natgillin/translations-raw huggingface dataset:
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
8 Some fatal cases of hepatic failure and of hepatic necrosis have been reported. 
Poročali so o nekaj primerih odpovedi jeter in nekroze jeter s smrtnim izidom.
During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly. 
Če med jemanjem zdravila Imatinib Teva začnete hitro pridobivati telesno maso, takoj obvestite zdravnika.
1200 mg 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. 
Odrasla populacija Odmerki od 1200 mg do 1600 mg (trajanje zdravljenja od 1 do 10 dni): navzea, bruhanje, driska,
This change is not thought to be clinically significant. 
Navedba smiselno ni potrebna.
- If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg: 400 mg to be taken as 1 capsule once a day, 600 mg to be taken as 1 capsule of 400 mg plus 2 capsules of 100 mg once a day. 
- 400 mg vzamete kot 1 kapsulo enkrat na dan, 600 mg vzamete kot 1 kapsulo po 400 mg in še 2 kapsuli po 100 mg enkrat na dan.
Pack sizes of 60 or 120 film-coated tablets in blisters. 
Škatle, ki vsebujejo po 30 ali 90 filmsko obloženih tablet v pretisnem omotu.
monthly for 13 months; Prednisolone 200 mg oral, 5 days per month for 13 months All treatment regimens include administration of steroids for CNS prophylaxis. 
prednizolon 200 mg peroralno, 5 dni na mesec v obdobju 13 mesecev
ARA-C (3 g/m2/dose q 12 h x 4, IV): days 2 and 3 G-CSF (5 μg/kg, SC): days 4-13 or until ANC > 1500 post nadir 
in 3. dan G-CSF (5 μg/kg, s.c.): 4.-13. dan oziroma do ANC > 1500 po doseženem najnižjem številu
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction 
pruritus, edem obraza, suha koža, eritem,
NAME OF THE MEDICINAL PRODUCT Imatinib Teva 400 mg film-coated tablets imatinib 
NAVODILO ZA UPORABO Imatinib Teva 400 mg filmsko obložene tablete imatinib
Clinical studies in chronic myeloid leukaemia 
Za otroke s kronično fazo KML
Daunorubicin 45 mg/m2 i.v., days 6-7, 13-14 
daunorubicin 30 mg/m2 i.v., 1.-3., 15.-16. dan;
bone marrow, peripheral blood basophils < 20%, platelets > 100 x 10 
< 30 %, blasti in promielociti skupaj ≥ 30 % v krvi ali kostnem mozgu (pogoj: blasti < 30 %), bazofilci v periferni krvi ≥ 20 %, trombociti < 100 x 10
Neutropenia, thrombocytopenia, anaemia 
nevtropenija, trombocitopenija, anemija pogosti:
ANC < 0.5 x 10 
Če se pojav/a ANC < 1,0 x
In CML, cytopenias, particularly neutropenia and thrombocytopenia, have been a consistent finding in all studies, with the suggestion of a higher frequency at high doses ≥ 750 mg (phase I study). 
Podatki kažejo, da so lahko citopenije pogostejše pri velikih odmerkih ≥ 750 mg (študija prve faze),
Breast-feeding 
propilenglikol
400 mg to be taken as 4 tablets once a day, 
- 400 mg vzamete kot 4 tablete enkrat na dan, 600 mg vzamete kot 6 tablet enkrat na dan.
Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172) 
(E172), smukec, titanov dioksid (E171), rdeči železov oksid (E172).
Imatinib Teva is also a treatment for adults for: - Myelodysplastic/myeloproliferative diseases (MDS/MPD). 
- z mielodisplastičnimi/mieloproliferativnimi boleznimi (MDS/MPD).
CPM (300 mg/m2/day, IV): days 22-26 
): 3. in 4. dan CPM (250 mg/m
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 200 mg/m2. 
dokler ni ANC ≥ 1 x 109/l in koncentracija trombocitov ≥ 20 x 109/l, nato spet začnite zdravljenje z odmerkom 200 mg/m2.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg of imatinib (as mesilate). 
Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44 
G-CSF (5 μg/kg, s.c.): 27.-36. dan oziroma do ANC > 1500 po doseženem najnižjem številu
Pharmacokinetics in paediatric population 
Posebne skupine bolnikov Uporaba v pediatriji
Hepatic failure8, hepatic necrosis Skin and subcutaneous tissue disorders Very common 
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti:
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 300 mg. 
109/l in/ali koncentracija trombocitov < 50 x 109/l ponovi/ta, ponovite točko 1 in spet začnite zdravljenje z imatinibom z zmanjšanim odmerkom 300 mg.
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir 
): 22.-26. dan G-CSF (5 μg/kg, s.c.):27.-36. dan oziroma do ANC > 1500 po doseženem najnižjem številu
VCR (1.5 mg/m2/day, IV): days 1, 8, and 15 
VCR (1,5 mg/m2/dan, i.v.
MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15 
zdravljenje (prilagojeno na starost): 1. in 15. dan DEX (6 mg/m2/dan, peroralno): 1.-7. dan in 15.-21. dan 2. intenzifikacijski blok metotreksat (5 g/m2 v času 24 ur, i.v.
DEX 10 mg/m2 oral, days 1-5; CP 200 mg/m i.v., days 3, 4, 5; MTX 12 mg intrathecal, day 1 
daunorubicin 30 mg/m2 i.v., 1.-3., 15.-16. dan; VCR skupni odmerek 2 mg i.v., 1., 8., 15., 22. dan; CP 750 mg/m2 i.v., 1., 8. dan;
Ara-C 1,000 mg/m2/12 h i.v. 
ARA-C (3 g/m2, vsakih 12 ur, i.v.
Weight increased 
Preveliko odmerjanje
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 400 mg of imatinib (as mesilate). 
Ena filmsko obložena tableta vsebuje 400 mg imatiniba (v obliki mesilata).
Frequency categories are defined using the following convention: very common 
Splošne težave in spremembe na mestu aplikacije zelo pogosti:
If cytopenia persists for 2 weeks, reduce further to 300 mg. 
Če citopenija traja 2 tedna,
Dyspnoea, epistaxis, cough 
disfagija, pankreatitis redki:
CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4 
): 1. in 2. dan CPM (250 mg/m2/odmerek vsakih 12 ur x 4 odmerki, i.v.
600 mg to be taken as 6 capsules once a day. 
- 400 mg vzamete kot 4 kapsule enkrat na dan, 600 mg vzamete kot 6 kapsul enkrat na dan.
Name and address of the manufacturers responsible for batch release Teva Czech Industries s.r.o. 
Ime in naslov izdelovalca, odgovornega za sproščanje serije
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg of imatinib (as mesilate). 
Ena trda kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema 
draženje očesa, bolečine v očesu, orbitalni edem, krvavitev v beločnico, krvavitev v mrežnico,
Tumour haemorrhage/tumour necrosis* Immune system disorders Not known 
sindrom tumorske lize pogostnost neznana:
Reproductive system and breast disorders Uncommon 
Infekcijske in parazitske bolezni občasni:
Methotrexate (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m2 at hour 36, IV; 15 mg/m2 IV or PO q6h x 6 
): 1. in 15. dan levkovorin (75 mg/m2 36 ur po začetku, i.v.
Cardiac disorders Uncommon 
glivične okužbe pogostnost neznana:
This summary was last updated on 22/04/2013. 
Povzetek je bil nazadnje posodobljen dne 22/04/2013.
In very rare cases they may be serious or fatal. 
V zelo redkih primerih so lahko resni ali smrtno nevarni.
The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxidolor on 22/04/2013. 
Evropska komisija je dovoljenje za promet z zdravilom Meloxidolor, veljavno po vsej Evropski uniji, odobrila dne 22/04/2013.
It must not be used in cats weighing less than 2 kg. 
Zdravilo se ne sme uporabljati pri mačkah, lažjih od 2 kg.
If someone accidentally injects themselves with the medicine, the advice of a doctor should be sought immediately. 
Če si kdo po nesreči injicira to zdravilo, naj se takoj posvetuje z zdravnikom.
For meat the withdrawal period is 15 days and for milk it is five days. 
Za meso je obdobje karence 15 dni, za mleko pa pet dni.
In dogs, these generally occur within the first week of treatment and usually disappear once treatment has stopped. 
Pri psih se ti neželeni učinki v splošnem pojavijo v prvem tednu zdravljenja in po končanem zdravljenju običajno minejo.
For meat the withdrawal period is five days. 
Za meso je obdobje karence pet dni.
The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxidolor has been considered to be bioequivalent to Metacam. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je menil, da je v skladu z zahtevami Evropske unije zdravilo Meloxidolor biološko enakovredno zdravilu Metacam.
As Meloxidolor is considered to be bioequivalent to the reference medicine, its benefit is taken as being the same as that of the reference medicine. 
Ker je zdravilo Meloxidolor biološko enakovredno referenčnemu zdravilu, se njegove koristi obravnavajo kot enake koristim referenčnega zdravila.
Other information about Meloxidolor: 
Druge informacije o zdravilu Meloxidolor:
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxidolor. 
Osebe, ki so preobčutljive za (alergične na) nesteroidna protivnetna zdravila, naj se izogibajo stiku z zdravilom Meloxidolor.