natgillin/translations-raw huggingface dataset:
One open label, multicentre, phase II clinical trial (study B2225) was conducted testing imatinib in diverse populations of patients suffering from life-threatening diseases associated with Abl, Kit or PDGFR protein tyrosine kinases.
V enem odprtem multicentričnem kliničnem preskušanju faze II (študija B2225) so preskušali zdravilo Imatinib Actavis pri različnih populacijah bolnikov z življensko ogrožujočimi boleznimi v povezavi z Abl, Kit ali PDGFR protein tirozin kinazami.
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).
Za otroke s kronično fazo KML oziroma z napredovalimi fazami KML je priporočeni odmerek 340 mg/m2 na dan (ne sme preseči celotnega odmerka 800 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.
Bolnike je treba pred začetkom zdravljenja z zdravilom Imatinib Actavis testirati glede okužbe z virusom hepatitisa B. Pri bolnikih s pozitivno serologijo na hepatitis B (vključno z bolniki z aktivno boleznijo) in bolnikih, pri katerih se med zdravljenjem test glede okužbe z virusom hepatitisa B izkaže za pozitivnega, se je treba pred začetkom zdravljenja posvetovati s strokovnjaki za obolenja jeter in zdravljenje hepatitisa B. Pri prenašalcih virusa hepatitisa B, pri katerih je potrebno zdravljenje z zdravilom Imatinib Actavis, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glej poglavje
Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria*
levkocitoklastični vaskulitis, Stevens-Johnsonov sindrom, akutna generalizirana eksantemska pustuloza (AGEP) pogostnost neznana: sindrom palmoplantarne eritrodisestezije*, lihenoidna keratoza*, lichen planus*, toksična epidermalna nekroliza*, izpuščaj zaradi zdravila z eozinofilijo in sistemskimi simptomi (DRESS - drug rash with eosinophilia and systemic symptoms)*, psevdoporfirija*
9 Musculoskeletal pain during treatment with imatinib or after discontinuation has been observed in post-marketing.
9 V obdobju trženja zdravila so opažali mišično-skeletne bolečine med zdravljenjem z imatinibom ali po prekinitvi zdravljenja.
Imatinib Actavis 100 mg film-coated tablets Pack containing either 10, 20, 30, 60, 90, 120 or 180 film-coated tablets
Imatinib Actavis 100 mg filmsko obložene tablete Pakiranje, ki vsebuje po 10, 20, 30, 60, 90, 120 ali 180 filmsko obloženih tablet.
- The other ingredients are: Capsule content: cellulose microcrystalline, copovidone, crospovidone, sodium stearyl fumarate, silica (colloidal hydrophobe and colloidal anhydrous).
- Druge sestavine zdravila so: Vsebina kapsule: mikrokristalna celuloza, kopovidon, krospovidon, natrijev stearilfumarat, silicijev hidroksid (hidrofoben koloidni in brezvodni koloidni).
(3 h), day 1; daunorubicin 60 mg/m2 i.v.
(3 ure), 1. dan; daunorubicin 60 mg/m2 i.v.
Resume treatment with imatinib at 600 mg.
Spet začnite zdravljenje z zdravilom Imatinib Actavis z odmerkom 600 mg.
Active substances that may increase imatinib plasma concentrations:
Učinkovine, ki lahko zvišajo plazemske koncentracije imatiniba:
- The active substance is imatinib (as mesilate).
- Učinkovina je imatinib (v obliki mesilata).
- Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
- oslabelost mišic in mišični spazmi z nepravilnim ritmom bitja srca (znaki spremenjenih vrednosti kalija v krvi), - modrice,
Active substances that may decrease imatinib plasma concentrations:
Učinkovine, ki lahko znižajo plazemske koncentracije imatiniba:
Since increased vascularity and propensity for bleeding is a part of the nature and clinical course of GIST, standard practices and procedures for the monitoring and management of haemorrhage in all patients should be applied.
Ker sta povečana vaskularnost in nagnjenje h krvavitvam del narave in kliničnega poteka
VCR 1.3 g/m2 i.v., day 1; prednisolone 60 mg/m2 oral, days 1-5
VCR 1,3 g/m2 i.v., 1. dan; prednizolon 60 mg/m2 peroralno, 1.-5. dan
How long to take Imatinib Actavis
Koliko časa jemati zdravilo Imatinib Actavis
The active substance imatinib demonstrates an environmental risk for sediment organisms.
Zdravilna učinkovina imatinib predstavlja tveganje za okolje, in sicer za organizme v usedlinah.
In a 39-week monkey study, no NOAEL (no observed adverse effect level) was established at the lowest dose of 15 mg/kg, approximately one-third the maximum human dose of 800 mg based on body surface.
V 39-tedenski študiji na opicah pri najmanjšem odmerku 15 mg/kg, kar je približno ena tretjina največjega odmerka za človeka (ki je 800 mg, izračunan na podlagi telesne površine), niso našli odmerka brez opaženih neželenih učinkov (NOAEL - no observed adverse effect level).
In eleven patients PDGFR gene rearrangements was detected, 9 of them achieved a CHR and 1 PHR.
Pri enajstih bolnikih so odkrili preureditev gena za PDGFR, 9 izmed njih je doseglo popolni hematološki odziv, 1 pa delni hematološki odziv.
However, some of these reactions may be serious or lifethreatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure.
Več bolnikov z blastno krizo je namreč umrlo z zapleteno klinično anamnezo plevralnega izliva, kongestivnega popuščanja srca in ledvične odpovedi.
Haemolytic anaemia, thrombotic microangiopathy
limfadenopatija redki hemolitična anemija, trombotična mikroangiopatija
In addition, mortality was observed in juvenile animals (around weaning phase) at approximately 2 times the average paediatric exposure at the highest recommended dose of 340 mg/m2.
Pri mladih živalih (okrog obdobja odstavljanja) so opažali tudi povečano smrtnost pri približno 2-kratniku izpostavljenosti, do kakršne v povprečju pride pri otrocih, ki prejemajo največji priporočeni odmerek
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.
Snovi, ki zavirajo aktivnost izoencima CYP3A4 citokroma P450 (na primer zaviralci proteaze, kot so indinavir, lopinavir/ritonavir, ritonavir, sakvinavir, telaprevir, nelfinavir, boceprevir; azolni antimikotiki vključno s ketokonazolom, itrokonazolom, posakonazolom, vorikonazolom; določeni makrolidi kot so eritromicin, klaritromicin in telitromicin), bi lahko zmanjševale presnovo in zviševale koncentracije imatiniba.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na filmsko obložene tablete, kar v bistvu pomeni ‘brez natrija'.
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na trdo kapsulo, kar v bistvu pomeni ‘brez natrija'.
10 hard capsules 30 hard capsules 60 hard capsules 90 hard capusles
10 trdih kapsul 30 trdih kapsul 60 trdih kapsul 90 trdih kapsul
- Dry mouth, dry skin or dry eye. - Decreased or increased skin sensitivity.
- suha usta, suha koža ali suhe oči, - zmanjšana ali povečana občutljivost kože, - navali vročine, mrazenje ali nočno znojenje.
DAUN (45 mg/m2/day bolus, IV): days 1 and 2
DAUN (45 mg/m2/dan bolus, i.v.
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.
Pogostnost neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov): - rdečina in/ali otekanje dlani in podplatov, lahko z občutkom mravljinčenja in s pekočo bolečino,
The age of these patients ranged from 2 to 16 years and imatinib was given at dose 300 mg/m2 daily or doses ranging from 200 to 400 mg daily.
Ti bolniki so bili stari od 2 do 16 let, imatinib pa so prejemali v odmerku 300 mg/m2 na dan oziroma v odmerkih od 200 mg do 400 mg na dan.
Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac or renal failure should be evaluated and treated.
Srčni bolniki Srčne bolnike, bolnike z dejavniki tveganja za srčno popuščanje ali bolnike z anamnezo ledvične odpovedi je potrebno skrbno opazovati.
(1 h), days 1-5; VM26 60 mg/m2 i.v.
(1 ura), 1.-5. dan; VM26 60 mg/m2 i.v.
Total bilirubin: = 1.5 ULN
Testi jetrnih funkcij blaga celotni bilirubin: = 1,5 IULN
- Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
- mišični spazmi z vročino, rdeče-rjavo obarvan urin, boleče ali oslabele mišice (znaki težav z mišicami),
The age of these patients ranged from 3 months to 4 years and imatinib was given at dose 50 mg daily or doses ranging from 92.5 to 340 mg/m2 daily.
Ti bolniki so bili stari od 3 mesece do 4 leta, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 92,5 mg/m2 do 340 mg/m2 na dan.
Depression, libido decreased, anxiety
Psihiatrične motnje pogosti nespečnost občasni depresija, zmanjšan libido, anksioznost redki zmedenost
In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 109/L) and thrombocytopenia (platelet count < 10 x 10
V na novo diagnosticirani kronični fazi KML sta bili odkriti nevtropenija 4. stopnje (ANC < 0,5 x 109/L) in trombocitopenija 4. stopnje (< 10 x 109/L) pri
6400 mg (single dose): One case reported in the literature of one patient who experienced nausea, vomiting, abdominal pain, pyrexia, facial swelling, decreased neutrophil count, increased transaminases.
Odmerek 6400 mg (enkraten odmerek): V literaturi je opisan en primer pri enem bolniku, pri katerem je prišlo do navzee, bruhanja, bolečin v trebuhu, zvišane telesne temperature, otekanja v obraz,
The pharmacokinetics of imatinib have been evaluated over a dosage range of 25 to 1,000 mg.
Farmakokinetiko imatiniba so ovrednotili v območju odmerjanja od 25 mg do 1.000 mg. Plazemski farmakokinetični profili so bili analizirani 1.
The doctor will tell you how many capsules of Imatinib Actavis to give to your child.
Zdravnik vam bo povedal, koliko kapsul zdravila Imatinib Actavis dajte svojemu otroku.
What Imatinib Actavis looks like and contents of the pack
Izgled zdravila Imatinib Actavis in vsebina pakiranja
(1 h) days 4-5; Ara- C 2x 2 g/m2 i.v.
(1 ura) 4.-5. dan; Ara-C 2x 2 g/m2 i.v.
The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m2 daily.
Ti bolniki so bili stari od starosti novorojenčka do 14 let, imatinib pa so prejemali v odmerku 50 mg na dan oziroma v odmerkih od 400 mg/m2 na dan do 520 mg/m2 na dan.
Clinical studies in DFSP One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with imatinib 800 mg daily.
Klinične študije pri protuberantnem dermatofibrosarkomu (DFSP) Eno odprto, multicentrično klinično preskušanje faze II (študija B2225) je vključevalo 12 bolnikov z DFSP, zdravljenih z zdravilom Imatinib Actavis 800 mg na dan. Starost bolnikov z DFSP se je gibala med 23 in 75 leti.
Complete haematological response (CHR)
Hematološki odziv1 popolni hematološki odziv (CHR) nobenih znakov levkemije (NEL)
The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
Priporočeni odmerek zdravila Imatinib Actavis pri odraslih bolnikih s Ph+ ALL je 600 mg/dan.
In an oral pre- and postnatal development study in rats, red vaginal discharge was noted in the 45 mg/kg/day group on either day 14 or day 15 of gestation.
V peroralni študiji predporodnega in poporodnega razvoja pri podganah so pri skupini s 45 mg/kg/dan
Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people): - Rapid weight gain.
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) ali pogosti (pojavijo se lahko pri največ
The increase is approximately 1.5- to 2-fold, corresponding to a 1.5-fold elevation of plasma AGP, to which imatinib binds strongly.
1,5-kratnemu zvišanju alfa kislega proteina v plazmi, na katerega se imatinib močno veže.
- Chronic renal failure.
- kronična ledvična bolezen,
Posology for MDS/MPD The recommended dose of imatinib is 400 mg/day for adult patients with MDS/MPD.
Priporočeni odmerek zdravila Imatinib Actavis pri odraslih bolnikih z MDS/MPD je 400 mg/dan.
This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
To je bila skupina že prej močno zdravljenih bolnikov, saj jih je pred začetkom preizkušanja 46 % imelo presaditev kostnega mozga (BMT - bone marrow transplantation),
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see sections 4.5 and 4.8).
Kadar se imatinib uporablja v kombinaciji s kemoterapevtskimi shemami, pri katerih je znana povezava z motnjami delovanja jeter, je treba skrbno spremljati delovanje jeter (glejte poglavji 4.5 in 4.8).
Haematological experts in the management of this disease should supervise the therapy throughout all phases of care.
V vseh fazah naj zdravljenje nadzira hematolog, strokovnjak za vodenje te bolezni.
Triple IT therapy (age-adjusted): days 1, 29 VCR (1.5 mg/m2, IV): days 1, 29
zdravljenje (prilagojeno na starost): 1. in 29. dan VCR (1,5 mg/m2/dan, i.v.
Imatinib Actavis 100 mg film-coated tablets 2 years
Imatinib Actavis 100 mg filmsko obložene tablete 2 leti
Imatinib Actavis 400 mg film-coated tablets 21 month
Imatinib Actavis 400 mg filmsko obložene tablete 21 mesecev
GI tumour sites may have been the source of the GI bleeds (see section 4.4).
Vir gastrointestinalnih krvavitev so bile morda lokacije gastrointestinalnih tumorjev (glejte poglavje 4.4).
Keep taking Imatinib Actavis every day for as long as your doctor tells you.
Zdravilo Imatinib Actavis jemljite vsak dan, dokler vam zdravnik ne naroči, da ga prenehate jemati.
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.
- pediatričnih bolnikov z na novo diagnosticirano kronično mieloično levkemijo (KML), s prisotnim kromosomom Philadelphia (bcr-abl) (Ph+), pri katerih presaditev kostnega mozga kot zdravljenje prve izbire ne pride v poštev.
aANC < 0.5 x 109/L and/or platelets < 10 x 109/L
aANC < 0,5 x 109/l in/ali koncentracija trombocitov < 10 x 109/l
- Joint pain with swelling.
- bolečine v sklepih z otekanjem.
The required number of tablets should be placed in the appropriate volume of beverage (approximately 50 ml for a 100 mg tablet, and 200 ml for a 400 mg tablet) and stirred with a spoon.
(približno 50 ml za tableto po 100 mg in 200 ml za tableto po 400 mg) in premešati z žlico.
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m2)
Pospešena faza KML in blastna kriza pri pediatričnih bolnikih (začetni odmerek
Exposure to direct sunlight should be avoided or minimised due to the risk of phototoxicity associated with imatinib treatment.
Zdravljenje z imatinibom je lahko povezano s pojavom fototoksičnosti, zato se je treba izogibati izpostavljenosti direktni sončni svetlobi oziroma jo čimbolj omejiti.
In Ph+ ALL patients, there is clinical experience of co-administering imatinib with chemotherapy (see section 5.1), but drug-drug interactions between imatinib and chemotherapy regimens are not well characterised.
obstajajo (glejte poglavje 5.1), pa interakcije med imatinibom in posameznimi kemoterapevtskimi shemami niso dobro opredeljene.
EU/1/13/825/003 24 capsules EU/1/13/825/004 48 capsules EU/1/13/825/019 60 capsules EU/1/13/825/005 96 capsules EU/1/13/825/006 120 capsules EU/1/13/825/007 180 capsules
EU/1/13/825/003 24 kapsul EU/1/13/825/004 48 kapsul EU/1/13/825/019 60 kapsul EU/1/13/825/005 96 kapsul EU/1/13/825/006 120 kapsul EU/1/13/825/007 180 kapsul
Hard capsule of size 3 with light yellow cap and light yellow body imprinted with “50 mg” in black ink.
Trda kapsula velikosti 3 s svetlo rumenim pokrovčkom in svetlo rumenim telesom kapsule s črnim napisom “50 mg”.
(24 h), day 1, Ara-C 1 g/m2 i.v.
(24 ur), 1. dan, Ara-C 1 g/m2 i.v.
In addition, gastric antral vascular ectasia (GAVE), a rare cause of gastrointestinal haemorrhage, has been reported in post-marketing experience in patients with CML, ALL and other diseases (see section 4.8).
Poleg tega so v okviru izkušenj v obdobju trženja zdravila pri bolnikih s KML, ALL in drugimi boleznimi poročali o žilnih ektazijah antruma želodca (GAVE - gastric antral vascular ectasia) redkem vzroku gastrointestinalne krvavitve (glejte poglavje 4.8).
EU/1/13/825/015 10 tablets EU/1/13/825/016 30 tablets EU/1/13/825/017 60 tablets EU/1/13/825/018 90 tablets
EU/1/13/825/015 10 tablet EU/1/13/825/016 30 tablet EU/1/13/825/017 60 tablet EU/1/13/825/018 90 tablet
Active substances that may have their plasma concentration altered by imatinib:
Učinkovine, katerih plazemske koncentracije lahko imatinib spremeni:
Your doctor will tell you exactly how many capsules of Imatinib Actavis to take.
Zdravnik vam bo natančno povedal, koliko kapsul zdravila Imatinib Actavis morate jemati.
If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second in the evening.
Če je vaš dnevni odmerek 800 mg (2 tableti), morate vzeti eno tableto zjutraj in drugo zvečer.
Pack sizes: The capsules are supplied in aluminium blister packs of 30 or 90 capsules.
Kapsule so na voljo v aluminiastih pretisnih omotih, pakiranih po 30 ali 90 kapsul.
However, always take this medicine exactly as your doctor or pharmacist has told you.
Seveda pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
In vivo the compound shows anti-tumour activity as a single agent in animal models using Bcr-Abl positive tumour cells.
In vivo spojina kaže protitumorsko aktivnost, če se uporablja kot edino sredstvo, v živalskih modelih z
Each film-coated tablet contains 0.75 mg lecithin (soya) (E322) For the full list of excipients, see section 6.1.
Ena filmsko obložena tableta vsebuje 0,75 mg sojin lecitin (E322).
Iron oxide yellow (E172) Titanium dioxide (E171) Iron oxide red (E172) Lecithin (soya) (E322) Xanthan gum (E415)
(E171), rdeči železov oksid (E172), sojin lecitin (E322), ksantanski gumi (E415).
In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/kg/day resulted in a statistically significant reduction in the longevity of males at 60 mg/kg/day and females at ≥ 30 mg/kg/day.
60 mg/kg/dan povzročilo statistično značilno skrajšanje življenjske dobe samcev pri 60 mg/kg/dan in samic pri ≥ 30 mg/kg/dan.
Daunorubicin 30 mg/m2 i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8; prednisone 60 mg/m2 oral, days 1-7, 15-21; IDA 9 mg/m2 oral, days 1-28; MTX
VCR skupni odmerek 2 mg i.v., 1., 8., 15., 22. dan; CP 750 mg/m2 i.v., 1., 8. dan; prednizon 60 mg/m2 peroralno, 1.-7., 15.-21. dan; IDA 9 mg/m2 peroralno, 1.-28. dan;
EU/1/13/825/008 10 tablets EU/1/13/825/009 20 tablets EU/1/13/825/010 30 tablets EU/1/13/825/011 60 tablets EU/1/13/825/012 90 tablets EU/1/13/825/013 120 tablets EU/1/13/825/014 180 tablets
EU/1/13/825/008 10 tablet EU/1/13/825/009 20 tablet EU/1/13/825/010 30 tablet EU/1/13/825/011 60 tablet EU/1/13/825/012 90 tablet EU/1/13/825/013 120 tablet EU/1/13/825/014 180 tablet
8 Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
8 Poročali so o nekaj primerih odpovedi jeter in nekroze jeter s smrtnim izidom.
ANC < 1.0 x 109/L and/or platelets < 50 x 109/L
ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/l
Triple IT therapy (age-adjusted): days 1 and 22
zdravljenje (prilagojeno na starost): 8. in 15. dan
Imatinib Actavis 100 mg film-coated tablets Each film-coated tablet contains 100 mg imatinib (as mesilate).
Imatinib Actavis 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
- 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).
- bolečine v medenici, včasih z občutkom slabosti s siljenjem na bruhanje in bruhanjem, z nepričakovano krvavitvijo iz nožnice, omotičnost ali izguba zavesti zaradi nizkega krvnega tlaka (znaki težav z jajčniki ali maternico),
How to take Imatinib Actavis
Kako jemati zdravilo Imatinib Actavis
Caution should be used when taking imatinib with protease inhibitors, azole antifungals, certain macrolides (see section 4.5), CYP3A4 substrates with a narrow therapeutic window (e.g. cyclosporine, pimozide, tacrolimus, sirolimus, ergotamine, diergotamine, fentanyl, alfentanil, terfenadine, bortezomib, docetaxel, quinidine) or warfarin and other coumarin derivatives (see section 4.5).
Previdnost je potrebna pri uporabi imatiniba z zaviralci proteaze, anolnimi antimikotiki, določenimi makrolidi (glejte poglavje 4.5), s substrati CYP3A4 z ozkim terapevtskim oknom (na primer s ciklosporinom, pimozidom, takrolimusom, sirolimusom, ergotaminom, diergotaminom, fentanilom, alfentanilom, terfenadinom, bortezomibom, docetakselom, kinidinom) ali z varfarinom in drugimi derivati kumarina (glejte poglavje 4.5).
EU/1/13/825/020 10 capsules EU/1/13/825/021 30 capsules EU/1/13/825/022 60 capsules EU/1/13/825/023 90 capsules
EU/1/13/825/020 10 kapsul EU/1/13/825/021 30 kapsul EU/1/13/825/022 60 kapsul EU/1/13/825/023 90 kapsul
The dose is 800 mg per day (2 capsules), to be taken as one capsule in the morning and a second capsule in the evening.
Odmerek je 800 mg na dan (2 kapsuli), ki ga vzamete kot eno kapsulo zjutraj in drugo kapsulo zvečer.
If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.
Če je vaš dnevni odmerek 800 mg (8 tablet), morate vzeti 4 tablete zjutraj in 4 tablete zvečer.
Pack sizes: The capsules are supplied in aluminium blister packs of 10, 30, 60, or 90 capsules.
Kapsule so na voljo v aluminiastih pretisnih omotih, pakiranih po 10, 30, 60 ali 90 kapsul.
Imatinib Actavis 50 mg hard capsules Al/PVC/Aclar blister.
Imatinib Actavis 50 mg trde kapsule Pretisni omoti iz Al/PVC/Aclar.
Liver dysfunction
Disfunkcija jeter
(24 h), days 1, 15; 6-MP 25 mg/m2 oral, days 1-20
(24 ur), 1., 15. dan; 6-MP 25 mg/m2 peroralno, 1.-20. dan konsolidacijska terapija II, IV
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.
Zato je pri bolnikih s HES/CEL in bolnikih z velikimi koncentracijami eozinofilcev v povezavi z MDS/MPD pred uporabo imatiniba potrebno razmisliti o pregledu pri specialistu kardiologu, izvedbi ehokardiograma in določitvi serumskega troponina.
Imatinib Actavis 400 mg hard capsules Al/PVC-PVDC blister.
Imatinib Actavis 400 mg trde kapsule Pretisni omoti iz Al/PVC/PVDC.
The adult patients reported in the published literature were treated with either 400 mg (4 cases) or 800 mg (1 case) imatinib daily.
Odrasli bolniki, o katerih so pisali v objavljeni literaturi, so bili zdravljeni z odmerki bodisi 400 mg (v 4 primerih) ali pa 800 mg (v 1 primeru) zdravila Imatinib Actavis na dan. Do odziva je prišlo pri petih (5) bolnikih, pri 3 do popolnega in pri 2 do delnega.