natgillin/translations-raw huggingface dataset:
The dose is 800 mg per day (2 capsules), to be taken as 1 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 eno kapsulo zvečer.
If your daily dose is 800 mg (2 tablets), you should take one tablet in the morning and a second tablet in the evening.
Če je vaš dnevni odmerek 800 mg (2 tableti), morate vzeti 1 tableto zjutraj in 1 tableto zvečer.
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m2 i.v., days 3-5;
DEX 10 mg/m2 peroralno, 1.-5. dan; CP 200 mg/m2 i.v., 3.-5. dan;
The dose is 800 mg per day (2 tablets), to be taken as 1 tablet in the morning and a second tablet in the evening.
Odmerek je 800 mg na dan (2 tableti), ki ga vzamete kot eno tableto zjutraj in eno tableto zvečer.
Your doctor will tell you exactly how many capsules of Imatinib Teva to take.
Zdravnik vam bo natančno povedal, koliko kapsul zdravila Imatinib Teva morate jemati.
Major cytogenetic response2
Pomemben citogenetični odziv2
diagnosis
ZDRAVILA
Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.
Zdravilo Imatinib Teva 100 mg filmsko obložene tablete je pakirano v škatli po 20x1, 60x1, 120x1 ali 180x1 v perforiranih pretisnih omotih.
Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
plevritična bolečina, pljučna fibroza, pljučna hipertenzija, pljučna krvavitev pogostnost neznana:
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).
% odmerka odstranilo iz telesa v 7 dneh z blatom (68 % odmerka) in urinom (13 % odmerka).
Imatinib Teva 100 mg film-coated tablets Each film-coated tablet contains 100 mg of imatinib (as mesilate).
Imatinib Teva 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
Tumour haemorrhage/tumour necrosis*
krvavitev iz tumorja/nekroza tumorja*
Titanium dioxide (E171) Iron oxide red (E172)
Ovojnine kapsule želatina titanov dioksid (E171) rumeni železov oksid (E172)
Pack sizes of 60 or 120, hard capsules in blisters.
Škatla, ki vsebuje po 60 ali 120, trdih kapsul v pretisnem omotu.
What Imatinib Teva looks like and contents of the pack Imatinib Teva 400 mg hard capsules are non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Zdravilo Imatinib Teva 400 mg trde kapsule so neprozorne oranžne kapsule s črno oznako 7630 na jedru in s črno oznako Teva na pokrovčku kapsule.
The starting dose is 400 mg, to be taken as 4 capsules once a day.
Začetni odmerek je 400 mg, ki ga vzamete kot 4 kapsule enkrat na dan.
Fluid retention and oedema, fatigue
zastajanje tekočine in edemi, utrujenost pogosti:
• Bruising.
• srbenje,
Cytogenetic abnormalities were evaluated in 117 of the total population of 176 patients.
objavljenih opisih primerov in skupinah primerov, je prejemalo imatinib v odmerkih od 75 mg do 800 mg na dan. Citogenetske nepravilnosti so pregledali pri 117 bolnikih od celotne populacije 176 bolnikov.
Imatinib Teva 400 mg film-coated tablets Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Imatinib Teva 400 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 400 mg imatiniba (v obliki mesilata).
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
zmanjšan apetit, dehidracija, protin, hiperurikemija, hiperkalciemija, hiperglikemija, hiponatriemija redki:
The capsule shell is composed of gelatin, titanium dioxide (E171), iron oxide yellow (E172) and iron oxide red (E172).
- Ovojnica kapsule vsebuje želatino, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
Partial
zmedenost
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 400 mg.
Če se pojav/a ANC < 1,0 x 109/l in/ali koncentracija trombocitov < 50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 400 mg.
Paediatric use
Uporaba v pediatriji
Study AUS01 Induction-consolidation therapy
Študija AUS01
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
• bolečine v želodcu z občutkom slabosti s siljenjem na bruhanje (navzea), • mišični spazmi z vročino, rdeče-rjavo obarvan urin, boleče ali oslabele mišice (znaki težav z mišicami),
Imatinib Teva 100 mg hard capsules imatinib
Imatinib Teva 100 mg trde kapsule imatinib
• Chest pain, irregular heart rhythm (signs of heart problems).
1.000 bolnikov): • bolečine v prsnem košu, neredno bitje srca (znaki težav s srcem),
Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6
navzea, driska, bruhanje, dispepsija, bolečine v trebuhu6
What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg hard capsules are non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Zdravilo Imatinib Teva 100 mg trde kapsule so neprozorne oranžne kapsule s črno oznako 7629 na jedru in s črno oznako Teva na pokrovčku kapsule.
Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 60 or 120 film-coated tablets in blisters.
Zdravilo Imatinib Teva 100 mg filmsko obložene tablete je pakirano v škatli po 60 ali 120 filmsko obloženih tablet v pretisnem omotu.
The recommended dosage of Imatinib Teva is 600 mg/day for adult patients in accelerated phase.
Priporočeno odmerjanje zdravila Imatinib Teva za odrasle bolnike v pospešeni fazi je 600 mg/dan.
Imatinib Teva 400 mg hard capsules imatinib
Imatinib Teva 400 mg trde kapsule imatinib
Consolidation (de novo Ph+ ALL)
Indukcijsko zdravljenje (novo odkrita Ph+ ALL)
Iron oxide yellow (E172) Talc
rdeči železov oksid (E172)
doses)iii: days 2, 3, 16, and 17
ali peroralno vsakih 6 ur x 6 odmerkov) iii: 2., 3., 16. in 17. dan trojno i.t.
Imatinib Teva 100 mg hard capsules are available in pack sizes of 60 or 120 hard capsules in blisters.
Zdravilo Imatinib Teva 100 mg trde kapsule je pakirano v škatli po 60 ali 120 trdih kapsul v pretisnem omotu.
This was a population of heavily pretreated patients, as 46% had received prior BMT and 73% a prior multi-agent chemotherapy.
46 % imelo presaditev kostnega mozga (BMT - bone marrow transplantation), 73 % pa kemoterapijo z več zdravili.
Posology for DFSP The recommended dose of Imatinib Teva is 800 mg/day for adult patients with DFSP.
Priporočeni odmerek zdravila Imatinib Teva pri odraslih bolnikih z DFSP je 800 mg/dan.
The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once a day.
Začetni odmerek je 100 mg, ki ga vzamete kot eno tableto po 100 mg enkrat na dan.
Imatinib Teva 400 mg hard capsules are available in pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Zdravilo Imatinib Teva 400 mg trde kapsule je pakirano v škatli po 30x1 ali 90x1 trdih kapsul v perforiranem pretisnem omotu.
Imatinib Teva 100 mg hard capsules Each hard capsule contains 100 mg of imatinib (as mesilate).
Imatinib Teva 100 mg trde kapsule Ena kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
Imatinib Teva 400 mg hard capsules Each hard capsule contains 400 mg of imatinib (as mesilate).
Imatinib Teva 400 mg trde kapsule Ena kapsula vsebuje 400 mg imatiniba (v obliki mesilata).
The starting dose is 400 mg, to be taken as 4 tablets once a day.
Začetni odmerek je 400 mg, ki ga vzamete kot 4 tablete enkrat na dan.
Imatinib Teva 400 mg hard capsules
Imatinib Teva 400 mg trde kapsule
Pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Škatla, ki vsebuje po 20x1, 60x1, 120x1 ali 180x1 trdih kapsul v perforiranem pretisnem omotu.
Imatinib Teva 100 mg hard capsules are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 hard capsules in perforated unit dose blisters.
Zdravilo Imatinib Teva 100 mg trde kapsule je pakirano v škatli po 20x1, 60x1, 120x1 ali 180x1 trdih kapsul v perforiranem pretisnem omotu.
You may become more sensitive to the sun while taking Imatinib Teva.
Med jemanjem zdravila Imatinib Teva lahko postanete občutljivejši na sonce.
The starting dose is 100 mg, to be taken as 1 capsule of 100 mg once a day.
Začetni odmerek je 100 mg, ki ga vzamete kot eno kapsulo po 100 mg enkrat na dan.
EU/1/12/808/001 20 x 1 film-coated tablets EU/1/12/808/002 60 film-coated tablets EU/1/12/808/003 60 x 1 film-coated tablets EU/1/12/808/004 120 film-coated tablets EU/1/12/808/005 120 x 1 film-coated tablets EU/1/12/808/006 180 x 1 film-coated tablets EU/1/12/808/007 20 x 1 film-coated tablets EU/1/12/808/008 60 film-coated tablets EU/1/12/808/009 60 x 1 film-coated tablets EU/1/12/808/010 120 film-coated tablets EU/1/12/808/011 120 x 1 film-coated tablets EU/1/12/808/012 180 x 1 film-coated tablets
EU/1/12/808/001 20x1 filmsko obloženih tablet EU/1/12/808/002 60 filmsko obloženih tablet EU/1/12/808/003 60x1 filmsko obloženih tablet EU/1/12/808/004 120 filmsko obloženih tablet EU/1/12/808/005 120x1 filmsko obloženih tablet EU/1/12/808/006 180x1 filmsko obloženih tablet EU/1/12/808/007 20x1 filmsko obloženih tablet EU/1/12/808/008 60filmsko obloženih tablet EU/1/12/808/009 60x1 filmsko obloženih tablet EU/1/12/808/010 120 filmsko obloženih tablet EU/1/12/808/011 120x1 filmsko obloženih tablet EU/1/12/808/012 180x1 filmsko obloženih tablet
Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30x1or 90x1 film-coated tablets in perforated unit dose blisters.
Zdravilo Imatinib Teva 400 mg filmsko obložene tablete je pakirano v škatli po 30x1 ali 90x1 v perforiranih pretisnih omotih.
EU/1/12/808/013 30 film-coated tablets EU/1/12/808/014 30 x 1 film-coated tablets EU/1/12/808/015 90 film-coated tablets EU/1/12/808/016 90 x 1 film-coated tablets EU/1/12/808/017 30 film-coated tablets EU/1/12/808/018 30 x 1 film-coated tablets EU/1/12/808/019 90 film-coated tablets EU/1/12/808/020 90 x 1 film-coated tablets
EU/1/12/808/013 30 filmsko obloženih tablet EU/1/12/808/014 30x1 filmsko obloženih tablet EU/1/12/808/015 90 filmsko obloženih tablet EU/1/12/808/016 90x1 filmsko obloženih tablet EU/1/12/808/017 30 filmsko obloženih tablet EU/1/12/808/018 30x1 filmsko obloženih tablet EU/1/12/808/019 90 filmsko obloženih tablet EU/1/12/808/020 90x1 filmsko obloženih tablet
Non transparent orange capsules with black marking 7629 on capsule body and black marking TEVA on capsule cap.
Bel do svetlo rumen prašek v oranžnori neprozorni kapsuli, s črno oznako 7629 na jedru in s črno z oznako Teva na pokrovčku kapsule.
If any of these apply to you, tell your doctor before taking Imatinib Teva
Če kaj od zgoraj navedenega velja za vas, se še pred jemanjem zdravila Imatinib Teva posvetujte s svojim zdravnikom.
IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
metotreksat (prilagojen na starost): SAMO 1. dan trojno i.t.
Imatinib Teva 100 mg hard capsules
Imatinib Teva 100 mg trde kapsule
Imatinib Teva 400 mg film-coated tablets are available in pack sizes of 30 or 90 film-coated tablets in blisters.
Zdravilo Imatinib Teva 400 mg filmsko obložene tablete je pakirano v škatli po 30 ali 90 filmsko obloženih tablet v pretisnem omotu.
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
trombocitemija, limfopenija, depresija kostnega mozga, eozinofilija, limfadenopatija redki:
Pack sizes of 30x1 or 90x1 hard capsules in perforated unit dose blisters.
Škatla, ki vsebuje po 30x1 ali 90x1 trdih kapsul v perforiranem pretisnem omotu.
How much Imatinib Teva to take
Koliko zdravila Imatinib Teva jemati Uporaba pri odraslih
• Joint pain with swelling.
• bolečine v sklepih z otekanjem,
Study 0110 37-month data Chronic phase, IFN failure (n=532)
Študija 0110 podatki pri 37 mesecih kronična faza,
Respiratory, thoracic and mediastinal disorders Common
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti:
asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 μM, q6h
oziroma dokler koncentracija MTX ni < 0,1 µM, Gy= Gray
However, always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Seveda pri jemanju tega zdravila natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
Out of the 12 patients enrolled, 9 responded, one completely and 8 partially.
Od 12 vključenih bolnikov je do odziva prišlo pri 9
The starting dose is 100 mg, to be taken as 1 capsule once a day.
Začetni odmerek je 100 mg, ki ga vzamete kot eno kapsulo enkrat na dan.
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• izcedek iz oči s srbenjem, rdečino in otekanjem (vnetje očesne veznice), prekomerno solzenje ali zamegljen vid, • krvavitve iz nosu,
Cycle 5
V 3
See section 4
V 4
(2 h, q 12
(2 uri, na 12 ur),
Imatinib Teva 100 mg film-coated tablets
Imatinib Teva 100 mg filmsko obložene tablete
Imatinib Teva 100 mg film-coated tablets imatinib
Imatinib Teva 100 mg filmsko obložene tablete imatinib
VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
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;
For doses other than 400 mg and 800 mg (see dose recommendation below) a 100 mg hard capsule is available.
Za odmerke razen 400 mg in 800 mg (glejte spodaj navedeno priporočeno odmerjanje) so na voljo
Contents of the pack and other information
Shranjevanje zdravila Imatinib Teva Vsebina pakiranja in dodatne informacije
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• mišični krči ali bolečine v sklepih, mišicah ali kosteh v obdobju, ko se zdravite z zdravilom
- The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow (E172), talc, titanium dioxide (E171) and iron oxide red (E172).
Obloga tablete polivinilalkohol delno hidroliziran makrogol rumeni železov oksid (E172) smukec titanov dioksid (E171)
EU/1/12/808/033 30 hard capsules EU/1/12/808/034 30 x 1 hard capsules EU/1/12/808/035 90 hard capsules EU/1/12/808/036 90 x 1 hard capsules EU/1/12/808/037 30 hard capsules EU/1/12/808/038 30 x 1 hard capsules EU/1/12/808/039 90 hard capsules EU/1/12/808/040 90 x 1 hard capsules
EU/1/12/808/033 30 trdih kapsul EU/1/12/808/034 30x1 trdih kapsul EU/1/12/808/035 90 trdih kapsul EU/1/12/808/036 90x1 trdih kapsul EU/1/12/808/037 30 trdih kapsul EU/1/12/808/038 30x1 trdih kapsul EU/1/12/808/039 90 trdih kapsul EU/1/12/808/040 90x1 trdih kapsul
Non transparent orange capsules with black marking 7630 on capsule body and black marking TEVA on capsule cap.
Bel do svetlo rumen prašek v oranžnočrni neprozorni kapsuli, s črno oznako 7630 na jedru in s črno oznako Teva na pokrovčku kapsule.
- Each film-coated tablet of Imatinib Teva contains 100 mg imatinib (as mesilate).
- Ena filmsko obložena tableta zdravila Imatinib Teva vsebuje 100 mg imatiniba (v obliki mesilata).
Imatinib Teva 400 mg film-coated tablets imatinib
Imatinib Teva 400 mg filmsko obložene tablete imatinib
- Each film-coated tablet of Imatinib Teva contains 400 mg imatinib (as mesilate).
- Ena filmsko obložena tableta zdravila Imatinib Teva vsebuje 400 mg imatiniba (v obliki mesilata).
EU/1/12/808/021 20 x 1 hard capsules EU/1/12/808/022 60 hard capsules EU/1/12/808/023 60 x 1 hard capsules EU/1/12/808/024 120 hard capsules EU/1/12/808/025 120 x 1 hard capsules EU/1/12/808/026 180 x 1 hard capsules EU/1/12/808/027 20 x 1 hard capsules EU/1/12/808/028 60 hard capsules EU/1/12/808/029 60 x 1 hard capsules EU/1/12/808/030 120 hard capsules EU/1/12/808/031 120 x 1 hard capsules EU/1/12/808/032 180 x 1 hard capsules
EU/1/12/808/021 20x1 trdih kapsul EU/1/12/808/022 60 trdih kapsul EU/1/12/808/023 60x1 trdih kapsul EU/1/12/808/024 120 trdih kapsul EU/1/12/808/025 120x1 trdih kapsul EU/1/12/808/026 180x1 trdih kapsul EU/1/12/808/027 20x1 trdih kapsul EU/1/12/808/028 60 trdih kapsul EU/1/12/808/029 60x1 trdih kapsul EU/1/12/808/030 120 trdih kapsul EU/1/12/808/031 120x1 trdih kapsul EU/1/12/808/032 180x1 trdih kapsul
The starting dose is 100 mg, to be taken as 1 tablet once a day.
Začetni odmerek je 100 mg, ki ga vzamete kot eno tableto enkrat na dan.
The recommended dose of Imatinib Teva is 600 mg/day for adult patients in blast crisis.
Priporočeni odmerek zdravila Imatinib Teva za odrasle bolnike v blastni krizi je 600 mg/dan.
Posology for HES/CEL The recommended dose of Imatinib Teva is 100 mg/day for adult patients with HES/CEL.
Priporočeni odmerek zdravila Imatinib Teva pri odraslih bolnikih s HES/CEL je 100 mg/dan.
Renal pain, haematuria, renal failure acute, urinary frequency increased
bolečina v ledvicah, hematurija, akutna odpoved ledvic, pogostejše odvajanje vode pogostnost neznana:
Imatinib Teva 400 mg hard capsules are available in pack sizes of 30 or 90 hard capsules in blisters.
Zdravilo Imatinib Teva 400 mg trde kapsule je pakirano v škatli po 30 ali 90 trdih kapsul v pretisnem omotu.
Imatinib Teva 400 mg film-coated tablets
Imatinib Teva 400 mg filmsko obložene tablete
What Imatinib Teva looks like and contents of the pack Imatinib Teva 400 mg film-coated tablets are dark yellow to brownish orange oblong film-coated tablets with a score line on one side.
Zdravilo Imatinib Teva 400 mg filmsko obložene tablete so temno rumene do rjavkastooranžne, podolgovate filmsko obložene tablete, z zarezo na eni strani ter z oznako “IT” na eni strani zareze in “4” na drugi strani zareze.
9/l.
9/l ne glede na zdravljenje.
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 capsule of 400 mg once a day, depending on how you respond to treatment.
Vaš zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot eno kapsulo po 400 mg enkrat na dan, odvisno od vašega odziva na zdravljenje.
Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Ta študija je vključevala 7 bolnikov z MDS/MPD, ki so bili zdravljeni z odmerkom imatiniba 400 mg na dan. Trije bolniki so dosegli popolni hematološki odziv (CHR), en bolnik pa je dosegel delni hematološki odziv (PHR - partial haematological response).
- Each hard capsule of Imatinib Teva contains 400 mg imatinib (as mesilate).
Ena trda kapsula zdravila Imatinib Teva vsebuje 400 mg imatiniba (v obliki mesilata).
Fungal infection
Indukcijsko zdravljenje
- Each hard capsule of Imatinib Teva contains 100 mg imatinib (as mesilate).
Ena trda kapsula zdravila Imatinib Teva vsebuje 100 mg imatiniba (v obliki mesilata).
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
• Weight gain.
• povečanje telesne mase.
What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg film-coated tablets are dark yellow to brownish orange round film-coated tablets with a score line on one side.
Zdravilo Imatinib Teva 100 mg filmsko obložene tablete so temno rumene do rjavkastooranžne, okrogle filmsko obložene tablete, z zarezo na eni strani ter z oznako “IT” na eni strani zareze in “1” na drugi strani zareze.
Your doctor may decide to increase the dose to 400 mg, to be taken as 1 tablet of 400 mg once a day, depending on how you respond to treatment.
Vaš zdravnik se lahko odloči za zvečanje odmerka na 400 mg, ki ga vzamete kot eno tableto po 400 mg enkrat na dan, odvisno od vašega odziva na zdravljenje.
DEX 10 mg/m2 oral, days 6-7, 13-16; VCR 1 mg i.v., days 7, 14;
DEX 10 mg/m2 peroralno, 6.-7., 13.-16. dan;
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg hard capsules imatinib
NAVODILO ZA UPORABO Imatinib Teva 100 mg trde kapsule imatinib
Crospovidone Magnesium stearate Silica colloidal, anhydrous
Vsebina kapsule manitol krospovidon magnezijev stearat brezvodni koloidni silicijev dioksid
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),
Use in adults
Ženske v rodni dobi
Pharmacokinetics of imatinib
AUC imatiniba.
Rash pustular, contusion, sweating increased, urticaria, ecchymosis,
gnojen izpuščaj, kontuzije, povečano potenje,
In the event of recurrence of ANC < 1.0 x109/l and/or platelets < 50 x 109/l, repeat step 1 and resume imatinib at reduced dose of 260 mg/m2.
109/l in/ali koncentracija trombocitov < 50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 260 mg/m2.
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia,
hipokaliemija, povečan apetit, hipofosfatemija,
Printing ink Shellac
PDGFR protein tirozin kinazami.
The increase in mean AUC with increasing dose was linear and dose proportional in the range of 25-1,000 mg imatinib after oral administration.
Plazemska farmakokinetika Po peroralnem dajanju zdravim prostovoljcem je bil t1/2 približno 18 ur, kar kaže na ustreznost enega odmerka na dan. Zvečevanje povprečne AUC z večanjem odmerka je bilo po peroralnem dajanju linearno in sorazmerno odmerku v območju 25-1000 mg imatiniba.
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg hard capsules imatinib
NAVODILO ZA UPORABO Imatinib Teva 400 mg trde kapsule imatinib
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
stomatitis, razjede ustne sluznice, krvavitev iz prebavil7, spahovanje, melena, ezofagitis, ascites,
• Painful and/or blistering skin lesions.
• boleče spremembe na koži z ali brez nastanka mehurjev,
You may feel dizzy or drowsy or get blurred vision while taking this medicine.
V času jemanja zdravila Imatinib Teva lahko postanete omotični ali zaspani ali se vam zamegli vid.
DAUN (45 mg/m2/day bolus, IV): days 1 and 2
): 1., 8. in 15. dan DAUN (45 mg/m2/dan bolus, i.v.
Chronic phase CML is defined when all of the following criteria are met: blasts < 15% in blood and
Pospešeno fazo opredeljuje eno ali več sledečih meril: blasti v krvi ali kostnem mozgu ≥ 15 %, vendar
Cytogenetic response Major response n (%) [95% CI] Complete CyR n (%)
Citogenetični odziv bolniki s pomembnim odzivom, število (%) [95 % interval zaupanja] bolniki s popolnim citogenetičnim odzivom, število bolniki z delnim citogenetičnim odzivom, število
DEX (6 mg/m2/day PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 8-28
): 1. in 29. dan DEX (6 mg/m2/dan, peroralno): 1.-5. dan in 29.-33. dan 6-MP (75 mg/m2/dan, peroralno: 8.-28. dan metotreksat (20 mg/m2/teden, peroralno):8., 15. in 22. dan VP-16 (100 mg/m2 i.v.
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets imatinib
NAVODILO ZA UPORABO Imatinib Teva 100 mg filmsko obložene tablete imatinib
AST: any
): 4. dan
Three (3) patients with HES and CEL associated with PDGFR gene re-arrangements were reported in 3 publications.
publikacijah so objavljeni podatki treh (3) bolnikov s HES in CEL s preureditvijo gena za PDGFR.
penicillin V) only erythromycin (IC50 50 μM) and fluconazole (IC50 118 μM) showed inhibition of imatinib metabolism which could have clinical relevance.
Od skupine možnih zdravil za sočasno uporabo (paracetamol, aciklovir, alopurinol, amfotericin, citarabin, eritromicin, flukonazol, hidroksisečnina, norfloksacin, penicilin V) sta samo eritromicin (IC50 50 μM) in flukonazol (IC50 118 μM) pokazala inhibicijo presnove imatiniba, ki bi bila lahko klinično pomembna.
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 100 mg film-coated tablets Imatinib Teva 400 mg film-coated tablets
Imatinib Teva 100 mg filmsko obložene tablete Imatinib Teva 400 mg filmsko obložene tablete