natgillin/translations-raw huggingface dataset:
There is no experience in children or adolescents with HES/CEL.
Nema iskustva s HES/KEL-om u djece ili adolescenata.
Resume treatment with imatinib at 600 mg.
2. Ponovno uvesti liječenje imatinibom u dozi od 600 mg.
• 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).
• bol u zdjelici ponekad s mučninom i povraćanjem te neočekivanim krvarenjem iz rodnice, omaglica ili nesvjestica zbog sniženog krvnog tlaka (znakovi problema s jajnicima ili maternicom)
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and non-glandular stomach.
Ciljni organi neoplastičkih promjena bili su bubrezi, mokraćni mjehur, uretra, žlijezda prepucija i klitorisa, tanko crijevo, paratireoidne žlijezde, nadbubrežne žlijezde i ne-žljezdani želudac.
Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation,
Pustularni osip, kontuzije, pojačano znojenje, urtikarija, ekhimoza, povećana sklonost modricama, hipotrihoza, hipopigmentacija kože, eksfolijativni dermatitis, onihoklazija, folikulitis, petehije, psorijaza, purpura, hiperpigmentacija kože, bulozne erupcije
No evidence of leukaemia (NEL) Return to chronic phase (RTC) Major cytogenetic response Complete (Confirmed
Hematološki odgovor Potpuni hematološki odgovor (CHR) Nema dokaza leukemije (NEL) Vraćanje na kroničnu fazu (RTC) Veliki citogenetski odgovor2 Potpuni (Potvrđeni3) [95 % CI]
If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 400 mg.
2. Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 400 mg.
Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Prije početka liječenja bolesnika s pozitivnim serološkim nalazima na hepatitis B (uključujući one s aktivnom bolešću) te za bolesnike za koje se pokaže da su pozitivni na HBV tijekom liječenja, potrebno je savjetovati se sa stručnjacima za bolesti jetre i liječenje hepatitisa B.
You may feel dizzy or drowsy or get blurred vision while taking this medicine.
Tijekom uzimanja ovog lijeka možete osjetiti omaglicu ili imati zamagljen vid.
In thyroidectomy patients receiving levothyroxine, the plasma exposure to levothyroxine may be decreased when imatinib is co-administered (see section 4.4).
U bolesnika u kojih je obavljena tireoidektomija i koji primaju levotiroksin, izloženost levotiroksinu u plazmi može biti smanjena kada se istodobno primjenjuje imatinib (vidjeti dio 4.4).
There are limited data on the use of imatinib in pregnant women.
Podaci o primjeni imatiniba u trudnica su ograničeni.
The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day.
Početna doza je 100 mg, a uzima se kao 1 kapsula od 100 mg jednom na dan.
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 ALL patients.
Supstancija selektivno inhibira proliferaciju te inducira apoptozu u Bcr-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).
Dose increases from 340 mg/m daily to 570 mg/m daily (not to exceed the total dose of 800 mg) may be considered in the absence of severe adverse drug reaction and severe non-leukaemia-related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time); failure to achieve a satisfactory haematological response after at least 3 months of treatment; failure to achieve a cytogenetic response after 12 months of treatment; or loss of a previously achieved haematological and/or cytogenetic response.
Povećanja doze od 340 mg/m² na dan do 570 mg/m² na dan (ne smije se prekoračiti ukupna doza od 800 mg) mogu se razmotriti u odsutnosti teške nuspojave i teške neutropenije ili trombocitopenije nepovezane s leukemijom u sljedećim situacijama: progresija bolesti (u bilo kojem trenutku); neuspjeh u postizanju zadovoljavajućeg hematološkog odgovora nakon liječenja u trajanju od najmanje 3 mjeseca; neuspjeh u postizanju citogenetskog odgovora nakon 12 mjeseci liječenja; ili gubitak ranije postignutoga hematološkog i/ili citogenetskog odgovora.
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of
• grčevi mišića s vrućicom, crveno-smeđe obojena mokraća, bol ili slabost mišića (znakovi mišićnih problema)
Posology modification
Promjene doziranja
Stomatitis, mouth ulceration, gastrointestinal haemorrhage
Stomatitis, ulceracija u ustima, gastrointestinalno krvarenje
Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Aritmija, fibrilacija atrija, srčani zastoj, infarkt miokarda, angina pektoris,
Vertigo, tinnitus, hearing loss
Vrtoglavica, tinitus, gubitak sluha
Improvements were reported in cardiac, nervous, skin/subcutaneous tissue, respiratory/thoracic/mediastinal, musculoskeletal/connective tissue/vascular, and gastrointestinal organ systems.
Poboljšanja su zabilježena u srčanom, živčanom, koži/potkožnom tkivu, dišnom/prsištu/sredoprsju, mišićno-koštanom/vezivnom tkivu/krvožilnom i probavnom organskom sustavu.
In this study, 14 patients with HES/CEL were treated with 100 mg to 1,000 mg of imatinib daily.
U tom kliničkom ispitivanju, 14 bolesnika s HES/KEL-om liječeno je imatinibom od 100 mg do 1000 mg na dan.
Imatinib medac is indicated for the treatment of
Imatinib medac indiciran je za liječenje
Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Migrena, pospanost, sinkopa, periferna neuropatija, poremećaj pamćenja, ishijalgija, sindrom nemirnih nogu, tremor, cerebralno krvarenje
1) Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
1) Upala pluća je najčešće zabilježena u bolesnika s transformiranim KML-om i u bolesnika s GIST-om.
Imatinib medac contains lactose.
Imatinib medac sadrži laktozu.
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity
Svrbež, edem lica, suhoća kože, eritem, alopecija, noćno znojenje, reakcija preosjetljivosti na svjetlo
Based on the recovery of compound(s) after an oral 14C-labelled dose of imatinib, approximately 81 % of the dose was recovered within 7 days in faeces (68 % of dose) and urine (13 % of dose).
C-označene doze imatiniba, oko 81 % doze izlučilo se u roku od 7 dana u stolici (68 % doze) i mokraći (13 % doze).
Posology for HES/CEL in adult patients
Doziranje za HES/KEL u odraslih bolesnika
Palpitations, tachycardia, cardiac failure congestive 3, pulmonary oedema
Palpitacije, tahikardija, kongestivno zatajenje srca3, plućni edem
No significant age-related pharmacokinetic differences have been observed in patients in clinical trials which included over 20 % of patients aged 65 and older.
U kliničkim ispitivanjima koja su uključivala preko 20 % bolesnika u dobi od 65 godina i više, nisu zapažene značajne farmakokinetičke razlike vezane uz dob.
Active substances that may increase imatinib plasma concentrations Substances that inhibit the cytochrome P450 isoenzyme CYP3A4 activity (e.g. protease inhibitors such as indinavir, lopinavir/ritonavir, ritonavir, saquinavir, telaprevir, nelfinavir, boceprevir; azole antifungals including ketoconazole, itraconazole, posaconazole, voriconazole; certain macrolides such as erythromycin, clarithromycin and telithromycin) could decrease metabolism and increase imatinib concentrations.
Djelatne tvari koje mogu povećati koncentracije imatiniba u plazmi Tvari koje inhibiraju djelovanje CYP3A4 izoenzima citokroma P450 (npr. inhibitori proteaze kao što su indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotici uključujući ketokonazol, itrakonazol, posakonazol, vorikonazol; određeni makrolidi kao što su eritromicin, klaritromicin i telitromicin) mogle bi smanjiti metabolizam i povećati koncentracije imatiniba.
If any of these apply to you, tell your doctor before taking Imatinib medac.
Ako se bilo što od navedenog odnosi na Vas, obavijestite svog liječnika prije uzimanja Imatinib medaca.
How much Imatinib medac to take
Koliko Imatinib medaca uzeti
Treatment of CML patients with imatinib has been associated with neutropenia or thrombocytopenia.
Liječenje imatinibom je kod bolesnika s KML-om povezano s neutropenijom ili trombocitopenijom.
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 od 800 mg na dan.
Imatinib medac 100 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Imatinib medac 100 mg tvrde kapsule PA-aluminij/PVC/aluminij blisteri.
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of
• mučnina uz gubitak apetita, tamno obojena mokraća, žutilo kože ili očiju (znakovi problema s jetrom)
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 10
4. Ako citopenija ustraje 4 tjedna i još uvijek nije povezana s leukemijom, prekinuti primjenu imatiniba sve dok ABN ne bude ≥1 x 109/i trombociti ≥20 x 10
Maintenance (8-week cycles) Cycles 1-4
(8-tjedni ciklusi) Ciklusi 1-4
INFORMATION IN BRAILLE Imatinib medac 100 mg
16. PODACI NA BRAILLEOVOM PISMU Imatinib medac 100 mg
Posology for Ph+ ALL in children
Doziranje za Ph+ ALL u djece
Liver function tests
Poremećaj funkcije jetre Testovi funkcije jetre Blagi
Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
U obje su vrste zapažena blaga do umjerena povećanja razine transaminaza, te mala smanjenja razina kolesterola, triglicerida, ukupnih proteina i albumina.
If cytopenia is unrelated to leukaemia, reduce dose of imatinib to 260 mg/m 3.
2. Ako citopenija nije povezana s leukemijom, dozu imatiniba treba smanjiti na 260 mg/m².
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
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).
Imatinib medac 400 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Imatinib medac 400 mg tvrde kapsule PA-aluminij/PVC/aluminij blisteri.
Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Pleuralna bol, plućna fibroza, plućna hipertenzija, plućno krvarenje
As cardiac adverse events have been reported uncommonly with imatinib, a careful assessment of the benefit/risk of imatinib therapy should be considered in the HES/CEL population before treatment initiation.
Budući da su srčane nuspojave zabilježene manje često uz imatinib, prije početka liječenja u HES/KEL populaciji potrebno je uzeti u obzir pažljivu procjenu omjera koristi i rizika od terapije imatinibom.
Imatinib medac is also a treatment for adults for:
Imatinib medac se također koristi kod odraslih osoba za liječenje:
Therefore, caution is recommended when administering imatinib with CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporin, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil,
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, docetaksel i kinidin).
• adult patients with relapsed or refractory Ph+ ALL as monotherapy.
• odraslih bolesnika s recidivirajućim ili refraktornim Ph+ ALL-om u obliku monoterapije,
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).
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):
Vrlo česte (mogu se javiti u više od 1 na 10 osoba) ili česte (mogu se javiti u do 1 na 10 osoba):
• adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
• odraslih i pedijatrijskih bolesnika s novodijagnosticiranom akutnom limfoblastičnom leukemijom s pozitivnim Philadelphia kromosomom (Ph+ ALL) uz kemoterapiju,
For patients unable to swallow the film-coated tablets, the tablets may be dispersed in a glass of still water or apple juice.
Bolesnicima koji ne mogu progutati filmom obložene kapsule, sadržaj kapsule može se otopiti u čaši negazirane vode ili soka od jabuke.
Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia.
Teška jetrena toksičnost zapažena je u pasa koji su liječeni 2 tjedna, uz povišene jetrene enzime, hepatocelularnu nekrozu, nekrozu žučnih vodova te hiperplaziju žučnih vodova.
This inhibition has not been observed in vivo after the administration of imatinib 400 mg and paracetamol 1000 mg. Higher doses of imatinib and paracetamol have not been studied.
Ovakva inhibicija nije uočena in vivo nakon primjene imatiniba u dozi od 400 mg i paracetamola u dozi od 1000 mg.
Imatinib medac contains lactose monohydrate
Imatinib medac sadrži laktozu hidrat
There are no controlled trials in paediatric patients with HES/CEL.
Nema kontroliranih ispitivanja u pedijatrijskih bolesnika s HES/KEL-om.
Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis
Akutna febrilna neutrofilna dermatoza (Sweetov sindrom), promjena boje nokta, angioedem, vezikularni osip, multiformni eritem, leukocitoklastični vaskulitis, Stevens-Johnsonov sindrom, akutna generalizirana egzantematozna pustuloza (AGEP)
MTX 15 mg intrathecal, days 1, 8, 15, 22;
MTX 15 mg intratekalno, dani 1, 8, 15, 22;
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
10) Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
10) Mišićno-koštana bol i srodni događaji češće su uočeni u bolesnika s KML-om nego u bolesnika s GIST-om.
9/l and platelets ≥ 20 x 10
9/l, a trombociti ≥20 x 10
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
• 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.
Posology for CML in paediatric patients Dosing for paediatric patients should be on the basis of body surface area (mg/m2).
U pedijatrijskih bolesnika doziranje se treba temeljiti na veličini površine tijela (mg/m²).
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/m 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
Plasma pharmacokinetics
Farmakokinetika u plazmi
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.
5) Pleuralni izljev je češće zabilježen u bolesnika s GIST-om i u bolesnika s transformiranim KMLom (KML-ubrzana faza i KML-blastična kriza), nego u bolesnika s kroničnim KML-om.
In rats, hyperplasia of the transitional epithelium in the renal papilla and in the urinary bladder was observed at doses > 6 mg/kg in the 13-week study, without changes in serum or urinary parameters.
U ispitivanju kod štakora koje je trajalo 13 tjedana zapažena je hiperplazija prijelaznog epitela u bubrežnoj papili te u mokraćnom mjehuru uz doze ≥6 mg/kg, bez promjena parametara za serum ili mokraću.
Packs containing 60 hard capsules.
Pakiranja sadrže 60 tvrdih kapsula.
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.
Istodobna primjena imatiniba i lijekova koji induciraju CYP3A4 (npr. deksametazon, fenitoin, karbamazepin, rifampicin, fenobarbital ili Hypericum perforatum, poznat također kao gospina trava) može značajno smanjiti izloženost imatinibu, što potencijalno povećava rizik od neuspjeha terapije.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. Do not store above 30 °C.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza kratice EXP/ „Rok valjanosti“.
Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Prije početka liječenja liječnik će pažljvo pregledati bolesnike radi utvrđivanja eventualnih znakova te infekcije.
Posology for Ph+ ALL in adult patients
Doziranje za Ph+ ALL u odraslih bolesnika
Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS)* Poremećaji mišićno-koštanog sustava i vezivnog tkiva Vrlo često:
Patients with mild and moderate impairment of renal function appear to have a higher plasma exposure than patients with normal renal function.
Izgleda da je plazmatska izloženost veća u bolesnika s blagim i umjerenim oštećenjem funkcije bubrega nego u bolesnika s normalnom funkcijom bubrega.
1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
1, sinusitis, celulitis, infekcija gornjih dišnih puteva, gripa, infekcija mokraćnog sustava,
Imatinib medac inhibits the growth of these cells.
Imatinib medac inhibira rast ovih stanica.
Posology for CML in adult patients
Doziranje za KML u odraslih bolesnika
Blast crisis is the most
Blastična kriza predstavlja najuznapredovaliji stadij ove bolesti.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
• Akutne limfoblastične leukemije s pozitivnim Philadelphia kromosomom (Ph-pozitivni ALL).
The most commonly reported (≥ 10 %) treatment-related adverse reactions were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Najčešće zabilježene nuspojave (≥10 %) povezane s liječenjem, bile su blaga mučnina, povraćanje, proljev, bol u trbuhu, umor, bol u mišićima, grčevi u mišićima i osip.
The starting dose is 600 mg to be taken as 6 capsules of 100 mg (or 1 capsule of 400 mg plus 2 capsules of 100 mg) once a day.
Početna doza iznosi 600 mg, a uzima se jednom na dan kao 6 kapsula od 100 mg (ili 1 kapsula od 400 mg i 2 kapsule od 100 mg).
Imatinib medac 400 mg hard capsules Each hard capsule contains 50.072 mg lactose monohydrate.
Imatinib medac 400 mg tvrde kapsule Svaka tvrda kapsula sadrži 50,072 mg laktoze hidrata.
The paediatric patient received 400 mg/m2/daily, subsequently increased to 520 mg/m2/daily.
Pedijatrijski bolesnici primali su 400 mg/m² na dan, kasnije je doza povećana na 520 mg/m² na dan.
4) Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
Crvenilo uz osjećaj vrućine je bilo najčešće u bolesnika s GIST-om, a krvarenje (hematomi, hemoragija) je bilo najčešće u bolesnika s GIST-om i u bolesnika s transformiranim KML-om (KML-ubrzana faza i KML-blastična kriza).
Dose adjustments for neutropenia and thrombocytopenia:
Prilagođavanje doze zbog neutropenije i trombocitopenije:
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red
• blijeda koža, umor i gubitak daha te tamno obojena mokraća (znakovi snižene razine crvenih krvnih stanica)
• Swelling such as round your ankles or puffy eyes.
• oticanje kao što je oticanje gležnjeva ili otečene oči
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
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.
However if it is nearly time for the next
Međutim, ako je uskoro vrijeme za sljedeću dozu, preskočite propuštenu dozu.
Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Iritacija oka, bol u oku, orbitalni edem, krvarenje bjeloočnice, krvarenje mrežnice, blefaritis, makularni edem
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry
Flatulencija, abdominalna distenzija, gastroezofagealni refluks, konstipacija,
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane Često:
Imatinib medac 100 mg hard capsules Each hard capsule contains 12.518 mg lactose monohydrate.
Imatinib medac 100 mg tvrde kapsule Svaka tvrda kapsula sadrži 12,518 mg laktoze hidrata.
Packs containing 30 hard capsules.
Pakiranja sadrže 30 tvrdih 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)
• Feeling dizzy or weak.
• omaglica ili slabost
Triple IT therapy (age-adjusted): days 1, 29
Trostruka i.t. terapija (prilagođena dobi): dani 1, 29
Biochemistry
Biokemija
Laboratory test abnormalities
Abnormalne vrijednosti laboratorijskih testova
Imatinib medac is a treatment for adults and children and adolescents for:
Imatinib medac se koristi kod odraslih osoba, djece i adolescenata za liječenje:
9, arthralgia, bone
9, artralgiju,
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of
• teška bol u trbuhu, krv u sadržaju povraćanja, stolici ili mokraći, crne stolice (znakovi probavnih problema)
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 općim hematološkim i citogenetskim stopama odgovora i preživljenju bez progresije.
What Imatinib medac contains
Što Imatinib medac sadrži
Intensification block 2 (9 weeks)
Intenzifikacijska terapija 2 (9 tjedana)