FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of Glivec is 600 mg/day for adult patients with Ph+ ALL.
Slovenian: Priporočeni odmerek zdravila Glivec pri odraslih bolnikih s Ph+ ALL je 600 mg/dan.
English: In the IFN arm, patients were treated with a target dose of IFN of 5 MIU/m 2/day subcutaneously in combination with subcutaneous Ara-C
Slovenian: Na kraku z zdravilom Glivec so bili bolniki zdravljeni s 400 mg na dan. Na kraku z IFN so bili bolniki zdravljeni 10 dni na mesec s tarčnim odmerkom IFN 5 MIU/m2/dan subkutano v kombinaciji s subkutanim Ara-C 20 mg/m2/dan.
English: 9/l and platelets  20 x 10
Slovenian: 9/l in trombociti  20 x 10
English: Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP)
Slovenian: 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)*, psevdoporfirija*
English: What Glivec looks like and contents of the pack Glivec 50 mg capsules are light yellow to orange-yellow and marked “NVR SH”.
Slovenian: Glivec 50 mg kapsule so svetlo rumene do oranžnorumenkaste, označene z “NVR SH”.
English: The recommended dosage of Glivec is 600 mg/day for adult patients in accelerated phase.
Slovenian: Priporočeno odmerjanje zdravila Glivec za odrasle bolnike v pospešeni fazi je 600 mg/dan.
English: 9/l and platelets  75 x 10
Slovenian: 9/l in koncentracija trombocitov  75 x 10
English: 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 one tablet once a day, 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Slovenian: - Če se zdravite zaradi KML: Glede na fazo bolezni je običajni začetni odmerek bodisi 400 mg ali 600 mg: 400 mg vzamete kot eno tableto enkrat na dan 600 mg vzamete kot eno tableto po 400 mg in še 2 tableti po 100 mg enkrat na dan.
English: Glivec 50 mg capsules imatinib
Slovenian: Glivec 50 mg kapsule imatinib
English: In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of Glivec was escalated to 800 mg in patients progressing at the lower daily doses of 400 mg or 600 mg.
Slovenian: V dveh kliničnih študijah (študija B2222 in študija med skupinami S0033) so pri bolnikih, pri katerih je pri manjših odmerkih 400 mg ali 600 mg na dan, bolezen napredovala, zvečali odmerek zdravila Glivec na 800 mg na dan. Odmerek so zvečali na 800 mg na dan pri vsega skupaj 103 bolnikih; po zvečanju odmerka je 6 bolnikov doseglo delni odziv, 21 pa stabilizacijo svoje bolezni, kar je pomenilo celotno klinično koristnost 26 %.
English: Metabolism and nutrition disorders Common:
Slovenian: Presnovne in prehranske motnje pogosti:
English: Glivec 100 mg tablets imatinib
Slovenian: Glivec 100 mg tablete imatinib
English: Glivec 100 mg capsules imatinib
Slovenian: Glivec 100 mg kapsule imatinib
English: MTX 15 mg intrathecal, days 1, 8, 15, 22; Ara-C 40 mg intrathecal, days 1, 8, 15, 22; Methylprednisolone 40 mg intrathecal, days 1, 8, 15, 22
Slovenian: MTX 15 mg intratekalno,1., 8., 15., 22. dan; Ara-C 40 mg intratekalno, 1., 8., 15., 22. dan; metilprednizolon 40 mg intratekalno, 1., 8., 15., 22. dan konsolidacija (novo odkrita Ph+ ALL)
English: Glivec 400 mg film-coated tablets PVDC/alu blisters
Slovenian: Glivec 400 mg filmsko obložene tablete Pretisni omoti iz PVDC/aluminija.
English: Glivec 100 mg film-coated tablets PVC/alu blisters
Slovenian: Glivec 100 mg filmsko obložene tablete Pretisni omoti iz PVC/aluminija.
English: Resume treatment with Glivec at 600 mg. 3.
Slovenian: Glivec z odmerkom 600 mg.
English: Glivec 100 mg hard capsules Capsule content: Cellulose microcrystalline Crospovidone
Slovenian: Glivec 100 mg trde kapsule Vsebina kapsule: mikrokristalna celuloza krospovidon magnezijev stearat brezvodni koloidni silicijev dioksid
English: Glivec 50 mg hard capsules Capsule content: Cellulose microcrystalline Crospovidone
Slovenian: Glivec 50 mg trde kapsule Vsebina kapsule: mikrokristalna celuloza krospovidon magnezijev stearat brezvodni koloidni silicijev dioksid
English: DEX (6 mg/m2/day, PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 1-56 Methotrexate (20 mg/m2/week, PO): days 1, 8, 15, 22, 29, 36, 43, 50
Slovenian: DEX (6 mg/m 2/dan, peroralno): 1.-5. dan in 29.-33. dan 6-MP (75 mg/m 2/dan, peroralno): 1.-56. dan metotreksat (20 mg/m 2/teden, peroralno): 1., 8., 15., 22., 29., 36., 43. in
English: The capsule shell is composed of gelatin, yellow iron oxide (E172) and titanium dioxide (E171).
Slovenian: Ovojnico kapsule sestavljajo želatina, rumeni železov oksid (E172) in titanov dioksid (E171).
English: The capsule shell is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171).
Slovenian: Ovojnico kapsule sestavljajo želatina, rdeči železov oksid (E172), rumeni železov oksid (E172) in titanov dioksid (E171).
English: Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day, depending on how you respond to treatment.
Slovenian: 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.
English: Iron oxide, red (E172) Iron oxide, yellow (E172) Macrogol
Slovenian: Obloga tablete: rdeči železov oksid (E172) rumeni železov oksid (E172) makrogol smukec hipromeloza
English: An observational registry (study L2401) was conducted to collect long-term safety and efficacy data in patients suffering from myeloproliferative neoplasms with PDGFR- β rearrangement and who were treated with Glivec.
Slovenian: Pri bolnikih z mieloproliferativnimi neoplazmami s preureditvijo PDGFR-β, ki so se zdravili z zdravilom Glivec, je bila izvedena opazovalna študija (študija L2401) in sicer uvedba registra za dolgoročno zbiranje podatkov o varnosti in učinkovitosti.
English: 24.6 2/70 vs. 11/67
Slovenian: zmerno v pr. z 11/67
English: Each film-coated tablet contains 100 mg imatinib (as mesilate).
Slovenian: Ena filmsko obložena tableta vsebuje 100 mg imatiniba (v obliki mesilata).
English: 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
Slovenian: ):1., 8. in 15. dan DAUN (45 mg/m 2/dan bolus, i.v.
English: Glivec 100 mg film-coated tablets
Slovenian: Glivec 100 mg filmsko obložene tablete
English: CP 200 mg/m i.v., days 3-5; MTX 15 mg intrathecal, day 1 Induction therapy I DEX 10 mg/m oral, days 1-5;
Slovenian: CP 200 mg/m2 i.v., 3.-5. dan; MTX 15 mg intratekalno, 1. dan indukcijsko zdravljenje I
English: If you are being treated for GIST: The starting dose is 400 mg, to be taken as 8 capsules once a day.
Slovenian: - Če se zdravite zaradi GIST: Začetni odmerek je 400 mg, ki ga vzamete kot 8 kapsul enkrat na dan.
English: If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 8 capsules once a day.
Slovenian: - Če se zdravite zaradi MDS/MPD: Začetni odmerek je 400 mg, ki ga vzamete kot 8 kapsul enkrat na dan.
English: - If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as 6 tablets once a day.
Slovenian: - Če se zdravite zaradi Ph pozitivne ALL: Začetni odmerek je 600 mg, ki ga vzamete kot 6 tablet enkrat na dan.
English: 6-MP 25 mg/m oral, days 1-20
Slovenian: 6-MP 25 mg/m peroralno, 1.-20. dan konsolidacijska terapija II, IV
English: Glivec 400 mg film-coated tablets
Slovenian: Glivec 400 mg filmsko obložene tablete
English: In newly diagnosed chronic phase CML grade 4 neutropenia (ANC < 0.5 x 10
Slovenian: Nevtropenija 3. ali 4. stopnje (ANC  1,0 x 10
English: - 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 4 tablets once a day, 600 mg to be taken as 6 tablets once a day.
Slovenian: - Če se zdravite zaradi KML: Glede na fazo bolezni je običajni začetni odmerek bodisi 400 mg ali 600 mg: 400 mg vzamete kot 4 tablete enkrat na dan 600 mg vzamete kot 6 tablet enkrat na dan.
English: (1 h), days 1-5;
Slovenian: (1 ura), 1.-5. dan;
English: What Glivec looks like and contents of the pack Glivec 100 mg capsules are orange to greyish-orange and marked “NVR SI”.
Slovenian: Glivec 100 mg kapsule so oranžne do sivkastooranžne, označene z “NVR SI”.
English: If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 capsules once a day.
Slovenian: - Če se zdravite zaradi GIST: Začetni odmerek je 400 mg, ki ga vzamete kot 4 kapsule enkrat na dan.
English: In the event of recurrence of ANC < 1.0 x 10
Slovenian: Če se pojav/a ANC  1,0 x 10
English: DEX (6 mg/m2/day PO): days 1-5; 29-33 6-MP (75 mg/m2/day, PO): days 8-28 Methotrexate (20 mg/m2/week, PO): days 8, 15, 22
Slovenian: DEX (6 mg/m 2/dan, peroralno): 1.-5. dan in 29.-33. dan 6-MP (75 mg/m 2/dan, peroralno: 8.-28. dan metotreksat (20 mg/m 2/teden, peroralno):8., 15. in 22. dan
English: If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as 12 capsules once a day.
Slovenian: - Če se zdravite zaradi Ph pozitivne ALL: Začetni odmerek je 600 mg, ki ga vzamete kot 12 kapsul enkrat na dan.
English: The recommended dose of Glivec is 600 mg/day for adult patients in blast crisis.
Slovenian: Priporočeni odmerek zdravila Glivec za odrasle bolnike v blastni krizi je 600 mg/dan.
English: If you are being treated for GIST: The starting dose is 400 mg, to be taken as one tablet once a day.
Slovenian: - Če se zdravite zaradi GIST: Začetni odmerek je 400 mg, ki ga vzamete kot eno tableto enkrat na dan.
English: Each capsule contains 100 mg of imatinib (as mesilate).
Slovenian: Ena kapsula vsebuje 100 mg imatiniba (v obliki mesilata).
English: MTX 15 mg intrathecal, day 1;
Slovenian: MTX 15 mg intratekalno, 1.dan; metilprednizolon 40 mg intratekalno, 1. dan
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželeni učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Iron oxide, red (E172) Shellac
Slovenian: Tiskarska barva: rdeči železov oksid (E172) šelak
English: Uncommon:
Slovenian: nespečnost občasni:
English: Overall hazard ratio (95%CI)*
Slovenian: klasifikacija tveganj velikost tveganja bolnikov št. dogodkov/ št. bolnikov skupno razmerje tveganj (95 % IZ)*
English: - If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 tablets once a day.
Slovenian: - Če se zdravite zaradi GIST: Začetni odmerek je 400 mg, ki ga vzamete kot 4 tablete enkrat na dan.
English: Posology for HES/CEL The recommended dose of Glivec is 100 mg/day for adult patients with HES/CEL.
Slovenian: Priporočeni odmerek zdravila Glivec pri odraslih bolnikih s HES/CEL je 100 mg/dan.
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms (DRESS)*, pseudoporphyria* Musculoskeletal and connective tissue disorders Very common:
Slovenian: sindrom tumorske lize pogostnost neznana: krvavitev iz tumorja/nekroza tumorja* Bolezni imunskega sistema pogostnost neznana: anafilaktični šok* Bolezni krvi in limfatičnega sistema zelo pogosti:
English: The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.
Slovenian: - Če se zdravite zaradi DFSP: Odmerek je 800 mg na dan (8 tablet), ki ga vzamete kot 4 tablete zjutraj in 4 tablete zvečer.
English: - If you are being treated for MDS/MPD: The starting dose is 400 mg to be taken as one tablet once a day.
Slovenian: - Če se zdravite zaradi MDS/MPD: Začetni odmerek je 400 mg, ki ga vzamete kot eno tableto enkrat na dan.
English: Probability of recurrence-free survival
Slovenian: število tveganju izpostavljenih bolnikov : število dogodkov verjetnost preživetja brez ponovitve bolezni
English: Respiratory, thoracic and mediastinal disorders Common:
Slovenian: Bolezni jeter, žolčnika in žolčevodov pogosti:
English: Each capsule contains 50 mg of imatinib (as mesilate).
Slovenian: Ena kapsula vsebuje 50 mg imatiniba (v obliki mesilata).
English: If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 4 capsules once a day.
Slovenian: - Če se zdravite zaradi MDS/MPD: Začetni odmerek je 400 mg, ki ga vzamete kot 4 kapsule enkrat na dan.
English: Intermediate 25.7 4/75 vs. 6/78
Slovenian: zmerno v pr. s 6/78
English: The dose is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.
Slovenian: - Če se zdravite zaradi DFSP: Odmerek je 800 mg na dan (8 kapsul), ki ga vzamete kot 4 kapsule zjutraj in 4 kapsule zvečer.
English: If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as 6 capsules once a day.
Slovenian: - Če se zdravite zaradi Ph pozitivne ALL: Začetni odmerek je 600 mg, ki ga vzamete kot 6 kapsul enkrat na dan.
English: Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain
Slovenian: navzea, driska, bruhanje, dispepsija, bolečine v trebuhu pogosti:
English: Triple IT therapy (age-adjusted): day 1 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
Slovenian: in 3. dan G-CSF (5 μg/kg, s.c.): 4.-13. dan oziroma do ANC > 1500 po doseženem najnižjem številu
English: Total bilirubin: >3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Slovenian: IULN = zgornja meja normalnih vrednosti, specifična za ustanovo
English: If any of these apply to you, tell your doctor before taking Glivec.
Slovenian: Če kaj od zgoraj navedenega velja za vas, se še pred jemanjem zdravila posvetujte s svojim zdravnikom.
English: G-CSF (5 μg/kg, SC): days 5-14 or until ANC > 1500 post nadir Triple IT therapy (age-adjusted): days 1 and 15 DEX (6 mg/m2/day, PO): days 1-7 and 15-21
Slovenian: zdravljenje (prilagojeno na starost): 1. in 15. dan DEX (6 mg/m2/dan, peroralno): 1.-7. dan in 15.-21. dan
English: - If you are being treated for MDS/MPD: The starting dose is 400 mg to be taken as 4 tablets once a day.
Slovenian: - Če se zdravite zaradi MDS/MPD: Začetni odmerek je 400 mg, ki ga vzamete kot 4 tablete enkrat na dan.
English: Each capsule of Glivec contains 50 mg imatinib (as mesilate).
Slovenian: Ena kapsula zdravila Glivec vsebuje 50 mg imatiniba (v obliki mesilata).
English: < 10 x 10
Slovenian: v pr. s 100
English: Each capsule of Glivec contains 100 mg imatinib (as mesilate).
Slovenian: Ena kapsula zdravila Glivec vsebuje 100 mg imatiniba (v obliki mesilata).
English: 20 mg/m 2/day for 10 days/month.
Slovenian: prednizolon 200 mg peroralno, 5 dni na mesec v obdobju 13 mesecev
English: Three patients presented a complete haematological response (CHR) and one patient experienced a partial haematological response (PHR).
Slovenian: Ta študija je vključevala 7 bolnikov z MDS/MPD, ki so bili zdravljeni z odmerkom zdravila Glivec 400 mg na dan. Trije bolniki so dosegli popolni hematološki odziv (CHR), en bolnik pa je dosegel delni hematološki odziv (PHR - partial haematological response).
English: MTX (5 g/m over 24 hours, IV): day 1 Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Slovenian: ): 1. dan levkovorin (75 mg/m2 36 ur po začetku, i.v.
English: (2) Imatinib 36 MO: │││ Censored observations
Slovenian: (2) imatinib 36 mes.
English: Each tablet of Glivec contains 400 mg imatinib (as mesilate).
Slovenian: Ena tableta zdravila Glivec vsebuje 400 mg imatiniba (v obliki mesilata).
English: Iron oxide, red (E172) Iron oxide, yellow (E172) Titanium dioxide (E171)
Slovenian: Ovojnica kapsule: želatina rdeči železov oksid (E172) rumeni železov oksid (E172) titanov dioksid (E171)
English: The dose is 800 mg per day (16 capsules), to be taken as 8 capsules in the morning and 8 capsules in the evening.
Slovenian: - Če se zdravite zaradi DFSP: Odmerek je 800 mg na dan (16 kapsul), ki ga vzamete kot 8 kapsul zjutraj in 8 kapsul zvečer.
English: The recommended dose of Glivec is 400 mg/day for the adjuvant treatment of adult patients following resection of GIST.
Slovenian: Za adjuvantno zdravljenje odraslih bolnikov po resekciji GIST je priporočeni odmerek zdravila Glivec 400 mg na dan.
English: Glivec 100 mg film-coated tablets imatinib
Slovenian: Glivec 100 mg filmsko obložene tablete imatinib
English: Each tablet of Glivec contains 100 mg imatinib (as mesilate).
Slovenian: Ena tableta zdravila Glivec vsebuje 100 mg imatiniba (v obliki mesilata).
English: Iron oxide, yellow (E172) Titanium dioxide (E171)
Slovenian: Ovojnica kapsule: želatina rumeni železov oksid (E172) titanov dioksid (E171)
English: PVC/aluminium blisters
Slovenian: Pretisni omoti iz PVC/aluminija.
English: PVDC/alu blisters Packs containing 60, 120 or 180 film-coated tablets
Slovenian: Škatle, ki vsebujejo po 60, 120 ali 180 filmsko obloženih tablet.
English: Leucovorin (75 mg/m at hour 36, IV; 15 mg/m
Slovenian: ): 1. in 15. dan levkovorin (75 mg/m
English: Glivec 400 mg film-coated tablets imatinib
Slovenian: Glivec 400 mg filmsko obložene tablete imatinib
English: CPM (250 mg/m2/dose q12h x 4 doses, iv): Days 3 and 4 PEG-ASP (2500 IUnits/m2, IM): day 4
Slovenian: CPM (250 mg/m2/odmerek vsakih 12 ur x 4 odmerki, i.v.
English: No overall survival benefit has been observed.
Slovenian: Prav tako niso opažali, da bi zdravljenje izboljšalo celotno preživetje.
English: How to store Glivec
Slovenian: Shranjevanje zdravila Glivec
English: Glivec 100 mg hard capsules imatinib
Slovenian: Glivec 100 mg trde kapsule imatinib
English: 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 8 capsules once a day.
Slovenian: - Če se zdravite zaradi KML: Glede na fazo bolezni je običajni začetni odmerek bodisi 400 mg ali 600 mg: 400 mg vzamete kot 8 kapsul enkrat na dan, 600 mg vzamete kot 12 kapsul enkrat na dan.
English: Induction therapy II CP 1 g/m i.v.
Slovenian: CP 1 g/m i.v.
English: 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 4 capsules once a day.
Slovenian: - Če se zdravite zaradi KML: Glede na fazo bolezni je običajni začetni odmerek bodisi 400 mg ali 600 mg: 400 mg vzamete kot 4 kapsule enkrat na dan, 600 mg vzamete kot 6 kapsul enkrat na dan.
English: 100 vs. 98.7 100 vs. 95.5
Slovenian: v pr. s 95,5
English: During treatment with Glivec, tell your doctor straight away if you put on weight very quickly.
Slovenian: Če med jemanjem zdravila Glivec začnete hitro pridobivati telesno maso, takoj obvestite zdravnika.
English: VP-16 (100 mg/m 2, IV): days 29-33
Slovenian: VP-16 (100 mg/m2/dan, i.v.
English: Cen
Slovenian: N dog cen
English: Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) have been reported in approximately 2.5% of newly diagnosed CML patients taking Glivec.
Slovenian: Pri približno 2,5 % bolnikov z na novo diagnosticirano KML, ki so jemali zdravilo Glivec, so poročali o pojavih hude retence tekočine (plevralni izliv, edemi, pljučni edem, ascites, površinski edem).
English: CPM (300 mg/m2, IV): days 29-33
Slovenian: CPM (300 mg/m2/dan, i.v.
English: 9/l) and thrombocytopenias (platelet count
Slovenian: 9/l) in trombocitopenija (koncentracija trombocitov  50 x 10
English: Confusional state Nervous system disorders Very common:
Slovenian: Bolezni živčevja zelo pogosti:
English: < 50 x 10
Slovenian: 50. dan
English: 29.5 0/86 vs. 2/90
Slovenian: majhno v pr. z 2/90
English: Glivec 50 mg hard capsules imatinib
Slovenian: Glivec 50 mg trde kapsule imatinib
English: Reproductive system and breast disorders Uncommon:
Slovenian: okorelost sklepov in mišic redki:
English: Glivec 100 mg hard capsules
Slovenian: Glivec 50 mg trde kapsule
English:  20 x 10
Slovenian: zelo majhno 20,7
English: • Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (eg.
Slovenian: • občutek slabosti s siljenjem na bruhanje (navzea), zadihanost, neredno bitje srca, moten urin, utrujenost in/ali bolečine v sklepih skupaj z nenormalnimi izvidi laboratorijskih preiskav (na primer z visokimi vrednostmi kalija, sečne kisline in kalcija ter nizko vrednostjo fosforja v krvi),
English: 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
Slovenian: G-CSF (5 μg/kg, s.c.):5.-14. dan oziroma do ANC > 1500 po doseženem najnižjem številu trojno i.t.
English: You may feel dizzy or drowsy or get blurred vision while taking this medicine.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev V času jemanja zdravila Glivec lahko postanete omotični ali zaspani ali se vam zamegli vid.
English: High
Slovenian: Od
English: The application was submitted to the Concerned Member States (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovak Republic, Spain and Sweden) under the mutual recognition procedure.
Slovenian: V skladu s postopkom medsebojnega priznavanja je bila vloga predložena zadevnim državam članicam (Avstrija, Belgija, Češka, Danska, Finska, Francija, Nemčija, Grčija, Madžarska, Islandija, Irska, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Slovaška, Španija in Švedska).
English: Assessment of the data submitted
Slovenian: Vrednotenje predloženih podatkov
English: Frequency and route of administration
Slovenian: Pogostnost in pot uporabe
English: The reason for the anomalous pharmacokinetic profile in this cat is not known.
Slovenian: Vzrok za neobičajni farmakokinetični profil pri tej mački ni znan.
English: Clavudale 50 mg was authorised in the United Kingdom on 08/01/2010 under Article 13(1) of Directive 2001/82/EC.
Slovenian: Zdravilo Clavudale 50 mg je bilo v Združenem kraljestvu odobreno dne 8. januarja 2010 v skladu s členom 13(1) Direktive 2001/82/ES.
English: The proposed standard dose rate is 12.5 mg/kg twice daily for 5-7 days.
Slovenian: Predlagani standardni odmerek je 12,5 mg/kg dvakrat na dan 5-7 dni.
English: • the similarity of the generic and reference product formulations;
Slovenian: • podobnosti formulacij generičnega in referenčnega zdravila;
English: However, the CVMP considered that it was inappropriate to exclude results from a bioequivalence analysis if provision for this had not been made in the study protocol.
Slovenian: Vendar pa je CVMP menil, da je izključevanje rezultatov iz analize biološke enakovrednosti neprimerno, če to ni opredeljeno v protokolu študije.
English: During the procedure, there was disagreement between the Reference Member State and Concerned Member States on the demonstration of bioequivalence in the cat target species.
Slovenian: Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevnimi državami članicami glede dokazovanja biološke enakovrednosti pri ciljni živalski vrsti mačk.
English: The proposed indications are a range of diseases including deep and superficial pyoderma, soft tissue infections, dental infections, urinary tract infections, respiratory disease and enteritis in dogs and cats.
Slovenian: Predlagane indikacije so različne bolezni ter vključujejo globoko in površinsko piodermo, okužbe mehkega tkiva, zobne okužbe, okužbe sečil, dihalno bolezen in enteritis pri psih in mačkah.
English: • the well-known active substances and excipients;
Slovenian: • dobro znanih zdravilnih učinkovin in pomožnih snovi;