natgillin/translations-raw huggingface dataset:
Severe liver toxicity was observed in dogs treated for 2 weeks, with elevated liver enzymes, hepatocellular necrosis, bile duct necrosis, and bile duct hyperplasia.
Pri psih, ki so zdravilo dobivali po 2 tedna, so opazili hudo toksičnost za jetra z zvišanimi jetrnimi encimi, hepatocelularno nekrozo, nekrozo žolčevodov in hiperplazijo žolčevodov.
Imatinib medac 100 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Imatinib medac 100 mg trde kapsule Pretisni omot iz PA-aluminija/PVC/aluminija.
As in adult patients, imatinib was rapidly absorbed after oral administration in paediatric patients in both phase I and phase II studies.
Tako kot pri odraslih bolnikih, se je pri pediatričnih bolnikih v študijah tako prve kot druge faze imatinib po peroralni uporabi hitro absorbiral.
Blast crisis is the most
Blastna kriza je najbolj napredovali stadij te bolezni.
In a study of fertility, in male rats dosed for 70 days prior to mating, testicular and epididymal weights and percent motile sperm were decreased at 60 mg/kg, approximately equal to the maximum clinical dose of 800 mg/day, based on body surface area.
V študiji plodnosti na podganjih samcih, ki so dobivali zdravilo 70 dni pred parjenjem, se je pri odmerku 60 mg/kg, ki je približno enakovreden največjemu kliničnemu odmerku 800 mg/dan, izračunanemu na podlagi telesne površine, zmanjšala masa mod in obmodkov in odstotek gibljivih semenčic.
Days 2 and 3
): 1. in 2. dan
Resume treatment with imatinib at previous dose (i.e. before severe adverse reaction).
Spet začnite zdravljenje z imatinibom s prejšnjim odmerkom (t.j.
When imatinib is combined with high dose chemotherapy regimens, an increase in serious hepatic reactions has been detected.
Pri uporabi imatiniba v kombinaciji z visokoodmernimi kemoterapevtskimi shemami so ugotavljali zvečanje obsega resnih neželenih učinkov na jetrih.
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.
(1 h), days 1-3; i.v., days 1, 8, 15, 21; 2/day oral Consolidation therapy Alternating chemotherapy course: high dose chemotherapy with MTX 1 i.v.
(1 ura), 1.-3. dan; vinkristin 1,3 mg/m² i.v., 1., 8., 15., 21. dan; prednizolon 60 mg/m²/dan peroralno konsolidacijsko zdravljenje izmenična kemoterapija: visokoodmerna kemoterapija z MTX 1 g/m² i.v.
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 NOAEL (odmerek brez opaženih neželenih učinkov).
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 imatinibom 800 mg na dan. Starost bolnikov z DFSP se je gibala med 23 in 75 leti.
Adverse reactions and their frequencies are reported in Table 1.
V preglednici 1 so navedeni neželeni učinki in njihove pogostnosti.
In eleven patients PDGFR gene rearrangements were 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.
The recommended dose of imatinib is 600 mg/day for adult patients with Ph+ ALL.
Priporočeni odmerek imatiniba pri odraslih bolnikih s Ph+ ALL je 600 mg/dan.
(n = 5), 340 mg/m2/day (n = 7) and 570 mg/m 2/day (n = 5).
Bolniki so bili zdravljeni z odmerki imatiniba 260 mg/m²/dan (n = 5), 340 mg/m²/dan (n = 9), 440 mg/m²/dan (n = 7) in 570 mg/m²/dan (n = 5).
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of
• občutek slabosti s siljenjem na bruhanje (navzea) z izgubo apetita, temno obarvan urin, rumena
Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
ginekomastija, erektilna disfunkcija, menoragija, neredne menstrualne krvavitve, motnje spolnih funkcij, boleče bradavice, povečanje dojk, edem redki:
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
zvišana vrednost kreatinina v krvi, zvišana vrednost kreatin-kinaze v krvi, zvišana vrednost laktat-dehidrogenaze v krvi, zvišana vrednost alkalne redki:
Patients with cardiac disease
Srčni bolniki
(24 h), day 4; DEX 40 mg/day on days 1-4 and 11-14, alternated with MTX 1 g/m i.v.
DEX 40 mg/dan 1.-4. in 11.-14. dan, izmenjaje z MTX 1 g/m² i.v.
Imatinib medac 400 mg hard capsules PA-Aluminium/PVC//Aluminium blisters.
Imatinib medac 400 mg trde kapsule Pretisni omot iz PA-aluminija/PVC/aluminija.
There are no controlled trials in paediatric patients with HES/CEL.
Pri pediatričnih bolnikih s HES/CEL niso opravili nobenega kontroliranega preskušanja.
Paediatric accelerated phase CML and blast crisis (starting dose 340 mg/m
pospešena faza KML in blastna kriza pri pediatričnih bolnikih (začetni odmerek 340 mg/m²)
Dose adjustments for neutropenia and thrombocytopenia:
Prilagajanje odmerkov zaradi nevtropenije in trombocitopenije:
i.v., days 1-3, 15-16; VCR 2 mg total dose i.v., days 1, 8, 15, 22;
daunorubicin 30 mg/m² i.v., 1.-3., 15.-16. dan; VCR skupni odmerek 2 mg i.v., 1., 8., 15., 22. dan;
For patients unable to swallow the capsules (e.g. paediatric patients), their content may be dispersed in a glass of still mineral water or apple juice.
pediatričnim bolnikom), lahko njihovo vsebino raztopimo v kozarcu navadne mineralne vode ali jabolčnega soka.
Fluid retention
Retenca tekočine
Isolated cases of imatinib overdose have been reported spontaneously and in the literature.
V literaturi in spontano so poročali o posameznih primerih prevelikega odmerjanja imatiniba.
Imatinib medac contains lactose.
Zdravilo Imatinib medac vsebuje laktozo.
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).
Clinical cases of hypothyroidism have been reported in thyroidectomy patients undergoing levothyroxine replacement during treatment with imatinib (see section 4.5).
Pri bolnikih, ki so med zdravljenjem z imatinibom prejemali nadomestno zdravljenje z levotiroksinom po tiroidektomiji, so poročali o kliničnih primerih hipotiroidizma (glejte poglavje 4.5).
There is limited information on imatinib distribution on human milk.
Podatkov o prehajanju imatiniba v materino mleko pri človeku ni veliko.
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.
Srčne bolnike, bolnike z dejavniki tveganja za srčno popuščanje ali bolnike z anamnezo ledvične odpovedi je potrebno skrbno opazovati.
DEX 10 mg/m oral, days 1-5;
DEX 10 mg/m² peroralno, 1.-5. dan;
Hepatic function should be carefully monitored in circumstances where imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see section 4.5 and 4.8).
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).
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,
Zato je pri uporabi imatiniba skupaj s substrati CYP3A4 z ozko terapevtsko širino (na primer s ciklosporinom, pimozidom, takrolimusom, sirolimusom, z ergotaminom, diergotaminom, s fentanilom, z alfentanilom, s terfenadinom, z bortezomibom, docetaksel in s kinidinom).
In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 10
9/l) in trombocitopenija 4. stopnje (koncentracija bili odkriti nevtropenija 4. stopnje (ANC < 0,5 x 10
Plasma pharmacokinetics
Plazemska farmakokinetika
Musculoskeletal and connective tissue disorders Very common: Muscle spasm and cramps, musculoskeletal pain including myalgia
mišični spazmi in krči, mišično-skeletne bolečine, vključno z mialgijo artralgijo in bolečinami v kosteh pogosti:
ANC = absolute neutrophil count a occurring after at least 1 month of treatment
ANC = absolutno število nevtrofilcev (absolute neutrophil count)
Dizziness, paraesthesia, taste disturbance, hypoaesthesia
vrtoglavost, parestezije, motnje okušanja, hipestezije občasni:
Intensification block 2 (9 weeks)
2. intenzifikacijski blok (9 tednov)
• If you are unable to swallow the capsules, you can open them up and pour the powder into a glass of still mineral water or apple juice.
• Če kapsul ne morete pogoltniti, jih lahko odprete in vsebino zmešate v kozarec navadne
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 imatiniba 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 imatiniba, je treba med zdravljenjem in nekaj mesecev po njegovem zaključku skrbno spremljati pojav znakov in simptomov aktivne okužbe z virusom hepatitisa B (glej poglavje 4.8).
MESNA IV days 29-33
): 29.-33. dan
The age of these patients ranged from newborn to 14 years and imatinib was given at dose 50 mg daily or doses ranging from 400 to 520 mg/m daily.
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 do 520 mg/m na dan.
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) O plevralnem izlivu so pogosteje poročali pri bolnikih z GIST in pri bolnikih s transformacijo KML (kronična mieloična levkemija v pospešeni fazi: KML-AP in kronična mieloična levkemija v blastni krizi: KML-BC) kot pri bolnikih s kroničnim potekom KML.
Intensification block 1 (9 weeks)
1. intenzifikacijski blok (9 tednov)
9/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m
9/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 260 mg/m².
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.
There have been case reports of growth retardation occurring in children and pre-adolescents receiving imatinib.
Pri otrocih in mladostnikih pred puberteto, ki so prejemali imatinib, so poročali o posameznih primerih zaostajanja v rasti.
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.
Pogostejše so pri bolnikih s pospešeno fazo KML ali blastno krizo kot pri bolnikih s kronično fazo KML.
7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
7, spahovanje, melena, ezofagitis, ascites, želodčna razjeda, hematemeza, vnetje ustnice, disfagija,
Five (5) patients with DFSP and PDGFR gene re-arrangements were reported in 3 publications.
V 3 publikacijah so objavljeni podatki petih (5) bolnikov z DFSP s preureditvijo gena za PDGFR.
Remission induction DEX 10 mg/m oral, days 6-7, 13-16; i.v.
indukcija remisije DEX 10 mg/m² peroralno, 6.-7., 13.-16. dan; IDA 8 mg/m² i.v.
When and how to take Imatinib medac • Take Imatinib medac with a meal.
Kdaj in kako jemati zdravilo Imatinib medac
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry
flatulenca, napihnjen trebuh, gastroezofagealni refluks, obstipacija, suha občasni:
The liver was a target organ in rats and dogs.
Pri podganah in psih so bila tarčni organ jetra.
Caution should be taken when administering imatinib with inhibitors of the CYP3A4 family.
Pri uporabi imatiniba z zaviralci družine CYP3A4 je potrebna previdnost.
9/l and platelets ≥ 20 x 10
9/l in trombociti ≥ 20 x 10
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• bolečine v trebuhu ali napihnjen trebuh, vetrovi, zgaga ali zapeka,
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 visokimi koncentracijami eozinofilcev v povezavi z MDS/MPD pred uporabo imatiniba potrebno razmisliti o pregledu pri specialistu kardiologu, izvedbi ehokardiograma in določitvi serumskega troponina.
(0.5 h), days 7, 8, 14, 15; i.v., days 22-25, 29-32
(0,5 ur), 7., 8., 14., 15. dan;
The recommended dose of imatinib is 100 mg/day for patients with HES/CEL.
Priporočeni odmerek imatiniba pri bolnikih s HES/CEL je 100 mg/dan.
Pleural effusion
PRETISNI OMOT
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.
Pri vseh bolnikih je treba upoštevati standardne prakse in postopke za spremljanje in zdravljenje krvavitev, saj sta povečana ožiljenost in nagnjenost h krvavitvam del naravnega in kliničnega poteka GIST.
What Imatinib medac looks like and contents of the pack Imatinib medac 100 mg hard capsules are gelatin capsules of size “3” with orange body and cap. Imatinib medac 400 mg hard capsules are gelatin capsules of size “00” with caramel body and cap. Imatinib medac 100 mg capsules are supplied in packs containing 60 capsules in blisters.
Izgled zdravila Imatinib medac in vsebina pakiranja Imatinib medac 100 mg trde kapsule so želatinske kapsule velikosti ”3” z oranžnim trupom in pokrovčkom.
Do not take Imatinib medac: • if you are allergic to imatinib or any of the other ingredients of this medicine (listed in
• če ste alergični na imatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
(24 h), day 1, and Ara-C 2 g/m i.v.
(24 ur), 1.dan in Ara-C 2 g/m² i.v.
9/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
9/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 400 mg.
The capsule shell for 100 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171) and red iron oxide (E172).
Ovojnico kapsule za 100 mg kapsulo sestavljajo želatina, rumeni železov oksid (E172), titanov dioksid (E171) in rdeči železov oksid (E172).
Based on the available data, no predisposing factors (e.g. tumour size, tumour location, coagulation disorders) have been identified that place patients with GIST at a higher risk of either type of haemorrhage.
velikost tumorja, lokacija tumorja, motnje strjevanja krvi), zaradi katerih bi bili ti bolniki izpostavljeni večjemu tveganju za eno od obeh oblik krvavitve.
Clinical monitoring should be considered when administering imatinib to patients treated with metoprolol.
Pri bolnikih, ki se zdravijo z metoprololom, je treba razmisliti o kliničnem nadzoru, kadar jim damo imatinib.
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia,
trombocitemija, limfopenija, depresija kostnega mozga, eozinofilija,
Consolidation therapy DEX 10 mg/m oral, days 1-5; Vindesine 3 mg/m i.v., day 1;
DEX 10 mg/m² peroralno, 1.-5. dan; vindezin 3 mg/m² i.v., 1. dan;
The capsule shell for 400 mg capsule is composed of gelatine, yellow iron oxide (E172), titanium dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
Ovojnico kapsule za 400 mg kapsulo sestavljajo želatina, rumeni železov oksid (E172), titanov dioksid (E171), rdeči železov oksid (E172) in črni železov oksid (E172).
If any of these apply to you, tell your doctor before taking Imatinib medac.
Če kaj od zgoraj navedenega velja za vas, se še pred jemanjem zdravila Imatinib medac posvetujte s svojim zdravnikom.
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, nonrandomised 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 študijo faze III z oznako I2301 in z zaporednimi kohortami so vključili skupno 93 otrok, mladostnikov in mladih odraslih (starih od 1 do
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 nevtrofilna dermatoza (Sweetov sindrom), sprememba barve nohtov, angionevrotični edem, mehurčkast izpuščaj, multiformni eritem, 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)*
Imatinib medac is also a treatment for adults for:
Zdravilo Imatinib medac je tudi zdravilo za odrasle:
Investigations Very common: Weight increased
Preiskave zelo pogosti: pogosti: občasni:
In the rest of this leaflet, we will use the abbreviations when talking about these diseases.
V nadaljnjem besedilu tega navodila za uporabo so bolezni navedene s kraticami.
9/l and platelets ≥ 75 x 10
9/l in koncentracija trombocitov ≥ 75 x 10
All patients received imatinib and consolidation chemotherapy (see Table 3) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
Ravni transkriptov bcr-abl so bile po 8 tednih v obeh krakih enake.
Five (5) patients with MDS/MPD associated with PDGFR gene re-arrangements were reported in 4 publications.
V 4 publikacijah so objavljeni podatki petih (5) bolnikov z MDS/MPD s preureditvijo gena za PDGFR.
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.
Začetni odmerek je 600 mg, kar vzamete kot 6 kapsul po 100 mg (ali 1 kapsulo po 400 mg in
• Joint pain with swelling.
• bolečine v sklepih z otekanjem.
Partial
Delen
(24 h), day 1; Etoposide 250 mg/m i.v.
(24 ur), 1. dan; etopozid 250 mg/m² i.v.
Imatinib medac 100 mg hard capsules Imatinib medac 400 mg hard capsules
Imatinib medac 100 mg trde kapsule Imatinib medac 400 mg trde kapsule
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).
81 % odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
VCR (1.5 mg/m 2/day, IV): days 1, 8, and 15 DAUN (45 mg/m 2/day bolus, IV): days 1 and 2
): 1., 8. in 15. dan DAUN (45 mg/m 2/dan bolus, i.v.
Total bilirubin: >3-10 ULN AST: any
zmerna celotni bilirubin: > 1,5-3,0 ULN AST: kakršnakoli težka celotni bilirubin: >3-10 ULN AST: kakršnakoli ULN = zgornja meja normalnih vrednosti, specifična za ustanovo AST = aspartat-aminotransferaza
Reinduction block 1 (3 weeks)
1. reindukcijski blok (3 tedne)
Talk to your doctor before taking Imatinib medac:
Ne jemljite zdravila Imatinib medac:
Reinduction block 2 (3 weeks)
2. reindukcijski blok (3 tedne)
Common (may affect up to 1 in 10 people):
Pogosti (lahko prizadene do 1 bolnika od 10 bolnikov):
Skin and subcutaneous tissue disorders Very common: Periorbital oedema, dermatitis/eczema/rash
periorbitalni edemi, dermatitis/ekcem/izpuščaj pogosti:
9/l, repeat step 1 and resume imatinib at reduced dose of 300 mg.
9/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 300 mg.
Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172) Black iron oxide (E172)
Ovojnica kapsule želatina rumeni železov oksid (E172) titanov dioksid (E171) rdeči železov oksid (E172) črni železov oksid (E172)
G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir
G-CSF (5 μg/kg, s.c.): 4.-13. dan oziroma do ANC > 1500 po doseženem najnižjem številu
In the event of recurrence of ANC < 1.0 x 10
Če se pojav/a ANC < 1,0 x 10
VCR (1.5 mg/m 2/day, IV): days 1, 29
VCR (1,5 mg/m 2/dan, i.v.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Zdravilo Imatinib medac vsebuje laktozo monohidrat Če vam je zdravnik povedal, da ne prenašate nekaterih vrst sladkorjev, se obrnite na svojega zdravnika, preden vzamete to zdravilo.
Yellow iron oxide (E172) Titanium dioxide (E171) Red iron oxide (E172)
Ovojnica kapsule želatina rumeni železov oksid (E172) titanov dioksid (E171) rdeči železov oksid (E172)
2/day PO): days 1-5; 29-33 6-MP (75 mg/m 2/day, PO): days 8-28 Methotrexate (20 mg/m 2/week, PO): days 8, 15, 22
): 1. in 29. dan 2/dan, peroralno): 1.-5. dan in 29.-33. dan 2/dan, peroralno): 8.-28. dan 2/teden, peroralno): 8., 15. in 22. dan metotreksat (20 mg/m
The dose is 800 mg per day, to be taken as 1 capsule of 400 mg in the morning and 1 capsule of
• Če se zdravite zaradi DFSP: Odmerek je 800 mg na dan, kar vzamete kot 1 kapsulo po 400 mg zjutraj in 1 kapsulo po
Weight decreased
odpoved jeter
Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
hemoragij) naj bolniki, pri katerih je potrebna antikoagulantna terapija, namesto kumarinskih derivatov, n.pr.
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel
• občutek slabosti s siljenjem na bruhanje (navzea) z drisko, in bruhanjem, bolečine v trebuhu ali povišana telesna temperatura (znaki težav s črevesjem),
However, always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Seveda pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika, farmacevta ali medicinske sestre.
The recommended dose of imatinib is 600 mg/day for adult patients in blast crisis.
Priporočeni odmerek imatiniba za odrasle bolnike v blastni krizi je 600 mg/dan.
Imatinib medac 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Imatinib medac 100 mg trde kapsule Ena trda kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
Marketing Authorisation Holder medac
Imetnik dovoljenja za promet z zdravilom medac
NAME OF THE MEDICINAL PRODUCT Imatinib medac 400 mg hard capsules Imatinib
IME ZDRAVILA Imatinib medac 400 mg trde kapsule imatinib
(1 h), days 1-5; i.v.
): 1.-5. dan 2/dan, i.v.