natgillin/translations-raw huggingface dataset:
1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Odmerki od 1200 mg do 1600 mg (trajanje zdravljenja od 1 do 10 dni): navzea, bruhanje, driska, izpuščaj, eritemi, edemi, otekanje, utrujenost, mišični spazmi, trombocitopenija, pancitopenija, bolečine v trebuhu, glavobol, zmanjšan tek.
There was no change in the kinetics of imatinib on repeated dosing, and accumulation was 1.5-2.5-fold at steady state when dosed once daily.
Pri ponavljajočem se odmerjanju se kinetika imatiniba ni spreminjala, kopičenje pa je bilo pri enem odmerku na dan v stanju dinamičnega ravnovesja 1,5-2,5-kratno.
- Chronic myeloid leukaemia (CML).
- kronično mieloično levkemijo (KML).
These patients received imatinib for a median of 47 months (range 24 days - 60 months).
Ti bolniki so prejemali zdravilo Imatinib Actavis mediano 47 mesecev (od 24 dni do 60 mesecev).
Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]).
Imatinib je v odmerku 400 mg dvakrat na dan zaviral presnovo metoprolola s CYP2D6, tako da sta se Cmax in AUC metoprolola povečala za približno 23 % (90 % IZ [1,16-1,30]).
Contents of the pack and other information What Imatinib Actavis contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Imatinib Actavis
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.
V študiji toksičnih učinkov na razvoj mladičev so opažali vpliv na rast ter zakasnjeno odpiranje nožnice in ločevanje prepucija pri izpostavljenosti, ki ustreza približno 0,3 do 2-kratniku izpostavljenosti, do kakršne v povprečju pride pri otrocih, ki prejemajo največjii priporočeni odmerek 340 mg/m2.
In adult patients, Imatinib Actavis is intended for use in the most advanced phase of the disease (blast crisis).
Pri odraslih bolnikih se zdravilo Imatinib Actavis uporablja za zdravljenje pozne napredovale faze bolezni, imenovane tudi blastna kriza.
(0.5 h), days 7, 8, 14, 15; CP 500 mg/m2 i.v.
(0,5 ure), 7., 8., 14., 15. dan; CP 500 mg/m2 i.v.
In adults the dose should be reduced from 400 to 300 mg or from 600 to 400 mg, or from 800 mg to 600 mg, and in children from 340 to 260 mg/m2/day.
Pri odraslih je treba zmanjšati odmerek s 400 mg na 300 mg ali s 600 mg na 400 mg ali z 800 mg na 600 mg, pri otrocih pa s 340 mg/m2/dan na 260 mg/m2/dan.
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
1 O pljučnici so najpogosteje poročali pri bolnikih s transformacijo KML in pri bolnikih z GIST.
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 Dogodke v zvezi s srcem, vključno s kongestivnim popuščanjem srca, so na podlagi enote bolnik-leto pogosteje opažali pri bolnikih s transformacijo KML kot pri bolnikih s kroničnim potekom KML.
Plasma pharmacokinetic profiles were analysed on day 1 and on either day 7 or day 28, by which time plasma concentrations had reached steady state.
Farmakokinetiko imatiniba so ovrednotili v območju odmerjanja od 25 mg do 1.000 mg. Plazemski farmakokinetični profili so bili analizirani 1. dne, nato pa bodisi 7. bodisi 28. dne, ko so plazemske koncentracije že dosegle stanje dinamičnega ravnovesja.
(1 h), days 1-5
(1 ura), 1.-5.
What Imatinib Actavis is and what it is used for
Kaj je zdravilo Imatinib Actavis in za kaj ga uporabljamo
Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients).
Imatinib je v kombinaciji z indukcijo s kemoterapijo (glejte preglednico 3) povzročil popolni hematološki odziv pri 93 % (147 od 158 za oceno primernih bolnikov) in pomembni citogenetični odziv pri 90 % (19 od 21 za oceno primernih bolnikov).
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.
Pediatrični bolniki: V odprto, nerandomizirano, multicentrično preizkušanje faze III z oznako I2301 in z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do 22 let) s Ph+ ALL in jih zdravili z imatinibom (340 mg/m2/dan) v kombinaciji z intenzivno kemoterapijo po indukcijskem zdravljenju.
Additionally, partial cytogenetic response (PCyR) was observed in 16% for a MCyR of 81%.
Poleg tega so zabeležili tudi delen citogenetični odziv (PCyRpartial cytogenetic response) pri 16 % bolnikov ob 81 % s pomembnim citogentičnim odzivom.
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.
Adenome/karcinome ledvic, papilome sečnega mehurja in sečnice, adenokarcinome tankega črevesa, adenome obščitničnih žlez, benigne in maligne medularne tumorje nadlevičnih žlez in papilome/karcinome ne-žleznega dela želodca so opazili pri odmerku 60 mg/kg/dan, kar predstavlja približno 1,7 do 1-kratnik dnevne izpostavljenosti človeka (na podlagi AUC) pri odmerku 400 mg/dan oziroma 800 mg/dan in 1,2-kratnik dnevne izpostavljenosti otrok (na podlagi AUC) pri 340 mg/m2/dan.
Induction therapy (de novo Ph+ ALL)
indukcijsko zdravljenje (novo odkrita Ph+ ALL)
Some medicines can interfere with the effect of Imatinib Actavis when taken together.
Nekatera zdravila lahko ob sočasnem jemanju vplivajo na delovanje zdravila Imatinib Actavis.
Ara-C 1,000 mg/m2 /12 h i.v.
Ara-C 1.000 mg/m2/12 ur i.v.
DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
DEX 40 mg/dan 1.-4. in 11.-14. dan, izmenjaje z MTX 1 g/m2 i.v.
CHR: In study 0102 [ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, no blood blasts, BM blasts < 5% and no extramedullary disease]
CHR V študiji 0102 [ANC ≥ 1,5 x 109/L, trombociti ≥ 100 x 109/L, brez blastov v krvi, BM blasti
- adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
- odraslih in pediatričnih bolnikov z na novo diagnosticirano akutno limfoblastno levkemijo, s prisotnim kromosomom Philadelphia (Ph+ ALL) skupaj s kemoterapijo.
Other medicines and Imatinib Actavis
Druga zdravila in zdravilo Imatinib Actavis
Excipients(s)
Pomožna(e) snov(i)
Maintenance (8-week cycles) Cycles 1-4
): 44. dan vzdrževalno zdravljenje (8-tedenski ciklusi) 1.-4. ciklus
- If you are being treated for HES/CEL:
- Če se zdravite zaradi HES/CEL:
- Do not breast-feed during the treatment with Imatinib Actavis.
- Med zdravljenjem z zdravilom Imatinib Actavis ne dojite.
Posology for CML in paediatric patients Dosing for children should be on the basis of body surface area (mg/m2).
Odmerjanje za otroke mora temeljiti na telesni površini (mg/m2).
This is because Imatinib Actavis could cause hepatitis B to become active again, which can be fatal in some cases.
- če ste kdaj bili ali ste sedaj okuženi z virusom hepatitisa B. Zdravilo Imatinib Actavis namreč lahko povzroči ponovno aktivacijo hepatitisa B, kar utegne biti v nekaterih primerih smrtno nevarno.
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).
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - kombinacija hudo razširjene hude oblike izpuščaja, siljenja na bruhanje, povišane telesne temperature, visoke ravni določenih belih krvnih celic ali porumenelost kože ali oči (znaki zlatenice) z zasoplostjo, bolečinami v prsnem košu / neugodje, zelo zmanjšanim izločanjem urina in občutekom žeje itd (znaki alergijske reakcije povezane z zdravljenjem).
- if you experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Actavis, contact your doctor.
- Če se v obdobju, ko jemljete zdravilo Imatinib Actavis, pri vas pojavijo modrice, krvavitev, povišana telesna temperatura, utrujenost in zmedenost, se posvetujte z zdravnikom.
A large, international, open-label, non-controlled phase II study was conducted in patients with Philadelphia chromosome positive (Ph+) CML in the blast crisis phase of the disease.
Opravili so veliko mednarodno odprto nekontrolirano študijo druge faze pri bolnikih s KML, s prisotnim kromosomom Philadelphia (Ph+), v blastni krizi.
Caution should therefore be exercised when using high doses of imatinib and paracetamol concomitantly.
Zato je pri sočasni uporabi velikih odmerkov imatiniba in paracetamola potrebna previdnost.
days 2 and 3
Dne in 1.
Due to the possible occurrence of tumour lysis syndrome (TLS), correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of imatinib (see section 4.8).
Zaradi možnosti, da pride do sindroma tumorske lize, je pred začetkom zdravljenja z imatinibom priporočeno odpraviti klinično pomembno dehidriranost in veliko koncentracijo sečne kisline (glejte poglavje 4.8).
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.
Razpored zdravljenja: Na osnovi obstoječih podatkov se je zdravilo Imatinib Actavis izkazalo kot učinkovito in varno zdravilo, če je bilo pri odraslih bolnikih z novo diagnosticirano Ph+ALL uporabljeno v odmerku 600 mg/dan v kombinaciji s kemoterapijo v začetni fazi, konsolidacijski in vzdrževalni fazi kemoterapije (glejte poglavje 5.1).
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 tudi zaviralec receptorskih tirozin-kinaz za rastni faktor iz trombocitov (PDGF-platelet derived growth factor), PDGF-R in zavira celične dogodke, ki jih posreduje PDGF.
No significant age-related pharmacokinetic differences have been observed in adult patients in clinical trials which included over 20% of patients age 65 and older.
Pri odraslih bolnikih v kliničnih preskušanjih, v katerih je bilo več kot 20 % bolnikov starih 65 let ali več, ni bilo pomembnih farmakokinetičnih razlik, povezanih s starostjo.
Pack sizes: The capsules are supplied in aluminium blister packs of 24, 48, 60, 96, 120 or 180 capsules.
Velikosti pakiranja: Kapsule so na voljo v aluminiastih pretisnih omotih, pakiranih po 24, 48, 60, 96, 120 ali 180 kapsul
There is very limited experience in children with MDS/MPD, DFSP, and HES/CEL.
Izkušenj pri otrocih z MDS/MPD, DFSP in s HES/CEL je zelo malo.
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.
Spojina selektivno zavira proliferacijo in inducira apoptozo pri Bcr-Abl pozitivnih celičnih linijah, pa tudi pri svežih limfatičnih celicah bolnikov s KML, s prisotnim kromosomom
- Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
- s hipereozinofilnim sindromom (HES) ali kronično eozinofilno levkemijo (CEL) ali z obojim.
If you forget to take Imatinib Actavis
Če ste pozabili vzeti zdravilo Imatinib Actavis
Relapsed/refractory Ph+ ALL: When imatinib was used as single agent in patients with relapsed/refractory Ph+ ALL, it resulted, in the 53 out of 411 patients evaluable for response, in a haematological response rate of 30% (9% complete) and a major cytogenetic response rate of 23%.
Relaps/neodzivna Ph+ ALL: Zdravljenje z imatinibom kot edinim zdravilom pri bolnikih z relapsom/neodzivno Ph+ ALL je povzročilo pri 53 od 411 za oceno odziva primernih bolnikov stopnjo hematološkega odziva 30 % (v 9 % popolni hematološki odziv) in stopnjo pomembnega citogenetičnega odziva 23 %.
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.
Pediatrični bolniki: V preskušanje stopnjevanja odmerka prve faze so vključili skupaj 26 pediatričnih bolnikov, starih < 18 let, bodisi s kronično fazo KML (n=11) bodisi s KML v blastni krizi ali Ph+ akutnimi levkemijami (n=15).
- 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).
- Druge sestavine zdravila so mikrokristalna celuloza, kopovidon, krospovidon, natrijev stearilfumarat, silicijev hidroksid (hidrofoben koloidni in brezvodni koloidni), polivinil alkohol delno hidroliziran, smukec, rumeni železov oksid (E172), titanov dioksid (E171), rdeči železov oksid (E172), sojin lecitin (E322), ksantan gumi (E415).
If cytopenia persists for 4 weeks and is still unrelated to leukaemia, stop imatinib until ANC ≥ 1 x 109/L and platelets ≥ 20 x 109/L, then resume treatment at 300 mg.
Če citopenija vztraja 4 tedne in še vedno ni povezana z levkemijo, prekinite zdravljenje z imatinibom, dokler ni ANC ≥ 1 x 109/l in koncentracija trombocitov ≥ 20 x 109/l, nato spet začnite zdravljenje z odmerkom 300 mg.
Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
IULN = zgornja meja normalnih vrednosti, specifična za ustanovo AST = aspartat-aminotransferaza
30 hard capsules 90 hard capsules
30 trdih kapsul 90 trdih kapsul
This medicinal product contains lecithin (soya).
Zdravilo vsebuje sojin lecitin.
The plasma AUC for imatinib decreased by 73% compared to patients not on EIAEDs.
Pri teh bolnikih se je AUC imatiniba v plazmi zmanjšal za 73 % v primerjavi z bolniki, ki niso jemali antiepileptičnih zdravil, ki inducirajo encime.
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).
(povprečna Cmax in AUC imatiniba sta se povečali za 26 % oziroma 40 %), kadar je bil uporabljen z enim samim odmerkom ketokonazola (zaviralec CYP3A4).
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
= intramuskularno, 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 = oziroma dokler koncentracija MTX ni < 0,1 µM, Gy= Gray
The most commonly reported (≥ 10%) drug-related adverse reactions in both settings were mild nausea, vomiting, diarrhoea, abdominal pain, fatigue, myalgia, muscle cramps and rash.
Z zdravilom povezane neželene reakcije, o katerih so najpogosteje poročali (≥ 10 %), so bile blaga navzea, bruhanje, driska, bolečine v trebuhu, utrujenost, mialgija, mišični krči in izpuščaj.
However, the occurrence of cytopenias was also clearly dependent on the stage of the disease, the frequency of grade 3 or 4 neutropenias (ANC < 1.0 x 109/L) and thrombocytopenias (platelet count < 50 x 109/L) being between 4 and 6 times higher in blast crisis and accelerated phase (59-64% and 44-63% for neutropenia and thrombocytopenia, respectively) as compared to newly diagnosed patients in chronic phase CML (16.7% neutropenia and 8.9% thrombocytopenia).
Stopnje (ANC < 1,0 x 109/L) in trombocitopenija (koncentracija trombocitov < 50 x 109/L) sta bili štirikrat do šestkrat pogostejši v blastni krizi in pospešeni fazi (nevtropenija 59-64 % in trombocitopenija 44-63 %) kot pri na novo diagnosticiranih bolnikih v kronični fazi KML (nevtropenija 16,7 % in trombocitopenija 8,9 %).
EU/1/13/825/001 30 capsules EU/1/13/825/002 90 capsules
EU/1/13/825/001 30 kapsul EU/1/13/825/002 90 kapsul
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Izkušenj pri otrocih s Ph pozitivno ALL je malo, pri otrocih z MDS/MPD, DFSP ali s HES/CEL pa zelo malo.
(3 h, q 12 h), days 1-3; vincristine 2 mg i.v., days 4, 11; doxorubicine 50 mg/m2 i.v.
(3 ure, na 12 ur), 1.-3. dan; vinkristin 2 mg i.v., 4., 11. dan; doksorubicin 50 mg/m2 i.v.
Target organs for neoplastic changes were the kidneys, urinary bladder, urethra, preputial and clitoral gland, small intestine, parathyroid glands, adrenal glands and nonglandular stomach.
Tarčni organi za neoplastične spremembe so bili: ledvice, sečni mehur, sečnica, žleze prepucija in klitorisa, tanko črevo, obščitnične žleze, nadledvične žleze in ne žlezni del želodca.
The dose of 340 mg/m2 daily is recommended for children with Ph+ ALL (not to exceed the total dose of 600 mg).
Za otroke s Ph+ ALL je priporočeni odmerek 340 mg/m2 na dan (ne sme preseči celotnega odmerka 600 mg).
10 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
10 Mišično-skeletne bolečine in z njimi povezane dogodke so pogosteje opažali pri bolnikih s
Hyper-CVAD regimen: CP 300 mg/m2 i.v.
indukcijskokonsolidacijsko zdravljenje hyper-CVAD shema: CP 300 mg/m2 i.v.
- Feeling light-headed, dizzy or fainting (signs of low blood pressure).
- stemnitev pred očmi, omotičnost ali izguba zavesti (znaki nizkega krvnega tlaka),
(1 h), days 26, 46; Ara-C 75 mg/m2 i.v.
(1 ura), 26., 46. dan; Ara-C 75 mg/m2 i.v.
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).
Klinične študije pri Ph+ ALL Novo odkrita Ph+ ALL: V kontrolirani študiji (ADE10) imatiniba v primerjavi z indukcijo s kemoterapijo pri 55 bolnikih z novo odkrito boleznijo, ki so bili stari 55 let ali več, je imatinib kot edino zdravilo povzročil značilno večji delež bolnikov s popolnim hematološkim odzivom kot kemoterapija (96,3 % v primerjavi s 50 %; p=0,0001).
There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.
Kontroliranih preskušanj, ki bi pokazala klinično koristnost ali izboljšanje preživetja pri teh boleznih, ni.
Mild to moderate increases in transaminases and slight decreases in cholesterol, triglycerides, total protein and albumin levels were observed in both species.
Pri obeh živalskih vrstah so opazili blago do zmerno zvišanje aminotransferaz in rahlo zmanjšanje koncentracij holesterola, trigliceridov, celotnih beljakovin in albuminov.
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.
Pri proučevanju prehajanja pri eni doječi materi so za imatinib določili razmerje med koncentracijama v mleku in plazmi 0,5, za njegov presnovek pa 0,9, kar kaže, da se presnovek v večji meri izloča v materinem mleku kot imatinib.
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
18 Gy v 10 frakcijah za bolnike, ki imajo ob postavitvi diagnoze CNS3 VCR (1,5 mg/m2/dan, i.v.
When imatinib was combined with high dose chemotherapy in Ph+ ALL patients, transient liver toxicity in the form of transaminase elevation and hyperbilirubinaemia were observed.
Ph+ ALL, je prišlo do prehodne toksičnosti za jetra v obliki zvišanja aminotransferaz in hiperbilirubinemije.
The doctor will tell you how many tablets of Imatinib Actavis to give to your child.
Zdravnik vam bo povedal, koliko tablet zdravila Imatinib Actavis dajte svojemu otroku.
Imatinib Actavis 400 mg film-coated tablets Pack containing either 10, 30, 60 or 90 film-coated tablets
Imatinib Actavis 400 mg filmsko obložene tablete Pakiranje, ki vsebuje po 10, 30, 60 ali 90 filmsko obloženih tablet.
Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/5.
In vitro so pokazali, da je imatinib kompetitiven inhibitor markerskih substratov za CYP2C9,
The plasma AUC for this metabolite was found to be only 16% of the AUC for imatinib.
Ugotovili so, da je plazemska AUC tega presnovka samo 16 %
A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Nadaljnjih 162 bolnikov s HES/CEL, o katerih so poročali v 35 objavljenih opisih primerov in skupinah primerov, je prejemalo zdravilo Imatinib Actavis v odmerkih od 75 mg do 800 mg na dan. Citogenetske nepravilnosti so pregledali pri 117 bolnikih od celotne populacije 176 bolnikov.
Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Imatinib povečuje povprečni Cmax in AUC simvastatina (substrat CYP3A4) 2-krat oziroma 3,5-krat, kar kaže na to, da imatinib zavira CYP3A4.
Total bilirubin: >1.5-3.0 ULN AST: any
zmerna celotni bilirubin: > 1,5-3,0 IULN AST: kakršnakoli huda celotni bilirubin: > 3-10 IULN AST: kakršnakoli
Muscle spasm and cramps, musculoskeletal pain including myalgia9, arthralgia, bone pain10
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti mišični spazmi in krči, mišično-skeletne bolečine, vključno z mialgijo9, artralgijo in bolečinami v kosteh10
The tablets are supplied in aluminium blister packs of 10, 20, 30, 60, 90, 120 or 180 film-coated tablets.
Tablete so na voljo v aluminiastih pretisnih omotih, pakiranih po 10, 20, 30, 60, 90, 120 ali 180 filmsko obloženih tablet.
Active substances that may have their plasma concentration altered by imatinib Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Učinkovine, katerih plazemske koncentracije lahko imatinib spremeni Imatinib povečuje povprečni Cmax in AUC simvastatina (substrat CYP3A4) 2-krat oziroma 3,5-krat, kar kaže na to, da imatinib zavira CYP3A4.
The dose can be reduced if not tolerated (see sections 4.2 and 5.2).
Odmerek je mogoče zmanjšati, če ga bolnik ne prenaša dobro (glejte poglavji 4.2 in 5.2).
As in adult patients, imatinib was rapidly absorbed after oral administration in paediatric patients in both phase I and phase II studies.
Farmakokinetika pri pediatrični populaciji Tako kot pri odraslih bolnikih, se je pri pediatričnih bolnikih v študijah tako prve kot druge faze imatinib po peroralni uporabi hitro absorbiral.