natgillin/translations-raw huggingface dataset:
In the juvenile toxicology study, effects upon growth, delay in vaginal opening and preputial separation were observed at approximately 0.3 to 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
U toksikološkom ispitivanju u juvenilnih životinja, učinci na rast, odgodu vaginalnog otvaranja i odvajanje prepucija uočeni su pri izloženosti koja iznosi otprilike 0,3 do 2 puta prosječne izloženosti u djece pri najvišoj preporučenoj dozi od 340 mg/m2.
Increased hepatic enzymes
Povišeni jetreni enzimi
- Do not breast-feed during the treatment with Imatinib Actavis.
- Nemojte dojiti tijekom liječenja Imatinib Actavisom.
The milk plasma ratio studied in a single patient was determined to be 0.5 for imatinib and 0.9 for the metabolite, suggesting greater distribution of the metabolite into the milk.
Omjer koncentracije u mlijeku i plazmi ispitivan u jedne bolesnice bio je 0,5 za imatinib i 0,9 za metabolit, što ukazuje na veću raspodjelu metabolita u mlijeko.
Periorbital oedema, dermatitis/eczema/rash
Periorbitalni edem, dermatitis/ekcem/osip
- If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still water or apple juice.
Ako niste u stanju progutati kapsule, možete ih otvoriti i istresti prašak u čašu obične vode ili soka od jabuke.
Close monitoring of growth in children under imatinib treatment is recommended (see section 4.8).
Preporučuje se pažljivo praćenje rasta kod djece koji se liječe imatinibom (vidjeti dio 4.8).
Keep taking Imatinib Actavis every day for as long as your doctor tells you.
Actavis nastavite uzimati svaki dan onoliko dugo koliko Vam je liječnik rekao.
This Ki value is far higher than the expected plasma levels of imatinib in patients, consequently no interaction is expected upon coadministration of either 5-fluorouracil or paclitaxel and imatinib.
Ta Ki vrijednost je daleko viša nego što su očekivane razine imatiniba u plazmi bolesnika, pa se prema tome ne očekuje nikakva interakcija nakon istodobne primjene bilo 5-fluorouracila bilo paklitaksela i imatiniba.
Grade 3 and 4 neutropenia was seen in 7.5% and 2.7% of patients, respectively, and grade 3 thrombocytopenia in 0.7% of patients.
Neutropenija 3. i 4. stupnja zapažena je u 7,5% odnosno u 2,7% bolesnika, a trombocitopenija 3. stupnja u 0,7% bolesnika.
How much Imatinib Actavis to take Use in adults
Koliko Imatinib Actavisa uzeti Primjena u odraslih osoba
However, the occurrence of these cytopenias is likely to be related to the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML.
Međutim, pojava ovih citopenija ovisi o stadiju liječene bolesti, a mnogo su češće u bolesnika s ubrzanom fazom KML-a ili blastičnom krizom, u odnosu na bolesnike s kroničnom fazom KML-a.
3 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
3 Na temelju procjene bolesnik-godina, srčani događaji uključujući kongestivno zatajenje srca su bili češće uočeni u bolesnika s transformiranim KML-om, nego u bolesnika s kroničnim KML
- Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
- mišićna slabost i grčevi mišića s abnormalnim srčanim ritmom (znakovi promjena količine kalija u krvi).
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Postoji ograničeno iskustvo kod djece s Ph-pozitivnim ALL-om te vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om i HES/KEL-om.
Traces of the dissolved tablets may be left behind in the glass.
Ostatke otopljene tablete(a) u čaši možete ostaviti.
6+7 Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
6+7 Bol u trbuhu i gastrointestinalno krvarenje su najčešće uočeni u GIST bolesnika.
The dose of 340 mg/m2 daily is recommended for children with chronic phase CML and advanced phase CML (not to exceed the total dose of 800 mg).
Doza od 340 mg/m2 na dan preporučuju se za djecu s kroničnom fazom KML-a i s uznapredovalom fazom KML-a (ne smije se prekoračiti ukupna doza od 800 mg).
- Cough, having difficulty breathing or painful breathing (signs of lung problems).
- kašalj, otežano disanje ili bolno disanje (znakovi plućnih problema).
Carriers of HBV who require treatment with Imatinib Actavis should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Nositelje virusa HBV kojima je potrebno liječenje Imatinibom Actavis potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
Pretreatment with multiple doses of rifampicin 600 mg followed by a single 400 mg dose of imatinib resulted in decrease in Cmax and AUC(0-∞) by at least 54% and 74%, of the respective values without rifampicin treatment.
Prethodno liječenje s višestrukim dozama rifampicina od 600 mg, nakon čega je slijedila jednokratna doza imatiniba od 400 mg, rezultiralo je smanjenjem Cmax i AUC(0-∞) za najmanje 54% odnosno 74%
11 Fatal cases have been reported in patients with advanced disease, severe infections, severe neutropenia and other serious concomitant conditions.
11 Smrtni slučajevi zabilježeni su u bolesnika s uznapredovalom bolešću, teškim infekcijama,
ANNEX II
PRILOG III
Pack containing either 24, 48, 60, 96, 120 or 180 capsules
Pakiranje sadrži 24, 48, 60, 96, 120 ili 180 kapsula.
Imatinib Actavis is a treatment for:
Imatinib Actavis se koristi za liječenje:
In GIST patients (study B2222), 6.8% of grade 3 or 4 ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
U bolesnika s GIST-om (studija B2222), zapaženo je 6,8% ALT (alanin-aminotransferaza) povišenja 3. ili 4. stupnja, kao i 4,8% AST (aspartat-aminotransferaza) povišenja 3. ili 4. stupnja.
Pack containing either 30 or 90 capsules.
Pakiranje sadrži 30 ili 90 kapsula.
If either is abnormal, follow-up with a cardiology specialist and the prophylactic use of systemic steroids (1-2 mg/kg) for one to two weeks concomitantly with imatinib should be considered at the initiation of therapy.
Ako je bilo što abnormalno, na početku terapije je potrebno razmisliti o kontrolnom pregledu kod specijaliste kardiologa i profilaktičkoj primjeni sistemskih steroida (1-2 mg/kg) tijekom jednog do dva tjedna istodobno uz imatinib.
In paediatric CML patients the most frequent toxicities observed were grade 3 or 4 cytopenias involving neutropenia, thrombocytopenia and anaemia.
U pedijatrijskih KML bolesnika najčešće uočene toksičnosti bile su citopenije 3. ili 4. stupnja uključujući neutropeniju, trombocitopeniju i anemiju.
Imatinib Actavis is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Actavis se kod odraslih osoba također koristi za liječenje: - Mijelodisplastičnih/mijeloproliferativnih bolesti (MDS/MPD).
Since studies in animals have shown reproductive toxicity, and the potential risk for the human foetus is unknown, women of child-bearing potential who open capsules should be advised to handle the contents with caution and avoid skin-eye contact or inhalation (see section 4.6).
Budući da su ispitivanja kod životinja pokazala reproduktivnu toksičnost, a potencijalni rizik za ljudski plod nije poznat, žene u generativnoj dobi koje otvaraju kapsule treba savjetovati da pažljivo rukuju sa sadržajem te da izbjegavaju kontakt s kožom i očima ili inhaliranje (vidjeti dio 4.6).
Dyspnoea, epistaxis, cough
Dispneja, epistaksa, kašalj
Avascular necrosis/hip necrosis*, growth retardation in children*
Avaskularna nekroza/nekroza kuka*, zastoj u rastu kod djece*
When given with a high-fat meal, the rate of absorption of imatinib was minimally reduced (11% decrease in Cmax and prolongation of tmax by 1.5 h), with a small reduction in AUC (7.4%) compared to fasting conditions.
Kada im je doza dana uz obrok s velikim sadržajem masti, brzina apsorpcije imatiniba se minimalno smanjila (11% smanjenje vrijednosti Cmax i produženje tmaxza 1,5 h), uz malo smanjenje AUC vrijednosti (7,4%) u usporedbi kod stanja natašte.
The dose of 340 mg/m2 daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Doza od 340 mg/m2 na dan preporučuje se za djecu s Ph+ ALL (ne smije se prekoračiti ukupna doza od 600 mg).
Imatinib Actavis is indicated for the treatment of - paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.
Imatinib Actavis indiciran je za liječenje - 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.
There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Ne postoje kontrolirana ispitivanja koja bi demonstrirala kliničku korist ili povećano preživljenje za ove bolesti.
CML in blast crisis and Ph+ ALL (starting dose 600 mg)
KML u blastičnoj krizi i Ph+ ALL (početna doza
- If you are being treated for MDS/MPD:
- Ako se liječite zbog MDS/MPD-a:
Patients with mild and moderate impairment of renal function appear to have a higher plasma exposure than patients with normal renal function.
Izgleda da bolesnici s blagim i umjerenim oštećenjem funkcije bubrega imaju veću izloženost u plazmi od bolesnika s normalnom funkcijom bubrega.
Hepatic insufficiency: Imatinib is mainly metabolised through the liver.
Insuficijencija jetre: Imatinib se uglavnom metabolizira preko jetre.
An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with imatinib.
Proveden je opservacijski registar (ispitivanje L2401) da bi se prikupili podaci o dugoročnoj sigurnosti primjene i djelotvornosti u bolesnika s mijeloproliferativnim novotvorinama s PDGFR- β preraspodjelom, a koji su liječeni imatinibom.
Blood amylase increased
Povišena amilaza u krvi
Not known (frequency cannot be estimated from the available data): - Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
Nepoznate (učestalost se ne može procijeniti iz dostupnih podataka): - kombinacija teškog proširenog osipa, mučnine, vrućice, visoke razine određenih bijelih krvnih stanica ili žutila kože ili očiju (znakovi žutice) s nedostatkom zraka, bolovima/nelagodom u prsima, jako smanjenim mokrenjem i žeđi, itd. (znakovi alergijske reakcije povezane s liječenjem).
Pharmacokinetics in paediatric population
Farmakokinetika u pedijatrijskoj populaciji
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Kategorije učestalosti se definiraju kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko
Imatinib Actavis is a medicine containing an active substance called imatinib.
Actavis je lijek koji sadrži djelatnu tvar zvanu imatinib.
ALT (alanine aminotransferase) elevations and 4.8% of grade 3 or 4 AST (aspartate aminotransferase) elevations were observed.
(alanin-aminotransferaza) povišenja 3. ili 4. stupnja, kao i 4,8% AST (aspartat-aminotransferaza) povišenja 3. ili 4. stupnja.
Liver function tests
Testovi funkcije jetre
Pleural effusion5, pharyngolaryngeal pain, pharyngitis
Pleuralni izljev5, faringolaringealna bol, faringitis
Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria*
Sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima (DRESS)*, pseudoporfirija*
Maintenance (8-week cycles) Cycles 1-4
Održavanje (8-tjedni ciklusi) Ciklusi 1-4
A total of 51 paediatric patients with newly diagnosed and untreated CML in chronic phase have been enrolled in an open-label, multicentre, single-arm phase II trial.
Ukupno 51 pedijatrijski bolesnik s novodijagnosticiranim i neliječenim KML-om u kroničnoj fazi je uključen u otvoreno, multicentrično, ispitivanje faze II s jednim krakom.
Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 µM) and fluconazole (IC50 118 µM) showed inhibition of imatinib metabolism which could have clinical relevance.
Od skupine potencijalnih lijekova za istodobnu primjenu (acetaminofen, aciklovir, alopurinol, amfotericin, citarabin, eritromicin, flukonazol, hidroksiureja, norfloksacin, penicilin V) samo su eritromicin (IC50 50 µM) i flukonazol (IC50 118 µM) pokazali da inhibiraju metabolizam imatiniba što bi moglo biti klinički značajno.
Patients concerned about their fertility on imatinib treatment should consult with their physician.
Bolesnici zabrinuti radi svoje plodnosti tijekom liječenja imatinibom moraju se posavjetovati sa svojim liječnikom.
Paediatric patients: 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-randomised phase III trial, and were treated with imatinib (340 mg/m2/day) in combination with intensive chemotherapy after induction therapy.
U ispitivanju I2301 ukupno 93 djece, adolescenata i mladih odraslih osoba (u dobi od 1 do 22 godine) 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.
ANC < 0.5 x 10
ABN <1,0 x 10
Imatinib is a protein-tyrosine kinase inhibitor which potently inhibits the Bcr-Abl tyrosine kinase at the in vitro, cellular and in vivo levels.
Imatinib je inhibitor protein-tirozin kinaze koji snažno inhibira Bcr-Abl tirozin kinazu na in vitro, staničnom te in vivo nivou.
- Swelling such as round your ankles or puffy eyes.
- oticanje kao što je oticanje oko gležnjeva ili otečene oči.
- Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
- znakovi infekcije kao što su vrućica, teška zimica, grlobolja ili čirevi u ustima.
Metabolism of imatinib is mainly hepatic, and only 13% of excretion is through the kidneys.
Hepatotoksičnost Metabolizam imatiniba odvija se uglavnom preko jetre, dok se samo 13% izlučuje preko bubrega.
This medicinal product contains lecithin (soya).
Ovaj lijek sadrži sojin lecitin.
For patients (children) unable to swallow the capsules, their content may be diluted in a glass of either still water or apple juice.
Bolesnicima (djeci) koji ne mogu progutati kapsule, njihov sadržaj može se otopiti u čaši obične vode ili soka od jabuke.
Total bilirubin: >1.5-3.0 ULN AST: any
Ukupni bilirubin: >1,5-3,0 GGN AST: bilo koji
Not known (frequency cannot be estimated from the available data): - Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka): - crvenilo i/ili oticanje dlanova ruku i tabana stopala koje može biti praćeno trncima i bolnim žarenjem.
10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets
10 filmom obloženih tableta 30 filmom obloženih tableta 60 filmom obloženih tableta 90 filmom obloženih tableta
The plasma protein binding of the N-demethylated metabolite is similar to that of the parent compound.
Vezanje N-demetiliranog metabolita na bjelančevine plazme je slično onom roditeljske tvari.
- Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
- Hipereozinofilnog sindroma (HES) i/ili kronične eozinofilne leukemije (KEL).
Dose adjustment for adverse reactions
Prilagođavanje doze zbog nuspojava
There was a significant increase in exposure to imatinib (the mean Cmax and AUC of imatinib rose by 26% and 40%, respectively) in healthy subjects when it was co-administered with a single dose of ketoconazole (a CYP3A4 inhibitor).
U zdravih je ispitanika došlo do značajnog povećanja izloženosti imatinibu (srednji Cmax i AUC imatiniba povećali su se za 26%, odnosno 40%), kada je imatinib primjenjivan istodobno s jednokratnom dozom ketokonazola (CYP3A4 inhibitor).
Continuous daily exposure to imatinib early in the course of treatment in combination with chemotherapy in cohort 5-patients (n=50) improved the 4-year event-free survival (EFS) compared to historical controls (n=120), who received standard chemotherapy without imatinib (69.6% vs. 31.6%, respectively).
Stalna svakodnevna izloženost imatinibu u ranoj fazi liječenja u kombinaciji s kemoterapijom dovela je u bolesnika iz kohorte 5 (n=50) do poboljšanja stope 4-godišnjeg preživljavanja bez događaja (EFS) u usporedbi s bolesnicima iz kontrolne kohorte (n=120), koji su primali standardnu kemoterapiju bez imatiniba (69,6% u odnosu na 31,6%).
The safety database for children with Ph+ALL is very limited though no new safety concerns have been identified.
vrlo je ograničena iako nisu uočena nikakva nova sigurnosna pitanja.
For doses of 400 mg and above (see dosage recommendation above) a 400 mg tablet (not divisible) is available.
Za doze od 400 mg i više (vidi niže navedenu preporuku doziranja) dostupna je tableta od 400 mg (koja se ne može podijeliti).
NEL Same criteria as for CHR but ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L RTC < 15% blasts BM and PB, < 30% blasts+promyelocytes in BM and PB, < 20% basophils in PB,
NEL Isti kriteriji kao i za CHR, ali je ABN ≥1 x 109/l i/ili trombociti ≥20 x 109/l RTC <15% blasta u KS i PK, <30% blasta+promijelocita u KS i PK, <20% bazofila u PK, nema ekstramedularne bolesti osim u slezeni i jetri.
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.
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.
10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 120 film-coated tablets 180 film-coated tablets
10 filmom obloženih tableta 20 filmom obloženih tableta 30 filmom obloženih tableta 60 filmom obloženih tableta 90 filmom obloženih tableta 120 filmom obloženih tableta 180 filmom obloženih tableta
In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP.
Učinkovitost imatiniba u odraslih i pedijatrijskih bolesnika temelji se na ukupnim hematološkim i citogenetskim stopama odgovora i preživljenju bez napredovanja bolesti u bolesnika sa KML-om, na hematološkim i citogenetskim stopama odgovora u bolesnika s Ph+ ALL-om i MDS/MPD-om, na hematološkim stopama odgovora u bolesnika s HES/KEL-om i na objektivnim stopama odgovora u odraslih bolesnika s inoperabilnim i/ili metastazirajućim DFSP-om.
The renal adenoma/carcinoma, the urinary bladder and urethra papilloma, the small intestine adenocarcinomas, the parathyroid glands adenomas, the benign and malignant medullary tumours of the adrenal glands and the non-glandular stomach papillomas/carcinomas were noted at 60 mg/kg/day, representing approximately 1.7 or 1 times the human daily exposure (based on AUC) at 400 mg/day or 800 mg/day, respectively, and 1.2 times the daily exposure in children (based on AUC) at 340 mg/m2/day.
Bubrežni adenom/karcinom, papilom mokraćnog mjehura i uretre, adenokarcinomi tankog crijeva, adenomi paratireoidnih žlijezda, dobroćudni i zloćudni medularni tumori nadbubrežnih žlijezda i papilomi/karcinomi nežljezdanog dijela želuca zabilježeni su uz 60 mg/kg/dan, što odgovara otprilike 1,7 odnosno 1 puta dnevne izloženosti u ljudi (temeljeno na AUC) kod 400 mg/dan, odnosno 800 mg/dan te 1,2 puta dnevne izloženosti u djece (temeljeno na AUC) kod 340 mg/m2/dan.
Imatinib is also an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF), PDGF-R, and inhibits PDGF-mediated cellular events.
Imatinib je također inhibitor receptorskih tirozin kinaza za faktor rasta koji potječe od trombocita (PDGF), PDGF-R, te inhibira stanične događaje do kojih dolazi posredstvom PDGF-a.
MESNA IV days 29-33
MESNA i.v., dani 29-33
What Imatinib Actavis contains
Što Imatinib Actavis sadrži
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 tablete, sadržaj tablete se može otopiti u čaši obične vode ili soka od jabuke.
Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
Pokazalo se da je imatinib in vitro kompetitivni inhibitor supstrata markera za CYP2C9, CYP2D6 i
Each film-coated tablet contains 0.19 mg lecithin (soya) (E322) Imatinib Actavis 400 mg film-coated tablets Each film-coated tablet contains 400 mg imatinib (as mesilate).
Svaka filmom obložena tableta sadrži 0,19 mg sojinog lecitina (E322) Imatinib Actavis 400 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 400 mg imatiniba (u obliku imatinibmesilata).
Pack containing either 10, 30, 60, or 90 capsules.
Pakiranje sadrži 10, 30, 60 ili 90 kapsula.
No new target organs were identified in the rat juvenile development toxicology study (day 10 to 70 postpartum) with respect to the known target organs in adult rats.
Nisu bili uočeni novi ciljni organi u toksikološkom ispitivanju juvenilnog razvoja u štakora (10 do 70
Hepatitis B reactivation*
Ponovna aktivacija hepatitisa B *
If you forget to take Imatinib Actavis
Ako ste zaboravili uzeti Imatinib Actavis
If this applies to you, tell your doctor without taking Imatinib Actavis.
Ako se to odnosi na Vas, obavijestite svog liječnika bez uzimanja Imatinib Actavisa.
This study included 7 patients with MDS/MPD who were treated with imatinib 400 mg daily.
Ovo je kliničko ispitivanje uključivalo 7 bolesnika s MDS/MPD-om koji su liječeni imatinibom 400 mg na dan.
A further 6 DFSP patients treated with imatinib were reported in 5 published case reports, their ages ranging from 18 months to 49 years.
U 5 objavljenih prikaza slučajeva zabilježeno je dodatnih 6 bolesnika s DFSP-om liječenih imatinibom, s rasponom starosti od 18 mjeseci do 49 godina.
Weight increased
Povećana tjelesna težina
- Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
- mučnina uz gubitak apetita, tamno obojenje mokraće, žutilo kože ili očiju (znakovi problema s jetrom).
The age of these patients ranged from 2 to 79 years.
Starost tih bolesnika se kretala od 2 do 79 godina.
In the study in patients with unresectable and/or metastatic GIST, both gastrointestinal and intra-tumoural haemorrhages were reported (see section 4.8).
U ispitivanju s bolesnicima s inoperabilnim i/ili metastazirajućim GIST-om zabilježena su i gastrointestinalna i intratumorska krvarenja (vidjeti dio 4.8).
G-CSF (5 μg/kg, SC): days 34-43
G-CSF (5 μg/kg, s.c.): dani 34-43
L-ASP (6000 IUnits/m2, IM): day 44
L-ASP (6000 IU/m2, i.m.): dan 44