1-5
VP-16 (100 mg/m²/dan, i.v.): dani 1-5
9/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
9/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 400 mg.
What Imatinib medac looks like and contents of the pack Imatinib medac 100 mg hard capsules are gelatin capsules of size “3” with orange body and cap. Imatinib medac 400 mg hard capsules are gelatin capsules of size “00” with caramel body and cap. Imatinib medac 100 mg capsules are supplied in packs containing 60 capsules in blisters.
Kako Imatinib medac izgleda i sadržaj pakiranja Imatinib medac 100 mg tvrde kapsule želatinske su kapsule veličine “3”, s narančastim tijelom i kapicom.
Ifosfamide (1.8 g/m2/day, IV): days 1-5
Ifosfamid (1,8 g/m²/dan, i.v.): dani 1-5
Consolidation block 2 (3 weeks)
Konsolidacijska terapija 2 (3 tjedna)
Consolidation block 1 (3 weeks)
Konsolidacijska terapija 1 (3 tjedna)
G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
G-CSF (5 μg/kg, s.c.): dani 5-14 ili do porasta ABN >1500 nakon
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).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel
• mučnina s proljevom i povraćanjem, bol u trbuhu ili vrućica (znakovi crijevnih problema)
9/l and platelets ≥ 75 x 10
9/l i trombociti ≥75 x 10 9/l.
CPM (250 mg/m2/dose q12h x 4 doses, IV): days 3 and 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
MTX 15 mg intrathecal, day 1;
MTX 15 mg intratekalno, dan 1
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 capsule of 400 mg once a day, depending on how you respond to treatment.
Ovisno o tome kako reagirate na liječenje, liječnik može odlučiti povećati dozu do 400 mg, a uzima se kao 1 kapsula od 400 mg jednom na dan.
VP-16 (100 mg/m 2, IV): days 29-33
VP-16 (100 mg/m², i.v.): dani 29-33
In GIST the investigational medicinal product was discontinued for imatinib-related adverse reactions in 4 % of patients.
U ispitivanju GIST-a, primjena ispitivanog lijeka je prekinuta u 4 % bolesnika zbog nuspojava povezanih s primjenom imatiniba.
Posology for DFSP in adult patients The recommended dose of imatinib is 800 mg/day for patients with DFSP.
Za bolesnike s DFSP-om preporučena doza imatiniba iznosi 800 mg/dan.
VCR 2 mg i.v., days 6, 13, 20; Daunorubicin 45 mg/m i.v., days 6-7, 13-14
I DEX 10 mg/m² peroralno, dani 1-5; VCR 2 mg i.v., dani 6, 13, 20; daunorubicin 45 mg/m² i.v., dani 6-7, 13-14
Pleural effusion
Oticanje zglobova
9/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
9/l, treba ponoviti 1. korak i nastaviti primjenu imatiniba u smanjenoj dozi od 300 mg.
9/l and/or platelets < 10 x 10
9/l i/ili trombociti <10 x 10
9/l and/or platelets < 50 x 10
9/l i/ili trombociti <50 x 10
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 preraspodjelom gena za PDGFR.
• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
• osip, crvenilo kože s mjehurićima na usnama, očima, koži ili u ustima, ljuštenje kože, vrućica,
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 preraspodjelom gena za PDGFR.
Study AUS01
Studija AJP01
Liver dysfunction
Oštećenje funkcije bubrega
Imatinib medac 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
Imatinib medac 400 mg tvrde kapsule Svaka tvrda kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
Ovojnica kapsule za kapsule od 100 mg sastoji se od želatine, žutog željezovog oksida (E172), titanijevog dioksida (E171) i crvenog željezovog oksida (E172).
Reinduction block 2 (3 weeks)
Reindukcijska terapija 2 (3 tjedna)
Theaterstr.
BROJ SERIJE
Very common: Headache Common:
Poremećaji oka Često:
The capsule shell for 400 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
Ovojnica kapsule za kapsule od 400 mg sastoji se od želatine, žutog željezovog oksida (E172), titanijevog dioksida (E171), crvenog željezovog oksida (E172) i crnog željezovog oksida (E172).
The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m once daily (not exceeding 400 mg once daily) or 340 mg/m 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.
400 mg jedanput na dan) ili 340 mg/m 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.
• Joint pain with swelling.
• bolovi u zglobovima s oticanjem
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, kao i nakon prekida liječenja.
Evaluation by a cardiology specialist, performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD associated with high eosinophil levels before imatinib is administered.
Prije primjene imatiniba u bolesnika s HES/KEL-om i u bolesnika s MDS/MPD-om povezanim s visokim razinama eozinofila potrebno je razmisliti o pregledu kod specijalista kardiologa, obavljanju ehokardiograma i određivanju serumskog troponina.
When and how to take Imatinib medac • Take Imatinib medac with a meal.
Kada i kako uzimati Imatinib medac
12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis 18 Gy in 10 fractions for patients that are CNS3 at diagnosis VCR (1.5 mg/m2/day, IV): days 1, 29
Kranijalna iradijacija (samo blok br. 5) 12 Gy u 8 frakcija za sve bolesnike koji imaju CNS1 i CNS2 u trenutku dijagnoze
Consolidation therapy DEX 10 mg/m oral, days 1-5; Vindesine 3 mg/m i.v., day 1;
DEX 10 mg/m² peroralno, dani 1-5; vindezin 3 mg/m² i.v., dan 1;
No patient developed grade 4 thrombocytopenia.
Trombocitopenija 4. stupnja nije nastupila niti u jednog bolesnika.
DEX (6 mg/m 2/day, PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 1-56 Methotrexate (20 mg/m 2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50 G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 µM, q6h = every 6 hours, Gy= Gray
= u mišić, ARA-C = citarabin, CPM = ciklofosfamid, VCR = vinkristin, DEX = deksametazon, DAUN = daunorubicin, 6-MP = 6-merkaptopurin, E.Coli L-ASP = L-asparaginaza, PEG-ASP = PEG asparaginaza, MESNA = natrijev 2-merkaptoetan sulfonat, iii = ili dok vrijednost MTX-a ne bude <0,1 μM, Gy = Gray
Reinduction block 1 (3 weeks)
Reindukcijska terapija 1 (3 tjedan)
200 mg/m
(doza od 340 mg/m²)
Breast-feeding
Cerebralni edem*
monthly for 13 months;
VCR 2 mg i.v. mjesečno tijekom 13 mjeseci;
Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision
Edem kapaka, pojačano suzenje, konjunktivalno krvarenje, konjunktivitis, suhe oči, zamagljen vid
Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules
Imatinib medac 100 mg tvrde kapsule Imatinib medac 400 mg tvrde kapsule
9/l) and thrombocytopenias (platelet count < 50 x 10
9/l) i trombocitopenija (broj trombocita <50 x 10
• Rash.
• osip
VCR (1.5 mg/m 2/day, IV): days 1, 29
VCR (1,5 mg/m², i.v.): dani 1, 29
Imatinib medac 100 mg hard capsules Size “3” hard capsules with orange body and cap. Imatinib medac 400 mg hard capsules Size “00” hard capsules with caramel body and cap.
Imatinib medac 100 mg tvrde kapsule Tvrde kapsule veličine “3” narančastog tijela i kapice.
Each 100 mg hard capsule of Imatinib medac contains 100 mg imatinib (as mesilate).
Svaka tvrda kapsula Imatinib medaca od 100 mg sadrži 100 mg imatiniba (u obliku imatinibmesilata).
The dose of
NAZIV LIJEKA
Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172)
Ovojnica kapsule želatina željezov oksid, žuti (E172) titanijev dioksid (E171) željezov oksid, crveni (E172)
9/l) and thrombocytopenia (platelet count < 10 x 10
9/l) i trombocitopenija (broj trombocita <10 x 10
(24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
DEX 40 mg/dan na dane 1-4 i 11-14, izmjenjivano s MTX 1 g/m² i.v. (24 h), dan 1, Ara-C 1 g/m² i.v. (2 h, svakih 12 h), dani 2-3 (ukupno
Remission induction DEX 10 mg/m oral, days 6-7, 13-16; i.v.
Indukcija remisije DEX 10 mg/m² peroralno, dani 6-7, 13-16; VCR 1 mg i.v., dani 7, 14;
Each 400 mg hard capsule of Imatinib medac contains 400 mg imatinib (as mesilate).
Svaka tvrda kapsula Imatinib medaca od 400 mg sadrži 400 mg imatiniba (u obliku imatinibmesilata).
G-CSF (5 μg/kg, SC): days 34-43
MESNA i.v.: dani 29-33 G-CSF (5 μg/kg, s.c.): dani 34-43
IV or PO q6h x 6 doses)iii:
6 sati x 6 doza)iii: dani 2 i 3
(3 h), days 1-4; Mitoxantrone 10 mg/m i.v.
Ara-C 1000 mg/m²/12 h i.v.(3 h), dani 1-4; mitoksantron 10 mg/m² i.v. dani 3-5;
• paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+)
• pedijatrijskih bolesnika s novodijagnosticiranom kroničnom mijeloičnom leukemijom (KML) s pozitivnim Philadelphia (Ph+) kromosomom (bcr-abl), u kojih se transplantacija koštane srži ne smatra prvom linijom liječenja,
(n = 5), 340 mg/m2/day (n = 7) and 570 mg/m 2/day (n = 5).
Bolesnici su liječeni dozama imatiniba od 260 mg/m²/dan (n=5), 340 mg/m²/dan (n=9), 440 mg/m²/dan (n=7), te 570 mg/m²/dan (n=5).
Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172)
Ovojnica kapsule želatina željezov oksid, žuti (E172) titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni E172)
2/day, IV): days 1, 8 and 15 2/day bolus, IV): days 1 and 2 2/dose q12h x 4 doses, iv): Days 3 and 4 2, IM): day 4 G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15 2/day, PO): days 1-7 and 15-21
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 ABN >1500 nakon najniže izmjerene vrijednosti
Imatinib medac 400 mg hard capsules Capsule content
Imatinib medac 400 mg tvrde kapsule imatinib
Imatinib medac 100 mg hard capsules Capsule content
Imatinib medac 100 mg tvrde kapsule imatinib
Renal failure chronic Reproductive system and breast disorders
Poremećaji reproduktivnog sustava i dojki Manje često:
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg of imatinib (as mesilate).
NAVOĐENJE DJELATNE(IH) TVARI Svaka tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
• 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
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 400 mg of imatinib (as mesilate).
NAVOĐENJE DJELATNE(IH) TVARI Svaka tvrda kapsula sadrži 400 mg imatiniba (u obliku imatinibmesilata).
Table 1 Tabulated summary of adverse reactions Infections and infestations
Terapijska indikacija Toksični učinci: neutropenija i
Haematological adverse reactions
Hematološke nuspojave
(1 h), days 28-31, 35-38, 42-45;
Ara-C 75 mg/m² i.v. (1 h), dani 28-31, 35-38, 42-45; 6-MP 60 mg/m² peroralno, dani 26-46
Mild
Umjereni
Avascular necrosis/hip necrosis*, growth retardation in children* Renal and urinary disorders
Avaskularna nekroza/nekroza kuka*, zastoj u rastu kod djece* Poremećaji bubrega i mokraćnog sustava Manje često:
months (range 24 days - 60 months).
Ti su bolesnici primali imatinib za medijan od 47 mjeseci (raspon 24 dana - 60 mjeseci).
Eye disorders
• oslabljen sluh
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
• mučnina, nedostatak zraka, nepravilni otkucaji srca, zamućenje mokraće, umor i/ili osjećaj nelagode u zglobovima udruženi s poremećenim nalazima laboratorijskih pretraga (npr. visoke razine kalija, mokraćne kiseline i kalcija te niske razine fosfora u krvi).
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3
Ara-C 2x 2 g/m² i.v. (3 h, svakih 12 h), dan 5
Chest pain, malaise
Bol u prsnom košu, malaksalost
9/l.
9/l) bila između 4 i
• Mouth ulcers.
• čirevi u ustima
Gastrointestinal disorders Very common: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain
Mučnina, proljev, povraćanje, dispepsija, bol u trbuhu
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 ABN >1500 nakon najniže izmjerene vrijednosti i.t. metotreksat (prilagođeno dobi): SAMO dan 1
Frequency categories are defined using the following convention: very common
Pretrage Vrlo često: Često:
Imatinib medac 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
KVALITATIVNI I KVANTITATIVNI SASTAV Imatinib medac 100 mg tvrde kapsule Svaka tvrda kapsula sadrži 100 mg imatiniba (u obliku imatinibmesilata).
Cases of liver injury, including hepatic failure and hepatic necrosis, have been observed with imatinib.
Uz imatinib su uočeni slučajevi oštećenja jetre, uključujući zatajenje jetre i jetrenu nekrozu.
Methotrexate (5 g/m over 24 hours, IV): days 1 and 15 at hour 36, IV; 15 mg/m
Metotreksat (5 g/m² kroz 24 sata, i.v.): dani 1 i 15
Nervous system disorders
Konfuzno stanje Poremećaji živčanog sustava Vrlo često:
Ara-C 1,000 mg/m2/12 h i.v.
CP 500 mg/m² i.v.(1 h) dan 1;
Weakness, pyrexia, anasarca, chills, rigors
Slabost, vrućica, anasarka, zimica, tresavica
Flushing, haemorrhage
Pancitopenija, febrilna neutropenija
9/l, no blood blasts, BM blasts < 5 % and no extramedullary disease] NEL: Same criteria as for CHR but ANC ≥ 1 x 10
NEL: Isti kriteriji kao za CHR, ali je ABN ≥1 x 10
(0.5 h), days 7, 8, 14, 15; i.v., days 22-25, 29-32
Ara-C 60 mg/m² i.v., dani 22-25, 29-32
Clinical studies in chronic myeloid leukaemia
Pedijatrijska kronična faza KML-a
The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
Za odrasle bolesnike s Ph+ ALL-om preporučena doza imatiniba iznosi 600 mg/dan.
In the event of recurrence of ANC < 1.0 x10
3. U slučaju da je ABN ponovno <1,0 x10 9/l i/ili trombociti <50 x10
VCR (1.5 mg/m 2/day, IV): days 1, 8, and 15 DAUN (45 mg/m 2/day bolus, IV): days 1 and 2
VCR (1,5 mg/m²/dan, i.v.): dani 1, 8, i 15
In the event of recurrence of ANC < 1.0 x 10
3. U slučaju da je ABN ponovno <1,0 x 109/l i/ili trombociti <50 x 10
Ara-C 40 mg intrathecal, days 1, 8, 15, 22;
Ara-C 40 mg intratekalno, dani 1, 8, 15, 22; metilprednizolon 40 mg intratekalno, dani 1, 8, 15, 22
Vitreous haemorrhage* Ear and labyrinth disorders
Hemoragična cista žutog tijela/hemoragična cista jajnika
The starting dose is 400 mg, to be taken as 1 capsule of 400 mg once a day.
• Ako se liječite zbog MDS/MPD-a: Početna doza je 400 mg, a uzima se kao 1 kapsula od 400 mg jednom na dan.
(24 h), day 1; Etoposide 250 mg/m i.v.
MTX 1,5 g/m² i.v. (24 h), dan 1; etopozid 250 mg/m² i.v. (1 h) dani 4-5;
The recommended dose of imatinib is 100 mg/day for patients with HES/CEL.
Za bolesnike s HES/KEL-om preporučena doza imatiniba iznosi 100 mg/dan.
• Stomach pain with feeling sick (nausea).
• bol u trbuhu s mučninom
The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis.
Za odrasle bolesnike u blastičnoj krizi preporučena doza imatiniba iznosi 600 mg/dan.
Pharmacokinetics of imatinib
Farmakokinetika imatiniba
Study AJP01 Induction therapy i.v.
Studija AUS01 Indukcijskokonsolidacijska terapija
Further information on MabThera can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/mabthera.
Više informacija o lijeku MabThera dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/mabthera.
Depending on the condition being treated, the patients can also be given other medicines.
Ovisno o bolesti koja se liječi, bolesnicima se mogu davati i drugi lijekovi.
It can only be obtained with a prescription.
Izdaje se samo na recept.
Before each infusion or injection, the patient should be given an antihistamine (to prevent allergic reactions) and an anti-pyretic (a medicine for fever).
Prije svake infuzije ili injekcije bolesniku je potrebno dati antihistaminik (kako bi se spriječile alergijske reakcije) i antipiretik (lijek protiv vrućice).
What measures are being taken to ensure the safe and effective use of MabThera?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka MabThera?